Ga. Comp. R. & Regs. 111-8-10-.23

Current through Rules and Regulations filed through October 29, 2024

Rule 111-8-10-.23 - Evaluation

The Department shall conduct a clinical laboratory performance evaluation (proficiency testing) program with the following requirements:

(a) All clinical laboratories shall enroll and successfully participate in a Department approved proficiency testing program. Point of Care testing areas shall be enrolled or participate in approved proficiency testing programs subscribed to by the responsible laboratory. No proficiency testing agency will be Department-approved unless it meets current requirements found in Title 42 U.S.C. Section 263 a.

(b) In addition, the Department may require the clinical laboratory to analyze test samples submitted or authorized by the Department and to report on the results of such analysis.

(c) Laboratories shall enroll in one or more representative segments of approved proficiency testing programs, if available, based upon the categories, subcategories and/or procedures for which a license is issued, and shall have copies of the results sent to the Department. External proficiency testing is not required for blood, tissue, and/or plasmapheresis donor screening procedures.

(d) Proficiency testing must be conducted in the laboratory being evaluated, by regular employees of that laboratory and in the same manner as patient testing. If a laboratory is found to have intentionally sent proficiency testing samples to another laboratory for analysis prior to receiving results back from the testing agency, it shall have its license revoked for a minimum of one year or a period that is equal to or more stringent than current federal law and regulations and, shall be subject to other appropriate sanctions as provided for in Chapter 111-8-25 of the Georgia Rules and Regulations for General Licensing and Enforcement Requirements; all records of proficiency testing must be retained and available for inspection for a period of not less than two years.

(e) Proficiency testing performance standards must be consistent with current federal requirements unless the Department elects to require more stringent standards.

Ga. Comp. R. & Regs. R. 111-8-10-.23

O.C.G.A. §§ 31-2-8 and 31-22-1et seq.

Original Rule entitled "Evaluation" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.