Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 the review of the laboratory's policy, proficiency testing record, and confirmed in an interview, the laboratory failed to have documentation of attestation statement for 1 of 1 proficiency testing event: Nonchemistry M3 2024. The findings were: 1. Review of the laboratory's policy titled Proficiency Testing Guidelines under Procedure revealed "8. Attestation statements are signed by each individual performing the testing and by the laboratory Director or designee." 2. Review of the laboratory proficiency testing from AAB MLE revealed no documentation of attestation statement for 1 of 1 proficiency testing event. Nonchemistry M3 2024 3. An interview on 11/07/24 at 11:30 am in the lab, the technical consultant confirmed the above findings. Key: AAB MLE=American Association of Bioanalysts Medical Laboratory Evaluation 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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)