Pilots Use Checklists. Doctors Don’t. Why Not? By Maggie Mahar

Frequent THCB contributor Maggie Mahar returns today with another of her no-holds barred pieces on the practice of medicine, examining the the controversey over checklists for doctors. Many physicians are opposed to the idea on general principles, arguing that checklists "dumb down" medicine and remove the "art" from their craft. Outside observers disagree, noting that there is room in medicine for an approach that has helped make airline travel safe and improved efficiency in countless industries. If you enjoy this piece, you’ll find a wonderful collection of similar pieces tackling the inner workings of the healthcare system over at HealthBeat, Maggie’s blog at the Century Foundation.

Pilots Use Checklists. Doctors Don’t. Why Not?This is a question Dr. Atul Gawande explores in the December 10 issue of The New Yorker. “The Checklist”is a shocking story, it’s an important story—and it’s also very long. I, of course, would be the last person on earth to criticize someone for “writing long”but it occurs to me that many of HealthBeat’s readers may not have the time to peruse the full nine-page story, so I decided to offer a capsule summary here. (To read the story in its entirety, click here).

Gawande is the author of one of my favorite healthcare books, Complications: A Surgeon’s Notes on an Imperfect Science, and he writes wonderfully well. This piece begins with a riveting tale of a three-year-old who falls into in icy fishpond in a small Austrian town in the Alps. "She is lost beneath the surface for 30 minutes before her parents find her on the bottom of the pond and pull her up.”By then“she has a body temperature of 68 degrees—and no pulse.”A helicopter takes her to a near-by hospital.  There a surgical team puts her on a heart-lung bypass machine. She now has been lifeless for an hour and a half. Gradually, the machine begins to work. After six hours, her core temperature reaches 98.6 degrees, but she is hardly out of the woods. Her lungs are too badly damaged to function, so the surgeons use a power saw to open her chest down the middle and sew lines to and from an artificial lung system into her aorta and beating heart. “Over the next two days, all of her organs recover except her brain. When a CT scan shows global brain swelling, the team drills a hole into her skull, threads in a probe to monitor cerebral pressure, and adjusts fluids and medications to keep her stable. “

Slowly, over two weeks, she comes back to life. "Her right leg and left arm [are] partially paralyzed.  Her speech [is] thick and slurry.  But by age five, after extensive outpatient therapy, she has recovered her faculties completely. She [is] like any little girl again.” 

“What makes her recovery astounding,” Gawande writes, is "the idea that a group of people in an ordinary hospital could do something so enormously complex. To save this one child, scores of people had to carry out thousands of step correctly; placing the heart-pump tubing into her without letting in air bubbles, maintaining the sterility of her lines, her open chest, the burr hole in her skull; keeping a temperamental battery of machines up and running”all the while "orchestrating each of these steps in the right sequence, with nothing dropped . . .”

This, Gawande says, is what happens in intensive care units, every day of the year, all across the country. “Intensive care medicine has become the art of managing extreme complexity—and a test of whether such complexity can, in fact, be humanly mastered.”

American medicine doesn’t do too badly. "The average stay of an I.C.U. patient is four days, and the survival rate is eighty-six percent. [This is something to keep in mind when someone says that we shouldn’t spend so much money on patients in I.C.U. units during their final days of life. Eighty-six out of 100 survive—and usually, it’s impossible to know with any certainty which 14 will die.—M. Mahar] “Going into an I.C.U. is not a sentence of death,”Gawande notes, "But the days will be the most precarious of your life.”

The complexity and intensity of the care is astounding. The average patient in an I.C.U. requires “a hundred and seventy-eight individual actions per day, ranging from administering a drug to suctioning the lungs, and every one of them poses risks,” Gawande observes, citing a study done by engineers who tracked I.C.U. care for 24-hour stretches. “Remarkably,”the engineers found that the nurses and doctors made errors in just one percent of these actions—“but that still amounted to an average of two errors a day with every patient.”

