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 surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to verify the accuracy of Andrology & Embryology test results obtained from the American Association of Bioanalysts (AAB) for the S2 2024 event. The findings include: 1. The laboratory received an artificial 100% for Sperm Morphology: Cell ID. 2. Samples 7 and 10 were coded "?" "This score may not truly evaluate performance for this specimen which was not graded because of a lack of participant consensus". 3. The laboratory reported sample 7 as "normal" the PT provider reported the Mean/Intended result as "Abnormal head". 4. The laboratory reported sample 10 as "Abnormal head" the PT provider reported the Mean/Intended result as "Normal". 5. The laboratory failed 2 out of 5 PT challenges for Sperm Morphology: Cell ID event S2 2024 with a score of 60% 6. There was no documented evidence of