Tuesday, January 22, 2008

When Process Improvement is Judged to be Dangerous

I'll have to pursue this further later, but for now I'll just quote from Manoj Pawar in the Tom Peters Weblog.

A simple checklist, similar to pre-flight checklists used by pilots, has been proven to reduce ICU deaths. People die less ... much less ... as a result of this. Plans to spread this nationally in the US were underway. Simple. Elegant. And primed for implementation on a broad scale, BUT ...

The Office for Human Research Protections (OHRP), upon learning of this, stopped the project immediately.

Why? The OHRP treats this as research (despite the fact that results are proven). Because they see it as research, they feel that it was unethical that patients were not informed that a checklist was being used, and that its use was being measured. In essence, they treated this in the same way that they would a study in which patients were being given a medication with unknown efficacy.

Can they really do this? Sure. And in fact, they can cut off all federal funding to groups (hospitals, researchers, etc.) that fail to obey.

Since that 12/30/07 decision, health care institutions and quality improvement specialists across the country have been running scared, fearing the wrath of the OHRP and the subsequent loss of funding. They've asked their quality improvement folks to stop doing what they're doing immediately, based on these legal and regulatory concerns.

More from Maggie Mahar:

The Office of Human Research Protections (OHRP) is the agency that has nixed the use of checklists. Who runs the OHRP? Until his recent resignation (as of Sept. 30), Bernard Schwetz was the director of OHRP. Who is Schwetz? He is a veterinarian (DVM). That’s right, he’s vet, not a M.D....

I’m told that the OHRP is a “strange creature.” It was created in 2000 to replace the small, underfunded Office of Protection from Research Risks. That office reported to the NIH. OHRP, by contrast, reports directly to the Assistant Secretary of Health, putting it under the White House’s control.

OHRP began sending what only can be described as threatening letters to Michigan and Johns Hopkins last summer—on Schwetz’s watch. He announced his resignation at the beginning of August. I haven’t been able to find an explanation for the resignation or whether it is in any way connected to OHRP’s decision about the checklist.

I have been in touch with Dr. Peter Provonost, who invented the checklist. He tells me that OHRP’s investigation was based on “one anonymous complaint.”...

Is this simply an example of bureaucratic incompetence, or was someone threatened by the checklist?

The checklist poses no danger to patients. It makes them safer. Was it a threat to some doctors or hospitals?

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