“This is the reality of intensive care,”Gawande adds. “At any point, we are as apt to harm as we are to heal.” Line infections are common…I.C.U.s put five million lines into patients each year, and national statistics show that, after ten days, four percent of those lines become infected. Line infections occur in eighty thousand people a year in the United States and are fatal between five and twenty-eight percent of the time, depending on how sick one is at the start.  . . . The I.C. U., with its spectacular success and frequent failures, therefore poses a distinctive challenge: what do you do when expertise is not enough?”

Gawande then turns to the story of how pilots began making checklists.“On October 30, 1935, at Wright Air Field in Dayton, Ohio, the U.S. Army Air Corps held a flight competition for airplane manufacturers vying to build its next-generation long-range bomber.”Everyone thought they knew who would win. Boeing’s “gleaming aluminum-alloy Model 299”was the clear favorite. "It could fly faster than previous bombers and almost twice as far. A small crowd of Army brass and manufacturing executives watched as the Model 299 . . . roared down the tarmac, lifted off smoothly, and climbed sharply to three hundred feet. Then it stalled, turned on one wing and crashed in a fiery explosion. Two of the five crew members died, including the pilot, Major Ployer P. Hill,” the U.S. Army Air Corps’ chief of flight testing.

The cause of the crash?  Pilot error. “Substantially more complex than previous aircraft, the new plane required the pilot to attend to the four engines, a retractable landing gear, new wing flaps, electric trim tabs . . . and constant-speed propellers whose pitch had to be regulated with hydraulic controls . . While doing all this, Hill had forgotten to release a new locking mechanism on the elevator and rudder controls. The Boeing model was deemed as one newspaper put it, ‘too much airplane for one man to fly.’”

Perhaps the pilot should have had more training. “But it was hard to imagine having more experience and expertise than Major Hill,”Gawande writes. "Instead, they came up with an ingeniously simple approach: they created a pilot’s checklist, with step-by-step checking for takeoff, flight, landing and taxing.”

With that checklist, “pilots would go on to fly the Model 299 a total of 1.8 million miles without one accident,” Gawande writes. "The army ultimately ordered almost thirteen thousand of the aircraft, which is dubbed the B-17.”

At this point in his narrative, Gawande returns to intensive care, announcing that “Medicine today has entered its B-17 phase. Substantial parts of what hospitals do—most notably, intensive care—are now too complex for clinicians to carry them out reliably from memory alone. I.C.U. life support has become too much medicine for one person to fly.”

Could something as simple as a checklist help hospitals? Six years ago, a critical-care specialist at Johns Hopkins Hospital named Peter Pronovost decided to give it a try.”He started with just one problem—line infections—and wrote out the steps a health care provider must take to avoid these infections when putting a line in. "Doctors are supposed to 1) wash their hands with soap, 2) clean the patient’s skin with chlorhexidine antiseptic 3) put sterile drapes over the entire patient, 4) wear a sterile mask, hat, gown and gloves and 5) put a sterile dressing over the catheter site once the line is in.” It doesn’t sound hard, does it? 

Pronovost then "asked the nurses in his I.C.U. at Johns Hopkins to observe the doctors for a month as they put lines into patients. “It turned out that in more than a third of all cases, doctors skipped at least one step. The hospital administration than gave the nurses permission to stop doctors if they saw them skipping a step.

Over the next year: "The results were so dramatic that they weren’t sure whether to believe them: the ten-day line-infection rate went from eleven percent to zero. So they followed patients for fifteen more months. Only two line infections . . . in this one hospital, the checklist had prevented forty-three infections and eight deaths, and saved two million dollars in costs.”

Once again, higher quality care and less expensive care go hand in hand.  Keep this in mind when someone tries to scare you by saying that under national health care reform, the government will try to lower health care spending. If the government uses medical evidence to reduce costs—which is what the Democratic candidates plan to do—we will all be safer.

Pronovost made other checklists for other procedures and ultimately “took his findings on the road, showing his checklists to doctors, nurses, insurers, employers—anyone who would listen.”  But he found few people interested in adopting the lists. “So far, he’d shown only that checklists worked in one hospital, Johns Hopkins, where the I.C.U.s have money, plenty of staff, and Peter Pronovsot waking the hallways to make sure the checklists are being used properly.”  Gawande explains.

