Download MBBS Transfusion Medicine and Blood Bank Presentations 9 Quality Control In Blood Bank Lecture Notes

Download MBBS (Bachelor of Medicine, Bachelor of Surgery) 1st Year, 2nd Year, 3rd Year and Final year Transfusion Medicine and Blood Bank 9 Quality Control In Blood Bank PPT-Powerpoint Presentations and lecture notes


QUALITY CONTROL IN

BLOOD BANK

Content

? Definition
? Types
? Need
? Inclusions
? How to do that?
Quality Assurance

? It is the sum total of the organized arrangements with the objective

of ensuring that products will be of the quality required for their

intended use.

? It includes retrospective review and analysis of operational

performance data to determine that the overall process is in a state

of control and to detect shift or trends that require attention.

Quality Control

? Testing routinely performed tests/activities on materials and

equipments to check their proper function

? The monitoring system that checks the effectiveness of existing

process/steps by testing the quality of final products
Quality System Essentials (QSEs)

1. Organization and leadership

2. Facilities work environment and safety

3. Human resources

4. Customer focus

5. Suppliers and material management

6. Equipment management

7. Process management

8. Documents and records

9. Information management

10. Management of non conforming events

11. Monitoring and assessment

12. Process improvement

Types

? Internal Quality control

? External Quality Control


Internal Control

? The internal quality control can be maintained by

going through a complete checklist of items or test
daily to make sure that all systems are being
monitored and in control.

? Immediate decisions can be taken to accept or reject

results / products.

External Quality Control

? External quality control is a way to compare the

performance of a laboratory with reference to other
laboratories

? External Quality Assurance also know as `proficiency

testing' or External Quality control
Quality in Blood Transfusion Services

In blood transfusion service, the primary goal of quality
is 'transfusion of safe unit of blood.'

The quality system deals with all aspects to ensure that
the product or 'safe unit of blood' is as safe as possible.

Objectives of Quality in Blood Bank

? To ensure availability of a sufficient supply of blood,

blood components of high quality with maximum
efficacy and minimum risk to both donors and patients.

? To determine problems in the whole transfusion chain

and solve it to achieve the goal .
Quality Management System in Blood Bank

In a blood transfusion center, it means that a management system should
exist to look into provision of a safe unit of blood and if any errors are
identified, these should be corrected.

Steps involving Quality Control in

Blood Bank

? Donor selection and Blood collection

? Serology Laboratory

? Transfusion transmitted Infection

? Component preparation

? Cross-match & Antibody screening

? Storage , issue and transportation
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.

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 clerical or technical errors

Quality Control for Reagents

The primary objective of a reagent quality control is to ensure that
reagent is functioning as expected.
Quality Control for Reagents

Reagent requirements

? All reagents should be clearly labeled with batch

number, expiry date and storage temp;

? Instructions for use should be in-form of SOP's

with training.

? All reagents and kit should be used according to

the manufacturer's instructions.

? FIFO shall be maintained

Quality Control for Reagents

? Use of positive & negative controls should be done with each

batch to show that reagents are potent and specific.

? Al reagents must be carefully stored at recommended temp.

? Reagents to be kept at 4-6oC should never be frozen and are

stored according to manufacturer's instructions only

? Supply, storage and transportation of kits and reagents should

be strictly standardized & manufacturer's instructions should be

fol owed with ensured continuous power supply and periodic

temperature monitoring.


Log of Reagents

? Reagent records should include:

? The name of each reagent with

? Lot number
? Batch number
? Expiry date
? Name of manufacturer
? Date of receipt and put in use

? Grade and strength of reactions at time of receipt (Kit

verification).

Frequency of Quality Control of Reagent

Reagents

Frequency of testing along with

Controls

Anti human serum

Each day of use

Blood grouping serum

Each day of use

Antibody screening and reverse

Each day of use

grouping cells

Enzymes

Each run

Normal saline (LISS and BPS)

Each day of use

Bovine albumin

Each day of use
Quality Control of Reagent Red Blood Cells

Parameters

Quality

Frequency of

Requirement

Control

Appearance

No haemolysis or

Each day

turbidity in

supernatant by visual

inspections

Reactivity and specificity Positive reactions with Each day

known sera against red

blood cells antigens

Quality Control of ABO Reagent

(Anti-A, Anti-B and Anti-AB)

Parameters Quality Requirement

Frequency of Control

Appearance No turbidity, precipitate, particles or gel

Each day

formation by visual inspection

Specificity Positive reaction with red cel s having

Daily and of each new

corresponding antigen(s); and no reaction with

lot/batch

negative control

Avidity

Macroscopic agglutination with 50% red cel s

Daily and of each new

suspension in homologous serum/normal saline lot/batch

using the slide test;

10 seconds for anti-A, anti-B and anti-AB with A1

and/or B cel s at R.T; 20 seconds with A2 and A2B

cel s.

