Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of 2018 and 2019 American Association of Bioanalysts (AAB) proficiency testing (PT) records and interview with testing personal (TP) 12/4/19, the laboratory failed to ensure 1 of 2 TP who perform testing in the speciality of hematology participated in PT. Findings: Review of 2018 and 2019 AAB PT records revealed TP # 2 failed to participate in 6 of 6 "Hematology with Differential analytes" AAB PT events for the speciality of hematology. Interview with TP #2 at approximately 10:25 a.m. confirmed she had not participated in the 6 AAB PT events for the "Hematology with Differential analytes", she stated she only performs testing if she is needed and did not realize she should be participating in PT. 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