But then he caught a break. In 2003 the Michigan Health and Hospital Association asked Pronovost to try out three of his checklist in all of Michigan’s I.C.U.s.   Once again, the results were astounding. Before the project began “infection rates for I.C.U. patients in Michigan hospitals were higher than the national average, and in some hospitals dramatically so . . . Within the first three months of the experiment . . . Michigan’s infection rates fell so low that its average I.C.U. outperformed ninety percent of I.C.U.s nationwide. Overall, infection rates in Michigan had fallen by sixty-six percent.” After eighteen months, the hospitals saved an estimated $175 million in costs and more than 1500 lives. “The successes have been sustained for almost four years,” Gawande notes, “all because of a stupid little checklist.”

In December of 2006, the results were published in The New England Journal of Medicine.  How many U.S. hospitals have adopted checklists since? 

None. No doubt, many doctors insist that they don’t need a checklist. They know what they are doing. They went to Yale. The idea of being “checked”rankles. But while “the still limited response to Pronovost’s work may be easy to explain . . .it is hard to justify,”Gawande writes. “If someone found a new drug that could wipe out infections with anything remotely like the effectiveness of Pronovost’s lists, there would  be television ads with Robert Jarvik extolling its virtues , detail men offering free lunches to get doctors to make it part of their practice . . .That’s what happened when manufacturers  marketed central-line catheters coated with silver or other antimicrobilas; they cost a third more, and reduced infections only slightly—and hospitals have spent million of dollars on them. But, with the checklist, what we have is Peter Pronovost trying to see if maybe, in the next year or two, hospitals in Rhode Island and New Jersey will give his idea a trial.”

Why? Gawande may be too polite to say this, but the answer seems to me clear. There is no profit to be made on a checklist. What do you sell? Any experienced intensive care specialist knows what should be on the list.  All anyone needs is a few pieces of paper and a pencil. Pronovost has invented a process for delivering health care—not a new hi-tech procedure, not a new product. And like Jonas Salk, who invented the polio vaccine, he is willing to give his idea away for free.

If there were something to sell, Johnson & Johnson or Genentech would have turned Pronovost and his idea into a new medical breakthrough long ago. The story would be reported in U.S.A. Today, trumpeted on the Evening News, splashed on billboards across the nation. Hospitals would be spending millions on ads bragging that they had this new breakthrough product: “At Mount Hope, Where We Care About Your Safety…”

In our for-profit healthcare system, people become truly excited about an idea when someone sees way to make a fortune. So Merck’s new vaccine, Gardasil,  that protects against 70 percent of the viruses that cause cervical cancer has gotten extended play in the press, on TV, and on Wall Street.  Meanwhile, the Pap Smear—a test that detects virtually all cases of cervical cancer  and has, in fact, made this type of cancer a “rare disease” in the U.S., gets little notice. No national campaign to make sure every woman gets annual Pap Smears. It’s not a high-profit procedure.

In the U.S. the idea that the point of healthcare is better health seems to have been lost in the rush to make money. As Harvard’s Dr. Arnold Relman wrote in the most recent issue of JAMA, ours is “the only health system in the world” where “investors and business considerations play such an important role. In no other country are the organizations that provide medical care so driven by income and profit-generating considerations.” 

Recently, Gawande asked Pronovost how much it would cost to do for the whole country what he did for Michigan, and how long it would take. The answer: about two million dollars and two years—“if the country wanted it.”

“So far,” Gawande writes, “it seems that we don’t. The U.S. could have been the first to adopt medical checklists nationwide.” Instead Spain, of all places, is beating us to the punch. While New Jersey mulls the idea over, Spain has already signed up for Pronovost’s program.

Finally, Gawande circles back to the beginning of his story, and confides that he recently spoke to Markus Thalmann, “the cardiac surgeon on the team that saved the little Austrian girl who had drowned.”  In the context of Gawande’s larger story, what he learned is almost unbearably ironic: “a checklist had been crucial to her survival.”  The team at the Austrian hospital faces three to five patients like the little girl every year, often the victims of an avalanche. For years, they could never save them—until Thalmann and a couple of colleagues made and distributed a checklist. The rescue of the three-year-old girl was their first success with the checklist in place. Since then, it has saved other lives.

But it seems that this is the sort of thing that can happen only in a small town in Austria. Or in Spain. Not in the U.S.  In the U.S., no one is going to tell us how to practice medicine.

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21 replies »

  1. “Back Off?” That’s a very emotional response.
    Doctors are human, right? Are they not fallible? Is not the purpose of any checklist – “professional” or not – to ensure we fallible humans don’t miss a step?
    But really isn’t the first step for the grumpy physician to admit that s/he isn’t perfect?
    Somewhere in that emotional response is hubris, Doc. At what point was a “non professional” writing this simple checklist?
    No, that response is indefensible, emotionally and logically.
    Not to mention a little insulting. I’d like a checklist whenever a physician invades my profession and insists he or she knows something about technology and people. I have 25 years of hard-won experience that is subject to some big ego’s whim.
    But I don’t tell one to “back off.” Even when they piss off this professional. That would be rude.

  2. Thank you for this article. I’ll have this in the back of my head as I start med school. Hopefully I can make some worthwhile checklists for appropriate procedures.

  3. I strongly suspect that the PHPR’s objections were to the conduct of medical research w/o proper consent and oversight by an IRB and/or violations of HIPAA’s (poor) requirements for extra-precautions for research (but not for insurance companies who want to sell your “de-identified” information to their business partners).
    PHPR has no authority to regulate the practice of medicine. While there are other watchdog agencies (primarily relating to facility certifications, controlled substances) at the federal level, this is currently relegated to the states.
    At a state level I am sure that medial boards are able to require a specific physician to use check-lists, but I seriously doubt that they would ever object to an otherwise competent physician using them.
    Most physician’s have an under-appreciation for the types of cognitive errors that plague the most expert decision makers. This is changing over time as medical school and residency curriculum adapt to this under looked aspect of clinical practice. Some of this is ego, but mostly it is just a lack of understanding of what and how humans make errors. Understand this: in my field, we make thousands of critical decisions every day without perfect information under time pressures with great accuracy. Adding the checklists adds effort (and I believe an additional margin of safety) but it takes educating people that even if they think they are doing well, they are still missing things that someday will leap up from the underbrush and bite them on the ass.
    People who are critical of physicians who have not yet leapt on this bandwagon need to consider their response if I insisted that they use a checklist every time they operated an automobile (where they have a much greater potential to kill someone than most physicians!) Since I routinely observe people not signaling lane changes (when they cut me off), using cell phones (anyone who thinks they drive well when talking on a cell phone is a perfect example why most physicians don’t think they need checklists–hang up and drive!), not stopping for pedestrians in cross walks, speeding in school zones, etc. it is clear to me that some reminder is needed.
    As far as physicians use of check-lists, I (a practicing emergency physician) have developed, taught and used checklists for critical aspects of care (sedation, acute cardiac care, stroke management, post-resuscitation care, intubation/airway management, trauma care, medical clearance of psychiatric patients w/ acute psychosis, and contraindications/dosing for specific drugs w/ narrow safety windows) for about 8-9 years now.

  4. So, it is unreasonable for patients who need a line for an extended period of time to expect all the steps to be followed in the right sequence to avoid infection, because they are an individual? Or is it that each doc is an individual and shouldn’t be burdened by the oversight of an “underling”? I have one question for those who do accept the effectiveness of checklists: What else has been tried and achieved such results?
    About conspiracy theories, when I first read about the OHPR pulling the plug on Hopkins and Michigan, I immediately thought it was an industry insider – someone like a detail man for a medical equipment manufacturer, or some such person who would stand to lose financially from a reduction in infections. I can’t believe a provider would be so callous to put their ego ahead of the lives of their patients. Providers are too busy to hatch a scheme like this. It had to have come from someone more stupid and less invested in good outcomes.

