By now, you have likely heard about former Vanderbilt nurse Radonda Vaught and her criminal trial which concluded in a guilty verdict earlier this week.
If you are a nurse or other healthcare worker, I’m also betting you have some feelings about this outcome - or even the trial itself. I would like to first and foremost acknowledge that this case is concluding at an incredibly emotionally charged time for nurses, in the midst of a pandemic and exacerbated staffing shortages. If you don’t want to dig into this topic right now, I fully respect your decision and wish you lots of rest and peace. Read no further.
Folks still reading, know that I am not impartial to this event. I am an Emergency Department nurse turned ED nurse leader. This case feels too close for comfort from a practicing nurse perspective and an operational leader perspective. From a Systems Nurse perspective, this is a case study I can’t ignore.
Because change starts with us, it’s important to acknowledge how our reactions and perspectives towards this case WILL be deeply informed by our experience as nurses - in the context of 2022. This does not invalidate our perspective. Our perspective is valuable and holds power. That being said, for the purpose of this blog post, I have reflected on how my positionality may influence my delivery of the following information (as described above). I invite you to do the same.
Today, I offer you information from two primary sources and one secondary source. The secondary source is a timeline of events from The Tennessean, a daily newspaper and website that covers Tennessee news. The article offers a reliable summary and order of events in this complex case. If you are new to this case, I recommend starting there. (God bless journalists.)
My contribution to this conversation is my summary and analysis of the intake form from the CMS Anonymous Complaint as well as the federal investigation report from CMS stating its findings, alongside Vanderbilt’s corrective action plan.
Up until last month, I was an assistant nurse manager in an ER and was responsible for daily evaluation of safety reports. I share this because in an informal poll in my Instagram story yesterday, only 18% of over 100 nurses reported that they had a solid understanding of the safety event review process in their organization. When nurses - the very people filling out these safety event reports - don’t understand where these reports go and what happens next, how can we ensure the process is working effectively? Let me break it down.
The vast majority of hospitals have an online reporting tool where any staff member can report safety events, from ‘near miss’ non-events to sentinel events resulting in permanent harm or death. The purposes of this tool are to track and promptly respond to safety events, by providing coaching or additional training to staff and by identifying opportunities to address system failures. (After all, early systems thinker W. Edward Demings warned us that 94% of the outcomes we experience in our workplaces, good or bad, are the result of systems, not people.)
When safety reports are submitted, they are typically reviewed by a frontline operational leader (like a nurse manager) as well as members of the quality and/or risk management teams. These safety events are then assigned a severity rating, based on the level of harm that came to the patient (or visitor or employee). Depending on an event’s severity, the hospital may have a policy around how the event must be investigated internally. Additionally, the state and federal healthcare regulatory bodies (the state Department of Health and the Centers for Medicaid and Medicare Services) have legal guidelines around which type and severity of safety events that hospitals must report to them.
In this case, the Vanderbilt Health System had a patient die due to a medication error in their facility and did not report it to the Department of Health. Now, sometimes a safety event rating is not clear; it requires multiple clinical experts with the support of quality and risk management professionals to accurately determine whether or not an event is reportable. However, patient death related to a KNOWN medication error involving a paralytic being administered without mechanical ventilation support that immediately resulted in a code….is as clear cut as they come.
CMS and the Tennessee Department of Health did not become aware of this case until TEN months after its occurrence, thanks to an anonymous complaint that was filed by (presumably) a Vanderbilt clinician. This complaint prompted an unannounced survey by CMS, wherein regulatory officials reported to the hospital and conducted a 9-day investigation of the complaint from 10/31/18-11/8/18.
What follows are the key deviations that CMS found in their investigation.
Vanderbilt “failed to ensure…staff followed standards of practice and utilized their nursing skills and training to ensure the correct medications were administered to all patients” (p 2). This refers to the fact that the RN retrieved, reconstituted, and administered the wrong medication to a patient without completing the 5 rights of medication administration or documenting the medication appropriately, to name a few deviations.
Vanderbilt “failed to ensure patients were free from neglect” (p 2). This refers to the fact that the RN gave what she believed to be Versed (midazolam) intravenously and did not stay to monitor the patient for any adverse events. Instead, the patient was left unmonitored except for a camera in the radiology suite for what witnesses approximate to be about 30 minutes. It was when a transporter came to take the patient back to the unit post-scan that they noticed she was not breathing, started CPR, and called a rapid response (an in-hospital emergency resuscitation code) (p. 21).
