Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on interview with the testing personnel, technical supervisor and laboratory director and proficiency testing (PT) record review, the laboratory director or designee and testing personnel failed to sign the attestation statement page provided by American Proficiency Institute (API) , the proficiency testing provider. Findings include: 1. The attestation statement page were not signed by the testing personnel and laboratory director or designee for the following testing events. a) 2nd event 2019 Hematology. b) 2nd and 3rd event 2019 Comprehensive Chemistry. c) 2nd and 3rd event 2019 Immunoassay. 2. The Laboratory Director, Technical Supervisor ,Testing Personnel and the Chief Operation Officer concurred with these findings 01/06/20 @ 17:00 PM. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 interview with the testing personnel, technical supervisor and laboratory director and proficiency testing (PT) record review, the laboratory director or designee and testing personnel failed to document