Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey conducted on April 9, 2025 at Kindred Hospital Albuquerque found the laboratory to be not in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory's Calibration & Calibration Verification policy, Calibration Verification records for the Nova Prime CCS, lack of documentation, and interview with Testing Personnel 2 (TP2); the laboratory failed to follow their own procedure requiring calibration verification for the Nova Prime CCS `be performed at least every six months in 2023 and 2024. Findings include: 1. Review of laboratory's Calibration & Calibration Verification policy stated calibration verification must be performed "At least every six months." 2. Review of laboratory's calibration verification records for the Nova Prime CCS for 2023 and 2024 revealed calibration verification was performed once in 2023 (4/4/2023) and once in 2024 (7/22/2024). 3. A request was made for calibration verification records demonstrating the six-month minimum requirement was met, none were provided. 4. Interview with TP2 on 4/9 /2025 at 1:45 pm confirmed the above findings. 5. The laboratory reports 2000 Routine Chemistry tests annually. D5781