  5. Being both a pilot and a physician, I try to be a professional in two professions. Checklists are common to both fields, when created by professionals. Amateurs need not apply.
    None of you would presume to write a checklist for a 747 pilot, nor would you presume to create a checklist for doctors. None of you would want a checklist applied to you, as each of you is unique. None of you are generic.
    Back off. Checklists, like practice guidelines, will create more problems in practice than they solve, resulting in worse outcomes, and piss-off the professionals.

  6. The hospital gave the nurses permission to stop the doctors if they saw them missing a step.
    Now there you see, is the source of the problem. Doctors as Gods. Until that is dealt with and changed, the whole of western medical science and health care delivery is going to stay *#$* up.

  7. Thanks for your comments–
    Bev M.D. — The other day I received an e-mail from Peter Provonost (who invented the check-list) saying that an “anonymous complaint” started the whole thing.
    I agree with you; it could well have been a docotor who didn’t like having to use a checklist.
    And the results could, indeed be catastrophic for quality improvement efforts . . .

  8. Bev M.D,–
    In answer to your question about who complained: It was “one anonymous complaint.”

  9. Oh – and I forgot to mention – aren’t central line infections one of the things that CMS just announced they will no longer pay hospitals for, since it’s a medical error? So essentially the government is saying to hospitals, we (CMS) won’t pay you for this medical error, but we(OHRP) also won’t allow you to implement the successful research findings on ways to avoid this medical error – even though we, the government (AHRQ), funded the research in the first place.
    Sorry for elevating this to a rant, but good grief, Charlie Brown!

  10. Maggie;
    I have reviewed all 3 letters provided by elliottg and the law review article, and I reread the New England Journal article which is the subject of this controversy. Although it’s hard to get through all the jargon, it appears to me that the OHRP’s objections are entirely technical, to wit:
    1. Hopkins seems to have claimed that the research was “exempt” and therefore did not require obtaining informed consent. They also claimed that the interventions carried out in the Michigan hospitals were not human subjects research, but quality improvement activities (duh!) OHRP went to great lengths in their letters to indicate why it WAS research and not quality improvement, and that the research was NOT exempt and therefore informed consent should have been obtained. Furthermore, they indicate that the “human subjects” of the research were BOTH the patients and the caregivers.
    2. OHRP claims that the research was not approved by an Institutional Review Board (IRB), although the NEJM article states that the IRB of Hopkins approved it. I am gathering that the OHRP thinks the IRB of each Michigan hospital should have also approved it.
    There appears to have been some confusion on the part of the researchers as to how to fill out the various forms and grant applications, which led to OHRP tripping them up for appearing to be lying. I interpret this confusion as being due to the fact that there is not a clear definition in anyone’s mind of what is RESEARCH (like giving a patient an experimental drug or trying a new treatment on them) and what is QUALITY IMPROVEMENT (e.g. standardizing or improving existing care-giving processes within hospitals) Therefore this project fell in a gray area and was interpreted one way by the hospitals and another way by the OHRP.
    Although I can entirely understand how this could have developed, knowing how bureaucracies work; it does not change the fact that, if allowed to stand, OHRP asserting its authority over what is essentially a quality improvement activity will destroy any embryonic desire on the part of hospitals to study how to improve their processes to avoid medical errors. The consequences could be catastrophic. The tragicomedy of this project is that it was funded by the Agency for Healthcare Quality and Improvement – now isn’t that funny??!! (not)
    The only remaining question I have is, how did this come to the attention of OHRP in the first place? Did some caregiver object to having to use a checklist and “blow the whistle”? If so, he/she knows not what he/she did, and the terrible result it may have.
    In my mind, the only solution is that quality improvement activities and the associated effectiveness research must be clearly defined as such by somebody (Congress?) and exempted from this bureaucratic BS, and FAST. Let’s work toward that positive goal.

  11. I had the same questions when I read the article and posted a comment of my own on my site Dec 15th. I was truly amazed with the data that was reported and still there were no takers. When there is clearly a better way of approaching something like this I don’t fully understand why it is not developed and utilized. It is disappointing to say the least. As far as some of the comments from the MD community regarding cook book medicine. I disagree with the analogy. Certainly medicine needs to be tailored to the needs of every patient as each on of us will likely respond differently to a given treatment. But certain things are always done the same way no matter what.

