FMEA

Question 1

2001 Joint commission leadership standard LD
5.2:SUPPORT OF PT SAFETY AND MEDICAL/HEALTH CARE ERROR REDUCTION GOAL: Reduce sentinel events and significant errors (4)

Answer 1

• Hospitals must prevent adverse events/errors, rather than react to them
• Hospitals must conduct proactive risk assessments
• Sentinel event RCA is reactive and will not meet compliance on its own
• Hospitals (perfusionists) must provide a “failure mode analysis” for proactive process review

Question 2

-Hospitals (perfusionists) must provide a “failure mode analysis” for proactive process review

Answer 2

Analysis of a process in active use or a process under
revision using an FMEA can fulfill the Joint Commission
accreditation requirement for proactive risk assessment

Question 3

The avoidance of unnecessary incidents that result in adverse patient outcomes (4)

Answer 3

Malfunctioning/defective equipment and supplies
Communication failure between healthcare
professionals
Human error or incorrect execution of procedures
Failure to anticipate adverse events

Question 4

Seven steps to Perfusion Safety

Answer 4

1. Procedures
2. Safety devices
3. Checklists
4. Trouble shooting
5. Root Cause Analysis
6. FMEA (failure mode effects analysis)
7. Documented Competency

Question 5

FMEA

Answer 5

• -Commonly known as a bottom up approach
• -Tabulation of equipment/components and their associated single point failure modes, consequences, and safeguards
• -Identification of risk is derived from looking at each component

Question 6

How can FMEA be implemented?

Answer 6

can be implemented using a hardware or functional approach (or a combination or the two due to complexity of the system)
Hardware: Loss of a component
Functional: loss of a function or feature

Question 7

FMEA practical benefits?

Answer 7

• -Self-assessment exercise that reveals just how well prepared a CPB program is for an emergency
• -Provides documentation of rare incidents dealt with in the past so that perfusionists and their patients can benefit if a future incident occurs
• -Provides exemplary documentation for self-assessment and evaluation by hospital risk managers & outside assessors

Question 8

Outside assessors?

Answer 8

Joint Commission
Centers for Medicare and Medicaid Services
Patient Safety Organizations
Liability and healthcare insurance carriers

Question 9

FMEA description ? (5)

Answer 9

1. Identifies potential problems in a design or process by itemizing the conceivable failures
   A. personnel issues / operator error / treatment error
   B. disposable component failure
   C. equipment failure
2. Describes the consequences of a failure
3. Describes the specific configuration or action causing the failure
4. Ranks the risk of each failure
5. Lists specific actions that can prevent or mitigate the failure

Question 10

5 FMEA columns ?

Answer 10

Column I. Failure Mode
Column II. Potential Effects of Failure
Column III. Potential Cause of Failure
Column IV. Risk Priority Number
Column V. Intervention

Question 11

Column 1?

Answer 11

Failure mode
List of potential failures.
Example: open purge line at weaning

Question 12

Column II?

Answer 12

POTENTIAL EFFECTS OF FAILURE
Possible consequences of the failure

EX: open purge line at weaning
Bleed back to cardiotomy reservoir
Hypotension after CPB

Question 13

Column III?

Answer 13

Potential Cause of Problem
The specific action that can result in the failure

EX: open purge line at weaning
Perfusionist lack of attention
Item not described or identified in weaning checklist

Question 14

Column IV - sub column A?

Answer 14

Sub-column A. Severity Rating Scale: how harmful the failure can be

1. Slightly harmful (open purge line)
2. Low level harm
3. Moderately harmful (roller pump failure)
4. Seriously harmful
5. Critically harmful

Question 15

Column IV - sub column B?

Answer 15

Sub-column B. Occurrence Rating Scale: how frequently the failure occurs

1. Rarely occurs (roller pump failure)
2. Infrequently occurs (open purge line)
3. Moderate occurrence
4. Frequently occurs
5. Commonly occurs

Question 16

Column IV - sub column C?

Answer 16

Sub-column C. Detection rating Scale: how easily the potential failure can be detected before it occurs

1. Very easily detected (open purge line)
2. Easily detected
3. Moderately easy to detect
4. Difficult to detect
5. No means of detection (roller pump failure)

Question 17

Column IV - sub column D?

Answer 17

Sub-column D. Patient Frequency Rating Scale: how often the failure occurs in the total patient population

1. Few patients are at risk (MAPCAs at STLH)
2. A significant number of patients are at risk (MAPCAs at CMH)
3. All patients are at risk (roller pump failure), (open purge line)

Question 18

Column V ?

Answer 18

Intervention

Lists specific actions to prevent each failure
May be several actions needed to prevent occurrence of a failure
The most important interventions are often preemptive
With some failure modes preemptive interventions are not possible

EX: open purge line at weaning
Wean from CPB checklist: close purge line (pre-emptive)
Clamp arterial line distal to the purge line