Page 36 - PRECONGRESS COURSE 01

Risk assessment - examples
Aspect
Probability
Consequence*
Counter action
Long time to test
Likely (home collection)
Severe
Prefer centre collection
Cold chock
Likely (home collection)
Severe
Prefer centre collection
Not representative
Likely (<10 μL)
Moderate/Severe
50 μL for concentration replicate for < 50 μL
Depth error (conc)
Likely/Probable
Moderate/Severe
Fixed sperm in 100 μm hemocytometer
Temperature error imotility assessment
Common, if no heated microscope stage
Moderate
Controlled temperature
100 spermatozoa assessed
Probable
Severe
400 observations for the basic minimum of ±10% error
No replicate comparison
High
Severe** Mild***
Replicate comparison Conc + Motility
* Related to any clinical decision limit. ** Concentration and Motility. *** Morphology and Vitality
ESHRE-SIGA PreCongress Course 25 July 2, 2017
Risk assessment - examples
Aspect
Probability
Consequence*
Counter action
No internal QC
High
High technical variabiilty
IQC
No external QC
High – Moderate**
Morphology staining
High
Poor optic resolution***
Always
Poor detection
Improve optics
Poor phase contrast
**
Staff fatigue...
Improve optics
Poor light path in microscopes
**
Poor detection
Improve light path
* Related to any clinical decision limit. ** Dependent on training. *** Morphology and Vitality
ESHRE-SIGA PreCongress Course 26 July 2, 2017
36
Page 32 of 175