subchapter 13b – licensing of hospitals

 

10a ncac 13B .0100       reserved for future codification

Section .0200 – reserved for future codification

 

10A NCAC 13B .0200       Reserved for future codification

section .0300 – reserved for future codification

 

10A NCAC 13B .0300       Reserved for future codification

section .0400 – reserved for future codification

 

10A NCAC 13B .0400       Reserved for future codification

 

section .0500 – reserved for future codification

 

10A NCAC 13B .0500       Reserved for future codification

 

section .0600 – reserved for future codification

 

10A NCAC 13B .0600       Reserved for future codification

 

section .0700 – reserved for future codification

 

10A NCAC 13B .0700       Reserved for future codification

 

section .0800 – reserved for future codification

 

10A NCAC 13B .0800       Reserved for future codification

 

section .0900 – reserved for future codification

 

10A NCAC 13B .0900       Reserved for future codification

 

section .1000 – reserved for future codification

 

10A NCAC 13B .1000       Reserved for future codification

 

section .1100 – reserved for future codification

 

10A NCAC 13B .1100       Reserved for future codification

 

section .1200 – reserved for future codification

 

10A NCAC 13B .1200       Reserved for future codification

 

section .1300 – reserved for future codification

 

10A NCAC 13B .1300       Reserved for future codification

 

section .1400 – reserved for future codification

 

10A NCAC 13B .1400       Reserved for future codification

 

section .1500 – reserved for future codification

 

10A NCAC 13B .1500       Reserved for future codification

 

section .1600 – reserved for future codification

 

10A NCAC 13B .1600       Reserved for future codification

 

section .1700 – reserved for future codification

 

10A NCAC 13B .1700       Reserved for future codification

 

section .1800 – reserved for future codification

 

10A NCAC 13B .1800       Reserved for future codification

 

SECTION .1900 ‑ SUPPLEMENTAL RULES FOR THE LICENSURE OF THE SKILLED: INTERMEDIATE: adult care home BEDS IN A HOSPITAL

 

10A NCAC 13b .1901       SUPPLEMENTAL RULES

When a hospital offers nursing facility or adult care home long‑term care services, the services shall be included under one hospital license as provided in Rule .0201(c).  The general requirements included in this Subchapter shall apply when applicable but in addition the nursing facility care and adult care home care unit must meet the supplemental requirements of this Section.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March 1, 1991.

 

10A NCAC 13b .1902       DEFINITIONS

The following definitions shall apply throughout this Section, unless text otherwise clearly indicates to the contrary:

(1)           "Accident" means something occurring by chance or without intention which has caused physical or mental harm to a patient, resident or employee.

(2)           "Administer" means the direct application of a drug to the body of a patient by injection, inhalation, ingestion or other means.

(3)           "Administrator" means the person who has authority for and is responsible to the governing board for the overall operation of a facility.

(4)           "Brain injury long‑term care" is defined as an interdisciplinary, intensive maintenance program for patients who have incurred brain damage caused by external physical trauma and who have completed a primary course of rehabilitative treatment and have reached a point of no gain or progress for more than three consecutive months.  Services are provided through a medically supervised interdisciplinary process and are directed toward maintaining the individual at the optimal level of physical, cognitive and behavioral functioning.

(5)           "Capacity" means the maximum number of patient or resident beds which the facility is licensed to maintain at any given time.  This number shall be determined as follows:

(a)           Bedrooms shall have minimum square footage of 100 square feet for a single bedroom and 80 square feet per patient or resident in multi‑bedded rooms.  This minimum square footage shall not include space in toilet rooms, washrooms, closets, vestibules, corridors, and built‑in furniture.

(b)           Dining, recreation and common use areas available shall total no less than 25 square feet per bed for skilled nursing and intermediate care beds and no less than 30 square feet per bed for adult care home beds.  Such space must be contiguous to patient and resident bedrooms.

(6)           "Combination Facility" means any hospital with nursing home beds which is licensed to provide more than one level of care such as a combination of intermediate care and/or skilled nursing care and adult care home care.

(7)           "Convalescent Care" means care given for the purpose of assisting the patient or resident to regain health or strength.

(8)           "Department" means the North Carolina Department of Health and Human Services.

(9)           "Director of Nursing" means the nurse who has authority and direct responsibility for all nursing services and nursing care.

(10)         "Dispense" means preparing and packaging a prescription drug or device in a container and labeling the container with information required by state and federal law.  Filling or refilling drug containers with prescription drugs for subsequent use by a patient is "dispensing".  Providing quantities of unit dose prescription drugs for subsequent administration is "dispensing".

(11)         "Drug" means substances:

(a)           recognized in the official United States Pharmacopoeia, official National Formulary, or any supplement to any of them;

(b)           intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;

(c)           intended to affect the structure or any function of the body of man or other animals, i.e., substances other than food; and

(d)           intended for use as a component of any article specified in (a), (b), or (c) of this Subparagraph; but does not include devices or their components, parts, or accessories.

(12)         "Duly Licensed" means holding a current and valid license as required under the General Statues of North Carolina.

(13)         "Existing Facility" means a licensed facility; or a proposed facility, proposed addition to a licensed facility or proposed remodeled licensed facility that will be built according to plans and specifications which have been approved by the department through the preliminary working drawings stage prior to the effective date of this Rule.

(14)         "Exit Conference" means the conference held at the end of a survey, inspection or investigation, but prior to finalizing the same, between the department's representatives who conducted the survey, inspection or investigation and the facility administration representative(s).

(15)         "Incident" means an intentional or unintentional action, occurrence or happening which is likely to cause or lead to physical or mental harm to a patient, resident or employee.

(16)         "Licensed Practical Nurse" means a nurse who is duly licensed as a practical nurse under G.S. 90, Article 9A.

(17)         "Licensee" means the person, firm, partnership, association, corporation or organization to whom a license has been issued.

(18)         "Medication" means drug as defined in (12) of this Rule.

(19)         "New Facility" means a proposed facility, a proposed addition to an existing facility or a proposed remodeled portion of an existing facility that is constructed according to plans and specifications approved by the department subsequent to the effective date of this Rule.  If determined by the department that more than one half of an existing facility is remodeled, the entire existing facility shall be considered a new facility.

(20)         "Nurse Aide" means any individual providing nursing or nursing‑related services to patients in a facility, and is not a licensed health professional, a qualified dietitian or someone who volunteers to provide such services without pay, and who is listed in a nurse aide registry approved by the Department.

(21)         "Nurse Aide Trainee" means an individual who has not completed an approved nurse aide training course and competency evaluation and is demonstrating knowledge, while performing tasks for which they have been found proficient by an instructor. These tasks shall be performed under the direct supervision of a registered nurse. The term does not apply to volunteers.

(22)         "Nursing Facility" means that portion of a nursing home certified under Title XIX of the Social Security Act (Medicaid) as in compliance with federal program standards for nursing facilities.  It is often used as synonymous with the term "nursing home" which is the usual prerequisite level for state licensure for nursing facility (NF) certification and Medicare skilled nursing facility (SNF) certification.

(23)         "Nurse in Charge" means the nurse to whom duties for a specified number of patients and staff for a specified period of time have been delegated, such as for Unit A on the 7‑3 or 3‑11 shift.

(24)         "On Duty" means personnel who are awake, dressed, responsive to patient needs and physically present in the facility performing assigned duties.

(25)         "Patient" means any person admitted for care to a skilled nursing or intermediate care facility.

(26)         "Physician" means a person licensed under G.S. Chapter 90, Article 1 to practice medicine in North Carolina.

(27)         "Qualified Dietitian" means a person who meets the standards and qualifications established by the Committee on Professional Registration of the American Dietetic Association included in "Standards of Practice" seven dollars and twenty-five cents ($7.25) or "Code of Ethics for the Profession of Dietetics" two dollars and fifteen cents ($2.15), American Dietetic Association, 216 W. Jackson Blvd., Chicago, IL 60606‑6995.

(28)         "Registered Nurse" means a nurse who is duly licensed as a registered nurse under G.S. 90, Article 9A.

(29)         "Resident" means any person admitted for care to an adult care home.

(30)         "Sitter" means an individual employed to provide companionship and social interaction to a particular resident or patient, usually on a private duty basis.

(31)         "Supervisor‑in‑Charge" means a duly licensed nurse to whom supervisory duties have been delegated by the Director of Nursing.

(32)         "Ventilator dependence" means physiological dependency by a patient on the use of a ventilator for more than eight hours a day.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire on February 28, 1991;

Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. February 1, 1993; December 1, 1991; March 1, 1991; March 1, 1990.

 

10A NCAC 13B .1903       INSPECTIONS

(a)  Any hospital with beds licensed by the Department under Section .1900 of these Rules may be inspected by one or more authorized representatives of the Department at any time.  Generally, inspections will be conducted between the hours of 8:00 a.m. and 6:00 p.m., Monday through Friday.  However, complaint investigations shall be conducted at the most appropriate time for investigating allegations of the complaint.

(b)  At the time of inspection, any authorized representative of the Department shall make his presence known to the administrator or other person in charge who shall cooperate with such representative and facilitate the inspection.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March 1, 1991; March 1, 1990.

 

10A NCAC 13B .1904       PROCEDURE FOR APPEAL

A hospital with nursing facility or adult care home beds may appeal any decision of the Department to deny, revoke or alter a license by making such an appeal in accordance with G.S. Chapter 150B.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire

on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March 1, 1991; March 1, 1990.

 

10A NCAC 13B .1905       ADMISSIONS

(a)  No patient shall be admitted except under the orders of a duly licensed physician.

(b)  The facility shall acquire prior to or at the time of admission orders from the attending physician for the immediate care of the patient or resident.

(c)  Within 48 hours of admission, the facility shall acquire medical information which shall include current medical findings, diagnosis, rehabilitation potential, a summary of the hospital stay if the patient is being transferred from a hospital, and orders for the ongoing care of the patient.

(d)  If a patient is admitted from somewhere other than a hospital, a physical examination shall be performed either within 5 days prior to admission or within 48 hours following admission.

(e)  Hospitals offering nursing facility or domiciliary home care as a new service must prepare a plan of admission which, at a minimum, assures availability of staff time and plans for individual patient assessments, initiation of health care or nursing care plans, and implementation of physician and nursing treatment plans.  This plan must be available for inspection during the initial licensure survey prior to issuance of a license.

(f)  Only persons who are 18 years of age or older shall be admitted to adult care home beds in a facility.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire

on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March 1, 1991; March 1, 1990.

 

10A NCAC 13B .1906       POLICIES AND PROCEDURES

The governing board shall assure written policies and procedures which are available to and implemented by staff.  These policies and procedures shall cover at least the following areas:

(1)           admissions;

(2)           dietary;

(3)           discharges with physician orders and patients or residents leaving against physician advice;

(4)           gratuities and solicitation which at a minimum shall provide that no owner, operator, agent or employee of a facility nor any member of his family shall accept a gratuity directly or indirectly from an patient or resident in the facility or solicit for any type of contribution;

(5)           housekeeping;

(6)           infection control which must include, but shall not be limited to, requirements for sterile, aseptic and isolation techniques; and communicable disease screening including, at a minimum, annual tuberculosis screening for all staff and inpatients of the facility;

(7)           maintenance of patient medical or health care records including charging or record keeping;

(8)           orientation of all facility personnel;

(9)           patient or resident care plans, treatment and other health care or nursing care, including but not limited to all policies and procedures required by rules contained in this Subchapter;

(10)         patients' or residents' rights;

(11)         physical evaluation for residents and patients at least annually;

(12)         physician services and utilization of the individual's private physician;

(13)         procurement of supplies and equipment to meet individual patient care needs;

(14)         protection of patients from abuse and neglect;

(15)         range of services provided;

(16)         recording and reporting to the department of accidents or incidents occurring to patients in any part of the facility and maintenance of such reports or records;

(17)         rehabilitation services;

(18)         release of medical record information;

(19)         screening and reporting communicable disease to the local health department; and

(20)         transfers.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. March 1, 1990.

 

10A NCAC 13B .1907       GENERAL

The governing board shall assure that policies and procedures are available and implemented for assessing each patient's or resident's health care needs and planning for meeting identified health care needs.  There shall be a system for evaluating the effectiveness of the assessment, planning and implementation (delivery of care processes) for each patient or resident.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1908       FREQUENCY: METHOD AND CONTENT OF ASSESSMENT: PLANNING

Each patient's and resident's condition must be assessed on a regular, periodic basis, at least quarterly, with appropriate notation and updating of the health care plan.  Health care planning for each patient and resident shall be an on‑going process and must include, but shall not be limited to, the following:

(1)           data which is systematically and continuously collected about his or her health status; the data shall be recorded so as to be accessible and communicated to all staff involved in the patient's or resident's care;

(2)           current problems or needs identified and prioritized from a completed assessment relevant to the patient's or resident's response to aging, illness and general health status; and

(3)           a current plan of care developed in conjunction with the patient or resident or legal guardian that includes measurable time related goals and approaches, or measures to be employed by various disciplines in order to achieve the identified goals.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. March 1, 1990.

 

10A NCAC 13B .1909       IMPLEMENTATION OF HEALTH PLAN

All parts of the plan of care shall be assigned to specific disciplines or staff as indicated in the plan of care to assure that health care and rehabilitative services are performed daily and documented for those patients and residents who require such services.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1910       NURSING/HEALTH CARE ADMINISTRATION AND SUPERVISION

(a)  A licensed facility shall have a director of nursing service who shall be responsible for the overall organization and management of all nursing services and shall be currently licensed to practice as a registered nurse by the North Carolina Board of Nursing in accordance with G.S. 90, Article 9A.

(b)  The Director of Nursing shall not serve as administrator or assistant administrator.

(c)  A licensed facility with nursing facilities shall provide a full‑time director of nursing on duty at least eight hours per day, five days a week.  A registered nurse shall relieve the Director of Nursing (be in charge of nursing) during the Director's absence.

(d)  A licensed facility shall employ and assign registered nurses, licensed practical nurses, nurse aides and nurse aide trainees for duties in accordance with G.S. 90, Article 9A.

(e)  The Director of Nursing shall cause the following to be accomplished:

(1)           establishment and implementation of nursing policies and procedures which shall include, but shall not be limited to the following:

(A)          assessment of and planning for patients' nursing care or health care needs, and implementation of nursing or health care plans;

(B)          daily charting of any unusual occurrences or acute episodes related to patient care, and progress notes written monthly reporting each patient's performance in accordance with identified goals and objectives and each patient's progress toward rehabilitative nursing goals;

(C)          assurance of the delivery of nursing services in accordance with physicians' orders, nursing care plans and the facility's policies and procedures;

(D)          notification of emergency physicians or on‑call physicians;

(E)           infection control to prevent cross‑infection among patients and staff;

(F)           reporting of deaths;

(G)          emergency reporting of fire, patient and staff accidents or incidents, or other emergency situations;

(H)          use of protective devices or restraints to assure that each patient or resident is restrained in accordance with physician orders and the facility's policies, and that the restrained patient or resident is appropriately evaluated and released at a minimum of every two hours;

(I)            special skin care and decubiti care;

(J)            bowel and bladder training;

(K)          maintenance of proper body alignment and restorative nursing care;

(L)           supervision of and assisting patients with feeding;

(M)         intake and output observation and reporting for those patients whose condition warrants monitoring of their fluid balance.  This will include those patients on intravenous fluids or tube feedings, and patients with kidney failure and temperatures elevated to 102 degrees Fahrenheit or above;

(N)          catheter care; and

(O)          procedures used in caring for patients in the facility;

(2)           development of written job descriptions for nursing personnel;

(3)           periodic assessment of the nursing department with identification of personnel requirements as they relate to patient care needs and reporting same to the administrator;

(4)           a planned orientation and continuing inservice education program for nursing employees and documentation of staff attendance and subject matter covered during inservice education programs;

(5)           provision of appropriate reference materials for the nursing department, which includes a Physician's Desk Reference or comparable drug reference, policy and procedure manual, and medical dictionary for each nursing station; and

(6)           establishment of operational procedures to assure that appropriate supplies and equipment are available to nursing staff as determined by individual patient care needs.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March 1, 1991; March 1, 1990.

10A NCAC 13B .1911       VACANT DIRECTOR OF NURSING POSITION

(a)  The administrator shall notify the Department within 72 hours when the director of nursing position becomes vacant and shall provide the name and license number of the individual who is acting director or the replacement for the director of nursing.

(b)  A facility shall not operate without either a director of nursing or acting director or nursing.

(c)  The administrator shall employ a director of nursing within 30 days after a position becomes vacant.  A vacancy which exceeds 30 days shall be reviewed by the Department for action relative to licensure status of the facility.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. March 1, 1990.

 

10A NCAC 13B .1912       NURSE STAFFING REQUIREMENTS

(a)  A licensed facility shall provide licensed nursing personnel sufficient to accomplish the following:

(1)           patient needs assessment,

(2)           patient care planning, and

(3)           supervisory functions in accordance with the level of patient or resident care advertised or offered by the facility.

The facility also shall provide other nursing personnel sufficient to assure that at least activities of daily living, personal grooming, restorative nursing actions and other health care needs as identified in each patient's or resident's plan of care are met.

(b)  A licensed multi‑storied facility (one having more than one story) shall provide at least one person on duty on each patient care floor at all times.

(c)  Daily direct patient care nursing staff, licensed and unlicensed, shall equal or exceed 2.1 nursing hours per patient.  (This is sometimes referred to as nursing hours per patient day or NHPPD or NH/PD.)

(1)           Inclusive in these figures is the requirement that at least one licensed nurse is on duty for direct patient care at all time; and

(2)           Nursing care shall include the services of a registered nurse for at least eight consecutive hours a day, seven days a week.  This coverage can be spread over more than one shift if such a need exists.  The Director of Nursing may be counted as meeting the requirements for both the Director of Nursing and patient and resident care staffing for facilities of a total census of 60 beds or less.

(d)  Nursing support personnel including ward clerks, secretaries, nurse educators and persons in primarily administrative management positions and not actively involved in direct patient care shall not be counted toward compliance with minimum daily requirements for direct care staffing.

(e)  All exceptions to meeting minimum staffing requirements shall be reported to the Department at the end of each month.  Staffing waivers granted by the federal government for Medicare and Medicaid certified beds shall be accepted for licensure purposes.

(f)  The ratio of male to female nurse aides will be determined by the needs of the patients, particularly the numbers of male patients requiring assistance with personal care.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (b)(4)(C);

Eff. February 1, 1986;

Amended Eff. March 1, 1991; March 1, 1990.

 

10A NCAC 13B .1913       reserved for future codification

 

10a NCAC 13B .1914       reserved for future codification

 

10A NCAC 13B .1915       adult care HOME PERSONNEL REQUIREMENTS

(a)  The administrator shall designate a person to be in charge of the adult care home residents at all times.  The nurse in charge of nursing services may also serve as supervisor‑in‑charge of the adult care home beds.

(b)  If adult care home beds are located in a separate building or a separate level of the same building, there must be a person on duty in the adult care home areas at all times.

(c)  A licensed facility shall provide sufficient staff to assure that activities of daily living, personal grooming, and assistance with eating are provided to each resident.  Medication administration as indicated by each resident's condition or physician's orders shall be carried out as identified in each resident's plan of care.

(d)  Adult care home facilities (Home for the Aged beds) licensed as a part of a combination facility shall comply with the staffing requirements of 10 NCAC 42D .1407 as adopted by the Social Services Commission for freestanding adult care homes.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March 1, 1991.

 

10A NCAC 13B .1916       REHABILITATIVE NURSING AND DECUBITUS CARE

Each patient or resident shall be given care to prevent contractures, deformities, and decubiti, including but not limited to:

(1)           changing positions of bedfast and chairfast patients or residents every two hours and administering simple preventive care.  Documentation of such care and outcome must be included in routine summaries or progress notes;

(2)           maintaining proper alignment and joint movement to prevent contractures and deformities, which must be documented in routine summaries or progress notes;

(3)           implementing an individualized bowel and bladder training program except for patients or residents whose records are documented that such training is not effective.  A monthly summary for patients and quarterly summaries for domiciliary residents shall be written relative to each patient's or resident's performance in the bowel and bladder training program; and

(4)           such other services as necessary to meet the needs of the patient.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March 1, 1991; March 1, 1990.

 

10A NCAC 13B .1917       MEDICATION ADMINISTRATION

(a)  A licensed facility shall have policies and procedures governing the administration of medications which shall be enforced and implemented by administration and staff.  Policies and procedures shall include, but shall not be limited to:

(1)           automatic stop orders for treatment and drugs;

(2)           accountability of controlled substances as defined by the North Carolina Controlled Substances Act, G.S. 90, Article 5;

(3)           dispensing and administering behavior modifying drugs, such as hypnotics, sedatives, tranquilizers, antidepressants and other psychotherapeutic agents; insulin; intravenous fluids and medications; cardiovascular regulating drugs; and antibiotics.

(b)  All medications or drugs and treatments shall be administered and discontinued in accordance with signed physician's orders which are recorded in the patient's or resident's medical record.

(1)           Only physicians, registered nurses, licensed practical nurses or physician assistants, if in accordance with the assistant's approved practice, shall administer medications.

(2)           To ensure accountability, any medication shall be administered by the same licensed personnel who prepared the dose for administration.  This Rule does not apply to the dispensing of medications from a pharmacy utilizing a unit of use drug delivery system.

(3)           Medications shall be administered within a half hour prior to or half hour after the prescribed time for administration unless precluded by emergency situations.

(4)           The person administering medications shall identify each patient or resident in accordance with the facility's policies and procedures prior to administering any medication.

(5)           Medication administered to a patient or resident shall be recorded in the patient's or resident's medication administration record immediately after administration in accordance with the facility's policies and procedures.

(6)           Omission of medication and the reason for the omission shall be indicated in the patient's or resident's medical record.

(7)           The person administering medications which are ordered to be given as needed (PRN) shall justify the need for the same in the patient's or resident's medical record.

(8)           Medication administration records shall provide identification of the drug and strength of drug, quantity of drug administered, name of administering employee, title of employee and time of administration.

(c)  Self‑administration of medications shall be permitted only if prescribed by a physician and directions are printed on the container.

(d)  The administration of one patient's or resident's medications to another patient or resident is prohibited except in the case of an emergency.  In the event of such an emergency, steps shall be taken to assure that the borrowed medications shall be replaced promptly and so documented.

(e)  Verbal orders shall be countersigned by a physician within five days of issuance.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. December 1, 1991; March 1, 1990.

 

10A NCAC 13B .1918       TRAINING

(a)  A licensed facility shall provide for all patient or resident care employees a planned orientation and continuing education program emphasizing patient or resident assessment and planning, activities of daily living, personal grooming, rehabilitative nursing or restorative care, other patient or resident care policies and procedures, patients' rights, and staff performance expectations.  Attendance and subject matter covered shall be documented for each session and available for licensure inspections.

(b)  The administrator shall assure that each employee is oriented within the first week of employment to the facility's philosophy and goals.

(c)  Each employee shall have specific on‑the‑job training as necessary for the employee to properly perform his individual job assignment.

(d)  Unless otherwise prohibited, a nurse aide trainee may be employed to perform the duties of a nurse aide for a period of time not to exceed four months.  During this period of time the nurse aide trainee shall be permitted to perform only those tasks for which minimum acceptable competence has been demonstrated and documented on a skills check‑off record.  Job applicants for nurse aide positions who were formerly qualified nurse aides but have not been gainfully employed as such for a period of 24 consecutive months or more shall be employed only as nurse aide trainees and must re‑qualify as nurse aides within four months of hire by successfully passing an approved competency evaluation.  Any individual, nursing home, or education facility may offer Department approved vocational education for nursing home nurse aides.  An accurate record of nurse aide qualifications shall be maintained for each nurse aide used by a facility and shall be retained in the general personnel files of the facility.

(e)  The curriculum content required for nurse aide education programs shall be subject to approval by the Division of Health Service Regulation and shall include, as a minimum, basic nursing skills, personal care skills, cognitive, behavioral and social care, basic restorative services, and patients' rights.  Successful course completion shall be determined by passing a competency evaluation test.  The minimum number of course hours shall be 75 of which at least 20 hours shall be classroom and at least 40 hours of supervised practical experience.  The initial orientation to the facility shall be exclusive of the 75 hour training program.  Competency evaluation shall be conducted in each of the following areas:

(1)           Observation and documentation,

(2)           Basic nursing skills,

(3)           Personal care skills,

(4)           Mental health and social service needs,

(5)           Basic restorative services,

(6)           Residents' Rights.

(f)  Successful course completion and skill competency shall be determined by competency evaluation approved by the Department.  Commencing July 1, 1989, nurse aides who had formerly been fully qualified under nurse aide training requirements may re‑establish their qualifications by successfully passing a competency evaluation test.

 

History Note:        Filed as a Temporary Rule Eff. October 1, 1990 For a Period of 142 Days to Expire on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (b)(5);

Eff. February 1, 1986;

Amended Eff. March 1, 1991; March 1, 1990.

 

10A NCAC 13B .1919       DENTAL CARE

(a)  A dental examination shall be performed at the time of admission with the following information being placed in the patient's or resident's medical or health care record:

(1)           type of diet which the patient or resident can best manage (such as normal, soft or pureed);

(2)           the presence of infection of gums, teeth, or jaws;

(3)           brief descriptions of any removable dental appliances and a statement of their condition; and

(4)           indications for dental treatment at the time of admission.

(b)  Names of dentists who have agreed to render emergency dental care shall be maintained at each nursing station and at the supervisor's station in a adult care home.

(c)  Staff of the facility shall ensure that:

(1)           necessary daily dental care is provided;

(2)           each patient or resident possesses appropriate toothbrushes and is encouraged and, when necessary, assisted in their use; and

(3)           each patient or resident having a removable denture is furnished a receptacle in which to immerse the denture in water overnight.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. March 1, 1990.

 

10A NCAC 13B .1920       AVAILABILITY OF PHARMACEUTICAL SERVICES

(a)  A licensed facility shall provide pharmaceutical services under the supervision of a pharmacist currently licensed to practice pharmacy in North Carolina.

(b)  A facility shall be responsible for obtaining drugs, therapeutic nutrients and related products prescribed or ordered by a physician for patients or residents in the facility.

(c)  Services shall include documented on‑site pharmaceutical reviews accomplished at least every 31 calendar days for all patients and residents.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1921       DINING FACILITIES

Patients, including wheelchair patients, shall be encouraged to eat at the tables in the dining area and shall be assisted when necessary by non‑dietary staff.  An overbed table shall be provided for patients who eat in bed.  A sturdy tray stand shall be provided for those patients who eat out of bed but are unable to go to the dining area.  An overbed table which can be lowered to chair height may substitute for the tray stand.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1922       ACTIVITIES AND RECREATION

(a)  The administrator shall designate an activities and recreation director to be in charge of activities and recreation for all patients and residents.  The activities and recreation director shall have training and experience in directing recreational and group activities.  The designated activities and recreation director shall be under the supervision of the administrator and shall be qualified to meet the needs of the patients and residents.  A qualified individual shall be anyone eligible for a N.C. license as an occupational therapist or assistant therapist under G.S. 90‑270; anyone eligible for N.C. certification as a recreation therapist or assistant therapist under G.S. 90C‑9; anyone with a baccalaureate degree and one year experience; anyone who has completed an approved 36‑hour or longer course in activities program management; or anyone not otherwise qualified but receiving at least four hours consultation per month from one who is qualified.

(b)  The facility shall maintain and make available a listing of local resources for activities and recreation to be utilized in meeting the needs and interests of all patients and residents.

(c)  Restoration to self care and resumption of normal activity shall be one of the main goals of the recreation or activity program.  The scope of the activity program shall include:

(1)           social activities involving individual and group participation which are designed to promote group relationships;

(2)           recreational activities, both indoor and outdoor;

(3)           opportunity to participate in activities outside the facility;

(4)           religious programs, including the right of each patient and resident to attend the church or religious program of his choice;

(5)           creative and expressive activities;

(6)           educational activities; and

(7)           exercise.

(d)  The facility shall have written policies and procedures which are available and implemented by staff that:

(1)           attempt to prevent the further mental or physical deterioration for those patients or residents who cannot realistically resume normal activities;

(2)           assure opportunities for patient involvement, both individual and group, in both planning and implementing the activity program;

(3)           provide patients or residents the opportunity for choice among a variety of activities; and

(4)           encourage participation by each patient or resident in social and recreational activities according to individual need and abilities and desires unless the patient's or resident's record contains documentation that he is unable to participate.

(e)  Each patient's or resident's activity plan shall be a part of his overall plan of care and shall contain documentation of periodic assessments of the individual's activity needs and interests.  A record of activities and individuals participating shall be maintained in the facility.

(f)  A licensed facility shall display a monthly activities calendar which includes variety to appeal to different interest groups in the nursing care and adult care home services.

(g)  A licensed facility shall provide:

(1)           Space for recreational and diversional activities.  In hospitals offering new nursing home services, space shall be provided separately from the main living and dining areas; however, these areas may also be used for social activities.

(2)           Designated indoor and outdoor activity areas for independent and group needs of patients and residents, and which are:

(A)          accessible to wheelchair and ambulatory patients; and

(B)          of sufficient size to accommodate necessary equipment and permit unobstructed movement of wheelchair and ambulatory patients or personnel responsible for instruction and supervision.

(3)           Adequate space to store equipment and supplies without blocking exists or otherwise threatening the health and safety of patients and residents.

(h)  There shall be equipment and supplies sufficient to carry out planned programs for both individual and group activities.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire on February 1, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March 1, 1991; March 1, 1990.

 

10A NCAC 13B .1923       SOCIAL SERVICES

(a)  The administrator shall designate an employee to be responsible for the provision of social services.  This person shall be known as the social services director.  Subsequent to the effective date of the rules contained in this Subchapter any newly designated person must be a graduate of a four year college or university with one year's experience in the health care or long‑term care field or have an equivalent combination of education and experience.  An equivalent combination of education and experience means the number of years of education leading to a baccalaureate or associate degree plus the number of years of long‑term nursing facility experience equal to five years; or eligible for certification as a social worker pursuant to G.S. 90B‑7.  The social services director shall have authority to carry out provisions contained in Rule .1923(b) of this Section.

(b)  Each patient's or resident's plan of care shall contain a written plan for meeting his individual social needs and involving his active participation, the plan shall provide for:

(1)           needed assistance in meeting the patient's or resident's physical, social and emotional needs through consultation with the patient or resident or his legal guardian, and relative, physician or others;

(2)           assisting the patient or resident in adjusting to his environment, for referral to other supporting resources, for protective services, for financial services and for assistance at the time of discharge or transfer into a new environment;

(3)           the utilization of caseworkers employed by the county department of social services in the case of recipients of public assistance and for the utilization of appropriate persons with experience and training in the general area of social work in the case of those not on public assistance.

(c)  Discharge planning shall be in keeping with each patient's and resident's discharge needs.  These are as follows:

(1)           The administrator shall assure that a medical order for discharge including any special instructions for meeting rehabilitation potential is obtained from all patients or residents except when a patient or resident leaves against a physician's order or advice; and

(2)           The social services director shall coordinate discharge instructions and assure that patients and residents and their families are instructed in accordance with discharge orders.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. March 1, 1990.

 

10A NCAC 13B .1924       RESTRAINTS

(a)  Patients and residents shall be restrained only by physician orders.

(b)  The nurse in charge shall be responsible for making the decision relative to necessity for, type and duration of restraint in emergency situations requiring restraints while contacting the physician.  The nurse also shall be responsible for documenting same in the patient's or resident's record.

(c)  The type of restraint used and the time of application and removal shall be recorded by a licensed nurse in the patient's or resident's record.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1925       REQUIRED SPACES

The total space requirements shall be those set forth in Rule .1902(5) of this Section.  Physical therapy and occupational therapy space shall not be included in these totals.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1926       NURSING HOME PATIENT OR RESIDENT RIGHTS

(a)  Written policies and procedures shall be developed and enforced to implement requirements in G.S. 131E‑115 et seq.  (Nursing Home Patients' Bill of Rights) concerning the rights of patients and residents.  The administrator shall make these policies and procedures known to the staff, patients and residents, and families of patients and residents and shall ensure their availability to the public by placing them in a conspicuous place.

(b)  Any violation of patient rights contained in G.S. 131E‑117 shall be determined by representatives of the Department by investigation or survey.

(c)  If a licensed facility is found to be in violation of any of the rights contained in G.S. 131E‑117, the Department shall impose penalties for each violation as provided by G.S. 131E‑129.

(d)  When the Department has been notified that corrective action has been taken for each violation, verification of same shall be made by a representative of the Department.

(e)  The Department shall calculate a total of all fines levied against a facility based on the number of violations and the number of days and patients or residents involved in each violation.

(f)  The Department shall mail a statement to the facility showing a total fine for each violation and a total of fines due to be paid for all violations.  The facility shall pay the penalty within 60 days unless a hearing is requested under G.S. Chapter 150B.

(g)  When it is found that a violation of G.S. 131E‑117 has occurred but corrective action was taken prior to the date of discovery, fines shall be calculated and assessed in accordance with (e) and (f) of this Rule.

(h)  In matters of patient abuse, neglect or misappropriation the definitions shall have the meanings defined for abuse, neglect and exploitation respectively as contained in the North Carolina PROTECTION OF THE ABUSED, NEGLECTED OR EXPLOITED DISABLED ADULT ACT, G.S. 108A‑99 et seq.

 

History Note:        Filed as a Temporary Amendment Eff. October 1, 1990 For a Period of 142 Days to Expire on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (e)(2)(B);

Eff. February 1, 1986;

Amended Eff. March 1, 1991; March 1, 1990.

 

10A NCAC 13B .1927       BRAIN INJURY LONG‑TERM CARE PHYSICIAN SERVICES

(a)  For nursing facility patients located in designated brain injury long‑term care units, there shall be an attending physician who is responsible for the patient's specialized care program.  The intensity of the program requires that there shall be direct patient contact by a physician at least once per week and more often as the patient's condition warrants.  Each patient's interdisciplinary, long‑term care program shall be developed and implemented under the supervision of a physiatrist (a physician trained in Physical Medicine and Rehabilitation) or a physician of equivalent training and experience.

(b)  If a physiatrist or physician of equivalent training or experience, is not available on a weekly basis to the facility, the facility shall provide for weekly medical management of the patient, by another physician.  In addition, oversight for the patient's interdisciplinary, long‑term care program shall be provided by a qualified consultant physician who visits patients monthly, makes recommendations for and approves the interdisciplinary care plan, and provides consultation as requested to the physician who is managing the patient on a weekly basis.

(c)  The attending physician shall actively participate in individual case conferences or care planning sessions and shall review and sign discharge summaries and records within 15 days of patient discharge.  When patients are to be discharged to either another health care facility or a residential setting the attending physician shall assure that the patient has been provided with a discharge plan which incorporates optimum utilization of community resources and post discharge continuity of care and services.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991;

Amended Eff. February 1, 1993.

 

10A NCAC 13B .1928       BRAIN INJURY LONG‑TERM CARE PROGRAM REQUIREMENTS

(a)  The general requirements in this Subchapter shall apply when applicable, but brain injury long‑term care units shall meet the supplement requirements in this Rule and Rules .1901 (4) and .1929 of this Section.  Brain injury long‑term care is an interdisciplinary, intensive maintenance program for patients who have incurred brain damage caused by external physical trauma and who have completed a primary course of rehabilitative treatment and have reached a point of no gain or progress for more than three consecutive months.  Services are provided through a medically supervised interdisciplinary process as provided in Rule .1927 of this Section and are directed toward maintaining the individual at the optimal level of physical, cognitive and behavioral functioning.  Following are the minimum requirements for specific services that may be necessary to maintaining the individual at optimum level:

(1)           Overall supervisory responsibility for brain injury long‑term care services shall be assigned to a registered nurse with one year experience in caring for brain injured patients.

(2)           Physical therapy shall be provided by a physical therapist with a current valid North Carolina license.  Occupational therapy shall be provided by an occupational therapist with a current valid North Carolina License.  The services of a physical therapist and occupational therapist shall be combined to provide one full‑time equivalent for each 20 patients.  The assistance of a physical therapy aide and an occupational therapy aide with appropriate supervision shall be combined to provide one full‑time equivalent for each 20 patients.  A proportionate number of hours shall be provided for a census less than 20 patients.

(3)           Clinical nutrition services shall be provided by a qualified dietician with two years clinical training and experience in nutrition.  The number of hours of clinical nutrition services on either a full‑time or part‑time employment or contract basis shall be adequate to meet the needs of the patients. Each patient's nutrition needs shall be reviewed at least monthly.  Clinical nutrition services shall include:

(A)          Assessing the appropriateness of the ordered diet for conformance with each patient's physiological and pharmacological condition;

(B)          Evaluating each patient's laboratory data in relation to nutritional status and hydration;

(C)          Applying technical knowledge of feeding tubes, pumps and equipment to each patient's specialized needs.

(4)           Clinical Social Work shall be provided by a Social Worker meeting the requirements of Rule .1923 of this Section.

(5)           Recreation therapy, when required, shall be provided on either a full‑time or part‑time employment or contract basis by a clinician eligible for certification as a therapeutic recreation specialist by the State Board of Therapeutic Recreation Certification. The number of hours of therapeutic recreation services shall be adequate to meet the needs of the patients.  In the event that a qualified specialist is not locally available, alternate treatment modalities shall be developed by the occupational therapist and reviewed by the attending physician.  The program designed must be adequate to meet the needs of this specialized population and must be administered in accordance with Section .1200 of this Subchapter.

(6)           Speech therapy, when required, shall be provided by a clinician with a current valid license in speech pathology issued by the State Board of Speech and Language Pathologists and Audiologists.

(7)           Respiratory therapy, when required, shall be provided and supervised by a respiratory therapist currently registered by the National Board for Respiratory Care.

(b)  Each patient's program shall be governed by an interdisciplinary treatment plan incorporating and expanding upon the health plan required under Rules .1908 and .1909 of this Section.  The plan is to be initiated on the first day of admission.  Upon completion of baseline data development and an integrated interdisciplinary assessment the initial treatment plan is to be expanded and finalized within 14 days of admission.  Through an interdisciplinary process the treatment plan shall be reviewed at least monthly and revised as appropriate.  In executing the treatment plan the interdisciplinary team shall be the major decision‑making body and shall determine the goals, process, and time frames for accomplishment of each patient's program.  Disciplines to be represented on the team shall be medicine, nursing, clinical pharmacy and all other disciplines directly involved in the patient's treatment or treatment plan.

