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Virginia Administrative Code (Last Updated: January 10, 2017) |
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Title 1. Administration |
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Agency 30. Department of General Services |
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Chapter 41. Regulation for the Certification of Laboratories Analyzing Drinking Water |
Section 150. Onsite laboratory assessment
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A. Frequency of onsite laboratory assessments.
1. DCLS shall assess a drinking water laboratory when the laboratory owner initially applies for certification and at least once every three years after initial certification is granted.
2. DCLS may perform an onsite assessment if major changes in personnel or equipment occur at the laboratory or if the location of the laboratory changes.
3. DCLS may perform interim onsite assessments to confirm that a laboratory has carried out a corrective action plan.
4. DCLS may perform unannounced onsite assessments.
B. Action prior to a scheduled onsite assessment.
1. DCLS shall arrange a mutually agreeable date and time for the onsite assessment with the drinking water laboratory's management.
2. Prior to the onsite audit, DCLS shall request and the laboratory shall provide current records and information that are necessary to evaluate the laboratory. These records and information may include the following:
a. Quality manual.
b. Personnel list.
c. Instrument list or equipment list or both.
d. Standard operating procedure (SOP) for each method to be evaluated.
e. A data package specified by the certification officer.
f. For chemistry, the most recent method detection limit (MDL) study for each regulated contaminant to which the MDL requirement applies.
C. Opening conference. The DCLS onsite assessor or team shall begin the process of the onsite assessment by holding a conference to state the purpose of the assessment, identify the assessment team, and set out the tasks to be done during the assessment.
D. Assessment process.
1. The DCLS onsite assessment team shall evaluate laboratory personnel qualifications and training, operations, equipment, supplies, general laboratory practices, sample handling procedures, methodology, written procedures, and records. The team shall perform the assessment for those specific methods and contaminants for which the laboratory has requested certification.
2. DCLS may require a laboratory to demonstrate drinking water testing methods during the assessment.
3. The DCLS onsite assessment team shall perform a data audit on at least one sample and on one PT sample for at least one method.
4. The DCLS onsite assessment team shall discuss observed deviations at the time such deviations are observed.
5. Findings or deviations are considered preliminary until the final report is issued.
E. Closing conference.
1. The onsite assessment team shall conduct a closing conference to review the results of the assessment with laboratory staff and management.
2. The onsite assessment team shall discuss the following:
a. Any deviations in the observed procedures and records.
b. The time frame for any corrective actions needed and the response.
c. Recommendations, if necessary, for changes in equipment and supplies, staffing, and facility.
F. Notification. Within 30 calendar days after the onsite assessment, DCLS shall notify the laboratory of its certification status and send the laboratory the final onsite assessment report.
G. Final report. In its final onsite report, DCLS:
1. Shall list the certification status for each contaminant or, if applicable, each class of contaminants evaluated as determined by DCLS as a result of the onsite assessment.
2. Shall list and describe each finding, providing a reference to the underlying requirement.
3. May recommend changes to correct the problems described in the findings that have resulted in the laboratory not obtaining certification for a particular contaminant.
4. May recommend improvements to laboratory operation, recognize outstanding performance, and provide other information of use to the laboratory.
H. Results of the onsite assessment.
1. DCLS shall certify the laboratory when the onsite assessment shows that the laboratory has established or is maintaining the standards of quality required under this chapter.
2. When DCLS finds during the onsite assessment that the laboratory is not maintaining the standards of quality required under this chapter, the laboratory shall follow the procedure in subsection I of this section.
I. Procedures and requirements when findings are reported.
1. The laboratory shall respond with a corrective action plan for all findings issued in the report within 60 calendar days. This corrective action plan shall specify what immediate corrective actions are being taken and any proposed actions that need the concurrence of DCLS.
2. DCLS shall review the corrective action plan. If DCLS finds that any aspect of the laboratory's corrective action plan is inadequate, it shall notify the laboratory director in writing by certified mail or other equivalent mailing service of its intent to downgrade the laboratory.
3. The laboratory director shall respond within 30 calendar days with an additional corrective action plan. If the additional corrective action plan is still deficient, DCLS shall not issue a certificate for the initial application or shall downgrade the laboratory to provisionally certified status.
4. DCLS shall respond within 14 days of determining the laboratory's letter and corrective action plan are deficient.
5. The laboratory shall correct the problems cited in the initial notification letter within three months of the date the laboratory was downgraded.
6. If within three months the laboratory has not corrected the problems for which DCLS downgraded the laboratory to provisionally certified status, DCLS shall revoke the laboratory's certification status.
7. DCLS shall revoke certification only for the contaminants and methods for which the laboratory was initially cited.
8. DCLS shall follow the provisions of 1VAC30-41-240 in revoking the laboratory's certification.
9. When DCLS reports a finding that had been identified in the previous triennial onsite assessment where the laboratory had not implemented corrective action, DCLS shall downgrade the laboratory to provisionally certified.
10. A provisionally certified laboratory may continue to analyze samples for compliance purposes but shall notify its clients in writing of its downgraded status and shall indicate its downgraded status in writing on any report.
Historical Notes
Derived from Volume 30, Issue 14, eff. May 1, 2014; Errata, 30:23 VA.R. 2590 July 14, 2014.