Hazards tied to medical records rush
Subsidies given for computerizing, but no reporting required when errors cause harm
Theresa Robertson’s bedside oxygen alarm sounded at 2:52 a.m., sending an urgent beep through the South Shore Hospital emergency room.
The alarm came as something of a surprise. The 46-year-old visual artist from Weymouth, who suffered from diabetes, congestive heart failure, and other serious health problems, had arrived at the nearby community hospital complaining of shortness of breath the previous afternoon. But by midnight, her vital signs were stable and she was resting peacefully.
Now, in the wee hours of Oct. 11, 2010, a new, more serious problem emerged. Four minutes after nurses responded to the oxygen alarm, Robertson had no pulse. The staff began pushing on her chest, racing to keep her alive.
The cause of Robertson’s crisis, it would later be learned, was a precipitous drop in her blood glucose — severe hypoglycemia. The deadly turn was the result of a medication error, lawyers for her family say, and that error can be traced in part to a major innovation in modern medical practice: electronic health records.
President Obama and Congress poured $30 billion in taxpayer subsidies into the push for digital medical records beginning in 2009, with only a few strings attached and no safety oversight of the vendors who sell the systems.
The move was touted as a way to improve patient care and help rein in medical costs. Five years later, the explosion in the use of the electronic records has created the potential for efficiencies and safety benefits but also new risks for patients, the scope of which still is not fully understood.
Academics, policy gurus, health care leaders, and patient safety advocates generally agree that the American medical system has long needed to abandon its old paper charts and catch up with the rest of the digital age. For instance, wider use of bar-coding in hospitals, matching patient wristbands with the drugs they are given, is creating a safer environment, specialists say.
But the scramble by doctors and hospitals to cash in on the incentives has thrust complex, balky, unwieldy, and error-prone computer systems into highly sensitive clinical settings at a record pace. From 2008 to 2013, the percent of US doctor’s offices with electronic health records rose from 17 to 48 percent. Growth in hospitals was even more dramatic, from 13 to 70 percent.
The scope and pace of change has been far beyond the capacity of medical institutions and government regulators to track, many officials and health care safety advocates agree.
Yet, facing staunch resistance to any regulation by the politically influential health records industry, the Obama administration has opted against mandatory reporting that would enable officials to track unsafe conditions, injuries, and deaths relating to these systems — to draw lessons, that is, from the tragedies of patients such as Theresa Robertson.
In her case, nurses gave her an excessive amount of insulin with three injections, over about two hours, that sent her glucose levels plummeting, her family alleges in a lawsuit.
Multiple orders issued
The nurses were acting in response to multiple orders for insulin that had been entered into two separate prescribing systems used by the hospital — one digital, one involving paper and a fax — and were listed under the names of different doctors, the lawyers said.
“The root cause is having two different systems that weren’t interacting with each other. It creates human error,” said Nicholas Cappiello, a malpractice lawyer at Lubin & Meyer in Boston who represents the family. “Essentially, the right hand didn’t know what the left hand was doing.”
South Shore Hospital said it stands behind the care it provided to Robertson. A spokeswoman for the Weymouth hopsital, said it is not accurate to claim that the use of electronic and paper health records at the same time was the “central issue” in the case, but she refused to discuss any details of the incident, citing requirements for patient confidentiality.
The hospital, pointing to the ongoing litigation, also declined to say what actions it had taken in the wake of Robertson’s death, including whether any doctors or nurses were disciplined.
Numerous adverse and even tragic incidents such as Robertson’s insulin overdose have been traced to errors related to electronic records.
One study of malpractice claims published this year, by safety researchers for a Harvard-affiliated malpractice insurance group, CRICO, produced an unsettling snapshot of the problem. The researchers sifted through a large database of malpractice claims from Boston and other health care centers around the country, looking for cases in which the use or misuse of electronic heath records was suspected of causing harm.
They found 147 instances in which electronic health records contributed to “adverse events” that affected patients — half of them designated as serious. The cases were culled from a one-year period of newly filed malpractice claims overlapping 2012 and 2013, a total pool of around 5,700 cases.
Forty-six of those events resulted in patient death, CRICO officials told the Globe — a toll that before now has not been disclosed publicly.
