SUBCHAPTER 14e ‑ CERTIFICATIONS OF CLINICS FOR ABORTION

 

SECTION .0100 ‑ CERTIFICATION PROCEDURE

 

10A NCAC 14E .0101       DEFINITIONS

The following definitions will apply throughout this Subchapter:

(1)           "Clinic" means a freestanding facility (a facility neither physically attached nor operated by a licensed hospital) for the performance of abortions during the first 20 weeks of pregnancy.

(2)           "Complication" includes but is not limited to hemorrhage, infection, uterine perforation, cervical laceration or retained products of conception.

(3)           "Division" means the Division of Health Service Regulation of the North Carolina Department of Health and Human Services.

(4)           "Fetal age" means the length of pregnancy as indicated by the date of conception.

(5)           "Governing authority" means the individual, agency or group or corporation appointed, elected or otherwise designated, in which the ultimate responsibility and authority for the conduct of the abortion clinic is vested.

(6)           "New facility" means one that is not certified as an abortion clinic by the Division as of July 1, 1994, and has not been certified within the previous six months of the application for certification.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994; December 1, 1989; June 30, 1980.

10A NCAC 14E .0102       CONFERENCE

Before proceeding with construction and operational plans, a potential sponsor or owner of a freestanding abortion clinic shall discuss with the staff of the Division of Health Service Regulation the scope of the proposed facility.  This will provide an opportunity for the owner and the Division's staff to discuss certification requirements.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

10A NCAC 14E .0103       CHANGES

All stages of the plans from schematics through working drawings shall be reviewed by the Division's staff each time a change is made.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

10A NCAC 14E .0104       PLANS

Three copies of the plans will be required for certification purposes.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

10A NCAC 14E .0105       APPROVAL

Approval from the Division of Health Service Regulation, the Division of Environmental Health, and the Department of Insurance should be obtained before construction is commenced.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. December 1, 1989.

 

10A NCAC 14E .0106       APPLICATION

(a)  Prior to the admission of patients, an application from the clinic for certification shall be submitted to and approved by the Division.

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

(c)  The application form shall set forth the ownership, staffing patterns, clinical services to be rendered, professional staff in charge of services, and general information that would be helpful to the Division's understanding of the clinic's operating program.

(d)  After construction requirements in Section .0200 of this Subchapter have been met and the application for certification has been received and approved, the Division shall conduct an on-site, certification survey.

(e)  Each certificate must be renewed at the beginning of each calendar year.  The governing authority shall file an application for renewal of certification with the Division at least 30 days prior to the date of expiration on forms furnished by the Division.  Failure to file a renewal application shall result in expiration of the certificate to operate.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994.

 

10A NCAC 14E .0107       ISSUANCE OF CERTIFICATE

(a)  The Division shall issue a certificate if it finds the facility can:

(1)           Comply with all requirements described in this Subchapter; and

(2)           Assure that, in the event that complications arise from the abortion procedure, an OB-GYN board certified or board eligible physician shall be available.

(b)  Each certificate shall be issued only for the premises and persons or organizations named in the application and shall not be transferable.

(c)  The governing authority shall notify the Division in writing, within 10 working days, of any change in the name of the facility or change in the name of the administrator.

(d)  The facility shall report to the Division all incidents, within 10 working days, of vandalism to the facility such as fires, explosions or other action causing disruption of services.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994.

 

10A NCAC 14E .0108       POSTING

Certificates shall be posted in a conspicuous place on the premises.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

10A NCAC 14E .0109       RENEWAL

Each certificate, unless previously suspended or revoked, shall be renewable annually without charge upon the filing of an application and its approval by the Division.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

10A NCAC 14E .0110       REVOCATION

The Department shall deny, suspend, or revoke a certificate in any case where it finds that substantial failure to comply with these regulations renders the facility unsuitable for the performance of abortions.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10; 150B;

Eff. February 1, 1976;

Amended Eff. December 1, 1989.

 

10A NCAC 14E .0111       INSPECTIONS

(a)  The Division shall make such inspections as it may deem necessary.

