Summary:
Summary Statement of Deficiencies D0000 A Validation Survey conducted on May 19, 2026, at Rio Rancho Branch Laboratory Tricore 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 the COAG 83 D-Dimer Test- ALERE Triage MeterPro for Branch Labs Procedure, the laboratory's In House Worksheet, patient test results, and interview with Technical Consultant 2, the laboratory failed to follow their own policy by not completing their In House Worksheet for abnormal D-Dimer results for 1 of 5 results in January and 1 of 6 results in March of 2026. Finding included: 1. Review of the policy titled COAG 83 D-Dimer Test- ALERE Triage MeterPro for Branch Labs Procedure, under section X. Reporting Results, under bullet B stated, "Affix the printed D-Dimer result to the In House Test Worksheet. Check the result box Squares" 2. Review of the In House Worksheet revealed the following boxes required to be checked for D-Dimer results outside of normal range. - Room Temp 20-24 C (Celsius): Yes/No - Abnormal: >229 - Outside Linearity: >5000 - Provider Notified 3. Review of patient results for D-Dimers ran on the ALERE Triage MeterPro tested in January through March of 2026 revealed the In House worksheet did not have the "Abnormal" box checked for 1 of 5 results reviewed in January and did not have the "Abnormal" or "Room Temp" boxes checked for 1 of 6 results reviewed in March. 4. Interview on 05/19/2026 at 10:30 am with Technical Consultant 2 confirmed the above finding. 5. The laboratory reported performing 80 D-Dimer tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --