Preventing blood transfusion failures: FMEA, an effective assessment method

Area of Science:

• Medical Safety
• Healthcare Management
• Risk Assessment

Background:

• Failure Mode and Effect Analysis (FMEA) is a systematic method for evaluating potential failures and patient harm in medical processes.
• This study applied FMEA to assess risks within the blood transfusion process at a teaching general hospital.

Purpose of the Study:

• To conduct a comprehensive risk assessment of the blood transfusion process using FMEA.
• To identify critical failure modes and inform the development of risk reduction strategies.

Main Methods:

• A structured FMEA was implemented in 2014, involving sixteen 2-hour sessions over six months.
• The process included establishing context, team selection, process analysis, hazard analysis, and developing a risk reduction protocol.

Main Results:

• Failure modes were ranked by Risk Priority Numbers (RPNs), with scores ranging from 5 to 100.
• The highest RPNs (over 75) were identified for: labeling (100), transfusion of blood/component (100), patient identification (80), and sampling (75).

Conclusions:

• Mis-transfusion of blood or blood components represents the most significant error, posing risks of serious morbidity or mortality.
• Implementing personnel training, hazard awareness, and standardized safety guidelines are crucial for all transfusion steps.