Medical Errors Archives - ºÚÁϳԹÏÍø News /news/tag/medical-errors/ Wed, 16 Aug 2023 22:17:32 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.5 /wp-content/uploads/sites/2/2023/04/kffhealthnews-icon.png?w=32 Medical Errors Archives - ºÚÁϳԹÏÍø News /news/tag/medical-errors/ 32 32 161476233 The Case of the Two Grace Elliotts: A Medical Billing Mystery /news/article/mistaken-identity-two-grace-elliotts-medical-billing-mystery/ Wed, 21 Dec 2022 10:00:00 +0000 https://khn.org/?post_type=article&p=1595073 Earlier this year, Grace Elizabeth Elliott got a mysterious hospital bill for medical care she had never received.

She soon discovered how far a clerical error can reach — even across a continent — and how frustrating it can be to fix.

During a college break in 2013, Elliott, then 22, began to feel faint and feverish while visiting her parents in Venice, Florida, about an hour south of Tampa. Her mother, a nurse, drove her to a facility that locals knew simply as Venice Hospital.

In the emergency department, Elliott was diagnosed with a kidney infection and held overnight before being discharged with a prescription for antibiotics, a common treatment for the illness.

“My hospital bill was about $100, which I remember because that was a lot of money for me as an undergrad,” said Elliott, now 31.

She recovered and eventually moved to California to teach preschool. Venice Regional Medical Center was bought by Community Health Systems, based in Franklin, Tennessee, in 2014 and eventually renamed ShorePoint Health Venice.

The kidney infection and overnight stay in the ER would have been little more than a memory for Elliott.

Then another bill came.

The Patients: Grace E. Elliott, 31, a preschool teacher living with her husband in San Francisco, and Grace A. Elliott, 81, a retiree in Venice, Florida.

Medical Services: For Grace E., an emergency department visit and overnight stay, plus antibiotics to treat a kidney infection in 2013. For Grace A., a shoulder replacement and rehabilitation services in 2021.

Service Provider: Venice Regional Medical Center, later renamed ShorePoint Health Venice.

Total Bill: $1,170, the patient’s responsibility for shoulder replacement services, after adjustments and payments of $13,210.21 by a health plan with no connection to Elliott. The initial charges were $123,854.14.

What Gives: This is a case of mistaken identity, a billing mystery that started at a hospital registration desk and didn’t end until months after the file had been handed over to a collection agency.

Early this year, Grace E. Elliott’s mother opened a bill from ShorePoint Health Venice that was addressed to her daughter and sought more than $1,000 for recent hospital services, Elliott said. She “immediately knew something was wrong.”

Months of sleuthing eventually revealed that the bill was meant for Grace Ann Elliott, a much older woman who underwent a shoulder replacement procedure and rehabilitation services at the Venice hospital last year.

Experts said that accessing the wrong patient’s file because of a name mix-up is a common error — but one for which safeguards, like checking a patient’s photo identification, usually exist.

The hospital had treated at least two Grace Elliotts. When Grace A. Elliott showed up for her shoulder replacement, a hospital employee pulled up Grace E. Elliott’s account by mistake.

“This is the kind of thing that can definitely happen,” said Shannon Hartsfield, a Florida attorney who specializes in health care privacy violations. (Hartsfield does not represent anyone involved in this case.) “All kinds of human errors happen. A worker can pull up the names, click the wrong button, and then not check [the current patient’s] date of birth to confirm.”

It was a seemingly obvious error: The younger Elliott was billed for a procedure she didn’t have by a hospital she had not visited in years. But it took her nearly a year of hours-long phone calls to undo the damage.

At first, worried that she had been the victim of identity theft, Grace E. Elliott contacted ShorePoint Health Venice and was bounced from one department to another. At one point, a billing employee disclosed to Elliott the birthdate the hospital had on file for the patient who had the shoulder replacement — it was not hers. Elliott then sent the hospital a copy of her ID.

It took weeks for an administrator at ShorePoint’s corporate office in Florida to admit the hospital’s error and promise to correct it.

In August, though, Grace E. Elliott received a notice that the corporate office had sold the debt to a collection agency called Medical Data Systems. Even though the hospital had acknowledged its error, the agency was coming after Grace E. Elliott for the balance due for Grace A. Elliott’s shoulder surgery.

“I thought, ‘Well, I’ll just work with them directly,’” Grace E. Elliott said.

Her appeal was denied. Medical Data Systems said in its denial letter that it had contacted the hospital and confirmed the name and address on file. The agency also included a copy of Grace A. Elliott’s expired driver license to Grace E. — along with several pages of the older woman’s medical information — in support of its conclusion.

“A collection agency, as a business associate of a hospital, has an obligation to ensure that the wrong patient’s information is not shared,” Hartsfield said.

In an email to KHN, Cheryl Spanier, a vice president of the collection agency, wrote that “MDS follows all state and federal rules and regulations.” Spanier declined to comment on Elliott’s case, saying she needed the written consent of both the health system and the patient to do so.

Elliott’s second appeal was also denied. She was told to contact the hospital to clear up the issue. But because the health system had long since sold the debt, Elliott said, she got no traction in trying to get ShorePoint Health Venice to help her. The hospital .

Resolution: In mid-November, shortly after a reporter contacted ShorePoint Health, which operates other hospitals and facilities in Florida, Grace E. Elliott received a call from Stanley Padfield, the Venice hospital’s outgoing privacy officer and director of health information management. “He said, ‘It’s taken care of,’” Elliott said, adding that she was relieved but skeptical. “I’ve heard that over and over.”

Elliott said Padfield told her that she had become listed as Grace A. Elliott’s guarantor, meaning she was legally responsible for the debt of a woman she had never met.

Elliott soon received a letter from Padfield stating that ShorePoint Health had removed her information from Grace A. Elliott’s account and confirmed that she had not been reported to any credit agencies. The letter said her information had been removed from the collection agency’s database and acknowledged that the hospital’s fix initially “was not appropriately communicated” to collections.

Padfield said the error started with a “registration clerk,” who he said had “received additional privacy education as a result of this incident.”

Devyn Brazelton, marketing coordinator for ShorePoint Health, told KHN the hospital believes the error was “an isolated incident.”

Using the date of birth provided by a hospital worker, Elliott was able to contact Grace A. Elliott and explain the mix-up.

“I’m a little upset right now,” Grace A. Elliott told KHN on the day she learned about the billing error and disclosure of her medical information.

The Takeaway: Grace E. Elliott said that when she asked Padfield, the Venice hospital’s outgoing privacy officer, whether she could have done something to fight such an obvious case of mistaken identity, he replied, “Probably not.”

This, experts said, is the dark secret of identity issues: Once a mistake has been entered into a database, it can be remarkably difficult to fix. And such incorrect information can live for generations.

For patients, that means it’s crucial to review the information on patient portals — the online medical profiles many providers use to manage things like scheduling appointments, organizing medical records, and answering patient questions.

