Of Course MRI Safety Training Is Required... [It *Is* Required, Right?]

Let's start with the painful and obvious (but not painfully obvious)... in the USA non-ionizing radiation (i.e., MRI) safety at the point of care is almost entirely unregulated by the states. There aren't operational requirements for licensure (e.g., appointment of MR Safety Officers or MR Medical Director), and virtually no MRI safety competency or training requirements for either the operators of MRI equipment or the physicians who supervise the studies. This isn't a big deal if the accreditation organizations, which all work across state lines to enforce federal requirements, standardize MRI safety training requirements, right?

The accreditation organizations do standardize MRI safety training, don't they?

Well, let's begin with what the federal requirements (for CMS reimbursement) are for radiology safety training, as taken from the 2015 CMS interpretive guidelines memo.

The above criteria are written generically to apply to all radiologic services exams, so let me re-word the above two CMS safety training requirements to be specific to MRI.

First, like radioisotopes (and unlike X-rays), MRI has safety concerns that are ever-present, not limited to the performance of the exam. For MRI we have an existing definition of physical hazard regions (ACR 4-zones) which describe physical hazard areas as being Zones 3 and 4.

With these pieces of information we can re-tool the CMS bullet points as they might read if they were written specifically for MRI:

• Training required by personnel permitted to enter Zones 3 or 4 where MRI services are provided.
• Training and, as applicable, qualifications, required for personnel who perform diagnostic studies or or therapeutic procedures using MRI equipment. This includes proper operation of equipment per manufacturer's instructions and hospital policy.

Missing from the CMS radiology safety training criteria (perhaps they thought it was already covered as a requirement, elsewhere) is the specific safety training of the physician who is legally responsible for the safe execution of the MRI exam. So I'd like to add a third bullet point specific to the supervising physician:

• Training required of physicians protocoling, interpreting, or overseeing the execution of clinical MRI services.

Made more plain, it is my belief that MRI safety training should be required of the following roles:

1. The physicians directly involved in MRI patient care.
2. The technologist / radiographer / operator who administers the MRI exam.
3. Any person working within Zones 3 or 4 with patient care / patient monitoring duties.

Let's look at how each of the accreditation organizations fare in terms of these three minimum requirements (either my personal minimum, or minimums prescribed by CMS for healthcare providers).

The Joint Commission (TJC)

Not to steal my own thunder, but Joint Commission is the only major US healthcare accreditation organization that has explicit MRI safety training criteria for technologists / operators as a part of their accreditation requirements (though not the only one with an explicit MRI safety training requirement).

You'll note, however, that TJC's explicit MRI safety training requirements only apply to 'technologists who perform MRI examinations,' meaning that the minimum MRI safety training requirements don't apply to either supervising physicians or to non-technologists working in the MRI area. The second training bullet from CMS also talks specifically about 'proper operation of equipment per manufacturer's instructions' but TJC's training requirements are only tangentially about the operation of the MRI machine and are much more directly focused on patient preparation, incidental equipment, and emergency response.

DNV Healthcare

DNV Healthcare is like TJC in that they're an enterprise-level healthcare accreditation organization, but with a different regulatory approach. Approach differences aside, DNV is also an accrediting organization 'deemed' by CMS to verify quality and safety of hospital-based providers, which means that DNV-accredited hospitals need to meet the CMS requirements just as much as the TJC-accredited hospitals do. Let's read what their radiology safety requirements are...

Per SR.1, the organization needs to comply with professionally approved standards, federal and state laws relative to radiation safety (which don't apply to MRI). SR.1 states "medical imaging services, particularly ionizing medical imaging procedures, shall be free from hazards for patients and personnel." So, because MRI point of care isn't subject to state or federal laws (and 'professionally approved standards' is pretty ambiguous), there are effectively no objective DNV standards for MRI safety... which I suppose makes the diminishing statement, 'particularly ionizing radiation being free from hazards,' make sense, as it seems that -by only referencing non-existent external safety provisions- DNV appears to be saying that there *are no* MRI safety requirements.

There is a section in the DNV standards that is ostensibly about radiology safety, but it's identified as 'Radiation Protection' and, as one would expect from the title, deals only with ionizing radiation.

So DNV has no MRI safety-specific safety requirements, let alone MRI safety training requirements for supervising radiologists, technologists, or anyone else working within the MRI environment.

Now the CMS interpretive guideline memo I've referenced above speaks specifically to hospital accreditation requirements, and I'm seeking clarification from CMS to understand what specific radiology safety conditions of participation they hold for outpatient-based providers (this has been surprisingly difficult to identify). Since radiology risks tend to be produced by the radiology device, irrespective of whether it's in a hospital or in an outpatient imaging center, I'll be continuing with the the above evaluation for modality-specific accreditation providers that are frequently used in outpatient facilities (along with hospitals).

