First Healthcare Compliance CONNECT November 2022

CONNECT 

November 2022 

 

A Monthly Publication for the Healthcare Compliance Community 

FAQ: When does OSHA 

prohibit food and beverages 

in the workplace? 

Infographic: Naughty or 

Nice? The Rules of Giving and 

Receiving in Healthcare 

The Legal Risks Behind 

Valuable Health Data Sharing 

Automatic Dispensing 

Cabinets & the Case of 

RaDonda Vaught: Q&A 

5 Key Benefits of Auditing to 

Help Avoid Scary Scenarios 

1st Talk Compliance: 

A Business Associate 

Agreement? Tell Me More!

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In This Issue: 

FAQ: When does OSHA prohibit food and 

beverages in the workplace? 

The Legal Risks Behind Valuable Health Data 

Sharing 

Infographic: Naughty or Nice? The Rules of 

Giving and Receiving in Healthcare 

Automatic Dispensing Cabinets & the Case of 


2 

Panacea Healthcare Solutions LLC © 2022

Compliance Super Ninja 

Jack Crystle 

Manager, Christiana Cosmetic Surgery 

How would you describe your experience with First Healthcare Compliance? 

It has been very good, providing me with the necessary training and also helps me in maintaining employee 

records. 

What do you enjoy most about working with Christiana Cosmetic Surgery? 

My favorite thing about working at Christiana Cosmetic Surgery is having a dependable and loyal staff. 

Would you rather have an unlimited international first class ticket or never have to 

pay for food at restaurants? Why? 

Unlimited international travel. Why? I would prefer to see some countries that we haven’t visited. 

5 Key Benefits of Auditing to Help Avoid Scary 

Scenarios 

1st Talk Compliance: A Business Associate 

Agreement? Tell Me More! 

Contact Toll Free: 888-54-FIRST 3

FAQ Corner 

When does OSHA prohibit food and beverages in the workplace? 

OSHA’s bloodborne pathogens standard, 29 CFR 1910.1030(d)(2)(ix), prohibits the consumption of food and 

beverages in work areas where there is a reasonable likelihood of occupational exposure to blood or other 

potentially infectious material (OPIM) takes place, or where the potential for contamination of work surfaces exists. 

This standard also prohibits storage of food or drink in refrigerators, freezers, shelves, cabinets or on countertops or 

bench tops where blood or OPIM are present. 

OSHA also prohibits consumption of food/beverages in any area exposed to a toxic material under its sanitation 

standard, 29 CFR 1910.141(g)(2). The term toxic material is defined as a “material in concentration or amount... 

which is of such toxicity so as to constitute a recognized hazard that is causing or is likely to cause death or serious 

physical harm.” In determining this, employers will need to review Safety Data Sheets (SDS) for hazardous materials 

in the work area. 

It is important for employers to evaluate the workplace to determine in which locations food or beverages may 

potentially become contaminated and must train and prohibit employees from eating or drinking in such areas. 

Explore the FAQs tab in your compliance solution 

to find answers to your compliance questions! 

CLIENT 

ALERT 

4 


The Legal Risks 

Behind Valuable 

Health Data 

Sharing 

Catherine Short 

Iliana L. Peters, Shareholder at Polsinelli 

PC will lead the complementary webinar, 

“Health Data, A Value Proposition: Legal Risks 

with Innovative Data Sharing Projects” on 

December 13, 2022 at 1 pm ET. Watch as 

Iliana discusses: 

• the scope and 

breadth of data 

sharing projects in 

development in the 

health care sector 

• contractual, state, 

federal, and 

international legal 

obligations for data 

privacy and security 

for such projects 

• issues related to data ownership that may also 

be part of such projects 

These days, data is more valuable than oil. And 

health data is the most valuable of all data! 

Companies of all types should consider the legal 

risk with data valuation, data ownership, and data 

sharing agreements. Data sharing projects take 

many forms and address many important issues, 

including improvements in patient safety, fraud and 

abuse, population health, research, and costs to the 

health care system. That said, the contractual, state, 

federal, and international regulatory requirements 

applicable to such data sharing projects are 

significant. 

Health care entities may be particularly vulnerable to 

legal risk related to data sharing projects involving 

health data. Specifically, health care entities should 

consider contractual obligation, HIPAA, state privacy 

laws, and other requirements, as well as discuss 

risk assessment, data sharing agreements, key 

provisions, and business associate relationships. 

The presentation offers best practices for these 

important issues and projects. Sign up for Iliana’s 

complimentary webinar here and earn valuable 

CEUs! 


