International Accreditation
Government Model
Dr Reem Al Radwan
Director of Blood Transfusion
Administration
International Accreditation
 Introduction.
 Process
of Accreditation.
 Newton’s Three Laws.
 KCBB Accreditation.
Introduction
Kuwait Central Blood Bank
What’s our Scope?
The
ONLY Central Blood Bank
23 Government Hospitals
20 Private Hospitals
2 Military Hospitals
Blood product supplier to Allied armies
What’s our Scope?
60,000
Whole blood donations
100% PRBC & Plasma
6,800 Apheresis Platelets (40,000 units)
What’s our Scope?
AABB
Accredited 1989.
CAP Survey.
Accredited by the National Quality
Program.
National Reference Laboratory.
Accredited as regional reference center for
Arabian countries.
AABB IHRL self assessment 2008.
What’s our Scope?
Training
facility for post-graduate
hematologist and allied health
technologists.
Training center for regional countries.
Therapeutic Apheresis Center.
National Antenatal screening program.
Human Resources
KCBB staff by qualification:
Medical Doctors
10
Nursing Staff
45
Technical staff
193
Clerical staff
70
History of testing
Test
Date
Syphilis
1965
HBVs-Ag
1970
HIV-Ab
1985
Malaria-Ab
1987
HBVc-Ab
1992
HBVs-Ab
1992
HCV-Ab
1992
HTLV-I&II Ab
1994
HIV-I & II Ab
1997
HIV-Ag
1997
Bacterial Detection
2005
NAT- HIV, HCV, HBV
Pathogen Inactivation
2006
2008
International Accreditation
 Introduction.
 Process
of Accreditation.
 Newton’s Three Laws.
 KCBB Accreditation.
Process of
Accreditation
Definitions
 Certification,
licensing and accreditation
are terms used to describe the
organizational mechanisms that support
and enforce the establishment of quality
system in the organization.
Definitions

Certificate

An official proof of a
job performance or
product production.
 Marriage, ownership,
passing exam, course
study or training.
 Compulsory
 Do NOT refer to
quality.
Definitions

Certificate
 Licensing

An official permission
to perform a job or
produce a product.
 Compulsory.
 Do NOT refer to
quality.
Definitions

Certificate
 Licensing
 Standard

Level of excellence or
quality.
Definitions

Certificate
 Licensing
 Standard
 Quality

Distinguishing
characteristic of
excellence.
 Measurement of how
close to a standard.
Definitions





Certificate
Licensing
Standard
Quality
Quality assurance

The sum of the
activities planned and
performed to provide
confidence that all
systems and their
elements that
influence the
QAULITY of the
product are working
as expected.
Definitions






Certificate
Licensing
Standard
Quality
Quality assurance
Accreditation

Official recognition
given by an
association or agency
to an institution that
satisfy specific
standard of quality
criterion.
 VULANTERY.
 DO refer to quality.
Process of Accreditation
Accreditation
Facility
Inspection
Process of Accreditation
Pre-Accreditation
Accreditation
Facility
Inspection
Process of Accreditation
Pre-Accreditation
Facility
Inspection
Facility Growth by Time
Accreditation
Process of Accreditation
Pre-Accreditation
Facility
Inspection
Facility Growth by Time
Accreditation
Process of Accreditation
Pre-Accreditation
Accreditation
Facility
Inspection
Facility Growth by Time
Process of Accreditation
Pre-Accreditation
Accreditation
Facility
Inspection
Facility Growth by Time
Accredited
Process of Accreditation
Pre-Accreditation
Accreditation
Facility
Inspection
Facility Growth by Time
Accredited
Process of Accreditation
Pre-
Accreditation
Facility
Inspection
Facility Growth by Time
Accredited
Process of Accreditation
Pre-
Accreditation
Facility
Inspection
Facility Growth by Time
Accredited
International Accreditation
 Introduction.
 Process
of Accreditation.
 Newton’s Three Laws.
 KCBB Accreditation.
Newton’s Three Laws of
Motion
Newton’s Three Laws

