POSITION STATEMENT

MEDICAL DIRECTOR OF LABORATORIES RESPONSIBILITIES AND ROLE
Prepared by: Dr. G. Hoag and Dr. J. Wm. Ibbott

This position statement was reviewed and approved by the CAP Executive, September 25, 1996. Published in the September/October 1996 issue of CAP Newsletter.
This position statement was reviewed by the CAP Executive, July 3, 2004 – no changes.


THE MEDICAL LABORATORY DIRECTOR
The medical director of the laboratory is a suitably qualified physician who is legally, morally, and ethically responsible for the scope, standards, and quality of service. The medical director has the knowledge and skills in all areas of practice which includes administration, teaching and education, research, and patient care. The director stands responsible for medically useful, accurate information made available in a timely fashion to enhance medical services to patients. The director participates in all managerial decisions and guides the operation of the laboratory ranging from selection of staff, choice of methods, purchase of equipment, quality assurance, quality control, safety, hours of operation, scheduling of staff, and utilization management. The director complies with the College of Physicians and Surgeons (provincial) and Canadian Medical Association (CMA) Code of Ethics.

Standards
The laboratory director shall be aware of and perform the duties and responsibilities of the position consistent with standards of accreditation of laboratories that exist at a national or provincial level. The standard of practice shall be consistent with the College of Physicians and Surgeons in each jurisdiction by suitably qualified individuals able to assume professional, scientific, consultative, organizational, administrative, and educational responsibilities for the service.

The Director Shall:

  • have sufficient authority to implement and maintain the standards
  • define and monitor accepted standards of performance and direct the implementation of laboratory services
  • function as a peer member of the medical community
  • support medical staff functioning as in integrated team, personally demonstrating leadership and team qualities
  • assist in the interpretation and correlation of laboratory data for patient management
  • establish short and long term goals and allocate the appropriate resources
  • provide cost-effective administration of all laboratory services
  • provide educational direction for the medical and laboratory staff
  • communicate effectively with accrediting, licensing, and regulatory bodies and maintain effective communication with the local board of directors of the hospital or institutional administration

 

A - THE ROLE OF THE DIRECTOR AS SERVICE PROVIDER

  1. Medical significance, interpretation, and correlation of data. Make judgments about the medical significance of clinical laboratory data and communicate effectively in interpreting laboratory data and relating correlations to referring physicians as appropriate.
  2. Direct Service
    Personally perform a variety of services expected of a laboratory physician, e.g.: surgical pathology, autopsies, frozen sections, bone marrows, needle biopsies, etc.
  3. Consultations
    Provide consultations to physicians regarding the medical significance of laboratory findings and utilization of the laboratory as appropriate.
  4. Medical Staff Privileges
    Serve as a member of the medical staff as appropriate, for those facilities served.
  5. Interaction With Physicians/Patient/ Administrators/Agencies
    a. Relate and function effectively with applicable accreditation and regulatory agencies, the medical community and the patient population served.
    b. Stand responsible to the hospital board through the administrator or to the agency owning the laboratory for the effective functioning of the laboratory where applicable.
  6. Standards of Performance
    Define, implement, and monitor accepted standards of performance in quality control, quality assurance, and cost-effectiveness of the laboratory service.
  7. Monitoring and Correlation of Laboratory Data
    Monitor all work performed in the laboratory to determine that reliable medical data are being generated; correlate laboratory data for diagnosis and patient management.
  8. Appropriate and Timely Service
    Stand responsible for the appropriate and timely response of the laboratory to physicians requests for testing plus the appropriate and timely reporting of results. Document compliance with national or provincial utilization protocols pertaining to laboratory services.
  9. Quality Assurance Responsibilities
    Assure that the laboratory participates effectively in the quality assurance program of the institute.
  10. Personnel
    Ensure there are sufficient qualified personnel with adequate training and experience to supervise and perform the work of the laboratory.
  11. Strategic Planning
    Perform planning for setting goals and allocation of resources appropriate to the medical environment. (Where appropriate in conjunction with the medical staff and administration of the hospital or institution).
  12. Administrative and Management Responsibilities
    Provide effective and efficient administration of the service including budget planning and control. (Where appropriate in conjunction with the administration of the hospital or institution). Certify and monitor accuracy of information used for third party payments. Promote a stimulating environment for team members to maintain a high quality of laboratory service.
  13. Education Responsibilities
    Provide educational direction and opportunities for the medical and laboratory staff, and participate in educational programs of the institution as appropriate.
  14. Research and Development Responsibilities
    Plan and direct research and development appropriate to the facility.
  15. Reference Laboratories
    Select all referral laboratories.
  16. Safety Responsibilities
    Promote a safe laboratory environment for personnel and other occupants.
  17. Ethical Responsibilities
    Promote practices that are consistent with accepted ethical standards for the medical profession.

 

B - DELEGATION OF RESPONSIBILITIES
The director need not perform all responsibilities personally. Administrative functions may be delegated to qualified laboratory managers and supervisors. Medical and technical responsibilities may be delegated to physicians and other qualified laboratory personnel as appropriate. The director, however, remains responsible for the overall operation and
administration of the laboratory to ensure that quality patient care services are provided. The qualification of the medical director should be consistent with the primary role of the laboratory.

 

C – PERSONNEL

  1. Staff Complement
    There shall be a sufficient number of qualified laboratory physicians, laboratory technologists, technicians, and other laboratory staff to perform the required tests promptly and efficiently. Staff morale should reflect reasonable workloads.
  2. Staff Qualifications
    The director shall assure that all procedures and tests performed by the medical technical staff are within the scope of education, training, and experience of the individual(s).
  3. Staff Scheduling
    Qualified technical staff shall be on duty, or available, at all times that laboratory testing is being performed.
  4. Staff Education
    Provision shall be made for all personnel, including physicians and supervisors, to further their knowledge and skills through on-the-job training, in-service education programs, or attendance at workshops, institutes, and/or professional meetings. In-service education programs shall be provided at defined intervals appropriate for the size and needs of the technical staff.
  5. Staff Orientation
    An adequate orientation program must be in place. Documentation of activities should be maintained.

 

D - ORGANIZATIONAL DUTIES

  1.  Infrastructure
    There is sufficient space, equipment, and supplies within the pathology and medical laboratory services to perform the required volume of work with optimal accuracy, precision, efficiency, timeliness, and safety.
  2. Communications
    There are channels of communication within the pathology and medical laboratory services, with other departments/services of the hospital and the medical staff, and outside services and agencies which are appropriate for the size and complexity of the hospital. Communication on patients shall be accessioned, reported, and stored in confidential data bases or registries.
  3. Documentation
    There is documentation that the required records and reports are maintained and, as appropriate, are filed in the patient's medical record and in the pathology and medical laboratory services. All records and reports are maintained as confidential.
  4. Quality Assurance
    There are quality control systems and measures of the pathology and medical laboratory services designed to assure the medical reliability of laboratory data. Such processes are available for internal review and action plans and resources appropriate to monitor effectiveness.
  5. Confidentiality
    Processes within the pathology and medical laboratory services shall be designed to assure confidentiality of laboratory data. Systems shall be monitored for compliance with accepted medical practices.
  6. Professional
    There are sufficient resources to provide professional coverage and remuneration for staff at a reasonable level. Interpersonal relations should respect guidelines adopted by the medical licensing authorities within Canada.
  7. Governance
    Leadership in development and implementation of patient focused laboratory services, including delivery systems that optimize services to achieve the desired health outcomes for patients.

 

Note:
Many of these statements are excerpts from the references cited below:

American Society of Clinical Pathologists (ASCP)
Alberta Society of Laboratory Physicians (ASLP)
College of American Pathologists (CAP)
British Columbia Association of Laboratory Physicians (BCALP)
Dr. Duncan Innes, Personal Communications
Medical Practitioners Act, BC
Ontario Medical Association (Section of Laboratory Medicine)