6 



Automatic Dispensing 

Cabinets & the Case of 


Catherine Short 

Rachel V. Rose, JD, MBA, principal with Rachel 

V. Rose – Attorney at Law, P.L.L.C., Houston, 

TX, has a unique background, having worked in 

many different facets of healthcare, securities, 

cybersecurity, as well as international law and 

business throughout her career. Her practice 

focuses on a variety of cybersecurity, health care 

and securities law, False Claims Act and Dodd- 

Frank matters and issues related to compliance, 

transactional work, litigation as well as representing 

persons before government agencies. As a member 

of the First Healthcare Compliance Editorial Council, 

Rachel is a frequent presenter at educational events. 

For more information regarding this topic please 

view the related webinar for further discussion and 

learning. 

Below, Rachel answers some common questions 

and provides explanations related to the education 

surrounding Automatic Dispensing Cabinets, Patient 

Care, and the Case of Nurse RaDonda Vaught. 

Can you describe what exactly is an 

Automatic Dispensing Cabinet and what 

does it hold? 

Fundamentally, an Automated Dispensing Cabinet, 

which is also known as an ADC, is essentially 

a drug storage device. It typically electronically 

dispenses medications or different types of scrubs, 

for example, or other items that you may see in 

the operating room or in the emergency room. The 

alleged benefit is to dispense these items in a 

controlled fashion in a way that normally integrates 

with an electronic health record system, or with a 

procurement software within a hospital, that then 

tracks the use and has almost a real-time data so 

that the staff can know when to replace or when a 

supporting traditional unit dose delivery system may 

need to be utilized. 

The other type of dispensing cabinet does not hold 

pharmaceuticals or drugs. Rather, it holds items that 

a nurse or a physician would use during surgery or 

in the emergency room such as sterile suture packs 

or gauze. 

What are some important things to know 

about an ADC? 

Medications are dispensed in a controlled fashion. 

ADCs are not new. In fact, they came in to being in 

the 1980s. And then by the 1990s, their use was 

very prevalent. Having said that, their safety and 

8 


efficacy began to be studied. And the studies that 

came out even 20-30 years ago, are still relevant 

today because of some of the safety and patient 

care issues that were highlighted at that time. For 

example, the mislabeling of drugs, the improperly 

filling of dispensing cabinets, the lack of safety 

record procedures, numbers of doses dispensed, 

and the ability to override system access tracking. 

Today, now more than ever, and especially with the 

advent of the HIPAA Security Rule, which has been 

in effect since 2005, and then we now have the 

HITECH Act, in effect, the HIPAA Omnibus Rule, and 

then we have other laws and the related regulations 

as well, such as the Cybersecurity Act of 2015, 

all of which espouse the requirements of having 

adequate technical, administrative, and physical 

safeguards. 

One of the most fundamental safeguards is user 

ID and unique user password. There should be for 

every individual accessing a cabinet, there needs to 

be an individual user ID and password. Alternatively, 

some types of these devices use a biometric or 

fingerprint. And from there, organizations really 

need to look at two-factor identification. These 

are areas which can create significant liability, not 

only from a cybersecurity standpoint, but more 

importantly, from a patient care standpoint, which is 

one of the issues in the RaDonda Vaught case. 

Tell me about the role of the Automatic 

Dispensing Cabinet and the facts of the 

RaDonda Vaught case? 

What’s interesting is that there was a quote that 

was made by her attorney that said, while it’s not 

all her fault, meaning all his client’s fault, there 

are some real systemic problems with the way a 

medical center dispenses medicine through the 

automated dispensing systems. And so, in this 

case unfortunately, the nurse, the defendant, did 

have personal errors. It wasn’t solely the fault of 

the ADC. However, there were a lack of technical, 

administrative, and physical safeguards, there was 

a lack of check and balance. And that led to Ms. 

Murphy the patient, dying as a result of this error. 

So, our players in this case are Ms. Murphy, the 

deceased patient, RaDonda Vaught, the nurse and 

defendant, Vanderbilt University Medical Center 

(“Medical Center”), the district attorney, who 

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prosecuted the case, CMS, which is the Centers of 

Medicare and Medicaid Services, the Tennessee 

Department of Health, the Tennessee Board of 

Licensing, both for health care facilities and for 

nursing, and then we also have the coroner’s office, 

as well as the Joint Commission. 

Can you tell us the story of what happened? 

RaDonda Vaught was a licensed nurse who began 

working at Vanderbilt University Medical Center 

in 2015. In late 2017, a patient Charlene Murphy, 

who was 75, checked into Vanderbilt with what is 

known as a subdural hematoma. This is essentially 

bleeding in her brain between the various layers 

of the brain. Anytime you have bleeding on the 

brain, this typically requires immediate attention. 

