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 a review of the American Proficiency Institute (API) proficiency testing records and an interview with the Technical Consultant (TC), the laboratory failed to ensure attestation statements were signed by the laboratory director for 4 of 6 surveys reviewed in 2017. The findings include: 1. A review of the 2017 API proficiency testing records revealed attestation statements for the second and third Chemistry survey events and the first and second Hematology survey events were not not signed by the laboratory director. 2. During an interview on 5/2/2018 at 11:06 AM, the TC reviewed the 2017 proficiency testing records with the surveyor and confirmed attestation statements for Chemistry surveys second and third events and Hematology surveys first and second events were not signed by the laboratory director. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --