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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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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In nearly concurrent moves, the Joint Commission (JC) unveils their just-developed Advanced Imaging (AI) accreditation program, the FDA is clamoring for new authority to regulate medical device safety (or gearing-up to use authority that it’s been hiding for safe-keeping, that isn’t exactly clear to me), the US Congress whips together a set of hearings on the issue, and, at those hearings,  the American College of Radiology (ACR) recommends that the Feds expand the scope of the AI accreditation requirement to include radiation therapy and to apply the expanded accreditation requirements to hospitals, too.

Whew, that’s a lot of ground covered for radiology in just the last few weeks! Wait a minute… who is that sitting in the backseat? Who has been drug through all of the hullabaloo about radiation exposure and patient safety without once having been considered, individually? MRI, that’s who.

So congress is alarmed at the lack of regulatory oversight on ionizing modalities, such as CT or beam therapies, hmm? The ACR couldn’t get to the hearings fast enough to recommend that the Congress mandate both deeper and broader accreditation requirements (which the ACR would be pleased to provide, by the way). The argument in favor of these enhanced accreditation requirements is that the patchwork body of existing state requirements are simply inadequate to protect patient safety.

What was the reaction to the fact that there are zero (and I’m not being dramatic here… I mean zero) requirements at state or federal levels for physical safety around MRI systems? Or what was the reaction to the fact that the FDA’s own data shows a near-four-fold increase in the number of MRI accidents in recent years? What about the fact that in states like Missouri, where I was born, don’t even require any credentialling of technologists who administer MRI exams? (Seriously, in Missouri you have to have vastly more proof-of-competence to give someone colored highlights in their hair than administer their MRI exam.)

MRI Accidents As Reported To The FDA

What was the reaction? None. Nada. Zilch.

Why? Because MRI has just been ‘along for the ride,’ apparently.

Regulation:

It’s important to realize that the bulk of radiology’s regulatory oversight grew out of federal standards for ionizing radiation protection of workers on the Manhattan project. Those standards became the template to be adopted and adapted by the individual states. The FDA, which regulates the approval of radiology equipment as diagnostic or therapeutic device, has left the oversight of the safety of the administration of that exam / procedure to the states.

What resulted was a patchwork of mix-matched state regulations governing ionizing radiation devices that use X-rays (such as CT and mammography), and radioisotopes (such as in nuclear medicine and many therapies).

In the 80′s, MRI came along. Since MRI didn’t use ionizing radiation, it was almost as if the absence of regulation was seen as ‘proof’ that MRI was safe. Neither hospitals nor the equipment manufacturers were interested in promoting regulation for this new modality, and quite honestly most state authorities and elected officials didn’t really understand what MRI was (and their inaction probably saved us from some very bad legislation at the time… look no further than the contemporary European Physical Agents Directive to see what ill-informed regulation can do to MRI).

Accreditation:

Let there be no mistake about it, MRI accreditation efforts have been driven primarily by payors. Apart from the last few weeks, the overall accreditation program balance between image quality and patient safety has leaned heavily towards the side of image quality. Let’s use the ACR’s MRI accreditation program as the example…

To be accredited by the ACR for MRI, there is a long list of quality controls that have to be implemented regularly. And since image interpretation is largely a qualitative skill, the ACR went so far as to develop a specialized imaging phantom to distill otherwise-subjective quality differences into objective tests (can you see the proper number of spokes on the phantom image?). There are logs, tests, data-collection, reports, all necessary to help assure that the machine is capable of producing pictures of a minimum requisite quality.

ACR Phantom Showing Radiating 'Spokes' Of Contrast Dots

At the same time that the ACR has made such remarkable efforts at standardizing measures of quality, they have largely ignored even their own MR Safety Committee’s request to include physical safety criteria in the MR accreditation program.