One downside of electronic medical records is that errors spread easily and repeat frequently. It is important to challenge and correct errors in medical records early and forcefully, with every bit of documentation available. That is true whether the problem is an incorrect name, a medication no longer (or never) taken, or an inaccurate diagnosis.

The process of amending a record can be “very involved,” Hartsfield said. “But with patients able now to see more and more of their medical records, they are going to want those amendments, and health systems and their related entities need to get prepared for that.”

Grace A. Elliott told KHN that she had received a call from ShorePoint Health in the previous few months indicating that she owed money for her shoulder replacement.

She asked for a copy of the bill, she told KHN. Months after she asked, it still hadn’t arrived.

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No Prison Time for Tennessee Nurse Convicted of Fatal Drug Error /news/article/radonda-vaught-nurse-homicide-sentencing-probation-drug-error/ Fri, 13 May 2022 19:50:00 +0000 https://khn.org/?post_type=article&p=1495842 RaDonda Vaught, a former Tennessee nurse convicted of two felonies for a fatal drug error, whose trial became a rallying cry for nurses fearful of the criminalization of medical mistakes, will not be required to spend any time in prison.

Davidson County criminal court Judge Jennifer Smith on Friday granted Vaught a judicial diversion, which means her conviction will be expunged if she completes a three-year probation.

Smith said that the family of the patient who died as a result of Vaught’s medication mix-up suffered a “terrible loss” and “nothing that happens here today can ease that loss.”

“Miss Vaught is well aware of the seriousness of the offense,” Smith said. “She credibly expressed remorse in this courtroom.”

The judge noted that Vaught had no criminal record, has been removed from the health care setting, and will never practice nursing again. The judge also said, “This was a terrible, terrible mistake and there have been consequences to the defendant.”

As the sentence was read, cheers erupted from a crowd of hundreds of purple-clad protesters who gathered outside the courthouse in opposition to Vaught’s prosecution.

Vaught, 38, a former nurse at Vanderbilt University Medical Center in Nashville, faced up to eight years in prison. In March she was convicted of criminally negligent homicide and gross neglect of an impaired adult for the 2017 death of 75-year-old patient Charlene Murphey. Murphey was prescribed Versed, a sedative, but Vaught inadvertently gave her a fatal dose of vecuronium, a powerful paralyzer.

Charlene Murphey’s son, Michael Murphey, testified at Friday’s sentencing hearing that his family remains devastated by the sudden death of their matriarch. She was “a very forgiving person” who would not want Vaught to serve any prison time, he said, but his widower father wanted Vaught to receive “the maximum sentence.”

“My dad suffers every day from this,” Michael Murphey said. “He goes out to the graveyard three to four times a week and just sits out there and cries.”

Vaught’s case stands out because medical errors ― even deadly ones ― are generally within the purview of state medical boards, and lawsuits are almost never prosecuted in criminal court.

The Davidson County district attorney’s office, which did not advocate for any particular sentence or oppose probation, has described Vaught’s case as an indictment of one careless nurse, not the entire nursing profession. Prosecutors argued in trial that Vaught overlooked multiple warning signs when she grabbed the wrong drug, including failing to notice Versed is a liquid and vecuronium is a powder.

Vaught admitted her error after the mix-up was discovered, and her defense largely focused on arguments that an honest mistake should not constitute a crime.

During the hearing on Friday, Vaught said she was forever changed by Murphey’s death and was “open and honest” about her error in an effort to prevent future mistakes by other nurses. Vaught also said there was no public interest in sentencing her to prison because she could not possibly re-offend after her nursing license was revoked.

“I have lost far more than just my nursing license and my career. I will never be the same person,” Vaught said, her voice quivering as she began to cry. “When Ms. Murphey died, a part of me died with her.”

At one point during her statement, Vaught turned to face Murphey’s family, apologizing for both the fatal error and how the public campaign against her prosecution may have forced the family to relive their loss.

“You don’t deserve this,” Vaught said. “I hope it does not come across as people forgetting your loved one. … I think we are just in the middle of systems that don’t understand one another.”

Prosecutors also argued at trial that Vaught circumvented safeguards by switching the hospital’s computerized medication cabinet into “override” mode, which made it possible to withdraw medications not prescribed to Murphey, including vecuronium. Other nurses and nursing experts have told KHN that overrides are routinely used in many hospitals to access medication quickly.

Theresa Collins, a travel nurse from Georgia who closely followed the trial, said she will no longer use the feature, even if it delays patients’ care, after prosecutors argued it proved Vaught’s recklessness.

“I’m not going to override anything beyond basic saline. I just don’t feel comfortable doing it anymore,” Collins said. “When you criminalize what health care workers do, it changes the whole ballgame.”

Vaught’s prosecution drew condemnation from nursing and medical organizations that said the case’s dangerous precedent would worsen the nursing shortage and make nurses less forthcoming about mistakes.

The case also spurred considerable backlash on social media as nurses streamed the trial through Facebook and rallied behind Vaught on TikTok. That outrage inspired Friday’s protest in Nashville, which drew supporters from as far as Massachusetts, Wisconsin, and Nevada.

Among those protesters was David Peterson, a nurse who marched Thursday in Washington, D.C., to demand health care reforms and safer nurse-patient staffing ratios, then drove through the night to Nashville and slept in his car so he could protest Vaught’s sentencing. The events were inherently intertwined, he said.

“The things being protested in Washington, practices in place because of poor staffing in hospitals, that’s exactly what happened to RaDonda. And it puts every nurse at risk every day,” Peterson said. “It’s cause and effect.”

Tina Vinsant, a Knoxville nurse and the Nashville protest, said the group had spoken with Tennessee lawmakers about legislation to protect nurses from criminal prosecution for medical errors and would pursue similar bills “in every state.”

Vinsant said they would pursue this campaign even though Vaught was not sent to prison.

“She shouldn’t have been charged in the first place,” Vinsant said. “I want her not to serve jail time, of course, but the sentence doesn’t really affect where we go from here.”

Janis Peterson, a recently retired ICU nurse from Massachusetts, said she attended the protest after recognizing in Vaught’s case the all-too-familiar challenges from her own nursing career. Peterson’s fear was a common refrain among nurses: “It could have been me.”

“And if it was me, and I looked out that window and saw 1,000 people who supported me, I’d feel better,” she said. “Because for every one of those 1,000, there are probably 10 more who support her but couldn’t come.”

Nashville Public Radio’s Blake Farmer contributed to this report.

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Why Nurses Are Raging and Quitting After the RaDonda Vaught Verdict /news/article/nurses-react-radonda-vaught-verdict-conviction/ Tue, 05 Apr 2022 09:00:00 +0000 https://khn.org/?post_type=article&p=1473587 Emma Moore felt cornered. At a community health clinic in Portland, Oregon, the 29-year-old nurse practitioner said she felt overwhelmed and undertrained. Coronavirus patients flooded the clinic for two years, and Moore struggled to keep up.

