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Checklists, Guidelines, Standards and Rules

Martin McKneally
Martin McKneally
At the time that the checklist story broke in the New England Journal of Medicine and international media in January, I was involved in a spirited online writing group setting standards for cardiothoracic surgeons. Like the orthopaedic surgeons described in our article on page 5 on the conflict of interest debate, members of my specialty are receiving increased attention to their financial relationships with manufacturers of expensive intracardiac devices such as valves, pacemakers, defibrillators and pumps. As we developed our recommendations, we were concerned about the tone and the level of forceful persuasion that would be appropriate. The ethics committees of our two specialty societies were put to work.

Should they be guidelines? Somehow this seemed too slack. A nautically inclined physician-lawyer-ethicist in my Practical Ethics class gave a helpful explanatory definition. Guidelines were originally ropes that ran from the bow to the stern when boats were less safe and seamen were at greater risk of being swept off the deck in rough seas. They could seize the guideline to save themselves from washing overboard. The coercive enforcement was by common sense rather than mandate. Guidelines are helpful, but they aren't mandatory.

After some discussion, libertarian arguments in our surgical group gave way to a consensus that we would set professional standards for managing conflicts of interest. Such standards are enforced by collegial opinion within the community. However, because they are codified and referencable as standards, they can be used in a court of law against a professional who does not comply with them.

The checklist that was introduced into the operating room at Toronto General is a policy instrument. Enforcement of its use is coerced by peer pressure, a form of soft power (1) toward the accomplishment of an aspirational goal of complete compliance. Similarly, Jack Cronenwett's policies adopted at the cooperating vascular surgery sites of the Northern New England Group (see page 8) depends on peer respect, collegiality and loyalty to an enterprise undertaken by consensus in a voluntary group of professionals. By definition, professionals are self-regulating because their arcane skills and knowledge are not readily susceptible to external regulation by non-professionals in the community, the institutional administration or the government. As our electronic discussion group developed what we initially characterized as guidelines, we worried that non-compliance by some of our members might incite eloquent exposés in the news media, resentment in the community, and more rigorous enforcement through government regulation. Conflict of interest issues in banking, finance, medicine and surgery are moving community opinion toward requiring regulation with the force of law, particularly in the United States where Senator Grassley of Iowa is threatening to file criminal charges against orthoapedic surgeons for taking kickbacks to influence institutional choices of expensive prosthetic devices.

Returning to the World Health Organization checklist, Bryce Taylor draws an accurate analogy to automobile seatbelts. Once their safety was proven, their use had the moral force of guidelines. As further evidence developed through the Cornell crash survey and other scholarly evaluations analogous to the WHO checklist project, their use became a standard, and now in many jurisdictions it is enforced by the rule of law. Just as we owe a debt of gratitude to the trauma surgeons who demonstrated the lifesaving value of automobile seatbelts, we owe a debt of gratitude to our WHO researchers, including our Toronto team of Bryce Taylor, Anne Slater and Richard Reznick for developing the proof that will eventually make the checklist the standard of practice for surgical patients and operating teams.

Martin McKneally
Editor

(1) Nye, Joseph S., Jr. Soft Power. Foreign Policy. 1990;80: 153-171.




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