Reactivity No immune haemolysis, rouleaux formation or

Each new lot/batch.

Prozone

Potency

Undiluted serum should give +++reactions in

Each new lot/batch.

saline tube test using a 3% red cel s suspensions

at R.T., titre should be 256 for anti-A, anti-B, and

anti-AB with A1 and/or B cel s, 64 with A2 and A2B

cel s.
Quality Acceptable of Rh Anti-sera (Anti-D)

Parameter

Quality requirement

Frequency of control

Appearance

No turbidity, precipitation,

Each day

particles or gel formation by

visual inspection

Specificity

Positive reaction with R1r

Each day and each new

cells / Known D Positive cells lot/batch. And no reaction

with rr cells.

Avidity

Visible agglutination with

Each day and each new

40% red cells suspension in lot/batch

homologous serum using the

slide test.

Reactivity

No immune haemolysis,

Each new lot/batch

rouleaux formation or

prozone phenomenon.

Potency

Undiluted serum gives +++

Each new lot/batch

reactions in designated test

for each serum and a titre 32-

64 for anti-D.

Acceptable Titre and Avidity of ABO Reagents

Anti-sera

Type of the reagent Type of red cells (2 Titre

Avidity Time

Intensity

-3% cells

suspension)

Anti-A

Polyclonal

A1

1:256

10-12 sec

+++

Monoclonal

A2

1:128

15-18 sec

++ To +++

A2B

1:64

15-18 sec

++

O

-

-

-

B

-

-

-

A1

1:256

3.4 sec

+++

A2

1:128

5-6 sec

++ To +++

A2B

1:64

5-6 sec

++++

O

-

-

-

B

-

-

-

Anti-B

Polyclonal

B

1:256

10-12 sec

+++

Monoclonal

A1B

1:128

12-15 sec

++

O

-

-

-

A1

-

-

-

B

1:256

3-4 sec

++++

A1B

1:128

5-6 sec

+++

O

-

-

-

A1

-

-

-

Anti-AB

Polyclonal

A1

1:256

10-12 sec

+++

Monoclonal

B

1:256

10-12 sec

+++

A2

1:64

15-18 sec

++ To +++

O

-

-

-

A1

1:256

3-4 sec

++++

B

1:256

3-4 sec

++++

A2

1:128

5-6 sec

+++

O

-

-

-
Acceptable Quality of Anti-globulin (Gel / Beads) Reagent

Parameter

Quality requirement

Frequency of control

Appearance

No precipitate, particles or Each day

gel formation by visual in

inspection.

Reactivity and Specificity

No prozone phenomenon

Each lot


No haemolysis or

Each day

agglutination of

unsensitized red cells


Agglutination of red cells

Each day and each new

sensitised with anti-D serum lot/batch.

containing not more than

0.2 mg/ml antibody activity

Transfusion Transmitted Infection testing Done in Blood

Bank

?HBs Ag
?HIV 1 & 2
?HCV
?Syphilis
?Malaria Parasite
Frequency of Transfusion Transmitted disease

Reagents

Frequency of testing along with

controls

Hepatitis B Antigen

Each run

HIV 1 & 2 Antibody

Each run

Hepatitis C Virus

Each run

Syphilis serology reagents

Each run

Malaria Test

Each run

Assuring quality of examination procedure

? The daily QC values shall be documented on Levey

Jennings curve and CV % from monthly QC data must be
calculated.
Flow chart should be made to manage "Out of control situation"

? If a reagent produces results outside the limits set by the manufacturer

or Blood Bank, the deficiency should be reported to the Quality

Manager.

? Search for recent events that could have caused changes

? Examine environmental condition

? Follow manufactures troubleshooting guide

? Refer to manufacturer of equipment, reagents or QC/Calibrator vendor.

Quality Control in Blood/ Blood Components

Frequency of Testing

1% of component shall be tested for Quality Control out of

which 75% shall match the acceptable ranges as per

National guidelines set by Govt. of India(DGHS).


QC of blood/blood component preparation

1. Whole blood:

? Frequency of control: 1% of all units with minimum of 4 units

per month

? Storage :- 2?C to 6 ?C, for CPDA-1 the storage time is 35

days, CPD & CD2D ? 22days.

Parameter

Quantity Requirement

Frequency of Control

Volume

350/450 ml + 10%

1% of all units

Anticoagulants

49/63 ml

All units

PCV (Hct)

30 to 40%

4 units per month

HBsAg

Negative by ELISA

All units

Anti-HCV

Negative by ELISA

All units

Anti-HIV ?

