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18/12/2017
1
Hemostasis - Definition
Hemostasis is a «delicate» balance between opposite forces which:
Maintains blood fluidity in normal blood vessels
Prevents excess bleeding (hemorrhage) when vessels are injured
A “functional” hemostasis can hence be defined as an effectivemechanism which prevents hemorrhage from an injured blood vessel,requiring the activation and interplay between many variables andeffectors. Namely:
• Blood vessels
• Platelets
• Coagulation factors
The activity of which is normally modulated and counterbalanced by manyinhibitory mechanisms, aimed to limit the extent of clotting in both termsof LOCATION and AMOUNT.
NormalitàDeficit
-
Hemorrage
Eccesso
+
Thrombosis
Hemostasis can be divided into:
• Primary hemostasis
Vessel-platelet interplay
• Secondary hemostasis
Coagulation factors
Bruising
Petechiae (hemorrhages <2 mm)
Purpura (hemorrhages 0.2-1 cm)
Ecchymoses (hemorrhages > 1cm)
Bleeding
- From gums
- After invasive procedures
- Metromenorrhagia
Hematomas
Bleeding
- In joints
- In muscles
- In other soft tissues
- GI and genitourinary tract
- CNS
Vessel-platelet interplay
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2
The three little pigs…
- The first little pig builds a house
of straw (paglia), but a wolf
blows it down and eats him.
- The second little pig builds a
house of furze sticks (legno),
which the wolf also blows down
and eats him.
- The third little pig builds a house
of bricks (mattoni). The wolf
fails to blow down the house.
Emostasi Secondaria
La “protezione del muro”
Platelets
Fibrin
Clotting Factors
PT
APTT
ActivationThrombin
burst
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Coagulation cascade, from a Pathology book
?????
Despite FXII being essential for
surface activation of blood
coagulation, individuals with severe
deficiencies of this clotting factor do
not experience clinically meaningful
bleeding events.
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Clotting test
Clotting test
Clotting test
PLT functional assay
Clotting test
Clotting test
Clotting (chromogenic) assay
Immuno(turbidimetric) assay
PLT functional assay
Immuno(enzymatic) assay
Immuno(enzymatic/turbidimetric) assay
Immuno(turbidimetric) assay
Genetic testing
D-dimer
- Antithrombin
- Protein C
- Protein S
- Activated Protein C resistance
- Factor V Leiden
- Prothrombin gene mutation
- Lupus anticoagulants
- Anticardiolipin antibodies
- D-dimer
Chromogenic assay
Immuno(turbidimetric) assay for free PS
Chromogenic assay
Clotting assay
Genetic testing
Genetic testing
Clotting assay(s)
Immuno(enzymatic) assay
Immuno(enzymatic) assay or immuno(turbidimetric) assay
In summary… we would need:
- Clotting assays
- Chromogenic assays
- Immuno(turbidimetric) assays
- Immuno(enzymatic) assays
- Platelet function assays
- Genetic testing
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5
The route towards personalized laboratory testing will be
influenced by many factors such as:
- Healthcare reforms
- Cost-containment strategies
- Consolidation of laboratories and in vitro diagnostic
testing
- Impact of new technologies and tests on the existing
laboratory organization.
Take your hemostasis lab to the next level
The ongoing revolution of diagnostic testing, squeezed
between reduced funding and increasing volumes, carries
notable implications in the way laboratory resources are
organized and coagulation tests delivered.
It is therefore predictable that the newer generation of
hemostasis analyzers may be designed to face these emerging
needs whilst maintaining a high degree in the quality of
testing.
Clotting
assays
Chromogenic
assays
Imuno
(turbidimetric)
assays
Imuno
(enzymatic)
assays
Platelet
function
assays
Moving towards the future….
Clotting
assays
Chromogenic
assays
Imuno
(turbidimetric)
assays
Imuno
(enzymatic)
assays
Platelet
function
assays
Consolidation!
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6
ADVANTAGES
1. Reduces unnecessary tasks/steps
2. Lowers costs
3. Improve efficiency (TAT and throughput)
4. Improve process standardization (and probably quality through MIDDLEWARE)
5. Improves tests complexity and high-volume management
6. Reduces biological risk and errors
7. Allows more accurate specimen control
8. Simplifies accreditation/certification
9. Reprofessionalization (use of scilled staff for more complex
10. tasks)
11. Better confidence from stakeholders
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Centralized management of
Hemostasis testing (Middleware)
Allow to manage workflow, monitor
quality control and support decision-
making for better patient care, all from a
single workstation.
MAIN ADVANTAGES:
1. View many analyzers status in real-
time, even from different labs
2. Minimize workflow interruptions
3. Manage analyzer quality control
more simply and efficiently
4. Compare analyzer QC
5. Support clinical decision-making by
reviewing data of patient history
6. Availability of automatic rules,
reruns and reflexes
7. Optimize operations and facilitate
accreditation (!!!)
8. Run customized reports and track
key performance indicators
WEAKNESSES & THREATS
1. Dependence on manufacturer
2. Dependence on IT
3. Reduced flexibility
4. Stat handling
5. Cost for maintenance
6. High initial investment cost
7. Overexpanding test menu
8. Loss of technical skills
9. Dependence on supplier
10. What if the system fails?
- Specimen preparation, including centrifugation, aliquoting, sorting, and consumable costs:
- 20% of total costs
- 37% of the time required for testing.
- Disposal and result reporting, including archiving
and transport of finished samples:
- 10% of total costs
- 18% of the time required for testing.
- Extra-analytical activities:
- 30% of total costs
- 45% of the time required for testing.
Error rate
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8
MLO, 2002
Case study: Automations impact on
productivity and turnaround time
Ralph Dadoun
Prior to automation: every coagulation sample centrifuged and
managed with no automation processes.
After automation: all coagulation specimens dropped into the inlet of the
automation system.
Outcomes:
- Statistically significant improvement in TAT (from 30 minutes to 17
minutes)
- No change in quality.
Before automation is introduced in a haemostasis
lab, the work process needs to be examined in
detail.
Only then, automation can be embedded into an
appropriate concept of:
1. Space
2. Quality
3. IT-capability
4. Staffing
Recommended