Iowa Admin. Code r. 641-12.10 - Documentation of the confirmatory testing process
The following documents shall be retained for at least two years and, if requested, made available for inspection.
(1) Chain of custody documentation shall be
maintained for each sample tested with the identification of the sample, the
person(s) handling and testing the sample, the storage of the sample, and the
eventual disposal of the sample.
(2) Documents regarding the following:
analytical information for each batch assayed; instrument identification;
calibration records; identification of reagent lot numbers and expiration
dates; quality control results; and any other pertinent information.
(3) Copies of proficiency testing results for
ongoing monitoring and evaluation of laboratory performance. Approved
confirmatory laboratories inspected by the UHL shall submit copies of
proficiency testing results to the UHL or shall ensure that proficiency testing
programs submit copies of proficiency testing results directly to the UHL on
their behalf
(4) Current procedure
manuals must be maintained for all procedures.
(5) An annual review of manuals shall be
performed and documented. Alterations and additions to procedures shall be
incorporated into manuals and approved by the laboratory director before
implementation.
Notes
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