(b)  The Division shall have authority to investigate any complaint relative to the care, treatment or complications of any patient.

(c)  Representatives of the Division may review any records in any medium necessary to determine compliance with the rules, while maintaining the confidentiality of the complainant and the patient, unless otherwise required by law.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994.

 

10A NCAC 14E .0112       ALTERATIONS

Any certificate holder or prospective applicant desiring to make specified types of alteration or addition to a clinic or to construct a new clinic, before commencing such alteration, addition or new construction shall submit plans and specifications therefor to the Division for preliminary inspection and approval or recommendations with respect to compliance with the regulations and standards herein authorized.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. December 1, 1989.

 

SECTION .0200 ‑ MINIMUM STANDARDS FOR CONSTRUCTION AND EQUIPMENT

 

10A NCAC 14E .0201       BUILDING CODE REQUIREMENTS

(a)  The physical plant for a facility must meet or exceed minimum requirements of the North Carolina State Building Code for Group B occupancy (business office facilities) which is incorporated by reference including subsequent amendments. Copies of The North Carolina Building Code, Volume One, General Construction, may be obtained for thirty dollars ($30.00) from the N.C. Department of Insurance, P.O. 26387, Raleigh, NC 27611.

(b)  The requirements contained in this Section shall apply to new facilities and to any alterations, repairs, rehabilitation work, or additions which are made to a previously certified facility.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994; December 1, 1989.

 

10A NCAC 14E .0202       SANITATION

Abortion clinics must 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 which is hereby incorporated by reference including subsequent amendments and editions.  Copies of 15A NCAC 18A .1300 may be obtained at no charge from the Environmental Health Services, 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. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994.

 

10A NCAC 14E .0203       ELEVATOR

(a)  In multi‑story buildings, at least one elevator for patient use shall be provided.

(b)  At least one dimension of the elevator cab shall be six and one‑half feet to accommodate stretcher patients.

(c)  The elevator door shall have an opening of no less than three feet in width, which is minimum for stretcher use.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

10A NCAC 14E .0204       CORRIDORS

The width of corridors shall be sufficient to allow for patient evacuation by stretcher, but in no case shall patient-use corridors be less than 60 inches.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994.

 

10A NCAC 14E .0205       DOORS

Minimum width of doors to all rooms needing access for stretchers shall be three feet.  No door shall swing into corridors in a manner that might obstruct traffic flow or reduce the required corridor width except doors to spaces such as small closets not subject to occupancy.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994.

 

10A NCAC 14E .0206       ELEMENTS AND EQUIPMENT

The physical plant shall provide appropriate elements and equipment to carry out the functions of the facility with the following minimum requirements:

(1)           Mechanical requirements

(a)           Temperatures and humidities:

(i)            The mechanical systems shall be designed to provide the temperature and humidities shown in this Paragraph:

 

Area                       Temperature                         Relative Humidity

Procedure              70-76 degrees F.                   50-60 %

Recovery               75-80 degrees F.

 

(b)           All air supply and exhaust systems for the procedure suite and recovery area shall be mechanically operated.  All fans serving exhaust systems shall be located at the discharge end of the system.  The ventilation rates shown herein shall be considered as minimum acceptable rates.

(i)            The ventilation system shall be designed and balanced to provide the pressure relationships shown herein.

(ii)           All air supplied to procedure rooms shall be delivered at or near the ceiling of the room and all exhaust or return from the area shall be removed near the floor level at not less than three inches above the floor.

(iii)          Corridors shall not be used to supply air to or exhaust air from any procedure or recovery room except to maintain required pressure relationships.

(iv)          All ventilation or air conditioning systems serving procedure rooms shall have a minimum of one filter bed with a minimum filter efficiency of 80 percent.

(v)           Ventilation systems serving the procedure or recovery rooms shall not be tied in with the soiled holding or work rooms, janitors' closets or locker rooms if the air is to be recirculated in any manner.

