Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the laboratory lead, the laboratory failed to rotate the American Association of Bioanalysts (AAB) hematology test events through all testing personnel since the AAB 2017 quarter 1 event. Findings: 1. A record review of PT documents from AAB revealed the laboratory lead was the only testing personnel performing the hematology PT events. 2. An interview on July 25, 2018 at 3:00 PM, with the laboratory lead, confirmed the laboratory failed to rotate the PT events through all the testing personnel listed on the CMS-209 Personnel Report form. 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. 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 -- This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the laboratory lead, the laboratory director failed to sign the American Association of Bioanalysts (AAB) hematology test attestation statements since 2017 quarter 1 event. Findings: 1. A record review of PT documents from AAB revealed the laboratory director failed to sign the attestation statements for testing performed in the specialty of hematology since the 2017 quarter 1 event. 2. An interview on July 25, 2018 at 3: 00 PM, with the laboratory lead, confirmed the laboratory director failed to sign the attestation statements since 2017 quarter 1 through 2018 quarter 1. 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 proficiency testing (PT) record review and an interview with the laboratory lead, the laboratory failed to document