Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed on 12/06/19. The findings were reviewed with the laboratory director at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies 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 a review of records and interview with the laboratory director, the laboratory director failed to sign a proficiency testing attestation statement for 2 of 5 events. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following for 2 of 5 events: (a) First 2018 Immunohematology Event - The attestation statement had not been signed by the laboratory director; (b) Second 2018 Immunohematology Event - The attestation statement had not been signed by the laboratory director. (2) The surveyor reviewed the findings with the laboratory director, who stated the attestation statements had not been signed by the laboratory director. 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 --