QUALITY ASSURANCE IN BLOOD COMPONENTS-10TH FEB 08 SRK

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QUALITY ASSURANCE OF
BLOOD COMPONENTS IN
THE LABORATORY & PRIOR
TO TRANSFUSION
• Dr. Manoj A. Kahar
Incharge, Blood Bank
Indian Red Cross Society, Navsari
Webster defines Quality as “the
level of excellence of something”
and defines Assurance as “a
promise, guarantee”
• In a blood bank, the definitions of quality and
assurance are combined to become the activity
of providing the evidence needed to establish
confidence that quality functions are performed
at an elevated level.
Quality Assurance- The creation and operation
of standards, programmes and effective
management systems to ensure quality.
Benefits of quality
•
•
•
•
•
Reduce variation in processes
Reduce rework
Prevent problems from occurring
Attends legal issues & Accreditation
Improvement in processes through the
use of various measuring tools
• Reduce costs due to mistakes and
errors
• Production of consistent and effective
products
Deming Cycle of Continuous
Improvement
DO
CHECK
PLAN
Assurance
quality plan
CORRECT/
IMPROVE
On-going
process of
improvement
Concept of Quality
Quality
Assurance
Quality
Management
Quality system is a broad based program
Total Quality
Management
Quality
Control
Factors Affecting Quality
Equipment, reagents
INPUT
Environment
PROCESS
Personnel
OUTPUT
Methods
TOTAL PROCESS CONTROL:
• It is the evaluation of the performance of a
process, comparing actual performance
with goal, and then taking action on
difference.
• The intent of process control is to build
quality into the process from very
beginning and not just to inspect for quality
into the final product.
Personnel
•
Qualified ,Oriented,
MOTIVATED &
experienced– Medical
specialist, Production
Manager, Quality
assurance officer
•
Trained
Safety, hygiene
•
Sufficient
•
Organizational chart
– job descriptions
Equipment
• Vendor evaluation
• Planned according to
through-put and workflow
• Appropriate for use
• Open system
• Maintenance,
Calibration &
validation
Equipment- QC
• Electronic weighing
scale
• pH meter/strips
• Cell counter
• Coagulometer
• Flow Cytometer
• Large volume
counting chamber
50µL
(Nageotte, Hausser,
Horsham)
EQUIPMENT
EQUIPMENT MAINTENANCE REQ.
Refrigerator
(blood Storage)
Deep freezer
Record temp. thrice daily
Test alarm system
- do -
Centrifuge
Speed (tachometer) and time
pH meter
Two point calibration ( 4 & 7) before
use
Weighing balance
Platelet shaker
Check with known standard weights
Temperature / speed
cum Incubator
Kits/Reagents/Bags
• Vendor evaluation
(authorized)
• Inventory records
(Critical Stock
Maintenance)
• Selection and
Validation
• Regular QC checks
• Appropriate storage
Methods
• Standard followed :
AABB, WHO
• Reference
• SOP
• Current, approved
• Process
improvement with
periodic reviews
The Basic Transfusion Chain
Each link
consists of
several
smaller links
(primary
processes)
Blood donors
Collection
Processing
Screening
and testing
Cold
chain
Transfusion
The strength of the
chain depends on the
strength of the weakest
link — not the
strongest one
The quality of the BTS
is influenced by the
quality of each of the
links
Production process control: For a unit of
Blood intended for component preparation
QA
Donor
Selection
Blood
collection
Component Product Quaran. Lot
Storage
Documen.
prep.
testing
release distribution
Blood Component Processing
• To assure quality for a product, Critical
Control Points (CCPs) in the process are
to be identified and executed properly to
ensure that the final outcome is not
compromised.
Donor suitability:
• Donor must be healthy (preferably non
remunerated regular voluntary blood
donor)
• Hb >12.5gm/dl
• No history of anti-platelet agents taken
within 72 hrs.
• Weight >55Kg
Blood collection:
•
•
•
•
•
Adequate disinfection of the venepuncture site
Confirmation of donor identity with labeling of
the blood bag & donation samples
Correct volume of blood collected in
accordance with the amount of anticoagulation
used within acceptable time.
Continuous flow of blood( donation time not
more than 8 minutes)
Proper mixing with anticoagulant during
collection ( 12-14 mixings/min)
Component processing:
•
•
Temperature and volume requirements,
time restrictions are observed
Rejected in-house materials such as
incompletely collected, contaminated,
overweight, NFT are identified and
quarantined.
Labeling


