Egypt National Blood Policy 2007

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Page 1 of 22 ARAB REPUBLIC OF EGYPT MINISTRY OF HEALTH & POPULATION NATIONAL BLOOD POLICY

Transcript of Egypt National Blood Policy 2007

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ARAB REPUBLIC OF EGYPT

MINISTRY OF HEALTH & POPULATION

NATIONAL BLOOD POLICY

Egyptian National Blood Policy

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TABLE OF CONTENTS

INTRODUCTION..............................................................................................................................................................4

BACKGROUND ...............................................................................................................................................................5

CURRENT SITUATION ..................................................................................................................................................5

GOAL OF THE NATIONAL BLOOD POLICY ............................................................................................................6

1. ORGANIZATION OF THE NATIONAL BLOOD SYSTEM (NBS) .............................................................7

2. FINANCING ......................................................................................................................................................11

3. VOLUNTARY NON-REMUNERATED BLOOD DONOR PROGRAMME ..............................................11

4. LABORATORY TESTING..............................................................................................................................12

5. STORAGE AND DISTRIBUTION OF BLOOD AND BLOOD PRODUCTS...........................................13

6. APPROPRIATE CLINICAL USE OF BLOOD AND BLOOD PRODUCTS (ACUB).............................13

7. HAEMOVIGILANCE........................................................................................................................................13

8. QUALITY MANAGEMENT SYSTEM (QMS) ..............................................................................................14

9. NATIONAL INFORMATION MANAGEMENT SYSTEM (IMS) ................................................................14

10. HUMAN RESOURCES ...................................................................................................................................15

11. COLLABORATING WITH NATIONAL AND INTERNATIONAL PARTNERS ......................................15

12. THE IDENTIFICATION OF NATIONAL NEEDS FOR FRACTIONATED PRODUCTS.......................15

13. CAPACITY BUILDING IN TISSUE AND STEM CELL COLLECTION AND BANKING .....................16

14. NATIONAL BLOOD TRANSFUSION STANDARDS ................................................................................16

15. THE DEVELOPMENT OF A NATIONAL CONTINGENCY PLANNING MECHANISM.......................16

16. THE ROLES AND RESPONSIBILITIES OF HOSPITAL BLOOD BANKS (HBBs).............................17

17. PROFESSIONAL AND ETHICAL PRINCIPLES IN TRANSFUSION .....................................................18

ANNEX 1: BASIC ORGANIZATIONAL STRUCTURE OF THE NATIONAL BLOOD SYSTEM (NBS) .........19

ANNEX 2: BASIC ORGANIZATIONAL STRUCTURE OF THE NATIONAL BLOOD TRANSFUSION

SERVICE (NTBS) ............................................................................................................................................20

ANNEX 3: ISBT CODE OF ETHICS FOR BLOOD TRANSFUSION SERVICES .........................................21

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LIST OF ABBREVIATIONS

ACUB Appropriate Clinical Use of Blood

AIDS Acquired Immune- Deficiency Syndrome

CME Continuous Medical Education

CPD Continuous Professional Development

DBB District Blood Bank

GDBA General Directorate of Blood Affairs

GLP Good Laboratory Practices

GOE Government of Egypt

HBB Hospital Blood Bank

HBV Hepatitis B Virus

HCV Hepatitis C Virus

HIV Human Immune Deficiency Virus

HTC Hospital Transfusion Committee

IMS Information Management System

ISBT International Society of Blood Transfusion

LHA Local Health Authority

MOH&P Ministry of Health & Population

NBRA National Blood Regulatory Authority

NBS National Blood System

NBTC National Blood Transfusion Centre

NBTS National Blood Transfusion Services

NGO Non-Governmental Organisation

QMS Quality Management System

RBTC Regional Blood Transfusion Centre

Rh Rhesus

SOP Standard Operating Procedure(s)

TTI Transfusion Transmitted Infection(s)

WHO World Health Organization

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INTRODUCTION

The National Blood Policy document demonstrates the commitment and support by the

Government of Egypt (GOE), represented by Ministry of Health and Population (MOH&P), to

establish and maintain a system that will ensure the safety and adequacy of the national blood

supply as an integral part of the national health care system. The objective of this document is to

define the organizational, financial and legal measures relating to the establishment of an efficient,

cost-effective and sustainable national blood system. It will also define the measures that will be

taken to meet the transfusion requirements of the Egyptian population through the provision of safe

blood and related products and their appropriate use. The implementation of this National Blood

Policy will be over a specified time frame to avoid system failure and insure gradual conversion

from the current situation to the one stated in the National Blood Policy.

