Summary:
Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record reviews and staff interview, the laboratory director failed to ensure policies were followed for quality assessment (QA) quarterly reviews, sharing reviews at monthly meetings, and sharing at all labs semiannual meetings for two of two subspecialties (microbiology and general immunology) for five of five quarters reviewed (2018 - Q1, Q2, Q3, Q4 and 2019 - Q1). Finding(s) included: 1. The policy "Management Review and Audit Program for Public Health Laboratories", "policy Stat ID: 4805661", revised 5/2018, read: "2 ...A summary of the quarterly reports is shared at the next monthly Management Meeting ....4.