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 November 16-17, 2021. 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. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the director approved policy entitled "Proficienty (sic) Testing," the lack of laboratory records of twice per year verification of accuracy for the following analytes not included in the College of American Pathologists (CAP) Drug Monitoring for Pain Management (DMPM) Proficiency Testing (PT) enrollment for 2019, 2020 and 2021: MDEA, Mephedrone, Methylphenidate, Ritalinic Acid, Nordiazapam, Secobarbital, Flurazepam, Metaxalone, Zaleplon, Zolpidem, Amitriptyline, Cuclobenzaprine, Desipramine, Doxepin, Duloxetine, Nortriptyline, JWH-018 Pentanoic acid, JWH-073 Butanoic acid, JWH-073 Hydroxybutyl, Mitragynine, Baclofen, Clonidine, Ketamine, Naphyrone, Norketamine, Norpseudoephedrine, Naloxone, Naloxone Glucoronide, Naltrexone, Morphine 3 Glucuronide, and Morphine 6 Glucuronide, the laboratory failed to perform twice per year verification of accuracy for analytes not included in commercially available Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 24 -- proficiency testing enrollment (refer to D5217), a review of the College of American Pathologists (CAP) Drug Monitoring for Pain Management (DMPM) Proficiency Testing (PT) 2020 and 2021 laboratory evaluation reports and