The patient safety and quality movements are precious and fragile. Just as IOM reports I and II spawned these modern, life-saving revolutions, the Federal shutdown of the Hopkins/Michigan checklist program may help extinguish them. After all, Tipping Points can tip both ways.
I laid out the issues in this prior post. Those of you who know me know that I am anything but a rabble-rouser – I have the affliction of seeing both sides of every issue. But, as someone who cares about the lives of patients, this one gets me PISSED. Apparently, many of you feel the same way – particular thanks to Paul Levy, Charlie Baker, Maggie Mahar, Jim Sabin, AHA Prez Rich Umbdenstock, and of course Atul Gawande. After many of you wrote, blogged, and otherwise bellowed, “I’m Mad As Hell And I’m Not Gonna Take This Anymore,” the Office for Health Research Protection issued an Orwellian statement today; I’ll quote the highlights:
… some readers have contacted the [OHRP] concerning… the [Gawande] op-ed. While some expressed concern that OHRP has prohibited hospitals in Michigan and elsewhere from implementing a program intervention consisting of a checklist and other measures to prevent certain hospital-acquired infections, OHRP has taken no such action. On the contrary, if any hospital or intensive care unit decides to implement the use of checklists or other measures only for the reason that they believe those measures will improve the quality of care provided, they may do so without consideration of the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46)…
Then comes some bureaucracy-speak, punctuated by a “note that the [Gawande] op-ed also inaccurately characterized certain facts of the case involving the Michigan hospitals and how the regulations apply.” The OHRP never enumerates these alleged inaccuracies, instead segueing to this chilling statement:
As stated above, the regulations do not apply when institutions are only implementing practices to improve the quality of care. At the same time, if institutions are planning research activities examining the effectiveness of interventions to improve the quality of care, then the regulatory protections are important to protect the rights and welfare of human research subjects… [emphasis added]
Can OHRP define “research activities” – which, we are now given to understand, will always require IRB approval and the consent of every patient and provider – when used in this context? Will somebody tell Don Berwick to pull the plug on his 5 Million Lives campaign? (IHI is doing “research examining the effectiveness of interventions to improve the quality of care,” aren’t they?) How about the CDC and CMS’s Surgical Care Improvement Project? The WHO’s patient safety initiative? And every healthcare consortium that collects data, analyzes it, and disseminates it in an effort to support quality improvement? If these aren’t research activities, why not: Does it hinge on whether I have a hypothesis? Or that I intend to send the results to JAMA? Or the fact that I’m not 100% sure that my intervention will work?
In fact, there is no real distinction. It seems to me that we’ll need to change the rapid PDSA (Plan-Do-Study-Act) cycle so central to Quality Improvement into the P-GIRBA-CEPAP-D-S-A cycle. As in “Get IRB Approval” and “Consent Every Patient and Provider.” Just might slow us down a tad.
OK, I’ve been reasonable enough. It’s time to open my window and shout:
DAMN IT, I RUN A SERVICE OF 120 VERY SICK PATIENTS. IT IS PRECISELY MY JOB TO TRY TO IMPROVE THE QUALITY OF CARE FOR THESE PATIENTS, TO MEASURE THE RESULTS OF THE THINGS WE TRY, AND TO USE THOSE MEASUREMENTS TO TRY TO MAKE THINGS BETTER!!! HAVE I BEEN VIOLATING FEDERAL REGS FOR THE PAST 15 YEARS???
My mother will be very disappointed. And she was so very proud.
Let me reiterate: OHRP does important work, and local and regional IRBs are critical to protecting patients from potential harm. But we’re talking about checklists here. CHECKLISTS!
I urge you to keep those cards and letters coming. The following people really need to know how you feel about the impact of this ludicrous ruling on the lives of real patients:
- Your Representative: Here
- Your Senator: Here
- HHS Secretary Michael Leavitt: Here
- Ivor Pritchard, Director of OHPR: email@example.com
I know that writing takes a bit of time, but just pretend that you’re submitting an incident report to your hospital after having identified an unsafe practice or condition that might kill people if it isn’t fixed.
Because that’s exactly what you’ll be doing.