Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Laboratory Director (LD) or designee failed to attest to the integration of proficiency testing (PT) samples into the routine patient workload on two of four occasions reviewed from 2022 and 2023. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the LD during a tour of the laboratory at 9:35 a.m. on June 1, 2023. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. The LD or designee failed to sign the attestation statement for two of four Hematology/Coagulation API PT events reviewed in the January 2022 through June 2023 timeframe. See below. Event Specialty missing attestation 2022-1 Hematology /Coagulation 2023-1 Hematology/Coagulation 4. The Proficiency Testing policy, found in the Laboratory Procedure Manual, did not address the requirement of the LD (or designee) and testing personnel's signature on the Attestation Statement form. 5. In an interview at 10:42 a.m. on June 1, 2023, the LD confirmed the above findings stating that either the LD or the Technical Consultant can sign the Attestation Statement form. . 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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)