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: Based on review of the laboratory procedure manual, laboratory staff personnel records and interview with testing personnel (TP) #1 and #3 at 4:00 pm on the day of survey, the laboratory director failed to document in writing the responsibilities and duties for the laboratory consultants (clinical consultant and technical consultant) as well as the testing personnel. Findings include: 1. Review of the general laboratory procedure manual and personnel records revealed no policies were available which specified in writing the duties and responsibilities of each individual involved in the performance of preanalytic, analytic and postanalytic phases of testing. There was no list of examinations and procedures that each testing personnel was qualified to perform or report. 2. There was no policy stating the responsibilities and duties of the technical or clinical consultants available for review during the survey on 10/08/19. 3. Interview with TP #1 and #3 confirmed there was no list of duties or responsibilities for individuals involved in patient laboratory testing on the day of survey, 10/8/19. 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 --