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) record and patient sample log review and interview with the technical consultant (TC), the laboratory did not handle bacteriology, mycology, and parasitology PT specimens in the same manner as patient samples. Findings: 1. All patient samples which enter the laboratory are recorded on a patient log. 2. A review of patient logs from January, 2017 to December, 2018 showed that PT samples performed on the BD Affirm MicroProbe Processor were not documented on the patient log along with patient specimens in 4 of 6 PT events; and 3. PT specimens performed on the Cepheid GeneXpert for Group B Strep were not documented on the patient log along with patient specimens in 2 of 4 PT events. Patient logs were not available for review for 2 of 4 events; and 4. PT specimens performed on the Cepheid GeneXpert for Chlamydia trachomatis and Neisseria gonorrhoeae were not documented on the patient log along with patient specimens in 2 of 5 PT events. Patient logs were not available for review for 3 of 5 events. 5. During an interview on 1/8/19 at 1:15 PM, the TC confirmed that PT samples were not handled in the same manner as patient specimens. D2015 TESTING OF PROFICIENCY TESTING 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 4 -- CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Note: This is a repeat deficiency. The laboratory was cited during the re-certification survey on 1/30/2017 for failing to ensure that PT records are maintained for a minimum of two years. The