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 American Association of Family Practice (AAFP) proficiency testing (PT) documentation for 2016 and 2017, confirmed by staff interview, testing personnel failed to document that proficiency testing samples were tested in the same manner as patient specimens in four out of six testing events. Findings: 1. AAFP PT attestation forms for 2016 and 2017 were reviewed. Forms for the third event 2016 and first, second and third events of 2017 showed signatures for the director and the laboratory manager (testing person 2-CMS form 209). 2. The attestation form for the third event 2016, AAFP-PT 2016-C, also showed the name of testing person 1, written a similar style to that of testing person 2. The form for the first event 2017, AAFP-PT 2017-A, showed the names of testing persons 1 and 3, written in a similar style to that of testing person 2. The form for the second event 2017, AAFP-PT 2017- B, showed the name of testing person 3, written in a similar style to that of testing person 2. The form for the third event 2017, AAFP-PT 2017-B, showed the name of testing person 3, written in a similar style to that of testing person 2. 3. In an interview at the site on 3-21-2018, the laboratory manager (testing person 2) stated she had Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- written in the names of testing personnel 1 and 3, who had performed proficiency testing on the specimens and dates noted, rather than have them sign the forms. . -- 2 of 2 --