Federal Agency Kills Lifesaving Hospital Checklist Program

The Office for Human Research Protections recently shut down a Johns Hopkins University program that had intensive care units across Michigan following “a simple five-step checklist designed to prevent certain hospital infections.” The program resulted in dramatic improvements to patient infection rates, but the federal agency said it was unethical, because a checklist interferes with medical care in the same way an experimental drug does—and because a checklist may put doctors at risk by revealing which ones don’t “follow basic infection-prevention procedures.”

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.

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. It’s not for lack of effort. People in health care work long, hard hours. They are 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.

“A Lifesaving Checklist” [New York Times]

RELATED
“The Checklist” [The New Yorker]
(Photo: Getty)

Comments

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  1. What The Geek says:

    Wow – just wow…. ’cause saving lives AND money are bad if they make Dr’s follow silly rules about hygiene.

  2. AstroPig7 says:

    So, rather than admit that some doctors have a problem with basic procedures, they will instead be protected by obscurity, and patients will continue to die as a result. I love our healthcare system.

  3. char says:

    “but the federal agency said it was unethical, because a checklist medical care in the same way an experimental drug does”

    Is there a typo in this sentence? It doesn’t seem to make any sense to me.

  4. savdavid says:

    Lordy, can’t make doctors who don’t follow rules look bad. That might hurt their wittle feelings. They might even be so distraught they would miss golf tee times. What’s a few saved lives anyway?

  5. Jean-Baptiste Emanuel Zorg says:

    “because a checklist medical care in the same way an experimental drug does”

    I don’t usually comment on typos because it’s typically pretty easy to figure out the original intent. But this is a head scratcher. Apparently a checklist does something in the same way an experimental drug does. I can’t even begin to guess what, though

  6. What The Geek says:

    There seems to be a disturbing level of neglect in hospitals lately, and this story doesn’t put me at ease at all.

    I was recently in the ER late at night with my girlfriend. We arrived at 11:30 pm. She was taken in fairly quickly, asked a few questions, and left to sit for about an hour (maybe closer to two) before she had any blood taken, or was given any treatment. Then (as it was a condition that required monitoring) we were left sitting and waiting. Until 5AM. The shift had changed, and the Dr that had been dealing with us told us that another Doc would be taking over for her, and that he had been briefed on my girlfriend’s situation. We never saw the second Dr. Ever. He sent a nurse (same one who neglected to ever come back w/ more pain medicine btw) over with discharge papers after completely ignoring us for several hours. Fast forward a week – she’s at the Dr’s – the regular doc, not the ER – and she was told that the neglect shown in the ER could have lead to her death. She should have been treated, but the convoluted system used in that ER kept her from getting any actual attention, let alone treatment. And the gov’t wants FEWER checklists??

  7. cmdr.sass says:

    A stunningly stupid decision by an incompetent agency.

    I remember reading about this in the New Yorker awhile ago. The man behind the checklist program would be a national hero if given free reign to implement checklists as he suggests for many common procedures. It reduces costs, reduces errors, and improves patient care. It’s win-win for everyone except those profiting on health care.

  8. Chris Walters says:

    @TinyBug @char: I removed a word I didn’t like and forgot to put in one I did like. It has since been corrected.

  9. Instigator says:

    The restrooms in the ER in my town’s hospital (which is a branch of a major healthcare system)have posters illustrating correct handwashing technique. The scary part, of course, is that these posters are obviously intended to instruct the hospital staff. Excuse me, but if you’re a healthcare professional or tech, shouldn’t you already KNOW how to wash your hands so as to not infect patients?

  10. char says:

    Thanks for fixing it promptly, I had my phone ready to dial “Consumerist Executive line” but I’ll put it down now.

  11. Instigator says:

    How could I forget? It turns out that a patient in this same hospital had to have all four limbs amputated because she became infected with flesh-eating bacteria!

  12. What The Geek says:

    @Instigator:
    What?!? Yikes. Never mind – your ER story wins.

  13. 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.

    If by “blinkered logic” they mean “rampant stupidity” then I completely agree!

