What are the key success factors in developing a hospital safety program?
One of the most important interventions is for hospital leadership to get the hospital's board involved with safety and quality. Not only does the board have fiduciary responsibility for the organization, but they have responsibility for quality and safety as well. Accordingly, it is crucial for the board to explicitly make safety and quality a top priority. Boards are typically comprised of mostly nonclinical individuals, so hospital leaders and staff will need to educate them.(1)
Other key strategies include designation of champions with authority to facilitate change and incorporation of safety and quality goals into both organizational strategic plans and executive compensation. These could be clinicians, executives, or board members.
Strategically, what should an organization try to improve when it comes to safety?
You can divide the work into three major categories: creating reliable team interactions, ensuring reliably designed processes, and promoting the value of a just culture. Reliable team interaction should focus on improving understanding of communication, situational awareness, appropriate assertion, leadership skills, and mutual support. Reliable design focuses on process; the end result will be that a hospital can guarantee, for example, that patients will have their medications reconciled every time they are admitted, or they will have preoperative antibiotics delivered on time. A just culture is one that supports and encourages open and honest reporting of medical errors. It has a system in place to fairly consider the actions of clinicians when incidents occur, often using an algorithm such as that advanced by James Reason.(2)
Changing culture takes the most work, but it is the foundation for any safety improvement work. Efforts to promote a safety culture require persistence and involvement from all areasno one person or department is exempt due to the complexity of processes and the ever-present interdependencies in the provision of care.
Who should lead this work?
Since 2001, each hospital has been required by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to have someone designated to carry safety responsibilities.(3) Because of the effort and time that this work requires, this needs to be a paid position, even in a relatively small hospital, although it may be part time in such institutions. The ideal Patient Safety Officer generally has a clinical background, such as a nurse, physician, or pharmacist. The characteristics of the person you hire, however, are more important than their precise clinical background and title. Because safety crosses so many boundaries and departments, their ability to negotiate and communicate effectively is critical, as is their ability to educate a wide range of people, from clinicians to administrators. Finally, they need to be passionate about the work.
What training do Patient Safety Officers need?
Patient safety officers need training on tools such as failure mode and effects analysis (FMEA), root cause analysis (RCA), simulation in health care, crew resource management (CRM), and basic human factors. Trending and analysis of data, such as that drawn from incident reports, is an important skill. It is important for officers to have a clear understanding about what it means to work in a just culture and how they can promote this. Safety officers need basic training in some form of process improvement methodology, such as Six Sigma, Lean, or the Institute for Healthcare Improvement's Model for Improvement. They also need a clear understanding of how poor quality and safety impact the organization, a "feel" for the perspective of both patients and families, and an understanding of the impact of poor quality/safety on staff morale, motivation, and satisfaction.
What departments need to interface closely with the Patient Safety Officer?
The Quality, Safety, and Risk Departments must work well together, regardless of who the departments report to. In particular, the Quality and Safety Departments will need to coordinate their use of resources. The Risk Department must share data with the safety officer, as the best form of risk protection is the prevention of errors. Because patient safety is related to the products owned and purchased by the hospital, coordination between Materials Management, Biomedical Equipment, and Patient Safety is needed to facilitate reporting of problems with equipment, recalls, and the purchase of new equipment. As organizations move toward electronic medical records and computerized provider order entry, the safety officer needs to be informed about and involved with the deployment and tailoring of these tools, necessitating a close working relationship with their information system department. Lastly, some safety officers have found their relationship with the Patient Advocacy or Patient Relations Department to be quite valuable, often providing a much-needed window into what is really happening in the facility, particularly the patients' experience.
What committee structure best supports patient safety?
