Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with the technical consultant, the laboratory failed to test proficiency testing samples the same as patient samples for six of six events reviewed for 2020, 2021, and 2022. The findings include: 1. Review of the laboratory's proficiency testing records revealed the laboratory tested proficiency testing samples multiple times by multiple personnel on multiple days prior to the results submission date as follows: 2020 event one: due date=05/13/20, sample numbers UDS-04, UDS-05, UDS-06, UAD-04, UAD-05, and UAD-06 run once on 05/01/20 by one testing person and then again on 05/05/20 by a different testing person. 2020 event two: Due date=11/04/20, sample numbers UDS- 04, UDS-05, UDS-06, UAD-04, UAD-05, and UAD-06 run twice on 10/27/22 by two different testing persons. 2021 event one: Due date=05/12/21, sample numbers UAD- 01, UAD-02, and UAD-03 run twice on 04/27/21; sample numbers UDS-03 run twice on 04/27/21 by two different testing personnel. 2021 event two: Due date=11/03/21, sample number UDS-06 run on 10/17/21, then again on 10/21/22 by a different testing person; sample numbers UAD-04 and UAD-05 run on 10/17/21, then again on 10/21 /22 by a different person. 2022 event one: Due date=05/11/22, sample numbers UDS- 01 run twice on 05/02/22 by two different testing persons. 2022 event two: Due 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 -- date=11/02/22, sample numbers UAD-04 and UAD-06 run twice on 10/17/22. 2. Interview with the technical consultant on 10/26/22 at 11:30 am confirmed the laboratory did not test proficiency testing samples the same as it tests patient samples when it tested the proficiency testing samples multiple times, on multiple dates and by multiple testing personnel. She further stated they do not routinely test patient samples in the same manner. The laboratory failed to ensure it tested its' proficiency testing samples the same as patient samples in 2020, 2021, and 2022 for six of six events. -- 2 of 2 --