FOCUS Sets Priorities

By Bruce Spiess, M.D. and Joyce A. Wahr, M.D.

In 2009, the first year of the FOCUS research project, Dr. Peter Pronovost and the Quality and Safety Research Group (QSRG) at Johns Hopkins Hospital (JHU). completed an extensive review of the cardiac patient safety literature and reviewed the National Heath Service (United Kingdom) error reporting database, focusing on cardiac surgical errors. From this rich background, QSRG developed an in-depth, two-day observational process to research operating room factors that contribute to human errors. This observational process was conducted in cardiac operating rooms at five separate hospitals. At each of the five sites, surgeons, anesthesiologists, nurses, perfusionists, surgical technicians and hospital executive management personnel participated. Each individual completed extensive surveys on motivation and patient safety culture, and observations were conducted over several days at each site. The surveys and observations have been coded into a database and used to create a taxonomy of errors and to develop interventions. The data collected are both informative and distressing. For example, errors were made in nearly every skin preparation procedure, and in nearly every programming of the “smart” intravenous pumps. These errors were made despite the high level of motivation to provide flawless care by the OR staff who were surveyed. The data are currently being analyzed and will be presented in a series of publications over the next 6-12 months.

Although the full analysis of the observations will not be complete for some time, the FOCUS Steering Committee and QSRG have identified three priorities for interventions to improve patient safety.

1. Develop a learning collaborative within the cardiac surgical teams to enhance patient safety. This process will use the Michigan Keystone model developed by Dr. Pronovost and the QSRG team that has been so successful in eliminating catheter based infections in the ICU setting. The FOCUS learning collaborative will use reduction in wound infections as the metric that will inform us of how we are doing.

2. Develop a peer-to-peer assessment tool that can be used by operating room teams to assess their own safety performance, or be used by an invited visiting team to provide feedback regarding areas for improvement in safety. This non-judgmental, for-internal-use-only peer-to-peer assessment tool will be based on the highly successful WANO (World Association of Nuclear Operators) process that has made the nuclear industry a “highly reliable” industry.

3. Design the operating room of the future. Tackle the issues of equipment and OR design to improve the interfaces between humans and the machines they use to deliver patient care in the operating room.

The FOCUS committee is looking for more sites and individuals to get involved in the project, whether it is on a committee, on a workgroup of the three priorities above, or as a site for one of the workgroups. Committees that you can be involved in include Data, Fundraising/Grants, Public and Society Relations, Patient Safety Initiatives Liaison, Publications, Site Selection, Speaker’s Bureau, and Summit Planning. To get involved and for more details, contact the SCA Foundation at foundation@scahq.org or call John Melleky, Executive Director at 804-565-6324.

A FOCUS Update

By Bruce Spiess, M.D.

The FOCUS Initiative is making strong progress through the summer months. At the SCA Annual Meeting in San Antonio, the curtains were pulled back for a slight peek into the initial data regarding human errors in the cardiac operating rooms. At that meeting the data was described as “robust”, meaning a number of problems had been uncovered. We are happy to report that since the Annual Meeting, the remainder of site visits and follow-up questionnaires have all been completed. The Johns Hopkins University Center for Innovation in Quality Patient Care (JHUIQPC) is now hard at work collating the data and inputting it into computers for analysis. That process is huge. As part of their analysis, JHUIQPC has undertaken a review of the data using the National Reporting and Learning System from the United Kingdom, which is the largest known error reporting system in the world.

FOCUS will convene a meeting in Baltimore at JHUIQPC on August 13, 2009 for an initial review of data. At this meeting a number or representatives from the FOCUS leadership, data management committee and consultants will be present as well as the JHUIQPC team. Importantly, leadership from the Society of Thoracic Surgeons and AORN are expected to attend. Enthusiasm from other associations is growing so that we can all work together to improve patient care. Letters and phone contacts have been completed to AMSECT and we hope to solicit their participation/sponsorship of FOCUS in the future.

The committees within the FOCUS Initiative have been formed and their charges have been given to them. Notably, the publications committee is moving forward with a written process with regards to authorship and participation in publications from FOCUS data. This process should be available to all for review through our FOCUS web site. Once our August meeting is complete, we will develop our next steps based on the data obtained at our initial sites. To become involved as a volunteer with FOCUS, you can contact the SCA Foundation via email at foundation@scahq.org.

