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 record review and interview with the Technical Consultant (TC), the laboratory failed to verify the accuracy of its toxicology testing at least twice annually for 1 (November 2019 to November 2020) of 1 year reviewed. Findings include: 1. An interview on 11/17/20 at 9:38 am with the TC revealed the laboratory started testing in November 2019. 2. A review of the laboratory's test menu revealed it is currently testing the following analytes: a. Amphetamines b. Cocaine c. Opiates d. Oxycodone e. Benzodiazapine 3. A review of the laboratory's proficiency testing documentation revealed a lack of verification of accuracy at least twice annual verification of accuracy for the analytes listed above. 4. A review of the laboratory's established "Proficiency Testing" procedure revealed a section titled "Split Samples" stating, "If proficiency testing is not provided for an analyte, then split samples will be run twice per year. Two samples will be run and each samples difference must be within 25%. A score of less than 80% will be considered failing and