New tools and standards are designed to lessen risks in the MR suite
The knowledge base for safety in the MRI suite suffers from a number of profound disparities. The types of risks and potential accidents for persons in the MR suite are well known to clinical and technical MR personnel, but the rates at which these accidents occur on a national basis are obscured by profound under-reporting. And though many experienced MR staffers understand the risks, it is likely that the incidental personnel—such as housekeeping, engineering, transport—who may regularly serve the area know little of the breadth of risks to which they may be exposed (or to which they may be exposing others). 2007, however, has already seen the introduction of new tools and standards, which will help improve safety in the MR suite and also may work to narrow the dangerous gaps in our knowledge and promote enhanced standards of care.
Chief among these resources is the new American College of Radiology (ACR) Guidance Document for Safe MR Practices: 2007, which supersedes the two previous ACR safety documents published in 2002 and 2004 under the title of the White Paper on MR Safety. The new document was recently published in the American Journal of Roentgenology (AJR), though, through a special arrangement, the text has been circulating in electronic format since early this spring. Because of the importance of this document and the pressing safety issues it addressed, the ACR and AJR agreed to provide the document on both organizations’ web sites for free download as soon as the final manuscript was accepted for publication.
The arrival of this new document came not a moment too soon as the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database recorded a 140% increase in reported MRI accidents for the 12-month period ending in mid 2006. Though Emanuel Kanal, MD, chair of the ACR’s MR Safety Committee, and other MR safety experts believe that accidents reported to the FDA represent less than 10% of the actual number of incidents that occur (some, including John Gosbee, MD, formerly of the VA’s National Center for Patient Safety, have speculated that reporting of MRI accidents is near 1%), this recent dramatic increase is suspected to be the result of compounding increases in risk more than a significant shift in reporting.
Factors such as increasing magnet strength, greater utilization for emergent/trauma cases, wider patient dependence on medical devices or implants that may be contraindicated for MR exams, larger numbers of sedation/general anesthesia patients, and interventional applications from image-guided biopsies to intraoperative imaging are all perceived to ratchet up the opportunities for mishaps.
These increasing risk factors, perhaps statistically insignificant individually, compound in many facilities, and, when multiplied by the estimated 20,000,000 MRI exams performed annually in the United States alone, can be the source for dramatic increases in rates of accidents. If all of these factors combined to create only 1/100th of 1% likelihood of an MR accident resulting in a serious injury, statistics would suggest that we would see an increase of 2,000 serious MR injuries, some potentially even fatalities, in any given year. For a modality with an unparalleled safety record, this sort of accident frequency would be abhorrent, particularly given the fact that the vast majority of MR accidents are completely avoidable.
At the present time, there are no specific MR safety standards at the site level that are a part of payor credentialing, national provider accreditation programs, or even state or federal regulations. The absence of professional regulations, however, is on the brink of changing.
MR safety issues are currently under scrutiny by groups as varied as the American Society of Anesthesiologists, the committee that writes the building code for hospitals and health care facilities, the VA health care system, The Joint Commission, and the ACR’s Committee on MR Accreditation. These examples highlight the disconnects that have plagued concerted efforts to standardize MR safety issues, namely, the absence of unified professional standards. The ACR’s MR accreditation program, however, has worked to bridge this gap and references ACR’s MR safety guidance as a recommendation for those seeking accreditation. But soon sites seeking MR accreditation from the ACR may face new questions and scrutiny about safety provisions as a part of that process.
A. Joseph Borelli, Jr, MD, chair of the ACR’s Committee on MR Accreditation, indicated that MR safety standards for patients and staff from the Guidance Document are currently before his committee, under consideration to become part of ACR MR site accreditation in the future. Referring to the ACR’s new Guidance Document for Safe MR Practices: 2007, Borelli stated, “I believe we should incorporate these practices to the extent possible and practicable.
“I’d be willing to guess that 90% of facilities’ staff out there aren’t aware of this [safety guidance] document … even ACR-accredited facilities,” Borelli speculated. “One way we’re addressing this is through the current reference to the Guidance Document in the accreditation materials,” he continued. And because specific safety provisions and protocols haven’t been a part of prior accreditation processes, any new safety requirements for accreditation will likely have to be implemented gradually.
The full range of safety principles identified in the ACR’s Guidance Document are under consideration for incorporation as specific components of the ACR’s MR accreditation process. If incorporated as hoped, some safety principles that are relatively straightforward and easy to put in place, such as reporting of accidents and near misses to MR manufacturers and the FDA, may become instant standards. Other principles that may necessitate significant changes to the physical facility may have a different timeline. Over time, Borelli hopes safety principles will migrate from recommendations to enforceable requirements for ACR MR accreditation.
If implemented, there will likely be provisions accommodating existing accredited MR providers. Borelli stated, “If we do move forward, while newly built facilities seeking accreditation will likely have to conform with physical standards, I’d like to see grandfathering or an extended grace period for existing accredited facilities.” Borelli ultimately hopes to see all MR sites conforming to ACR safety guidance. “This is a goal we hope to facilitate through our MR accreditation process,” he said.