Then the stakes became clear. On March 25, about 2,400 miles away in a Tennessee courtroom, former nurse RaDonda Vaught was convicted of two felonies and facing eight years in prison for a fatal medication mistake.

Like many nurses, Moore wondered if that could be her. She’d made medication errors before, although none so grievous. But what about the next one? In the pressure cooker of pandemic-era health care, another mistake felt inevitable.

Four days after Vaught’s verdict, Moore quit. She said Vaught’s verdict contributed to her decision.

“It’s not worth the possibility or the likelihood that this will happen,” Moore said, “if I’m in a situation where I’m set up to fail.”

In the wake of Vaught’s trial ― an extremely rare case of a health care worker being criminally prosecuted for a medical error ― nurses and nursing organizations have condemned the verdict through tens of thousands of social media posts, shares, comments, and videos. They warn that the fallout will ripple through their profession, demoralizing and depleting the ranks of nurses already stretched thin by the pandemic. Ultimately, they say, it will worsen health care for all.

Statements from the , the , and the National Medical Association each said Vaught’s conviction set a “dangerous precedent.” Linda Aiken, a nursing and sociology professor at the University of Pennsylvania, said that although Vaught’s case is an “outlier,” it will make nurses less forthcoming about mistakes.

“One thing that everybody agrees on is it’s going to have a dampening effect on the reporting of errors or near misses, which then has a detrimental effect on safety,” Aiken said. “The only way you can really learn about errors in these complicated systems is to have people say, ‘Oh, I almost gave the wrong drug because …’

“Well, nobody is going to say that now.”

Fear and outrage about Vaught’s case have swirled among nurses on Facebook, Twitter, and Reddit. On TikTok, a video platform increasingly popular among medical professionals, totaled more than 47 million views.

Vaught’s supporters catapulted to the top of Change.org, a petition website. And thousands also joined a Facebook group planning to gather in protest outside Vaught’s sentencing hearing in May.

Ashley Bartholomew, 36, a Tampa, Florida, nurse who followed the trial through YouTube and Twitter, echoed the fear of many others. Nurses have long felt forced into “impossible situations” by mounting responsibilities and staffing shortages, she said, particularly in hospitals that operate with lean staffing models.

“The big response we are seeing is because all of us are acutely aware of how bad the pandemic has exacerbated the existing problems,” Bartholomew said. And “setting a precedent for criminally charging [for] an error is only going to make this exponentially worse.”

Vaught, who worked at Vanderbilt University Medical Center in Nashville, was convicted in the death of Charlene Murphey, a 75-year-old patient who died from a drug mix-up in 2017. Murphey was prescribed a dose of a sedative, Versed, but Vaught accidentally withdrew a powerful paralyzer, vecuronium, from an automated medication-dispensing cabinet and administered it to the patient.

Prosecutors argued that Vaught overlooked many obvious signs she’d withdrawn the wrong drug and did not monitor Murphey after she was given a deadly dose. Vaught owned up to the error but said it was an honest mistake ― not a crime.

Some of Vaught’s peers support the conviction.

Scott Shelp, a California nurse with a small YouTube channel, posted that Vaught deserves to serve prison time. “We need to stick up for each other,” he said, “but we cannot defend the indefensible.”

Shelp said he would never make the same error as Vaught and “neither would any competent nurse.” Regarding concerns that the conviction would discourage nurses from disclosing errors, Shelp said “dishonest” nurses “should be weeded out” of the profession anyway.

“In any other circumstance, I can’t believe anyone ― including nurses ― would accept ‘I didn’t mean to’ as a serious defense,” Shelp said. “Punishment for a harmful act someone actually did is justice.”

Vaught was acquitted of reckless homicide but convicted of a lesser charge, criminally negligent homicide, and gross neglect of an impaired adult. As outrage spread across social media, the Nashville district attorney’s office defended the conviction, saying in a statement it was “not an indictment against the nursing profession or the medical community.”

“This case is, and always has been, about the one single individual who made 17 egregious actions, and inactions, that killed an elderly woman,” said the office’s spokesperson, Steve Hayslip. “The jury found that Vaught’s actions were so far below the protocols and standard level of care, that the jury (which included a longtime nurse and another health care professional) returned a guilty verdict in less than four hours.”

The office of Tennessee Gov. Bill Lee confirmed he is not considering clemency for Vaught despite the Change.org petition, which had

Lee spokesperson Casey Black said that outside of death penalty cases the governor relies on the Board of Parole to recommend defendants for clemency, which happens only after sentencing and a board investigation.

But the controversy around Vaught’s case is far from over. As of April 4, more than 8,200 people had joined a Facebook group planning a march in protest outside the courthouse during her sentencing May 13.

Among the event’s planners is Tina Vinsant, the host of “,” a podcast that followed Vaught’s case and opposed her prosecution.

“I don’t know how Nashville is going to handle it,” Vinsant said of the protest during a recent episode about Vaught’s trial. “There are a lot of people coming from all over.”

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Reaction to the RaDonda Vaught Verdict: KHN Wants to Hear From Nurses /news/article/reaction-to-the-radonda-vaught-verdict-khn-wants-to-hear-from-nurses/ Wed, 30 Mar 2022 17:50:00 +0000 https://khn.org/?post_type=article&p=1470638 RaDonda Vaught, a former Tennessee nurse, killed a patient in 2017 by administering the wrong drug.  She was criminally prosecuted and convicted of gross neglect and negligent homicide on March 25. She faces up to eight years in prison. 

Vaught’s conviction drew national attention and left many in the nursing profession worried it will set a precedent for criminalizing medical mistakes. Some observers believe the conviction will make hospitals less transparent about medical errors or dissuade people from pursuing a nursing career.

In light of these concerns, KHN wants to hear from nurses and other medical professionals about their reactions to Vaught’s conviction. If you fill out the form below reacting to the case, we might use it in our upcoming coverage.

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Nurse Convicted of Neglect and Negligent Homicide for Fatal Drug Error /news/article/radonda-vaught-nurse-drug-error-vanderbilt-guilty-verdict/ Fri, 25 Mar 2022 19:55:00 +0000 https://khn.org/?post_type=article&p=1469331 NASHVILLE, Tenn. — RaDonda Vaught, a former nurse criminally prosecuted for a fatal drug error in 2017, was convicted of gross neglect of an impaired adult and negligent homicide Friday after a three-day trial that gripped nurses across the country.

Vaught faces three to six years in prison for neglect and one to two years for negligent homicide as a defendant with no prior convictions, according to sentencing guidelines provided by the Nashville district attorney’s office. Vaught is scheduled to be sentenced May 13, and her sentences are likely to run concurrently, said DA spokesperson Steve Hayslip.

Vaught was acquitted of reckless homicide. Criminally negligent homicide was a lesser charge included under reckless homicide.

Vaught’s trial has been closely watched by nurses and medical professionals across the country, many of whom worry it could set a precedent of criminalizing medical mistakes. Medical errors are generally handled by professional licensing boards or civil courts, and criminal prosecutions like Vaught’s case are exceedingly rare.

Janie Harvey Garner, the founder of Show Me Your Stethoscope, a Facebook nursing group with more than 600,000 members, worried the conviction would have a chilling effect on nurses disclosing their own errors or near-errors, which would have a detrimental effect on the quality of patient care.

“Health care just changed forever,” she said after the verdict. “You can no longer trust people to tell the truth because they will be incriminating themselves.”

In the wake of the verdict, the American Nurses Association expressing similar concerns about Vaught’s conviction, saying it sets a “dangerous precedent” of “criminalizing the honest reporting of mistakes.” Some medical errors are “inevitable,” the statement said, and there are more “effective and just mechanisms” to address them than criminal prosecution.

“The nursing profession is already extremely short-staffed, strained and facing immense pressure — an unfortunate multi-year trend that was further exacerbated by the effects of the pandemic,” the statement said. “This ruling will have a long-lasting negative impact on the profession.”

Vaught, 38, of Bethpage, Tennessee, was arrested in 2019 and charged with reckless homicide and gross neglect of an impaired adult in connection with the killing of Charlene Murphey, who died at Vanderbilt University Medical Center in late December 2017. The neglect charge stemmed from allegations that Vaught did not properly monitor Murphey after she was injected with the wrong drug.

Murphey, 75, of Gallatin, Tennessee, was admitted to Vanderbilt for a brain injury. At the time of the error, her condition was improving, and she was being prepared for discharge from the hospital, according to courtroom testimony and a federal investigation report. Murphey was prescribed a sedative, Versed, to calm her before being scanned in a large, MRI-like machine.

Vaught was tasked to retrieve Versed from a computerized medication cabinet but instead grabbed a powerful paralyzer, vecuronium. According to an investigation report filed in her court case, the nurse overlooked several warning signs as she withdrew the wrong drug — including that Versed is a liquid but vecuronium is a powder — and then injected Murphey and left her to be scanned. By the time the error was discovered, Murphey was brain-dead.

During the trial, prosecutors painted Vaught as an irresponsible and uncaring nurse who ignored her training and abandoned her patient. Assistant District Attorney Chad Jackson likened Vaught to a drunken driver who killed a bystander, but said the nurse was “worse” because it was as if she was “driving with [her] eyes closed.”

“The immutable fact of this case is that Charlene Murphey is dead because RaDonda Vaught could not bother to pay attention to what she was doing,” Jackson said.

Vaught’s attorney, Peter Strianse, argued that his client made an honest mistake that did not constitute a crime and became a “scapegoat” for systemic problems related to medication cabinets at Vanderbilt University Medical Center in 2017.

But Vanderbilt officials countered on the stand. Terry Bosen, Vanderbilt’s pharmacy medication safety officer, testified that the hospital had some technical problems with medication cabinets in 2017 but that they were resolved weeks before Vaught pulled the wrong drug for Murphey.

In his closing statement, Strianse targeted the reckless homicide charge, arguing that his client could not have “recklessly” disregarded warning signs if she earnestly believed she had the right drug and saying that there was “considerable debate” over whether vecuronium actually killed Murphey.

During the trial, Dr. Eli Zimmerman, a Vanderbilt neurologist, testified it was “in the realm of possibility” Murphey’s death was caused entirely by her brain injury. Additionally, Davidson County Chief Medical Examiner Feng Li testified that although he determined Murphey died from vecuronium, he couldn’t verify how much of the drug she actually received. Li said a small dose may not have been lethal.

“I don’t mean to be facetious,” Strianse said of the medical examiner’s testimony, “but it sort of sounded like some amateur ‘CSI’ episode — only without the science.”

Vaught did not testify. On the second day of the trial, prosecutors played an audio recording of Vaught’s interview with law enforcement officials in which she admitted to the drug error and said she “probably just killed a patient.”

During a separate proceeding before the Tennessee Board of Nursing last year, Vaught testified that she allowed herself to become “complacent” and “distracted” while using the medication cabinet and did not double-check which drug she had withdrawn despite multiple opportunities.

“I know the reason this patient is no longer here is because of me,” Vaught told the nursing board, starting to cry. “There won’t ever be a day that goes by that I don’t think about what I did.”

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In Nurse’s Trial, Investigator Says Hospital Bears ‘Heavy’ Responsibility for Patient Death /news/article/radonda-vaught-fatal-drug-error-vanderbilt-hospital-responsibility/ Thu, 24 Mar 2022 09:00:00 +0000 https://khn.org/?post_type=article&p=1467982 A lead investigator in the criminal case against former Tennessee nurse RaDonda Vaught testified Wednesday that state investigators found Vanderbilt University Medical Center had a “heavy burden of responsibility” for a grievous drug error that killed a patient in 2017, but pursued penalties and criminal charges only against the nurse and not the hospital itself.

Vaught, 38, was stripped of her nursing license and is now on trial in Nashville for charges of reckless homicide and abuse of an impaired adult. If convicted, she faces as much as 12 years in prison.

Vanderbilt received no punishment for the fatal drug error.

This testimony — from a Tennessee Bureau of Investigation agent — appears to support defense arguments that Vaught’s fatal error was made possible by systemic failures at Vanderbilt. Vaught’s attorney, Peter Strianse, has described his client as a “disposable person” who was scapegoated to protect the invaluable reputation of the most prestigious hospital in Tennessee.

“We are engaged in a pretty high-stakes game of musical chairs and blame-shifting. And when the music stopped abruptly, there was no chair for RaDonda Vaught,” Strainse said during opening statements. “Vanderbilt University Medical Center? They found a seat.”

Vaught is on trial for the death of Charlene Murphey, a 75-year-old Vanderbilt patient who died on Dec. 27, 2017, after she was prescribed a sedative, Versed, but was inadvertently injected with a powerful paralyzer, vecuronium. Vaught does not deny she accidentally confused the drugs but has pleaded not guilty to all charges. Her trial ― a rare example of a health care professional facing prison for a medical error ― has been closely watched by nurses across the country who worry it could set a precedent for future prosecutions.

In the wake of Murphey’s death, Vanderbilt took several actions that resulted in the medication error not being disclosed to the government or the public, according to county, state, and federal records related to the death. Vanderbilt did not report the error to state or federal regulators as required by law, a federal investigation report states. The hospital told the local medical examiner’s office that Murphey died of “natural” causes, with no mention of vecuronium, according to Murphey’s death certificate and Davidson County Chief Medical Examiner Dr. Feng Li. Vanderbilt also fired Vaught and negotiated an out-of-court settlement with Murphey’s family that barred them from publicly discussing the death.

The error was revealed months later when an anonymous tip alerted Centers for Medicare & Medicaid Services and the Tennessee Department of Health. The health department also alerted the Tennessee Bureau of Investigation, which began a criminal investigation.

TBI Special Agent Ramona Smith testified Wednesday for the prosecution that her investigation focused only on Vaught’s drug error, not the actions of Vanderbilt or its other employees.