In 2006, during the MR Safety Committee’s working session to develop what became the ACR Guidance Document for Safe MR Practices: 2007, the Safety Committee, unanimously, issued a formal request to the College to include the standards developed by the Safety Committee as a part of the MR accreditation program. Four years later, there is no objective evidence that this formal request has been taken seriously.

Both the ACR and the other primary imaging accrediting body, the Intersocietal Accreditation Commission (IAC), assert that their standards for MRI accreditation are serious and robust, yet neither have identified how their MRI safety standards have successfully responded to the nearly 300% increase in MRI accidents in the last several years. If these accrediting bodies are serious about MRI safety, how can the reconcile the alarming MRI accident growth with their wet-noodle protections?

I have left the Joint Commission out of this evaluation of accreditation standards because – prior to this year – the JC has not offered a single modality-specific accreditation standard for MRI, or any other imaging device. From an MRI patient safety perspective, they’ve been virtually a non-factor, even though their accreditation services cover thousands of providers across the US that offer MRI services.

So today, MRI is lumped-in with CT and PET as a part of the AI accreditation program. And AI accreditation is largely seen as the way to address the headline-grabbing concerns about ionizing radiation exposure.

To be perfectly clear, I support greater attention to standards and safeguards for ionizing modalities, but I find the omission of any mention of MRI safety in the current conversation surrounding the Advanced Imaging accreditation program as an indictment of the earnestness of this as a patient safety campaign.

I think that accreditation should follow the path that the ACR has laid out, and I don’t begrudge them their efforts at positioning themselves as the preferred accrediting body for this expanded role. However, I think that a little ‘truth in advertising’ is called for (one could even call it a quid pro quo).

The ACR (and IAC, who I imagine is equally interested in expanded mandatory accreditation) should balance their own indisputable self-interest in new accreditation requirements with some substantive action on objective MRI physical safety requirements. Standards for MRI safety have literally been ‘laid at their doorstep,’ now all they have to do is adopt them.

If we fail to look at the escalating rates of accidents and injuries in MRI and address them as a part of the broader ‘radiology safety’ conversation; if we focus solely on ionizing radiation to the exclusion of all else, then we will again ignore the giant magnetic elephant in the room… the one that represents the alarming rate at which we’re increasingly injuring MRI patients.

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The other two have had modality-specific accreditation programs for years, so what was the TJC going to do? Well, they’ve released their accreditation criteria, and one of the most wonderful surprises is that MRI safety is more prominent than it is in either of the other two ‘imaging’ accrediting bodies!

That’s right, the ACR, despite having been the name behind three publications of the ‘White Paper on MR Safety’  (now the ‘Guidance Document for Safe MRI Practices’), has no physical safety standards for their MRI accreditation program. And at last check, ICAMRL didn’t even have the contemporary terminology for MRI safety-tested medical devices in their standards. So, in an amazing ‘come from behind’ showing, TJC has now bested the veteran agencies in patient safety protections.

From the perspective of MRI patient safety, one of the most wonderful things is the addition to the Joint Commission’s Environment of Care (EC) standard. In this updated version (effective immediately), TJC explicitly mandates MRI safety protections:

Excerpted from EC 02.01.01, EP 14

At a minimum, the organization manages safety risks in the magnetic resonance imaging (MRI) environment associated with the following:
- Patients who may experience claustrophobia, anxiety, or emotional distress
- Patients who may require urgent or emergent medical care
- Metallic implants and devices
- Ferrous objects entering the MRI environment

OK, I might have chosen a slightly different list, but these four items nail some of the greatest environmental threats to the safety of patients and staff in the MRI suite. And given that it’s the first requirement from an accrediting body (the recent MRI safety changes to the healthcare building code, Guidelines, are regulatory / licensure requirements), I’m more than happy to give JCAHO a little slack.

If you would like to download your own PDF copy of the changes to the ambulatory accreditation program’s Environment of Care standards, which includes the explicit MRI safety requirements, identified above, please click here.

In a nutshell, these new standards echo many, many prior recommendations, including JCAHO’s own, for MRI safety. Namely, these are to plan for emergent situations, screen patients more effectively for contraindications, and screen for ferromagnetic materials.

