Summary:
Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #5 (refer to the Laboratory Personnel Report) at approximately 10: 15 am on 02/14/2022, the laboratory failed to perform a self evaluation of ungraded PT scores for two out of six PT testing events from 01/01/2020- 12/31/2021 (2020 event 3 and 2021 event 3). The findings include: 1. For 2020 testing event 3, the laboratory received ungraded PT test scores for the following: *2020 Hematology /Coagulation 3rd event: urine sediment (specimen US-06) 2. For 2021 testing event 3, the laboratory received ungraded PT test scores for the following: *2021 Hematology /Coagulation 3rd event: vaginal wet prep (KOH) (Specimen VKP-03) 3. At the time of the survey, the laboratory did not have additional documentation or