Smith testified she believed Vanderbilt did not accurately document Murphey’s cause of death on her death certificate, but Smith did not investigate this as a potential crime.

“It seemed odd to me that a ‘natural death’ came as a result of a medication error,” she testified. “And that concerned me, yes.”

Smith also described how the TBI, the Department of Health, and the Nashville district attorney’s office met to discuss Vaught’s case in January 2019, shortly before criminal charges were filed. At that meeting, it became clear the Department of Health had determined Vanderbilt had a significant role in the death, Smith said on the stand, reading a meeting summary from an internal report she wrote.

“In this case, the review led the [Department of Health] to believe that Vanderbilt Medical Center carried a heavy burden of responsibility in this matter,” Smith said. “There was no discipline because, according to [a DOH lawyer], a malpractice error has to be gross negligence before they can discipline for it.”

Although the health department did not try to fine or sanction Vanderbilt, it did punish Vaught. Several months after that meeting, the agency began the public process of revoking her nursing license, reversing a prior decision to close her case with no action.

Vanderbilt declined to comment on this new testimony. The Department of Health did not immediately respond to a request for comment.

Vaught has admitted her role in the fatal drug mix-up, but she insists the error was possible only because of technical problems and flawed procedures in place at Vanderbilt at the time.

The case against Vaught hinges on her use of an electronic medication cabinet, a computerized device that dispenses drugs and is widely used in hospitals. According to documents filed in the case, Vaught initially tried to withdraw Versed from a cabinet by typing “VE” into its search function without realizing she should have been looking for its generic name, midazolam. When the cabinet did not produce Versed, Vaught triggered an override that unlocked a much larger swath of medications, then searched for “VE” again. This time, the cabinet offered vecuronium.

Prosecutors describe this override as a reckless act and a foundation for Vaught’s reckless homicide charge. Some experts have said cabinet overrides are a daily event at many hospitals.

Vaught insisted last year that overrides were common at Vanderbilt, and that a 2017 upgrade to the hospital’s electronic health records system was causing rampant delays at medication cabinets. Vaught said Vanderbilt instructed nurses to use overrides to circumvent delays and get medicine as needed.

“Overriding was something we did as part of our practice every day,” Vaught testified to the nursing board. “You couldn’t get a bag of fluids for a patient without using an override function.”

Vanderbilt has never confirmed or denied whether the hospital widely used overrides to overcome cabinet delays in 2017. But, on Monday, a witness testified that the hospital’s medication cabinets were hampered by technical issues at the time of Murphey’s death.

Ethan Gulley, a former Vanderbilt nurse called as a witness by the prosecution, testified that all Vanderbilt nurses were experiencing delays at medication cabinets in late 2017, and nurses could use overrides to overcome these delays.

Separately, Gail Lanigan, a state health investigator, told the Tennessee Board of Nursing she had heard about computer issues causing problems with medication cabinets at Vanderbilt in 2017.

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As a Nurse Faces Prison for a Deadly Error, Her Colleagues Worry: Could I Be Next? /news/article/radonda-vaught-nurse-error-medication-dispenser-homicide-trial-tennessee/ Tue, 22 Mar 2022 09:00:00 +0000 https://khn.org/?post_type=article&p=1466463 NASHVILLE, Tenn. — Four years ago, inside the most prestigious hospital in Tennessee, nurse RaDonda Vaught withdrew a vial from an electronic medication cabinet, administered the drug to a patient, and somehow overlooked signs of a terrible and deadly mistake.

The patient was supposed to get Versed, a sedative intended to calm her before being scanned in a large, MRI-like machine. But Vaught accidentally grabbed vecuronium, a powerful paralyzer, which stopped the patient’s breathing and left her brain-dead before the error was discovered.

Vaught, 38, admitted her mistake at a last year, saying she became “complacent” in her job and “distracted” by a trainee while operating the computerized medication cabinet. She did not shirk responsibility for the error, but she said the blame was not hers alone.

“I know the reason this patient is no longer here is because of me,” Vaught said, starting to cry. “There won’t ever be a day that goes by that I don’t think about what I did.”

If Vaught’s story followed the path of most medical errors, it would have been over hours later, when the Board of Nursing revoked her RN license and almost certainly ended her nursing career. But Vaught’s case is different: This week she goes on trial in Nashville on criminal charges of reckless homicide and felony abuse of an impaired adult for the killing of Charlene Murphey, a 75-year-old patient who died at Vanderbilt University Medical Center on Dec. 27, 2017.

Prosecutors do not allege in their court filings that Vaught intended to hurt Murphey or was impaired by any substance when she made the mistake, so her prosecution is a rare example of a health care worker facing years in prison for a medical error. Fatal errors are generally handled by licensing boards and civil courts. And experts say prosecutions like Vaught’s loom large for a profession terrified of the criminalization of such mistakes — especially because her case hinges on an automated system for dispensing drugs that many nurses use every day.

The Nashville district attorney’s office declined to discuss Vaught’s trial. Vaught’s lawyer, Peter Strianse, did not respond to requests for comment. Vanderbilt University Medical Center has repeatedly declined to comment on Vaught’s trial or its procedures.

Vaught’s trial will be followed by nurses nationwide, many of whom worry a conviction may set a precedent even as the coronavirus pandemic leaves countless nurses exhausted, demoralized, and likely more prone to error.

Janie Harvey Garner, a St. Louis registered nurse and founder of Show Me Your Stethoscope, a nursing group with more than 600,000 members on Facebook, said the group has closely watched Vaught’s case for years out of concern for her fate — and their own.

Garner said most nurses know all too well the pressures that contribute to such an error: long hours, crowded hospitals, imperfect protocols, and the inevitable creep of complacency in a job with daily life-or-death stakes.

Garner said she once switched powerful medications just as Vaught did and caught her mistake only in a last-minute triple-check.

“In response to a story like this one, there are two kinds of nurses,” Garner said. “You have the nurses who assume they would never make a mistake like that, and usually it’s because they don’t realize they could. And the second kind are the ones who know this could happen, any day, no matter how careful they are. This could be me. I could be RaDonda.”

As the trial begins, the Nashville DA’s prosecutors will argue that Vaught’s error was anything but a common mistake any nurse could make. Prosecutors will say she ignored a cascade of warnings that led to the deadly error.

The case hinges on the nurse’s use of an electronic medication cabinet, a computerized device that dispenses a range of drugs. According to , Vaught initially tried to withdraw Versed from a cabinet by typing “VE” into its search function without realizing she should have been looking for its generic name, midazolam. When the cabinet did not produce Versed, Vaught triggered an “override” that unlocked a much larger swath of medications, then searched for “VE” again. This time, the cabinet offered vecuronium.

Vaught then overlooked or bypassed at least five warnings or pop-ups saying she was withdrawing a paralyzing medication, documents state. She also did not recognize that Versed is a liquid but vecuronium is a powder that must be mixed into liquid, documents state.

Finally, just before injecting the vecuronium, Vaught stuck a syringe into the vial, which would have required her to “look directly” at a bottle cap that read “Warning: Paralyzing Agent,” the DA’s documents state.