So, having said that, a couple of days later, her 

condition improves and she’s almost ready to be 

discharged from the medical center. As is common 

with this type of condition, a final scan is done in 

the radiology department just to make sure that 

there isn’t any new bleed or that everything is going 

according to plan. Now, it’s not uncommon for a 

patient to be given a sedative such as Versed for a 

closed MRI scan. 

However, the defendant Nurse Vaught accidentally 

gave a dose of vecuronium, which is in fact a 

powerful, paralyzing medication, it is not just a 

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10 


sedative that is given on a regular basis. What 

happened, unfortunately, was that the drug left the 

patient brain dead. Later that day, two neurologists 

from the medical center report the death to the 

Davidson County Medical Examiner. However, 

they did not mention the medication error, or the 

vecuronium. The death was attributed to bleeding in 

her brain and deemed to be natural, as bleeding in 

the brain was what she initially came in for. Based 

on information provided by the medical center, 

the medical examiner did not do an independent 

investigation into the death. That’s not uncommon, 

either unless there’s a reason, especially when it’s 

a renowned medical center, to dispute the findings 

or to probe further or if the family has a request that 

an autopsy be done. Normally, it is taken as natural. 

In January of 2018, in light of the death, the Medical 

Center took some significant actions first, they 

did not report to state or federal officials which is 

required by law that this had occurred. Secondly, 

defendant Vaught was fired by Vanderbilt University. 

And then subsequently, Vanderbilt negotiated a 

settlement with the descendant’s family. That 

primarily did three things: first, it gave them a 

monetary settlement; secondly, the settlement was 

not made publicly known, and lastly, there was a 

provision that required them not to speak publicly 

about the death or the medication error. Now having 

a confidential agreement under a situation where 

a patient either dies or has an adverse patient 

outcome, that constitutes at a minimum negligence 

is not unusual. But for their not reporting and not 

being completely truthful with the family about what 

happened, there was nothing ill or untoward about 

the settlement. So that happens in early 2018. 

By October of 2018, an anonymous person 

alerts state and federal health authorities to the 

unreported medication error that was responsible 

for the patient’s death. From there, we have 

different licensing boards begin to take interest and 

begin investigating. For example, the Tennessee 

Department of Health, investigated and decided 

not to pursue any disciplinary action against Nurse 

Vaught. In a letter to Vanderbilt the agency’s 

investigations director said Vaught’s case did 

not constitute a violation of the statutes or rules 

governing her profession, which is the nursing 

profession. And on the same day, the defendant 

Vaught was sent a letter saying this matter did not 

merit further action. 

CMS had a different response. And in fact, they 

came in to the Medical Center unannounced to do 

a surprise inspection. And the inspection did in fact 

confirm that the patient died from an accidental 

dose of vecuronium and that the Medical Center did 

not report the medication error to the government 

or to the medical examiner, according to an 

inspection report, and in late November 2018, the 

circumstances of the fatal medication error became 

public for the first time when CMS released their 

report. However, they did not identify the nurse or 

patient by name. And in fact, the Medical Center’s 

reimbursement for Medicare was threatened unless 

it could prove it took steps to prevent a similar error 

and to provide a correction plan, which it did. So 

that appeased the federal agency and its Medicare 

reimbursements were secured. 

In early 2019, the nurse was identified publicly for 

the first time when she was arrested on a criminal 

indictment for her alleged role in the death. Initially, 

she was charged with reckless homicide and 

impaired adult abuse. But Vanderbilt was not named 

as a codefendant, and Vanderbilt did not take 

any disciplinary action, nor did the board did not 

take any disciplinary action. That’s the Tennessee 

Board of Licensing, despite Vanderbilt purchasing 

the automatic dispensing cabinet that was utilized, 

despite it being responsible for the internal, 

technical, physical, and administrative safeguards 

being in place. And in light of, some of the issues 

that nurses dealt with on a regular basis. 

This is a large case. It seems like there were 

so many different players in it that could 

have been sued or prosecuted and I am 

surprised they were not. 

Right. So, at the beginning, I mentioned different 


players in different proceedings that were going on. 

