Summary:
Summary Statement of Deficiencies D0000 An onsite Validation survey conducted on January 30, 2025, at Baymark Health Srvcs/ Recovery Services of NM Lab found the laboratory to be not in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. 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 review of the laboratory's test menu, College of American Pathologist (CAP) proficiency testing (PT) drug master list, lack of documentation, and interview with the General Supervisor, the laboratory failed to verify the accuracy at least twice annually for 3 of 30 non-regulated analytes in 2023 and 2024. Findings included: 1. A review of the laboratory's test menu from 2023 and 2024 revealed the following non- regulated analytes the laboratory failed to verify the accuracy at least twice annually: - 2-hydroxyethylflurazepam - Alphahydroxymidazolam - Ritalantic Acid 2. A review of the CAP PT drug master list for the Urine Toxicology Survey kit in 2023 and 2024 revealed the 3 above analytes are not listed as analytes tested for by the CAP PT kit. 3. A request was made for documentation verifying the accuracy at least twice annually for the above 3 analytes. The laboratory failed to provide any documentation. 4. An Interview on 01/30/2025 at 10:16 am with the General Supervisor, confirmed the above findings. 5. The laboratory reported performing 459,756 toxicology tests annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of College of American Pathologist (CAP) proficiency testing (PT) records, lack of documentation, and interview with the General Supervisor, the laboratory failed to perform