The scope of the policy is:

1. The development of the National Blood System (NBS) implemented by MOH&P. The

system includes:

- National Blood Transfusion Service (NBTS)

- National Blood Regulatory Authority (NBRA)

- An expert advisory board for transfusion activities

2. The establishment of a sustainable financial structure for the National Blood System.

3. Recruitment and retention of voluntary non-remunerated blood donors from low risk

populations.

4. The testing of blood and blood products for Transfusion Transmissible Infections (TTIs),

and the performance of appropriate blood grouping and compatibility testing.

5. Storage and distribution of blood and blood products.

6. The promotion of the Appropriate Clinical Use of Blood (ACUB)

7. The establishment of a national haemovigilance system.

8. The development of a comprehensive Quality Management System (QMS) to cover the

entire transfusion process.

9. The development of a national information management system.

10. Capacity building of human resources in blood transfusion activities.

11. Collaborating with national and international partners supporting the NBS.

12. The identification of national needs for plasma fractionation products and the meeting of

those needs.

13. Capacity building in tissue and stem cell collection and banking activities and their

regulations.

14. The development of appropriate national standards for all transfusion related activities.

15. The development of a national contingency planning mechanism.

16. The identification of the roles and responsibilities of Hospital Blood Banks (HBBs).

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17. Professional and ethical principles in transfusion.

BACKGROUND

The Egyptian Blood Transfusion Service started in 1938 with the formation of a non-governmental

organization for blood donors.

� In 1960 the first legalization of official organization of the Egyptian Blood Transfusion Service

started with the issuance of presidential decree with Law No. 178 stipulating the formation of

the blood transfusion council.

� In 1975 the General Directorate for Blood and Blood Derivatives Affairs was established within

the infrastructure of MOH&P.

� In 1980 a ministerial decree categorized the blood banks into three categories (main – satellite

– storage) according to:

- Population and area served

- Qualifications of the staff

- Premises

� Since then, MOH&P, represented by the Higher Council of Blood and the General Directorate

for Blood and Blood Derivatives Affairs, has carried the responsibility of upgrading, organizing

and administrating blood transfusion activities all over the country in order to meet the needs

for blood and related products.

� In 1999 MOH&P Decree No. 25 prohibited the collection of blood from paid donors in all

government and private blood banks.

� In 1997 The Project for Restructuring the Blood Transfusion Services of the MOH&P was

initiated. The Project’s target is to establish a customised and modern blood transfusion service

that covers all of Egypt and to strengthen the national regulatory body that governs blood

practices. The implementation of the Project will last until last quarter of 2008.

It is an important principle of the National Blood Policy that adequate, safe and effective blood

products and services for Egypt are ensured in the entire country (including remote areas). This

policy therefore sets out the intention and commitment of the GOE to develop a modern blood

transfusion service which has the responsibility for the collection, testing, processing and

distribution of blood and blood products to the entire country. This policy also identifies the

responsible regulatory body for blood transfusion activities in Egypt.

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CURRENT SITUATION

There are several stakeholders within the MOH&P that carry the responsibility of collection, testing,

processing and issuing of blood and blood components. These stakeholders are categorized into

two main groups:-

1. Direct MOH&P institutions

• NBTS

• General Hospitals Blood Banks

• Specialized Medical Centres Blood Banks

• Teaching Hospitals Blood Banks

• Curative Care Hospitals Blood Banks

2. Indirect MOH&P institutions

• Health Insurance Organization Hospitals Blood Banks

• VACSERA

The Hospital Blood Banks (HBBs) that belong to the above mentioned institutions are more than

250 operating Banks. Those HBBs do not engage in the management of the patients' needs due to

the overwhelming work of blood production. There is no consistency in the performance of these

HBBs due to several reasons: e.g.