(c)  Each patient's overall program shall be assigned to an individually designated case manager.  The case manager acts as the coordinator manager for assigned patients.  Any professional staff member involved in the patient's care may be assigned this responsibility for one or more patients. Professional staff may divide this responsibility for all patients on the unit in the best manner to meet all patients' needs for a coordinated interdisciplinary approach to care. The case manager shall be responsible for:

(1)           coordinating the development, implementation and periodic review of the patient's treatment plan;

(2)           preparing a monthly summary of the patient's progress;

(3)           cultivating the patient's participation in the program;

(4)           general supervision of the patient during the course of treatment;

(5)           evaluating appropriateness of the treatment plan in relation to the attainment of stated goals; and

(6)           assuring that discharge decisions and arrangements for post discharge follow‑up are properly made.

(d)  For each 20 patients or fraction thereof dedicated treatment facilities and equipment shall be provided as follows:

(1)           A combined therapy space equal to or exceeding 600 square feet, adequately equipped and arranged to support each of the therapies.

(2)           Access to one full reclining wheelchair per patient.

(3)           Special physical therapy and occupational therapy equipment for use in fabricating positioning devices for beds and wheelchairs including splints, casts, cushions, wedges, and bolsters.

(4)           There shall be roll‑in bath facilities with a dressing area available to all patients which shall afford maximum privacy to the patient.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991;

Amended Eff. February 1, 1993.

 

10A NCAC 13B .1929       SPECIAL NURSING REQUIREMENTS FOR BRAIN INJURY LONG‑TERM CARE

Direct care nursing personnel staffing ratio (NH/PD) established in Rule .1912 of this Section shall not be applied to nursing services for patients who require brain injury long‑term care, due to their more intensive maintenance and nursing needs.  The minimum direct care nursing staff shall be 5.5 hrs. per patient day allocated on a per shift basis as the facility chooses to appropriately meet the patient's needs.  It is also required that regardless of how low the patient census the direct care nursing staff shall not fall below a registered nurse and a nurse aide I at any time during a 24‑hour period.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991;

Amended Eff. February 1, 1993.

 

10A NCAC 13B .1930       VENTILATOR DEPENDENCE

The general requirements in this Subchapter shall apply when applicable.  In addition, facilities having patients requiring the use of ventilators for more than eight hours a day must meet the following requirements:

(1)           Respiratory therapy shall be provided and supervised by a respiratory therapist currently registered by the National Board for Respiratory Care.  The respiratory therapist shall:

(a)           make, as a minimum, weekly on‑site assessments of each patient receiving ventilator support with corresponding progress notes;

(b)           be on‑call 24 hours daily; and

(c)           assist the pulmonologist and nursing staff in establishing ventilator policies and procedures, including emergency policies and procedures.

(2)           Direct nursing care staffing shall be in accordance with Rule .1912 of this Section.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991.

 

10A NCAC 13B .1931       PHYSICIAN SERVICES FOR VENTILATOR DEPENDENT PATIENTS

Hospitals with nursing facility beds with ventilator dependent care patients shall contract with a physician who is licensed to practice in North Carolina with Board Certification and who has specialized training in pulmonary medicine.  This physician shall be responsible for respiratory services and shall:

(1)           establish, with the respiratory therapist and nursing staff, appropriate ventilator policies and procedures, including emergency procedures;

(2)           assess each ventilator patient's status at least monthly with corresponding progress notes;

(3)           be available on an emergency basis; and

(4)           participate in individual patient case planning.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991.

 

10A NCAC 13B .1932       EMERGENCY ELECTRICAL SERVICE

(a)  A minimum of one dedicated emergency branch circuit per bed is required for ventilator dependent patients in addition to the normal system receptacle at each bed location required by the National Electrical Code.  This emergency circuit shall be provided with a minimum of two duplex receptacles identified for emergency use.  Additional emergency branch circuits/receptacles shall be provided where the electrical life support needs of the patient exceed the minimum requirements stated in this Paragraph.  Each emergency circuit serving ventilator dependent patients shall be fed from the automatically transferred critical branch of the essential electrical system.  This Paragraph shall apply to both new and existing facilities.

(b)  Heating equipment provided for ventilator dependent patient bedrooms shall be connected to the critical branch of the essential electrical system and arranged for delayed automatic or manual connection to the emergency power source if the heating equipment depends upon electricity for proper operation.  This Paragraph shall apply to both new and existing facilities.

(c)  Task lighting connected to the automatically transferred critical branch of the essential electrical system shall be provided for each ventilator dependent patient bedroom.  This Paragraph shall apply to both new and existing facilities.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991.

 

SECTION .2000 – specialized rehabilitative and habilitative services

 

10A NCAC 13B .2001       ADMISSIONS TO THE HIV DESIGNATED UNIT

If a facility declines admission to a patient known to have Human Immunodeficiency Virus disease, the reasons for the denial shall be documented.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2002       DISCHARGE OF PATIENTS FROM THE HIV DESIGNATED UNIT

A record shall be maintained of all discharges of patients indicating the reasons for discharge, the physician's order for or other authorization for discharge, and the condition of the patient at the time of discharge.

A patient known to have Human Immunodeficiency Virus disease may not be discharged solely on the basis of the diagnosis of Human Immunodeficiency Virus disease except as authorized by the provisions of N.C. General Statute 131E-117 (15) or other provisions of the N.C. General Statutes or regulations promulgated thereunder or provisions of applicable federal laws and regulations.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2003       HIV DESIGNATED UNIT POLICIES AND PROCEDURES

(a)  In units dedicated to the treatment of patients with Human Immunodeficiency Virus disease, policies and procedures specific to the specialized needs of the patients served shall be developed.  At a minimum they shall include staff training and education, and the availability of consultation by a physician with specialized education or knowledge in the management of Human Immunodeficiency Virus disease.

(b)  Policies and procedures for infection control shall be in conformance with 29 CFR 1910 Occupational Safety and Health Standards which is incorporated by reference including subsequent amendments.  Emphasis shall be placed on compliance with 29 CFR 1910-1030 (Bloodbourne Pathogens).  Copies of Title 29 Part 1910 may be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15202-7954 for $38.00 and may be purchased with a credit card by a direct telephone call to the G.P.O. at (202) 783-3238.  Infection control shall also be in compliance with the Centers for Disease Control and Prevention Guidelines as published by the U.S. Department of Health and Human Services, Public Health Service which is incorporated by reference including subsequent amendments.  Copies may be purchased from the National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal Road, Springfield, Virginia, 22161 for $15.95.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2004       PHYSICIAN SERVICES IN A HIV DESIGNATED UNIT

In facilities with a Human Immunodeficiency Virus designated unit the facility shall insure that attending physicians have documented, pre-arranged access, either in person or by telephone, to a physician with specialized education or knowledge in the management of Human Immunodeficiency Virus Disease.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2005       SPECIAL NURSING REQUIREMENTS FOR A HIV DESIGNATED UNIT

(a)  Facilities with a Human Immunodeficiency Virus designated unit shall have a registered nurse with specialized education or knowledge in the care of Human Immunodeficiency Virus disease.

(b)  Nursing personnel assigned to the Human Immunodeficiency Virus unit shall be regularly assigned to the unit.  Rotations are acceptable to alleviate staff burnout or staffing emergencies.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2006       SPECIALIZED STAFF EDUCATION FOR THE HIV DESIGNATED UNIT

For facilities with a Human Immunodeficiency Virus designated unit an organized, documented program of education specific to the care of patients infected with the Human Immunodeficiency Virus shall be provided and include at a minimum:

(1)           Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome disease processes;

(2)           transmission modes, causes, and prevention of Human Immunodeficiency Virus;

(3)           treatment of Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome;

(4)           psycho-socio-economic needs of the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome patients;

(5)           in addition to the general hospital orientation to Occupational Safety and Health Administration guidelines for universal precautions, orientation to infection control specific to Human Immunodeficiency Virus disease must be provided upon employment or permanent assignment to the unit; Copies of Title 29 Part 1910 may be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15202-7954 for $38.00 and may be purchased with a credit card by a direct telephone call to the G.P.O. at (202) 512-1800;

(6)           policies and procedures specific to the Human Immunodeficiency Virus designated unit; and

(7)           annual continuing education in infection control.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2007       USE OF INVESTIGATIONAL DRUGS ON THE HIV DESIGNATED UNIT

(a)  The supervision and monitoring for the administration of investigational drugs is the responsibility of the pharmacist and a licensed registered nurse, acting pursuant to the orders of a physician duly authorized to prescribe or dispense such drugs.  Responsibilities shall include, but not be limited to, the following:

(1)           to insure the provision of written guidelines for any investigational drug or study are provided; and

(2)           training and determination of staff's abilities regarding administration of drugs, policies and procedures and regulations.

(b)  The pharmacist or physician dispensing the investigational drug is to provide the facility with information regarding at least the following:

(1)           a copy of the protocol, including drug information;

(2)           a copy of the patient's informed consent;

(3)           drug storage;

(4)           handling;

(5)           any specific preparation and administration instructions;

(6)           specific details for drug accountability, resupply and return of unused drug; and

(7)           a copy of the signed consent to participate in the study.

(c)  Labeling of investigational drugs shall be in accordance with written guidelines of protocol and State and federal requirements regarding such drugs.  Prescription labels for investigational drugs are to be distinguishable from other labels by an appropriate legend, "Investigational Drug" or "For Investigational Use Only".

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2008       SOCIAL WORK SERVICES IN A HIV DESIGNATED UNIT

The facility shall provide either by direct employment or by contract for social work services to include assistance to the patient in identification of supportive resources, financial services and assistance with discharge and transfer arrangements.  In addition, for patients in a Human Immunodeficiency Virus disease designated unit, the social worker shall provide or arrange for the provision of spiritual, pastoral and grief counseling for patients and staff where appropriate.  Support services shall be provided to patient families and significant others.  Where necessary, coordination with treatment services for substance abuse, legal services and other community resources shall be identified.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2009       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2010       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2011       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2012       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2013       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2014       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2015       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2016       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2017       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2018       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2019       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2020       DEFINITIONS

The following definitions shall apply to inpatient rehabilitation facilities or units only:

(1)           "Case management" means the coordination of services, for a given patient, between disciplines so that the patient may reach optimal rehabilitation through the judicious use of resources.

(2)           "Comprehensive, inpatient rehabilitation program" means a program for the treatment of persons with functional limitations or chronic disabling conditions who have the potential to achieve a significant improvement in activities of daily living.  A comprehensive, rehabilitation program utilizes a coordinated and integrated, interdisciplinary approach, directed by a physician, to assess patient needs and to provide treatment and evaluation of physical, psycho-social and cognitive deficits.

(3)           "Inpatient rehabilitation facility or unit" means a free-standing facility or a unit (unit pertains to contiguous dedicated beds and spaces) within an existing licensed health service facility approved in accordance with G.S. 131E, Article 9 to establish inpatient, rehabilitation beds and to provide a comprehensive, inpatient rehabilitation program.

(4)           "Medical consultations" means consultations which the rehabilitation physician or the attending physician determine are necessary to meet the acute medical needs of the patient and do not include routine medical needs.

(5)           "Occupational therapist" means any individual licensed in the State of North Carolina as an occupational therapist in accordance with the provisions of G.S. 90, Article 18D.

(6)           "Occupational therapist assistant" means any individual licensed in the State of North Carolina as an occupational therapist assistant in accordance with the provisions of G.S. 90, Article 18D.

(7)           "Psychologist" means a person licensed as a practicing psychologist in accordance with G.S. 90, Article 18A.

(8)           "Physiatrist" means a licensed physician who has completed a physical medicine and rehabilitation residency training program approved by the Accreditation Council of Graduate Medical Education or the American Osteopathic Association.

(9)           "Physical therapist" means any person licensed in the State of North Carolina as a physical therapist in accordance with the provisions of G.S. 90, Article 18B.

(10)         "Physical therapist assistant" means any person duly licensed in the State of North Carolina as a physical therapist assistant in accordance with the provisions of G.S. 90-270.24, Article 18B.

(11)         "Recreational therapist" means a person certified by the State of North Carolina Therapeutic Recreational Certification Board.

(12)         "Rehabilitation nurse" means a registered nurse licensed in North Carolina, with training, either academic or on‑the‑job, in physical rehabilitation nursing and at least one year experience in physical rehabilitation nursing.

(13)         "Rehabilitation aide" means an unlicensed assistant who works under the supervision of a registered nurse, licensed physical therapist or occupational therapist in accordance with the appropriate occupational licensure laws governing his or her supervisor and consistent with staffing requirements as set forth in Rule .2027 of this Section.  The rehabilitation aide shall be listed on the North Carolina Nurse Aide Registry and have received additional staff training as listed in Rule .2028 of this Section.

(14)         "Rehabilitation physician" means a physiatrist or a physician who is qualified, based on education, training and experience regardless of specialty, of providing medical care to rehabilitation patients.

(15)         "Social worker" means a person certified by the North Carolina Social Work Certification and Licensure Board in accordance with G.S. 90B-3.

(16)         "Speech and language pathologist" means any person licensed in the State of North Carolina as a speech and language pathologist in accordance with the provisions of G.S. 90, Article 22.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2021       PHYSICIAN REQS FOR INPATIENT REHABILITATION FACILITIES OR UNITS

(a)  In a rehabilitation facility or unit a physician shall participate in the provision and management of rehabilitation services and in the provision of medical services.

(b)  In a rehabilitation facility or unit a rehabilitation physician shall be responsible for a patient's interdisciplinary treatment plan.  Each patient's interdisciplinary treatment plan shall be developed and implemented under the supervision of a rehabilitation physician.

(c)  The rehabilitation physician shall participate in the preliminary assessment within 48 hours of admission, prepare a plan of care and direct the necessary frequency of contact based on the medical and rehabilitation needs of the patient.  The frequency shall be appropriate to justify the need for comprehensive inpatient rehabilitation care.

(d)  An inpatient rehabilitation facility or unit's contract or agreements with a rehabilitation physician shall require that the rehabilitation physician shall participate in individual case conferences or care planning sessions and shall review and sign discharge summaries and records.  When patients are to be discharged to another health care facility, the discharging facility shall assure that the patient has been provided with a discharge plan which incorporates post discharge continuity of care and services.  When patients are to be discharged to a residential setting, the facility shall assure that the patient has been provided with a discharge plan that incorporates the utilization of community resources when available and when included in the patient's plan of care.

(e)  The intensity of physician medical services and the frequency of regular contacts for medical care for the patient shall be determined by the patient's pathophysiologic needs.

(f)  Where the attending physician of a patient in an inpatient rehabilitation facility or unit orders medical consultations for the patient, such consultations shall be provided by qualified physicians within 48 hours of the physician's order.  In order to achieve this result, the contracts or agreements between inpatient rehabilitation facilities or units and medical consultants shall require that such consultants render the requested medical consultation within 48 hours.

(g)  An inpatient rehabilitation facility or unit shall have a written procedure for setting the qualifications of the physicians rendering physical rehabilitation services in the facility or unit.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993;

Amended Eff. December 1, 1993.

 

10A NCAC 13B .2022       ADMISSION CRITERIA FOR INPATIENT REHABILITATION FACILITIES OR UNITS

(a)  The facility shall have written criteria for admission to the inpatient rehabilitation facility or unit.  A description of programs or services for screening the suitability of a given patient for placement shall be available to staff and referral sources.

(b)  For patients found unsuitable for admission to the inpatient rehabilitation facility or unit, there shall be documentation of the reasons.

(c)  Within 48 hours of admission a preliminary assessment shall be completed by members of the interdisciplinary team to insure the appropriateness of placement and to identify the immediate needs of the patient.

(d)  Patients admitted to an inpatient rehabilitation facility or unit must be able to tolerate a minimum of three hours of rehabilitation therapy, five days a week, including at least two of the following rehabilitation services:  physical therapy, occupational therapy or speech therapy.

(e)  Patients admitted to an inpatient rehabilitation facility or unit must be medically stable, have a prognosis indicating a progressively improved medical condition and have the potential for increased independence.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2023       COMPREHENSIVE INPATIENT REHABILITATION EVALUATION

(a)  A comprehensive, inpatient rehabilitation evaluation is required for each patient admitted to an inpatient rehabilitation facility or unit.  At a minimum this evaluation shall include the reason for referral, a summary of the patient's clinical condition, functional strengths and limitations, and indications for specific services.  This evaluation shall be completed within three days.

(b)  Each patient shall be evaluated by the interdisciplinary team to determine the need for any of the following services: medical, dietary, occupational therapy, physical therapy, prosthetics and orthotics, psychological assessment and therapy, therapeutic recreation, rehabilitation medicine, rehabilitation nursing, therapeutic counseling or social work, vocational rehabilitation evaluation and speech-language pathology.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2024       COMPREHENSIVE INPATIENT REHABILITATION INTERDISCIPLINARY TREAT/PLAN

(a)  The interdisciplinary treatment team shall develop an individual treatment plan for each patient within seven days after admission.  The plan shall include evaluation findings and information about the following:

(1)           prior level of function;

(2)           current functional limitations;

(3)           specific service needs;

(4)           treatment, supports and adaptations to be provided;

(5)           specified treatment goals;

(6)           disciplines responsible for implementation of separate parts of the plan; and

(7)           anticipated time frames for the accomplishment of specified long-term and short-term goals.

(b)  The treatment plan shall be reviewed by the interdisciplinary team at least every other week.  All members of the interdisciplinary team, or a representative of their discipline, shall attend each meeting.  Documentation of each review shall include progress toward defined goals and identification of any changes in the treatment plan.

(c)  The treatment plan shall include provisions for all of the services identified as needed for the patient in the comprehensive, inpatient rehabilitation evaluation completed in accordance with Rule .2023 of this Subchapter.

(d)  Each patient shall have a designated case manager who is responsible for the coordination of the patient's individualized treatment plan.  The case manager is responsible for promoting the program's responsiveness to the needs of the patient and shall participate in all team conferences concerning the patient's progress toward the accomplishment of specified goals.  Any of the professional staff involved in the patient's care may be the designated case manager for one or more cases, or the director of nursing or social worker may accept the coordination responsibility for the patients.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2025       DISCHARGE CRITERIA FOR INPATIENT REHABILITATION FACILITIES OR UNITS

(a)  Discharge planning shall be an integral part of the patient's treatment plan and shall begin upon admission to the facility.  After established goals have been reached, or a determination has been made that care in a less intensive setting would be appropriate, or that further progress is unlikely, the patient shall be discharged to an appropriate setting.  Other reasons for discharge may include an inability or unwillingness of patient or family to cooperate with the planned therapeutic program or medical complications that preclude a further intensive rehabilitative effort.  The facility shall involve the patient, family, staff members and referral sources in discharge planning.

(b)  The case manager shall facilitate the discharge or transfer process in coordination with the facility social workers.

(c)  If a patient is being referred to another facility for further care, appropriate documentation of the patient's current status shall be forwarded with the patient.  A formal discharge summary shall be forwarded within 48 hours following discharge and shall include the reasons for referral, the diagnosis, functional limitations, services provided, the results of services, referral action recommendations and activities and procedures used by the patient to maintain and improve functioning.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2026       COMPREHENSIVE REHABILITATION PERSONNEL ADMINISTRATION

(a)  The facility shall have qualified staff members, consultants and contract personnel to provide services to the patients admitted to the inpatient rehabilitation facility or unit.

(b)  Personnel shall be employed or provided by contractual agreement in sufficient types and numbers to meet the needs of all patients admitted for comprehensive rehabilitation.

(c)  Written agreements shall be maintained by the facility when services are provided by contract on an ongoing basis.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2027       COMPREHENSIVE INPATIENT REHABILITATION PROGRAM STAFFING REQS

(a)  The staff of the inpatient rehabilitation facility or unit shall include at a minimum:

(1)           The inpatient rehabilitation facility or unit shall be supervised by a rehabilitation nurse.  The facility shall identify the nursing skills necessary to meet the needs of the rehabilitation patients in the unit and assign staff qualified to meet those needs.

(2)           The minimum nursing hours per patient in the rehabilitation unit shall be 5.5 nursing hours per patient day.  At no time shall direct care nursing staff be less than two full-time equivalents, one of which must be a registered nurse.

(3)           The inpatient rehabilitation unit shall employ or provide by contractual agreements sufficient therapists, licensed in North Carolina, to provide a minimum of three hours of specific (physical, occupational or speech) or combined rehabilitation therapy services per patient day.

(4)           Physical therapy assistants and occupational therapy assistants shall be licensed or certified and shall be supervised on-site by licensed physical therapists or licensed occupational therapists.

(5)           Rehabilitation aides shall have documented training appropriate to the activities to be performed and the occupational licensure laws of his or her supervisor.  The overall responsibility for the on‑going supervision and evaluation of the rehabilitation aide remains with the registered nurse as identified in Subparagraph (a)(1) of this Rule.  Supervision by the licensed physical therapist or by the occupational therapist is limited to that time when the therapist is on‑site and directing the rehabilitation activities of the aide.

(6)           Hours of service by the rehabilitation aide are counted toward the required nursing hours when the aide is working under the supervision of the licensed nurse.  Hours of service by the rehabilitation aide are counted toward therapy hours during that time the aide works under the immediate, on‑site supervision of the licensed physical therapist or occupational therapist.  Hours of service shall not be dually counted for both services.  Hours of service by rehabilitation aides in performing nurse‑aide duties in areas of the facility other than the rehabilitation unit shall not be counted toward the 5.5 hour minimum nursing requirements described for the rehabilitation unit.

(b)  Additional personnel shall be provided as required to meet the needs of the patient, as defined in the comprehensive, inpatient rehabilitation evaluation.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2028       STAFF TRAINING FOR INPATIENT REHABILITATION FACILITIES OR UNIT

Prior to the provision of care, all rehabilitation personnel, excluding physicians, assigned to the rehabilitation unit shall be provided training or shall provide documentation of training, that includes at a minimum the following:

(1)           active and passive range of motion;

(2)           assistance with ambulation;

(3)           transfers;

(4)           maximizing functional independence;

(5)           the psycho-social needs of the rehabilitation patient;

(6)           the increased safety risks of rehabilitation training (including falls and the use of restraints);

(7)           proper body mechanics;

(8)           nutrition, including dysphagia and restorative eating;

(9)           communication with the aphasic and hearing impaired patient;

(10)         behavior modification;

(11)         bowel and bladder training; and

(12)         skin care.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2029       EQUIPMENT REQS/COMPREHENSIVE INPATIENT REHABILITATION PROGRAMS

(a)  The facility shall provide each discipline with the necessary equipment and treatment methods to achieve the short and long-term goals specified in the comprehensive inpatient rehabilitation interdisciplinary treatment plans for patients admitted to these facilities or units.

(b)  Each patient's needs for a standard wheelchair or a specially designed wheelchair or additional devices to allow safe and independent mobility within the facility shall be met.

(c)  Special physical therapy and occupational therapy equipment for use in fabricating positioning devices for beds and wheelchairs shall be provided, including splints, casts, cushions, wedges and bolsters.

(d)  Physical therapy devices, including a mat table, parallel bars and sliding boards and special adaptive bathroom equipment shall be provided.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2030       PHYSICAL FACILITY REQS/INPATIENT REHABILITATION FACILITIES OR UNITS

(a)  The inpatient rehabilitation facility or unit shall be in a designated area and shall be used for the specific purpose of providing a comprehensive, inpatient rehabilitation program.

(b)  The floor area of a single bedroom shall be sufficient for the patient or the staff to easily transfer the patient from the bed to a wheelchair and to maneuver a 180-degree turn with a wheelchair on at least one side of the bed.

(c)  The floor area of a multi-bed bedroom shall be sufficient for the patient or the staff to easily transfer the patient from the bed to a wheelchair and to maneuver a 180-degree turn with a wheelchair between beds.

(d)  Each patient room shall meet the following requirements:

(1)           Maximum room capacity of no more than four patients;

(2)           Operable windows;

(3)           A nurse call system designed to meet the special needs of rehabilitation patients;

(4)           In single and two-bed rooms with private toilet room, the lavatory may be located in the toilet room;

(5)           A wardrobe or closet for each patient which is wheelchair accessible and arranged to allow the patient to access the contents;

(6)           A chest of drawers or built-in drawer storage with mirror above, which is wheelchair accessible; and

(7)           A bedside table for toilet articles and personal belongings.

(e)  Space for emergency equipment such as resuscitation carts shall be provided and shall be under direct control of the nursing staff, in proximity to the nurse's station and out of traffic.

(f)  Patients' bathing facilities shall meet the following specifications:

(1)           There shall be at least one shower stall or one bathtub for each 15 beds not individually served.  Each tub or shower shall be in an individual room or privacy enclosure which provides space for the private use of the bathing fixture, for drying and dressing and for a wheelchair and an assisting attendant.

(2)           Showers in central bathing facilities shall be at least five foot square without curbs and designed to permit use by a wheelchair patient.

(3)           At least one five‑foot‑by‑seven‑foot shower shall be provided which can accommodate a stretcher and an assisting attendant.

(g)  Patients' toilet rooms and lavatories shall meet the following specifications:

(1)           The size of toilets shall permit a wheelchair, a staff person and appropriate wheel-to-water closet transfers.

(2)           A lavatory in the room must permit wheelchair access.

(3)           Lavatories serving patients shall:

(A)          allow wheelchairs to extend under the lavatory; and

(B)          have water supply spout mounted so that its discharge point is a minimum of five inches above the rim of the fixture.

(4)           Lavatories used by patients and by staff shall be equipped with blade-operated supply valves.

(h)  The space provided for physical therapy, occupational therapy and speech therapy by all inpatient rehabilitation facilities or units may be shared but must, at a minimum, include:

(1)           office space for staff;

(2)           office space for speech therapy evaluation and treatment;

(3)           waiting space;

(4)           training bathroom which includes toilet, lavatory and bathtub;

(5)           gymnasium or exercise area;

(6)           work area such as tables or counters suitable for wheelchair access;

(7)           treatment areas with available privacy curtains or screens;

(8)           an activities of daily living training kitchen with sink, cooking top (secured when not supervised by staff), refrigerator and counter surface for meal preparation;

(9)           storage for clean linens, supplies and equipment;

(10)         janitor's closet accessible to the therapy area with floor receptor or service sink and storage space for housekeeping supplies and equipment, one closet or space may serve more than one area of the inpatient rehabilitation facility or unit; and

(11)         hand washing facilities.

(i)  For social work and psychological services the following shall be provided:

(1)           office space for staff;

(2)           office space for private interviewing and counseling for all family members; and

(3)           workspace for testing, evaluation and counseling.

(j)  If prosthetics and orthotics services are provided, the following space shall be made available as necessary:

(1)           work space for technician; and

(2)           space for evaluation and fittings (with provisions for privacy).

(k)  If vocational therapy services are provided, the following space shall be made available as necessary:

(1)           office space for staff;

(2)           workspace for vocational services activities such as prevocational and vocational evaluation;

(3)           training space;

(4)           storage for equipment; and

(5)           counseling and placement space.

(l)  Recreational therapy space requirements include the following:

(1)           activities space;

(2)           storage for equipment and supplies;

(3)           office space for staff; and

(4)           access to male and female toilets.

(m)  The following space shall be provided for patient's dining, recreation and day areas:

(1)           sufficient room for wheelchair movement and wheelchair dining seating;

(2)           if food service is cafeteria type, adequate width for wheelchair maneuvers, queue space within the dining area (and not in a corridor) and a serving counter low enough to view food;

(3)           total space for inpatients, a minimum of 25 square feet per bed;

(4)           for outpatients participating in a day program or partial day program, 20 square feet when dining is a part of the program and 10 square feet when dining is not a part of the program; and

(5)           storage for recreational equipment and supplies, tables and chairs.

(n)  The patient dining, recreation and day area spaces shall be provided with windows that have glazing of an area not less than eight percent of the floor area of the space.  At least one half of the required window area must be operable.

(o)  A laundry shall be available and accessible for patients.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2031       ADDITIONAL REQUIREMENTS FOR TRAUMATIC BRAIN INJURY PATIENTS

Inpatient rehabilitation facilities providing services to persons with traumatic brain injuries shall meet the requirements in this Rule in addition to those identified in this Section.

(1)           Direct-care nursing personnel staffing ratios established in Rule .2027 of this Section shall not be applied to nursing services for traumatic brain injury patients in the inpatient, rehabilitation facility or unit.  The minimum nursing hours per traumatic brain injury patient in the unit shall be 6.5 nursing hours per patient day.  At no time shall direct care nursing staff be less than two full-time equivalents, one of which shall be a registered nurse.

(2)           The inpatient rehabilitation facility or unit shall employ or provide by contractual agreements physical, occupational or speech therapists in order to provide a minimum of 4.5 hours of specific or combined rehabilitation therapy services per traumatic brain injury patient day.

(3)           The facility shall provide special facility or equipment needs for patients with traumatic brain injury, including a quiet room for therapy, specially designed wheelchairs and standing tables.

(4)           The medical director of an inpatient traumatic brain injury program shall have two years management in a brain injury program, one of which may be in a clinical fellowship program and board eligibility or certification in the medical specialty of the physician's training.

(5)           The facility shall provide the consulting services of a neuropsychologist.

(6)           The facility shall provide continuing education in the care and treatment of brain injury patients for all staff.

(7)           The size of the brain injury program shall be adequate to support a comprehensive, dedicated ongoing brain injury program.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. December 1, 1993.

 

10A NCAC 13B .2032       ADDITIONAL REQUIREMENTS FOR SPINAL CORD INJURY PATIENTS

Inpatient rehabilitation facilities providing services to persons with spinal cord injuries shall meet the requirements in this Rule in addition to those identified in this Section.

(1)           Direct-care nursing personnel staffing ratios established in Rule .2027 of this Section shall not be applied to nursing services for spinal cord injury patients in the inpatient, rehabilitation facility or unit.  The minimum nursing hours per spinal cord injury patient in the unit shall be 6.0 nursing hours per patient day.  At no time shall direct care nursing staff be less than two full-time equivalents, one of which shall be a registered nurse.

(2)           The inpatient rehabilitation facility or unit shall employ or provide by contractual agreements physical, occupational or speech therapists in order to provide a minimum of 4.0 hours of specific or combined rehabilitation therapy services per spinal cord injury patient day.

(3)           The facility shall provide special facility or special equipment needs of patients with spinal cord injury, including specially designed wheelchairs, tilt tables and standing tables.

(4)           The medical director of an inpatient spinal cord injury program shall have either two years experience in the medical care of persons with spinal cord injuries or six month's minimum in a spinal cord injury fellowship.

(5)           The facility shall provide continuing education in the care and treatment of spinal cord injury patients for all staff.

(6)           The facility shall provide specific staff training and education in the care and treatment of spinal cord injury.

(7)           The size of the spinal cord injury program shall be adequate to support a comprehensive, dedicated ongoing spinal cord injury program.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. December 1, 1993.

 

10A NCAC 13B .2033       DEEMED STATUS FOR INPATIENT REHABILITATION FACILITIES OR UNITS

(a)  If an inpatient rehabilitation facility or unit with a comprehensive inpatient rehabilitation program is surveyed and accredited by the Joint Commission for the Accreditation of Health Care Organizations (JCAHO) or the Commission on Accreditation of Rehabilitation Facilities (CARF) and has been approved by the Department in accordance with Article 9 Chapter 131E of the North Carolina General Statutes, the Department deems the facility to be in compliance with Rules .2020 through .2030 and .2033 of this Section.

(b)  Deemed status shall be provided only if the inpatient rehabilitation facility or unit provides copies of survey reports to the Division.  The JCAHO report shall show that the facility or unit was surveyed for rehabilitation services.  The CARF report shall show that the facility or unit was surveyed for comprehensive rehabilitation services.  The facility or unit shall sign an agreement (Memorandum of Understanding) specifying these terms.

(c)  The inpatient rehabilitation facility or unit shall be subject to inspections or complaint investigations by representatives of the Department at any time.  If the facility or unit is found not to be in compliance with the rules listed in Paragraph (a) of this Rule, the facility shall submit a plan of correction and be subject to a follow‑up visit to assure compliance.

(d)  If the inpatient rehabilitation facility or unit loses or does not renew its accreditation, the facility or unit shall notify the Division in writing within 30 days.

 

History Note:        Authority G.S. 131E-79;

Eff. May 1, 1993.

 

section .2100 – reserved for future codification

 

10A NCAC 13B .2100       Reserved for future codification

 

SECTION .2200 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2200       Reserved for future codification

 

SECTION .2300 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2300       Reserved for future codification

 

SECTION .2400 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2400       Reserved for future codification

 

SECTION .2500 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2500       Reserved for future codification

 

SECTION .2600 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2600       Reserved for future codification

 

SECTION .2700 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2700       Reserved for future codification

 

SECTION .2800 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2800       Reserved for future codification

 

SECTION .2900 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2900       Reserved for future codification

 

SECTION .3000 - GENERAL INFORMATION

 

10A NCAC 13B .3001       DEFINITIONS

The following definitions shall apply throughout this Section, unless the context clearly indicates to the contrary:

(1)           "Appropriate" means suitable or fitting, or conforming to standards of care as established by professional organizations.

(2)           "Authority having jurisdiction" means the Division of Health Service Regulation.

(3)           "Certified Dietary Manager" or "CDM" means an individual who is certified by the Certifying Board of the Dietary Managers and meets the standards and qualification as referenced in the "Dietary Manager Training Program Requirements."  These standards include any subsequent amendments and editions of the referenced manual.  Copies of the "Dietary Manager Training Program Requirements" may be purchased for fifteen dollars ($15.00) from the Dietary Managers Association, 406 Surry Woods Dr., St. Charles, IL 60174.

(4)           "Competence" means the state or quality of being able to perform specific functions well; skill; ability.

(5)           "Comprehensive" means covering completely, inclusive; large in scope or content.

(6)           "Continuous" means ongoing or uninterrupted, 24 hours per day.

(7)           "CRNA" means a Certified Registered Nurse Anesthetist as credentialed by the Council on Certification of Nurse Anesthetists and recognized by the Board of Nursing in 21 NCAC 36 .0226.

(8)           "Credentialed" means that the individual having a given title or position has been credited with the right to exercise official responsibilities to provide specific patient care and treatment services, within defined limits, based primarily upon the individual's license, education, training, experience, competence, and judgment.

(9)           "Department" means the Department of Health and Human Services.

(10)         "Dietetics" means the integration and application of principles derived from the science of nutrition, biochemistry, physiology, food and management and from behavioral and social sciences to achieve and maintain optimal nutritional status.

(11)         "Dietitian" means an individual who is licensed according to G.S. 90, Article 25, or is registered by the Commission on Dietetic Registration (CDR) of the American Dietetic Association (ADA) according to the standards and qualifications as referenced in the second edition of the "Accreditation/Approval Manual for Dietetic Education Programs", "The Registration Eligibility Application for Dietitians" and the "Continuing Professional Education" and subsequent amendments or editions of the reference material.  Copies of the "Accreditation/Approval Manual for Dietetic Education Programs" may be purchased for twenty-one dollars and ninety-five cents ($21.95) plus three dollars ($3.00) minimum shipping and handling from ADA 216 W. Jackson Blvd., Chicago, IL 60606-9-6995.

(12)         "Dietetic Technician Registered" or "DTR" means an individual who is registered by the Commission on Dietetic Registration (CDR) of the American Dietetic Association (ADA) according to the standards and qualifications as referenced in the second edition of the "Accreditation/Approval Manual for Dietetic Education Programs" which is incorporated by reference including any subsequent amendments and editions.  Copies of the "Accreditation/Approval Manual for Dietetic Education Programs" may be purchased for twenty-one dollars and ninety-five cents ($21.95) plus three dollars ($3.00) minimum for shipping and handling from the ADA 216 W. Jackson Blvd., Chicago, IL 60606-9-6995.

(13)         "Direct Supervision" means the state of being under the immediate control of a supervisor, manager, or other person of authority.

(14)         "Division" means the Division of Health Service Regulation.

(15)         "Facility" means a hospital as defined in G.S. 131E-76.

(16)         "Free standing facility" means a facility that is physically separated from the primary hospital building or separated by a three hour fire containment wall.

(17)         "Full-time equivalent" means a unit of measure of employee work time that is equal to the number of hours that one full-time employee would work during one calendar year if the employee worked eight hours a day, five days a week, and 52 weeks a year; i.e. 2,080 hours per year.

(18)         "Governing body" means the authority as defined in G.S. 131E-76.

(19)         "Imaging" means a reproduction or representation of a body or body part for diagnostic purposes by radiologic intervention that may include conventional fluoroscopic exam, magnetic resonance, nuclear or radio-isotope scan.

(20)         "Invasive procedure" means a procedure involving puncture or incision of the skin, insertion of an instrument or foreign material into the body (excluding venipuncture and intravenous therapy).

(21)         "LDRP" (labor, delivery, recovery, post-partum) means a specific single occupancy obstetrical use room counted as a licensed bed.

(22)         "License" means formal permission to provide services as granted by the State.

(23)         "Medical staff" means the formal organization that is comprised of all of those individuals who have sought and obtained clinical privileges in a facility.  Those members of the medical staff who regularly and routinely admit patients to a facility constitute the active medical staff.

(24)         "Mission statement" means a written statement of the philosophy and beliefs of the organization or hospital as approved by the governing body.

(25)         "Neonate" means the newborn from birth to one month.

(26)         "NP" means a Nurse Practitioner as defined in G.S. 90-6; 90-18(14) and 90-18.2.

(27)         "Nurse executive" means a registered nurse who is the director of nursing services or a representative of decentralized nursing management staff.

(28)         "Nurse midwife" means a Certified Nurse Midwife as defined in G.S. 90, Article 10.

(29)         "Nursing facility" means that portion of a hospital that is approved to provide skilled nursing care.

(30)         "Nursing staff" means the registered nurses, licensed practical nurses, nurse aides, and others under nurse supervision, who provide direct patient care.  The term also includes clerical personnel who work in clinical areas under nurse supervision.

(31)         "Nutrition therapy" ranges from intervention and counseling on diet modification to administration of specialized nutrition therapies as determined necessary to manage a condition or treat illness or injury.  Specialized nutrition therapies include supplementation with medical foods, enteral and parenteral nutrition.  Nutrition therapy integrates information from the nutrition assessment with information on food and other sources of nutrients and meal preparation consistent with cultural background and socioeconomic status.

(32)         "Observation bed" means a bed used for no more than 24-hours, to evaluate and determine the condition and disposition of a patient and is not considered a part of the hospital's licensed bed capacity.

(33)         "Patient" means any person receiving diagnostic or medical services at a hospital.

(34)         "Pharmacist" means a person licensed according to G.S. 90, Article 4A, by the N.C. Board of Pharmacy to practice pharmacy.

(35)         "Physical Rehabilitation Services" means any combination of physical therapy, occupational therapy, speech therapy or vocational rehabilitation.

(36)         "Physician" means a person licensed according to G.S. 90, Article 1, by the N.C. Board of Medical Examiners to practice medicine.

(37)         "Provisional license" means a hospital license recognizing significantly less than full compliance with the licensure rules.

