subchapter 13K – hospice licensing rules

 

section .0100 – general information

 

10A NCAC 13K .0101       reserved for future codification

10A NCAC 13K .0102       DEFINITIONS

In addition to the definitions set forth in G.S. 131E‑201 the following definitions shall apply throughout this Subchapter following:

(1)           "Agency" means a licensed hospice as defined in Article 10 G.S. 131E‑201(3).

(2)           "Attending Physician" means the physician licensed to practice medicine in North Carolina who is identified by the patient at the time of hospice admission as having the most significant role in the determination and delivery of medical care for the patient.

(3)           "Care Plan" means the proposed method developed in writing by the interdisciplinary care team through which the hospice seeks to provide services which meet the patient's and family's medical, psychosocial and spiritual needs.

(4)           "Clergy Member" means an individual who has received a degree from an theological school and has fulfilled appropriate denominational seminary requirements; or an individual who, by ordination or authorization from the individual's denomination, has been approved to function in a pastoral capacity.  Each hospice shall designate a clergy member responsible for coordinating spiritual care to hospice patients and families.

(5)           "Coordinator of Patient Family Volunteers" means an individual on the hospice staff who coordinates and supervises the activities of all patient family volunteers.

(6)           "Dietary Counseling" means counseling given by a licensed dietitian as defined in G.S. 90‑357.

(7)           "Director" means the person having administrative responsibility for the operation of the hospice.

(8)           "Governing Body" means the group of persons responsible for overseeing the operations of the hospice, specifically for the development and monitoring of policies and procedures related to all aspects of the operations of the hospice program.  The governing body ensures that all services provided are consistent with accepted standards of hospice practice.

(9)           "Hospice" means a coordinated program of services as defined in G.S. 131E‑176(13a).

(10)         "Hospice Caregiver" means an individual on the hospice staff who has completed hospice caregiver training as defined in 10A NCAC 13K .0402 and is assigned to a hospice residential facility or unit.

(11)         "Hospice Inpatient Facility or Unit" means a licensed facility as defined in G.S. 131E‑201(3a).

(12)         "Hospice Residential Facility" as defined in G.S. 131E‑201(5a) is a facility licensed to provide hospice care to hospice patients as defined in G.S. 131E‑201(4) and their families in a group residential setting.

(13)         "Hospice Staff" means members of the interdisciplinary team as defined in G.S. 131E‑201(7), nurse aides, administrative and support personnel and patient family volunteers.

(14)         "Informed Consent" means the agreement to receive hospice care made by the patient and family which specifies in writing the type of care and services to be provided.  The informed consent form shall be signed by the patient prior to service.  If the patient's medical condition is such that a signature cannot be obtained, a signature shall be obtained from the individual having legal guardianship, applicable power of attorney, or the family member or individual assuming the responsibility of primary caregiver.

(15)         "Inpatient Beds" means beds licensed as such by the Department of Health and Human Services for use by hospice patients, for medical management of symptoms or for respite care.

(16)         "Interdisciplinary Team" means a group of hospice staff as defined in G.S. 131E‑201(7).

(17)         "Licensed Practical Nurse" means a nurse holding a valid current license as required by G.S. 90, Article 9A.

(18)         "Medical Director" means a physician licensed to practice medicine in North Carolina who directs the medical aspects of the hospice's patient care program.

(19)         "Nurse Aide" means an individual who is authorized to provide nursing care under the supervision of a licensed nurse, has completed a training and competency evaluation program or competency evaluation program and is listed on the Nurse Aide Registry, at the Division of Health Service Regulation.  If the nurse aide performs Nurse Aide II tasks, he or she must also meet the requirements established by the N.C. Board of Nursing as defined in 21 NCAC 36 .0405.

(20)         "Occupational Therapist" means a person duly licensed as such, holding a current license as required by G.S. 90‑270.29.

(21)         "Patient and Family Care Coordinator" means a registered nurse designated by the hospice to coordinate the provision of hospice services for each patient and family.

(22)         "Patient Family Volunteer" means an individual who has received orientation and training as defined in Rule .0402 of this Subchapter, and provides volunteer services to a patient and the patient's family in the patient's home or in a hospice inpatient facility or unit, or a hospice residential facility.

(23)         "Pharmacist" means an individual licensed to practice pharmacy in North Carolina as required in G.S. 90‑85(15).

(24)         "Physical Therapist" means an individual holding a valid current license as required by G.S. 90, Article 18B.

(25)         "Physician" means an individual licensed to practice medicine in North Carolina.

(26)         "Premises" means the location or licensed site from which the agency provides hospice services or maintains patient service records or advertises itself as a hospice agency.

(27)         "Primary Caregiver" means the family member or other person who assumes the overall responsibility for the care of the patient in the home.

(28)         "Registered Nurse" means a nurse holding a valid current license as required by G.S. 90, Article 9A.

(29)         "Respite Care" means care provided to a patient for the purpose of temporary relief to family members or others caring for the patient at home.

(30)         "Social Worker" means an individual who performs social work and holds a bachelor's or advanced degree in social work from a school accredited by the Council of Social Work Education or a bachelor's or an advanced degree in psychology, counseling or psychiatric nursing.

(31)         "Speech and Language Pathologist" means an individual holding a valid current license as required by G.S. 90, Article 22.

(32)         "Spiritual Caregiver" means an individual authorized by the patient and family to provide for their spiritual direction.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; February 1, 1995; June 1, 1991; November 1, 1989.

 

SECTION .0200 ‑ LICENSE

 

10A NCAC 13K .0201       LICENSE REQUIRED

Each hospice agency premises shall obtain a license unless exempted by G.S. 131E‑203.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996.

 

10A NCAC 13K .0202       APPLICATION FOR AND ISSUANCE OF A LICENSE

(a)  An application for a license to operate a hospice agency or facility shall be submitted to the Department prior to the scheduling of an initial licensure survey.  The hospice agency shall establish, maintain and make available for inspection such documents, records and policies as required in this Section and statistical data sufficient to complete the licensure application and upon request of the Department, to submit an annual data report, including all information required by the Department as noted in Rule .0303 of this Subchapter.

(b)  The Department shall issue a license to each hospice agency premises when determined to be in compliance with licensure rules.  Initial licensure inspections shall be conducted at the Department offices.  On‑site inspections shall include one or all sites as described in Rule .0209 of this Subchapter.  Initial licensure shall be for a period of not more than one year.  Subsequent licensure shall extend for a minimum of one year and a maximum of three years, at the discretion of the Department.  Each license shall expire at midnight on the expiration date on the license and is renewable upon application.

(c)  The license shall be posted in a prominent location accessible to public view within the premises.  The agency shall also post a sign at the public access door with the hospice agency name.

(d)  The license shall be issued for the premise and persons named in the application and shall not be transferable.  The name and street address under which the agency operates shall appear on the license.  If the agency operates an inpatient facility or unit, or a residential facility to provide inpatient or residential hospice care, the number of beds for each shall be reflected on the license.

(e)  Prior to change of ownership or the establishment of a new hospice agency, the agency shall be in compliance with all the applicable statutes and rules established under Article 10 of G.S. 131E.

(f)  The licensee shall notify the Department in writing of any proposed change in ownership or name at least 30 days prior to the effective date of the change.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. April 1, 1996; June 1, 1991; November 1, 1989.

 

10A NCAC 13K .0203       reserved for future codification

 

10A NCAC 13K .0204       Reserved for Future Codification

 

10A NCAC 13K .0205       reserved for future codification

 

10A NCAC 13K .0206       ADVERSE ACTION

A hospice may appeal any adverse decision made by the Department concerning its license by making such appeal in accordance with the Administrative Procedure Act, G.S. 150B and Departmental Rules 10ANCAC 01 et seq.  As provided for in G.S. 131E‑206, the Department shall seek injunctive relief to prevent an entity from establishing or operating a hospice agency without a license.

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

(a)           the licensee has substantially failed to comply with the provisions of Article 10 of G.S. 131E and the rules promulgated under that Part; and

(b)           there is a reasonable probability that the licensee can remedy the licensure deficiencies within a reasonable length of time; and

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

The Department shall give the licensee written notice of the amendment of its license.  This notice shall be given by registered or certified mail or by personal service and shall set forth the reasons for the action.

