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 review of proficiency testing (PT) records, the PT standard operating procedure (SOP), and patient testing logs and interview with the laboratory director (LD), the laboratory failed to ensure that PT results were documented in the same manner as patient results and PT samples were tested by the testing personnel (TP) who routinely performed patient testing. Findings: 1. Records for six PT events were reviewed for the Microbiology 2020 3rd event through the 2022 2nd event. 2. The laboratory used the Affirm VPIII Microbial Identification Test system which required the TP to visually read the test results from the Probe Analysis Card. The only records of the test results were what was manually documented by the TP. 3. The TP documented patient results on the Affirm Log Sheet which captured the date of testing, patient name, test results and the initials of the TP who performed the testing. 4. The laboratory's PT SOP stated to "[d]ocument testing numbers ( VP-01, VP-02, etc) onto Affirm log sheet." 5. The PT results were not recorded on the Affirm Log Sheet in three of the six PT events (2022 2nd event, 2021 3rd event, and 2021 1st event). 6. The PT SOP stated "[r]emove cards from processor, lay them on a paper towel for Lab Director to review and validate results." The LD did not review and validate results for routine patient testing. 7. The laboratory personnel report (CMS- 209) listed four TP. 8. Review of the attestation statements showed that TP 1 performed testing for five of the six PT events, TP 2 performed testing for one of the six PT events, and TP 3 performed none of the six PT events (TP 4 was recently hired). Review of the Affirm Log Sheets from 08/18/2020 - 08/23/2022 showed that TP 1 did not perform routine patient testing, only testing of PT samples. 9. During the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- survey on 08/25/2022 at 12:00 PM, the LD confirmed that PT sample results were not consistently documented with routine patient results and were not tested by the TP who routinely performed patient testing. D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to document an investigation into the unsatisfactory results received during the 2021 Microbiology 2nd PT event. Findings: 1. The laboratory used the Affirm VPIII Microbial Identification Test system to identify Candida species, Gardnerella vaginalis, and Trichomonas vaginalis in patient specimens. 2. The laboratory received a score of 60 percent for Gardnerella vaginalis in the 2021 Microbiology 2nd PT event. 3. In the section titled "