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, 2018. 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. D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on a random patient audit of patient laboratory test records from 8/23/16 through 5/29/18 and an interview with the clinical manager, the laboratory failed to retain instrument records of patient laboratory tests performed. Findings include: A random audit of patient test reports from 8/23/16 through 5/29/18 revealed that eight of eight patient test records failed to have the corresponding instrument printouts retained from the HMS coagulation analyzer for the performance of Activated Clotting Time (ACT). This was confirmed by the clinical manager on June 20, 2018 at approximately 3:00 pm. The laboratory performs approximately 11,600 hematology and chemistry 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 --