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POLICY & MANAGEMENT

ISSUE: 10/2008 | VOLUME: 34:10

FOCUS Takes Aim at Safer Cardiac SurgeryMulti-hospital Program To Probe Best Practices for Heart Patients

Larry Beresford

A major long-term patient safety initiative aims to reduce human error in the cardiac operating room. Sponsored by the Society of

Cardiovascular Anesthesiologists (SCA) Foundation, the goal of the project is to identify sources of medical errors and near misses in

the OR, then find ways of reducing these risks.

The Richmond, Va.based foundation, which raised $3 million for patient safety and research since its creation in November 2007, has

committed $500,000 for the first phase of the Flawless Operative Cardiovascular Unified Systems (FOCUS) initiative, which will be

rolling out ORs at five hospitals over the next several months. Observation and analysis will be conducted by the Quality and Safety

Research Group at The Johns Hopkins School of Medicine, in Baltimore, led by Peter Pronovost, MD, a nationally recognized leader in

ICU safety.

Lessons From the Military

FOCUS makes considerable use of human factors

engineering, a field that emerged during World War II from

efforts by the U.S. military to make aviation safer. The

initiative combines psychology and ergonomics for

deciphering and applying properties of human capability

and performance.

Scott Shappell, PhD, a consultant to the project and

professor of industrial engineering at Clemson University,

in South Carolina, said human factors engineering comes

into play in the OR when, for example, certain alarms are

designed to sound louder and more insistently than other

lights, bells and whistles in the surgical setting, or when

drug vials carry distinctive labeling to prevent personnel

from mistakenly administering the wrong drug.

Dr. Pronovosts broadly multidisciplinary team will visit the

five FOCUS hospitals for a day or two, reviewing policies,

procedures, error reports and outcomes data; interviewing

staff; and observing surgeries. These data will be

integrated into a meaningful framework for identifying the

greatest opportunities for improving patient safety.

The Hopkins group will bring anthropological attention to the cultures of the insular tribes that inhabit the cardiac OR, and observe how

they communicate with each other. We need a multidisciplinary approach, using clinicians, epidemiologists and social scientists, Dr.

Pronovost said. The strategy is to get in and understand whats really going on in the OR in a robust way.

Based on results from the visits, a second round in a larger group of approximately 20 hospitals will start in early 2009 to try out some

of the most promising ideas for improvement. Eventually, a self-study guide will aid other hospitals in repeating the process of

investigating problems in their own operating rooms. Other stakeholders, including cardiac surgeons, perfusionists, nurses, and groups

such as the American Society of Anesthesiologists and the Anesthesia Patient Safety Foundation, will be involved. Initial results will be

reported at the April 2009 SCA annual meeting in San Antonio, while journal articlesthe currency of change in medicinewill be

drafted.

What Will They Find?

The FOCUS principals emphasize that they will be receptive to whatever emerges from the observation of working ORsalthough they

have some ideas about what they might find. Dr. Pronovost, winner of a 2008 MacArthur fellowship for his efforts to improve patient

safety in the ICU, said he expects to see many clumsy human factors, from equipment design and layout to overcrowding, that are ripe

for improvement. Specific risks from medication errors and anesthesia interventions, as well as opportunities for standardization and

enhanced efficiency, also are likely to surface. Institutional policies may favor production pressures and throughput over quality and

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safety concerns. We may end up breaking down the OR and rebuilding it in simulation in the way it ought to be designed, he said.

Other likely goals include allowing every member of the surgical team to recognize and voice problems as they occur, and preventing

interruptions such as phone calls in the OR, which have been shown to produce negative outcomes from surgery. FOCUS may also

produce checklists, which Dr. Pronovost has brought to ICUs and similar settings with good effect.

There are physical obstacles, such as not being able to see monitors without physical contortions and literally tripping over wires,

noted Joyce Wahr, MD, a retired anesthesiologist who chairs the SCA Foundation board. Ive preached for 20 years that we need

computerized bar-coding and recognition of every syringe used in the OR.

This effort will go on for years, we hope, added Bruce Spiess, MD, an anesthesiologist at Virginia Commonwealth University inRichmond, who conceived and chairs the FOCUS project. It will take a number of years to get deeply into the root cause analysis.

Dr. Spiess said he hopes the project will inspire other researchers to conduct more specific testing of the themes identified, using

FOCUS data as a benchmark. Some of the findings also may have applications in other medical sectors. The project could affect the

working lives of anesthesiologists within a year, he added, as results begin to be published.

Over the next five years, they will see FOCUS become a household word, Dr. Spiess said. We hope it will become the industrywide

standard for continuous self-study and improvement, ingrained into the culture of cardiac ORs, such that preventing human error

becomes a major focus of everything we do.

Not About Blame

The project leaders emphasize two key messages for the field from this large-scale, long-term initiative. FOCUS, they said, is not

intended to generate blame of individual surgeons, anesthesiologists, perfusionists or other clinicians for their mistakes. Instead, it is

designed to identify how current systems facilitate medical errors and redesign those systems to reduce errors. Nor do the FOCUSresearchers consider the cardiac OR, or cardiovascular anesthesia in particular, hotbeds of quality problems.

In 2000, the landmark Institute of Medicine report To Err is Human: Building a Safer Health System brought national attention to

problems of patient safety, with its estimate that up to 98,000 people die every year from medical errors in hospitals.

I dont think we have any idea what those numbers are for cardiac surgery, Dr. Spiess said. But I have seen any number of bad things

happen in the operating room. I have seen people killed. I have given the wrong drug myself. I dont think I killed anyone, but bad things

could have happened.

Examples of the dangers of medical errors in the cardiac OR include when the medical team forgets to administer heparin in an

emergency or neglects to turn on the ventilator when the patient is weaned from bypass.

Every experienced anesthesiologist can name four or five instances where they made a human error, added Dr. Wahr, which either

was captured and corrected, or it wasnt. We all make these errors, which seem to pop out of nowhere in a split second of lack of

attention, sometimes with devastating results. Everybody wants to stop the person who made the errorbut these are dedicated,

hardworking professionals. I tell residents: Only if we admit errors and look them in the eye can we get better.

At the Tipping Point?

In the broadest sense, I think were at a momentous point in medicine, where the technology has gotten incredibly effective and

complex, said Thor Sundt, MD, a cardiac surgeon at Mayo Clinic in Rochester, Minn. I believe the next major improvements in cardiac

care are less likely to come from improvements in medical technology than from advances related to human interactions, social skills

and teamwork. I think part of the answer from FOCUS will be a more effective team. There is so much leverage in effective teamwork

that its just staggering.

Alan Merry, a cardiovascular anesthesiologist in Auckland, New Zealand, and a consultant to the World Health Organization on patient

safety issues, called FOCUS an extremely commendable, proactive initiative and a good example of anesthesiologys tradition of

pursuing safety improvements. Cardiovascular anesthesiology has made huge progress in the last 20 years, but the real question is:

How safe is safe enough? The answer has to be: Very safe, and were not there yet.

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