  12. David;
    Your statement, “…..or agree to aggregate error data into method improvements that actually achieve system level results” seems to describe exactly what the authors of the checklists were attempting to do – use the checklists as method improvements to achieve system level improvement. So why were they shut down? This is either an extreme example of bureaucratic incompetence,(which is quite possible; I have seen similar stupidity during my career), or some weird political agenda that would seem to benefit no one – least of all the patient.
    Maggie, since you’re the investigative journalist, I suggest you investigate ‘what the hell is going on here.’ I, for one, will email the source kindly provided by eliot and ask the same question. I suggest the heads of hospitals who contacted you do the same – unless they have to be afraid to. I am retired, so couldn’t care less.

  13. Although Maggie ports a well developed and clearly articulated thesis, avoiding the assumption of more competency and focus wrapped in a conspiracy than people have the skills to concoct is a challenge for anyone, particular within a two trillion dollar industry. In this case, the facts are so surreal that its difficult to imagine what anyone involved might be thinking. It does the question of incentives in each aspect of a system matching the desired behavior we expect. Systems that measure ideas against institutions as opposed to the other way around are prone to thinking that leads to convoluted choices.
    Researchers, regulatory communities as well as clinical institutions and professionals are generally paid to accomplish disparate objectives thus why would we be surprised that the clinical, regulatory and research functions make irrational choices from an integrated system perspective?
    Physicians and health care institutions are not going to willingly accept potentially punitive measures any more than people in other industries. We can battle over the publics right to know each error and squeeze minimal compliance or agree to aggregate error data into method improvements that actually achieve system level results. Atul Gawande’s airline industry analogy is well taken.

  14. Bev md. Elliottg and chris w.
    Bev, you’re right. Originaly an investigative jourailst, I’m trained to be suspicious.
    But the healthcare renewal post doesn’t explain the reason for the shutdown. It explains that the agency that is halting use of the checklist (OHRP) is supposed to be concerned about patient confidentiality, but that those concerns really don’t apply here. Finally, Roy Poses, author of healthcare renewal ends his post saying: “Maybe it is time for conspiracy theories . . .”
    I know Roy, and he means this.
    Before I wrote my second post, I read the leters that OHRP sent to Johns Hopkins and Michigan. They are dense with beaurocratic language, but make no sense whatsoever.
    So then I looked into OHRP and who runs it. When ORHP began writing letters to Johns Hopkins and Michigan the head of OHRP was Bernard Scwetz. (He suddenly resigned in August, but this all happened on his watch.)
    Schwetz, the head of OHRP (the Office of Human Research Protections)is a veterinarian. I’m not kidding. He’s a DMV. He also has a Ph.D. and is a toxologist.
    When you look into his background, you find out that he seems to be a poltical appointee. AT the very beginning of Bush’s first term, Schwetz was made deputy acting commissioner of the FDA. That’s right a vet was deputy acting commissioner of the FDA for a year. (I have nothing against vets, but this doesn’t make a lot of sense.)
    This was not a bright period in the FDA’s history. During Schwetz’ tenure, Dan Troy, who was the FDA’s counsel, began running the FDA from behind the scenes. Troy had a been long-time enemy of the FDA– representing Brown & Williamson in its fight against the FDA and, just a few months before he joined the agency, Troy was representing Pfizer in another battle with the FDA. As one magazine (U.S. News?) put it “Mr. Outside Goes Inside” and proceeded to do his best to dismantle the FDA.(This is all documented in my book, Money-Driven Medicine. Congressmen protested and eventually Troy was forced to resign.)
    As for the agency OHRP– it was created in 2000. The agency it replaced had reported to NIH. OHRP would report to the asst. sec of heatlh–in other words, it would be controlled by the administration.
    The law journal article that elliottg sent me
    explains that when ORHP decides to audit a hospital, it is usually in response to a complaint:
    “Far more common than compliance audits
    are what we will call complaint investigations, which arise in response tospecific complaints of investigator misconduct or IRB default. These focus
    on the particular incident raised in the complaint. The majority of complaint some from institutions themselves, which are required to report deficiencies
    they discover to the OHRP,14 but complaints also come from research subjects and whistle-blowers.”
    I have a hard time believing the complaint came from a patient in the ICU (or relative of a patient). What would they have to complain about?
    Elliottg– thanks very much for sending me the law review article and letters. (I had seen the letters, but not the law review article.)
    The law review article criticizes OHRP for “nitpicking”, generating needless red tape and being overly-bureaucratic. Conceivably that is what happened here. Except– the law review article also emphasizes that OHRP’s “heaviest sanction—shutting
    down some or all research—is hardly ever deployed.”
    So why was that heaviest sanction used here? No patient was in danger of dying because a doctor was using a check-list. In no way was the patient being put at risk, nor was his privacy invaded. (The doctors using the checklists already had access to his charts.) The
    checklist project, in fact, was not about the patients, it was about the doctors. If anyone’s privacy was being invaded, it was theirs. (Nurses were watching them to make sure they did the right thing.)
    I’ve now heard from a couple of heads of hospitals who are asking what I’m asking: “What the hell is going on here?” There is more to this story than meets the eye.

