19 CSR 30-30.060 - Standards for the Operation of Abortion Facilities
PURPOSE: This amendment updates the list of laws, regulations, and standards that governing bodies must ensure abortion facilities abide by or otherwise comply with.
(1) Governing Body , Administration, and
Medical Staff.
(A) The facility shall have a
governing body which may be an individual owner or owners, partnership,
corporate body, association, or public agency.
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 the policies are
administered in a manner to provide acceptable care in a safe environment and
in accordance with all legal requirements and standards of care.
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.
3. If there is any change in the designation
of the administrator , the governing body shall notify the department within ten
(10) calendar days of the change.
4. The governing body shall ensure that, in
the absence of the administrator from the facility, a person who meets the
qualifications of an administrator as defined in this regulation shall be
present at the facility and fulfill the administrator 's duties.
5. Bylaws of the governing body shall
acknowledge that department surveyors shall be allowed to inspect the facility
at any time the facility is in operation. Surveyors shall have due regard for
the medical condition and reasonable privacy of the on-site patients.
6. Bylaws of the governing body shall require
that the medical staff, facility personnel and all others providing services
relative to the facility shall be directly or indirectly responsible to the
governing body through the administrator .
7. The governing body , through the
administrator , shall establish criteria for the content of patient records and
shall provide for timely completion of those records and disciplinary action
for noncompliance.
8. The governing
body , through the administrator , shall ensure that the abortion facility abides
by all applicable state and federal laws and regulations. This shall include,
but not be limited to, compliance with Chapter 188, RSMo,
13 CSR
70-3.030(3), and:
A. Notifying pathology lab of failed abortion
within twenty-four (24) hours;
B.
Ensuring that the physician providing informed consent to the patient is the
physician who performs the procedure;
C. Ensuring that all medical records
associated with abortions accurately reflect the date and time the record was
created;
D. Ensuring that the
physician who performs the abortion performs a pelvic exam at least seventy-two
(72) hours before an abortion unless, in the physician 's clinical judgment,
such pelvic exam is not medically necessary and said physician documents the
reason for such determination;
E.
Ensuring that any physician , nurse, or other health care provider, or their
contracted agents, cooperate with any Department of Health and Senior Services
investigator upon written request of the investigator;
F. Ensuring that all employees participate in
an annual fire drill;
G. Ensuring
that policies are written in accordance with regulatory requirements;
H. Ensuring that endotracheal equipment is
maintained and that staff is aware of the location of the equipment;
I. Following all acceptable sterilization
standards for surgery instruments and equipment; and
J. Maintaining controlled substance logs in
accordance with published regulations.
9. Any violation of law or regulation shall
be immediately referred, in writing, with details of said violation or
violations, to the Medicaid Audit and Compliance Unit of the Department of
Social Services.
10. The governing
body , through the administrator , shall be responsible for developing,
implementing, and enforcing a policy to ensure protection of facility
employees, physicians, and volunteers from retaliation or adverse employer
actions by the facility for disclosing information regarding alleged infection
control concerns; alleged facility mismanagement or fraudulent activity; or
alleged violations of state of federal law or regulations regarding patient
care, patient safety, or facility safety.
(B) An administrator shall organize the
administrative functions of the facility.
1.
The administrator shall be responsible for establishing effective security
measures to protect patients, employees, and visitors.
2. The reporting of suspected incidences of
child abuse shall be made to the Department of Social Services as required by
section 210.115.1, RSMo.
3. The
administrator shall be responsible for developing a written plan for evacuation
of patients and personnel in the event of fire, explosion, active shooter, or
other disaster. The plan shall be kept current and all personnel shall be
knowledgeable of the plan. Disaster drills with participation of all staff
shall be conducted and documented at least annually.
4. The administrator shall be responsible for
reporting all fires, explosions, and disasters affecting the abortion facility
and physical actions taken against the facility to the department within
twenty-four (24) hours.
5. The
administrator shall be responsible for establishing, posting, and enforcing
written policies prohibiting smoking throughout the facility.
6. The administrator shall be responsible
for establishing, implementing, enforcing, and maintaining comprehensive
programs for identifying and preventing infections as further detailed in this
regulation and for maintaining a safe environment.
7. The administrator shall develop written personnel
policies which contain at least the following:
A. Provisions for orientation of all
personnel to the policies and objectives of the facility;
B. Provisions for participation by all
personnel in training and orientation periods appropriate to the needs and
level of preparation as required by the individual job description;
C. Provision for periodic evaluation of each
employee's performance;
D.
Provisions for written job descriptions, including job
qualifications;
E. Provisions for
licensed personnel to have current cardiopulmonary (CPR) training so that at
least one (1) licensed and trained personnel is at the facility at all times
when patients are present for abortions; and
F. Provisions for criminal background checks
and department Employee Disqualification List (EDL) checks for every person
within the facility who will have contact with patients within the facility,
including physicians, staff, and volunteers. These checks shall be completed
before allowing the person to have unsupervised contact with patients within
the facility. Provisions shall be made for periodic EDL checks
thereafter.
8. The
administrator shall be responsible for ensuring that a personnel record is
maintained regarding each employee and includes documentation of the employee's
job description, qualifications, orientation period, health status, criminal
background, EDL status, performance assessment, CPR training, if applicable,
education, and training. Each personnel record for a physician , Registered
Nurse (RN), or Licensed Practical Nurse (LPN) shall contain verification of
current licensure.
(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. Medical staff membership shall be limited
to physicians.
2. Each physician
requesting staff membership 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 qualifications, licensure, and standards of performance.
3. The governing body , acting upon
recommendations of the medical staff, shall approve or disapprove appointments
to the medical staff. There shall be written criteria for determining
privileges of medical staff. Medical staff shall use a formal method for making
recommendations to the governing body regarding delineation of privileges;
curtailment, suspension , or revocation of privileges; and appointments and
reappointments to the medical staff.
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.
5. Each abortion facility shall arrange for
at least one (1) OB/GYN to be available either as a staff member or as a
consultant for the purpose of providing consultation as needed and advising
staff members regarding maintenance of a satisfactory quality of patient
treatment.
(2)
Direct patient care services.
(A) An abortion
shall be performed or induced only by a physician .
(B) Each patient shall be given all the
information required by sections
188.027 and
188.039, RSMo, in the formats
and time-frames required, by the type of professional required.
(C) The physician who is to perform or induce
the abortion shall provide the information required in section 188.027.6, RSMo,
orally and in person to the patient at least seventy-two (72) hours before the
abortion.
(D) A written medical
history shall be obtained for each patient. At least seventy-two (72) hours
before the abortion, a health assessment and a pelvic examination shall be
performed by the physician who is to perform or induce the abortion, unless in
the clinical judgment of that physician such pelvic examination is not
medically indicated at such time for that individual patient, in which case
such pelvic examination shall be completed on the day of the abortion by the
physician performing or inducing the abortion. The basis for the determination
to delay the pelvic examination shall be documented in detail in the patient's
medical record. Pregnancy shall be confirmed by clinical evidence and
laboratory tests. This information 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 medical
record.
(E) Ultrasounds at an
abortion facility to confirm gestational age and for other imaging purposes
such as ultrasounds per section
188.027(4),
RSMo, shall be performed by a physician or a
person who holds a current certification by the American Registry for
Diagnostic Medical Sonography (ARDMS) with advanced training in
obstetric/gynecological imaging, or other certified training deemed acceptable
by the department .
(F) Nursing
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 RN, 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 surgical technologist or shall provide documentation of adequate
training in assisting surgical procedures, including surgical
abortions.
(G) At facilities
performing surgical procedures, an RN or an LPN shall be present in the
recovery room when a patient is in the recovery room.
(H) At facilities performing surgical
procedures, a physician shall be on the premises and immediately available for
any assistance to a patient in the recovery room following a surgical
procedure.
(I) No patient shall be
discharged from the facility until she is fully reactive and her vital signs
are stable.
(J) Written
instructions shall be issued to all patients and shall include at least the
following:
1. Symptoms of
complications;
2. Activities to be
avoided; and
3. Abortion facility
phone numbers. Numbers provided shall include the number for the OB/GYN or
OB/GYN group providing complication care under a complication plan as required
by section 188.021, RSMo, and
19 CSR
30-30.061.
(K) The facility shall ensure that each
patient is prepared for the abortion in a manner that facilitates her safety
and comfort.
