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March 30, 2009

Mistakes Happen
By Selena Chavis
For The Record
Vol. 21 No. 7 P. 20

As the recent failings in the VA’s EMR network indicate, even the most lauded systems can fail at times.

In January, the U.S. Department of Veterans Affairs (VA) made headlines when software glitches in the department’s electronic medical record (EMR) raised concerns about patient safety. Rep Bob Filner of California, chairman of the House Committee on Veterans’ Affairs, came forward saying he would investigate the errors that, according to the Associated Press, caused incorrect doses of drugs to be administered and treatment delays.

While the VA stands behind the computer system that managed more than 1.6 billion transactions in 2008, the event has garnered plenty of media attention and caused heads to turn in the industry.

“In the healthcare IT space, these [events] are mortal wounds. People just aren’t willing to cut the industry any slack when it comes to errors,” says Michael Christopher, managing officer at Oklahoma-based Healthcare IT Transition Group. “What you are seeing in healthcare are the growing pains that IT in other industries faced several years ago. The difference is that other industries were not faced with such sensitive information and the external threats we have today.”

The glitch affected medical data pertaining to items such as vital signs, lab results, and active meds, according to Associated Press reports. Findings suggest that information would pop up under the wrong patient’s name on the computer screen, and some records failed to display a physician’s stop order for a treatment.

As of February 20, there had been no reports or evidence of patient harm, but the glitches, which began in August 2008 after upgrades were initiated for the system and lingered until December of last year, were not disclosed to patients, leading to some distrust in the government and medical communities. Lack of disclosure was found for errors such as Heparin—a drug that can be life-threatening in excessive amounts—infusions for up to 11 hours longer than necessary.

Associated Press reports quoted Filner as saying that the “VA continues to discover problems and attempts to fix them quietly and internally, and then downplays them as inconsequential and nonthreatening. No one expects new software to operate perfectly, but confidence must be inherent in any electronic medical records system.”

Mary Alice Annecharico, MS, senior vice president and chief information officer with University Hospitals in Ohio and board director for the National Alliance for Health Information Technology, agrees, noting that “anytime we are involved in clinical records documentation systems and they are upgraded, it is incumbent on any organization, including governmental agencies, to make sure there is testing, testing, testing [before going live].”

“This is disturbing on a number of levels because of what could have happened,” said Veterans of Foreign Wars National Commander Glen Gardner in Associated Press reports. “Being told that no patients were harmed still does not absolve the VA from its responsibility to forewarn patients that something is amiss. Trust is paramount in doctor-patient relationships, and nothing should ever be allowed to undermine that confidence.”

Not the First Time
Having errors occur in an EMR system is certainly not something new—or indigenous—to U.S. health systems.

A Mytob worm attack on the network of Barts and the London NHS Trust last year caused the organization’s “major internal incident” plan to activate. Considered one of the most severe network failures to have occurred at an NHS hospital trust, the event caused some ambulances to be redirected. An interim report on the incident says clinical services were affected, and the protracted delays in getting the network back up created potential risks to patient care.

In November 2007, two female patients were scheduled for CT scans at a Dominican Republic hospital. Because of the test results, the first patient underwent an unnecessary appendectomy that evening. A radiologist later discovered the patient’s CT scan was actually that of a second patient.

The error was caused due to software incompatibility between the system used by radiology and that of the scan room, an issue that, according to The Joint Commission, should become a major focal point in HIT implementation projects.

In a Sentinel Event Alert published by the organization last December titled “Safely Implementing Health Information and Converging Technologies,” the organization noted that “as health information technology and ‘converging technologies’—the interrelationship between medical devices and HIT—are increasingly adopted by health care organizations, users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate. Technology-related adverse events can be associated with all components of a comprehensive technology system and may involve errors of either commission or omission. These unintended adverse events typically stem from human-machine interfaces or organization/system design. The overall safety and effectiveness of technology in health care ultimately depend on its human users, ideally working in close concert with properly designed and installed electronic systems.”

While the VA foul-up is not the first time there has been a software glitch associated with an EMR that affected patient care, the intense scrutiny of the event may be associated with the fact that it’s the first time an error has occurred over an extended period of time with definite impact on patient care. According to Annecharico, the fact that the VA has also experienced problems with the losses of sensitive data may be a  factor and may have exacerbated the situation. But, she says, the VA should be given credit for being a leader in the EMR movement, as it currently boasts one of the largest and most robust systems to date.

“The VA has cornered the market and jumped on the bandwagon quicker than the rest of the industry in its ability to share patient records,” she says, pointing out that the industry needs to be ready for this intense scrutiny on all fronts of data exchange. “EMRs are meant to enhance the patient experience, but there is a tremendous amount of scrutiny.”

All Eyes on Healthcare
In 2006, the U.S. Pharmacopeia MEDMARX database contained 176,409 medication error records, 1.25% of which resulted in harm. It is estimated that approximately 25% involved some aspect of computer technology as at least one cause of the error.

