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 review of CAP (College of American Pathologist) proficiency testing records and interview with laboratory director, the laboratory failed to keep on site the attestation records for years 2016 and 2017 Review of CAP proficiency records revealed that the attestation records for 6 out of 6 events were not available on site for years 2016 and 2017. During an interview on 5/30/2018 at 11:30 AM the laboratory director confirmed that the attestation records were not available onsite during the inspection. 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 --