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 February 20, 2025. 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. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderate complexity testing must-- (a) possess a current license issued by the State in which the laboratory is located, if such licensing is required; and This STANDARD is not met as evidenced by: Based on a review of the State of Nevada Division of Public and Behavioral Health (DPBH) personnel certification database, a review of the laboratory personnel records of training and competency assessment and State personnel certification, a review of the completed CMS-209 list of testing personnel, and an interview with the Center Manager and the Quality Assurance Manager, the director failed to ensure that the testing personnel obtained or maintained personnel certification required by the State prior to performing donor testing. Findings include: 1. A review of the State of Nevada DPBH personnel certification database, and a review of the laboratory personnel records revealed that two of 25 testing personnel failed to obtain or maintain the personnel certification required by the State of Nevada to perform moderate complexity testing as follows: A. Testing personnel number six listed on the completed CMS-209 form failed to apply for the appropriate personnel certification required by the State of Nevada to perform moderate complexity testing. The personnel applied for certification as a laboratory assistant. The required certification for the performance of moderate complexity testing is designated as an Office 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 -- Laboratory Assistant. The personnel performed donor testing beginning in July, 2024. B. Between the dates of September 9, 2023 and August 9, 2024, testing personnel number 13 listed on the completed CMS-209 form performed moderate complexity donor testing without an active Office Laboratory Assistant certification. The testing personnel possessed an Office Laboratory Assistant certification prior to beginning employment at the laboratory that expired on March 26, 2023. The testing personnel began donor testing after initial training and competency assessment was completed on September 9, 2023. The testing personnel then applied for a separate, new Office Laboratory Assistant certification on April 4, 2024. The new certification was issued on August 9, 2024. The findings were confirmed during an interview conducted on February 20, 2025 at approximately 10:15 AM with the Center Manager and the Quality Assurance Manager. The laboratory performs approximately 80,000 chemistry tests annually. -- 2 of 2 --