Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of the U.S. Food & Drug Administration (FDA) database, CoaguChek XS prothrombin time international normalized ratio (PT/INR) test instructions for use (IFU), laboratory's PT/INR procedure, patient records, and interview with the testing personnel (TP), the laboratory failed to follow the manufacturer's instructions for waived testing by performing PT/INR testing beyond the monitoring of warfarin therapy for two (2) out of four (4) patient samples in July 2024. Findings include: 1. A review of the FDA database revealed that the CoaguChek XS PT system is Clinical Laboratory Improvement Amendments (CLIA) waived test. 2. A review of the CoaguChek XS PT IFU revealed that "the manufacturer CoaguCheck XS system is intended for the use by professional healthcare providers for quantitative PT testing for monitoring warfarin therapy." 3. A request for test reports from July 2024 revealed that the laboratory reported two (2) out of four (4) patients outside of the manufacturer's recommended usage for patients not on warfarin therapy. See below: Date PT Order Diagnosis 7/11/2024 806511713 Epistaxis 7/23/2024 836380283 Easy Bruising 4. A review of the laboratory's "CoaguChek XS Analyzer Procedure for PT/INR" revealed that the laboratory performed testing to assist in diagnosis. 5. An interview with TP-1 on 7/24/2024 at 2: 33 pm confirmed that the laboratory performed PT/INR test on "patients not on warfarin therapy and for diagnosis if a provider suspects coagulation issues." 6. The laboratory reports performing 49 PT/INR tests annually. 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 -- 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)