I guess there are a lot of things in the newspapers that leave you shaking your head, but a recent Op Ed by surgeon Atul Gawande left both Mrs. R. and me shaking our heads simultaneously, accompanied by jaws headed south and and eyes bulging. Quite a visual, I admit. But consider the source. I’ll let Gawande describe it:
In Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.
A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.
The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.
Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island. (New York Times; hat tip GH)
Two thoughts about this occur to me. Well, maybe three. Thought number one. These guys are the counterpart to “Corporate Legal.” Interpret everything in the most conservative possible manner. In this case, that the checklist is an alteration in the usual standard of medical care and collecting information on it is research, research that might put doctors at risk by showing they weren’t doing the right thing. the second thought is that they saw themselves as protecting doctors against predatory trial lawyers. The third is probably closest to the truth: another example of colossally incompetent bozos at the wheel of a Bush federal agency, driving it off the road and killing by-standers.
I’m not a lawyer basher or a federal agency basher. We need lawyers. They preserve our legal rights and represent us in an extremely complicated system. We need federal agencies, too. Research subjects need to be protected. But we also need to be protected from lawyers and agencies with no common sense or worse, no intention of using their abilities and authority for the public good.
Concerning the main point, damage done specifically by a complex and chaotic medical care system is increasing as pressure on everyone in it increases. Much of this damage is avoidable, caused by inappropriate human actions if not error. Human error is hard to prevent completely, but you can minimize it by training and by routinizing critical tasks. Checklists are an important tool for accomplishing this. Evaluating a checklist’s efficacy should be encouraged, not punished. If they had just put up a checklist without evaluating it, presumably this wouldn’t have been a problem.
So I’ve got a checklist item to pin to the wall of everyone who works at the Office for Human Research Protections:
Step One: Remove head from up your ass.
Feel free to evaluate it at your leisure. Which I hope you’ll have a lot of when the nightmare of this administration is finally over (385 days, 23 hours, 21 minutes and 43 seconds at the instant of finishing writing this post).