  15. Here are some sources. The three letters below are the OHRP’s notification to John Hopkins and Michigan of problems. The Law Review article basically outlines the problems with OHRP.
    Kristina Borror is the responsible person. Her contact information is at the head of each letter.
    Email is E-mail:kborror@osophs.dhhs.gov
    Phone is 240-453-8132

  16. Maggie;
    I literally could not believe what I just read in your comment above. The apparent reasoning behind the decision appears on the Health Care Renewal Blog (http://hcrenewal.blogspot.com/); to wit, that it apparently had more to do with confidentiality concerns than anything else. (Your journalist’s suspicion that it was protecting docs’ reputations, while understandable, appears unjustified.) But this is completely incomprehensible; researchers collect data from patient’s charts literally every day! I can’t recall the number of patient’s charts I reviewed when our laboratory was doing some kind of internal study on the efficacy of a new lab test or something. Forbidding this is Crazy with a capital C!
    I would be interested if you could obtain the name and address of the bureaucrat responsible for this decision; I for one would like to write him/her a letter explaining what medical research and quality improvement are all about. I am sure many others would, too.

  17. You beat me to it, Maggie; thanks for pointing to this article. For other readers of this post, here is a link to Gawande’s New York Times op-ed, which should remain available on the site indefinitely (given the Times’ new policy).

  18. April–
    Thanks very much for your comment. I agree. This is definitely an area where Medicare should take the lead.
    But instead, today (Sunday, Dec. 30) Atul Gawande wrote an op-ed in the New York Times revealing that a U.S. government agency has stopped the use of checklists in Michigan and at Johns Hopkins:
    ” 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. . . .
    “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.
    “The government’s decision was bizarre and dangerous. 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.
    [But] “testing a checklist for infection prevention, is not the same as testing an experimental drug — 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. This work is different from drug testing not merely because it poses lower risks, but because a failure to carry it out poses a vastly greater risk to people’s lives.
    “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, 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.

    WHAT IS GOING ON HERE?? I very much doubt that the decision had anything to do with medical ethics. 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.”
    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 contact me at mahar@tcf.org
    Thanks very much.

  19. I thought the Gawande piece was brilliant. I hope it leads to more momentum behind the rolling out of the use of checklists and other innovations to improve healthcare quality in the US health system.
    I don’t think we need a fundamentally different health system to achieve such a rollout however (though we need serious reforms to get us to universal coverage): we could easily get checklists used in every hospital if Medicare reimbursement were made contingent on their use.
    Many such quality improvements could be brought about – if Medicare, and private insurers, shifted to apply more quality-related process and outcome indicators in their eligibiity and reimbursement regulations.

  20. This excellent artikle would half presented itselfs a lot more betterer if someonce had proofreaded it; maype with a stoopit liddle chekleest?