With the new EC standards it is no longer acceptable to simply say, ‘yeah, we have a policy and procedure manual that outlines how to handle each of these.’ Now, as a part of regular accreditation, providers will have to provide risk assessments and explain how their actions are proportionate responses to those risks.

Earlier in that same EC standard, it makes specific mention to seeking external sources of information to establish risks and responses. For MRI, that list would likely include the ACR Guidance Document, the VA’s MRI Design Guide, the ASHE monograph ‘Designing and Engineering MRI Safety’, the ECRI Institute’s Top-10 Medical Technology Hazards, and perhaps even the MHRA MRI risk assessment.

What recommendation is common to all of these industry-standard-setting publications (that explicitly addresses one of the 4 new EC requirements)? The use of ferromagnetic detection systems.

As you conduct your risk assessments, and determine a path to MRI safety and regulatory conformance, I hope that you’ll contact the people at Mednovus regarding their ferromagnetic MRI screening systems. When your next state or accreditation surveyor comes around, you’ll be so very glad you did.

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The National Council on Aging just released a study which details these alarming numbers. The matter-of-fact language of their release did nothing to diminish my welling fear as the study went on to detail chronic failures in our healthcare system to educate, alert, and prevent the dangers inherent in MR imaging of medical implant patients. Here are a few of the particulars:

• Medical implant patients over age 65 have between a 50% and 75% chance of requiring imaging during the useful life of their implant.
• While 90% of physicians knew of MRI risks for some pacemakers, over half of doctors say that they aren’t informed about imaging limitations when a patient is implanted.
• Nearly a third of patients who receive medical implants are not informed of MRI restrictions.
• After exposed to the MRI risks to their implant, nearly 20% of these device patients experience some sort of problem or malfunction with their implant.

Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams

The near universal opinion (98%) of healthcare providers is that they require additional information and training on these MRI safety risks.

Let’s hope that regulatory (FDA and States) and accreditation (JCAHO, ACR, and IC) bodies for MR imaging look at ways that they can take a more active role in promoting education and protecting these patients.

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Ready? OK…

Let’s start at the very beginning (“what a very good place to start”). Back in the 80′s, when GE was seeking FDA approval for their new-fangled ‘nuclear magnetic resonance’ scanner, they were keenly aware of the risks of things going flying into the giant magnet. It turns out to be extremely difficult to have a giant, super-powerful electromagnet (one that doesn’t have an on/off switch) that doesn’t draw in every conventional ferromagnetic wheelchair, oxygen tank, gurney, mop bucket, rolling cart, etc… that comes near.

New Ferromagnetic Detector Requirement to Mitigate Magnetic Projectiles Risks In MRI Suites

In an effort to help identify these threats before they were brought into the room, the GE application to the FDA called for mandatory metal detectors for screening patients and equipment as a part of each and every MRI installation.

Well, it turns out that this well-intentioned gesture was not very practical. As sites that have foolheartedly ventured down this path can tell you, darn near everything that is brought to the MRI suite has metal in it. This means that darn near everything, including objects that are at no risk of flying into the MRI, will set off the conventional metal detector. If the objective is to find only those things that would like to go flying into the MRI scanner, your conventional ‘airport style’ metal detector is of no use.

In the 1980′s there weren’t alternative means of detecting only ferromagnetic materials (those that become magnetized and get drawn to the MRI scanner), so the GE requirement for metal detection atrophied to nothing, becoming a forgotten (well-intended) bad idea.

Fast-forward about 20 years. At this point MRI technology is ubiquitous at hospitals (those with at least a couple hundred beds) across the country. Estimates were that there were somewhere around 8,000 MRI scanners in the US, and that most of them were GE products.

