Section 660. Required records

A. Sample handling.

1. The laboratory shall maintain a record of all procedures to which a sample is subjected while in the possession of the laboratory. These shall include but are not limited to all records pertaining to sample preservation, identification, receipt, acceptance or rejection, log-in, storage and tracking. The laboratory shall also maintain sampling information on each sample. This includes time and date of collection, type of sample (grab or composite), type of container, sampling point and preservation.

2. The laboratory shall have documented procedures for the receipt and retention of samples, including provisions necessary to protect the integrity of the samples.

B. Laboratory support activities. The laboratory shall retain the following documents and data:

1. All original raw data, whether hard copy or electronic, for calibrations, samples and quality control measures, including analysts' work sheets and data output records (chromatograms, strip charts, and other instrument response readout records).

2. A written description or reference to the specific test method used that includes a description of the specific computational steps used to translate parametric observations into a reportable analytical value.

3. Copies of final reports.

4. Archived standard operating procedures.

5. Correspondence relating to laboratory activities.

6. All corrective action plans, audits, and audit responses.

7. Proficiency test results and raw data.

8. Results of data review, verification, and cross-checking procedures.

C. Analytical records. The laboratory shall retain essential information associated with analytical documents, such as strip charts, tabular printouts, computer data files, analytical notebooks, and run logs. This information includes, but is not limited to, all manual calculations (e.g., manual integrations); sample preparation; standard and reagent origin, receipt, preparation, and use; quality control protocols and assessment; and method performance criteria.

D. Administrative records. The laboratory shall maintain the following administrative records:

1. Personnel qualifications, experience and training records.

2. Records of demonstration of capability for each analyst or work cell.

3. A log of names, initials and signatures for all individuals who are responsible for signing or initialing any laboratory record.

Historical Notes

Derived from Volume 25, Issue 07, eff. January 1, 2009; amended, Virginia Register Volume 32, Issue 22, eff. September 1, 2016.

Statutory Authority

§ 2.2-1105 of the Code of Virginia.