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 11/29/2021, the laboratory director failed to ensure proficiency test results were reviewed for one (1) out of three (3) events for 2020, and one (1) out of two (2) events for 2021. Findings include: 1. The laboratory scored an eighty percent (80%) for the analyte Hematocrit (Hct) for the API PT 3rd event of 2020 and an eighty percent (80%) for the analyte Hct for API PT 1st Event of 2021. Record review revealed that the laboratory failed to document a