Current through Register Vol. 24-23, December 1, 2024
Section 16-309-280 - Reports(1) All sample test results must be supported by analytical data and all analytical data must have a documented review, once reviewed by an analyst, and once reviewed by a certifying scientist prior to being reported.(2) Laboratories must report results as either "negative," "none detected," "pass/fail," or the numeric concentration equal to or above the decision point or cutoff of the required analytes tested as indicated in rules.(3) For the purpose of reporting, decision points or cutoff limits have been written in chapter 314-55 WAC to the number or significant digits that laboratories are expected to use when reporting results.(4) If the result is above the established ULOL, the laboratory must dilute the sample and retest to bring the results within the linear range of the test, unless allowed differently in the guidelines.(5) The concentration of a diluted primary sample prior to applying the dilution factor must be above the concentration of the lowest calibrator or control in the batch.(6) At a minimum, the computer generated COA reports for samples going to the customer must contain: (a) A title: "Certificate of Analysis" or "Test Report";(b) Laboratory name, lab ID number, and address;(c) Unique identification of the test report certificate and on each page an identification in order to ensure that the page is recognized as a part of the COA, and a clear identification of the end of the report;(d) The name, address, and license number of the customer;(e) Date of sample collection;(f) Sample identification number from transportation manifest;(g) Sample/matrix type (flower, concentrate etc.);(h) Product/sample name and category;(i) Amount of sample received;(j) Date received by laboratory;(k) Name of certifying scientist;(l) Date reported by the laboratory;(m) Results of each test performed to include name of test, results, measurands (i.e., mg/g), cutoffs, and instrument/method of testing used;(n) A statement to the effect that the results relate only to the items tested.(7) Laboratories must use the analyte terminology and abbreviations specified by rules to ensure consistency in reporting and interpretation of test results.(8) Laboratories must not release any cumulative or individual test result prior to the completion of all analysis by the lab for that sample.(9) Any amendments to a COA after the original issuance must include a statement for the reason issued like "Corrected Report," "Supplement to COA (to include COA number)," or an equivalent form of wording.(10) When it is necessary to issue a completely new COA, it must be uniquely identified and contain a reference to the original that it replaces (i.e., reprint).(11) All records must include the identity of personnel performing the aliquoting, sample preparation, calibration, testing of samples and controls, and review of results.(12) Observations, data, and calculations must be recorded at the time they are made and must be identifiable to the specific task.(13) When mistakes occur in records, each mistake must be lined out, not erased, or made illegible or deleted, and the correct value entered alongside. All such alterations or corrections to records must be signed or initialed and dated by the person making the correction.(14) All entries to hard copy laboratory records must be made using indelible ink. No correction fluid or tape may be used on laboratory data records.Wash. Admin. Code § 16-309-280
Adopted by WSR 24-09-079, Filed 4/17/2024, effective 5/18/2024