Email to Me From ACR

My Faustian bargain was this, I will throw my support enthusiastically behind HR 3269 if the ACR will simply identify a concrete timeline and performance objectives for MRI safety for their MR Accreditation program.

This should be very simple for the organization that has published the industry standard MRI safety document three (soon to be four) times over the last 10 years…

This should be simple for an organization that publicly stated that they would be doing exactly this three years ago at the AHRA annual meeting…

This should be simple for an imaging accrediting organization whose self-professed reason for being is “quality and safety”…

This should be simple for an organization that went before Congress stating that the country needed more radiology device accreditation requirements to protect the safety of patients…

It should be simple… but apparently it’s not.

While the ACR MR Accreditation program makes reference to the organization’s industry best-practice MR safety documents, it doesn’t actually require any of the performance criteria be met for accreditation. The ‘safety’ part of ‘quality and safety’ apparently isn’t applicable to the ACR’s MR Accreditation program.

Representatives of the ACR with whom I’ve spoken object, strenuously, to this characterization, insisting that the reason for image quality is to improve the read and patient outcomes, and isn’t that synonymous with safety?

In a word, no.

Yes, image quality holds out the promise of better reads and interpretations, and that is important. But one needs to look no further than the public records of how people are getting injured in the MRI environment. The overwhelming majority of injuries in MRI come down to burns, projectiles, and hearing damage.

If these are the top sources of MRI injury (together comprising more than 90% of FDA-reported incidents from 2009 and 2010 which I evaluated with Dr. Kanal), wouldn’t it seem appropriate that any meaningful MR safety standards would require preventions for at least one of these? The fact is that ACR MR accreditation has no explicit standards that would mitigate any of these types of injuries.

So, despite my thinking that the overwhelming sources of injury in MRI would be at the top of the list of a ‘quality and safety’ MRI accreditation organization’s to-do list, I’ve found myself bargaining, unsuccessfully, with the ACR to support the MRI safety initiatives that they’ve previously promised to implement.

So, Dr. John Patti, Chair of the ACR Board of Chancellors, if you are reading this, please know that my offer still stands. I am willing to call my elected officials and support HR 3269, and all I need in return is an official statement from the ACR that outlines when and how you will honor prior promised to incorporate safety requirements in the MR Accreditation standards.

In the meantime, I’ll be sitting by my computer, waiting for your email.

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Yes, I’m talking about the ACR…

Before I launch into what they do that makes me crazy, it is only fair that I acknowledge what they do for which I am tremendously proud. The ACR has released the industry standard set of safety practices to address virtually every element of MRI safety. These practice standards could virtually eliminate all MR and MR-related adverse events, they’re that comprehensive and well developed. Three editions of these safe practice guidelines have already been published, and a fourth is in the final pre-publication steps as I write this. For one of these, the ACR deserves the industry’s thanks. For an ongoing effort that is about to produce the fourth iteration of this document, the ACR deserves praise and accolades. I wish that’s where this story stopped, but it isn’t.

While the ACR has gone to significant lengths to develop and keep current their MR safe practice guidelines, they don’t actually require them for their own accreditation clients (this despite an explicit request to do so from their MR safety committee, and even public promises that they would do so in 2009). That fact, however, hasn’t stopped the organization from promoting itself as the standard-bearer for MRI safety. Below is a screen capture of the press release that comes in the ACR’s ‘congratulations, you’ve been awarded MR accreditation’ package for all newly (re-)accredited sites.

Standard ACR Press Release For MRI Accreditation

For those who can’t read ‘microscopic’, you can click on the image to see it larger. The key phrase is in the lead sentence of the 2nd paragraph, which reads:

“The ACR gold seal of accreditation represents the highest level of image quality and patient safety.”

Click here to download the Word document template that the ACR provides on its website (which, as of December, 2011, reads exactly as the image above). Click here to see a Google search for items with exactly that sentence (will only show a couple of months of news items).

