Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 21, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing (PT) document review and staff interview, the laboratory failed to test the PT samples with the laboratory's regular patient workload by personnel who routinely perform the laboratory testing. Findings include: 1. Review of Wisconsin State Lab of Hygiene (WSLH) PT 2016 documents (Semen Events 1 and 2) and review of American Association of Bioanalysts (AAB) PT 2017 documents (Sperm Analysis Events 1 and 2) revealed Staff #3 (CMS 209) tested the PT samples for all events for 2016 and 2017. 2. An interview with the laboratory director on 2-21-18 at approximately 12:30 p.m. in the laboratory confirmed Staff #3 (CMS 209) tested the PT samples for all PT events for 2016 and 2017. 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 --