Inertia
 Acceleration
 Reaction
Newton’s Three Laws

Inertia
 Acceleration
 Reaction

The tendency of an
object to maintain its
state of motion.
 An object at rest
remains at rest, and
an object in motion
continues in motion
unless the object
experiences an
external force.
Process of Accreditation
Pre-Accreditation
Accreditation
Facility
Inspection
Facility Growth by Time
Accredited
Newton’s Three Laws

Inertia
 Acceleration
 Reaction

An object of greater
mass needs a greater
force to accelerate
than object of smaller
mass.
Process of Accreditation
Pre-Accreditation
Accreditation
Facility
Inspection
Facility Growth by Time
Accredited
Newton’s Three Laws

Inertia
 Acceleration
 Reaction

For every action there
is equal an opposite
reaction.
Process of Accreditation
Pre-Accreditation
Accreditation
Facility
Inspection
Facility Growth by Time
Accredited
International Accreditation
 Introduction.
 Process
of Accreditation.
 Newton’s Three Laws.
 KCBB Accreditation.
KCBB Accreditation
KCBB Accreditation
 Pre-accreditation.
 Accreditation.
 Post-accreditation.
Pre-accreditation

1965
Kuwait blood
transfusion services
started with donation
room (2 beds) and a
lab for testing blood
group and syphilis.
Before that date all
blood units were
imported.
Pre-accreditation

1968
Complete self
dependency on the
local blood donation.
Total blood collected
was 7348.

1965
Pre-accreditation

1970
Centralized service
moved to its second
location next to Amiri
Hospital.
Rh testing of all units.
Pre-transfusion testing,
HBV-sAg, ALT, AST.

1965
 1968
Pre-accreditation

1985
The administration
structure changed to
introduce specialized
units for serology,
donation,
immunohematology
and blood distribution.

1965
 1968
 1970
Pre-accreditation

1985
Blood Transfusion
Administration
Services (BTAS) was
established as
centralized service at
the Ministry of Health.

1965
 1968
 1970
Pre-accreditation

1987
New facility that meets
the GMP
requirements was
build and equipped
with advanced
technology.

1965
 1968
 1970
 1985
Pre-accreditation

1987
This was the primary
requirements to
improve the quality of
work and to seek
international
accreditation of the
American Association
of Blood Banks
(AABB).

1965
 1968
 1970
 1985
Newton’s Three Laws

Inertia
 Acceleration
 Reaction

The tendency of an
object to maintain its
state of motion.
 An object at rest
remains at rest, and
an object in motion
continues in motion
unless the object
experiences an
external force.
Newton’s Three Laws

Inertia
 Acceleration
 Reaction

The tendency of an
organization to
maintain its state of
motion.
 An organization at
rest remains at rest,
and an organization in
motion continues in
motion unless the
organization
experiences an
external force.
Pre-accreditation
 Challenges




Start the process.
Follows structured typed of thinking and
working.
Change the environment.
Meets the standards of ABB
KCBB Accreditation
 Pre-accreditation.
 Accreditation.
 Post-accreditation.
Accreditation

1989
KCBB met the
requirements and
gets the accreditation
of the AABB, the
highest organization
in this field.





1965
1968
1970
1985
1987
Accreditation
 Quality
Plan.
 AABB Standards for Blood Banks &
Transfusion Services.
Standards

Organization.
 Resources.
 Equipments.
 Supplier Issues.
 Process Control.
 Documentation.
 Deviations.
 Assessments.
 Process Improvement.
 Facility & Safety.
Accreditation

1997
Quality Management
Department.
Specialized in the follow
up of quality
assurance.
Quality plan based on
continuous
improvement.






