How Safe Are We?
Frank Federico
Safety and Quality
Safety as a dimension of quality
IOM STEEP– Safe– Timely– Effective– Efficient– Patient-centered
What should we measure?
Errors
Harm resulting from errors
Incidents that have been deemed to be preventable
What is being measured?Errors– Incident/voluntary reports– Observation
Preventable harm– Infections – Pressure ulcers
All harm– IHI Global Trigger Tool
Accepting the Harm BurdenAdverse Event/Harm and Errors
– “Error” definition bears upon concept of preventability and human mistake
– “Adverse event” describes harm to the patient regardless of error and is often system-based
– Relationship between errors and adverse events:
Errors
Adverse Events
Mortality
What else?
Process measures
Culture of the organization
Staff injuries
Incident Reports
Voluntary reports of incidents – Mostly errors– Most by nurses
Dependent on– Knowledge that an error was made– The time to report– Ease of reporting– Culture of safety– Expanding the scope of what is reported to include harm
What percent of medical errors actually lead to harm ?
3.7% of patients experienced adverse events;
58% due to error(Harvard Medical Practice Study, 1991)
2.99% of reported medication errors (41,296) led to harm
(Med Marx 2000 Report; NCC MERP data)
5% of reported medication errors (>11,000) in perioperative settings led to harm
US Pharmacopiea 3/5/07
Voluntary Reporting
“We found that less than 4% of all adverse drug events involving use of rescue drugs were reported.”
Schade, Am J Med Qual. 2006 Sep-Oct;21(5):335-41
Studies of medical services suggest that only 1.5% of all adverse events result in an incident report.
O'Neil A,. Ann Intern Med 1993;119:370-376)
Copyright ©2007 BMJ Publishing Group Ltd.
Olsen, S. et al. Qual Saf Health Care 2007;16:40-44
Incidents Detected by Three Methods
Hospital Acquired Conditions
Infections
Pressure Ulcers
Falls with Harm
Adverse Drug Events
What about all other types of harm?
Serious Reportable Events
Surgical or Invasive Procedure events
Product or Device events
Patient Protection events
Care Management events
Environmental events
Radiologic events
Potential Criminal events
http://www.qualityforum.org/Topics/SREs/Serious_Reportable_Events.aspx
Safety Culture Surveys
Assess the attitudes of staff
Determine the strengths and weaknesses of a safety program
Strongly influenced by the most recent event
Requires significant response rate to be valuable
Variation within areas of the organization
Variation among different layers of the organization
You are the leader of the organization…
….what would you like to know?
Do you feel safe?
Do you believe that your organization is safe?
S+P=O
Avedis Donabedian
Structure, Process, Outcomes
Structures– Hiring system– Learning system– Committees to review events– Competency assessments– Sustainability models
Structure, Process, Outcomes
Processes– Processes that support evidence-based care– Reliably implemented and followed
Structure, Process, Outcomes
Outcomes– Reduction in harm– Effective outcomes
There is no single measure of safety, but early warning signals can be valuable and should be maintained and heeded.
A promise to learn– a commitment to act
Improving the Safety of Patients in England
National Advisory Group on the Safety of Patients in England
Perhaps We Should Be Proactive
Reliability of processes
Sensitivity to operations– Walkrounds– Patient Safety Officers– Meetings, handovers, rounds– Day-to-day conversations– Patient involvement
Briefings and safety huddles
Situational Awareness in Healthcare
Perception: Each huddle participant to systematically report on patients on their unit who they thought may deteriorate in the near future and label them as ‘watchers’
Comprehension: asking senior nurses and physician leads to coach charge nurses on how to integrate their perceptions into an informal severity of illness assessment
Projection: training the clinicians on how to use the information to facilitate prediction and planning for at-risk patients
Horsens, Denmark
Safety Cases
High risk situations must present with evidence of safety before can undertake a hazardous operation
A safety case is a ‘documented body of evidence that provides a convincing and valid argument that a system is adequately safe for a given application in a given environment’.*
*Bishop P and Bloomfield RE. 1999. A methodology for safety case development. In: Redmill F and Anderson T (eds.) Industrial Perspectives of Safety-Critical Systems: Proceedings of the Sixth Safety-critical Systems Symposium, Feb 1998, Birmingham, UK. Springer; 1998.
Summary
Safety is a dynamic non-event
Measuring safety and measuring harm are not the same
Different measures exist– Each has advantages and disadvantages
We must learn how safe we have been, how safe we are now, and how safe we expect to be.
Questions and Comments