Minn. R. agency 144, ch. 4740, pt. 4740.2095

Current through Register Vol. 49, No. 20, November 12, 2024

Part 4740.2095 - REPORTING

A. Analytical results must be reported accurately, legibly, unambiguously, objectively, and according to any specific instructions in the laboratory's standard operating procedure or quality assurance manual.

B. Laboratories that are operated by a facility and whose sole function is to provide data to the facility management for compliance purposes must have all applicable information specified in item C readily available for review by the state agency administering the permit, program, or rule. Formal reports detailing the information are not required if:

(1) the laboratory is itself responsible for preparing the regulatory reports; or

(2) the laboratory provides information to another individual within the organization for preparation of regulatory reports.

C. The test report must include:

(1) a title, such as "Test Report" or "Laboratory Results";

(2) the name, address, and commissioner-designated identification number of the laboratory;

(3) the telephone number and name of a contact person;

(4) the information in subitem (2) for the subcontracted laboratory and the phrase "This report contains data that were produced by a subcontracted laboratory certified for the fields of testing performed," if data were produced by a laboratory other than the laboratory reporting the results;

(5) a unique identification of the test report, such as a serial number, an identification on each page to ensure that the page is recognized as a part of the test report, and a clear identification of the end of the test report;

(6) the name of the client and project name, if applicable;

(7) identification of the approved method used;

(8) a description of, the condition of, and unambiguous identification of the sample, including the client's identification code;

(9) date and time of sample collection;

(10) the date of receipt of the sample when critical to the validity and application of the results;

(11) time of sample preparation and time of sample analysis when critical to the validity of the sample result;

(12) date of analysis of the environmental test;

(13) the test results with, when appropriate, the units of measurement; whether data are calculated on a dry weight or an "as received" basis; the reporting or detection limit for each sample with appropriate units of measurement; and the counting error for each radiochemistry sample;

(14) the name, function, and signature or equivalent electronic identification of the person authorizing the test report and the date of issue;

(15) a statement to the effect that the results relate only to the samples;

(16) a statement that the report must not be reproduced, except in full, without the written approval of the laboratory;

(17) deviations from the standard operating procedure, such as failed quality control, additions to, or exclusions from the test method and information on specific test conditions, such as environmental conditions and any nonstandard conditions that may have affected the quality of results, including the use and definitions of data qualifiers; and

(18) test results that do not meet the requirement, or for which the laboratory is not certified, must be documented with the reason why the result does not meet the requirements and justification as to why the result was reported.

D. When the laboratory analyzes samples by a procedure other than as written, the laboratory record must include:

(1) the sample identification traceable to client;

(2) the modification to the procedure;

(3) the reason for the modification; and

(4) the client's authorization or acknowledgment of the modification.

Minn. R. agency 144, ch. 4740, pt. 4740.2095

31 SR 446

Statutory Authority: MS s 144.97; 144.98