And we already heard about the Tennessee licensing 

board initially saying there’s no issue here. After 

things become more public, the Tennessee licensing 

board for health care facilities, says to Vanderbilt, 

you know what? We’re not taking any action here 

either. And that was after CMS came in. According 

to the court records, prosecutors revealed more 

details about the case. And first, the investigators 

allege that the nurse defendant made 10 separate 

errors when giving the wrong medication to Murphy, 

including, overlooking multiple warning signs that 

she had the wrong medication. Now, think back to 

that process I described in-between the pharmacy 

authorizing a drug to be dispensed and the patient 

receiving the drug. There are a lot of different steps 

both on the technical side and on the physical 

person side as well. The court records state that 

the nurse would have had to look directly at a 

warning saying, “Warning: paralyzing agent” before 

injecting the drug. Additionally, a difference between 

Versed. Versed does not need to be mixed. It’s just 

a suspension formula. But the other drug was a 

powder and required mixing and agitation before 

it could be administered. So, two very different 

drugs with very different purposes, one with a very 

pronounced warning, and a different mechanism as 

well before a drug could be injected. So that is very, 

very key. 

Now, about the same time or at least in 2019, at the 

request of law enforcement, the Nashville medical 

examiner reexamined the circumstances of the 

death. And the manner of death was changed from 

natural to accidental and the term accidental is 

critical because accidental, especially in criminal 

law has a very mitigating effect. So, in August of 

2019, we have this change on the death certificate. 

In September of 2019, The Tennessee Department 

of Health reverses its prior decision not to pursue 

professional discipline against Nurse Vaught. Again, 

this is the Tennessee Board of Nursing. The agency 

did not issue a statement as to why it reversed its 

prior decision. But reasonable minds would probably 

reach a conclusion that the amount of press, the 

number of documents that had been produced, and 

the changing in the coroner’s report did have an 

impact on that. So now we have what are known 

as a parallel proceeding. There is the criminal trial 

which is brought at the local level. In this case by 

the district attorney and a professional discipline 

hearing, a debate begins over which the case should 

first proceed. 

So here we have on December 15 of 2019, and 

a Tennessean Investigation. For those of you not 

familiar with Tennessee, The Tennessean is the 

main paper and media outlet in Nashville. They 

investigated how the actions taken by Vanderbilt 

officials obscured the circumstances of the death. 

And one of those circumstances was in fact, the 

ability for nurses and other medical professionals 

who could access the ADCs to in fact, circumvent 

that procedure. And this is important because we 

get through COVID and we fast forward to the 

July 2021, medical disciplinary hearing before the 

Tennessee licensing board. During her testimony, 

the defendant was forthright, she did not shirk 

her responsibility for the patient’s death, for her 

part of her role, saying it was her fault that she 

did not double check the medication and she 

took responsibility for that. However, her attorney 

indicated that a mistake was made, possibly 

because of flawed procedures at the Medical 

Center. And at the time, she attested that the 

Medical Center was struggling with a problem 

that prevented communication between its EHR, 

medication cabinets, and the hospital’s pharmacy. It 

was causing delays in dispensing and accessing the 

medications. So, the hospital short term workaround 

was to override those safeguards. Remember what 

I said before with the key, not using the unique user 

ID and password a key is one way to circumvent 

that there could also be a code that could be 

entered in the event of an emergency which would 

not require all that other information to be entered? 

So those are two ways that you can override it. 

In July of 2021, the Tennessee Board of Nursing 

revoked Nurse Vaught’s nursing license. Although 

board members appear sympathetic to her case, 

they do not overlook the errors. This is important 

12 


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because as we’ll see in the criminal case, and what 

happened at the sentencing, I believe the judge took 

a similar approach. Her trial began on March 21 of 

2022. And the trial ended with a jury finding her 

guilty of criminally negligent homicide and abuse 

of an impaired adult. Now if you recall, what the 

indictment was for reckless homicide, which is 

different. That’s an important distinction because for 

those of you who watch Law and Order or Boston 

Legal or any other legal show, you often hear the 

term scienter or mens rea, and that’s the required 

mental state. Once you start getting into intentional 

intent is that mens rea or scienter component, so all 

that is very important. 

Now we have the sentencing. And here we know 

that the jury found her guilty on two charges of 

criminally negligent homicide and the other abuse 

of an impaired adult. She, however, was sentenced 

to three years of supervised probation, but the 

sentencing guidelines could have given her up to 

eight years in prison. And the judge took an extra 

step and from my perspective, she took it for two 

reasons. First, the defendant took responsibility for 

her role in the unfortunate outcome. But additionally, 

the judge probably looked at what was going 

on with COVID, the exodus of people leaving the 

medical profession, and what these circumstances 

really warrant for someone who’s never encountered 

any issue before. Judge Smith, along with giving 

three years of probation, also issued a judicial 

diversion. And this is a program, in which first time 

offenders can have their records expunged, after 

completing their probation without any issues. 

