1 Va. Admin. Code § 30-46-90

Current through Register Vol. 41, No. 8, December 2, 2024

Section 1VAC30-46-90 - Notifications and changes to accreditation elements and status

A. Changes to key accreditation criteria. The accredited laboratory shall notify DCLS in writing of any changes in key accreditation criteria within 30 calendar days of the change. Key accreditation criteria are laboratory ownership (including legal, commercial, or organizational status), location, resources and premises, key personnel (including top management), major instrumentation, and quality system policies.

B. Changes to scope of accreditation.

1. DCLS may approve a laboratory's application to add a new matrix, technology, analyte, or test method to a laboratory's scope of accreditation or otherwise modify the laboratory's scope of accreditation by performing a data review.

2. To apply, the owner of the accredited 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 accreditation.

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 accreditation by performing a review of the application materials submitted, without an on-site assessment. The addition of a new 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 accredited 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 accreditation is approved, DCLS shall amend the laboratory's certificate of accreditation.

6. DCLS shall not send the amended certificate of accreditation to the laboratory until DCLS receives the payment of the fee required under 1VAC30-46-150 E 1.

C. Change of ownership or location of laboratory.

1. The accredited 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. Accreditation may be transferred when the legal status or ownership of a accredited 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 reaccreditation or reapplication in any or all of the categories for which the laboratory is accredited.

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 accredited laboratory shall keep for a minimum of five years all records and analyses performed by the previous owner pertaining to accreditation. These records and analyses are subject to inspection by DCLS during this five-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 accreditation status or from being accredited, in total or in part, shall submit written notification to DCLS. DCLS shall provide the laboratory with a written notice of withdrawal.

1 Va. Admin. Code § 30-46-90

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; Amended, Virginia Register Volume 32, Issue 01, eff. 11/1/2015.

Statutory Authority: § 2.2-1105 of the Code of Virginia.