Summary:
Summary Statement of Deficiencies D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must 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 Surveyor review of personnel training & competency evaluation records, laboratory policy & procedure, patient testing records, lack of records, and interview with the laboratory testing personnel, the laboratory failed to provide any record showing that the laboratory Director has authorized the lab personnel of any responsibilities and duties in writing. The findings include: a. The laboratory did not have any records of written authorization by laboratory Director of any responsibilities and duties for any lab personnel. b. On March 14, 2019 at 2:30 pm, laboratory personnel affirmed that the laboratory Director did not assign any responsibilities and duties to any personnel in writing. c. The laboratory testing declaration form, signed by the laboratory Director on February 28, 2019 stated that the laboratory performs 10,000 tests annually. 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 --