• Shortage or surplus of staff.

• Staff inadequate or obsolete training.

• Inadequate or old cold chain equipment.

• No national standards for all activities.

• Inappropriate vicinity in most of HBBs.

• Etc…

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GOAL OF THE NATIONAL BLOOD POLICY

The goal of MOH&P regarding the safety of blood and related products is to provide a

comprehensive national system that ensures:

1. The provision of an adequate supply of safe and effective blood and related products to all

patients.

2. The appropriate use of blood and related products.

3. Equal access to safe blood transfusions across all of Egypt.

4. The sustainability and cost-effectiveness of the NTBS.

In addition, the policy defines the role of HBBs in the transfusion process, their relationship with the

NBS and the NBTS and their specific responsibilities

1. ORGANIZATION OF THE NATIONAL BLOOD SYSTEM (NBS)

1.1 Establishment of the NBS

In order to meet the national demand for safe blood, the NBS shall be established, which will result

in efficient and optimal use of available resources. The NBS includes:

- The NBTS, which has the responsibility and authority for providing for all of the blood

needs of the country

- The NBRA, responsible for regulations

- An expert advisory board for transfusion activities

Therefore, the following shall be adopted and enshrined within the constitution by the GOE through

MOH&P:

1.1.1 MOH&P is the official body responsible for the NBS.

1.1.2 MOH&P shall adopt the National Blood Policy, which identifies the NBTS as the sole

provider of blood and blood products within the MOH&P and defines the organizational,

financial and legal measures to ensure adequate supplies of safe blood and blood

products over a specified period of time.

1.1.3 MOH&P shall constitute and support the NBRA, which will regulate all blood transfusion

activities within the whole of Egypt through monitoring, evaluation and oversight of the

delivery, access and quality of the blood transfusion service.

1.1.4 MOH&P shall establish the appropriate legal framework for the NBS to protect donors

and recipients and to ensure the quality of blood transfusion services, i.e. the Egyptian

Blood Law.

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1.1.5 MOH&P shall oversee the formation of the NBTS, which has the sole responsibility and

authority to collect, process, screen and supply blood and products within the MOH&P.

1.1.6 MOH&P shall be responsible for the approval and implementation of national standards

for all blood transfusion activities within the whole of Egypt. These standards will be

revised periodically every three years or whenever required.

1.1.7 MOH&P shall ensure adequate financial resources and mechanisms for the NBS

through annual fiscal allocation of sufficient budgetary resources.

1.1.8 MOH&P shall ensure the use of their central procurement programme for all reagents,

consumables and equipment needed for the NBS to ensure high quality with cost

effectiveness.

1.1.9 MOH&P shall establish a national expert advisory board for transfusion activities whose

role would be to advise the Minister of Health & Population regarding the overall

strategy, policy, direction and organisation of the NBTS.

1.2 Establishment of a National Blood Transfusion Service (NBTS)

An effective and well-managed NBTS will provide an adequate and safe supply of high quality

blood and blood products that meet the needs of the Egyptian population. The following shall be

adopted for the development of the Egyptian NTBS:

1.2.1 The MOH&P shall identify the NBTS as the sole provider of blood and blood products for

the Egyptian population, formally delegating the responsibility and authority needed to

fulfil this role (refer to annex 2 of this document).

1.2.2 The MOH&P will develop the NBTS by creating a suitable network of appropriately

managed, equipped and staffed transfusion centres which cover the whole country.

These centres together will form the NBTS.

1.2.3 The MOH&P shall appoint a board of directors for the NBTS (executive board)

responsible for the overall organisation and management of the NBTS.

1.2.4 The MOH&P shall appoint a full-time competent management team with the

responsibility and authority for day-to-day operations of the NBTS.

1.2.5 The NBTS shall have the duty of developing, implementing and co-ordinating the

following:

� The national QMS.

� National standards for blood transfusion.

� The voluntary non-remunerated blood donor programme.

