1. (1) There shall be a written quality assurance program consisting of an interdisciplinary committee which shall perform quality assurance reviews for maternal and newborn care provided in the birthing center, including, but not limited to:

   1. (a) At least annual review of protocols, policies, and procedures relating to the maternal and newborn care provided during the prenatal, intrapartum, and postpartum periods.
   2. (b) The appropriateness of the criteria for determining eligibility for admission to and continuation in the birthing center's program of care.
   3. (c) The appropriateness of diagnostic and screening procedures, including laboratory studies, sonography, and nonstress tests, and their impact on quality of care and patient cost.
   4. (d) The appropriateness of medications prescribed, dispensed, or administered in the birthing center.
   5. (e) Performance evaluations of medical and support staff employed by the birthing center (peer review - self evaluation).
   6. (f) Quarterly meetings of medical staff to review the management of care of individual patients (medical chart reviews) and make recommendations for improving the plan for care.
   7. (g) Quarterly review of all transfers of mothers and neonates to hospital care, to determine the appropriateness and quality of the transfer.
   8. (h) Immediate review and evaluation of all complications of pregnancy, labor, and postpartum periods arising in the birthing center and the appropriateness of medical staffs consultation and treatment of the same.
   9. (i) Evaluation of staff's ability to manage emergency situations via unannounced periodic drills for fire, maternal/newborn emergencies, power failures, etc.
   10. (j) The birthing center's responses to patient grievances and feedback.

2. (2) Patient records shall be audited by the medical staff at least every 3 months and a sample audited by the quality assurance committee at least every 6 months. The audit shall evaluate the following for accuracy and completeness:

   1. (a) Initial history, physical examination, risk assessments, and laboratory tests.
   2. (b) Documentation of clinical observations, examinations, and treatments.
   3. (c) Evidence that appropriate actions have been taken in response to clinical findings.
   4. (d) Counseling, education, consultation, and referral activities are recorded.
   5. (e) Consent forms are signed.
   6. (f) All entries are legible, dated, and signed in ink or typed.
3. (3) The quality assurance committee shall analyze the incidence of maternal and perinatal morbidity and mortality, obstetrical risk assessments, pre-term labor risk assessments, consultant referrals and outcomes, and transfers of care and outcomes.

4. (4) The quality assurance program ensures quality of care to patients and the community through an effective system for collection and analysis of data, which includes, but is not limited to, utilization of information obtained through the following:

   1. (a) Orientation sessions.
   2. (b) Patient registrations.
   3. (c) Women attending educational programs at the birthing center.
   4. (d) Total number of encounters/visits antepartum.
   5. (e) Number of and reasons for antepartum transfers.
   6. (f) Intrapartum care admissions.
   7. (g) Number of and reasons for intrapartum transfers.
   8. (h) Time in the birthing center before delivery.
   9. (i) Births occurring in the birthing center.
   10. (j) Births occurring en route to the birthing center.
   11. (k) Time in birthing center after delivery.
   12. (l) Number of and reasons for maternal postpartum transfers.

   13. (m) Number of and reasons for newborn transfers

       (n)Postpartum home visits.

   14. (o) Follow-up maternal postpartum office visits.
   15. (p) Follow-up newborn office visits.
   16. (q) Total classes conducted antepartum.
   17. (r) Total classes conducted postpartum.

   18. (s) Outcomes of care provided.

       1. 1. Loss of pregnancy before 20 weeks gestation.
       2. 2. Type of anesthesia/analgesia used.
       3. 3. Type of delivery.
       4. 4. Place of delivery.
       5. 5. Complications of delivery, including postpartum hemorrhages of more than 1,000 cc.
       6. 6. Episiotomies, lacerations.
       7. 7. Infants with birth weight below 2,500 grams or over 4,000 grams.
       8. 8. Apgar scores.
       9. 9. Neonatal morbidity/mortality.
       10. 10. Maternal morbidity/mortality.
       11. 11. Maternal or newborn admissions from home to hospital in a 4-week postpartum period.
   19. (t) Deviations from written protocols.

5. (5) The birthing center's quality assurance plan should, at a minimum, address any issues related to the following:

   1. (a) Administrative or supervisory action.
   2. (b) Continuing education or simulation.
   3. (c) Modification of policies and procedures.
   4. (d) Revision of risk criteria.
   5. (e) Revision of health record or other forms.
   6. (f) Utilization of outside consultation and expertise.
   7. (g) Changes to facility, equipment, or supplies.
6. (6) Professional Accreditation. The birthing center must apply for, obtain, and maintain accreditation from a nationally recognized accrediting organization as a condition of receiving a license.

7. (7) Yearly Evaluation. The birthing center shall assess the needs of the childbearing community and continue to develop services and programs to address the following:

   1. (a) The general geographical area to be served.
   2. (b) Demographic data and vital statistics of the community to be served.
   3. (c) Availability of and access to maternal and newborn services, including practitioners, hospital obstetrical and newborn services, home birth services, family-centered maternity care programs, birthing rooms/suites, clinics for disadvantaged families, laboratory services, supplementary social and welfare services, childbirth education, and parental support programs.
   4. (d) Periodic market surveys to determine the impact of the birthing center on the community and to assess the needs of childbearing families in the population served, for purposes of program planning and development.
   5. (e) Changes in population, environment, regulations, legislation, reimbursement, and access to and availability of maternal and newborn services in the community.
8. (8) Reports of the quality assurance committee shall be given to the governing body.
9. (9) The governing body shall examine the reports of the quality assurance committee and shall make such reports available for inspection by the licensing authorities for the facility and the providers.

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.