Grouping an assurance of image quality (for which the ACR does have some of the most exacting standards in the industry) with MR safety is erroneous, at best, if not outright deceit.

In order to obtain ACR accreditation for MRI, a site needs to go through rigorous image quality testing and validation. Highly specific imaging sequences must be recorded, both on quality-control phantoms (special test objects which, when scanned, can reveal several quality measures of images) and patients. A long series of images must be submitted for review, and regular followup must be done to assure that the MRI system sustains high levels of image quality.

In order to obtain ACR accreditation for the MRI physical safety criteria… well… just promise to do a safe job. That’s it!

• No requirement to have or use table pads / positioning aids (to prevent burns).
• No requirement to screen patients for clinical or physical contraindications.
• No requirement to provide patients with hearing protection.
• No requirement to label unsafe items kept in the controlled access areas of the suite.
• Heck, there’s not even a requirement to have a controlled access area of the suite!

It dumbfounds me that the ACR can put image quality and safety in the same sentence that extolls the value of their MRI accreditation program. Is it just their PR people running amok?

The ACR has been remarkably busy in the last couple of years. I mean they’ve been busy lobbying congress to require their accreditation services of all advanced imaging modalities (see the ACR’s own press release here). They might not be aware of the MRI safety situation and the constructive role that their own optional accreditation standard could have… except that it was presented to them at their Quality and Safety forum over a year ago (see the video recording here).

Personally, I find it unfathomable (and morally indefensible) to promote ACR accreditation as a safety advantage when the accreditation criteria don’t actually respond to the systemic (and preventable) accidents and injuries.

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Guess what? Today is one of my somedays! Or, I should say, today promises to be one of my somedays (there’s the cautious vein running through my optimism).

Today the FDA announced that they are hosting a public workshop on MRI Safety! Faced with staggering growth in MRI accidents and a diaspora of state, accreditation, professional and regulation organizations (who either can’t or won’t acknowledge the role that they each could have played in preventing the dramatic increase in accidents), the FDA is assembling a public workshop not unlike the one that fostered unprecedented cooperation among industry, providers and regulatory bodies to address ionizing radiation exposure concerns in ionizing medical imaging.

Like the ionizing predecessor, the challenge for the MRI safety workshop will be twofold… first, getting stakeholders (who disavow being stakeholders with a responsibility) to work together will be like herding cats. Fortunately, there are a few of us crazies [ahem] zealots, er enthusiasts who won’t forsake this opportunity and will help marshal the kitten rodeo. Second, and more critical, will be the commitment to actually doing something!

“Try harder” or “Improve tech education” or “Develop a policy” have all been tried to death! The ‘we promise we’ll do better in the future’ line, without specific, measurable criteria, has been the staple of MRI safety improvement efforts over the course of time in which we’ve seen the rates of MRI accidents grow to five times what they were just a few years ago. The promise to ‘do better’ is wholly inadequate. The promise to ‘measure up’ to an explicit standard is what we need.

Alarming Growth In MRI Accidents

This planned meeting – or more specifically, the progress that it represents – is long overdue, as is this contribution to this forum.

If you would like to participate in this upcoming FDA meeting, scheduled for October 25th – 26th, 2011, please sign up soon on the FDA’s registration website, here.

I hope to see you in DC, herding cats and agitating for standards for the safety of MRI patients and staff!

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First, a little background. I am neither beholden to, or have an axe to grind against, any of the prominent (potential) players in MRI safety. They’ve each provided me opportunities to advance the cause, and rebuffed me. In the interest of transparency, here are my relationships with both the American College of Radiology (ACR) and the Joint Commission (TJC).

