Risk Assessment and TG 100

Bruce Thomadsen

University ofWisconsin -Madison

Disclosure

I am the President of the Center for the Assessment of Radiological Sciences, a non-profit Patient Safety Organization listed with the Agency for Heathcare Research and Quality. The Center is dedicated to improving patient safety in radiotherapy and radiology. More about that tomorrow.

Learning Objectives

1. To understand the basic concept of risk assessment

2. To learn the vocabulary of the systems approach

3. To understand to overview of TG-100’s approach to risk-assessment-based quality management

About TG-100 Report

Title of the report of TG 100, Application of Risk Analysis Methods to Radiation Therapy Quality Management.

TG members:Saiful Huq (Chair)Dick FraassPeter DunscombeJohn Gibbons, Jr.Geoff Ibbott

Arno MundtSasa MuticJatinder PaltaFrank RathBruce ThomadsenJeff Williamson

What is TG 100?

Originally TG-100 was to produce a prescriptive QA guidance for technologies new since TG 40.

After about a year of finding that no two facilities perform IMRT similarly enough that a prescriptive list would work, TG 100 looked to new approaches.

They finally settled on a systems approach to QM.

What does TG 100 Look Like?

The report comes in two volumes:The first is a tutorial on techniques to address quality and safety. The second is using the techniques to establish a quality-management program for IMRT as practiced at one of the author’s institution.

Where is TG 100

Approved by Science Council early fall Ready to go to Medical Physics

When TG 100 Started

At TG 100 Publication

When Bad Things Happen

First step is to recognize that humans and equipment will fail

Then set up procedures to try to prevent failures from negatively affecting the patient

Vocabulary

Incident – a situation or actions that could have resulted, or did result, in unnecessary harm to a patient, staff or other person.

Event – an incident that affected a patient, staff or other person.

Near event, close call, good catch – an incident that had no affect on any person. Sometimes referred to as a near miss.

Vocabulary 2

Failure – not achieving the desired end or goal. Error – a failure to execute a planned action as

intended. Mistake – a failure to make an appropriate plan. Error of commission – an error consisting of taking

an action, also referred to as a blunder. Error of omission – an error consisting of failing to

take an action when necessary.

Some Principles

Most of the time, those in health care want to do a good job.

Often, when someone fails, it is because something led them to the wrong action (or inaction).

The goal is to design the “system:” to support staff and equipment to prevent failures to be resilient to failures

Some Principles 2

Recognize that most incidents result from human failures rather than equipment failures and put more resources into making procedures resilient.

Recognize that the prescriptive QA approach for equipment is taking increasing amounts of time to perform comprehensively.

Exercise 1

Why should an industrial/systems approach be expected to work in healthcare and why shouldn’t it?

Exercise 1Should Should Not

TG-100 Risk-based QM Development

1. Understand the process – Process Map2. Assess the hazards - FMEA3. Establish the failure propagation - Fault Tree4. Address the hazards

a. From the greatest risk and most severeb. Use the most effective tools

5. Test and evaluate

Adopting the TG-100 Approach Start with a small project or a small part of a

bigger procedure. Build Confidence Important to have the early project work

Assemble a team of all the players Important for getting information and generating

ideas Very important for buy-in and ownership

Be open to new ideas Be wary of, but do not exclude, major departures