international accreditation government model
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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?. - PowerPoint PPT PresentationTRANSCRIPT
International AccreditationGovernment Model
Dr Reem Al RadwanDirector 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 Bank23 Government Hospitals20 Private Hospitals2 Military HospitalsBlood product supplier to Allied armies
What’s our Scope?60,000 Whole blood donations100% PRBC & Plasma6,800 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 ResourcesKCBB staff by qualification:Medical Doctors 10Nursing Staff 45Technical staff 193Clerical staff 70
History of testingTest DateSyphilis 1965HBVs-Ag 1970HIV-Ab 1985Malaria-Ab 1987HBVc-Ab 1992HBVs-Ab 1992HCV-Ab 1992HTLV-I&II Ab 1994HIV-I & II Ab 1997HIV-Ag 1997Bacterial Detection 2005NAT- HIV, HCV, HBV 2006
Pathogen Inactivation 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
Accreditation
Facility Inspection
Pre-Accreditation
Process of Accreditation
Accreditation
Facility Inspection
Pre-Accreditation
Facility Growth by Time
Process of Accreditation
Accreditation
Facility Inspection
Pre-Accreditation
Facility Growth by Time
Process of Accreditation
Accreditation
Facility Inspection
Pre-Accreditation
Facility Growth by Time
Process of Accreditation
Accreditation
Facility Inspection
Pre-Accreditation
Facility Growth by Time
Accredited
Process of Accreditation
Accreditation
Facility Inspection
Pre-Accreditation
Facility Growth by Time
Accredited
Process of Accreditation
Accreditation
Facility Inspection
Pre-
Facility Growth by Time
Accredited
Process of Accreditation
Accreditation
Facility Inspection
Pre-
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
Accreditation
Facility Inspection
Pre-Accreditation
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
Accreditation
Facility Inspection
Pre-Accreditation
Facility Growth by Time
Accredited
Newton’s Three Laws
Inertia Acceleration Reaction
For every action there is equal an opposite reaction.
Process of Accreditation
Accreditation
Facility Inspection
Pre-Accreditation
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.
1965Kuwait 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
1968Complete self dependency on the local
blood donation.Total blood collected was 7348.
1965
Pre-accreditation
1970Centralized 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
1985The administration structure changed to
introduce specialized units for serology, donation, immunohematology and blood distribution.
1965 1968 1970
Pre-accreditation
1985Blood Transfusion Administration Services
(BTAS) was established as centralized service at the Ministry of Health.
1965 1968 1970
Pre-accreditation
1987New facility that meets the GMP
requirements was build and equipped with advanced technology.
1965 1968 1970 1985
Pre-accreditation
1987This 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
Pre-accreditation
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.
Challenges Start the process. Follows structured typed of thinking and
working. Change the environment. Meets the standards of ABB
Pre-accreditation
KCBB Accreditation
Pre-accreditation. Accreditation. Post-accreditation.
1989KCBB met the requirements and gets the
accreditation of the AABB, the highest organization in this field.
1965 1968 1970 1985 1987
Accreditation
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.
1997Quality Management Department.Specialized in the follow up of quality
assurance.Quality plan based on continuous
improvement.
1965 1968 1970 1985 1987 1989AABB
Accreditation
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
Accreditation
Facility Inspection
Pre-Accreditation
Facility Growth by Time
Accredited
1997Quality Management Department.5 specialized personnel (quality
coordinators).Directly under the top management.
1965 1968 1970 1985 1987 1989AABB
Accreditation
Challenges Quality Coordinators (Inspectors). NOT at the ministry chart. Under the manager with higher authority. Disqualify supplier, operation and product.
Accreditation
KCBB Accreditation
Pre-accreditation. Accreditation. Post-accreditation.
1998Immunohematology Unit:
RBC Serology (Donors). RBC Serology (Patients).
1965 1968 1970 1985 1987 1989AABB 1997QM
Post-accreditation
1999ISBT 128 1965 1968 1970 1985 1987 1989AABB 1997QM 1998IH
Post-accreditation
2001Immunohematology Unit:
RBC Serology (Donors). RBC Serology (Patients). Platelet Serology.
1965 1968 1970 1985 1987 1989AABB 1997QM 1998IH 1999ISBT 128
Post-accreditation
2001PLT 2003Immunohematology Unit:
RBC Serology (Donors). RBC Serology (Patients). Platelet Serology. Antenatal Laboratory.