Dr. Emanuel Kanal, MRI safety guru extraordinaire, has been the ACR’s MRI Safety Committee chairperson since the group was formed in 2001. He invited me to serve on that committee in 2006, and an ACR executive group, which holds veto power over committee appointments, approved me. I participated on that committee and am one of the authors of what became the 2007 ACR Guidance Document for Safe MR Practices. When Dr. Kanal successfully lobbied the ACR to support an update to the Guidance Document last year, the prior committee was disbanded and each individual was subject to re-appointment. I was renominated by Dr. Kanal, but my reappointment was blocked by the ACR executive group. I do not serve on the current incarnation of that committee (which is working on an update to the ACR Guidance Document due out later this year).

Through the ACR, I got one superb opportunity to influence MRI safety. I thought I would get more than one… but it was just one. I have no engrained personal interest in lifting up the ACR, so when I recommend the Guidance Document, it’s because I believe that this product is worth my support. Similarly, when I criticize the ACR with respect to MRI safety (as I did, pretty unabashedly, here), it is because I believe that they can do better, and not some petty personal resentment. I did, after all, get that superb opportunity through them.

Switching gears, my relationship with the Joint Commission is strikingly similar to my relationship with the ACR. Over the years, Joint Commission Resources (their educational arm) has asked me to write several pieces for them on MRI safety for various publications. They’ve also interviewed me for another publication (a piece that almost didn’t see print because of a disagreement between me and TJC’s Standards and Survey Methods division about what SEA #38 meant to an accredited provider’s internal risk assessment). I also had the opportunity to provide an introduction to MRI safety as surveyor training to TJC’s ambulatory accreditation surveyor corps after TJC was selected as an approved radiology accrediting body under the MIPPA law. That’s the good (or, at least ‘mostly good’).

TJC is a large organization, and while I’ve gotten along successfully with their education group, spoken at one of their conferences, and provided services to their ambulatory group, the ‘mother ship’ of TJC is their hospital accreditation organization. I’ve butted heads, usually privately… though sometimes not, with the hospital side of the organization. Most recently I’ve been informed that TJC can not accept any of my services, paid or volunteered, because of a potential appearance of a conflict of interest. Effectively, I’ve been ‘blackballed’ from the Joint Commission. While there is much more that I would like to accomplish with and through TJC, I’ve already managed to do a fair amount with them. As with the ACR, I think I’m on even terms with TJC… no debt… no malice.

I lay this groundwork to get around to the main gist of this post. A few weeks ago I posted, and then, within a week, took down the TJC companion piece to the ACR critique.

“Why would you give preferential treatment to the Joint Commission… or did you go off the deep-end and say something you regretted?”

I think that the TJC piece was equivalent to the ACR piece. They’re both accurate and critical of certain actions within each organization. I don’t think that anything in either piece is inflammatory, or hurtful. I didn’t write anything that I regret having put down in bits. I know that several regular readers of this blog did see the TJC piece, and I invite any who did read it to post with any thoughts they had that it was / wasn’t appropriate and fair.

“So, why’d you take it down then?”

Those of you who know me know that I’m something of an MRI safety evangelist. I have said and done (foolishly and unrepentantly) things that were not in my own personal best interest when I felt that they advanced MRI safety. I have zero interest in having an “I told you so” moment, either in elevating myself or in denigrating healthcare / radiology institutions. I want improvement. I want results. And that’s why I took down the Joint Commission critique.

“Ummm, OK… But how did taking it down advance those improvements or results?”

For a long time, years in fact, TJC has been toying with the idea of substantive MRI safety programs, but there are both internal and external hurdles to overcome to allow this to happen. Every historical effort towards implementing MRI safety on the hospital side of the organization has atrophied and died.

Very shortly after I posted the Joint Commission MRI safety critique, I learned that my friend and colleague, Dr. Kanal, was arranging a meeting with TJC to re-spark the conversation about advancing MRI safety within TJC’s hospital accreditation program. While I have no direct involvement with TJC and Dr. Kanal in these conversations, Dr. Kanal and I did collaborate for the non-hospital MRI safety introduction for the Joint Commission, and I didn’t want the critique I wrote, coupled with any legacy of prior collaboration, to poison Dr. Kanal’s current efforts. So I took the post down.