While the ACR may be leading the way, many organizations are actively reviewing the guidance and regulation provided for MR safety issues. New standards for facility design and operations are expected in the months and years ahead from governmental and professional organizations.
The message to the profession that MR safety must be more effectively addressed appears to have been received loud and clear and is currently being acted upon. Ultimately, however, the effectiveness of improvements to the safety of patients and staff in the MR environment comes down to the level of the provider. If motivations to carefully review current safety practices and make the indicated corrections weren’t universally present before, soon there will be professional prompts—with growing levels of impetus—for MR providers to conform to current standards of care relative to the safety of their patients.
Tobias Gilk is an imaging consultant for MRI-Planning in Kansas City, Mo, which specializes in MRI and multimodal suite planning. He is also an editor of the MRI Newsletter and a member of the American College of Radiology’s MR Safety Committee.
Get Your Black Belt in ACR MRI Accreditation
By Robert A. Bell, PhD
Some insurance payors have signaled that they will soon restrict MRI reimbursement to only accredited scan providers. For example, United Healthcare announced in January that after March 2008 it will no longer pay for MRI examinations at nonaccredited sites. Proactive groups are ensuring future revenue by verifying their ACR MRI accreditations. This review identifies critical steps to help you avoid some problems others have faced.
Designate a “black belt” for the process. This should be your local expert, someone who will review information on the ACR web site (www.ACR.org), including the FAQs, and undertake the responsibility to complete the application materials. Empower your black belt to make things happen. If you treat accreditation as a low priority, you may have a nasty surprise in your bottom line.
Develop a timeline for accreditation and stay on it. Certain steps in the process can each take 1 to 2 months. It is also advisable to reserve extra time should you initially fail or need to appeal a negative finding. In general, 6 months from application submission to grant of accreditation should be sufficient.
Use qualified and competent help. ACR now requires annual independent testing of all participating MRI systems. These exams are carefully defined in the ACR MRI QC Manual, and reports that do not address all required categories will be rejected by ACR staff. Inadequate physics reports will be returned to the sites for completion, which will delay the entire accreditation process. When contracting for the annual MRI exam, make sure your tester has appropriate experience, can run your MRI without assistance, and will guarantee the report’s thoroughness.
What are some common reasons for denial or delay of accreditation?
Clinical exams that do not meet minimum ACR resolution requirements: In its application materials, ACR includes a table specifying the maximum acceptable slice thickness, gap, and in-plane dimension. For example, in the brain exam ACR requires slice thickness of no more than 5 mm, a gap of not more than 2 mm, and in-plane resolution of no more than 1.2 mm. In the knee, however, these dimensions are 4 mm, 1 mm, and 0.75 mm, respectively. Submitted clinical exams that exceed ACR requirements will result in denial of accreditation in the clinical portion. Check your exams before submitting them.
ACR phantom exams that do not meet minimum standards: Studies done on the ACR phantom must demonstrate minimum ACR technical levels. These are defined in the ACR Phantom Test Guidance document. For example, geometric distortion cannot exceed ±2 mm from the nominal dimension (148 mm or 190 mm). Failures also occur in systems that do not meet minimum image intensity uniformity (IIU) requirements (87.5% for 1.5T and below, 82% for 3T). If you scan the phantom with an eight-channel head coil, consider using your vendor’s image correction software (eg, SCIC for GE, CLEAR for Philips, Prescan Normalize for Siemens) to improve IIU performance.
Inadequate physics assistance: Your MRI scientist or medical physicist (hereafter referred to as MRI physicist) is key to a proper QC program and to ensuring an acceptable annual report. ACR defines 16 criteria that must be addressed annually. When ACR staff checks a report for content, if all 16 are not included, the report is likely to be rejected and accreditation will be delayed. Your MRI physicist also should be an educational resource to ensure your staff understands and is properly conducting the weekly in-house QC testing. Technical questions on the ACR accreditation program should first be addressed to your MRI physicist.
Incomplete quality control records: Your black belt should be thoroughly aware of the technologist section of the ACR MRI QC Manual, which covers the weekly QC, visual checklist, and film densitometry records. Sites applying for the first time should show evidence that they have established their on-site QC program. Sites applying for reaccreditation must have their QC records reviewed and signed off by their MRI physicist and must show that they have been collecting the required information.
When contracting for MRI physics assistance and annual testing, ask a few questions to determine competency. How long has the MRI physicist been testing MRI and how many systems like yours have they done? Does the MRI physicist know how to run the system or do they require your technologist and/or vendor service to be present? Would you trust your car to a mechanic who couldn’t drive? If others are needed to run the system, make sure that your contract specifies that the MRI physicist will pay all costs of these additional personnel (service costs alone can be $400 per hour or more). Additionally, ask for a guarantee that if the physics report is rejected by ACR, your MRI physicist will return and complete it without additional costs to you.
Robert A. Bell, PhD, has provided consulting services in MRI since 1987 and tested more than 900 MRI systems. For more information, contact .