(2)           The provisional license shall be effective immediately upon its receipt by the licensee and must 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:

(a)           the Department restores the licensee to full licensure status; or

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

(c)           the end of the licensee's licensure year.

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

(3)           The Department may revoke a license whenever:

(a)           The Department finds that:

(i)            the licensee has substantially failed to comply with the provisions of Article 10 of G.S. 131E and the rules promulgated under those parts; and

(ii)           it is not reasonably probable that the licensee can remedy the licensure deficiencies within a reasonable length of time; or

(b)           The Department finds that:

(i)            the licensee has substantially failed to comply with the provisions of Article 10 of G.S. 131E; and

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

(c)           The Department finds that there has been any failure to comply with the provisions of Article 10 of G.S. 131E and the rules promulgated under those parts that endangers the health, safety or welfare of the patients receiving services from the agency.

The issuance of a provisional license is not a procedural prerequisite to the revocation of a license pursuant to Sub‑Item (3)(a), (b) or (c) of this Rule.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; November 1, 1989.

 

10A NCAC 13K .0207       reserved for future codification

 

10A NCAC 13K .0208       INSPECTIONS

(a)  Any hospice agency or facility shall be subject to inspections by authorized representatives of the Department at any time as a condition of holding such license.

(b)  Any person or organization subject to licensure which presents itself to the public as a hospice which does not hold a license, and is or may be in violation of Rule .0202 of this Section and G.S. 131E‑203(a) shall be subject to proper inspections at any time by authorized representatives of the Department.

(c)  Representatives of the Department shall make their identities known to the person in charge prior to the inspection.

(d)  Licensure inspection of medical records shall be carried out in accordance with G.S. 131E‑207.

(e)  An inspection shall be conducted whenever the purpose of the inspection is to determine whether the agency complies with the provisions of this Subchapter or whenever there is reason to believe that some condition exists which is not in compliance with the rules in this Subchapter.  The agency shall allow immediate access to its premises and the records necessary to conduct an inspection and determine compliance with the rules of this Subchapter.  Failure to do so shall result in termination of the survey and may result in injunctive relief as outlined in G.S. 131E‑206.

(f)  An agency shall file a plan of correction for cited deficiencies within 10 working days of receipt of a report of deficiencies.  The Department shall review and respond to a written plan of correction within 10 working days of receipt.

(g)  Representatives of the Department may visit patients in their homes to assess the agency's compliance with the patients' plans of care and with the licensure rules.  Patients shall be contacted by the hospice agency staff in the presence of the Department staff for permission to visit.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996.

 

10A NCAC 13K .0209       MULTIPLE PREMISES

If a person operates multiple hospice agency premises:

(1)           the Department may conduct inspections at any or all of the premises and may issue a license to each of the premises based upon inspection of any or all of the premises;

(2)           with 72 hours advance notice, the Department may request records from any of the premises necessary to ensure compliance with the rules of this Subchapter be brought to the site being inspected, including the portions of personnel records subject to review.  For agencies for whom a business or government policy precludes the disclosure of employee evaluations, a statement signed by the employee's supervisor attesting to its completion shall be accepted;

(3)           the premises may share staff or administrative staff, and may centralize the maintenance of records.

 

History Note:        Authority G.S. 131E‑202;

Eff. February 1, 1996.

 

10A NCAC 13K .0210       COMPLIANCE WITH LAWS

(a)  The hospice agency shall be in compliance with all applicable federal, state and local laws, rules and regulations.

(b)  Staff of the hospice agency shall be currently licensed, listed or registered in accordance with applicable laws of the State of North Carolina.

 

History Note:        Authority G.S. 131E‑202;

Eff. February 1, 1996.

 

SECTION .0300 ‑ ADMINISTRATION

 

10A NCAC 13K .0301       AGENCY MANAGEMENT AND SUPERVISION

(a)  The governing body or its designee shall establish and implement at a minimum, a description of written policies governing all aspects of the hospice program.  Such policies shall be available for inspection by the Department and shall include at a minimum:

(1)           provision for offering of the full scope of hospice services in the agency's defined service area;

(2)           admission and discharge policies;

(3)           patient's rights policies, including the right to have an advance directive;

(4)           personnel policies and records;

(5)           orientation, patient family volunteer training, and inservice education policies;

(6)           communicable disease exposure and infection control policies;

(7)           care planning and updates policies;

(8)           medical record content and handling of orders for drug treatment administration;

(9)           annual evaluation of the agency;

(10)         storage, preventive maintenance, and infection control of supplies and equipment;

(11)         handling of complaints about services; and

(12)         emergency preparedness and disaster planning.

(b)  The governing body shall designate an individual to serve as agency director.

(c)  There shall be written policies that specify the authority and responsibilities of the director.  In the event this position becomes vacant, the Department shall be notified in writing within five working days of the vacancy along with the name of the replacement if available.  Agency policies shall define the order of authority in the absence of the administrator.

(d)  The agency shall have the ultimate responsibility for the services provided under its license; however, it may make arrangements with contractors and others to provide services in accordance with Rule .0505 of this Subchapter.

(e)  A hospice agency shall have written policies which identify the specific geographic areas in which the agency provides its services.

(f)  If an agency plans to permanently expand its geographic service area beyond that currently on file with the Department without opening an additional site, the Department shall be notified in writing 30 days in advance.  The agency must offer its full scope of hospice services in its entire geographic service area.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996.

 

10A NCAC 13K .0302       reserved for future codification

 

10A NCAC 13K .0303       ADMINISTRATIVE FINANCIAL AND STATISTICAL RECORDS

(a)  The hospice shall establish, maintain and make available for inspection the hospice annual budget.

(b)  The hospice shall record, maintain and make available to the Department statistical records as requested.  Records shall include:  hours worked by staff, including patient family volunteers; patient census information regarding the numbers of referrals, admissions and discharges; and patient diagnoses and service location (home or inpatient).

(c)  Records shall be retained for a period of not less than five years.

(d)  When a hospice agency or facility operates as a part of a health care facility licensed under Article 5 or 6 of G.S. 131E, or as part of a larger diversified agency, records of hospice activities and expenditures that are separate and identifiable shall be maintained for the hospice agency.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; November 1, 1989.

 

SECTION .0400 ‑ PERSONNEL

 

10A NCAC 13k .0401       PERSONNEL

(a)  Written policies shall be established and implemented by the agency regarding infection control and exposure to communicable diseases consistent with 10A NCAC 41A.  These policies and procedures shall include provisions for compliance 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 (Airborne and Bloodborne Pathogens).  Copies of Title 29 Part 1910 can be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15250‑7954 or by calling Washington, D.C. (202) 512‑1800.  The cost is twenty one dollars ($21.00) and may be purchased with a credit card.  Hands‑on care employees must have a baseline skin test for tuberculosis.  Individuals who test positive must demonstrate non‑infectious status prior to assignment in a patient's home.  Individuals who have previously tested positive to the tuberculosis skin test shall obtain a baseline and subsequent annual verification that they are free of tuberculosis symptoms.  The verification shall be obtained from the local health department, a private physician or health nurse employed by the agency.  The Tuberculosis Control Branch of the North Carolina Department of Health and Human Services, Division of Public Health, 1902 Mail Service Center, Raleigh, NC 27699-1902 will provide, free of charge guidelines for conducting verification and Form DEHNR 3405 (Record of Tuberculosis Screening).  Employees identified by agency risk assessment to be at risk for exposure are required to be subsequently tested at intervals prescribed by OSHA standards.

(b)  Written policies shall be established and implemented which include personnel record content, orientation, patient family volunteer training and in‑service education.  Records on the subject of in‑service education and attendance shall be maintained by the agency and retained for at least one year.

(c)  Job descriptions for every position, including volunteers involved in direct patient/family services, shall be established in writing which include qualifications and specific responsibilities.  Individuals shall be assigned only to duties for which they are trained and competent to perform and when applicable for which they are properly licensed.

