Minn. R. agency 144, ch. 4740, pt. 4740.2065
A laboratory must possess a written manual of standard operating procedures used by laboratory personnel for the analysis of samples. A laboratory must prepare written procedures for all laboratory activities including, but not limited to, sample analysis, operation of instrumentation, generation of data, and performance of corrective action.
Actual practice must conform to the written procedures. A laboratory must ensure that the applicable requirements in parts 4740.2080 to 4740.2120 are incorporated into each procedure. All quality control measures must be assessed and evaluated on an ongoing basis. Quality control acceptance criteria in the laboratory's quality assurance manual must be used to determine the validity of the data.
A standard operating procedures manual must contain:
A laboratory must maintain a record of effective dates for all procedures. A copy of the procedure and the record of effective dates must be maintained for the same period of time that records of the data generated by those procedures are required to be maintained.
A copy of a written procedure must be available to all personnel that engage in that particular activity.
An analyst must use the laboratory's standard operating procedure beginning on the effective date for all laboratory activities for the analysis of samples for which certification is required.
A laboratory must submit a copy of its laboratory standard operating procedures manual to the commissioner at the time of application and within 30 days after the effective date of the revision. All changes to the standard operating procedures must be documented. The changes must be incorporated into the manual at least annually. All updated standard operating procedures must include the signature of the managing agent upon revision. The revised procedure manual must be forwarded to the commissioner in its entirety no later than 30 days after its effective date of revision.
Minn. R. agency 144, ch. 4740, pt. 4740.2065
Statutory Authority: MS s 144.97; 144.98