(38)         "Qualified" means having complied with the specific conditions for employment or the performance of a function.

(39)         "Reference" means to use in consultation to obtain information.

(40)         "Special Care Unit" means a designated unit or area of a hospital with a concentration of qualified professional staff and support services that provide intensive or extra ordinary care on a 24-hour basis to critically ill patients; these units may include but are not limited to Cardiac Care, Medical or Surgical Intensive Care Unit, Cardiothoracic Intensive Care Unit, Burn Intensive Care Unit, Neurologic Intensive Care Unit or Pediatric Intensive Care Unit.

(41)         "Unit" means a designated area of the hospital for the delivery of patient care services.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of Statutory Authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

section .3100 - procedure

 

10A NCAC 13B .3101       GENERAL REQUIREMENTS

(a)  An application for licensure shall be submitted to the Division prior to a license being issued or patients admitted.

(b)  An existing facility shall not sell, lease or subdivide a portion of its bed capacity without the approval of the Division.

(c)  Application forms may be obtained by contacting the Division.

(d)  The Division shall be notified in writing prior to the occurrence of any of the following:

(1)           addition or deletion of a licensable service;

(2)           increase or decrease in bed capacity;

(3)           change of chief executive officer;

(4)           change of mailing address;

(5)           ownership change; or

(6)           name change.

(e)  Each application shall contain the following information:

(1)           legal identity of applicant;

(2)           name or names under which the hospital or services are presented to the public;

(3)           name of the chief executive officer;

(4)           ownership disclosure;

(5)           bed complement;

(6)           bed utilization data;

(7)           accreditation data;

(8)           physical plant inspection data; and

(9)           service data.

(f)  A license shall include only facilities or premises within a single county.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. April 1, 2003.

 

10A ncac 13B .3102       PLAN APPROVAL

(a)  The facility design and construction shall be in accordance with the construction standards of the Division, the North Carolina Building Code, and local municipal codes.

(b)  Submission of Plans:

(1)           Before construction is begun, color marked plans and specifications covering construction of the new buildings, alterations or additions to existing buildings, or any change in facilities shall be submitted to the Division for approval.

(2)           The Division shall review the plans and notify the licensee that said buildings, alterations, additions, or changes are approved or disapproved.  If plans are disapproved the Division shall give the applicant notice of deficiencies identified by the Division.

(3)           In order to avoid unnecessary expense in changing final plans, as a preliminary step, proposed plans in schematic form shall be submitted by the applicant to the Division for review.

(4)           The plans shall include a plot plan showing the size and shape of the entire site and the location of all existing and proposed facilities.

(5)           Plans shall be submitted in triplicate in order that the Division may distribute a copy to the Department of Insurance for review of North Carolina State Building Code requirements and to the Department of Environment and Natural Resources for review under state sanitation requirements.

(c)  Location:

(1)           The site for new construction or expansion shall be approved by the Division.

(2)           Hospitals shall be so located that they are free from noise from railroads, freight yards, main traffic arteries, schools and children's playgrounds.

(3)           The site shall not be exposed to smoke, foul odors, or dust from industrial plants.

(4)           The area of the site shall be sufficient to permit future expansion and to provide parking facilities.

(5)           Available paved roads, water, sewage and power lines shall be taken into consideration in selecting the site.

(d)  The bed capacity and services provided in a facility shall be in compliance with G.S. 131E, Article 9 regarding Certificate of Need.  A facility shall be licensed for no more beds than the number for which required physical space and other required facilities are available.  Neonatal Level II, III and IV beds are considered part of the licensed bed capacity.  Level I bassinets are not considered part of the licensed bed capacity however, no more bassinets shall be placed in service than the number for which required physical space and other required facilities are available.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Temporary Amendment Eff. March 15, 2002;

Amended Eff. April 1, 2003.

 

10A NCAC 13B .3103       CLASSIFICATION OF MEDICAL FACILITIES

(a)  For purpose of this Subchapter the classification of "hospital" shall be restricted to facilities that provide as their functions diagnostic services and medical and nursing care in the treatment of acute stages of illness.  On the basis of specialized facilities and services available, the Division shall license each such hospital according to the following medical types:

(1)           general acute care hospital;

(2)           rehabilitation hospital;

(3)           critical access hospital; or

(4)           long term acute care hospital which is a hospital which has been classified and certified as a long term care hospital pursuant to 42 CFR Part 412.

(b)  All other inpatient medical facilities accepting patients requiring skilled nursing services but which are not operated as a part of any hospital within the above meaning shall be considered to be operating as a nursing home and, therefore, are not subject to licensure pursuant to this Subchapter.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. June 1, 2005.

 

10A NCAC 13B .3104       LENGTH OF LICENSE

Licenses shall remain in effect until one of the following occurs:

(1)           Division imposes an administrative sanction which specifies license expiration;

(2)           change of ownership;

(3)           closure;

(4)           change of site;

(5)           failure to comply with Rule .3105 of this Section.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3105       STATISTICAL INFORMATION

Utilization data shall be submitted annually upon request by the Division.  Forms for collection of this data will be forward to each facility by the Division.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3106       LICENSURE SURVEYS

(a)  Prior to the initial issuance of a license to operate a facility, the Division shall conduct a survey to determine compliance with rules promulgated pursuant to G.S. 131E-79.

(b)  The Division may conduct an investigation of a complaint in any facility.

(c)  Facilities that are accredited through an accrediting body approved pursuant to section 1865(a) of the Social Security Act shall not be subject to routine inspections.

(d)  The Division shall survey non-accredited facilities at least once every three years.

 

History Note:        Authority G.S. 131E-79; 131E-80;

Eff. January 1, 1996;

Amended Eff. October 1, 2010.

 

10A NCAC 13B .3107       DENIAL, AMENDMENT OR REVOCATION OF LICENSE

(a)  The Department may deny any licensure application upon becoming aware that the applicant is not in compliance with any applicable provision of the Certificate of Need law located in G.S. 131E, Article 9 and the rules adopted under that law.

(b)  The Department may amend a license by reducing it from a full license to a provisional license whenever the Department finds that:

(1)           the licensee has failed to comply with the provisions of G.S. 131E, Article 5 and the rules promulgated under that article;

(2)           there is a probability that the licensee can remedy the licensure deficiencies within a length of time not to exceed the expiration date on the license; and

(3)           there is a probability that the licensee will be able thereafter to remain in compliance with the hospital licensure rules for the foreseeable future.

(c)  The Department shall also amend a license to provisional status by specifically prohibiting a licensee from providing certain services, for which it has been found to be out of compliance with G.S. 131E, Articles 5 or 9.  In all cases the Department shall give the licensee written notice of the amendment of the license.  This notice shall be given by registered or certified mail or by personal service and shall set forth:

(1)           the length of the provisional license;

(2)           the factual allegations;

(3)           the statutes and rules alleged to be violated; and

(4)           notice of the facility's right to a contested case hearing on the amendment of the license.

(d)  The provisional license shall be effective immediately upon its receipt by the licensee and shall be posted in a prominent location, accessible to public view, within the licensed premises in lieu of the full license.  The provisional license shall remain in effect until:

(1)           the Department restores the licensee to full licensure status;

(2)           the Department revokes the licensee's license; or

(3)           the end of the licensee's licensure period.  If a licensee has a provisional license at the time that the licensee submits a renewal application, the license, if renewed, shall also be a provisional license unless the Department determines that the licensee can be returned to full licensure status.  A decision to issue a provisional license is stayed during the pendency of an administrative appeal and the licensee may continue to display its full license during the appeal.

(e)  The Department shall revoke a license whenever:

(1)           The Department finds that:

(A)          the licensee has failed to comply with the provisions of G.S. 131E, Article 5 and the rules promulgated under that article; and

(B)          it is not probable that the licensee can remedy the licensure deficiencies within a length of time acceptable to the Department; or

(2)           The Department finds that:

(A)          The licensee has failed to comply with the provisions of G.S. 131E, Article 5; and

(B)          although the licensee may be able to remedy the deficiencies within a reasonable time, it is not probable that the licensee will be able to remain in compliance with hospital licensure rules for the foreseeable future; or

(3)           The Department finds that the licensee has failed to comply with any of the provisions of G.S. 131E, Article 5 and the rules promulgated thereunder that endangers the health, safety or welfare of the patients in the facility.

The issuance of a provisional license is not a procedural prerequisite to the revocation of a license pursuant to Subparagraphs (e)(1), (2) or (3) of this Rule.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3108       SUSPENSION OF ADMISSIONS

(a)  The Department may amend a license, pursuant to G.S. 131E-78, by suspending the admission of any new patients to any facility when the conditions in the facility are detrimental to the health or safety of the patients in the facility.

(b)  The Department shall notify the facility by registered or certified mail or by personal service of the decision to suspend admissions.  Such notice will include:

(1)           the period of the suspension;

(2)           factual allegations;

(3)           citation of statutes and rules alleged to be violated; and

(4)           notice of the facility's right to a contested case hearing.

(c)  The suspension shall be effective when the notice is served or on the date specified in the notice of suspension, whichever is later.  The suspension shall remain effective for the period specified in the notice or until the facility demonstrates to the Department that conditions are no longer detrimental to the health and safety of the patient.

(d)  The facility shall not admit new patients during the effective period of the suspension.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3109       PROCEDURE FOR APPEAL

A facility may appeal any decision of the Department to deny, revoke or amend a license or any decision to suspend admissions by making such an appeal in accordance with G.S. 150B.

 

History Note:        Authority G.S. 131E-78; 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3110       ITEMIZED CHARGES

(a)  The facility shall either present an itemized list of charges to all discharged patients or the facility shall include on patients' bills, which are not itemized, notification of the right to request an itemized bill within 30 days of receipt of the non-itemized bill.

(b)  If requested, the facility shall present an itemized list of charges to each patient, or the patient's responsible party.

(c)  The itemized listing shall include, at a minimum, those charges incurred in the following service areas:

(1)           room rates;

(2)           laboratory;

(3)           radiology and nuclear medicine;

(4)           surgery;

(5)           anesthesiology;

(6)           pharmacy;

(7)           emergency services;

(8)           outpatient services;

(9)           specialized care;

(10)         extended care;

(11)         prosthetic and orthopedic appliances; and

(12)         professional services provided by other independently billing medical personnel.

 

History Note:        Authority G.S. 131E-79; 131E-91;

Eff. January 1, 1996.

 

10A NCAC 13B .3111       TEMPORARY CHANGE IN BED CAPACITY

(a)  A hospital may temporarily increase its bed capacity by up to 10 percent over its licensed bed capacity, as determined by the administrator, by utilizing observational beds for inpatients for a period of no more than 60 consecutive days following approval by the Division of Health Service Regulation. 

(b)  To qualify for a temporary change in licensed capacity, the hospital census shall be at least 90 percent of its licensed bed capacity, excluding beds that are under renovation or construction, and the hospital must demonstrate conditions requiring the temporary increase that may include but are not limited to the following:

(1)           natural disaster;

(2)           catastrophic event; or

(3)           disease epidemic.

(c)  The Division may approve a temporary increase in licensed beds only if:

(1)           It is determined that the request has met the requirements of Paragraphs (a) and (b) of this Rule; and

(2)           The hospital administrator certifies that the physical facilities to be used are adequate to safeguard the health and safety of patients.  However this approval shall be revoked if the Division determines, as a result of a physical site visit, that these safeguards are not adequate to safeguard the health and safety of patients.

 

History Note:        Authority G.S. 131E-79;

Eff. April 1, 2003.

 

SECTION .3200 - GENERAL HOSPITAL REQUIREMENTS

 

10A NCAC 13B .3201       HOSPITAL REQUIREMENTS

A facility shall have all of the following:

(1)           an organized governing body;

(2)           a chief executive officer;

(3)           an organized medical staff;

(4)           an organized nursing staff;

(5)           continuous medical services;

(6)           continuous nursing services;

(7)           permanent on-site facilities for the care of patients 24 hours a day;

(8)           a hospital-wide infection control program;

(9)           minimum on-site clinical provisions as follows:

(a)           appropriately equipped inpatient care areas;

(b)           nursing care units;

(c)           diagnostic and treatment areas to include on-site laboratory and imaging facilities with the capacity to provide immediate response to patient emergencies;

(d)           pharmaceutical services in compliance with the Pharmacy Laws of North Carolina;

(e)           facilities to assure the sterilization of equipment and supplies;

(f)            medical records services;

(g)           provision for social work services;

(h)           current reference sources to meet staff needs; and

(i)            nutrition services.

(10)         minimum supportive capabilities or facilities as follows:

(a)           nutrition and dietetic services;

(b)           scheduled general and preventive maintenance services for building, services and biomedical equipment;

(c)           capability for obtaining police and fire protection, emergency transportation, grounds-keeping, and snow removal;

(d)           personnel recruitment, training and continuing education;

(e)           business management capability;

(f)            short and long-range planning capability;

(g)           financial plan to provide continuity of operation under both normal and emergency conditions;

(h)           provision for patient, employee, and visitor safety; and

(i)            policies for preventive and corrective maintenance including procedures to be followed in the event of a breakdown of essential equipment.

(11)         facilities must comply with construction rules in Sections .6000 - .6200 of this Subchapter.

(12)         a risk management program as follows:

(a)           a specific staff member shall be assigned responsibility for development and administration of the program;

(b)           a written policy statement evidencing a current commitment to the risk management program together with written procedures, policies and educational programs applicable to a risk management program which are reviewed at least every three years and updated as necessary;

(c)           established lines of communication between the risk management program and other functions relating to quality of patient care, safety, and professional staff performance; and

(d)           a written report of the activities of the risk management program shall be annually submitted to the governing body.

(13)         a quality assessment and improvement program which provides:

(a)           continuous assessment and evaluation of patient care and related services in all services and departments;

(b)           a designated individual to coordinate the quality assessment and improvement program who will assist in the establishment of quality assessment and improvement plans and reporting methods for each service and department;

(c)           a committee made up of representatives of the medical and nursing staff, administration, and other services or departments as defined by the hospital to coordinate the program, meet at least quarterly and maintain minutes of the meetings and committee activities; and

(d)           for each service and department as defined by the hospital to be involved in the continuous assessment, monitoring and evaluation of patient care and related services.

 

History Note:        Authority G.S. 131E-75; 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3202       ADMISSION AND DISCHARGE

(a)  The facility shall provide written admission and discharge, and referral policies.

(b)  There shall be on the premises at all times an employee authorized to receive patients and to make arrangements for their disposition.

(c)  A patient shall be admitted only under the care of a member of the medical staff meeting the provisions of Section .3700 of this Subchapter.

(d)  The facility shall take appropriate precautions to protect the safety and legal rights of patients and employees.

(e)  The facility shall maintain a complete and permanent record of all outpatients and inpatients including the date and time of admission and discharge.  Effort shall be made to verify the full and true name, address, date of birth, nearest of kin, provisional diagnosis, condition on admission and discharge, referring physicians, attending physician or service.

(f)  Facility staff shall provide at the time of admission an identification bracelet, band, or other suitable device for positive identification of each patient.

(g)  No mentally competent adult shall be detained by the facility against his will, except as authorized by law.

 

History Note:        Authority G.S. 131E-75; 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3203       DISCHARGE PLANNING

(a)  Discharge planning shall be an integral part of in-patient hospitalization.

(b)  The facility shall have written policies and procedures governing discharge planning.  These shall include but need not be limited to the following:

(1)           appropriate screening to determine the need for discharge planning;

(2)           methods to facilitate the provision of follow-up care;

(3)           information to be given to the patient or his family or other persons involved in caring for the patient on matters such as the patient's condition; his health care needs; the amount of activity he should engage in; any necessary medical regimens including drugs, nutrition therapy, appointments or other forms of therapy; sources of additional help from other agencies; and procedures to follow in case of complications; and

(4)           procedures for assisting the patient and his family in gaining information regarding financial assistance in paying bills incurred as a result of the hospitalization, including how to receive assistance from the various federal and State government programs.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3204       TRANSFER AGREEMENT

(a)  Any facility which does not provide hospital based nursing facility service shall maintain written agreements with institutions offering this kind of care.  Such agreements shall provide for the transfer and admission of patients who no longer require the services of the hospital but do require nursing facility services.

(b)  A patient shall not be transferred to another medical care facility unless prior arrangements for admission have been made.  Clinical records of sufficient content to provide continuity of care shall accompany the patient.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3205       DISCHARGE OF MINOR OR INCOMPETENT

Any individual who cannot legally consent to his own care shall be discharged only to the custody of parents, legal guardian, person standing in loco parentis, or another competent adult unless otherwise directed by the parent or guardian or court of competent jurisdiction.  If the parent or guardian directs that discharge be made otherwise, he shall so state in writing, and the statement shall become a part of the permanent medical record of the patient.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3300 - PATIENT'S BILL OF RIGHTS

 

10A NCAC 13B .3301       PRINCIPLE

It is the purpose of these requirements to promote the interests and well-being of the patients in facilities subject to this Subchapter even in those instances where the interests of the patients may be in opposition to the interests of the facility.  The facility has the right to expect the patient to fulfill patient responsibilities as may be stated in the facilities' policies affecting patient care and conduct.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3302       MINIMUM PROVISIONS OF PATIENT'S BILL OF RIGHTS

This Rule does not apply to patients in licensed nursing facility beds since these individuals are granted rights pursuant to G.S. 131E-117. A patient in a facility subject to this Rule has the following rights: 

(1)           A patient has the right to respectful care given by competent personnel.

(2)           A patient has the right, upon request, to be given the name of his attending physician, the names of all other physicians directly participating in his care, and the names and functions of other health care persons having direct contact with the patient.

(3)           A patient has the right to privacy concerning his own medical care program.  Case discussion, consultation, examination, and treatment are considered confidential and shall be conducted discreetly.

(4)           A patient has the right to have all records pertaining to his medical care treated as confidential except as otherwise provided by law or third party contractual arrangements.

(5)           A patient has the right to know what facility rules and regulations apply to his conduct as a patient.

(6)           A patient has the right to expect emergency procedures to be implemented without unnecessary delay.

(7)           A patient has the right to good quality care and high professional standards that are continually maintained and reviewed.

(8)           A patient has the right to full information in laymen's terms, concerning his diagnosis, treatment and prognosis, including information about alternative treatments and possible complications.  When it is not possible or medically advisable to give such information to the patient, the information shall be given on his behalf to the patient's designee.

(9)           Except for emergencies, a physician must obtain necessary informed consent prior to the start of any procedure or treatment, or both.

(10)         A patient has the right to be advised when a physician is considering the patient as a part of a medical care research program or donor program.  Informed consent must be obtained prior to actual participation in such a program and the patient or legally responsible party, may, at any time, refuse to continue in any such program to which he has previously given informed consent.  An Institutional Review Board (IRB) may waive or alter the informed consent requirement if it reviews and approves a research study in accord with federal regulations for the protection of human research subjects including U.S. Department of Health and Human Services (HHS) regulations under 45 CFR Part 46 and U.S. Food and Drug Administration (FDA) regulations under 21 CFR Parts 50 and 56.  For any research study proposed for conduct under an FDA "Exception from Informed Consent Requirements for Emergency Research" or an HHS "Emergency Research Consent Waiver" in which informed consent is waived but community consultation and public disclosure about the research are required, any facility proposing to be engaged in the research study also must verify that the proposed research study has been registered with the North Carolina Medical Care Commission.  When the IRB reviewing the research study has authorized the start of the community consultation process required by the federal regulations for emergency research, but before the beginning of that process, notice of the proposed research study by the facility shall be provided to the North Carolina Medical Care Commission.  The notice shall include:

(a)           the title of the research study;

(b)           a description of the research study, including a description of the population to be enrolled;

(c)           a description of the planned community consultation process, including currently proposed meeting dates and times;

(d)           an explanation of the way that people choosing not to participate in the research study may opt out; and

(e)           contact information including mailing address and phone number for the IRB and the principal investigator.

The Medical Care Commission may publish all or part of the above information in the North Carolina Register, and may require the institution proposing to conduct the research study to attend a public meeting convened by a Medical Care Commission member in the community where the proposed research study is to take place to present and discuss the study or the community consultation process proposed.

(11)         A patient has the right to refuse any drugs, treatment or procedure offered by the facility, to the extent permitted by law, and a physician shall inform the patient of his right to refuse any drugs, treatment or procedures and of the medical consequences of the patient's refusal of any drugs, treatment or procedure.

(12)         A patient has the right to assistance in obtaining consultation with another physician at the patient's request and expense.

(13)         A patient has the right to medical and nursing services without discrimination based upon race, color, religion, sex, sexual orientation, gender identity, national origin or source of payment.

(14)         A patient who does not speak English shall have access, when possible, to an interpreter.

(15)         A facility shall provide a patient, or patient designee, upon request, access to all information contained in the patient's medical records.  A patient's access to medical records may be restricted by the patient's attending physician.  If the physician restricts the patient's access to information in the patient's medical record, the physician shall record the reasons on the patient's medical record.  Access shall be restricted only for sound medical reason.  A patient's designee may have access to the information in the patient's medical records even if the attending physician restricts the patient's access to those records.

(16)         A patient has the right not to be awakened by hospital staff unless it is medically necessary.

(17)         The patient has the right to be free from duplication of medical and nursing procedures as determined by the attending physician.

(18)         The patient has the right to medical and nursing treatment that avoids unnecessary physical and mental discomfort.

(19)         When medically permissible, a patient may be transferred to another facility only after he or his next of kin or other legally responsible representative has received complete information and an explanation concerning the needs for and alternatives to such a transfer.  The facility to which the patient is to be transferred must first have accepted the patient for transfer.

(20)         The patient has the right to examine and receive a detailed explanation of his bill.

(21)         The patient has a right to full information and counseling on the availability of known financial resources for his health care.

(22)         A patient has the right to be informed upon discharge of his continuing health care requirements following discharge and the means for meeting them.

(23)         A patient shall not be denied the right of access to an individual or agency who is authorized to act on his behalf to assert or protect the rights set out in this Section.

(24)         A patient has the right to be informed of his rights at the earliest possible time in the course of his hospitalization.

(25)         A patient has the right to designate visitors who shall receive the same visitation privileges as the patient's immediate family members, regardless of whether the visitors are legally related to the patient.

 

History Note:        Authority G.S. 131E-75; 131E-79; 143B-165;

RRC Objection due to ambiguity Eff. July 13, 1995;

Eff. January 1, 1996;

Temporary Amendment Eff. April 1, 2005;

Amended Eff. January 1, 2011; May 1, 2008; November 1, 2005.

 

10A NCAC 13B .3303       PROCEDURE

(a)  The facility shall develop and implement procedures to inform each patient of his rights.  Copies of the facilities' Patient's Bill of Rights shall be made available through one of the following ways:

(1)           prominent displays in appropriate locations in addition to copies available upon request; or

(2)           provision of a copy to each patient or responsible party upon admission or as soon after admission as is feasible.

(b)  The address and telephone number of the section in the Department responsible for the enforcement of the provisions of this part shall be posted.

(c)  The facility shall adopt procedures to ensure effective and fair investigation of violations of patients' rights and to ensure their enforcement.  These procedures shall ensure that:

(1)           a system is established to identify formal written complaints;

(2)           formal written complaints are recorded and investigated;

(3)           investigation and resolution of formal complaints shall be conducted; and

(4)           disciplinary and education procedures shall be developed for members of the hospital and medical staff who are noncompliant with facility policies.

(d)  The Division shall investigate or refer to appropriate State agencies all complaints within the jurisdiction of the rules in this Subchapter.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3400 - SUPPLEMENTAL RULES FOR THE LICENSURE OF critical access HOSPITALS

 

10A NCAC 13B .3401       SUPPLEMENTAL RULES

The rules of this Section pertain only to designated Critical Access Hospitals in accordance with 42 CFR 485 Subpart F.  The general requirements of this Subchapter shall apply to such facilities except where they are specifically waived or modified by the rules of this Section.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. November 1, 2004.

 

10A NCAC 13B .3402       DEFINITIONS

The following definitions shall apply throughout this Section, unless context otherwise clearly indicates to the contrary:

(1)           "Available" means provided directly by the facility or by written agreement with a qualified provider of the service within one hour driving time.

(2)           "Critical Access Hospital" means a facility designated by the North Carolina Office of Research, Demonstrations and Rural Health Development in accordance with 42 CFR 485 Subpart F.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. November 1, 2004.

 

10A NCAC 13B .3403       LICENSURE APPLICATION

10A NCAC 13B .3404       FEDERALLY CERTIFIED PRIMARY CARE HOSPITAL

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Repealed Eff. November 1, 2004.

 

10A NCAC 13B .3405       DESIGNATED CRITICAL ACCESS HOSPITALS

The requirements of 10A NCAC 13B shall apply to Critical Access Hospitals with the following modifications:

(1)           Autopsy facilities required in Rule .4907 of this Subchapter are not required provided that the facility has in effect a written agreement with another facility meeting Rule .4907 of this Subchapter for providing autopsy services.

(2)           Radiological services required in Section .4800 and Rule .6210 of this Subchapter are not required provided that the facility has a written agreement with another licensed facility meeting the requirements of Section .4800 and Rule .6210 of this Subchapter which makes radiological service available.

(3)           Emergency services required in Rules .4102-.4110 of this Subchapter are not required.  Emergency response capability set forth in Rule .4101 of this Subchapter shall be provided.  Medical staff shall require that facility personnel are capable of initiating life-saving measures at a first-aid level of response for any patient or person in need of such services.  This shall include:

(a)           Establishing protocols or agreements with any facility providing emergency services;

(b)           Initiating basic cardio-pulmonary resuscitation according to the American Red Cross or American Heart Association standards;

(c)           Availability of intravenous fluids and supplies required to establish intravenous access; and

(d)           Availability of first-line emergency drugs as specified by the medical staff.

(4)           Anesthesia services required in Section .4600 of this Subchapter are not required in hospitals not offering outpatient surgery services.

(5)           Food services required in Section .4700 of this Subchapter shall be provided for inpatients directly or made available through contractual arrangements.

(6)           "Observation bed" as defined in Rule .3001(32) of this Subchapter does not apply.  For purposes of this Section, "Observation bed" means a bed used for no more than 48-hours, to evaluate and determine the condition and disposition of a patient and is not considered a part of the hospital's licensed bed capacity.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. November 1, 2004.

 

SECTION .3500 - GOVERNANCE AND MANAGEMENT

 

10A NCAC 13A .3501       GOVERNING BODY

(a)  The governing body, owner or the person or persons designated by the owner as the governing authority shall be responsible for seeing that the objectives specified in the charter (or resolution if publicly owned) are attained.

(b)  The governing body shall be the final authority in the facility to which the administrator, the medical staff, the personnel and all auxiliary organizations are directly or indirectly responsible.

(c)  A local advisory board shall be established if the facility is owned or controlled by an organization or persons outside of North Carolina.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3502       REQUIRED POLICIES, RULES, AND REGULATIONS

(a)  The governing body shall adopt written policies, rules, and regulations in accordance with all requirements con­tained in this Subchapter and in accordance with the community responsibility of the facility.  As a minimum, the written policies, rules, and regulations shall:

(1)           state the general and specific goals of the facility;

(2)           describe the powers and duties of the governing body officers and committees and the responsibilities of the chief executive officer;

(3)           state the qualifications for governing body membership, the procedures for selecting members, and the terms of service for members, officers and committee chairmen;

(4)           describe the authority delegated to the chief executive officer and to the medical staff.  No assignment, referral, or delegation of authority by the governing body shall relieve the governing body of its responsibility for the conduct of the facility.  The governing body shall retain the right to rescind any such delegation;

(5)           require Board approval of the bylaws of any auxiliary organizations established by the hospital;

(6)           require the governing body to review and approve the bylaws of the medical staff organization;

(7)           establish a procedure for processing and evaluating the applications for medical staff membership and for the granting of clinical privileges;

(8)           establish a procedure for implementing, disseminating, and enforcing a Patient's Bill of Rights as described in Rule .3302 of this Subchapter and in compliance with G.S. 131E-117 where applicable; and

(9)           require the governing body to institute procedures to provide for:

(A)          orientation of newly elected board members to specific board functions and procedures;

(B)          the development of procedures for periodic reexamination of the relationship of the board to the total facility community; and

(C)          the recording of minutes of all governing body and executive committee meetings and the dissemination of those minutes, or summaries thereof, on a regular basis to all members of the governing body.

(b)  The written policies, rules, and regulations shall be reviewed at least every three years, revised as necessary, and dated to indicate when last reviewed or revised.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3503       FUNCTIONS

The governing body shall:

(1)           provide management, physical resources and personnel required to meet the needs of the patients for which it is licensed;

(2)           require management to establish a quality control mechanism which includes as an integral part a risk management component and an infection control program;

(3)           formulate short-range and long-range plans for the development of the facility;

(4)           conform to all applicable federal, State and local laws and regulations;

(5)           provide for the control and use of the physical and financial resources of the facility;

(6)           review the annual audit, budget and periodic reports of the financial operations of the facility;

(7)           consider the advice of the medical staff in granting and defining the scope of clinical privileges to individuals.  When the governing body does not concur in the medical staff recommendation regarding the clinical privileges of an individual, there shall be a review of the recommendation by a joint committee of the medical staff and governing body before a final decision is reached by the governing body;

(8)           require that applicants be informed of the disposition of their application for medical staff membership or clinical privileges, or both, within an established period of time after their application has been submitted;

(9)           review and approve the medical staff bylaws, rules and regulations body;

(10)         delegate to the medical staff the authority to evaluate the professional competence of staff members and applicants for staff privileges and hold the medical staff responsible for recommending initial staff appointments, reappointments and assignments or curtailments of privileges;

(11)         require that resources be made available to address the emotional and spiritual needs of patients either directly or through referral or arrangement with community agencies;

(12)         maintain effective communication with the medical staff which shall be established, through:

(a)           meetings with the Executive Committee of the Medical Staff;

(b)           service by the president of the medical staff as a member of the governing body with or without a vote;

(c)           appointment of individual medical staff members to governing body committees; or

(d)           a joint conference committee;

(13)         require the medical staff to establish controls that are designed to provide that standards of ethical professional practices are met;

(14)         provide the necessary staff support to facilitate utilization review and infection control within the facility and to support quality control, any other medical staff functions required by this Subchapter or by the facility bylaws;

(15)         meet the following disclosure requirements:

(a)           provide data required by the Division;

(b)           disclose the facility's average daily inpatient charge upon request of the Division; and

(c)           disclose the identity of persons owning 5.0 percent or more of the facility as well as the facility's officers and members of the governing body upon request;

(16)         establish a procedure for reporting the occurrence and disposition of any unusual incidents.  These procedures shall require that:

(a)           incident reports are analyzed and summarized; and

(b)           corrective action is taken as indicated by the analysis of incident reports;

(17)         in a facility with one or more units, or portions of units, however described, utilized for psychiatric or substance abuse treatment, adopt policies implementing the provisions of G.S. 122C, Article 3, and Article 5, Parts, 2, 3, 4, 5, 7, and 8;

(18)         develop arrangements for the provision of extended care and other long-term healthcare services.  Such services shall be provided in the facility or by outside resources through a transfer agreement or referrals;

(19)         provide and implement a written plan for the care or for the referral, or for both, of patients who require mental health or substance abuse services while in the hospital;

(20)         develop a conflict of interest policy which shall apply to all governing body members and corporate officers.  All governing body members shall execute a conflict of interest statement;

(21)         prohibit members of the governing body from engaging in the following forms of self-dealing:

(a)           the sale, exchange or leasing of property or services between the facility and a governing board member, his employer or an organization substantially controlled by him on a basis less favorable to the facility than that on which such property or service is made available to the general public;

(b)           furnishing of goods, services or facilities by a facility to a governing board member, unless such furnishing is made on a basis not more favorable than that on which such goods, services, or facilities are made available to the general public or employees of the facility; or

(c)           any transfer to or use by or for the benefit of a governing board member of the income or assets of a facility, except by purchase for fair market value; and

(22)         prohibit the lease, sale, or exclusive use of any facility buildings or facilities receiving a license in accordance with this Subchapter to any entity which provides medical or other health services to the facility's patients, unless there is full, complete disclosure to and approval from the Division.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3600 - MANAGEMENT AND ADMINISTRATION OF OPERATIONS

 

10A NCAC 13B .3601       CHIEF EXECUTIVE OFFICER

(a)  The governing body shall designate a chief executive officer whose qualifications, authority, responsibilities and duties shall be defined in a written statement adopted by the governing body.

(b)  The chief executive officer shall be the designated representative of the governing body and may be given any one or more or all of the responsibilities set out in Rule .3602 of this Section.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3602       RESPONSIBILITIES

The governing body shall adopt written policies, rules, and regulations that specify the officer or officers that shall:

(1)           act for the chief executive officer in his absence;

(2)           manage the facility consonant with its expressed aims and policies;

(3)           attend meetings of the governing body and appropriate meetings of the medical staff;

(4)           implement policies adopted by the governing body for the operation of the facility;

(5)           organize the administrative functions of the facility, delegate duties and establish formal means of accountability on the part of subordinates;

(6)           establish such facility departments as are indicated, provide for departmental and interdepartmental meetings and attend or be represented at such meetings, and appoint hospital departmental representatives to medical staff committees where appropriate or when requested to do so by the medical staff;

(7)           appoint the heads of administrative departments;

(8)           report to the governing body and to the medical staff on the overall activities of the facility as well as on appropriate federal, State and local developments that affect health care in the facility;

(9)           review the annual audit of the financial operations of the facility and acting upon recommendations therein;

(10)         provide fiscal planning and financial management of the facility including the provision of annual budgets and periodic financial status reports to the governing board;

(11)         develop in cooperation with the departmental heads and other appropriate staff, an overall organizational plan for the facility which will coordinate the functions, services and departments of the facility, when possible; and

(12)         require that the agreements with service providers, such as laundry, laboratory and imaging, specifically indicate that compliance will be maintained with applicable State rules as would apply to the same services if provided directly by the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3603       PERSONNEL POLICIES AND PRACTICES

The facility shall develop, establish and maintain personnel policies and practices which support sound patient care.  The policies shall be in writing and made available to all employees, and they shall be reviewed periodically but no less often than once every three years.  The date of the most recent review shall be indicated on the written policies.  A procedure shall be established for notifying employees of changes in the established personnel policies.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3604       JOB DESCRIPTIONS

The facility shall develop and make available to the employee a written job description for each type of job in the facility, including the chief executive officer and heads of departments.  Each job description shall include a written description of the education, experience, license, certification, or other qualifications required for the position.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3605       PERSONNEL RECORDS

(a)  The facility shall maintain accurate and complete personnel records for each facility employee during the term of employment and for two years thereafter.  The chief executive officer may designate an individual to carry out this assignment.

(b)  Personnel records shall be maintained under such conditions as may be required by state or federal law and shall contain at least the following:

(1)           information regarding the employee's education, training and experience and clinical competence, including, if applicable, professional licensure status and license number, sufficient to verify the employee's qualifications for the job for which he is employed.  Such information shall be kept current.  Applicants for positions requiring a licensed person shall be hired only after obtaining verification of their licenses from the appropriate board;

(2)           current information relative to periodic work performance evaluations;

(3)           records of such pre-employment health examinations and of subsequent health services rendered to the employees as are necessary to determine that all facility employees are physically able to perform the essential duties of their positions.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3606       EDUCATION PROGRAMS

The facility shall provide new employee orientation and continuing education programs for all employees to maintain the skills necessary for the performance of their duties and learn new developments in health care.  Records shall be maintained of all orientation and educational programs, and of the participants.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3607       PERSONNEL HEALTH REQUIREMENTS

Employees shall have pre-employment medical examinations and interim examinations in accordance with medical criteria established by the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3608       INSURANCE

The governing board shall have in place an insurance program which provides for the protection of the physical and financial resources of the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3609       AUDIT OF FINANCIAL OPERATIONS

An audit of the financial operations of the facility shall be performed by a public accountant at least once a year.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3700 - MEDICAL STAFF

 

10A NCAC 13B .3701       GENERAL PROVISIONS

The facility shall have a medical staff organized in accordance with the facility's by-laws which shall be accountable to the governing body and which shall have responsibility for the quality of professional services provided by individuals with clinical privileges.  Facility policy shall provide that individuals with clinical privileges shall perform only services within the scope of individual privileges granted.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3702       ESTABLISHMENT

The medical staff shall be established in accordance with the by-laws, rules or regulations of the medical staff and with the written policies, rules or regulations of the facility.  The governing body of the facility, after considering the recommendations of the medical staff, may grant clinical privileges to other qualified, licensed practitioners in accordance with their training, experience, and demonstrated competence and judgment in accordance with the medical staff by-laws, rules or regulations.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3703       APPOINTMENT

Formal appointment for membership and granting of clinical privileges shall follow procedures set forth in the by-laws, rules or regulations of the medical staff.  These procedures shall require the following:

(1)           a signed application for membership, specifying age, year and school of graduation, date of licensure, statement of postgraduate or special training and experience with a statement of the scope of the clinical privileges sought by the applicant;

(2)           verification by the hospital of the qualifications of the applicant as stated in the application, including evidence of continuing education;

(3)           written notice to the applicant from the medical staff and the governing body, regarding appointment or reappointment which specifies the approval or denial of clinical privileges and the scope of the privileges granted; and

(4)           members of the medical staff and others granted clinical privileges in the facility shall hold current licenses to practice in North Carolina.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3704       STATUS

(a)  Every facility shall have an active medical staff to deliver medical services within the facility.  The active medical staff shall be responsible for the organization and administration of the medical staff.  Every member of the active medical staff shall be eligible to vote at medical staff meetings and to hold office.

(b)  The active medical staff may establish other categories for membership in the medical staff.  These categories for membership shall be identified and defined in the medical staff bylaws, rules or regulations adopted by the active medical staff.  Examples of these other categories for membership are:

(1)           associate medical staff;

(2)           courtesy medical staff;

(3)           temporary medical staff;

(4)           consulting medical staff;

(5)           honorary medical staff; or

(6)           other staff classifications.

The medical staff bylaws, rules or regulations may grant limited or full voting rights to any one or more of these other membership categories.

(c)  Medical staff appointments shall be reviewed at least once every two years by the governing board.

(d)  The facility shall maintain an individual file for each medical staff member.  Representatives of the Department shall have access to these files in accordance with G.S. 131E-80.

(e)  Minutes of all actions taken by the medical staff and the governing board concerning clinical privileges shall be maintained by the medical staff and the governing board, respectively.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3705       MEDICAL STAFF BYLAWS, RULES OR REGULATIONS

(a)  The active medical staff shall develop and adopt, subject to the approval of the governing body, a set of bylaws, rules or regulations, to establish a framework for self governance of medical staff activities and accountability to the governing body.