1965 1968 1970 1985 1987 1989AABB 1997QM 1998IH 1999ISBT 128
Post-accreditation
2001PLT 2003ANT 2004Data Management System:
Departments connection. Braches connection. Auditing process. Error reporting.
1965 1968 1970 1985 1987 1989AABB 1997QM 1998IH 2001PLT
Post-accreditation
2001PLT 2003ANT 2004DMS 2005Re-organization of BTAS.Re-writing of quality plan.
1965 1968 1970 1985 1987 1989AABB 1997QM 1998IH 2001PLT
Post-accreditation
اإلدارة مديرAdministration Director
المدير نائبDeputy Director
المعلومات- 5 قسم5- InformationDepartment
المختبرات- 4 قسم4- LaboratoryDepartment
التوجيه- 3 و الطبية الخدمات قسم3- Medical
Department
المساندة- 2 الخدمات و اإلدارية الشئون قسم2- Administration & Support
Services
الجودة- 1 إدارة قسم1- Quality Management
Department
الجودة- 1.1 ضمان وحدة1.1- Quality Assurance
Unit
السالمة -2.1 و األمن وحدة1.2- Safety
Unit
التطو)ير- 3.1 و األبحاث وحدة1.3- Research & Development Unit
المستمر- 4.1 التعليم و التدريب وحدة1.4- Training & Continuing
Education Unit
الجودة -5.1 قياس وحدة1.5- Quality Control
Unit
الطبية- 6.1 األجهزة صيانة متابعة وحدة1.6- Medical Equipments
Maintenance Unit
المباني- 7.1 شئون وحدة1.7- Building Affairs
Unit
العامة- 1.2 العالقات وحدة2.1- Public Relation
Unit
المخازن- 2.2 وحدة2.2- Storage
Unit
العاملين- 3.2 شئون وحدة2.3- Employee Affairs
Unit
المحاسبة -4.2 وحدة2.4- Accounting
Unit
النقليات- 5.2 و االتصاالت وحدة2.5- Transport & Communication
Unit
بالدم- 1.3 التبرع وحدة3.1- Blood Donation
Unit
العالجية- 2.3 الوحدة3.2- Therapeutic
Unit
بالخاليا- 3.3 التبرع وحدة3.3- Cellular Donation
Unit
التمريض -4.3 وحدة3.4- Nursing
Unitالطبي- 5.3 التنسيق وحدة
3.5- Hospital LiaisonUnit
المناعة- 1.4 و الدم أمراض وحدة4.1- Immunohematology
Unit
الميكروبيولوجي- 2.4 وحدة4.2- Microbiology
Unit
الدم- 3.4 مشتقات وحدة4.3- Blood Component
Unit
الساقية -4.4 الخاليا وحدة4.6- Cellular Storage & Distribution
Unit
المرجعية- 5.4 الوحدة4.5- Reference
Unit
الصرف - 6.4 و التخزين وحدة4.6- Blood Storage & Distribution
Unit
المعلومات- 1.5 تقنية وحدة5.1- Information Technology
Unitالطبية- 2.5 السجالت وحدة
5.2- Medical RecordUnit
المكتبة- 4.5 وحدة5.3- Library
Unit
بالدم- 1.1.3 التبرع شعبةالكامل
3.1.1- Platelet Apheresis
Section
المتنقلة- 2.1.3 التبرع شعبة3.1.2- Mobile Donation
Section
المتبرعين -3.1.3 توجيه شعبة3.1.3- Static Blood Donation
Section
اآللي -3.1.3 بالفرز التبرع3.1.4- Donor Counselling
Section
اآللي- 1.2.3 بالفرز العالج وحدة3.2.1- Therapeutic Apheresis
Section
العالجي- 2.3.3 التبرع وحدة3.2.2- Therapeutic Donation
Section
الدم- 1.5.3 تفاعالت تقصي شعبة3.5.1- Hemovigilance
Section
المطبوعات -2.5.3 و الدوريات شعبة3.5.2- Educational Circular
Section
الساقية -1.3.1 بالخاليا التبر شعبة3.3.1- Peripheral Stem Cell
Section
السري -2.3.3 الحبل بخاليا التبرع3.3.2- Cord Blood
Section
1.1.4- ( المتبرعين ( الحمراء الدم كريات مختبر4.1.1- RBC Donor Testing
Section (Lab)
2.1.4- ( المرضى ( الحمراء الدم كريات مختبر4.1.2-RBC Patient Testing
Section (Lab)
الحوامل -3.1.4 فحص مختبر4.1.3- Antenatal Testing
Section (Lab)
الدموية -4.1.4 الصفائح مختبر4.1.4- Platelet Serology
Section (Lab)
األمصال- 1.2.4 فحص مختبر4.2.1- Serology Section (Lab)
