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 lack of accuracy verification documentation for review and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Toxicology at least twice annually. Findings include: 1. The laboratory began patient testing on 3/03/2020. The laboratory performs a urine drug screen test on the Sciex 4000 Q Trap LC/MS/MS analyzer and a urine drug confirmation test on the Sciex API4000 LC/MS analyzer, with an approximate annual test volume of 119,790. 2. During the survey conducted on August 3, 2022, no documentation was presented for review to indicate the laboratory verified the accuracy of the urine screen test and the urine confirmation test at least twice annually from March 3, 2020 through August 30, 2021. 3. At 10:55am on 08/03/2022, the facility personnel interviewed confirmed the laboratory failed to verify the accuracy of the urine drug screen and confirmation testing at least twice annually during the time period indicated above. D5785