1965
1968
1970
1985
1987
1989
AABB
Newton’s Three Laws

Inertia
 Acceleration
 Reaction

An object of greater
mass needs a greater
force to accelerate
than object of smaller
mass.
Newton’s Three Laws

Inertia
 Acceleration
 Reaction

An organization of
greater mass needs a
greater force to
accelerate than
organization of
smaller mass.
Process of Accreditation
Pre-Accreditation
Accreditation
Facility
Inspection
Facility Growth by Time
Accredited
Accreditation

1997
Quality Management
Department.
5 specialized personnel
(quality coordinators).
Directly under the top
management.






1965
1968
1970
1985
1987
1989
AABB
Accreditation
 Challenges




Quality Coordinators (Inspectors).
NOT at the ministry chart.
Under the manager with higher authority.
Disqualify supplier, operation and product.
KCBB Accreditation
 Pre-accreditation.
 Accreditation.
 Post-accreditation.
Post-accreditation

1998
Immunohematology
Unit:


RBC Serology
(Donors).
RBC Serology
(Patients).







1965
1968
1970
1985
1987
1989
1997
AABB
QM
Post-accreditation

1999
ISBT 128








1965
1968
1970
1985
1987
1989
1997
1998
AABB
QM
IH
Post-accreditation

2001
Immunohematology
Unit:

RBC Serology
(Donors).
RBC Serology
(Patients).
Platelet Serology.











1965
1968
1970
1985
1987
1989
1997
1998
1999
AABB
QM
IH
ISBT 128
Post-accreditation

2001
PLT
 2003
Immunohematology
Unit:




RBC Serology
(Donors).
RBC Serology
(Patients).
Platelet Serology.
Antenatal Laboratory.









1965
1968
1970
1985
1987
1989
1997
1998
1999
AABB
QM
IH
ISBT 128
Post-accreditation

2001
PLT
 2003
ANT
 2004
Data Management
System:




Departments
connection.
Braches connection.
Auditing process.
Error reporting.









