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 upon a review of proficiency testing records and interview with the Laboratory Supervisor on the date of the survey (06/17/2020), the laboratory failed to ensure that 1 of 2 Wisconsin State Laboratory of Hygiene (WSLH), 2020 attestation statements was signed by the Director and analyst. Findings: 1. At the time of the survey, (09:30 06/17/2020), 1 of 2 WSLH 2020 testing event attestation statements reviewed did not have the analyst and Laboratory Director's signature. 2. During the survey (10:30 06 /17 2020), Laboratory Supervisor confirmed the above findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 -- This STANDARD is not met as evidenced by: Based a review of proficiency testing records and interview with the Laboratory Supervisor on the date of the survey (06/17/2020), the Laboratory failed to ensure review and evaluation of the results obtained on proficiency testing for 1 of 3 American Academy of Family Physicians (AAFP) 2019 events. . Findings: 1. The Director's review signature for proficiency test score reports was not found for 1 of 3 AAFP microbiology proficiency events in 2019. 2. The laboratory could not provide documentation of evaluation & review performed on the 2019 AAFP microbiology event 1, with a score of 80%. 3. During the survey (10:30 06/17/2020), the Laboratory Supervisor confirmed the above findings. -- 2 of 2 --