Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted 05/08/2024 through 05/09 /2024. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: 42 C.F.R. 493.1250 Condition: Analytic systems 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer instructions for use, laboratory's policies /procedures, test verification studies, quality control records, calibration records, maintenance records, patient test records and staff interview, the laboratory failed to ensure overall quality of the analytic systems was maintained for 3 of 3 test platforms used by the laboratory, the Beckman Coulter DxH 500, Access 2 UniCel DxI and DxC AU480. Findings included: 1. Laboratory failed to include in its procedure manual 7 of 14 procedural requirements for its chemistry and hematology testing platforms. Refer to D5403. 2. Laboratory failed to follow manufacturer instructions for testing PSA on patients aged 50 years or older. Refer to D5411. 3. Laboratory failed to ensure verification studies were complete for 3 of 3 test platforms used by the laboratory. Refer to D5421. 4. Laboratory failed to follow manufacturer Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- instructions for documentation of calibration of the Apolipoprotein B test every 7 days. Refer to D5437. 5. Laboratory's quality assurance failed to evaluate QC over time to detect shift and trends. Refer to D5791. 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) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)