(d)  Personnel records shall be established and maintained for all hospice staff, both paid and direct patient/family services volunteers.  These records shall be maintained at least one year after termination from agency employment.  When requested, the records shall be available on the agency premises for inspection by the Department.  The records shall include:

(1)           an application or resume which lists education, training and previous employment that can be verified, including job title;

(2)           a job description with record of acknowledgment by the staff;

(3)           reference checks or verification of previous employment;

(4)           records of tuberculosis annual screening for those employees for whom the test is necessary as described in Paragraph (a) of this Rule;

(5)           documentation of Hepatitis B immunization or declination for hands on care staff;

(6)           airborne and bloodborne pathogen training for hands on care staff, including annual updates, in compliance with 29 CFR 1910 and in accordance with the agency's exposure control plan;

(7)           performance evaluations according to agency policy and at least annually;

(8)           verification of staff credentials as applicable;

(9)           records of the verification of competencies by agency supervisory personnel of all skills required of hospice services personnel to carry out patient care tasks to which the staff is assigned.  The method of verification shall be defined in agency policy.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; November 1, 1989.

 

10A NCAC 13K .0402       INSERVICE EDUCATION AND TRAINING

(a)  Written policies shall be established and implemented which include orientation, patient family volunteer training and inservice education for all hospice staff.  Hospice residential facilities shall establish and implement a policy addressing hospice caregiver training.  Attendance records on training shall be kept.  Patient family care volunteers shall be required to meet the requirements of Rule .0401 of this Section.  Training hours for patient family care volunteers shall include a minimum of 12 hours.  Staff shall be required to participate in a minimum of eight hours included with other job specific training.

(b)  Training for hospice staff, including patient family volunteers, providing direct patient and family services shall include, but not be limited to the following:

(1)           an introduction to hospice;

(2)           the patient family volunteer role in hospice care;

(3)           concepts of death and dying;

(4)           communication skills;

(5)           care and comfort measures;

(6)           diseases and medical conditions;

(7)           psychosocial and spiritual issues related to death and dying;

(8)           the concept of the hospice family;

(9)           stress management;

(10)         bereavement;

(11)         infection control;

(12)         safety;

(13)         confidentiality; and

(14)         patient rights.

(c)  In addition to the training described in Paragraph (b) of this Rule, the following additional training shall be provided to hospice caregivers assigned to a hospice residential facility:

(1)           training specific to the types of medications being administered when assisting the patient with self administration of medicines and provision of personal care from a curriculum approved by the Division of Health Service Regulation;

(2)           orientation and instruction specific to the care needs of individual patients in the hospice residential facility; and

(3)           notification criteria for licensed nursing staff as defined in the agency policies and procedures.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; February 1, 1995; November 1, 1989.

 

10a NCAC 13K .0403       reserved for future codification

 

SECTION .0500 ‑ SCOPE OF SERVICES

 

10A NCAC 13K .0501       SERVICE REQUIREMENTS

The governing body shall ensure through policies and implemented procedures that the following services encompassing the essential elements of hospice care be provided, either directly by hospice personnel, or by contractual arrangement:

(1)           Hospice nursing services, available 24 hours a day, by or under the supervision of a registered nurse; provided in accordance with the North Carolina Nurse Practice Act (G.S. 90, Article 9A) and the hospice care plan; and sufficient to ensure that nursing needs of each patient are met.

(a)           Registered nurse duties include the following as a minimum:

(i)            regularly assess the nursing needs of the hospice patient;

(ii)           develop and implement the patient's hospice nursing care plan;

(iii)          provide hospice nursing services, treatment, and diagnostic and preventive procedures;

(iv)          initiate nursing procedures appropriate for the patient's hospice care and safety;

(v)           observe signs and symptoms and report to the physician any unexpected changes in the patient's physical or emotional condition;

(vi)          teach, supervise, and counsel the hospice patient and family members about providing care for the patient at home; and

(vii)         supervise and train other nursing service personnel.

(b)           Licensed practical nurse duties are delegated by and performed under the supervision of a registered nurse.  Consistent with the hospice care plan, duties may include:

(i)            participating in assessment of the patient's condition;

(ii)           implementing nursing activities, including the administration of prescribed medical treatments and medications;

(iii)          assisting in teaching the hospice patient and family members about providing care to the patient at home; and

(iv)          delegating tasks to nurse aides and supervising their performance of tasks within the limitations established in 21 NCAC 36 .0225(d)(2) adopted by reference.

(c)           The agency must retain current nursing on‑call schedules and previous schedules for one year and make them available, on request, to the Department.

(2)           Social work services which shall include, but not be limited to conducting an assessment of the psychosocial needs of the patient and family with the establishment of goals in the care plan to meet those needs; on‑going counseling related to issues of death and dying to the patient and family as needed; and assisting the patient and family in the utilization of appropriate community resources.

(3)           Spiritual counseling shall be offered to each hospice patient/family.  The hospice shall assure that:

(a)           no spiritual value or belief system is imposed on patients and families;

(b)           a spiritual assessment is completed on each patient during the admission process; and

(c)           a liaison and consultation is maintained with the patient family clergy or spiritual caregiver and other community based clergy or spiritual caregivers.

(4)           Patient family volunteer services for a broad range of activities under the direction of the coordinator of patient family volunteers.

(5)           Inpatient care services, for symptom management or respite care in a licensed hospital, nursing facility or licensed hospice inpatient facility, unless the hospice operates its own inpatient facility.  The hospice shall assure that:

(a)           a written agreement, is signed by both providers, which assures that the inpatient facility will provide care and services to hospice patients when necessary;

(b)           the inpatient provider has policies consistent with the needs of hospice patients and their families and will, if necessary, modify policies such as visiting hour restrictions and routine tests, to meet those needs;

(c)           the hospice monthly updated plan of care is furnished to the inpatient provider to ensure that the regimen established is followed as closely as feasible during the inpatient stay;

(d)           all inpatient treatment and services are documented in the inpatient medical record and copy of the discharge summary retained as part of the hospice record; and

(e)           effective transition from one type care to another be maintained with continuity of care being the primary goal.

(6)           If the hospice provides or arranges for nurse aide services, those services shall be provided in accordance with physician's orders and interdisciplinary team care plan.

(a)           Nurse aides shall only be assigned duties for which competence has been demonstrated and recorded in appropriate personnel records.

(b)           Nurse aide duties may include, but are not limited to:

(i)            providing or assisting with personal care, i.e. bathing, mouth care, hair and skin care;

(ii)           checking vital signs and observing the patient's condition;

(iii)          assisting with ambulation and limited, routine exercises.

(c)           All nurse aide services shall be performed in accordance with a written assignment prepared by and under the supervision of the registered nurse.  Supervision shall include a visit to the home by the nurse at least every two weeks, with or without the aide's presence, to assess the care and services provided.  Documentation of supervisory visits shall be maintained in the medical record and include an assessment of the aide's performance in carrying out assigned duties and of the aide's relationship with the patient and family.

(7)           Additional services shall be offered either directly by the hospice or by arrangement when ordered by the physician.  These include physical therapy, occupational therapy, nutritional assessment and dietary counseling and other services as needed and ordered by the physician in accordance with the hospice plan of care.

(8)           Bereavement counseling shall be offered to family members and others identified in the bereavement plan of care for a period of 12 months after the patient patient's death.  The hospice shall assure that:

(a)           an assessment of survivor risk factors is completed during the patient's admission to hospice and during the patient's illness;

(b)           the bereavement care plan is established within six weeks after the patient's death;

(c)           the bereavement care plan shall contain information about who shall receive bereavement services and what services will be offered;

(d)           the bereavement care plan is reviewed quarterly at a minimum or more often as needed; and

(e)           discharge from bereavement services before the 12 months expire is justified and documented.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; June 1, 1991; November 1, 1989.

 

10A NCAC 13K .0502       reserved for future codification

 

10A NCAC 13K .0503       reserved for future codification

 

10A NCAC 13k .0504       HOME MEDICAL EQUIPMENT AND SUPPLIES

(a)  The hospice shall make arrangements for obtaining any necessary supplies, equipment or prosthetic devices needed by the patient in the home, e.g., dressings, catheters, and oxygen.  If the agency provides its own equipment and supplies, such services shall be in compliance with G.S. 90‑85.22 unless exempted by the law.

(b)  The agency shall have policies that address at a minimum:

(1)           Set‑up, delivery, electrical safety and environmental requirements for equipment.

