Summary:
Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory procedures, testing records, quality control records and patients' reports; the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1267, and 493.1281 through 493.1299 when it performed chemistry tests. Findings: 1. There was no written comprehensive procedures manual available to laboratory personnel. See D tag 5403 2. There were no criteria established for monitoring conditions for proper storage of reagents and specimens and test performance. See D tag 5413 3. The laboratory did not verify performance specifications established by the manufacturer for their test method. See D tag 5421 4. The laboratory failed to perform and document quality control procedures, before testing and reporting patients test results. See D tags 5447, 5537, and 5539 5. The laboratory did not include all pertinent information on the final report of patients' records. See D tag 5805. 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 examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- (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)