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Egyptian National Blood Transfusion Policy 2007 PDF
Egyptian National Blood Transfusion Policy 2007 PDF
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Egyptian National Blood Policy
TABLE OF CONTENTS
INTRODUCTION.............................................................................................................................................................. 4
BACKGROUND............................................................................................................................................................... 5
2. FINANCING ...................................................................................................................................................... 11
4. LABORATORY TESTING.............................................................................................................................. 12
7. HAEMOVIGILANCE........................................................................................................................................ 13
13. CAPACITY BUILDING IN TISSUE AND STEM CELL COLLECTION AND BANKING ..................... 16
ANNEX 1: BASIC ORGANIZATIONAL STRUCTURE OF THE NATIONAL BLOOD SYSTEM (NBS) ......... 19
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Egyptian National Blood Policy
LIST OF ABBREVIATIONS
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Egyptian National Blood Policy
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.
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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Egyptian National Blood Policy
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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Egyptian National Blood Policy
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:-
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.
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Egyptian 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
Therefore, the following shall be adopted and enshrined within the constitution by the GOE through
MOH&P:
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Egyptian National Blood Policy
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.
1.2.1 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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Egyptian National Blood Policy
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.
1.3.1 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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Egyptian National Blood Policy
1.3.6 NBRA shall be overseen by the expert advisory board to ensure that their activities are
focused on regulatory and licensing issues.
1.4.3 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.
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Egyptian National Blood Policy
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.
3.1 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.
3.4 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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Egyptian National Blood Policy
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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Egyptian National Blood Policy
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.
6.1 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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Egyptian National Blood Policy
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.
9.1 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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Egyptian National Blood Policy
9.1 MOH&P shall be responsible for the ongoing financial support for the maintenance and
development of the national IMS.
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.
11.1 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.
12.1 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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Egyptian National Blood Policy
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.
14.1 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.
15.1 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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Egyptian National Blood Policy
15.3 The NBS shall test the mechanism at least once annually.
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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Egyptian National Blood Policy
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.
Page 18 of 22
Egyptian National Blood Policy
MOH&P
Advisory Board
National Blood
System
Page 19 of 22
Egyptian National Blood Policy
RBTC RBTC
RBTC RBTC RBTC RBTC RBTC RBTC RBTC RBTC
Shebine Kafr el
Damanhour Mansoura Alexandria Tanta Cairo Assiout Zagazig Geiza
el Kom Sheikh
DBB DBB
DBB DBB
Marsa Wadi
Luxor Hurghada DBB
Matrouh Gadid
Areesh
DBB
Sharm el
Sheikh
Key:
Large RBTCs
Small RBTCs
DDBs
• 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.
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Egyptian National Blood Policy
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.
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.
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Egyptian National Blood Policy
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.
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.
Page 22 of 22
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