(2)           Proper cleaning and storage, preventive maintenance and repair according to manufacturer's guidelines.

(3)           Transportation, tracking and recall of equipment to meet all applicable regulatory requirements.

(4)           Emergency preparedness and backup of systems for equipment or power failure.

(5)           Patient instruction materials for each item of home medical equipment or supplies provided.  Appropriate staff shall document the instruction.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996.

 

10A NCAC 13k .0505       SERVICES ARRANGED WITH OTHER AGENCIES AND INDIVIDUALS

(a)  When a hospice makes arrangements for the provision of services by other agencies and individuals; there shall be a written agreement, signed by both parties prior to the initiation of services, which includes the following:

(1)           the specific service to be provided;

(2)           the period of time the contract is to be in effect;

(3)           the availability of service;

(4)           the financial arrangements;

(5)           the provision for supervision of contracted personnel where applicable;

(6)           the verification that any individual providing services is appropriately licensed or registered as required by statute;

(7)           the assurance that individuals providing services under contractual arrangement meet the same requirements as found in this Subchapter for hospice staff;

(8)           the provision for the documentation of services provided in the patient's medical record; and

(9)           provision for the sharing of assessment and care plan data.

(b)  All contracted services shall be provided in accordance with the orders of the attending physician and the care plan.

(c)  The hospice shall assure that all contracted services are provided in accordance with the agreement.  The agreement shall be reviewed annually and updated as needed.

(d)  The hospice shall provide information and training as necessary on the hospice philosophy and concept of care to all agencies and individuals providing contracted services.

(e)  Contract providers of direct patient care shall document services on the day of care, and shall submit, every two weeks at a minimum, records of all services provided within that timeframe.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; November 1, 1989.

 

SECTION .0600 ‑ PATIENT/FAMILY CARE

 

10A NCAC 13K .0601       ACCEPTANCE OF PATIENTS FOR HOSPICE SERVICES

A hospice shall implement and follow written policies governing the acceptance of patients which include at the minimum:

(1)           Involvement of the interdisciplinary care team in making decisions regarding acceptance of patients and families and the designation of a primary caregiver.

(2)           Initial assessment of the patient prior to acceptance to ensure that its resources are sufficient to meet the needs of the patient and family.

(3)           Provision for a determination by the patient's physician that hospice care is appropriate and agreement to continue as the attending physician while the patient receives hospice services.  All care and services provided shall be in accordance with the attending physician's written orders and the plan of care.  Physician's orders shall be reviewed and signed by the physician at least every 90 days.

(4)           Informed consent signed by the patient thereby agreeing to hospice services being provided.

(5)           Advance notification of at least 48 hours to the patient or family when service provision is to be terminated, except in cases where the patient is in agreement with changes or there is a danger to a patient or staff member.

(6)           Each patient or family accepted for hospice care shall receive written information pertaining to services available, including the means for contacting "on‑call" personnel when needed and other information as necessary.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; June 1, 1991; November 1, 1989.

 

10A NCAC 13K .0602       reserved for future codification

 

10A NCAC 13K .0603       reserved for future codification

 

10a NCAC 13K .0604       PATIENT'S RIGHTS AND RESPONSIBILITIES

(a)  A hospice agency shall provide each patient with a written notice of the patient's rights and responsibilities in advance of furnishing care to the patient or during the initial evaluation visit before the initiation of services.  The agency must maintain documentation showing that each patient has received a copy of his rights and responsibilities.

(b)  The notice shall include at a minimum the patient's right to:

(1)           be informed and participate in the patient's plan of care;

(2)           voice grievances about the patient's care and not be subjected to discrimination or reprisal for doing so;

(3)           confidentiality of the patient's records;

(4)           be informed of the patient's liability for payment for services;

(5)           be informed of the process for acceptance and continuance of service and eligibility determination;

(6)           accept or refuse services;

(7)           be informed of the agency's on‑call service;

(8)           be advised of the agency's procedures for discharge; and

(9)           be informed of supervisory accessibility and availability.

(c)  A hospice agency shall provide all patients with a business hours telephone number for information, questions or complaints about services provided by the agency.  The agency shall also provide the Division of Health Service Regulation's complaints number and the Department of Health and Human Services Careline number.  The Division of Health Service Regulation shall investigate all allegations of non‑compliance with the rules.

(d)  A hospice agency shall initiate an investigation within 72‑hours of complaints made by a patient or their family.  Documentation of both the existence of the complaint and the resolution of the complaint shall be maintained by the agency.

 

History Note:        Authority G.S. 131E‑202;

Eff. February 1, 1996.

 

10a NCAC 13K .0605       HOME CARE

If a hospice agency wishes to provide home care services as defined in G.S 131E‑136 and meets the requirements of 10A NCAC 13J and the standards for the specific home care services applied for, the hospice agency may apply for a home care license.  The licensure inspection shall be conducted either at the Department offices or on-site.

 

History Note:        Authority G.S. 131E‑202;

Eff. April 1, 1996.

 

SECTION .0700 ‑ PATIENT/FAMILY CARE PLAN

 

10a NCAC 13K .0701       CARE PLAN

(a)  The hospice shall develop and implement policies and procedures which ensure that a written care plan is developed and maintained for each patient and family.  The plan shall be established by the interdisciplinary care team in accordance with the orders of the attending physician and be based on the complete assessment of the patient's and family's medical, psychosocial and spiritual needs.  The patient and family care coordinator shall have the primary responsibility for assuring the implementation of the patient's care plan.  The plan shall include the following:

(1)           patient's diagnosis and prognosis;

(2)           identification of problems or needs and the establishment of appropriate goals;

(3)           types and frequency of services required to meet the goals; and

(4)           identification of personnel and disciplines responsible for each service.

(b)  The care plan shall be reviewed by appropriate interdisciplinary care team members and updated at least once monthly.  The interdisciplinary care team and other appropriate personnel shall meet at least once every two weeks for the purpose of care plan review and staff support.  Minutes shall be kept of these meetings that include the date, names of those in attendance and the names of the patients discussed.  Additionally, entries shall be recorded in the medical records of those patients whose care plans are reviewed.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; November 1, 1989.

 

10A NCAC 13K .0702       reserved for future codification

 

10A NCAC 13K .0703       reserved for future codification

 

SECTION .0800 ‑ PHARMACEUTICAL AND MEDICAL TREATMENT ORDERS AND ADMINISTRATION

 

10A NCAC 13K .0801       PHARMACEUTICAL AND MEDICAL TREATMENT ORDERS

(a)  The hospice shall develop and implement written policies and procedures for the administration of drugs and treatments including controlled substances.

(b)  The original order for drugs and treatments shall be signed by the attending physician and incorporated in the patient's medical record.  Signed faxed orders are acceptable.  The receiver of faxed orders shall assure a hard copy is incorporated in the patient record.  Thermal paper faxes are not acceptable.

(c)  Verbal orders shall be given to a licensed nurse, physician or other person authorized by state law to implement orders, recorded and signed by the person receiving it and countersigned by the prescribing physician, or person authorized by the North Carolina Medical Board to sign for another physician.  Care may commence with a verbal order documented in the patient record.

(d)  Changes in drugs and treatments shall be signed by the physician and incorporated in the medical record within 30 days.

(e)  Each patient's drug regimen shall be monitored to assure optimal symptom control in accordance with physician's orders.  Individuals qualified to perform such reviews are registered nurses, pharmacists, licensed physicians, nurse practitioners, and physician's assistants approved to practice in North Carolina.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. April 1, 1996; November 1, 1989.

 

10A NCAC 13K .0802       ADMINISTRATION OF PHARMACEUTICALS

(a)  In a private home, the administration of prescribed medications is the primary responsibility of the patient, family member or caregiver.  Where special skills or knowledge are required, medication shall be administered by a licensed registered nurse, licensed practical nurse with training specified by the North Carolina Board of Nursing, or physician.

