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No shortcuts to evolution : A holistic laboratory approach to blood safety. Dr. Neelam Marwaha , M.D., F.A.M.S, F.I.S.H.T.M . Professor& Head Department of Transfusion Medicine, PGIMER, Chandigarh.

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No shortcuts to evolution:

A holisticlaboratoryapproach to bloodsafety

Dr. NeelamMarwaha, M.D., F.A.M.S, F.I.S.H.T.M.

Professor& Head

Department of Transfusion Medicine,

PGIMER, Chandigarh


Shortcuts on keyboard may be fine shortcuts elsewhere brew trouble
Shortcuts on keyboard may be fineShortcuts elsewhere brew trouble


  • Collection of blood only from voluntary unpaid blood donors at low risk of acquiring transfusion-transmissible infections, and stringent blood donor selection criteria;

  • Testing of all donated bloodfor transfusion-transmissible infections, blood groups and compatibility;

  • Production of blood componentsto maximize the use of donated blood and enable the provision of therapeutic support for patients with special transfusion requirements;

Comprehensive quality system covering the entire transfusion process, from donor recruitment to the follow-up of recipients of transfusion

  • Appropriate clinical use of blood and the use of alternatives, where possible, to minimize unnecessary transfusions;


Change in the Blood Banking Scenario

  • Blood banks to Departments of Transfusion Medicine

  • Introduction of Cord blood banks and Stem cell therapy

  • Slides to Automation in grouping & compatibility testing

  • Blood bottles to Multiple Blood Bags with integral filter

  • Whole blood to Blood Components

    Single donor apheresis

    Specialised products ( Leucodepleted ,irradiated,washed,pooled)

  • Basic TTI Screening tests to NAT testing

  • Simple Blood storage to Specialized blood storage systems

  • Simple Freezer to Blast Freezer


Key activities in blood transfusion services

No

Yes

Disposal,

Donor notification

  • Inventory,

  • Storage

Key activities in blood transfusion services

Requisition

Quality Practice


Holistic approach in laboratories
Holistic approach in laboratories


Laboratories
Laboratories

  • Area for receiving samples from donors and requests from wards

  • Blood Group Serology

  • Crossmatch and Issue

  • TTI Testing

  • Blood Component Preparation

  • Quality Control

  • Training


Laboratory staff
Laboratory Staff

  • Minimum employed as per Drug Rules

  • Director / MO - in charge

  • Q manager – not yet a req. of Drug rules

  • Technical Supervisor

  • Technician /s

  • Lab Attendant/s

Adequate staff / no pendency of work / no undue delays


Standard operating procedures
Standard operating procedures

  • SOPs are an essential part of the quality system

  • SOPs should be written for all the procedures through team work

  • SOPs must be clear, concise and easy to follow

  • Staff should be trained to use SOPs

  • SOPs should be validated

  • SOPs should be reviewed and updated regularly

  • Staff must have easy access to the SOPs

  • SOPs must be followed


Equipment Management Program

  • Maintains a high level of performance

  • Reduces interruption of services due to breakdowns and failures

  • Lowers repair costs

  • Lengthens life of instrument

  • Provides greater reliability of results



Serological tests in blood banks
Serological tests in blood banks

ABO grouping and Rh typing

Weak D or Du testing

Antibody detection and identification

Cross matching

Antibody titration

Direct antiglobulin test

Haemagglutination inhibition test



Effects of alloantibodies


Blood grouping manual to automated
Blood Grouping: Manual to Automated

Work Area: Shifting of grouping lab

Sample collection: 3 clotted pilot tubes to 1 ACD and 1 clotted

Centrifugation: Essential step now

Barcode labelling: Essential additional step

Reagents:More stringent inventory management

Training: Test runs, interpretation, troubleshooting,

validation

Staff change: Two senior technicians

Duty hours: To balance workload and throughput

Results:Change in format of documentation


Managing test e rrors
Managing test errors

  • Clerical errors

    • Mislabeled tubes

    • Patient misidentification

    • Inaccurate interpretations recorded

    • Computer entry error

  • Reagent or equipment problems

    • Using expired reagents

    • Using an uncalibrated centrifuge

    • Contaminated or hemolyzed reagents

    • Incorrect storage temperatures

  • Procedural errors

    • Reagents not added

    • Manufacturer’s directions not followed

    • RBC suspensions incorrect concentration

    • Cell buttons not resuspended before grading reaction


Reagents e.ggrouping antisera

  • Define expectations

  • - quantity required (annual demand)

  • - one time supply / in instalments

  • - technical specifications

  • - documentary support e.g. approval from DCGI / NIB,

  • - original reagent inserts

  • - cold chain maintenance


Department of Transfusion Medicine, PGIMER, Chandigarh Quality Control Report of Anti A monoclonal antisera

30-12-11

  • Remarks: Anti A monoclonal antisera from _M_ does not meet the required Q.C. criteria (DGHS technical manual)

  • and are not found to be satisfactory.

