Tag Archives: Design Guide

New Joint Commission Environment of Care (EC) Requirements

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

“Ferromagnetic Detection? Yeah, Who Says So?”

For those in the unenviable role of having to make tough decisions about which safety features to invest in and which to forgo, one key factor to these decisions is compliance.

For those administrators stuck between ‘legal liability’ and ‘budgetary constraints’, sometimes the decision of which safety improvement to invest in has a lot to do with who recommends (expects) it. Regulatory compliance is an imperfect litmus test of safety, to be sure, but like it or not, when the accrediting bodies speak, people listen. In the past year there has been a growing chorus of accrediting and regulating bodies that have all called for ferromagnetic detection in MRI patient screening.

Let’s start at the very beginning (“What a very good place to start.”), with last summer’s publication of the ACR Guidance Document for Safe MR Practices: 2007…

“[F]erromagnetic detection systems are currently available that are simple to operate, capable of detecting even very small ferromagnetic objects external to the patient, and now, for the first time, differentiating between ferromagnetic and nonferromagnetic materials. While the use of conventional metal detectors is not recommended, the use of ferromagnetic detection systems is recommended as an adjunct to thorough and conscientious screening of persons and devices approaching Zone IV.” [Emphasis mine.]

Just a few months later, the UK’s MHRA released their 2007 MHRA Device Bulletin – Safety Guidelines for Magnetic Resonance Imaging Equipment, which included ferromagnetic detection in the document’s MR Suite Recommendations section. In the MHRA document, a two-stage ferromagnetic screening process is recommended, one near the door to the MRI room for large threats and a patient screening, capable of finding even smaller threats…

“As well as reducing the likelihood of small projectile incidents, the systems are designed to reduce the likelihood of an MRI scan having to be repeated e.g. due to the presence of an object distorting the MRI scan image.”

In February of 2008 the Joint Commission added their thoughts with something of an omnibus MRI safety Sentinel Event Alert (their highest patient safety alert). The top recommendations of the SEA included access controls and enhanced screening for threats…

“Use trained personnel to screen all non-emergent patients twice, providing two separate opportunities for them to answer questions about any metal objects they may have on them, any implanted devices, drug delivery patches, tattoos, and any electrically, magnetically, or mechanically activated devices they may have… [U]se other means to determine if the patient has implants or other devices that could be negatively affected by the MRI scan (e.g., look for scars or deformities, scrutinize the patient’s history, use plain-film radiography, use ferromagnetic detectors to assist in the screening process, etc.).” [Emphasis mine.]

And most recently, earlier in July of this year, the US Veterans Administration released a sweeping revision to their MRI Design Guide which offers design input on technical, operational and safety factors for MRI suites. The new MRI Design Guide covers a LOT of material, but included in its provisions is the use of ferromagnetic detection screening for all persons approaching the MRI magnet…

It is recommended that MRI facilities install ferromagnetic detection systems for use in screening persons and equipment entering Zones III and IV to interdict potential threat objects.” [Emphasis mine.]

For the moment, this chorus of official recommendations are not yet requirements, but that is about to change. The Joint Commission is said to be implementing a new risk-management requirement for accredited facilities which will demand that Joint Commission accredited facilities perform their own risk analysis using, as one of the criteria, the Joint Commission’s own Sentinel Event Alerts. Accredited MRI providers will need to demonstrate how it is that they provide quality-control review and redundancy of their MRI screenings.

The ACR’s MR Accreditation Committee is also entertaining a formal request to incorporate safety provisions of the ACR’s Guidance Document as a part of ACR MR Accreditation. Both the form and timeline of any changes in ACR accreditation are, as yet, unknown, but the current chair of the MR Accreditation Committee, Dr. A. Joseph Borelli, believes strongly in the principles of the Guidance Document.

So if the decision to embrace ferromagnetic detection or postpone it is influenced by what the regulatory / accrediting bodies think of it, the message is quite clear… ferromagnetic detection helps make a positive impact on patient safety and its use, at least among these four agencies, is universally called for.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com