Important medical errors in Ontario have occurred in surgical pathology.

A report commissioned by the Ontario government recommended an overhaul to the quality management system of surgical pathology.

The recommendations for surgical pathology might have implications for other aspects of medicine.

Because of public concern about reports of errors in surgery and pathology, the Ontario Minister of Health appointed an investigative team to review and report on issues related to the quality of care and treatment of patients at three Essex County hospitals.

Their report pointed out that there is no province-wide quality improvement and monitoring system for surgical pathology, and called for the establishment of such a system.

How is it possible that something as crucial as the diagnosis of cancer has not been subject to a rigorous quality assessment program?  Should this situation change?  Does the experience with pathology have lessons for other areas in medicine?

What is surgical pathology?

Every Monday to Friday thousands of Ontarians, have pieces of tissue removed (known as biopsies) because of concern that they might be diseased. The most common concern is that the worrisome lump might be a cancer.

The biopsy is carefully processed, often with the use of sophisticated stains and markers, and ultimately examined under a microscope by a pathologist. A pathologist is a physician who has specialized training in the study of body tissues and organs. Pathologists are responsible for making the final diagnosis after examining tissues from biopsies.

The pathology diagnosis markedly influences the choice of therapy – if the biopsy shows cancer some combination of surgery, radiation or chemotherapy is usually recommended.

In the last decade the processing and interpretation of cancer biopsies has become increasingly complicated and sophisticated. Today, biological markers and genetics play a big role in diagnosis and treatment. For example, in 2010, a breast cancer is no longer simply a breast cancer. It is either a breast cancer that is HER2 receptor positive or HER2 negative. Women whose breast cancers are HER2 positive are more likely to respond to some drugs than are women whose breast cancers are HER2 negative.

The expectations of surgical pathology teams have increased, and will continue to do so, due to increasingly sophisticated technology. Because the interpretation of these markers is not always straightforward, the implications for quality control are significant.

Does Ontario current have a quality assurance system for surgical pathology?

Ontario has an accreditation system, known as the Ontario Laboratory Accreditation Program, which all pathology labs must participate in. The system focuses on the technical aspects of surgical pathology, such as the processing of a sample.

Cancer Care Ontario has instituted a system that has markedly increased the standardization and quality of the format by which pathology results are reported in Ontario. They adopted a standardized template which helps ensure that the format of reports is similar and easy to follow. The improvement has been truly impressive, going from no hospitals using these standard templates for reporting in 2004/5 to over three quarters of hospitals using them in February 2010.

However, although improvements have been made in the format of pathology reporting, there is no uniform, standardized quality assurance program focused on the quality of the interpretation of biopsies by pathologists in Ontario.

What did the investigative team propose?

Every pathology laboratory in Ontario currently has its own quality assurance program. However, the quality of these programs varies considerably.

The investigative team struck after the Essex county hospitals incidents recommended an Ontario-wide, mandatory and standardized quality assurance program for all surgical pathology laboratories. It is based upon sharing of cases among colleagues, and improving the process of obtaining second opinions when necessary. The main focus will be on self-learning, but the system will also be able to identify pathologists who appear to be performing below an acceptable standard.

It may seem surprising that such a standardized quality improvement program does not exist, but once they have finished their training, Ontario doctors rarely undergo a standardized and formal assessment of their knowledge or clinical competence.

Are there impediments to implementing the recommended quality assurance program?

Although these recommendations sound great in principle, there are problems implementing them into practice.

Ontario currently has a shortage of pathologists. A leading senior pathologist working in a community hospital outside Toronto said that the new quality improvement program will increase pathologists’ workloads by 10 to 15%. In order to meet these time demands, Ontario will have to recruit more pathologists. However this may be a challenge as pathologists are paid by the Ministry of Health and Long-Term Care, or hospitals, both of which are cash strapped.

As mentioned above, most Ontario physicians do not participate in mandatory and standardized quality assessment programs. Some pathologists may resist, saying: “Why me? Why not radiologists who read xrays? An incorrect diagnosis on a CT scan can have profound implications as well.”

This is a complex problem, with no easy answers or solutions. Please participate in our poll, and provide your ideas in the comments section.

If you answered yes to the above poll, how do you think cash-strapped hospitals can pay for this program? Is there something that they can cut to make sure they can pay for quality assurance programs for pathologists?

Should mandatory quality assurance programs be instituted for parts of medicine other than pathology? If yes, what areas do you think are most important?