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

The review has been requested by Robert Russo, MD, with Scripps Research Institute. A copy of Dr. Russo’s request can be viewed here.

The public comment period is open through July 28, 2010, and I strongly encourage anyone with questions or concerns about the safety of MR imaging for patients with implanted cardiac devices (Dr. Russo correctly points out that CMS’ restriction fails to speak directly to implanted cardio-defibrillators, or ICD’s) to offer their comments to CMS.

The full explanation of the current restrictions on MR imaging of pacemaker patients (also aneurysm clip patients, and pregnant patients), as well as the instructions for reviewing other public comments or submitting your own, can be found here.

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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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