While they released a Sentinel Event Alert on MRI safety in 2008, and while they’ve interpreted MRI-specific applications of a couple of hospital-wide standards (mainly, non-magnetic portable fire extinguishers), it was this past December (2013) when they announced their first explicit MRI Safety Standards, which become effective in July of 2014.
There are a few highly-specific criteria that don’t leave much to interpretation (collect data on your failed screenings in which a ferromagnetic object was allowed to enter the MRI scanner room), and there are more somewhat ambiguously-worded standards (manage MRI safety risks). Any facility that has undergone more than one Joint Commission survey knows that there is often different emphasis from one survey to the next, even if the standards haven’t changed. What follows is my own, personal, compliance checklist of the new MRI standards. While not reviewed / approved / sanctioned / blessed by the Joint Commission, I would contend that anyone who can check all of these boxes should sail through any survey that uses the new MRI safety standards…
First thing I would recommend is that you get your very own copy of the new standards, available HERE. In addition to having the specific language of the standards for MRI, you may also have other modalities (CT, or Nuclear Medicine) that are governed by the new standard, and you should familiarize yourself with those requirements, too.
OK, on to our checklist…
EC.02.01.01 is all about managing risks, and it’s these two Elements of Performance (EPs) that contain some of the more ambiguous language, when it comes to specific measures. But based on what these say, I would offer the following performance criteria:
- Designate a physician MR Medical Director with the responsibility to review and approve MRI-specific policies and procedures.
- Designate a technologist / radiographer / medical physicist as MR Safety Officer with the responsibilities of daily compliance with the MRI-specific policies and procedures.
- Create (if you don’t have already) policies and procedures that:
- Address strategies for calming or responding to the anxious or distressed patient, including where, when, and how medications for anxiety are to be handled.
- Describe specific responses in the event of anticipated code events, including respiratory distress, cardiac arrest, slip-and-fall, contrast reaction, patient burn, projectile event, or magnet system quench.
- Describe standard clinical screening protocols for the identification of medical devices or retained foreign objects in persons who are to be allowed to access the MRI scanning room.
- Describe standard physical screening protocols for the identification of any and all objects and materials that may be ferromagnetic before they are allowed to access the MRI scanning room.
- Describe your site’s requirements or recommendations relative to acoustic injury protection.
- Describe the standard by which MR staff education (content, competency) is linked to independent access to a secured MRI suite.
- Implement the access-control, and line of sight supervision, and staff training requirements of the ACR 4-Zone principle.
- Provide warning signage about magnetic field hazards, as well as signage to indicate that the MRI scanner is always on.
EC.02.04.01 is about managing the risks specific to medical equipment.
- Document (and follow) a schedule of maintenance and quality control activities for the MRI scanner.
EC.02.04.03 is about testing and maintaining medical equipment.
- Follow a QA / QC plan to assure quality / consistency of clinical images (either one administered by someone else, or develop your own).
- For MRI, this means (at least annually) that a physicist or MRI scientist is to document an evaluation of the equipment to include (minimally):
- Image uniformity for all RF coils
- Signal-to-Noise ratio for all coils
- Slice thickness accuracy
- Slice position accuracy
- Alignment light accuracy
- High-contrast resolution
- Low-contrast resolution (contrast-to-noise ratio)
- Geometric or distance accuracy
- Magnetic field homogeneity
- Artifact evaluation
- Additionally, the console display monitors must be tested for
- Maximum and minimum luminance
- luminance uniformity
- Spatial accuracy
In short, if it’s a part of the MRI that is involved in capturing the image, or displaying it, make sure that you’ve got a plan to make sure that the bits are in working order, and stick to that plan.
HR.01.05.03 is about continuing education and training for staff.
- Any MR technologist / radiographer who performs MRI studies is to receive (at least) annual MRI safety training. To these, I would add this requirement to anyone who has a responsibility for safety in the MRI (MR Medical Director, MR Safety Officer, Enterprise-level Safety Officer). This training is to include:
- Screening for ferromagnetic threats
- Screening for medial devices / implants
- Screening for NSF risks (the ACR has developed a good list for identifying patients with risk-factors for reduced renal function, which might indicate eGFR testing)
- Patient positioning to prevent burns (to this I would add screening for burn risks, and the use of padding / positioning aids, and coils to reduce burn risks).
- Appropriate (MR Conditional) equipment and supplies for use in the MRI environment
- Procedures in a code (to which I would add at least one code drill per year)
- Emergency run-down procedures and protocols
- Emergency quench procedures and protocols
- Management of anxious or distressed patients
PC.01.02.15 This EP is about the necessity of providing diagnostic services at a hospital.
- Prior to imaging the patient, verify:
- Patient identify
- Imaging site for the study
- Patient positioning for the study
- Additionally, the provider is to identify the patient’s age and the appropriateness of the modality / exam.
And if there were a desire to ‘cut corners’ on any of the above standards (or my additions to them), the ‘gotcha’ provision lies in PI.01.01.01, which is about monitoring and improving performance in the delivery of care…
- Maintain a record of all patient burns that occur (or are purported to have occurred) during MRI exams.
- Maintain a record of failed screenings for ferromagnetic objects / materials when these objects were unintentionally / unknowingly brought into the MRI scanner room (whether the object was attracted to the magnet or not).
- Maintain a record of any and all injuries involving a ferromagnetic object in the MRI scanner room.
As I noted, the described protections in the standards to prevent burns and projectile accidents are pretty much, “try not to let these happen.” The language of TJC’s standards on these issues does not describe specific preventive actions that the provider could / should take, or the criteria by which surveyors will be evaluating the site.
MRI burn prevention involves screening the patient for electrically conductive materials, knowing the proper orientation / positioning / scanner or sequence selection to minimize these risks. Teaching techs positioning, yes, is important, but it – alone – won’t prevent burns. And since your facility will be required to record the burn incidents, you will be building a paper-trail for plaintiff / prosecuting attorneys if the facility doesn’t take a more comprehensive approach to preventing burns.
Similarly, the PI standard requires documenting not only projectile injuries, but also failed screenings for ferromagnetic materials… again, creating a paper-trail should you ever find yourself in litigation. While the only black-and-white standard preventive piece of the new standards says to ‘manage the risks of ferromagnetic objects’, I would strongly recommend that providers take the specific step to incorporate ferromagnetic detection systems in their preventative scheme.
I am pleased that TJC has issued these standards (and more than a little surprised that they’ve beat the ACR to the implementation of concrete MRI safety standards), but I think that the ambiguity and built-in liability risk with the documentation make it so that many providers will benefit from this checklist.