Negative by ELISA

All units

Syphilis

Negative by Screening test

All units

Sterility

By culture

Periodically (1% of all units)

Calculation for Total Volume of Whole Blood taken in

450 ml of Bag

Volume of Whole Blood: 450 ml ? 10% OR 472 gms. ? 10%
Calculate the volume from the formula given below:

Weight of the Bag with Blood (gms) Weight of the empty Bag

(with Anticoagulant)

Volume (ml) =

1.05

* Weight of the empty Bag (with Anticoagulant) of 450 ml = 100 gms
2. Red cell concentrates

? Perform the same assay as for Whole blood

? Storage : 2o-6? C, for 35 days if prepared from WB

collected in CPDA-1

The Quality Control of red cell concentrate (Prepared from 450 ml Blood)

Parameter

Quantity Requirement

Frequency of Control

Volume

280 + 40 ml

1% of all units

PCV (Hct)

70%+ 5%

Periodically (1% of all units)

The Quality Control of red cell in preservative sol. (ADSOL/SAGM)

Parameter

Quantity Requirement

Frequency of Control

Volume

350 + 20 ml

1% of all units

PCV (Hct)

55-65%

Periodically (1% of all units)

3. Platelet concentrates

? Prepared within 6 hours of blood collection

? Must evaluate at least 1% of platelets monthly for platelet

count, pH and plasma volume

? Platelets should be selected from each centrifuge in use

? Storage : 20o-24?C

Parameter Quality

Requirements

Frequency of control

Volume

50-70 ml

All units

Platelets count

> 5.5 x 1010

4 units per month/ 1% of all

units (whichever is more)

pH

>6.0

4 units per month/ 1% of all

units (whichever is more)

RBC contamination

0.5 ml

4 units per month/ 1% of all

units (whichever is more)

WBC contamination

5.5x107 ?5x108

4 units per month/ 1% of all

units (whichever is more)
4. Quality of Platelet concentrate by Apheresis

Parameter

Quality requirement

Volume

>200 ml

Platelets count

> 3.0 ? 7.0 x 1011

pH

> 6.0 (at the end of permissible

storage period)

Residual leucocytes

< 5.0 x 106

Red cells

Traces to 0.5 ml

5. Fresh Frozen Plasma

? frozen within 6 hours of blood collection using ?80oC

deep freezers or blast freezers

? Stored at ?30oC

? Date of expiry one year

Parameter

Quality control

Frequency of control

Volume

200?220 Plasma

4 units per month/ 1% of all

units (whichever is more)

Stable coagulation factors

200 units of each factor

4 units per month

Factor VIII

0.7 units/ml

4 units per month

Fibrinogen

200?400 mg

4 units per month


6. Cryoprecipitate

Parameter

Quality control

Frequency of control

Volume

10?20 ml

1% of all units

Factor VIII

80?120 units

1% of all units

Fibrinogen

150?250 mg

1% of all units

Labeling

? Unique identification number
? ABO and Rh type
? Date of collection and expiry
? TTI screening sticker
? Volume of component


Storage

Refrigerators

? External ambient temperature

? Range: 2 to 6?C

? Continuous monitor temperature

chart to record `fluctuations' -

? THERMOGRAPHS: Changed

weekly & preserve records

? Bacterial cultures

? Audible and visual alarm signal

? Digital temperature display

Deep freezers

? Temperature recording : Range: -35?C to -40?C

? Cooling down time: A full load of plasma packs at +25?C takes

a max. of 5 hrs for all the packs to reach below -5?C and 30 hrs

to below -20?C


Platelet agitator

? All PCs to be stored only in agitators:

continuous gentle flat bedded ?

5 days
? Interruption compromises the

viability

? Temperature monitoring
? "Swirling" to be checked before issue
? Regular Quality Control of RDPs and

AP-PCs

External Quality Assurance (EQA)

? Proficiency Testing Programme is designed to evaluate

the overall performance and accuracy engaged in blood

banking testing.

? Determine the performance of Individual Blood banks

for specific tests or measurement and to monitor Blood

Banks continual performance and improvement.

? To provide additional confidence to Blood Bank /

Laboratory clients.

? It i s a blind testing


External Quality Assurance

? The internal QC should be complemented by regular external quality

assurance e.g. participation in a proficiency testing programme

? Proficiency programme test, coded "normal" and "problem" blood

samples are distributed from national or regional reference laboratory

to the participants usually 2x to 4x a year.

Parameters / test covered under EQA

1. HBsAg

2. Anti- HIV 1&2

3. Anti- HCV

4. Syphilis (VDRL)

5. Malarial Parasite

6. NAT ( HBV/ HCV/ HIV-1, HIV-2, HIV-O & HIV-M)

7. Hemoglobin

8. Blood Group

9. Cross-match

10. Antibody Screening & Identification

11. Factor VIII

12. Fibrinogen

13. Sterility Testing

14. APTT



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This post was last modified on 08 April 2022