Vanderbilt’s High Alert Medications Policy “had no documentation…detailing any procedure or guidance regarding the manner and frequency of monitoring patients during and after medications were administered” (p. 3). Vecuronium AND Versed were listed as HA medications. Policies are often investigated by regulatory bodies in these instances, as they set expectations and guide professional practice within the organization.
There was no documentation in the patient’s chart of Versed OR Vecuronium having been administered on 12/26/17. Immediately post-event, the administering RN was unable to recall how much of the medication she had given the patient. When the CMS surveyor asked the RN if she had documented the Vecuronium administration in the patient’s MAR, the RN stated, “I did not. I spoke with [my nurse manager] and [they] told me the new system would capture it on the MAR. I asked and [they said] it would show up in a special area in a different color” (p. 11). The leftover vial and syringe were examined the day of the event and nearly a year later during the CMS investigation, but the contents (whether medication or saline flush) were unclear.
“The hospital failed to ensure patients were free from all forms of abuse when a Critical Care RN neglected to administer medication as ordered…and failed to monitor for any untoward effects” (p 14).
High-risk medications (like Vecuronium) were available for nurses to override from the automatic medication dispenser (AMD) despite evidence from national medication safety experts that this is a potential safety risk (p 3-5).
“The hospital failed to ensure all physicians followed policies, and rules and regulations for reporting unusual and unexpected deaths to the County Medical Examiner.” (p 38). In the event of a death that may have been caused by a medication error, it is “the responsibility of the physician completing the Report of Death…to notify the Davidson County ME when a death falls within any of the categories described above. In the case of uncertainty of the need to report a death, the ME is consulted regarding whether or not the death is reportable. The ME makes the final determination of case acceptance for examination.” (p. 39) In the CMS interview with a member of the Medical Examiner’s office, the physician stated that they received information that the patient had died of an intracerebral bleed and reported, “We released jurisdiction because there was an MRI that confirmed the bleed” (p. 46). According to the ME, the Vanderbilt physician who provided this information did apparently report to the ME’s office that there may have been a medication error but said, “That was hearsay, nothing has been documented” (p. 46). The ME also reports the name of the medication given in error was not disclosed to them.
“The hospital failed to report this incident to the Tennessee Department of Health as mandated.” According to the Health Data Reporting Act of 2022, hospitals have 7 days from the date the incident is identified to report to the Department of Health” (p 17). We can be certain that Vanderbilt knew of the medication error because the administering RN reported the event on the date of its occurrence to the healthcare team and her nurse manager, and she submitted a safety report. Radonda also reports speaking with Risk Management multiple times in the days following the event, which healthcare leaders corroborated. Vanderbilt hospital leaders reported to CMS that an internal Event Analysis had been completed post-event. There is no reason stated in the CMS report why Vanderbilt did not report to the Department of Health.
Vanderbilt received notice of these CMS findings in November of 2018 and was tasked with developing a corrective action plan to address these gaps. If Vanderbilt did not offer a satisfactory plan, CMS threatened to suspend their Medicare reimbursements, which would be a significant financial hit for the organization. Vanderbilt developed the plan which they submitted to CMS but declined to release it to the public. However, the Tennessean later retrieved it through a public records request.
In this plan, Vanderbilt listed many policy and process changes that they stated would be put into place by November or December of 2018 (depending on the action item). Of note, the time between the CMS survey conclusion and Vandy’s latest change implementation deadline was less than one month. I do not know if CMS gave Vandy a deadline by which they had to implement changes. Objectively, these are significant changes to implement across a large medical center in just a few weeks. To my knowledge, we have no way of verifying if Vanderbilt fully implemented these plans or met the proposed timelines. Typically, CMS monitors an organization’s progress, but I do not know to what extent or for how long.
Below are the key action items Vanderbilt developed in response to the CMS survey findings.
Nursing Policy Review
Reviewed existing policies and procedures and updated for consistency and clarity including the Transport Policy, High Alert Medication Policy, and Medication Administration Policy.
