Comments on: The Feds Reverse Their Decision on Checklists! http://www.leanblog.org/2008/02/feds-reverse-their-decision-on/ Mark Graban's leanblog.org - Lean Healthcare, Lean Thinking, Lean Manufacturing, Toyota Production System Thu, 09 Feb 2012 22:59:58 +0000 hourly 1 http://wordpress.org/?v=3.3.1 By: andrewmc http://www.leanblog.org/2008/02/feds-reverse-their-decision-on/#comment-3159 andrewmc Tue, 19 Feb 2008 16:43:00 +0000 http://leanblog.bigbigdesign.net/2008/02/the-feds-reverse-their-decision-on-checklists/#comment-3159 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.<br/><br/>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.<br/><br/>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.<br/><br/>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. 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.

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