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: During an onsite recertification survey on 6/7/2018, based on proficiency testing record review and testing personnel interview, the laboratory director and testing personnel failed to sign the attestation statement for four of five proficiency testing events reviewed (2016, Events 2 and 3; 2017, Events 1 and 2). Findings include: 1. Review of proficiency testing records from American Proficiency Institute (API) revealed that the attestation statements for the four events listed above revealed the following: a. 2016, Event 2; 2017, Events 2 and 3: attestation not signed by the laboratory director b. 2016, Event 3: attestation not signed by the laboratory director or testing personnel 2. Testing personnel confirmed during the exit interview at 1:30 pm that the laboratory director and testing personnel failed to sign the attestation statements. D5785