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Nouman Transfusion 1

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26 views8 pages

Nouman Transfusion 1

Uploaded by

areebabajwa24
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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ASSIGNMENT # 01

NAME:

MUHAMMAD NOUMAN.

SAP ID:

70129054.

DEPARTMENT:

BS-MLS (B).

SUBMITTED TO:

SIR HAFIZ REHMAN.

SUBJECT:

TRANSFUSION MEDICINE.

TOPIC:

QUALITY ASSURANCE IN BLOOD BANK .


Definition:

“Quality assurance (QA) in a blood bank is a system of processes that


ensure the safety and effectiveness of blood transfusions”

OR
“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”

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.

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.

Quality Control for Reagents:


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

• Use of positive & negative controls should be done with each batch to show
that reagents are potent and specific.

• All 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 followed with
ensured continuous power supply and periodic temperature monitoring.

Log of Reagents:
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).


Quality control of reagent RBCs

Parameters Quality Requirement Frequency of Control

Appearance No haemolysis or turbidity in Each day


supernatant by visual inspections

Reactivity and Positive reactions with known Each day


specificity sera against red blood cells
antigens

Quality assurance (QA) in a blood bank is critical to ensure the safety, efficacy,
and quality of blood products. Here’s a detailed overview:

1. Regulatory Compliance:
Standards and Guidelines: Blood banks must adhere
to regulations set by organizations like the FDA, AABB, and WHO. These standards
outline requirements for blood collection, testing, processing, and storage.

Licensing and Accreditation: Blood banks must be licensed and may pursue
accreditation to demonstrate compliance with quality standards.

2. Quality Management System (QMS):


Document Control: Establish and
maintain comprehensive documentation of all procedures, policies, and records
related to blood banking activities.

Standard Operating Procedures (SOPs): Develop SOPs for all processes, including
donor selection, blood collection, testing, processing, and storage.

3. Donor Management:
Screening: Implement thorough screening processes to
evaluate donor eligibility, including medical history and physical examinations.

Informed Consent: Ensure donors provide informed consent, understanding the


procedures and potential risks.

4. Testing Procedures:
Pre-Donation Testing: Test for infectious diseases (e.g.,
HIV, hepatitis) prior to donation.

Post-Donation Testing: Perform confirmatory tests and additional screening as


required by regulations.

Quality Control: Regularly verify the accuracy and reliability of testing equipment
and reagents.

5. Blood Collection and Processing:


Collection Protocols: Follow strict protocols
for blood collection to minimize contamination and ensure sterility.

Processing: Use validated methods for blood component separation, ensuring


that all components are processed under controlled conditions.

6. Storage and Distribution:


Temperature Control: Maintain proper storage
conditions (e.g., refrigerated, frozen) to preserve blood products.
Inventory Management: Implement tracking systems to monitor stock levels and
expiration dates of blood products.

Traceability: Ensure all blood products can be traced back to their source through
robust labeling and documentation.

7. Training and Competency:


Staff Training: Regular training programs for staff on
current best practices, safety protocols, and regulatory requirements.

Competency Assessments: Periodic evaluations of staff competency in


performing their duties.

8. Incident Management and Reporting:


Adverse Events: Establish protocols
for reporting and investigating adverse events or near misses.

Corrective and Preventive Actions (CAPA): Implement CAPA processes to address


any identified issues and prevent recurrence.

9. Internal Audits and Continuous Improvement:


Regular Audits: Conduct
internal audits to assess compliance with QA policies and identify areas for
improvement.

Feedback Mechanisms: Encourage feedback from staff and donors to enhance


processes.

10. Patient Safety and Outcomes:

Transfusion Practices: Ensure that blood


products are transfused according to established guidelines, minimizing the risk of
transfusion reactions.

Monitoring and Evaluation: Collect data on transfusion outcomes to evaluate the


effectiveness of the blood bank’s QA processes.
REFERENCES

https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1751-2824.2009.01275.x

https://www.bbguy.org/education/glossary/glq05/

https://iris.who.int/bitstream/handle/10665/41752/9241544481-
eng.pdf?sequence=1&isAllowed=y

https://www.transfusionguidelines.org/red-book/chapter-4-premises-and-
quality-assurance-at-blood-donor-sessions

https://aiimsrishikesh.edu.in/newwebsite/wp-content/uploads/2019/09/Quality-
Control-in-Blood-Bank.pptx

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