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 September 10, 2024. 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 moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on a review of the completed CMS-209 form listing the laboratory personnel, a review of the State of Nevada Division of Public and Behavioral Health personnel certification records, and an interview with the Center Manager and the Quality Specialist, the director failed to ensure that testing personnel ceased donor testing between the time of the Office Laboratory Assistant certification expiration and reinstatement as required by the State of Nevada. Findings include: 1. 1. A review of the laboratory testing personnel records revealed that one of 25 testing personnel continued performing donor testing during a lapse in the Office Laboratory Assistant certification required by the State of Nevada. 2. Testing personnel number 17 listed on the CMS-209 failed to maintain the State of Nevada Office Laboratory Assistant certification required to perform donor testing. The certification expired on July 2, 2023. It was reinstated on October 11, 2023. 3. The findings were confirmed that the personnel continued to perform donor testing while the certification was expired during an interview conducted with the Center Manager and the Quality Specialist on September 10, 2024 at approximately 10:00 AM. The laboratory performs approximately 62,505 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 --