(vi)          Air handling duct systems shall not have duct linings in ducts serving procedure or recovery rooms.

(vii)         The following general air pressure relationships to adjacent areas and ventilation rates shall apply:

 

Area                       Pressure Relationship          Minimum Air

Changes/Hour

Procedure                              P                                       6

Recovery                               P                                       6

Soiled work,

janitor's closet,

toilets,

Soiled holding                       N                                    10

Clean work or

Clean holding                       P                                       4

 

(P = positive pressure  N = negative pressure)

 

(2)           Plumbing And Other Piping Systems

(a)           Medical Gas and Vacuum Systems

(i)            Piped-in medical gas and vacuum systems, if installed, shall meet the requirements of NFPA-99-1990, type one system, which is hereby incorporated by reference including subsequent amendments and editions.  Copies of NFPA-99-1990 may be purchased from the National Fire Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, MA 02269-9101, for twenty eight dollars and fifty cents ($28.50).

(ii)           If inhalation anesthesia is used in any concentration, the facility must meet the requirements of NFPA 70-1993 and NFPA 99-1990, current editions relating to inhalation anesthesia, which are hereby incorporated by reference including subsequent amendments and editions.  Copies of NFPA 70-1993 and NFPA 99-1990 may be purchased from the National Fire Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, MA 02269-9101, for thirty two dollars and fifty cents ($32.50) and twenty eight dollars and fifty cents ($28.50) respectively.

(b)           Lavatories and sinks for use by medical personnel shall have the water supply spout mounted so that its discharge point is a minimum distance of five inches above the rim of the fixture with mixing type fixture valves which can be operated without the use of the hands.

(c)           Hot water distribution systems shall provide hot water at hand washing and bathing facilities at a minimum temperature of 100 degrees F. and a maximum temperature of 116 degrees F.

(d)           Floor drains shall not be installed in procedure rooms.

(e)           Building drainage and waste systems shall be designed to avoid installations in the ceiling directly above procedure rooms.

(3)           Electrical Requirements

(a)           Procedure and recovery rooms, and paths of egress from these rooms to the outside shall have at a minimum, listed battery backup lighting units of one and one-half hour capability that will automatically provide at least five foot candles of illumination at the floor in the event of a utility or local lighting circuit failure.

(b)           Essential electrically operated medical equipment necessary for the safety of the patient shall have, at a minimum, battery backup.

(c)           Receptacles located within six feet of sinks or lavatories shall be ground-fault protected.

(d)           Provide at least one wired-in, ionization-type smoke detector within 15 feet of each procedure or recovery room entrance.

(4)           Each facility and its grounds shall be maintained to minimize hazards and enhance safety for staff and patients.  Buildings systems and medical equipment must have preventative maintenance conducted as recommended by the equipment manufacturers' or installers' literature to assure satisfactory operation.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994; December 1, 1989.

 

10A NCAC 14E .0207       AREA REQUIREMENTS

The following areas are considered minimum requirements for abortion clinics:

(1)           Receiving area;

(2)           Examining room;

(3)           Preoperative preparation and holding room;

(4)           Individual patient locker facilities or equivalent;

(5)           Operating room;

(6)           Recovery room;

(7)           Clean workroom;

(8)           Soiled workroom;

(9)           Medicine room (may be defined as area in the clean workroom if a self‑contained secure cabinet complying with security requirements of state and federal laws is provided);

(10)         Linen Storage.  Separate and distinct areas for storage and handling clean and soiled linen shall be provided;

(11)         Patient toilet;

(12)         Personnel lockers and toilet facilities;

(13)         Laboratory;

(14)         Nourishment station with storage and preparation area for serving meals or in‑between meal snacks;

(15)         Janitor's closets appropriately located;

(16)         Adequate space and equipment for assembling, sterilizing and storing medical and surgical supplies;

(17)         Storage space for medical records;

(18)         Office space for nurses' charting, doctors' charting, communications, counseling, and business functions.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. December 24, 1979.

