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
- 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
- Anatomic Pathology - Perform anatomic pathology procedures
- 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
- 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
- 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.
Reaffirmed March 1990
Reaffirmed February 1993
Revised May 1996
Reaffirmed May 1999