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� The testing strategy of donated blood for TTIs and appropriate blood group

serology, using the most appropriate and effective tests.

� Good manufacturing practice and good laboratory practice in all areas of its

activities.

� The cold chain for the storage and transportation of blood and blood products from

the NBTS to all users.

� Good clinical practice in blood usage through close collaboration with clinical

services and Hospital Transfusion Committees (HTCs) and participation in the audit

of clinical blood use.

� Continuing education and training for all NBTS personnel and those hospital staff

who may have multidisciplinary responsibilities, and assistance in training doctors

who prescribe blood in the ACUB.

� Research and development related to transfusion medicine and blood safety.

� Reference facilities and services to support the NBTS itself and the re-designated

HBBs.

� Regular reporting of activities and performance to MOH&P, through the expert

advisory board for transfusion activities.

� A national haemovigilance system.

� Technical supervision of all MOH&P Hospital Blood Banks.

1.3 National Blood Regulatory Authority (NBRA)

1.3.1 A competent NBRA shall be established on two stages, first stage as a part of the

NBTSs' Quality System for a period of two years. In the second stage NBRA will become

an independent body.

1.3.2 The NBRA shall regulate, license and accredit the NBTS and hospital blood practices in

Egypt through a programme of regular inspections performed to high standards and in

accordance with the appropriate national standards.

1.3.3 The NBRA shall be responsible for ensuring that the NBTS fulfils its responsibility to

provide sufficient safe blood and blood products to meet the needs of the Egyptian

population.

1.3.4 NBRA shall work in conjunction with the NBTS and any other appropriate bodies in

developing and reviewing appropriate standards and regulations for the blood

transfusion activities in Egypt.

1.3.5 NBRA shall ensure that the National Blood Policy is enforced.

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1.3.6 NBRA shall be overseen by the expert advisory board to ensure that their activities are

focused on regulatory and licensing issues.

1.4 Constitution of an Expert Advisory Board for Transfusion Activities

An expert advisory Board for transfusion activities shall be established by MOH&P to act as an

advisory counsel to the Minister of Health & Population in the setting of policies and strategy for

the NBS, and ensure that the NBTS and NBRA are able to function effectively in their respective

roles. The members of this board shall include experts in transfusion medicine not only from the

NBTS but also including doctors who prescribe blood, and other experts in the field.

The roles and responsibilities of the expert advisory board are:

1.4.1 To advise the Minister of Health and Population in relation to decision making and

strategy formulation on national health policies and relevant technical and medical

issues as they relate to blood transfusion.

1.4.2 To contribute to the development and implementation of legislation and regulations as

required.

1.4.3 To ensure the effective organization and management of the NBTS and the NBRA.

1.4.4 To monitor and evaluate the implementation of the National Blood Policy and to regularly

review and, where necessary, revise or update the National Blood Policy in accordance

with technological developments and emerging threats to blood transfusion.

1.4.5 To ensure the adequate and appropriate allocation of funding for the NBTS and the

NBRA from MOH&P.

1.4.6 To develop, in conjunction with MOH&P, annual activity targets for the NBTS and a

monitoring programme.

1.4.7 To identify the need for and appoint specialist expert advisory groups to assist in the

strategy and direction of the NBS.

1.4.8 To mobilize and coordinate external support and collaborate with national and

international partners to strengthen the NBS.

1.4.9 To review all national standards for blood transfusion practices.

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1.4.10 To revise handling charges for blood and products on a regular basis and advice

MOH&P on pricing policy.

2. FINANCING

The following measures shall be taken to ensure the availability of a sustainable financial system

for the NBS:

2.1 MOH&P shall provide single, sufficient, annual and separate fiscal budget allocations for

both the NBTS and the NBRA.

2.2 Resources from other government agencies provided for blood transfusion activities

shall be re-allocated to the NBS through MOH&P.

2.3 Any general funding obtained for the NBS from international donors shall be co-

ordinated by MOH&P.

2.4 The financial system will be in compliance and according to the developed Health

Insurance system.

