Summary:
Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and 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 results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through review of the CMS 209 form, lack of documentation and interview it was determined that the laboratory director failed to specify which examinations and procedures testing personnel are authorized to perform for four of four testing personnel identified on the CMS 209 form. Findings follow: A) Review of the CMS 209 form provided by the laboratory identified four testing personnel in the laboratory. B) Upon request, the laboratory was unable to provide documentation signed by the laboratory director specifying what procedure(s) each testing personnel is authorized to perform. C) In an interview on 6/13/19 at approximately 09:45 AM, the general supervisor, identified as number two on the CMS 209 form, confirmed that there was no documentation of authorization to perform procedures signed by the laboratory director for the testing personnel identified on the CMS 209 form and confirmed the testing personnel identified on the CMS 209 form had performed and reported testing. 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 --