Summary:
Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on staff interview and record review of proficiency testing (PT) results from American Proficiency Institute (API) on 09/13/2021, the laboratory director failed to ensure proficiency test results were reviewed for two (2) out of three (3) events for 2020. The findings include: 1. Record review revealed the laboratory scored an overall ninety-six percent (96%) for Hematology and an eighty percent (80%) for the analyte Red Blood Cell Count (RBC) for API PT second (2nd) Event of 2020. Record review revealed the laboratory failed to document any