The DA’s office points to this override as central to Vaught’s reckless homicide charge. Vaught acknowledges she performed an override on the cabinet. But she and others say overrides are a normal operating procedure used daily at hospitals.

While testifying before the nursing board last year, foreshadowing her defense in the upcoming trial, Vaught said at the time of Murphey’s death that Vanderbilt was instructing nurses to use overrides to overcome cabinet delays and constant technical problems caused by an ongoing overhaul of the hospital’s electronic health records system.

Murphey’s care alone required at least 20 cabinet overrides in just three days, Vaught said.

“Overriding was something we did as part of our practice every day,” Vaught said. “You couldn’t get a bag of fluids for a patient without using an override function.”

Overrides are common outside of Vanderbilt too, according to experts following Vaught’s case.

Michael Cohen, president emeritus of the Institute for Safe Medication Practices, and Lorie Brown, past president of the American Association of Nurse Attorneys, each said it is common for nurses to use an override to obtain medication in a hospital.

Cohen and Brown stressed that even with an override it should not have been so easy to access vecuronium.

“This is a medication that you should never, ever, be able to override to,” Brown said. “It’s probably the most dangerous medication out there.”

Cohen said that in response to Vaught’s case, manufacturers of medication cabinets modified the devices’ software to require up to five letters to be typed when searching for drugs during an override, but not all hospitals have implemented this safeguard. Two years after Vaught’s error, Cohen’s organization documented a “strikingly similar” incident in which another nurse swapped Versed with another drug, verapamil, while using an override and searching with just the first few letters. That incident did not result in a patient’s death or criminal prosecution, Cohen said.

Maureen Shawn Kennedy, the editor-in-chief emerita of the American Journal of Nursing, wrote in 2019 that Vaught’s case was

In the pandemic, she said, this is truer than ever.

“We know that the more patients a nurse has, the more room there is for errors,” Kennedy said. “We know that when nurses work longer shifts, there is more room for errors. So I think nurses get very concerned because they know this could be them.”

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Electronic Health Records Creating A ‘New Era’ Of Health Care Fraud /news/electronic-health-records-creating-a-new-era-of-health-care-fraud-officials-say/ Mon, 23 Dec 2019 10:00:59 +0000 https://khn.org/?p=1033126 Derek Lewis was working as an electronic health records specialist for the nation’s largest hospital chain when he heard about software defects that might even “kill a patient.”

The doctors at Midwest (City) Regional Medical Center in Oklahoma worried that the software failed to track some drug prescriptions or dosages properly, posing a “huge safety concern,” Lewis said. Lewis cited the alleged safety hazards in a whistleblower lawsuit that he and another former employee of Community Health Systems (CHS) filed against the Tennessee-based hospital chain in 2018.

The suit alleges that the company, which had $14 billion in annual in 2018, obtained millions of dollars in federal subsidies fraudulently by covering up dangerous flaws in these systems at the Oklahoma hospital and more than 120 others it owned or operated at the time.

The whistleblowers also allege that Medhost, the Tennessee firm that developed the software, concealed defects during government-mandated reviews that were supposed to ensure safety.

Both CHS and Medhost have the allegations and moved to dismiss the suit. The motions are pending. Last month, Department of Justice lawyers wrote in court filings that they were still investigating the matter and had not yet decided whether to take over the case.

The lawsuit is one of dozens filed by whistleblowers, doctors and hospitals alleging that some electronic health records (EHR) software used in hospitals and medical offices has hidden flaws that may pose a danger to patients — and that a substantial chunk of the $38 billion in federal subsidies went to companies that deceived the government about the quality of their products, an ongoing Fortune-KHN investigation shows. The subsidies were designed to persuade hospitals and doctors’ offices to install software that would track the medical history of every patient and share the information seamlessly with other health care providers.

But the software makers allegedly gamed the system, repeatedly. Three major EHR vendors have made multimillion-dollar settlement deals — totaling $357 million — over Justice Department investigations which include allegations that they rigged or otherwise gamed the government’s certification test. At least two other companies are under investigation.

Beyond those cases, federal officials have paid hundreds of millions of dollars in subsidies to doctors and hospitals that could not show they were even qualified to receive them, according to federal officials. Nearly 28% of doctors and 5% of hospitals who attested to meeting government standards later failed audits. Federal officials told Fortune and KHN that they have clawed back $941 million in improper subsidies.

“We’re entering an entirely new area of health care fraud,” John O’Brien, senior counsel with the Department of Health and Human Services Office of Inspector General, said in a July 2017 announcing a with eClinicalWorks, one of the nation’s leading sellers of EHRs for physicians.

The concern is not just over wasteful spending of tax dollars. EHRs monitor the medicines people take and their vital signs, so software glitches that prevent doctors from accessing files quickly, that mix up patients or send vital test results to the wrong file can contribute to serious injuries, or even deaths.

In March, Fortune and KHN revealed that thousands of injuries, deaths or near misses tied to software defects, user errors and other problems have piled up in various government-sponsored and private repositories.

“Ultimately, it’s about patients getting the right care,” Andrew Vanlandingham, the HHS inspector general’s senior counselor for health information technology, said in an interview. He said that investigators are “gearing up” for more scrutiny of the important industry, including closer monitoring to make sure that records software is safe.

Leaping Into The Digital Era

In 2009, Congress committed billions of dollars in economic stimulus funds to bring the era of paper medical records to a close. Officials hoped to cut down on medical errors caused by illegible paper records and draw on the power of massive troves of medical data to drive down the cost of health care and help develop improved treatments for disease.

The hastily devised plan offered Medicare doctors and other medical professionals up to $44,000 and $64,000 in subsidies if they bought the software and accepted patients on Medicaid, the federal health care program for low-income people.

The money was intended to help them pay vendors to install EHRs in their offices. Hospitals, which required more sophisticated and costlier software, could receive millions in subsidies, based on the number of inpatients treated. To give them a nudge, officials warned doctors and hospitals that failure to wire up would trigger gradual cuts in their Medicare payments. EHR vendors had to meet certification standards set by the HHS Office of the National Coordinator for Health Information Technology, or ONC.

Providers had to attest that their EHR software could perform a variety of functions, which the government described as making “meaningful use” of the technology.

Certification was essentially an open-book test in which the government gave vendors the questions in advance — for instance, the names of 16 or so drugs the system would have to prescribe electronically to pass. The Justice Department has alleged that some vendors simply doctored their software to pass the test — for example, programming the required codes for just the specified 16 drugs they would be tested on, rather than all medicines — as officials had expected.

Frank Poggio who recently retired from a 45-year career in health technology, saw the cases of fraud coming, he said, because the tests “were superficial, and if you wanted to game it, you could game it.”

Poggio said there were many weaknesses in the system that allowed a vendor to show a “prototype” as opposed to live software.

