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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?.

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International accreditation government model

International AccreditationGovernment Model

Dr Reem Al Radwan

Director of Blood Transfusion Administration


International accreditation

International Accreditation

  • Introduction.

  • Process of Accreditation.

  • Newton’s Three Laws.

  • KCBB Accreditation.


Introduction

Introduction


Kuwait central blood bank

Kuwait Central Blood Bank


What s our scope

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 scope1

What’s our Scope?

60,000 Whole blood donations

100% PRBC & Plasma

6,800 Apheresis Platelets (40,000 units)


What s our scope2

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 scope3

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

Human Resources

KCBB staff by qualification:

Medical Doctors10

Nursing Staff45

Technical staff 193

Clerical staff70


History of testing

History of testing

Pathogen Inactivation2008


International accreditation1

International Accreditation

  • Introduction.

  • Process of Accreditation.

  • Newton’s Three Laws.

  • KCBB Accreditation.


Process of accreditation

Process of Accreditation


Definitions

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.


Definitions1

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


Definitions2

Certificate

Licensing

An official permission to perform a job or produce a product.

Compulsory.

Do NOT refer to quality.

Definitions


Definitions3

Certificate

Licensing

Standard

Level of excellence or quality.

Definitions


Definitions4

Certificate

Licensing

Standard

Quality

Distinguishing characteristic of excellence.

Measurement of how close to a standard.

Definitions


Definitions5

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


Definitions6

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.

Definitions


Process of accreditation1

Process of Accreditation

Accreditation

Facility Inspection


Process of accreditation2

Process of Accreditation

Pre-Accreditation

Accreditation

Facility Inspection


Process of accreditation3

Process of Accreditation

Pre-Accreditation

Accreditation

Facility Inspection

Facility Growth by Time


Process of accreditation4

Process of Accreditation

Pre-Accreditation

Accreditation

Facility Inspection

Facility Growth by Time


Process of accreditation5

Process of Accreditation

Pre-Accreditation

Accreditation

Facility Inspection

Facility Growth by Time


Process of accreditation6

Process of Accreditation

Pre-Accreditation

Accreditation

Accredited

Facility Inspection

Facility Growth by Time


Process of accreditation7

Process of Accreditation

Pre-Accreditation

Accreditation

Accredited

Facility Inspection

Facility Growth by Time


Process of accreditation8

Process of Accreditation

Pre-

Accreditation

Accredited

Facility Inspection

Facility Growth by Time


Process of accreditation9

Process of Accreditation

Pre-

Accreditation

Accredited

Facility Inspection

Facility Growth by Time


International accreditation2

International Accreditation

  • Introduction.

  • Process of Accreditation.

  • Newton’s Three Laws.

  • KCBB Accreditation.


Newton s three laws of motion

Newton’s Three Laws of Motion


Newton s three laws

Inertia

Acceleration

Reaction

Newton’s Three Laws


Newton s three laws1

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


Process of accreditation10

Process of Accreditation

Pre-Accreditation

Accreditation

Accredited

Facility Inspection

Facility Growth by Time


Newton s three laws2

Inertia

Acceleration

Reaction

An object of greater mass needs a greater force to accelerate than object of smaller mass.

Newton’s Three Laws


Process of accreditation11

Process of Accreditation

Pre-Accreditation

Accreditation

Accredited

Facility Inspection

Facility Growth by Time


Newton s three laws3

Inertia

Acceleration

Reaction

For every action there is equal an opposite reaction.

Newton’s Three Laws


Process of accreditation12

Process of Accreditation

Pre-Accreditation

Accreditation

Accredited

Facility Inspection

Facility Growth by Time


International accreditation3

International Accreditation

  • Introduction.

  • Process of Accreditation.

  • Newton’s Three Laws.

  • KCBB Accreditation.


Kcbb accreditation

KCBB Accreditation


Kcbb accreditation1

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


Pre accreditation1

1968

Complete self dependency on the local blood donation.

Total blood collected was 7348.