If I felt that there were any parallel efforts underway at the ACR, and that taking down that post would advance those efforts, I’d pull it down in a heartbeat, too. To my knowledge, however, there aren’t, so until I see an advantage to taking it down, it stays and I invite everyone interested in this topic to read it, here.

And if the situation with the Joint Commission changes, and the current effort on MRI safety slips into the comfortable, well-worn precedent of failure, know that the post isn’t gone, it’s only disappeared, and will reappear if / when it’s absence isn’t more constructive.

Ultimately, it’s all about affecting change. We expect that we have thousands, perhaps tens-of-thousands, of MRI adverse events occurring every year in the US, and the vast, VAST majority of these are readily preventable, or would be if we had enforced standards. That’s what I’m after.

And this is me, being as transparent about the whole situation as I can be.

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One can only presume that this is the commentary that US States and radiology accreditation agencies have to offer on the contemporary state of MRI safety. After all, there’s been nothing more than navel-gazing when it comes to measurable changes in standards for MRI providers. Let’s break it down…

This first installment will look specifically at MRI safety standards as implemented by the American College of Radiology (ACR). By tackling them, first, I don’t mean to suggest that they’re the only concern with respect to MRI safety. In fact, in a weird, schizophrenic way, ACR has simultaneously advanced and held back MRI safety. More on that towards the end of this piece.

MRI Accident Rate Slide from ACR Quality & Safety Forum 2010

The American College of Radiology has distinguished itself with the premier industry best practice publication on MR safety, the Guidance Document for Safe MR Practices. Originally named the White Paper on MR Safety (published in 2002), its name switched to the Guidance Document with a 2004 update. I was fortunate enough to be a part of the ACR’s MR Safety Committee (the authoring body) for what became the 2007 edition.

When the Committee met at the ACR headquarters in the late summer of 2006, to review drafts and collectively decide on the final revisions, it was noted that the ACR’s contemporary MR accreditation program didn’t actually require any of the safety provisions found in the (then twice published) Guidance Document. In that meeting, five years ago, the MR Safety Committee unanimously voted to formally request that the ACR incorporate safety provisions found in the Guidance Document in the MR accreditation program (this was frightfully easy since the representatives of the College were there in the room with us).

Surrounding that Committee meeting in 2006, Nephrogenic Systemic Fibrosis (NSF) was the hot topic in MR safety. The radiology community and trade press were trading speculation, recrimination, and early analyses. The 2006 Guidance Document was held until it could be published with the collected best available information regarding NSF, which meant that it wasn’t released until early 2007.

Perhaps the ACR was waiting for the new Guidance Document to be released, I thought, so they didn’t implement any of the safety requirements in their MR accreditation program prior to the new version’s publication. So the rest of 2006 came and went, as did all of 2007, without so much as a hint that the MR Accreditation program would include the Guidance Document‘s safety standards. Nearly all of 2008 passed the same way, with no indication that the ACR intended to include it’s own MRI safety standards in its accreditation requirements. But things showed promise of moving forward at the 2008 RSNA meeting.

I learned that the ACR’s MR accreditation committee was entertaining the notion of including some elements of the Guidance Document’s safety standards and that they had asked one of their physicists (not anyone from the MR Safety Committee) to draft a checklist set of safety standards. Purportedly, at that 2008 RSNA meeting, it was proposed that the 30+ page Guidance Document be distilled to about a half-dozen check-box question. One could argue that ‘something was better than nothing’, but the notion that these questions actually captured the essential safety elements of the Guidance Document was laughable. It didn’t fly. Back to square one.