 

10A NCAC 14E .0208       SHARED SERVICES

When there is written indication that services are to be shared or purchased, appropriate modifications or deletions in space requirements may be anticipated.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

SECTION .0300 ‑ ADMINISTRATION

 

10A NCAC 14E .0301       OWNERSHIP

The ownership of the abortion clinic shall be fully disclosed to the Division.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

10A NCAC 14E .0302       PERSON IN AUTHORITY

The governing authority shall designate a person to have authority and responsibility for the administrative and professional functions of the clinic.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. December 1, 1989.

 

10A NCAC 14E .0303       POLICIES AND PROCEDURES

The governing authority shall prepare a manual of clinic policies and procedures for use by employees, medical staff, and contractual physicians to assist them in understanding their responsibilities within the organizational framework of the clinic.  These shall include:

(1)           Patient selection and exclusion criteria, and clinical discharge criteria.

(2)           Policy and procedure for each type of abortion procedure performed at the clinic.

(3)           Protocol for determining fetal age.

(4)           Protocol for referral of patients for whom services have been declined.

(5)           Protocol for discharge instructions that informs patients who to contact for post-procedural emergencies.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994.

 

10A NCAC 14E .0304       ADMISSION AND DISCHARGE

(a)  There shall be on the premises throughout all hours of operation an employee authorized to receive patients and to make administrative decisions on their disposition.

(b)  All patients shall be admitted only under the care of a physician who is currently licensed to practice medicine in North Carolina.

(c)  Any patient not discharged within 12 hours following the abortion procedure shall be transferred to a general hospital.

(d)  Following admission and prior to obtaining the consent for surgery required by Rule .0305(a) of this Section, representatives of the clinic's management shall provide to each patient the following information:

(1)           A fee schedule and any extra charges routinely applied;

(2)           The name of the attending physician(s) and hospital admitting privileges, if any. In the absence of admitting privileges a statement to that effect shall be included;

(3)           Instructions for post-procedure emergencies as outlined in Rule .0313(d) of this Section;

(4)           Grievance procedures a patient may follow if dissatisfied with the care and services rendered; and

(5)           The telephone number of the Complaints Investigation Branch of the Division.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1995; July 1, 1994; December 1, 1989.

 

10A NCAC 14E .0305       MEDICAL RECORDS

(a)  A complete and permanent record shall be maintained for all patients including the date and time of admission and discharge; the full and true name; address; date of birth; nearest of kin; diagnoses; duration of pregnancy; condition on admission and discharge; referring and attending physician; a witnessed, voluntarily-signed consent for each surgery or procedure and signature of the physician performing the procedure; and the physician's authenticated history and physical examination including identification of pre-existing or current illnesses, drug sensitivities or other idiosyncrasies having a bearing on the operative procedure or anesthetic to be administered.

(b)  All other pertinent information such as pre- and post-operative instructions, laboratory report, drugs administered, report of operation and follow-up instruction including family planning advice shall be recorded and authenticated.

(c)  If Rh is negative, the significance shall be explained to the patient and so recorded.  The patient in writing may reject or accept the appropriate desensitization material.  A written record of the patient's decision shall be a permanent part of her medical record.

(d)  An ultrasound examination shall be performed and the results posted in the patient's medical record for any patient who is scheduled for an abortion procedure.

(e)  The facility shall maintain a daily procedure log of all patients receiving abortion services.  This log shall contain at least patient name, estimated length of gestation, type of procedure, name of physician, name of RN on duty, and date and time of procedure.

(f)  Medical records shall be the property of the facility and shall be preserved or retained in the State of North Carolina for at least 20 years regardless of change of facility ownership or administration.  Such medical records shall be made available to the Division upon request and shall not be removed from the premises where they are retained except by subpoena or court order.

(g)  The facility shall have a plan for destruction of medical records to identify information to be retained and the manner of destruction to ensure confidentiality of all material.

(h)  Should a facility cease operation, arrangements shall be made for preservation of records for at least 20 years.  The facility shall notify the Division, in writing, concerning the arrangements.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994; December 1, 1989.

