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