(L) The facility shall
assist each patient in deciding what method of birth control she will use, if
any, after the procedure, respecting her choices.
(M) Facilities performing surgical procedures
shall have an emergency tray equipped to treat seizures, bleedings,
anaphylactic shock, respiratory arrest, and cardiac arrest immediately
available to the procedure room and recovery room of the facility.
(N) Facilities performing surgical procedures
shall have emergency drugs, oxygen, and intravenous fluids 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.
(3) Records and reports.
(A) The facility shall maintain a daily
roster of all patients receiving abortion services. The facility shall retain
the roster for seven (7) years.
(B)
The facility shall maintain a medical record according to professional
standards for each patient.
(C) All
medical record entries shall be timed, dated, and signed or authenticated by
the person making the entry.
(D)
The medical record shall contain-
1.
Documentation with a unique identifying record number; patient identifying
information; name of physician ; diagnosis; medical history and physical
examination record; laboratory reports; anesthesia administered; allergies/drug
reactions; physician 's orders; clinical notes; counseling notes; patient
consent form; medication administration records; and discharge
summary;
2. Documentation
establishing that the patient was given all the information required by
sections 188.027 and
188.039, RSMo, in the formats
and timeframes required, by the type of professional required. If any of the
informed consent requirements are performed by a referring physician or
qualified professional (where authorized by sections
188.027 or
188.039, RSMo) before the
patient presented at the abortion facility, the facility shall obtain
documentation from the referring physician or qualified professional
establishing such performance in compliance with the law, and shall place the
documentation in the patient's medical record;
3. Method used to determine gestational age;
gestational age; informed consent checklist required by section 188.027.3,
RSMo; copy of abortion report required by section
188.052, RSMo, and
19 CSR
10-15.010; for surgical abortions, copy of tissue
report required by section
188.047, RSMo, and
19 CSR
10-15.030; where applicable, copy of complication
report required by section
188.052, RSMo, and
19 CSR
10-15.020; and
4. For any patient transferred from the
facility due to an emergency or complication, the medical record shall include
a report detailing the reason for the transfer. The abortion facility shall
attempt to obtain the treatment record of the receiving facility and shall
place it in the patient's medical record.
(E) The facility shall retain medical records for
adults for seven (7) years from the time of discharge. For minors, the facility
shall retain medical records for seven (7) years from the time of discharge or
two (2) years past the age the patient reaches majority, whichever is
longer.
(F) The facility shall
safeguard medical records against loss and unofficial use.
(G) The facility shall ensure that an
individual abortion report for each abortion performed or induced via the
facility is submitted to the department within forty-five (45) days of the
abortion as required by section
188.052, RSMo, and
19 CSR
10-15.010.
(H) The facility shall ensure that an
individual complication report for any complication care provided via the
facility is submitted to the department within forty-five (45) days of the care
as required by section
188.052, RSMo, and
19 CSR
10-15.020.
(4) Infection Control Program. The facility
shall establish a comprehensive program for identifying and preventing
infections. The infection control program shall be appropriate for scope and
type of abortion procedures performed at the facility.
(A) Infection control standards of the
facility must be identified in writing, in compliance with generally-agreed
upon national standards such as those of the Centers for Disease Control and
Prevention (CDC), Association for Professionals in Infection Control and
Epidemiology (APIC), Association of peri-Operative Registered Nurses (AORN), or
other standards determined acceptable by the department .
(B) The facility shall have in place
procedures for monitoring and enforcing compliance with infection control
standards in accordance with section
197.150, RSMo.
(C) The facility shall report healthcare
associated infection rates to the department in accordance with section
192.667, RSMo, and
19 CSR
10-33.050.
(D) In accordance with section
192.667, RSMo, the facility
shall, in consultation with medical staff, establish an antimicrobial
stewardship program for evaluating the judicious use of antimicrobials,
especially antibiotics that are the last line of defense against resistant
infections.
(E) Infectious and
pathological wastes at the facility 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.
(F) If kept on-site for more than twelve (12)
hours, tissue removed during an abortion shall be refrigerated.
(G) The facility shall ensure that all
reportable diseases, disabilities, conditions, and findings regarding facility
patients are reported in accordance with
19 CSR
20-20.020.
