Wachter's World : The Checklist Saga: Victory!
This is great news for patients and is probably great news for those of you who have been following the “checklists” saga. The federal government has reversed its earlier decision to shutdown the Michigan hospital checklist usage, recognizing that quality improvement protocols are NOT the same as experimenting with a new drug.
For those of you catching up on this story, here's my original blog post about the use of checklists at Johns Hopkins and the follow up about the government putting a stop to the program.
“We do not want to stand in the way of quality improvement activities that pose minimal risks to subjects,” said Dr. Ivor Pritchard, acting director of OHRP. “HHS regulations provide great flexibility and should not have inhibited this activity. The regulations are designed to protect human subjects.”
The Johns Hopkins study demonstrated that a comprehensive five-step program can dramatically reduce the incidence of catheter-borne infections in ICUs. HHS strongly encourages hospitals nationwide to adopt the program, which can save thousands of lives and millions of dollars each year.
OHRP noted that the Johns Hopkins project has evolved to the point where the intervention, including the checklist, is now being used at certain Michigan hospitals solely for clinical purposes, not medical research or experimentation. Consequently, the regulations that govern human subjects research no longer apply and neither Johns Hopkins nor the Michigan hospitals need the approval of an institutional review board (IRB) to conduct the current phase of the project.
Bob Wachter, in his blog post (hat tip to him for breaking this update to the story and kudos to him for writing such informative and passionate posts on the subject), wrote:
The prior OHRP decision, if left standing, could have mandated regulatory approval and the need to obtain patient and provider consent every time one wanted to improve a process and measure its impact.
The one thing that bugged me about the prior OHRP ruling… the hospitals were measuring the impact of the checklists (an important part of the Plan-Do-Check-Act cycle), therefore it became research? So it would have been OK if the hospital were just using the checklist without measuring the impact? Seems a bit irresponsible. But what is really more irresponsible is a hospital NOT using checklists (or standardized work) to ensure consistent care and patient safety.
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It is true. OHRP made clear that they had no objection to any organization using checklists so long as they were not collecting data. The reason for this was that they were essentially collecting data on patients and clinicians without obtaining consent in spite of the fact that it was anonymized.
I’d be careful to say that it is irresponsible of OHRP to be cautious about measuring impact or doing research without patients consent. They have clarified this because there are real issues about where a process improvement and a clinical intervention meet. If you changed a clinical intervention, collected data and essentially conducted a PDSA without a patients consent that would effectively be clinical research and without consent it would be completely unethical.
There is a real issue here, in that if at some point moving forwards a piece of work is undertaken such as Rapid Response Teams or any other piece of work and data is collected and its determined that actually it has a negative effect I think we will find that there are real liability issues and organizations will become cautious in the extreme about undertaking such work.
I completely accept that OHRP were incorrect in this case but I can think of lots of pieces of work that have been undertaken where there have been process changes and clinicians have changed their clinical practice and to change a clinical practice and not consent the patient presents some very real ethical and research issues.