Description:
California investigated the Redwood City MRI accident… So where is the state’s report—and what authority did it have to investigate in the first place?

After an ICU nurse was crushed between a hospital bed and an MRI scanner, investigators from the California Department of Public Health examined what happened and documented serious safety failures on behalf of the federal government. But when The Invisible Force went looking for California’s own investigation and enforcement action, the answers became increasingly difficult to reconcile.

Requests for the state’s report produced the federal CMS report. Public-records requests produced exemptions for investigative files. And CDPH has separately maintained that the California laws it identified do not give it jurisdiction over MRI safety.

In Episode 5, John Posh and Tobias Gilk follow the paper trail to ask a deceptively simple question: When a catastrophic MRI accident happens in a California hospital, who is responsible for enforcing MRI safety?

The answer leads from the state health department to the next potential layer of oversight: hospital accreditation.


Show Notes:
California Department of Public Health (CDPH) Public Records Request Page
California Department of Public Health (CDPH) Citizen Petition Page
California Department of Public Health (CDPH) State Enforcement Actions Page
California Department of Public Health (CDPH) State Enforcement Actions Dashboard Page


Transcript:
“Dear sir or madam, I am writing to request a copy of the CDPH investigation report into the near-fatal MRI accident at Redwood City Hospital in February. Please send a copy of the state’s report at your earliest convenience. Thank you.”

“Dear Mr. Gilk, Attached, please find a copy of the report from the California Department of Public Health on this accident.”

“Oh, excellent. What did we? Wait, this is the CMS report.”

“Thank you for the file you sent. However, my request was for the CDPH report. The document you sent was the CMS report. Please send a copy of the state’s report at your earliest convenience.”

“Thank you. Dear Mr. Gilk, Apologies for any confusion. Attached, please find a copy of the report prepared by the California Department of Public Health staff on this accident.”

“All right, what the hell? This is the CMS report, again!”

“Thank you for the second file you sent. However, you again sent CMS report. Please send a copy of the underlined bold states report at your earliest convenience.”

“Thank you. Dear Mr. Gilk, attach please find the only report prepared by the California Department of Public Health for this accident.”

“[Growl]. Again, why are they sending me the CMS report and not the states report?”

Hello, and welcome back to the Invisible Force Podcast. Invisible Force is an investigative documentary podcast about MRI accidents, patient safety failures, health care mysteries, and some of the hidden risks of modern medicine. In this third series, we’re doing a deep dive into an MRI accident in which a nurse was badly injured when she was crushed by an ICU bed. This accident occurred in early 2023 in California, and the ripples from this accident are still with us today. But before we pick up our story from our prior episode, this is a great time to reintroduce you to the co-hosts for our little podcast.

I’m John Posh, an MRI technologist, educator, and longtime advocate of MRI safety practices. I’m also the chief academic officer at one university and adjunct faculty at another. I’ve been teaching MRI safety for over 30 years.

I’m Toby Gilk. I’m a certified MRI safety officer, certified MRI safety expert, an MRI facility architect, safety consultant, and a co-author of a new MRI safety textbook, The Technologist’s MRI Safety Handbook.

In episode three, we had received the CMS report, which detailed 13 pages of identified deficiencies and around 50 pages of Redwood City Hospital’s corrections. In episode four, we got the Cal OSHA report that was comparatively weak on findings but much stronger in terms of supporting documentation. In this episode, we’re going for the trifecta, the third report from the overseeing organization closest to the incident, this one from the California Department of Public Health, or CDPH.

From previous episodes in this series, you’ll remember that, much to our surprise, we were the ones who originally alerted CDPH to this incident about a week after it happened. That original call to CDPH was intended just to secure a place in line to get whatever eventual state report about this incident that came out. After all, as a mandatory reportable event that critically injured a nurse and threatened the safety of an ICU patient, that had to be investigated by the state license authority, right?

Our odyssey with the CDPH continued as we tried, repeatedly, to get copies of the state’s report. As the original complainant, we asked about what happened at the state level as a result of our complaint, and CDPH sent us the CMS report.

So we submitted a separate request, this time not as the complainant, but just as a member of the public. We asked for a copy of the state’s report. Maybe, maybe, as a member of the public, they might be more responsive to give us a different answer. Low and behold, after a few weeks, CDPH sent us the CMS report again.

Then we went back to them a third time. This time, we said, you’ve previously provided us with the CMS report twice now, but what we really want now is the state’s report.

Because of course they must have taken some action, right? Redwood City Hospital was licensed by the CDPH. There was a horrible accident that very nearly killed a nurse. The hospital apparently didn’t comply with the law requiring them to report the incident directly to the state. Even if the state didn’t have any enforceable MRI safety requirements, that’s more foreshadowing, by the way, we figured that the fact that the nurse was badly injured, that surely went against some general CDPH be safe blanket requirement. That, plus the fact that the hospital failed to meet the statutory, mandatory reporting timeline for the incident, there just had to be something from CDPH in response to this event.

Eventually, CDPH got back to us on our third request. We were excited to finally be getting the information on the department’s formal response to the accident, even if it wasn’t a report like CMS or the Cal OSHA reports. We had braced ourselves to expect less than the other two reports. But even CDPH didn’t take any enforcement actions. Surely, there’d be at least a letter to the hospital that said something to the effect of, be more careful in the future. Eventually, we got the response, except that it turned out that CDPH had only just sent us the CMS report again.

Sending us the wrong report on our first request? Okay, sure. Easy mistake. Sending us the wrong report a second time? Well, we did request it through a different channel, so maybe it was just the same mistake made by two different people. But sending us the wrong report a third time? When we explicitly said, don’t send us the CMS report, there had to be something going on here.

So we thought we’d ask something that perhaps we should have asked at the very beginning. Is there a CDPH report or finding or memo or anything related to this accident or the hospital’s failure to report it with respect to the state licensing requirements? CDH personnel had investigated on behalf of CMS, yes, but that wasn’t a CDPH investigation. What we still hadn’t found was a separate state license report or evidence that CDPH had taken any state administrative enforcement action over either the MRI accident itself or the hospital’s reporting failure. Turns out that CDPH has never identified or produced a separate state investigation report.

And that’s when our questions changed. We stopped asking, where is the state report? And we started asking, what did the state actually do? Why when CMS was threatening to kick the hospital out of their reimbursement program? And why when Cal-OSHA fined the hospital $18,000 for dangerous practices that put employees at risk? Why did those findings apparently produce federal consequences, but no identifiable state hospital license consequences? That simple seeming question has sent us down the most convoluted bureaucratic rabbit hole that we’re still exploring and mapping.

The state of California has their own state version of the Freedom of Information Act, called the California Public Records Act or CPRA. We submitted a CPRA request for information about any state investigations in the incident, their findings, as well as any considerations of administrative or enforcement acts taken by CDPH in response to this accident.

For those of you who are with us for our first series on that fatal MRI accident last year in New York, you may remember that there are sometimes exemptions to public record laws, specific circumstances under which the state doesn’t have to turn over the requested documents. Well, there’s an exemption in the California Public Records Act called the Investigatory File Exemption. It allows state agencies to withhold certain records that pertain to criminal or civil or license investigations.

That makes sense. You shouldn’t be able to get copies of crucial evidence during criminal investigation through a public records request.

Yes, but the text of that exemption has been widely construed by the courts to cover not only that, but also any sort of state license investigation.

Including hospital licenses? So records from a hospital licensing investigation can potentially fall under the exemption?

Yes, and CDPH has invoked that exemption in some of the responses to our request for records concerning this accident.

Okay, I can understand that there may be parts of an investigation that aren’t public, but the final state enforcement actions are public, right?

They are, in fact. CDPH has an entire online state enforcement actions dashboard that everyone has access to. They say it provides access to state enforcement actions going all the way back to July of 1998.

So, what does it show for Kaiser Redwood City?

We checked, and nothing.

Nothing at all about the accident?

More than that, Kaiser Foundation Hospital, Redwood City, the hospital’s official name in the CDPH records, it isn’t even among the facilities listed in the dashboard.

Not at all?

Not at all. We checked every Kaiser Foundation hospital in the facility list. None of them was Redwood City, or appeared to be a different name for the Redwood City Hospital. We searched for any hospital listed under Kaiser or under Redwood City. Nothing. And we checked CDPH’s downloadable enforcement data, too. That data set runs all the way up to June of 2024. We couldn’t find Kaiser Foundation Hospital Redwood City there either. Now, that doesn’t prove that no state administrative action of any kind exists somewhere outside of the database. But CDPH’s own public enforcement system, it doesn’t identify anything.

So not only can we not find a state enforcement action over the MRI accident…

Right.

but you can’t find one over the hospital’s failure to report the accident either.

Correct. And that reporting requirement is important because it doesn’t depend on whether CDPH believes that it had any jurisdiction over MRI safety.