1965

Pre-accreditation


Pre accreditation2

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


Pre accreditation3

1985

The administration structure changed to introduce specialized units for serology, donation, immunohematology and blood distribution.

1965

1968

1970

Pre-accreditation


Pre accreditation4

1985

Blood Transfusion Administration Services (BTAS) was established as centralized service at the Ministry of Health.

1965

1968

1970

Pre-accreditation


Pre accreditation5

1987

New facility that meets the GMP requirements was build and equipped with advanced technology.

1965

1968

1970

1985

Pre-accreditation


Pre accreditation6

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

Pre-accreditation


Newton s three laws4

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


Newton s three laws5

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 organizationexperiences an external force.

Newton’s Three Laws


Pre accreditation7

Pre-accreditation

  • Challenges

    • Start the process.

    • Follows structured typed of thinking and working.

    • Change the environment.

    • Meets the standards of ABB


Kcbb accreditation2

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


Accreditation1

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.

Standards


Accreditation2

1997

Quality 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 laws6

Inertia

Acceleration

Reaction

An object of greater mass needs a greater force to accelerate than object of smaller mass.

Newton’s Three Laws


Newton s three laws7

Inertia

Acceleration

Reaction

An organization of greater mass needs a greater force to accelerate than organization of smaller mass.

Newton’s Three Laws


Process of accreditation13

Process of Accreditation

Pre-Accreditation

Accreditation

Accredited

Facility Inspection

Facility Growth by Time


Accreditation3

1997

Quality Management Department.

5 specialized personnel (quality coordinators).

Directly under the top management.

1965

1968

1970

1985

1987

1989AABB

Accreditation


Accreditation4

Accreditation

  • Challenges

    • Quality Coordinators (Inspectors).

    • NOT at the ministry chart.

    • Under the manager with higher authority.

    • Disqualify supplier, operation and product.


Kcbb accreditation3

KCBB Accreditation

  • Pre-accreditation.

  • Accreditation.

  • Post-accreditation.


Post accreditation

1998

Immunohematology Unit:

RBC Serology (Donors).

RBC Serology (Patients).

1965

1968

1970

1985

1987

1989AABB

1997QM

Post-accreditation


Post accreditation1

1999ISBT 128

1965

1968

1970

1985

1987

1989AABB

1997QM

1998IH

Post-accreditation


Post accreditation2

2001

Immunohematology Unit:

RBC Serology (Donors).

RBC Serology (Patients).

Platelet Serology.

1965

1968

1970

1985

1987

1989AABB

1997QM

1998IH

1999ISBT 128

Post-accreditation


Post accreditation3

2001PLT

2003

Immunohematology Unit:

RBC Serology (Donors).

RBC Serology (Patients).

Platelet Serology.

Antenatal Laboratory.

1965

1968

1970

1985

1987

1989AABB

1997QM

1998IH

1999ISBT 128

Post-accreditation


Post accreditation4

2001PLT

2003ANT

2004

Data Management System:

Departments connection.

Braches connection.

Auditing process.

Error reporting.

1965

1968

1970

1985

1987

1989AABB

1997QM

1998IH

2001PLT

Post-accreditation


Post accreditation5

2001PLT

2003ANT

2004DMS

2005

Re-organization of BTAS.

Re-writing of quality plan.

