For those of you who aren’t familiar with the Guidelines, they are the design requirements that are cited by the Joint Commission and, at last count, 42 of the 50 U.S. State Departments of Health. Technically, they aren’t a building code, but the function in almost the exact same way. For the first time, the Guidelines are going to have specific MRI suite design requirements for patient safety.

2010 Guidelines

The 2010 edition of the Guidelines are purported to codify the single most often cited MRI suite safety design criteria, the 5-gauss line (or three-dimensional bubble, more accurately). The design must necessarily control access to locations where the static magnetic field is present at strengths of 5-gauss or more.

the 2010 Guidelines will also define situational-awareness requirements for suite layouts. These will include a requirement that the patient can be seen inside the scanner from the operators’ console location, and that the operator has direct visual control of the entrance to the MR scanner room.

The unique challenges of infection control and handwashing in the MRI environment are also explicitly addressed, for the first time, in the new Guidelines.

And one of my favorite provisions is the new requirement that MRI suites be designed to follow the ACR 4-Zone model for screening and access controls, including ferromagnetic detection systems!

The Guidelines publication is undergoing a significant organizational overhaul along with the regular content update, so I don’t have specific section citations to where the new MRI safety design requirements will be (though MRI probably won’t have the same section numbers as the current, 2006, edition has). My understanding, however, is that the publication will be released on schedule in January, so it is only a very short time until we can verify the specific contents and section numbers.

It is particularly encouraging that these new requirements validate what the some of the best MRI providers have been doing for years. Clearly MRI site-safety, including ferromagnetic detection, can no longer be regarded as simply “a good idea.” With the 2010 edition of Guidelines, we will have one more codified example of how these elements are truly part of the contemporary standard of care.

If you would like more information about the Guidelines, including information on how to order a copy of the document, please click here.

Link

The first special event is a presentation that AHRA invited me to give entitled ‘MRI Safety, Liability, and Best Practice.’ If you received the conference program mailers a few weeks ago that indicated that I am giving this presentation on that first Sunday of the conference, don’t believe it! I am not giving this presentation on Sunday, but I am giving it on Monday, August 10th, from 2:30 – 4:00. (They’ve done a little juggling that changed a few scheduled presentations.)

The program will touch on a number of the MR safety developments of the last several years, though even more from a management perspective than any of my prior presentations to AHRA.

This is the first special invitation and I would very much love for you to join me on Monday afternoon. There are lots of other great sessions, however, and I understand if you have your eyes on another program scheduled for the same slot. I’ll miss you though, and will stare wistfully at your empty chair in the presentation.

Which brings me to my ½-event invitation. It’s actually a full event. It’s 90-minutes long, just like my Monday presentation. In fact, it’s almost exactly like the 90-minute Monday presentation because AHRA has asked me to offer this program twice! If you can’t make Monday afternoon, please come by Tuesday morning, from 8:00 – 9:30, to see ‘MRI Safety, Liability, and Best Practice’. I’ll actually feel much better on Monday if you’re not there, since we have this opportunity to meet up on Tuesday. And if you’re a glutton for punishment, or if you just want to see what I do to mix it up from one day to the next, you’re welcome to attend both sessions.

The last special event to which this post invites you is actually a revolving, ongoing set of conversations that I would love to share with you. When I’m not on the podium in front of large audiences, I will be in the Mednovus booth on the exhibit hall floor (booth #828 / 830), having one-on-one and small group conversations. I invite you to come by and join in a personal conversation with me and my colleagues about how best to prepare your MRI facility for the rapid-fire changes that are in process.

Though it’s only 4 weeks until AHRA, the great people at Mednovus are diligently working on special announcements that will be released in the lead-up to the annual meeting. Please stay tuned to be among the first to learn of what’s going on.

I hope to have the chance to see you at the annual meeting. Please do join me in one (or both) of my presentations, and do visit with me and my colleagues in our booth. I’m really looking forward to it.

As I see it, the new ASA MRI Practice Advisory does three things… First, with its rigorous methodology it validates (as if it needed the validation) the best practice standards outlined in the ACR’s Guidance Document for Safe MR Practices. Second, it introduces the concept of levels of care to the MR suite (a la trauma centers or nurseries) that correspond to patient acuity and level of intervention. Third, it lends its voice to the rising chorus of government agencies, professional bodies and individual MRI safety experts that are increasingly alarmed over recent trends in MRI safety.

