Friday, December 09, 2011

When is a protocol not a protocol?

Answer:  When people don't follow it?  Better answer:  When people don't think they should follow it?  Still better answer:  When people don't follow it and people are harmed.

Lola Butcher (could we have picked a better teaser of a last name?) writes in Hospital and Health Networks that, according to the head of The Joint Commission, "surgeries on the wrong side of the body, the wrong site or even the wrong patient continue to occur an estimated 40 times every week."  She notes that the JC "first highlighted the problem of wrong-site surgery in 1998."  Further:

The Joint Commission already requires accredited hospitals and surgery facilities to use a universal protocol that covers preoperative verification, marking of the surgical site and taking a time-out by all members of the surgical team immediately before the procedure begins. The extent to which the protocol is followed varies widely.

While things sounds like a prima facie case of failure on the part of the accreditation body, it is more than that.  The clinical director of the Pennsylvania Safety Authority notes that  there have been some successes in the country, but:

"When you subtract out the 50 facilities that have been in those collaborations, we don't see any change at all in the remaining facilities," Clarke says. "We do think we have made a difference, but it's only when hospitals actually make a commitment to change their systems.""

The simple truth is that many doctors don't buy in to this.  I've heard of some anesthesia writings that cite the statistics indicating the errors continue as evidence that the checklist protocol does not work!  These observers completely ignored whether the protocol was actually being followed or not.

Let's go back to The Joint Commission.  As I have discussed, failure to pay for such "never" events is not effective.  While I am not keen on regulatory interventions, it is possible to use a light, but effective hand that could make a difference.  How about starting by publicizing all cases on the public JC website, with the name of the hospital?  Keep them in the public eye until a root cause analysis has been done and a remediation plan put in place.  Then, share those success stories widely, as opposed to hiding them behind the JC paywall.  

If that approach doesn't start to get results, adopt a policy of putting the hospital on probation, in terms of its accreditation, until a root cause analysis has been done and a remediation plan put in place.


e-Patient Dave said...

Holy and wholly crap. After years of reading this blog and others, and attending meetings, we're still at THIS level??

Methinks it's time to start holding hospital boards civilly liable for knowingly not implementing these known improvements, leading negligently to irreparable harm.

That quote from the Penna Patient Safety Authority is just stunning. More snips from it - first the good:

"20 facilities in the UPMC system avoided wrong-site surgeries altogether for more than a year."


In another Penna initiative, "30 hospitals and ambulatory surgery centers were able to reduce wrong-site surgeries from an average of 15 a year to 4 a year." Gosh, I'm glad they cut it ~75%, but still, another gross mistake every three months??

(Nobody better tell me that's only "1 in 10,000" or something, unless they're asserting that it would be okay for Ford to deliver an exploding gas tank once as long as it's only in every 10,000 cars.)

But then the Minnesota quote - and remember, MN is a major thought leader in healthcare -

"Before this campaign, we were having a wrong-site procedure about every 12 or 13 days, and since we kicked off the campaign, the average over the last six months has been about every 30 days or so."

Good heavens.


Where does this leave us, aside from issues of legal liability and moral turpitude? From the perspective of the responsible, engaged patient, and the perspective of Shared Medical Decision Making, I'll say this:

I want to know the hospitals that have NOT implemented these protocols.

Because we can't responsibly send people to those hospitals without letting them know about the risk.

We already know from the HHS Inspector General's report last year that 1 in 70 Medicare admissions leads to accidental death. (If we want to reduce utilization of hospitals, the cheapest way would be to broadcast that statistic loud and wide.)

People really have a right to know what they're getting themselves into when they trust a hospital blindly.

e-Patient Dave said...

btw, I can't BELIEVE what you seem to be saying: that the Joint Commission on Accreditation continues to accredit hospitals that don't follow its protocols!

How is this different from a judge allowing a repeat drunk driver to continue driving? (Or am I misunderstanding?)


James said...

This may seem a bit simplistic but how about a reporting mechanism on all hospitals similar to our own private credit reports. And similar to credit reports infractions would stay on the report until X number of years have passed, and not just until a root cause analysis has been completed with recommendations. The official R/C determination and plan could be part of the report as well. The public would be able to determine the hospital's true ability to 'learn' or follow its protocols by monitoring 'mandatory' quality measurement reporting.

