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 the laboratory proficiency testing records, and interview with the laboratory liaison, the laboratory director / designee failed to sign the proficiency testing attestation statement for 2019 event one hematology/urine sediment. 1) Review of the laboratory's proficiency testing records revealed the attestation statement for hematology/urine sediment 2019 event one was not signed by the laboratory director or designee. 2) Interview with the laboratory liaison on August 12, 2019 at 12:15 pm confirmed the proficiency testing attestation statement for hematology/urine sediment 2019 event one was not signed. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved