LABORATORY DIRECTOR DEFINITION AND RESPONSIBILITIES

24 March 1997

I. PREAMBLE

The following statement is the recommendation of the Section on Laboratory Medicine of the Ontario Medical Association. The Section is the only representative organisation for all the Laboratory Medicine specialist physicians in the Province. The statement reflects the wisdom of the membership of the Section and has been approved by the Council of the Section. The statement is intended to be a guideline for health facilities that operate a laboratory or contract with a provider of laboratory services. It is recommended to be applied in small and large hospitals, other publicly owned laboratories and in the private sector. In preparing the statement, accreditation guidelines and provincial legislation and regulations have been considered and this statement is intended to be generally compatible.

II. DEFINITION

Whereas Laboratory Medicine is the practice of medicine, it is strongly recommended that a Laboratory Director be a licensed physician who is a suitably qualified specialist in Laboratory Medicine. A suitably qualified specialist for full time, part-time and consultant appointments must be qualified in a specialty of Laboratory Medicine by the Royal College of Physicians and Surgeons of Canada or possess an equivalent qualification recognised by the provincial laboratory licensing body.

Under exceptional circumstances, the Laboratory Director may not be medically qualified or may be a physician without specialist qualifications in Laboratory Medicine. The Laboratory Director must be approved by the provincial laboratory licensing body and, in such circumstances, the facility must retain a suitably qualified Laboratory Medicine specialist as a consultant to advise the Laboratory Director.

III. RELATIONSHIPS AND ACCOUNTABILITIES

The Laboratory Director must be a member of the medical staff whenever there is a medical staff organization.

Each facility should have an advisory body to the owners of the facility comprised by medical practitioners. In hospital facilities, this is often the Medical Advisory Committee. The Laboratory Director should be a member of the Medical Advisory Committee or similar advisory body. In organizations that have several Laboratory Directors, at least one Laboratory Director should be selected to represent the group as a member of the Medical Advisory Committee. In organizations that lack a Medical Advisory Committee, a group that includes the Laboratory Director should be identified to serve a medical advisory function.

The Laboratory Director functions in a complex organizational structure that includes the medical staff and the administration of the facility. The accountabilities of the Laboratory Director must be clearly defined; the accountabilities are appropriately set out in the Rules, Bylaws and Policies of the facility and/or in the terms of engagement or employment of the Laboratory Director. It is recommended that the Laboratory Director be accountable:

to the medical staff and to the Medical Advisory Committee or comparable advisory group for clinical matters;

to the Chief Executive Officer or designate, according to the organization's management reporting structure, for specified administrative matters.

The Laboratory Director shall be guided by the Code of Ethics of the O.M.A. Section on Laboratory Medicine.

IV. RESPONSIBILITIES

It is recognized that a Laboratory Director may function as a member of a team to provide medical and administrative direction to the laboratory services. The laboratory services include but may not be limited to: (a) diagnostic and testing services on tissues, blood, urine, feces and other body fluids; and (b) noninvasive laboratory procedures for tissue and fluid components and cellular activities. This includes sample collection including phlebotomy.

In general, the laboratory director’s responsibilities will include all laboratory services provided by the institution, facility or company including alternate site (point of care, near patient, bedside) laboratory services. Where responsibility is shared as part of a team, there should be Terms of Reference that define the distribution of responsibilities completely. In general, a Laboratory Director is responsible for:

The administration of all scientific, medical, technological and support functions in an effective and efficient manner including:

service, education and research programs according to the department's Statement of Purpose (Mission) and Objectives;

preparing and managing the laboratory's operating and capital budgets according to the facility's policies and procedures;

coordinating Laboratory Services;

providing a legally acceptable form of signature for documents requiring the Director's signature;

being available for appropriate personal or telephone consultations;

being on the premises of the laboratory for a time commensurate with the workload of the laboratory;

arranging for a qualified substitute to carry out the responsibilities of the Director when the Director is unavailable for a significant time, according to the terms of the agreement between the Director and the facility owner;

recommending appropriate consultants when the Director is either not qualified or not knowledgeable about services for which the Director is responsible.

Strategic planning including:

developing a statement of purpose for laboratory services;

setting goals and objectives and allocating resources to achieve these.

The definition, implementation and monitoring of standards of performance including:

the selection, establishment and supervision of appropriate testing procedures and the standards related to such procedures;

the development and implementation of policies and procedures;

the preparation and maintenance of an up-to-date procedure manual in each class of test for which the laboratory is licensed;

the accuracy, precision and clinical relevance of laboratory test results;

the sample collection and specimen accessioning and preparation.

The establishment and monitoring of quality improvement, utilization review, risk management and occupational health and safety activities.

The appointment, supervision, training and discipline of the technological and professional staff of the laboratory by:

the assignment of duties to personnel in terms of their qualifications, responsibilities and job description;

developing a human resource plan for the laboratory with the human resource service of the facility;

selecting, placing, promoting, transferring or terminating staff according to the facility's policies and procedures;

ensuring that staff receives regular written performance appraisals;

reviewing and revising position descriptions;

ensuring that the licensing, certification or registration of staff is verified.

The direction of programs to assure the competency of the staff by:

ensuring the orientation, staff development and continuing education of technological and support staff;

encouraging and monitoring the continuing educational activities of the medical staff according to the policies of the facility;

ensuring the provision of student and/or resident clinical education, if applicable.

The communication of laboratory information in an effective and timely manner including:

the reporting of the results of the test procedures;

the interpretation of laboratory information for patient management and diagnosis;

ensuring that the results of tests critical to the health of the patient from whom the specimen was taken are reported immediately to the practitioner who ordered the tests.

Effective communication and interaction with accrediting, regulatory, administrative groups, the medical community and the population served.

Supporting the continuum of total care from the community to the health care institution by:

participating in and, where appropriate, leading the development of local and regional service delivery models;

encouraging laboratory service delivery systems that optimize cooperation among service providers and minimize duplication.

Leadership in development and implementation of patient focused laboratory services, including delivery systems that optimize services to achieve the desired health outcomes for patients.

The establishment and direction of research programs relevant to the purpose and functions of the facility.

Approved at the Annual General Meeting of the Section on Laboratory Medicine May 27, 1995.