(b)  The medical staff bylaws, rules and regulations shall provide for at least the following:

(1)           organizational structure;

(2)           qualifications for staff membership;

(3)           procedures for admission, retention, assignment, and reduction or withdrawal of privileges;

(4)           procedures for fair hearing and appellate review mechanisms for denial of staff appointments, reappointments, suspension, or revocation of clinical privileges;

(5)           composition, functions and attendance of standing committees;

(6)           policies for completion of medical records and procedures for disciplinary actions;

(7)           formal liaison between the medical staff and the governing body;

(8)           methods developed to formally verify that each medical staff member on appointment or reappointment agrees to abide by current medical staff bylaws and facility bylaws; and

(9)           procedures for members of medical staff participation in quality assurance functions.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3706       ORGANIZATION AND RESPONSIBILITIES OF THE MEDICAL STAFF

(a)  The medical staff shall be organized to accomplish its required functions and provide for the election or appointment of its officers.

(b)  There shall be an executive committee, or its equivalent, which represents the medical staff, which has responsibility for the effectiveness of all medical activities of the staff, and which acts for the medical staff.

(c)  All minutes of proceedings of medical staff committees shall be recorded and available for inspections by members of the medical staff and the governing body.

(d)  The following reviews and functions shall be performed by the medical staff:

(1)           credentialing review;

(2)           surgical case review;

(3)           medical records review;

(4)           medical care evaluation review;

(5)           drug utilization review;

(6)           radiation safety review;

(7)           blood usage review; and

(8)           bylaws review.

(e)  There shall be medical staff and departmental meetings for the purpose of reviewing the performance of the medical staff, departments or services, and reports and recommendations of medical staff and multi-disciplinary committees.  The medical staff shall ensure that minutes are taken at each meeting and retained in accordance with the policy of the facility.  These minutes shall reflect the transactions, conclusions and recommendations of the meetings.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3707       MEDICAL ORDERS

(a)  No medication or treatment shall be administered or discontinued except in response to the order of a member of the medical staff in accordance with established rules and regulations and as provided in Paragraph (f) below.

(b)  Such orders shall be dated and recorded directly in the patient chart or in a computer or data processing system which provides a hard copy printout of the order for the patient chart.  A method shall be established to safeguard against fraudulent recordings.

(c)  All orders for medication or treatment shall be authenticated according to hospital policies.  The order shall be taken by personnel qualified by medical staff rules and shall include the date, time, and name of persons who gave the order, and the full signature of the person taking the order.

(d)  The names of drugs shall be recorded in full and not abbreviated except where approved by the medical staff.

(e)  The medical staff shall establish a written policy in conjunction with the pharmacy committee or its equivalent for all medications not specifically prescribed as to time or number of doses to be automatically stopped after a reasonable time limit, but no more than 14 days.  The prescriber shall be notified according to established policies and procedures at least 24 hours before an order is automatically stopped.

(f)  For patients who are under the continuing care of an out-of-state physician but are temporarily located in North Carolina, a hospital may process the out-of-state physician's prescriptions or orders for diagnostic or therapeutic studies which maintain and support the patient's continued program of care, where the authenticity and currency of the prescriptions or orders can be verified by the physician who prescribed or ordered the treatment requested by the patient, and where the hospital verifies that the out-of-state physician is licensed to prescribe or order the treatment.

 

History Note:        Authority G.S. 131E-75; 131E-79; 143B-165;

Eff. January 1, 1996;

Amended Eff. April 1, 2005; August 1, 1998.

 

10A NCAC 13B .3708       MEDICAL STAFF RESPONSIBILITIES FOR QUALITY IMPROVEMENT REVIEW

(a)  The medical staff shall have in effect a system to review medical services rendered, to assess quality, to provide a process for improving performance when indicated and to monitor the outcome.

(b)  The medical staff shall establish criteria for the evaluation of the quality of medical care.

(c)  The facility shall have a written plan approved by the medical staff, administration and governing body which generates reports to permit identification of patient care problems.  The plan shall establish a system to use this data to document and identify interventions.

(d)  The medical staff shall establish and maintain a continuous review process of the care rendered to both inpatients and outpatients in every medical department of the facility.  At least quarterly, the medical staff shall have a meeting to examine the review process and results.  The review process shall include both practitioners and allied health professionals from the facility staff.

(e)  Minutes shall be taken at all meetings reviewing quality improvement, and these minutes shall be made available to the medical staff on a regular basis in accordance with established policy.  These minutes shall be retained as determined by the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3800 - NURSING SERVICES

 

10A NCAC 13B .3801       NURSE EXECUTIVE

(a)  Whether the facility utilizes a centralized or decentralized organizational structure, a nurse executive shall be responsible for the coordination of nursing organizational functions.

(b)  A nurse executive shall develop facility wide patient care programs, policies and procedures that describe how the nursing care needs of patients are assessed, met and evaluated.

(c)  The nurse executive shall develop and adopt, subject to the approval of the facility, a set of administrative policies and procedures to establish a framework to accomplish required functions.

(d)  There shall be scheduled meetings, at least every 60 days, of the members of the nursing staff to evaluate the quality and efficiency of nursing services.  Minutes of these meetings shall be maintained.

(e)  The nurse executive shall be responsible for:

(1)           the development of a written organizational plan which describes the levels of accountability and responsibility within the nursing organization;

(2)           identification of standards and policies and procedures related to the delivery of nursing care;

(3)           planning for and the evaluation of the delivery of nursing care delivery system;

(4)           establishment of a mechanism to validate qualifications, knowledge, and skills of nursing personnel;

(5)           provision of orientation and educational opportunities related to expected nursing performance, and maintenance of records pertaining thereto;

(6)           implementation of a system for performance evaluation;

(7)           provision of nursing care services in conformance with the North Carolina Nursing Practice Act;

(8)           assignment of nursing staff to clinical or managerial responsibilities based upon educational preparation, in conformance with licensing laws and an assessment of current competence; and

(9)           staffing nursing units with sufficient personnel in accordance with a written plan.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3802       NURSING STAFF

(a)  Licensed nurses and other nursing personnel shall be qualified by training, education, experience and demonstrated abilities to provide nursing care within their scope of practice.

(b)  Staffing schedules which reflect personnel assignment by date and service unit shall be kept on file for at least three years by hospital management.

(c)  The facility shall establish policies for the provision of services for all contractual agreement personnel that include at a minimum the following:

(1)           verification of licensure or certification by the appropriate occupational board;

(2)           delivery and documentation of care;

(3)           participation on interdisciplinary care planning activities; and

(4)           supervision of contractual agreement personnel.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3803       NURSING POLICIES AND PROCEDURES

(a)  Nursing policies and procedures shall be available to the nursing staff in each nursing care unit and service area and shall include the following:

(1)           method of noting diagnostic and therapeutic orders;

(2)           method of assigning nursing care of patients;

(3)           infection control measures;

(4)           patient safety measurers; and

(5)           method of implementing orders for medication or treatment.

(b)  Each unit shall have relevant clinical reference materials available.  The following shall be provided to each unit:

(1)           a facility formulary or comparable drug reference;

(2)           a policy and procedure manual; and

(3)           a medical dictionary.

(c)  The facility shall provide a program of inservice education which shall be maintained and documented for all nursing staff personnel.  Annual inservices shall include infection control measures, cardiopulmonary resuscitation and fire and safety.

(d)  Nursing care policies and procedures shall be reviewed at least every three years by the nursing staff and facility management and revised as necessary.  They shall include the date to indicate the time of the most recent review or revision.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3804       PATIENT CARE

(a)  Each patient's need for nursing care related to his or her admission shall be determined by a registered nurse.  Patient needs shall be reassessed when warranted by the patient's condition.

(b)  Each patient's nursing care shall be based upon assessed needs and shall be coordinated with the therapies of other disciplines.

(c)  The patient's medical record shall include documentation of:

(1)           the initial assessment and reassessments of patient clinical status;

(2)           patient care needs;

(3)           interventions performed to meet the patient's nursing care needs;

(4)           implementation of physician's orders;

(5)           the nursing care provided; and

(6)           the patient's response to, and the outcomes of, the care provided.

(d)  Each plan of care shall be initiated within 24 hours of admission.  The plan of care shall become a part of the clinical record.

(e)  The nursing care plan shall be readily available to all physicians and facility personnel involved with the care of the patient.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3900 - MEDICAL RECORD SERVICES

 

10A NCAC 13B .3901       ORGANIZATION

(a)  The facility shall establish a medical record service.  It shall be directed, staffed and equipped to accurately process, index, and file all medical records.  Orientation, on-the-job training and inservice programs for medical records personnel shall be provided.

(b)  The medical record service shall be equipped to enable its personnel to maintain medical records so that they are readily accessible and secure from unauthorized use.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3902       MANAGER

(a)  The medical records service shall be directed and supervised by a qualified medical records manager.  If the manager is not a registered record administrator or an accredited records technician, the facility shall retain a person with those qualifications on a part-time or consulting basis.

(b)  The manager of the medical record service shall advise, administer, supervise and perform work involved in the development, analysis, maintenance and use of medical records and reports.

(c)  Where the manager is employed on a part-time or consulting basis, he or she shall organize the department, train the regular personnel and make periodic visits to the facility.  The manager shall evaluate the records and the operation of the service  and document the visits by written reports.  A written contract specifying his or her duties and responsibilities shall be kept on file and made available for inspection by the Division's surveyor.

(d)  The manager of the medical record service shall maintain a system of identification and filing to facilitate the prompt location of medical record of any patient.

(e)  The manager of the medical records service shall store medical records in such a manner as to provide protection from loss, damage, and unauthorized access.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of Statutory Authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .3903       PRESERVATION OF MEDICAL RECORDS

(a)  The manager of medical records service shall maintain medical records, whether original, computer media, or microfilm, for a minimum of 11 years following the discharge of an adult patient.

(b)  The manager of medical records shall maintain medical records of a patient who is a minor until the patient's 30th birthday.

(c)  If a hospital discontinues operation, its management shall make known to the Division where its records are stored. Records shall be stored in a business offering retrieval services for at least 11 years after the closure date.

(d)  The hospital shall give public notice prior to destruction of its records, to permit former patients or representatives of former patients to claim the record of the former patient.  Public notice shall be in at least two forms: written notice to the former patient or their representative and display of an advertisement in a newspaper of general circulation in the area of the facility.

(e)  The manager of medical records may authorize the microfilming of medical records.  Microfilming may be done on or off the premises.  If done off the premises, the facility shall provide for the confidentiality and safekeeping of the records.  The original of microfilmed medical records shall not be destroyed until the medical records department has had an opportunity to review the processed film for content.

(f)  Nothing in this Section shall be construed to prohibit the use of automation in the medical records service, provided that all of the provisions in this Rule are met and the information is readily available for use in patient care.

(g)  Only personnel authorized by state laws and Health Insurance Portability and Accountability Act regulations shall have access to medical records.  Where the written authorization of a patient is required for the release or disclosure of health information, the written authorization of the patient or authorized representative shall be maintained in the original record as authority for the release or disclosure.

(h)  Medical records are the property of the hospital, and they shall not be removed from the facility jurisdiction except through a court order.  Copies shall be made available for authorized purposes such as insurance claims and physician review.

 

History Note:        Authority G.S. 90-21.20B; 131E-79; 131E-97;

Eff. January 1, 1996;

Amended Eff. July 1, 2009.

 

10A NCAC 13B .3904       PATIENT ACCESS

The manager of medical records shall provide patients or patient designees, when requested, access to or a copy of their medical records, or both.  Upon the death of a patient, the executor of the decedent's estate, or in the absence of an executor, the next of kin responsible for the disposition of the remains, shall have access to all medical records of the deceased patient.  The patient or the patient's next of kin may be charged for the cost of reproducing copies.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3905       PATIENT MEDICAL RECORDS

(a)  Hospital management shall maintain medical records for each patient treated or examined in the facility.

(b)  The medical record or medical record system shall provide data for each episode of care and treatment rendered by the facility.

(c)  Where the medical record does not combine all episodes of inpatient, outpatient and emergency care, the medical records system shall:

(1)           assemble, upon request of the physician, any or all divergently located components of the medical record when a patient is admitted to the facility or appears for outpatient or clinic services; or

(2)           require placing copies of pertinent portions of each inpatient's medical record, such as the discharge resume, the operative note and the pathology report, in the outpatient or combined outpatient emergency unit record file as directed by the medical staff.

(d)  The manager of medical records shall ensure that:

(1)           each patient's medical record is complete, readily accessible and available to the professional staff concerned with the care and treatment of the patient;

(2)           all clinical information pertaining to a patient is incorporated in his medical record;

(3)           all entries in the record are dated and authenticated by the person making the entry;

(4)           symbols and abbreviations are used only when they have been approved by the medical staff and when there exists a legend to explain them;

(5)           verbal orders include the date and signature of the person recording them.  They shall be given and authenticated in accordance with the provisions of Rule .3707(c) of this Subchapter; and

(6)           records of patients discharged are completed within 30 days following discharge or disciplinary action is initiated as defined in the medical staff bylaws.

 

History Note:        Authority G.S. 131E-75; 131E-79; 143B-165;

Eff. January 1, 1996;

Amended Eff, April 1, 2005.

 

10A NCAC 13B .3906       CONTENTS

(a)  The medical record shall contain sufficient information to justify the diagnosis, verify the treatment and document the course of treatment and results accurately.

(b)  All in-patient records shall include the following information:

(1)           identification data (name, address, age, sex) and, when the identification data is not obtainable, the reason for such;

(2)           date and time of admission and discharge;

(3)           medical history:

(A)          chief complaint;

(B)          details of the present illness;

(C)          relevant past, social, and family histories; and

(D)          reports of relevant physical examinations;

(4)           diagnostic and therapeutic orders;

(5)           reports of procedures, tests and their results;

(6)           provisional or admitting diagnosis;

(7)           evidence of appropriate informed consent or a written statement explaining why consent was not obtained;

(8)           clinical observations, including results of therapy;

(9)           record of medication and treatment administration;

(10)         progress notes of all disciplines;

(11)         conclusions at termination of hospitalization or evaluation and treatment;

(12)         all relevant diagnosis established by the time of discharge;

(13)         consultation reports;

(14)         surgical record, including anesthesia record, pre-operative diagnosis, surgeon's operative report and post-operative orders and any instructions given to the patient or family; and

(15)         autopsy findings, if performed.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3907       MEDICAL RECORDS REVIEW

The medical staff shall review medical records periodically for completeness and shall:

(1)           establish requirements regarding completion of medical records, including a system for disciplinary actions for those who do not complete records in a timely manner; and

(2)           make recommendations to the medical records department regarding clinical information sufficient for medical care evaluation.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4000 - OUTPATIENT SERVICES

 

10A NCAC 13B .4001       ORGANIZATION

(a)  The facility shall establish and maintain outpatient care services in accordance with the facility's written mission statement.

(b)  The relationship of outpatient services to other divisions within the facility, including channels of responsibility and authority, shall be documented and made available for review by the facility.

(c)  The facility shall vest the direction of outpatient services in one or more individuals whose qualifications, authority and duties are defined in writing.

(d)  The facility shall establish and maintain procedures for the review and evaluation of outpatient services.

(e)  Each medical staff member shall have privileges delineated in accordance with criteria established by the medical staff by-laws, rules, or regulations.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4002       STAFFING

(a)  The director of outpatient services shall require that ambulatory care services are staffed with sufficient personnel in accordance with a written plan.

(b)  The responsibility for the delivery of outpatient services by the professional staff shall be defined and documented by the director of ambulatory care services.

(c)  The facility shall provide education programs specifically related to outpatient care for the staff and document the extent of participation in education and training programs.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4003       POLICIES AND PROCEDURES

(a)  The provision of outpatient services shall be guided by written policies and procedures which shall be developed by the facility and approved by the medical staff.  The policies and procedures shall be reviewed by the medical staff at least every three years.

(b)  The policies shall include the following:

(1)           patient access to outpatient services;

(2)           the process of obtaining informed consent;

(3)           the location, storage and procurement of medications, supplies and equipment; and

(4)           the mechanism to be used to contact patients for necessary follow-up.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4004       OUTPATIENT SURGICAL AND ANESTHESIA SERVICES

(a)  When surgical or anesthesia services are provided in an outpatient setting, the facility shall require that the medical staff approve all types of surgical procedures to be offered.  The facility shall maintain and make available a current listing of approved outpatient procedures.

(b)  The facility shall define the scope of anesthesia services that may be provided, the locations where such anesthesia services may be administered and who shall provide anesthesia services.

(c)  The facility shall require that standards for informed consent, history and physical examination, preoperative studies, administration of anesthesia, medical records and discharge criteria meet the same standards of care as apply for inpatient surgery unless otherwise specified by the medical staff.

(d)  The facility shall provide for back-up service by other departments in the case of emergencies or complications.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4005       MEDICAL RECORDS

(a)  The manager of outpatient services shall require that a record of outpatient care and services for each patient is maintained either in the ambulatory care services or medical records department.

(b)  The facility shall develop a system of identification and filing to prepare for safe storage and prompt retrieval of records upon subsequent inpatient or outpatient visits.

(c)  The facility shall establish medical records procedures which include provisions for maintaining the confidentiality of patient information and for the release of information to authorized individuals.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4100 - EMERGENCY SERVICES

 

10A NCAC 13B .4101       EMERGENCY RESPONSE CAPABILITY REQUIRED

The medical staff of each facility shall require that facility personnel are capable of initiating life-saving measures at a first-aid level of response for any patient or person in need of such services.  This shall include:

(1)           initiating basic cardio-respiratory resuscitation according to American Red Cross or American Heart Association standards;

(2)           availability of first-line emergency drugs as specified by the medical staff;

(3)           availability of IV fluids and supplies required to establish IV access; and

(4)           establishing protocols or agreements for the transfer of patients to a facility for a higher level of care when these services are not available on site.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4102       CLASSIFICATION OF OPTIONAL EMERGENCY SERVICES

(a)  Any facility providing emergency services shall classify its capability in providing such services according to the following criteria:

(1)           Level I:

(A)          the facility shall have a comprehensive, 24-hour-per-day emergency service with at least one physician experienced in emergency care on duty in the emergency care area;

(B)          the facility shall have in-hospital physician coverage by members of the medical staff or by senior-level residents for at least medical, surgical, orthopedic, obstetric, gynecologic, pediatric and anesthesia services;

(C)          services of other medical and surgical specialists shall be available; and

(D)          the facility shall provide prompt access to labs, radiology, operating suites, critical care and obstetric units and other services as defined by the governing body.

(2)           Level II:

(A)          the facility shall have 24-hour per day emergency service with at least one physician experienced in emergency care on duty in the emergency care area; and

(B)          the facility shall have consultation available within 30 minutes by members of the medical staff or by senior level residents to meet the needs of the patient.  Consultation by phone is acceptable.

(3)           Level III:  The facility shall have emergency service available 24 hours per day with at least one physician available to the emergency care area within 30 minutes through a medical staff call roster.

(b)  Facilities seeking trauma center designation shall comply with G.S. 131E-162.

(c)  The location of the emergency access area shall be identified by clearly visible signs.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4103       PROVISION OF EMERGENCY SERVICES

(a)  Any of any facility providing emergency services shall establish and maintain policies requiring appropriate medical screening, treatment and transfer services for any individual who presents to the facility emergency department and on whose behalf treatment is requested regardless of that person's ability to pay for medical services and without delay to inquire about the individual's method of payment.

(b)  Any facility providing emergency services under this Section shall install, operate and maintain, on a 24-hour per day basis, an emergency two-way radio licensed by the Federal Communications Commission in the Public Safety Radio Service capable of establishing voice radio communication with ambulance units transporting patients to said facility or having any written procedure or agreement for handling emergency services with the local ambulance service, rescue squad or other trained medical personnel.

(c)  All communication equipment shall be in compliance with current rules established by North Carolina Rules for Basic Life Support/Ambulance Service (10 NCAC 3D .1100) adopted by reference with all subsequent amendments.  Referenced rules are available at no charge from the Office of Emergency Medical Services, 2707 Mail Service Center, Raleigh, N.C. 27699-2707.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4104       MEDICAL DIRECTOR

(a)  The governing body shall establish the qualifications, duties, and authority of the director of emergency services.  Appointments shall be recommended by the medical staff and approved by the governing body.

(b)  The medical staff credentials committee shall approve the mechanism for emergency privileges for physicians employed for brief periods of time such as evenings, weekends or holidays.

(c)  Level I and II emergency services shall be directed and supervised by a physician with experience in emergency care.

(d)  Level III services shall be directed and supervised by a physician with experience in emergency care or through a multi-disciplinary medical staff committee.  The chairman of this committee shall serve as director of emergency medical services.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4105       NURSING

(a)  Level I and Level II emergency services shall have one or more registered nurses assigned and on duty within the emergency service area at all times.

(b)  A Level III emergency service shall have a registered nurse available on at least an on-call, in-house basis at all times.

(c)  The facility shall document that all emergency services nursing personnel shall have orientation, training and continuing education in the reception and care of emergency patients.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10 NCAC 03C .4106          POLICIES AND PROCEDURES

Each emergency department shall establish written policies and procedures which specify the scope and conduct of patient care to be provided in the emergency areas.  They shall include the following:

(1)           the location, storage, and procurement of medications, blood, supplies, equipment and the procedures to be followed in the event of equipment failure;

(2)           the initial management of patients with burns, hand injuries, head injuries, fractures, multiple injuries, poisoning, animal bites, gunshot or stab wounds and other acute problems;

(3)           the provision of care to an unemancipated minor not accompanied by a parent or guardian, or to an unaccompanied unconscious patient;

(4)           management of alleged or suspected child, elder or adult abuse;

(5)           the management of pediatric emergencies;

(6)           the initial management of patients with actual or suspected exposure to radiation;

(7)           management of alleged or suspected rape victims;

(8)           the reporting of individuals dead on arrival to the proper authorities;

(9)           the use of standing orders;

(10)         tetanus and rabies prevention or prophylaxis; and

(11)         the dispensing of medications in accordance with state and federal laws.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4107       EMERGENCY RECORDS

(a)  The facility shall require all levels of emergency departments to maintain a continuous control register on each patient seen for services which shall include at least the name, age, sex, date, time, and means of arrival, nature of complaint, disposition, and time of discharge.

(b)  The facility shall maintain a record for each patient seeking emergency care.  This shall include:

(1)           patient identification, time and means of arrival;

(2)           pertinent history and physical findings and patient vital signs;

(3)           diagnostic and therapeutic orders;

(4)           clinical observations including results of treatment;

(5)           reports of procedures, tests and results;

(6)           diagnostic impression; and

(7)           discharge or transfer summary of treatment including final disposition, the patient's condition, and any instructions given to the patient and or family for follow-up care.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4108       OBSERVATION BEDS

When observation beds are used, the facility shall implement written policies and procedures that address the type of patient use, the mechanism for providing appropriate clinical monitoring, the length of time services may be provided in this setting and documentation requirements.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4109       TRANSFER

(a)  The facility shall establish and implement protocols for stabilization and transportation of emergency patients.

(b)  A facility with specialized capabilities, such as burn units, shock-trauma units and neonatal intensive care units, shall not refuse to accept an appropriate transfer for those services if the hospital has the capacity to treat the individual.

(c)  The facility shall not transfer a patient until the receiving organization has consented to accept the patient and the patient is sufficiently stable for transport.

(d)  If the patient or the person acting on the patient's behalf refuses transfer, the facility staff shall:

(1)           explain to the individual or his representative the risks and benefits of transfer; and

(2)           shall request the patient's or his representative's refusal of transfer in writing.

(e)  The facility shall forward at the time of transfer a copy of all medical records related to the emergency condition for which the individual has presented.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4110       DISASTER AND MASS CASUALTY PROGRAM

(a)  The facility shall describe:

(1)           the level of emergency services available during an external disaster;

(2)           the emergency department's role in the facility's external disaster plan;

(3)           procedures to be followed in the event of an internal disaster; and

(4)           the facility's connection to other community services such as fire, police and the American Red Cross.

(b)  The medical staff and governing body shall approve the plan, review it and revise it if needed, annually.

(c)  The plan shall:

(1)           provide for prompt medical attention for all emergency patients as their needs may dictate;

(2)           include protocols for handling non-emergency cases;

(3)           establish medical staff coverage procedures or methods;

(4)           specify drugs, solutions and equipment to be continuously available;

(5)           provide for the evacuation and transfer for all inpatients as their needs may indicate in the event of an internal disaster; and

(6)           include mutual support agreements with area providers.

(d)  Schedules, names and telephone numbers of all physicians and others on emergency duty shall be maintained by the facility.

(e)  Names and telephone numbers of those to be contacted in the event of an internal disaster shall be maintained by the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4200 - SPECIAL CARE UNITS

 

10A NCAC 13B .4201       ORGANIZATION

(a)  The governing body shall approve the type and scope of special care units.

(b)  The facility shall document the relationship of the special care units to the other departments within the hospital, including channels of responsibility and authority.

(c)  The facility shall provide necessary equipment and supplies for delivery of nursing care specific to the unit population for each special care unit.

(d)  The facility shall provide sufficient emergency drugs and equipment to meet anticipated needs as determined by the medical staff.

(e)  The governing body shall delegate to the medical and nursing staff the responsibility to develop policies and procedures concerning the scope and provision of safe care in each unit.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4202       MEDICAL STAFF

(a)  The governing body shall provide that each special care unit or group of similar units be directed by qualified members of the medical staff whose clinical and administrative privileges have been approved by the governing board.

(b)  The governing body shall designate the director to be responsible for making decisions in consultation with the physician responsible for the patient, for the disposition of a patient when patient load exceeds optimal operation capacity.

(c)  The governing body shall require that the medical staff provide medical staff coverage sufficient to meet the specific needs of the patients on a 24-hour basis.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4203       NURSING STAFF

The supervision of nursing care for each special care unit shall be provided by a qualified registered nurse and shall include the following:

(1)           unit-specific orientation and competency evaluation for each staff member;

(2)           a staffing plan based upon the needs of the patient population which is implemented to ensure a sufficient number of qualified Registered Nurses are on duty when patients are in the unit;

(3)           assessment, planning, implementation and evaluation of nursing care which is documented according to policy; and

(4)           delivery of nursing care in accordance with the North Carolina Nurse Practice Act.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4204       POLICIES AND PROCEDURES

(a)  The facility in conjunction with the medical and nursing staff shall develop written policies and procedures which guide the provision of care in a special care unit.  These policies and procedures shall be approved by the medical staff and include:

(1)           patient admission and discharge criteria;

(2)           notification of appropriate medical staff for changes in the condition of the patient;

(3)           use of standing orders and emergency protocols;

(4)           designation of staff members authorized to perform special procedures and special circumstances requiring such authorization;

(5)           patient care procedures, including medication administration;

(6)           infection control;

(7)           pertinent safety practices;

(8)           use of equipment and procedures to be followed in the event of equipment failure;

(9)           regulations governing visitors and traffic control; and

(10)         role of special care unit in internal and external disaster plans.

(b)  The governing body shall review, update and approve regularly, but at least every three years, its policies and procedures.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4300 - MATERNAL - NEONATAL SERVICES

 

10A NCAC 13B .4301       ORGANIZATION MATERNAL SERVICES

(a)  The governing body shall approve the scope of obstetric services offered based upon the level of patient need, qualifications of the credentialed staff, and resources of the facility.

(b)  The following capabilities and minimum services shall be made available when obstetric services are provided:

(1)           identification of high-risk mothers and fetuses;

(2)           continuous electronic fetal monitoring;

(3)           cesarean delivery capability within 30 minutes of decision;

(4)           blood or fresh frozen plasma for transfusion;

(5)           anesthesia on a 24-hour or on-call basis;

(6)           radiology and ultrasound examination;

(7)           stabilization of unexpectedly small or sick neonates before transfer;

(8)           neonatal resuscitation;

(9)           laboratory services on a 24-hour or on-call basis;

(10)         consultation and transfer agreements;

(11)         assessment and care for the neonates; and

(12)         nursery or other appropriate space for care of the neonates.

(c)  In a facility without intensive care nursery services, the facility management shall establish and maintain a plan for the stabilization and transportation of sick newborns to a regional neonatal unit.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4302       MEDICAL STAFF MATERNAL SERVICES

(a)  The medical staff shall require that each birth be attended by a physician or certified nurse midwife who has documented evidence of current competence and appropriate privileges.

(b)  At all times medical staff with obstetrical privileges shall be available within 30 minutes to provide services and attend deliveries.  An on-call schedule shall be available to the Division for review.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4303       NURSING SERVICES MATERNAL SERVICES

(a)  The nurse executive or the decentralized nursing management staff shall designate a registered nurse who has education, training, and experience in obstetrical care as supervisor of obstetrical services.

(b)  A registered nurse shall be responsible for providing the type and amount of nursing care needed by each patient.  A staffing plan shall be available to the Division for review.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4304       POLICIES AND PROCEDURES MATERNAL SERVICES

(a)  The provision of patient care shall be guided by written policies and procedures developed by the medical and nursing staff and approved by the medical staff.

(b)  Written policies shall relate to at least the following:

(1)           a system for informing the physician or certified nurse midwife responsible for a patient of the following:

(A)          the patient's admission;

(B)          the onset of labor; and

(C)          pertinent information about progress of labor or changes in patient's condition.

(2)           emergency response protocols for patients who demonstrate evidence of maternal, fetal or neonatal distress;

(3)           a program to prevent isoimmunization of RH-negative mothers;

(4)           administration of oxytocic agents when used for induction or stimulation of labor;

(5)           the use and administration of analgesics and anesthetics;

(6)           administration of magnesium sulfate when and for the treatment preeclampsia;

(7)           the location and storage of medications, supplies, and special equipment;

(8)           the method of identification for the neonates;

(9)           assessment and care of the neonates;

(10)         provision of resuscitation, stabilization, and preparation for the transport of sick neonates at any hour; and

(11)         an infection control plan.

(c)  Accurate and complete medical records shall be provided for each obstetric patient.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A ncac 13B .4305       ORGANIZATION OF NEONATAL SERVICES

(a)  The governing body shall approve the scope of all neonatal services and the facility shall classify its capability in providing a range of neonatal services using the following criteria:

(1)           LEVEL I: Full-term and pre-term neonates that are stable without complications.  This may include, small for gestational age or large for gestational age neonates.

(2)           LEVEL II: Neonates or infants that are stable without complications but require special care and frequent feedings; infants of any weight who no longer require Level III or LEVEL IV neonatal services, but who still require more nursing hours than normal infant.  This may include infants who require close observation in a licensed acute care bed

(3)           LEVEL III: Neonates or infants that are high-risk, small (or approximately 32 and less than 36 completed weeks of gestational age) but otherwise healthy, or sick with a moderate degree of illness that are admitted from within the hospital or transferred from another facility requiring intermediate care services for sick infants, but not requiring intensive care.  The beds in this level may serve as a "step-down" unit from Level IV. Level III neonates or infants require less constant nursing care, but care does not exclude respiratory support.

(4)           LEVEL IV (Neonatal Intensive Care Services): High-risk, medically unstable or critically ill neonates approximately under 32 weeks of gestational age, or infants, requiring constant nursing care or supervision not limited to continuous cardiopulmonary or respiratory support, complicated surgical procedures, or other intensive supportive interventions.

(b)  The facility shall provide for the availability of equipment, supplies, and clinical support services.

(c)  The medical and nursing staff shall develop and approve policies and procedures for the provision of all neonatal services.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Temporary Amendment Eff. March 15, 2002;

Amended Eff. April 1, 2003.

 

10A NCAC 13B .4306       MEDICAL STAFF OF NEONATAL SERVICES

The medical staff shall require that the director or other designated physician in charge of the neonatal special or intensive care unit has training and experience in care of the neonate.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4307       NURSING STAFF OF NEONATAL SERVICES

(a)  The nurse executive or the decentralized nursing management staff shall designate a registered nurse who has training and experience in the care of neonates as supervisor of neonatal services.

(b)  A registered nurse shall be responsible for providing the type and amount of nursing care needed by each patient.  A staffing plan shall be available to the Division for review.

(c)  The nursing staff shall provide educational opportunities for parents of neonates on routine care and procedures needed by the neonate.

(d)  The nursing staff shall provide opportunities for parental participation in care of the neonate to facilitate bonding and family adjustment to the neonate's needs.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4308       POLICIES AND PROCEDURES OF NEONATAL SERVICES

(a)  The provision of neonatal care at all levels shall be guided by written policies and procedures developed and approved by the medical and nursing staffs.

(b)  The policies and procedures shall include but are not limited to:

(1)           emergency resuscitation and stabilization of the neonate;

(2)           equipment for routine and emergency care of the neonate;

(3)           continuous oxygen supply and means of administration including ventilators;

(4)           administration of medications;

(5)           insertion and care of invasive lines;

(6)           prevention of infectious diseases or processes; and

(7)           family involvement in care of the neonate.

(c)  The medical and nursing staff shall review, update and approve its policies and procedures every three years.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4400 - RESPIRATORY CARE SERVICES

 

10A NCAC 13B .4401       ORGANIZATION

(a)  The governing body shall appoint a medical director of the respiratory care service who is an anesthesiologist, pulmonologist or other qualified physician.

(b)  The facility shall appoint a qualified individual as the director of respiratory care services.

(c)  When the facility is without a distinct respiratory care service, the facility shall:

(1)           designate the department responsible for the delivery of respiratory care services;

(2)           designate a person to supervise the delivery of respiratory care services; and

(3)           establish and maintain policies and procedures for the delivery of respiratory care services offered.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4402       STAFFING

(a)  Staffing numbers shall be determined by the types and complexities of the services offered.

(b)  The director of the service shall provide for the availability of trained respiratory technicians, Certified Respiratory Therapy Technicians, registry eligible or Registered Respiratory Therapist needed for the scope of services offered.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4403       POLICIES AND PROCEDURES

The facility shall establish and maintain written policies and procedures for the services offered.  These shall include but are not limited to:

(1)           scope of services and treatment offered;

(2)           medication administration;

(3)           cleaning, assembly and storage of equipment;

(4)           safety;

(5)           infection control;

(6)           documentation of delivered care or treatments; and

(7)           care and supervision of all ventilated patients.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4500 - PHARMACY SERVICES AND MEDICATION ADMINISTRATION

 

10A NCAC 13B .4501       PROVISION OF SERVICE

The facility shall provide for pharmaceutical services which are administered in accordance with the pharmacy laws of North Carolina including but not limited to G.S. 90 and G.S. 106.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4502       PHARMACIST

(a)  The pharmacy service shall be directed by a pharmacist licensed by the State of North Carolina.  If a facility has a limited service as defined by the N.C. Board of Pharmacy, a part-time director of pharmacy shall have responsibility for control and dispensing of drugs.

(b)  The director of pharmacy shall be responsible to the chief executive officer or his designee for developing, supervising, and coordinating all the activities of pharmacy services throughout the facility.

(c)  The director of pharmacy shall require that the pharmacists are trained in the specialized functions of facility pharmacy.

(d)  The dispensing of drugs in the absence of a pharmacist shall be done by facility staff under the direct supervision of staff approved by the pharmacy committee and who are responsible for following policies established by the pharmacy committee.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4503       STAFF

The director of pharmacy shall be assisted by additional pharmacists and such other personnel as the activities of the pharmacy may require to meet the pharmaceutical needs of the patients served.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4504       PHARMACY COMMITTEE

(a)  A pharmacy committee or its equivalent, to include physicians, registered nurses, pharmacists and the administrator or designee shall be established.

(b)  The committee shall meet at least quarterly, record its proceedings and report to the medical staff.  It shall assist in the formulation of broad professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use and safety procedures, and all other matters relating to drugs in the facility.  This shall include a mechanism to review and evaluate adverse drug reactions and drug usage evaluations, offering appropriate recommendations, actions, and follow-up if necessary.  The committee shall:

(1)           serve as an advisory group to the medical staff and the pharmacy director on matters pertaining to drug selection;

(2)           develop an ongoing mechanism to review a formulary or drug list for use in the hospital;

(3)           recommend and develop policies regarding the use and control of investigational drugs and research in the use of U.S. Food and Drug Administration approved drugs;

(4)           evaluate clinical data concerning new drugs or preparations requested for use in the facility;

(5)           make recommendations concerning drugs to be stocked on the nursing units and by other services;

(6)           establish mechanisms which will prevent formulary duplication;

(7)           establish policies and procedures that address therapeutic drug substitution;

(8)           establish a policy describing the duration of drug therapy or number of doses for all medication orders; and

(9)           make recommendations regarding medication administration policies and procedures.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4505       PHARMACY FACILITIES

(a)  The facility shall provide sufficient space for the pharmaceutical service to carry out its professional and administrative functions.

(b)  Equipment shall be provided for the storage, preparation, dispensing, distributing and safeguarding of drugs throughout the hospital.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4506       SUPPLIES

The director of pharmacy shall maintain an inventory of drugs and pharmaceutical devices to meet the needs of the patients as described in the facility's formulary.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4507       STORAGE

(a)  All drugs and related pharmaceutical supplies located throughout the facility shall be under the control of the pharmacy service.

(b)  All areas where drugs and related pharmaceutical supplies are stored shall be monitored at least monthly by the pharmacy service.

(c)  The director of pharmacy shall require that corresponding records are maintained of drug inventory variances and the corrective action taken.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4508       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .4509       SECURITY

(a)  The director of pharmacy shall require that all drugs and related pharmaceutical supplies be stored in a lockable environment except when under the direct supervision of personnel authorized by the pharmacy committee to handle drugs.

(b)  Controlled substances and other drugs the facility deems subject to abuse shall be stored as outlined in the U.S. Controlled Substance Act, CFR 1301.41 and the N.C. Controlled Substances Act, G.S. 90, Article 5.  These rules are available from the Drug Regulatory Branch of the N.C. Division of Mental health, Development Disabilities & Substance Abuse Services, 3016 Mail Service Center, Raleigh, NC 27699-3016 (919/715-0652) without charge to current registrants.

(c)  All keys and other locking devices to the pharmacy and controlled substances throughout the facility shall be under the control of the director of pharmacy and the facility management.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4510       RECORDS

(a)  The director of pharmacy shall provide that all drug transactions of the pharmacy shall be recorded as described in policies approved by the pharmacy committee.

(b)  The director of pharmacy shall establish and maintain a system of records and bookkeeping in accordance with the policies of the facility in order to maintain adequate control over the requisitioning and dispensing of all drugs and pharmaceutical supplies and over patient billing for all drugs and pharmaceutical supplies.

(c)  The director of pharmacy shall maintain records for all drugs purchased, ordered, dispensed, distributed, returned and disposed of in accordance with the pharmacy laws of North Carolina from the pharmacy.