1965

1968

1970

1985

1987

1989AABB

1997QM

1998IH

2001PLT

Post-accreditation


International accreditation government model

مدير الإدارة

Administration Director

نائب المدير

Deputy Director

1- قسم إدارة الجودة

1- Quality Management

Department

5- قسم المعلومات

5- Information

Department

4- قسم المختبرات

4- Laboratory

Department

3- قسم الخدمات الطبية و التوجيه

3- Medical

Department

2- قسم الشئون الإدارية و الخدمات المساندة

2- Administration & Support

Services

1.1- وحدة ضمان الجودة

1.1- Quality Assurance

Unit

1.5- وحدة تقنية المعلومات

5.1- Information Technology

Unit

1.3- وحدة التبرع بالدم

3.1- Blood Donation

Unit

1.2- وحدة العلاقات العامة

2.1- Public Relation

Unit

2.5- وحدة السجلات الطبية

5.2- Medical Record

Unit

1.1.3- شعبة التبرع بالدمالكامل

3.1.1- Platelet Apheresis

Section

2.1.3- شعبة التبرع المتنقلة

3.1.2- Mobile Donation

Section

2.2- وحدة المخازن

2.2- Storage

Unit

2.1- وحدة الأمن و السلامة

1.2- Safety

Unit

4.5- وحدة المكتبة

5.3- Library

Unit

3.1.3- شعبة توجيه المتبرعين

3.1.3- Static Blood Donation

Section

3.1.3- التبرع بالفرز الآلي

3.1.4- Donor Counselling

Section

3.2- وحدة شئون العاملين

2.3- Employee Affairs

Unit

1.4- وحدة أمراض الدم و المناعة

4.1- Immunohematology

Unit

2.4- وحدة الميكروبيولوجي

4.2- Microbiology

Unit

3.1- وحدة الأبحاث و التطوير

1.3- Research &

Development Unit

2.3- الوحدة العلاجية

3.2- Therapeutic

Unit

4.2- وحدة المحاسبة

2.4- Accounting

Unit

1.1.4- مختبر كريات الدم الحمراء (المتبرعين)

4.1.1- RBC Donor Testing

Section (Lab)

2.1.4- مختبر كريات الدم الحمراء (المرضى)

4.1.2-RBC Patient Testing

Section (Lab)

1.2.4- مختبر فحص الأمصال

4.2.1- Serology

Section (Lab)

2.2.4- مختبر فحص الحمض النووي

4.2.2- NAT

Section (Lab)

4.1- وحدة التدريب و التعليم المستمر

1.4- Training & Continuing

Education Unit

1.2.3- وحدة العلاج بالفرز الآلي

3.2.1- Therapeutic Apheresis

Section

2.3.3- وحدة التبرع العلاجي

3.2.2- Therapeutic Donation

Section

5.2- وحدة الاتصالات و النقليات

2.5- Transport &

Communication

Unit

3.1.4- مختبر فحص الحوامل

4.1.3- Antenatal Testing

Section (Lab)

4.1.4- مختبر الصفائح الدموية

4.1.4- Platelet Serology

Section (Lab)

3.2.4- مختبر فحص البكتيريا

4.2.3- Bacteriology

Section (Lab)

4.2.4- مختبر فهرسة العينات

4.2.4- Sample Archiving

Section (Lab)

5.1- وحدة قياس الجودة

1.5- Quality Control

Unit

3.3- وحدة التبرع بالخلايا

3.3- Cellular Donation

Unit

3.4- وحدة مشتقات الدم

4.3- Blood Component

Unit

4.4- وحدة الخلايا الساقية

4.6- Cellular Storage & Distribution

Unit

6.1- وحدة متابعة صيانة الأجهزة الطبية

1.6- Medical Equipments

Maintenance Unit

1.3.1- شعبة التبر بالخلايا الساقية

3.3.1- Peripheral Stem Cell

Section

2.3.3- التبرع بخلايا الحبل السري

3.3.2- Cord Blood

Section

4.3- وحدة التمريض

3.4- Nursing

Unit

1.4.4- مختبر الخلايا الساقية

4.4.1- Stem Cell

Section (Lab)

2.4.4- مختبر خلايا الحبل السري

4.4.2- Cord Blood

Section (Lab)

1.3.4- شعبة تحضير الدم

4.3.1- Component

Preparation (Lab)

2.3.4- مختبر معالجة الدم

4.3.2- Component

Modification (Lab)

5.3- وحدة التنسيق الطبي

3.5- Hospital Liaison

Unit

7.1- وحدة شئون المباني

1.7- Building Affairs

Unit

5.4- الوحدة المرجعية

4.5- Reference

Unit

6.4- وحدة التخزين و الصرف

4.6- Blood Storage & Distribution

Unit

1.5.3- شعبة تقصي تفاعلات الدم

3.5.1- Hemovigilance

Section

2.5.3- شعبة الدوريات و المطبوعات

3.5.2- Educational Circular

Section


Newton s three laws8

Inertia

Acceleration

Reaction

For every action there is equal an opposite reaction.

