1. (1) Organization. There shall be an organized medical staff consisting of a minimum of one staff physician or consultant physician, and CNMs and RNs. CPMs may also provide assistive care to the medical staff of a birthing center while a patient is laboring, during birth, and throughout the postpartum period when in the birthing center. The staff physician shall have overall responsibility for the quality of a11 clinical care provided to patients, and for the ethical conduct and professional practices of its staff members. In the event the birthing center does not have a qualified staff physician on the medical staff, the consultant physician shall have overall responsibility for the quality of all clinical care provided to patients, and for the ethical conduct and professional practices of its staff members. The staff physician and consultant physician shall maintain independent medical judgment related to the practice of medicine at all times.

   1. (a) The medical staff shall be accountable to the governing authority and organized in a manner consistent with the birthing center's documented staff organization and bylaws, rules, and regulations, provided that only a physician may conduct an annual appraisal or evaluation of another physician.
   2. (b) The medical staff shall conduct annual appraisals of its members, examine the credentials of candidates for medical staff membership, and make recommendations to the governing authority on the appointment of the candidates.

2. (2) The staff physician shall develop written policies and protocols for clinical care identifying the roles and responsibilities of each staff member and consultant. In the event the birthing center does not have a qualified staff physician on the medical staff, the consultant physician shall develop written policies and protocols for clinical care identifying the roles and responsibilities of each staff member and consultant. Each policy and protocol shall be signed by the staff physician or consultant physician who is a member of the medical staff. The organization and policies and protocols of the medical staff shall be approved by the birthing center's governing authority. The policies and protocols shall require that patients are admitted to the birthing center only when they have been prescheduled to deliver there following a documented period of prenatal care for a patient who has been determined to be low risk, as defined herein, through an ongoing risk assessment from the first prenatal visit throughout admission in labor, and the labor, birth, and postpartum period, and upon immediate evaluation by the medical staff to be low risk.

   1. (a) Consultant Physician.

      1. 1. Services of a consultant physician are required in those birthing centers which do not have an Alabama licensed physician on the medical staff who serves as the staff physician. The consultant physician must have hospital obstetrical privileges with the hospital that is a party to the birthing center's Transfer Agreement and must be available to be physically present at the birthing center within 30 minutes to provide needed hands-on care to patients at the birthing center when called.
      2. 2. The responsibilities and functions of the consultant physician shall be specifically described in the policy and procedure manual and the patient care protocols.
      3. 3. The governing body shall maintain a written agreement with each consultant physician who agrees to provide advice and services to the birthing center as requested.
      4. 4. If a birthing center does not have a staff physician and is unable to enter into an agreement with a consultant physician, the license of the birthing center shall be denied or suspended, and no patient services may be rendered until an agreement with a consultant physician is formalized.
   2. (b) The initial appointment and continued medical staff membership shall be dependent upon professional competence and ethical practice in keeping with the qualifications, standards, and requirements set forth in the medical staff policies and protocols and governing authority bylaws, rules, and regulations.
   3. (c) Hospital Privileges. The staff physician and/or consultant physician shall have full active privileges in obstetrics at the hospital that is a party to the birthing center's Transfer Agreement.
   4. (d) Staffing. There shall be a minimum of two licensed RNs at the birthing center at all times when patients are present, with a staffing ratio of one licensed RN for every two patients. There shall be a staff physician or consultant physician or CNM at the birthing center when a patient is laboring, during delivery, and for a minimum of 2 hours post-delivery. When the patient census exceeds the above, additional medical staff are to be called in or the patients are to be transferred to a hospital. There shall be an adequate number of medical and support staff on duty and on call to meet demands for services routinely provided and periods of high demand or emergency, to assure that no mother in active labor shall remain unattended.
   5. (e) Licensure. All birthing center personnel shall be currently licensed to perform the services they render when such services require licensure under the laws of the state of Alabama.
   6. (f) Health Examinations. At a minimum, each employee coming in contact with patients shall have a pre-employment health examination by a physician, certified registered nurse practitioner, or physician assistant. The examination is to be repeated annually and more frequently if indicated to ascertain freedom from communicable diseases. The extent of such examinations shall be determined by the governing authority in consultation with the staff physician and documentation made in the employee's personnel folder. The examination shall include a chest x-ray or a tuberculin test. Each employee must be offered a Hepatitis B vaccine and sign a written declination if the vaccination is refused. Documentation of immunization status for vaccine preventable diseases in pregnancy may be required.
   7. (g) Staff Development. All medical staff will participate in an orientation and training program developed by the birthing center upon hire and at least annually in staff development, including, but not limited to, recertification of adult and infant CPR training and education programs to maintain knowledge and skills used in birthing center practice.

   8. (h) Nursing Service.

      1. 1. Staffing Pattern. There shall be 24-hour availability of qualified RNs and CNMs as defined in these rules. A minimum of two RNs shall be in the birthing center whenever a patient is in labor, during birth, and throughout the postpartum period while a patient is in the center.
      2. 2. Nursing Care Plan. An RN must plan, supervise, and evaluate the nursing care of each patient from admission to discharge. Prior to discharge, each patient shall be given a referral with a specific time, date, and place for postpartum, family planning, and infant care. A 2-week health status of the baby shall be documented on the patient's record following review of records evidencing the pediatric or neonatal care provided at the birthing center or other facility.
      3. 3. LPNs who are currently licensed to practice within the state may provide nursing care that does not require the skill and judgment of an RN, under the supervision of an RN. LPNs providing such care shall maintain current certification in both adult and infant CPR.

   9. (i) Certified Nurse Midwifery and Physician Service.

      1. 1. A CNM or the staff physician or consultant physician shall be in the birthing center when a patient is in labor, during birth, and for a minimum of 2 hours postpartum, or longer if necessary. A physician obstetrician and pediatrician shall be available 24 hours a day for phone consultation pursuant to a written agreement with the birthing center.
      2. 2. There shall be a minimum of one CNM or physician for every two patients in the birthing center, to ensure that every patient in labor is attended.

      3. 3. Care policies and procedures shall be consistent with professionally recognized standards and shall be in accordance with the Nurse Practice Act and Medical Practice Act of the State of Alabama. Policies shall, at a minimum, include the following:

         1. (i) Diagnostic and therapeutic orders.
         2. (ii) Assignment of care of patients.
         3. (iii) Medication orders.
         4. (iv) Charting.
         5. (v) Infection control.
         6. (vi) Patient and personnel safety.
         7. (vii) Family centered maternity care.

   10. (j) Inservice and Continuing Education. An inservice education program shall be provided for all staff members of the birthing center to improve existing practices, obtain new knowledge and skills, keep personnel informed of changes in policies and procedures, and discuss problems in the birthing center.

       1. 1. The inservice program shall be planned, scheduled, documented, and held monthly.
       2. 2. All medical staff shall participate annually in appropriate training programs for the safe and effective use of diagnostic and therapeutic equipment, for CPR, and infant resuscitation and transport.
       3. 3. All personnel shall have training that meets state and federal guidelines, as applicable, including, but not limited to, regulations of the Occupational Safety and Health Administration (OSHA), the Health Insurance Portability and Accountability Act (HIPAA), and Clinical Laboratory Improvement Amendments (CLIA).

Author: Dana Billingsley, Denise Milledge

Statutory Authority: Code of Ala 1975, §22-2-2(6), et seq.; §22-21-20, et seq.

History: Filed November 19, 1987. Repealed: Filed April 16, 2010; effective May 21, 2010. New Rule: Published August 31, 2023; effective October 15, 2023.