(d)  Verbal orders for drugs shall be subject to medical staff policies.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4511       MEDICATION ADMINISTRATION

(a)  A facility shall establish and maintain policies and procedures governing the administration of medications which shall be enforced and implemented by administration and staff.  Policies and procedures shall include:

(1)           accountability of controlled substances as defined by the G.S. 90, Article 5; and

(2)           storage, distribution, administration and monitoring the effects of medications.

(b)  All medications and treatments shall be administered and discontinued in accordance with signed medical staff orders which are recorded in the patient's medical record.

(c)  The categories of staff that are privileged to administer medications shall be delineated by the operational policies of the facility.  These policies shall be in agreement with current rules of North Carolina Occupational Boards for each category of staff.

(d)  Medications shall be scheduled and administered according to the established policies of the facility.

(e)  Variances to the medication administration policy shall be reviewed and evaluated by the nurse executive or her designee.

(f)  The person administering medications shall identify each patient in accordance with the facility's policies and procedures prior to administering any medication.

(g)  Medication administered to a patient shall be recorded in the patient's medication administration record immediately after administration in accordance with the facility's policies and procedures.

(h)  Omission of medication and the reason for the omission shall be indicated in the patient's medical record.

(i)  The person administering medications which are ordered to be given as needed (PRN) shall justify the need for the same in the patient's medical record.

(j)  Medication administration records shall provide identification of the drug and strength of drug, quantity of drug administered, route administered, name and title of person administering the medication, and time and date of administration.

(k)  Self-administration of medications shall be permitted only if prescribed by the medical staff.  Directions must be printed on the container.

(l)  The administration of one patient's medications to another patient is prohibited except in the case of an emergency.  In the event of such as emergency, steps shall be taken by a pharmacist to ensure that the borrowed medications shall be replaced and so documented.

(m)  Verbal orders shall be signed in accordance with Rule .3707(c) of this Subchapter.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. November 1, 2005; May 1, 2005.

 

10A NCAC 13B .4512       MEDICATIONS DISPENSED

(a)  Except as provided in Paragraph (c) of this Rule, the pharmacy shall dispense only those drugs which are listed in one or more of the references listed in Paragraph (b) of this Rule.  No drug which is listed in Paragraph (b) of this Rule shall be used for any purpose which is not approved by the U.S. Food and Drug Administration unless the use has been approved by the facility's pharmacy committee.

(b)  References:

(1)           United States Pharmacopoeia;

(2)           National Drug Formulary;

(3)           Evaluations of Drug Interactions by the American Pharmaceutical Association;

(4)           American Hospital Formulary Service; and

(5)           Other references approved by the Pharmacy Committee.

(c)  Any drug approved for use as an investigational drug or otherwise by the U.S. Food and Drug Administration but not listed in Paragraph (b) of this Rule may be used in accordance with standards established by the facility's pharmacy committee, or its equivalent and approved by the U.S. Food and Drug Administration, Dockets Management Branch, FDS, Room 4062, 5600 Fishers Lane, Rockfield, Maryland 20857, at a cost dependent on the material requested.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4513       DRUG DISTRIBUTION SYSTEMS

(a)  The pharmacy committee shall develop written policies and procedures pertaining to the intra-facility drug distribution system.  In developing such policies the committee shall utilize representatives of other disciplines within the facility, including nursing services.

(b)  The label of each patient's individual medication container shall bear all information required by the Pharmacy Laws of North Carolina.

(c)  The pharmacist, with the advice and guidance of the pharmacy committee or its equivalent, shall be responsible for specifications as to quality, quantity and source of supplies of all drugs.

(d)  There shall be a formulary or list of drugs accepted for use in the facility which shall be developed and amended as necessary by the pharmacy committee.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4514       EMERGENCY PHARMACEUTICAL SERVICES

The director of pharmacy shall be responsible for emergency pharmaceutical services as currently described in the Pharmacy Laws of North Carolina.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4515       DISPOSITION

Drugs, and pharmaceutical devices which are outdated, visibly deteriorated, unlabeled, inadequately labeled, recalled, discontinued or obsolete shall be identified by a pharmacist and shall be disposed of in compliance with applicable state and federal laws and regulations.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4516       COMMERCIAL PHARMACEUTICAL SERVICE

A facility using an outside pharmacist or pharmaceutical service must have a contract with that pharmacist or service.  As part of the contract, the pharmacist or service shall be required to maintain at least the standards for operation of the pharmaceutical services outlined in this Subchapter.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4600 - SURGICAL AND ANESTHESIA SERVICES

 

10A NCAC 13B .4601       ORGANIZATION

(a)  The governing body shall approve the types of surgery and types of anesthesia services to be available throughout the hospital consistent with identified needs and resources.

(b)  The facility shall require that surgical or anesthesia procedures are performed only when the necessary equipment and personnel are available.

(c)  A facility that provides surgical or obstetric services shall provide anesthesia services on a 24-hour basis.

(d)  The requirements and standards identified in this Section apply when any patient, in any setting, receives for any purpose, by any route:

(1)           general, spinal or other major regional anesthesia; or

(2)           sedation or analgesia that may result in the loss of protective reflexes; or

(3)           surgery or other invasive procedure while receiving such anesthesia.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4602       DIRECTOR OF SURGICAL SERVICES

(a)  Each department or service providing surgical services shall be directed by members of the medical staff whose clinical and administrative privileges have been approved by the governing body.

(b)  The medical staff shall establish and maintain a system for monitoring and evaluating the quality and appropriateness of the care and treatment of surgical patients, and for monitoring the clinical performance of all individuals with clinical privileges.

(c)  In facilities where there is no anesthesiologist on staff the facility shall:

(1)           with review of the medical staff, establish a consultation agreement with a board-certified or board-eligible anesthesiologist for the purpose of establishing policies and procedures that relate to the safe administration of anesthesia in all departments or services of the facility;

(2)           assume the responsibility for establishing general policies for anesthesia services; and

(3)           establish a line of communication and supervision for staff.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4603       SURGICAL AND ANESTHESIA STAFF

(a)  The facility shall develop processes which require that each individual provides only those services for which proof of licensure and competency can be demonstrated.

(b)  The facility shall require that:

(1)           when anesthesia is administered, a qualified physician is immediately available in the facility to provide care in the event of a medical emergency;

(2)           a roster of practitioners with a delineation of current surgical and anesthesia privileges is available and maintained for the service;

(3)           an on-call schedule of surgeons with privileges to be available at all times for emergency surgery and for post-operative clinical management is maintained;

(4)           the operating room is supervised by a qualified registered nurse or doctor of medicine or osteopathy; and

(5)           an operating room register which shall include date of the operation, name and patient identification number, names of surgeons and surgical assistants, name of anesthetists, type of anesthesia given, pre- and post-operative diagnosis, type and duration of surgical procedure, and the presence or absence of complications in surgery is maintained.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4604       DIRECTION OF ANESTHESIA SERVICES

(a)  The facility shall be organized, directed and integrated with other related services or departments of the facility.

(b)  The department of anesthesia shall require that all anesthetics are administered according to procedures established in medical staff rules.  In facilities where there is no department of anesthesia, the medical staff shall assume the responsibility for establishing general policies and for supervising the administration of anesthetics.

(c)  The facility shall provide that anesthesia services be directed by a member, or members, of the medical staff whose responsibilities shall be approved by the governing body and shall include:

(1)           establishment of criteria and procedures for the evaluation of the quality of all anesthesia care rendered;

(2)           review of clinical privileges for all licensed practitioners whose primary clinical activity is the provision of anesthesia services; and

(3)           establishment of written policies and procedures for anesthesia services.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4605       POLICIES AND PROCEDURES

(a)  The director of surgical services shall develop policies and procedures for surgical and anesthesia services which shall be available to the medical, surgical, anesthesia staff and nursing personnel.

(b)  The facility shall require that policies on anesthesia procedures include the delineation of pre-anesthesia and post-anesthesia responsibilities.

(c)  The facility shall require that the policies listed in this Paragraph are followed and that each surgical patient's record contain the following documentation:

(1)           a complete history and physical documented in the record of every patient prior to surgery, including clinical indications for the surgical procedure;

(2)           written evidence of informed consent, in the patient's record before surgery.  If prior written consent was not obtained, the record shall contain a written explanation of why prior consent was not obtained;

(3)           an evaluation of the patient and anesthesia planned, documented according to medical staff bylaws by an individual qualified to administer anesthesia services.  Re-evaluation of the patient immediately prior to the induction of anesthesia shall be performed prior to surgery;

(4)           an operative report describing techniques, findings, tissue removed or altered, and pre and post-surgical diagnosis.  This report must be written or dictated following surgery and signed by the surgeon in compliance with medical staff rules;

(5)           an intraoperative anesthesia record including the dosage of all drugs and agents used, the duration of anesthesia, and the type and amount of all fluids or blood and blood products administered shall be documented;

(6)           evaluation and documentation of the postoperative status of the patient on admission to and discharge from the post-anesthesia recovery area.

(d)  The director of anesthesia services shall establish criteria for discharge and facility management shall require that a physician or CRNA with appropriate clinical privileges be responsible for the decision to discharge a patient from a post-anesthesia recovery area.

(e)  The facility shall establish regulations governing visitors and traffic control.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4700 - NUTRITION AND DIETETIC SERVICES

 

10A NCAC 13B .4701       PROVISION OF SERVICES

The nutrition and dietetic services shall be organized, directed, staffed and integrated with other facility departments to provide optimal nutritional therapy and quality food service to patients.  Nutrition therapy shall apply the principles of the science of nutrition and be administered in accordance with the law and rules including but not limited to G.S. 90, Article 25.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4702       ORGANIZATION

(a)  The nutrition and dietetic services shall be under the full-time direction of a person who is trained or experienced in food services administration and therapeutic diets.  The director shall be one of the following:

(1)           A qualified dietitian;

(2)           Bachelor's degree in Foods and Nutrition or Food Service Management;

(3)           Dietetic Technician Registered (DTR); or

(4)           Certified Dietary Manager (CDM); or

(5)           An individual who is enrolled in a program to complete the minimum qualifications in Paragraph (a)(1)(2)(A)(B)(C) of this Rule.

(b)  The nutrition and dietetic services of the facility shall have at least one dietitian either full-time, part-time, or as consultant.  The qualifications of the dietitian shall be included in the personnel files.  If the director of nutrition and dietetic services is not a registered dietitian, there shall be an established method of communication between the director and the dietitian which ensures that the dietitian supervises the nutritional aspects of patient care and ensures that quality nutritional care is provided to patients.  Dietitians or qualified designees shall attend and participate in meetings relevant to patient nutritional care, including but not limited to patient care conferences and discharge planning.

(c)  When a dietitian serves only in a consultant capacity, the facility management shall establish and maintain a written contract with the individual defining the responsibilities of the dietician including requirements for submission of written reports to the hospital administrator and the director of the nutrition and dietetic services describing the extent and quality of the services provided.  Frequency of visits of the consultant dietitian shall be defined in the contract.  The consultant dietitian shall provide, on site, no less than eight hours of service every two weeks to provide the nutritional aspects of patient care including but not limited to the following:

(1)           approval of regular and modified menus, including standardized recipes;

(2)           performance of nutritional assessments;

(3)           development of nutrition care plans;

(4)           provision of nutrition therapy;

(5)           participation in development of policies and procedures; and

(6)           monitoring and evaluation of the effectiveness and appropriateness of nutrition and dietetic services.

(d)  The facility shall establish and maintain written policies and procedures to govern all nutrition and dietetic service activities.  These policies shall be developed by the nutrition and dietetic services in cooperation with personnel from other departments or services which are involved with nutrition and dietetic services and they shall be reviewed at least every three years, revised as necessary, and dated to indicate the time of last review.  Administrative policies and procedures concerning food procurement, preparation, and service shall be written by the director of the nutrition and dietetic services.  Nutritional care policies and procedures shall be written by the qualified dietitian.  The nutrition and dietetic service policies and procedures shall include, but not be limited to the following:

(1)           provision of food and nutrition therapy prescriptions/orders;

(2)           development, approval and provision of regular and modified menus, including standardized recipes;

(3)           food purchasing, storage, inventory, preparation and service;

(4)           identification system designed to ensure that each patient receives appropriate diet as ordered;

(5)           ancillary dietetic services, as appropriate, including food storage and kitchens on patient care units, formula supply, cafeterias, vending operations and ice making;

(6)           preparation, storage, distribution, and administration of enteral nutrition programs;

(7)           assessment and monitoring of patients receiving enteral and total parenteral nutrition;

(8)           personal hygiene and health of dietetic personnel;

(9)           infection control measures to minimize the possibility of contamination and transfer of infection, including establishment of monitoring procedure to ensure that personnel are free from communicable infections and open skin lesions; and

(10)         pertinent safety practices, including control of electrical, flammable, mechanical, and radiation hazards.

(e)  Nutrition and dietetic services shall be provided by qualified personnel under supervision to meet needs of patients.  The director of the nutrition and dietetic services shall require that personnel assigned to the department perform all functions necessary to meet the nutritional needs of patients.  The director or qualified designee shall attend and participate in meetings, including that of department heads, and function as an integral member of the facility.

(f)  A facility which has a contract with an outside food management service, shall require as a part of the contract that the company complies with all applicable requirements and standards outlined in Section .4700 of this Subchapter for such service.  The contract shall be available for review by the Division.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4703       SANITATION AND SAFETY

(a)  The nutrition and dietetic service shall comply with current laws and rules for sanitation as promulgated by the Commission for Public Health, including but not limited to 15A NCAC 18A .1300.  Copies of 15A NCAC 18A .1300 may be obtained at no charge from the Environmental Health Services Section, Division of Environmental Health, N.C. Department of Environment and Natural Resources, 1630 Mail Service Center, Raleigh, NC 27699-1630.  The facilities and equipment of the nutrition and dietetic services shall also comply with applicable and safety laws and rules.

(b)  Sufficient space and equipment shall be provided for the nutrition and dietetic services to accomplish the following:

(1)           store food and nonfood supplies under sanitary and secure conditions;

(2)           store food separately from nonfood supplies.  When storage facilities are limited, paper products may be stored with food supplies;

(3)           prepare and distribute food, including therapeutic diets;

(4)           clean and sanitize utensils and dishes apart from food preparation areas; and

(5)           allow personnel to perform their duties.

(c)  Cleaning schedules and instructions for cleaning all equipment and work and storage areas shall be posted and followed in the nutrition and dietetic services area and accessible to all nutrition and dietetics staff.  Procedures for cleaning all equipment and work areas shall be followed consistently and documented to safeguard the health of the patient.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4704       DISTRIBUTION OF FOOD

(a)  Food shall be transported and displayed pursuant to the rules adopted by the Commission for Public Health.

(b)  At the time of serving, the temperature of hot foods shall be no less than:

(1)           Hot liquids - 150 degrees Fahrenheit (minimum);

(2)           Hot Cereal - 150 degrees Fahrenheit (minimum);

(3)           Hot Soups - 130 degrees Fahrenheit (minimum); and

(4)           Other hot foods - 110 degrees Fahrenheit (minimum).

(c)  At the time of serving, the temperature of cold foods shall be no more than:

(1)           Cold liquids - 50 degrees Fahrenheit (maximum); and

(2)           Other cold foods - 65 degrees Fahrenheit (maximum).

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4705       NUTRITIONAL SUPPORT

(a)  The administration of the nutritional support shall be directed by a qualified dietitian.  Observations and information pertinent to nutrition therapy shall be documented in the medical record of the patient.

(b)  The facility shall have a current nutrition care manual accessible to hospital personnel.  The nutrition care manual shall be reviewed every three years, revised as necessary by a qualified dietitian, and approved jointly by the nutrition service and medical staff.

(c)  Therapeutic diets and enteral and parenteral nutrition therapy shall be prescribed in written orders on the medical records and provided as ordered.

(d)  The nutrition care manual shall reflect the standards for nutrition care in accordance with those referenced in the most current edition of "Recommended Dietary Allowance" of the Food and Nutrition Board of the National Research Council of the National Academy of Sciences which are hereby incorporated by reference.  These standards include any subsequent amendments and editions of the referenced material and are available from the National Academy Press, 2101 Constitution Avenue, N.W., Lockbox 285, Washington, D.C. 20055 at a cost of six dollars ($6.00) per copy.  The nutrition deficiencies of any modified diet that is not in compliance with the recommended dietary allowances shall be specified in the nutrition care manual.

(e)  The qualified dietitian shall be responsible for the development of a nutritional care plan in compliance with medical staff's orders to meet the nutritional needs of the patient.  The nutrition care plan shall be included in the medical record of the patient on his discharge plan and transfer orders to the extent necessary for continuity of care.  Facilities with long term care units shall have at least a three week menu cycle in the long term care units.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

SECTION .4800 - DIAGNOSTIC IMAGING

 

10A NCAC 13B .4801       ORGANIZATION

(a)  Imaging services shall be under the supervision of a full-time radiologist, consulting radiologist, or a physician experienced in the particular imaging modality and the physician in charge must have the credentials required by facility policies.

(b)  Activities of the imaging service may include radio-therapy.

(c)  All imaging equipment shall be operated under professional supervision by qualified personnel trained in the use of imaging equipment and knowledgeable of all applicable safety precautions required by the North Carolina Department of Environment and Natural Resources, Division of Environmental Health Radiation Protection Section.  Copies of regulations are available from the N.C. Department of Environment and Natural Resources, Radiation Protection Section, 3825 Barrett Drive, Raleigh, NC  27609 at a cost of sixteen dollars ($16.00) each.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority and ambiguity Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4802       RECORDS

(a)  A documented record on each imaging examination shall be included in the patient's medical record.

(b)  Imaging reports shall be signed by the physician interpreting the study.

(c)  Copies of current reports made by private physicists or governing authority surveying the radiographic facilities shall be available to the Division.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4803       STAFFING

(a)  The staffing of the imaging department shall be determined by the radiologist in charge or by another person designated by hospital management.

(b)  There shall be a minimum of one radiologic technologist available to the department on at least an on-call basis.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4804       MONITORING RADIATION EXPOSURE OF PERSONNEL

(a)  The facility shall establish procedures for the monitoring of personnel and shall maintain a record for each individual working in the area of radiation where there is a reasonable probability of receiving one-fourth of the maximum permissible dose.

(b)  Records documenting the monitoring of personnel receiving radiation exposure through the use of film badges or dosimeters must also be maintained by the facility.  Readings from badges or dosimeters shall be recorded on at least a monthly basis.

(c)  Upon termination of employment, each employee shall be provided with a summary of his exposure record.

(d)  Permanent records of radiological exposure on all monitored personnel shall be maintained for review by the Division.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4805       SAFETY

(a)  The facility shall require that all imaging equipment is operated under the supervision of a physician and by qualified personnel.

(b)  The facility shall require that proper caution is exercised to protect all persons from exposure to radiation.

(c)  Safety inspections of the imaging department, including equipment, shall be conducted by the North Carolina Division of Environmental Health, Radiation Protection Services Section.  Copies of the report shall be available for review by the Division.

(d)  The governing authority shall appoint a radiation safety committee.  The committee shall include but is not limited to:

(1)           a physician experienced in the handling of radio-active isotopes and their therapeutic use; and

(2)           other representatives of the medical staff.

(e)  All radio-active isotopes, whether for diagnostic, therapeutic, or research purposes shall be received, handled, and disposed of in accordance with the requirements of the North Carolina Department of Environment and Natural Resources, Division of Environmental Health, Radiation Protection Services Section.  Copies of regulations are available from the North Carolina Department of Environment, Health, and Natural Resources, Division of Radiation Protection, 3825 Barrett Drive, Raleigh, NC 27609 at a cost of six dollars ($6.00) each.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4806       NUCLEAR MEDICINE SERVICES

When nuclear medicine services are offered, the facility shall establish and maintain written policies and procedures for the provision of those services which shall provide for the safety of patients and staff, management of radioactive isotopes and the maintenance of equipment according to the manufacturers' recommendations.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4900 - LABORATORY SERVICES AND PATHOLOGY

 

10A NCAC 13B .4901       ORGANIZATION

The laboratory shall be under the supervision of a clinical pathologist, or a physician who has training in clinical laboratory diagnosis designated by the governing body.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4902       RECORDS

(a)  All requests for laboratory services shall be documented.

(b)  All reports of laboratory services performed, including autopsy, shall be placed in the patient's medical record.

(c)  Records of proficiency testing appropriate to the scope of services offered shall be available to the Division for review.

(d)  Records of equipment calibration and quality controls as recommended by the manufacturer shall be maintained and be available to the Division for review.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4903       STAFFING

The laboratory supervisor or his appointed designee, shall require that:

(1)           procedures and tests conducted are within the scope of the laboratory as approved by the hospital;

(2)           at least one qualified medical technologist is available at all times; and

(3)           qualified staff are available to carry out the functions of the laboratory.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4904       TESTS

(a)  Laboratory tests to be performed on a patient at the time of admission (if any) shall be established by the medical staff and be approved by the governing board of the hospital.  In the event the medical staff and governing body elect not to establish routine laboratory tests for new admissions, the request for such tests shall be left to the discretion of the attending medical staff members.

(b)  Serological tests for patients admitted shall be optional with the hospital.  However, there shall be records indicating that obstetrical patients have had a serological test during their current pregnancy.

(c)  When laboratories outside of the facility are used, such laboratories shall be approved by the governing body and medical staff of the facility.  In case of such usage, a legible copy of the laboratory report must be included in the patient record.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4905       TISSUE REMOVAL AND DISPOSAL

(a)  The medical staff shall establish and maintain written policies for pathological examination of tissue and specimens removed during surgery.

(b)  Pathological waste disposal shall comply with the rules Governing the Sanitation of Hospitals, Nursing and Rest Homes, Sanitariums, Sanatoriums, and Educational and Other Institutions, contained in 15A NCAC 18A .1300.  Copies of 15A NCAC 18A .1300 may be obtained at no charge from the Environmental Health Services Section, Division of Environmental Health, N.C. Department of Environment and Natural Resources, 1630 Mail Service Center, Raleigh, NC 27699-1630.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4906       BLOOD BANK

(a)  Facilities which provide for procurement, storage and transfusion of blood shall meet the standards of the American Association of Blood Banks as outlined in the most current edition of Standards of Blood Banks and Transfusion Services, which is incorporated by reference, including all subsequent amendments and additions, and which is available from the American Association of Blood Banks, 8101 Glenbrook Road, Bethesda, Maryland 20814-2749 at a cost of thirty-three dollars and fifty cents ($33.50) per copy.

(b)  The governing body shall approve the pathologist or physician as physician-in-charge of the blood bank service.

(c)  Records shall be kept on file indicating the receipt and disposition of all blood handled.  Care shall be taken to ascertain that blood administered has not exceeded its expiration date, and meets all criteria for safe administration.

(d)  The facility shall make arrangements to secure on short notice all necessary supplies of blood, typed and cross-matched as required, for emergencies.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4907       MORGUE AND AUTOPSY FACILITIES

(a)  Morgue and autopsy services shall be provided either on site or by written agreement with a facility that provides those services.

(b)  Procedures for the transport and storage of deceased patients shall be established and maintained by the facility.

(c)  Procedures for post mortem cleaning of patients with diagnosed contagious diseases shall be established and maintained by the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .5000 - PHYSICAL REHABILITATION SERVICES

 

10A NCAC 13B .5001       ORGANIZATION

The facility shall designate an individual responsible for the administration and supervision of each rehabilitation service.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5002       DELIVERY OF CARE

(a)  A member of the medical staff shall be responsible for the general medical care of the inpatient.

(b)  The delivery of all rehabilitation services shall be provided by practitioners credentialed or licensed in their respective fields.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .5003       POLICIES AND PROCEDURES

The facility shall establish and maintain written policies and procedures that include but are not limited to:

(1)           provision for assessment and evaluation of the services performed;

(2)           safety measures;

(3)           infection control measures; and

(4)           procedures for referral to other facilities for services not available on site.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5004       PATIENT RECORDS

The patient record shall contain documentation of physical rehabilitation services utilized that include but is not limited to:

(1)           diagnosis to support the services requested;

(2)           assessment of patient's rehabilitative status;

(3)           re-assessment and progress of patient's rehabilitative status;

(4)           individualized plan of care and goals of rehabilitation; and

(5)           discharge plan.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5005       CARDIAC REHABILITATION PROGRAM

When a facility elects to provide an outpatient cardiac rehabilitation program, the program shall be subject to 10 NCAC 3S, Sections .0300 - .1000, which are incorporated by reference with all subsequent amendments.  Referenced rules are available from the North Carolina Department of Health and Human Services, Division of Health Service Regulation, Licensure and Certification Section, 2711 Mail Service Center, Raleigh, NC 27699 at a cost of three dollars ($3.00) each.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .5100 - INFECTION CONTROL

 

10A NCAC 13B .5101       ORGANIZATION

(a)  The governing body shall establish and maintain an infection control program that includes all patient care and patient care support services and departments for the surveillance, prevention and control of infection.

(b)  The infection control committee shall include representatives of the medical staff, nursing staff, administration and the person directly responsible for the surveillance program activities.

(c)  The infection control committee shall assume responsibility for the infection control program.

(d)  The facility shall designate a person to manage the infection control, prevention and surveillance program.

(e)  The infection control committee shall involve facility departments and services as needed to maintain the infection control program.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5102       POLICY AND PROCEDURES

(a)  Each facility department or service shall establish and maintain written infection control policies and procedures.  These shall include but are not limited to:

(1)           the role and scope of the service or department in the infection control program;

(2)           the role and scope of surveillance activities in the infection control program;

(3)           the methodology used to collect and analyze data, maintain a surveillance program on nosocomial infection, and the control and prevention of infection;

(4)           the specific precautions to be used to prevent the transmission of infection and isolation methods to be utilized;

(5)           the method of sterilization and storage of equipment and supplies, including the reprocessing of disposable items;

(6)           the cleaning of patient care areas and equipment;

(7)           the cleaning of non-patient care areas; and

(8)           exposure control plans.

(b)  The infection control committee shall approve all infection control policies and procedures.  The committee shall review all policies and procedures at least every three years and indicate the last date of review.

(c)  The infection control committee shall meet at least quarterly and maintain minutes of meetings.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5103       LAUNDRY SERVICE

The facility shall provide, directly or by contract, a laundry service or department that provides the following:

(1)           24 hour a day availability of clean linen for patient care needs; and

(2)           delivery of clean linen and removal of soiled linen in a manner that reduces the spread of infection.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5104       ENVIRONMENTAL SERVICES

The facility shall require that environmental services (housekeeping) provide the following:

(1)           24 hour a day availability of personnel or supplies and equipment for the cleaning of patient rooms, patient care equipment, and the cleaning of spills;

(2)           a routine cleaning schedule for all areas of the facility to assist in the prevention and spread of disease; and

(3)           removal and appropriate disposal of waste materials including biologicals.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5105       STERILE SUPPLY SERVICES

The facility shall provide for the following:

(1)           decontamination and sterilization of equipment and supplies;

(2)           monitoring of sterilizing equipment on a routine schedule;

(3)           establishment of policies and procedures for the use of disposable items; and

(4)           establishment of policies and procedures addressing shelf life of stored sterile items.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .5200 - PSYCHIATRIC SERVICES

 

10A NCAC 13B .5201       PSYCHIATRIC OR SUBSTANCE ABUSE SERVICES: APPLICABILITY OF RULES

The rules contained in this Section shall apply to all psychiatric and substance abuse services provided by any facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5202       DEFINITIONS APPLICABLE TO PSYCHIATRIC OR SUBSTANCE ABUSE SERVICES

(a)  "Certified counselor" means an alcoholism, drug abuse or substance abuse counselor who is certified by the North Carolina Substance Abuse Professional Certification Board.

(b)  "Certified substance abuse counselor/supervisor" means an individual who is a "certified counselor" as defined in 10 NCAC 3C .5202(a) and is designated by the North Carolina Substance Abuse Professional Certification Board as a qualified substance abuse supervisor.

(c)  "Clinical/professional supervision" means regularly scheduled assistance by a qualified mental health, professional or a qualified substance abuse professional to a staff member who is providing direct, therapeutic intervention to a client or clients.  The purpose of clinical supervision is to ensure that each client receives appropriate treatment or habilitation which is consistent with accepted standards of practice and the needs of the client.

(d)  "Detoxification service" means a unit or department whose primary purpose is the medical management or care of persons who are under the influence of alcohol or drugs.

(e)  "Direct care staff" means an individual who provides active direct care, treatment, or rehabilitation or habilitation services to clients on a continuous and regularly scheduled basis.

(f)  "Psychiatric nurse" means an individual who is licensed to practice as a registered nurse in North Carolina by the North Carolina Board of Nursing; and has:

(1)           a graduate degree from an accredited master's level program in psychiatric mental health nursing with two years of experience; or

(2)           a master's degree in behavioral science with two years of supervised clinical experience in psychiatric mental health nursing; or

(3)           a baccalaureate degree in behavioral science with four years of supervised clinical experience in psychiatric mental health nursing.

(g)  "Psychiatric service" means an inpatient or outpatient unit or department whose primary purpose is the treatment of mental illness.  It also means the mental health treatment provided in such a unit or department.

(h)  "Psychiatric social worker" means an individual who holds a master's degree in social work from an accredited school of social work and has two years of clinical social work experience.

(i)  "Psychiatrist" means an individual who is licensed to practice medicine in North Carolina and who has completed an accredited training program in psychiatry.

(j)  "Psychologist" means an individual licensed to practice psychology in North Carolina by the North Carolina State Board of Examiners of Practicing Psychologists.

(k)  "Qualified mental health professional" means any one of the following: psychiatrist, psychiatric nurse, practicing psychologist, psychiatric social worker, an individual with at least a masters degree in a related human service field and two years of supervised clinical experience in mental health services or an individual with a baccalaureate degree in a related human service field and four years of supervised clinical experience in mental health services.

(l)  "Qualified substance abuse professional" means an individual who is:

(1)           certified by the North Carolina Substance Abuse Professional Certification Board;

(2)           certified by the National Consortium of Chemical Dependency Nurses, Inc;

(3)           certified by the National Nurses Society on Addictions; or

(4)           a graduate of a college or university with a baccalaureate or advanced degree in a human service related field with documentation of at least two years of supervised experience in the profession of alcoholism and drug abuse counseling.

(m)  "Restraint" means the limitation of one's freedom of movement and includes the following:

(1)           mechanical restraint which means restraint of a client with the intent of controlling behavior with mechanical devices which include, but are not limited to, cuff, ankle straps, sheets or restraining shirts; or

(2)           physical restraint which means restraint of a client until calm.  As used in these Rules, the term physical restraint does not apply to the use of professionally recognized methods for therapeutic holds of brief duration (five minutes or less).

(n)  "Restrictive facility" means a facility so designated by the Division of Health Service Regulation which uses mechanical restraint or seclusion in accordance with G.S. 122C-60 in order to restrain a client's freedom of movement.

(o)  "Seclusion" means isolating a client in a separate locked room for the purpose of controlling a client's behavior.

(p)  "Substance abuse service" means inpatient or outpatient unit or department whose primary purpose is the treatment of chemical dependency.  It also means the chemical dependency treatment provided in such a unit or department.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .5203       STAFFING FOR PSYCHIATRIC OR SUBSTANCE ABUSE SERVICES

(a)  General Requirements:

(1)           A physician shall be present in the facility or on call 24 hours per day.  The medical appraisal and medical treatment of each patient shall be the responsibility of a physician;

(2)           Each facility shall determine its overall staffing requirements based upon the age categories (child, adolescent, adult, elderly), clinical characteristics, treatment requirements and numbers of patients;

(3)           There shall be a sufficient number of appropriately qualified clinical and support staff to assess and address the clinical needs of the patients;

(4)           Staff members shall have training or experience in the provision of care in each of the age categories assigned for treatment.

(b)  Psychiatric Services:

(1)           Staff coverage for psychiatric services shall include at least one each of the following: psychiatrist, psychiatric nurse, psychologist, and psychiatric social worker;

(2)           A qualified mental health professional shall be available by telephone or page and able to reach the facility within 30 minutes on a 24 hour basis;

(3)           Each clinical or direct care staff member who is not a qualified mental health professional shall receive professional supervision from a qualified mental health professional;

(4)           When detoxification services are provided, there shall be liaison and consultation with a qualified substance abuse professional prior to the discharge of a client.

(c)  Substance Abuse Services:

(1)           At least one registered nurse shall be on duty during each shift;

(2)           Certified substance abuse counselors or qualified substance abuse professionals shall be employed at the ratio of one staff member for each 10 inpatients or fraction thereof.  In documented instances of bona fide shortages of certified persons, uncertified individuals expecting to become certified may be employed for a maximum of 38 months without qualifications;

(3)           The facility shall have a minimum of two staff members providing care, treatment and services directly to patients on duty at all times and maintain a shift ratio of one staff member for each 20 or less inpatients with the following exceptions:

(A)          When there are minor inpatients there shall be staff available on the ratio of one staff member for each five minor inpatients or fraction thereof during each shift from 7:00 a.m. - 11:00 p.m.;

(B)          When detox services are offered there shall be no less than one staff member for each nine inpatients or fraction thereof on each shift.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5204       PSYCHIATRIC OR SUBSTANCE ABUSE SERVICES RECORD REQUIREMENTS

(a)  In addition to the general record keeping requirements of 10A NCAC 13B .3906, specialized assessment and treatment plans for individuals undergoing psychiatric or substance abuse treatment are as follows:

(1)           Within 24 hours following admission each individual shall have a completed admission assessment.  The initial assessment shall include the reason for admission, admitting diagnosis, mental status including suicide potential, diagnostic tests or evaluations, and a determination of the need for additional information to include the potential for the physical abuse of self or others and a family assessment when a minor is involved;

(2)           Within 72 hours following admission, a preliminary individual treatment plan shall be completed and implemented; and

(3)           Within five days following admission, a comprehensive individual treatment plan shall be developed and implemented.  For outpatient services, the plan shall be developed and implemented within 30 days of admission to treatment.

(b)  Individual treatment plans for psychiatric and substance abuse patients shall be developed in partnership with the patient or individual acting on behalf of the patient.  Clinical responsibility for the development and implementation of the plan shall be clearly designated.  Minimum components of the comprehensive treatment plan shall include diagnosis and time specific short and long term measurable goals, strategies for reaching goals, and staff responsibility for plan implementation.  The plan shall be revised as medically or clinically indicated.

(c)  Progress notes shall be entered in each individual's record.  Included is information which may have a significant impact on the individual's condition or expected outcome such as family conferences or major events related to the patient.  Patient status shall be documented each shift for any inpatient psychiatric or substance abuse services, and on a per visit basis for outpatient psychiatric and substance abuse services.

(d)  For each individual to whom substance abuse services are provided, a written plan for aftercare services shall be developed which minimally includes:

(1)           plan for delivering aftercare services, including the aftercare services which are provided; and

(2)           provision for agreements with individuals or organizations if aftercare services are not provided directly by the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5205       SECLUSION

At least one seclusion room shall be provided in all hospitals licensed to provide a psychiatric program, a substance abuse program or both.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5206       COMPLIANCE WITH STATUTORY REQUIREMENTS

(a)  Facilities providing psychiatric or substance abuse services shall develop procedures to protect the rights of psychiatric and substance abuse patients in accordance with North Carolina statutes addressing the rights of psychiatric and substance abuse patients.  Statutes addressing such rights are as follows:

(1)           G.S. 122C-51.  Declaration of policy on clients' rights;

(2)           G.S. 122C-52.  Right to confidentiality;

(3)           G.S. 122C-53.  Exceptions; client;

(4)           G.S. 122C-54.  Exceptions; abuse reports and court proceedings;

(5)           G.S. 122C-55.  Exceptions; care and treatment;

(6)           G.S. 122C-56.  Exceptions; research and planning;

(7)           G.S. 122C-57.  Right to treatment and consent to treatment;

(8)           G.S. 122C-58.  Civil rights and civil remedies;

(9)           G.S. 122C-59.  Use of corporal punishment;

(10)         G.S. 122C-60.  Use of physical restraints or seclusion;

(11)         G.S. 122C-61.  Treatment rights in 24-hour facilities;

(12)         G.S. 122C-62.  Additional rights in 24-hour facilities;

(13)         G.S. 122C-65.  Offenses relating to clients; and

(14)         G.S. 122C-66.  Protection from abuse and exploitation; reporting.

(b)  Facilities providing psychiatric or substance abuse services shall develop procedures to protect confidentiality of information regarding communicable disease and conditions in compliance with G.S. 130A-143.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5207       PSYCHIATRIC OR SUBSTANCE ABUSE OUTPATIENT SERVICES

Partial hospitalization, outpatient and day treatment facilities shall be subject to 10A NCAC 27G .1100, 10A NCAC 27G .3500, and 10A NCAC 27G .3700 respectively, which are incorporated by reference with all subsequent amendments.  Referenced rules are available from the N.C. Division of Mental Health, Developmental Disabilities, and Substance Abuse Services, Advocacy, Client Rights and Quality Improvement Section, 3009 Mail Service Center, Raleigh, NC 27699-3009 at a cost of five dollars and seventy-five cents ($5.75) per copy.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .5300 - NURSING AND ADULT CARE HOME BEDS

 

10A NCAC 13B .5301       THE LICENSURE OF NURSING AND ADULT CARE HOME BEDS IN A HOSPITAL

When a facility has nursing facility beds or adult care home beds, the beds shall be provided under the hospital's license as provided in Rule .3101 of this Subchapter.  The nursing facility beds and the adult care home beds shall be subject to the rules in 10A NCAC 13D with the exception that the following rules shall not apply: 10A NCAC 13D .2001(5); .2101 - .2108; .2201; .2208; .2209; .2211; .2212; .2302; .2401; .2402; .2503; .2504; .2602; .2607; .2701; and .2901.  With these exceptions, the rules in 10A NCAC 13D are incorporated by reference with all subsequent amendments.  Referenced rules are available from the NC Division of Health Service Regulation, 2711 Mail Service Center, Raleigh, N.C. 27699-2711 at a cost of six dollars ($6.00) per copy.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

SECTION .5400 - COMPREHENSIVE INPATIENT REHABILITATION

 

10A NCAC 13B .5401       DEFINITIONS

The following definitions shall apply to inpatient rehabilitation facilities or units only:

(1)           "Case management" means the coordination of services, for a given patient, between disciplines so that the patient may reach optimal rehabilitation through the judicious use of resources.

(2)           "Comprehensive, inpatient rehabilitation program" means a program for the treatment of persons with functional limitations or chronic disabling conditions who have the potential to achieve a significant improvement in activities of daily living.  A comprehensive, rehabilitation program shall utilize a coordinated and integrated, interdisciplinary approach, directed by a physician, to assess patient needs and to provide treatment and evaluation of physical, psycho-social and cognitive deficits.