Faulty use of “hybrid” paper and electronic records (the sort of confusion-inducing circumstance at South Shore Hospital that is alleged by lawyers for Robertson’s family) was among the most frequently cited examples of harm in the review.
The analysts also identified as hazards: medical staff entering incorrect data; improper use of a computer’s “cut-and-paste” function to duplicate, without updating, daily notes on patients; and computer crashes that caused loss of data and left medical staff temporarily without access to critical records.
The study bolstered findings of an earlier review by a medical quality and safety group, the nonprofit ECRI Institute, which ranked electronic data hazards as the No. 1 patient safety concern for 2014. The Pennsylvania-based nonprofit analyzed voluntary reports of 171 events in 36 hospitals across the country — most causing harm to patients but also many “near misses.”
That study period spanned just nine weeks.
At least three of the 171 cases were suspected or confirmed to have resulted in a patient’s death.
Such devastating errors can be triggered not only by computer glitches that generate flawed information but also through human error compounded by poor systems design and sloppy implementation, both supporters and critics of the federal program told the Globe.
The systems can be complex, time-draining, and frustrating to use, especially early on. Hospital staff members routinely override automatic warnings, cut corners, and develop “workarounds” as they struggle to balance caring for patients with the demands of cumbersome drop-down menus and other forms that appear on their computer screens.
Savings not fully realized
This was not part of the promise when the Obama administration won passage of the massive subsidy program as part of the economic stimulus package in 2009. White House officials sold the concept with claims that widespread use of computers in hospitals and doctors’ offices would improve patient care and save tens of billions of dollars a year.
While making sense intuitively, those claims have yet to be realized, and the estimates of cost savings have thus far turned out to be dramatically overblown. What has become clear to specialists in the field is that medical errors and “near misses” related to digital records — many inconsequential, but some serious — are a threat that needs more attention.
In 2011, the Institute of Medicine said the lack of a central repository for reporting error-prone software, patient injuries, and deaths, combined with nondiclosure and confidentiality clauses in vendor contracts, “pose unacceptable risks to safety.”
It strongly recommended that the Obama administration mandate that vendors report “deaths, serious injuries, and unsafe conditions” to a centralized, government-designated entity. Such reports should be made available to the public, it said, without information that would identify individual patients and providers.
Three years later, no such reporting system exists.
The Food and Drug Administration, along with the Office of the National Coordinator for Health IT, the division of the Department of Health and Human Services in charge of distributing the subsidies for digital records systems, said in April that they do not intend to exercise safety oversight of clinical record-keeping or of computer systems that manage prescriptions. Nor do they plan to impose a system of mandatory death and injury reporting.
Voluntary reporting of adverse events to private safety associations, with no public disclosure, will remain the norm, the agencies said.
The industry — while supporting voluntary reporting systems — contends that mandatory reporting of injuries and death would discourage medical staff from revealing mistakes, for fear of repercussions.
“We have felt that reporting by both providers and vendors should be voluntary. That is most consistent with the notion of a learning environment,” said Mark Segal, the current chairman of the Electronic Health Records Association, a leading industry trade group, and a vice president at GE Healthcare, which markets digital records systems.
But critics say the government’s hands-off approach is wrong. It’s as though, they say, jetliner pilots were flying in poorly designed cockpits with malfunctioning equipment, and repeatedly slamming into mountains, while the Federal Aviation Administration and the National Transportation Safety Board decided not to regulate — or even keep a list of the crashes and near misses.
“There’s certainly got to be a focus on safety that currently does not exist,” said Ross Koppel, an adjunct professor of sociology at the University of Pennsylvania who has studied the systems extensively and whose warnings about patient harm have been published in respected academic journals. “You don’t have to kill somebody to know that the accelerator pedal is sticking.”
Records system vendors have insisted that academic studies analyzing safety issues be “blinded” so dangers are not publicly linked to specific systems, said Dr. David Bates, executive director of the Center for Patient Safety Research and Practice at Brigham and Women’s Hospital and a leading member of a government advisory panel. Bates is a foremost advocate for digital records adoption, but he is critical of the industry on key points regarding hazards reporting.
“Vendors have resisted in sharing of screen shots, and screen shots of safety issues,” Bates said in an interview with the Globe. “Vendors have blocked that.”