Dr. Scott Monteith, a Michigan psychiatrist who served as an early certification juror, said he saw some limitations firsthand. He said one vendor took 30 minutes to produce a list of patients who had diabetes and also smoked, data he figured any computer program should be able to spit out in seconds. The vendor passed.

“That’s an example of how poorly thought-out the whole thing was,” said Monteith, who noted he was then, and still is, a big booster of EHRs.

Jeffery Daigrepont, a senior vice president at Coker Group, a firm that advises health providers on business decisions, said the government erred by handing out too much money in the early stages of the program, when many doctors and hospitals had not yet done much more than agree to participate.

“It was an upside-down pyramid,” he said. “You got the bulk of the money for doing the least amount of effort.”

Dr. John Halamka, a physician and Harvard Medical School professor who chaired the ONC standards committee, which wrote the certification rules, defended the process.

“The only problem [with certification] is that it presupposed that the product the vendor certified would be the same product they sold,” Halamka said. “It presupposes that people will go into the certification process and participate in good faith.”

That did not always happen in the rush to snatch up subsidy dollars, according to the whistleblowers’ suits. The Justice Department case against eClinicalWorks, which has 130,000 providers, accused the company of rigging tests to win certification, claims the company has denied. The company did not respond to numerous requests for comment.

The government accused Greenway Health, a Florida-based EHR developer with 75,000 providers, of doing the same thing. The DOJ’s complaint included a number of instant-message exchanges between Greenway employees in which they allegedly discuss their plan for gaming the certification process by “shortcutting some functionality” of the software. In February, Greenway Health for just over $57 million without admitting wrongdoing.

The whistleblower case filed by Lewis and former co-worker Joey Neiman accuses the CHS hospital chain of submitting more than $385 million in false claims for EHR stimulus payments between 2012 and 2014.

Visiting the Oklahoma hospital as part of a troubleshooting team in June 2015, Lewis heard that physicians worried flaws in the system could result in patients being sent home “with the wrong drugs, doses or instructions,” according to the suit.

Things got so bad that local doctors were threatening to admit patients elsewhere unless the hospital fixed the software problems, according to the suit.

In a statement, CHS said it had “complete confidence” in its records systems. “The allegations made in the lawsuit against our hospitals are completely without merit,” the company said. Medhost denied its software has flaws, noting in its : “Hundreds of facilities have successfully used our software over the years and continue to do so today.”

Few in the industry seemed surprised by such allegations. When news of the eClinicalWorks case broke, Farzad Mostashari, who led the ONC from 2011 to 2013, : “Let me be plain-spoken. eClinicalWorks is not the only EHR vendor who ‘flouted certification/misled’ customers. Other vendors better clean up.”

The Electronic Health Record Association, a trade group that represents more than 30 vendors, did not respond to a request for comment. However, vendors have argued that they faced a tangle of regulations that required them to meet constantly shifting standards that government officials often could not explain.

ONC officials declined to answer written questions. But in a statement, ONC said it takes steps to ensure that products “are safe for patients and usable by providers.”

System Glitches And Accusations Of ‘Gaming’ The System

While the ONC sets the standards, the federal Centers for Medicare & Medicaid Services (CMS) had the job of paying doctors and hospitals that attested to meeting the “meaningful use” criteria. As of September 2018, CMS had paid out $38.4 billion in these funds.

In 2012, CMS hired accounting firm Figliozzi and Co. of Garden City, N.Y., which audited almost 50,000 medical professionals. Nearly 28% failed, despite the fact that they had previously attested to meeting the standards. Hospitals did better, posting a 5% failure rate. CMS officials said they have recovered some $941 million in these improper payments. The losses to the Treasury are likely far higher because only 14% of the medical professionals and 40% of the hospitals receiving payments were audited.

Michael Arrigo, who has served as an expert witness in health IT-related fraud and medical malpractice cases, said that in some cases EHR vendors misled hospitals about the challenges of replacing paper records with computers.

Others rolled the dice, apparently hoping the program was so large and complicated that they were unlikely to be targeted for audit. “Sometimes [providers] got away with it until a whistleblower found out,” Arrigo said.

Reviewing state and federal court filings, Fortune and KHN found more than two dozen cases, many filed by hospitals against vendors, which depict chaotic EHR installations and safety concerns as they pursued meaningful-use dollars.

Parrish Medical Center, a 210-bed public hospital on Florida’s Space Coast, is one. In December 2010, the Titusville hospital contracted with McKesson’s Enterprise Information Solutions. One of America’s largest companies, McKesson said its product would be easy for doctors and nurses to learn and help them “deliver high-quality, safe patient care.”

But the deal collapsed, prompting a bitter court battle in which the hospital repeatedly assailed McKesson’s competence. For instance, the hospital alleged that bugs in the software caused it to create more than one record for the same patient, a flaw dubbed a “major safety issue.”

An expert hired by Parrish said he contacted eight other hospitals, including three in Florida, which had dumped McKesson due to what he called “poor or unsatisfactory customer service.”

The medical staff at one of those hospitals was “up in arms” because it took 63 mouse clicks to look up a patient’s lab results, according to the expert’s report.

Parrish later signed on with another EHR vendor and the suit has since been settled. Both Parrish and McKesson declined to comment for this story. McKesson sold its health IT business to Allscripts in October 2017. Earlier this year, Allscripts reported to the Securities and Exchange Commission that government attorneys have requested documents from the company as part of an investigation into McKesson’s certification.

In another lawsuit, Weirton Medical Center, a hospital in West Virginia, stated in a court filing that it submitted “inaccurate” meaningful-use data to the government ― though it blamed the vendor. The hospital alleged the system failed to identify a patient who was critically ill and in the hospital. The hospital declined to comment to KHN and Fortune about the case, which has been settled.

Hamstrung By Technology?

ONC officials said they keep no log of complaints they receive.

A published in JAMA this month found that 40% of the software that ONC singled out for post-marketing review had flaws that could lead to patient harm, including inaccurate drug codes, information displaying incorrectly and decimal points gone missing.

That’s “a concerning number, and we have to do something to address that,” said researcher Raj Ratwani, the director of the MedStar Health National Center for Human Factors in Healthcare and a co-author of the study. These systems were used in 786 hospitals and by 37,365 provider organizations, according to Ratwani, who said there’s no way to know how many defects have been fixed.

ONC has about 100 pieces of once-approved software products. But most were tiny market players that had few or no users and went out of business. PlatinumMD, which had just 48 “meaningful” users, is an example. In a 2014 whistleblower lawsuit, San Diego urologist Dr. Scott Brown alleged that PlatinumMD filed for $18,000 in subsidies on his behalf even though it had not yet fully installed his EHR. In February 2016, the defunct company’s owners settled the case without admitting liability by paying the government $180,000.

Another 132 government-certified products have been flagged for corrective action due to “non-conformities.” As for the technology that the government alleges was fraudulently certified, it’s still used in health care settings across the country.

While those vendors faced multimillion-dollar settlements and now must operate under the oversight of a government monitor, their technology was not taken off the market. Nor were they dumped by many customers who, for the most part, however dissatisfied, were stuck with it.