(3)           "Inpatient rehabilitation facility or unit" means a free-standing facility or a unit (unit pertains to contiguous dedicated beds and spaces) approved in accordance with G.S. 131E, Article 9 to establish inpatient, rehabilitation beds and to provide a comprehensive, inpatient rehabilitation program within an existing licensed health service facility.

(4)           "Medical consultations" means consultations which the rehabilitation physician or the attending physician determine are necessary to meet the acute medical needs of the patient and do not include routine medical needs.

(5)           "Occupational therapist" means any individual licensed in the State of North Carolina as an occupational therapist in accordance with the provisions of G.S. 90, Article 18D.

(6)           "Occupational therapist assistant" means any individual licensed in the State of North Carolina as an occupational therapist assistant in accordance with the provisions of G.S. 90, Article 18D.

(7)           "Psychologist" means a person licensed as a practicing psychologist in accordance with G.S. 90, Article 18A.

(8)           "Physiatrist" means a licensed physician who has completed a physical medicine and rehabilitation residency training program approved by the Accreditation Council of Graduate Medical Education or the American Osteopathic Association.

(9)           "Physical therapist" means any person licensed in the State of North Carolina as a physical therapist in accordance with the provisions of G.S. 90, Article 18B.

(10)         "Physical therapist assistant" means any person licensed in the State of North Carolina as a physical therapist assistant in accordance with the provisions of G.S. 90-270.24, Article 18B.

(11)         "Recreational therapist" means a person certified by the State of North Carolina Therapeutic Recreational Certification Board.

(12)         "Rehabilitation aide" means an unlicensed assistant who works under the supervision of a registered nurse, licensed physical therapist or occupational therapist in accordance with the appropriate occupational licensure laws governing his or her supervisor and consistent with staffing requirements as set forth in Rule .5508 of this Section.  The rehabilitation aide shall be listed on the North Carolina Nurse Aide Registry and have received additional staff training as listed in Rule .5509 of this Section.

(13)         "Rehabilitation nurse" means a registered nurse licensed in North Carolina, with training, either academic or on-the-job, in physical rehabilitation nursing and at least one year experience in physical rehabilitation nursing.

(14)         "Rehabilitation physician" means a physiatrist or a physician who is qualified, based on education, training and experience regardless of specialty, of providing medical care to rehabilitation patients.

(15)         "Social worker" means a person certified by the North Carolina Social Work Certification and Licensure Board in accordance with G.S. 90B-3.

(16)         "Speech and language pathologist" means any person licensed in the State of North Carolina as a speech and language pathologist in accordance with the provisions of G.S. 90, Article 22.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff. January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5402       PHYSICIAN REQUIREMENTS FOR INPATIENT REHABILITATION FACILITIES OR UNITS

(a)  In a rehabilitation facility or unit, a physician shall participate in the provision and management of rehabilitation services and in the provision of medical services.

(b)  In a rehabilitation facility or unit, a rehabilitation physician shall be responsible for a patient's interdisciplinary treatment plan.  Each patient's interdisciplinary treatment plan shall be developed and implemented under the supervision of a rehabilitation physician.

(c)  The rehabilitation physician shall participate in the preliminary assessment within 48 hours of admission, prepare a plan of care and direct the necessary frequency of contact based on the medical and rehabilitation needs of the patient.  The frequency shall be appropriate to justify the need for comprehensive inpatient rehabilitation care.

(d)  An inpatient rehabilitation facility or unit's contract or agreements with a rehabilitation physician shall require that the rehabilitation physician shall participate in individual case conferences or care planning sessions and shall review and sign discharge summaries and records.  When patients are to be discharged to another health care facility, the discharging facility shall ensure that the patient has been provided with a discharge plan which incorporates post discharge continuity of care and services.  When patients are to be discharged to a residential setting, the facility shall ensure that the patient has been provided with a discharge plan that incorporates the utilization of community resources when available and when included in the patient's plan of care.

(e)  The intensity of physician medical services and the frequency of regular contacts for medical care for the patient shall be determined by the patient's pathophysiologic needs.

(f)  Where the attending physician of a patient in an inpatient rehabilitation facility or unit orders medical consultations for the patient, such consultations shall be provided by qualified physicians within 48 hours of the physician's order.  In order to achieve this result, the contracts or agreements between inpatient rehabilitation facilities or units and medical consultants shall require that such consultants render the requested medical consultation within 48 hours.

(g)  An inpatient rehabilitation facility or unit shall have a written procedure for setting the qualifications of the physicians, rendering physical rehabilitation services in the facility or unit.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff. January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5403       ADMISSION CRITERIA FOR INPATIENT REHABILITATION FACILITIES OR UNITS

(a)  The facility shall have written criteria for admission to the inpatient rehabilitation facility or unit.  A description of programs or services for screening the suitability of a given patient for placement shall be available to staff and referral sources.

(b)  For patients found unsuitable for admission to the inpatient rehabilitation facility or unit, there shall be documentation of the reasons.

(c)  Within 48 hours of admission, a preliminary assessment shall be completed by members of the interdisciplinary team to insure the appropriateness of placement and to identify the immediate needs of the patients.

(d)  Patients admitted to an inpatient rehabilitation facility or unit must be able to tolerate a minimum of three hours of rehabilitation therapy, five days a week, including at least two of the following rehabilitation services: physical therapy, occupational therapy or speech therapy.

(e)  Patients admitted to an inpatient rehabilitation facility or unit must be medically stable, have a prognosis indicating a progressively improved medical condition and have the potential for increased independence.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5404       COMPREHENSIVE INPATIENT REHABILITATION EVALUATION

(a)  A comprehensive, inpatient rehabilitation evaluation is required for each patient admitted to an inpatient rehabilitation facility or unit.  At a minimum this evaluation shall include the reason for referral, a summary of the patient's clinical condition, functional strengths and limitations, and indications for specific services.  This evaluation shall be completed within three days.

(b)  Each patient shall be evaluated by the interdisciplinary team to determine the need for any of the following services: medical, dietary, occupational therapy, physical therapy, prosthetics and orthotics, psychological assessment and therapy, therapeutic recreation, rehabilitation medicine, rehabilitation nursing, therapeutic counseling or social work, vocational rehabilitation evaluation and speech-language pathology.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5405       COMPREHENSIVE INPATIENT REHABILITATION INTER-DISCIPLINARY TREAT/PLAN

(a)  The interdisciplinary treatment team shall develop an individual treatment plan for each patient within seven days after admission.  The plan shall include evaluation findings and information about the following:

(1)           prior level of function;

(2)           current functional limitations;

(3)           specific service needs;

(4)           treatment, supports and adaptations to be provided;

(5)           specified treatment goals;

(6)           disciplines responsible for implementation of separate parts of the plan; and

(7)           anticipated time frames for the accomplishment of specified long-term and short-term goals.

(b)  The treatment plan shall be reviewed by the interdisciplinary team at least every other week.  All members of the interdisciplinary team, or a representative of their discipline, shall attend each meeting.  Documentation of each review shall include progress toward defined goals and identification of any changes in the treatment plan.

(c)  The treatment plan shall include provisions for all of the services identified as needed for the patient in the comprehensive inpatient rehabilitation evaluation completed in accordance with Rule .5404 of this Section.

(d)  Each patient shall have a designated case manager who shall be responsible for the coordination of the patient's individualized treatment plan.  The case manager shall be responsible for promoting the program's responsiveness to the needs of the patient and shall participate in all team conferences concerning the patient's progress toward the accomplishment of specified goals.  Any of the professional staff involved in the patient's care may be the designated case manager for one or more cases.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5406       DISCHARGE CRITERIA FOR INPATIENT REHABILITATION FACILITIES OR UNITS

(a)  Discharge planning shall be an integral part of the patient's treatment plan and shall begin upon admission to the facility.  After established goals have been reached, or a determination has been made that care in a less intensive setting would be appropriate, or that further progress is unlikely, the patient shall be discharged to an appropriate setting.  Other reasons for discharge may include an inability or unwillingness of patient or family to cooperate with the planned therapeutic program or medical complications that preclude a further intensive rehabilitative effort.  The facility shall involve the patient, family, staff members and referral sources in discharge planning.

(b)  The case manager shall facilitate the discharge or transfer process in coordination with the facility social worker.

(c)  If a patient is being referred to another facility for further care, appropriate documentation of the patient's current status shall be forwarded with the patient.  A formal discharge summary shall be forwarded within 48 hours following discharge and shall include the reasons for referral, the diagnosis, functional limitations, services provided, the results of services, referral action recommendations and activities and procedures used by the patient to maintain and improve functioning.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5407       COMPREHENSIVE REHABILITATION PERSONNEL ADMINISTRATION

(a)  The facility shall have qualified staff members, consultants and contract personnel to provide services to the patients admitted to the inpatient rehabilitation facility or unit.

(b)  Personnel shall be employed or provided by contractual agreement in sufficient types and numbers to meet the needs of all patients admitted for comprehensive rehabilitation.

(c)  Written agreements shall be maintained by the facility when services are provided by contract on an ongoing basis.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff. January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5408       COMPREHENSIVE INPATIENT REHABILITATION PROGRAM STAFFING REQUIREMENTS

(a)  The staff of the inpatient rehabilitation facility or unit shall include at a minimum:

(1)           the inpatient rehabilitation facility or unit shall be supervised by a rehabilitation nurse.  The facility shall identify the nursing skills necessary to meet the needs of the rehabilitation patients in the unit and assign staff qualified to meet those needs;

(2)           the minimum nursing hours per patient in the rehabilitation unit shall be 5.5 nursing hours per patient day.  At no time shall direct care nursing staff be less than two full-time equivalents, one of which must be a registered nurse;

(3)           the inpatient rehabilitation unit shall employ or provide by contractual agreements sufficient therapist to provide a minimum of three hours of specific (physical, occupational or speech) or combined rehabilitation therapy services per patient day;

(4)           physical therapy assistants and occupational therapy assistants shall be supervised on-site by physical therapists or occupational therapists;

(5)           rehabilitation aides shall have documented training appropriate to the activities to be performed and the occupational licensure laws of his or her supervisor.  The overall responsibility for the on-going supervision and evaluation of the rehabilitation aide remains with the registered nurse as identified in Subparagraph (a)(1) of this Rule.  Supervision by the physical therapist or by the occupational therapist is limited to that time when the therapist is on-site and directing the rehabilitation activities of the aide; and

(6)           hours of service by the rehabilitation aide are counted toward the required nursing hours when the aide is working under the supervision of the nurse.  Hours of service by the rehabilitation aide are counted toward therapy hours during that time the aide works under the immediate, on-site supervision of the physical therapist or occupational therapist.  Hours of service shall not be dually counted for both services.  Hours of service by rehabilitation aides in performing nurse-aide duties in areas of the facility other than the rehabilitation unit shall not be counted toward the 5.5 hour minimum nursing requirement described for the rehabilitation unit.

(b)  Additional personnel shall be provided as required to meet the needs of the patient, as defined in the comprehensive inpatient rehabilitation evaluation.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff. January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5409       STAFF TRAINING FOR INPATIENT REHABILITATION FACILITIES OR UNIT

Prior to the provision of care, all rehabilitation personnel, excluding physicians, assigned to the rehabilitation unit shall be provided training or shall provide documentation of training that includes at a minimum the following:

(1)           active and passive range of motion;

(2)           assistance with ambulation;

(3)           transfers;

(4)           maximizing functional independence;

(5)           the psycho-social needs of the rehabilitation patient;

(6)           the increased safety risks of rehabilitation training (including falls and the use of restraints);

(7)           proper body mechanics;

(8)           nutrition, including dysphagia and restorative eating;

(9)           communication with the aphasic and hearing impaired patient;

(10)         behavior modification;

(11)         bowel and bladder training; and

(12)         skin care.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff. January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5410       EQUIPMENT REQUIREMENTS/COMPREHENSIVE INPATIENT REHABILITATION PROGRAMS

(a)  The facility shall provide each discipline with the necessary equipment and treatment methods to achieve the short and long-term goals specified in the comprehensive inpatient rehabilitation interdisciplinary treatment plans for patients admitted to these facilities or units.

(b)  Each patient's needs for a standard wheelchair or a specially designed wheelchair or additional devices to allow safe and independent mobility within the facility shall be met.

(c)  Special physical therapy and occupational therapy equipment for use in fabricating positioning devices for beds and wheelchairs shall be provided including splints, casts, cushions, wedges and bolsters.

(d)  Physical therapy devices shall be provided, including a mat, table, parallel bars, sliding boards, and special adaptive bathroom equipment.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5411       PHYSICAL FACILITY REQUIREMENTS/INPATIENT REHABILITATION FACILITIES OR UNIT

(a)  The inpatient rehabilitation facility or unit shall be in a designated area and shall be used for the specific purpose of providing a comprehensive inpatient rehabilitation program.

(b)  The floor area of a single bedroom shall be sufficient for the patient or the staff to easily transfer the patient from the bed to a wheelchair and to maneuver a 180 degree turn with a wheelchair on at least one-side of the bed.

(c)  The floor area of a multi-bed bedroom shall be sufficient for the patient or the staff to easily transfer the patient from the bed to a wheelchair and to maneuver a 180 degree turn with a wheelchair between beds.

(d)  Each patient room shall meet the following requirements:

(1)           maximum room capacity of no more than four patients;

(2)           operable windows;

(3)           a nurse call system designed to meet the special needs of rehabilitation patients;

(4)           in single and two-bed rooms with private toilet room, the lavatory may be located in the toilet room;

(5)           a wardrobe or closet for each patient which is wheelchair accessible and arranged to allow the patient to access the contents;

(6)           a chest of drawers or built-in drawer storage with mirror above, which is wheelchair accessible; and

(7)           a bedside table for toilet articles and personal belongings.

(e)  Space for emergency equipment such as resuscitation carts shall be provided and shall be under direct control of the nursing staff, in proximity to the nurse's station and out of traffic.

(f)  Patients' bathing facilities shall meet the following specifications:

(1)           there shall be at least one shower stall or one bathtub for each 15 beds not individually served.  Each tub or shower shall be in an individual room or privacy enclosure which provides space for the private use of the bathing fixture, for drying and dressing and for a wheelchair and an assisting attendant;

(2)           showers in central bathing facilities shall be at least five feet square without curbs and designed to permit use by a wheelchair patient;

(3)           at least one five-foot-by-seven-foot shower shall be provided which can accommodate a stretcher and an assisting attendant.

(g)  Patients' toilet rooms and lavatories shall meet the following specifications:

(1)           the size of toilet room shall permit a wheelchair, a staff person and appropriate wheel-to-water closet transfers;

(2)           a lavatory in the room shall permit wheelchair access;

(3)           lavatories serving patients shall:

(A)          allow wheelchairs to extend under the lavatory; and

(B)          have water supply spout mounted so that its discharge point is a minimum of five inches above the rim of the fixture; and

(4)           lavatories used by patients and by staff shall be equipped with blade-operated supply valves.

(h)  The space provided for physical therapy, occupational therapy and speech therapy by all inpatient rehabilitation facilities or units may be shared but shall, at a minimum, include:

(1)           office space for staff;

(2)           office space for speech therapy evaluation and treatment;

(3)           waiting space;

(4)           training bathroom which includes toilet, lavatory and bathtub;

(5)           gymnasium or exercise area;

(6)           work area such as tables or counters suitable for wheelchair access;

(7)           treatment areas with available privacy curtains or screens;

(8)           an activities of daily living training kitchen with sink, cooking top (secured when not supervised by staff), refrigerator and counter surface for meal preparation;

(9)           storage for clean linens, supplies and equipment;

(10)         janitor's closet accessible to the therapy area with floor receptor or service sink and storage space for housekeeping supplies and equipment (one closet or space may serve more than one area of the inpatient rehabilitation facility or unit); and

(11)         hand washing facilities.

(i)  For social work and psychological services the following shall be provided:

(1)           office space for staff;

(2)           office space for private interviewing and counseling for all family members; and

(3)           work space for testing, evaluation and counseling.

(j)  If prosthetics and orthotics services are provided, the following space shall be made available as necessary:

(1)           work space for technician; and

(2)           space for evaluation and fittings (with provisions for privacy).

(k)  If vocational therapy services are provided, the following space shall be made available as necessary:

(1)           office space for staff;

(2)           work space for vocational services activities such as prevocational and vocational evaluation;

(3)           training space;

(4)           storage for equipment; and

(5)           counseling and placement space.

(l)  Recreational therapy space requirements shall include the following:

(1)           activities space;

(2)           storage for equipment and supplies;

(3)           office space for staff; and

(4)           access to male and female toilets.

(m)  The following space shall be provided for patient's dining, recreation and day areas:

(1)           sufficient room for wheelchair movement and wheelchair dining seating;

(2)           if food service is cafeteria type, adequate width for wheelchair maneuvers, queue space within the dining area (and not in a corridor) and a serving counter low enough to view food;

(3)           total space for inpatients, a minimum of 25 square feet per bed;

(4)           for outpatients participating in a day program or partial day program, 20 square feet when dining is a part of the program and 10 square feet when dining is not a part of the program;

(5)           storage for recreational equipment and supplies, tables and chairs; and

(6)           the patient dining, recreation and day area spaces shall be provided with windows that have glazing of an area not less than eight percent of the floor area of the space, and at least one-half of the required window area must be operable.

(n)  A laundry shall be available and accessible for patients.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5412       ADDITIONAL REQUIREMENTS FOR TRAUMATIC BRAIN INJURY PATIENTS

Inpatient rehabilitation facilities providing services to persons with traumatic brain injuries shall meet the requirements in this Rule in addition to those identified in this Section.

(1)           Direct-care nursing personnel staffing ratios established in Rule .5408 of this Section shall not be applied to nursing services for traumatic brain injury patients in the inpatient, rehabilitation facility or unit.  The minimum nursing hours per traumatic brain injury patient in the unit shall be 6.5 nursing hours per patient day.  At no time shall direct care nursing staff be less than two full-time equivalents, one of which shall be a registered nurse.

(2)           The inpatient rehabilitation facility or unit shall employ or provide by contractual agreements physical, occupational or speech therapists in order to provide a minimum of 4.5 hours of specific or combined rehabilitation therapy services per traumatic brain injury patient day.

(3)           The facility shall provide special facility or special equipment needs for patients with traumatic brain injury, including specially designed wheelchairs, tilt tables and standing tables.

(4)           The medical director of an inpatient traumatic brain injury program shall have two years management in a brain injury program, one of which may be in a clinical fellowship program and board eligibility or certification in the medical specialty of the physician's training.

(5)           The facility shall provide the consulting services of a neuropsychologist.

(6)           The facility shall provide continuing education in the care and treatment of brain injury patients for all staff.

(7)           The size of the brain injury program shall be adequate to support a comprehensive, dedicated ongoing brain injury program.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff. January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5413       ADDITIONAL REQUIREMENTS FOR SPINAL CORD INJURY PATIENTS

Inpatient rehabilitation facilities providing services to persons with spinal cord injuries shall meet the requirements in this Rule in addition to those identified in this Section.

(1)           Direct-care nursing personnel staffing ratios established in Rule .5408 of this Section shall not be applied to nursing services for spinal cord injury patients in the inpatient rehabilitation facility or unit.  The minimum nursing hours per spinal cord injury patient in the unit shall be 6.0 nursing hours per patient day.  At no time shall direct care nursing staff be less than two full-time equivalents, one of which shall be a registered nurse.

(2)           The inpatient rehabilitation facility or unit shall employ or provide by contractual agreements physical, occupational or speech therapists in order to provide a minimum of 4.0 hours of specific or combined rehabilitation therapy services per spinal cord injury patient day.

(3)           The facility shall provide special facility or special equipment needs of patients with spinal cord injury, including specially designed wheelchairs, tilt tables and standing tables.

(4)           The medical director of an inpatient spinal cord injury program shall have either two years experience in the medical care of persons with spinal cord injuries or six months minimum in a spinal cord injury fellowship.

(5)           The facility shall provide continuing education in the care and treatment of spinal cord injury patients for all staff.

(6)           The facility shall provide specific staff training and education in the care and treatment of spinal cord injury.

(7)           The size of the spinal cord injury program shall be adequate to support a comprehensive, dedicated ongoing spinal cord injury program.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff. January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5414       DEEMED STATUS FOR INPATIENT REHABILITATION FACILITIES OR UNIT

(a)  If an inpatient rehabilitation facility or unit with a comprehensive inpatient rehabilitation program is surveyed and accredited by the Joint Commission for the Accreditation of Health Care Organizations (JCAHO) or the Commission on Accreditation of Rehabilitation Facilities (CARF) and has been approved by the Department in accordance with G.S. 131E, Article 9, the Department deems the facility to be in compliance with Rules .5401 through .5413 of this Section.

(b)  Deemed status shall be provided only if the inpatient rehabilitation facility or unit provides copies of survey reports to the Department.  The JCAHO report shall show that the facility or unit was surveyed for rehabilitation services.  The CARF report shall show that the facility or unit was surveyed for comprehensive rehabilitation services.  The facility or unit shall sign an agreement (Memorandum of Understanding) with the Department specifying these terms.

(c)  The inpatient rehabilitation facility or unit shall be subject to inspections or complaint investigations by representatives of the Department at any time.  If the facility or unit is found not to be in compliance with the rules listed in Paragraph (a) of this Rule, the facility shall submit a plan of correction and be subject to a follow-up visit to ensure compliance.

(d)  If the inpatient rehabilitation facility or unit loses or does not renew its accreditation, the facility or unit shall notify the Division in writing within 30 days.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

section .5500 – supplemental rules for hospitals providing living organ donation transplant services

 

10A NCAC 13B .5501       applicability of rules

The rules contained in this Section shall apply to hospitals providing living organ donation transplant services.

 

History Note:        Authority G.S. 131E-75; 131E-79; 143B-165;

Eff. April 1, 2006.

 

10A NCAC 13B .5502       INDEPENDENT DONOR ADVOCATE TEAM

(a)  The facility shall appoint an Independent Donor Advocate Team (IDAT) whose sole purpose is to represent and ensure the well-being of the potential donor, making sure he or she is aware of the risks and benefits of donation and that the choice to donate is voluntary.  The IDAT shall ensure the potential donor learns about the entire donation process.  This would include the selection of recipients for the transplant, the procedures to be employed for both the donor and recipient, and possible outcomes.  Sufficient time for the discussion, supplemented with written materials, must be allowed for comprehension and assimilation of the information about transplantation and the ramifications of donation.  Written and verbal presentations shall be in language in accordance with the person's ability to understand. 

(b) The IDAT shall consist of a physician, a clinical transplant coordinator, and a social worker or qualified mental health professional as defined in Rule .5202(k) of this Subchapter.  The physician shall be the leader of the IDAT.  The IDAT members shall have experience in organ transplantation processes and programs and shall be able to act for the interests of the potential donor independent of any financial or facility influence.  Based on the outcome of the evaluation of the potential donor pursuant to Rule .5504 of this Section, if the IDAT determines any potential donor is unsuitable for donation, it shall provide the reasons both verbally and in writing. 

(c)  In order to ensure the well-being of the potential donor, the IDAT shall:

(1)           Protect and represent the interests of the potential donor;

(2)           Make it clear to the potential donor that the choice to donate is entirely his or hers;

(3)           Inform and discuss with the potential donor the medical, psychosocial and financial aspects related to the live donation;

(4)           Explain to the potential donor the evaluation process, what it means and his or her option to stop at any time;

(5)           Determine the intellectual and emotional ability of the potential donor to understand the legal and ethical aspects of informed choice;

(6)           Assess if the potential donor has understood the risks and the benefits and how they impact on his or  her own core beliefs and values; and

(7)           Identify for the potential donor resources that will be available to provide continuous care during hospitalization and referrals in medicine, psychiatry or social work, which may be needed or required following discharge.

 

History Note:        Authority G.S. 131E-75; 131E-79; 143B-165;

Eff. May 1, 2006.

 

10A NCAC 13B .5503       INFORMED CHOICE

(a)  The potential donor must be free to make an informed independent decision, which has been termed informed choice. Informed choice addresses the decision process of the potential donor as he or she determines whether or not to donate.  Informed choice has several aspects.  First, the potential donor must know he or she has a choice, meaning he or she can freely decide either to donate or not to donate an organ.  Second, the potential donor must be aware of both the risks and benefits of donation.  The potential donor must be able to weigh the positive aspects of the donation as well as take into account the technical aspects such as the surgery, recovery, financial impact and any unexpected but potential consequences that may result such as a change in the patient's life, health, insurability, employment or emotional stability.

(b)  The person who consents to be a live organ donor shall be:

(1)           Legally competent;

(2)           Willing to donate;

(3)           Free from coercion, including financial coercion, actual or implied;

(4)           Medically suitable;

(5)           Informed and able to express understanding of the risks and benefits of donation; and

(6)           Informed of the risks, benefits and alternative treatment regimens available to the recipient.

(c)  A statement signed by the potential donor that his or her participation is completely voluntary and may be withdrawn at any time shall be placed in the medical record.

(d)  Understanding

(1)           The potential donor shall be able to demonstrate that he or she understands the essential elements of the donation process with emphasis on the risks associated with the procedure;

(2)           With the potential donor's permission, the donor's designee, family or next of kin shall be given the opportunity to openly discuss the donor's concerns in a safe and non-threatening environment; and

(3)           The potential donor shall understand, agree to, and commit to postoperative follow-up and testing by the facility performing the surgical removal of the organ and subsequent organ transplant.

(e)  Disclosure

(1)           The donor surgical team and the IDAT shall disclose any facility affiliations to the potential donor;

(2)           The potential donor shall have a period of reflection appropriate to the acuity of the clinical condition of the recipient and reaffirmation of the decision to donate subsequent to the completion of the medical work-up and final approval to proceed by the IDAT.  After the period of reflection the potential donor may sign the consent for the donation procedure;

(3)           Non-English speaking candidates and hearing impaired candidates must be provided with a non-family interpreter who understands the donor's language and culture;

(4)           A member of the IDAT shall witness the potential donor signing the consent documents for removal of the donor organ; and

(5)           The overall donation process and experience shall be explained to the potential donor and shall be provided in writing to include:

(A)          Donor evaluation procedure;

(B)          Surgical procedure;

(C)          Recuperative period;

(D)          Short-term and long term follow-up care;

(E)           Alternative donation and transplant procedure;

(F)           Potential psychological benefits to donor;

(G)          Transplant facility and surgeon-specific statistics of donor and recipient outcomes;

(H)          Confidentiality of the donor's information and decisions;

(I)            Donor's ability to opt out at any point in the process;

(J)            Information about how the facility performing the transplant will attempt to follow the health of the donor; and

(K)          Need for the donor to review potential personal insurability for future insurance coverage.

(f)  The IDAT shall make the potential donor aware of the following risk factors:

(1)           Physical

(A)          Potential for surgical complications including risk of donor death;

(B)          Potential for organ failure and the need for future organ transplant for the donor;

(C)          Potential for other medical complications including long-term complications and complications currently unforeseen;

(D)          Scars;

(E)           Pain;

(F)           Fatigue; and

(G)          Abdominal or bowel symptoms such as bloating and nausea.

(2)           Psychosocial

(A)          Potential for problems with body image;

(B)          Possibility of transplant recipient death;

(C)          Possibility of transplant recipient rejection and need for re-transplantation;

(D)          Possibility of recurrent disease in a transplant recipient;

(E)           Possibility of post surgery adjustment problems;

(F)           Impact on the donor's family or next of kin;

(G)          Impact on the transplant recipient's family or next of kin; and

(H)          Potential impact of donation on the donor's lifestyle.

(3)           Financial

(A)          Out of pocket expenses;

(B)          Child care costs;

(C)          Possible loss of employment;

(D)          Potential impact on the ability to obtain future employment; and

(E)           Potential impact on the ability to obtain or afford health and life insurance.

(g)  The potential donor shall provide assurance and consent that the following areas have been addressed:

(1)           That there is no monetary profit to the potential donor.  Coverage for expenses incurred as a result of the organ donation is not considered monetary profit;

(2)           That family members or others did not coerce the potential donor into making his or her decision;

(3)           That the potential donor has been provided with a general statement of unsuitability for donation if requested.  Medical information regarding the potential donor shall not be falsified to provide the donor with an excuse to decline donation;

(4)           That the potential donor is intellectually and emotionally capable of participation in a discussion of potential risks and benefits;

(5)           That the potential donor has been provided adequate information to ensure his or her understanding regarding the risks of the donation;

(6)           That the potential donor has been educated regarding the recipient's options for organs from deceased persons, including risks and outcomes; and

(7)           That the potential donor understands that he or she may decline to donate at any time.

(h)  Documentation

(1)           A medical record, separate and distinct from the transplant recipient's record, shall be maintained to protect donor confidentiality; and

(2)           The informed choice process and evaluation protocol shall be documented and placed in the potential donor's medical record.

(i)  Decision to Donate.  Once the IDAT determines the suitability of the potential donor the IDAT shall discuss with the potential donor's surgical team and transplant team its decision prior to its presentation to the potential donor.  If the potential donor wishes to donate, but the IDAT does not agree, the IDAT's opposition shall be so noted in a report to the donor surgeon, who shall document reasons for proceeding against the IDAT advice.  The reason why the IDAT has objections shall be explained to the potential donor.  For example, the potential donor may not have the ability to understand the information provided to him or her or the donor may be unable to integrate the degree of risk pertinent to his or her situation or there may be a lack of balance between the risks to the potential donor and potential benefits to the transplant recipient.  Even if the potential donor is willing to donate his or her organ, the final review and decision whether or not to proceed with the donation rests with the donor surgical team and transplant team.

(j)  In cases involving living liver donation, prior to reaching a decision to donate the potential donor shall be provided in writing the U.S. Department of Health and Human Services Advisory Committee on Organ Transplantation (ACOT) recommendations entitled "Living Liver Donor Initial Consent for Evaluation" which is hereby incorporated by reference with all subsequent amendments.  The ACOT recommendations can be obtained free of charge via the internet at: http://www.organdonor.gov/acotrecs.html.  The items contained in the ACOT recommendations must be explained to the potential donor in language and terms which he or she can understand and then be signed by the donor and the signature witnessed.  Subsequent to this, if all the facts show that the potential donor is, in fact, in all respects a viable potential donor, then he or she shall execute the ACOT recommended form entitled "Living Liver Donor Informed Consent for Surgery" which is hereby incorporated by reference with all subsequent amendments.  In addition, this form shall comply with G.S. 90-21.13 Informed Consent which is hereby incorporated by reference with all subsequent amendments.

 

History Note:        Authority G.S. 131E-75; 131E-79; 143B-165;

Eff. May 1, 2006.

 

10A NCAC 13B .5504       EVALUATION PROTOCOL FOR LIVING ORGAN DONORS

Hospitals shall complete the following evaluation protocols prior to living organ donation:   

(1)           The facility shall confirm the potential donor's ABO blood type.

(2)           Only individuals 18 years of age or older shall be considered for living organ donation. The facility shall complete a screening interview with the potential donor which confirms the donor's age, height, weight, demographic information, medical and surgical history, medications, drug or alcohol history, smoking history, and a family or social history.  Insurance issues (health and life) shall also be discussed with the potential donor and an attempt shall be made to answer any questions asked by the donor.  Written information on the living donor process shall be made available to the potential donor.

(3)           The donor surgical team shall determine whether the potential donor shall be excluded based on the medical information or family history: for example, exclusionary criteria may include the presence of diabetes, uncontrolled hypertension, liver, pulmonary or cardiac disease, renal dysfunction or high Body Mass Index (BMI).

(4)           An IDAT shall be assigned for the potential donor pursuant to Rule .5502(c) of this Section.  The IDAT leader shall not be a physician who is the primary physician of the potential transplant recipient.

(5)           The IDAT leader shall conduct a medical evaluation of the potential donor.  The medical evaluation shall include a full and frank discussion of the risks associated with the evaluation tests with the potential donor and the donor's chosen designee.  If the potential donor wishes to proceed, laboratory and diagnostic tests shall be ordered as necessary.

(6)           An IDAT member shall conduct a psychosocial evaluation of the potential donor.  The IDAT member shall also discuss financial considerations.

(7)           The IDAT shall review the laboratory and diagnostic test results, as well as psychosocial evaluation and discuss them with the donor to decide whether to move forward with the potential donor's evaluation. 

(8)           The donor surgeon shall evaluate the mortality and morbidity risks associated with donation and disclose those risks to the potential donor with adequate time for any questions to be answered in detail. The donor's designee shall also be present at this appointment.

(9)           The IDAT shall perform a final review and makes its recommendation as set out in Rule .5503(i) of this Section. 

(10)         The hospital shall schedule an appointment for pre-operative screening with the potential donor after the entire process of evaluation is complete.  An informed consent as required in Rule .4605(c)(2) of this Subchapter is necessary for the donation and surgical procedure and shall be completed by this time.  In addition, where applicable, the potential donor shall be given ample time for autologous blood donation through the American Red Cross.

 

History Note:        Authority G.S. 131E-75; 131E-79; 143B-165;

Eff. May 1, 2006.

 

10A NCAC 13B .5505       Perioperative Care and Facility Support

(a)  The donor surgical team shall have primary concern and responsibility for the donor's care and welfare throughout his or her entire hospital stay.  The donor surgical team consists of the donor surgeon, his or her surgical and medical partners, fellows, residents, and physician assistants or nurse practitioners. 

(b)  Preoperative Preparation

(1)           The facility shall have the ability to allow donors to bank a minimum of one unit of blood before surgery.  Facilities shall have the ability to store and transfuse autologous blood;

(2)           The transplant coordinator or another team member shall be assigned the responsibility of providing updates to the families of both the donor and transplant recipient during the surgical procedures; and

(3)           For live donor liver procedures, surgeries shall be scheduled only when staffing will be available for the postoperative period.  If surgery is scheduled on a Thursday or Friday, the hospital shall ensure that there is adequate attending physician, resident physician, physician assistant or nurse practitioner, and registered nursing coverage during the weekend.

(c)  Postoperative Care

(1)           After live donor nephrectomy, the patient shall receive post-operative care equivalent to that provided for abdominal procedures under general anesthesia; and

(2)           For live liver donors:

(A)          Day 0-1: The live adult liver donor shall receive care in the intensive care unit (ICU) or post-anesthesia care unit (PACU);

(B)          Day 2: If stable and cleared for transfer by the donor surgical team, the donor shall be cared for in a hospital unit that is dedicated to the care of transplant recipients or a hospital unit in which patients who undergo hepatobiliary resectional surgery are provided care.  Liver donors shall not at any time be cared for on any other unit unless a specific medical condition of the donor warrants such a transfer;

(C)          The donor shall be evaluated at least daily by a liver transplant attending physician with documentation in the medical record;

(D)          The donor surgical team shall be responsible for the clinical management of the donor;

(E)           The patient care staff shall be familiar with the common complications associated with the donor and transplant recipient operations and have appropriate monitoring in place to detect these problems if they arise; and

(F)           If there is an emergent complication requiring re-operation, these patients shall be prioritized for access to the operating room based on the facility's operating room policies and guidelines.

(d)  Medical Staffing.   For live donor nephrectomy patients, there shall be continuous physician coverage available for patient evaluation as needed.  These patients shall be provided post-operative care equivalent to patients undergoing a nephrectomy. 

(e)  Nurse Staffing

(1)           Nursing staff shall be familiar with recovery of nephrectomy patients.  They shall be aware of the signs and symptoms of hypovolemia due to post-operative bleeding or to excessive diuresis.   They shall have ready access to the surgical team responsible for the patient's post-operative care;

(2)           For live liver donors, nursing staff shall have ongoing education and training in live donor liver transplantation nursing care for both donors and recipients.  This shall include education on the pain management issues particular to the donor.  The registered nursing to patient ratio in the ICU or PACU level setting shall be appropriate for the acuity level of the patients.  For live liver donors, the same registered nurse shall not take care of both the donor and the recipient.  For live liver donors, the nursing service shall provide the potential donor with pre-surgical information including, if possible, a tour of the unit before surgery; and

(3)           For all donors, the names and beeper numbers of the donor surgical team or team responsible for the donor's post-operative surgical care (e.g. urology service or laparoscopic general surgery service for some donor nephrectomy patients) shall be posted on all units receiving transplant donors.

(f)  Radiology.  For facilities performing live donor nephrectomies, radiological staff shall be available for pre-operative assessment, peri-operative care, and post-operative follow-up as required.

 

History Note:        Authority G.S. 131E-75; 131E-79; 143B-165;

Eff. April 1, 2006.

 

10A NCAC 13B .5506       DISCHARGE PLANNING

(a)  Pre-Donation.  At the time of evaluation by the IDAT, a discussion shall be held between the IDAT social worker and the potential donor and his or her family or next of kin to address the following areas:

(1)           Living arrangements after discharge from the surgery or while the donor recuperates until able to travel;

(2)           Transportation arrangements from the hospital to the donor's accommodations or back to follow up appointments;

(3)           Caregivers to provide assistance or support upon discharge; if the donor has children or other dependents, a plan for the children's or dependent's care while the donor recuperates;

(4)           Financial considerations:  Encourage donor to discuss with employer about medical leave or disability. This discussion shall include checking with health or life insurance carriers about future "pre-existing conditions" or "exclusions" that may result from donation;

(5)           Provided consent is first obtained, referrals to other living organ donors from that particular facility and suggestions from other resources such as publications and websites; and

(6)           Emotional issues surrounding the organ donation process.

(b)  Day of Discharge

(1)           A written discharge plan shall be provided to the donor with the following instructions:

(A)          Restrictions on activities;

(B)          Permitted activities (i.e. return to work);

(C)          Diet;

(D)          Pain medication with prescription;

(E)           Follow up appointments with surgeon;

(F)           Contact numbers for the Independent Donor Advocate Team should the donor have questions, concerns or problems; and

(G)          Additional instructions for caregivers, if any.

(2)           The discharge plan shall be reviewed with the donor by the facility discharge planner or primary care nurse.

(c)  Post Discharge medical follow-up, social, psychological and financial support

(1)           Post-operative visits shall be scheduled by the donor with the surgeon to assess the following:

(A)          Wound healing;

(B)          Signs and symptoms of infections; and

(C)          Laboratory results as appropriate to the organ type, as well as any imaging or other diagnostic findings.

(2)           Dictated summaries of surgery and follow-up visits shall be sent to the donor's primary care physician by the facility to ensure appropriate medical care.

(3)           Referrals shall be made to community agencies to address the donor's emotional and psychological issues if needed or requested by the donor, his or her designee, family, next of kin or the IDAT to;

(A)          Provide the donor the opportunity to participate in a support group; and

(B)          Provide the donor recognition as determined by the facility.

(d)  Any questions or concerns regarding the discharge plan or discharge planning process by the donor, the donor's designee, the donor's next of kin or legally responsible party shall be addressed by facility staff.

 

History Note:        Authority G.S. 131E-75; 131E-79; 143B-165;

Eff. April 1, 2006.