1965
1968
1970
1985
1987
1989
1997
1998
2001
AABB
QM
IH
PLT
Post-accreditation

2001
PLT
 2003
ANT
 2004
DMS
 2005
Re-organization of
BTAS.
Re-writing of quality
plan.









1965
1968
1970
1985
1987
1989
1997
1998
2001
AABB
QM
IH
PLT
‫مدير اإلدارة‬
Administration Director
‫نائب المدير‬
Deputy Director
‫ قسم المعلومات‬-5
5- Information
Department
‫ قسم المختبرات‬-4
4- Laboratory
Department
‫ قسم الخدمات الطبية و التوجيه‬-3
3- Medical
Department
‫ وحدة التبرع بالدم‬-1.3
3.1- Blood Donation
Unit
‫ وحدة تقنية المعلومات‬-1.5
5.1- Information Technology
Unit
‫ وحدة السجالت الطبية‬-2.5
5.2- Medical Record
Unit
‫ وحدة المكتبة‬-4.5
5.3- Library
Unit
‫ وحدة أمراض الدم و المناعة‬-1.4
4.1- Immunohematology
Unit
)‫ مختبر كريات الدم الحمراء (المتبرعين‬-1.1.4
)‫ مختبر كريات الدم الحمراء (المرضى‬-2.1.4
4.1.1- RBC Donor Testing
4.1.2-RBC Patient Testing
Section (Lab)
Section (Lab)
‫ مختبر فحص الحوامل‬-3.1.4
4.1.3- Antenatal Testing
Section (Lab)
‫ مختبر الصفائح الدموية‬-4.1.4
4.1.4- Platelet Serology
Section (Lab)
‫ وحدة مشتقات الدم‬-3.4
4.3- Blood Component
Unit
‫ شعبة تحضير الدم‬-1.3.4
4.3.1- Component
Preparation (Lab)
‫ قسم الشئون اإلدارية و الخدمات المساندة‬-2
‫ قسم إدارة الجودة‬-1
1- Quality Management
2- Administration & Support
Department
Services
‫ مختبر معالجة الدم‬-2.3.4
4.3.2- Component
Modification (Lab)
‫ الوحدة المرجعية‬-5.4
4.5- Reference
Unit
‫ وحدة الميكروبيولوجي‬-2.4
4.2- Microbiology
Unit
‫ مختبر فحص األمصال‬-1.2.4
4.2.1- Serology
Section (Lab)
‫ مختبر فحص الحمض النووي‬-2.2.4
4.2.2- NAT
Section (Lab)
‫ مختبر فحص البكتيريا‬-3.2.4
4.2.3- Bacteriology
Section (Lab)
‫ مختبر فهرسة العينات‬-4.2.4
4.2.4- Sample Archiving
Section (Lab)
‫ وحدة الخاليا الساقية‬-4.4
4.6- Cellular Storage & Distribution
Unit
‫ مختبر الخاليا الساقية‬-1.4.4
4.4.1- Stem Cell
Section (Lab)
‫ مختبر خاليا الحبل السري‬-2.4.4
4.4.2- Cord Blood
Section (Lab)
‫ وحدة التخزين و الصرف‬-6.4
4.6- Blood Storage & Distribution
Unit
‫ وحدة العالقات العامة‬-1.2
2.1- Public Relation
Unit
‫ شعبة التبرع بالدم الكامل‬-1.1.3
3.1.1- Platelet
Apheresis
Section
‫ شعبة التبرع المتنقلة‬-2.1.3
3.1.2- Mobile Donation
Section
‫ وحدة المخازن‬-2.2
2.2- Storage
Unit
‫ شعبة توجيه المتبرعين‬-3.1.3
3.1.3- Static Blood Donation
Section
‫ التبرع بالفرز اآللي‬-3.1.3
3.1.4- Donor Counselling
Section
‫ وحدة شئون العاملين‬-3.2
2.3- Employee Affairs
Unit
‫ الوحدة العالجية‬-2.3
3.2- Therapeutic
Unit
‫ وحدة العالج بالفرز اآللي‬-1.2.3
3.2.1- Therapeutic Apheresis
Section
‫ وحدة التبرع العالجي‬-2.3.3
3.2.2- Therapeutic Donation
Section
‫ وحدة التبرع بالخاليا‬-3.3
3.3- Cellular Donation
Unit
‫ شعبة التبر بالخاليا الساقية‬-1.3.1
3.3.1- Peripheral Stem Cell
Section
‫ التبرع بخاليا الحبل السري‬-2.3.3
3.3.2- Cord Blood
Section
‫ وحدة التنسيق الطبي‬-5.3
3.5- Hospital Liaison
Unit
‫ شعبة تقصي تفاعالت الدم‬-1.5.3
3.5.1- Hemovigilance
Section
‫ شعبة الدوريات و المطبوعات‬-2.5.3
3.5.2- Educational Circular
Section
‫ وحدة المحاسبة‬-4.2
2.4- Accounting
Unit
‫ وحدة االتصاالت و النقليات‬-5.2
2.5- Transport &
Communication
Unit
‫ وحدة التمريض‬-4.3
3.4- Nursing
Unit
‫ وحدة ضمان الجودة‬-1.1
1.1- Quality Assurance
Unit
‫ وحدة األمن و السالمة‬-2.1
1.2- Safety
Unit
‫ وحدة األبحاث و التطوير‬-3.1
1.3- Research &
Development Unit
‫ وحدة التدريب و التعليم المستمر‬-4.1
1.4- Training & Continuing
Education Unit
‫ وحدة قياس الجودة‬-5.1
1.5- Quality Control
Unit
‫ وحدة متابعة صيانة األجهزة الطبية‬-6.
1.6- Medical Equipments
Maintenance Unit
‫ وحدة شئون المباني‬-7.1
1.7- Building Affairs
Unit
Newton’s Three Laws

Inertia
 Acceleration
 Reaction

For every action there
is equal an opposite
reaction.
Process of Accreditation
Pre-
Accreditation
Facility
Inspection
Facility Growth by Time
Accredited
Post-accreditation
 Challenges


Continuous process control.
Continuous process improvement.
Do
Check
Write
Correct/improve
QA
Plan
Continuous
process for
improvemen
t
Post-accreditation
 Challenges

Data collection, analysis and follow-up of
issues requiring corrective or preventive
action.
Do
Check
Write
Correct/improve
QA
Plan
Continuous
process for
improvemen
t
KCBB Accreditation
 Pre-accreditation.
 Accreditation.
 Post-accreditation.
Pre-accreditation







