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 CAP PT records and confirmed in an interview with the current laboratory director, the laboratory failed to verify the accuracy of the of 9 out of 9 toxicology analytes and 2 adulterants at least twice a year in the calendar year 2018. FINDINGS: The laboratory director confirmed on September 9, 2019 at approximately 2:30 PM, that the laboratory failed to verify the accuracy of the 9 toxicology analytes and 2 adulterants at least twice a year in the calendar year 2018. The laboratory uses the CAP modules Drug Adulterant Integrity (DAI) and Drug Monitoring Pain Management (DMPM) for twice year verification. The laboratory only performed CAP testing once in the calendar year 2018 for 9 toxicology analytes and 2 adulterants. Approximately 2000 patient's specimens were tested during this time-period. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require