California Center For Reproductive

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of the procedure documentation and an interview with the general supervisor (GS), it was determined that the laboratory director failed to ensure that the competency reports were completed for the testing personnel (TP). The laboratory inspection occurred on 8/18/21 between 3:00 and 4:00 p.m. Findings include: 1.The GS was asked to produce competency reports for the TP for 2019 and 2020. 2.The GS indicated on 8/18/21 at 3:45 p.m. that the competency reports for 2019 and 2020 were not available. 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 --

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 (Q1-2017) American Association of Bioanalysts (AAB) proficiency testing records and interview with the testing personnel, it was determined that the laboratory failed to verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance. The findings included: a. Q1-2017, AAB proficiency testing, the laboratory received a 100% score for Sperm Count, traditional (Makler) analyte. Spec.: Reported Value: Grading Range: Mean: #1? 54 4-18 11.3 Note: True score for Sperm Count, Traditional (Makler) should have been 50%. Per AAB footnote (?) denotes that, " This score may not truly evaluate performance for this specimen which was not graded because of a lack of participant consensus. b. For eight (8) out of eight (8) random patient test results reviewed covering period from 2/1/2017 to 2/7/2019 , eight (8) patients have Sperm Count, traditional (Makler) test analyzed and reported that cannot be assured. c. The testing personnel confirmed (2/15/2019, 16:15) that the laboratory received the above artificial 100% score for Sperm Count, traditional (Makler) test analyzed and reported that cannot be assured, and that the laboratory did not have a