Whitney Palmer

The Human Factor: Researching How Human Behavior Impacts Medical Errors

Published in the February 2004 AAMC Reporter

When patients enter a hospital for a routine examination or a surgical procedure, they go in with the assumption that they either will receive the proper medication or will be healed. No one expects to be harmed. Yet this is what inadvertently happens for some patients who enter the U.S. healthcare system each year.

According to a report by the Institutes of Medicine in 1999, anywhere from 44,000 to 98,000 people die in hospitals due to preventable mistakes. Logically, the number of people who are harmed each year by errors as simple as a miscalculated  drug does is much higher. It is estimated that in hospitals across the country, these mistakes cost between $17 million and $29 million each year, including additional care needed to correct the errors, lost household income, and disability.

But in addition to the monetary losses, hospitals are hurt by these errors because patients begin to doubt and become less satisfied with the healthcare system. In turn, health professionals grow restless and the quality of work falls, creating a vicious cycle that helps no one and can potentially harm others.

Research medical errors and “near misses”

Five years ago, Eric Thomas, M.D., MPH, a general practice internist, came to the University of Texas-Houston (UTH) with an interest in improving patient safety. He had previously researched and worked on this subject at Harvard University and wanted to continue his work at his university home, he says.

“I knew of [Robert] Helmreich at the University of Texas in Austin, and he’s worked on the relationship between teamwork and errors, primarily in aviation,” Dr. Thomas says. “He had developed activities for pilots to improve their teamwork, so we thought about ways to apply it to healthcare.”

Two years later in 2001, the Agency for Healthcare Research and Quality (AHRQ) requested applications for centers that would study patient safety, and the University of Texas Center of Excellence in Patient Safety Research and Practice was established.

As one of three patient safety centers across the United States (the others are at the University of Pennsylvania and Harvard), the UTH center is funded by a five-year $7.2 million AHRQ grant. Dr. Thomas is the principal, and Robert Helmreich, Ph.D., is the center’s director.

More than 30 co-investigators and consultants at the center contribute knowledge from several areas of medical research, including cognitive psychology, epidemiology, nursing and gynecology. These men and women are currently involved with five projects at the center, ranging from human-device-interactions to close-call reporting and error reductions.

Most recently, Dr. Thomas completed a project designed to study human factor errors in infant resuscitation in labor and delivery rooms. He and his team searched for teamwork behaviors, such as information sharing between physicians, discussions of facts and opinions, and workload management. They recorded 140 resuscitations and viewed them twice — the first time looking for the frequency of these teamwork behaviors and the second time for how the behaviors affected the level of care a patient received.

“We found that the behaviors directly correlated with the process of care,” Dr. Thomas says. “Not only were the doctors using the teamwork behaviors to prevent the mistakes, but when things went wrong, they were using them to manage the errors, also.”

But, Dr. Thomas says, the center is interested in more than errors that actually occur — the researchers also want to quantify the mistakes that almost happened. In another project, called Close Call Reporting and Error Reduction, the center gathers information about these “near misses,” such as an incorrect dosage sent from the pharmacy that a nurse caught and corrected. This data is much easier to accumulate because people are more willing to discuss it since no error actually occurred — there is no legal liability and no punishment involved, and it provides a bird’s-eye view into when and why errors happen.

One of the center’s goals, Dr. Thomas says, is to ensure the data gleaned from these projects is used to persuade hospitals and healthcare systems to train their providers in teamwork behaviors in order to minimize the amount of human factor errors in their institutions.

Perhaps the farthest-reaching initiative the UTH center has produced so far to meet this goal is the Safety Climate Survey. Designed to determine healthcare workers’ comfort with reporting and discussing medical errors, this survey is now used independently of the center.

The Institute of Healthcare Improvement (IHI) promotes the Safety Climate Survey on its Web site as a way to foster open discussion between hospital leadership and healthcare workers in an effort to decrease the error rate. Dr. Thomas says the survey allows the leadership to “get a better understanding of how doctors and nurses feel.” The IHI scores the surveys after the hospitals complete them and gives the institutions a breakdown of ways to most effectively reduce errors.

In addition, the IHI advocates “leadership walkarounds” — a time when hospitals leaders visit the units and talk to healthcare workers in this environment about safety issues, errors that occur, and possible reasons behind these mistakes.

A corporate point of view

Two years ago, an organization known as the Leap Frog Group, located in Washington, D.C., joined ranks with academic institutions, such as the UTH center, in an effort to highlight ways hospitals and healthcare centers could prevent mistakes. The group, a consortium of Fortune 500 companies and healthcare purchasers that have fused their purchasing power to promote patient safety, called these steps “leaps.”

