Effect Measure

Who will protect us from our protectors?

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).


  1. #1 RobT
    January 1, 2008

    Maybe Bill O’Reilly can expose this? You never know, he might do some good for a change?

  2. #2 revere
    January 1, 2008

    RobT: Yeah, but can you imagine the spin that bastard would put on it? And who knows. It’s a Bush initiative. He might not even think it was so bad!

  3. #3 AnnaS
    January 1, 2008

    One wonders how they found out – did someone really report a violation by the program in question??? I also don’t understand why HIPAA sign offs aren’t sufficient to cover any necessary disclosures. My perception is that it’s impossible to get any health care services these days without signing a HIPAA privacy agreement – and these usually include appropriate language on use of data for quality improvement.

  4. #4 revere
    January 1, 2008

    Anna: I don’t know what triggered it. But this was definitely a nobrainer — they didn’t use any brains.

  5. #5 L. Roy
    January 1, 2008

    Ignaz Semmelweis has been gone for 143 years but apparently, little has changed. Future generations will forgive us our ignorance but not our arrogance.

  6. #6 PFT
    January 1, 2008

    The fact of the matter is, the powers that be do not want people to live longer since we are a costly drain on society. Our manufacturing has moved offshore, we are no longer a nation of producers, we are a nation of consumers, and worse, we are a nation that needs to borrow in order to consume. Once we are unable to pay the interest on the public and private debt, the plug will be pulled, and America as we know it will be taken off life support.

    Hence the effort to pull the plug on social security, force people into bankruptcy and poverty to pay for health care, encourage our capital goods, factories and jobs to be exported, allow the banks to charge usury interest rates on money created out of nothing, lie about the real inflation to lower the working class wages low, tax the working class to death (47% of a middle class family income is spent on taxes in one form or another) while allowing the rich to get richer and reducing their taxes so they can invest it overseas or SIV’s, CDO’s, etc.

    Is it a conspiracy. Yes, indeed. Our leaders no longer represent American citizens, they represent the Global citizens, as they are global leaders. Our currency and economy are controlled by a globally owned private banking cartel called the Fed. As Rothschild said (they may own almost 50% of the Class A shares in the Fed), give me the power over your currency and I care not who makes the laws.

    These interests are said to control the Federal Reserve through about 300 stockholders:

    Rothschild Banks of London and Berlin
    Lazard Brothers Bank of Paris
    Israel Moses Seif Bank of Italy
    Warburg Bank of Hamburg and Amsterdam
    Lehman Brothers Bank of New York
    Kuhn, Loeb and Co. of New York
    Chase Manhattan Bank of New York
    Goldman, Sachs of New York


  7. #7 A Nonny Mouse
    January 1, 2008

    How could PFT not point out that it was a Jewish conspiracy? Pffft, indeed.

  8. #8 carl
    January 1, 2008

    Yeah – I noticed that report. New Yorker (as distinct from NYT) did story on this a couple of months ago. Dramatic, double digit reductions in death rates in some of the instances reported in the New Yorker peice. My first inclination would be to tell OHRP to f**k off. With dramatic results in infection / death rates – dare OPHR to sue / cut off funds or whatever they can do – Hopkin’s program has the data to raise a lot of political hell with relevant legislative bodies if bureaucrats try to actually punish them for saving lives. That said, I’m a teacher and I don’t live in medical bureaucracy so it is easy for me to say.

  9. #9 revere
    January 1, 2008

    carl: No institution is going to do that. They will stop funding every research project in the medical center until it’s straightened out. That’s how it works.

  10. #10 Michael Pezzulli
    January 2, 2008

    Do you have access to the 5 step program and, if so, can you publish it for us?
    Being the recipient of a 6 day vacation in the ICU as a result of getting MRSA at a local hospital when the radiologist failed to even wear a mask when he aspirated a baker’s cyst post knee surgery, (no I did not sue), I would love to hand out the list to any future surgeon with the request that he comply with the procedures. LOL

  11. #11 revere
    January 2, 2008

    Michael: Sorry, all I know is what is in Gawande’s op ed. You might query Hopkins or Gawande (he is at Brigham and Women’s in Boston) or the Michigan Hospital Association.

  12. #12 Michael Pezzulli
    January 2, 2008

    Correction: No mask and no gloves.

  13. #13 Michael Pezzulli
    January 2, 2008

    Thanks. I will track it down and post it here.
    Cheers and Happy New Year!

  14. #14 Marissa
    January 2, 2008

    I am not surprised. In helping a number of researchers publish their findings last year we had a lot of problems with approval of studies, even when the studies only involved deidentified data. The HIPAA police are going nuts.