Thomas Pane said...

Wrong site surgery is a more complex topic than it seems. One issue with protocols is that they can be perceived as silly (i.e. the orthopedic time out when one leg is completely split open).

When that happens, surgical teams might downplay their importance, and then trouble can happen. Even the best surgeons have been burned.

But protocols are important and work best when they are well designed and involve the patient in the marking process.

Root cause analysis, and having surgeon involvement in protocol design is important because there are specialty-specific risks for different procedures.

It also makes them feel included in the safety initiative and makes use of their natural compulsive tendencies.

e-Patient Dave said...

I hear you Thomas, but what about the point of this post - that so many hospitals aren't even DOING the protocol, when there's clear evidence that it reduces harm?

Does anyone who KNOWS that still say "I'm not gonna, because it'll be stupid if one leg's split open?"

I'm not being argumentative, I'm seriously asking.

Anonymous said...

Bravo e-Patient Dave! This isn't about the trees ('wrong sites, readmissions, central lines, (add procedures here) are so complicated!') but the whole perverse forest that protects providers from accountability for preventable harm.

Medicine is stuck. Pedagogy, licensing, and practice culture are anachronistic and obstructionist. We can learn to speak design, innovation, patient rights. But the test (and promotion) will still reward us to imitate authority, harumph at challenges from a lectern or conference table, and ignore what doesn't fit 19th and 20th century medical school world view. I'm still going to take five years of Latin to prepare for the MCATs rather than wasting time in shop, art, or engineering. I'm not paid, after all, to measure what I do or create safer work.

Everything from medical school to the JC hone a slavery of ideas and ambition. Even when shown the possibilities, we don't see them as the serious challenge to 'business as usual' that they are.

This is the sad conclusion of the 'TRUST' experiment. Physician leaders said 'trust us' and we'll be transparent. 'Trust us' and we'll pursue safety with gusto. 'Trust us' and your loved one will not die of poor care. 'Trust us' to police ourselves. 'Trust us, don't sue' (your only recourse to our failures).

e_Patient Dave, I'm done with trust. The existing system will not disclose harm. It is time for patients and fed-up providers to do so.

Anonymous said...

Dr. Pane is corrrect that this is not a simple issue, but there is certainly misapprehension about its purpose and validity. In the case of the orthopedic leg-split-open example, it is critical to appreciate that variation in practice (e.g. skipping the timeout because it seems obvious) introduces its own errors. Who, for instance, decides that the situation is so obvious that the timeout can be cancelled? What about subtler variations of this example?

I am reminded of the evolution of precautions when AIDS was first recognized in the '80's, when I was practicing pathology. At first we all tried our own ways to be extra careful grossing AIDS surgical specimens and autopsies, and tried to draw up special protocols for dealing with these procedures. Eventually we realized that varying our practice from the norm was actually increasing our chances of cutting ourselves. When this situation was duplicated enough times at bedsides and in surgical suites, universal precautions evolved - do the same thing every time, with every patient or specimen. It should be the same with the timeouts.
The fact that it is not means that the players are not yet educated enough in the principles of process improvement and patient safety.

nonlocal MD

Thomas Pane said...

e-Patient Dave:

I don't think the protocol should be ignored even in "leg-split-open" cases. Although I am sure that there are facilities that don't enforce it, I have not personally seen the policy completely ignored.

Even on "obvious" cases, I have still seen the protocols followed. But that doesn't happen everywhere.

Assuring compliance is a shared responsibility, but ultimately it falls on the hospital through the O.R. manager.

If there are non-compliant circulators/surgeons, the issue should be addressed in whatever fashion that works, and most importantly, minimizes the chances of a wrong-site event.

If entire facilities are non-compliant, the accreditation body needs to sit down with managers and figure out why.

nonlocal: Your comments on AIDS brought up another thought. I developed a "no worries" philosophy on HIV patients. Be careful with sharps at all times, on all patients, and it really doesn't matter what their status is.

Considering that one never knows how many undiagnosed patients one is operating upon, this makes sense to me. And contracting other things (Hep C comes to mind) is actually statistically more likely.