Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 14, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D2015 TESTING OF PROFICIENCY TESTING SAMPLES 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: Based on review of proficiency testing (PT) records and staff interview, the laboratory failed to retain a copy of the instrument print outs showing results obtained when analyzing PT samples for 4 of 5 testing events reviewed. Findings include: 1. Review of PT records for 2017 and 2018 revealed no instrument printouts or raw data showing results obtained from the Emerald Cell Dyn Hematology analyzer for PT samples on 4 of 5 events reviewed (events 1,2 and 3 of 2017 and event 1 of 2018). 2. Interview with the technical consultant on November 14, 2018 at approximately 12 pm in the break room confirmed instrument printouts for the events listed above are not available. 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 --