Administrative Code

Virginia Administrative Code
6/13/2021

Article 2. On-Site Assessment

1VAC30-45-300. Frequency of 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.

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.

1VAC30-45-310. Announced and unannounced on-site assessments.

A. DCLS may conduct, at its discretion, either announced or unannounced on-site assessments.

B. Advance notice of an assessment shall not be necessary.

C. To the maximum extent practical, DCLS, when necessary, shall work with the owner of an environmental laboratory to obtain government security clearances for assessment personnel as far in advance as possible. The owner of the environmental laboratory shall facilitate expeditious attainment of the necessary clearances.

D. To the maximum extent practical, assessment personnel shall minimize disruption of a laboratory's operations and take into account competing demands on the time of laboratory personnel.

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.

1VAC30-45-320. Request for records.

Prior to the actual site visit, DCLS may request in writing from a laboratory those records required to be maintained by this chapter.

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.

1VAC30-45-330. Areas to be assessed.

DCLS shall assess the laboratory against the personnel and quality control standards in Article 1 (1VAC30-45-200 et seq.) and Article 4 (1VAC30-45-600 et seq.) of this part. The specific areas evaluated in an on-site assessment shall include but not be limited to:

1. Adequacy of the laboratory facility.

2. Organization and management of the laboratory.

3. Qualifications and experience of laboratory personnel.

4. Receipt, tracking and handling of samples.

5. Quantity, condition, and performance of laboratory instrumentation and equipment.

6. Preparation and traceability of calibration standards.

7. Test methods (including the adequacy of the laboratory's standard operating procedures as well as confirmation of the analyst's adherence to SOPs, and the analyst's proficiency with the described task).

8. Data reduction procedures, including an examination of raw data and confirmation that final reported results can be traced to the raw data/original observations.

9. Quality assurance and quality control procedures, including adherence to the laboratory's quality assurance plan and adequacy of the plan.

10. Recordkeeping.

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.

1VAC30-45-340. National security considerations.

A. Assessments at facilities owned or operated by federal agencies or contractors may require security clearances, appropriate badging, or a security briefing before the assessment begins.

B. The laboratory shall notify DCLS in writing of any information that is controlled for national security reasons and cannot be released to the public.

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.

1VAC30-45-350. Arrival, admittance, and opening conference.

A. Arrival. Assessment personnel shall arrive at the laboratory during established working hours. The laboratory manager (or, if unavailable, the laboratory manager's designee) shall be located as soon as possible after the assessment personnel arrive on the premises.

B. Admittance of assessment personnel.

1. A laboratory's refusal to admit the assessment personnel for an on-site assessment shall result in an automatic failure of the laboratory to receive certification or loss of an existing certification by the laboratory, unless there are extenuating circumstances that are accepted and documented by DCLS. The team leader for the assessment personnel shall notify DCLS as soon as possible after refusal of entry.

2. DCLS shall consider any verbal or physical threat to the health and safety of its assessors or any overt antagonism towards its assessors as a refusal to admit the assessors for the purpose of on-site assessment. The assessors shall vacate the laboratory and shall notify DCLS as soon as possible of the circumstances of this refusal to admit. This refusal to admit shall result in an automatic failure of the laboratory to receive certification or the automatic loss of an existing certification by the laboratory.

C. Health and safety.

1. Under no circumstance, and especially as a precondition to gain access to a laboratory, shall assessment personnel be required or even allowed to sign any waiver of responsibility on the part of the laboratory for injuries incurred during an assessment.

2. Assessment personnel shall comply with all facility and laboratory safety procedures.

D. Opening conference. An opening conference shall be conducted and shall address the following topics:

1. The purpose of the assessment;

2. The identification of assessment personnel;

3. The test methods that will be examined;

4. Any pertinent records and procedures to be examined during the assessment and the names of the individuals in the laboratory responsible for providing assessment personnel with such records;

5. The roles and responsibilities of laboratory staff and managers;

6. Any special safety procedures that the laboratory may think necessary for the protection of assessment personnel;

7. The standards and criteria that will be used in judging the adequacy of the laboratory operation;

8. Confirmation of the tentative time for the exit conference; and

9. Discussion of any questions the laboratory may have about the assessment process.

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.

1VAC30-45-360. On-site laboratory records review and collection.

A. Records shall be reviewed by assessment personnel for accuracy, completeness and the use of proper methodology for each analyte and test method to be evaluated.

B. Records required to be maintained pursuant to this chapter shall be examined as part of an assessment for certification.

Statutory Authority

§ 2.2-1105 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-370. Observations of and interviews with laboratory personnel.

A. As an element of the assessment process, the assessment team shall evaluate an analysis regimen by requesting that the analyst normally conducting the procedure give a step-by-step description of exactly what is done and what equipment and supplies are needed to complete the regimen. Any deficiencies shall be noted and discussed with the analyst. In addition, the deficiencies shall be discussed in the closing conference.

