HHDS.12 - Patient Safety and Proactive Risk Assessment

This is Chapter 12 of 50 in a summary of the textbook Handbook of Healthcare Delivery Systems. Go to the series index here. Listen on YouTube Playlist, or search your podcast app: Gregory Schmidt

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Chapter 12 Summary
Patient Safety and Proactive Risk Assessment

Chapter Authors
Pascale Carayon - University of Wisconsin-Madison
Helene Faye - Institut de radioprotection et de Surete Nucleaire
Ann Schoofs Hundt - University of Wisconsin-MAdison
Ben-Tzion Karsh - University of Wisconsin-Madison
Tosha B. Wetterneck - University of Wisconsin-Madison

1. Patient Safety

This chapter provides a brief overview of techniques of patient safety and proactive risk assessment. Risk assessment helps people to understand the complexity and interrelated nature of the healthcare environment.

Patient Safety Paradigms

  1. Reduce healthcare professional errors: reduce, eliminate, or reduce

  2. Reduce patient injuries: including near misses

  3. Improve evidence-based medicine: to create higher quality and safer care

Safety Engineering

  1. Safety in design: of products, processes, and systems

  2. Hazards: proactively identify, eliminate or reduce risk

  3. Errors or harm: when it occurs, the cause needs to be identified

Hazard: defined as “anything that increases the probability of errors or of patient/employee injury and is analogous to ‘risk factor’”

2. Proactive Risk Assessment

There are many tools that can be used in proactive risk assessment. These generally focus on

  1. RCA - Root Cause Analysis (retrospective):

  2. FMEA - Failure mode and effects analysis (prospective): identify all the steps and MODES (aka ways) something can fail. Then study the EFFECTS and consequences of those failures.

  3. Probabilistic Risk Assessment: used at system level (prospective). This can help compute actual risks attributed to errors in a process.

The different tools for proactive risk assessment are listed. In general, their process overlaps. It moves from observations & process analysis to then prioritization and control.

Example Workflow for Proactive Risk Assessment

  1. SET UP

    1. Set the safety objective to study. Identify the scope or assessment and topic clear.

    2. Identify the processes to be studied. Make sure one differentiates between “prescribed work” and “real work”. Often there is a difference in these. If the risk assessment doesn’t capture the work that actually happens, it will be incomplete.

    3. Identify the context / setting / organization to study the objective and process in

    4. Prepare the resources needed for a proactive risk assessment

  2. DO

    1. Use a methodology (eg FEMA)

    2. Participants (how many, who?). A wide team of people involved in the process is helpful.

    3. Meetings (how many, when, how long?). How will the process be studied

    4. Identify failure modes, impact of each failure, severity of each failure, contributing factors. Consider running simulations to identify potential failures

    5. Consider short and long term solutions. What are the recovery processes?


    1. How are researchers used in project?

    2. What scoring system will be used? How will success be measured?

    3. How will proactive risk assessment be evaluated?

3. Examples

A FMEA to reduce medication infusion errors using a new IV pump is presented in the chapter. The outcome is that the process was divided into 38 steps and a total of 200 possible failure modes identified. The team sorted these into the following categories and had a different approach to addressing each one:

  1. Policy and Procedure

  2. Training or education

  3. Environment

  4. People

  5. Technology hardware and software (long and short term solutions)

A second example is presented, and in this instance many risks and concerns were identified that were outside the scope of the specific risk assessment. These were placed in a “parking lot” to be considered at a future assessment.

HHDS.13 - Toward More Effective Implementation of Evidence-Based Practice

John Hancock to stop selling 'traditional' life insurance