This really gives Nurse Vaught the ability to move 

forward after she completes her three years of 

supervised probation, which given that she did have 

a role in this, is very reasonable. 

To your point, it is interesting that the Medical Center 

was not named because of the various issues that 

even CMS found so people can speculate all one 

wants, but I am choosing not to speculate as to why 

Vanderbilt was not named. And as you know, and as 


people who have listened to me before, I obtained 

one of my degrees from Vanderbilt, but I do not 

represent them legally. 

At the end of any criminal case, the defendant has 

an opportunity to show remorse to the family, and 

the defendant expressly stated something along 

the lines of saying “I’m sorry, doesn’t seem like 

enough, but you deserve to hear that. And I am to 

know that I’m very sorry for what happened.” Now 

the patient’s family had a divergent reaction. And 

in fact, the family spokesman said that her mom 

would not have wanted the nurse to go to jail under 

these circumstances, because her mom was a very 

forgiving person, there was another family member 

who did want the defendant to go to prison. There 

was an outpouring of applause once the sentence 

was rendered by the judge, and a lot of those 

people who were outside, were, in fact, health care 

professionals. So that pretty much sums up the 

case. 

What are some key takeaways from the case 

from a compliance standpoint? 

Well, first and foremost, when you think about 

hospitals, the goal should be patient centered 

care and getting the best clinical outcomes for the 

patient. It comes down to making sure that the 

technical, administrative, and physical safeguards 

are in place across an entire organization. And 

when there is a requirement under law to be made 

to a governmental entity, make sure that you follow 

those requirements. 

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Violence Prevention 

Under OSHA 

Workplace violence is a serious issue, 

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guidelines help employees and 

employers alike by providing the 

necessary steps to maintain a safe 

work environment. 

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14 


Physician Auditing and Compliance 

Many practitioner audits fall short of best practices. 

The modern healthcare environment and complex 

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potential billing and coding risk. There are also some 

surprising upsides of professional audits that include 

greater visibility of under-coding. 

What are the benefits of auditing in a 

medical organization? 

Key Benefits of Auditing 

• Improve documentation/coding skills 

• Provide focused education in-person, online, 

remotely, or in combination 

• Ensure you are auditing the right practitioners 

and cases 

• Find cases with the highest probability for over 

and under coding for practitioners using datamining 

tools 

• Improve practitioners’ knowledge of E&M and 

documentation requirements 

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Auditing is a daunting task, and every situation is 

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collaboration and understanding among your team. 

If you’re ready to feel more confident, please get 

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hosted by Catherine Short 

1st Talk Compliance features guest Rachel V. Rose, JD, MBA, principal with Rachel V. Rose – Attorney at 

Law, P.L.L.C., Houston, TX, on the topic of “A Business Associate Agreement? Tell Me More!” Rachel joins 

our host Catherine Short to discuss how Business Associate Agreements (BAA) are not new; however, some 

individuals are new to healthcare and others never understood what a BAA is exactly. A BAA is a contract that 

fundamentally gives assurances that the parties are complying with the Security Rule and Privacy Rule, setting 

parameters in the event of a reportable security incident or a breach, and states how the sensitive data will be 

returned and destroyed at the end of the relationship. Some of the items in a BAA are required, while others 

are optional but common. This presentation not only seeks to dispel myths about why certain language is 

prevalent in nearly all BAAs, but also provides insight into other provisions, and items for consideration, in light 

of the 21st Century Cures Act. 

Listen weekdays at 

7:30am, 3:30pm, 11:30pm ET 

Check out our Show Page! 

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COVID-19 Healthcare 

Compliance Toolkit 

Healthcare compliance amidst COVID-19 presents new challenges for 

hospitals and healthcare providers. At top importance is the question 

of how to slow or stop the spread of COVID-19, while ensuring that your 

organization stays compliant. 

Now more than ever, your compliance department needs to have the necessary tools 

to help track, analyze, and respond to compliance challenges. To help navigate the 

process, we’ve gathered our best COVID-19 resources below. If you need further 

assistance, please contact us here. 

VIEW TOOLKIT 

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Health Data, A Value Proposition: Legal Risks with 

Innovative Data Sharing Projects 

Preserving and Protecting Assets In Healthcare 

Automatic Dispensing Cabinets, Patient Care, & the 

Actual Sentence in the RaDonda Vaught Case 

The Dobbs Opinion, the Repealing of Roe, & the Impact on 

the Privacy & Security of Patient Information 

Workplace Civility: What Non-Unionized Employers Need 

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First Healthcare Compliance CONNECT November 2022

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