Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, review of manufacturer's package insert, surveyor observation and interview with General Supervisor (GS) #2 10/08/21, the laboratory failed to follow the procedure for the storage of urine specimens for Ethyl Gluconoride (ETG) testing. Findings: Review of the laboratory procedure "Specimen Analysis for Ethyl Gluconoride Assay on the Indiko Plus Chemistry Analyzer Version 4" revealed "Use fresh urine specimen for the the test. To protect the integrity of the sample...store refrigerated at all times when not in use." Review of the manufacturer's package insert "DRI Ethyl Glucuronide Assay" "revealed "Urine samples must be stored refrigerated at all times when not in use." During tour of laboratory the surveyor observed urine specimens for ETG testing stored at room temperature. Interview with GS #2 at approximately 12:00 p.m. confirmed the laboratory failed to follow the procedure for storage of ETG urine specimens and also confirmed urine specimens were stored at room temperature when not in use. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)