Now we have the FDA, pointing out frightening growth in MRI accident rates. There’s renewed concern about infection control in the MRI suite. Add to these, Anesthesiologists now expressing concern about safety and practice standards for care of sedated patients receiving MRI exams. This all begs the question, who has the most direct oversight role in patient safety at the point of care? Who is best positioned to respond to these broad, multidisciplinary concerns about MRI safety?

• It would have to be an organization with a broad reach across the healthcare provider spectrum, including both hospital-based providers and outpatient / IDTF’s.
• It would have to be an organization with an existing base of authority including real potential for disciplinary action.
• It would have to be an organization that has the capability of more than promulgating written standards, as there have been many of these on MRI patient safety and yet the accident rates have soared.
• To verify real-world conditions at the provider level, it would have to be an organization with the capability to survey the point of care.
• Ideally, it would be an organization that already had provisions on the books that gave it the authority to act in the specific interests of MRI safety.

Can anyone think of an organization that meets this bill? An organization with authority over multiple provider types (JCAHO)? An organization with national authority as well as enforcement tools (JCAHO)? An organization with the structure to help it promote an educational agenda to raise provider awareness of corrective actions (JCAHO)? An organization that has the capability to survey and verify that contemporary standards of care are being met at the provider level (JCAHO)? An organization that already has established advisories on MRI safety issues that are referenced by its own standards (JCAHO)?

Where can we possible turn to find a single entity with the authority and an interest in preventing accidents and injuries in the MRI suite?

And if we found such an organization or commission, would they be willing to accept such a charge?

When organizations outside of radiology, such as the ASA, step up and confront their part of these multivalent risks, isn’t it encumbent upon the organizations charged with patient safety to do something about the overall picture?

That, my friends, is the $43,172 question.

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.

On February 19th, Joint Commission Resources (JCR), the education and consulting arm of JCAHO, will offer a web-based teleconference on the EC standard and what it means to MRI providers.

The teleconference will be hosted by yours truly and will lay-out the explicit requirements of the new EC standard, tie these back to the Joint Commission’s own MRI Sentinel Event Alert (#38), reference the ACR Guidance Document and other industry standards, as well as offer thoughts on what surveyors may be asking to see when they show up at accredited providers’ sites.

There is a fee for the teleconference ($249) and, no, I don’t get a ‘cut’ of the revenue. I do get compensated, but I get my year’s supply of Rice-a-Roni whether I’m talking only to myself or if there are 1,000 other people on the call.

The webinar will also include other materials in support of MRI safety.

I hope that the information and materials provided in the webinar will be of use to you and I hope that you are able to join us on the call in a couple weeks.

This isn’t to say that surveyors haven’t made their way to MRI, either shadowing a patient or as an intended visit to simply see the department. And this isn’t to say that the surveyors haven’t reviewed and commented upon MRI safety issues in the suite. What I do intend to say is that without a substantive backing of codified standards, Joint Commission surveyors ‘from the hip’ comments on MRI safety will be irregular and not very effective. But has all of this been changed – today, January 1st, 2009 – for accredited MRI providers?

That’s right, today the 2008 revisions to the Joint Commission’s Environment of Care (EC) standard are in effect. And while the JC has not been promulgating new MRI-specific standards, a major change just slipped in through the back door.

The new EC standard requires that accredited providers perform risk analyses using, as a minimum standard, all previously released Sentinel Event Alerts (42 as of this writing). One of these is the MRI Sentinel Event Alert (#38) which details a number of MRI safety objectives.

Once the risk analysis is completed for MRI, a corrective plan must be developed (complete with concrete objectives and a time line for implementation) and each incremental step documented.

This, at least, is how the new EC standard reads on MRI safety. Whether the Joint Commission surveyors will be taking the safety criteria of their own Sentinel Event Alert seriously should be revealed in the next few weeks as the first surveys of 2009 are completed.

While not every MRI provider is Joint Commission accredited, there’s no denying JCAHO’s influence in the broader industry. The Joint Commission now has the opportunity to not only to promote MRI safety at their accredited providers, but to the entire MRI community.

They have the criteria (SEA #38), they have the accreditation standard (Environment of Care), now the only question is ‘are they serious about MRI safety?’

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.