(H) Upon request, the facility shall provide
the department access to data and information related to infection control
practices, rates, or treatments of infections as required by section
197.160, RSMo.
(I) 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
contract for these services.
(5) Pathology, Laboratory, and Pharmaceutical
Services.
(A) All fetal tissue from surgical
abortions shall be grossly examined at the time of the procedure by the
physician . The results of the tissue examination shall be recorded in the
patient's medical record.
(B)
Facilities performing surgical abortions shall ensure that all requirements of
section 188.047, RSMo, and
19 CSR
10-15.030 are met, including timely submission of
tissue reports to the department . If the facility does not perform pathology
services internally, the facility shall have a written agreement with a
pathology laboratory that shall clearly delineate the laboratory's duties under
section 188.047, RSMo, and
19 CSR
10-15.030 regarding tissue reports. The facility shall
perform periodic checks to ensure that the laboratory is in compliance with the
agreement.
(C) The following
laboratory procedures shall be performed on every abortion patient: hemoglobin;
urinalysis, including pregnancy test; and Rh typing.
(D) 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 patient's record, and, if possible, documented by the
patient's signature on appropriate forms.
(E) The use of drugs in the facility shall be
under the direction of a designated individual in accordance with accepted
standards of practice and applicable state and federal laws. Drugs must be
prepared and administered according to established policies and acceptable
standards of practice. The facility shall have procedures regarding
procurement, storage, security, records, labeling, preparation, orders,
administration, adverse reactions, and disposal or other disposition of
drugs.
(F) The facility shall
follow all applicable laws and regulations pertaining to controlled
substances.
(6) Medical
emergencies.
(A) The facility shall develop,
implement, and enforce a written protocol for managing medical emergencies
including the transfer of any patient requiring further emergency care to a
hospital within a reasonable distance from the abortion facility.
(B) The facility shall develop, implement,
and enforce a written policy to ensure its compliance with section
574.200, RSMo, regarding the
offense of interference with medical assistance.
(7) Complaints.
(A)
The facility shall develop, implement, and enforce a policy that provides
patients with an efficient means of communicating complaints regarding care
provided via the facility.
(B) The
facility shall document details of each complaint and the facility's response
to each complaint. This documentation shall be available to the department for
review upon request.
(C) Anyone
with a complaint pertaining to patient care via an abortion facility may send
the complaint in writing to the Missouri Department of Health and Senior
Services, Bureau of Ambulatory Care, PO Box 570, Jefferson City, MO 65102. The
complainant shall provide his or her contact information with the complaint.
The department shall contact the complainant within five (5) working days of
receipt of the complaint and shall investigate the complaint within twenty (20)
working days of receipt of the complaint.
(8) Quality Assessment and Performance
Improvement Program.
(A) Each abortion
facility shall develop a quality assessment and performance improvement (QAPI)
program that includes all health and safety aspects of patient care and shall
include a review of appropriateness of care. Results of the QAPI program shall
be reviewed at least quarterly by the administrator , director of patient care,
a representative of the medical staff, and the governing body .
(B) The facility QAPI program shall include a
documented review of at least the following criteria:
1. Completeness of clinical
records;
2. Incidence of morbidity
and mortality;
3. Complications,
including number and percentage of patients affected by the most common types
of complications for both surgical and drug- or chemically-induced abortions,
as applicable;
4. Specific review
of any significant or unusual complications;
5. All cases transferred to a hospital,
including a review of assessment and patient risk factors that may have existed
before the procedure;
6. All cases
that resulted in a length of stay within the facility of more than eight (8)
hours;
7. Errors in
diagnosis;
8. Problems in
compliance with laws and regulations, including violations cited by the
department and reports required by Chapter 188, RSMo;
9. All cases in which the gestational age was
determined to be beyond eighteen (18) weeks;
10. For drug- or chemically-induced
abortions, the number and percentage of patients who failed to return to the
facility for follow-up to confirm the completion of the abortion, and common
reasons why the patients failed to return (unless termination of pregnancy was
otherwise confirmed); and
11.
Periodic evaluation and review of all contracted services, including, but not
limited to, pathology services.
(C) The QAPI program shall show evidence of
action the facility took regarding problems identified and shall identify
opportunities for improvement.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.