    I shouldn’t have to say this but CHECKLIST != EXPERIMENTAL DRUG

    You should not need me to sign a piece of paper just because the doctor consulted a checklist to make sure s/he was doing what THEY WERE SUPPOSED TO BE DOING ANYWAY! How is this considered a change in care?

    Next thing you know they’ll be banning post-it notes!

  14. Propaniac says:

    Even after reading the article, I seriously don’t understand how they could compare using a checklist to perform standard, widely accepted procedures, to using an experimental drug. And getting rid of the checklist in order to protect doctors is pretty nonsensical, too; the reason the checklist was useful is because you don’t have to be a poor doctor or nurse in order to miss a step that could turn out to be crucial. There are hundreds of these steps that are supposed to be followed each day for each critical patient.

    I read that New Yorker article, too, and I thought it was very inspiring.

    Can the checklists be reimplemented if the hospital just asks each patient, “Hey, will you let us use this checklist so we’ll remember to do everything right and drastically reduce the chances that you’ll get a horrible infection and die?” I’m sure the insurance companies would pose no objection.

  15. goller321 says:

    @Rectilinear Propagation: Because the checklist keeps doctors from forgetting or skipping steps the should be performing. While their care is of the utmost importance, medical staff are still humans prone to mistake. Having a list helps lower the risk of making those mistakes.

  16. Propaniac says:

    @Propaniac: After looking back at the article, I now see that requiring permissions WOULD drastically reduce the number of patients that this could be used for. This is so damn stupid.

  17. goller321 says:

    This is EXACTLY why we’re ranked 37th in medical care…

    We’re number 37, we’re number 37…!!!!!!!!

    I think subjecting the bureaucrats to the sub par level of health care the rest of us gets is only fair…

  18. @goller321: OK, I think my comment was confusing. I’m for doctors using the checklist. What I’m yelling about is the idea that the checklist represents a change in care equivalent to an experimental drug and therefore required a patient’s signature.

    People should be able to consult lists of things they already need to do without asking permission first.

  19. TangDrinker says:

    This sucks. How can saving money and lives be a bad thing?

    I just finished the article in the New Yorker. The checklist for ICU contained such ground breaking items as “full body drapes before inserting lines” as opposed to just draping the part of the body nearest where the line is inserted and using a specific soap (the hospital system eventually got the company that packaged drapes to include the soap in the package with the drapes).

    Read the article yourself – google New Yorker icu checklist. Not sure if the link below will work.

    [www.newyorker.com]

  20. SacraBos says:

    @whatthegeek: That’s why when you go into the hospital, you should have an advocate. A spouse, friend, etc to make sure you get the care you deserve and help watch you. If you need something, they can make sure you get it. It’s sad, but you cannot just assume they will proactively take care of you. You need someone that can help understand what treatment is supposed to entail, make sure followups are done, and shift changes are handled correctly. And if you have any doubts, go to the nurses station and make sure something is done, and possibly document your actions.

    Some hospitals are better than others. One wouldn’t check on some medication for my wife because the nurses on duty didn’t want to disturb the doctor at night. The convenience of the doctor outweighed the health of the patient!

  21. What The Geek says:

    @sacrabos: Without going into too much of my gf’s medical details, I was being a very vocal advocate – I had a much tighter grasp on the situation than anyone else in the ER (which was occupied by only two other patients btw), however, everytime I piped up on behalf of my girlfriend, I was met with “in a minute” or “I have to go to *insert excuse here* first” or some other dismissive “concerned boyfriend doesn’t know what he’s talking about” response. It was a little upsetting – much like your situation, the convenience of the staff seemed to outweigh the health of the patient. It was downright scary.

  22. ppiddyp says:

    I totally agree that this ruling is an example of how stupid the bureaucracy is, but I completely understand why OHRP shut it down. They’re not exactly right to shut it down, but they’re not 100% wrong, either. This is really two separate issues: A) This is a promising study that saved lives and worked but, B) this is an ill-conceived study that wasn’t following standards that are put in place to protect us.

    Hypothetically speaking, how do we _know_ that this checklist was using widely accepted standards of care? What federal regulatory body oversaw the creation of the checklist? What if one of the steps contained some sort of egregious error? Personally, I don’t want the IRB for Johns Hopkins making decisions that alter standards of care in my home state.