Clear, concise and stick well
Processed products need re-labeling






Additional donation numbers to ‘new’
packs
To describe what they actually are
Any new expiry date
Any new storage instructions
Label as per regulatory requirements
Labeling done in undisturbed area
GMP & Blood Pack Labeling
Label
Product
Volume
ABO
Group
Donation
Number
Producer’s
Name
Rh Group
Product description
Storage
conditions
Collection
& expiry date
Blood storage
• At correct temperature and for the
correct length of time
•
The conditions of storage areas should be
monitored.
Maximum and minimum temperature settings
• determined.
Alarms for temperature variation/electrical
• failure are set
Storage Precautions of Blood
And Components






Blood to be stored at 2 to 6o C
Never allow to freeze - red cells
FFP stored below - 30o C or lower
Temperature of refrigerators must be
checked thrice a day
If plasma is to be thawed, temperature should
never go above 37o C
If frozen plasma thawed, it should be kept at
2 to 6o C and used within 24 hours
Importance of Safe Storage

Blood must be stored at a temperature
between + 2o C to + 6o C.



to maintain oxygen carrying capacity
to maintain its viability
to minimize growth of any bacterial
contamination

Plasma must be rapidly frozen and stored
at - 30o c or lower

to maintain coagulation factor levels
(Factor VIII, Factor V)
Storage of Untested/quarantined Blood

Label storage area according to status
quarantine (unavailable): products that have
not been tested or have been partially tested.
restrictive access to such products
released (approved): products available for use
rejected (non-conforming): products do not
conform and are awaiting disposal

Ensure that there is no mix up of quarantined
products with tested (approved) products
Monitoring Temperature of Refrigerators

Use of thermometers
early in the morning , afternoon & at the end of working
day



top, middle, bottom shelf
Documentation

thermal charts / manual records
Temperature record
Date
Time
Shelf Temp
Action
19/12
19/12
8am
2 pm
High
low
4o c
6o c
19/12
8 pm
low
5o c
none
to be checked
in 1 hour
none
Documentation
• Traceability from donor to recipient
• Results of all donation tests
• Standard Operating Procedures (SOPs)
• Training records for each member of staff
Documentation
Forms/ datasheets, etc.




Record sheets for products prepared
Monitoring data
Equipment cleaning / maintenance,
calibration records
Stock levels of prepared and released
products
Incident Reporting
• An incident is an occurrence or event that
affects the quality of the blood bank’s
procedures and services.
• All employees are encouraged to
participate in incident reporting.
• It is essential that incident reporting is not
used as tool for disciplinary or finger
pointing.
• Instead it is a process improvement tool
that is used for FADE
– Focus and define the right problem
– Analyse the problems
– Develop realistic and worthwhile solutions.
– Execute new procedures and systems
Process measures or Quality
indicators are activities that are
repeatable and measurable over time
• Quality indicators selected should be able to
demonstrate that all systems are functioning
within acceptable limits.
• Process measures (Quality Indicators) are used
to determine : frequency of failure, potential
cause(s) of failure, effect of any changes to the
process.
Quality monitoring



