Monday, January 14, 2008

On checklists

Lots of you have been asking me to comment on the story by Atul Gawande in the New York Times, in which he discusses a hospital that had to stop a quality improvement checklist program because of an adverse ruling by the federal agency that reviews human subject experiments. I really didn't know what more to say on this, in that Atul wrote the story in his usual brilliant manner, made the case clearly, and certainly got as much publicity for the cause as possible by its placement.

Meanwhile, though, a movement has started to make sure the government does not overreach in this area. Charlie Baker, for one, has written very well on the subject, and so, especially, has Bob Wachter. And I just received, through Bob, a copy of a letter from the American Hospital Association to Secretary Leavitt on the matter. I haven't heard anything about a reply from the Secretary. I know he has a blog, and this might be a good time to use it and reassure all of us.

Here is the AHA letter, in whole:

January 3, 2008

The Honorable Michael Leavitt
The U.S. Department of Health and Human Services
200 Independence Avenue, S.W., Room 615F
Washington, D.C. 20201

Dear Mr. Secretary:

In a December 30 New York Times op-ed piece, Dr. Atul Gawande raises important questions about a misguided and potentially dangerous policy of the Office for Human Research Protections that would impose an unprecedented deterrent to quality improvement efforts across the country. I am writing to ask you to immediately retract any statements from the Office of Human Research Protections that imply that quality improvement efforts should undergo review by Institutional Review Boards, and that consent should be obtained from all patients before changes could be incorporated.

As you know, hospitals across the nation are engaged in a variety of activities aimed at redesigning health care delivery systems to ensure that our patients get the best possible care we can deliver. Some of these activities are organized by hospitals, such as the Michigan Health and Hospital Association’s Keystone project that Dr. Gawande cites. Others include projects initiated by the Institute for Healthcare Improvement, the Quality Improvement Organizations funded by the Centers for Medicare & Medicaid Services, and the work of several professional societies and organizations such as the American College of Surgeons and the American College of Cardiology.

As Dr. Gawande points out, research to determine which drugs or procedures will benefit patients requires appropriate oversight by an Institutional Review Board (IRB) and informed consent by the patients. However, those efforts are far different from the quality improvement efforts exploring the use of checklists, computerized reminders, teamwork training, and other steps to ensure that the care we intend to deliver is actually delivered.

It is worth noting that hospitals and health care professionals are not the only ones engaged in such projects. The quality transparency efforts in which the AHA, the Department of Health and Human Services (HHS), and several other organizations have partnered, the local value exchanges your department has fostered, and the value-based purchasing initiatives you have championed are other examples. Yet, HHS has, quite reasonably, sought no IRB review or informed consent for these changes, because they, too, are intended simply to improve the delivery of care.

As quality improvement efforts become more standardized and rigorous, and as the data collection efforts that support this work become more extensive, it would be right and appropriate to contemplate how we can collaborate to ensure that the welfare of patients remains the central concern and that patient privacy is protected. It also would be appropriate to consider effective ways for hospitals and other providers to communicate with the public about their quality improvement efforts. However, it would be wholly inappropriate and detrimental to the patients and communities we serve if the measures apparently championed by the Office for Human Research Protections were to force hospitals and others to discontinue their quality improvement efforts.

On behalf of America’s hospitals, I urge you to ensure that the essential quality improvement efforts underway across the nation continue unabated.


Rich Umbdenstock
President and CEO


Anonymous said...

I am glad to see the AHA take up the battle on this one. I specifically requested the AMA to look at it in a post on Sermo (entitled 'Attention AMA'; they are new "partners" with Sermo) and got some nice comments from doctors but NOTHING from the AMA. I also wrote the OHRP and the AHRQ with essentially the same protests as the AHA. Dr. Francis Chesley of the AHRQ wrote back a thoughtful but carefully worded letter to the effect that the AHRQ agrees that a clearer definition between human subject research and quality improvement activity is needed and, apparently , being sought. No response from the OHRP as yet. This whole incident kind of blew my mind. Trying to improve patient care is difficult enough without the feds obstructing you on paperwork grounds at every turn.

Toni Brayer, MD said...

The idea that the Feds are putting up these untenable barriers to quality improvement is simply unbelievable. Dr. Gawande's terrific writings in The New Yorker have been manna from heaven in promulgating these activities and in helping doctors and nurses understand the standardization that needs to occur. I agree that Dr. Wachter wrote a great piece (thanks for the link, Paul)and we all need to take a deep breath and NOT let government get in our way on this one. Congrats also to the AHA for speaking out on this.

Anonymous said...

"It also would be appropriate to consider effective ways for hospitals and other providers to communicate with the public about their quality improvement efforts."

Does Rich Umbdenstock know about this blog?

Do any other hospitals in this country have a mechanism to reflect the inner workings of their hospitals as you have done on this blog? How do other hospitals support transparency?

Does BI have an official statement on transparency in our mission statement?

Can the feds regulate what you say?

I believe that transparency is the strongest catalyst to change. If the truth is out there for everyone to see it demands attention to problem solving. While it may feel messy and unsettling initially the rewards are endless.

It is ironic that the very system in which we plug those who needing healing into is the very same system that requires healing itself....

- A supporter of Hospitals Healing from the Inside Out



Anonymous said...

Please see the update on this situation on Dr. Wachter's blog. Take the time to click on the actual link to the OHRP statement - they are getting more bizarre by the moment.

Kudos to Dr. Wachter for speaking out on this despite the very real possibility that any of his future research will receive extra scrutiny by the OHRP.

Anonymous said...

(Post: Aspirations for BIDMC/Needham)

I guess we have an official statement on transparency now....