If you’ve ever been on an email mailing list for the ACR, then you’ve probably received a few of these in the last few months… emails imploring you to contact your Senators and Representatives to urge them to support the Diagnostic Imaging Services Access Protection Act (HR 3269). So far I’ve received three or four of them, and for the ones I’d received previously, I replied, agreeing to contact my elected officials on their behalf, but on one condition…
Those who know me know that I’m an upbeat person. Not the spring-out-of-be-fifteen-minutes-before-the-alarm-“so-happy-to-greet-the-morning” type of upbeat, but more of an indefatigable cautious-optimism. Yes, there are bad days… days when I’d just prefer to pull the covers over my head to wait to see if next week Thursday offers enough to coax me out of bed. But I’m of the firm belief that – on those days – you have to drag your sorry butt out of bed and put one foot in front of the other, if for no other reason than you might forget how if you skip a day. Someday, no matter how distant or unlikely, you will meet your goal.
Guess what? Today is one of my somedays! Continue reading
Here we sit, on the cusp of mandatory accreditation for ‘Advanced Imaging’ modalities at outpatient providers (these are CT, MRI and PET), and a series of articles on medical radiation exposure splashes across the New York Times.
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.
In stark contrast to the speed with which we expect to see medical technology advance, the more bureaucratic process of regulatory or accreditation tends to be more deliberative and… oh heck, I’ll just say it… glacial in its pace to keep up. Every once in a while, however, these efforts ‘sling-shot’ forward.
Much to my surprise (and delight), this is happening with the new Guidelines for Design and Construction of Health Care Facilities (or Guidelines, for short). Though the 2010 edition of Guidelines has only been published for about a month (and the publisher has been struggling to catch up on back-ordered copies), two states have already adopted the 2010 edition as their requirements for licensure.
A few weeks ago the announcements came down, CMS had ‘deemed’ three organizations to accredit the new classification of Advanced Imaging in order to be eligible for Medicare & Medicaid reimbursement: the American College of Radiology (ACR), the Intersocietal Commission, and the Joint Commission (TJC).
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!
Break out the can of alphabet soup, because here we go, off into the far reaches of acronym land…
That’s right, the Joint Commission is offering a teleconference / webinar on the 2009 changes to the Environment of Care (EC) standard and what they mean to accredited MRI providers. Never heard of the EC standards before? Well, you’re not alone, but that doesn’t mean that they don’t apply to you. In just a couple weeks, however, you can get the low-down on the new requirements.
Last month, I was honored to have been given the opportunity to present to one of the national American Healthcare Radiology Administrators (AHRA) meetings. In October I gave a presentation on the current state of MRI Safety, including regulatory, legal and accreditation changes that are all in the works.
The full presentation was 90 minutes, including an extensive audience Q&A, but I’ve pulled out one particular section that is particularly relevant to our topic at hand, ferromagnetic detection for MRI pre-screening.
The video excerpt below addresses forthcoming changes to the ‘Guidelines for Design and Construction of Health Care Facilities’, a poly-cyllabic mouthful that roughly translated means the healthcare building code, and changes regarding MRI suite design…
As mentioned in the video above, the proposed changes to the healthcare building code are currently open for public review and comment. The proposed language includes references to the ACR 4-zone principles as well as planning for ferromagnetic detection.
If you would like to see, review or even comment upon the proposed changes to the hospital and healthcare provider building code, public comment for the ‘Guidelines’ is open until December 15th, 2008.Tobias Gilk, President & MRI Safety Director Mednovus, Inc. Tobias.Gilk@Mednovus.com www.MEDNOVUS.com
Starting in January of 2009, the drought of MRI safety regulation will begin to end.
It surprises many that the Joint Commission has no specific MRI safety accreditation standards. Surveys of accredited MRI providers have, over the past many years, focused largely on general safety standards, adapted for the MRI environment. Historically, a surveyor’s check for a non-magnetic portable fire extinguisher was the only MRI-specific safety check provided by the Joint Commission.
Despite the fact that many MRI-specific safety articles, recommendations, and, most recently, Sentinel Event #38 have been offered by the Joint Commission and its allied Joint Commission Resources educational arm, there have not previously been specific MRI safety standards for accreditation, and it is only through the new Environment of Care requirements that MRI safety will become an implicit standard for Joint Commission accredited facilities.
Starting this coming January 2009, inpatient and outpatient accredited facilities will need to abide by the new Risk Management provisions of the Joint Commission Environment of Care standard. The Standards Improvement Initiative will require facilities to prospectively define the physical hazards within the facility and develop specific responses to manage and mitigate those hazards.
The new standard specifically cites Sentinel Event Alerts as one external reference that must be considered in defining risks. For MRI, this automatically means Sentinel Event Alert #38. And since SEA #38 draws so heavily from the ACR Guidance Document for Safe MR Practices: 2007, it only follows that the ACR Guidance Document is the underlying industry standard document for defining MRI safety. Another external reference that specifically addresses MRI physical hazards which should be used as a basis for risk analysis is the VA MRI Design Guide.
What do Sentinel Event Alert #38, the ACR Guidance Document, and the VA MRI Design Guide all recommend? Well, lots of common elements, actually, but one of the key recommendations is for the use of ferromagnetic screening (click here to download a PDF document that outlines many of the recent recommendations for ferromagnetic detection).
While it is starting with the Joint Commission Environment of Care, my expectation is that MRI-specific patient safety requirements will spread to other accreditation requirements, building codes, and standards of practice. This will include not just recommendations, but requirements for the use of ferromagnetic detection for MRI pre-screening.
Over the next few months, all Joint Commission accredited MRI providers will need to review the standards of practice in the ACR Guidance Document for MR Safe Practices. Specific actions must be taken to identify, document, and respond to the unique hazards in the MR environment. One of those immediate actions should be planning for ferromagnetic detection at your MRI facility.
If you have any questions about the new MRI safety standards, the best-practice recommendations for ferromagnetic equipment siting, and incorporating these vital safety instruments in your MRI screening practices, I recommend that you heed the advice of the ACR Guidance Document, the VA MRI Design Guide, and other safety practice documents. If you still have questions about these standards, I invite you to contact me.Tobias Gilk, President & MRI Safety Director Mednovus, Inc. Tobias.Gilk@Mednovus.com www.MEDNOVUS.com