Summary:
Summary Statement of Deficiencies 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 document review and interview, the laboratory failed to verify the accuracy of one of twenty-two tests (buprenorphine) performed on the Liquid Chromatography Mass Spectrometry (LCMS) analyzer during 2019. Findings included: 1. Review of accuracy verification documentation for 2019 indicated the following: a. The laboratory performed a comparison with "From Pain To Wellness" laboratory (FPTW) twice for their accuracy verification activities during 2019 for buprenorphine. The laboratory director reviewed the comparison test results on 4-3-2019 for the accuracy verification performed on 3-18-2019. b. During the March, 2019 comparison, the laboratory noted: "There is a discrepant results (sic) for...Buprenorphine," and indicated the laboratory would only report qualitative results "until the issue is resolved." 2. Review of patient records indicated the following: a. Patient #10 had quantitative test results for buprenorphine reported on 3-26-2019 (1037 nanograms per milliliter (ng/mL)); 4-24-2019 (446 ng/mL); and 5-1-2019 (277 ng/mL). b. Patient #11 had quantitative test results for buprenorphine reported on 5-1-2019 (226 ng/mL). c. Patient #12 had quantitative test results for buprenorphine reported on 3-26-2019 (663 ng/mL). 3. In interview on 11-19-2020 at 3:05 PM, SP1, Laboratory Director, acknowledged the buprenorphine accuracy verification was not acceptable during the March, 2019 accuracy verification event. SP1 further acknowledged they reviewed and signed the accuracy verification report on 4-3-2019. SP1 indicated the