(b)  In a licensed hospice residence, medications shall be administered by a licensed nurse.  Exceptions to this requirement are as follows:

(1)           persons who hold statutory authority to administer medications;

(2)           hospice patients, their families or caregivers who provide personal care to individuals whose health care needs are incidental to the personal care required;

(3)           administration of oral nutritional supplements;

(4)           applications of non‑systemic, topical skin preparations which have local effects only provided that ongoing, periodic assessment of any skin lesion present is carried out by a person licensed to make such assessments; and

(5)           administration of commonly used cleansing enema solutions or suppositories with local effects only.

(c)  In a hospice inpatient unit or freestanding hospice inpatient facility, medications shall be administered by a licensed nurse, in accordance with the agency's, policies or in accordance with the contractual agreement between the hospice and the facility.

(d)  The administration of all medications must be documented in the patient's record by the licensed nurse, including those medications administered by the licensed nurse and those administered by the patient family or, caregiver, as ordered by the physician.

(e)  The provision of medications shall be specified in the agency's policies or in accordance with the contractual agreement between the hospice and the facility.

(f)  A hospice agency or facility shall develop and implement written policies and procedures to govern the procurement, storage, administration and disposal of all drugs and biologicals in accordance with federal and state laws.

(g)  Medications used in the home are the property of the patient and family and shall be appropriately stored.  Hospice staff shall encourage disposal of unused or discontinued medications.  Witnessed or reported disposal of medications shall be documented by hospice staff in the patient's record.

(h)  If the agency maintains an emergency drug kit, handling shall be in accordance with the North Carolina Board of Pharmacy 21 NCAC 46 .1400.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; June 1, 1991.

 

10a NCAC 13K .0803       reserved for future codification

 

SECTION .0900 ‑ MEDICAL RECORDS

 

10A NCAC 13K .0901       CONTENT OF MEDICAL RECORD

(a)  The hospice shall develop and implement policies and procedures to ensure that a medical record is maintained for each patient and is made available for licensure inspection.  If the patient or responsible party wishes to deny the Department access to the medical record, that person shall sign a statement denying access.  This statement shall be kept at the front of the record.  If the patient is not able to approve or disapprove the release of such information for inspection, the patient's legal guardian shall make the decision and so indicate in writing.

(b)  The record shall contain past and current medical and social data and include the following information:

(1)           identification data (name, address, telephone, date of birth, sex, marital status);

(2)           name of next of kin or legal guardian;

(3)           names of other family members;

(4)           religious preference and church affiliation and spiritual caregiver if appropriate;

(5)           diagnosis, as determined by attending physician;

(6)           authorization from attending physician for hospice care;

(7)           source of referral;

(8)           initial assessments, including physical, social, spiritual, environmental, and bereavement;

(9)           consent for care form;

(10)         physician's orders for drugs, treatments and other special care, diet, activity and other specific therapy services;

(11)         care plan;

(12)         clinical notes containing a record of all professional services provided directly or by contract with entries signed by the individual providing the services;

(13)         nurse aide and hospice caregiver notes describing activities performed and pertinent observations;

(14)         a copy of the signed patient's rights form or documentation of its delivery;

(15)         patient family volunteer notes, as applicable, indicating type of contact, activities performed and time spent;

(16)         discharge summary to include services provided, or reason for discharge if services are terminated prior to the death of the patient; and

(17)         bereavement counseling notes.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. April 1, 1996; February 1, 1995; November 1, 1989.

 

10A NCAC 13K .0902       RECORD CONTENT, HANDLING AND RETENTION

(a)  The hospice agency shall develop and implement written policies governing the content, handling and retention of patient records.

(b)  The agency shall maintain a patient record for each patient.  Each page of the patient record shall have the patient's name.  All entries in the record shall reflect the actual date of entry.  Reference to any activity which occurred on a date prior to the date of entry shall be identified as a late or out of sequence entry.  A system for maintaining originals and copies shall be described in the agency policies and procedures.

(c)  The agency shall assure that originals of patient records are kept confidential and secure on the licensed premises unless in accordance with Rule .0209 of this Subchapter, or subpoenaed by a court of legal jurisdiction, or to conduct an evaluation as required in Rule .1001 of this Subchapter.

(d)  If a record is removed to conduct an evaluation, the record shall be returned to the agency premises within five working days.  The agency shall maintain a sign out log that includes to whom the record was released, patient's name and date removed.

(e)  A copy of the patient record for each patient must be readily available to the hospice staff providing services or managing the delivery of such services.

(f)  Patient records shall be retained for a period of not less than three years from the date of discharge of the patient, unless the patient is a minor in which case the record must be retained until five years after the patient's eighteenth birthday.  If a minor patient dies, as opposed to being discharged for other reasons, the minor's records must be retained at least five years after the minor's death.  When an agency ceases operation, the Department shall be notified in writing where the records will be stored for the required retention period.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996.

 

SECTION .1000 ‑ EVALUATION

 

10A NCAC 13K .1001       EVALUATION REQUIRED

(a)  The hospice shall develop and implement policies and a written plan for the implementation of a comprehensive assessment at least annually of its overall program and performance.  The quality and appropriateness of care provided shall be assessed with the findings used to verify policy implementation, to identify problems and to establish problem resolution and policy revision as necessary.

(b)  The hospice shall determine what individuals will carry out the evaluation.  Representatives of the governing body, hospice staff, the interdisciplinary care team, and other appropriate professionals may be used.

(c)  The evaluation shall include, as a minimum, a review of all policies and procedures and a medical record review.

(d)  Documentation of the evaluation shall include the names and qualifications of the persons carrying out the evaluation, the criteria and methods used to accomplish it, and the action taken by the agency as a result of the findings.

 

History Note:        Authority G.S. 131E‑202;

Eff. November 1, 1984;

Amended Eff. February 1, 1996; November 1, 1989.

 

10A NCAC 13K .1002       reserved for future codification

 

SECTION .1100 ‑ HOSPICE RESIDENTIAL CARE

 

10A NCAC 13K .1101       ADMINISTRATION

(a)  Hospice residences must conform to the rules outlined in 10A NCAC 13K .0100 through .1000.

(b)  The hospice shall maintain administrative control of and responsibility for the provision of all services.

(c)  The governing body shall have written policies and procedures governing the admission and delivery of all residential and inpatient hospice care services, including the management of medical and other emergencies.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1102       HOSPICE RESIDENCE STAFFING

(a)  There shall be trained hospice caregivers on duty 24 hours a day.  A registered nurse shall be continuously available, for consultation and direct participation in nursing care.  The registered nurse shall be on site when required to perform duties specified in the Nurse Practice Act.  Supervision shall be provided by the Patient and Family Care Coordinator who may delegate this responsibility to the registered nurse on call.

(b)  There shall be at least two staff on duty at all times.

(c)  All staff, including patient family volunteers, counselors and clergy, shall complete training specific to dealing with the terminally ill and their families.

(d)  Nurse aides employed to provide direct care shall be supervised by licensed nurses.

(e)  Interdisciplinary team services shall be provided in accordance with the hospice plan of care.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991;

Amended Eff. February 1, 1996; February 1, 1995.

 

10A NCAC 13K .1103       PHARMACEUTICAL SERVICES

(a)  The hospice shall establish and implement written policies and procedures to govern the procurement, storage, administration and disposal of all drugs and biologicals in accordance with federal and state laws.

(b)  Pharmaceutical services shall be provided directly or through written agreement under the supervision of a licensed pharmacist and in accordance with Rule .0505 of this Subchapter.  The pharmacist's duties shall include, but are not limited to the following:

(1)           advising the hospice and the hospice interdisciplinary team on all matters pertaining to the procurement, storage, administration, disposal and record‑keeping of drugs and biologicals; interactions of drugs; and counseling staff on appropriate and new drugs;

(2)           inspecting all drug storage areas at least monthly;

(3)           conducting patients' drug regimen reviews frequently enough to monitor symptom control, no less often than monthly, with appropriate recommendations to the physician and hospice staff.

(c)  The hospice shall establish and implement written policies and procedures for drug control and accountability.  Records of receipt and disposition of all controlled drugs shall be maintained for accurate reconciliation.

(d)  Medications shall be labeled as described in the Pharmacy Laws of North Carolina.

(e)  Medications must be stored in locked areas, at proper temperature, and accessible only to authorized persons in accordance with federal and state laws.  Separately locked compartments must be provided for storage of controlled substances listed in the North Carolina Controlled Substances Act and other drugs subject to abuse.

(f)  Controlled substances no longer needed by the patient are to be disposed of in compliance with the North Carolina Controlled Substances Act.

(g)  The hospice shall maintain an emergency drug kit appropriate to the needs of the facility, assembled in consultation with the pharmacist and readily available for use.  The pharmacist shall check and restock the kit as necessary, at least monthly, or more often if needed.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1104       DIETARY SERVICES

(a)  The hospice shall develop and maintain written policies and procedures for dietary services.

(b)  Dietary services shall be provided directly or may be provided through written agreement with a food service company.  The written agreement, if applicable, shall meet the provisions of Rule .0505 of this Subchapter.

(c)  The hospice shall assure that residents' favorite foods are included in their diets whenever possible.

(d)  The food service shall be planned and staffed to serve three balanced meals at regular intervals or at a variety of times depending upon the needs of the residents.  No more than 14 hours shall elapse between a substantial evening meal and breakfast.

(e)  The hospice shall appoint a staff member trained or experienced in food management to:

(1)           plan menus to meet the nutritional needs of the residents.

(2)           supervise meal preparation and service.

(f)  Therapeutic diets shall be prescribed by the physician and planned by a registered dietitian.

(g)  Between‑meal snacks of nourishing quality shall be offered and be available on a 24 hour basis.

(h)  The procurement, storage and refrigeration of food, refuse handling and pest control shall comply with the most current sanitation rules promulgated by the Division of Environmental Health.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1105       HOSPICE VISITATION

(a)  The hospice shall:

(1)           provide areas that ensure privacy for visitation and at the time of death;

(2)           arrange for family members to remain with the patient overnight.

(b)  Family and friends may visit at any hour.  Children and pets shall not be excluded.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1106       INFECTION CONTROL

(a)  The hospice shall develop and implement an infection control program which shall aim to protect the residents, family and personnel from hospice or community associated infections.

(b)  There shall be written policies and procedures governing the infection control program, developed by the hospice administrator and medical director and approved by the governing body.

(c)  Universal precautions, as specified by the Centers for Disease Control (CDC), shall be defined in writing and strictly followed.

(d)  All employees shall wear clean garments or protective clothing at all times and shall practice good personal hygiene and cleanliness.

(e)  A procedure shall be developed whereby the implementation of the infection control program is monitored on a monthly basis.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1107       HOUSEKEEPING AND LINENS

(a)  Requirements for linens and personal care articles shall include:

(1)           The use of common towels, washcloths, cups or any other personal care articles is prohibited.

(2)           Each resident shall have a supply of towels, washcloths and soap.

(3)           There shall be a supply of clean bed linens, towels, and washcloths.

(4)           There shall be a separate closed area for storage of clean linen.

(5)           Clean bed linens shall be changed as often as necessary, but no less than twice each week.

(6)           Mattress pads and pillows shall be of washable material.

(7)           There shall be separate storage for soiled linen and clothing.  Such storage may consist of individual plastic bags or covered hampers or a soiled linen room.  All personnel shall wash their hands thoroughly after handling soiled linen.

(8)           Laundry equipment shall be maintained in the facility or arrangements made with a commercial laundry to handle soiled linen.

(b)  Housekeeping requirements are as follows:

(1)           Housekeeping practices and procedures shall be employed to keep the home free from offensive odors, and accumulations of dirt, rubbish and dust.

(2)           Cleaning shall be performed in a manner to minimize the spread of pathogenic organisms.  Floors shall be cleaned regularly.  Polishes on floors shall provide a non‑skid finish; throw or scatter rugs shall not be used except for non‑skid entrance mats.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1108       REPORT OF DEATH

The hospice shall have a written plan to be followed in case of patient death.  The plan must provide for:

(1)           collection of data needed for the death certificate, as required by G.S. 130A‑117;

(2)           recording time of death;

(3)           pronouncement of death;

(4)           notification of attending physician responsible for signing death certificate;

(5)           notification of next of kin or legal guardian;

(6)           authorization and release of body to funeral home; and

(7)           notification to the Department of any death resulting from an injury, accident, or other possible unnatural causes.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1109       RESIDENT CARE AREAS

(a)  Resident rooms shall meet the following requirements:

(1)           There shall be private or semiprivate rooms;

(2)           Infants and small children shall not be assigned to a room with an adult resident unless requested by residents and families;

(3)           Each resident room shall contain at least a bed, a mattress protected by waterproof material, mattress pad, pillow, and a chair;

(4)           Each resident room shall have a minimum of 48 cubic feet of closet space or wardrobe for clothing and personal belongings that provides security and privacy for each resident.  Each resident room shall be equipped with a towel rack for each individual;

(5)           Each resident bedroom shall:

(A)          be located at or above grade level;

(B)          have provisions to ensure visual privacy for treatment or visiting;

(6)           Artificial lighting shall be provided sufficient for treatment and non‑treatment needs, 50 foot candles for treatment, 35 foot candles for non‑treatment areas; and

(7)           A room where access is through a bathroom, kitchen or another bedroom will not be approved for a resident's bedroom.

(b)  Bathrooms shall meet the following requirements:

(1)           Bathroom facilities shall be conveniently accessible to resident rooms.  One bathroom may serve up to four residents and staff.  Minimum size of any bathroom shall be 18 square feet.  The door shall be at least 32 inches wide.

(2)           The bathroom shall be furnished with the following:

(A)          toilet with grab bars;

(B)          lavatory with four inch wrist blade controls;

(C)          mirror;

(D)          soap, paper towel dispensers, and waste paper receptacle with a removable impervious liner;

(E)           water closet; and

(F)           tub or shower.

(c)  Space shall be provided for:

(1)           charting, storage of supplies and personal effects of staff;

(2)           the storage of resident care equipment;

(3)           housekeeping equipment and cleaning supplies;

(4)           storage of test reagents and disinfectants distinct from medication;

(5)           locked medication storage and preparation; and

(6)           drugs requiring refrigeration.  They may be stored in a separate locked box in the refrigerator or in a lockable drug‑only refrigerator, capable of maintaining a temperature range of 36 degrees F (2 degrees C) to 46 degrees F (8 degrees C).  The storage and accountability of controlled substances shall be in accordance with the North Carolina Controlled Substances Act, Article 5 of Chapter 90 of the General Statutes.

(d)  Kitchen and dining areas shall have:

(1)           a refrigerator;

(2)           a cooking unit ventilated to the outside;

(3)           a 42 inch minimum double‑compartment sink and domestic dishwashing machine capable of sanitizing dishes with 160 degrees F. water;

(4)           dining space of 20 square feet per resident; and

(5)           storage space for non‑perishables.

(e)  Other areas shall include:

(1)           a minimum of 150 square feet exclusive of corridor traffic for recreational and social activities;

(2)           an audible and accessible call system furnished in each resident's room and bathroom; and

(3)           heating and air cooling equipment to maintain a comfort range between 68 degrees and 80 degrees Fahrenheit.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991;

Amended Eff. February 1, 1995.

10A NCAC 13K .1110       FURNISHINGS

Furnishings of the residence shall be home‑like and non‑institutional and include lounge furniture in addition to furnishings in resident rooms.  Accessories such as wallpaper, bedspreads, carpets and lamps shall be selected to create such an atmosphere.  Provision shall be made for each resident to bring items from home to place about the room to the extent available space allows.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13k .1111       HOSPICE RESIDENCE ZONING AND FIRE SAFETY REQUIREMENTS

Hospices maintained as residential facilities shall provide documentation of approval from local zoning commissions, fire departments and building departments.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1112       DESIGN AND CONSTRUCTION

(a)  Hospice residences and inpatient units must meet the requirements of the North Carolina State Building Code in effect at the time of construction, additions, alterations or repairs.

(b)  Each facility shall be planned, constructed, and equipped to support the services to be offered in the facility.

(c)  Any existing building converted to a hospice facility shall meet all requirements of a new facility.

