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 30-30.090 - Organization and Management Standards for Birthing Centers
Universal Citation: 19 MO Code of State Regs 30-30.090
Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule establishes standards for the operation of birthing centers in order to provide care in a safe environment.
(1) The center shall have a governing body which may be individual owner(s), partnership, corporate body, association or public agency.
(A) The governing body shall have full legal
responsibility for determining, implementing and monitoring policies governing
the center's total operation and for ensuring that the policies are
administered in a manner to provide acceptable care in a safe
environment.
(B) The governing body
shall select and employ one (1) of the following as an administrator: a
physician licensed in Missouri, a certified nurse-midwife (CNM), a registered
nurse licensed in Missouri or an individual with a bachelor's degree in a
related field and at least one (1) year of administrative experience in health
care.
(C) The governing body shall
require that an individual who complies with subsection (1)(B) of this rule
shall be in charge when the administrator is unavailable in person or by
telecommunications.
(D) Governing
body bylaws shall acknowledge that duly appointed representatives of the
department shall be allowed to inspect the center operation at any time, with
consideration for client privacy and confidentiality.
(E) Bylaws of the governing body shall
require that the clinical staff, center personnel and all auxiliary
organizations directly or indirectly be responsible to the governing body
through the administrator.
(F) The
governing body, through the administrator, shall establish criteria for the
content of patients' records, provision for their timely completion and
disciplinary action on occasion of noncompliance.
(G) The governing body shall ensure that the
birthing center abides by all applicable state and local laws.
(2) The administrator shall organize the administrative functions of the center and establish a system of authorization, record procedures and internal controls.
(A) The administrator shall be responsible
for establishing effective security measures to protect patients, employees and
visitors.
(B) The administrator is
responsible for assuring that all patients admitted to the center are under the
care of a physician or CNM practicing pursuant to a collaborate agreement with
a physician who is a member of the clinical staff.
(C) A certificate of live birth shall be
filed in accordance with section
193.085,
RSMo.
(D) The administrator shall
develop procedures and have a written agreement with a licensed ambulance
service for emergency transportation. If a written agreement with the ambulance
service cannot be achieved due to reasons that are neither regulatory or
statutory, the administrator can request a waiver or mediation from the
department.
(E) The administrator
shall have procedures and a written transfer agreement with a hospital
providing emergency, obstetrical and newborn services. If a written agreement
with a licensed hospital cannot be achieved due to reasons that are neither
regulatory or statutory, the administrator can request a waiver or mediation
from the department. Peer review report may be submitted as evidence for
mediation.
(F) The administrator
shall be responsible for a written plan for evacuation of patients and
personnel in the event of fire, explosion or natural disaster. The plan shall
be kept current and all personnel shall be knowledgeable of the plan.
(G) The administrator shall be responsible
for developing, enforcing and posting written policies which prohibit smoking
throughout the birthing center.
(H)
Smoking or open flames 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 SMOKING OR OPEN
FLAME signs.
(I) The administrator
shall establish a program for identifying and preventing infections and for
maintaining a safe environment. The center shall be responsible for identifying
infections up to thirty (30) days postpartum in the mother and the infant
unless and until they are transferred to another healthcare provider prior to
thirty (30) days. 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. Infectious waste shall be
disposed of in accordance with provisions of
10 CSR
80-7.010.
(J) The administrator shall establish
policies and procedures for the handling, processing, storing and transporting
of clean and dirty laundry. The facility may provide laundry services on-site
or utilize contract services.
(K)
The administrator shall develop written personnel policies which contain at
least the following:
1. Provision for
orientation of all personnel to the policies and objectives of the center and
participation by all personnel in appropriate employee training;
2. Provision for periodic evaluation of
employees' performance including clinical skills, resuscitation and use of
equipment; and
3. Provision for
written job descriptions, including job qualifications system for the
completion and storage of medical records.
(L) A personnel record shall be maintained on
each employee and shall include documentation of each employee's orientation,
education, training and health information, as well as verification of current
licenses for physicians, registered nurses and licensed practical nurses and
documentation of certification for nurse-midwives.
