In addition to other requirements specified in these rules, all licensed birth centers or advanced birth centers shall have at least the following:

1. (1) A governing body organized under and have written bylaws, rules and regulations, which it reviews at least every two years, denotes dates to indicate time of last review, and revises as necessary and enforces. The governing body bylaws shall state the role and purpose of the birth center or advanced birth center, including an organizational chart defining the lines of authority.
2. (2) An administrator or other similarly titled official to whom the governing body delegates the full-time authority for the operation of the center in accordance with the established policy of the governing body;
3. (3) An organized clinical staff to which the governing body delegates responsibility for maintaining proper standards of medical and other health care.

4. (4) Birth centers. The clinical staff of the birth center shall be responsible for maintaining quality of care provided to the clients.

   1. (a) At least one clinical staff member must be available for every two clients in labor in a birth center.
   2. (b) A clinical staff member or qualified personnel must be available on-site during the entire time the client is in the birth center. Services during labor and delivery shall be provided by physicians or by certified nurse midwives or licensed midwives, assisted by at least one other staff member, under protocols developed by the clinical staff and approved by the governing body in accordance with accepted standards of care.
   3. (c) All qualified personnel and clinical staff of the birth center shall be trained in infant and adult resuscitation. Clinical staff or qualified personnel who have demonstrated ability to perform neonatal resuscitation procedures shall be present during each birth.
   4. (d) Clinical records describing the history, conditions, treatment and progress of the client shall be maintained in sufficient completeness and accuracy to assure transferable comprehension of the case at any time.
   5. (e) Clinical record reviews must evaluate the quality of clinical care on the basis of documented evidence.
   6. (f) The administrator or delegated clinical staff must review admissions with respect to eligibility, course of pregnancy and outcome, evaluation of services, condition of mother and newborn on discharge, or transfer to other providers.
   7. (g) The administrator or delegated clinical staff must review infection risk and cases and the promotion of a preventive and corrective program designed to minimize these hazards.
5. (5) Services of a consultant physician are required in those birth centers which do not have a physician on the clinical staff who is certified or eligible for certification by the American Board of Obstetrics and Gynecology, the American Board of Osteopathic Obstetricians and Gynecologists or has hospital obstetrical privileges.
6. (6) The responsibilities and functions of the consultant physician shall be specifically described in the policy and procedure manual and the client care protocols.
7. (7) The governing body shall maintain in writing a consultation agreement, signed within the current license year, with each consultant who agrees to provide advice and services to the birth center as requested.

8. (8) The birth center or advanced birth center shall have a defined client record system, policies and procedures which provide for identification, security, confidentiality, control, retrieval, and preservation of client care data and information. A current and complete clinical record for each client accepted for care in the birth center or advanced birth center shall include the following data:

   1. (a) Identifying information including client’s name, address and telephone number;
   2. (b) Initial history and physical examination including laboratory findings and dates;
   3. (c) Obstetrical risk assessments and pre-term labor risk assessments including the dates of the assessments;
   4. (d) The dates and topics of the educational sessions attended;
   5. (e) The date and time of the onset of labor;
   6. (f) The course of labor including all pertinent examinations and findings;
   7. (g) The exact date and time of birth, the presenting part, the sex of the newborn, the numerical order of birth in the event of more than one newborn, to include filing of the birth certificate, and the Apgar score at one minute and five minutes;
   8. (h) Time of expulsion and condition of placenta;
   9. (i) All treatments rendered to the mother and newborn including prescribing prescriptions, the time, type, and dose of eye prophylaxis;
   10. (j) Copy of the metabolic screening report;
   11. (k) Condition of the mother and newborn including any complications and action taken;
   12. (l) All medical consultations relevant to the client specifically;
   13. (m) Referrals for medical care and transfers to hospitals including that information germane to the circumstances;
   14. (n) Examinations of the newborn and postpartum mother; and,

   15. (o) Information and instructions given to the client regarding postpartum care as outlined in Rule 59A-11.016, F.A.C.

       1. All entries shall be dated and signed by the attending clinical staff members.

       2. The clinical record is confidential and shall not be released without the written consent of the client except under the following conditions:

       a. When the client is transferred to another source of care; and,

       b. For audit by the agency during licensure inspection or complaint investigation.

       3. The clinical records shall be kept on file for a minimum of seven years from the date of last entry.

       4. The clinical record shall be immediately available at the time of the client’s admission to the birth center in labor and to the practitioner or hospital when the client is transferred.

9. (9) A policy requiring that all clients be accepted on the authority of and under the care of a member of the organized clinical staff;

10. (10) A procedure for providing care and transfer in an emergency;

    1. (a) The birth center or advanced birth center shall have a written protocol which shall include:

       1. The name, address, telephone numbers and contact persons of the licensed ambulance service, the hospital licensed to provide emergency obstetrical and neonatal services, and other hospitals in the vicinity;

       2. The conditions specified in the arrangements between the birth center or advanced birth center and the ambulance service and the hospital, including financial responsibility for services rendered; and,