Such updates included increased patient monitoring, standardized clinical handoffs, thorough medication checks, and EHR documentation expectations.
All nursing staff including leaders, paramedics, and RTs received mandatory online education about updated policy changes.
CNO to audit 5 charts from each unit per week for a total of 3 months for nursing compliance with the updated Med Admin, Transport, and High Alert Med policies.
If inconsistencies or concerns, CNO to follow up with the unit manager to discuss further training needs.
Will report audit results on monthly basis to VU Nursing Quality Committee.
Reviewed their Moderate Sedation SOP (Standards of Practice) and determined it was thorough and did not require updates.
Reviewed and updated all Resource Nurse Scope of Care documents for clarity, including the ‘Help-All Nurse’ (Vaught’s role on the day of then error)
Reviewed policies and procedures around Paralytic administration
All references in policy and procedures to paralytic agents have been changed to “Paralyzing Agents” for clarity and consistency. (rather than ‘Neuromuscular Blocking Agent’)
Paralytic Medication Management Changes
Interdisciplinary hospital workgroup convened to review Paralytic Agents present on override medication list. Determined to remove Vecuronium, but did keep Rocuronium as clinical benefit outweighed potential risk
Paralytic agents on override med list are to be reviewed annually
Both EHR and Automated Dispensing Machine (ADM) will now display “PARALYZING AGENT [medication name]”
To override the dispensation of a paralyzing agent, nurses must now type in “PARA" instead of the drug name. The 4 paralytics in the system are the only names that will pop up in a search for “PARA”.
Warning to pop-up in EHR and ADM: “WARNING: PARALYZING AGENT - Causes Respiratory Arrest - Patient Must Be Ventilated” for all paralyzing agents
Shrink wrap packaging was added to all vials of paralyzing agents.
Pharmacy leadership to monitor packaging compliance for a minimum of 3 consecutive months of 100% compliance.
All paralytic medication administrations will require an independent double check of 2 licensed RNs. This will be prompted by the EHR.
All Vanderbilt nurses and paramedics were required to complete online training about paralyzing agent administration changes, as listed above.
Monthly auditing of medication override reports (of [paralyzing agents) x3 months.
Audits will then be monitored ‘periodically’ by the system Medical Safety Officer as part of ongoing safety work.
CNOs to monitor all paralytic administration’s independent double checks on a monthly basis for no fewer than 3 consecutive months of 100% compliance.
Medication Safety Training for Nurses
Implemented mandatory Safe Medication Administration online training for all new hire nurses
New grad nurses (<6 months experience) must also attend a medication safety workshop
Implemented additional medication safety training for all nurses on annual basis
Safety Event Review + Reporting Changes
Reviewed its Occurrence Reporting policy (who needs to report what when errors happen).
Existing policy stated requirements to report certain events either via electronic safety reporting tool OR via phone call to Risk Management. Policy places responsibility for reporting safety events to regulatory bodies with the Risk Management office.
Revised the policy post-review to state that Risk Management is now required to report any incidents of “abuse, neglect, or misappropriation”, strike by staff, external disaster affecting facility, any disruption of vital service, or fires that disrupt care of cause harm that they receive to the Tennessee Department of Health. Unclear to me what the prior policy outlined.
The Hospital's Event Review Committee already met weekly pre-survey, but they since added “regular evaluations” of reportable events to the weekly agenda.
The Senior VP of Quality + Risk to oversee these new requirements. The hospital also stated they were working to receive additional guidance from the Department of Health on reportable event requirements.
Hospital reviewed its current process for analysis of ‘critical adverse events’.
It was as follows:
Staff enters online safety report
All reports are analyzed by Risk Management, Quality, and operational leadership (nurse managers)
May be escalated to Event Review Committee for further discussion, if appropriate
Clinical review with committee to determine if there were any deviations resulting in harm
If yes, Serious Safety Event team (CEO, CNO, COO, Risk Management, and others as needed) review the case.
If confirmed by team, a SSE alert goes out to leadership across the health system.
SSE investigation occurs (participating parties dependent on case but include those directly involved)
Develop an Action Plan which is distributed to relevant leaders and departments for implementation
All SSEs and their action plans are presented to the hospital executive team for awareness on a monthly basis.
