Summary:
Summary Statement of Deficiencies 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 proficiency testing records review, delegation of duties review, and interview with staff, the laboratory director and the technical consultant delegated by the director to sign attestation statements in his stead failed to attest proficiency testing samples are performed in the same manner as patient specimens for 3 of 6 testing events reviewed. Findings include: 1. Proficiency testing records reviewed included attestation statements signed by person A for the director for hematology American Proficiency Institute hematology event 2 of 2018, and the 1st and 2nd events of 2019. 2. Delegation of duties from the Director to attest the laboratory performed testing in the same manner as patients did not include person A as the person delegated to perform this duty of the director. 3. In an interview with person A on 08/22/2019 at approximately 4:45 P.M. staff confirmed the technical consultant delegation list did not include person A as being delegated to sign the attestation statement. 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 --