PURPOSE: Section 197.205, RSMo 1986 authorizes the Department of Health to establish standards for the operation of abortion facilities in order to provide acceptable care in a safe environment. Abortion facilities are considered ambulatory surgical centers as defined by section 197.200(1), RSMo 1986 and are subject to licensure as required by section 197.205, RSMo 1986.

1. (1) Governing Body, Administration and Medical Staff.

   1. (A) The facility shall have a governing body which may be an individual owner(s), partnership, corporate body, association or public agency.

      1. 1. The governing body shall have full

legal responsibility for determining, implementing and monitoring policies governing a facility’s total operation and for ensuring that these policies are administered in a manner to provide acceptable care in a safe environment.

1. 2. The governing body shall select and

employ an administrator who is a physician licensed in Missouri, a registered nurse licensed in Missouri or an individual who has at least one (1) year of administrative experience in health care.

1. 3. Bylaws of the governing body shall

require that an individual who complies with paragraph (1)(A)2. of this rule shall be in charge in the absence of the administrator.

1. 4. The department shall be notified in

writing of any change in the designation of the administrator of the facility.

1. 5. Governing body bylaws shall

acknowledge that duly appointed ambulatory surgical center surveyors of the department shall be allowed to inspect the facility at any time the facility is in operation consistent with due regard for the medical condition and privacy of the on-site patients.

1. 6. Bylaws of the governing body shall

require that the medical staff, facility personnel and all auxiliary organizations shall be directly or indirectly responsible to the governing body through the administrator.

1. 7. The governing body, through the

administrator, shall establish criteria for the content of patients’ records and shall provide for timely completion of those records and disciplinary action for noncompliance.

1. 8. The governing body shall ensure that

the abortion facility abides by all applicable state and federal laws.

1. (B) An administrator shall organize the administrative functions of the facility and establish a system of authorization, record procedures and internal controls.

   1. 1. The administrator shall be responsi-

ble for establishing effective security measures to protect patients, employees and visitors.

1. 2. The reporting of suspected incidences

of child abuse shall be made to the Division of Family Services as established under section 210.115.1, RSMo 1986.

1. 3. The administrator shall be responsi-

ble for a written plan for evacuation of patients and personnel in the event of fire, explosion or other internal disaster. The plan shall be kept current and all personnel shall be knowledgeable of the plan.

1. 4. All fires, explosions or other physical

actions taken against the facility shall be reported to the department.

1. 5. The administrator shall be responsi-

ble for the development and enforcement of written policies which prohibit smoking throughout the abortion facility except specific designated areas where smoking may be permitted. Each such designated area shall have one hundred percent (100%) of the air supplied to the room exhausted.

1. 6. Written smoking control policies shall

be posted throughout the abortion facility.

1. 7. Smoking shall be prohibited in any

room or compartment where flammable liquids, combustible gases or oxygen are used or stored and in any other hazardous location. These areas shall be posted with NO SMOK- ING signs.

1. 8. The facility shall establish a program

for identifying and preventing infections and for maintaining a safe environment. Infectious and pathological wastes shall be segregated from other wastes at the point of generation and shall be placed in distinctive, clearly marked, leak-proof containers or plastic bags appropriate for the characteristics of the infectious wastes. Containers for infectious waste shall be identified with the universal biological hazard symbol. All packaging shall maintain its integrity during storage and transport.

1. 9. All reportable infectious or commu-

nicable diseases identified shall be reported to the Department of Health.

1. 10. The facility shall have policies and

procedures for the handling, processing, storing and transporting of clean and dirty laundry. The facility may provide laundry services at the facility or utilize contract services.

1. 11. The administrator shall develop

written personnel policies which contain at least the following:

1. A. Provisions for orientation of all

personnel to the policies and objectives of the facility and participation by all personnel in appropriate employee training;

1. B. Provision for periodic evaluation of

employees’ performance;

1. C. Provisions for written job descrip-

tions, including job qualifications; and

1. D. Provisions for licensed personnel

to have current Cardiopulmonary (CPR) training so that at least one (1) licensed and trained personnel is on-site at all times patients are present during and following surgery.

