Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 8/15/18. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 review of the American Proficiency Institute (API) proficiency testing (PT) evaluations, review of laboratory records, and interview with the laboratory manager, the laboratory failed to verify the accuracy of the sperm morphology test consisting of the sperm classification and per cent (%) normal sperm for 2017. Findings include: 1. The laboratory did not have a system in place to verify the accuracy of the sperm morphology test at least twice annually when the API PT test evaluations of the laboratory results were not graded. 2. Review of the API PT evaluations and laboratory records revealed for the first event of 2017 that four of ten sperm classification results were not graded and two of two % normal sperm results were not graded. 3. For the second test event (identified by API as the third event) of 2017, five of ten sperm classification results were not graded and two of two % normal sperm results were not graded. The laboratory manager confirmed the finding during the on- site survey on 8/15/18 at approximately 10:00 AM and indicated that the laboratory performed approximately six sperm morphology tests annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) evaluations, review of laboratory records, and interview with the laboratory manger, the laboratory failed to document PT evaluations and PT verification activities for sperm morphology consisting of sperm classification and percent (%) normal sperm for the two PT events of 2017 and the first PT event of 2018. Findings include: 1. Review of the API PT sperm morphology evaluation for the first event of 2017 showed that two of ten PT reported results for sperm classification did not match the expected results. No