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 surveyor's review of the American Proficiency Institute (API) records and confirmed in an interview with the two laboratory supervisors and technical consultant, the laboratory failed to evaluate and verify the accuracy of 7 out of 7 toxicology analytes in the year 2018. FINDINGS: The two laboratory supervisors and technical consultant, confirmed on July 30, 2019 at approximately 12:00 PM, that the laboratory failed to evaluate and verify the accuracy of 7 toxicology analytes for screening in the year 2018. 1. The laboratory uses the API modules the Urine Drug Screening (UDS) for twice year verification. The laboratory failed to verify 7 of 7 toxicology analytes for screening. 2. Approximately 150 patient specimens were tested and reported during this time-period. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on surveyor's review of the