2003
2004
2005
2005
2006
2007
2008
Antenatal
DMS
Re-BTAS
Bacterial
Detection
NAT
ULD
PI adopted










1965
1968
1970
1985
1987
1989
1997
1998
1999
2001
Established
Sufficiency
Central
BTAS
New Facility
AABB
QM
IH
ISBT 128
Platelets Lab
KCBB Accreditation
 Pre-accreditation.
 Accreditation.
 Post-accreditation.
Accreditation







2003
2004
2005
2005
2006
2007
2008
Antenatal
DMS
Re-BTAS
Bacterial
Detection
NAT
ULD
PI adopted










1965
1968
1970
1985
1987
1989
1997
1998
1999
2001
Established
Sufficiency
Central
BTAS
New Facility
AABB
QM
IH
ISBT 128
Platelets Lab
KCBB Accreditation
 Pre-accreditation.
 Accreditation.
 Post-accreditation.
Post-accreditation







2003
2004
2005
2005
2006
2007
2008
Antenatal
DMS
Re-BTAS
Bacterial
Detection
NAT
ULD
PI adopted










1965
1968
1970
1985
1987
1989
1997
1998
1999
2001
Established
Sufficiency
Central
BTAS
New Facility
AABB
QM
IH
ISBT 128
Platelets Lab
Post-accreditation







2003
2004
2005
2005
2006
2007
2008
Antenatal
DMS
Re-BTAS
Bacterial
Detection
NAT
ULD
PI adopted










1965
1968
1970
1985
1987
1989
1997
1998
1999
2001
Established
Sufficiency
Central
BTAS
New Facility
AABB
QM
IH
ISBT 128
Platelets Lab
International Accreditation
 Introduction.
 Process
of Accreditation.
 Newton’s Three Laws.
 KCBB Accreditation.
 Does it worth.
Does it worth ?!
Accreditation

Expensive.

Accreditation fees.
 Specialized
personnel.
 Time consuming.
Accreditation

Expensive.
 Paper work.

Legal protection.
 Computerization of
the system.
Accreditation

Expensive.
 Paper work.
 Benefits.

High quality.
 Prevention of miss
falls.
 Aids for emergencies.
 Project planning.
Emergencies
 Disaster
Plan.
Emergencies
 Disaster
 SARS.
Plan.
Project Planed

Guided by the
standards.
 New improvements
help in raising the
quality of service.
Project Planed
 Bacterial
Detection System.
 NAT for HCV, HBV and HIV.
 Regional Reference Laboratory.
Bacterial Detection System
 2002
guidelines to decrease BC.
 2003
bulletin GL for implementation
New Bacteria Reduction and Detection
Standard.
 2004
STD all AABB accredited BB
should have the system.
Bacterial Detection System
 To
eliminate bacterial contamination for
platelet concentrate which are stored at
room temperature.
 Extending the storage time of platelets
from 5 to 7 days.
NAT testing
 NAT
test the presence of DNA or RNA of
the virus using automated PCR
technology.
 Using this screening policy will reduce the
window period of the viruses transmitted
by blood transfusion.
 HCV, HIV and HBV.
Analyte Level
100
80
60
40
20
0
Time
|------Pre-seroconversion window-------|
HCV RNA Window = approximately 11 days
Anti-HCV Window = 70 days (3rd Gen);
82 days (2nd Gen)
100
Analyte Level
80
60
40
20
0
Time
|-Pre-seroconversion window-|
HIV RNA Window = 10-12 days
HIV-1 p24 Antigen Window = 16-17 days
Anti-HIV-1 Window = 20-25
days
Regional Reference Laboratory
 Immunohematology
reference laboratory.
 Using highly specializes technology;


PCR.
Flow cytometry.
 Following
the AABB standards for
reference lab accreditation.
Accreditation of Blood
Transfusion
Does it worth?
Accreditation
Improve the quality of blood transfusion
service from vein to vein.
Accreditation
Accreditation is step that boots our efforts to
reach the quality we aim.
Accreditation
 Only
by continuous improvement can keep
the facility accredited by continuously
raising the quality of work to reach the
changing standard.