3. VOLUNTARY NON-REMUNERATED BLOOD DONOR PROGRAMME

3.1 The targets for the numbers of blood donations to be collected every year shall be based

on patient needs and the level of healthcare provided.

3.2 The basis of the blood donor programme shall be the recruitment and retention of

voluntary non-remunerated blood donors from low-risk population groups.

3.3 No payment or other gifts or services shall be given to blood donors.

3.4 Replacement donation shall be discouraged and replaced with voluntary donation as

quickly as possible.

3.5 The community at large will be mobilized to participate actively in recruitment and

retention of voluntary blood donors, using mass media outlets for promoting voluntary

and regular donation, and by establishing voluntary donor associations.

3.6 The establishment of blood donor associations shall be encouraged in each region.

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3.7 Blood donor association representatives shall be encouraged to participate in developing

and implementing donor recruitment and retention strategies within the NBTS.

3.8 Due recognition and appreciation shall be given to regular voluntary non-remunerated

blood donors for their humanitarian act.

3.9 Within the Egyptian national standards for blood transfusion, national selection criteria

for donors shall be established and implemented. (refer to Egyptian National Blood

Standards)

3.10 A mechanism of donor deferral, counselling and notification shall be developed and

implemented. (refer to Egyptian National Blood Standards)

. 4. LABORATORY TESTING

4.1 All blood donations shall be screened for those transfusion-transmissible diseases as

defined in the Egyptian national standards for blood transfusion. (refer to National

Egyptian Blood Testing Strategy)

4.2 All blood donations shall be ABO1 and Rh typed/tested, together with any additional and

appropriate serological testing as defined in the Egyptian national standards for blood

transfusion.

4.3 Compatibility testing shall be carried out before transfusion as defined in the Egyptian

national standards for blood transfusion.

4.4 All diagnostic tests and testing shall be fully evaluated and validated prior to their

introduction and use.

4.5 The principle of Good Laboratory Practice (GLP) shall be followed at all times, ensuring

laboratory safety procedures and mechanisms are in place for the disposal of hazardous

waste.

4.6 All laboratory equipment shall be appropriate for its purpose, and properly maintained

and calibrated at all times.

1 ABO is the main blood grouping system which classifies people into four blood groups – A, B, AB, and O.

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5. STORAGE AND DISTRIBUTION OF BLOOD AND BLOOD PRODUCTS

5.1 MOH&P and the NBTS shall procure and make available the equipment needed to

ensure that all blood and blood products are stored and transported at the correct

temperatures at all points throughout the transfusion chain.

5.2 The NBTS shall be responsible for the safe and secure transportation of blood and blood

products to the HBBs, ensuring that the correct storage temperature is maintained

throughout transportation and that the products cannot be tampered with in any way.

5.3 The NBTS and HBBs are responsible for ensuring that all storage and transport

equipment is maintained appropriately.

6. APPROPRIATE CLINICAL USE OF BLOOD AND BLOOD PRODUCTS (ACUB)

6.1 National Guidelines for the ACUB shall be produced, updated and promoted by the

NBTS to suit the health needs of the country.(refer to National Egyptian Appropriate

Clinical Use of Blood Guidelines)

6.2 All hospitals or other healthcare institutions that undertake the transfusion of blood or

blood products shall establish a HTC to ensure the appropriate use of blood and blood

products, and to provide a forum to meet with the NBTS to discuss any issues relating to

transfusion activities.

6.3 The membership of the committee shall be determined by the director of the hospital,

and will include all the key users of blood in the hospital and those other professionals

involved in transfusion activities.

7. HAEMOVIGILANCE

7.1 The NBTS shall establish a haemovigilance system for Egypt covering all transfusion

activities, from the collection of blood and its components to the follow-up of its

recipients, wherever they are performed.

7.2 The MOH&P shall be responsible for ensuring that any critical issues affecting patient

safety that are identified through this system, but lie outside the direct responsibility of

the NBS, are investigated and resolved.

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8. QUALITY MANAGEMENT SYSTEM (QMS)

8.1 The NBTS shall ensure the quality of all of its blood and related products through the

development of a comprehensive and appropriate national QMS.