Fast forward about a year, to summer 2009, when, at the AHRA annual meeting, representatives from ACR were giving a status update about accreditation standards. It was a packed meeting as the writing was on the wall about CMS requiring modality accreditation through the new MIPPA law. In that presentation, the ACR representatives stated that ACR would be incorporating elements of the Guidance Document‘s safety principles in the MR Accreditation program. Precisely how this was to happen was yet to be determined, but it would happen.

In early 2010 CMS announced that the ACR would be one of three approved accreditation bodies to accredit imaging providers’ CT, PET, and MRI scanners to qualify for reimbursement under the MIPPA law.

I was tremendously optimistic that this new requirement status would help to remove the concern within the ACR that implementing safety standards, unilaterally, would make other accreditation programs comparatively easier, and therefore more appealing to MRI providers. Now providers would be required to get accreditation, and ACR was clearly the front-runner in modality accreditation of the three named agencies. I called the ACR and spoke with a senior person within the organization about the safety standards. That person quickly burst my bubble…

Despite the public promise to incorporate elements of the Guidance Document from the prior year, in 2010 the ACR representative told me there would be no such plan going forward because they were now an approved accrediting body under the MIPPA law. According to this person, it was determined that it would be far too ‘bureaucratically burdensome’ to have to go through CMS (a step which would be required for any change to the accreditation structure, now that it was CMS sanctioned) to update it’s standards to include the safety elements in the Guidance Document. The irony of a federal law mandating quality and safety standards being the reason that an accrediting agency claimed it couldn’t enact safety standards wasn’t lost on me. Fortunately, I was just about to get the chance to talk with the principal radiology quality and safety person at CMS to let her know what I thought of their safety-inhibiting bureaucracy.

In the summer of 2010, I was a participant in a joint presentation on MRI safety between the FDA and CMS.  One of the CMS representatives in that presentation was Jeannie Miller, Deputy Director of the Clinical Standards Group. After that presentation, I followed up with Ms. Miller and asked her about the ACR contention that it was now too ‘burdensome’, because of their new role with CMS, to add safety standards to their existing MR Accreditation program. In a word, Ms. Miller was incredulous.

She told me that, just a few weeks prior to our conversation, the ACR had submitted their breast MR accreditation program to CMS for their approval. How long did the ‘burdensome’ CMS bureaucratic review take for this new and unprecedented MR accreditation program? Less than two weeks! Ms. Miller was dumbfounded at the suggestion that CMS would make it anything but easy for a quality and safety standard to enhance its safety components. So, if CMS ‘burdensome bureaucracy’ is just a smoke screen, what’s the real reason ACR is unwilling to heed the recommendation of their own MR Safety Committee, and honor the promise they made two years ago, to incorporate substantive safety requirements in their MR Accreditation program? Could it be money?

Though ACR is one of the accrediting bodies from which CMS mandates that outpatient participants must obtain accreditation, it’s still one of three. While ACR is seeking to ‘make the pie bigger’ by advocating for mandatory accreditation of more modalities than just CT, MRI, and PET and for accreditation of hospital-based imaging, nuclear medicine and radiation therapy, they’re also looking at their proportional slice of that pie. Were they to unilaterally decide on MR safety enhancements to their accreditation program, it might make providers looking for the lowest-threshold CMS accreditation steer clear of ACR. I suspect that the ACR’s thinking goes that, by enacting MR safety standards, they’re likely to lose prospective members and the revenue that their participation in the ACR’s accreditation program provides.

So we’re left with this profound contradiction presented by the ACR. One one hand, they have produced the industry’s best MRI safety best-practice document. On the other hand, they’re playing ‘see no evil, hear no evil, speak no evil’ when it comes to implementing the real-world safety benefits that their own Guidance Document.

And it’s not as if the ACR has any doubts about the value of the Guidance Document… as a safety tool. They have brought together many of the best minds on MR safety, four times now (the 4th release of the Guidance Document is likely to come out in the 2nd half of 2011). The MR Safety Committee lead the charge in disseminating best practice standards relative to NSF screening. And at the ACR’s own radiology quality and safety forum, last year, they were presented with a paper jointly authored by their own MR Safety Committee chair, Dr. Emanuel Kanal, and me, which showed that the explicit provisions in the Guidance Document could mitigate at least 80% of the clinical MRI accidents (see the video of that presentation, here).