Newton’s Three Laws


Process of accreditation14

Process of Accreditation

Pre-

Accreditation

Accredited

Facility Inspection

Facility Growth by Time


Post accreditation6

Do

Check

Write

Correct/improve

QA Plan

Continuous process for improvement

Post-accreditation

  • Challenges

    • Continuous process control.

    • Continuous process improvement.


Post accreditation7

Do

Check

Write

Correct/improve

QA Plan

Continuous process for improvement

Post-accreditation

  • Challenges

    • Data collection, analysis and follow-up of issues requiring corrective or preventive action.


Kcbb accreditation4

KCBB Accreditation

  • Pre-accreditation.

  • Accreditation.

  • Post-accreditation.


Pre accreditation8

2003Antenatal

2004DMS

2005Re-BTAS

2005Bacterial Detection

2006NAT

2007ULD

2008PI adopted

1965 Established

1968Sufficiency

1970Central

1985BTAS

1987New Facility

1989AABB

1997QM

1998IH

1999ISBT 128

2001Platelets Lab

Pre-accreditation


Kcbb accreditation5

KCBB Accreditation

  • Pre-accreditation.

  • Accreditation.

  • Post-accreditation.


Accreditation5

2003Antenatal

2004DMS

2005Re-BTAS

2005Bacterial Detection

2006NAT

2007ULD

2008PI adopted

1965 Established

1968Sufficiency

1970Central

1985BTAS

1987New Facility

1989AABB

1997QM

1998IH

1999ISBT 128

2001Platelets Lab

Accreditation


Kcbb accreditation6

KCBB Accreditation

  • Pre-accreditation.

  • Accreditation.

  • Post-accreditation.


Post accreditation8

2003Antenatal

2004DMS

2005Re-BTAS

2005Bacterial Detection

2006NAT

2007ULD

2008PI adopted

1965 Established

1968Sufficiency

1970Central

1985BTAS

1987New Facility

1989AABB

1997QM

1998IH

1999ISBT 128

2001Platelets Lab

Post-accreditation


Post accreditation9

2003Antenatal

2004DMS

2005Re-BTAS

2005Bacterial Detection

2006NAT

2007ULD

2008PI adopted

1965 Established

1968Sufficiency

1970Central

1985BTAS

1987New Facility

1989AABB

1997QM

1998IH

1999ISBT 128

2001Platelets Lab

Post-accreditation


International accreditation4

International Accreditation

  • Introduction.

  • Process of Accreditation.

  • Newton’s Three Laws.

  • KCBB Accreditation.

  • Does it worth.


Does it worth

Doesit worth ?!


Accreditation6

Expensive.

Accreditation fees.

Specialized personnel.

Time consuming.

Accreditation


Accreditation7

Expensive.

Paper work.

Legal protection.

Computerization of the system.

Accreditation


Accreditation8

Expensive.

Paper work.

Benefits.

High quality.

Prevention of miss falls.

Aids for emergencies.

Project planning.

Accreditation


Emergencies

Emergencies

  • Disaster Plan.


Emergencies1

Emergencies

  • Disaster Plan.

  • SARS.


Project planed

Project Planed

  • Guided by the standards.

  • New improvements help in raising the quality of service.


Project planed1

Project Planed

  • Bacterial Detection System.

  • NAT for HCV, HBV and HIV.

  • Regional Reference Laboratory.


Bacterial detection system

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 system1

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 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.


International accreditation government model

100

80

60

Analyte Level

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

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

Accreditation of Blood Transfusion

Does it worth?


Accreditation9

Accreditation

Improve the quality of blood transfusion service from vein to vein.


Accreditation10

Accreditation

Accreditation is step that boots our efforts to reach the quality we aim.


Accreditation11

Accreditation

  • Only by continuous improvement can keep the facility accredited by continuously raising the quality of work to reach the changing standard.


International accreditation government model

Thank You


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