Section 640. Recordkeeping system and design

A. The laboratory shall have a recordkeeping system that allows historical reconstruction of all laboratory activities that produced the analytical data. The history of the sample shall be readily understood through the documentation. This shall include inter-laboratory transfers of samples or extracts or both.

B. The records shall include the identity of personnel involved in sampling, sample preservation, sample receipt, preparation, calibration or testing, all documentation sent by the person transmitting the sample, including a chain of custody record form, if utilized.

C. The laboratory shall document all information relating to the laboratory facility's equipment, analytical test methods, and related laboratory activities, such as sample receipt, sample preparation, or data verification.

D. The laboratory shall have a recordkeeping system that facilitates the retrieval of all working files and archived records for inspection and verification purposes, e.g., set format for naming electronic files.

E. Responsible staff shall sign or initial all changes to records. The reason for the signature or initials shall be clearly indicated in the records such as "sampled by," "prepared by," or "reviewed by."

F. All generated data except those that are generated by automated data collection systems, shall be recorded directly, promptly and legibly in permanent ink.

G. Entries in records shall not be obliterated by methods such as erasures, overwritten files or markings. All corrections to recordkeeping errors shall be made by one line marked through the error. The individual making the correction shall sign or initial and date the correction. These criteria also shall apply to electronically maintained records.

H. The laboratory shall keep computer and electronic data records in accordance with the pertinent provisions of this section, 1VAC30-45-650 C and E and 1VAC30-45-730 K.

Historical Notes

Derived from Volume 25, Issue 07, eff. January 1, 2009.

Statutory Authority

§ 2.2-1105 of the Code of Virginia.