So, ACR, you’ve been asked to implement the Guidance Document in your MR Accreditation standards. You’ve said that you would do so. Then you reneged on that promise with an excuse that’s been shown to be tissue-thin. At the same time, representatives have testified before Congress that in the interest of safety, there should be more accreditation of imaging and therapy devices in more healthcare settings.

Explain to me one more time why it is that you can’t honor your promise to include MRI safety standards in your MR Accreditation program?

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PS: Tune back in for the next installment, which will be taking a close look at the Joint Commission’s role in MRI safety.

The Joint Commission (TJC or, to those of us schooled in their acronym more than 3 years ago, JCAHO): TJC has just referenced the 2010 edition of the Guidelines for Design and Construction of Health Care Facilities as the new design and construction standard (effective today). The 2010 Guidelines codifies a number of the MR safety recommendations that have passed from the Joint Commission’s own lips and makes them standards for new construction. In 2011 I will apply whatever cajoling, leveraging, sweet-talking, or shaming that will help the Joint Commission to apply it’s own standards to the thousands of existing MRIs at TJC accredited providers. This began last year with training provided to TJC’s ambulatory care surveyors, forestalled and rebuffed offers of the same for their hospital surveyors.

Centers for Medicare / Medicaid (CMS): At least somewhat in response to the public attention that was focused on the issues of radiology / nuclear medicine safety through the ongoing series of articles by Walt Bogdanich of the New York Times, in 2010 CMS began development of a set of radiology / nuclear medicine patient safety standards that they intend to roll-out as a condition of reimbursement. It is anticipated that these will be unveiled in the spring for public comment before being enacted some time later. I know that, last year, MR safety proposals were presented to CMS, and at the anticipated public meeting I will seek to make sure that the single largest healthcare benefits provider in the US includes substantive MR safety standards.

Food and Drug Administration (FDA): Quick as they were to arrange public hearings on radiology safety (after the first couple Bogdanich articles saw print), the FDA has been ‘in the planning and coordination’ stages of a similar meeting on MRI safety for well over six months. Originally proposed for last year September, the prospective date has been nudged enough times that, as of my last inquiry, they’ve stopped even suggesting months, or even seasons, and I was last left with the promise of ‘sometime in 2011… hopefully the first half…’ I will endeavor to see that this meeting takes place (perhaps in concert with the CMS meeting), because I know that smart, capable people within the FDA have done analyses of MRI accidents and have developed an MR safety ‘short list’ of preventions which the FDA has yet to release, to say nothing of promulgate or endorse. Sitting on effective safety solutions when the accident rate is quadrupling is… well… inconceivable.

American College of Radiology (ACR): At the ACR’s presentation at the 2009 annual meeting of the American Healthcare Radiology Administrators (AHRA), the ACR representatives announced that the organization was going to incorporate MR safety standards from it’s own ACR Guidance Document for Safe MR Practices: 2007 in the ACR’s MR accreditation program. In 2010 I was privately told by a very well-placed person within the ACR that the new CMS oversight of the MIPPA accreditation process made it ‘logistically onerous’ to change the existing MR accreditation program (this despite the fact that the ACR was pleased to submit to CMS — and receive prompt approval for — an entirely new breast MR accreditation program). In 2011 we expect to see a new edition of the Guidance Document, which will make the fourth publication appearing under the ACR’s name that speaks to effective solutions for the reduction of MR accidents… and the fourth one that the ACR will have not included as an element of their own MR accreditation program. Whether it’s through meaningful standards passed down from CMS, or by reversing the apparent hypocrisy of the ACR, itself, I will spend 2011 working to see that substantive MR safety standards are incorporated as a part of the ACR’s MR accreditation program.

So what is the monster-list of standards that would be necessary to mitigate the vast majority of MRI accidents and injuries? Well, it turns out that it isn’t long at all, and all of these are already promulgated as best practice recommendations…

1. Provide annual MR safety training for all MR personnel (and MR irregulars)
2. Restrict access to controlled areas of the MR suite for unscreened / unsupervised persons and untested equipment per the ACR 4-zone model
3. Provide uniform and documented screening for all persons entering controlled areas of the MR suite
4. Screen persons and objects with a ferromagnetic-only detector before allowing access to controlled areas of MR suite
5. Provide hearing protection (and ensure proper usage) for all persons remaining in the magnet room during the MR exam
6. Use positioning aids and insulating pads as recommended to separate the MR patient from RF elements and conductive materials (including their own tissues)

These six items would likely cut the rates of MR accidents by more than 90%! These items have also been recommended (or very similar elements) by the Joint Commission, ACR, and others. If they were enforced, however, we could very nearly eliminate MR accidents in governed facilities!

Getting us to enforcement, that is my 2011 New Year’s Resolution, but I won’t make it there alone. Can I count on you to work on this with me?

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I was invited to present a paper at the American College of Radiology’s meeting on quality and safety held October 22 – 23 in Phoenix, Arizona. Actually, the invitation came in response to an abstract of a paper that hadn’t been written yet [not to self, don't promise papers you've not yet written again].

While the FDA’s adverse event data was clearly never intended to be useful to the outside world (we eliminated over 50% of the events from consideration, primarily because of too little narrative), it did provide a great snapshot of the diversity of accidents. We wound up with 104 useful event reports from an 18 month period of reporting.

We then compared each of these 104 events against the criteria in both the ACR Guidance Document and the Joint Commission Sentinel Event Alert #38. What we found gave us tremendous encouragement… encouragement tempered with some very unpleasant contemporary realities.

Stunning: Our review found that the ACR Guidance Document for Safe MR Practices: 2007 had explicit, actionable criteria that could have interdicted 80% of the 104 tested adverse events! And that doesn’t even include the general provisions for safety such as technologist training, or situational awareness.

The TJC Sentinel Event Alert (SEA) #38 fared somewhat less well, with a 49% effectiveness, though preventing half of the MRI adverse events that are occurring is certainly nothing to scoff at!

Frustrating: Neither the ACR nor the Joint Commission currently have any… ANY… explicit standards for MRI safety, despite the fact that each organization has published best-practice standards that promise to be 80% and 49% effective (respectively) in mitigating MR specific hazards in the MRI suite!

So the conclusion of the presentation offers a challenge to the ACR, the Joint Commission, DNV, and the IAC, to adopt explicit MRI safety standards as a requisite element of accreditation.

If you would like to view the presentation, please see the video (below).

http://www.youtube.com/watch?v=O4zsQ1Yh15A

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“Hey, you, MR technologist! Make sure you know what you’re supposed to know to keep people safe around MRI.“

Make no mistake, as someone who spent a decade in college (which included a Masters degree and about half of a 2nd Bachelors), I’m a huge fan of education. What I’m adamantly opposed to – when it comes to MRI safety – is education without any standards or benchmarks, which is precisely where we find ourselves today.

The title of this post really isn’t far off the mark of what the current expectations of safety are. Regulatory, licensing and accreditation bodies seem to be unanimous in their concern that explicit MRI safety standards (even for education) would be ‘burdensome’ to the provider. As a result, many MRI providers find themselves in a position where they aren’t provided support tools to enhance safety, with the rationale that a ‘good tech is all you need.’ But at the same time, nobody has defined what MRI safety knowledge makes the ‘good tech’, well… good.