(d)  The sanitation, water supply, sewage disposal, and dietary facilities must comply with the rules of the Commission for Public Health.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1113       PLANS AND SPECIFICATIONS

(a)  When construction or remodeling is planned, final working drawings and specifications must be submitted by the owner or the owner's appointed representative to the Department of Health and Human Services, Division of Health Service Regulation for review and approval.  Schematic drawings and preliminary working drawings shall be submitted by the owner prior to the required submission of final working drawings.  The Department shall forward copies of each submittal to the Department of Insurance and Division of Environmental Health for review and approval.  Three copies of the plans shall be provided at each submittal.

(b)  Construction work shall not be commenced until written approval has been given by the Department.  Approval of final plans and specifications shall expire one year from the date granted unless a contract for the construction has been signed prior to the expiration date.

(c)  If an approval expires, a renewed approval shall be issued provided revised plans meeting all current regulations, codes, and standards are submitted.

(d)  Completed construction shall conform to the minimum standards established in these Rules.

(e)  The owner or designated agent shall notify the Department when actual construction starts and at points when construction is 75 percent and 90 percent complete and upon final completion, so that periodic and final inspections can be performed.

(f)  The owner or owner's designated agent shall submit for approval by the Department all alterations or remodeling changes which affect the structural integrity of the building, functional operation, fire safety or which add beds or facilities over those for which the facility is licensed.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991;

Amended Eff. February 1, 1996.

 

10A NCAC 13K .1114       PLUMBING

(a)  The water supply shall be designed, constructed and protected so as to assure that a safe, potable and adequate water supply is available for domestic purposes in compliance with the North Carolina State Building Code.

(b)  All plumbing in the residence or unit shall be installed and maintained in accordance with the North Carolina State Plumbing Code. All plumbing shall be maintained in good repair and free of the possibility of backflow and backsiphonage, through the use of vacuum breakers and fixed air gaps, in accordance with state and local codes.

(c)  For homes with five or more residents, a 50‑gallon quick recovery water heater is required.  For homes with fewer than five residents, a 40‑gallon quick recovery water heater is required.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1115       WASTE DISPOSAL

(a)  Sewage shall be discharged into a public sewer system, or if such is not available, it shall be disposed of in a manner approved by the North Carolina Division of Environmental Health.

(b)  Garbage and rubbish shall be stored in impervious containers in such a manner as not to become a nuisance or a health hazard.  A sufficient number of impervious containers with tight‑fitting lids shall be provided and kept clean and in good repair.  Refuse shall be removed from the outside storage at least once a week to a disposal site approved by the local health department.

(c)  The home or unit shall be maintained free of infestations of insects and rodents, and all openings to the outside shall be screened.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1116       APPLICATION OF PHYSICAL PLANT REQUIREMENTS

The physical plan requirements for each hospice residential facility or unit shall be applied as follows:

(1)           New construction shall comply with the requirements of Section .1100 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 .1100 of this Subchapter; however, where strict conformance with current requirements would be impracticable, the authority having jurisdiction may approve alternative measures where the facility can demonstrate to the Department's satisfaction that the alternative measures do not reduce the safety or operating effectiveness of the facility;

(4)           Rules contained in Rule .1109 of this Section 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 Department'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 or codes have any conflict, the more stringent requirement shall apply.

 

History Note:        Authority G.S. 131E‑202;

Eff. February 1, 1996.

 

SECTION .1200 ‑ HOSPICE INPATIENT CARE

 

10A NCAC 13K .1201       REQUIREMENTS FOR HOSPICE INPATIENT UNITS

(a)  Hospice inpatient units must conform to the rules outlined in 10A NCAC 13K .0100 through .1100 and those in this Section.

(b)  Hospice inpatient units located in a licensed hospital shall meet the requirements of 10A NCAC 13B with the exception of:  10A NCAC 13B .1912, .1919, 1922 and .1923.

(c)  Hospice inpatient units located in a licensed nursing facility shall meet the requirements of 10A NCAC 13D with the exception of:  10A NCAC 13D .0507, .0600, .0800, .0907, .1004, .1200 and .1300.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1202       ADDITIONAL STAFFING REQUIREMENTS FOR HOSPICE INPATIENT UNITS

(a)  All nursing services shall be provided under the supervision of a registered nurse.

(b)  A facility providing respite care must provide 24-hour nursing services that meet the nursing needs of all patients and are furnished in accordance with each patient's plan of care.  Each patient must receive all nursing services as prescribed by the physician and must be kept comfortable, clean, well-groomed and protected from accident, injury and infection. The presence of a Registered Nurse (RN) to provide direct care on all shifts is not required for patients receiving general inpatient care for respite unless specific nursing needs are in an individual patient's plan of care.  If a patient in an inpatient facility is receiving general inpatient care for symptom management, then the 24-hour patient care RN staff must be available.

(c)  Considerations for determining sufficiency of nursing personnel include:

(1)           number of patients;

(2)           specific patient care requirements;

(3)           family care needs; and

(4)           availability of support from other interdisciplinary team members.

(d)  Hospice caregivers shall only provide care to patients in licensed hospice residential beds in a combined hospice inpatient and residential facility.

 

History Note:        Authority G.S. 131E-202;

Eff. June 1, 1991;

Amended Eff. January 1, 2010; February 1, 1996.

 

10A NCAC 13K .1203       ADDITIONAL SERVICES REQUIRED FOR HOSPICE INPATIENT CARE

(a)  The hospice shall assure, directly or through written agreement, the provision of duly licensed radiology, laboratory, pathology and other medically related services in accordance with physicians' orders.  Written agreement shall be in keeping with Rule .0505 of this Subchapter.  If those services are provided directly, written policies and procedures shall govern their implementation.

(b)  Radiology, laboratory and pathology services shall be under the direction of a physician qualified by education, training and experience to assume that function.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1204       ADDITIONAL PATIENT CARE AREA REQUIREMENTS FOR HOSPICE INPATIENT UNITS

(a)  The floor area of a single bedroom shall not be less than 100 square feet and the floor area of a room for more than one bed shall not be less than 80 square feet per bed.  The 80 square feet and 100 square feet requirements shall be exclusive of closets, toilet rooms, vestibules or wardrobes.

(b)  The total space set aside for dining, recreation and other common uses shall not be less than 30 square feet per bed.  Physical therapy and occupational therapy space shall not be included in this total.

(c)  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 for each 15 beds not individually served.  There shall be a wheelchair and stretcher accessible central bathing area for staff to bathe a patient who cannot perform this activity independently.  There shall be at least one such area per each level in a multi‑level facility.

(d)  For each nursing unit or fraction thereof on each floor, the following shall be provided:

(1)           an adequate medication preparation area with counter, sink with four‑inch handles, medication refrigerator, eye‑level medication storage, cabinet storage, and double‑locked narcotic storage room, located adjacent to the nursing station or under visual control of the nursing station;

(2)           a clean utility room with counter, sink with four‑inch handles, wall and under counter storage;

(3)           a soiled utility room with counter, sink with four‑inch handles, wall and under counter storage, a flush‑rim clinical sink or water closet with a suitable device for cleaning bedpans and a suitable means for washing and sanitizing bedpans and other utensils;

(4)           a nurses' toilet and locker space for personal belongings;

(5)           an audiovisual nurse‑patient call system arranged to ensure that a patient's call in the facility is noted at a staffed station;

(6)           a soiled linen storage area;

(7)           a clean linen storage room area; and

(8)           at least one janitor's closet.

(e)  Dietary and laundry each must have a janitor's closet.

(f)  Stretcher and wheelchair storage shall be provided.

(g)  Bulk storage shall be provided at the rate of five square feet of floor area per bed.

(h)  Office space shall be provided for persons with administrative responsibilities for the unit.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991;

Amended Eff. February 1, 1996.

 

10A NCAC 13K .1205       FURNISHINGS FOR HOSPICE INPATIENT CARE

(a)  Handgrips shall be provided for all toilet and bath facilities used by patients.  Handrails shall be provided on both sides of all corridors used by patients.

(b)  For each nursing unit or fraction thereof on each floor, the following shall be provided:

(1)           a nourishment station with work space, cabinet, and refrigerated storage, a small stove or hotplate in an area physically separated from the nurses' station; and

(2)           one nurses' station consisting of adequate desk space for writing, storage space for office supplies and storage space for patients' records.

