Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA validation survey conducted at your facility on March 30, 2022. 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. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a random audit of nine patients tested between the dates of March 17, 2020 and February 19, 2022, and an interview with the laboratory supervisor, the laboratory failed to ensure that the correct name, CLIA identification number and laboratory director of the laboratory that performed the arterial blood gas and blood oximetry testing was listed on the patient test reports. Findings include: 1. A random patient audit of nine patients tested between the dates of March 17, 2020 and February 19, 2022 revealed that the name of the laboratory that performed the arterial blood gas and blood oximetry testing was not correct on nine of nine patient test reports reviewed. In addition, the CLIA identification number, and the name of the laboratory director of the laboratory included on the report were incorrect. 2. The findings were Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- confirmed during an interview conducted with the laboratory supervisor on March 30, 2022 at approximately 11:30 AM. The laboratory performs approximately 192,765 chemistry tests and 14,118 hematology tests annually. -- 2 of 2 --