1VAC30-45-90. Notifications and changes to certification elements and status.
A. Changes to key certification criteria. The certified laboratory shall notify DCLS in writing of any changes in key certification criteria within 30 calendar days of the change. Key certification criteria are laboratory ownership, location, key personnel, and major instrumentation.
B. Changes to scope of certification.
1. DCLS may approve a laboratory's application to add a new matrix, technology, analyte, or test method to a laboratory's scope of certification or to otherwise modify the laboratory's scope of certification by performing a data review.
2. To apply, the owner of the certified laboratory shall submit the following to DCLS:
a. A written request signed by the owner that briefly summarizes the addition to be made to the laboratory's scope of certification.
b. Pertinent information demonstrating the laboratory's capability to perform the additional matrix, technology/method, or analyte, such as proficiency testing performance and quality control performance.
c. A written standard operating procedure covering the new matrix, technology/method, or analyte.
3. DCLS may approve a laboratory's application for modification to its scope of certification by performing a review of the application materials submitted, without an on-site assessment. The addition of a technology or test method requiring the use of specific equipment may require an on-site assessment. Other reviews of performance and documentation may be carried out by DCLS depending on the modification for which the laboratory applies.
4. Within 90 calendar days of the receipt of the application from the certified environmental laboratory, DCLS shall review and determine whether the proposed modification may be approved.
5. If the proposed modification to the laboratory's scope of certification is approved, DCLS shall amend the laboratory's certificate of certification.
6. DCLS shall not send the amended certificate of certification to the laboratory until DCLS receives the payment of the fee required under 1VAC30-45-130 F 1.
C. Change of ownership or location of laboratory.
1. The certified laboratory shall submit a written notification to DCLS of the change of ownership or location of the laboratory within 30 calendar days of the change. This requirement pertaining to change of location does not apply to mobile laboratories.
2. Certification may be transferred when the legal status or ownership of a certified laboratory changes as long as the transfer does not affect the laboratory's personnel, equipment, or organization.
3. If the laboratory's personnel, equipment, or organization are affected by the change of legal status or ownership, DCLS may require recertification or reapplication in any or all of the categories for which the laboratory is certified.
4. DCLS may require an on-site assessment depending on the nature of the change of legal status or ownership. DCLS shall determine the elements of any on-site assessment required.
5. When there is a change in ownership, the new owner of the certified laboratory shall keep all records and analyses performed by the previous owner pertaining to certification for a period of three years, or longer if required by other regulations. These records and analyses are subject to inspection by DCLS during this three-year period. This provision applies regardless of change of ownership, accountability or liability.
D. Voluntary withdrawal. Any environmental laboratory owner who wishes to withdraw the laboratory from its certification status or from being certified, in total or in part, shall submit written notification to DCLS. DCLS shall provide the laboratory with a written notice of withdrawal.
Statutory Authority
§ 2.2-1105 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.