Summary:
Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on January 22, 2024, at Albuquerque - AMG Specialty Hospital found the laboratory to be in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the submitted CMS form 209, laboratory policy, and confirmed in staff interview, the laboratory failed establish and follow a policy for assessing the competency for 1 of 1 Technical Consultants (2022 through 2023). Findings included: 1. A review of the submitted CMS form 209 listed one Technical Consultant. 2. A request was made for a policy for assessing the competency of Technical Consultants. No policy was provided. 3. During an interview on 01/22/2024 at 1115 am, after review of the above records, the Technical Consultant confirmed the findings. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. 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 review of Chemistry Controls Auto-Cartridge package insert, Blood Gas Laboratory Refrigerator Log, and staff interview, the laboratory failed to follow manufacturer's acceptable temperature ranges for 16 of 114 events from October 2023 through January 2024. Findings included: 1. Review of Chemistry Controls Auto- Cartridge package insert states reagents are to be stored at 37 to 46 Fahrenheit (F) 2. Review of Blood Gas Laboratory Refrigerator Log showed an acceptable range of 35.6 to 46.4 F, which is outside manufacturer approved range. 3. Review of Blood Gas Laboratory Refrigerator Log showed the following dates out of manufacturers acceptable range. 1. 10/31/2023: Refrigerator Temperature 36F 2. 11/05/2023: Refrigerator Temperature 36F 3. 11/11/2023: Refrigerator Temperature 36F 4. 11/28 /2023: Refrigerator Temperature 36F 5. 11/30/2023: Refrigerator Temperature 36F 6. 12/04/2023: Refrigerator Temperature 36F 7. 12/07/2023: Refrigerator Temperature 36F 8. 12/09/2023: Refrigerator Temperature 36F 9. 12/19/2023: Refrigerator Temperature 36F 10. 12/ 20/2023: Refrigerator Temperature 36F 11. 12/21/2023: Refrigerator Temperature 36F 12. 1/01/2024: Refrigerator Temperature 36F 13. 1/14 /2024: Refrigerator Temperature 36F 14. 1/16/2024: Refrigerator Temperature 36F 15. 1/18/2024: Refrigerator Temperature 36F 16. 1/22/2024: Refrigerator Temperature 36F 4. Interview on 1/22/2024 at 11:30 am with the technical consultant confirmed the findings. -- 2 of 2 --