Section 300. Frequency of on-site assessment

Article 2. On-Site Assessment

A. Frequency.

1. A comprehensive on-site assessment shall be conducted of each laboratory as a condition for granting certification initially.

2. DCLS shall reassess each certified laboratory at least once every three years starting from the date of the previous assessment plus or minus six months.

3. DCLS may conduct an on-site assessment of a laboratory every two years plus or minus six months under any of the following circumstances:

a. When a laboratory has received "not acceptable" PT results.

b. When a laboratory's corrective action presented to VELAP for "not acceptable" PT studies does not identify and correct the root cause of the PT study failure.

c. When DCLS has suspended certification for a laboratory in full or in part.

d. When on-site observations include nonconformances previously identified at an on-site assessment, indicating the corrective action was not implemented or not maintained.

e. When on-site observations include failure to qualify nonconforming data to the data user.

f. When on-site observations indicate the laboratory's failure to monitor and maintain regulatory conformance in documentation, traceability, or quality control requirements such that data generated by the laboratory are of questionable quality or defensibility.

B. Other on-site assessments.

1. If DCLS identified a deficiency on a previous on-site assessment, the agency may conduct a follow-up on-site assessment.

2. DCLS may conduct an on-site assessment when a laboratory applies to modify its scope of certification; when a transfer of owner occurs that affects personnel, equipment, or the laboratory facilities; or when a laboratory applies for an exemption or a variance. Any other change occurring in a laboratory's operations that might reasonably be expected to alter or impair analytical capability and quality may trigger an on-site assessment.

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.