8.2 The NBRA shall ensure the quality of all of its activities through the development of a

comprehensive and appropriate national QMS.

8.3 The NBS shall appoint a national quality manager for both the NBTS and the NBRA who

will have the responsibility and authority for ensuring the overall functioning and

effectiveness of the systems in their respective organisations. The NBTS’ QMS will carry

the regulatory function for two years, after then the NBRA will operate independently

with its own QMS.

8.4 The NBTS’ QMS shall include all the quality requirements as described in the WHO’s

Quality Management Programme for Blood Transfusion Services.

8.5 The NBS shall ensure that there is a regular review of all of the QMS activities of the

NBTS and NBRA to assess their overall effectiveness and to ensure that appropriate

measures are taken to address any critical issues identified.

8.6 The NBTS, in conjunction with the NBRA and other experts, and with the support and

authorisation of MOH&P, shall ensure that appropriate national standards for blood

transfusion practice are developed and implemented.

8.7 The NBTS shall ensure that it is fully and appropriately licensed and accredited to

function as the responsible body for blood transfusion within MOH&P.

8.8 The NBRA shall ensure that it is fully and appropriately licensed and accredited to

function as the responsible body for the regulation of blood transfusion activities within

Egypt.

9. NATIONAL INFORMATION MANAGEMENT SYSTEM (IMS)

9.1 The NBTS shall be responsible for the initial development, implementation and ongoing

development of a comprehensive IMS covering all of the activities of the NBTS.

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9.1 MOH&P shall be responsible for the ongoing financial support for the maintenance and

development of the national IMS.

10. HUMAN RESOURCES

10.1 MOH&P shall ensure the establishment of a career structure within the NBTS in order to

achieve stability in staffing, both in numbers and competence.

10.2 MOH&P, through consultation and interventions at the governmental level shall ensure

the incorporation of transfusion medicine/science into the curricula of institutions offering

education programmes in medicine, nursing and medical laboratory technology.

10.3 The NBTS is responsible for the continuing education and training of all personnel

working in the field of transfusion medicine. This includes the medical training required to

support those studying for the MOH&P national board examination in transfusion

medicine.

10.4 The NBTS is responsible for the continuous competency assessment, education and

training of all personnel working in the MOH&P HBBs.

11. COLLABORATING WITH NATIONAL AND INTERNATIONAL PARTNERS

11.1 The NBS shall strive to collaborate with national and international partners to improve

the quality and distribution of transfusion services provided to the country.

11.2 The NBS shall ensure that any external funding provided is used solely for the purpose

of developing the services offered and improving patient care.

12. THE IDENTIFICATION OF NATIONAL NEEDS FOR FRACTIONATED PRODUCTS

12.1 MOH&P shall determine the needs of the country for fractionated products.

12.2 MOH&P shall ensure that the NBTS collects and provides the fractionators with sufficient

raw plasma for the production of these fractionated products.

12.3 MOH&P shall ensure that the NBTS is allocated sufficient funding to cover the

fractionation process, but that the overall process is cost-neutral.

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12.4 MOH&P shall ensure that the fractionators are regularly inspected and fully licensed and

accredited according to national and international regulations.

13. CAPACITY BUILDING IN TISSUE AND STEM CELL COLLECTION AND BANKING

13.1 The NBTS shall be responsible for creating and establishing facilities for stem cell

collection and cord blood banking.

13.2 The NBTS shall establish a national registry for HLA typed stem cell donors in co-operation

with all relevant health institutions.

14. NATIONAL BLOOD TRANSFUSION STANDARDS

National standards for blood transfusion activities are key to a high quality and reliable national

service.

14.1 The NBTS, in conjunction with the NBRA and other experts, shall ensure that

appropriate national standards for blood transfusion practice are developed and

implemented.

14.2 MOH&P shall ensure that the standards developed are formally recognised and adopted

as Egyptian national standards.

14.3 The standards shall be reviewed every three years and updated regularly.

15. THE DEVELOPMENT OF A NATIONAL CONTINGENCY PLANNING MECHANISM

A national contingency planning mechanism is needed to ensure that the NBS has procedures in

place to ensure adequate continuity of service to all of its clinical users in response to emergencies

or other similar situations.