What information does trickle outside the walls of hospitals and executive suites is in the limited form of malpractice claims and internal hospital reviews following adverse events — reviews that are typically shrouded in confidentiality but are sometimes disclosed in litigation.
Health care authorities urgently need to fill in the blanks, said Dr. Alan Brookstone, a physician and cofounder of a service that rates the performance of digital records systems.
“Is this technology doing the job right? Is it doing it safely and accurately?” he said. “There’s almost like a missing link.”
Multibillion-dollar subsidies for electronic health records were part of a campaign promise Barack Obama made during the 2008 campaign. Installing the systems, he said, was crucial to reforming the health care system.
The goal was to make sure “medical records are actually on computers,’’ Obama said in an October 2008 debate against Republican John McCain, “instead of you filling forms out in triplicate when you go to the hospital. That will reduce medical errors and reduce costs.’’
The president’s call for change was rooted in digital innovations that began in Boston a half-century ago but failed to keep pace with the rest of the modern economy.
MIT and Harvard scientists experimented with computers to facilitate patient care and speed access to patient information at Massachusetts General Hospital in the 1960s, with government grants from the National Institutes of Health. They built rudimentary systems that transmitted data at the agonizingly slow rate of 10 characters per second.
By the 1990s and early 2000s, hospitals across the country used fast and modern computer systems for patient billing and administration. But the use of electronic records for tracking patient care and prescribing lagged. Thick paper files dominated clinical practice, even as other sectors of the American economy went digital.
Blame for the slow pace of change is often traced to simple economics: Doctors and hospitals had and largely still have little business incentive to become more efficient in the way they deliver care. Under traditional fee-for-service models, they just send bills to insurance companies or to Medicare and Medicaid, the big government entitlement programs.
Any savings or efficiencies would benefit the insurers paying the bills — not the providers. So why should providers invest hundreds of thousands or even millions of dollars in computer record management systems?
“Computerization in health care was a market failure,” said Dr. Robert Wachter, a physician and medical school professor at the University of California, San Francisco. “The idea that you would need a federal incentive program to get United Airlines to computerize or Walmart to computerize is laughable.”
In Washington, a groundswell built in the 2000s to solve that market failure with billions in federal cash, led by lawmakers such as the late Senator Edward M. Kennedy of Massachusetts.
Researchers, including a cadre of digital medicine gurus in Boston, argued that electronic health records were a prerequisite of health care market reforms.
Among the most prominent of these academics was Harvard professor David Blumenthal, the former head of health information systems at Partners Healthcare — the corporate parent of Massachusetts General Hospital and Brigham and Women’s Hospital and the umbrella group for the biggest health care network in Massachusetts.
Blumenthal advised Obama on health care policy during the 2008 presidential campaign. He co-authored Obama’s campaign forecast that wiring the health care economy and other reforms would save the “typical American family” $2,500 a year.
Soon after the election, Blumenthal went to work for the Obama administration. He became head of the Office of the National Coordinator for Health IT, putting him in charge of deciding how to dole out the $30 billion in subsidies that Democrats pushed through in early 2009 as part of the $787 billion economic stimulus package.
Individual physicians can receive up to $44,000 over five years for installing the systems and showing they meet minimum performance standards. Hospitals get between $2 million and $6.3 million. That’s the carrot. The stick is a system of financial penalties, in the form of reduced Medicare reimbursements, for providers who are not operating on the new systems after 2015.
The overriding consideration at the time was getting the computer systems in place, not regulatory oversight, because most academics and industry officials believed the computers would enhance safety, Blumenthal said in an interview.
“The overwhelming evidence was that electronic health records improve safety, and I still think that is going to be the case,” he said.
Blumenthal, who returned to Harvard in 2011 and now runs the Commonwealth Fund, a health policy foundation in New York, likened challenges encountered in the massive launch of electronic health records to the early days of President Dwight Eisenhower’s plan to lace the country with interstate highways.
“If you had gone and looked at the Eisenhower highway system in 1959, it was nowhere near completion,” he said. “Road safety was inadequate. The cars on it were polluting and dangerous.”
Obama and the Democrats, meanwhile, have received support from heavy-hitting campaign contributors from the digital records industry, some of which has been reported in the news media and by conservative bloggers.