1. 12. The administrator shall be responsi-

ble for ensuring that the provisions of Chapter 188, Regulation of Abortions, RSMo 1986 are adhered to.

1. 13. A personnel record shall be main-

tained on each employee and shall include documentation of each employee’s orientation, health status, education and training, as well as verification of current licenses for physicians, registered nurses (RNs) and licensed practical nurses (LPNs).

1. (C) The medical staff shall develop and, with the approval of the governing body, shall adopt policies governing physician activities in the abortion facility.

   1. 1. Medical staff membership shall be

limited to physicians.

1. 2. Each physician requesting staff mem-

bership shall submit a written application to the administrator of the facility on a form approved by the governing body. Each application shall be accompanied by evidence of education, training, professional qualification, license and standards of performance.

1. 3. The governing body, acting upon rec-

ommendations of the medical staff, shall approve or disapprove appointments. Written criteria shall be developed for privileges extended to each member of the staff. A formal mechanism shall be established for recommending to the governing body delineation of privileges, curtailment, suspension or revocation of privileges and appointments and reappointments to the medical staff.

1. 4. Physicians performing abortions at

the facility shall have staff privileges at a hospital within fifteen (15) minutes’ travel time from the facility or the facility shall show proof there is a working arrangement between the facility and a hospital within fifteen (15) minutes’ travel time from the facility granting the admittance of patients for emergency treatment whenever necessary.

1. 5. Each facility shall arrange for at least

one (1) physician who is board-certified or board-eligible by the American Board of Obstetrics and Gynecology or the American Osteopathic Board of Obstetrics and Gynecology to be available either as a staff member or as a consultant for the purpose of providing consultation as needed and to advise staff members with respect to maintenance of a satisfactory quality of treatment.

1. (2) Records.

   1. (A) The facility shall maintain a daily patient roster of all patients receiving abortion services. This daily patient roster shall be retained for a period of two (2) years.
   2. (B) The facility shall maintain a medical record according to professional standards for each patient. Information required for the individual abortion report required by section 188.052, RSMo 1986 shall be readily retrievable from the medical record.
   3. (C) The medical record shall contain—a unique identifying record number, patient identifying information, name of physician, diagnosis, medical history and physical examination record, laboratory reports, tissue reports, anesthesia, allergies/drug reactions, physician’s orders, clinical notes, counseling notes, patient consent form, medication administration records and discharge summary. All pharmaceutical agents administered shall be timed, dated and signed by the person making the entry.
   4. (D) Medical records for adults shall be retained for seven (7) years from the time of discharge and medical records for minors shall be retained for seven (7) years from the time of discharge or two (2) years past the age the patient reaches majority, whichever is longer. All medical records shall be safeguarded against loss and unofficial use.
   5. (E) Medical records are the property of the abortion facility and shall not be removed from the facility except by court order, subpoena, for the purposes of microfilming or for off-site storage approved by the governing body. Information provided with tissue sent to a laboratory, information provided for statistical purposes and information provided for any other purpose shall contain the unique identifying number, not the patient’s name.

2. (3) Patient care services shall be under the direction of an RN. An RN shall be present in the clinical area whenever there is a patient in the procedure room or recovery room. An LPN or a surgical technician shall be present in the procedure room whenever there is a patient in the procedure room. The surgical technician shall be a certified surgical technologist or shall provide documentation of training in assisting abortion procedures.

   1. (A) An RN or an LPN shall be present in the recovery room when a patient is in the recovery room.
   2. (B) An abortion shall be performed only by a physician.
   3. (C) A medical history shall be obtained and a health assessment including a pelvic examination shall be performed. There must be confirmation of pregnancy by clinical evidence and laboratory tests. The findings shall be used in determining the duration of gestation, identifying preexisting medical or other complications, and detecting any factors which could influence the choice of the procedure, anesthesia or preoperative and postoperative management. If the physician determines gestation is beyond the first trimester, an ultrasound examination shall be performed and results shall be recorded in the patient’s chart.
   4. (D) A physician shall be on the premises and immediately available for any assistance to a patient in the recovery room.
   5. (E) A patient shall be fully reactive and her vital signs shall be stable before discharge from the facility.