In addition, the organization’s Web site gives patients a chance to research a hospital’s error performance before they decide which facility to use for any  medical care.

“We want to encourage patients to make more informed decisions about their healthcare,” says Clair Turner, Leap Frog’s director of communications.

Since 2001 when Leap Frog began harvesting data from hospitals in seven regions nationwide, the group has added another 15 areas (mostly along the East Coast and the Midwest) to its membership. In three years, the membership has grown from 75 hospitals to 1,085.

Leap Frog is in the process of launching another leap to reduce the risk of error for outpatients. The Physician Office Clinical Decision Support (POCDS) electronically reminds doctors to give their outpatients pertinent information, such as how often the patient should return for check-ups. POCDS will also alert doctors and tell them to call patients in an annual visit is needed.

The organization already has three leaps in place, and has garnered significant success with them since implementation in 2001. Roughly 40 percent of member hospitals already comply with one or more of the original leaps: a computer physician order entry system (CPOE), an evidence-based hospital referral (EBHR), and an ICU physician staffing system (IPS).

Briefly, the CPOE is an electronic system through which physicians can write prescriptions (rather than handwriting them). The CPOE will also alert a doctor is the prescription is likely to interact with something already in the patient’s system. The doctor must formally override the system to proceed with the prescription. Five percent of Leap Frog’s member hospitals already fulfill this leap, and another 17 percent have vowed to do so before 2005.

The EBHR requires hospitals to publish data about the number of high-risk procedures performed in the facility each year and the outcomes. This database gives patients an opportunity to objectively assess the odds of receiving quality treatment in the facility.

Lastly, the IPS asks hospitals to staff their ICUs with critical-care credentialed physicians who can respond to 95 percent of pages within five minutes. Already 24 percent of hospitals in Leap Frog’s 22 member areas comply with this leap. Turner says another 4.5 percent had pledged to comply before the start of 2004.

Regulating the non-human factor in human factors

The Food and Drug Administration (FDA) began paying attention to human factors in medical errors over a decade ago after several anesthesiology procedures in Colorado raised questions about the frequency and magnitude of human mistakes.

Rather than focus on actions taken by doctors and nurses in the hospital setting, the FDA has chosen to set standards for medical devices, say both Pet Carstensen, a systems engineer for the FDA and Dick Sawyer, an FDA human factors scientist. Both men work with the FDA’s Human Factors Program.

An FDA study conducted in 1990 discovered that 44 percent of all manufactured medical devices contained some sort of design problem that led to user error.

“A lot of these designs were counter-intuitive,” Sawyer says. “So, as a regulatory authority, we’ve placed tremendous emphasis on design because if most medical equipment is designed like the early VCRs that no one could program, they will be impossible to operate correctly.”

Since the early 1990s, the FDA has drafted voluntary standards for product design in the United States. Companies do face a large liability, however, if they don’t comply with the FDA recommendations — if an error occurs, the company could be responsible for any damages.

Most recently, however, Carstensen and Sawyer note, the agency is in the process of implementing international standards. These guidelines are targeted toward American companies that produce and market their projects in Europe but also sell them in the United States. If accepted, the standards, which have been well accepted by the international community, Carstensen says, could be in place by this spring. These companies wouldn’t be able to enter the American market without complying with the standards.

But FDA authority doesn’t extend beyond recommending improved design and labeling on medical devices, Carstensen says, so the agency has mainly combated human factors errors through educational endeavors, such as educational videos and meetings with company personnel. In addition, the FDA tries to educate doctors and nurses on the best way to find good medical devices.

“Getting doctors and nurses to ask the right questions is critical,” Sawyer says. “Get them involved in the purchasing — don’t do third-party-purchasing, and don’t make the decision of what to buy based on economics.”

Getting physicians who actually use the medical devices and are award of any pitfalls involved in the purchasing process could help reduce the number of avoidable human factors errors in each hospital setting, Sawyer says.

Whether these programs are conducted in an academic institution, a corporate environment, or a federal agency, the meaning and goal behind them are the same: to reduce the amount of human-related errors occurring in the healthcare system. Each initiative is designed to pinpoint the best ways to reduce the human impact on medical procedures and relieve any anxiety doctors and patients might have over even the most routine measures. And according to  Drs. Thomas, Turner, Carstensen and Sawyer, there are still many avenues open to hospitals on the road to improvement.

March 28, 2010 - Posted by wjpalmer | Healthcare, Politics | human-based medical errors, Institute of Healthcare Improvement, Institutes of Medicine To Err is Human report, Leap Frog Group, medication errors, reducing medical errors