Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 18, 2018. The laboratory was not in compliance with 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 review of the Proficiency Testing (PT) documents, and staff interview, the laboratory failed to rotate PT samples to all testing personnel(TP) who routinely perform the testing. Findings: 1. Review of the PT documents for the Cell-Dyn 1800 Complete Blood Count (CBC) analyzer for 2016(3rd event), all events of 2017 and event 1 of 2018, the laboratory failed to rotate the testing of PT samples among all TP listed on the Laboratory Personnel Report (CMS 209 form). Only one TP had signed the attestation statement as performing all PT testing. 2. Interview with staff #1, on July 18, 2018, at approximately 11 am in the extra office, confirmed that only one TP had performed all PT testing for 2016(3rd event), 2017 (all events), and 2018 (1st event). 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 --