College of American Pathologists

  Criteria for the Clinical
  Laboratory Director




Policy Synopsis

Optimal criteria are established for a director of a clinical laboratory in order to improve the quality of medical services to the public. These criteria reflect the appropriate training and background in order to discharge the relevant responsibilities of such a position. Professional associations may also choose to use these criteria to develop programs and services for the improvement of members’ medical practice. The criteria are included in the policy.


State governments, through laws regulating laboratories, and the federal government, through Medicare regulations, have established minimum qualifications for director of a medical laboratory. These qualifications are based on varying combinations of academic degrees, certifications by other organizations, and work experience.

Voluntary accreditation by organizations such as the JCAHO and the CAP has established standards for accreditation which include a standard for the director of the hospital laboratory. This standard may be more stringent than those established by governmental agencies. It is, however, designed to reflect the optimal, rather than the minimal.

Criteria for director of a clinical laboratory have been developed with this principle in mind. How they are applied in specific cases will vary, but regardless of the environment, each of the criteria is applicable.

Knowledge and Performance Criteria for Clinical Laboratory Director

Qualifications, Responsibilities, and Role of the Director

To function effectively in fulfilling the duties and responsibilities as director of the pathology or medical laboratory service, the director should possess a broad knowledge of clinical medicine, basic medical sciences, clinical laboratory sciences, and operations. The director should have the appropriate training and background to be able to discharge the following responsibilities:

  • Medical Significance, Interpretation, and Correlation of Data - Provide consultations about the medical significance of clinical laboratory data. Interpret, correlate, and communicate laboratory data to clinical requestors.
  • Anatomic Pathology - Perform anatomic pathology procedures as appropriate.
  • Consultations - Provide consultations to physicians regarding the medical significance of laboratory findings as appropriate.
  • Medical Staff Privileges - As applicable, serve as an active member of the medical staff for those facilities served.
  • Interaction with Others - Relate and function effectively with applicable accrediting and regulatory agencies, appropriate administrative officials, the medical community, the medical device industry, and the patient population served.
  • Standards of Performance - Define, implement, and monitor standards of performance in quality control, quality improvement, and cost-effectiveness of the pathology and clinical laboratory service(s).
  • Monitoring and Correlation of Laboratory Data - Monitor all work performed in the laboratory to determine that medically reliable data are being generated; correlate laboratory data for diagnosis and patient management.
  • Quality Improvement Responsibilities - Assume responsibility for implementation of the quality improvement plan. The director and professional laboratory personnel must participate as members of the various quality improvement committees of the institution.
  • Personnel - Ensure that there are sufficient qualified personnel with adequate documented training and experience to meet the needs of the laboratory.
  • Strategic Planning - Perform planning for setting goals and developing and allocating resources appropriate to the medical environment.
  • Administrative and Management Responsibilities - Provide effective and efficient administration of the pathology service including budget planning and control with responsible financial management, in accordance with institutional assignment of such responsibilities.
  • Educational Responsibilities - Provide educational programs for the medical and laboratory staff, and participate in educational programs of the institution.
  • Research and Development Responsibilities - Plan and direct research and development appropriate to the facility.
  • Reference Laboratories - Select and monitor all reference laboratories for quality of service.
  • Safety - Implement a safe laboratory environment in compliance with good practice and applicable regulations.

The criteria are offered as guidelines for improving the quality of medical services to the public. They may also serve professional associations in developing programs and services for the improvement of medical practice.

Revision History

Reaffirmed March 1990
Reaffirmed February 1993
Revised May 1996
Reaffirmed May 1999