Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey conducted on August 25, 2026, at PHC Las Cruces Inc. DBA Memorial Medical Center found the laboratory to be not in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on direct observation, interview with the technical consultant (TC), and lack of documentation, the laboratory failed to, at least twice a year, evaluate the relationship between test results for activated clotting time (ACT) performed on 6 of 6 of their i- STAT analyzers in 2025. Findings included: 1. During a tour of the hospital on 08/25 /2026 at 11:00 AM the following i-STAT analyzers were observed in use, 2 in the cardiac catheterization laboratory (S/N: 423244 and 352040) and 2 in the intensive care unit (S/N: 318518 and 345201). 2. During an interview on 08/25/2026 at 1:10 PM the TC stated there were also 2 i-STAT analyzers (S/N: 441459 and 44389) in the operating room. During the same interview the TC also confirmed all 6 analyzers performed ACT testing. 3. The laboratory was asked to provide documentation they had performed an evaluation of test results for the ACT testing performed on the 6 i- STAT analyzers. The laboratory provided an email communication dated 10/08/2024 from their accrediting organization stating they did not need to perform an instrument- to-instrument evaluation of results for the i-STAT analyzer. 4. During an interview on 08/25/2026 at 11:40 AM the TC stated they used to perform instrument-to-instrument 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 -- evaluation of results for ACT testing performed on the i-STAT analyzers but stopped in 2025 after they had received the email communication from their accrediting organization, confirming the above findings. 5. The laboratory reported performing 1,825 ACT tests annually. -- 2 of 2 --