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 document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of one 2020 non-graded proficiency testing (PT) results for a non-regulated analyte when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Urine Sediment testing as confirmed by Testing Personnel 2 (TP2) during a tour of the laboratory at 10:40 a.m. on 12/08/21. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. One Urine Sediment result from the third 2020 Hematology/Coagulation PT event was not graded by API due to lack of consensus. See below. Sample ID Analyte US-06 Urine Sediment 4. The API report referred the laboratory to the expected result data summary for evaluation of the non- graded test result. The data summary for the above sample was not present in laboratory records. Evaluation of the non-graded result was not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded result upon request. 5. Requirements for the evaluation of non-graded PT results was not included in the Proficiency Testing procedures found in the Lab Policy Manual. 6. In an interview at 1:30 p.m. on 12/08/21, TP2 confirmed the above finding. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --