Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the testing personnel (TP), the laboratory failed to document a self-evaluation of PT scores that were not graded by the PT provider. Findings: 1. Gram stain PT sample GS-05 was not graded in the 2022 1st Microbiology PT event. 2. Oxycodone PT sample UDS-04 was not graded in the 2022 2nd Chemistry - Miscellaneous PT event. 3. Vaginal wet preparation PT sample VA-02 was not graded in the 2022 2nd Hematology /Coagulation PT event. 4. Blood cell identification PT samples ECI-02 and ECI-05 were not graded in the 2023 1st Hematology/Coagulation PT event. 5. There was no documentation that the laboratory's results for the above PT samples were compared with the results listed in the PT provider's data summary to verify accuracy. 6. During the survey on 09/15/2023 at 5:45 PM, the TP confirmed that there was no documentation that ungraded PT results were self-evaluated. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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)