  15. #15 Ed Darrell
    January 2, 2008

    The legal team at Johns Hopkins should generate a simple release form. It should note the research results, the $200 million in savings, the lives saved and infections prevented, and then state that Hopkins cannot ethically back down from this program without a signed release from the agency — that is, the agency must acknowledge that it is ordering bad health practices and that it is fully informed of the consequences.

    I’d have the lawyers deliver the form in person, noting that they have to protect themselves from lawsuits, and that the federal agency must provide immunity for its order.

    When I worked in government (education and Congress, not in a health care agency), I never had to actually generate such a release form. But I was able to stop idiots from messing up programs on several occasions merely by making it clear the idiots would get all the credit — or blame, as they usually phrased it.

    I hope Hopkins fights it.

  16. #16 revere
    January 2, 2008

    Ed: I don’t think it is so simple. This is an IRB issue (protection of human subjects) and thus must go through an involved process that includes an informed consent form, not a simple release. By putting it under this rubric, the gov’t has made it much more complicated than otherwise.

  17. #17 Mike
    January 2, 2008

    Good coverage on the article. Sad day for us all, regardless of the “reasoning” behind it. I love your reviews Revere. Tell us how you really feel. I got such a laugh from,

    “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.”

    And if the shoe fits, wear it!!

  18. #18 jen_m
    January 2, 2008

    That’s simply bizarre. I mean, JCAHO requires nosocomial infection surveillance as part of evidence-based infection control programs, so the tracking is already happening and has been for years. It’s accepted practice to implement infection control measures and study outcomes at the institutional level, too. This looks like a power grab on the part of OHRP, but OHRP is already so overextended I’m kind of surprised.

  19. #19 Dave Briggs
    January 2, 2008

    Concerning the main point, damage done specifically by a complex and chaotic medical care system is increasing as pressure on everyone in it increases.

    It’s easy to see how you ended up a victim of jaw on top of the shoe syndrome! I need to break out the shoe polish myself after reading this post!
    In an ever more complex system, the initial get the patient well and protect the public sometimes gets completely lost in a maze!
    Dave Briggs :~)

  20. #20 stu
    January 4, 2008

    “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.”

    WTF!!!! Is this saying that there needs to be a f*cking checklist for basic medical hygiene? And having one posted actually reduces the infection rate? It’s hard to believe that:

    a: medical personnel can’t remember to do this on their own
    b: they actually react to a sign.

    Usually nobody does jack unless you monitor and apply disciplinary measures. I have been seeing PSA’s that tell people to ask their doctor/hospital to avoid shaving before surgeries to avoid staph infections but you’d think the other measures are common sense. BTW if people start suing for infections they picked up under medical care then you’d see a big improvement in this as well.

  21. #21 revere
    January 4, 2008

    stu: Yes. Just like all of us who use computers intensively back things up every night. You did back up your computer last night, didn’t you?

  22. #22 David Harmon
    January 4, 2008

    I’d say this falls under ShrubCo’s ongoing campaign to demolish America.

    The program’s trying to save lives (and money) rather than destroy them, so the ShrubCo appointees are against it. Now if the study had advocated shutting down any hospital with “too many” MRSA reports, that would have been just fine with them….

  23. #23 brook
    January 6, 2008

    I’m late to the party here, but my understanding of the project, based on the New Yorker article and an interview on NPR, was that the checklist provided a measurable way to make sure everybody followed the obvious but often ignored steps. More importantly, the project gave anybody (ie nurses or technicians) the right to stop a procedure if the steps weren’t being followed. It also involved management on the floor -rather than in the conference room – to insure that the materials – drapes, chlorhexidine scrub etc – were readily available and that the docs knew that if nurses stopped a procedure for a missed step administration backed the nurses.

    I really don’t get the OFHRP folk: the hospital I work in recently instituted a new checklist to make sure appropriate patient information gets shared between departments in a concise, timely manner. We aren’t a research hospital, (and we’re really really tiny) so we aren’t going to attract their ire, but does changing the manner in which you perform patient care really constitute human research? All this stuff is stuff we were doing (or were supposed to be doing) before, having a checklist just means you don’t miss a step by accident or because you’ve been working there for so long that you know that everybody knows what you mean even if you don’t say or do it.

    Could research facilities get around this nonsense by having a clause in their admission papers that says we won’t perform invasive research procedures on you without explicit permission but we may change how we perform things in order to keep you healthy.

    Given all the press about MRSA and the like you’d think the bureaucrats would delight in programs like this.

  24. #24 revere
    January 6, 2008

    brook: I think this was construed as “research” because they were collecting information and analyzing it. JHU got into big time IRB trouble with studies at Kennedy-Krieger on lead poisoning and I don’t think they are taking any chances. Infractions can shut the whole place down.

  25. #25 anon
    October 7, 2008

    so does this mean that they have to take down all those signs in the bathroom that say “wash your hands?”