Checklists Update–Administration Stops Program

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Today (Sunday, Dec. 30) the New York Times published a shocking op-ed by Dr. Atul Gawande revealing that a U.S. government agency has stopped an enormously successful "checklist" program that was being used to reduce infections in intensive care units at Johns Hopkins and throughout the state of Michigan. (To see my original piece  on checklists, scroll down to my Dec. 14 post below.)

Below, an excerpt from today’s op-ed:

" 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. . .

"The results were stunning. . . . 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," Gawande explains.  "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.

"The government’s decision was bizarre and dangerous," he adds. "But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore it is no less unethical and illegal to do the same with a checklist. Indeed, a checklist may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures. [my emphasis]

[But] "testing a checklist for infection prevention, is not the same as testing an experimental drug," Gawande observes, "and neither are like-minded efforts now under way to reduce pneumonia in hospitals, improve the consistency of stroke and heart attack treatment and increase flu vaccination rates. Such organizational research work, new to medicine, aims to cement minimum standards and ensure they are followed, not to discover new therapies. . . .

He puts the checklist in context: "A large body of evidence gathered in recent years has revealed a profound failure by health-care professionals to follow basic steps proven to stop infection and other major complications. We now know that hundreds of thousands of Americans suffer serious complications or die as a result. . . . People in health care work long, hard hours . . .struggling, however, to provide increasingly complex care in the absence of effective systematization.

"Excellent clinical care is no longer possible without doctors and nurses routinely using checklists and other organizational strategies and studying their results. There need to be as few barriers to such efforts as possible. Instead, the endeavor itself is treated as the danger.

"If the government’s ruling were applied more widely," Gawande notes, "whole swaths of critical work to ensure safe and effective care would either halt or shrink: efforts by the Centers for Disease Control and Prevention to examine responses to outbreaks of infectious disease . . .

"I work with the World Health Organization on a new effort to introduce surgical safety checklists worldwide. It aims to ensure that a dozen basic safety steps are actually followed in operating rooms here and abroad — that the operating team gives an antibiotic before making an incision, for example, and reviews how much blood loss to prepare for. A critical component of the program involves tracking successes and failures and learning from them. If each of the hundreds of hospitals we’re trying to draw into the program were required to obtain permissions for this, even just from research regulators, few could join.

"Scientific research regulations had previously exempted efforts to improve medical quality and public health — because they hadn’t been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. . . .The agency should allow this research to continue unencumbered. If it won’t, then Congress will have to," Gawande concludes.

WHAT IS GOING ON HERE? I very much doubt that the decision had anything to do with medical ethics or patients’ rights. I suspect the key to the decision is buried in this sentence: "Checklists may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures."

Someone was worried that the checklist program would draw too much attention to just how prone to error our healthcare system is. I’m going to try to find out more about what motivated this decision, who runs the agency in question, etc.

If anyone reading this post has any ideas, please comment here or contact me at mahar@tcf.org. Your e-mail will be kept confidential.

15 thoughts on “Checklists Update–Administration Stops Program”

  2. OK, call me a wacko, conspiracy theorist or whatever (wouldnt be the first time). If we stand to save 200 million, then someone stands to lose 200 million, that seems like motive to me? I would say, follow the money trail, good luck though, the bigger the dollar amount the better the trail is covered. In my ICU experience, this is where we are likely to use/try medications we might not otherwise use, antibiotic use alone (especially in the ICU) is astronomical!!! So pharma will lose money (and data) also, the hospitals most expensive beds/services are in the ICU, so they lose out as well. I can’t imagine the govt cares if we see how many medical mistakes are made here, infact they have used similar data to argue for electronic medical records and shorter hours for medical interns and residents (imagine, they are down to a mere 80 hours a week). I wonder who else stands to lose money here?

  3. Money, money, money$$$$$$
    What about patient and family dignity, how about some compassion, privacy – isn’t there a law about that? Why are sanitatiion and isolation protocols a mystery? How about reading the “allergy to” signs, how about cleaning feces from the mattress cover? What kind of care allows patients to have 9 cm decub with tendons showing??? I could go on and on, but after two years of talking and emailing etc idiots and morons in the legal and medical fields, I just don’t know any longer. $$$$$$$$$$$$$$$$$$$$$$$$$$$
    Oh, and before I close, didn’t all the medical pros know the situations before they entered their fields? How much is suffering worth? How much is devestation worth? How much is a human life worth?

