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 review of proficiency testing (PT) scores supplied by the PT agency and interview with the facility personnel, the laboratory failed to provide evidence of remedial action for the unsatisfactory scores of 0 received under the specialty of Hematology and for the regulated analyte Prothrombin Time respectively for the 3rd event of 2017. Findings include: 1. There was no documented