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