On at least 1% of all components
produced for all parameters to be
measured in that component
If the number of components
manufactured is fewer than 10, then all
components must be monitored
75% or more of components monitored
must meet specifications (which need to
be defined and understood)
Sampling
• Non-destructive sampling methods
usually involve use of blood bag tubing
• Mixing of product and stripping of
tubes are vital and methods need to be
standardized
• Sampling methods must be validated
to ensure that they produce consistent
samples, regardless of the operator
Samples for Hb/Plt.Ct.must be taken
in dry EDTA tube
QC criteria – Red cell Components
RBCs from 450ml blood
Volume: 240-320 ml
Hct: 65-75%
RBCs from 450ml blood
In preservative solution
Volume: 330-370ml
Hct: 55-65%
Leucocyte-reduced Red cells
Retain 80% of original RBC;
<5 X 106 WBC
Washed Red Cells
Retain 80% of original RBC
<1% protein of that from the primary
bag before washing
< 10% WBCs of that from the primary
bag before washing
QC criteria – Platelets (PRP
method from 450 ml whole blood)
Count:
> 5.5x1010
Volume: 50-70ml
pH:
>6
Sterility
Swirling movement: test
for functional viability
QC criteria – Platelets (Buffy coat
method from 450 ml whole blood)
Count:
> 6x1010
Volume: 70-90ml
pH:
>6
Sterility
Swirling movement: test
for functional viability
QC criteria – Platelets
(by Apheresis)
Count:
> 3x1011
Volume: 200-300ml
pH:
>6
Residual leucocytes:
• < 5x106
QC criteria – Fresh Frozen Plasma
Volume: 200-220ml
Stable Coagulation
factors: 200 units of
each factor
Factor VIII : 0.7
units/ml
Fibrinogen: 200400mg/dl
QC criteria – Cryoprecipitate
80 IU of Factor VIII
Fibrinogen > 150
mg/dl
Distribution of Blood Products:
•
Component Distribution:
– RBC products are visually inspected before
issue for material contamination, clots,
icteric plasma, fungal growth and correct
product labelling.
– Frozen products are inspected for evidence
of thawing and correct product labelling.
Quality Audit
• Internal quality audits to ensure
operations continue to conform to
cGMP specifications
• External assessment, usually by a licensing
authority (FDA, MoH ) or by peer
audit (by another centre)
Blood Issue
• Transported as close to the
temperature of storage as possible
• Delivered and re-stored under the
correct conditions as quickly as
possible
• Issued blood should rarely be
returned for re-use
Storage and Transportation


Blood & blood products are labile biological
materials which need to be kept under the
right conditions to ensure that they remain
viable, safe and clinically effective
Blood and products need to be transported
under the right condition
to maintain product viability
to ensure product security


Transportation
• Red cells should be carried in insulated
box & coolant packs which maintain the
temperature between 2-100 c. Should
be stored in refrigerator until
transfused.
• Platelets should be carried in insulated
box that will keep the temperature at
22-240 c.
should be kept at room temperature
until Tx
• FFP and cryo are thawed before Tx &
transported and stored at 2-80 C until
Tx
storage
 storage conditions need to be appropriate
and correct for each product
temperature
cleanliness
 storage needs to be secure to prevent
unauthorized access
to people
to insects / vermin etc
 storage needs to be monitored to ensure
that the correct conditions are maintained
continuous temperature monitoring
alarm system on all storage equipment




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
Proper Storage of Blood
Air circulation
Units of the blood should be standing
Upright in baskets laid flat on the shelf

Never store food items in
blood bank refrigerator
Never store blood in the door of
refrigerator
Check for signs of deterioration of
blood during storage
Look for Hemolysis in the
plasma.
 Look for any change in the
colour in the Red Cells e.g.
Purple/ Black indicate
contamination.
Look for any clots.
The Cold Chain


Definition:
System for storing & transporting blood and
components in as safe a way as possible to
maintain all the functions of the component
Two essential parts of cold chain


people to organize and manage storage
and transportation
equipment to store and transport blood
and plasma safely
Maintaining the Cold Chain

The cold chain is central to the storage and
distribution of blood and products




the correct temperature must be maintained
The cold chain runs from donor to the patient
The length of the time that products are not
at the correct storage temp. must be defined
Procedures for detail action to be taken in
case of “out of specification” products must
be in place
Transportation of Blood and Products
 Transport containers must be kept
clean and regularly disinfected
condensation often occurs, the
moisture is an ideal place for
bacteria to multiply



If sealed ice packs are used, they
must be regularly cleaned and
disinfected
If ice packs are using home-made ice,
the ice must be changed regularly to
prevent growth of contaminants
Transportation

Distribution needs to be secure


BTS transport or external agency
the product should arrive at its destination in
the time expected


the product has not been damaged in transport
the product has not been interfered with
Protecting the Product
Packaging that protects the product from
physical damage
 Packaging that maintains the optimum
temperature
 Clean packaging to minimize the risk of
microbial contamination
 Physical separation of cellular products from
any ice packs used to maintain temperature

Documentation

Documentation is needed to record key
parameters during storage and distribution
temperature at the start, during, destination






product dispatched and actually received
times of dispatch and receipt
destination of product
integrity of the product
integrity of the transport container
allowable “out-of-specification” temp. and
duration
Temperature Data Loggers
• Comprehensive & user
friendly Windows
software.
• Device helps in validation
of packing methods used
for transportation of
blood/blood components.
• Device helps to validate
fridges & freezers used
for storage.
Reception of Blood / Product

Record the time of arrival

Measure & record the temperature in the
container
 Inspect blood or the product for any signs
of hemolysis or contamination
Measure
& record the temperature of blood
(sandwich method)
Recipient’s Identity check
• The final identity check should be
done at patient’s bedside
immediately before starting Tx
• Ask the patient to identify
himself/herself,
check the pt’s identity & gender
against pt’s wristband/label, hospital
reg. number, ward number, pt’s blood
group
• Check blood group on blood pack &
compatible label and in pt’s notes
Component transfusion
• Should be through disposable
plastic Tx set.
• Transfusion sets are
available having integral 170200 micron filter
• If required use special
pediatric sets for pediatric
pt.
Component transfusion
• Blood should never be warmed
• Do not add any medicine or infusion
solution other than normal saline to
any blood component
• Use separate IV lines if an IV
fluids has to be given at the same
time
Blood Administration
• Temperature of Blood
 Routine warming is not needed
 Warming is required in
 Receiving multiple transfusion at the rate
> 50ml/kg/hr for Adult
> 15ml/kg/hr for Children
 Infant receiving exchange transfusion
 Patient with cold agglutinins
 Method of warming(not >37ºC)
 Water bath with warming coil
 Dry heat warmer
 High volume heat exchanger
Blood Administration
• Rate of Transfusion




Adverse effects are rate related.
15-50ml during first 15 min.
Total infusion within 2-4 hr.
In acute loss 100ml/min until the systolic BP reaches to 100mm
Hg.
 Chronic anemia with cardio vascular compensation 2ml/min or
1ml/kg body weight/hr.
• Monitoring the Patient
 Temp.,Pulse,BP,Respiration rate before starting BT
 Close observation for the first 15-20min
 Temp.,Pulse,BP,Respiration rate recheck after the first 25-30 ml
has been infused then every half hourly till the transfusion is
complete
Hospital Transfusion
Committee
• Powerful tools for appropriate utilization
of blood products
• Comprises of head of transfusion
services, director of the hospital and
other key personals involved in blood
transfusions
• Appropriate step to improve the
services as well as the clinical practices
Hospital Trans. Committee
• Formulating policies for use of blood components
• Developing guidelines for use of products
• Establishing Standard Surgical Blood Ordering
Schedule (SSBOS)
• Monitoring source & supply of components
• Monitoring adverse effects of blood Tx
• Auditing blood transfusion services
Transfusion Audit
• Management Tool - Analyze data
of current practices to find trend
• Follow-Up - Make appropriate
changes in policy/procedure,
which is on basis of agreement
between blood banker & users
• Example - FFP abuse; PT &
APTT 1.5 times normal on blood
request form before issue of
components
Summary




Blood processing into components is an
important activity of a BTS
Involves manipulation of blood and
must be performed following cGMP
The final products must be of high
quality, safe, effective and consistent
Activities must be well-controlled &
fully documented
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