 

SECTION .5600 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .5600       Reserved for future codification

 

SECTION .5700 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .5700       Reserved for future codification

 

SECTION .5800 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .5800       Reserved for future codification

 

SECTION .5900 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .5900       Reserved for future codification

 

SECTION .6000 - PHYSICAL PLANT

 

10A NCAC 13B .6001       LOCATION

(a)  The site of any facility shall be accessible to service vehicles, fire protection and emergency apparatus.

(b)  The water supply system available to the site shall be tested to determine the mineral and salts content and their effect on the various water systems in the facility.  When these tests indicate the facility will have problems in maintenance and upkeep, the facility shall provide a water treatment system.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6002       ROADS AND PARKING

(a)  Paved roads shall be provided within the property lines to provide access to the main entrance, emergency entrance, and to service entrances, including loading and unloading docks for delivery trucks.

(b)  Facilities having an organized emergency services department shall have the emergency entrance well marked to facilitate entry from the public roads or streets serving the site.

(c)  Paved walkways shall be provided for necessary pedestrian traffic.

(d)  Off-street parking shall be made available for patients, staff, and visitors.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .6100 - GENERAL REQUIREMENTS

 

10A NCAC 13B .6101       GENERAL

The design, construction, maintenance and operation of a facility shall be in accordance with those codes and standards listed in Rule .6102, LIST OF REFERENCED CODES AND STANDARDS of this Section, and codes, ordinances, and regulations enforced by city, county, or other state jurisdictions with the following requirements:

(1)           Notify the Division when all construction or renovation has been completed, inspected and approved by the architect and engineer having responsibility, and the facility is ready for a final inspection.  Prior to using the completed project, the facility shall receive from the Division written approval for use.  The approval shall be based on an on-site inspection by the Division or by documentation as may be required by the Division;

(2)           In the absence of any requirements by other authorities having jurisdiction, develop a master fire and disaster plan with input from the local fire department and local emergency management agency to fit the needs of the facility.  The plan shall require:

(a)           Training of facility employees in the fire plan implementation, in the use of fire-fighting equipment, and in evacuation of patients and staff from areas in danger during an emergency condition;

(b)           Conducting of quarterly fire drills on each shift;

(c)           A written record of each drill shall be on file at the facility for at least three years;

(d)           The testing and evaluation of the emergency electrical system(s) once each year by simulating a utility power outage by opening of the main facility electrical breaker(s).  Documentation of the testing and results shall be completed at the time of the test and retained by the facility for three years; and

(e)           Disaster planning to fit the specific needs of the facility's geographic location and disaster history, with at least one documented disaster drill conducted each year.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6102       LIST OF REFERENCED CODES AND STANDARDS

The following codes and standards are adopted by reference including subsequent amendments.  Copies of these publications can be obtained from the various organizations at the addresses listed:

(1)           The North Carolina State Building Code, current edition, all volumes including subsequent amendments.  Copies of this code may be purchased from the N.C. Department of Insurance Engineering and Codes Division located at 410 North Boylan Avenue, Raleigh, NC 27603 at a cost of two hundred fifty dollars ($250.00).

(2)           The National Fire Protection Association codes and standards listed in this Paragraph, current editions including subsequent amendments.  Copies of these codes and standards may be obtained from the National Fire Protection Association, 1 Batterymarch Park, PO Box 9101, Quincy, MA  02269-9101 at the cost shown for each code or standard listed.

(a)           10                           Portable Fire Extinguishers                                                                ($22.50)

(b)           12                           Carbon Dioxide Extinguishing Systems                                          ($20.25)

(c)           12A                        Halon 1301 Fire Extinguishing Systems                                         ($22.25)

(d)           12B                        Halon 1211 Fire Extinguishing Systems                                         ($20.25)

(e)           13                           Installation of Sprinkler Systems                                                     ($28.50)

(f)            13D                        Installation of Sprinkler Systems in One- and

Two-Family Dwellings and Manufactured Homes                       ($20.25)

(g)           13R                        Installation of Sprinkler Systems in Residential

Occupancies up to and including Four Stories

in Height                                                                                                ($20.25)

(h)           14                           Installation of  Standpipe and Hose Systems                                                ($20.25)

(i)            15                           Water Spray Fixed Systems                                                              ($20.25)

(j)            17                           Dry Chemical Extinguishing Systems                                              ($20.25)

(k)           17A                        Wet Chemical Extinguishing Systems                                             ($16.75)

(l)            20                           Installation of Centrifugal Fire Pumps                                            ($20.25)

(m)          22                           Water Tanks for Private Fire Protection                                          ($22.25)

(n)           25                           Water-Based Fire Protection Systems                                             ($22.25)

(o)           30                           Flammable and Combustible Liquids Code                                  ($22.25)

(p)           31                           Installation of Oil-Burning Equipment                                            ($20.25)

(q)           37                           Stationary Combustion Engines and Gas Turbines                      ($16.75)

(r)            45                           Fire Protection for Laboratories Using Chemicals                         ($20.25)

(s)            49                           Hazardous Chemicals Data                                                              ($26.50)

(t)            50                           Bulk Oxygen Systems at Consumer Sites                                       ($16.75)

(u)           53                           Fire Hazards in Oxygen-Enriched Atmospheres                            ($22.50)

(v)           54                           National Fuel Gas Code                                                                     ($26.50)

(w)          55                           Compressed and Liquefied Gases in Portable Cylinders             ($16.75)

(x)           58                           Storage and Handling of Liquefied Petroleum Gases                  ($26.50)

(y)           59A                        Liquefied Natural Gas (LNG)                                                            ($20.25)

(z)           72                           National Fire Alarm Code                                                                  ($32.25)

(aa)         80                           Fire Doors and Windows                                                                    ($22.50)

(bb)         82                           Incinerators, Waste and Linen Handling Systems

and Equipment                                                                                    ($16.75)

(cc)         88A                        Parking Structures                                                                               ($16.75)

(dd)         90A                        Installation of Air Conditioning and Ventilating Systems           ($20.25)

(ee)         90B                        Installation of Warm Air Heating and Air Conditioning

Systems                                                                                                 ($16.75)

(ff)          92A                        Smoke-Control Systems                                                                    ($20.25)

(gg)         92B                        Smoke Management Systems in Malls, Atria, Large Areas        ($20.25)

(hh)         96                           Ventilation Control and Fire Protection of Commercial

Cooking Operations                                                                            ($20.25)

(ii)           99                           Health Care Facilities                                                                         ($32.25)

(jj)           99B                        Hypobaric Facilities                                                                            ($20.25)

(kk)         101                         Safety to Life from Fire in Buildings and Structures                    ($39.50)

(ll)           101M                     Alternative Approaches to Life Safety                                           ($22.25)

(mm)      105                         Smoke-Control Door Assemblies                                                     ($16.75)

(nn)         110                         Emergency and Standby Power Systems                                       ($20.25)

(oo)         111                         Stored Electrical Energy Emergency and Standby

Power Systems                                                                                     ($16.75)

(pp)         204M                     Smoke and Heat Venting                                                                  ($20.25)

(qq)         220                         Types of Building Construction                                                        ($16.75)

(rr)           221                         Fire Walls and Fire Barrier Walls                                                      ($16.75)

(ss)          241                         Construction, Alteration, and Demolition Operations                  ($20.25)

(tt)           251                         Fire Tests of Building Construction and Materials                        ($20.25)

(uu)         255                         Test of Surface Burning Characteristics of Building

Materials                                                                                               ($16.75)

(vv)         321                         Basic Classification of Flammable and Combustible

Liquids                                                                                                   ($16.75)

(ww)       325                         Fire Hazard Properties of Flammable Liquids, Gases,

and Volatile Solids                                                                              ($22.25)

(xx)         407                         Aircraft Fuel Servicing                                                                        ($20.25)

(yy)         418                         Roof-top Heliport Construction and Protection                            ($16.75)

(zz)         704                         Identification of the Fire Hazards of Materials                             ($16.75)

(aaa)      705                         Field Flame Test for Textiles and Films                                          ($16.75)

(bbb)      780                         Lightning Protection Code                                                                 ($20.25)

(ccc)       801                         Facilities Handling Radioactive Materials                                      ($20.25)

(3)           American Society of Heating, Refrigerating & Air Conditioning Engineers Inc., (ASHRAE) HVAC APPLICATIONS, current edition including subsequent amendments.  Copies of this document may be obtained from the American Society of Heating, Refrigerating & Air Conditioning Engineers, Inc. at 1791 Tullie Circle NE, Atlanta, GA 30329 at a cost of one hundred nineteen dollars ($119.00).

(4)           Rules and Statutes Governing the Licensure of Ambulatory Surgical Facilities, current edition including subsequent amendments.  Copies of this document may be obtained from the N.C. Department of Health and Human Services, Division of Health Service Regulation, Licensure and Certification Section, 2711 Mail Service Center, Raleigh, NC  27699-2711 at a cost of three dollars ($3.00).

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6103       APPLICATION OF PHYSICAL PLANT REQUIREMENTS

The physical plant requirements for each facility shall be applied as follows:

(1)           New construction shall comply with the requirements of Section .6000 of this Subchapter;

(2)           Existing buildings shall meet licensure and code requirements in effect at the time of construction, alteration, or modification;

(3)           New additions, alterations, modifications, and repairs shall meet the technical requirements of Section .6000 of this Subchapter, however, where strict conformance with current requirements would be impractical, the authority having jurisdiction may approve alternative measures where the facility can demonstrate to the Division's satisfaction that the alternative measures do not reduce the safety or operating effectiveness of the facility;

(4)           Rules contained in Section .6000 of this Subchapter are minimum requirements and not intended to prohibit buildings, systems or operational conditions that exceed minimum requirements;

(5)           Equivalency: Alternate methods, procedures, design criteria, and functional variations from the physical plant requirements, because of extraordinary circumstances, new programs, or unusual conditions, may be approved by the authority having jurisdiction when the facility can effectively demonstrate to the Division's satisfaction, that the intent of the physical plant requirements are met and that the variation does not reduce the safety or operational effectiveness of the facility; and

(6)           Where rules, codes, or standards have any conflict, the most stringent requirement shall apply.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6104       ACCESS AND SAFETY

Projects involving replacement, alterations of, and additions to existing facilities shall be planned and phased so that construction will minimize disruptions of essential facility operations.  Facility access, exit ways, safety provisions, and building and life safety systems shall be maintained so that the health and safety of the occupants will not be jeopardized during construction.  Additional safety and operating measures shall be planned and executed to compensate for hazards related to construction or renovation activities to maintain an equivalent degree of health, safety, and operational effectiveness to that required by rules, standards, and codes for a facility not under construction or renovation.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .6200 - CONSTRUCTION REQUIREMENTS

 

10A NCAC 13B .6201       MEDICAL, SURGICAL AND POST-PARTUM CARE UNIT

The following requirements shall apply to licensed beds:

(1)           Each patient room shall meet the following requirements:

(a)           Maximum room capacity shall be four patients;

(b)           Minimum room areas exclusive of toilet rooms, closets, lockers, wardrobes, bathing room, or vestibules less than six feet wide shall be 100 square feet in single bed rooms and 80 square feet per bed in multi-bed rooms;

(c)           A minimum of three feet of clear working space on three sides of each bed shall be provided;

(d)           A window which can be opened from the inside shall be provided.  The window sill shall not be higher than three feet above the floor and shall be above grade;

(e)           A nurses' calling station at each patient bed and toilet room shall be provided;

(f)            At least one lavatory shall be provided in each patient room.  In a single bedroom other than post-partum rooms, the lavatory may be omitted from the patient room when a lavatory is located in an adjoining toilet room which serves that room only;

(g)           A toilet room containing a water closet and a lavatory shall be provided to serve no more than four beds or two patient rooms;

(h)           A wardrobe, locker or closet shall be provided for each patient suitable for hanging garments as well as for storage of personal effects; and

(i)            Provision shall be made for the visual privacy of each patient in multi-bed rooms.

(2)           The following service areas shall be located no further than 120 feet travel distance from each patient bedroom door:

(a)           Nurses' station with work counter and storage facilities;

(b)           Hand washing facilities located at the nurses' station;

(c)           Charting facilities;

(d)           A clean workroom or a clean holding room for storage and distribution of clean supply materials.  The clean workroom shall contain a work counter and hand washing and storage facilities.  A clean holding room shall be similar to a clean workroom except it shall be a part of a clean supply system and the work counter and hand washing facilities may be omitted;

(e)           A soiled workroom or a soiled holding room as a part of a system for the collection and disposal of soiled materials.  The soiled workroom shall contain a clinical sink or other suitable flushing device, sink equipped for hand washing, a work counter, a waste receptacle, and a linen receptacle.  A soiled holding room shall be similar to the soiled workroom except that it shall be a part of the soiled disposal system. The waste receptacle clinical sink and work counter may be omitted;

(f)            A drug distribution station that meets the current minimum requirements of governing state and federal agencies regulating controlled substances including a lavatory;

(g)           A clean linen storage closet.  This may be a designated area within the clean workroom.  If a closed cart system is used, storage may be in a controlled alcove out of corridor traffic;

(h)           A separate nourishment station that contains a lavatory, equipment for serving nourishment between meals, refrigerator and storage facilities.  Ice dispensing facilities for patient service and treatment shall be of a type that will not require use of scoops;

(i)            Storage of equipment including emergency equipment shall be provided to insure corridors are kept clear; and

(j)            Parking for stretchers and wheelchairs located out of corridor widths.

(3)           The following service areas shall be provided for each nursing unit:

(a)           Nurses office;

(b)           Closets or compartments for the safekeeping of coats and personal effects of staff;

(c)           Conference room;

(d)           Room for examination and treatment of patients.  This room may be omitted if all patient rooms are single-bed rooms.  This room shall have a minimum floor area of 100 square feet, excluding space for vestibule less than six feet wide, toilet, closets and work counters (whether fixed or movable).  The minimum room dimension shall be 10 feet.  The room shall contain a lavatory, a work counter, storage facilities and a desk, counter or shelf space for writing;

(e)           Lounge and toilet room for staff;

(f)            Janitors' closet.  This room shall contain a floor receptor or service sink and storage space for housekeeping supplies and equipment; and

(g)           Individually enclosed bathtubs or individually enclosed showers at the rate of one for each 12 beds or fraction thereof which are not otherwise served by bathing facilities within the patient rooms.

(4)           Each facility shall make provisions for at least one room for patients needing close supervision including provisions to minimize the chance of a patients' hiding, escape, injury or suicide.

(5)           Isolation Rooms.  Rooms for patients requiring protective or infectious isolation for infection control purposes shall be provided at the ratio of one isolation room for each 30 acute care licensed beds or major fraction thereof.  These may be located within each nursing unit or placed together in a separate unit.  Each isolation room shall be a single-bed room and shall conform to the requirements of Item (1) of this Rule except as follows:

(a)           A private toilet room containing a water closet and a bath or shower for the exclusive use of the patient which can be entered directly from the patient bed area without passing through the vestibule or anteroom shall be provided;

(b)           A lavatory for the exclusive use of the patient shall be provided.  It may be located in the patient room or in the private toilet room;

(c)           Entrance from the corridor shall be through a closed anteroom which contains facilities to assist staff personnel in maintaining aseptic conditions.  The anteroom shall contain a lavatory equipped for hand washing, storage for clean and soiled materials, and gowning facilities; and

(d)           A view window in the door for nursing observation of the patient from the anteroom shall be provided.

(6)           Provision shall be made for delivery of medications to patients.  All medications and related items shall be stored in compliance with current Federal and State laws and rules and made accessible only to authorized personnel.  A medication preparation area, alcove, room or other designated area shall be under the direct supervision of the nursing staff when not in use.  It shall contain at least a work counter, lavatory, medication-only refrigerator and designated locked area for controlled substances; if mobile systems are used, storage in corridors is prohibited except when in use by the nursing staff.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6202       SPECIAL CARE UNIT

(a)  Each patient room shall meet the following requirements:

(1)           Clearance between beds in multi-bed rooms shall be not less than 7 feet with provision for visual privacy of patients.  Each patient bed space shall have a minimum of 130 square feet with a minimum dimension of 11 feet;

(2)           One single isolation bedroom meeting the requirements of Rule .6201(5) of this Section shall be provided for each 12 special care beds or fraction thereof;

(3)           Glazing in all viewing panels in partitions and doors shall be safety glass, wire glass, or fire rated glass;

(4)           A lavatory shall be provided in each patient room.  In multi-bed rooms, lavatories shall be provided within 10 feet of each bed;

(5)           A nurse call system is required except in neonatal units;

(6)           Each single-bed cubicle or room shall have a window to the outdoors.  In the case of ward-type patient bed areas of two or more patients where cubicle privacy curtains are used, at least one window shall be provided for every two beds.  Windows shall be positioned to provide a maximum distance of 18 feet between the normal head position of each patient and a window.  Window sills shall not exceed five feet above the floor; and

(7)           Toilet facilities provided for each special care unit shall be accessible from within the unit. Portable toilets may be used within the patient room.  Storage and service of portable toilets shall be provided, if used.  Fixed toilets shall have sufficient clearance to facilitate use by patients needing assistance.

(b)  The service elements and areas listed below shall be provided within each special care unit:

(1)           A nurses' station located to permit visual observation of each patient served;

(2)           Hand washing facilities convenient to nurses' station;

(3)           Designated charting space in addition to monitoring service space;

(4)           A staff toilet room containing a water closet and a lavatory;

(5)           Facilities for the safekeeping of coats and personal effects of staff;

(6)           A clean workroom or a system for storage and distribution of clean supplies.  The clean area shall contain a work counter, hand washing facilities and storage facilities;

(7)           A soiled workroom, or a soiled holding room as part of a system for the collection and disposal of soiled materials.  The soiled workroom shall contain a clinical sink or other flushing device, a sink equipped for hand washing, and a work counter.  A soiled holding room shall be similar to the soiled workroom except that the clinical sink and work counter may be omitted;

(8)           A drug distribution station that meets the current minimum requirements of governing state and federal agencies including lavatory;

(9)           A clean linen storage closet or alcove.  This may be a designated area within the clean workroom.  If a closed cart system is used, storage may be in a controlled alcove clear of corridor width;

(10)         A separate nourishment area with a sink, equipment for serving nourishment between meals, a refrigerator, and storage facilities.  New or replacement ice dispensing equipment for patient service shall be of a self-dispensing type that will not require use of utensils;

(11)         Storage area for emergency and other rolling equipment outside of corridor width;

(12)         Secure facilities for storage of patients' personal effects;

(13)         Bedpan washing devices; and

(14)         A separate waiting room with seating accommodations for visitors, a toilet room, and a public telephone.  The waiting room may serve more than one special care unit.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6203       NEONATAL LEVEL I AND LEVEL II NURSERY UNIT

(a)  Neonatal infant units shall be on the same floor as post-partum nursing units. No nursery shall open directly into another nursery.  Each nursery shall contain the following:

(1)           Lavatory located within 20 feet travel distance of each bassinet;

(2)           Emergency calling system;

(3)           Glazed observation windows for viewing infants from public areas; and

(4)           Charting facilities.

(b)  A full term nursery shall contain not more than 24 bassinets.  The minimum floor area per bassinet shall be 30 square feet exclusive of fixed work or storage counters, toilet rooms, or vestibules less than six feet wide.  There shall be available three feet clear in all directions for each bassinet.

(c)  Each nursery shall be served by a connecting workroom.  It shall contain gowning facilities at the entrance for staff and housekeeping personnel, lavatory, and storage area.  One workroom may serve more than one nursery.

(d)  Space for examination and treatment shall contain a counter, storage, and a lavatory.  It may serve more than one nursery room and may be located in a workroom.

(e)  If commercially-prepared formula is not used, space and equipment to accommodate the handling, storage, and preparation of formula shall be provided.

(f)  A janitor's closet for the exclusive use of the housekeeping staff in maintaining the nursery suite shall be provided.  It shall contain a floor receptor or service sink and storage space for housekeeping equipment and supplies.

(g)  Doors to nurseries shall be no less than three feet wide.  If doors are provided directly from nurseries to public corridors or public spaces, they shall be equipped with "one-way" hardware for exit only to prevent unauthorized entry.

(h)  Smoke detection shall be provided in each nursery bed space.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6204       NEONATAL LEVEL III AND LEVEL iv NURSERY

(a)  Units shall be accessible to post-partum nursing and delivery units.

(b)  The nursery shall be located and arranged to preclude unrelated traffic through the nursery.

(c)  Each nursery shall contain the following:

(1)           Lavatory located within 20 feet travel distance of each bassinet;

(2)           Emergency calling system; and

(3)           Charting facilities.

(d)  There shall be six feet between bassinets for Neonatal Level IV units and five feet between bassinets for Neonatal Level III units.  Neonatal Level IV nurseries shall have 80 square feet per bassinet not including corridors and cabinets.  Neonatal Level III nurseries shall have 50 square feet per bassinet not including cabinets and corridors.  Corridors or aisles shall have at least eight feet of clear width for access to bassinets.

(e)  Each nursery shall be served by a connecting workroom.  It shall contain gowning facilities at the entrance for staff and housekeeping personnel, lavatory, and storage.  One workroom may serve more than one nursery.  The workroom may be omitted if equivalent work area and facilities are provided within the nursery.  Gowning and hand washing facilities shall be provided at the entrance to each nursery.

(f)  Space for examination and treatment shall be provided and shall contain a counter, storage, and lavatory. It may serve more than one nursery room and may be located in a workroom.

(g)  If commercially prepared formula is not used, space and equipment to accommodate the handling, storage, and preparation of formula shall be provided.

(h)  A janitor's closet for the exclusive use of the housekeeping staff in maintaining the nursery suite shall be provided.  It shall contain a floor receptor or service sink and storage space for housekeeping equipment and supplies.

(i)  Doors to nurseries shall be no less than three feet wide.  If doors are provided directly from nurseries to public corridors or public spaces, they shall be equipped with "one-way" hardware for exit only to prevent unauthorized entry.

(j)  Smoke detection shall be provided in each nursery bed space.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. November 1, 2004.

 

10A NCAC 13B .6205       PSYCHIATRIC UNIT

When a facility elects to establish an identifiable psychiatric unit, the following requirements shall be met:

(1)           Patient rooms shall meet the requirements of Rule .6201 of this Section with the following exceptions:

(a)           Patient room doors shall be designed with hardware that will permit the doors to swing into the corridors by the use of a special tool for emergency purposes;

(b)           Patient room doors shall be lockable from the corridor side only;

(c)           Outside wall corners shall be omitted where possible;

(d)           The ceiling shall be of monolithic construction and the air distribution devices, lighting fixtures, sprinkler heads, and other appurtenances shall be of the security type;

(e)           Oxygen and suction outlets are not required;

(f)            All windows shall have security screens or be designed to prevent escape and shall be openable without keys or tools; and

(g)           Each patient room shall be provided with a private toilet that meets the following requirements:

(i)            The door shall not be lockable;

(ii)           The door shall be capable of swinging outward;

(iii)          Where provided, electrical outlets shall be protected by ground fault interrupting devices;

(iv)          A nurse call system is not required where the documented programmatic demands of the facility prohibit its use; and

(v)           The ceiling shall comply with the requirements of Subitem (1)(d) of this Rule.

(2)           Where provided, a seclusion room shall meet the following requirements:

(a)           The room shall meet the requirements of Subitems (1)(a), (b), (c), (d) and (f) of this Rule;

(b)           The room shall have a view window of impact resistant glass in the door that permits visual observation of the entire room;

(c)           The floor space of the room shall not be less than 50 square feet in area with a ceiling height of not less than eight feet; and

(d)           The walls shall be completely free of objects.

(3)           The service areas noted in Rule .6201 of this Section and the following shall be provided:

(a)           Consultation room;

(b)           Examination and treatment room for exclusive use of the psychiatric unit located within the unit;

(c)           A conference room for exclusive use of the psychiatric unit located within the unit;

(d)           Space for dining and recreation with a total area of 35 square feet per patient;

(e)           Storage closets or cabinets for recreational and occupational therapy equipment; and

(f)            Storage facilities for patients' personal effects.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6206       SURGICAL DEPARTMENT REQUIREMENTS

(a)  Each operating room shall have an emergency communication system connected to the operating suite control station.

(b)  A separate room for direct observation of post-anesthesia surgical patients shall be provided.  This space shall include medicine dispensing facilities, hand washing facilities, charting facilities, clinical sink with flushing device, and storage space for supplies and equipment.  A toilet room for nursing staff with water closet and lavatory shall be provided adjacent to the recovery room.  Provisions shall also be made for observation and isolation of infectious patients.

(c)  Service areas shall be provided in individual rooms when so noted; otherwise, alcoves or other open space which will not interfere with traffic may be used.  Services, except for the soiled workroom and the janitor's closet, may be shared with and organized as a part of the obstetrical facilities.  The following service areas shall be provided:

(1)           An operating suite control station.  The station shall be located to permit visual surveillance of all traffic which enters the operating suite or provisions shall be made to prevent unauthorized entry into the suite;

(2)           Supervisor's office or station;

(3)           Sterilizing facilities with a high speed autoclave located to serve the operating rooms;

(4)           Medicine dispensing facilities;

(5)           Scrub stations adjacent to each operating room and arranged to minimize any incidental splatter on nearby personnel or supply carts.  A minimum of two scrub sinks per operating room shall be provided.  Facilities with no more than three operating rooms may reduce the number of scrub sinks to four;

(6)           A soiled workroom containing a flushing device, a work counter, and a sink equipped for hand washing;

(7)           A soiled linen holding room with a sink equipped for hand washing.  This service may be combined with soiled workroom and/or trash holding room;

(8)           A trash holding room with a sink equipped for hand washing.  This service may be combined with the soiled workroom and/or soiled linen holding room;

(9)           Clean workroom or clean supply room when clean materials require assembly prior to use and this assembly is performed within the surgical suite.  This room shall contain a work counter, a sink equipped for hand washing and space for clean and sterile supplies.  A clean supply room shall be provided when the program defines a system for the storage and distribution of clean and sterile supplies which would not require the use of a clean workroom;

(10)         Anesthesia storage.  If facility bylaws do not prohibit flammable anesthetics, a separate room shall be provided for storage of flammable gases;

(11)         Anesthesia workroom with a work counter and sink for cleaning, testing, and storage of anesthesia equipment;

(12)         A room for storage of medical gas reserve cylinders;

(13)         Equipment storage room for equipment and supplies used in surgical suite;

(14)         Staff clothing change areas appropriate for male and female personnel working within the surgical suite.  These areas shall contain lockers, showers, toilets, lavatories, and space for donning scrub suits and boots.  These areas shall be arranged to provide a one-way traffic pattern so that personnel entering from outside the surgical suite can change, shower, gown and move directly into the surgical suite;

(15)         Patients' holding area to accommodate stretcher patients waiting for surgery.  This waiting area shall be under the visual control of operating room staff and shall be in a room or in an alcove out of the direct line of normal traffic;

(16)         Storage area for stretchers out of the corridor width;

(17)         Staff lounges and toilet facilities for staff located to facilitate use without leaving the surgical suite; and

(18)         Janitors' closet containing a floor receptor or service sink and storage space for housekeeping supplies and equipment for the exclusive use of the surgical suite.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6207       OUTPATIENT SURGICAL FACILITIES

(a)  When a facility elects to share outpatient surgical facilities with inpatient surgical facilities, the outpatient operating room and support areas shall meet the same physical plant requirements as inpatient, general operating rooms and support areas.

(b)  When a facility elects to provide separate, non-sharable outpatient surgical facilities, the operating rooms and support areas shall meet the physical plant construction requirements of Outpatient Surgical Licensure requirements of 10A NCAC 13C .1400.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6208       OBSTETRICAL DEPARTMENT REQUIREMENTS

(a)  The obstetrical unit shall be located so as to prevent unrelated traffic through the unit and to provide for reasonable protection of mothers from infection and from cross-infection.

(b)  An emergency communication system connected to the operations and control station shall be provided by the facility.

(c)  Resuscitation facilities for neonates shall be provided within the obstetrical unit and convenient to the delivery room.

(d)  A labor room shall be provided and shall meet the following requirements:

(1)           A minimum of 80 sq. ft. of area shall be provided per labor bed;

(2)           The labor rooms shall be located so as to permit visual observation of each room from the nurses' work station;

(3)           Labor rooms shall afford privacy, and shall be conveniently located with reference to the delivery room;

(4)           If labor rooms also serve as birthing rooms, they shall be equipped to handle obstetric and neonatal emergencies;

(5)           A labor room shall contain facilities for medication, hand washing, charting, and storage for supplies and equipment;

(6)           At least one shower with direct access from within the delivery unit shall be provided;

(7)           At least two labor beds with adjacent toilet shall be provided for each delivery room; and

(8)           No more than two labor beds may be located in one labor room.

(e)  A toilet with hand-washing facilities shall be provided for the staff.

(f)  A separate recovery room may be omitted in facilities with less than 1500 births per year.  When provided, the recovery room shall meet the following requirements:

(1)           A recovery room shall contain not less than two beds and shall have charting facilities located so as to permit visual observation of all beds;

(2)           Provisions for medicine dispensing, hand washing, clinical sink with bedpan washer, and storage for supplies and equipment shall be provided; and

(3)           A toilet with hand washing facilities shall be provided for staff.

(g)  When a facility elects to provide labor, delivery and recovery room (LDR) service as a part of its total services, the following requirements shall be met:

(1)           Each LDR room shall have a minimum of 250 square feet of floor space exclusive of toilet room, closet, or vestibule;

(2)           A toilet directly accessible from each LDR room shall be provided for use by that room only and equipped with a clinical sink or other suitable flushing device for emptying bed pans;

(3)           Each LDR room shall be provided with directly accessible shower for use by that room only;

(4)           Each LDR room shall be equipped with oxygen, suction, medical air, and electrical outlets; and

(5)           Each LDR room shall contain facilities for medication storage, hands-free hand washing, charting, and storage for supplies and equipment.

(h)  When a facility elects to provide labor, delivery, recovery and postpartum (LDRP) service as a part of its total services the following requirements shall be met:

(1)           Each LDRP room shall meet the requirements listed in Paragraph (g) of this Rule; and

(2)           Each LDRP room shall be counted as a single patient room for purposes of determining the facility's bed capacity.

(i)  The following shall be provided:

(1)           If analgesia is used, beds shall be equipped with side rails; and

(2)           There shall be facilities for examination and preparation of patients.

(j)  The obstetrical (OB) unit shall be provided with the following services either in individual rooms, alcoves, or other open spaces not subject to traffic:

(1)           Scrub facilities with stations located adjacent to each pair of delivery rooms and arranged to minimize incidental splatter on nearby personnel or supply carts;

(2)           A storage room for equipment and supplies;

(3)           One delivery room with support services meeting the requirements of a surgical operating room and support services referenced in Rule .6206 of this Section if caesarean sections are to be performed in the obstetrical delivery unit; and

(4)           One janitor's closet exclusively for use by the obstetrics unit.

(k)  The obstetrical unit shall be provided with the following services either in individual rooms, alcoves, or other open spaces not subject to traffic, however, they may be located either in the obstetrics unit or may be shared with the surgical unit if arranged so as to avoid cross traffic between the surgical and obstetrics units:

(1)           Delivery unit control station located so as to permit visual surveillance of all traffic which enters the obstetrical unit;

(2)           Supervisor's office or station;

(3)           Medicine dispensing facilities;

(4)           Scrub facilities with stations located adjacent to each pair of delivery rooms and arranged so as to minimize incidental splatter on nearby personnel or supply carts;

(5)           Soiled workroom or a soiled holding room as a part of a system for the collection and disposal of soiled materials:

(A)          A soiled workroom may not be shared with the surgical unit and shall contain a flushing device, a work counter and sink equipped for hand washing, a waste receptacle, and a linen receptacle; and

(B)          A soiled holding room may be shared with the surgical unit and shall be similar to the soiled workroom except that the flushing device and work counter may be omitted.

(6)           Fluid waste disposal facilities convenient to the delivery rooms; the flushing device in a soiled workroom meets this requirement;

(7)           Staff clothing change areas appropriate for male and female personnel working within the obstetrics unit including lockers, shower, toilet, and lavatory, and space for donning scrub suit and boots;

(8)           Lounge and toilet facilities for obstetrical staff;

(9)           Stretcher storage provisions out of direct line of traffic;

(10)         Clean workroom, or clean supply room:

(A)          A clean workroom or supply room is required when clean materials require assembly prior to use and this assembly is performed within the obstetrics unit; and

(B)          Clean workroom shall contain a work counter, a sink equipped for hand washing, and space for clean and sterile supplies;

(11)         Anesthesia workroom for the cleaning, testing, and storage of anesthesia equipment with a work counter and sink;

(12)         Space for storage of nitrous oxide and oxygen cylinders;

(13)         A storage room for equipment and supplies used in a surgical unit;

(14)         Delivery room(s) used for no other purpose than for the completion of labor and delivery and including a minimum clear area of 300 square feet, exclusive of fixed and movable cabinets and shelves.  The minimum room dimension shall be 16 feet; and

(15)         One delivery room meeting the following requirements if caesarean sections are to be performed in the obstetrics unit:

(A)          The delivery room shall meet the requirements for surgical operating rooms; and

(B)          Support services required for surgical operating rooms shall be provided.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. July 1, 1996.

 

10A NCAC 13B .6209       EMERGENCY SERVICES

(a)  The minimum requirements for emergency care required under Section .4100 of this Subchapter shall determine the type facilities to be provided.

(b)  When a facility provides emergency services under one of the classifications listed in Section .4100 of this Subchapter, the following shall be provided:

(1)           Level I, II, III:

(A)          a drive at grade level with provision for ambulance and pedestrian service and a well marked covered entrance with a minimum clear passage height of 12 feet 8 inches and a clear width of 16 feet;

(B)          public waiting space with toilet facilities, telephone, drinking fountain, stretcher, and wheelchair storage;

(C)          nurses' work and charting space shall be provided.  This may be combined with reception and control area for Level III;

(D)          storage for clean supplies and equipment.  Facilities shall be available for the administration of blood, blood plasma, and intravenous medication as well as for the control of bleeding, emergency splinting of fractures, and the administration of oxygen, anesthesia, and suction;

(E)           soiled holding area with flushing device;

(F)           janitor's closet with service sink;

(G)          patient toilets; and

(H)          staff toilets.

(2)           Level I, II:

(A)          a reception and control area that is staffed around the clock;

(B)          visual control of the entrance, waiting room, and treatment area shall be maintained;

(C)          communication with other facility departments;

(D)          at least one treatment room shall be available around the clock for the examination and initial treatment of emergency patients.  This room shall be independent of the operating room;

(E)           treatment rooms or areas shall contain cabinets, medication storage, work counters, X-ray film illuminators, and space for storage of emergency equipment;

(F)           the size of the rooms or areas shall allow for a minimum of 3 feet clear on three sides of each stretcher; and

(G)          hand washing facilities shall be provided.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6210       IMAGING SERVICES

Imaging services include fluoroscopy, radiography, mammography, computerized tomography scanning, position emission tomography, ultrasound, magnetic resonance imaging, angiography, cardiac catheterization and other similar techniques.

(1)           Radiology services are required for all facilities and shall contain the following:

(a)           Radiographic and fluoroscopic rooms;

(b)           Film processing equipment;

(c)           Administration and viewing areas;

(d)           Provisions for film storage;

(e)           Toilet room with hand washing facilities directly accessible to each fluoroscopy and radiography room where gastrointestinal or genitourinary system procedures are performed;

(f)            Dressing area with immediate access to toilets;

(g)           Waiting room or alcove for patients;

(h)           Holding area for stretcher patients out of corridor width; and

(i)            A shielded control alcove with a view window for full view of patient.

(2)           Angiography or cardiac catheterization services are not required for licensure; however, when either service is offered, the following shall be provided:

(a)           Procedure room sized to accommodate and service the equipment purchased but having a minimum area of 400 square feet;

(b)           A control room with a view window that permits a full view of the patient;

(c)           A designated radiographic view area having a minimum length of 10 feet (3.05 meters);

(d)           Scrub sink outside staff entrance to the procedure room;

(e)           Patient holding area large enough to accommodate two stretchers out of the corridor width;

(f)            Storage area for portable equipment and supplies out of the corridor width; and

(g)           Post procedure observation area for patients.

(3)           Computerized Tomography (CT) Scanning or positron emission tomography service is not required for licensure; however, when either service is offered, the following shall be provided:

(a)           Procedure room sized to accommodate and service the equipment purchased;

(b)           Control room with a view window to permit full view of the patient;

(c)           Film processing area adjacent to the control room;

(d)           Patient toilet with hand washing facilities, located within 50 feet of the procedure room door; accessible to the procedure room located to permit the patient to exit the toilet without reentering the procedure room;

(e)           At least one emergency light located in the procedure room; and

(f)            Hand washing sink within the procedure room.

(4)           Magnetic Resonance Imaging (MRI) service is not required for licensure; however, when this service is offered, the following shall be provided:

(a)           Procedure and support rooms sized to accommodate and service the equipment purchased;

(b)           A control room with full view of the patient and MRI unit and having a minimum area of 100 square feet;

(c)           A patient holding area located near the MRI unit and large enough to accommodate stretchers out of the corridor width;

(d)           Patient toilet with hand washing facilities, located within 50 feet of the procedure room door;

(e)           At least one emergency light located in the procedure room; and

(f)            Hand washing sink adjacent to the entrance to the procedure room.

(5)           Design and performance specifications related to the radiation shielding of imaging rooms shall be furnished by a qualified physicist approved by the Radiation Protection Division of the N.C. Department of Environment and Natural Resources.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6211       LABORATORY SERVICES

Laboratory services may be provided within the facility or through contract with a laboratory service.  If laboratory services are offered within the facility, then the following shall be provided:

(1)           Laboratory work counter with sink, vacuum, gas and electrical outlets;

(2)           Lavatory or counter sinks equipped for hand washing;

(3)           Blood storage equipment with temperature monitoring and alarm signals; and

(4)           Specimen collection:

(a)           Urine collection rooms shall be equipped with a water closet and lavatory; and

(b)           Blood collection area shall have space for a chair, work counter, and hand washing sink.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6212       MORGUE

(a)  Where facilities have an agreement to transfer bodies within six hours of death, a single room large enough to contain a stretcher is acceptable.

(b)  When autopsies are conducted at the facility, the morgue shall be directly accessible to the service entrance or an outside entrance, and shall be located to avoid movement of bodies through lobbies and other public areas.  The following elements shall be provided:

(1)           Refrigeration equipment for body-holding; and

(2)           Autopsy room containing:

(A)          Work counter with sink equipped for hand washing;

(B)          Storage space for supplies, equipment, and specimens;

(C)          Autopsy table;

(D)          A deep sink for washing of specimens;

(E)           Clothing change area with shower, toilet, and lockers; and

(F)           Janitor's closet with service sink or receptor.

