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 January 29, 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. D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on a review of laboratory personnel performing patient laboratory testing and test interpretation and an interview with the laboratory manager, the laboratory failed to ensure that the location where the interpretation of patient laboratory results were performed was a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. Findings include: The laboratory failed to ensure that personnel performing patient toxicology result interpretations from remote locations were done by CLIA-certified laboratories at each of the remote locations. This was confirmed by the laboratory manager on January 29, 2019 at approximately 10:30 AM. The laboratory performs approximately 472,000 patient chemistry tests annually. D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. 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 -- This STANDARD is not met as evidenced by: Based on a review of patient testing personnel records, a review of the State of Nevada laboratory personnel database for persons with laboratory license's in the State of Nevada and an interview with the laboratory manager, the laboratory failed to ensure that all laboratory testing personnel performing high complexity laboratory testing possessed a current laboratory personnel license issued by the State of Nevada. Findings include: The laboratory failed to ensure that one of four testing personnel possessed a current laboratory license issued by the State of Nevada. This was confirmed by the laboratory manager on January 29, 2019 at approximately 10:30 AM. The laboratory performs approximately 472,000 patient chemistry tests annually. -- 2 of 2 --