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Quality Assurance procedure and protocols
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Quality assurance in blood banking
Dr. Shahida Baloch
Quality assurance in blood banking
• Fitness for purpose
Introducing Quality
Quality is a process
A continues cycle of PlanDoCheckAct (Deming cycle)
Quality is an ongoing activity, not a goal to be reached.
Quality control
Checks puts in places to ensure that process, procedures and products meets the quality requirements.
(consistency)
How to start QC
Start from today and make a plan for QC.
The quality requirements involve:-
Quality control and proficiency testing Internal and external auditsPersonnel and organizationPremises, equipment and materialsDocumentationBlood processingComplaints and component recall Investigation of errors and accidents
Premises- must be located , designed, constructed and adapted to suit the operation to be carried out.It should include separate areas for :-
a) Donor selection
b) Blood collection
c) Blood processing
d) Storage
e) Laboratory facilities
f) Auxiliary facilities (Supportive facilities)
.
QA IN COLLECTION OF BLOOD
The quality, safety and efficacy of the product transfused is the result of many steps:-– Donor selection– Blood collection– Component preparation– Storage , issue and transportation
Donor Selection Information collection & evaluation
– Consent form– Donor is registered for permanent record– Donor must be checked for possible self harm or
potential harm to recipient( list of questionnaires).– Blood Collection:
Aseptic techniqueSeal closed method
Blood processing
After blood Collection immediate storage at 1-6ºC
Components preparation has to be done within 6 hours after collection
Labels/Records : ABO and Rh groupingScreening, expiry date and volume of the
blood
Equipment requirements :- All the equipment in blood transfusion laboratory
should meet mandatory specifications. A written record of periodic function checks and
maintenance on each piece of equipment should be mandatory.
A preventive maintenance should be planned for trouble free operation.
Uninterrupted power supply should be maintained for all the equipment with efficient back-up system.
Annual maintenance contract with manufacturers and suppliers should be obtained.
Equipments Method of control Frequency of control
Control executed by
Laboratory refrigerator, freezers, water bath
Thermometer, precision thermometer
Daily Technician
blood bag refrigerators, Freezer containing transfusates
Graphic recorder plus independent audible and visual alarm for appropriate high and low temperature parameter
Daily Technician
Laboratory refrigerator, Freezer, water bath
Precision thermometer# For Calibration #
Every 6 month Technician
Equipments QC
Equipment Method of control Frequency of control
Control executed
CryofugePrecision RPM meter plus stopwatch to control speed, acceleration and retardation
Twice / month Technician
Cryofuge Temperature Daily Technician
Table centrifuge RPM meter plus stopwatch to control speed, acceleration and retardation
Daily Technician
Haemoglobin spectrophotometer
Calibrate with standard Daily Technician
Haemoglobin spectrophotometer
Hb- QC Sample Monthly Technician
Equipments QC
Equipment Method of control Frequency of control
Control executed by
Cell counter Calibration; reference samples,
Daily Technician
pH meter Control solution pH 4-7, 7-10
Each time of useTechnician
Platelet agitator Frequency of agitation Monthly Technician
Laminar flow hood Air pressure Daily Microbiologist
Laminar flow hood and sterile area filter
Particle counter 3 times / Month Microbiologist
Equipments QC
Equipment Method of control Frequency of control
Control executed by
Blood mixer Control weighing and mixing
Twice /month Engineer
Blood bag tube sealer
Pressure on bag and tube Every bag and weld
Technician
Blood transport container
Temperature control device Every time on
use (on receipt)Technician
Equipments QC
-Control for equipment–Control for reagents–Control for techniques
Based upon internal QC and external QC.
Internal quality control are subdivided into
Color codes for Anti sera by the FDA:
Quality control for reagents
Select the reagent with high specifications- reference preparation has been established for ABO, Rh and anti-human globulin (AHG) by FDA
Use according to manufacturer's instruction The new reagent has to be assessed & confirmed
satisfactory The appearance each reagent has to be checked each day The reactivity and specificity has to checked each new lot
Grouping laboratory
Parameters to be checked
Minimal requirement for testing
Control samples Frequency of control
Control executed by
ABO Typing Use of Anti A and Anti B duplicate reagent (Monoclonal
reagent)
One blood sample each of the following: O,A and B
Each test series or at least once a day provided the same reagent are used throughout
Grouping laboratory
Parameters to be checked
Minimal requirement for testing
Control samples
Frequency of control
Control executed by
Rh- D typingUsing 2 anti D sera from different batches, and should be different clones.
1 Rh – D Positive1 Rh – D NegativeSample
Each test series / at least once a day provided the same reagent are used throughout
Grouping lab.
Anti globulin testing, tube method
Washing the cells 3 times before adding anti globulin
Addition of sensitized blood cells to negative test
Each negative test
Grouping lab
Grouping laboratory
Blood Processing and Quality Control
No leakage or puncture.• Whole bloodPack Red cellPlateletsFFPCryoprecipitate
QC of Blood Components
Products Storage Volume
W/B 2ºC to 6 ºC 500ml ±50 ml
P/C 2ºC to 6 ºC 280ml ± 50ml
Platelets 20ºC to 24ºC Volume > 40ml
QC of Blood Components
Blood Components
Frequency of Control
Sterility
W/B 1% No Growth
P/C 1% No Growth
Platelets 1% No Growth
W/B P/C Platelets
HCT : 40 ± 5%pH > 6.5K < 27mmol/LHb minimum 45g/unit
HCT :65% to 75%pH > 6.5K < 78 mmol/LHb : minimum 45g/unit
Platelet count : at least: 5.5 x 10¹º / bag
At least 75% of the units tested at the end of the storage.. pH : 6.8-7.4WBC contamination: < 2 x 10³/bagRBC contamination:
< 2 x 10⁹/bag Macroscopic appearance : no visible platelets aggregates
FFP CP
Every 10 unit/week estimate the volume
Volume: 220-250mlStorage:
24 months at below –30ºC12 months at –25 to –30ºC3 months at –18 to –25ºC
Factor VIII : > 70 IU/unit every 2 months
Every 10 unit/week estimate the volume
Volume : 10-20 mlStorage:
24 months at below –30ºC12 months at –25 to –30ºC3 months at –18 to –25ºC
Factor VIII : > 70 IU/unitFibrinogen : > 140 mg per unit
FFP CP
Macroscopic : no abnormal color or visible clotsResidual cell:Leukocyte: < 0.1 x 10⁹/l
Red cell: < 6.0 x 10 ⁹/lPlatelets : < 50 x 10 ⁹/l
Macroscopic : homogenousSterility: no growth
Transportation
W/B 1-10ºC
P/C 1-10ºC
Platelets 20 – 24 ºC
Frozen Components –18ºC or colder
Maintain cold chain during transportation
QC OF INFECTIOUS DISEASE TEST
To reduce the blood borne infectious diseaseDoes not use assay beyond its expiry date.Storage conditions for samples.Preparation of samples.Test kit manufacturer's controls for every assayPositive and negative controlPositive and negative control as test sample.
– Following manufacturer instructions for performing an assay
– Adequate training– Using sensitive assays to screen samples– IQAS (Internal Quality Assurance System)– EQAS (External Quality Assurance System)
References
Guide to the preparation, use and quality assurance of blood components, 7th edition, Council of Europe Publishing
Technical Manual American Association of blood Banks, 11th edition