(1) The birthing center may provide a clinical laboratory or make contractual arrangements with a certified laboratory to perform services commensurate with the needs of the birthing center and the laboratory's level of certification.
(a) Outside Laboratory.
- 1. Qualifications. An approved outside laboratory may be a state licensed hospital laboratory or state licensed independent clinical laboratory and must have all necessary current federal CLIA numbers and waivers.
- 2. A contractual arrangement shall be deemed as meeting the requirements of this rule so long as the arrangement includes written policies, procedures, and individual chart documentation evidencing that the policies of the birthing center are met and the needs of the patients are being provided, including the processing of specimens and reporting of test results to the birthing center on a 24/7 basis, as the demands of labor and delivery require.
(b) In-House Laboratory.
- 1. In-house laboratory services shall be licensed by the state as required and have all necessary federal CLIA certificates and waivers. The laboratory shall be under the direction and supervision of an individual meeting the qualifications set forth in the Department's Rules and Regulations for Independent Clinical Laboratories and CLIA regulations, based on the level of laboratory testing performed.
- 2. The laboratory must be of sufficient size and adequately equipped to perform the necessary services of the birthing center.
- 3. Provisions shall be made for a preventive maintenance and an acceptable quality control program covering all types of analyses performed by the laboratory. Documentation must be maintained for both programs.
- 4. Written policies and procedures shall be developed and approved for all services provided by the laboratory.
- 5. Documentation of patient laboratory values shall be recorded on appropriate laboratory report forms and duplicate copies of these reports retained for a minimum of2 years in the laboratory. A record must be maintained to reflect the apparent condition of the specimen collected, time and date collected, and name of the patient. All personnel collecting specimens shall be adequately and appropriately trained and, where otherwise required by law shall be licensed, and their personnel files shall reflect such training and licensure.
- 6. Contractual arrangements for referral laboratory testing shall be made in accordance with subsection (l)(a) above for laboratory testing procedures not provided by the in house laboratory.
7. If medical laboratory technologists are employed on the staff of the birthing center, such technologists must meet one of the following requirements.
- (i) Successful completion of2 years of academic study (a minimum of 60 semester hours or equivalent) in an accredited college or university, with an associate degree as a medical laboratory technologist; or
- (ii) Graduation from high school, and subsequent to graduation, 2 years of documented, hands-on experience as a technician trainee in a clinical laboratory of a hospital, health department, university, or medical research institution, or in a clinical laboratory providing equivalent hands-on training accepted by the Alabama Department of Public Health; or
- (iii) Graduation from high school and successful completion of an official military laboratory procedures course of at least 12 calendar months of study, with at least 1 year of hands-on experience as a technician trainee in a clinical laboratory of a hospital, health department, university, or medical research institution, or in a clinical laboratory providing equivalent hands-on training accepted by the Alabama Department of Public Health.
Author: Dana Billingsley, Diane Milledge
Statutory Authority: Code of Alabama, 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.