Wednesday, June 3, 2009

This Just In: Systems Designed to Fail, Fail

By Steven Lewis

First there is the disaster that comes to light long after the fact. Then there is the inquiry. Then there is the scathing report that meticulously unearths the causes of the disaster. Then there is the apology (they’re allowed now – it’s the law!). Then there is restitution. Finally there is the commitment: never again. And then the same thing happens, somewhere else, again, and again, and again.

Canadian medicine – it is quite different in some other jurisdictions – is organized around four fundamental premises. First, doctors are highly trained professionals whose license to practice needs no expiry or renewal date. Second, initial certification exams are reliable guarantors of lifelong competence and consistent, high quality practice. Third, it is both unnecessary and unsporting to subject the autonomous judgments of professionals to rigorous and regular scrutiny. Fourth, professional self-regulation is the ideal mechanism for preventing harm.

To quality improvement and harm reduction experts in every other industry, these premises are not merely dubious, but laughable. Yet they persist in medicine, and the inevitable result is that people get hurt. Radiology and pathology are high-stakes diagnostic professions where errors can kill. When massive failures occur, as in the Newfoundland and Labrador breast cancer testing debacle of 1997-2005 (!), or the Charles Smith forensic pathology fiasco of 1981-2005 in Ontario (!), the root causes turn out to be depressingly pedestrian. That’s what makes them as pathetic as they are tragic.

Even more damning is the repetition. The lid has just come off Quebec’s breast cancer diagnostic breakdown. Saskatchewan is cleaning up after a pathologist who may have put thousands of people at risk over 5 years. It will cost millions of dollars to have every one of his 70,000 images reread out of province, and perhaps tens of millions to settle the malpractice claims (the notorious Regina lawyer Tony Merchant has already launched a class action suit). The only difference between these jurisdictions and those so far untouched by the contagion is that the time bombs are on different schedules.

Despite the repeated revelations of system errors that demand system solutions, nothing has fundamentally changed to guarantee safer health care and prevent the birth of gestating misadventures. When push comes to shove, the right to practice shoddy medicine trumps public safety; no one gets to cancel the flight or shut down the assembly line without definitive proof of repeated incompetence. A health region or regulatory body that moves aggressively to suspend a practitioner pending investigation of suspicious results will be harassed and condemned for violating due process. The first reflex will not be to acknowledge the problem or seek mentorship; it will be to lawyer up. The medical association with go to bat to keep the practitioner in the saddle. Physicians and others in the know who would not send their own kids to an incompetent colleague either can’t or won’t stop yours from ending up in his care.

It’s not just a conspiracy between the guilds and the law; it’s a systematic failure to manage risk. Built in redundancy, rigorous peer review, structured continuing education, and mandatory recertification are cornerstones of safety. The higher the stakes, the greater the need for vigilance and tightly organized quality control systems. Geographically isolated professionals are obviously at risk, and many will fail without carefully designed, reliable supports in place. But everyone needs audit, feedback and peer support to perform reliably over time. In medicine it is well-documented that performance declines with age. The response to this chilling reality has been to let the chips fall where they may – the pathology of denial.

The Saskatchewan case is especially instructive. There were suspicions about the radiologist’s competence 3 years ago. With the regulatory noose tightening around his neck, he volunteered to go for remedial education. No educational program in western Canada stepped up to the plate. After he spent 3 months at McMaster, the Saskatchewan College received a perfunctory and brief report on his progress and skills that it rejected as inadequate. He returned to practice, and on the evidence to date, his interpretation of every 20th image may have put someone at risk.

The system is designed to fail, and it must be redesigned to succeed. The solution is not to expect physicians to look furtively over their colleagues’ shoulders and snitch to the authorities. The remedies must be systemic, obligatory, and woven into the fabric of medical education, ethics, and organization. Among the obvious requirements are:

  • Mandatory review of randomly drawn samples of diagnostic interpretations. The frequency and intensity of the scrutiny should be commensurate with the complexity of the practice, known error rates, and the consequences of mistakes.
  • A formal, standardized protocol for addressing competency problems. The first signs of problems should trigger mandatory supervision and intensified case reviews until performance is demonstrably up to snuff.
  • Beyond certain thresholds of error, automatic suspension followed by the launch of a remediation algorithm.
  • Specific additional support, review, and continuing competency assurance procedures for isolated practitioners.
  • Transparent reporting to the public of performance results.

It is delusional to believe that everything is now out in the open, with nothing more to uncover. It’s not just the outliers who cause harm; because medicine is so fraught with unjustifiable variations in practice, it is certain that the errors resulting from “satisfactory” practice far outnumber the misdeeds of the visibly incompetent. The graveyards are filled with anonymous victims whose stories will never surface in a public inquiry. Until professionals take their collective obligations seriously and embrace a culture of safety, prevention will fail, detection will be late, and the victims will pile up. If they view peer review, recertification, and remediation as violations of sacred entitlements, sleepwalking through mandated processes won’t accomplish much.

Sad to say, for radiology and pathology our salvation may come from machines. It is foreseeable that computerized pattern recognition software will be able to diagnose more accurately and consistently than specialists in all but the most unusual of cases. If that day comes, we can be sure that these highly reliable machines will be programmed to self-diagnose and identify anomalies in their own findings and performance at regular intervals, and will be examined, refurbished, and re-tested according to strict protocols. In other words, we will treat them and their needs with care and respect, governed by the duty to put patients first. Too bad that we don’t do the same for fallible diagnosticians and their victims.

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