Summary:
Summary Statement of Deficiencies D0000 Based on an announced validation survey, the laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the laboratory's records and staff interview, the laboratory failed to have documentation of performing two of two accuracy assessments in 2024 for two non- regulated analytes: D-dimer and Myoglobin. Findings include: 1. A review of the laboratory's records revealed the laboratory performed D-dimer and Myoglobin testing in 2024 on the Triage meter. 2. Further review of the laboratory's records revealed the laboratory failed to have documentation of performing two accuracy assessments for the non-regulated analytes D-dimer and Myoglobin in 2024. 3. In an interview on 5/1/25 at 11:10 a.m. in the nurse's station, after review of the records, the laboratory director confirmed the above findings. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 a review of laboratory records and staff interview, the laboratory failed to identify issues with analytic systems for two of four tests run on the Triage meter. Findings include: 1. The laboratory failed to have documentation of performing verification studies (accuracy, precision, reportable range, normal reference values) for two of four tests run on the Triage meter. (Refer to D5421) 2. The laboratory failed to establish an IQCP (Individualized Quality Control Plan) to support the modification in quality control testing for one of four tests run on the Triage meter. (Refer to D5445) D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)