So if we can’t identify any state enforcement action, why are the investigative records exempt?

That was the question. And the public records requests weren’t giving us any answers. So we started looking for another way to ask CDPH, one where they would actually have to tell us why.

The sponsor of Invisible Force Podcast is CAIREreporting.org. That’s CAIRE spelled C A I R E. CAIREreporting.org is a confidential MRI adverse incident reporting system, available to us, the public, as well as offering an enterprise level solution to hospitals and imaging centers for secure and confidential reporting of MRI incidents, accidents, and near misses.If you have direct knowledge of an MRI accident that may have been swept under the rug, or if you want information about how CAIRE could be set up as a private internal error reporting tool for your hospital or imaging center, CAIREreporting.org can help you with both of those. CAIRE has assembled a panel of international experts in MRI safety and accidents. Reports submitted either through the public website or through an enterprise level system get reviewed by their experts who then deliver insights into the contributing causes of how accidents or near miss events happened and, more importantly, steps that could prevent similar accidents in the future. For more information, please visit CAIREreporting.org. That’s CAIRE spelled C A I R E.

In the first half of this episode, we shared how we repeatedly asked for the California Department of Public Health state level report on the accident, and how repeatedly, instead of giving us the state report, the state gave us the CMS report. Eventually, we still had no separate state investigative report, and no identifiable state enforcement action. When we used the Public Records Act to ask for records concerning the state’s investigation and possible enforcement, CDPH invoked an investigatory files exemption for some of the materials we’d asked for.

If you learned nothing else about the two of us by this point, you should know that when there’s a story like this, we’re like a dog with a bone, unrelenting. The public records route had taken us about as far as it could, so we started looking for another way to get at the question.

One of the limitations of public records requests is that the state is only required to provide you with existing records in response to your request. So if we wanted to know why, and there wasn’t a document about why, the CDPH could come back with no response of documents.

But we discovered a different mechanism. A citizen petition. You can formally petition a California agency to adopt or change a regulation. And if the agency denies the petition, it has to explain why.

So we submitted a citizen petition that said the CDPH should create rules for licensed hospitals with respect to point of care safety. Very quickly we got a response denying our petition. But this time we had a why to inform us.

The upshot of the denial of our petition is that despite the fact that the state defines radiology services as including ultrasound and MRI and thermography, CDPH asserts that the authority to regulate radiology modalities can only come from the state’s radiation control law, which regulates radioactive materials and equipment that generates ionizing radiation, or the state’s Radiologic Technology Act, which regulates minimum credentials for health care workers who work with ionizing radiation materials or devices. Because MRI doesn’t use ionizing radiation and falls outside of the radiation control law and the Radiologic Technology Act, CDPH claims it has no jurisdiction over MRI. It’s important to note that CDPH response didn’t include any supporting legislation or policy or rules, only their statement that it was outside their jurisdiction.

Now, this is weird and inconsistent, both because MRI is identified as an included modality in one of the state’s definitions of radiologic services, but also because the state actively regulates the qualifications of ultrasonographers for prenatal screening ultrasounds. If the state has no authority over non-ionizing modalities, why include them in the definitions? And why do they regulate ultrasound providers? We ask about both of these conflicts through the public records requests. CDPH did point us to legislation underlying its authority concerning prenatal ultrasonography. What it did not produce were records explaining how that ultrasound authority fits with its assertion that they can’t regulate MRI because it falls outside the Radiation Control Law and Radiology Technology Act.

In response to our various public records requests, CDPH did give us a copy of one of its own policy documents, 2900.4.1, its guidelines for inspection of public records policy. And that’s where we hit on another puzzle. In discussing the investigatory file exemption, the same exemption CDPH has repeatedly invoked in order to not provide us the records we’ve asked for, the department’s own policy says they only get to use this exemption when the prospect of enforcement is substantial.

Wait, substantial prospect of enforcement?

That’s what the policy says.

But we already looked for the enforcement.

Exactly.

And Redwood City isn’t even in the CDPH’s enforcement database?

Which left us with a pretty obvious question. What enforcement was actually contemplated here? Was it state enforcement involving the hospital’s license? Or are they referencing federal enforcement on behalf of CMS? Or something unrelated to MRI safety? We’ve asked CDPH for the records that would explain that. And to date, we still haven’t gotten an answer that resolves that question.

So, we asked CDPH directly, if you say your state regulatory authority doesn’t extend to MRI safety, and your own policy ties this exemption to a substantial prospect of enforcement, what enforcement prospect justified withholding these records from us?

