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 American Proficiency Institute (API) proficiency testing (PT) records and interview with the technical consultant (TC) ( CMS 209 personnel #1), the laboratory failed to verify the accuracy of the PT results obtained for 1 of 2 API Hematology/Coagulation testing events in 2022. Findings Include: 1. On the day of survey, 02/14/2024 at 11:28 am., review of the laboratory's API PT records revealed that the laboratory did not verify the accuracy for the following analyte that was not scored by the PT agency due to non-consensus: - API 2022 Hematology / Coagulation 2nd event: Vaginal Wet Preparation - VA 02 2. The API Proficiency Testing performance Evaluation form states " Laboratories are responsible for documenting and performing