By Tobias Gilk
[Editorial: There’s no shortage of people who like to use California as their ‘state punching bag’ of choice… this is not that. I want to -prospectively- state that California is the subject of this article only because I’ve had the opportunity to learn far more about its regulatory oversight of MRI as a result of quite a number of MRI accidents that have happened there in the past months / years of which I’ve been made aware. Consider that it’s very likely that whatever I write about California, below, is probably also true about the other 49 US States.]
In February of 2023 the MRI world was captivated and horrified by the story of an ICU bed accident in which a nurse was trapped between an ICU bed and the MRI scanner that was attracting it with super-human strength. Within a few days of the accident I had an image and a general description provided to me by the grapevine.
Probably about a week or two after the accident it occurred to me that there would have to be an investigation by the California Department of Public Health (CDPH), the state body that licenses hospitals and healthcare providers. I called up the corresponding district office with jurisdiction over the hospital and asked person-after-person ‘how do I get a copy of the report on the injury MRI accident, once the report is complete?’
Over and over again, I was transferred to different people, each of whom asked me to confirm the description I’d given the prior person, and then asked me a few more details, and then asked me to re-confirm details I’d already confirmed. After about the third person I got the strong sense that this was absolutely the first time that anyone in CDPH had heard of this accident! (Which, if true, would mean that the hospital didn’t report it directly to CDPH! 
)
CDPH did begin an investigation, classifying this accident as one that represents “immediate jeopardy” to patients / workers (the highest level of concern). But because the hospital in question was also a participant in federal insurance payments from Medicare, Medicaid, and Tricare, CDPH informed Center for Medicare Medicaid Services (CMS, the administrators of those insurance programs) about the concern because they have safety-related conditions of participation in order for providers to remain eligible for payment. At this point, CMS essentially ‘took over’ the investigation into the MRI safety shortcomings of the hospital.
To be clear, CMS’s rules are the minimum requirements to be eligible to participate in the federal insurance payment programs. CDPH’s rules are to make sure that healthcare providers that are licensed by the state are taking appropriate minimum actions to protect the citizens of the state. That distinction becomes important in a minute.
Ultimately, CMS produced a report, called ‘Statement of Deficiencies / Plan of Correction,’ or CMS-2567 for short. That report identified the different CMS standards for payment eligibility that the hospital had violated, on one side, and the accepted corrective actions that were described / promised by the hospital, on the other. CDPH provided me with a copy of the completed report, once it was finished.
In an overlapping timeline, because this was a workplace injury accident, there was another state-federal collaboration, in the form of Cal/OSHA, that conducted a separate investigation into workplace safety. The findings of the CMS-2567 and the Cal/OSHA report had some overlap, but each also had a lot of unique material. Together they give a good portrayal of the accident and the circumstances that allowed it to happen.
But one significant difference between the two investigations and reports was that I learned that there was an $18,000 fine from the Cal/OSHA investigation, but I hadn’t been told anything about a fine -or any other administrative action, like increased state inspections, or ‘consent decree’ types of corrective actions- from CDPH.
I reached back out to CDPH, asking about what State-level administrative actions were taken by them, the licensing authority? The answer I got back was effectively, ‘well, we just turned it over to CMS and they did everything.’
In January of 2024 I learned of a new MRI accident in the state of California (literally only a few miles from the location of the ICU bed accident), a wheelchair that was drawn to the mouth of an MRI in an outpatient imaging center:
I started again with this accident as I had with the ICU bed accident, asking the CDPH about how I could get a copy of their report once it was concluded. CDPH looked up the facility and informed me that, as an outpatient facility, they didn’t have to be licensed by CDPH… that this site had exercised an option to be regulated by the Medical Board of California (MBC). So I called MBC to ask them the same question, ‘how do I get a copy of their investigation into this MRI accident?’
MBC responded by asking me the name of the physician who caused the accident.
ME: “I’d be surprised if a physician was even in the radiology department… I don’t think that this was directly caused by a physician.”
MBC: “Then MBC can’t help you. By statute, MBC can only regulate licensed physicians who are registered with us.”
ME: “But if the facility has a radiology service where patient care is administered by technologists, are you saying that nobody regulates that care?”
MBC: “We don’t know if anyone else does or doesn’t. We only know that we only regulate the direct conduct of physicians. Have you tried the Radiation Protection Branch of CDPH? They might have statewide statutes on radiology / MRI safety…”
So I reached out to CDPH’s specialty bureau, the Radiation Protection Branch, to ask about MRI safety state standards. I wound up getting bounced around several people in RPB, until I finally got a return message that informed me that RPB only managed ionizing radiation risks (found in X-ray, CT scans, and nuclear medicine), not MRI. When I asked who -within CDPH- did oversee MRI, I got the verbal equivalent of 
, ‘perhaps try CDPH Licensing and Certification,’ (where I had begun this particular journey).
I reached out asking about CDPH state standards for MRI safety… nobody returned my messages.
Thinking my dead-end in having asked about administrative actions (ICU bed accident) and minimum MRI safety standards (wheelchair accident) might be related, I made a public records request for all state licensure standards for MRI safety. California actually has a very robust (and helpful) public records law (similar to the federal Freedom of Information Act).
My worst fears were realized when I got the response to my public records request. There were no specific mentions of MRI or MRI safety anywhere in the California healthcare licensing statutes! Not only is MRI not specifically mentioned in ‘radiological services’ definition in the state administrative code, the only non-ionizing modalities mentioned individually are thermography and ultrasound, and the statute includes no umbrella language that might include any other non-ionizing imaging.
I now suspect that the stonewalling I was on the receiving-end of for both my ‘administrative action’ question, and my question about ‘MRI state licensure standards’ both stem from the fact that the State of California Administrative Code doesn’t even acknowledge, much less regulate, MRI and MRI safety! So with respect to MRI safety of patients in California, the state licensing requirements have a hole large enough to drive a truck through… or at least an ICU bed, a ventilator, and an assortment of wheelchairs (see pictures below).
If correct, this means that CDPH’s referral to CMS is the only way that anyone in the state can have MRI safety incidents looked at. It appears that CDPH may be effectively banned from directly acting in the interests of the people of the State of California when it comes to identifying and correcting MRI safety issues that occur in the licensed healthcare providers in the state, if they’re only permitted to act in response to the California Administrative Code’s ‘black letter’ text.
And lest you think that it was only the one or two accidents, below is a collection of several MRI accidents (some involving injuries, one resulting in a fatality) that I know occurred within the State of California…
You can read and comment on the LinkedIn version of this at https://www.linkedin.com/
