Section 520. PT criteria for laboratory certification

A. Result categories.

1. The criteria described in this section apply individually to each FoPT, as defined by the laboratory seeking to obtain or maintain certification in its certification request. These criteria apply only to the PT portion of the overall certification standard.

2. There are two PT result categories: "acceptable" and "not acceptable."

B. Initial and continuing certification.

1. A laboratory seeking to obtain or maintain certification shall successfully complete one PT study for each requested FoC.

2. Once a laboratory has been granted certification status, it shall continue to complete PT studies for each FoPT and maintain a history of at least one acceptable PT study each calendar year. The laboratory shall complete its PT studies by September 30 of each calendar year.

3. When the PT sample used for initial certification was analyzed by the laboratory prior to the date of application, the analysis date of the PT sample shall be no more than 12 months prior to the application date of certification.

4. For a laboratory performing supplemental testing, the PT studies shall be at least 15 calendar days apart from the closing date of one study to the shipment date of another study for the same FoPT.

5. When the PT study result is reported by the PT provider as "acceptable" the environmental laboratory has satisfied the PT requirement.

6. When the PT study result is "not acceptable," the environmental laboratory shall follow the procedure in subsection C of this section.

7. DCLS shall consider a laboratory's analytical result for a FoPT not acceptable when the laboratory makes any reporting error or omission that results in a nonspecific match between the analytical result for the FoPT and any criterion that identifies the laboratory or the field of certification for which the PT sample was analyzed for the purpose of initial or continued certification.

C. Procedure and requirements for "not acceptable" PT study results.

1. When a laboratory receives a PT study result of "not acceptable," the laboratory shall determine the cause for the failure and perform and document corrective action. The corrective action documentation shall be completed within 30 days of receiving the "not acceptable" PT study result and be submitted to DCLS upon request. DCLS may extend the time for corrective action and documentation.

2. Upon completion of the corrective action the laboratory shall perform another PT study for each FoPT that had a "not acceptable" result.

3. If the laboratory successfully completes the makeup PT study by receiving an "acceptable" result before December 31, DCLS shall not suspend the laboratory's certification for the pertinent FoC.

4. If the laboratory receives a "not acceptable" result on the makeup PT study, DCLS shall notify the laboratory that there is cause to suspend the laboratory's certification for the FoC for which the PT study was "not acceptable."

5. DCLS shall not extend the period for annual PT study completion beyond December 31 each year. Failure to satisfactorily complete a PT study, including any corrective action and makeup PT study, by December 31 shall result in suspension of certification in total or in part.

6. If the laboratory receives a "not acceptable" result on three successive PT studies, DCLS shall decertify the laboratory for the pertinent FoC until such time that the laboratory:

a. Completes corrective action for all failed studies and submits its corrective action report to DCLS;

b. Obtains an "acceptable" result for the PT studies; and

c. Applies for a change to its scope of certification and pays applicable fees required by 1VAC30-45-90 B and 1VAC30-45-130 F.

7. DCLS shall follow the provisions of 1VAC30-45-110 in decertifying the laboratory.

D. Withdrawal from PT studies. A laboratory may withdraw from a PT study for any FoPT on or before the close date of the study. Withdrawing from a study shall not exempt the laboratory from meeting the annual analysis requirements necessary for continued certification.

Historical Notes

Derived from Volume 25, Issue 07, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

Statutory Authority

§ 2.2-1105 of the Code of Virginia.