Joint Commission may survey for MRI safety

Mar 4, 2009

It's not news to the radiology community that the profession is heavily regulated. The list includes the responsibilities of clinical care, the hazards associated with exposure to ionizing radiation, and, in our post-9/11 world, homeland security keeping tabs on every drab of medical isotopes.

What may be surprising is that nearly every one of the vast array of state and federal regulations, accreditation standards, and payor criteria for a provider's radiology safety are based on either the dispensing of medication or exposure to ionizing radiation. What does this leave uncovered? The majority of MRI scans.

Joint Commission-accredited providers are familiar with the nail-chewing nervousness of onsite surveys and may have specific recollections of surveyors visiting MRI. These visits, however, have been to shadow a tracer-patient for clinical procedures, such as medication reconciliation, or to verify that a portable fire extinguisher is nonmagnetic.

The other unique physical hazards presented by magnetic fields -- most commonly 30,000 times greater than that of the Earth's own -- historically were not on surveyors' radars.

That situation changed this past January 1, when the Joint Commission's Environment of Care (EC) standard primarily began to address physical life-safety issues, such as hazardous chemicals, building security, fire safety, and building construction. It includes a section on medical equipment risks, which are based largely on the operability of the equipment in an emergent situation. Prior versions of the EC standard did not address MRI safety.

As part of the Joint Commission's Standards Improvement Initiative (SII) of 2008, the body of standards was updated. While many of the changes were structural to facilitate the navigation of those guidelines, the EC standard was amended to compel risk assessment and risk analyses of internally identified accidents and hazards and require providers to identify hazards from "credible external sources" including, for the first time, the Joint Commission's own Sentinel Event Alerts (SEA).

"Prior to SII and this year, we had a requirement through the Environment of Care chapter that the organization proactively identifies risks in the environment ... and that was it," said John Fishbeck, associate director of standards and survey methods for the Joint Commission. "And now we've presented better guidance that this is based on internal data and external data, such as Sentinel Event Alerts."

The EC standard update does not require a risk assessment based on each and every previously released alert, but will perform a risk assessment on alerts that identify physical hazards at the provider. This provision would include the risks of surgical fires (SEA #29) and failures of critical power systems (SEA #37).

In February 2008, the Joint Commission released SEA #38, Preventing Accidents and Injuries in the MRI Suite, which outlined 10 explicit objectives for enhancing provider-level MRI safety, nine of which are in direct response to the unique physical hazards in the MRI environment:

"Restrict access to all MRI sites by implementing the four-zone concept as defined in the [American College of Radiology (ACR)] Guidance Document ..."
"[S]creen all nonemergent patients twice, ... to answer questions about any metal objects they may have on them, any implanted devices, drug delivery patches, tattoos, and any ... devices they may have."
"Ensure that the MRI technologist has the patient's complete and accurate medical history to ensure that the patient can be safely scanned ..."
"Have a specially trained staff person who is knowledgeable about the MRI environment accompany any patient, visitors, and other staff ... at all times."
"Annually, provide all medical and ancillary staff ... with safety education about the MRI environment and provide all staff and patients and their families with appropriate materials that explain the potential for accidents and adverse events in the MRI environment."
"Take precautions to prevent patient burns during scanning ..."
"Use only equipment that has been tested and approved for use during MRI scans."
"Proactively plan for managing critically ill patients ..."
"Provide all patients with hearing protection."
"Never attempt to run a cardiopulmonary arrest code or resuscitation within the MR magnet room itself."

Each of the above objectives, with the exception of No. 8, are designed to combat one or more of the physical environment risks present near an MRI scanner or during MRI imaging: extreme magnetic attraction, negative interaction with medical devices, radiofrequency heating, and dangerous sound pressure levels. The patient management goal also has environmental safety implications when considered with the screening of code responders and resuscitation equipment.

While invoking prior alerts as metrics for Joint Commission standards brings MRI safety within the purview of surveyors, there have been no standards or survey criteria, apart from the fire extinguisher, that addressed the unique elements of MRI safety. This omission has presented new surveyor training challenges for the Joint Commission.

"Since these standards were revised for 2009, we prepared educational materials for the surveyors last fall," said Fishbeck. "We did the MRI alert and now we're doing the follow-up with the education relating back to the standards."

As the majority of physical MRI hazards do not depend on the type of magnet or the clinical usage, the obligation for risk assessment under the current EC standard appears universal to all Joint Commission-accredited MRI providers. Although the EC standard does not require surveyors to review every risk assessment for the quality of the analysis, surveyors can minimally verify that the provider has complied with the requirement and that the safety review is complete.

Risk assessment changes to the EC standard, in addition to their application to current conditions, also are forward-looking. EC 02.06.05 applies similar standards for "new, altered, or renovated space," compelling the provider to anticipate how the design and construction of buildings will influence physical safety. The bolus of MRI suite safety design guidance, released over the past couple of years, is likely to raise the safety bar for Joint Commission-accredited MRI providers planning for new equipment or suites.

Despite the referencing of the MRI alert in current standards and the heightened focus on physical safety, the Joint Commission has no immediate plans for developing MRI-specific safety standards. "If we had specific standards, say addressing MRI, maybe in two years that issue would go away and those specific requirements are [still] out there," said Fishbeck. "But the Environment of Care is about more of a management process, being proactive and developing strategies and education of staff, monitoring the environment, and making changes where needed."

By Tobias Gilk
AuntMinnie.com contributing writer
March 5, 2009

Tobias Gilk is a member of the American College of Radiology's MR Safety Committee and president and MRI safety director for Mednovus, a vendor of pre-MRI screening instruments. He has written hundreds of articles on MRI safety (including a few for the Joint Commission) and is a popular speaker on the subject.

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Back to the present: VA updates MRI design guide, part II, December 5, 2007

Back to the present: VA updates MRI design guide, part 1, December 3, 2007

Joint Commission MR safety surveys: Moving past the fire extinguisher, August 29, 2007