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 June 20, 2019. 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. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random audit of patient laboratory testing in hematology that was performed from April 12, 2018 through March 18, 2019 and an interview with the laboratory manager, the laboratory failed to perform at least two levels of quality control material of different concentrations every day that patient testing was assayed. Findings include: 1. A random audit of patient testing for Complete Blood Counts (CBC's) from April 12, 2018 through March 18, 2019, found four of seven days where the laboratory failed to perform two levels of quality control material of different concentrations when patient tests were assayed. 2. There was no documented evidence that two levels of quality control were performed on April 12, 2018, July 9, 2018, September 5, 2018 and November 16, 2018. Patient CBC tests were performed and reported on each of these dates. This was confirmed by the laboratory manager on June 20, 2019 at approximately 3:30 PM. The laboratory performs approximately 6,000 Hematology 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 1 --