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 review of 2018, 2019 proficiency testing (PT) and interview with the technical consultant the laboratory failed to verify accuracy for one of thirteen urine drug screen analytes in 2018. Findings: 1. Review of 2018 PT for urine barbiturates showed the laboratory failed to verify accuracy twice annually. 2. Interview with the technical consultant on November 5, 2019 at 2:00 PM confirmed the laboratory failed to verify accuracy for urine barbiturates twice annually in 2018. 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. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of 2018, 2019 instrument comparison documentation and interview with the technical consultant, the laboratory failed to perform instrument comparisons for two medtox instruments two times a year. Findings: 1. Review of two medtox instrument comparisons showed the laboratory failed to document comparisons for amphetamine, barbiturate, benzodiazepine, buprenorphine, cannabinoid, cocaine 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 -- metabolites, methadone, methamphetamine, opiate, oxycodone, phencyclidine, propoxyphene and TCA two times a year for 2018 and 2019. 2. Interview with the technical consultant on November 5, 2019 at 2:00 PM confirmed, the laboratory failed to perform instrument comparisons for two medtox instruments two times a year for 2018 and to date 2019. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require