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 records, laboratory policy, and interview with facility personnel, the laboratory failed to evaluated the performance of the testosterone assay on 1 of 1 event in 2018. The findings included: 1. Based on review of the American Proficiency Institute (API) performance summary for Chemistry - 2nd event, the laboratory received a score of 100 percent for the analyte testosterone. Based on review of the Comparative Evaluation, API reported a code of "Not Graded 3" under Performance for testosterone specimens IA-04, IA-05, and IA-06. A note below the comparative summary states: "3 - See Data Summary" 2. Based on review of the API performance evaluation page, the laboratory director reviewed the proficiency testing results on 11/25/2018. The laboratory did NOT document the evaluation of the specimens IA-04, IA-05, and IA-06 in the context of the API data summary. 3. Based on review of the laboratory's policy "Proficiency Testing", under Analysis of Results, the policy states the following: "The Lab Director will also review the results of PT and a summary will be emailed to the testing personnel in the PT group.