Concurrent with the growth in numbers of MRI scanners were increases in the magnetic strength and improvements to the ‘active shielding’ systems. Each of these enhancements had the coincidental effect of increasing the forces that draw magnetic materials into the scanner. When coupled, these factors actually multiplied the attractive force applied to magnetic objects, meaning that the risks associated with magnetic-projectiles flying into MRI scanners increased dramatically as the imaging technology advanced.

There have been magnetic-projectile accidents that jeopardize patients and staff in the MRI suite as long as there have been MRI scanners. The overwhelming majority of these remain ‘under the radar’ of safety, regulatory and accreditation bodies. One event occurred in the summer of 2001, however, that exploded through the veil of embarrassment that typically keeps these types of accidents secret.

In 2001, a young boy was anesthetized for an MRI scan and required oxygen during the exam. When the wall-outlet O2 didn’t work, the anesthesiologist called for oxygen. The technologists administering the exam left the control room to try and fix the oxygen supply problem and, while they were out, a nurse entered and told the anesthesiologist that there were oxygen tanks right there in the control room. Immediately upon bringing one of the portable tanks into the MRI scanner room, the magnetic field of the MRI ‘grabbed’ the tank and pulled it into the center of the doughnut-shaped scanner, where it struck the boy.

That six-year-old boy, Michael Colombini, died from the injuries a couple days later.

Splashed across the media and throughout radiology journals & trade publications, this event reignited the interest in metal detectors, many of the lessons learned from the prior experiments with ‘airport style’ detectors having been forgotten.

“If only there was a metal detector that only alarmed on magnetic materials,” was a common refrain. In 2001, there wasn’t (at least not an effective commercial product for pre-MRI screening). Ever the ‘mother of invention,’ the necessity for a magnetic-projectile screening tool prompted several companies, including Mednovus, to develop ferromagnetic only detection systems.

These products started becoming commercially available just a few years after the 2001 Colombini tragedy, and initially struggled to differentiate themselves from the failed legacy of’ ‘airport style’ detectors. In the years since, however, ferromagnetic detectors have become viewed as a valuable tool for safety in the MRI suite.

Would GE have mandated ferromagnetic detection (instead of the ‘airport style’ metal detectors) with their FDA application if the products had been available 20 years ago? Since the stated intention was to prevent projectile accidents, it would seem logical that they would have. They’re not the only MRI manufacturer to have indicated that choice, either.

In a 2008 interview with the Israeli business publication, Globes, Walter Marzendorfer, CEO of Siemens Medical Systems’ MRI Business Unit, was quoted as saying, “[t]he main safety issue where MRI is involved is the fact that it is a magnet. Accidents happen when a doctor enters the MRI room with a scalpel in his pocket and bends over the patient. People forget. There must be metal detectors at the entrance to every room with a MRI device.”

It would seem that Siemens has exactly the same take on the necessity for projectile safety in the MRI environment that GE had, namely that there should be some form of automated screening. I’ll chalk-up the use of the term “metal detector,” instead of the projectile-specific screening provided by a ferromagnetic detector, to the multiple languages likely involved in ultimately arriving at an English text. Both GE and Siemens have stated the necessity for some form of automated projectile screening, but it doesn’t end with the equipment manufacturers.

GE and Siemens aren’t alone in the calls for some form of  requisite screening for projectile risks…

• In 2007, the ACR Guidance Document for Safe MR Practices amended language from prior publications which recommended against ‘airport style’ detectors to include the explicit recommendation for using ferromagnetic detection systems.
• In 2008, the US Department of Veterans Affairs (VA) MRI Design Guide echoed this recommendation.
• In 2008, the Joint Commission’s Sentinel Event Alert #38 offered ferromagnetic detection systems as an example of a conformance tool for their objective of verified patient screening.
• In 2009, the American Society of Healthcare Engineering (ASHE) published a monograph entitled Designing and Engineering MRI Safety which explicitly called for ferromagnetic screening.
• In 2009, ECRI Institute published their Top-10 Medical Technology Hazards watch-list for 2010. On that list is MRI projectiles and among the ECRI Institute’s recommendations are ferromagnetic detection systems.