    Health research is crazy dangerous and current oversight bodies are already unable to manage it effectively. Fact is, if you want only good drugs and procedures to make it to market you’re going to have to shut down some promising studies for stupid technicalities from time to time. If you want to get those drugs and procedures out onto the market as fast as possible, some bad drugs will slip through the cracks and people will die.

    I’m sure the checklist was great, it looks like it worked insanely well. However, there are plenty of horror stories of studies that didn’t produce such nice results and I’d like scientists and doctors and regulators to err on the side of caution thankyouverymuch.

  23. Tonguetied says:

    This reminds me of the situation many,many, many years ago when doctors would go straight from the mortuary to the maternity rooms. Without washing their hands. A director promulgated regulations requiring handwashing. Rates of infection and illness among new mothers and infants dropped dramatically.

    The reward for the director? The doctors all got together and got him fired….

  24. Xerloq says:

    @PatrickAustin: Seems to me erring on the side of caution would be to save lives and use the checklist.

    It’s a poor argument to question the standards of the study and not question the standards designed to “protect” us. How do you know your state has the best health care standards? How do you know the federal government does? What if your doctor fails to follow one of those basic standards, and that results in your death? That sounds like an egregious error to me.

    I believe what this study shows is that the governing bodies don’t have the best standards. By implementing a method (checklist) to ensure that the standards are followed, good standards can be effective. It also suggests that the standards we have aren’t effective enough, which a few simple changes can correct.

  25. QuiteSpunky says:

    @TangDrinker: The New Yorker link works and the article is amazing! Consumerist– please make this its own post!

  26. PlayWithSlurry says:

    I remember being very impressed with the original New Yorker article when I read it. This decision is just scandalous. How could it be OK for doctors and nurses to do all of the things on the checklist without getting consent, but putting those exact things in a list and making sure they are done consistently requires a complicated ethics review process?

    I wrote a (probably ineffectual) email to that effect to the head of the agency (ivor.pritchard@hhs.gov). If enough people (or better, their Senators and Representatives) contacted them, it might have an effect. It seems like a pretty obscure agency, they might not be used to all the attention.

    This work is saving lives now, in America. It needs to go on.

  27. kbarrett says:

    “Checklist” equals “experimental drug” because if it didn’t, the bureaucracy that is trying to serve the malpractice insurance providers and incompetent doctors would be exceeding his authority.

    So they declare blue to be equal to red, ban blue items for being red, and hope that no one takes this crap into a courthouse any time soon.

  28. aegis1 says:

    Interesting to note that the program whose funding was cancelled was in place at financially strapped hospitals serving poor populations. Since the checklist clearly saves lives it makes me wonder what the federal government’s actual purpose is by cancelling the funding.

  29. sistrmoon says:

    To sacrabos and whatthegeek: I am a hospital nurse, and you have NO IDEA what is going on with your nurse’s other patients at the time
    that you are standing at the nurse’s station demanding that your loved one receive care. Your concern may be relatively minor in comparison
    to something life-threatening that is going on. We are trained to prioritize needs and while the other patient may not have a family member there to “advocate” for them, they may be in real danger. We are often waiting for callbacks from doctors, so it may seem like we’re just standing around. Trust me, we’re not. I’m curious what medicine you wanted the nurse to call the doctor about. If it’s
    something minor, yes, we’re not going to call in the middle of the night for it. We save those calls for serious issues, so as to not reduce the already tenuous credibility we have with the almighty
    doctors. As for the pain medication never getting delivered, etc, that never happens at my hospital. I may have several patients all calling for pain meds at the same time and there may be a 5 or 10 minute delay(and standing at the nurses’ station bellowing is not going to help with anything), but that’s one of our highest priorities. It’s not about our convenience. It’s about the utter lack of adequate staffing. I don’t work in ER, so I can’t speak to that.

  30. goller321 says:

    @sistrmoon: And let’s be honest also, hospital quality varies SUBSTANTIALLY. There are ERs in my area that I would gladly go to and ones that I wouldn’t set foot in for anything.