Current through Register Vol. 41, No. 3, September 23, 2024
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.
Statutory Authority: §
2.2-1105 of the Code of
Virginia.