For some parts of our request, CDPH said that it had no responsive public records. For other potentially responsive material, they then invoked attorney-client privilege or attorney-work product protections.

That doesn’t sound like it answered the question, did it?

No, it did not.

Do we know what the substantial prospect of enforcement was that they relied this statement on?

We asked, but no, they’ve not explained that. And that’s where things still stand.

And all of this prompted yet another question. Is MRI unique, or are there other hospital services that patients assume the state reviews for minimum safety standards, but doesn’t?

We asked CDPH whether it had identified other hospital services with comparable jurisdictional gaps. So far, the public records responses haven’t answered that question either.

Let’s bring this full circle. All of this began with the California Department of Public Health when we called just a week after the accident, asking to get a copy of the eventual state report. CMS investigated it and found the situation so concerning that the hospital was threatened with expulsion. CalOSHA ran a parallel investigation, cited the hospital and fined them $18,000. In the California Department of Public Health, the Hospital Licensing Authority for the State, CDPH has taken the position that it lacks state regulatory jurisdiction over MRI safety.

And despite all of that, we still can’t identify any state enforcement action against Kaiser Foundation Hospital, Redwood City, in CDPH’s own public enforcement data. Not for the MRI accident, which I suppose would make sense if CDPH says they don’t really have jurisdiction, but not for the hospital’s failure to report the accident either.

Now, CDPH hasn’t told us that hospital accreditation is the answer to this apparent regulatory gap, but Redwood City Hospital was accredited, and its accreditation organization did have MRI safety requirements that applied to the hospital.

So, if California State Hospital licensure wasn’t providing the minimum MRI-specific safety requirements, there’s another obvious question. Was hospital accreditation supposed to be the safety net that caught what state hospital licensure didn’t?

“Dear sir or madam, I am writing to request a copy of the CDPH investigation report into the near-fatal MRI accident at Redwood City Hospital in February. Please send a copy of the state’s report at your earliest convenience. Thank you.”

“Dear Mr. Gilk, Attached, please find a copy of the report from the California Department of Public Health on this accident.”

“Oh, excellent. What did we? Wait, this is the CMS report.”

“Thank you for the file you sent. However, my request was for the CDPH report. The document you sent was the CMS report. Please send a copy of the state’s report at your earliest convenience.”

“Thank you. Dear Mr. Gilk, Apologies for any confusion. Attached, please find a copy of the report prepared by the California Department of Public Health staff on this accident.”

“All right, what the hell? This is the CMS report, again!”

“Thank you for the second file you sent. However, you again sent CMS report. Please send a copy of the underlined bold states report at your earliest convenience.”

“Thank you. Dear Mr. Gilk, attach please find the only report prepared by the California Department of Public Health for this accident.”

“[Growl]. Again, why are they sending me the CMS report and not the states report?”

In our next episode, we’ll look at the Joint Commission and the hospital accreditation. What MRI safety requirements applied to Redwood City? What did accreditation actually evaluate? And did any of those systems identify weaknesses that CMS and Cal-OSHA found only after a nurse was nearly killed?

For this week’s show, our sources were repeated communication, public records requests, and the citizen petition responses, and the disclosures such as they were from the California Department of Public Health. Our opening radio play, well, that recreated my repeated and frustrating communications with the California Department of Public Health, trying to get a copy of the state’s investigative report.

If you have any information about this incident or any MRI accidents, please reach out to us through our website, invisibleforcepodcast.com. Episodes, show notes and a tip line contact page are always available there. Also, you can leave us a voicemail with information about this accident or any MRI accident at 631-MRI-TIPS. The number again is 631-MRI-TIPS or 631-674-8477.

If you work in hospital safety or state health regulation or CMS or healthcare policy or MRI and something in this story doesn’t make sense to you, we’d like to hear from you.

Lastly, we’d like to ask you to like and share our podcast with your friends, colleagues and coworkers. With your help, we’ll unravel MRI accident mysteries and with a little bit of luck, we can help make sure that accidents like this don’t ever occur again.

Podcast also available on PocketCasts, SoundCloud, Spotify, Google Podcasts, Apple Podcasts, and RSS.

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The Podcast

Join co-hosts John Posh and Tobias Gilk who together have about 60-years of MRI and MRI safety experience between them (boy that makes them sound old) for a podcast about MRI accidents and how we can protect ourselves (and those we love) from preventable accidents in MRI.

About the podcast