Summary:
Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the technical consultant (TC), the laboratory director (LD) failed to establish and maintain a quality assurance (QA) program for the overall quality of laboratory services. Findings: 1. The LD did not perform QA procedures that covered the preanalytic, analytic, and post analytic phases of laboratory testing. 2. The TC confirmed that the laboratory did not establish and maintain a QA program for the overall quality of laboratory services. 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 --