B. Assessment personnel may conduct interviews with appropriate laboratory personnel.

C. Calculations, data transfers, calibration procedures, quality control and quality assurance practices, adherence to test methods, and report preparation shall be assessed for the complete scope of certification with appropriate laboratory analysts.

Statutory Authority

§ 2.2-1105 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-380. Closing conference.

A. Assessment personnel shall meet with representatives of the laboratory following the assessment for a closing conference.

B. During the closing conference, assessment personnel shall inform the laboratory of the preliminary findings and the basis for such findings. The laboratory shall have an opportunity to provide further explanation or clarification relevant to the preliminary findings. If the laboratory objects to the preliminary findings during the closing conference, all objections shall be documented by the assessment personnel and included in the final report to DCLS.

C. Additional problem areas may be identified in the final report.

D. Any potentially illegal activity that may be the subject of further action shall not be discussed in the closing conference.

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.

1VAC30-45-390. Follow-up and reporting procedures..

A. DCLS shall present an assessment report to the laboratory within 30 calendar days of the assessment.

B. If there are deficiencies identified in the assessment report, the laboratory shall have 30 calendar days from the date of its receipt of the assessment report to provide a response to DCLS. This response shall be called a corrective action plan.

C. An exception to the deadlines specified in subsections A and B of this section may occur in appropriate circumstances. Two circumstances that may be considered appropriate by DCLS are where a possible enforcement investigation or other action has been initiated or where the laboratory shows good cause for an extension.

D. The corrective action plan shall include the following:

1. Any objections that the laboratory has with regard to the assessment report;

2. The action that the laboratory proposes to implement to correct each deficiency identified in the assessment report; and

3. The time period required to accomplish the corrective action.

E. DCLS shall determine and shall notify the laboratory within 30 calendar days of receipt whether the corrective action plan is an acceptable response to the deficiencies identified in the assessment report.

F. If the corrective action plan (or a portion of the plan) is determined to be unacceptable to remedy the deficiency, DCLS shall provide written notification to the responsible official and manager of the laboratory including a detailed explanation of the basis for such determination. Following receipt of such notification, the laboratory shall have an additional 30 calendar days to submit a revised corrective action plan acceptable to DCLS.

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.

1VAC30-45-400. Documentation of on-site assessment.

A. Checklists. The checklists used by assessment personnel during the assessment shall become a part of DCLS's file for the laboratory.

B. Assessment report format.

1. The final assessment report shall contain a narrative description of the adequacy of the laboratory as it relates to the assessment standards specified in this chapter and in 1VAC30-45-330.

2. Assessment reports shall contain:

a. Name of owner of the laboratory (or operator of the laboratory, if different from the owner);

b. Identification of the laboratory assessed;

c. Date of the assessment;

d. Identification and affiliation of all assessment personnel;

e. Identification of participants in the assessment process;

f. Identification of analytes and test methods assessed;

g. Statement of the objective of the assessment;

h. Summary;

i. Assessment observations, findings (including any deficiencies), objections noted by the laboratory, and requirements; and

j. Comments and recommendations.

3. The assessment findings and requirements shall be referenced to the standards in Part II (1VAC30-45-200 et seq.) of this chapter so that both the finding is understood and the specific requirement is outlined. The assessor shall specify the laboratory records, documents, equipment, procedures, or staff evaluated and the observations that contributed to each identified deficiency. The assessment report shall support with sufficient data all assessment findings and the overall evaluation of the laboratory.

4. The comments and recommendations section may be used to convey recommendations aimed at helping the laboratory improve.

C. Release of report.

1. The assessment report shall be released initially by DCLS to the responsible official and the laboratory manager. The assessment report shall not be released to the public until findings of the assessment and the corrective actions have been finalized, all information relating to national security has been stricken from the report in accordance with prescribed procedures, and the report has been provided to the laboratory.

2. Once the assessment report has been released to the laboratory, any member of the public may request a copy of the report under the requirements of the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

3. Checklists used by assessment personnel during the on-site assessment shall be provided to the laboratory with the final on-site assessment report upon request.

D. The laboratory shall have access to documentation pertaining to any on-site assessment of its facilities. Any laboratory wishing to review its files shall request such assistance of DCLS five days prior to visiting DCLS. A laboratory may request copies of its documents without visiting DCLS. A reasonable fee may be charged for copying, mailing, and staff time.

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.

1VAC30-45-410. (Reserved).

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-420. (Reserved).

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-430. (Reserved).

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-440. (Reserved).

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-450. (Reserved).

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-460. (Reserved).

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-470. (Reserved).

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-480. (Reserved).

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

1VAC30-45-490. (Reserved).

Historical Notes

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009.

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