The FOCUS Initiative

Executive Summary
Human error in medicine has been widely heralded as a major cause of morbidity and mortality. The Institute of Medicine published a blockbuster study in the 1990’s estimating approximately 100,000 deaths per year occur in the United States from human error in health care delivery. Government agencies, insurance carriers, legal groups, and medical societies are working to address the public’s and lay presses’ call to action.

In 2008, the Society of Cardiovascular Anesthesiologists Foundation (SCA Foundation) launched the Flawless Operative Cardiovascular Unified Systems (FOCUS) project. FOCUS is a groundbreaking research/practice effort to study human error in cardiac operating rooms.

Cardiac Surgery
Cardiac operating care takes place in a demanding and technologically advanced environment. Teams of highly trained medical professionals must perform complex tasks in concert. The potential for miscommunication and errors is immense. Yet, high rates of success and positive outcomes demonstrate teams’ mastery of modern medicine and technological achievement. Members of SCA are proud of our participation in this success—we believe that we can do even better.

FOCUS looks to the commercial aviation field and its high rate of success controlling human error through cockpit resource management (CRM) as we develop similar protocols in the operating theatre. CRM has become synonymous with human error reduction. John Nance, an Alaska Airlines Senior Pilot and commercial aviation consultant for ABC News recently said, “Individuals can and will forever commit errors, but teams have the ability to be flawless.”

Nance’s statement stresses the importance of a team’s ability to interact in healthy and productive ways. While CRM and mimicking the success of aviation protocol are not the entire answer to improving cardiac operating room success, they are excellent guides as our study uncovers more opportunities for successful change in surgery teams.

FOCUS is an on-going, multi-year (>20 year) project of research, self-study, innovation, and implementation. Dr. Peter Pronovost is leading the Quality and Safety Research Group at Johns Hopkins University (JHU) for our initial research. They administer questionnaires, interviews, and live observations in a technique known as Locating Errors through Network Surveillance (LENS). A variety of trained scientists are involved, including:
organizational sociologists,
human factors engineers,
industrial psychologists,
applied organizational psychologists,
clinical medical specialists, and
biostatisticians.
The JHU team has received wide acclaim for the successful application of this methodology in Michigan and elsewhere. SCA Foundation is proud to have them leading the FOCUS research.

Staging
A competitive, world-wide selection process weighed many aspects of health care and a large number of applicants to identify the finest research organizations with patient safety research experience . With the cooperation of these institutions, we will collect initial data from a range of possible practice scenarios and a broad geographic area. FOCUS is currently in its initial data collection phase.

This first round data will be gathered and analyzed to guide expansion of the project. Additional sites will be added to the study and practice recommendations made. Alpha and Beta tests will be conducted before changes are implemented.

We expect to create self-study guides in a few years that will enable other hospitals to conduct independent human error studies. Ideally, such data should circle back to the project to facilitate the overall goal of human error reduction in the cardiac operating rooms. FOCUS intends to serve as a leader in error reduction for not only cardiovascular care, but all of medicine.

Guiding Principles
Protect the privacy of institutions and individuals.
De-identify all data.
Maintain the highest scientific standards.
Maintain the ideologic spirit of the project.
Change medicine and create “flawless” patient care.
We cannot hope to change medicine unless we find areas for change in our daily practice first. From its inception, the vision for FOCUS has been to study cardiac anesthesia. It is impossible to understand cardiac anesthesia without understanding the entire cardiac environment:
surgery,
nursing,
perfusion,
anesthesia, and
the institutional matrix in which they exist.
Our success depends upon everyone’s cooperation. We are fortunate to have the benefit of input from advisors in each of these disciplines.
JHU has worked closely with their surgeons, perfusionists, and nurses to make sure the techniques are effective. The FOCUS Steering committee believes that this project will evolve into a unified whole through contributions from each of the major disciplines contributed through their society representatives.

We have a great deal of work ahead of us first. The current alpha phase will provide initial data, testing of research methods, and a demonstration of both the capabilities and implications of human error reduction research. We have carefully briefed government agencies and the World Health Organization on FOCUS. We’ve begun the work.

The Primary Investigator from each site has the research protocol, documents, JHU IRB approval, and other pertinent documents. We at the SCA Foundation and the FOCUS Steering Committee are available to answer any questions you may have. Communication is the key to success. Our goal is to be open and accessible.

We realize that participation in this sociologic study will be a unique departure from daily routine in many institutions. That being said, we took efforts to make planning for site visits as easy as possible. We wish to be as minimally intrusive as can. The JHU research team’s experience in studies like this has proven invaluable. We extend our gratitude to the institutions’ Primary Investigators who continue to facilitate communication and assure the success of this vital project. A successful start is important to the collection of meaningful data.

Thank you for your willingness to contribute to FOCUS. On behalf of all of our future patients, the JHU research team, your PI, and the SCA FOCUS Steering Committee, I thank you for your time and thoughtful contribution to this very important project.

Bruce D. Spiess, MD, FAHA
Chair, FOCUS Steering Committee

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