(c)  Where no transfer agreement exists with another facility, or bodies cannot be transferred within six hours or autopsies are not conducted at the facility, a well ventilated, temperature controlled body-holding room shall be provided.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6213       PHARMACY SERVICES

The size of the pharmacy and the type of services to be provided in the pharmacy will depend upon the facility mission statement, the type of drug distribution system to be used in the facility, and the extent of shared or purchased services.  When pharmacy services are planned, provisions shall be made for the following:

(1)           Administrative functions including pick-up and receiving, requisition processing, drug information and storage for general supplies, volatile fluids and alcohol;

(2)           Quality control area with sufficient counter space when bulk compounding and packaging functions are performed;

(3)           Secure storage for controlled substances;

(4)           An area for temporary storage, exchange and restocking of carts; and

(5)           Hand washing facilities within each separate room where open medication is handled.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6214       DIETARY SERVICES

(a)  Construction, equipment, and installation shall comply with the standards of the N.C. Department of Environment and Natural Resources.

(b)  The following shall be provided to implement the type of food service system outlined in the hospital's mission statement:

(1)           Control station for receiving food supplies;

(2)           Space for four days' food supply including refrigeration space is required for a conventional food preparation system;

(3)           Food preparation space for conventional food preparation equipment needed in preparing, cooking, and baking foods; convenience food service systems (frozen prepared meals, bulk packaged entrees, individual packaged portions, etc.) or systems utilizing contractual commissary services require space and equipment for thawing, portioning, cooking and baking.  In addition, a lavatory shall be provided in the food preparation area;

(4)           Tray assembly and distribution space;

(5)           Dining space for ambulatory patients, staff, and visitors;

(6)           Dietary office;

(7)           Locker room and toilet facilities for dietary staff;

(8)           Storage space for housekeeping equipment and supplies located within the dietary department, including a floor receptor or service sink; and

(9)           Ice making equipment convenient to salad preparation area and cafeteria.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6215       ADMINISTRATION

(a)  The facility entrance shall be at grade level, sheltered from the effects of inclement weather, and able to accommodate wheelchairs and stretchers.

(b)  The entrance lobby shall contain:

(1)           Reception and information counter or desk;

(2)           Waiting space;

(3)           Storage area(s) for wheelchairs and stretchers;

(4)           Public toilets;

(5)           Public telephone; and

(6)           Drinking fountain.

(c)  Private interview space shall be provided.

(d)  Office spaces for administrative staff shall be provided.

(e)  Medical library shall be provided.

(f)  Staff toilets shall be provided.

(g)  Storage for office equipment and supplies shall be provided.

(h)  A janitor's closet containing a floor receptor or service sink and storage space for housekeeping equipment and supplies shall be provided.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6216       MEDICAL RECORDS SERVICES

Medical records services shall include the following:

(1)           Medical record director's office or space;

(2)           A separate review and dictating room;

(3)           Work area for sorting, recording, or microfilming records;

(4)           Storage area for records; and

(5)           A smoke detection system, approved by the authority having jurisdiction, interconnected with the facility fire alarm system if medical records are stored in a separate building.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6217       CENTRAL MEDICAL AND SURGICAL SUPPLY SERVICES

(a)  A separate receiving room shall be provided and shall contain work space and equipment for initial sterilization and disinfection of medical and surgical equipment and for disposal or processing of unclean articles.  Hand washing facilities shall be provided.

(b)  A separate clean workroom shall be provided and shall contain work space and equipment for sterilizing medical and surgical equipment and supplies. Storage areas for clean supplies and for sterile supplies shall be included in this room.

(c)  A separate storage room for assembly, final packaging, and storage of sterile supplies and equipment shall be provided.

(d)  A storage room for unsterile supplies and equipment shall be provided but may be located in another area of the facility.

(e)  Provisions shall be made for cleaning and sanitizing carts serving the central supply services, dietary services, and linen services departments and may be centralized or departmentalized.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6218       GENERAL STORAGE

General storage room(s) shall have a total area of not less than 20 square feet (1.86 square meters) per inpatient bed and shall be concentrated in one area but may be divided in a multiple building complex and shall include:

(1)           Receiving area; and

(2)           Off street loading area.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6219       LAUNDRY SERVICES

(a)  When the facility elects to provide its own laundry, the laundry shall contain the following:

(1)           A soiled linen holding room;

(2)           A designated clean linen storage area unless a closed linen cart system is utilized;

(3)           A linen cart cleanup and storage area;

(4)           Toilet facilities accessible to employees from soiled linen, clean linen, and laundry processing;

(5)           Laundry processing area with hand washing facilities and commercial type equipment which can process seven days' needs within a scheduled work week;

(6)           A janitor's closet containing a floor receptor or service sink and storage space for housekeeping equipment and supplies; and

(7)           Supply storage.

(b)  When the facility elects to contract for laundry service off premises it shall provide the following:

(1)           Soiled linen holding room;

(2)           Clean linen holding room;

(3)           Linen cart cleanup and storage room; and

(4)           Hand washing facilities.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6220       PHYSICAL REHABILITATION SERVICES

When physical rehabilitation services are offered in the facility, the following shall be provided:

(1)           Patient waiting space, with provisions for wheelchair patients and stretcher patients;

(2)           Office space;

(3)           Patients' toilet;

(4)           Hand washing facilities;

(5)           Treatment areas or room that provides visual privacy (visual privacy not required for Occupational Therapy and Speech Therapy);

(6)           Soiled linen storage (not required for Occupational Therapy and Speech Therapy);

(7)           Clean linen storage (not required for Occupational Therapy and Speech Therapy);

(8)           Equipment storage; and

(9)           Wheelchair and stretcher storage.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6221       ENGINEERING SERVICES

The following provisions for engineering services shall be included:

(1)           A room or separate building for boilers, mechanical equipment, and electrical equipment;

(2)           Office;

(3)           Maintenance shop;

(4)           Maintenance supplies storage room; and

(5)           Locker and toilet rooms for engineering service employees.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6222       WASTE PROCESSING

Each facility shall provide for the processing and disposing of all waste products in accordance with local city or  county requirements and the requirements of the N.C. Department of Environment Health and Natural Resources and shall produce evidence of approval from each regulatory agency having jurisdiction prior to the start of facility operation.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6223       DETAILS AND FINISHES

(a)  All details and finishes for modernization projects as well as for new construction shall meet the following requirements:

(1)           All rooms containing baths, showers, and toilets, subject to patient occupancy, shall be equipped to open from the outside without the use of a key in any emergency.  When such rooms have only one opening, the door shall open outward from the room or shall be designed so that the door can be opened without need to push against the occupant in the room;

(2)           Doors in all openings between corridors and rooms or spaces subject to occupancy shall be of the side hinged type or an approved sliding type door;

(3)           No doors shall swing into corridors in a manner that might obstruct traffic flow or reduce the required corridor width except for doors to spaces such as closets less than 25 square feet in floor area, which are not subject to occupancy;

(4)           Grab bars shall be provided at all patient toilets, showers, and tubs.  Grab bars shall have not less than 1-1/2 inch clearance to the wall or support and shall be capable of supporting not less than a 250 pound concentrated load;

(5)           Single use soap dispensers, towel dispensers or air driers shall be provided at all hand washing fixtures except scrub sinks;

(6)           All rooms shall have not less than 8 foot high ceilings except that ceilings of corridors, storage rooms, toilet rooms, and other minor rooms shall be no less than 7 feet 6 inches high.  Suspended tracks, rails, pipes, etc., located in the path of normal traffic, shall be no less than 7 feet 6 inches above the floor;

(7)           Rooms containing equipment shall be insulated or ventilated to prevent any patient use floor surface above from exceeding a temperature 10 degrees F. above the ambient room temperature; and

(8)           Fire extinguishers shall be provided throughout the building to comply with National Fire Protection Association Standard 10 as found in Rule .6102(2) of this Section.

(b)  Finishes shall meet the following requirements:

(1)           Floors in areas used for food preparation or food assembly shall be water, oil and slip resistant.  Joints in tile and similar material in such areas shall be resistant to food acids.  In all areas subject to frequent wet cleaning, floors shall not be physically affected by germicidal and cleaning solutions.  Floors that are subject to traffic while wet, as in kitchens, showers, and bath areas and similar work areas, shall have a non-slip surface;

(2)           Floors and wall bases in operating and delivery rooms shall be joint free.  Wall bases shall be tightly sealed within the wall and constructed without voids that can harbor vermin;

(3)           Floors and wall bases in kitchens, soiled workrooms, and other areas subject to frequent wet cleaning, shall be made integral with the floor, tightly sealed to the wall, and constructed without voids that can harbor vermin;

(4)           In patient care areas, walls shall be washable; in the immediate area of plumbing fixtures, the finish shall be smooth, moisture resistant, and easily cleanable;

(5)           Floor and wall penetrations and joints of structural elements shall be tightly sealed to minimize entry of rodents and insects;

(6)           Ceilings throughout shall be easily cleanable.  Ceilings in operating and delivery rooms, nurseries, isolation rooms, sterile processing rooms, and other sensitive areas shall be readily washable and without crevices that can retain dirt particles.  Dietary and food preparation areas shall have a finished ceiling covering all overhead structural elements and building systems.  Finished ceilings may be omitted in mechanical and equipment spaces, shops, general storage areas, and similar spaces except where required for fire rating;

(7)           Rooms used for protective isolation shall not have carpet.  Ceilings shall be of monolithic construction; and

(8)           Rooms where impact noises are generated shall not be located directly over or under patient bed areas, and delivery or operating suites unless special provisions are made to minimize noise.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6224       ELEVATOR REQUIREMENTS

Elevators shall meet the following:

(1)           Facilities with patient areas located on other than the grade-level entrance floor shall have at least one hospital-type elevator;

(2)           In the absence of an engineered traffic study, the following guidelines for number of elevators shall apply:

(a)           At least one hospital-type elevator shall be installed when 60 patient beds or less are located on any floor other than the main entrance floor;

(b)           At least two hospital-type elevators shall be installed when 61 to 200 patient beds are located on floors other than the main entrance floor, or where inpatient services are located on a floor other than those containing patient beds.  Elevator service may be reduced for those floors providing only partial inpatient services;

(c)           At least three hospital-type elevators shall be installed where 201 to 350 patient beds are located on floors other than the main entrance floor, or where inpatient services are located on a floor other than those containing patient beds.  Elevator service may be reduced for those floors providing only partial inpatient services; and

(d)           For facilities with more than 350 beds, the number of elevators shall be determined from an engineering study of the facility plan and the expected vertical transportation requirements.

(3)           Hospital-type elevator cars shall have inside dimensions that will accommodate a patient's bed with attendants. Cars shall be at least five feet (1.52 meters) wide by seven feet six inches (2.29 meters) deep.  Car doors shall have a clear opening of not less than four feet (1.22 meters) wide and seven feet (2.13 meters) high; and

(4)           Elevators, except freight elevators, shall be equipped with a two-way service switch for staff use for bypassing all landing button calls and traveling directly to any floor.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6225       MECHANICAL REQUIREMENTS

(a)  Prior to occupancy of the facility, the facility shall obtain documentation verifying that all mechanical systems have been tested, balanced, and operated to demonstrate that the installation and performance of these systems conform to the approved design.  Test results shall be maintained in the facility maintenance files.

(b)  Upon completion of equipment installation, the facility shall acquire and maintain a complete set of manufacturers' operating, maintenance, and preventive maintenance instructions, parts lists, and procurement information including equipment numbers and descriptions.

(c)  Operating staff shall be provided with instructions for properly operating systems and equipment.

(d)  The facility structure, component parts, and building systems shall be kept in good repair and maintained with consideration for the safety and comfort of patients, staff and visitors.

(e)  There shall be a definite assignment of maintenance functions to qualified personnel under supervision.

(f)  General design requirements shall meet the following:

(1)           Heating plants shall be adequate to maintain a cold weather temperature of 70 degrees F. (21.1 degrees C.) in all rooms used by patients;

(2)           Boilers shall have capacity to supply all the heating functions of the facility.  The number and arrangement of boilers shall accommodate the facility's needs despite the breakdown or routine maintenance of any one boiler;

(3)           Insulating materials shall be provided within the facility to conserve energy, protect personnel, prevent vapor condensation, and reduce unnecessary noise and vibration;

(4)           Facility design considerations shall include recognized energy saving measures.  When using variable air volume systems within the facility special care shall be taken to assure that minimum ventilation rates and pressure relationships between various departments are maintained;

(5)           The general air pressure relationships, ventilation rates, and relative humidity requirements of Table 1 shall be maintained;

 

Table 1

Ventilation Requirements for Areas Affecting Patient Care in Hospitals and Skilled Nursing Units and Outpatient Facilities in Hospitals1


Area Designation

 

 

 

 

Air

movement relationship to adjacent area2

Minimum air changes of outdoor air per hour3

Minimum total air changes per hour4

All air exhausted directly to outdoors5

Recirculated by means of room units6

Relative humidity (%)7

Design temperature (o F/o C)8

 

Surgery and Critical Care

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating room9

Out

3

15

--

No

50

70-75/21-24

Delivery room9

Out

4

15

--

No

45

70-75/21-24

Recovery room9

--

2

6

--

No

30

70/21

Special care

--

2

6

--

No

30

70-75/21-24

Treatment room10

--

--

6

--

--

 

75/24

Trauma room10

Out

3

15

--

No

45

70-75/21-24

Anesthesia gas storage

--

--

8

Yes

--

 

--

 

NURSING

Patient room

Toilet room

Newborn nursery suite

Protective isolation when provided11

Infectious isolation when provided12

Isolation alcove or anteroom11 12

Labor/delivery/recovery

Labor/delivery/recovery/postpartum

Patient corridor

 

 

--

In

--

Out

In

In/Out

--

--

--

 

 

1

--

2

1

1

--

--

--

--

 

 

2

10

6

6

6

10

2

2

2

 

 

--

Yes

--

--

Yes

Yes

--

--

--

 

 

--

Yes

No

No

No

No

--

--

--

 

 

--

--

30-60

--

--

--

--

--

--

 

 

70-75/21-24

--

75/24

70-75/21-24

70-75/21-24

--

70-75/21-24

70-75/21-24

--

 

ANCILLARY

Radiology13

  X-ray (surg/critical care)

  X-ray (diagnostic & treat.)

  Darkroom

Laboratory

  General14

  Biochemistry14

  Cytology

  Glass Washing

  Histology

  Microbiology14

  Nuclear medicine13

  Pathology

  Serology

  Sterilizing

Autopsy room

Non refrigerated body-holding room15

Pharmacy

 

 

 

Out

--

In

 

--

Out

In

In

In

In

In

In

Out

In

In

In

--

 

 

 

3

--

--

 

--

--

--

--

--

--

--

 

--

--

--

--

--

 

 

 

15

6

10

 

6

6

6

10

6

6

6

6

6

10

12

10

4

 

 

 

 

--

--

Yes

 

--

--

Yes

Yes

Yes

Yes

Yes

Yes

--

Yes

Yes

Yes

--

 

 

 

No

--

No

 

--

No

No

--

No

No

No

No

No

--

No

Yes

--

 

 

 

45-60

--

--

 

--

--

--

--

--

--

--

--

--

--

--

--

--

 

 

 

70-75/21-24

75/24

--

 

--

--

--

--

--

--

--

--

--

--

--

70/21

--

 

DIAGNOSTIC AND TREATMENT

Examination Room

Medication room

Treatment room

Physical therapy and hydrotherapy

Soiled workroom or soiled holding

Clean workroom or clean holding

 

 

--

--

--

In

In

--

 

 

--

--

--

--

--

--

 

 

6

4

6

6

10

4

 

 

--

--

--

--

Yes

--

 

 

--

--

--

--

No

--

 

 

--

--

--

--

--

--

 

 

75/24

--

75/24

75/24

--

--

 

STERILIZING AND SUPPLY

ETO-sterilizer room16

Sterilizer equipment room16

Central medical and surgical supply

Soiled or decontamination room

Clean workroom and sterile storage

 

 

In

In

Out

In

Out

 

 

--

--

--

--

--

 

 

10

10

6

4

6

 

 

Yes

Yes

--

Yes

--

 

 

No

--

No

--

No

 

 

--

--

--

--

(Max) 70

 

 

75/24

--

--

--

75/24

 

 

 

 

 

 

 

 

 

SERVICE

Food preparation center17

Warewashing

Dietary day storage

Laundry, general

Soiled linen (sorting and storage)

Clean linen storage

Soiled linen and trash chute room

Bedpan room

Bathroom

Janitor's closet

 

 

--

In

In

--

In

--

In

In

--

In

 

 

--

--

--

--

--

--

--

--

--

--

 

 

10

10

2

10

10

2

10

10

10

10

 

 

--

Yes

--

Yes

Yes

--

Yes

Yes

--

Yes

 

 

No

No

--

--

No

--

No

Yes

--

No

 

 

--

--

--

--

--

--

--

--

--

--

 

 

--

--

--

--

--

--

--

--

75/24

--

 

Table Notes:

 

1                      The ventilation rates in this table cover ventilation for comfort, as well as for asepsis and odor control in areas of acute care hospitals that directly affect patient care and are determined based on health care facilities being predominantly "No Smoking" facilities.  Where smoking may be allowed, ventilation rates will need adjustments.  Specialized patient care areas, including organ transplant units, burn units, specialty procedure rooms, etc., shall have additional ventilation provisions for air quality control as may be appropriate. 

2                      Design of the ventilation system shall provide that air movement is from "clean to less clean" areas.  However, continuous compliance may be impractical with full utilization of some forms of variable air volume and load shedding systems that may be used for energy conversation.  Areas that do require positive and continuous control are noted with "Out" or "In" to indicate the required direction of air movement in relation to the space named.  Rate of air movement may be varied as needed within the limits required for positive control.  Air movement for rooms with dashes and non-patient areas may vary as necessary to satisfy the requirements of those spaces.  Additional adjustments may be needed when space is unused or unoccupied and air systems are de-energized or reduced.

3                      To satisfy exhaust needs, replacement air from outside is necessary.  Table 1 does not attempt to describe specific amounts of outside air to be supplied to individual spaces except for certain areas such as those listed.  Distribution of the outside air, added to the system to balance required exhaust, shall be as required by good engineering practice.

4                      Number of air changes may be reduced when the room is unoccupied if provisions are made to ensure that the number of air changes indicated is reestablished any time the space is being utilized.  Adjustments shall include provisions so that the direction of air movement shall remain the same when the number of air changes is reduced.  Areas not indicated as having continuous directional control may have ventilation systems shut down when space is unoccupied and ventilation is not otherwise needed.

5                      Air from areas with contamination and/or odor problems shall be exhausted to the outside and not recirculated to other areas.  Note that individual circumstances may require special consideration for air exhaust to outside, e.g., in intensive care unit in which patients with pulmonary infection are treated, and rooms for burn patients.

6                      Because of cleaning difficulty and potential for buildup of contamination, recirculating room units shall not be used in areas marked "No."  Isolation and intensive care unit rooms may be ventilated by reheat induction units in which only the primary air supplied from a central system passes through the reheat unit.  Gravity-type heating or cooling units such as radiators or connectors shall not be used in operating rooms and other special care areas.

7                      The ranges listed are minimum and maximum limits where control is specifically needed.

8                      Dual temperature indications (such as 70-75/21-24) are for an upper and lower variable range at which the room temperature shall be controlled.  A single figure indicates a heating or cooling capacity of at least the indicated temperature.  This is usually applicable when patients may be undressed and require a warmer environment.  Nothing in these rules shall be construed as precluding the use of temperatures lower than those noted when the patients' comfort and medical conditions make lower temperatures desirable.  Unoccupied areas such as storage rooms shall have temperatures appropriate for the function intended.

9                      For Information Only - National Institute of Occupational Safety and Health (NIOSH) Criteria Documents regarding Occupational Exposure to Waste Anesthetic Gases and Vapors, and Control of Occupational Exposure to Nitrous Oxide indicate a need for both local exhaust (scavenging) systems and general ventilation of the areas in which the respective gases are utilized.

10                   The term trauma room as used here is the operating room space in the emergency department or other trauma reception area that is used for emergency surgery.  The first aid room and/or "emergency room" used for initial treatment of accident victims may be ventilated as noted for the "treatment room."

11                   The protective isolation rooms described in these rules are those that might be utilized for patients with a high susceptibility to infection from leukemia, burns, bone marrow transplant, or acquired immunodeficiency syndrome and that require special consideration for which air movement relationship to adjacent areas would be positive rather than negative.  For protective isolation the patient room shall be positive to both anteroom and toilet.  Anteroom shall be neutral to corridor.   Where requirements for both infectious and protective isolation are reflected in the anticipated patient load, ventilation shall be modified as necessary.  Variable supply air and exhaust systems that allow maximum isolation room space flexibility with reversible air movement direction would be acceptable only if appropriate adjustments can be ensured for different types of isolation occupancies.  Control of the adjustments shall be under the supervision of the medical staff.

12                   The infectious isolation rooms described in these rules are those that might be utilized in the average community hospital.  The assumption is made that most isolation procedures will be for infectious patients and that the room is suitable for normal private patient use when not needed for isolation.  This compromise obviously does not provide for ideal isolation.  The design shall consider types and numbers of patients who might need this separation within the facility.  Isolation room shall be negative to anteroom and positive to toilet.  Anteroom shall be neutral to corridor.

13                   Large hospitals may have separate departments for diagnostic and therapeutic radiology and nuclear medicine.  For specific information on radiation precautions and handling of nuclear materials, refer to appropriate sections of requirements developed by the Division of Radiation Protection, NCDEHNR.

14                   When required, appropriate hoods and exhaust devices for the removal of noxious gases shall be provided.

15                   A non-refrigerated body-holding room would be applicable only for health care facilities in which autopsies are not performed on-site, or the space is used only for holding bodies for short periods prior to transferring.

16                   For Information Only - Specific OSHA regulations regarding ethylene oxide (ETO) use have been promulgated. 29CRF Part 1910.1047 includes specific ventilation requirements including local exhaust of the ETO sterilizer area.

17                   Food preparation centers shall have an excess air supply for "out" air movements when hoods are not in operation.  The number of air changes may be reduced or varied to any extent required for odor control when the space is not in use.

 

(6)           Air duct liners exposed to the air stream shall not be used in ducts serving special care areas or special procedure rooms when such liners are constructed with frangible materials that will enter the air stream;

(7)           All central ventilation or air conditioning systems shall be equipped with filters with efficiencies equal to, or greater than, those specified in Table 2.  Where two filter beds are required, filter bed No. 1 shall be located upstream of the air conditioning equipment and filter bed No. 2 shall be downstream of any fan or blowers.  A manometer shall be installed across each filter bed having a required efficiency of 75 percent or more;

 

Table 2

Filter Efficiencies for Central Ventilation and Air Conditioning Systems in General Hospitals

                Area Designation

No. filter beds

Filter bed No. 1

Filter bed No. 2

All areas for inpatient care, treatment, and diagnosis, and those areas providing direct service or clean supplies such as sterile and clean processing, etc.

                2

                25%o

                90%o

Protective isolation room when used

                2

                25%o

                99.7%5

Laboratories

                1

                80%o

                --

Administrative, bulk storage, soiled holding areas, food preparation areas, and laundries

                1

                25%o

                --

Table notes:          Note 1 - Ratings based on ASHRAE 52-76

Note 2 - Rating based on DOP (Dioctyl-phthalate) test method

 

(8)           Any system utilized for occupied areas shall include provisions to avoid air stagnation in interior spaces where comfort demands are met by temperatures of surrounding areas;

(9)           All rooms and areas in the facility used for patient care shall have provisions for year round mechanical ventilation;

(10)         Each patient's room shall have at least one openable window, opening to the outside to permit ventilation; and

(11)         In psychiatric units, all convectors, HVAC enclosures, or air distribution devices that are exposed in the room shall be constructed with rounded corners and shall be fastened with tamper-proof screws.

(g)  Mechanical air intakes shall meet the following:

(1)           Air intakes shall be located not less than 30 feet (9.14 m.) from exhaust outlets of combustion equipment stacks, ventilation exhaust outlets from the facility or adjoining buildings, medical-surgical vacuum system exhausts or areas that may be subject to vehicular exhaust or other noxious fumes; and

(2)           The bottom of the outdoor air intakes shall be at least 6 feet (1.83 m.) above ground level, or if installed above the roof, at least 3 feet (.91 m.) above roof level.

(h)  Mechanical air exhaust/ventilation systems shall meet the following:

(1)           Fans serving exhaust duct systems shall be located at the discharge end of the duct and shall be readily accessible for servicing; and

(2)           Exhaust outlets shall be located a minimum of 10 feet (3 m.) above ground and directed away from occupied areas, doors, or openable windows.  Prevailing winds, adjacent buildings, and discharge velocities shall be taken into account when designing such outlets.

(i)   Surgery and special care areas shall meet the following:

(1)           All air shall be supplied at or near the ceiling and removed from at least two remote locations near the floor;

(2)           Bottom of exhaust or return registers shall be no less than 3 inches (7.62 cm.) above the finished floor level; and

(3)           Exhaust grilles for anesthesia evacuation and other special applications shall be permitted to be installed in the ceiling.

(j)  Nursery, labor, delivery, recovery, postpartum, and invasive procedure rooms shall meet the following:

(1)           Air supply shall be at or near the ceiling. Return or exhaust air registers shall be near the floor;

(2)           Bottom of exhaust or return registers shall be no less than 3 inches (7.62 cm.) above the finished floor level; and

(3)           Exhaust grilles for anesthesia evacuation and other special applications shall be permitted to be installed in the ceiling.

(k)  Isolation units shall meet the following:

(1)           Rooms for isolation of patients shall meet the ventilation requirements of Table 1 (See 10A NCAC 13B .6225);

(2)           A separate anteroom used as an air lock to minimize the potential for airborne particulates from the patients' area reaching adjacent areas shall be provided; and

(3)           Air supply shall be introduced at or near the ceiling, flowing past the patient, and exhausted or returned at the floor.

(l)  Smoke control/evacuation system(s) shall meet the following:

(1)           When an engineered smoke control/evacuation system is provided, the system shall incorporate a design of the air duct system(s) and controls to inhibit the migration of smoke from the fire zone to the required means of egress and refuge areas;

(2)           When an emergency manual control stop switch is provided to shut down supply, return, and exhaust fans, the switch shall be incorporated into the smoke control system in a manner that will not jeopardize the effectiveness or dependability of the smoke control/evacuation system;

(3)           Static pressure sensors, freeze-stats, or other operating controls shall not jeopardize the effectiveness of the smoke control system during emergency operation;

(4)           Where smoke dampers are required to be installed as part of a passive smoke control system, smoke dampers shall be installed in ducts that are capable of communicating smoke between floors; and

(5)           Smoke dampers shall have a maximum air leakage of 10 cubic feet per minute per square foot of damper opening when tested at one inch water gauge of duct pressure.  Smoke dampers shall be fail-safe to the emergency position.  Dampers shall close upon activation of the fire alarm system unless a part of an engineered smoke control system.

(m)  Laboratories shall meet the following:

(1)           In new construction and renovation work, each hood used to process infectious or radioactive materials shall have a minimum face velocity of 150 feet per minute with static pressure operated dampers and audio-visual alarms to alert staff of ventilation system failure.  Each hood shall also have filters with a 99.7 percent efficiency (based on the DOP, dioctyl-phthalate test method) in the exhaust stream, and be designed and equipped to permit the safe removal, disposal, and replacement of contaminated filters; and

(2)           Each installation shall have an exhaust fan located at the discharge end of the duct system to maintain a negative pressure in the exhaust duct.

(n)  Where ethylene oxide is used, the following requirements shall be met:

(1)           Equipment utilizing ethylene oxide shall be installed in accordance with equipment manufacturer's installation instructions; and

(2)           An air flow sensing device shall be installed in the exhaust duct.  The sensor shall activate a visible and audible signal to alert personnel of ventilation system failure.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6226       PLUMBING AND OTHER PIPING SYSTEMS REQUIREMENTS

(a)  A toilet room shall be directly accessible from each patient room and from each central bathing area without going through the general corridor. One toilet room may serve two patient rooms but not more than eight beds. The lavatory may be omitted from the toilet room if one is provided in each patient room.

(b)  All plumbing systems shall be installed in such a manner as to completely prevent the possibility of cross connections between safe and unsafe supplies or back siphonage.

(c)  The following standards shall apply to plumbing fixtures:

(1)           Lavatories and sinks installed in patient care areas shall have the water spout mounted so that its discharge point is a minimum distance of 5 inches (12.7 cm.) above the rim of the fixture;

(2)           All fixtures used by medical and nursing staff and all lavatories used by patients and food handlers shall be trimmed with valves that can be operated without hands (single-lever devices may be used).  Blade handles used for this purpose shall not exceed 4.5 inches (11.4 cm.) in length.  Handles on scrub sinks and clinical sinks shall be at least 6 inches (15.2 cm.) long; and

(3)           Showers and tubs shall have non-slip walking surfaces.

(d)  The following standards shall apply to potable water supply systems:

(1)           Vacuum breakers shall be installed on hose bibbs and supply nozzles used for connection of hoses or tubing;

(2)           Bedpan-flushing devices shall be provided in each inpatient toilet room; installation is optional in psychiatric and substance-abuse treatment units where patients are ambulatory;

(3)           Potable water storage vessels (hot and cold) not intended for constant use shall not be installed; and

(4)           All piping, except control-line tubing, shall be identified.  All valves shall be tagged, and a valve schedule shall be provided to the facility owner for permanent record and reference.  Where the functional program includes hemodialysis, continuously circulated filtered cold water shall be provided.

(e)  The following standards shall apply to hot water systems:

(1)           The water-heating system shall have sufficient supply capacity at the temperatures and amounts indicated in Table 3.  Water temperature is measured at the point of use or inlet to the equipment; and

 

Table 3

Minimum Hot Water Capacity Requirements

 

 

Use

 

 

Clinical

Dietary

Laundry

Gallons/Hour/Bed

6.5

4

4.5

Liters/Second/Bed

.007

.004

.005

Temperature EF

116

180

180

Temperature EC

46.7

82.2

82.2

 

(2)           Hot-water distribution systems serving patient care areas shall be under constant recirculation to provide continuous hot water at each hot water outlet with a temperature range of 100EF to 116EF (37.8EC to 46.6EC).

(f)  The following standards shall apply to drainage systems:

(1)           Drain lines serving some types of automatic blood-cell counters shall be of carefully selected material that will eliminate the potential for undesirable chemical reactions or explosions between sodium azide wastes and copper, lead, brass, and solder;

(2)           Drainage piping shall be installed to avoid installations in the ceiling directly over operating and delivery rooms, nurseries, food preparation centers, food serving facilities, food storage areas, central services, electronic data processing areas, electrical closets, and other sensitive areas.  Where overhead drain piping in these areas is unavoidable, special provisions such as auxiliary drain pans shall be installed to protect the space below from leakage;

(3)           Floor drains shall not be installed in operating and delivery rooms, but may be installed in cystoscopic operating rooms;

(4)           Drain systems for autopsy tables shall be designed to avoid splatter or overflow onto floors or back siphonage and for easy cleaning and trap flushing;

(5)           Kitchen grease traps, unless of the self-skimming type, shall be located and arranged to permit access without the need to enter food preparation or storage areas; and

(6)           Where plaster traps are used, provisions shall be made for routine access and cleaning.

(g)  The performance, maintenance, installation, and testing of medical gas systems, laboratory gas systems, and clinical vacuum systems shall comply with the requirements of the latest edition of National Fire Protection Association Standard 99 and Table 4 for medical gas station outlet requirements.  When any piping or supply of medical gases is installed, altered, or augmented, the altered zone shall be tested and certified as required by National Fire Protection Association Standard 99.  Testing shall be conducted by the facility and at least one other independent testing organization to ensure that the system is safe for patient use.

 

Table 4

Minimum Medical Gas Station Outlets and Vacuum Station Inlets

Location

Oxygen

Vacuum

Medical Air

Operating Room

2/room

3/room

1/room

Delivery Rooms

2/room

3/room

1/room

Cystoscopy Room

1/room

3/room

-

Special Procedures Room

1/room

3/room

1/room

Other anesthetizing Locations

1/room

3/room

1/room

Recovery Room

1/bed

3/bed

1/bed

Intensive Care Unit

2/bed

3/bed

1/bed

Cardiac Intensive Care Unit

2/bed

2/bed

1/bed

Emergency Room

1/bed

1/bed

1/bed

Trauma Room

2/bed

3/bed

1/bed

Catheterization Lab

1/bed

2/bed

-

Labor Room

1/bed

1/bed

-

Nurseries

1/bassinet

1/bassinet

1/bassinet

Patient Room

1/bed

1/bed

-

Exam & Treatment Rooms

1/bed

1/bed

-

Anesthesia Workroom

1/room

1/room

1/room

Autopsy Room

-

1/room

-

 

(h)  The line pressure for the medical gases shall be set in the following order:

(1)           Oxygen, highest pressure;

(2)           Medical air, next to lowest pressure; and

(3)           Nitrous oxide, lowest pressure.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

10A NCAC 13B .6227       ELECTRICAL REQUIREMENTS

(a)  All material and equipment, including conductors, controls, and signaling devices, shall be installed in compliance with applicable sections of North Carolina State Building Code, Electrical Code as found in Rule .6102(1) of this Subchapter.  A written record of performance tests on electrical systems and equipment shall show compliance with applicable codes and standards.

(b)  The main switchboard shall be located in an area separate from plumbing and mechanical equipment and shall be accessible to authorized persons only.  The main switchboard shall be located in a dry, ventilated space free of corrosive or explosive fumes, gases, or any combustible material.

(c)  Panelboards serving normal lighting and appliance circuits shall be located on the same floor as the circuits they serve.  Panelboards for emergency system critical branch and equipment system branch circuits shall be located on each floor that has service requirements.  Only panels for emergency system life safety branch circuits may serve floors other than the floor that the panel is located on.

(d)  Lighting shall be provided as follows:

(1)           Approaches to buildings and parking lots, and all occupied spaces within buildings shall have fixtures for lighting;

(2)           Patient rooms shall have general lighting and night lighting.  A reading light shall be provided for each patient.  At least one night light fixture in each patient room shall be controlled at the room entrance.  All light controls in patient areas shall be quiet-operating.  Lighting for special care bed areas shall permit staff observation of the patient but shall minimize glare;

(3)           Nursing unit corridors shall have general illumination with provisions for reducing light levels at night; and

(4)           Consideration shall be given to controlling lighting intensity to prevent harm to the patients' eyes (i.e., retina damage in premature infants and cataracts due to ultraviolet light).

(e)  Receptacles shall be provided as follows:

(1)           Each operating room and delivery room shall have at least eight 120 volt duplex receptacles;

(2)           In areas where mobile X-ray equipment is intended to be used, single receptacles marked for X-ray equipment only shall be installed;

(3)           Neonatal Level I nurseries shall have a minimum of one 120 volt duplex receptacle located on each nursery wall connected to the critical branch of the emergency electrical system in addition to the receptacles for each bassinet required by Section 517-18 of the North Carolina State Building Code Volume IV;

(4)           Emergency department examination and treatment rooms shall have a minimum of two 120 volt duplex receptacles located convenient to the head of each bed. Trauma rooms shall have a minimum of three 120 volt duplex receptacles convenient to the head of each bed;

(5)           120 volt duplex receptacles for general use shall be installed 50 feet (15.2 m.) apart in all corridors and within 25 feet (7.6 m.) of corridor ends; and

(6)           Inhalation anesthetizing locations and other areas where patients are intended to have a direct electrical path to the heart muscle shall be equipped with an isolated power system, approved by the authority having jurisdiction including the following requirements:

(A)          The line isolation monitor shall be visible to attending staff while caring for the patient;

(B)          No more than one patient may be served by an isolated power system serving emergency power receptacles;

(C)          Transformers shall not be located over any patient bed location; and

(D)          Branch circuit wiring for isolated power systems shall have a dielectric constant of less than 3.5.

(f)  Emergency electrical service shall be provided as follows:

(1)           To provide electricity during an interruption of normal electrical service, a generating set or sets located on the facility site capable of carrying the full emergency load shall be installed;

(2)           Fuel shall be stored on the site in sufficient quantity to provide for not less than 24 hours of operation;

(3)           Where the generator sets are in close proximity to the heating plant, the emergency generator fuel storage capacity may be included in the standby fuel storage tank for the heating burners when the fuels are the same;

(4)           All devices, switches, receptacles, etc., connected to the automatically started generator shall be distinctively identified so that personnel can easily select which device is expected to operate during a failure of the normal source of power; and

(5)           As a minimum, the following areas shall be connected to the essential electrical system:

(A)          Task lighting connected to the critical branch of the emergency system to serve boiler rooms, main switchgear rooms, electrical closets, fire pump rooms, central fire alarm and control rooms, central telephone switchboard room; and

(B)          Heating equipment and associated controls to provide heating for patient care areas shall be connected to the equipment system.

(g)  A nurses' calling system shall be provided as follows:

(1)           Each patient room shall be served by at least one calling station for two-way voice communication.  Each bed shall be provided with a call device.  Two call devices serving adjacent beds may be served by one calling station.  Calls shall activate a visible signal in the corridor at the patient's door, in the clean workroom, in the soiled workroom, and at the nursing station of the nursing unit.  In multi-corridor nursing units, additional visible signals shall be installed at corridor intersections.  In rooms containing two or more calling stations, indicating lights shall be provided at each station.  Nurses calling systems at each calling station shall be equipped with an indicating light which remains lighted as long as the voice circuit is operating;

(2)           An emergency calling station shall be provided at each patient-use toilet, bath, sitz bath, and shower.  This station shall be accessible to a patient lying on the floor.  Inclusion of a pull cord approved by the authority having jurisdiction will satisfy this standard.  The emergency call system shall be designed so that a signal activated at a patient's calling station will initiate a visible and audible signal distinct from the regular nurse calling system that can be turned off only at the patient calling station.  The signal shall activate an enumerator panel at the nurse station, and a visible signal in the corridor at the room;

(3)           In areas such as special care where patients are under constant visual surveillance, the nurses' call system may be limited to a bedside button or station that activates a signal readily seen at the control station; and

(4)           A staff emergency assistance system for staff to summon additional assistance shall be provided in each operating, delivery, recovery, emergency examination or treatment area, and in special care units, nurseries, special procedure rooms, stress-test areas, triage, out-patient surgery admission and discharge areas, and areas for mental patients, including seclusion and security rooms, anterooms and toilet rooms serving them, communal toilet and bathing facility rooms, therapy, exam, and treatment rooms.  This system shall annunciate at the nurse station with back-up to another staffed area from which assistance can be summoned.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.