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 laboratory records and interview with the laboratory director (LD); the laboratory failed to verify the accuracy of ungraded proficiency testing (PT) analyte performance for sperm morphology for 2 of 5 PT events reviewed in 2018 through 2019. Findings Include: 1. American Proficiency Institute (API) PT documentation was reviewed for 2018 through 2019. 2. Review of API Hematology /Coagulation PT documentation revealed for event 3 of 2018 and event 1 of 2019 the laboratory failed to evaluate the performance of sperm morphology due to non-graded sperm morphology samples: 2018 Event 3 Reported Result Expected Result SCL-13 Abnormal Normal SCL-17 Normal Normal SCL-20 Normal Abnormal/Borderline 2019 Event1 Reported Result Expected Result SCL-04 Abnormal Normal SCL-05 Abnormal Normal SCL-07 Abnormal Normal SCL-08 Abnormal Normal SM-01 7 see Data Summary 3. Review of the laboratory's PT policy, "Proficiency Testing (SIU- 2016-021)", explained on page 3 that an incident report should be completed to document an investigation and