Summary:
Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the "Proficiency Testing (PT) for Point of Care Testing-LBH" procedures that included whole blood (WB) human chorionic gonadotropin (hCG) and interview with the general supervisor (GS) of point of care (POC) testing, the laboratory failed to provide instructions for verifying the accuracy of the of WB-hCG that was not listed in subpart I. Findings: 1. The "Proficiency Testing (PT) for Point of Care Testing-LBH" procedures states, "For Fingerstick hCG: The POCC has collaborated with the medical director to determine a suitable alternate PT assessment to be run semi-annually." 2. During the survey on 07/25/2022 at 11:00 AM, the GS of POC testing confirmed that the alternate PT procedure for fingerstick WB-hCG did not provide instructions for how to select specimens from the POC lab to be compared with hCG results from the main lab, document the findings for review, and