النووي -2.2.4 الحمض فحص مختبر4.2.2- NAT
Section (Lab)
البكتيريا -3.2.4 فحص مختبر4.2.3- Bacteriology
Section (Lab)
العينات -4.2.4 فهرسة مختبر4.2.4- Sample Archiving
Section (Lab)
الدم -1.3.4 تحضير شعبة4.3.1- Component Preparation (Lab)
الدم -2.3.4 معالجة مختبر4.3.2- Component Modification (Lab)
الساقية -1.4.4 الخاليا مختبر4.4.1- Stem Cell
Section (Lab)
السري -2.4.4 الحبل خاليا مختبر4.4.2- Cord Blood
Section (Lab)
Newton’s Three Laws
Inertia Acceleration Reaction
For every action there is equal an opposite reaction.
Process of Accreditation
Accreditation
Facility Inspection
Pre-
Facility Growth by Time
Accredited
Post-accreditation
Challenges Continuous process control. Continuous process improvement.
Do
Check
Correct/improveWrit
e
QA Plan
Continuous process for improveme
nt
Post-accreditation
Challenges Data collection, analysis and follow-up of
issues requiring corrective or preventive action.
Do
Check
Correct/improveWrit
e
QA Plan
Continuous process for improveme
nt
KCBB Accreditation
Pre-accreditation. Accreditation. Post-accreditation.
2003 Antenatal 2004 DMS 2005 Re-BTAS 2005 Bacterial Detection 2006 NAT 2007 ULD 2008 PI adopted
1965 Established 1968 Sufficiency 1970 Central 1985 BTAS 1987 New Facility 1989 AABB 1997 QM 1998 IH 1999 ISBT 128 2001 Platelets Lab
Pre-accreditation
KCBB Accreditation
Pre-accreditation. Accreditation. Post-accreditation.
2003 Antenatal 2004 DMS 2005 Re-BTAS 2005 Bacterial Detection 2006 NAT 2007 ULD 2008 PI adopted
1965 Established 1968 Sufficiency 1970 Central 1985 BTAS 1987 New Facility 1989 AABB 1997 QM 1998 IH 1999 ISBT 128 2001 Platelets Lab
Accreditation
KCBB Accreditation
Pre-accreditation. Accreditation. Post-accreditation.
2003 Antenatal 2004 DMS 2005 Re-BTAS 2005 Bacterial Detection 2006 NAT 2007 ULD 2008 PI adopted
1965 Established 1968 Sufficiency 1970 Central 1985 BTAS 1987 New Facility 1989 AABB 1997 QM 1998 IH 1999 ISBT 128 2001 Platelets Lab
Post-accreditation
2003 Antenatal 2004 DMS 2005 Re-BTAS 2005 Bacterial Detection 2006 NAT 2007 ULD 2008 PI adopted
1965 Established 1968 Sufficiency 1970 Central 1985 BTAS 1987 New Facility 1989 AABB 1997 QM 1998 IH 1999 ISBT 128 2001 Platelets Lab
Post-accreditation
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.
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.
Accreditation
Emergencies
Disaster Plan.
Emergencies
Disaster Plan. SARS.
Project Planed Guided by the
standards. New improvements
help in raising the quality of service.
Bacterial Detection System. NAT for HCV, HBV and HIV. Regional Reference Laboratory.
Project Planed
Bacterial Detection System
2002guidelines to decrease BC. 2003bulletin GL for implementation New
Bacteria Reduction and Detection Standard.
2004STD 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.
0
20
40
60
80
100
Time
An
aly
te L
evel
HCV RNA Window = approximately 11 days
Anti-HCV Window = 70 days (3rd Gen);82 days (2nd Gen)
|------Pre-seroconversion window-------|
0
20
40
60
80
100
Time
Ana
lyte
Lev
el
|-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 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.
Accreditation
