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 review of the laboratory procedure manual and interview with office personnel, the laboratory director failed to approve the current procedure manual in use. Findings include: a. The laboratory procedure was requested by the surveyor and the laboratory complied. Upon examination of the manual, the surveyor noted that it lacked documentation that it had been approved by the laboratory director. b. Office personnel present acknowledged (September 7, 2018, 9:45 A.M.) that the director's approval was absent from the documents presented. c. The laboratory stated that approximately 100 histopathology tests are performed annually, even though the laboratory procedure manual was not approved by the director. 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 --