East Bay Fertility

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and interview with testing personnel, proficiency samples are tested twice, patient samples are tested once. Findings include: 1. Proficiency testing record review included instrument printouts for each proficiency sample labeled 'test 1' and 'test 2'. 2. In an interview on 9/8/2021 at approximately 12:35 pm, testing personnel 1 (TP 1) confirmed that patient samples are tested once, but proficiency samples are tested twice. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview with testing personnel, no investigation, remedial action, or training took place after unsatisfactory performance on proficiency testing. The laboratory performs approximately 200 semen analysis tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Findings include: 1. Document review of proficiency testing results for CAP Sem-A proficiency testing event of 2020 included an unacceptable result for 1 of 2 proficiency test samples. 2. Review of proficiency testing documentation lacked investigation into proficiency testing failure, remedial action, or subsequent training. 3. In an interview on 9/8/2021 at approximately 12:20 pm, TP 1 confirmed that there was no investigation or

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation, SQA-V semen analysis instrument manufacturer's instructions, and interview with staff, the laboratory failed to verify semen analysis test accuracy at least twice a year for 2 of 2 years reviewed, 2017 and 2018. The laboratory performed approximately 3 semen analysis per week. Findings include: 1. The laboratory failed to document twice annual test verification for sperm count, motility, abnormal sperm morphology. 2. SQA-V manufacturer instructions included instructions for the laboratory to enroll in College of American Pathology semen analysis proficiency testing at least twice annually. 3. In an interview conducted on 08 /06/2019 at approximately 3:30 P.M., the laboratory manager confirmed the laboratory did not participate in a proficiency testing program that included the measured and assessed portions of the semen analysis reported by the SQA-V instrument. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on manufacturer's operator's manual review, lack of documentation and interview with staff, the laboratory failed to follow instructions to perform testing within the range of 22-26 degrees C for semen analysis performed using the SQA-V semen analysis instrument. The laboratory performed 3 semen analysis per week. Findings include: 1. The SQA-V manufacturer's operator's manual stated testing temperature range was 22-26 degrees C, 2, The laboratory failed to monitor room temperature each day of testing to ensure testing was performed within the 22-26 degree temperature range. 3. In an interview conducted on 08/06/2019 at approximately 3:45 P.M. staff stated the laboratory did not monitor room temperature each test day. -- 2 of 2 --