Canadian Association of Pathologists
Association canadienne des pathologistes

GUIDELINES FOR LABORATORY PHYSICIANS ACTING
AS DIRECTORS OF LABORATORIES WITHOUT AN ON-SITE PATHOLOGIST

Published in CAP January/February 1991 Newsletter
Published in CMAJ 1992: 147:1006-1005
Reviewed by CAP Executive, September 1996
Reviewed by CAP Executive, July 3, 2004

Bhubendra Rasaiah, MD, FRCPC; Gordon Hoag, MD, PhD, FRCPC

Alleviating the geographic undersupply and specialty maldistribution of physicians is an important goal for government and regulatory agencies. Many small laboratories have no on-site laboratory physician. To furnish them with the services of either a laboratory director or a consultant, laboratory physicians have negotiated various contractual arrangements. Although no specific requirements have been imposed by any regulatory agency the medical profession accepts the premise that it is the responsibility of the visiting laboratory physician to adopt and implement acceptable standards of practice.

The pathologist has multiple responsibilities - to the patient, the clinician and the hospital or institution. In many instances these responsibilities and other professional parameters affecting visiting laboratory physicians have not been spelled out or definitely established. Simply stated, it is hard for a laboratory physician to know whether he or she is fulfilling basic professional requirements when no formal guidelines exist. Moreover, government bodies, regulatory agencies, hospital administrators and clinicians need to be familiar with the role of visiting laboratory physicians in underserviced areas.

Recently there have been recommendations^1,2 that pathologists in all laboratories, in consultation with clinicians, develop protocols for requesting tests, investigate the advantages of cooperating with laboratories in other districts and make the best use of capital equipment. Despite the time limitations of a visiting pathologist it is essential in areas where access to pathologists is difficult that these medical specialist services be provided for the diagnosis, treatment and monitoring of disease. The efficient use of diagnostic tests, utilization reviews and the cost-effective delivery of laboratory services are other priorities. A cooperative relationship between clinicians and laboratory physicians should result in substantial clinical and economic benefits and in improved performance by both groups.

The Section of Clinical Pathology of the Canadian Association of Pathologist (CAP) formulated guidelines that were published in draft form early in 1991³ after review by the provincial associations of patologists and the provincial colleges of physicians and surgeons. The comments of the provincial colleges are in Appendix 1. The guidelines were finally approved by the CAP executive and council June 23, 1991.

Role of pathologist
The pathologist must be involved in the technical aspects of the laboratory operation to properly assume final responsibility as the laboratory physician. The depth of involvement must be sufficient to ensure reliable results, which depend also on the presence of a well-trained chief technologist and technologists who carefully follow the instructions of the laboratory physician as defined in the contractual agreement. The services provided by the laboratory physician include supervision of clinical areas, chemistry, hematology, blood bank, microbiology, surgical pathology, cytology and autopsies. For these services, he or she is responsible for the timely production of medically useful and accurate information.

Role of laboratory manager
In many instances the laboratory physician is simply unable to shoulder his or her professional activities and provide personal care while administering another laboratory. In such situations he or she is not required to perform all the responsibilities personally: an on-site laboratory worker can be designated to assume various duties. This will usually be an experienced medical technologist certified by the Canadian Society of Laboratory Technologists, who often is given the title "laboratory manager" to reflect the lesser technical role and enhanced managerial role. The laboratory manager is responsible for overseeing the entire operation of the laboratory in accordance with the instructions of the laboratory director, to whom he or she reports and who is ultimately responsible for the operation of the laboratory. These precepts have been recognized and accepted by administrators and external licensing bodies.

Relationship to institutions without an on-site pathologist
A pathologist faced with the responsibility of providing laboratory services usually has to custom build a system that can function effectively within the limitations of the particular institution and the pathologist's time, while ensuring high-quality services. The scope of activities provided depends on whether the pathologist is a director of the laboratory or a consultant, a generalist or a subspecialist. (A medical director of laboratories and a consultant laboratory physician are medical practitioners who have been certified by the Royal College of Physicians and Surgeons of Canada in general pathology or in a laboratory subspecialty or have specialist qualifications deemed equivalent; their responsibilities are discussed later.) The contractual agreement with the institution also governs the range of duties. Contracts can be made with or without appropriate legal counsel.

The number of laboratories that a pathologist can supervise is governed by his or her ability and by individual provincial licensing authorities. Laboratories in remote areas have difficulty in recruiting the services of a laboratory physician, and some pathologists may be required to service many laboratories.

The laboratory physician is expected to confer with the administrator, laboratory manager and medical staff to identify hospital and laboratory needs. He or she should be a member of the local medical advisory committee. Personal on-site discussions are important, and periodic telephone conferences with the administrator, laboratory manager and medical staff are also helpful. Regularly scheduled visits are essential, the frequency depending on the needs of the particular facility and staff. Visits may be supplemented by scheduled visits from other pathologists in a group practice or by a medical technologist supervisor. Coverage for weekends and vacations may be necessary.

Responsibilities of a medical director of laboratories
The responsibilities of a laboratory director are diverse. The director is responsible for the administration and technical operation of the laboratory to ensure high-quality service. He or she must retain a hand in all phases of laboratory operation, be familiar with all "stat" tests, routine laboratory procedures and test turnaround times. The instruments, equipment and technologies should be up to date, meet the hospital's needs and match the resources allocated to maintain the service. Staffing levels must be adequate. Budget preparation, cost accounting, employee selection and supervision of all delegated tests are important aspects of the director's role. Other key factors are instrument and supply purchase, management of personnel, quality assurance, quality control, safety, appropriate disposal of waster, and the addition of new tests and the elimination of old ones. The laboratory director is responsible for the inspection, accreditation and proficiency testing of the laboratory by external agencies.

Responsibilities of a consultant laboratory physician
The primary function of a laboratory consultant is to provide expertise and professional services as a full or subspecialty consultant and as an adviser. The consultant does not have the wide range of functions of a laboratory director and is not legally accountable for the entire laboratory operation. Although the consultant is not responsible for the inspection, accreditation or proficiency testing of the laboratory by external agencies, the consultant may act as an adviser and may assist in such practices.

Recommendations
For laboratories without an on-site laboratory physician the medical director has direct authority over or the consultant advises on the following duties.

Administrative duties

1. The appointment of an appropriate laboratory manager.
2. The selection of laboratory staff.
3. The provision of advice on staffing levels.
4. The maintenance of general laboratory policies and procedures manuals.
5. The development of a protocol for conveying critical test results by telephone.
6. Scheduled visits, telephone conferences and written reports of visits, including recommendations. (A minimum of two preorganized visits yearly is recommended.)
7. Liaison with administrative staff, laboratory manager and medical staff; membership in the medical advisory committee.
8. Staff (laboratory and medical) education.
9. Inspection, accreditation and proficiency testing by external agencies.
10. Maintenance of the confidentiality of laboratory data.
11. Periodic review of departmental performance and annual review of policies and procedures manuals.
12. Adequate laboratory coverage.
13. Consultation about and approval of long-range planning.

Medical and technical studies

1. Effective utilization of laboratory services.
2. Consultations on and interpretation of test results.
3. Quality assurance and internal and external quality control.
4. Selection of capital equipment and purchase of equipment and supplies.
5. Specimen collection.
6. Selection of laboratory procedures, Astat@ tests and utilization review.
7. Adequate turnaround time and reporting of test results.
8. Maintenance, troubleshooting and record keeping.
9. Other activities as agreed upon.
10. Safety precautions.
11. The disposal of waste.

The hospital, institution and laboratory physician may assign different priorities to these duties.

We thank the representatives of the provincial associations of pathologists and the provincial colleges of physicians and surgeons who reviewed and contributed to the final document. We thank Dr. E. Anne Shuttleworth, of Calgary Diagnostic Laboratories, and Dr. Trygve E. Larsen, of Calgary Medical Laboratories, for specific contributions to the recommendations in this article.

References
^1. Audit Commission : The Pathology Services: a Management Review, HMSO, London, 1991
^2. The well-managed laboratory, BMJ 1991; 302:198-199
^3. Rasaiah B, Hoag G: Guidelines for a laboratory physician who acts as director or visiting consultant to a laboratory without an on-site pathologist. Canadian Association of Pathologists Newsletter 1991;34 (1): 5-7

Appendix 1:
Specific comments of provincial colleges of physicians and surgeons on the draft guidelines for laboratory physicians acting as directors of or visiting consultants to laboratories without an on-site pathologist

College of Physicians and Surgeons of British Columbia:
To take or collect human samples, perform laboratory tests on them, and express test results and possibly an opinion on those results fall within the practice of medicine as defined in section 72 of the Medical Practitioners Act of British Columbia, 1979, and, as such, must remain the final responsibility of a physician duly qualified and licensed by the college (Dr.Thomas F. Handley, registrar of the college: personal communication, 1990).

College of Physicians and Surgeons of Saskatchewan:
As a means of dealing with the concerns of laboratory management and with issues of resource allocation the provincial government introduced the Medical Laboratory Licensing Act in 1989. However, the regulations under that act are still in the final stages of development. When available a copy of them can be obtained from Ms. Pauline Rousseau, director of support services and regulatory affairs, Laboratory and Disease Control Services Branch, Saskatchewan Health, 3211 Albert St., Regina, SK S4S 5W6 (Dr. Dennis A. Kendel, registrar of the college: personal communication, 1990).

College of Physicians and Surgeons of Manitoba:
The laboratory physician is the person responsible for the overall operation of the laboratory. The pathologist may delegate certain tasks to qualified people, but an experienced medical laboratory technologist must be on site for such tasks to be adequately carried out. A bylaw of the college recognizes a person with a doctoral degree as a consultant for his or her appropriate area (Dr. Kenneth R. Brown, registrar of the college: personal communication, 1990).

College of Physicians and Surgeons of Ontario:
Pathologists should be aware of the circumstances in Ontario governing medical directors of laboratories as specified in the Laboratories and Specimen Collection Centres Act, 1984, and the requirements set up by the Laboratory Proficiency Testing Program. Laboratory physicians should refer to the excerpt from the college's 1982 annual report (page 7) on the conflict of interest pertaining to relationships between a physician and a laboratory (Dr. Anthony A. Shardt, associate registrar of the college: personal communication, 1990).

Corporation professionnelle des médecins du Québec:
Laboratory physicians should refer to the Act Respecting Health Services and Social Services, 1983 (modified in 1989), and to the Regulation Adopted under the Act Respecting Health Services and Social Services. Certain articles indicate that the heads of medical biology laboratories must manage the resources of their clinical departments to the extent provided by regulation or, failing that, according to the organizational plan of the hospital. The government may regulate that the management of all or part of the resources of the department be entrusted by the director of professional services to a person other than the head of the clinical department. The head of the department, under the control of the director of professional services, will also manage the human, material and financial resources of the department. However, if there is no physician holding a specialist's certificate in biologic medicine the director of professional services shall designate a person to be responsible, under his or her control, for managing these resources. If that person is not a physician he or she will not be responsible for managing the medical resources of the department. In addition, the head of each of the clinical departments of a hospital must be a physician holding a specialist certificate of the corporation and be an active member of the council of physicians and dentists of the hospital (Dr. Augustin Roy, president and secretary general of the corporation: personal communication, 1990).

Prepared for the Section of Clinical Pathology, Canadian Association of Pathologists

Original authors:
Dr. Rasaiah, Chairman - Section of Clinical Pathology
Dr. Hoag, Vice-chairman - Section of Clinical Pathology
Canadian Association of Pathologists