In a few weeks I’m going to be at the ACR ‘Maximizing Value in Radiology through Quality and Safety Improvements‘ meeting. At that meeting, I’ll be presenting information from a paper written by Dr. Emanuel Kanal and me; a retrospective analysis of FDA adverse event reports on MRI. The data is pretty grim.

Since 2004, reported MRI adverse event reports are up to a number more than 4-times what they were. Of the MR-specific reports, just over 92% of them fall into 3 categories, each of which could be significantly attenuated if existing ‘best practice’ guidance was simply adopted as required standards. Our analysis found that 80% of these adverse events had an explicit, measurable best practices that would have stopped them, and that doesn’t even include benefits to be gained from ill-defined standards for ‘provide MR safety training.’ Presumably enhanced training would both reinforce the explicit performance measures (enhancing the effectiveness of mitigating those 80% of events), and would likely diminish the 20% remainder that weren’t directly combated by the explicit measures.

So while the trend data is very disconcerting, the good news is that we already have the tools to reverse the alarming growth in MRI accidents. This patient safety initiative is so extremely ‘shovel ready’ that it could be deployed with little more than a few words amending existing accreditation and license standards.

In the meantime, imaging providers are slashing staffing ratios, cutting out travel allowances for conferences and training, seeking out less-experienced MR personnel (who will work for a lower salary). So while we admonish MR techs to ‘learn what you don’t know that you don’t know,’ we’re simultaneously taking away the tools that they might actually need to accomplish this near-impossible task.

In the weeks ahead I’ll be able to share more of Dr. Kanal’s and my research, but the take-away is already apparent…

We will continue to injure our MR patients, visitors and techs at increasing rates unless the accrediting bodies (ACR, TJC, and IAC), the regulatory authorities (FDA and individual State departments of health) and 800-pound gorilla payors (CMS) pick up and codify the practice standards that have been laid at their feet.

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That’s right, the FDA has updated it’s MRI accident figures available online through the MAUDE database. We were alarmed and astonished when we thought that the rate of increases in MRI accidents was only 270% (from 2004 to 2008). Turns out that the FDA must have found additional accident reports that were in a stack of junk-mail, or got lost between the sofa cushions, which means that the rate if adverse events went up, significantly, in 2008 from the prior calculation.

Somehow, when I did the analysis last year (in 2009) of the 2008 numbers, it was apparently 11% shy of the final total. When we add the (previously uncounted) adverse events, the actual rate of accident growth is 310%!!!

Between 2004 and 2008, MRI Accident Rates Increased 310%

That’s right, in 2008 we were more than 4 times as likely to injure someone during an MR exam than we were just four years earlier!

What would happen in your town if:

• Traffic accidents quadrupled in 4 years?
• Rates of violence in schools quadrupled?
• Divorce rates increased 4x in 4 years?

Alarm bells, that’s what! People for certain would not be complacent.

There would be efforts to figure out why, and fix whatever was going wrong. Reduced speed limits or more traffic enforcement? You bet! Counselors in the schools and demands for greater teacher and parent involvement? Darn right! Lay and religious leaders reassessing the very nature of the marital institution in our society? Abso-friggin-lutely!

So, with an exploding rate of MRI injuries and adverse events, what is being done to identify and curb the source of these incidents? [cue cricket sounds]

NOTHING!

Apart from the continuous efforts of a small cadre of MR safety advocates, whose cries have (apparently) fallen on deaf ears, there are no substantive accreditation, licensure, or regulatory actions that have reversed the trend of the last several years.

The silver-lining may be that the increase from 2008 to 2009 was very modest. Perhaps we’re leveling-off, or perhaps, like 2004, this is just a momentary pause before we skyrocket upwards again. And given the FDA’s marked upward adjustment of the 2008 numbers, it may wind up being another year before we can feel confident about the 2009 accident report numbers.

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If you’d like to watch it, it’s in 3 parts. The first of 3 is available here (requires QuickTime viewer).

Click here for Tobias’ Twitter Profile