  5. Lisa, Lourraine, Dr. Matt and Graham–
    Yes, I’m afraid that this is all about money.
    And Graham, you are right, this wasn’t a decision made by an anonymous “government.”
    Some one or some group decided they didn’t like the idea of checklists and had enough clout to get the
    Office of Human Research Protections (OHRP) on the case.
    Who is OHRP and who runs it? So far, this is what I have discovered:
    Until August, OHRP was headed by Bernard Scwetz, who is a veterinarian (DVM) and Ph.D. He’s also a toxcologist. That’s right, he’s not a M.D. though he was overseeing the office of Human Reserach Protection.
    What’s even more surprising is that from January 20, 2001 to February 22, 2002, he was Acting Principal Deputy Commissioner of the FDA.
    This was not a bright period in the FDA’s history. During this time, the FDA counsel, a well known tobacco company and Big Pharma lobbyists was running the FDA from beind the scenes. (I’ve written about this in the book.)
    As for the ORHP itself, I’m told its a “strange creature” that was created in 2000 to replace the Office of PRotection from Reserarch Risks. Allegedly, the Office of Protection from Reserach Risks, which reported to the NIH, had been doing its job too zealously.
    The OHRP would report directly to the assistant secretary of health–giving the administration more control over its activities.
    When I know more I’ll write a second updated post, including this information

  6. It’s possible that this was a specifically politically motivated decision.But those who know the OHRP know that they often make decisions and pursue issues that make very little sense — that’s pretty much their M.O. Based on many years of experience, I believe that they make their capricious decisions partly out of incompetence, but also to to keep researchers on their toes. Universities live in fear of them, and that makes OHRP important. Usually their decisions don’t get into the NYT; this one did.
    Many benefit from the confusion and fear engendered by their complex and contradictory rulings. Beyond a bloated federal bureaucracy, research regulation itself is a big multimillion dollar business. For example, see the Western IRB, a firm held by a private equity concern that provides services to many universities, who hope that using WIRB will protect them from OHRP’s worst excesses:
    http://www.wirb.com/
    In another galaxy, AAHRPP is a group of research regulation junkies who have gotten in on the gravy train, and developed multi-million dollar IRB certification programs. http://www.aahrpp.org/www.aspx
    Universities are signing up to be certified with the hope that the gold star will shield them from being found to be “bad” by OHRP…
    I could go on and on.

  7. This adds more irrationality to the matter of whether things need approval, or do not. It’s generally a good thing, I believe, that the FDA introduced a reasonable approval process, 510(k), which covers medical information systems that manage the devices that always have needed approval. For an information system (disclaimer: one of these days, when my client’s priorities calm down, I’m supposed to take a product through the process), the approval process isn’t a long and convoluted trial, but a semiformal verification the product does what its specifications say.
    AFAIK, however, as long as no new drugs or devices are being introduced, there is no requirement to approve a new surgical technique. There is informed consent as there would be to any invasive procedure, but there isn’t a list of approved procedures in the same sense of approved devices or drugs.
    I can’t help but wonder if Hopkins and Michigan had called the checklist an information system, and put it through 510(k) approval, never calling it “research”, if it might have gotten FDA blessing.

  8. When human subjects protection stifles innovation

    The other day, I happened across an Op-Ed article in the New York Times that left me scratching my head at the seeming insanity of the incident it described. The article, written by Dr. Atul Gawande, author of Complications: A…

  9. While this article, as written, does make it sound like a bad move by OHRP, I suspect that much important information has been omitted.
    Such as: was this part of an evaluation “research” project? If so, did it receive IRB approval? If not, no, then it cannot continue in the same way. The hospitals could have continued the practice without IRB approval–but not if they planned to disseminate any findings as “research.”
    Like it or not, this is part of the IRB regulations that do protect patients in the larger picture.
    The principal investigators on quality improvement projects often think they should be exempt from IRB review. Well, they’re not. I’m a researcher as well as an IRB administrator, and I know from both sides how onerous the IRB process can be. But it is a necessary evil.
    If the PIs on this project had received IRB approval, this wouldn’t be an issue. There’s more here than the story is letting on…

  10. Thank you all for your continuing comments.
    I have found out more about ORHP and the source of the complaint–which I plan to post tomorrow.
    But I must admit that while I have determined that there is something very wrong with ORHP (the agency that halted used fo the checklist) I haven’t figured out whether this is simply a case of an extraordinarily stupid and incompetent agency being literal-minded, or whether there was a political agenda here.
    Either way, the ruling was simply wrong. And if Congress doesn’t do something, it will have a chilling effect on efforts to reduce errors and improve quality in hospitals nationwide.
    That is why I am going to continue to write about this.

  11. hospitals can use checklists any time they want to.
    These particular checklists have already been proven effective thru research.
    Therefore there is absolutely nothing stopping them, not the FDA, not the NIH, not the FDA, not the OHRP, from implementing these checklists nationwide in every hospital.

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