 

10A NCAC 14E .0306       PERSONNEL RECORDS

(a)  Application.  Each prospective employee or contractual employee must submit an application for employment which includes education, training, experience, and references.

(b)  Job Descriptions:

(1)           The facility shall have a written description which describes the duties of every position.

(2)           Each job description shall include position title, authority, specific responsibilities and minimum qualifications.  Qualifications shall include education, training, experience, special abilities and license or certification required.

(3)           The facility shall review annually and update all job descriptions, and shall provide a current copy to each employee or contractual employee assigned to the position.

(c)  The facility shall provide an orientation program to familiarize each new employee or contractual employee with the facility, its policies and the employee's job responsibilities.

(d)  The governing authority shall be responsible for implementing health standards for employees, as well as contractual employees, which are consistent with recognized professional practices for the prevention and transmission of communicable diseases.

(e)  Employee and contractual employee records for health screening, education, training and verification of professional certification shall be available for review by the Division.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994.

 

10A NCAC 14E .0307       NURSING SERVICE

(a)  There shall be a minimum of one registered nurse with experience in post‑operative or post‑partum care who is currently licensed to practice professional nursing in North Carolina on duty in the clinic at all times when patients are in the facility.

(b)  There shall be supporting personnel sufficient to meet patient needs and to provide safe patient care.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. December 1, 1989.

 

10A NCAC 14E .0308       reserved for future codification

 

10A NCAC 14E .0309       LABORATORY SERVICES

(a)  Pre-operative Tests.  As a minimum, there shall be performed for each patient the following laboratory tests which must be recorded in the patient's medical record prior to the abortion:

(1)           Pregnancy testing, except when a positive diagnosis of pregnancy has been established by ultrasound;

(2)           Anemia testing (hemoglobin or hematocrit); and

(3)           Rh factor testing.

(b)  Blood and Blood Products.  Those patients requiring the administration of blood shall be transferred immediately to a local hospital having blood bank facilities.

(c)  The facility shall have instructions for each test procedure performed, including:

(1)           Sources of reagents, standard and calibration procedures; and

(2)           Information concerning the basis for the listed "normal" ranges.

(d)  The facility shall perform and document, at least quarterly, calibration of equipment and validation of test results.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994; December 1, 1989; October 28, 1981.

 

10a NCAC 14E .0310       EMERGENCY BACK‑UP SERVICES

The facility shall provide intervention for emergency situations.  These provisions shall include but are not limited to:

(1)           Basic cardio-pulmonary life support;

(2)           Emergency protocols for:

(a)           Venous access supplies,

(b)           Air-way support and oxygen,

(c)           Bag-valve mask unit with oxygen reservoir, and

(d)           Suction machine;

(3)           Emergency lighting available in the operating room; and

(4)           Ultrasound equipment.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994; December 24, 1979.

 

10A NCAC 14E .0311       SURGICAL SERVICES

(a)  Facilities.  The operating room shall be maintained exclusively for surgical procedures and shall be so designed and maintained to provide an atmosphere free of contamination by pathogenic organisms.  The facility shall establish procedures for infection control and universal precautions.

(b)  Tissue Examination:

(1)           The physician performing the abortion is responsible for examination of all products of conception (P.O.C.) prior to patient discharge.  Such examination shall note specifically the presence or absence of chorionic villi and fetal parts or the amniotic sac.  The results of the examination shall be recorded in the patient's medical record.

(2)           The facility shall have written procedures, supplies and equipment available for gross and microscopic evaluation of abortion specimens.  If placental or fetal tissue is not identified by gross examination, a microscopic examination must be done on the P.O.C.  In cases where the microscopic evaluation is negative for chorionic villi and fetal parts, or the weight of the P.O.C. falls substantially below the appropriate weight range for the fetal age, a microscopic examination by a board certified or board eligible pathologist shall be done on the P.O.C.

(3)           The results of this examination, the findings of further patient evaluation and any subsequent treatment must be recorded in the patient's medical record.