There are others, but you get the gist. The technology of the ferromagnetic detector answers the need for MRI projectile protection which was identified nearly 30 years ago. It fits precisely with the intention of GE’s original FDA application for approval of MRI as a clinical device, and with the much more recent statement by Siemens’ top MRI guy. It has been recommended by major institutional standards and both professional and accrediting bodies, so it must be a ‘done deal,’ right?

Unfortunately, there has been one missing element… a requirement for MRI projectile safety protections.

It turns out that ‘perfect fits’ with manufacturers’ intentions and a ‘who’s who’ list of recommending bodies wasn’t enough. Yes, there have been many adopters of ferromagnetic screening tools, but estimates are that most of the MRI providers in the US still don’t use ferromagnetic screening for people entering the MRI suite. If they’ve been waiting for a requirement, that wait is just about over.

42 of the 50 US states, the Joint Commission, and many, many other health regulatory bodies around the world, use the Guidelines for Design and Construction of Health Care Facilities, originally jointly produced by the American Institute of Architects (AIA) and the US department of Health and Human Services (HHS). With updates to the standard published every 3 to 4 years, Guidelines is, in effect, the building code that governs most licensed and accredited MRI providers in the US. The 2010 edition of Guidelines just came out last month.

In the 2010 edition, for the very first time, Guidelines includes MRI safety protection requirements in the design criteria. Here’s one excerpt from the new code:

2.2-3.4.4.2 Design configuration of the MRI suite

(1) Suites for MRI equipment shall be planned to conform to the four-zone screening and access control protocols identified in the American College of Radiology’s “Guidance Document for Safe MR Practices.”

(2) The layout shall include provisions for the following functions:

(a) Patient interviews and clinical screening
(b) Physical screening and changing areas (as indicated)
(c) Siting of ferromagnetic detection systems
(d) Access control
(e) Accommodation of site-specific clinical and operational requirements

That’s right, the inclusion of ferromagnetic detection systems is a requisite element of MRI suite design in the 2010 Guidelines!

Since the 2010 edition of Guidelines has only just been published, it hasn’t (as of this writing) yet been adopted by the various authorities that use Guidelines, but that’s only a question of time.

And while the Guidelines, as a building code, might only apply to new MRI facilities and newly-sited MRI equipment, it appears that this may be just the first requirement-domino to fall.

In 2006 (yes, four years ago), the ACR’s MR Safety Committee issued a formal request to the ACR’s MR Accreditation Committee, include the Safety Committee’s Guidance Document principles as requirements for MR site accreditation. The MR Accreditation Committee has agreed that it will do something relative to MR safety in the accreditation process, but has yet to specify what this will be. It makes sense to me that the ACR MR Accreditation Committee would (minimally) appropriate existing physical safety requirements put forward by other entities (preserving the ability to deflect criticism with, ‘it’s not our standard, it’s just one that many of our accredited providers will be held to by other agencies and we felt it prudent to include it in our accreditation standards to make sure that they weren’t otherwise caught unaware.”).

Similarly, the Joint Commission (TJC), having just received ‘deemed status’ and the ability to accredit advanced imaging providers (CT, MRI, PET) for the 2012 Medicare requirements, is purportedly working on imaging-specific patient safety standards. While TJC will adopt the 2010 Guidelines as their physical facility standard, that may also provide them with the ability to develop their own MR safety specific accreditation standards. I would expect to see a flurry of imaging-specific guidance and standards coming from TJC starting this summer / fall.

What does this all mean if you’re an MRI provider? One of the things it means is that if you don’t already have a ferromagnetic detection system, you should get one, and get it soon. Setting aside the ‘best practice’ standards, loss-reduction, safety improvement, and throughput benefits, ferromagnetic detectors will be requirements of accreditation and licensure.

If I can be of any assistance to you, navigating the new requirements or addressing questions about ferromagnetic detection, please do contact me.

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