Quality Control
Changes
AABB Standards
1. Organization
2. Resources
3. Equipments
4. Supplier Issues.
5. Process Control.
6. Documentation.
7. Deviations.
8. Assessments.
9. Process Improvement.
10. Facility & Safety.
AABB Standards
1. Organization
2. Resources
3. Equipments
4. Supplier Issues.
5. Process Control.
6. Documentation.
7. Deviations.
8. Assessments.
9. Process Improvement.
10. Facility & Safety.
AABB Standard
5.0 Process Control
• The blood bank or transfusion services shall
have policies and validated processes and
procedures that ensure the quality of the
blood, blood components, tissue, derivatives,
and services. The blood bank or transfusion
services shall ensure that these policies,
processes, and procedures are carried out
under controlled conditions.
AABB Standard
5.0 Process Control
• The blood bank or transfusion services shall
have policies and validated processes and
procedures that ensure the quality of the
blood, blood components, tissue, derivatives,
and services. The blood bank or transfusion
services shall ensure that these policies,
processes, and procedures are carried out
under controlled conditions.
AABB Standard
5.0 Process Control
• The blood bank or transfusion services shall
have policies and validated processes and
procedures that ensure the quality of the
blood, blood components, tissue, derivatives,
and services. The blood bank or transfusion
services shall ensure that these policies,
processes, and procedures are carried out
under controlled conditions.
5.0 Process Control
5.1 General Elements
5.1.1 Change Control.
5.1.2 Proficiency Testing Program.
5.1.3 Quality Control.
5.1.4 Use of Materials.
5.1.5 Sterility.
5.1.6 Identification & Traceability.
5.1.7 Inspection.
5.1.8 Handling, Storage, and Transportation
5.0 Process Control
5.1 General Elements
5.1.1 Change Control.
5.1.2 Proficiency Testing Program.
5.1.3 Quality Control.
5.1.4 Use of Materials.
5.1.5 Sterility.
5.1.6 Identification & Traceability.
5.1.7 Inspection.
5.1.8 Handling, Storage, and Transportation
5.1.3 Quality Control
A program of quality control shall be
established that is sufficiently comprehensive
to ensure that reagents, equipments, and
methods perform as expected. Chapter 9,
Process Improvement Through Corrective and
Preventive Action, applies.
5.1.3 Quality Control
A program of quality control shall be
established that is sufficiently comprehensive
to ensure that reagents, equipments, and
methods perform as expected. Chapter 9,
Process Improvement Through Corrective
and Preventive Action, applies.
AABB
Standard
Quality
Control
Process
Lab/Sec
Data
Analysis
Accepted
Corrective Action
Action
• Root Cause
Rejection
KCBB-Accreditation
•
•
•
•
•
2004
2006
2008
2010
2012
Re-accreditation
Re-accreditation
Re-accreditation
Re-accreditation
Re-accreditation
KCBB-Accreditation
•
•
•
•
•
2004
2006
2008
2010
2012
Re-accreditation
Re-accreditation
Re-accreditation
Re-accreditation
Re-accreditation
Non-Conformance
STD-5.1.3
Quality Control
AABB
Standard
Quality
Control
Process
Lab/Sec
Data
Analysis
Accepted
Corrective Action
Action
• Root Cause
Rejection
KCBB
QC layout
Quality
Control
Process
Lab/Sec
Data
Analysis
Accepted
Corrective Action
Action
• Root Cause
Rejection
KCBB
Layout
Reject
Process
Lab/Sec
Quality
Control
Data
Analysis
Accept
• No Process Improvement.
• No Corrective Action taken.
• No Quality insured.
• STD 9 not followed
KCBB
Layout
Preparation
Lipemic
Quality
Control
• No Process Improvement.
• No Corrective Action taken.
• No Quality insured.
• STD 9 not followed
Data
Analysis
Reject
Accept
KCBB
Layout
Cryo-Preparation
QC FVIII
• No Process Improvement.
• No Corrective Action taken.
• No Quality insured.
• STD 9 not followed
Data
Analysis
Reject
Accept
Quality Control Lab.
•
•
•
•
•
QC.
Validation.
Evaluation.
Calibration.
CBC (Patients, Apheresis).
Corrective Action (1)
2006
• Validation SOP (Committee).
– Inline filtration.
– NAT.
– Others.
Corrective Action (2)
2006
• Validation SOP (Committee).
• Evaluation SOP (Committee).
Quality Control
Changes
AABB
Standard
Quality
Control
Process
Lab/Sec
Data
Analysis
Accepted
Corrective Action
Action
• Root Cause
Rejection
AABB
Standard
Quality
Control
Process
Lab/Sec
Lab/Sec
SOP
Accepted
Corrective Action
• Root Cause
QM
Audit
Rejection
Action
Data
Analysis
Quality Control
Laboratory
Quality Control
Laboratory
General
Laboratory
QC Laboratory
Action
Lab/Section
QC
• Reject
• Accept
QC Program
Quality
Manage
General
Lab.
Laboratories/
Sections
Quality Control Program
Lab/Sec
Sample
Collection
Data
Analysis
Corrective
Action
Audit
Report
General
QM
Sample
Processing
Audit
Report
Laboratory
or
Section
•
•
•
•
•
•
Sample Collection.
Send to GL.
Data Collection.
Data Processing.
Data Blotting.
Corrective plan for noncomplaints.
General
Laboratory
•
•
•
•
•
•
•
Bio-chemistry
pH
Clotting Factors
CBC
WBC
Culture
Calibration
Quality
Management
• Audit
• Non-complains
• Internal Assessment
Action Plan 2011
June 1
Starting Point
Quality
Management
Lab/Section
General Lab
June 30
QC SOPs
Re-Arrange
SOPs
NonCompliance
SOPs
Document
Control of
SOPs
July 1
Program in
Action
Program in
Action
Program in
Action
Program in
Action
Starting Point
Laboratory
or
Section
•
•
•
•
•
•
Sample Collection.
Send to GL.
Data Collection.
Data Processing.
Data Blotting.
Corrective plan for noncomplaints.
Out of Range
• Discard.
• Initiate non-compliance report for
investigations.
Delayed Action
Oct, 2012
General
Laboratory
•
•
•
•
•
•
•
Bio-chemistry
pH
Clotting Factors
CBC
WBC
Culture
Calibration
QC LAB SOPs
• Total No. 62
• 1 POL, 61 TECH.
• Per test.
– QC of Platelets, QC of RBC.
– Maintenance PRISM, maintenance OLYMPUS.
• Complicated training.
• Complicated internal assessment.
General Lab SOPs
• Total No. 18
– 1 POL, 10 TECH, 7 QC SOP
• Per process
– Sample Receiving SOP’s & Forms.
– Requested Test Results SOP’s.
• Less complicated training.
• Less complicated internal assessment.
Quality
Management
• Audit
• Non-complains
• Internal Assessment
Conclusion
What is Accomplished
June 1
Starting Point
Quality
Management
Lab/Section
General Lab
June 30
QC SOPs
Re-Arrange
SOPs
NonCompliance
SOPs
Document
Control of
SOPs
July 1
Program in
Action
Program in
Action
Program in
Action
Program in
Action
Conclusion
• QC is done at all blood banks
But……
IS IT EFFECTIVE
QC Concept
• Linear
• Action based on results
Process
Lab/Sec
Quality
Control
Data
Analysis
Reject
Accept
QC Concept
• Interactive.
• Process improvement.
Quality
Manage
General
Lab.
Laboratories
/ Sections
QC Concept
TEST
QC Concept
PROCESS
Thank You