It is important that there is opportunity at all medical staff meetings to discuss safety issues. In addition, an organization should consider having a committee that consists of representatives from both administration and the medical staff to oversee safety and quality. This committee should be able to authorize action in response to safety concerns or refer the actions to another group, such as the executive medical staff, that can muster resources and will take action. For the clinical staff to grow in their understanding of safety, there must be a structure that will allow the open discussion of safety-related issues. The clinical members of this safety committee are also seen as champions among their peers to help inform, educate, and obtain support, direction, and input.
What other important issues should you consider when starting a safety program?
Involving physician champions on appropriate projects from the start is very helpful. A surgeon along with an anesthesiologist would be beneficial if you were working on a project related with pre- and postoperative antibiotic prophylaxis, an endocrinologist if you were working on glycemic control in the intensive care unit, or a medical director if you were launching a form of CRM training (team training). Most of the time, physicians serve in these roles on a volunteer basis, but compensation should be considered depending on how much time is involved.
Feedback loops are essential to move the organization toward a just culture. Employees and medical staff must feel safe to report near misses and incidents in their organization, and these reports need to be acted on by administration. The feedback loop needs to be closed by getting back to those who have reported incidents and unsafe situations about the action that their reports generated. You can develop these types of feedback loops by doing executive walkrounds or by deploying near miss or incident report systems.(4)
Developing safety work groups at the department or microsystem level and training them for local safety projects has a great deal of value. Although some projects need to be implemented across the entire hospital, much of the work should be done at the microsystem (ie, clinical unit) level. As the frontline teams start to understand the need to improve safety on their units and are given the tools to make effective systems changes, they will begin to carry out safety projects on the local level without waiting for the central safety team.
Organizations need to develop appropriate safety indicators to gauge their progress. A mixed set of both outcome and process indicators would be helpful. These indicators could be outcome measures such as risk adjusted mortality, adverse events (measured by either manual or computer-generated triggers such as INR >6 or naloxone, etc., in which the triggers are further evaluated to see if actual harm occurred [5,6]), incident reports, nosocomial infection rates, and process measures such as percent of preoperative antibiotics given on time, percent of medications that are appropriately reconciled, and number of staff that have received teamwork (CRM) training.
As recently as 5 years ago, few organizations had patient safety officers and safety teams. As experience has accumulated, some of the attributes of effective organizational safety enterprises have become clearer. Although the exact structure varies from institution to institution, certain elements appear to be absolutely essential: strong support from senior leadership and the board; an effective and well-led central safety enterprise that can manage data, fix problems, provide feedback and training, and respond to regulatory and other mandates; and a culture that is just, encourages individuals to report errors, and does not depend on the central safety team for all activity. With these elements in place, many institutions appear to be making major strides in improving patient safety.
John Whittington, MDPatient Safety OfficerMedical Director of Knowledge ManagementOSF Healthcare System
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1. Reinertsen JL. Understanding and improving clinical quality: the role of trustees. Trustee. 2003;56:17-20. [ go to PubMed ]
2. Reason J. Managing the Risks of Organizational Accidents. Aldershot, UK: Ashgate; 1998.
3. Standard LD.4.40. The leaders ensure that an integrated patient safety program is implemented throughout the hospital. In: 2006 Comprehensive Accreditation Manual for Hospitals: The Official Handbook. Oakbrook Terrace, IL: Joint Commission Resources; 2006.
4. Frankel A, Graydon-Baker E, Neppl C, Simmonds T, Gustafson M, Gandhi TK. Patient Safety Leadership WalkRounds. Jt Comm J Qual Saf. 2003;29:16-26. [ go to PubMed ]
5. Rozich JD, Haraden CR, Resar RK. Adverse drug event trigger tool: a practical methodology for measuring medication related harm. Qual Saf Health Care. 2003;12:194-200. [ go to PubMed ]
6. Global Trigger Tool for Measuring Adverse Events (IHI Tool). Institute for Healthcare Improvement Web site. Available at: http://www.ihi.org/IHI/Topics/PatientSafety/SafetyGeneral/Tools/GlobalTriggerToolforMeasuringAEs.htm. Accessed June 19, 2006.