Summary:
Summary Statement of Deficiencies D0000 An announced Clinical Laboratory Improvement Amendments (CLIA) exempt-state validation survey was conducted at the BCHP Infusion Center on November 6, 2023, by a Centers for Medicare & Medicaid Services (CMS) New York CLIA Branch Location federal surveyor. The laboratory was surveyed under 42 CFR part 493 CLIA regulations. The laboratory was found to be in compliance with condition-level CLIA requirements. The following standard-level deficiencies were found during the CLIA exempt-state validation survey performed on November 6, 2023. 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 a review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1, the laboratory failed to ensure a