Paul Egerman, an entrepreneur from Weston who founded and sold two digital health care companies, has contributed heavily to Democrats and is a “bundler” of campaign donations who raised money for Obama’s reelection in 2012. He serves on a key administration advisory panel for health records, the Health IT Policy Committee.
Egerman hosted a fund-raiser featuring the president at his Weston home in June, benefiting the Democratic Senatorial Campaign Committee. Egerman did not respond to a request for comment.
Judith Faulkner, the chief executive of Epic Systems, which makes the software used by the most physician offices in America, is a longtime supporter of Congressional Democrats, including Massachusetts Senator Elizabeth Warren. She contributed to Obama’s first presidential campaign and also served on the Health IT Policy Committee, alongside Egerman, advising Blumenthal and his successors. Faulkner declined a request for an interview.
Glen Tullman, the former chief executive of digital health records company Allscripts, based in Chicago, was a major Democratic contributor and technology adviser to Obama’s 2008 campaign. Tullman began contributing to Obama’s political campaigns in 2004; business profiles of Tullman have reported how he worked out at the same gym and played basketball with the future president. Tullman did not respond to a request for comment.
Inside the White House, Obama brought on board a key health care adviser with strong ties to the electronic records industry.
Nancy Ann DeParle, a former Clinton administration official, spent eight years on the board of e-records company Cerner, from 2001 to 2009.
In the three years before she quit the Cerner board to join the administration in 2009, Cerner paid her $591,000 in cash and company stock. In an interview, DeParle pointed out that she arrived in the administration after the $30 billion in incentives had already been passed by Congress.
Doctors’ software struggles
As the Obama administration settled into Washington, the influence of the health records industry trade organization, the Health Information Management System Society, and its offshoot, the Electronic Health Records Association, quickly grew.
Their representatives said in interviews that the rapid growth of digital records in physician offices and hospitals since 2009 is solid proof the Obama incentives worked. Sales of such systems are expected to grow another 7.1 percent next year and reach $9.3 billion by the end of 2015, according to tech consulting firm Accenture.
“All of the concerns and issues that need to be addressed need to be balanced out against that kind of fundamental success,” said Segal, the GE Healthcare executive who is chairman of the Electronic Health Records Association. “The landscape has entirely changed.”
But surveys show many physicians are unhappy with that landscape. One large poll of doctors showed an increase in those who were “very dissatisfied” with their digital systems grew from 11 percent in 2010 to 21 percent in 2012. The number in the same survey who said they were “satisfied” dropped from 39 percent to 27 percent.
Medical professionals told the Globe in interviews that they don’t want to go back to paper charts — computers are better.
But they also want computer systems that work better.
“These are not programs that you would see Steve Jobs designing. It’s very nonintuitive. I can’t figure out where to find key pieces of information,” said Darshak Sanghavi, a Massachusetts pediatric cardiologist and fellow at the Brookings Institution.
At his 10-physician family practice in Hamilton and two other North Shore towns, Dr. Hugh Taylor, an early adopter of the digital records and a big supporter, said even he finds them frustrating to use — with complex drop-down menus for prescriptions and multiple boxes listing symptoms to check. Physicians struggling with the software, he said, call it “death by a thousand clicks.”
But vendors have not had a strong incentive to improve, Taylor said, because once physicians purchase a system and have all their old patient data entered into the computers, they are stuck, with little ability to shop around and switch because of technical and financial barriers.
The number of companies selling such systems to physicians has skyrocketed to more than 700 — making picking the right system difficult for busy physicians.
“There’s a lot of fly-by-night health information companies who started an electronic health record product to reap government subsidies,” said Dan Haley, vice president for government affairs and a registered lobbyist for athenahealth inc., a health IT company in Watertown. “This is a rich pot of money put on the table.”
Some worry many of those companies will go out of business once the incentives run dry.
David Brailer, former president George W. Bush’s health records czar and a staunch advocate for the electronic records systems, said the Obama stimulus money turned a market that was growing organically, if more slowly, into a “Frankenstein.”
“It’s a government-funded bubble,” Brailer said. “What do we do for doctors who bought (in under) the subsidy program and now their vendor is not around?”
Congress triggered another lobbying flurry when, in 2012, it told the Department of Health and Human Services to come up with a regulatory framework for digital records, and the department convened a working group to study the issue.
