Back to Safety topics

A framework for safety culture and reporting

Summary - Part II

Error report processes - identifying, tracking and reporting errors
Safety culture - leadership systems and improvement
Patient safety - practical approaches
Design concepts and human factor engineering

The term "patient safety" as used here applies to initiatives designed to prevent adverse outcomes from medical errors. The enhancement of patient safety encompasses three complementary activities: (1) preventing errors, (2) making errors visible, and (3) mitigating the effects of errors. Not all adverse events in healthcare are the result of medical errors; it is important to keep in mind that patients may not be cured of their disease or disability despite the fact that they are provided the very best of care. The Quality Interagency Coordinating Committee report "Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact" provides a schematic to better set a framework for thinking about types of errors, and may be downloaded or viewed online. (See Key documents: QuIC)

Error report processes - identifying, tracking, and reporting errors

QuIC report: The QuIC report "Doing What Counts for Patient Safety" provides a useful framework to identify and classify errors. This framework can be summarized as follows:

National Quality Forum: This organization has initiated a measurement project termed the "never events" now termed "serious reportable events." This project is focused on identifying and developing consensus on a core set of patient safety measurements related to avoidable, serious adverse events in hospital care, i.e., "events that should never occur." The core measure set, in turn, enables standardized data collection and reporting of these events within and across states. The 2006 report of "Serious Reportable Events" are available from the Safety Institute's Guidelines Web site.

CDC NNIS/NHSN: The CDC's National Nosocomial Infections Surveillance (NNIS) system has been cited as a potential model for collecting information on adverse health events caused by medical errors. The NNIS system has been renamed the National Healthcare Safety Network or NHSN and now includes healthcare worker and dialysis information. The NHSN system collects data on hospital-associated infections from participating hospitals throughout the United States, using a proactive surveillance model (see Resources: CDC NNIS). Standardized definitions and standardized data collection tools and methods are used. Interventions are measured and data are reported in a non-punitive atmosphere as described by in a special ISMP Medication Alert which may be downloaded or view online. (See Resources: ISMP). Research from the mid-1980s confirmed that hospitals with the lowest infection rates had strong surveillance programs and strong prevention/control programs (Resources: Haley 1985, CDC 1991). In addition, a recent report from CDC demonstrated reductions in hospital-associated infections in ICU settings among hospitals participating in the NNIS system. (See Resources: CDC 2000).

Back to top

Safety culture – leadership and system improvements

See also Culture - Patient safety

Culture and system improvements: The IOM reports have important implications regarding the "culture of safety" for an organization. As organizations pursue strategies of how to change to less punitive but still accountable systems for managing medical errors, the issue of what is meant by a "safety culture" needs to be considered. The IOM-1 report emphasizes that most medical errors are systems-related, and not attributable to individual negligence or misconduct. Lessons from other industries have demonstrated that system improvements can lead to reductions in error rates. The aviation industry is cited frequently as an example where system improvements have been made, as noted in the summary article Improving Quality, Minimizing Error. This article describes major changes and the need for an aggressive response.

Anesthesia and system improvements: Specific healthcare groups also have demonstrated the impact of system improvements. For example, in the field of anesthesia, the annual error rate as measured by this professional group, was reduced seven-fold, from 25 to 50 errors per million procedures to 5.4 errors per million procedures. This was accomplished by using standardized guidelines, protocols, and equipment.

VA system and DOD safety focus: These government departments are focusing on safety training of staff. The VA System is developing reporting systems and the Department of Defense (DOD) is investing in a computerized medical record system with an automated order/entry. These QuIC task force member agencies are focusing on "high hazard areas."

Back to top

Patient safety – practical approaches

IOM-1 makes recommendations The IOM-1 report has important implications regarding the "culture of safety" for an organization. As organizations pursue strategies of how to change to less punitive but still accountable systems for managing medical errors, the entire issue of what is meant by a "safety culture" needs to be considered.

The many facets of addressing and developing safety programs can be overwhelming. The following elements have been identified as practical actions that can be implemented immediately in most organizations. These suggestions include many that can be used by organization to begin the change now.

  1. Make patient safety improvement (healthcare errors reduction) a leadership priority What is patient safety?
    • A state of mind that recognizes the complexity and high risk nature of modern healthcare
    • A set of processes (reporting, investigating, analyzing, reducing hazards, improving)
    • A set of outcomes (fewer errors, less risk)
  2. Make a clear organizational commitment to patient safety – as reflected by infrastructure and dedicated resources – What is an ideal infrastructure?
    • Patient safety center
    • Patient safety leader
    • Patient safety event registry
    • Patient safety oversight committee
    • Lessons learned center
    • Internal safety alert process
  3. Create a healthcare culture of safety – What is a safety culture?
    • Acknowledges high risk, error-prone nature of modern healthcare
    • Ensures widespread shared acceptance of responsibility for risk reduction
    • Encourages open communication about safety concerns in a non-punitive environment; freedom of dear in reporting problems
    • Facilitates reporting of errors and safety concerns
    • Learns from errors
    • Embraces accountability for patient safety
    • Ensures organizational structure, processes, goals and rewards are aligned with improving patient safety
  4. Initiate routine safety assessments
    • Implement the AHA-ISMP Initiative to reduce medication errors
    • Design and develop own audit instruments (multiple examples)
  5. Implement known safety practices
    • Educate patients and family members about their medications (multiple examples)
    • Implement mechanisms to ensure follow-up
    • Implement a restraint free policy
    • Increase number of autopsies
  6. Incorporate patient safety into all healthcare professional training
  7. Be accountable for patient safety
    • Acknowledge error and resultant injury
    • Apologize; say you are sorry
    • Provide restorative or remedial care
    • Conduct root cause analysis
    • Fix system or process problems
  8. Promptly and decisively deal with professional misconduct
  9. Support efforts to create a non-punitive environment for healthcare error reporting
  10. Make patient safety research a priority

(Adopted from presentations by Ken Kizer, MD, President and CEO,NQF)

Back to top

Design concepts and human factor engineering

Human factor engineering: The IOM reports also brought to light the gains from other industries related to "human factor engineering." This refers to the study of relationships between humans, the tools used and the environments in which they work. It recognizes and examines how the physical environment can affect human senses (noise, fatigue, stress, disruptions and distractions) and the resulting errors. For example, there are expectations that computerized entry/order systems can dramatically reduce medication errors. Yet there is already recognition that computer use alone, without planning and design that considers human factors, can introduce another set of errors.

QuIC: To ensure that human factor engineering is taken into account, QuIC member agencies plan to learn about patient safety, using leading researchers on human factors analysis, systems design, error reporting, and quality improvement. The agencies' curriculum will serve as a model, and be expanded for future educational activities with private-sector partners. QuIC will sponsor an educational program to increase the awareness of federal regulators and policymakers regarding patient safety, human factors, and systems-based improvement.

FDA: To ensure that medical products are designed to minimize the chance of errors, the FDA will begin working with manufacturers of medical products to explore incorporating standards, including human factors standards, into guidance. The FDA has a specific site dedicated to human factor engineering.

IHI: Professional organizations (like the IHI) sponsor "breakthrough technology" that uses basic human factor design principles to reduce medication errors. The design features are both organizational and operational (Resources: Leape 1998). Examples of each follow:

Organizational design:

Process design:

Adapted from icanPREVENT. Used with permission of ican, Inc.

Back to top