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 proficiency testing (PT) and patient log record review and interview with the laboratory staff, the laboratory staff did not test PT samples in the same manner as patient samples. Findings: 1. The laboratory uses a BD Affirm Microbial Identification System to test for Candida, Gardnerella, and Trichomonas. Patient specimens are recorded on a patient log prior to testing. 2. A review of patient logs from 2016 to 2017 showed that PT specimens were not recorded on the patient log in 4 of 6 Bacteriology PT events. 3. During an interview on 1/22/18 at 11:00 AM, the laboratory staff confirmed that PT specimens were not being logged on to the patient log in the same manner as patients. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 1/18/2016 for not rotating PT among all staff performing patient testing. The