Summary:
Summary Statement of Deficiencies D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on lack of procedure manual and interview with laboratory director, the laboratory director failed to have an approved procedure manual available to personnel. Findings are: 1. No approved procedure manual was available on day of survey. 2. Interview with laboratory director on 1/15/2020 at 2:35 PM confirmed no approved procedure manual was available to personnel. 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 --