3 - RCA & FMEA

Question 1

Define:

Any identified reason in the sequence of events that, if prevented, will stop a recurrence of the particular event.

There must be a clear cause and effect such that if you eliminate the identified cause,
future events will be prevented

Answer 1

ROOT CAUSE

Question 2

Define:

A patient safety event
(not primarily related to the natural course of the patient’s illness or underlying condition)
that reaches a patient and results in
death, permanent harm, or severe temporary harm

Answer 2

SENTINAL EVENT

Question 3

Define:

• *Problem-solving tool** used to analyze a process or system to
• *identify possible modes of failure**, and
• *potential consequences of those failures**

Answer 3

FMEA

Failure Mode & Effects Analysis

Question 4

Criteria for an effective RCA Process

Answer 4

• Clearly defines the problem and its significance to the problem owners
• Clearly delineates the known causal relationships that combined to cause the problem.
• Clearly establishes causal relationships between the root cause(s) and the defined problem
• Clearly presents the evidence used to support the existence of identified causes
• Clearly explains how the solutions will prevent recurrence of the defined problem
• Clearly documents the above criteria in a final RCA report so others can easily follow the logic of the analysis

Question 5

WHEN to do an RCA?

REACTIVE
process

Answer 5

Leadership Group
Risk Management / Patient Safety Leaders
Decides which events to conduct a formal RCA

Typically based on a SCORE:

• *SAC = Safety Assessment Code**
• *Severity + Probability**

Can be:
Sentinel Event or Near Miss

Question 6

• *FMEA**
• *Failure Mode & Effects Analysis**

PRO-ACTIVE

Answer 6

Used to
examine the use of new products + design of new services/processes
to determine points of potential failure
and what their effect would be before any error actually happens

• *FMEA process recognizes that errors may occur, but seeks to prevent the error from becoming an accident**, through the use of
• *a safety system or error trap**

Question 7

FMEA STEPS

Answer 7

1) Assemble Multidisciplinary Team

2) DEFINE the specific focus of the FMEA topic

3) Process Flow Diagram

4) Hazard Analysis
* *RPN = Risk Priority Number** or Criticality Index (CI)

5) Actions

6) Follow Up