Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) attestation pages, CMS-209 personnel report and interview, the laboratory failed to include personnel who routinely perform the regular patient testing in the testing of proficiency samples. Findings: 1 Review of Wisconsin State Laboratory of Hygiene (WSLH) PT attestation pages from 6/29/22 to 4/16/24 revealed all testing had been performed by testing personnel (TP) #2 for four of four testing events. 2. Review of the CMS 209 personnel report revealed that TP #2 is also technical consultant (TC) #2. There was a total of six testing personnel on the CMS-209. Only one of six TP performed PT sample testing. 3. Interview with the Director of Operations on 6/6/24 at 10:20 a.m. confirmed, the laboratory failed to include personnel who routinely perform the regular patient testing in the testing of proficiency samples. 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. This STANDARD is not met as evidenced by: Based on a lack of PT performance evaluation records from WSLH for 2023 and interview, the laboratory failed to evaluate its proficiency testing results for two of 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 -- two events in 2023. Findings: 1. Review of the 2023 PT documents from WSLH revealed no evidence of evaluation for two of two 2023 events at the time of survey. a. 2023 MiscQA_POC1 b. 2023 MiscQA_POC2 2. Interview with the Director of Operations on 6/6/24 at 12:25 a.m. confirmed, the laboratory failed to evaluate its proficiency testing results for two of two events in 2023. -- 2 of 2 --