Summary:
Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's personnel competency records and an interview with the supervisor, the laboratory director is herein cited for failure to specify in writing the responsibilities and duties of each individual authorized to perform specimen processing, test performance, or result reporting whether supervisory or director review is required prior to reporting patient test results. The findings include: 1. The laboratory lacked in writing, a delegation of responsibilities and duties of each individual authorized to perform specimen processing, test performance, or result reporting as applicable, whether supervisory or director review is required prior to reporting patient test results. 2. The surveyor's review of the annual competency documentation for the histology technician (HT) was performed and signed by the laboratory manager, who was neither the technical supervisor (TS) or general supervisor (GS), qualified under high complexity testing. 3. The supervisor confirmed in an interview on November 6, 2025, at approximately 9:15 a.m., that the laboratory did not have the written document outlining the delegation of duties and responsibilities and that the competency assessment for the HT was not performed by a qualified TS or GS in the absence of the laboratory director. 4. The laboratory's Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- testing declaration form, signed by the laboratory director on September 9, 2025, stated that the laboratory processed approximately 135 Histopathology specimen annually. -- 2 of 2 --