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 review of proficiency testing attestation statements and an interview with the general supervisor at 10:45 AM on 8/15/2018, the laboratory failed to attest to the routine integration of sample into the patient workload using the laboratory's routine methods. Findings are: 1. Review of proficiency testing attestation statements for 2017 and 2018 revealed no director or designee signatures on 5 of 9 attestation statements for 2017 and no testing personal signatures on 2 of 9 attestation statements for 2017. 2. Interview with the general supervisor revealed another person had been assigned during this time period to ensure the statements had been properly signed, but this person had failed to perform this duty and the supervisor had failed to check that the duty had been performed. 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 --