(3) Clinical practice guidelines for the management of routine and emergency care of the mother and her fetus/newborn in pregnancy, birth and postpartum until discharge from care by the center, whether through completion of the program or referral or transfer to other levels of care, shall be drafted by a physician or certified nurse midwife who has clinical staff membership at the birthing center. The guidelines shall be available on-site at all times. Documentation of periodic review and revision are required.
(A) Clinical staff membership
shall include physicians or CNMs, or both, but, as defined by the birth center
bylaws, may also include other health professionals to provide service at the
birth center. A physician or CNM practicing pursuant to a collaborative
practice agreement with a physician shall be in attendance and responsible for
intrapartum management.
(B) On a
form approved by the governing body, each health professional requesting
clinical staff membership shall submit a written application to the
administrator of the center. Each application shall be accompanied by evidence
of education, training, professional qualification, health status certification
and licensure.
(C) A written
procedure shall be established for recommending to the governing body
delineation of privileges; curtailment, suspension or revocation of privileges;
and appointments and reappointments to the clinical staff. The governing body,
acting upon recommendations of the clinical staff, shall approve or disapprove
appointments. Written criteria shall be developed for privileges extended to
each member of the clinical staff. (D) Each birth center shall have at least
one (1) physician who is responsible for the following:
1. Sign collaborative practice agreement and
meet any other requirements of Missouri law for collaborative
practice;
2. Review and sign
clinical practice guidelines and risk assessment criteria at least annually;
and
3. Be available in person or by
telecommunication for consultation.
(4) The center shall maintain a system for the completion and storage of medical records.
(A) The daily patient roster shall be
retained for two (2) years.
(B) The
medical record shall contain
1. A unique
identifying medical record number;
2. Client identifying information;
3. Allergies;
4. Consent;
5. Maternal history;
6. Maternal and newborn physical
examinations;
7. Laboratory test
results;
8. Initial risk assessment
and periodic updates;
9. Interval
prenatal evaluations;
10. Problem
identification, plan, and follow-up;
11. Labor and birth records, including
apgars;
12. Newborn and postpartum
recovery records;
13. Medication
record, including any drug, and the dose, time, date and person
administering;
14. Discharge plan;
and
15. Postpartum and infant
follow-up visits up to thirty (30) days after the birth or documentation of
transfer to another health care provider.
(C) All medical records shall be safeguarded
against loss and unofficial use. Medical records for adults and newborns shall
be retained as required by the statute of limitations under section
516.105,
RSMo.
(D) Medical records are the
property of the birthing center and shall not be removed from the center except
by court order, subpoena, for microfilming or for off-site storage approved by
the governing body. Information provided for statistical purposes shall contain
the unique identifying number, not the patient's name.
(5) Patient care services shall be under the direction of a physician or a CNM practicing pursuant to a collaborative practice arrangement with a physician.
(A)
Women registering for care at the birthing center and their families shall be
informed and shall provide written acknowledgment that they have been informed
of the benefits and risks of the services available at the center. They shall
be made aware of the risk criteria used for admission and referral.
(B) Birth center clients are limited to those
women who are initially determined to be at low maternity risk and who are
evaluated regularly throughout pregnancy to assure that they remain at low risk
for a pregnancy outcome.
1. Each birth center
shall establish a written risk assessment system which shall be a part of the
clinical practice guidelines. The individual risk assessment shall be included
in the client's medical record.
2.
The general health status and risk assessment shall be determined by a
physician, CNM or other advanced practice nurse after obtaining a detailed
medical history, performing a physical examination and taking into account
family circumstances and other social and psychological factors. The client
shall be transferred to a hospital if complications occur requiring medical or
surgical intervention under the center's written risk criteria.
(C) The center shall provide at
least one (1) CNM or physician for each three (3) women in active labor. In
addition a qualified staff member shall be available for each client during the
entire time the client is in the birth center. All clinical staff shall provide
services during labor and delivery in accordance with the policies developed by
clinical staff and approved by the governing body.
