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 laboratory record review, direct observation, and interview with laboratory personnel, the laboratory failed to meet the requirements as specified in 493.1230 through 493.1256, 493.1267, and 493.1281 through 493.1299 Findings are as follows: 1. The laboratory failed to include accurate quality control information in the procedure manual. Refer to D5403. 2. The laboratory director failed to approve, sign, and date the performance verification for two Chemistry analytes prior to implementation. Refer to D5407. 3. The laboratory failed to verify the reportable range of two Chemistry analytes prior to reporting patient test results. Refer to D5421. 4. The laboratory failed to perform quality control testing using two control materials of different concentrations at least once each day of patient testing. Refer to D5447. . 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. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)