Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review, manuals, and an interview with the technical consultant (TC); the laboratory failed to ensure the laboratory director (LD) attest to the routine integration of proficiency testing (PT) samples into the patient workload using the laboratory's routine methods, during the years of 2017 through 2019. Findings include: 1. The laboratory procedures manual and PT documents were reviewed. 2. The laboratory's PT policy and procedure and the PT program instructions require the signature of the LD to attest to the treatment and testing of PT samples when submitting any PT results to the PT program, as a condition of participation, for each PT event. 3. The laboratory participated in 6 PT events during the years of 2017 through 2019. The PT documents revealed 5 out of 6 attestation statements were not signed by the LD. 4. On a Recertification survey conducted on 07/30/2018 at 11:30 AM, the TC confirmed the above findings. 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 --