Signed by: 1 2 3

Signature of HOD



Essential elements governing tti testing
Essential elements governing TTI testing

Quality of the specimen used for testing

Quality of kits used for testing

Calibration and validation of equipment used

Use of SOPs for testing

Type of Controls used while testing

Interpretation of results

Validation of results

Record keeping- kits,results

Training of staff-induction, refresher



Levey jennings chart record and evaluate the control values
Levey-Jennings Chart -Record and Evaluate the Control Values

+3SD

+2SD

+1SD

Mean

-1SD

-2SD

-3SD

Day

Look for trends, shifts and random errors


Window period
Window Period

Infection

HIV Ab Negative

HBsAg Negative

Window Period

HCV Ab Negative

Detection by

Serology markers


4 th generation elisa
4th generation ELISA

  • Simultaneous detection of both antigen and antibody

  • HIV

    • HIV P24 antigen

    • Anti-HIV1 and HIV2 antibody

  • HCV

    • Capsid core antigen

    • Anti-HCV capsid antibody


Window period closure
Window Period Closure

*

Sources: (1) Busch et al. Transfusion. 2005;45(2):254-264.

(2) Kleinman and Busch. J Clin Virol. 2006;36:S23-S29.

(3) Data on file at Chiron, Novartis Vaccines and Diagnostics, Inc.



Safety from bacterial contamination an issue of concern

Platelet PGD test Blood bag with diversion pouch

Safety from bacterial contamination : an issue of concern

  • Rapid, qualitative immunoassay for the detection of aerobic and anaerobic Gram-positive and Gram-negative bacteria in leukocyte reduced apheresis platelets (LRAP) .



Planning a component lab diversion pouch

Type of hospital and bed strength

Trained

manpower

Adequate

AC space

(+ 50 m2)

Trained

SOPs

QC program

Equipment

License from

Regulatory

authorities

Double, triple

or quadruple bags


Critical control points donation
Critical Control Points : diversion pouchDonation

Strict guidelines for selection of blood donor

Adequate disinfection of venipuncture site

Single non-traumatic venepuncture

Blood and anticoagulant mixing

Volume of blood collected

Total time of collection

No aspirin in 48 hrs. -Platelets

31


Critical control points pre processing
Critical Control Points: diversion pouchPre-processing

Storage conditions for blood prior to component preparation-

(cold chain:4/ 20-240 C)

Time restrictions for processing (6 hours)


Critical control points processing
Critical Control Points: diversion pouchProcessing

Validated equipment and program

Refrigerated Centrifuge

1. Time, speed, temperature

2. Monitor QC results in components prepared in

each centrifuge

Trained personnel


Critical control points post processing
Critical Control Points: diversion pouchPost-processing

Proper storage temp.

Quarantine

Labeling and releasing product from quarantine for issue

Separate storage: positive for TTI, their disposal and record of discarded units


Leukodepletion how far
Leukodepletion diversion pouch - How far

104

105

106

107

108

109

1010

G, M

NHFTR

M, B

Alloimmunization

CD4+

HTLV-1

G, M, L

CMV

GVHD

CD4+, CD8+

: High occurrence

: Unknown

: Preventable

G: Granulocytes M : Monocytes L : Lymphocytes B : Lymphocytes-B

Transfusion Reaction (WBC-associated)


Documentation
Documentation diversion pouch

The job is not done until the paperwork is complete

Do what is documented; document what you do

It is a legal requirement


Why documentation
Why Documentation diversion pouch

To ensure:

Consistency

Reproducibility

Traceability

Efficiency

Who performed the test?

When was it done?

What method was used?

What were the results?

Who approved the results?


“Challenges are what make life interesting; diversion pouchOvercoming them is what makes life meaningful”Joshua J. Marine

THANK YOU


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