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 a review of the policy and procedure manual and an interview with a staff member, the Laboratory Director, (LD), failed to approve written test procedures found in the lab's procedure manual. Findings were as follows: 1. Review of the laboratory's policy and procedure manual signature page titled "Annual Review of General Laboratory Policy and Procedure Manual by Laboratory Director", revealed the lab director failed to approve written test procedures, by signature and provide the date in which they were approved for 2017. 2. An interview with the LD verified the policy and procedure manual had not been approved by signature and date for 2017. 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 --