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 American Proficiency Institute (API) PT attestation pages from 4/1/22 to 10/10/23 revealed all testing had been performed by testing personnel (TP) #1 for eight of eight testing events. 2. Review of the CMS 209 reveals that TP #1 is also technical consultant (TC) #2. There was a total of eight testing personnel on the CMS-209. Only one of eight TP performed PT sample testing. 3. Interview with TC #2 on 10/18 /23 at 10:40 a.m. confirmed, the laboratory failed to include personnel who routinely perform the regular patient testing in the testing of proficiency samples. 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 --