(D) Qualified personnel and clinical staff of
the birth center shall be trained in infant and adult resuscitation and
recertified according to standards set by the American Heart Association and
the American Pediatric Association.
(E) A primary care giver shall remain on the
premises and be immediately available for assistance to the patient during
labor, delivery and immediate postpartum stages.
(F) A primary care giver shall be responsible
for ensuring and documenting prenatal care, health history, physical
examination, and appropriate laboratory studies which shall be placed in the
medical record at time of admission in preparation for delivery.
(G) A patient shall meet discharge criteria
as defined in the clinical practice guidelines prior to discharge from the
facility.
(H) Labor shall not be
inhibited, stimulated or augmented with chemical agents during the first or
second stage of labor.
(I) General
and induction anesthesia shall not be administered. Local and pudendal
anesthesia may be administered by a physician or CNM practicing pursuant to a
collaborative practice arrangement with a physician if use of the drugs
conforms with Missouri law and written clinical practice guidelines of the
birth center.
(J) A program for
prompt follow-up care and postpartum evaluation after discharge shall be
developed and implemented. The follow-up shall include assessment of infant
health including physical examination, laboratory screening tests at
appropriate times, maternal postpartum status, instruction in child care
including immunizations, referral to sources of pediatric care, provision of
family planning services, and assessment of mother-child relationship including
breast feeding.
(K) The center
shall be responsible for detection of Rh incompatibility and administration of
RhoGAM as appropriate.
(L) At a
minimum, there shall be provision for nutritious liquids and snacks in
accordance with
19 CSR
20-1.010.
(M) Prophylactic eye treatment as required in
section
210.070,
RSMo shall be provided.
(N) Drugs
shall be stored and handled under proper security and environmental conditions
and shall be accessible only to authorized persons. Drugs shall be administered
and disposed only by licensed practitioners in accordance with applicable state
laws and rules. The use of IV's shall be restricted to hydration only or to the
establishment of a central line prior to transport to emergency facilities. No
IV drugs such as pitocin shall be used for inducement or augmentation of
labor.
(O) An emergency drug kit
shall be available which includes oxygen, a Deelee suctioning trap or other
appropriate equipment for emergency suctioning.
(P) An adequate supply of sterile items shall
be available.
(6) The birthing center shall provide a quality assurance program that includes all health and safety aspects of patient care for both mother and newborn and shall include a review of appropriateness of care. Results of the quality assurance program shall be reviewed at least quarterly by the governing body.
(A) The quality assurance program shall
include, but not be limited to, the following:
1. A review of the medical record;
2. A determination that every mother-infant
pair have an identified source of primary care and have available methods by
which to contact that individual after discharge;
3. Incidences of morbidity and mortality of
mother and infant;
4. Postpartum
infections;
5. A review of all
cases transferred to a hospital for delivery, care of the infant or postpartum
care of the mother;
6. A review of
all cases that resulted in a length of stay of more than twelve (12) hours
beyond the birth of the baby;
7.
Incidents, problems, and potential problems identified by the staff of the
birthing center; and
8. Problems
with compliance with state laws and rules.
(B) The quality assurance program shall show
evidence of action taken as a result of the identification of a problem,
including documented outcome and evaluation.
(7) A birthing center shall provide for essential laboratory services, including, but not limited to, hemoglobin or hematocrit, urinalysis, microscopic analysis and culture, blood type and Rh, syphilis, hepatitis B, rubella, pap smears and pregnancy tests.
(A) Laboratory services may be provided
on-site or through a certified laboratory in accordance with federal
regulations.
(B) When services are
provided by arrangement with an outside provider, the original copy of the
signed and dated report shall become part of the mother's permanent record at
the birthing center.
(C) Results of
tests completed at the birthing center shall be entered, dated and signed in
the mother's or child's record by the individual who performed the test.
Abnormal test results shall be followed up by the primary provider in
accordance with birth center risk criteria and clinical practice
guidelines.
*Original authority 1975, amended 1986.
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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