   6. (F) Written instructions shall be issued to all patients in accordance with the practice of the physician in charge of the abortion facility and shall include the following:

      1. 1. Symptoms of noticeable complica-

tions;

1. 2. Activities to be avoided; and
2. 3. Abortion facility emergency tele-

phone numbers, available on a twenty-four (24)-hour basis, to be used by the patient should any complication occur or question arise.

1. (G) Professional and nonprofessional personnel providing patient care in the facility should be given the training and orientation period appropriate to the needs and level of preparation as required by the individual job description.

2. (H) A person who is trained to provide information on abortion procedures, alternatives, informed consent and family planning services shall be available to each patient to—

   1. 1. Assure written informed consent

establishing that the patient understands the particular risk associated with the abortion technique to be used;

1. 2. Prepare the patient for surgery in a

manner that facilitates her safety and comfort; and

1. 3. Assist the patient in reaching a deci-

sion about the method of birth control she will use, if any, after the procedure, respecting her choices.

1. (I) An emergency tray equipped to treat seizures, bleedings, anaphylactic shock, respiratory arrest and cardiac arrest shall be immediately available to the procedure room and recovery room.

2. (J) Each abortion facility shall develop a quality assurance program that includes all health and safety aspects of patient care and shall include a review of appropriateness of care. Results of the quality assurance program shall be reviewed at least quarterly by the administrator, director of patient care, a representative of the medical staff and the governing body. The quality assurance program shall include a review of at least the following:

   1. 1. Completeness of clinical records;
   2. 2. Incidence of morbidity and mortality;
   3. 3. Intraoperative and postoperative com-

plications;

1. 4. All cases transferred to a hospital;
2. 5. All cases that resulted in a length of

stay of more than twelve (12) hours;

1. 6. Errors in diagnosis;
2. 7. Problems in compliance with state

and local laws and regulations; and

1. 8. All cases in which the gestational age

was determined to be beyond eighteen (18) weeks.

1. (K) The quality assurance program must show evidence of action taken as a result of the identification of the problems.
2. (L) Emergency drugs, oxygen and intravenous fluids shall be available in the procedure room to stabilize the patient’s condition when necessary. A manual breathing bag, suction machine and endotracheal equipment shall be located in the clinical area for immediate access. 19 CSR 30-30

1. (4) Laboratory Services.

   1. (A) All fetal tissue shall be grossly examined at the time of the procedure by the attending physician. The results of the tissue examination shall be recorded in the patient’s chart.
   2. (B) In the absence of visible fetal parts or placenta, the tissue may be examined under a low-power microscope for the detection of villi. If this examination is inconclusive, the tissue shall be sent to a pathology laboratory for microscopic evaluation.
   3. (C) All tissue obtained from abortions, except tissue submitted to a pathologist for analysis, shall be submerged in a preservative solution and shall be transported in a leakproof container to a facility with a waste sterilizer or an incinerator approved by the Department of Natural Resources. If kept for more than twelve (12) hours, all tissue shall be refrigerated.
   4. (D) The following laboratory procedures shall be performed on every abortion patient: hematocrit; urinalysis, including pregnancy test; and Rh typing.
   5. (E) Anti-Rh immune globulin therapy shall be given to all Rh negative patients upon completion of the abortion procedure. If for any reason a patient refuses this therapy, this refusal shall be noted by the physician in the clinical record, and, if possible, documented by the patient’s signature on appropriate release forms in order to protect the physician and the facility.
2. (5) Complaints. Any persons having a complaint pertaining to the care of a patient rendered by an abortion facility shall direct the complaint in writing to the Missouri Department of Health, Bureau of Hospital Licensing and Certification, P.O. Box 570, Jefferson City, MO 65102. The person making the complaint shall be contacted by the Department of Health within five (5) working days of receipt of the complaint and the complaint shall be investigated by the Department of Health within twenty (20) working days of receipt of the complaint.

AUTHORITY: sections 197.200—197.240, RSMo 1986. Original rule filed July 15, 1987, effective Oct. 25, 1987. Amended: Filed June 14, 1988, effective Oct. 13, 1988.