ONC seemed to acknowledge that decertifying a large vendor would cause a major disruption, noting in an October 2016 regulation: “Our first and foremost desire would be to work with developers to address any problems.”

In the regulations, ONC cited the costs medical providers would face should their EHR vendor shut down as ranging from $33,000 to as much as $650 million.

“It is very difficult to switch product,” said Steve Waldren, chief medical informatics officer for the American Academy of Family Physicians. “You couldn’t just go down the street and pick up another EHR, put it in and move your data over.”

He noted that beyond the considerable cost of the technology, providers would have to take time to learn a new system.

“ONC does seem to have a stance that removing some of these players from the market would be very disruptive,” said Brad Ulrich, a Tennessee health IT expert. “They are almost too big to fail.”

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‘An Arm And A Leg’: Real Lessons Doctors Can Learn From Fake Patients /news/an-arm-and-a-leg-real-lessons-doctors-can-learn-from-fake-patients/ Wed, 24 Jul 2019 09:00:23 +0000 https://khn.org/?p=976333 Can’t see the audio player? 

Sometimes doctors get the “medical stuff” right while patients still get the wrong care.

That’s one finding from a study that sent fake patients — actors wired with recording devices — into real doctors’ offices.

When the “patients” walked into the doctor’s office to tell their story, physicians were often laser-focused on biomedical issues. But the physicians often missed the psychosocial problems that can be a barrier to good health.

Does the underweight, middle-aged man really need to undergo a battery of expensive tests and get screened for cancer? Instead, maybe he’s experiencing food insecurity and needs a referral to the local Meals on Wheels program.

Researchers from the University of Illinois at Chicago recorded hundreds of interactions between these actor-patients and doctors and then analyzed those conversations. They documented medical errors that can result in unnecessary, unhelpful care — and add hundreds of dollars to the cost of a doctor’s visit.

On Episode 7 of “An Arm and a Leg,” meet a doctor who had his listening skills tested and the actor-patient who put the doctor through his paces.

Season 2 is a co-production of Kaiser Health News and Public Road Productions.

To keep in touch with “An Arm and a Leg,” . You can also follow the show on Ìý²¹²Ô»åÌý. And if you’ve got stories to tell about the health care system, the producers .

To hear all Kaiser Health News podcasts,Ìýclick here.

And subscribe to “An Arm and a Leg” on ,Ìý,ÌýÌý´Ç°ùÌý.

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New Rules Will Ease Patients’ Access To Electronic Medical Records, Senate Panel Says /news/new-rules-will-ease-patients-access-to-electronic-medical-records-senate-panel-says/ Tue, 26 Mar 2019 11:01:36 +0000 https://khn.org/?p=931643 [UPDATED at 2 p.m. ET on March 26]

The chairman of the Senate health committee on Tuesday backed new federal regulations to remove roadblocks patients can face in obtaining copies of their electronic medical records.

“These proposed rules remove barriers and should make it easier for patients to more quickly access, use and understand their personal medical information,” Lamar Alexander (R-Tenn.), chairman of the Health, Education, Labor & Pensions Committee, said in a statement prepared for a hearing on the rules that kicked off Tuesday at 10 a.m.

The rules, proposed last month by the Department of Health and Human Services, take aim at so-called information blocking, in which tech companies or health systems limit the sharing or transfer of information from medical files.

Alexander said HHS believes the new rules should give more than 125 million patients easier access to their own records in an electronic format.

“This will be a huge relief to any of us who have spent hours tracking down paper copies of our records and carting them back and forth to different doctors’ offices. The rules will reduce the administrative burden on doctors so they can spend more time with patients,” Alexander said.

The proposal requires manufacturers to fashion software that can readily export a patient’s entire medical record — and mandates that health care systems provide these records electronically at no cost to the patient.

Congress jump-started the nation’s switch from paper to electronic health records in 2009 using billions of dollars in financial stimulus funding to help doctors and hospital purchase the equipment. Officials expected the shift to cut down on medical errors, reduce unnecessary medical testing and other waste and give Americans a bigger role in managing their health care.

Yet in the decade since the rollout, critics have argued that the government spent billions financing software that can cause some new types of errors and typically cannot share information across health networks as intended.

“,” a recent investigation published by KHN and Fortune, found that the federal government has spent more than $36 billion on the initiative. During that time, thousands of reports of deaths, injuries and near misses linked to digital systems have piled up in databases — while many patients have reported difficulties getting copies of their complete electronic files.

Sen. Patty Murray (D-Wash.), ranking member on the committee, cited two patients profiled in the article to illustrate the potential dangers from EHRs that can’t exchange information.

“It’s patients who get hurt. Like the man in California, who suffered brain damage after his diagnosis was delayed because a hospital’s software couldn’t properly interface with a lab’s software,” she said at the hearing. “Or the woman in Vermont, who died of a brain aneurysm that might have been caught if a software problem hadn’t stopped the order for a test she needed.”

Jonathan Lomurro, a medical malpractice attorney in New Jersey, said his clients usually have to go to court to get their complete medical record. The information that health care providers fight most bitterly to keep from them, he said, are the audit logs — or the data that show every time a record has been accessed or edited, and by whom and when.

That “metadata,” he and other plaintiff attorneys argue, is critical for patients to understand the history of their care, particularly in cases where something has gone wrong.

In an interview prior to Tuesday’s hearing, Lomurro criticized the HHS proposal, saying it limits a patient’s ability to obtain these logs. While the proposed rule requires the systems to share most data from a medical record with a patient, it excludes audit trails from that classification.

“While the proposal talks about the need of patient access … they then strip the greatest protections from the patient,” said Lomurro. “I am at a loss on how this could ever be a beneficial change to the rules and help patients.”

Seema Verma, who heads the Centers for Medicare & Medicaid Services, agreed that patients should be entitled to audit log information. “At the end of the day, it’s all of the patient’s data. If it affects and touches their medical record, then that belongs to them,” Verma said in an interview last month.

The HHS proposal also encourages doctors and other users of EHR technology to share information about software problems they encounter by prohibiting “gag clauses” in sales contracts. Critics have long argued that the clauses have prevented users from freely discussing flaws, including software glitches and other breakdowns that could result in medical errors and patient injuries. In 2012, an Institute of Medicine report blamed the confidentiality clauses for impeding efforts to improve the safety of health information technology.

But a major remaining problem in wiring up medicine is the lack of interoperability across rival data systems, said Christopher Rehm, chief medical informatics officer of LifePoint Health, a hospital system in Brentwood, Tenn. In testimony prepared for the Tuesday hearing, Rehm called it “the equivalent of telling people they must buy cars and move those cars from place to place, but there are no roads and no agreed-upon design for the roads, let alone the funding to actually pay for the construction.”

According to Rehm, the average-sized community hospital (161 beds) spends nearly $760,000 a year on information technology investments needed to meet federal regulations. He said the costs “are crushing our industry where margins are already thin.”

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