Summary:
Summary Statement of Deficiencies 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 review of the Proficiency testing (PT) documentation and bi-annual competency documentation presented during survey and interview with the facility's Technical Specialist, the laboratory failed to ensure bi-annual verification of performance for Gram stain (GS) and Acid Fast Bacterial (AFB) stain for each provider interpreting these stains on human tissue. Findings include: 1. Upon review of competency records for 2023 and 2024, it was noted that there was no evidence of bi-annual competency/performance verification for providers performing diagnostic interpretation of GS or AFB stain on human tissue. 2. Interview with the Technical Specialist at 2:00 pm confirmed that the laboratory was not currently performing bi- annual verification of performance for providers performing interpretation of GS and AFB stain. 3. The laboratory reports performing thirty (30) GS on human tissue in 2023 and twenty two (22) GS in 2024, as of date of survey. 4. The laboratory reports performing one hundred ninety (190) AFB stains in 2023 and one hundred thirty four (134) AFB stains in 2024, as of date of survey. 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 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 -- 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)