Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) Proficiency Testing (PT) summary reports and interview with the laboratory director (LD), the LD failed to document review and date of review for the CAP bacteriology PT summary reports. FINDINGS: 1. There was no documented CAP bacteriology PT summary report LD review and date of review for the third event of 2022 as well as the first and second events of 2023. 2. The LD confirmed on January 3, 2024, at approximately 11:00 A. M. the LD signature and date of signature were not included on the respective CAP bacteriology PT summary reports. 3. It was noted that the laboratory scored 100% for the third event of 2022 as well as the first and second events of 2023. 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 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 -- 493.1253. (7) Control procedures. (8)