The hospital made no changes to the critical adverse event process. The Senior VP of Quality, Safety, and Risk to ‘closely oversee.’
Medical Examiner Policy Changes
Updated their Medical Examiner policy to include more transparency around suspicious death or death related to a possible med error be included in reports sent to ME.
All conversations with ME must also now be documented in the health record.
Added new training for house staff and attending physicians around new ME policy and requirements.
Implemented new monitoring procedures involving random audits of ME cases for compliance.
Phew, that was a lot - which ultimately, is a good sign. By using a ‘swiss cheese’ error model, systems can be designed to *nearly* ensure safety by filling as many potential gaps as possible with safety solutions.
In Radonda’s case, independent double-check policies and EHR safety alerts would not have helped prevent the error, as she 1) did not know she was giving a paralytic, and 2) did not scan the medication into the EHR.
However, including the safety alert warning in the automated dispensing machine’s display AND making paralytics only available for selection by searching “PARA” could prevent another nurse from making the same error.
James Reasor, psychology professor and developer of the ‘swiss cheese’ error model, cautioned us: it is far more emotionally satisfying to blame individuals than it is to blame institutions. However, what this CMS survey tells me is that Radonda Vaught’s active failures during her shift were enabled by multiple latent conditions that created an unreliable working environment. The CMS investigation report and Vanderbilt’s own action plan point to the significant gap between the Vanderbilt University Medical Center of 2017-2018 and a true high-reliability organization.
An organization tasked with providing healthcare to its community has a moral obligation to recognize the inevitability of human error and proactively mitigate real and imagined safety risks through continuous change work. As someone who spent the last 13 months in hospital operations, I am the first to admit this quality improvement work is anything but easy. But we do not lower the standard because the work is complex. The standard was certainly not lowered for our nurse colleague Radonda Vaught, who has lost her job, her license, and faces likely prison time for her failures.
From what I understand, further legal repercussions are now off the table for Vanderbilt as they already settled a civil case with the deceased patient’s family outside of court. The details of this settlement are not publicly known. So what does it look like to hold a system accountable outside of a legal system?
Holding ‘the system’ accountable looks like ensuring the system is functioning in the way it is intended to function. In this case, Vanderbilt UMC’s mission is the system's intended function: “Through the exceptional capabilities and caring spirit of its people, Vanderbilt will lead in improving the healthcare of individuals and communities regionally, nationally and internationally.”
A question for you: From what you’ve read about Vanderbilt’s actions post-error, are you confident that this system is meeting its espoused purpose? If not, what would make you more confident?
Personally, while I did find Vanderbilt’s process improvement plans encouraging, I am left with some significant questions.
The 3 main questions that linger:
Has Vanderbilt successfully implemented this action plan? This action plan appears robust. Of course, the action plan is the easy part. It’s the implementation - and sustainment - of changes throughout complex systems that is the true challenge. But I do not have access to the information we’d need to assess how successful Vanderbilt has been with actually changing the processes within their organization.
Why didn’t Vanderbilt report this safety event to CMS in the first place? It seems clearly reportable to me, as it was an error that resulted in death. Hospital leaders admitted during the CMS survey that this was a failure on their part. But the public has not heard an answer on how Vanderbilt’s critical adverse event reporting process resulted in such a miss.
Why wasn’t Vanderbilt penalized by CMS or the TN DoH for failure to report? The Tennessee Board for Licensing Healthcare Facilities is a branch of the TN Department of Health responsible for regulating healthcare facilities. According to their website, “the Board may suspend or revoke licenses for chronic violations of federal or state laws or regulations or for any other practice deemed detrimental to patient health, safety, or welfare.” In February 2019, Vanderbilt executives spoke to the Board about the error and admitted their failure to report the death. I have not found any statements that explain why the Board did not pursue consequences for Vanderbilt.
These are three questions that Vanderbilt’s (and Tennessee’s) patients, healthcare workers, and community members have stake in. You all deserve answers. And the only way we’ll get them is to ask.
Feel your feelings: acknowledge the fear, anger, institutional betrayal. And ALSO acknowledge your individual agency and our collective power.
If you never want a nurse to experience what Radonda has…if you never want a family to experience what Charlene Murphey’s family has… then your goal is to ensure that systems are doing what we intend them to do. And that means thinking in systems.