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 record review and interview, the laboratory failed to perform remedial action for an unsuccessful score for one out of five analytes (platelet count (PLT)) tested using DxH 520 Automated Hematology Analyzer (SN: BD040304) for one (2022-A) of three proficiency testing (PT) for events in 2022. Findings include: 1. Review of PT testing evaluation from the American Academy of Family Physicians (AAFP) "EVENT: 2022-A Performance" indicated platelet count (PLT) had a score of 40% which is "unsatisfactory". 2. Review of laboratory "Policy # 3615LabAMB- SLFM-QA", signed by the laboratory director on 11/28/22, states: a. "Proficiency Testing for Moderate Complexity Testing is provided by American Academy of Family Physicians (AAFP)" on page 1 of 22. b. Under "