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 review of laboratory records, personnel records and interview with the lead testing person, the laboratory director failed to ensure delegation of duties to three of three persons performing technical consultant duties. The findings include: 1. Review of laboratory records including competency assessments and quality control revealed the technical consultant duties of testing personnel competency assessment and review of quality conrol being performed by three persons who were not the laboratory director. 2. Review of personnel records revealed there were no job descriptions or delegations for performing the technical consultant duties including competency assessments and review of quality control. 3. Interview with the lead testing person on 10/10/22 at 10:15 am confirmed there were no written delegation of duties to three of three persons who were performing technical consultant duties. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --