Quality control

Dr.Nasrin Akter
MBBS,MD Trasnsfusion Medicine
Specialist
Evercare Hospital chattogram
Quality control 

Activities including steps of verification and testing which are used to

assure the materials and processes meet their intended specifications.
This describes all the steps taken both in and outside the laboratory to
achieve reliable results, starting with the preparation of the patient and
collection of the specimen and ending with the correct interpretation
of the results.
 Main objectives

• To help lab staff to establish, manage and monitor a testing process to assure the analytical
quality of the test results .
• To determine problems and solved it.
• To develop uniform standard of lab.
• To increase lab staff confidence .
• To increase client confidence.
• Available good database for decisions maker.
• Help health planer to improve the programs.
• Reduce cost.
The quality requirements involve:-
• Quality control and proficiency testing
• Internal and external audits
• Personnel and organization
• Premises, equipment and materials
• Documentation
• Blood processing
• Complaints and component recall
• Investigation of errors and accidents
External Quality Assessment
• External quality assessment is the objective evaluation by an outside
agency of the performance by a number of laboratories on material
which is supplied specially for the purpose.
Why do we need External Quality Assessment?
• Is usually organized on a national or regional basis.
• To detect hidden problem
• To receive help and support
• To compare our performance with others and improve quality
Internal Quality Assessment
IQC refers to the set of procedures undertaken by the laboratory staff
for the Continuous and immediate monitoring of the laboratory work in
order to decide whether the results are reliable enough to be released.
Why do we need Internal Quality Control?
• Ensure that test results are reliable.
• Ensure that test results are reproducible.
• Control quality of daily routine work.
Need for Quality
A failure in the quality of blood collected or screening of donated blood
unit can be very serious and may result in fatal consequences. A failure
in the quality system can lead to numerous situations which may be
potentially dangerous to the patient, i.e.
1. failure to identify the patient correctly
2. wrong sample labeling
3.mix-up of results amongst different patients
4.failure to detect presence of an abnormality in the patient's sample.
5. issue of unscreened blood due to faulty laboratory procedures
QC in Blood Bank
• Positive and negative controls on all tests
• Reverse grouping
• Good documentation, SOPs etc
• Equipment monitoring, calibration, maintenance
Personnel
Designation
• Doctor
• Register
• Registered nurse
• Blood bank technologist
• Laboratory Assistant
• Laboratory Attendant
QC in Blood Bank Technology
• Donor services and Blood collection
• Blood grouping
• Crossmatch & antibody screening
• Transfusion
• Component preparation
• Storage , issue and transportationPositive and negative controls on all tests
• Reverse grouping
• Good documentation, SOPs etc
• Equipment monitoring, calibration, maintenance
QA IN COLLECTION OF BLOOD
• Blood bank area must be located, designed,constructed and adapted to suit
the operation to be carried out.The quality ,safety and efficacy of product
transfused is the result of many steps.It should include many areas for:-
• Donor selection
• Blood collection
• Component preparation
• Storage, issue and transportation
• Laboratory facilities
• Auxiliary facilities
• Contract testing
DONOR SELECTION
• Donor selection information collection and evaluation-consent form
• donor is registered for permanent record
• Donor must be checked for possible self harm or potential harm to
recipient
• Blood collection
• Aseptic technique
• Seal closed method
Equipment's required:-

• all the equipment in blood transfusion laboratory should meet

mandatory specification
• 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 equipment
with efficient back-up system
• Annual maintenance contract with manufacturers and suppliers should
be obtained.
 Grouping Laboratory
PARAMETER SHOULD BE Minimal requirement Control samples Frequency of control Control executed
CHECKED for testing by

Rh-D typing Using anti D sera from 1.Rh-D Positive Each test series or at least once Grouping Lab
different batches and 2. .Rh-D negative a day provided the same
should be different samples reagent are used throughout
clones

Anti globulin testing, test Washing the cells 4 Addition of Each negative test Grouping Lab
tube method times before adding sensitized blood
anti human globulin cells to negative
test
 Grouping Laboratory

PARAMETER SHOULD Minimal requirement Control samples Frequency of control Control executed by
BE CHECKED for testing

ABO Typing Use of anti A, anti B One blood sample each Each test series or at Grouping Lab
and anti AB reagent of following: O, A and B least once a day
provided the same
reagent are used
throughout
Quality Control for reagents
• Select the reagent with high specifications-
• Reference preparation has been established for ABO, Rh anti- human
globulin (AGH)
• Use according to manufacture’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
Blood Processing and Quality Control

No leaked or puncture in -
• Whole blood
• Pack Red cell
• Platelets
• FFP
• Cryoprecipitate
Equipment's QC
Equipment's Method of control Frequency of control Control executed by
Laboratory refrigerator, Thermometer, precision Daily Technologist
Freezers, water bath Thermometer
Blood bag refrigerator, Graphic recorder plus Daily Technologist
freezer containing independent audible
transudates and visual alarm for
appropriate high and
low temperature
parameter
Laboratory refrigerator, Precision Thermometer Every 6 month Technologist
Freezers, water bath # For calibration#
 Equipment's QC

Equipment Method of control Frequency of control Control executed by

Cryofuge Precision RPM stopwatch to Twice/month Technologist

control speed acceleration
and retardation
Cryofuge Temperature Daily
Table centrifuge RPM meter plus stopwatch to Daily Technologist
control speed, acceleration
and retardation
Hb spectrophotometer Calibrated with standard Daily Technologist

Hb spectrophotometer Hb-QC sample Monthly Technologist

 Equipment's QC
Equipment Method of control Frequency of Control executed by
control
Laboratory refrigerator, Thermometer, precision Thermometer Daily Technologist
Freezers, water bath

Blood bag refrigerator, Graphic recorder plus independent audible Daily Technologist
freezer containing and visual alarm for appropriate high and low
transudates temperature parameter
Laboratory refrigerator, Precision Thermometer , For calibration. Every 6 month Technologist
Freezers, water bath

Platelet agitator Thermometer, frequency of agitation Daily monthly Technologist

Balance Analytical – control weights 5mg – 100g Every 6 month Technologist

Preparative control 100mg – 100g
Equipment's QC
Equipment Method of control Frequency of control Control executed by

Blood mixer Control weighting and Twice /month Biomedical Engineer

mixing

Blood bag tube sealer Pressure on bag and tube Every bag and weld Technologist

Blood transport container Temperature control device Every time on use Technologist
Product
QC of Blood component
Storage Volume

Whole blood 2 500

Packed cell 2 280

Platelet 2 >40 ml

Single Donor Platelet 2 >40ml/60x109

Platelets
>200x109/unit
P-6.5-7.4
 QC of Blood components

Blood components Strerility

Whole blood No growth

Packed cell No growth

platelet No growth
FFP Cryoprecipitate
Every 10 unit/ week estimate the volume Every 10 unit/ week estimate the volume
Volume :220-250 ml Volume :10-20 ml
Storage: Storage:
24 months at below -30 12months at -25 24 months at below at -30
to -30 12months at below at -25 to-30
3 months at -30 3 months at below at -25
Factor VIII :>70 IU Every 2 months
Microscopic : no abnormal colour or Factor VIII :>70 IU Every 2 months
visible growth. Fibrinogen::>140 mg/unit
Residual cell Microscopic : no abnormal colour or visible growth.
Leucocyte :x
Red cell:x
Platelet:x
 Transportation
Maintenance cold chain during transport
Whole blood 1-10

Packed cell 1-10

Platelet 20-24

FFP -18 or colder

QC OF INFECCTIONS DISEASE TEST

• To reduce the blood borne infection disease

• Does not use assay beyond its expiry date.
• Storage conditions for sample.
• Preparation for sample.
• Test Kit manufacture’s control for every assay.
• Positive and negative control.
• Positive and negative control as test sample

• Following manufacture instructions for performing an assay

• Adequate training
• Using sensitive assays to screen samples
• IQAS (Internal Quality Assurance System)
• EQAS (External Quality Assurance System)
Thank you