Summary:
Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and an interview with the Technical Consultant (TC) #1, the Laboratory Director (LD) failed to delegate Proficiency Testing (PT) attestation to the routine integration of PT samples into the patient workload using the laboratory's routine methods to qualified personnel for 12 out of 12 proficiency testing events for 2018 and 2019. All patients tested under the speciality of general chemistry had the potential to be affected. Findings Include: 1. Review of ''General Supervisor Competency Evaluation,'' which listed the duties delegated to the TC #1 by the LD, found no mention of PT attestation delegation from the LD to the TC #1. Excerpt from "General Supervisor Competency Evaluation:" "...Is accessible to testing personnel at all times testing is performed to provide on-site telephone or electronic support Provide day to day supervision of personnel. Monitors test analyses and specimen examination to sure that acceptable levels of analytic performance are maintained. Fulfills certain responsibilities as delegated by the Laboratory Director or Technical Supervisor These may include: Resolving technical problems and ensuring that