(4)           The facility shall establish procedures for obtaining, identifying, storing and transporting specimens.

(5)           The facility shall establish a method for follow-up of patients on whom no villi are seen.

 

History Note:        Authority G.S. 14‑45.1(a);

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. July 1, 1994; December 1, 1989; November 1, 1984; September 1, 1984.

 

10A NCAC 14E .0312       MEDICATIONS AND ANESTHESIA

(a)  Medication

(1)           No medication or treatment shall be given except on written order of a physician.

(2)           Medications must be administered in accordance with the Nurse Practice Act of the State of North Carolina, and must be recorded in the patient's permanent record.

(b)  Anesthesia

(1)           The anesthesia must be administered only under the direct supervision of a licensed physician.

(2)           Flammable anesthetics shall be prohibited except when construction, storage and equipment meet the standards of the National Fire Protection Association (N.F.P.A.) incorporated in Bulletin No. 56, "Code for Use of Flammable Anesthetics."

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

10A NCAC 14E .0313       POST‑OPERATIVE CARE

(a)  Patients whose pregnancy is terminated on an ambulatory basis should be observed in the abortion clinic for a reasonable number of hours, not less than one, to insure that no immediate post‑operative complications are present.  Thereafter, such patients may be discharged if their course has been uneventful.

(b)  Any patient having an adverse condition or complication known or suspected to have occurred during or after the performance of the abortion shall be transferred to the back‑up hospital for evaluation or admission.

(c)  Any non‑ambulatory patient shall be accompanied by an attending medical or nursing staff member during any transfer within or outside the facility.

(d)  Written instructions shall be issued to all patients in accordance with the rules of the physician in charge of the abortion service and shall include the following:

(1)           symptoms and complications to be looked for,

(2)           activities to be avoided,

(3)           specific telephone number to be used by the patients should any complication occur or question arise.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. December 24, 1979.

 

10A NCAC 14E .0314       CLEANING OF MATERIALS AND EQUIPMENT

(a)  All supplies and equipment used in patient care shall be properly cleaned or sterilized between use for different patients.

(b)  Methods of cleaning, handling, and storing all supplies and equipment shall be such as to prevent the transmission of infection through their use.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

10A NCAC 14E .0315       HOUSEKEEPING

Abortion clinics shall meet the standards for sanitation as required by the Division of Environmental Health in the rules and regulations governing the sanitation of private hospitals, nursing and rest homes, sanitariums, sanatoriums, and educational and other institutions, 10 NCAC 10A, with special emphasis on the following:

(1)           There must be cleaning of such a frequency as to maintain the floors, walls, woodwork and windows in a manner to minimize the spread of dust particles in the atmosphere.  Accumulated waste material must be removed at least daily.

(2)           The premises must be kept free from rodents and insect infestation.

(3)           Bath and toilet facilities must be maintained in a clean and sanitary condition at all times.

(4)           Linen which comes directly in contact with the patient shall be provided as needed for each individual patient.  No such linen shall be interchangeable from one patient to another before being properly cleaned, sterilized, or laundered.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. December 1, 1989.

 

10A NCAC 14E .0316       FOOD SERVICE

(a)  Nourishments shall be available and offered to all patients.

(b)  Sanitary conditions shall be maintained in accordance with regulations of the North Carolina Sanitation Code administered by the Division of Environmental Health.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977;

Amended Eff. January 1, 1990.

 

SECTION .0400 ‑ MEDICAL STAFF

 

10A NCAC 14E .0401       QUALIFICATIONS

Every person admitted to practice in the clinic shall qualify by submitting a signed application in writing which shall contain the following data:  age, year and school of graduation, date of licensure, statement of postgraduate work, and experience.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.

 

10A NCAC 14E .0402       FILE

An individual file for each physician practicing in the clinic shall be maintained.  Each file shall contain the information outlined in Rule .0401 of this Section.

 

History Note:        Authority G.S. 14‑45.1(a); 143B‑10;

Eff. February 1, 1976;

Readopted Eff. December 19, 1977.