15.1 The NBS shall plan, develop and implement procedures to ensure adequate continuity of

service to all users at all times.

15.2 The NBS shall ensure that each blood transfusion centre has named responsible

individuals who are fully trained and authorised to act if the situation arises.

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15.3 The NBS shall test the mechanism at least once annually.

16. THE ROLES AND RESPONSIBILITIES OF HOSPITAL BLOOD BANKS (HBBs)

Government HBBs and other non-government2 HBBs are the main customers of the NBTS. They

are located in government and non-government health facilities that undertake procedures that

may require transfusion support.

16.1 MOH&P shall clearly define the roles and responsibilities of the HBBs as the responsible

entity for patient-associated activities within the transfusion process.

16.2 The NBRA shall be responsible for the regulation and licensing of all HBBs, both

government and non-government.

16.3 The HBBs shall be responsible for the grouping, antibody screening, cross-matching of

patients and hospital stock management.

16.4 The HBBs shall be responsible for the safe and proper local storage of the products

supplied by the NBTS.

16.5 The HBBs shall be responsible for ensuring that there are procedures in place at each

hospital to ensure the safe administration of blood and blood components.

16.6 The HBBs shall be responsible for implementing and fully supporting the national

haemovigilance programme.

16.7 The HBBs are not permitted to provide blood and blood products to other institutions

other than the hospitals to which they belong.

16.8 MOH&P, through the regional local health authorities, are responsible for ensuring that

the government HBBs have a sufficient and sustainable budget for their activities.

16.9 MOH&P Hospital Blood Banks will be technically supervised by the NBTS.

16.10 MOH&P Hospital Blood Banks will be administratively and financially under the

supervision of their relevant hospitals

2 Non-government health facilities include private sector institutions and Non-Governmental Organisations (NGOs).

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17. PROFESSIONAL AND ETHICAL PRINCIPLES IN TRANSFUSION

17.1 The safety of recipients and blood donors shall be given the utmost consideration at all

times.

17.2 The confidentiality of the donation and transfusion processes shall be maintained at all

times.

17.3 The donation and transfusion processes shall not in any way be discriminatory, whether

by race or religion.

17.4 The Code of Ethics for Blood Donation and Transfusion of the International Society of

Blood Transfusion (ISBT) as adopted in July 2000 (Annex 2) shall be incorporated into

the National Blood Policy.

17.5 All NBS documents shall be retained and accessible to health professionals for at least

five years.

17.6 NBTS donation sample archives must be retained at -40°C or lower for at least one year.

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ANNEX 1: BASIC ORGANIZATIONAL STRUCTURE OF THE NATIONAL BLOOD SYSTEM

(NBS)

MOH&P

Advisory Board

National Blood

Regulatory

Authority

National Blood

System

National Blood

Transfusion

Service

Hospital Blood

Banks

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ANNEX 2: BASIC ORGANIZATIONAL STRUCTURE OF THE NATIONAL BLOOD

TRANSFUSION SERVICE (NTBS)

• Egypt is divided into 12 Blood Transfusion Regions with one or more Regional Blood

Transfusion Centres (RBTCs).

• The National Blood Transfusion Centre (NBTC) is the headquarters of the National Blood

Transfusion Service (NBTS).

• The NBTS consists of the NBTC, 10 large and 7 small RBTCs and 6 District Blood Banks

(DBBs).

• DBBs are located in remote areas and they are overviewed and technically supervised by

the nearest RBTC.

