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 record review and interview, the laboratory failed to sign copies of attestation statements for 2017 (event 3), 2018 (events 1, 2 & 3) and 2019 (event 1). Findings: Review of the laboratory's proficiency testing records with American Proficiency Institute (API) showed that the laboratory director and testing personnel had not signed the attestation forms for the 1st, 2nd, and 3rd events in 2018, and the 1st event in 2019. API proficiency testing records also showed that the laboratory director had not signed the attestation forms for 3rd event in 2017. During an interview on 5/02/19 at 9:38 AM, Testing Personnel A acknowledged that the forms were not signed. 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 --