Even if CMS ultimately responds that the radiology safety criteria only apply to hospitals, I am of the opinion that device specific safety practices should be employed wherever that device is located, and just because it's in a strip mall imaging center doesn't mean that the X-rays are less ionizing, or that the MRI scanner is less likely to interrupt a medication pump. The MRI safety training standards ought to be equivalent between hospitals and outpatient imaging centers.

American College of Radiology (ACR)

The ACR's MRI accreditation program is a bit convoluted when it comes to identifying what their explicit MRI safety minimums are.

On one hand, on the page where they discuss the personnel requirements for MRI supervising physicians, they specifically state that the modality supervising physician is responsible for the "implementation and enforcement of policies regarding":

So the MRI supervising physician needs to implement and enforce the criteria of the ACR Manual on MR Safety, except that one of the criteria of the Manual is that no technologist should work alone, that there should always be +1 staffing. When pressed with questions about how to reconcile the ACR MR accreditation's supervising physician requirement for +1 staffing with the fact that this would impose operational costs on sites who have pared back to a single technologist working alone, the ACR updated their personnel requirement to clearly indicate that they wouldn't actually be looking at the safety elements (or at least this safety element) as a part of their accreditation review...

So the ACR appears to be saying, 'we're not actually going to check up on whether you're following our Manual's safety criteria... but if there's an accident and you haven't been following the safety standards, be forewarned we're prepared to throw you under the bus.'

So how does the ACR's MRI accreditation program specifically address MRI safety training? It doesn't... at least not directly. The supervising physicians identified as a part of the MRI accreditation application need to assure safety, but there don't appear to be any requirements that *any* associated physicians actually have any MRI safety training.

The technologists can qualify under ACR MRI accreditation through a number of means (many of which don't require any MRI safety training), and there are no ongoing or annual CE or provider-based MRI safety training requirements.

The ACR does have an MRI accreditation document, called the "MRI Safety Program Assessment Checklist" which is supposed to be completed by the site's contracted / staff medical physicist which does ask to verify the presence of 18 different MRI safety policies, one of them is supposed to be a policy on "documented MR safety education / training for all personnel."

However, the ACR offers neither specific content requirements (who are 'all personnel'? how often is the training to occur? what is the minimum content?), nor general qualitative guidance (e.g., would a policy that stated "MR safety education will be provided as decided by the supervising physician" suffice, when it could mean zero annual training or qualification?). Furthermore, the site-contracted physicist is supposed to make a pass/fail determination on the safety policies (and one non-policy safety performance criterion) without any ACR-provided grading scale. So pass / fail, with no qualitative guidance and no scoring criteria, graded by a person under the direct employ of the organization seeking accreditation... not exactly iron-clad.

So ACR does invoke MRI safety standards as a part of its accreditation, but clearly states that (at least for +1 staffing) that they're not actually going to check as a part of their accreditation process. Their "objective" MRI safety accreditation criteria turn out to be little more than policy titles, with no minimum compliance criteria and no objective grading information for pass / fail in a conflict-of-interest-ridden methodology.

Within ACR MRI accreditation standards there are no objective MRI safety training criteria for radiologists, technologists, or anyone else who works in Zone 3 or 4 of an MRI suite.

Intersocietal Accreditation Commission (IAC)

IAC is similar to ACR in that they are a modality-level accrediting organization, meaning that they ostensibly verify quality and safety of care delivered on an individual piece of equipment.

The IAC has specific standards for their MRI accreditation program, inducing personnel standards for Medical and Technical Directors, Medical and Technical Staff, Support Services and Medical Physicist:

The personnel standards recommend a minimum of 1 hour of CE / CME per year include MRI safety instruction for the director and staff positions, but there are no explicit requirements for MRI safety training. The general approach appears to be, 'we think it'd be a good idea for you to get MRI safety training, but it's not essential.' Notwithstanding my question about the CMS bullet points being applied to outpatient providers, IAC's flimsy MRI safety training standard does not appear to meet the staff safety training requirement.

IAC does have standards that call for a policy "that all individuals who may potentially enter the MRI environment be aware of the potential hazards and appropriate safeguards necessary with regard to the force of the magnet on ferromagnetic objects." This does appear to at least strive to meet CMS's first criterion, though it's odd that they're much more specific about requiring MRI safety training for visitors than they are for the site's own personnel.

Comparison

So if we reduce these three MRI safety training targets (incidental personnel, MRI technologists / operators, and radiologists) into check-box criteria, this is how I would view the performance of these four accreditation organizations:

Per my reading of each accreditation organization's imaging / MRI criteria, not a single one of them appears to meet both criteria from CMS about safety training, though TJC and IAC (arguably) each meet one of them (I'm feeling generous today). What's perhaps the most surprising is that the ACR, the organization that has probably done more in the development and promulgation of MRI safety best practices, is tied with DNV for 0/3 in terms of explicit MRI safety training requirements.