Ala. Admin. Code r. 538-X-10-.06

Current through Register Vol. 43, No. 02, November 27, 2024

Section 538-X-10-.06 - Proficiency Testing

In addition to the standard inspection requirements applicable to all licensees pursuant to Rule 538-X-4-.02 of Chapter 4 of these Rules, the Commission may require a State Testing Laboratory, at its own cost, to have an independent third party validate and monitor, on an ongoing basis, the State Testing Laboratory's basic proficiency to correctly execute its analytical testing methodologies.

(1) The Commission will establish a proficiency testing program for State Testing Laboratories. A proficiency testing program must include, without limitation, providing rigorously controlled and standardized proficiency testing samples to State Testing Laboratories for analysis, reporting the results of such analysis and performing a statistical evaluation of the collective demographics and results of all State Testing Laboratories.

(2) Each State Testing Laboratory must participate in the proficiency testing program established pursuant to this section.

(3) If required by the Commission as part of being issued or renewing a license, the State Testing Laboratory must have successfully participated in the proficiency testing program within the preceding 12 months.

(4) To maintain continued registration as a State Testing Laboratory, a laboratory must participate in the designated proficiency testing program with continued satisfactory performance as determined by the Commission.

(5) A State Testing Laboratory must analyze proficiency test samples using the same procedures with the same number of replicate analyses, standards, testing analysts and equipment as used for product testing.

(6) The scientific director of the State Testing Laboratory and all testing analysts that participated in a proficiency test must sign corresponding attestation statements.

(7) The scientific director of the State Testing Laboratory must review and evaluate all proficiency test results.

(8) Successful participation includes the positive identification of eighty percent (80%) of the target analytes that the State Testing Laboratory reports to include quantitative results when applicable. Any false positive or false negative results reported will be considered an unsatisfactory score for the proficiency test.

(9) Unsuccessful participation in a proficiency test may result in limitation, suspension, revocation, or non-renewal of the State Testing Laboratory's license.

(10) The Commission will select a proficiency testing provider to conduct the proficiency testing program and determine the schedule that the proficiency testing provider will follow when sending proficiency testing samples to State Testing Laboratories for analysis.

(11) In addition to achieving the standard required pursuant to paragraph 8. of this Rule, a State Testing Laboratory successfully participates in the proficiency testing program only if the State Testing Laboratory does all of the following:

(a) Obtains single-blind proficiency testing samples from the proficiency testing provider.

(b) Analyzes the proficiency testing sample for all analytes required by the Act and this Chapter.

(c) Reports the results of its analysis to the proficiency testing provider.

(d) Analyzes a proficiency testing sample pursuant to the proficiency testing program not less frequently than once each 12 months.

(e) Pays the costs of subscribing to the proficiency testing program.

(f) Authorizes the proficiency testing provider to submit to the Commission the results of any test performed pursuant to this section.

(12) The performance of a State Testing Laboratory is satisfactory pursuant to paragraph 4. of this Rule if the results of the testing performed pursuant to this Rule are within the limits of the acceptance range established by the proficiency testing provider.

(13) A State Testing Laboratory that fails to meet the requirements of this Rule may request that the Commission allow the State Testing Laboratory to retest a proficiency testing sample once to establish satisfactory performance. If the Commission denies the request or if the State Testing Laboratory fails to meet the standard on retesting, the Commission may limit, suspend, or revoke the State Testing Laboratory's license.

Ala. Admin. Code r. 538-X-10-.06

Adopted by Alabama Administrative Monthly Volume XL, Issue No. 11, August 31, 2022, eff. 10/15/2022.

Author: William H. Webster

Statutory Authority:Code of Ala. 1975, §§ 20-2A-22, as amended.

The amended version of this section by Alabama Administrative Monthly Volume XLII, Issue No. 12, September 30, 2024, filed September 12, 2024 is not yet available.