Patient safety in the balance

Questions mount about EHRs and a wide range of patient safety concerns
By Neil Versel
02:52 PM
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With Stage 2 of a planned three stages just barely underway, it probably is too soon to assess the overall effect of the $27 billion federal EHR incentive program known as meaningful use. But critics of the current state of health IT are becoming more vocal, particularly as evidence, both scientific and anecdotal, mounts, questioning whether EHRs truly are improving patient safety.

A lengthy story in the July 20 issue of the Boston Globe hit on many of the problems.

• The newspaper attributed a 2010 death at South Shore Hospital in Weymouth, Mass., to an overdose of insulin, caused by nurses administering multiple orders from an electronic and a paper-based system, each signed by different physicians.

• As the Globe pointed out and as Healthcare IT News reported earlier this year – the ECRI Institute listed health IT data integrity failure as its top patient-safety concern for 2014. "Health IT systems are very complex," James P. Keller, the organization's vice president of technology evaluation and safety, wrote in the report. "They are managing a lot of information, and it's easy to get something wrong."

No. 2 on the list was poor care coordination, followed at No. 3 by errors in reporting of test results, two conditions that health IT is supposed to remedy.

• Politics often trumps patient interests, and the Globe suggested that the Obama administration is beholden to health IT vendors. Epic Systems CEO Judith Faulkner and then-Allscripts CEO Glen Tullman supported Barack Obama's 2008 presidential campaign, and Tullman's support goes back to Obama's 2004 run for Senate. Once in office, Obama brought in former Cerner board member Nancy-Ann DeParle to run the White House Office of Health Reform, and later made her his deputy chief of staff for policy.

• The Obama administration also ignored the recommendations of the Institute of Medicine, which, in 2011, called for mandatory reporting of health IT-related "deaths, serious industries and unsafe conditions" to a federally designated watchdog. Those reports, stripped of patient and provider identifiers, should be released to the public, the IOM said. 

However, the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission said in a joint report this year that there would be no such mandate over EHRs, e-prescribing and computerized physician order entry systems. Instead, the report, called for in the 2012 Food and Drug Administration Safety Innovation Act, known as FDASIA, that HHS set up a Health IT Safety Center for confidential, voluntary error reporting.

The Globe also questioned the value and pace of meaningful use and the incentive money. "[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," the paper said.

The Globe did mislead readers in stating, "estimates of cost savings have thus far turned out to be dramatically overblown." In fact, supporters of the 2009 Health Information Technology for Economic and Clinical Health Act, which authorized the incentive program, did not expect to realize the promise of EHRs until Stage 3. The third stage will not start until at least 2017.

Still, members of Congress are getting restless, seeking value for all the Medicare and Medicaid incentive money Uncle Sam has shelled out since 2011, a total of $24.7 billion through the end of June. (The $27 billion estimate for the whole program represents a net amount, after factoring in expected cost savings.)

Much of the angst seems related to the slow pace of interoperability of electronic health data, and it's coming from both political parties. In July, Rep. Phil Gingrey, MD, R-Ga., said during a hearing, "It may be time for this committee to take a closer look at the practices of vendor companies in this space given the possibility that fraud may be perpetrated against the American taxpayer." A week later, the Senate Appropriations Committee, chaired by Sen. Barbara Mikulski (D-Md.) asked the ONC to "decertify [EHR] products that proactively block the sharing of information." 

Other critics outside the marble halls of the Capitol have pounced, too, hitting vendors and providers alike for interoperability and usability issues.

Vince Kuraitis, a Boise, Idaho-based consultant on digital health transformation and strategy, has argued recently that providers, have a "duty to share" patient information in the name of safer care. By extension, vendors should remove barriers to their customers sharing such data with those who use competing EHRs, Kuraitis says.

Kuraitis, a nonpracticing lawyer, tweeted in July that he was "Waiting for class action lawsuit testing liability for 'knowingly' NOT sharing pt #EHR data." He called it beyond negligent, bordering on reckless behavior, for healthcare providers to withhold records.

"There is the letter of the law and the spirit of the law," Kuraitis says. "In the case of health IT, there is a huge gap." 

Following only the letter of the meaningful use regulations, not the spirit, "hinders appropriate data sharing and interoperability," Kuraitis says.

Even if they wanted to engage in health information exchange, many hospitals and medical practices are hamstrung by their EHRs, which, in turn, might be hamstrung by health IT certification that is part of meaningful use. 

"They certainly have constrained innovation," Sarah T. Corley, MD, CMO of EHR vendor NextGen Healthcare, and vice chair of the HIMSS Electronic Health Records Association, says of the certification requirements.

Corley maintains that there has been "a lot of progress on interoperability," adding, "I think it's a little early in Stage 2 to say interoperability isn't going to work."

A number of vendors, including Cerner, Allscripts, athenahealth, Greenway Health, McKesson, Sunquest Information Systems and CPSI, came together in 2013 to create the CommonWell Health Alliance, ostensibly to promote interoperability. Many, however, have taken a more cynical view. 

"It's a coalition to compete against Epic," says Kuraitis. "It's Sun Tzu and 'The Art of War.'"

On the provider side, both Corley and Kuraitis say there must be a business case to share data with those who might appear to be competitors. Those instances are starting to appear.

"Obviously, in a referral, there is a business case," Corley says. The same is true in the context of an accountable care organization.

Population health management and liability fears also could drive HIE, according to Kuraitis, who believes that looking at data from external sources should be a standard of care. "I haven't seen any studies showing that data hoarding works as a business strategy," says Kuraitis, who expects HIE to be the norm in the next 5-10 years. "But this is one of the cases where the market can tip very rapidly," he adds.

It can't happen fast enough for Ross Koppel, a University of Pennsylvania sociologist who has long been critical of what he sees as complacency among major health IT vendors. "If we wanted systems to be useful," he says, "they would have started with that."

Koppel, who first reported in 2005 on how computerized physician order entry can actually raise the risk of medication error, says clinicians miss warnings because screens are cluttered. "The systems are definitely getting better, but they've still got state-of-the-art usability of the late 20th century," he says.

"There's no focus on unified data standards and data-format standards," Koppel continues. For example, he says, there is no uniformity about how to record blood pressure. Some systems have a single column for blood pressure, while others separate systolic and diastolic readings. This can be confusing for physicians who practice in multiple settings and a nightmare for IT departments when records do get shared between facilities.

Corley says certification and meaningful use also have a bearing on usability. "The growing concern about usability, part of it we can attribute to meaningful use," she says. The requirements force providers to perform "some things you wouldn't normally have to do."

EHRs have to prompt clinicians to ask patients about tobacco use, but doctors and nurses typically use words like "smoking" and "cigarettes" rather than "tobacco products," creating a bit of a semantic headache for vendors. "We're having to map them to Snomed," Corley says.

Additionally, patient education only counts toward meaningful use if it's suggested by the software, according to Corley. And prior to MU, patient reminders had typically been sent by practice management systems, not EHRs. "But that's not what's being certified," Corley says.

She expressed hope that CMS will take such concerns into consideration in Stage 3.