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 testing personnnel at 10:45 AM on 2/22/2019, 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 2017 and 2018 proficiency testing attestation statements revealed no signature from the laboratory director on 2017 event B chemistry and 2018 event C chemistry. 2. Interview with the testing personnel confirmed the absence of laboratory director's signature. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require