(c)  Flameproof privacy screens or curtains shall be provided in multi‑bedded rooms.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1206       HOSPICE INPATIENT FIRE AND SAFETY REQUIREMENTS

(a)  A new facility shall meet the requirements of the current North Carolina State Building Code and the following additional requirements:

(1)           Where nursing units are located on the same floor with other departments or services, the facility shall be designed to provide separation from the other departments or services with a smoke barrier.

(2)           Horizontal exits are not permitted in any new facility.

(3)           An addition to an existing facility shall meet the same requirements as a new facility except that in no case shall more than one horizontal exit be used to replace a required exit to the outside.  For all construction, an emergency generating set, including the prime mover and generator, shall be located on the premises and shall be reserved exclusively for supplying the emergency electrical system.

(b)  The hospice shall establish written policies and procedures governing disaster preparedness and fire protection.

(c)  The hospice shall have an acceptable written plan periodically rehearsed with staff with procedures to be followed in the event of an internal or external disaster, and for the care of casualties of patients and personnel arising from such disasters.

(d)  The fire protection plan shall include:

(1)           instruction for all personnel in use of alarms, fire fighting equipment, methods of fire containment, evacuation routes and procedures for calling the fire department and the assignment of specific tasks to all personnel in response to an alarm; and

(2)           fire drills for each shift of personnel at least quarterly.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10a NCAC 13K .1207       HOSPICE INPATIENT REQUIREMENTS FOR HEATING/AIR CONDITIONING

Heating and cooling systems shall meet the current American Society of Heating, Refrigeration, and Air Conditioning Engineers Guide and National Fire Protection Association Code 90A, which is hereby adopted by reference pursuant to G.S. 150B‑14(c), with the following modification:

(1)           Soiled linen, bathrooms, janitor closets and soiled utility rooms must have negative pressure with relationship to adjacent areas.

(2)           Clean linen, clean utility and drug rooms must have positive pressure with relationship to adjacent areas.

(3)           All areas not covered in Paragraphs (1) and (2) of this Rule must have neutral pressure.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1208       HOSPICE INPATIENT REQUIREMENTS/EMERGENCY ELECTRICAL SERVICE

Emergency electrical service shall be provided for use in the event of failure of the normal electrical service.  This emergency service shall be made up as follows:

(1)           In any existing facility, the following must be provided:

(a)           type 1 or 2 emergency lights as required by the North Carolina State Building Code;

(b)           additional emergency lights for all nursing stations, drug preparation and storage areas, and for the telephone switchboard, if applicable;

(c)           one or more portable battery‑powered lamps at each nursing station; and

(d)           a suitable source of emergency power for life‑sustaining equipment to ensure continuous operation for a minimum of 72 hours.

(2)           Any addition to an existing facility shall meet the same requirements as new construction.

(3)           Any conversion of an existing building such as a hotel, motel, abandoned hospital or abandoned school, shall meet the same requirements for emergency electrical services as required for new construction.

(4)           Battery‑powered corridor lights shall not replace the requirements for the emergency circuit nor be construed to substitute for the generator set.  Sufficient fuel shall be stored for the operation of the emergency generator for a period not less than 72 hours, on a 24‑hour per day operational basis.  The system shall be test run for a period of not less than 15 minutes on a weekly schedule.  Records of running time shall be maintained and kept available for reference.

(5)           To ensure proper evaluation of design of emergency power systems, the owner or operator shall submit with final working drawings and specifications a letter describing the policy for admissions and discharges to be used when the facility begins operations.  If subsequent inspections for licensure indicate the admission policies have been changed, the facility will be required to take immediate steps to meet appropriate code requirements for continued licensure.

(6)           Lighting for emergency electrical services shall be provided in the following places:

(a)           exit ways and all necessary ways of approach exits, including exit signs and exit direction signs, exterior of exits exit doorways, stairways, and corridors;

(b)           dining and recreation rooms;

(c)           nursing station and medication preparation area;

(d)           generator set location, switch‑gear location, and boiler room, if applicable; and

(e)           elevator, if required for emergency.

(7)           The following emergency equipment which is essential to life, safety, and the protection of important equipment or vital materials shall be provided:

(a)           nurses' calling system;

(b)           alarm system including fire alarm actuated at manual stations, water flow alarm devices of sprinkler systems if electrically operated, fire detecting and smoke detecting systems, paging or speaker systems if intended for issuing instructions during emergency conditions, and alarms required for nonflammable medical gas systems, if installed;

(c)           fire pump, if installed;

(d)           sewerage or sump lift pump, if installed;

(e)           one elevator, where elevators are used for vertical transportation of patients;

(f)            equipment such as burners and pumps necessary for auxiliaries and controls, required for heating and sterilization, if installed; and

(g)           equipment necessary for maintaining telephone service.

(8)           Where electricity is the only source of power normally used for space heating, the emergency service shall be provided for heating of patient rooms.  Emergency heating of patient rooms will not be required in areas where the facility is supplied by at least two separate generating sources, or a network distribution system with the feeders so routed, connected, and protected that a fault any place between the generators and the facility will not likely cause an interruption.

(9)           The emergency electrical system shall be so controlled that after interruption of the normal electric power supply, the generator is brought to full voltage and frequency and connected within ten seconds through one or more primary automatic transfer switches to all emergency lighting, alarms, nurses' call, equipment necessary for maintaining telephone service, and receptacles in patient corridors.  All other lighting and equipment required to be connected to the emergency system shall either be connected through the ten second primary automatic transfer switching or shall be subsequently connected through other automatic or manual transfer switching.  Receptacles connected to the emergency system shall be distinctively marked for identification.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1209       HOSPICE INPATIENT REQUIREMENTS FOR GENERAL ELECTRICAL

(a)  All main water supply shut off valves in the sprinkler system must be electronically supervised so that if any valve is closed an alarm will sound at a continuously manned central station.

(b)  No two adjacent emergency lighting fixtures shall be on the same circuit.

(c)  Receptacles in bathrooms must have ground fault protection.

(d)  Each patient bed location must be provided with a minimum of four single or two duplex receptacles.

(e)  Each patient bed location must be supplied by at least two branch circuits.

(f)  The fire alarm system must be installed to transmit an alarm automatically to the fire department that is, legally committed to serve the area in which the facility is located, by the direct and reliable method approved by local ordinances.

(g)  In patient areas, fire alarms shall be gongs or chimes rather than horns or bells.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1210       OTHER HOSPICE INPATIENT REQUIREMENTS

(a)  In general patient areas, each room shall be served by at least one calling station and each bed shall be provided with a call button.  Two call buttons serving adjacent beds may be served by one calling station.  Calls shall register with the floor staff and shall activate a visible signal in the corridor at the patient's or resident's door.  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 which provide two‑way voice communication shall be equipped with an indicating light at each calling station which lights and remains lighted as long as the voice circuit is operating.  A nurses' call emergency button shall be provided for patients' use at each patient toilet, bath, and shower room.

(b)  At least one telephone shall be available in each area to which patients are admitted and additional telephones or extensions as are necessary to ensure availability in case of need.

(c)  General outdoor lighting shall be provided adequate to illuminate walkways and drive.

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1211       ADDITIONAL PLUMBING REQUIREMENTS/HOSPICE INPATIENT UNITS

For inpatient units, the hot water system shall be adequate to provide:

 

Patient Areas                        Dietary                   Laundry

Gallons per hour per bed                                            6 ˝                                      4                            4 1/2

Temperature degrees F.                                            110‑116                            140 (min)              140 (min)

 

History Note:        Authority G.S. 131E‑202;

Eff. June 1, 1991.

 

10A NCAC 13K .1212       APPLICATION OF PHYSICAL PLANT REQUIREMENTS

The physical plant requirements for each hospice inpatient facility or unit shall be applied as follows:

(1)           New construction shall comply with the requirements of Section .1200 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 .1100 of this Subchapter; however, where strict conformance with current requirements would be impracticable, the authority having jurisdiction may approve alternative measures where the facility can demonstrate to the Department's satisfaction that the alternative measures do not reduce the safety or operating effectiveness of the facility;

(4)           Rules contained in Rule .1210 of this Section 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 Department'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 or codes have any conflict, the more stringent requirement shall apply.

 

History Note:        Authority G.S. 131E‑202;

Eff. February 1, 1996.