       3. Criteria to determine risk status which require medical consultation or transfer to a hospital of the newborn or the mother for any conditions such as:

       a. Premature labor, meaning labor occurring at less than 37 weeks gestation;

       b. Estimated fetal weight less than 2,500 grams or greater than 4,000 grams;

       c. Hypertension;

       d. Pre-eclampsia;

       e. Failure to progress in labor;

       f. Evidence of an infectious process;

       g. Premature rupture of the membranes, meaning rupture occurring more than 12 hours before onset of active labor;

       h. Suspected placenta praevia or abruptio;

       i. Non-vertex presentation;

       j. Hemorrhage of greater than 500 cc of blood;

       k. Anemia consisting of less than 10 grams of hemoglobin per 100 milliliters of blood or 30 percent hematocrit;

       1. Persistent fetal tachycardia (heart rate more than 160 beats per minute), repetitive fetal bradycardia (heart beat less than 120 beats per minute) or undiagnosed abnormalities of the fetal heart tones; and,

       m. Persistent hypothermia in the newborn.

       4. Criteria to determine risk status which require immediate emergency transfer to a hospital of the newborn or mother for any condition such as:

       a. Prolapsed cord;

       b. Uncontrolled hemorrhage;

       c. Placenta abruptio;

       d. Convulsions;

       e. Major anomaly of the newborn;

       f. Apgar score four or less at five minutes;

       g. Fetal heart rate of 90 or less beats per minute for three minutes;

       h. Thick meconium staining;

       i. Respiratory distress in the newborn; and,

       j. Weight less than 2,000 grams.

       5. The criteria and protocols for transfer shall be readily accessible to clinical staff members at all times.

    2. (b) The names and telephone numbers of the ambulance service, neonatal transport service, and hospital shall be clearly posted at each telephone in the birth center.

    3. (c) A written report of the transfer shall be documented and available for quality assurance review and agency inspection. The report shall include:

       1. The client’s name;

       2. The date of the event;

       3. The reason for transfer;

       4. The provider and mode of transportation to the hospital;

       5. The exact time of the initial call, any subsequent calls;

       6. Arrival of the emergency personnel;

       7. Departure of the client;

       8. Arrival at the hospital;

       9. Name of the hospital;

       10. Initiation of emergency medical services;

       11. The condition of the client at the time of transfer; and,

       12. Any information regarding the medical care of the client and outcome.

    4. (d) The clinical staff, consultants, and governing body shall review and evaluate the criteria, protocols, and emergency transfer reports annually. The findings of the evaluation shall be documented.

11. (11) A method and policy for infection control.

    1. (a) There shall be an Infection Control Committee, composed of the clinical staff and consultants, delegated responsibility for developing and maintaining current written policies and procedures for the prevention, control and investigation of infection in the birth center, and for assuring the effectiveness of current procedural techniques.

    2. (b) There shall be current written policies and procedures to assure, define, and validate infection control for any of the following subjects and areas:

       1. Medical asepsis;

       2. Surgical asepsis;

       3. Sterilization and disinfection;

       4. Housekeeping;

       5. Clean and soiled utility areas;

       6. Linen;

       7. Traffic flow patterns;

       8. Staff health status requirements;

       9. Infection control inservice education for all personnel;

       10. Recording and reporting of all potential infections;

       11. Bacteriological testing of potential infections, recording results and reporting to Infection Control Committee;

       12. Management of clients with specific or suspected infections;

       13. Postpartum follow-up system; and,

       14. Reporting of notifiable communicable disease in an infectious stage.

12. (12) An ongoing program to enhance the quality of client care and review the appropriateness of utilization of services. To ensure the program is effective, the following will be accomplished:

    1. (a) An interdisciplinary committee shall be appointed to do periodic quality assurance review. Two members of the committee shall have clinical expertise in maternal-infant care such as a physician or registered nurse. All members of the committee will be health care providers who are involved in the care or treatment of the clients being audited.

    2. (b) Clinical records shall be audited by the clinical staff at least every three months and a sample audited by the quality assurance committee at least every six months. The audit shall evaluate the following:

       1. Initial history, physical examination, risk assessments and laboratory tests;

       2. Documentation of clinical observations, examinations and treatments;

       3. Evidence that appropriate actions have been taken in response to clinical findings;

       4. Counseling, education, consultation, and referral activities are recorded;

       5. Consent forms are signed as required by subsections 59A-11.010(2), and (3), F.A.C.; and,

       6. All entries are legible, dated, and signed.

    3. (c) The quality assurance committee shall analyze the incidence of maternal and perinatal morbidity and mortality, obstetrical risk assessments, pre-term labor risk assessments, consultants’ referrals and outcomes, and transfers of care and outcomes.

13. (13) Laboratory testing shall be provided by qualified staff within a laboratory that holds the appropriate federal Clinical Laboratory Improvement Amendments (CLIA) certificate.

    1. (a) Each birth center shall have the capability of ordering laboratory tests as required by this rule.
    2. (b) The laboratory must be located onsite.
    3. (c) The birth center must obtain and maintain the appropriate CLIA certificate if testing is to be performed by clinic staff, including tests classified as waived.

Rulemaking Authority 383.309 FS. Law Implemented 383.307, 383.308, 383.309, 383.313, 383.315, 383.316, 383.318, 383.32, 383.327 FS. History–New 3-4-85, Formerly 10D-90.05, 10D-90.005, Amended 2-12-96, 9-17-96, 12-10-18, 6-9-26.