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 the first quarter (Q1-2016) Sperm Viability, first quarter (Q1- 2017) Sperm Count, Traditional, of the American Association of Bioanalyts (AAB) proficiency testing records, random patient sampling test results , and interview with the technical supervisor, it was determined that the laboratory failed to verify the accuracy of the above analytes with an artificial scores of 100%. The findings included: Q1-2016 a. AAB reported the following artificial score of 100% proficiency testing score. Analyte: Value Acceptable Sperm Reported: Range: Viability Spec#1? 2 20-40 Spec#2? 6 18-39 Note: True score should have been 0% Q1-2017 Analyte: Value Acceptable Sperm Reported: Range: Count Spec#1? 8 9-23 Note: True score should have been 50% b. For four (4) out of four (4) random patient sampling test results reviewed covering period from 2/4/2016 to 4/16/2018, the laboratory analyzed and reported semen analysis consisting Sperm Count and Sperm Viability that could have been affected by the artificial scoring of 100%. c. The technical supervisor affirmed (5/10/2018, 1300), that the laboratory received the above artificial 100% scores for the above analytes without any