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 May 7, 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. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the College of American Pathologists (CAP) proficiency testing results for toxicology and toxicology adulterants for testing years 2017 and 2018 and an interview with the laboratory director, the laboratory failed to at least twice annually, verify the accuracy of all non-regulated analyte testing that the laboratory performs. Findings include: 1. The laboratory failed to verify the accuracy of the adulterant test, quantitative creatinine, at least twice annually for the testing year 2017. 2. The CAP proficiency test result of quantitative creatinine testing for testing event DAI-A 2017 revealed that the proficiency testing score for this analyte was 33%. 3. The CAP proficiency test result of quantitative creatinine testing for testing event DAI-B 2017 revealed that the proficiency testing score for this analyte was 67%. This was confirmed by the laboratory director on May 7, 2018 at approximately 4:00 PM. The laboratory performs approximately 23,646 patient chemistry and toxicology tests annually. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) 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 -- 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 laboratory testing personnel records, a review of the State of Nevada requirements for laboratory testing personnel and an interview with the laboratory director, the director failed to ensure that each person performing moderate complexity laboratory testing possessed the correct current license from the State of Nevada. Findings include: 1. The laboratory director failed to ensure that one of one testing personnel possessed the correct laboratory license issued by the State of Nevada for the performance of moderate complexity testing. 2. One of one testing personnel who was performing moderate complexity toxicology and chemistry patient testing was found to have a State of Nevada Laboratory Assistant license which allows for the performance of waived laboratory testing only. This was confirmed by the laboratory director on May 7, 2018 at approximately 3:00 PM. The laboratory performs approximately 23,646 patient chemistry and toxicology tests annually. -- 2 of 2 --