26.08.05.10

.10 Laboratory Quality Assurance Program.

A. Quality Assurance Manual.

(1) Each certified water quality laboratory shall establish a quality assurance program consistent with U.S. Environmental Protection Agency Laboratory Certification Manual criteria or with TNI standards, if applicable.

(2) A water quality laboratory’s Quality Assurance Manual shall include a description of its quality assurance program.

(3) The quality assurance officer for a laboratory is responsible for maintaining the quality assurance manual.

(4) A water quality laboratory shall submit its Quality Assurance Manual for review to the Department as part of the initial certification application.

(5) A water quality laboratory shall submit in writing any revisions to a Quality Assurance Manual if there is a change in laboratory operations or if the Quality Assurance Manual is requested by the Department.

B. An acceptable quality assurance program shall include the following:

(1) A preventive maintenance program that ensures proper functioning of all instruments and equipment;

(2) Regular operational checks and calibrations to assure proper operation and standardization of equipment, instruments, and reagents;

(3) Routine testing of standard reference samples and other quality control materials. Quality control checks on reagents and media utilized in the performance of tests;

(4) Maintenance of quality control records, which will support the reliability of all procedures performed and which shall be kept on file and readily available for a period of 5 years;

(5) Satisfactory participation in a proficiency test program administered under NELAP or a TNI approved accredited proficiency test body, to be performed for every method and parameter requested for certification; and

(6) The analysis of proficiency testing samples at a frequency necessary to evaluate the performance of any certified water quality laboratory.

C. The water quality laboratory supervisor shall assure that a copy of the results of the proficiency testing analyses are forwarded directly to the Department from the approved proficiency test provider within 30 days of receipt.

D. Proficiency Testing Evaluation.

(1) If there is not a valid proficiency test for each parameter and test method combination for the review period, the Department shall downgrade the laboratory’s certification to a provisional status for the parameter and test method.

(2) Provisional certification for a parameter and test method is valid for 90 days.

(3) If the laboratory does not submit passing proficiency test results within the review period, the Department may revoke or deny certification for the parameter or test method that does not have a valid proficiency test report.

E. Test results may not be reported on samples when quality control samples included in the analysis are found to be outside acceptable analytical limits. The entire batch of samples in the test run shall be retested and analytical data may not be reported unless quality control samples for the test run are within acceptable limits.

F. The supervisor shall certify that each test or analysis is accurate and valid and that the test or analysis was performed in accordance with approved EPA methods for drinking water.