The panel turned out to be loaded with industry representatives, including executives from Cerner and Philips Healthcare, two of the largest digital records vendors. The result was predictable, one participant said: industry domination.
“The whole show was pretty much directed by a lot of these people who are in the field, the industry people,’’ said Mary Mastenbrook, a former FDA medical device safety investigator who volunteered as a consumer representative on the workgroup.
The workgroup recommended in September 2013 that the FDA and the Office of National Coordinator for Health IT maintain their hands-off approach to regulating electronic health records. It added that workgroup members “generally endorse” mandatory reporting. But that was only mentioned in passing — in a tiny footnote — buried on the bottom of the 42d slide of a PowerPoint presentation.
In April, the FDA and ONC came out with proposed regulatory framework. The recommendation for mandatory adverse event reporting, sought three years ago by the Institute of Medicine, was nowhere to be found. The current national coordinator for Health IT, Karen DeSalvo, declined to explain why mandatory reporting was left out.
“It’s a draft,” she said.
The FDA also did not answer when asked why it did not adopt mandatory reporting. It said the voluntary system it proposed will permit the government to assemble the necessary data.
Deadly errors, costly fixes
Some major errors relating to computerized medical records have found their way into headlines. In Chicago, a pharmacy technician typed incorrect information into a computer, resulting in the death of a premature baby boy who was injected with excessive sodium chloride.
In Rhode Island in 2011, a hospital network said 2,000 patients might have been given ordinary doses of medication, when they were supposed to receive time-release versions. No injuries were reported.
But most reports do not receive media attention. The CRICO study of incidents was released this year in a relatively obscure journal, Patient Safety and Quality Healthcare.
It lists the myriad ways electronic records contributed to errors that affected patient care. A history of an aneurysm was left out of a patient’s record during a conversion from paper files to digital. The aneurysm burst and the patient died during a subsequent procedure because the physician was unaware of the history.
A medical staff member accidently opened up the wrong patient file — something that is fairly easy to do, say specialists — and ordered up medication for a different person. A computer crash causes nursing notes for an entire shift to vanish.
When Theresa Robertson went to the emergency room at South Shore Hospital in October 2010, she had a voluminous medical history, dating back to when she developed insulin-dependent diabetes as a young child.
She was legally blind. She had received a transplanted kidney, donated by her sister, a few years earlier. She had congestive heart failure. She had coronary artery disease with a bypass. She had peripheral vascular disease with chronic ulcers on her left heel and ankle.
Multiple illnesses complex
Seriously sick people with multiple ailments create extra complexity for those using computerized medical records — with multiple screens to scroll through, long lists of medications, and numerous test results.
“The more complex the case, the more confusing the picture that electronic health record screens will present,’’ said Scot Silverstein, a health IT expert and safety activist who advises malpractice lawyers. “All it takes is one mistake in a complex and frail patient to seriously harm them or kill them.’’
According to a narrative provided in legal documents by Robertson’s lawyers, the quantity of insulin she received in the South Shore Hospital caused a “severe hypoglycemic episode.’’
Medical staff managed to get her heart started after her cardiac arrest, but it was too late. She was diagnosed with a shortage of glucose supply to the brain that caused serious brain damage.
Medical staff transferred Robertson from the emergency room to the intensive care unit, where she remained in a vegetative state. Family members, who declined to be interviewed, decided to withdraw life support.
She died Oct. 17, six days after arriving in the emergency room for shortness of breath.
For its electronic health records, South Shore Hospital contracted with two outside vendors: Meditech, a Westwood company that is among the largest in the industry and was co-founded by one of the early Mass. General researchers in the field, and DrFirst, a Maryland company that markets electronic prescribing software.
Both companies declined to respond to questions about the Robertson family claims.
In a promotional video filmed 11 months before Robertson arrived at the hospital, DrFirst’s chief strategy officer, Massachusetts cardiologist Dr. Thomas Sullivan, discussed South Shore as an example of institutions that were building new information systems in response to the $30 billion in government incentives.
“I have to admit, they’ve been catalyzed by the availability of billions of dollars now that we’ve never had before this past year,’’ Sullivan said.
“If there’s anything that makes people stand up and get interested in modernizing their health information technology,’’ he said, “it’s the sight and sound and the smell of funds from the government.’’