National Blood Transfusion Centre (NBTC)

RBTC

Damanhour

RBTCKena

RBTCSohag

RBTCMinia

RBTCBeni Sueif

RBTCIsmailia

RBTCBanha

RBTC

Mansoura

RBTC

Alexandria

RBTC

Tanta

RBTC

Cairo

RBTC

Assiout

RBTC

Shebine

el Kom

RBTC

Geiza

RBTC

Zagazig

RBTC

Kafr el

Sheikh

RBTCAswan

DBB

Luxor

DBB

Marsa

MatrouhDBB

Areesh

DBB

Wadi

Gadid

DBB

Hurghada

DBB

Sharm el

Sheikh

National Blood Transfusion Centre (NBTC)

RBTC

Damanhour

RBTCKena

RBTCSohag

RBTCMinia

RBTCBeni Sueif

RBTCIsmailia

RBTCBanha

RBTC

Mansoura

RBTC

Alexandria

RBTC

Tanta

RBTC

Cairo

RBTC

Assiout

RBTC

Shebine

el Kom

RBTC

Geiza

RBTC

Zagazig

RBTC

Kafr el

Sheikh

RBTCAswan

DBB

Luxor

DBB

Marsa

MatrouhDBB

Areesh

DBB

Wadi

Gadid

DBB

Hurghada

DBB

Sharm el

Sheikh

RBTC

Damanhour

RBTCKena

RBTCSohag

RBTCMinia

RBTCBeni Sueif

RBTCIsmailia

RBTCBanha

RBTC

Mansoura

RBTC

Alexandria

RBTC

Tanta

RBTC

Cairo

RBTC

Assiout

RBTC

Shebine

el Kom

RBTC

Geiza

RBTC

Zagazig

RBTC

Kafr el

Sheikh

RBTCAswan

DBB

Luxor

DBB

Marsa

MatrouhDBB

Areesh

DBB

Wadi

Gadid

DBB

Hurghada

DBB

Sharm el

Sheikh

Key:

Large RBTCs

Small RBTCs

DDBs

Key:

Large RBTCs

Small RBTCs

DDBs

Egyptian National Blood Policy

Page 21 of 22

ANNEX 3: ISBT CODE OF ETHICS FOR BLOOD TRANSFUSION SERVICES

The Code of Ethics was adopted by the General Assembly of the ISBT on 12 July 2000.

The objective of these principles is to define the ethical issues and rules to be observed in the field

of transfusion medicine.

1. Blood donation including haematopoietic tissues for transplantation shall, in all

circumstances be voluntary and non-remunerated; no coercion should be brought to bear

upon the donor. The donor should provide informed consent to the donation of blood or

blood components and to the subsequent (legitimate) use of the blood by the transfusion

service.

2. Patients should be informed of the known risks and benefits of blood transfusion and/or

alternative therapies and have the right to accept or refuse the procedure. Any valid

advance directive should be respected.

3. In the event that the patient is unable to give prior informed consent, the basis for treatment

must be in the best interest of the patient.

4. A profit motive should not be the basis for the establishment and running of a blood service.

5. The donor should be advised of the risks connected with the procedure; the donor's health

and safety must be protected. Any procedures relating to the administration to a donor of

any substance for increasing the concentration of specific blood components should be in

compliance with internationally accepted standards.

6. Anonymity between donor and recipient must be ensured except in special situations and

the confidentiality of donor information assured.

7. The donor should understand the risks to others of donating infected blood and his or her

ethical responsibility to the patient.

8. Blood donation must be based on regularly reviewed medical selection criteria and not

entail discrimination of any kind, including gender, race, nationality or religion. Neither

donor nor potential recipient has the right to require that any such discrimination be

practiced.

9. Blood must be collected under the overall responsibility of a suitably qualified, registered

medical practitioner.

Egyptian National Blood Policy

Page 22 of 22

10. All matters related to whole blood donation and hemapheresis should be in compliance with

appropriately defined and internationally accepted standards.

11. Donors and recipients should be informed if they have been harmed.

12. Transfusion therapy must be given under the overall responsibility of a registered medical

practitioner.

13. Genuine clinical need should be the only basis for transfusion therapy.

14. There should be no financial incentive to prescribe a blood transfusion.

15. Blood is a public resource and access should not be restricted.

16. As far as possible the patient should receive only those particular components (cells,

plasma, or plasma derivatives) that are clinically appropriate and afford optimal safety.

17. Wastage should be avoided in order to safeguard the interests of all potential recipients

and the donor.

18. Blood transfusion practices established by national or international health bodies and other

agencies competent and authorized to do so should be in compliance with these principles

of ethics.

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