Missouri Code of State Regulations
Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES
Division 30 - Division of Regulation and Licensure
Chapter 30 - Ambulatory Surgical Centers and Abortion Facilities
Section 19 CSR 30-30.061 - Complication Plans for Certain Drug- and Chemically-Induced Abortions Via Abortion Facilities
Universal Citation: 19 MO Code of State Regs 30-30.061
Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: This rule establishes the standards governing complication plans required by section 188.021, RSMo, for abortions induced by physicians via abortion facilities. This rule also explains the process for submitting such complication plans to the Department of Health and Senior Services for approval.
(1) For purposes of this rule, the following terms mean:
(A) Abortion-The act of using or
prescribing any instrument, device, drug, or any other means or substance
resulting in the intentional destruction of an embryo or fetus in a woman's
uterus or the intentional termination of a pregnancy of a woman with intent
other than to increase the probability of a live birth or to remove a dead or
dying embryo or fetus;
(B) Abortion
facility-Any clinic, physician's office, or any other place or facility in
which abortions are performed or induced other than a hospital;
(C) Complication-Includes, but is not limited
to, incomplete abortion, excessive hemorrhage, endometritis, parametritis,
pyrexia, pelvic abscess, uterine perforation, failed abortion, retained
products, cervical lacerations, or psychiatric issues;
(D) Department-The Missouri Department of
Health and Senior Services;
(E)
Drug-A drug or chemical used to induce an abortion for which the federal Food
and Drug Administration (FDA) label includes any clinical study in which more
than one percent (1%) of those administered the drug required surgical
intervention after its administration;
(F) OB/GYN-
1. A physician who is board-certified or
board-eligible by the American Osteopathic Board of Obstetrics and Gynecology,
or who is in a residency approved by that board; or
2. A physician who is board-certified by the
American Board of Obstetrics and Gynecology (ABOG); or who is an ABOG
Registered Residency Graduate or an ABOG Active Candidate; or who is in an
ABOG-approved residency;
(G) Physician-A person licensed to practice
medicine pursuant to Chapter 334, RSMo.
(2) Complication plans for certain drug- and chemically-induced abortions.
(A) A physician
shall not prescribe or administer a drug without first obtaining written
approval from the department of a complication plan applicable to the
physician's prescription or administration of the drug.
(B) Each abortion facility shall ensure that
no drug is prescribed or administered via its facility until the facility has
received written approval from the department of the complication plan of the
physician who will prescribe or administer the drug.
(C) To ensure the safety of all patients, a
primary objective of complication plans shall be to recognize the importance of
the physician-patient relationship by providing for continuity of care and
ensuring communication among the physician who induced the abortion and all
subsequent health care providers involved in treating the patient's
complication.
(D) Every
complication plan shall provide that an OB/GYN is on-call and available
twenty-four hours a day, seven days a week (24/7) to treat complications
related to drugs prescribed or administered via the facility. To ensure this
required twenty-four hours a day, seven days a week (24/7) coverage, the
complication plan for each physician who will prescribe or administer drugs
shall include a written agreement between the physician and an OB/GYN or group
of OB/GYNs to treat complications, or in the alternative, a written agreement
between the abortion facility and an OB/GYN or group of OB/GYNs to treat
complications.
(E) If the physician
who will prescribe or administer drugs is an OB/GYN, that physician's
complication plan may provide that the physician treats complications, but the
physician and/or the abortion facility must have a written agreement with an
OB/GYN or group of OB/GYNs to ensure the required twenty-four hours a day,
seven days a week (24/7) coverage when the physician is unavailable to treat
complications.
(F) An OB/GYN who is
a staff member or consultant to the abortion facility as required in
19
CSR 30-30.060 may have a written agreement to treat
complications under a complication plan.
(G) Every complication plan shall provide
that the OB/GYN with whom there is a written agreement or member of the group
of OB/GYNs with which there is a written agreement, or the physician who
prescribes or administers drugs if he or she is an OB/GYN, shall:
1. Personally treat all complications,
including those requiring surgical intervention, except in any case where doing
so would not be in accordance with the standard of care, or in any case where
it would be in the patient's best interest for a different physician to treat
her; and
2. Assess each patient
suffering a complication individually, and shall not, as a matter of course,
refer all patients to the emergency room or other facilities or physicians
unless the patient is experiencing an immediately life-threatening
complication.
3. This regulation
does not prohibit screening or triage of patients by a nurse or physician to
determine whether or when it is necessary to contact the OB/GYN.
(H) Every complication plan shall
provide that, in any case where it would not be in accordance with the standard
of care or would not be in the patient's best interest for the OB/GYN to
personally treat the complication (e.g., surgery in a hospital is required, and
it is not in the patient's best interest to travel to a hospital where the
OB/GYN has privileges), the OB/GYN shall arrange for hand-off of the patient to
an appropriately-qualified physician and shall fully brief such physician
regarding the patient at the time of hand-off.
(I) Every complication plan shall require
that the OB/GYN treat- ing a patient's complication shall prepare a
complication report as required by section
188.052,
RSMo and ensure that it is submitted to the department.
(J) The abortion facility shall ensure that
before discharge, every patient who receives a drug via the facility also
receives the phone number, in writing, for the OB/GYN or OB/GYN group providing
complication cove rage. The phone number given may be for the on- call service
rather than the OB/GYN's direct number.
(K) The physician or abortion facility shall
submit complication plans to the department for approval in writing using the
complication plan submission form provided by the department. The form shall
require at least the following information:
1. The full name of each physician whose
prescription or administration of drugs via the facility will be covered by the
plan;
2. The full name of the
OB/GYN who will provide complication coverage, or if a group of OB/GYNs will
provide coverage, the full legal name of the group and the full name of each
OB/GYN who is part of the group; and
3. A description of how the complication plan
meets each requirement in this regulation, including treating complications
requiring surgical intervention.
(L) With the completed complication plan
forms, the facility shall also submit:
1.
Documents establishing that each OB/GYN who will provide complication coverage
under the plan is board-eligible or board-certified by the American Board of
Obstetrics and Gynecology or the American Osteopathic Board of Obstetrics and
Gynecology; and
2. A copy of the
executed written agreement between the physician(s) whose prescription or
administration of drugs via the facility will be covered by the plan (and/or
the abortion facility) and the OB/GYN or group of OB/GYNs that will provide the
complication coverage. The written agreement shall cite this regulation and
specify that complication coverage under the written agreement shall be
provided in compliance with this regulation.
(M) If any change occurs that prevents full
compliance with a complication plan as approved by the department, the facility
shall immediately notify the department in writing, providing details regarding
the change. If the change results in the facility being unable to provide
twenty-four hours a day, seven days a week (24/7) OB/GYN coverage for
complications as required by this regulation, the facility shall ensure that no
drugs are prescribed or administered via the facility until 1) full compliance
with the plan is achieved and the facility has so notified the department in
writing, or 2) a new or revised complication plan has been submitted to and
approved by the department in writing.
(N) The facility shall ensure that each
complication plan approved by the department and currently in use is on file at
the facility. The facility shall maintain copies of complication plans no
longer in use for seven (7) years following the last use. The facility shall
make current and past complication plans available to patients or the
department for review upon request.
Disclaimer: These regulations may not be the most recent version. Missouri may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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