FOCUS – Our Next Steps

By Dr. Bruce Spiess

FOCUS is very excited to announce that all the initial hospital sites have been visited and observed. The human factors research team employs a number of tools (called “LENS’) that have undergone validation and testing prior to being used as research tools in the present project. FOCUS is very proud to partner with the JHU Center on Quality Patient Care not only because of their and Dr. Pronovost’s international reputation, but also because it allowed both groups to further refine these human factors investigational tools. The tools employ survey instruments distributed prior to site visitation, extensive interviews with the entire operating room team (anesthesiology, surgery, perfusion and nursing) as well as the administration, on-site observation of cases, and post visitation surveys and interviews. The on-site team in a 2 day visit, examines communications, breaks in flow, ergonomics of equipment, and other systems constructs, all with a FOCUS upon how a team performs in a highly complex environment. The data from the various LENS’ are now being coded and collated. In discussions with the JHU team we are told: “The data is very rich, and full of possibilities for interventions that to improve patient safety – ones that can be done relatively easily and soon, and some that will take more earnest work”. What that means we cannot tell at this time, but suffice it to say that there will be directions and conclusions that can be drawn form this original first look inside the cardiac operating rooms.
What are the next steps?

Clearly we must finish what we have set out to accomplish, the first gathering of data and its analysis. As stated throughout the formation of FOCUS, this will be a scientific, data driven medical and sociological intervention. Until the data is analyzed, it is hard to say what interventions should proceed or in what order we should invoke changes. Although there is much data collected already, only five, albeit carefully selected and representative, sites have been studied. The FOCUS steering committee envisions that more sites should be studied (5-20 more), and that the beginning of a self-study program should be initiated. The form of the self-study tools will grow out of the data through a combined effort of the JHU human factors experts and the FOCUS Data Analysis Committee. It could well be that in the next 12 months we see the first recommendations from FOCUS come forward to be implemented and field tested at cardiac sites around the country. The on-going success of the FOCUS program itself is feeding back towards improving/reducing human error. By the existence and success of the initial site visits, national and even international curiosity is peaking. The FOCUS project is gaining exposure with reporting on the programs for educational meetings not only within the SCA but in other societies. The recent 14th Annual Update on Cardiopulmonary Bypass was held at Whistler, Canada March 14-20, 2009. At that meeting a session on patient safety was well received and the attendees asked for more and expanded sessions, workshops and team building training for future meetings all with the end goals of reducing human error in the cardiac operating rooms. So, in a small way the FOCUS program has already succeeded by creating buzz, discussion, and insight by the rank and file into how we go about delivering such complex care.

FOCUS has only begun – join us!

FOCUS Update

FOCUS (Flawless Operative Cardiovascular Unified Systems) is making tremendous progress. On Sunday, April 19, 2009 at 11:00 am, as part of the upcoming SCA Annual Meeting in San Antonio, Texas, a one hour session will be devoted to the FOCUS initiative. The First Data from the LENS of FOCUS will showcase the first peek behind the curtain to look at the data will be presented by Dr Peter Pronovost of Johns Hopkins University Center on Quality Patient Care. Dr Spiess will then conjecture on what future direction FOCUS will take and describe the Next Steps to Continue Our Focus on Human Error. In some respects those directions will be like entering a traffic circle. Any number of branching points and spokes could/should be taken from the original entry point (our original data gathering). Which ones will be traveled are hard to predict until the data is fully analyzed and recommendations are created. But, the session should provide feedback to the membership and reward for not only their support but hard work over the four years to get to this point. We are sure that enthusiastic members who have undergone the site visitation may well provide participation from the floor on what it was like to participate in this process. All the membership is encouraged not only to attend the FOCUS session at the annual meeting but to watch for ways in which they can participate and help. Calls have gone to the membership for participation in committees of FOCUS. Please look for more requests for volunteerism as well as your personal philanthropic donations to move FOCUS forward.

The FOCUS team has held past and on-going discussions with the Society of Thoracic Surgeons on a very high level. Our goal is to involve all the stake-holders in the care of cardiac surgical patients. Eventually it is envisioned that FOCUS will be an example for all of medicine as a method of self study and self improvement with reduction in human error. Communications will be forthcoming from FOCUS to AMSECT, AORN and other surgical, nursing, critical care and allied health societies to see if they will band with SCA Foundation in driving FOCUS to it ultimate goal (improved patient safety).

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