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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The Technologist, Laura Price, claims that her former employer, Horizon Diagnostic Center in Orange Park, FL, ignored repeated requests from Ms. Price and other Technologists to repair the coils on the MRI, and that the image quality was so poor as to compromise the clinical value of the scans. She was purportedly fired for insisting that the coils be repaired. She is suing for wrongful termination and has taken her efforts public in an interview with a local television news station.

What is particularly interesting (to me at least) is that there is not currently any claim of injury or misdiagnosis based on the claimed failure to keep the MRI equipment in operational condition. Therefore, this is strictly a claim against the practices of the provider and their adherence to standards of care and best practices.

Though the MRI fatality case has yet to go to trial (having been postponed ad nasuem for years, now), the Technologists are named defendants in that suit, suggesting at least that Techs have a legal obligation for safety and the standard of care.

This Florida suit is intriguing because it puts operations squarely in the legal crosshairs. When legal liability is tied only to injury, it fosters an ‘ends justify the means’ culture of safety. Something akin to, “if we haven’t hurt anybody, it proves that we’re doing things right.”

Many patient safety experts decry this sort of ‘negative proof’ of safety. Getting all the way across the freeway unscathed, on foot, blindfolded, is not proof that walking blindfolded across the freeway is a safe practice, yet this is the logic that prevades MR safety at many locations.

Whatever you may think of this one case, or the Technologist who is bringing it, I am very interested simply because it does put safety practices in the spotlight. I’m also very interested in what you may think of this, so please share your comments, below.