Currently an issue at the forefront of the medical community, medication errors and concerns over patient safety are expected to continue to place the HIT movement under close observation. Pointing out that errors are more likely to occur and are more difficult to fix under manual processes, Christopher notes that HIT has to mature at an extremely quick rate to overcome the potential for errors, as well as alleviate skepticism and create unity.

“There’s no precedent for this,” he says, adding that with EMRs, there is at least a robust system that can’t be broken to the same degree as that of a lost paper record. “We’re going to have to expect that there is going to be some catch-up and that some of it is human related. When RHIOs [regional health information organizations] kick in, we’ll see another swath of growing pains.”

Jane Horowitz, chief operating officer of the National Alliance for Health Information Technology, points out that the VA has been doing a relatively good job in the area of medication error improvements. In fact, it has seen its error rate improve between 85% and 87%.

“The concept of IT being a journey is extremely important as we discuss HIT,” she says, adding that six years ago, many healthcare professionals mistakenly saw HIT as the “silver bullet.” “Rather, IT is an enable to transform work processes. We’re really at the infancy stage in many ways when it comes to the implementation of these complex technology systems.”

Annecharico agrees, pointing to her hope that some components of the newly passed economic stimulus bill will increase the momentum to move national interoperability standards forward more quickly. “If you look at the stimulus bill, what the bill is saying is that we should look to the NIST [National Institute of Standards and Technology] certification process,” she notes. “This makes sense because we are already moving in that direction as a result of the HIPAA standards that healthcare has adopted since 2003.”

Nationally recognized standards are expected to enable the flow of information reliably, consistently, accurately, and securely, providing a foundation for how data are managed. Horowitz says that there are also other areas addressed in the bill, such as the formation of a standards committee that will give the national coordinator recommendations on standards, implementation specifications, and certification criteria that they develop, harmonize, or recognize as harmonized by another entity.

While standards are expected to help improve EMRs and their interactions with other systems going forward, Annecharico says vendors and the healthcare community need to continue to work together to create systems that reflect this effort. “Vendors are saying that they are willing to cooperate,” she says, adding that while vendors have an important role to play in patient safety, it’s ultimately the job of the healthcare organization to make sure systems work. “Each institution has a legacy of hardware and software to deal with. It is the institution’s responsibility once they accept a software package to validate it and make sure it’s doing what it needs to do.”

— Selena Chavis is a Florida-based freelance journalist whose writing appears regularly in various trade and consumer publications covering everything from corporate and managerial topics to healthcare and travel.


Medication Error Reporting: Lifesaving Initiatives
In 2002, the Institute for Safe Medication Practices and the Pediatric Pharmacy Advocacy Group issued pediatric pharmacy medication safety guidelines designed to reduce the incidence of medication errors among children.

In 2004, The Joint Commission adopted recommendations from the institute’s list of look- and sound-alike drug names for use in its National Patient Safety Goals.
In that same year, a national hazard alert was initiated by the institute for the immediate, nationwide replacement of Brethine (terbutaline) ampuls with available vials to avoid potentially fatal mix-ups with look-alike ampuls of Methergine (methylergonovine).

These policy and program changes are just a tiny sampling of what one organization’s medication error reporting database and initiatives have accomplished, according to Michael R. Cohen, RPh, MS, ScD, FASHP, president of the Institute for Safe Medication Practices.

“There are many different types of reporting programs,” Cohen notes, pointing out that the institute’s program had evolved into a national voluntary reporting program by the early 1990s. “I think the voluntary practitioner reporting program is a very effective approach. They [healthcare organizations] report an actual incident and give us as much information as needed. Because of people’s willingness to come forward, there have been a number of program and policy changes.”

It’s no secret that medication errors have been at the forefront of the national healthcare scene for a number of years—with good reason. FDA statistics suggest that more than 770,000 Americans are injured each year due to medication errors.

In light of the recent software glitch within the VA’s EMR system that resulted in medication errors concerning a number of patients over a period of several months, attorney David Szabo of Nutter McClennen & Fish suggests that organizations need to think about how to use medication error reporting in a productive way that causes cultural change and process improvement.

“Organizations are always going to focus on whether information is confidential or public,” he points out, adding that if information is kept confidential, the perception becomes more aligned with process improvement. “We have to get straight in our heads what we want accomplished and build the rules around that goal.”

Szabo cites the 1994 case in which a breast cancer patient at Boston’s Dana-Farber Cancer Institute died after receiving toxic doses of chemotherapy drugs. He says the error was not uncovered until a clerk found it while doing routine research of the patient’s stay. A media storm followed, but Szabo says the tragedy eventually became a culture-changing moment for Dana-Farber, which today ranks as a national leader in patient safety.

Being forthcoming with information in a responsible and productive way is typically the best advice for healthcare organizations, according to Szabo. “Claims studies by insurance companies reveal that if a mistake is made, lawsuits often follow when communication channels are closed … if a bond of trust has been broken in some fundamental way,” he notes, adding that healthcare has an obligation to disclosure. “There’s been a body of work done about whether candor is productive … and most research points out that candor is the best approach.”

— SC