Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was conducted on July 16, 2025, at 9:00 A.M. by the Montana CLIA Certification Program. 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 a review of proficiency testing records from the American Proficiency Institute (API), patient results report, and an interview with the manager (not listed on the Laboratory Personnel Report, CMS 209 form), the laboratory failed to perform biannual verifications for Fentanyl for the year 2025 which were included in their Test Result Final Report dated July 3, 2025. Findings: 1. A review of the Test Result Final Report for accession #0100657302 listed test results for Fentanyl performed on July 03, 2025, at 3:43 PM. 2. A review of 2025 API records and biannual verification records lacked biannual verification of Fentanyl. 3. Interview on July 16, 2024, at 10: 24 AM with the manager (not listed on the CMS 209 form) confirmed the Test Result Final Report was for their drug therapy program and Fentanyl was not included in their proficiency testing or biannual verification program for the year 2025 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 --