National Standards 2007

Egyptian National BloodTransfusion Standards

Ministry of Health and Population

First Edition

Egypt – 2007

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IntroductionBlood and blood components play a vital and indispensable role in most health services. However, the use of improperly treated blood and blood components can lead to long-term morbidity and death. Consequently it is essential that the processing of blood and blood components be subjected to comprehensive and effective quality controls.

A blood transfusion service needs a quality control system based on the principles of Good Manufacturing Practice (GMP) that covers the collection, manufacture, storage, testing, and distribution of blood and blood components.

The purpose of the following standards is to assist the Blood Transfusion Services (BTS) in their implementation of GMP requirements. The provisions of the standards are applicable to all the procedures in blood transfusion centers that may affect product quality.

The first edition of “The Egyptian National Standards for Blood Transfusion” is based on GMP guidelines and the standards of practice of: the American Association of Blood Banks (AABB), blood transfusion in South Africa, and the Blood Transfusion Council of the Netherlands Red Cross.

The Egyptian National Standards will be reviewed once every two years to incorporate improvements in quality control and keep up with international trends and recommendations.

The first Egyptian National Standards for Blood Transfusion were created as part of the restructuring of Egypt’s National Blood Transfusion Services (NBTS). Based on AABB and South African Blood Transfusion Standards, as well as GMP guidelines, staff first identified items that needed to be covered in each process/department and the minimum standard required to maintain a comprehensive quality system. This resulted in the first draft of the National Standards.

Heads of Regional Blood Transfusion Centers (RBTCs) met with other stakeholders to review these standards; the result was a second draft. Subsequent alterations and modifications produced a further two versions.

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AcknowledgmentThe National Blood Transfusion Center (NBTC) would like to express our deepest gratitude to the following persons who have continuously assisted us and contributed greatly to this successful project:

Contributors:

Dr. Faten Moftah Director General, Head of the NBTS and Egyptian Head of Task Group TAP

Dr. Alan Kitchen Head of the Microbiology Lab of NBS in North London and External Expert of the TAP Project

Dr. Sabah Rasmy Deputy of the General Director of NBTC and the National Laboratory Manager

Mrs. Jennifer WhiteDeputy Scheme Manager UKNEQAS for Blood TransfusionLaboratory Practice Watford, UK

Dr. Afaf Ahmed National Quality Manager and Head of Quality Department, NBTC

Dr. Mohamed Nabeel Head of DCD at NBTC and Technical Advisor of DCD

Dr. Mohamed Farouk Head of Serology Department, NBTC

Dr. Mervat DossTechnical Advisor of ACUB

Dr. Huda Turk Head of the Therapeutic Unit, NBTC

Dr. Nehad MahmoudHead of Component Department, NBTC

Dr. Rania HassanienHead of Issuing Department, NBTC

Dr. Tarek MetwallieSupervisor of RCRL, NBTC

Dr. Mahmoud Said Head of Mansoura RBTC

Dr. Mahmoud SalehHead of Tanta RBTC

Dr. Perween Omar Head of Ismalia RBTC

Dr. Nadia AytaQO of Mansoura RBTC

Dr. Gladious Taha Head of El-Menia RBTC

Dr. Abeer ShenoudaHead of Aswan RBTC

Dr. Nehal Yakout QO of Alexandria RBTC

Dr. Fatma El-AnsaryHead of Alexandria RBTC

Dr. Ahmed El-AnsaryDeputy of DCD in NBTC

Task Group of Quality Management Area:Dr. Mohamed Magdy Quality Staff, NBTC

Dr. Dalia RifaieQuality Staff, NBTC

Dr. Amal Zakaria Quality Staff, NBTC

Dr. Enas FathyQuality Staff, NBTC

Dr. Shereen ShabayakQuality Staff, NBTC

Dr.Yasmin M, SalehQuality Staff, NBTC

Table of Contents

Description Page No.

Definitions 1

Section I: Organization of Blood Transfusion Services 4

Section II: Quality Management System 8

Section III: Blood Collection 13

Section IV: Blood Component Processing 17

Section V: Testing for Red Cell Serology and TTIs 22

Section VI: Issue and Compatibility Testing 26

Section VII: Documents and Records 34

Section VIII: Human Resources 38

Section IX: Purchasing & Incoming Receipt, Inspection and Testing 40

Section X: Safety, Health & Environment 42

Annex I: Egyptian National Donor Selection Criteria 44

Annex II: Egyptian National Processing Specifications 49

Annex III: Specifications: Performance Evaluation of Blood Grouping Reagents

54

Annex IV: Blood Components Suitable for Use in Intrauterine and Exchange Transfusion and Neonates and Infants under One Year – Specific Requirements

55

Annex V: Adverse Transfusion Reactions 56

Abbreviations 57

Glossary of QMP Terms 59

National Standards for Blood Transfusion Services, 1st Edition 1

Definitions•Allogeneic Donation: Blood collected from an individual and placed in the general blood supply for use in transfusion to another person.

•Antibody Screen: Serological test by which donor serum/plasma is tested with reagent red cells of known antigenic profile to determine if unexpected clinically significant antibodies are present. “Clinically Significant” refers to antibodies that may cause adverse reactions in the recipient due to incompatibility.

•Apheresis: The removal of one component of blood and the return of the remaining components to the donor.

•Autologous Donation: Blood collected from an individual for the purpose of transfusion back to the same individual.

•Blood: Whole blood collected from a single donor and processed either for transfusion or further manufacturing. The term is often used to describe blood components in general.

•Blood Component: A therapeutic agent produced by physical or mechanical separation of the constituents of whole blood. Components include, but are not limited to, red blood cells, platelets, plasma, and cryoprecipitated Anti-Hemophiliac Factor (AHF).

•Blood Donation: The act of withdrawing blood or plasma from a blood donor; can also refer to the unit of blood so collected.

•Blood Donor: Any living, voluntary, non-remunerated person from whom blood is taken for the subsequent administrating thereof to another living person, or to himself, or for processing into blood components.

•Calibration: The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system; or values represented by a material measure and the corresponding known values of a reference standard.

•Closed System: A system for collecting and/or processing blood in containers that have been joined together before sterilization, so that there is no possibility of microbial contamination from outside after collection of blood from the donor.

•Compatibility Test: A procedure whereby a blood component from a donor is tested to ensure serological compatibility with the intended recipient.

•Contract Facility: An organization performing work associated with the manufacturing process for the manufacturer.

•Critical Labeling: Labeling which identifies a product or status, such as a quarantine label or blood group label, if it is used to control release for inventory.

•Crossmatch: The procedure whereby red blood cells from a donor are directly mixed with the recipient serum to detect ABO and/or other red cell antigen compatibility.

•Directed Donation: Blood collected from an individual for the purpose of transfusion to a different individual, named by the donor, who has been identified in advance as compatible.

•Document: All written instructions and records involved in providing a product or service.

•Document Control: The control of the issue, use and review of authorized documents within the quality management system.

National Standards for Blood Transfusion Services, 1st Edition 2 National Standards for Blood Transfusion Services, 1st Edition 3

•Quality Assurance (QA): Part of quality management focused on providing confidence that quality requirements are fulfilled ─ ISO 9000 (2000).

•Quality Control (QC): Part of quality management focused on fulfilling quality requirements ─ ISO 9000 (2000).

•Quality Management (QM): Coordinated activities to direct and control an organization with regard to quality ─ ISO 9000 (2000).

•Quality Management System (QMS): System to establish a quality policy and quality objectives and to achieve those objectives ─ ISO 9000 (2000).

•Record: Document stating results achieved or providing evidence of activities performed ─ ISO 9000 (2000).

•Regulations: The regulations relating to blood and blood components.

•Sample: A small quantity of blood taken from a blood donor, donation or a patient for testing purposes.

•Serum: The liquid portion of clotted blood.

•Specification: Document stating requirements ─ ISO 9000 (2000).

•Standard: Minimum level required. •Standard Operating Procedure (SOP): Written instructions for the performance of a specific procedure.

•Unit: A specific volume of blood or one of its components obtained from a single collection of blood from one donor.

•Validation: Confirmation and provision of objective evidence that the requirements for a specific intended use or application have been fulfilled ─ ISO 9000 (2000).

•Withdrawal of Blood: The taking of a blood sample or donation.

•Facilities: Any area, including mobile clinic sites, used for the collection, testing, component production, storage (including records) or distribution of blood and blood components.

•General Director (or Director General): The person appointed by the Undersecretary of State for Specialized Medical Centers as the official ultimately responsible for the overall effective functioning of the blood service.

•Good Laboratory Practice (GLP): The means of ensuring that laboratory functions are carried out in accordance with regulatory requirements; these include planning, performance, recording, and reporting of laboratory functions.

•Good Manufacturing Practice (GMP): The means of ensuring that products are consistently produced and controlled in accordance with appropriate standards and regulatory requirements.

•Hematocrit (Hct): The proportion of red blood cells in the blood.

•Hemoglobin (Hb): The constituent of red blood cells responsible for oxygen carrying.

•Leucopheresis: The method by which whole blood is taken from the donor, the leucocytes are removed, and the formed elements and plasma are returned to the donor.

•Leucoreduced Components: Component units that have been treated by centrifugation, filtration or other methods to reduce the amount of leucocytes per unit to a level below a standard acceptable value.

•Maintenance: Includes preventative maintenance, normal repairs, replacement of parts and structural components, and other activities needed to preserve assets so that they continue to provide acceptable services and achieve their life expectancy.

•Management: Coordinated activities to direct and control an organization ─ ISO 9000 (2000).

•Medical Director: The authorized official, qualified by training and/or experience in blood transfusion and related disciplines, responsible for all medical and technical policies, procedures and support services relating to the safety of donors and the recipients of blood components.

•National Blood Transfusion Service (NBTS): The establishment licensed to withdraw blood from blood donors, to process blood into blood components, and supply them to health care professionals for administration to patients, the national fractionation establishment and other approved institutions.

•Open System: A blood collection and/or processing system which has been breached but where every effort is made to prevent external contamination by using sterilized materials and aseptic handling techniques in a clean environment.

•Plasma: The fluid portion of whole blood collected, stabilized against clotting and separated from red blood cells.

•Plasmapheresis: Separation of plasma from whole blood and the continuous or intermittent return of red blood cells and formed elements to the donor. Plasma collected by plasmapheresis may be used either as source plasma, or for further manufacturing, or as Fresh Frozen Plasma (FFP) for transfusion.

•Plateletpheresis: Separation of platelets from whole blood and the continuous or intermittent return of red blood cells, with or without platelet-reduced plasma, to the donor. If plasma is collected as a final product during plateletpheresis, the regulations for plasmapheresis apply

•Processing: Any fabricating step performed between the collection of blood and the issuing of a component.


1.1 Structure of the Blood Transfusion Services

• The Egyptian NBTS must have a clearly defined structure that designates the parties responsible for the provision of blood, blood components and services and defines the relationship of individuals responsible for key functions.

• The Blood Transfusion Services (BTS) must develop a well-defined structure that clarifies the relationship and interactions between operations, support services, and quality.

• The BTS must create comprehensive job descriptions and personnel specifications for all positions, outlining the responsibilities and authorities, and the knowledge, skills and education required for each position. Each staff member must be fully aware of and accountable for the duties and responsibilities of the job description.

• Job descriptions must be periodically reviewed and updated.

• The NBTS must have a competent and effective senior management team that is fully responsible for the day-to-day operation and activities of the organization:

• General Director (Head).• Finance and Administration Manager (Deputy).• National Head of the Information Technology.• National Quality Manager (see page 9).• National Blood Donor Recruitment and Collection Manager (see page 14).• National Laboratory Manager (see page 22).• Director of Regional Blood Transfusion Centers.

1.2 General Director

The BTS must have a General Director who is responsible for:

• The overall strategy and development of the BTS.• Providing adequate cost effective supply of blood to the Egyptian Population.• The overall performance and direction of the BTS.• Ensuring adequate and sustainable funding for the BTS.• Ensuring acceptance and compliance with the national quality standards.• Ensuring compliance with applicable national laws and regulations.• Advising the Advisory Body of the Ministry of Health & Population (MoHP) on all aspects of

transfusion activities in Egypt.• Heading the NBTS team consisting of the Director of Finance and Administration, Group

Director and National Technical Manager.

Section IOrganization of Blood Transfusion

Services

Organization of Blood Transfusion Services Organization of Blood Transfusion Services


1.5 Director of Regional Blood Transfusion Center

The RBTC Director is responsible for:

• Day-to-day management of the BTS.

• Ensuring that the RBTS meets its quality and supply targets.

• Ensuring that financial transparency is maintained and that there is full costing of all activities.

• Ensuring that the national QMS is supported fully across all sites.

• Chairing the national management team.

• Maintaining continuous communication with hospitals and other users within the region.

• Coordination and cooperation with the local health authorities and relevant external stakeholders.

1.3 Finance and Administration Manager

The NBTS Director of Finance and Administration is responsible for:

• The overall financial management of NBTS.

• Financial and administration planning of the NBTS.

• Preparing strategic, financial and administration plans in cooperation with the NBTS management team.

• The overall financial control of the NBTS and follows governmental financial management and accountability guidelines.

• The provision of appropriate local support services to NBTS sites in:

• Accounting.• Purchasing and Contracting.• Human Resources Management.• Legal Affairs.• Marketing.• Housekeeping.• Stores.• Engineering.

• Serves as deputy for the General Director of the NBTS.

1.4 National Head of Information Technology

The National Head of IT is responsible for:

• The management of all IT staff in accordance with BTS guidelines.

• Ensuring close cooperation between Platform and Application Engineers in order to achieve the most effective use of staff resources.

• Preparation of the NBTS strategic plan through the NBTS management team.

• Leading an IT Council of Senior Managers to develop strategic IT planning and to oversee major projects and operations.

• Maintaining an overall awareness of the business process and the use of IT.

• Ensuring a rapid and efficient escalation procedure to ensure major problems are identified and managed effectively.

• Working in close cooperation with Key System Users to ensure that IT solutions are meeting user needs.

• Ensuring that critical activities are carried out effectively in accordance with good practice and are properly documented.

• Ensuring effective security of IT systems through the implementation of robust and regularly updated security protocols.

Organization of Blood Transfusion Services Organization of Blood Transfusion Services


2.1 Quality System

• The quality system must be defined, documented and maintained.

• The National Quality Department shall be a distinct and independent BTS unit within the NBTS.

• The National Quality Department must develop a national quality policy and plan that must be available to all staff, and all staff must be able to understand the policy and its implications.

• A quality manual that outlines the QMS must be developed.

• Operational policies, processes, and procedures must be developed and implemented to ensure that the requirements of these standards are satisfied.

• All staff must be trained in the overall structure and functioning of the QMS.

2.2 Quality Representative

• The quality system shall be under the leadership of the National Quality Manager.

• The National Quality Manager reports to the General Director of the NBTS.

• The National Quality Manager has the authority and responsibility for ensuring the proper management, development, implementation, and maintenance of the national quality system.

• Responsible for ensuring NBTS meets the appropriate regulatory standards for all of its activities and across all of its sites.

• Constantly update the QMS across the NBTS through regular assessment.

2.3 Management Review

• Top management shall review the QMS at regular intervals to ensure continued suitability and effectiveness, taking into account the outcomes of external bodies’ assessments, internal audits, and outcomes of the monitoring of component conformance to specifications, and feedback from donors, patients and physicians.

• The management review must be documented, and records must be maintained.

2.4 Process Control

• The quality system in place must ensure appropriate continuous control and monitoring of processes, consumables and equipment used in blood collection, processing, testing and issuing.

• The BTS should identify the processes that need statistical analysis for monitoring and control, using acceptable and appropriate statistical techniques in the documentation and records maintained.

• The QMS in place must ensure continuous cleaning, maintenance and calibration of equipment in collecting, processing and testing of blood and blood components in accordance with documented Standard Operating Procedures (SOPs) and time schedules. Cleaning, maintenance and calibration of equipment must be recorded and records must be maintained.

• The QMS must ensure appropriate handling and storage of materials used in collection, production and testing of blood and blood components (e.g. blood bags, reagents, labels, etc.).

Section IIQuality Management System

Quality Management System Quality Management System


2.9 External Quality Assessment Scheme

• Where applicable, the BTS shall have policies, processes and procedures to ensure that external assessments of operations and quality systems are conducted and scheduled.

• The results of external assessments must be reviewed by personnel with the responsibility for the area being assessed and by senior management.

• When corrective action is needed, its development, implementation and evaluation shall be reviewed by the Quality Department, and in the case of serious events, by the Quality Manager together with other appropriate senior management.

2.10 Equipment

• Equipment maintenance and calibration:• The blood bank or transfusion service must have policies, processes, and procedures to ensure

that calibration, maintenance, and monitoring of equipment conform to the standards required for each item of equipment.

• Equipment used or intended to be used in Whole Blood (WB) collection, apheresis procedures, and component production should be designed and maintained to suit its intended purpose and must not present any hazard to donors, products or operators.

• All equipment must be maintained and calibrated on a regularly scheduled basis according to established procedures and the needs of the equipment as described in the Standard Operating Procedures (SOPs) and/or equipment manual.

• Monitoring of critical equipment:• The blood bank or transfusion service shall identify the equipment that is critical to the

provision of blood and blood components.• The blood bank or transfusion service must have a process for scheduled monitoring and

maintenance of all critical equipment. The process shall include: frequent checks, checking methods, acceptance criteria, and action to be taken for unsatisfactory results.

• Critical equipment must be calibrated and adjusted at the manufacturer’s prescribed intervals, as determined by the BTS and following activities that may affect the calibration (e.g. servicing/maintenance).

• Equipment malfunctions:Investigation and follow-up of equipment malfunctions or failures shall include:• Assessment of the conformance of blood and blood components when equipment is found to

be out of calibration.• Steps to ensure that the equipment is removed from service.• Investigations of the malfunction. • Steps for re-qualification of the equipment.• Reporting the nature of the malfunction or failure to the manufacturer, when indicated.

• Storage of blood components:• Storage devices must have the capacity and design to ensure that the proper temperature is

maintained.

• There must be a process to monitor the temperature of refrigerators, freezers, and platelet incubators continuously and to record the temperature at least every 4 hours.

2.5 Control of Change

• The QMS must ensure appropriate planning, control, approval, documentation and review of any changes that may affect the quality of components or services.

2.6 Product Status and Traceability

• The QMS must ensure that the status of each donation and any associated blood component can be identified at all times.

• The BTS must maintain records showing the history of each donation from collection to the distribution to end user of all components prepared from each donation.

2.7 Internal Quality Audits

• The quality system in place must be monitored periodically through a documented quality auditing program to ensure the proper and effective operation of the quality system.

• The internal quality audit must be performed by trained and skilled personnel independent of those having direct responsibility of the audited activity.

• The assigned internal auditor must prepare reports about the audit outcomes including non-conformance points, corrective actions needed, due dates and the person responsible for each corrective action.

• The reports must be reviewed and signed by the head of the relevant department, auditor, Head of Quality Department, and General Director.

• Follow-up internal audits must be performed when necessary.2.8 Error Reporting System

• The BTS must develop, apply and implement policies, processes and procedures for recording, assessing, investigating and monitoring: adverse events; events that deviate from accepted policies, processes and procedures; or events that result in the failure to meet the BTS’ defined requirements; these include the discovery of non-conforming components, complaints and services, as well as adverse reactions to blood donations and transfusions.

• The BTS’ policies, processes and procedures must clearly define how to:• Document, classify, and analyze all of these occurrences.• Establish and analyze the root causes of all errors.• Determine the appropriate corrective action to be taken.• Determine what preventive action is required.• Report to external agencies if required.

• All staff should be appropriately trained to recognize and report such occurrences.

• The BTS must develop procedures to analyze errors/incidents to identify their root causes.

• The BTS should track all events reported and look for trends.

• The outcomes of corrective actions must be investigated and documented.

• A summary of the event, investigation, and any follow-up must be documented.

• Reporting and monitoring of events are essential problem identification methods for process improvement activities in the QMS.

Quality Management System Quality Management System


Section IIIBlood Collection

• Alarm systems:Storage devices with alarms must conform to the following standards:• The alarm must be set to activate under conditions that will allow proper action to be taken

before blood and blood components reach unacceptable conditions.• Activation of the alarm must initiate a process for immediate investigation and appropriate

corrective action.

• Back-up power supply:• Equipment used for the storage of blood and blood components should be connected to an

emergency power supply to ensure that a continuous power supply is maintained.• Equipment used for processing and testing of donations should be connected to an emergency

power supply that is sufficient for work currently in progress to be completed and for the equipment to be shut down correctly. If significant periods of power loss are expected, a continuous power supply is needed to enable blood to be processed and tested effectively and with no delays that may result in the unavailability of blood or blood components.

• The back-up systems should be checked regularly to ensure an immediate switch to emergency power supply in the event of a power failure.

• It is the responsibility of the biomedical engineering department, users and Quality Department to determine the frequency and documentation of these checks for each item of equipment.

Quality Management System Blood Collection


3.4 Donor Notification of Abnormal Findings and Test Results

• Post-donation counseling system:• Is the responsibility of the Donor Care Department (DCD).• Ensures that the donor is notified appropriately about any abnormal test results.• Ensures that the appropriate education, follow-up and referral are provided.

3.5 Donor Call-up

• The recall system is based on:• Phone call system.• Automated and manual (card) system record keeping.• Responsibility for building up a pool of regular voluntary non-remunerated blood donors,

apheresis blood donors, and phenotyped donors with rare blood groups.• Maintaining contact with regular and lapsed donors.

3.6 Donor Care

• The collection team ensures that the donor qualification process is private and confidential.

• The donor shall be observed closely during the donation process.

• The collection team shall deal professionally with any donor’s adverse reactions and emergency medical care, if necessary.

• Post-donation care and advice shall be provided for every donor.

• An effective and sustainable donor retention strategy must be in place.

3.7 Blood Collection

• Blood bags must be:• Sterile and for single use only.• Inspected before use for any visible abnormality or other problems.

• The blood bag and sample tubes must be labeled with the unique donation number prior to performing the venepuncture.

• The collection team must ensure that no air enters the blood bag at any stage of the donation process. The bag must be properly sealed at the end of the donation process.

• Staff involved in phlebotomy must be trained appropriately prior to practicing this procedure.

• Prior to venepuncture, checks must be made to ensure that the identity of the donor matches the identification on the blood bag and associated documents, and that the donation number on the blood bag matches the number on all sample tubes and any other associated documents.

• The collection team must ensure that prior to venepuncture the site is properly cleaned using a disinfectant swab.

• During the collection process the venepuncture site must be covered with a sterile cotton swab.

• If the venepuncture is initially unsuccessful, up to 2 further attempts using the same needle are permitted. If the collection process has started and the flow later stops, repositioning of the needle WITHOUT complete withdrawal is allowed. If the flow does not re-start the collection process must be stopped.

3.1 National Blood Donor Recruitment Program

The program is to be headed by the National Blood Donor Recruitment and Collection Manager. Responsibilities include:

• Development and implementation of national donor recruitment and retention strategy and plans.

• Ensuring donor recruitment strategies are in line with current knowledge and developments in the areas of motivation and recruitment through applying basic research techniques. Strategies should be adapted to local culture and facilities.

• Establishing and maintaining a communication system that ensure effective liaison between the donor care department and other areas of operation.

3.2 Donor Qualifications

• Allogenic donors:• Blood is collected only from voluntary non-remunerated blood donors.• Prior to donation, all donors must complete the donor questionnaire. • Donor ID must be checked using the donor’s national ID card or any other ID card accredited

by the Ministry of Internal Affairs.• Donors should be identified using their full name (up to the 4th generation grandfather), date

of birth, and national ID number.• Donor confidentiality must be maintained throughout the donation procedure.• The donor health check must be performed by an appropriately trained medical officer and the

donor must fulfill the national donor selection criteria (see Annex I).

• Plateletpheresis donors:• Must have given a WB donation at the same blood bank. • With the exception of the donation interval, the standards that apply to allogenic WB donor

qualification shall apply to the selection of plateletpheresis donors.• The donor must not have taken analgesics 72 hours prior to the procedure.• The donor should have prominent anti-cubital veins.• Must not have had any serious complications during their last WB or plateletpheresis

donation.• A complete blood count shall be done for every donor prior/during the first half hour of each

donation process.• The interval between procedures for plateletpheresis donations must be at least 3 days but not

more than twice per week; the total number of plateletpheresis donations must not exceed 24 times per year.

• The total amount of plasma taken from the donor must not exceed 15 liters per year.

3.3 Donor Consent

• Informed consent: • Before each donation every donor must provide written consent.• Written consent should cover the whole donation process including information about the

risks of the procedure and the tests to be performed.• The donor shall have an opportunity to provide or refuse consent.• If consent is refused the pre-donation process must be stopped immediately.

Blood Collection Blood Collection


Section IVBlood Component Processing

• Samples shall be collected after completion of the donation process using vacuum tubes and in a way that prevents external contamination of the donation.

• The volume of blood collected shall be proportional to the amount of anticoagulant solution in the primary blood pack (follow manufacturer’s instructions).

• During collection the staff shall ensure that there is continuous mixing of the blood with the anticoagulant throughout the whole process either using a shaker balance or by manual mixing.

• All donations (main blood bag and satellite bags), sample tubes, donor register and donor questionnaire must be properly identified with the bar-coded donation number (ISBT 128) and date of collection (except sample tubes).

• A specific record must be kept of the identity of all items used during the collection process, the duration of the collection itself, and the staff member responsible.

• Additional labels (e.g. antibody screening, phenotyping) should be added as necessary.

• Inspection:• Prior to release from the blood collection session, the blood bag and its associated tubing must

be re-inspected for defects and its integrity must be checked by applying gentle pressure to the pack to detect any leakage.

• Any defective blood bag must be marked for disposal and held separately.

3.8 Apheresis Collections

• All equipment must be regularly maintained and calibrated.

• The operating software should be kept up-to-date by the supplier.

• All operators must be well-trained and competent, and able to deal appropriately with any problems that might arise during the collection procedure.

• Calcium (oral or intravenous) supplement must be in hand to overcome hypocalcaemia caused by the anticoagulant used during the procedure.

• A full blood count must be performed prior to every plateletpheresis procedure.• The platelet count must not be less than 150,000/mm3.• The hematocrit (Hct) must not be less than 38%.• The hematology profile must be checked carefully for any other abnormalities.

• The collection of plasma and Packed Red Cells (PRCs) on the cell separators is permitted during the collection of the Single Donor Platelets (SDPs).

3.9 Blood Storage during Mobile Sessions

• All donations must be stored at the appropriate temperatures prior to processing at the Blood Transfusion Center (BTC).

• All donations and their associated samples must be transported and stored under temperature controlled conditions, ensuring that, if ice packs are used, there is no direct contact between the ice packs and the blood bags or sample tubes.

• Donations to be used for platelet production must be stored and transported at 20-24°C until processed.

Blood Collection Blood Component Processing


• 1-2% of the daily platelet production should be monitored, depending on the number of processed units.

• 0.2% (minimum 3 units) of the monthly cryoprecipitate and FFP production should be monitored.

4.3 Handling and Storage of Processed Components

• SOPs must be developed and followed for storage areas.

• Blood component storage temperatures:For more details on storage of components, see Annex II.

• The equipment used for the storage of all clinical components should:

• Ensure all components are stored within the correct temperature ranges.• Ensure the safe segregation of quarantined and released components.• Provide adequate space for storage.• Be secure.• Be fitted with a temperature monitoring and alarm system (visual and acoustic).• Have an uninterrupted power supply.

• Each component must be clearly and appropriately labeled, using high quality labels which are:

• Self-adhesive using a non-invasive adhesive.• Smear-resistant.• Resistant to water and humidity.

• The labels should provide, as appropriate, the following information, and ensure that this complies, as necessary, with the relevant national legislation and international agreements:• Donation number (eye readable and barcode).• ABO group and Rh type.• Date of collection.• Expiry date.• Component type.• Storage temperature.• Volume.• The producer’s identification (text or code).• Phenotype result (if relevant).• Anticoagulant solution.• Warning:

• The component must be transfused through 170-200 μm filter (as relevant).• The component must not be used for transfusion if there is hemolysis or if it appears

abnormal in any other way.

• The shelf-life of all components must be defined individually (see Annex II)

4.4 Irradiating Components and Source of Irradiation

• SOPs must be developed and followed for irradiation.

• The preferred irradiation source is gamma radiation (Cesium 127).

• A blood irradiator must be used for irradiation.

• The recommended minimum dose of radiation is 25 Gy; maximum 50 Gy.

• Safety factors must be in place for the staff and the machine.

4.1 Starting Materials for Preparation

• The source donations for processing may be:• WB donations collected manually from individual donors.• Apheresis donations.

• Donations must not be processed if there is:• Any sign of hemolysis.• Any other abnormal color (e.g. jaundice).• Any other visible abnormality (e.g. clots).

• Blood bag intended for collection of a certain volume to maintain the ratio between blood and anticoagulant according to the volume of anticoagulant in the primary pack:• Packs with 70 ml anticoagulant:

• The ideal volume is 450-550 ml.• If outside the normal range, refer to SOPs.• (Volumes are total bag volumes including 70 ml anticoagulant).

• Packs with 63 ml anticoagulant:• The ideal volume is 405-495 ml.• If outside the normal range refer to SOPs. (Volumes are total pack volumes including 63 ml anticoagulant).

• WB is collected into a primary bag to be prepared depending on the number and type of satellite bags attached. • If configurations of bags need to be changed, transfer bags with different capacities can be

connected to the original bag set.• It is preferable to connect the two bags by using a sterile docking device. If this device is not

available, the WB is to be processed in an open system and must be maintained at an average temperature of 8° C and transfused within 24 hours.

• Both bags must be properly identified and matched.

• WB is stored between 10-24° C for preparation of blood components.• Blood to be used for platelet production must be stored at temperatures between 20-24° C.• Blood components should be separated from WB within 8 hours after collection to prepare

Fresh Frozen Plasma (FFP), platelets and cryoprecipitate.• Unprocessed blood older than 8 hours may only be used to prepare frozen plasma and PRCs.• Additive solution must be added to RBCs within 72 hours of collection.• Donations for leucocyte reduction must be collected within 3 days.• Donations to be used for the preparation of FFP, cryoprecipitate and platelets must be collected

within 10 minutes of the venepuncture.• Before the expiry date of FFP, cryoprecipitate can be prepared.

4.2 Component Preparation Procedures

• SOPs must be developed and followed for the preparation of all components.

• Component specifications must be defined for all components in line with international specifications (see Annex II).

• The quality of the blood components produced must be regularly monitored and the results must be documented:• 1-2% of the daily PRC production should be monitored, depending on the number of processed

units.

Blood Component Processing Blood Component Processing


Section VTesting for Red Cell Serology and TTIs

• Storage and regulations for irradiated red cell components (see Annex II).

• Platelets can be irradiated at any stage during their storage.

• The blood component dosimetry must be regularly monitored.

• A record of all units irradiated must be documented thoroughly.

4.5 Release of Components from Quarantine

• All components are to be kept in the quarantine area until the completion of the laboratory screening.

• Unsuitable components must be discarded prior to releasing of the proper components:

• Donation Department•Low volume. •Donor selection criteria not fully met.•High volume. •Self-deferral notification by the donor.

•Any other situations where the collection process has resulted in an unsuitable donation.

• Blood Components Department•Red cell contaminated plasma or platelets. •Hemolysis.•Interrupted closed system. •Punctured or leaking bags.

•Lipaemia. •Any component which does not meet specifications.

•Icteric unit. •Any component which does not meet specifications.

• Screening Laboratories•TTI screen reactive. •Presence of autoantibodies.•ABO mismatch which cannot be resolved. •Incomplete screening.

•Unidentified high titer irregular antibodies. •DAT positive.

• Issuing Department •Mishandled blood units. •Expired units.•Open system. •Hemolysed units.

• A dedicated staff in the Blood Components Department is responsible for discarding units.

• The reasons for the discard must be documented thoroughly.

• Statistical data on discard rates should be collated and analyzed regularly.

• Components must be released from quarantine to the stock after meeting the release criteria.

• The components released from the quarantine storage areas upon meeting specifications must be documented:

• Donation number.• ABO and Rh groups.• Component type released.• Signature of both Components and Issue Area staff performing and authorizing the release.• Date and time of release.

Blood Component Processing Testing for Red Cell Serology and TTIs


• The plasma of each donation should be screened for the presence of irregular red cell antibodies:

• By CAT or tube IAT using AHG.• Using a pooled panel.• IgG coated red cells must be used as control.

• The reagents used must be of high quality and evaluated prior to use:

• Only a test reagent based on microtube system or anti sera (tube technique) approved by an internationally recognized accrediting system (e.g. CE marked, etc.) must be used.

• The test reagent must be evaluated by the qualified Reference Laboratory of NBTC, and then validated in the testing laboratory before acceptance and use.

• The blood grouping to be performed must be done according to defined SOPs:

• All samples must be tested according to the mandatory requirements described.• All samples must be centrifuged prior to testing and checked for suitability for automated

testing.• Samples should be tested, preferably on an automated blood grouping system.• Samples unsuitable for automation should be tested using manual methods (tube technique) or

semi-automated methods (CAT).• Appropriate control and Quality Control (QC) samples must be included with each batch of

tests and must yield the expected results for the run to be considered valid.• Discrepant results should be confirmed using manual methods.• Blood and blood components must not be released from quarantine for clinical use until all of

the mandatory grouping tests have been completed, documented and authorized.• Donations with unresolved discrepant results must not be released for clinical use.

• QC procedures must be in place:

• To assess the day-to-day performance of all reagents and kits used.• To assess the performance of all equipment used.• Including both internal and external QCs.• Included in each batch of tests.• The results monitored to ensure standards are maintained and look for any trends.• To assess the performance of all new manufacturers’ lots of reagents prior to their acceptance

and use.

5.4 TTI Screening

• All donations must be screened for and show no evidence of infection with the following infectious diseases (using ELISA technique) before considered suitable for release for clinical use:

• Hepatitis B surface antigen (HBsAg).• Antibody to hepatitis C virus (anti-HCV).• HIV 1/2 antigen/antibody (HIV Ag/Ab).

• All donations must be screened for and show no evidence of infection with the following infectious diseases (using ELISA technique/column agglutination technique) before considered suitable for release for clinical use:• Syphilis antibodies (anti-Treponema pallidum).

5.1 National Laboratory Program

The program is to be headed by the National Laboratory Manager.

In accordance with the Egyptian national standards for blood transfusion, the National Laboratory Manager’s responsibilities include developing:

• National testing strategy.• National processing strategy.• National issuing strategy.

• Defining a national plan for laboratory training.

• Defining specifications of laboratory equipment, consumables and disposables.

5.2 General Standards for Screening Donation Samples

• Testing is performed on blood samples collected at the time of the donation.

• All samples are to be identified with an eye and scanner readable bar-coded donation number, attached at the time of the donation in order to link the sample to the donation and the donor.

• Two samples are to be obtained from each donation, at least 5 ml on Ethylenediaminetetraacetic Acid (EDTA) for blood grouping and 7 ml plain for automated screening.

• Serum is the sample of choice for TTI screening.

• Samples should preferably not be hemolysed, lipaemic or icteric.

• Samples must be tested within 5 days of collection.

• Samples must otherwise be suitable for use and stored as indicated in the manufacturer’s instructions and guidelines for the test kits or reagents used.

5.3 Blood Group Serology

• The ABO group shall be determined for each donation, irrespective of the previous donation history of the donor:

• Sensitive techniques suitable for testing large numbers of donations must be used (column agglutination technique/tube technique).

• The red cells must be tested against anti-A and anti-B reagents.• The plasma must be tested against standard A1, B and Ab screening. • Appropriate controls must be used and yield the expected results.

• The RhD type shall be determined for each donation, irrespective of the previous donation history of the donor:

• Sensitive techniques suitable for testing large numbers of donations must be used (column agglutination technique/tube technique).

• The red cells must be tested with anti-D.• Donations initially RhD negative must be tested further using an anti-D or another technique

designed to detect weak D antigens.• If the red cells are positive against either or both of the anti-D reagents, the donation is classified

as RhD positive.• If the red cells are negative against both of the anti-D reagents, the donation is classified as

RhD negative.• Appropriate controls must be used and yield the expected results.

Testing for Red Cell Serology and TTIs Testing for Red Cell Serology and TTIs


Section VIIssue and Compatibility Testing

• Only test kits approved by an international accreditation/regulatory system may be used (e.g. CE marked under the IVD Directive):• The kits must be evaluated for suitability for blood screening by the recognized and suitably

qualified and experienced NBTC reference laboratory prior to their introduction for blood screening.

• The kits must be validated in each screening laboratory prior to their use.

• TTI screening must be performed according to defined procedures:

• TTI screening using EIAs is normally to be performed on automated systems.• Samples should be centrifuged and checked for suitability for automated systems prior to

starting the testing.• Samples unsuitable for automated screening should be tested by manual/semi-automated

methods.• The results of each batch of tests performed must meet the manufacturer’s minimum criteria

for the results to be considered valid.• QC samples must be included with each batch of tests and must yield the expected results for

the run to be considered valid.• Initially non-reactive donations may be considered to be suitable for release.• Initially reactive donations are to be retested, in duplicate using the same assay.• Repeatedly reactive donations (2 or more out of 3 the screen results are reactive) are considered

to be unsuitable for release and the donations should either be discarded or stored securely for subsequent reagent/QC use.

• Components must not be released from quarantine for clinical use until all of the mandatory TTI screening tests have been completed and the results authorized.

• Repeat reactive samples should be referred for confirmatory testing by the suitably accredited and experienced NBTC Reference Laboratory.

• QC procedures must be in place:

• To assess the day-to-day performance of all reagents and kits used.• To assess the performance of all equipment used.• Including both internal and external QCs.• Included in each batch of tests to determine the validity of the results for that batch.• The results monitored to ensure standards are maintained and look for any trends.• To assess the performance of each new manufacturer’s lot of test kits prior to their acceptance

and use.

Testing for Red Cell Serology and TTIs Issue and Compatibility Testing


• Suitable samples must be booked in and labeled prior to investigation:• Samples must be recorded and given a unique identification number.• The request form must also be labeled with the same number.• Reconciliation checks of all samples and patient information should be completed prior to

investigation.• Incorrectly or poorly labeled samples must not be accepted.• The information on the sample and on the request form information must match.• Discrepancies must be resolved before any investigations are started.

• The sender must be informed if, for whatever reason, the sample or referral form is considered unsuitable and has been rejected:

• An SOP should be developed detailing the procedure to follow if a sample has been identified as unsuitable for the tests requested.

• The sender must be informed of the problem as soon as possible.• A resolution must be agreed to ensure that the patient involved receives the components

required.

• In situations where patients are being repeatedly transfused, a daily sample is not a requirement. These patients should be screened for irregular red cell antibodies every 3 days.

• WB samples will deteriorate over a period of time. Problems associated with storage include red cell lysis, bacterial contamination, loss of complement in serum and decrease in the potency of antibodies, particularly IgM antibodies. The suggested working limits are shown in Table 2.

N.B.: Although antibodies are probably stable for up to six months in frozen storage, the risk associated with incorrect sample identification of separated plasma/serum samples should be assessed before considering the use of stored samples for pre-transfusion testing.

• Patient and pack bleed line samples must be stored at 2-8°C for 7 days after transfusion for medical and legal reasons.

6.3 Pre-transfusion Testing of Patient Samples

• The ABO group of each patient shall be determined (column agglutination technique/tube technique):

Table 1 Timing of Pre-transfusion Samples

Patient transfused within Sample to be taken not more than

3-14 days 24 hours before transfusion

15-28 days 72 hours before transfusion

29 days-3 months 1 week before transfusion

Table 2 Suggested Maximum Storage Time of Samples

Types of Samples 18-25°C 4°C -30°C

EDTA WB Up to 48 hours Up to 7 days N/A

Separated Plasma/Serum N/A Up to 7 days Up to 6 months

6.1 Request for Blood & Blood Components

• Requests for components for transfusion must be documented appropriately: • A standard request form must be developed and used.• An SOP for the acceptance and processing of requests for components must be developed and

followed. This must include specific procedures for telephone requests and verbal requests for amendments to orders.

• Requests must specify component types required, numbers, ABO and Rh blood groups required (where appropriate) and any additional specific needs, e.g. phentoyped red cells, pediatric red cells, and CMV negative components.

• Requests must specify whether the components are for general stock or for a specific patient.

• Requests must be made on the NBTS compatibility testing request form, which must accompany the sample and be completed fully, correctly and legibly, signed by the person making the request.

• The request form must include:• The date and time that the blood is required.• The number and type of components required.• Any other requirements, e.g. CMV negative or irradiated and/or leucocyte-reduced/ washed

components.• Reason for the request/diagnosis.• Full name (up to the 4th generation grandfather).• Date of birth and age.

6.2 Compatibility Testing

• Compatibility testing is performed upon request.

• There must be an SOP for making and receiving requests for compatibility testing.

• A fresh sample of sufficient volume must be submitted with the request form.• An EDTA sample of at least 5 ml is required for grouping and crossmatching.

• The sample must be labeled correctly and clearly with the following minimum information:• Full name (up to the 4th generation grandfather).• Hospital name.

• Samples received for compatibility testing must be checked prior to booking in. Poor quality samples must not be accepted. Visual inspection to determine the suitability for testing should consider the following circumstances in relation to the equipment, methods and samples used:• The presence of visible hemolysis.• The presence of clots in an anticoagulated sample.• A low sample volume.• Diluted samples.• Insufficient labeling data.• The timing of samples for pre-transfusion testing should be determined in accordance with the

guidelines provided in Table 1.

Issue and Compatibility Testing Issue and Compatibility Testing


• The serum or plasma of either the infant or the mother may be used to screen for irregular antibodies.

• If the initial screen for irregular red cell antibodies is negative for the mother and DAT negative for the baby, immediate spin is enough.

• If the initial antibody screen demonstrates clinically significant irregular red cell antibodies, transfused components must not contain the corresponding antigen. If the antigen cannot be detected, the compatibility of the blood unit must be determined by a complete antiglobulin compatibility test.

• If non-group O red cells are to be issued that are not compatible with the maternal ABO group, the neonate’s serum or plasma shall be tested for anti-A or anti-B and the appropriate ABO group red cells selected.

6.6 Labeling and Checking of Compatible Components

• A label must be attached securely to each component and must contain the following information:

• Recipient’s full name (up to the 4th generation grandfather). • Name of the hospital. • Hospital identification number. • Compatibility testing results.

6.7 Transfusion Practice

• A blood transfusion record must be completed for each component transfused indicating: • Intended recipient’s name. • Hospital name and identification number. • Recipient ABO group and Rh D type. • Donor identification number. • Donor ABO group and Rh D type. • Interpretation of compatibility tests if performed.

• An information leaflet must be issued by the NBTS with each container of components issued. The pamphlet must include:

• The name, address and telephone number of the BTC that issued the component(s) unit. • The instruction that the contents must be maintained within a temperature range stipulated for the specific component at all times during storage, transportation and immediately prior to transfusion.

6.8 Urgent Requests

• When a delay in transfusion may be detrimental to the recipient, blood may be issued as follows:

• Recipients whose ABO group is not known must receive group O red cells. • Recipients whose ABO group has been determined without reliance on previous records may receive ABO group-compatible blood or red cell components before other tests for compatibility have been completed. • When the Rh type is unknown, only RhD negative should be issued to a female prior to or during childbearing years; otherwise RhD positive or negative may be given.

• By testing the red cells with anti-A and anti-B reagents.• By testing the serum or plasma for expected antibodies with A1 and B cells.

• The RhD type of each patient must be determined (column agglutination technique/tube technique):

• RhD type must be determined with a single anti-D reagent. • Weak D’s are considered to be RhD negative as recipients.

• Patient samples must be screened for clinically significant irregular antibodies: • The methods used should identify clinically significant antibodies reacting at 37°C. • Any clinically significant antibodies detected must be referred to the red cell laboratory for identification. • Where specific antibodies are detected, the red cell components provided should be phenotyped as negative for the relevant red cell antigens. • If a recipient has been exposed to red cell antigens within the preceding 3 months, the sample for crossmatching should be obtained within 3 days of the scheduled transfusion.

• Any previous records for patients must be crosschecked to ensure that the current findings are consistent with the previous ones:

• Any significant discrepancies, including appearance of irregular antibodies, must be investigated immediately and prior to the crossmatching and release of components. • Autologous donors and donations must have their ABO and RhD types checked and matched prior to release of the stored donations.

6.4 Selection of Compatible Blood & Blood Components for Transfusion

• All red cell components should normally be crossmatched prior to transfusion: • The NBTS must ensure that recipients receive ABO group compatible components. • The NBTS must ensure that RhD negative recipients receive RhD negative components, except when Rh negative blood is in short supply and an appropriately qualified and experienced medical officer has approved the use of RhD positive components. • Plasma and platelet components should preferably be ABO compatible, especially in the case of infants. • RhD negative blood must always be issued to RhD negative females, and to females where there is any uncertainty over their RhD type, prior to or during the childbearing years.

• A sample of the recipient’s serum must be crossmatched against red cells from the bleed lines of potential red cell components:

• The crossmatch must use methods that demonstrate ABO incompatibility and clinically significant red cell antibodies. • The crossmatch must include an antiglobulin test. • For patients needing special components, e.g. leucoreduced blood, washed red cells, irradiated red cells, etc., the components should undergo the additional processing after compatible units have been identified and relabeled accordingly.

6.5 Selection of Units for Neonates

• An initial pre-transfusion sample must be tested in order to determine ABO group and RhD type.



• That the component has not been opened or tampered with in any way unless for the purpose of preparing for the transfusion, and in which case immediately prior to the transfusion.

• The recipient is identified properly:• Bedside checking of all information before transfusion.

• The recipient has been informed fully about the transfusion process:• Benefits.• Risks.• Any appropriate alternatives.• The right to refuse transfusion.• Full informed consent has been obtained from the recipient and recorded.

• Full records of each transfusion are kept:• The type and donation numbers of all components transfused.• The date and time each component was transfused.• The volume transfused.• The person prescribing the transfusion.• The person setting up each component.• Pre- and post-transfusion vital statistics.• The observation of the patient during the transfusion process and for a defined time afterwards

with the recording of any reactions as a result of the transfusion and their subsequent manage-ment.

• All labels on components transfused should be attached until the end of the procedure and then attached to the patient’s records.

• Transfusion should be prescribed and monitored under medical observation.

• Blood and blood components should be transfused through a sterile, pyrogen-free transfusion set that has a filter designed to collect potentially harmful particles.

• Except for 0.9% NaCl (sodium chloride), drugs or medications should not be added to blood or blood components unless there is documentation available to show that the addition is safe and does not adversely affect the component:• Any drugs or medications added must be recorded on the patient’s notes.

• If home therapy is allowed, e.g. for hemophilia, clear instructions must be provided with the com-ponent, including additional instructions on the management of reactions outside of a healthcare institution.

• The NBTS shall ensure that the hospitals follow the strategy for Rh immune globulin prophylaxis for RhD negative patients who have been exposed to RhD positive red cells.

• Routine warming of red cell components is not recommended, except in situations where there is rapid infusion of large volumes of blood (generally occurring in the operating room or trauma settings) or in patients with identified cold agglutinins. Warming must only be undertaken using approved blood warmers.

6.12 Detecting, Reporting & Investigating Possible Adverse Events following Transfusion

• Each hospital must develop and implement a system for monitoring all transfused patients to identify, record and investigate any adverse incidents following the transfusion of any component:

• The patient must receive the appropriate care following any adverse reaction.• All incidents must be reported to the NBTS as soon as possible.

• There must be a record signed by the requesting medical practitioner indicating that the urgency of the clinical situation was sufficient to require release of red cells before completion of compatibility testing.

• The component must be clearly labeled with a warning statement that compatibility testing had not been completed at the time of issue.

• Standard compatibility tests must be completed promptly and any relevant information provided to the clinician responsible for the patient as soon as possible.

6.9 Transportation of Blood & Blood Components

• Components must be packaged appropriately for transportation:• Packaging must be secure and strong enough to protect the contents.

• All components must be packaged and transported securely and maintained at the correct temperature until arrival at their destination:

• Red cell components must be stored and transported between 1-10ºC (using ice packs with insulator).

• Frozen plasma components must be stored and transported below -18ºC (using dry ice).• Platelets must be stored and transported between 20-24ºC.

• Transport containers must be cleaned and disinfected regularly.

• If NBTS transport is not used, the transport providers must be trained and approved.

• Transportation times must be monitored and recorded.

• The condition of the components upon arrival at their destination must be monitored and recorded.

• Transportation time should not exceed 24 hours.

6.10 Re-issue of Blood Components

• WB and red cell components returned to the blood bank may be re-issued only if:• They are returned within half an hour of issue.• The unit containing the component has not been opened.• The bleed line should be sufficient for further compatibility testing, unless to be re-issued to

the same recipient within 72 hours of the initial transfusion.• There is satisfactory evidence that the unit of blood has been maintained at a temperature of

1-10ºC.• There is a clear record that the component is being re-issued.• The compatibility label attached to the component is cancelled and replaced with

a new one, unless the component is to be re-issued to the same recipient with-in 72 hours and it is confirmed that the patient has not been transfused within that time.

• If a returned component is deemed not safe for re-issue, it must be immediately labeled indicating that the component must not be used for transfusion and discarded.

6.11 Administration of Blood & Blood Components

• Each HTC should ensure that transfusion practice is defined within the hospital and that the in-structions are followed at all times.

• Each component must be carefully inspected prior to transfusion:• For any abnormalities, unusual appearance or other irregularities.• That the expiry date of each component has not passed.



Section VIIDocuments and Records

• The NBTS must develop and implement a system for investigating any reported adverse events following transfusion:

• Personnel attending the patient must immediately notify the physician responsible.• Records of the event must be maintained in the patient’s medical record.• The hospital must notify the NBTS in writing of the event, providing full details of the com-

ponents transfused together with the full medical history of the patient.

• All suspected transfusion complications reported shall be evaluated and reviewed by the NBTS Quality Department together with appropriate medical and technical staff to determine if the trans-fusion could have been the cause/source of the problem.• Full records of the review and the outcome must be kept.• As appropriate, the archive samples from the implicated donations should be recovered and

investigated accordingly.• As necessary, the donor(s) implicated should be contacted again and investigated further.• Any additional work needed to resolve the issue should be determined and undertaken.• A full report of the incident, investigations and outcomes must be prepared as soon as possible

and the hospital/ physician responsible informed of the outcomes.

Issue and Compatibility Testing Documents and Records


7.4 Record Retention

• All records must be retained in accordance with Egyptian legal or regulatory requirements as well as NBTS requirements.

• The retention times for critical documents are detailed below in table 3.

Table 3 Retention RecordItem No. Standard Record to be Retained Minimum Reten-

tion Time (Years)

1. 3.13.2

Donor Questionnaire, Donor Consent and uniqueidentification of each donor and unit 5

2. 3.3 Notification of donors with abnormal findings 5

3. 3.1 Platelet count for plateletpheresis donors 5

4. 3.4 Donor recall forms 5

5. 3.8 Transportation records 10

6.3.64.56.6

Identification of individuals performing each significant step in collection, processing, andcompatibility testing

5

7. 6.1Final disposition of each unit of blood or blood com-

ponents, and if issued by the facility for transfusion,identification of the recipient

5

8. 4.5 Preparation of specific components 5

9. 5.2 Determination of ABO group and Rh type for allcollections 5

10. 5.2 Ab screening for donor with previous history oftransfusion or pregnancy 5

11. 5.8 Serological test results for TTIs 5

12. 6.2 Serologic confirmation of donors ABO/Rh 5

7.1 Document Control System

• The NBTS shall develop a policy that defines the strategy, processes, and procedures required to ensure that documents are appropriately controlled throughout the BTS:

• The BTS must develop, validate and maintain a document control system, including all the procedures needed for protecting the integrity of all documents and data contained within them.

7.2 Documents

• The document control system must ensure proper validation and approval of new documents be-fore use, including defining who should produce documents.

• There must be a standard format for all documents.

• A continuously updated master list of all documents in use must be maintained, ensuring that ap-proved, current versions of appropriate documents are available at all relevant locations.

• The current revision status of each document must be recorded, ensuring the periodical revision of approved documents, along with the identification, withdrawal, and appropriate archival of invalid or obsolete documents.

7.3 Records

• The document control system must ensure the proper indexing, storage, access, and, where ap-propriate, disposal of all records:

• All records must be complete.• All records must be able to be retrieved within an appropriate time.• Records must be protected from accidental or unauthorized destruction, access or

modification. • The BTS must develop, apply and maintain a system to ensure confidentiality of records.

• The record system must ensure the full traceability of all components from donor to recipient, including the results of all performed tests and all donor details.

• Where appropriate there shall be processes and procedures to support the management of elec-tronic records on computer systems including routine back-up and appropriate retrieval of all critical data.

Documents and Records Documents and Records


Section VIIIHuman Resources

Retention of patient investigation records

Item No. Standard Record to be Retained

Minimum Retention Time

(Years)

1. 6.13 Therapeutic phlebotomy 5

2. 6.3 Patient’s ABO group and Rh type 5

3. 6.3 Patient testing to detect unexpected antibodies to redcell antigens 5

4. 6.3 Comparison of patients’ previous test results for ABO group and Rh type for the last 12 months, ifcomparison is not performed electronically

5

5. 6.3 Difficulty in blood typing, clinically significantantibodies 5

6. 6.6 Interpretation of serologic crossmatch 5

7. 6.1

Physician consent indicating that the clinical situationwas sufficiently urgent to require release of blood before completion of compatibility testing or infectiousdisease testing

5

8. 6.12 Recipient consent 5

9. 6.13

Patient’s medical record: verification of patient identification before transfusion, transfusion order, component name, donor unit or pool identification number, date and time of transfusion, pre-and post-transfusion vital signs, amount transfused and identification of the transfusionist, and if applicable,transfusion adverse events

5

10. 6.14 Evaluation of suspected transfusion adverse events 5

11. 6.15 Reference to the initial screening records of the recipients who may have been infected with HCV,HBV, Syphilis or HIV

5

Documents and Records Human Resources


Section IX Purchasing & Incoming Receipt,

Inspection and Testing

8.1 Qualification

• The BTS shall have a process to ensure the employment of an adequate number of individuals qualified by education for each job position.

8.2 Training

• The training needs of the staff must be identified and properly met through documented training programs.

• The records of the staff training must be maintained.

8.3 Competence

• Evaluations of continued competence shall be conducted at specified intervals.

8.4 Personnel Records

• Personnel records for each employee shall be maintained and updated.

Human Resources Purchasing & Incoming Receipt, Inspection and Testing


Section XSafety, Health & Environment

9.1 Purchasing Requirements

• The BTS must develop specific requirements for all items purchased that influence the overall quality of the blood and blood components produced and supplied by the NBTS.

• The BTS must develop, apply and maintain procedures to ensure that purchased items which have an effect on product quality conform to the specified requirements.

9.2 Inspection and Testing

• The different departments of the BTS perform the evaluation and validation and must keep records of acceptance testing of incoming materials such as blood bags, reagents and labels, etc.

• The QMS must develop and ensure implementation of systems for the evaluation and validation of new equipment, procedures, and reagents.

Purchasing & Incoming Receipt, Inspection and Testing Safety, Health & Environment


Annex IEgyptian National Donor Selection Criteria

Basic Criteria AcceptabilityAge 18-60 years (may be up to 65 years if regular donor)Weight >50 kgPulse Regular rhythm (60-95 beats/minute)Blood Pressure 90/60 up to 140/90Hemoglobin Level 13-17 g/dl for male donors

12-16 g/dl for female donors

Condition AcceptabilityAbortion Six months (minor surgery) Acne 2 years if on Ruoaccutaine or Tigason

6 months if on Retin A creamAcupuncture, tattooing, ear piercing, accidental needle prick.

6 months

AIDS/HIV Permanent deferralAlcoholism Permanent deferralAllergies Severe – permanent deferral

Seasonal – accepted during symptom free period Steroids/desensitization injections – permanent deferral

Anemia Iron deficiency – accepted 3 months after recovery Other causes – permanent deferral

Angina pectoris Permanent deferralArthritis Accepted unless acuteBilharzias Active (infection or lake contact) – 1 month after

completion of treatmentPast history treated by tablets – acceptedPast history treated by injection – permanent deferral

Biopsy Benign and healed – deferred for 6 monthsBlood donation 90 days for males

120 days for females Blood transfusion 1 year deferral and for antibody screeningBoils Deferred for 3 weeksBrain injury Permanent deferralBronchial Asthma Mild (< 7 attacks/week) – accepted

Moderate (7-14 attacks/week) – acceptedSevere (> 14 attacks/week) – permanent deferralOn steroids – permanent deferral

Bronchitis (acute) Deferred for 1 monthBrucellosis Deferred for 1 year (accepted as plasma donor only)Burns (minor) Acceptable if no sepsis

Cancer Permanent deferral

Cerebro-vascular disease Permanent deferral

10.1 Safety Policies and Procedures

• The BTS must develop, apply and maintain policies and procedures to ensure adequate safety and the appropriate environmental conditions in the work area.

• The BTS must have procedures to minimize environmental risks affecting the health and safety of staff, donors, patients and visitors.

• Where applicable, the BTS shall have a process for monitoring and ensuring biological, chemical and radiation safety.

• Blood and blood components must be handled and discarded in a manner that minimizes the hu-man exposure to infectious agents.

• The QMS must ensure that all sites in the NBTS network follow the safety policies and procedures.

Safety, Health & Environment


Hypothyroidism Permanent deferralInfectious mononucleosis Accepted 6 months after recovery

Influenza Accepted after recoveryInjecting drug use Addicts – permanent deferral

Non-addicts – accepted after one year from last injection Jaundice Permanent deferral if viral or unknown etiology, hepatitisMalaria Travelers to endemic area who have no history of febrile

illness during travel or since return – defer 1 year since lastvisit to malarial area

Travelers to endemic area with symptoms during or sincereturn – defer permanently

Previous resident (born in, lived at least 6 months in) inendemic area – permanent deferralHistory of malaria – permanent deferral

Measles Contact – accepted 3 weeks after recovery unless donorhas previously suffered from measlesPatient – accepted 3 weeks after recovery

Meningitis Accepted 6 months after recovery Menstruation AcceptedMigraine Accepted

Multiple sclerosis Permanent deferralMultiple sexual partners, homosexuals Permanent deferralMumps Contact – accepted 3 weeks after recovery unless donor

has previously suffered from mumpsPatient – accepted 3 weeks after recovery

Nephritis Acute – accepted 6 months after recoveryChronic – permanent deferral

Occupation Deferred donors working in areas that need full attention and concentration prior to their working hours (e.g. busdrivers, pilots, heavy industries working near machines)

Osteomyelitis (acute) Accepted 6 months after recovery Pancreatitis Accepted 6 months after recoveryPeptic ulcer Peptic ulcer Accepted if no hemorrhage for 6 months provided only on

diet and/or antacidsPeritonitis Accepted 6 months after recoveryPhlebitis Accepted 6 months after recoveryPneumonia Accepted 6 months after recoveryPneumothorax Accepted 6 months after recovery Poliomyelitis Accepted 6 months after recovery Polycythemia vera Permanent deferral, and for therapeutic bleeding Pregnancy Deferred until after delivery (see below)

Normal labor – accepted 6 months after delivery unless breast feeding Breast feeding – accepted 1 year after deliveryCaesarean section – accepted 1 year after delivery

Poliomyelitis Accepted 6 months after recovery

Cholecystitis Acceptable after recoveryColitis (ulcerative) Permanent deferral Common cold Accepted unless fever or malaiseConcussion Deferred for 3 months Convulsions Permanent deferralCoronary artery disease Permanent deferralCystitis Deferred for 3 weeksDental intervention Accepted after 6 monthsDermatitis (eczema/psoriasis) Acceptable when quiescent if venepuncture site clear, not

on systemic treatment and no indication of HIV/AIDSDiabetes Permanent deferral Diphtheria Acceptable 3 months after recoveryDrugs Inhaled or eaten accepted after 3 months from any drug

intakeDysentery Accepted 1 month after recoveryEmbolism Permanent deferralEmphysema Permanent deferralEncephalitis Accepted 6 months after recoveryEpilepsy Permanent deferralFainting (recurrent) Permanent deferralFracture Minor (e.g. crack fracture, closed reduction of ankle or

wrist) – accepted 3 months after fractureMajor/multiple – accepted 6 months after fracture (with-out surgical intervention)

Gall stones Accepted after recovery Gastroenteritis Accepted after 1 monthGerman measles Accepted 3 weeks after recovery Glandular fever Accepted 6 months after recovery Gonorrhea Permanent deferral, acceptable only if complete cure and

no risk activities for 3 years Gout Acceptable if quiescent and not on systemic treatment Heart disease Permanent deferral Hematurea Depending on the causeHemochromatosis Permanent deferral, and for therapeutic bleeding Hemorrhoids Accepted if no severe bleedingHepatitis A Permanent deferralHepatitis B Patient – permanent deferral

Contact – accepted after 6 monthsHepatitis C Patient – permanent deferral

Contact – accepted after 6 monthsHerpes (cold sores) Accepted after complete recoveryHypertension Permanent deferralHyperthyroidism Permanent deferralHypotension Accepted minimum 90/60


Vaccination Hepatitis A – acceptedHepatitis B – accepted after 7 daysPolio (Salk) – accepted Polio (Sabine) oral drops – accepted after 2 weeksTetanus – acceptedTAB – acceptedCholera – acceptedRabies (no exposure to bite) – acceptedPertussis – acceptedMeasles – accepted after 2 weeksMumps – accepted after 2 weeksRubella – accepted after 4 weeksVaricella – accepted after 4 weeksHepatitis B Ig – accepted after one yearNon-specific Ig – accepted after one yearRabies (after bite) – accepted after one yearAnti-D (Rhogam) – accepted after one year

Polycythemia vera Permanent deferral, and for therapeutic bleeding Pregnancy Deferred until after delivery (see below)

Normal labor – accepted 6 months after delivery unless breast feeding Breast feeding – accepted 1 year after deliveryCaesarean section – accepted 1 year after delivery

Prion-associated diseases including sporadic Creutzfeldt-Jakob Disease(CJD) and variant CJD (vCJD)

Individuals who are identified as having an increased riskof developing a prion-associated disease must be perma-nently excluded from donation

This includes individuals who are known to have received a blood transfusion since 1980. Transfusion is defined as any component containing red cells, platelets, granulocytes, FFP, cryoprecipitate and intravenous humannormal immunoglobulin

Psychiatric disorders Permanent deferralRaynaud’s disease Permanent deferral Renal colic Accepted when symptom free Rheumatic fever Permanent deferralSarcoidosis Permanent deferralScabies Accepted if symptom free and venepuncture site is free Scarlet fever Accepted after 3 monthsSepticemia Accepted 6 months after recoverySexually transmitted disease Permanent deferral, acceptable only if complete cure and

no risk activities for 3 years Shingles Permanent deferral Snake bite Accepted 3 months after recoveryStab injuries Accepted after 6 monthsSurgery: Major operations

Minor (e.g. abscess drainage, surgical sutures, ingrown nail, lumpectomy, varicose veins stripping, tonsillectomy)– accepted 6 months after recoveryMajor – accepted 1 year after operation

Syphilis Permanent deferral, acceptable only if complete cure andno risk activities for 3 years

Tetanus Accepted 6 months after recoveryThrombophlebitis Accepted 6 months after recoveryThyrotoxicosis Permanent deferral Tick bite fever Accepted 2 months after recovery Tonsillitis Accepted after recoveryToxoplasmosis Accepted after recovery Tuberculosis Permanent deferralTyphoid Patient – accepted 6 months after recovery Contact –

accepted after 1 month Typhus Accepted 6 months after recoveryUnder weight (below 50 kg) Permanent deferral


Com

pone

nt

Technical Information

Stor

age

Tem

p. (°

C)

Max. Storage Period (Days)

Tran

spor

t Te

mp.

(°C

)

Parameter Specification

Washed PRCs

Red blood cell component, which has been washed with 0.9% w/v NaCl (sodium chloride) for injection.

Then add approved additive solution for re-suspension.

For more details refer to SOPs.

4 ± 2

Open system → 24 hours in 4

oC.

2-10

Volume (ml)

Variable ac-cording to the original vol-ume.

Hematocrit value (Hct) 65-75%

Hemolysis Refer to WB.

Leucocyte count 2.9×108 /unit

Residual protein

< 5 mg/unitThe amount of residual protein will depend on the washing protocol.

IgA < 0.2 mg/unit

Leuco-reduced PRCs

A red blood cell component prepared by removing the majority of leucocytes.

Various techniques are used to produce this preparation (refer to SOPs).

4 ± 2

CPD =21d

CPDA-1 =35d

ACD =21d

*Interrupted closed system 24 hours.

2-10

Volume (ml) 280 + 50 ml

Hematocrit value (Hct) 65-75 %

Hemolysis No visual sign detected.

Residual Leucocytes < 5×106/unit

Irradi-ated PRCs

PRCs can be irradiated at any time up to 14 days after collection.


4 ± 2

It is stored for up to 14 days after irradiation.

2-10

Labeling

Specific labels to determine that the com-ponent was irradiated.

Hemolysis No visual sign detected.

Annex IIEgyptian National Processing Specifications

Com

pone

ntTechnical

Information

Stor

age

Tem

p. (°

C)


Tran

spor

t Te

mp.

(°C

)


WB

A unit of blood collected into an anticoagulant. A unit of WB consists of 450 ml ± 10% of blood including 63 ml OR500 ml ± 10% of blood including 70 ml anticoagulant & stored in approved container. For more details refer to SOPs.

4 ± 2

PD =21d

CPDA-1 =35d

ACD =21d *Interrupted closed sys-tem 24 hours

2-10

Volume(ml)

450 ± 45 ml with anticoag. 63 ml.500 ± 50 ml with anticoag. 70 ml.

Hemoglobin level

Minimum 12% (♀) & 13% (♂) LSL: 40 g/unit

Hematocrit value (Hct) 37-39 %

Hemolysis

Hemolysis of < 0.8% of the red cell mass at the end of component shelf life with a minimum of 20 components tested.

Leucocyte count 0.7 × 109 /unit

PRCs

Red cell component prepared by removing a proportion of the plasma from WB.


4 ± 2

CPD = 21d CPDA-1 =35d ACD = 21d

*Interrupted closed system 24 hours.

2-10

Volume (ml) 280 + 50 ml



Leucocyte count 0.8×109/unit

PRCs in Additive Solution

Packed red blood cell component prepared by removing a proportion of the plasma from WB and suspending in an approved additive solution.

For more details refer to SOPs

4 ± 2

SAGM

OR

Additive Solution→ 42d

*Interrupted closed system 24 hours

2-10

Volume(ml)

280 + 50 plus 100 ml SAGM.



Leucocyte count 0.8 × 109 /unit


Com

pone

nt

Technical Information

Stor

age

Tem

p. (°

C)


Tran

spor

t Te

mp.

(°C

)


SDPs (Apher-esis)

Platelet apheresis, Leucocyte-reduced platelets collected by a variety of apheresis systems using different protocols.

Appropriate pack specified for platelet concentration.

22 ± 2

5 days in continuous gentle agitation.

According to the manufacturer’s instructions recorded on the bag.

*Interrupted closed system 6 hours in the room temperature.

20-24

Volume(ml)

Variable according to session.

Platelet count > 2 × 1011/unit

PH at the end of the recommend-ed shelf life

6.8-7.4

Residual Leucocytes

< 5 × 106/leu-co-reduced unit

FFP

Plasma obtained either from WB or by aphaeresis.

The plasma has been rapidly frozen to a temperature that will maintain the activity of labile coagulation factors.

The plasma must be frozen within 8 hours of collection.

<-30

• Minus 18oC

→ 3 months.

• Fluctuating between minus 23-30

oC → 6

months.

• < minus 30oC

→ 12 months.

<-30

Volume(ml) > 170 ml

F VIII > 0.7 IU/ml

RBCs Trace or not

Visual changes

No abnormal color

Leucocyte count 1 × 107/unit

Total protein > 50 g/l

Com

pone

ntTechnical

Information

Stor

age

Tem

p. (°

C)


Tran

spor

t Te

mp.

(°C

)


RDPs

The component must be prepared at ambient temperature within 6-8 hours from collection before the red cell component is cooled to its storage temperature.

Appropriate pack specified for platelets concentration. For more details refer to SOPs.

22 ± 2

5 days in continuous gentle agitation.

According to the manufacturer’s instructions recorded on the bag.

*Interrupted closed system 6 hours in the room temperature.

20-24

Volume(ml) 50-60 ml

Platelet count

Minimum 3.5 × 1010/unit


6.8-7.4

Leucocyte count 0.2 × 109/unit

Leuco-depleted RDPs

Post-processing leuco-reduction of the RDPs.

22 ± 2

5 days in con-tinuous gentle agitation.

According to the manufactur-er’s instructions recorded on the bag.

*Interrupted closed system 6 hours in the room tempera-ture.

20-24

Volume (ml) 50-60 ml

Platelet count

Minimum 3.5 × 1010/unit


6.8-7.4

Residual Leucocytes < 0.2 × 106/unit


Annex IIISpecifications: Performance Evaluation of Blood Grouping Reagents

A blood grouping reagent recommended for use by a direct agglutination method shall be tested, by all methods recommended by the manufacturer with red cells lacking the antigen corresponding to the antibody specificity but sensitized with an IgG antibody.Blood grouping reagents recommended for use by a direct agglutination method should not contain antibodies reactive against red cells coated with IgG when used by direct agglutination methods recommended by the manufacturer.

Requirements for Conventional Blood Typing Reagents

Antibody Specifi-city

Specification

Performance Evaluation

As a minimum, two examples

of the following reference cells should be in-

cluded

Batch Release TestingSpecificity Potency

Positive Reactors

Negative Reactors

Cell Type

No. Cell Type

No. Cell Type

No.

Anti-A

Normally blue colored.Should equal or exceed potency of reference preparation(s).Should detect variants and sub-groups as detailed in the manufac-turer’s instructions for use.

Sub-group A1 2 B 2 A1 1

Anti-B

Normally yellow colored.Should equal or exceed potency of reference preparation(s).Should detect variants and sub-groups as detailed in the manufac-turer’s instructions for use.

Sub-group B 2 A1 2 B 1

Anti-A, B

Normally clear colored.Should equal or exceed potency of reference preparation(s).Should detect variants and sub-groups as detailed in the manufac-turer’s instructions for use.

A1, A2, B, A1B, A2B

A1 1 O 4 A1 1

Sub-group A A2 2 A2 2

Sub-group B B 2 B 2

Anti-D

Normally clear colored.Should equal or exceed potency of reference preparation(s).Should detect variants and sub-groups as detailed in the manufac-turer’s instructions for use.

Weak D R1r 2 r’r 1 R1r 2

Com

pone

ntTechnical

Information

Stor

age

Tem

p. (°

C)


Tran

spor

t Te

mp.

(°C

)


FFP- poor Platelets

The supernatant plasma has been obtained during the preparation of platelets from platelet-rich plasma. <-30

• Minus 18oC

→ 3 months.

• Fluctuating between minus 23-30

oC → 6

months.

• < minus 30oC

→ 12 months.

< -30

Volume(ml) < 150 ml

F VIII > 0.7 IU/ml

RBCs Trace or not

Visual changes

No abnormal color

Leucocyte count 1 × 107/unit

Cryo-ppt

Cryoprecipitate is the cryoglobulin fraction of plasma obtained by Freezing-thawing-refreezing technique of single donation of FFP at 4°C ± 2°C.


<-30

• Minus 18oC

→ 3 months.

• Fluctuating between minus23-30

oC → 6

months.

• < minus 30oC

→ 12 months.<-30

Volume (ml) 20-30 ml

F VIII > 70 IU/unit

Fibrinogen > 140 mg/unit

Content

von Willebrand factor Fibrino-gen, F XIII & Fibronectin.

Cryo-depleted Frozen Plasma

The supernatant plasma removed during the preparation of Cryoprecipitate.

<-30

• Minus 18oC

→ 3 months.

• Fluctuating between minus23-30

oC → 6

months.

• < minus 30oC

→ 12 months.

<-30

Volume (ml) > 170 ml

Content

Stable coagu-lation factors AlbuminIgs


Annex VAdverse Transfusion Reactions

Type Signs and Symptoms Usual Cause Treatment Prevention

Acute Intravascular Hemolytic (Immune)

Hemoglobine-mia, fever, chills, anxiety, shock, DIC, dyspnea, chest pain, flank pain.

Incompatibility due to clerical er-rors, involves ABO (primarily) or other erythrocyte Ag-Ab incompatibility.

Stop transfusion; hydrate, support blood pressure and respira-tion, induce diuresis, treat shock and DIC.

Avoid clerical errors; insure proper sample and recipient identifi-cation.

Delayed Extra-vascular Hemolytic (Immune)

Fever, malaise, indirect hyper-bilirubinemia, increased urine urobilinogen, falling Hct.

Usually involves non-ABO Ag-Ab incompatibility oc-curring 3-10 days post-transfusion.

Monitor hematocrit, renal function, co-agulation profile. No acute treatment gener-ally required.

Avoid clerical errors.

Febrile Fever, chills, rarely hypoten-sion.

Antibodies to leu-cocytes or plasma proteins.

Stop transfusion; give antipyretics: Aceta-minophen (or Aspirin if not thrombocyto-penic).

Pre-transfusion anti-pyretic; leucocyte-poor blood compo-nents.

Allergic Urticaria (hives), rarely hypoten-sion or anaphy-laxis.

Antibodies to plasma proteins.

Stop transfusion; give antihistamine (orally or IM); if severe, epinephrine and/or steroids.

Pre-transfusion an-tihistamine; washed red cell components.

Hypervolemia Dyspnea, hyper-tension, pul-monary edema, cardiac arrhyth-mias.

Too rapid and/or excessive blood transfusion.

Induce diuresis; phlebotomy; support cardio-respiratory system as needed.

Avoid rapid or exces-sive transfusion.

Non-cardiogenic pulmonary edema

Dyspnea, pul-monary edema, normal cardiac pressures.

Anti-HLA or Anti-leucocyte antibod-ies.

Support blood pres-sure and respiration (may require intuba-tion).

Washed red blood cells, avoid unneces-sary transfusion.

Bacterial sepsis Shock, chills, fever.

Contaminated blood components.

Stop transfusion; sup-port blood pressure; give antibiotics.

Care in blood collec-tion and storage.

Annex IVBlood Components Suitable for Use in Intrauterine and Exchange Transfusion and

Neonates and Infants under One Year, Specific Requirements

Requirement LeucocyteReduced

Mandatory Testing

Required

Prepared from

Previously Tested Donors

Gamma Irradiated

CMV Negative

Free from Clinically Significant Red Cell

Antibodies

RBCs for Intrauterine Transfusion (IUT), Leucocyte Reduced

√ √ √ √ √ √

WB for Exchange Transfusion, Leucocyte Reduced

√ √ √ √ √ √

RBCs for Exchange Transfusion, Leucocyte Reduced

√ √ √ √ √ √

RBC for Neonates and Infants, Leucocyte Reduced

√ √ √ - √ √

RBCs in Additive Solution for Neonates and Infants, Leucocyte Reduced

√ √ √ - √ √

Platelets for IUT, Leucocyte Reduced

√ √ √ √ √ √

Platelets for Neonatal Use, Leucocyte Reduced

√ √ √ - √ √

FFP, Neonatal Use √ √ √ - - √

Key: √= Mandatory; - = not Mandatory


HTC Hospital Transfusion CommitteeIAT Indirect Agglutination TestIg ImmunoglobulinIgA Immunoglobulin AIgG Immunoglobulin GIgM Immunoglobulin MIM IntramuscularIUT Intra-Uterine TransfusionIV IntravenousIVD In Vitro Diagnostic

NBTC National Blood Transfusion CenterNBTS National Blood Transfusion ServiceNEQAS National External Quality Assessment SchemePlt PlateletsPRCs Packed Red CellsQC Quality ControlQMP Quality Management ProgramQMS Quality Management SystemQO Quality OfficerRBCs Red Blood CellsRBTC Regional Blood Transfusion CenterRCRL Red Cell Reference LaboratoryRDP Random Donor PlateletRh Rhesus FactorSAGM Saline Adenine Glucose MannitolSDP Single Donor PlateletSOP` Standard Operating Procedure

TAP Technical Assistance ProgramTTIs Transfusion Transmissable InfectionsvCJD variant Creutzfeldt-Jakob DiseaseWB Whole BloodWHO World Health Organizationw/v Weight in Volume

Abbreviations AABB American Association of Blood BanksAb AntibodyACD Adenine Citrate DextoroseACUB Appropriate Clinical Use of BloodAHG Anti-Human GlobulinAg AntigenAIDS Acquired Immunodeficiency SyndromeAnti-A Antibodies aganist A Antigens on Red Blood CellsAnti-B Antibodies aganist B Antigens on Red Blood CellsAnti-D Antibodies aganist D Antigens on Red Blood CellsAnti-HCV Antibody to Hepatitis C VirusBP Blood PressureBTC Blood Transfusion CenterBTS Blood Transfusion ServiceBV Blood VolumeCAT Column Agglutination TestCDP Cryo-Depleted PlasmaCE Council of EuropeCJD Creutzfeldt-Jakob DiseaseCMV Cytomegalovirus CPD Citrate Phosphate DextroseCPDA-1 Citrate Phosphate Dextrose AdenineCryo-ppt CryoprecipitateDAT Direct Anti-human Globulin TestDCD Donor Care DepartmentDIC Disseminated Intravascular CoagulopathyEDTA Ethylenediaminetetraacetic AcidEIA Enzyme Immune AssayELISA Enzyme Linked Immunosorbent AssayFFP Fresh Frozen PlasmaFNHR Febrile Non-Hemolytic ReactionGLP Good Laboratory PracticeGMP Good Manufacturing PracticeGvHD Graft Versus Host DiseaseHb HemoglobinHBB Hospital Blood BankHBsAg Hepatitis B Surface AntigenHBV Hepatitis B VirusHct HematocritHCV Hepatitis C VirusHIV Human Immunodeficiency VirusHLA Human Leucocyte AntigenHR Heart Rate


English Term English Definition Arabic Definition Arabic TermAudit Findings: Identified compliances

and non-compliances against the standards used for the audit.

Results of the evaluation of the collected audit evidence against audit criteria.*

• ما تبين من تطابق ��عد� تطابق مقا�نة

بالمعايير�لقياسية لعملية �لمر�جعة.

• �� مقا�نة نتائج تقييم عملية �لمر�جعة بأسس/ معايير

�لمر�جعة.*

نتائج �لمر�جعة

Audit Program: Set of audits to be carried out during a planned timeframe.*

• مجموعة من عمليا]/ �نشطة �لمر�جعة �لتى سيتم

�لقيا� بها �فقا لخطة }منية.*

برنامج �لمر�جعة

Audit Scope: Extent or range of a given audit.*

• مد� ��نطا� �لمر�جعة.* مجا�/نطا� �لمر�جعة

Audit Team: One or more auditors conducting an audit, one of whom is appointed as leader.*

• مر�جع �� كثر يقومو� بعملية �لمر�جعة � يتم تكليف

�حدهم كقائد .*

فريق �لمر�جعة

Auditee: Organization being audited.*

�لعملية �� لقسم �� لمنظمة •�لتي ير�جع عليها.

�لمنظمة �لتي ير�جع �� •عليها.*

�لمر�جع عليه

Auditor: Person qualified and competent to conductaudits.*

�لشخص �لذ� يمتلك •�لمؤهال] ��لكفاء� للقيا�

بعملية �لمر�جعة.*

�لُمر�جع

Benchmarking: Audit Evidence: Records, verified statements of fact or other information relvant to the audit- ISO 9000 (2000)

�سة منتج �مما�سا] �� •�نشطة �لمنافس بغر�

تطوير �آل��ء فى �لشركة �لمعنية.

مقا!نة �آل��ء

Blood Cold Chain: The maintained storage of blood and blood components at the appropriate storage temperature and conditions from the point of collection tothe point of use –

‘from vein to vein’.

• سلسلة تبريد �لد� �� مشتقاته من �قت �لتبر� حتى �عطائه

للمريض.

�� تخزين �لد� �منتجاته في �لظر�¤ � ��جة �لحر

�لمناسبة من �قت �لجمع حتى .��قت �الستخد

�لسلسلة �لبا!�+ لتخزين �لد#

Glossary of QMP Terms�لمصطلحا< �لمستخدمة فى خدما< نقل �لد#

English Term English Definition Arabic Definition Arabic TermAccreditation: Procedure by which an

authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.

�إلجر�ء �لذ� تقو� به جهة •مسئولة، إلعتما� منظمة �� شخص للقيا� بالمها�

�لمتعا�¤ عليها.

�لعملية �لتي عن طريقها �� •تقو� جهة �] صالحية

بإعطاء تعريف �سمي بأ� جهة ما �� شخص ما يمتلك �لكفاء� �لال}مة للقيا� بمها�

معينة.

• ��قيا� جهة مسئولة باعتبا� شخص ما �� منظمة ما كفًء �سميًا آل��ء مهمة

محد��.

�عتما�/توثيق

Accuracy: Agreement between the results obtained and the true value.

• تو�فق �لنتائج �لتي تم �لحصو² عليها مع �لقيم

�لحقيقية.

�لدقة

Audit: Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.*

• عملية بحث/ كشف موثقة من جهة مستقلة �على

�طريقة منهجية لتحديد �كانت �لنشاطا] �لقائمة بالمكا� تتبع نظا� جو��

متفق عليه.

• ��عملية بحث/ كشف موثقة �مستقلة �على طريقة منهجية للحصو² على ��لة

ثم تقييم هذ¸ �أل�لة حيا�يا لتحديد مد� مر�عا� معايير

�لمر�قبة/ �لجو��.*

�لمر�جعة

Audit Client: Person or organization requesting an audit.*

�لمؤسسة �� لشخص •�لطالب لعملية �لمر�جعة.*

�لمر�جع عليه

Audit Conclusions: Outcome of an audit decided by the audit team after consideration of all the audit findings.*

�لنتائج �لتى يتفق عليها •فريق �لمر�جعة بعد

�عتبا�جميع �كتشافا] عملية �لمر�جعة.*

نتائج �لمر�جعة

Audit Criteria: Set of policies, procedures or requirements against which collected auditevidence is compared.*

• مجموعة �لسياسا] �لمتطلبا] � [��إلجر�ء�

�لتي يتم تقييم �أل�لة �لمكتشفة في �لمر�جعة على �ساسها.*

|سس/ معايير �لمر�جعة

Audit Evidence: Records, verified statements of fact or other informationrelevant to the audit.*

�لسجال] �� لحقائق •مؤكد� �� معلوما]

�خر� متعلقة بعملية �لمر�جعة.*

�لة �لمر�جعة|


English Term English Definition Arabic Definition Arabic TermConsistency: Doing the same thing

time after time, which makes the outcome more predictable and allows for reduced variation in products and processes.

• تكر��جر�ء �لعملية بطريقة ثابتة على نفس �لمستو�

لضما� ثبو] �لمنتج �لنهائى �لحد من �لتباين � �إلختال¤.�

• ��تكر�� نفس �لعملية مر� بعد مر�، بنفس �لمو�صفا]

مما يجعل �لنتائج متوقعه �كثر �يقلل من �لتباين في �لمنتجا]

�لعمليا].�

�لثبا</�ستمر�!ية

Continuous Quality Improvement:

The ongoing improvement process at the center of all quality systems: plan, do, check and act, as encapsulated in the Deming Cycle.

�لتحسين �لمستمر فى �نظمة •�لجو�� بطريقة خطط / �فعل/

قيم/ عد² كما هو مذكو�فى �ئر� �يمنج.�

+�|ستمر�! تحسين �لجو

Contract: Formal agreement of intention to supply a product or service in accordance with agreed specifications.

��تفا� �سمى على �إلمد •توفير منتج �� خدمة تتماشى

مع �لمعايير �لمتفق عليها.

عقد / تعاقد

Contract Review: Systematic activities carried out by the purchaser to ensure that contractual requirements have been met.

�ألنشطة �لمنهجية �لتى يقو� •بها �لمشتر� لضما� مطابقة

مو�صفا] �لعقد.

مر�جعة �لعقد / �لتعاقد

Correction: Action taken to eliminate a detected non-conformity.*

�لتصر¤ �لمتخذ إل}�لة •�لمخالفا] �� عد� �لمطابقة.*

تصحيح

Corrective Action: Action taken to eliminate the causeof a detected non-

conformity or otherundesirable situation.*

�لتصر¤ �لمتخذ إل}�لة •�لسبب فى �لمخالفا] �� عد�

�لمطابقة �� مو�قف �خر� غير مرغوبة.*

�جر�ء تصحيحى

Critical ControlPoints:

Those steps in a process or procedure that, without control, will lead to a poorquality outcome.

�لعملية �� إلجر�ء [�• خطو�لتى قد تؤ�� لى مخرجا] جو�� سيئة �� لم يتم �لتحكم

فيها.

نقا� �لتحكم �لحرجة |� �لرئيسية

Customer: Organization or person that receives aproduct.*

�لمنظمة �� لشخص �لذ� •يستقبل �لمنتج/ �لخدمة.*

�بو� /�لعميل

English Term English Definition Arabic Definition Arabic TermCalibration: The set of operations

which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding known values of a reference standard.

�لعمليا] �لتى تقو� بمقا�نة •�لعالقة بين �لقيم �لناتجة عن

�ستخد�� جها} ��لقيم �لمد�نة فى �لمعايير �لمرجعية

• �� مجموعة �لعمليا] �لتى تقو� بإنشاء �لعالقة بين �لقيم �� نظا� �� À لناتجة عن��لقيم �لمعر�فة � Áما�� قيا�لمماثلة للمعايير �لمرجعية.

معاير+

Capability: Ability of an organization, system or process to realize a product that fulfils the requirements for that product.*

• قد�� لمنظمة �� لنظا� Â��لعملية على �خر ��

�منتج مطابق لمتطلبا] هذ�لمنتج.*

مقد!+

Chief Executive Officer (CEO):

Chief Executive Officer.

�لمدير �لتنفيذ� • �لمدير �لتنفيذ�

Characteristic: Distinguishing feature.* �لصفا] �لمميز�.* • خصائص

Clinical Interface: The relationship between the producers and users of blood and blood components meeting required standards.

�لعالقة بين منتجى � •مستخدمى �لد� �� مشتقاته

�لمطابقة للمقاييس �لمطلوبة .

�لو�جهة �لسريرية/ �إلكلينيكية

Compliance: Meeting requiredstandards.

• مو�فقة/ مطابقة/ تحقيق �لمعايير �لمطلوبة.

�اللتز�#

Concession: Authorization to use or release a product that does not conform to specifiedrequirements.*

�لصالحيا] �لممنوحة) ) •�لمو�فقة �ستثنائيًا على

�إلفر�Â عن �� ستخدمنتج ال يطابق �لمتطلبا]

�لمنتج.* ��لخاصة بهذ

��تنا

Conformity: Fulfillment of arequirement.*

• مطابقة �لمعايير�لمرجعية.

• ��تحقيق متطلب من متطلبا] �لجو��.*

مطابقة


English Term English Definition Arabic Definition Arabic TermDocumentation: All the written

instructions, records and actions involved in providing a product or service information and its support medium.*

• جميع �لتعليما] �لمد�نة �لسجال] ��ألنشطة �لمتعلقة �

بتوفير �لمنتج �� معلوما] عن �لخدمة.*

�لتوثيق / �لتسجيل

Document Control: Formal control of the issue, use and review of authorized documents within the quality system.

��لتحكم �لرسمى فى �صد •��ستخد�� مر�جعة �لوثائق

�لمعتمد� ��خل نظا� جو��.

�لتحكم فى �لوثائق / �لسجال<

Effectiveness: Measure of the extent to which planned activities are realized and planned results achieved.*

• قياÁ مد� تحقيق �ألنشطة �لنتائج �لمخطط لها Ãلبلو�

مسبقا.*

فعالية

Efficiency: Relationship between the result achieved and the resources used.*

��لعالقة بين �لمو •�لمستخدمة � �لنتائج �لتى

تمت.*

كفاء+

External Quality Aِssessment Schemes(EQAS):

External qualityassessment scheme.

• منهج تقييم �آل��ء �لمعملى باستخد�� عينا] معر�فة/

معلومة � لكن � نتائج سرية �مقا�نتها بنتائج �لمعامل

�ألخر�.

منهج تقييم �لجو�+ �لخا!جى

Error: An incident where the quality system hasfailed.

�لناتج عن فشل Äلحا�� •نظا� �لجو��.

خطأ

Evaluation: The specific selection process to determine the suitability of a procedure or material (e.g. reagent,bloodpack, equipment).

• عملية �ختيا� محد�� يقو� على �ساسها تحديد مالئمة

�إلجر�ء �� لما��.

تقييم/ تقدير

Fitness for Purpose: Suitability of a product or service for the purpose for which it is intended.

• مالءمة �لمنتج/ �لخدمة للغر� �لمقصو� منه.

�لمالءمة للغر�/ للهد�

Good Laboratory Practice (GLP):

Good laboratory practice.

�لمما�سة �لمعملية �لجيد�. • �لمما!سة �لمعملية �لجيد+

Good Manufacturing Practice (GMP):


• مما�سة �لتصنيع �لجيد. مما!سة �لتصنيع �لجيد

English Term English Definition Arabic Definition Arabic TermCustomer Dissatisfaction:

Customer’s opinion of the degree to which a transaction has failed to meet the customer’s needs and expectations.*

�لزبو�/ �لعميل عن �� •مد� فشل عملية/معاملة ما فى مطابقة �حتياجاته �توقعاته.*

عد# !ضاء �لعميل

Customer Satisfaction:

Customer’s opinion of the degree to which a transaction has met the customer’s needs and expectations.*

�لزبو�/ �لعميل عن �� •مد� نجاÅ عملية/ معاملة ما

فى مطابقة �حتياجاته �توقعاته.*

!ضاء �لعميل

Defect: Non-fulfillment of a requirement related to an intended or specified use.*

• فشل �لمنتج ��لعملية / �إلجر�ء لمطابقة �لمو�صفا]

�لمطلوبة.�لفشل في تحقيق �حد �� -

��لمتطلبا] �لمتعلقة باالستخد�لمقصو� �� لمحد�.*

خلل/ عيب

Deming Cycle: The Plan-Do-Check-Act Cycle

�ئر� خطط← �فعل← قيم � •← عد².

��ئر+ �يمنج

Dependability: Collective term used to describe the availability performance and its influencing factors: reliability performance, maintainability performance and maintenance support performance.*

• مصطلح عا� يستخد� � Åلمتا�لوصف �آل��ء

�لعو�مل �لمؤثر� فيه من حيث �إلستمر��ية �مد� �إلعتما�

عليه.*

�العتما�ية

Design andDevelopment:

Set of processes that transforms requirements into specified characteristics and into the specification of the product realizationprocess.*

• مجموعة من �لعمليا] �لتى تحو² �لمتطلبا] �لى

خصائص محد�� *.Âإلنتا��مو�صفا] لعملية

�لتصميم � �لتطوير

Deviation Permit: Authorization to depart from the originally specified requirements of a product prior to realization, for a limited quantity of product or period of time, and for a specific use.*

�جا}� �إلنحر�¤ عن •�لمو�صفا] �لقياسية للمنتج �لعملية لفتر� محد��

لغر� معين.*

�جا�+ �إلنحر��


English Term English Definition Arabic Definition Arabic TermInternational Organization for Standardization (ISO):

International Organization for Standardization.

�لمنظمة �لعالمية لتوحيد � •�لجو��.* Áقيا

�لمنظمة �لعالمية لتوحيد +��قيا� �لجو

Maintenance: Includes preventative maintenance, normal repairs, replacement of parts and structural components, and other activities needed to preserve the asset so that it continues to provide acceptable services and achieves its expected life.

• تحتو� على �لصيانة �لوقائية، �لتصليحا] �لمعتا��، �فتغيير }�ء �مكونا] هيكلية

Èخر� للحفا�� نشطة على �لممتلكا] من �جل

�إلستمر�� في تقديم �لخدما] �لجها} ��لمرجو� ��ستمر

في �لعمل لحين �نتهاء عمر¸ �الفتر�ضي.

�لصيانة

Management: Coordinated activities to direct and control an organization.*

• نشاطا] متكاملة للتوجيه �لتحكم فى �لمنظمة / �

�لمنشأ�.*

+!��إل

Management System:

System to establish policy and objectives and to achieve those objectives.

¤�• نظا� لبناء سياسة ��هد .¤��لعمل لتحقيق هذ¸ �الهد�

+!��نظا# �إل

Measurement: Set of operations having the object of determining the valueof a quantity.*

• مجموعة من �لعمليا] تهد¤ �لى تحديد قيمة كمية

ما.*

�لقيا�

MeasurementProcess:

Set of interrelated resources, activities, and influences relatedto a measurement.*

��• مجموعة من �لمو [��لنشاطا] ��لمؤثر�

*.Áلمتعلقة بالقيا��لمتد�خلة

عملية �لقيا�

Monitoring: The (ongoing/ continual) collection and analysis of dataabout an activity.

�لتجميع ��لتحليل �لمستمر •للبيانا] �لمتعلقة بنشاÊ ما.

مر�قبة / متابعة

Non-compliance: Not meeting required standards (GMP). See also Non-conformity.

�لفشل فى �لوصو² للمقاييس •�لمطلوبة.(�فقا لمما�سة

�لتصنيع �لجيد)

عد# �اللتز�#

Non-conformity: Non-fulfillment of a requirement.*

.Ëلمطلو�• عد� �نجا} - �� عد� تحقيق متطلب من

متطلبا] �لجو��.*

عد# مطابقة

Objective Evidence: Data supporting the existence or verity of something.*

• بيانا] تساند �جو� �� حقيقة شىء.*

�لدليل �لملمو�

English Term English Definition Arabic Definition Arabic TermGood Laboratory Practice (GLP):


�لمما�سة �لمعملية �لجيد�. • �لمما!سة �لمعملية �لجيد+

Good Manufacturing Practice (GMP):


• مما�سة �لتصنيع �لجيد. مما!سة �لتصنيع �لجيد

Guidelines: Document stating recommendations or suggestions.*

• �ثائق تحد� �لتوصيا] �لمقترحا].*�

>��مسا!�< عمل / �!شا

Hemovigilance: The monitoring, reporting and investigating of adverse incidents/near misses related to all blood transfusion activities.

• مر�قبة ��إلبالÃ عن Ä��لتحقيق في �لحو�

�لوشيكة Ä��لعكسية �� لحو�لمتعلقة بجميع نشاطا] نقل

�لد�.

مر�قبة �ستخد�ما< �لد#

Indicator: Information gathered directly or indirectly at the critical control points in a process orprocedure.

�لمعلوما] �لمجمعة بطريق • Êمباشر �� غيرمباشرعن نقا

�لتحكم �لحرجة لعملية �� جر�ء.

مؤشر

Infrastructure: System of permanent facilities and equipmentof an organization.*

• مجموعة/منظومة من �لمنشئا]/�لمر�فق ��الجهز�

�لمستديمة �لخاصة بالمنظمة.*

�لبنية �لتحتية/ �ألساسية

Evaluation: The specific selection process to determine the suitability of a procedure or material (e.g. reagent,bloodpack, equipment).

• عملية �ختيا� محد�� يقو� على �ساسها تحديد مالئمة

�إلجر�ء �� لما��.

تقييم/ تقدير

Inspection: Conformity evaluation by observation and judgment accompanied, as appropriate by measurement, testing orgauging.*

• تقييم مطابقة �لمنتج �لخدمة عن طريق ��

�لمالحظة ��لتحكيم بمصاحبة �إلختبا� �� لمعيا� �� Áلقيا�

�لمناسب.*

فحص

Interested Party: Person or group having an interest in the performance or successof an organization.*

�لشخص �� لمجموعة • Åء �� نجا��لمعنية/ �لمهتمة بآ�

�لمنظمة.*

�لطر� �لمستفيد/ �لمعنى

Internal Quality Assessment (IQA):

The assessment of a laboratory’s overall quality system by the process of halving a sample, analyzing each half in the same manner and comparing the results.

• تقييم نظا� �لجو�� لشاملة بالمعمل عن طريق �خذ عينة

�تقسيمها �لى نصفين ثم �لقيا� بتحليل كل نصف على حد� بنفس �ألسلوË �مقا�نة

�لنتائج.

تقييم �لجو�+ �لد�خلى


English Term English Definition Arabic Definition Arabic TermQuality: Ability of a set of

inherent characteristics of a product, system or process to fulfill requirements of customers and other interested parties.*

• مقد�� مجموعة من �لصفا] �لمتد�خلة للمنتج �� للنظا�

�� للعملية لتحقيق متطلبا] �لعميل �� جهة معنية

�خر�.*

+�جو

Quality Assessment Schemes (QAS):

Quality assessment scheme.

• نظا� تقييم �لجو�� +�نظا# تقييم �لجو

Qualification: Combination of personal attributes, minimum education, training, work and audit experience, and competencies possessed by an auditor.*

• خليط من: �لصفا] �لشخصية ،��لحد �أل�نى من �لتعليم، ��لتد�يب، ��لخبر� �لعملية، �خبر� �لمر�جعة،

�لتى [�باالضافة �لى �لكفاءيمتلكها �لمر�جع.*

�لمؤهال<

Quality Assurance(QA):

Part of quality management focused on providing confidence that quality requirements arefulfilled.*

�لجو�� تركز ��• جزء من ��على توفير �لثقة بأ� متطلبا]

�لجو�� قد تم تحقيقها. �فقا للمو�صفة �لعالمية للجو�� Âإلنتا��لك فى مر�حل

�لمختلفة.*

توكيد �لجو�+/ تأكيد

QualityCharacteristic:

Inherent characteristic of a product, process or system derived fromrequirement.*

• صفا] �ساسية فى �لمنتج �� لعملية �� لنظا� مستمد من

�لطلب/ �لحاجة.*

+�خصائص �لجو

Quality Control(QC):

Part of quality management focused on fulfilling qualityrequirements.*

�لجو�� • جزءمن ��تركز على تحقيق متطلبا]

�لجو�� تتم فى Àخر مر�حل *.Âإلنتا�

+��لتحكم فى �لجو

Quality Department: The department identified and authorized within an organization that is responsible for the overall development, organization and management of quality and quality systems.

�لقسم �لمتعا�¤ عليه •�لمسئو² عن �لتطو� �لكلى �

�إل�� تنظيم �لجو�� نظم �لجو��.

�لقسم �لمعين � �� •�لصالحية/�لسلطة ��خل

�لمنظمة، �لمسئو² عن تطوير �لجو�� نظم ��تنظيم ��

�لجو��.

+�قسم �لجو

English Term English Definition Arabic Definition Arabic TermOrganization: Group of people and

facilities with an orderly arrangement of responsibilities, authorities and relationships.*

Íألشخا�• مجموعة من �لمر�فق لهم ترتيب منظم �

للمسؤ�ليا] ��لسلطا]/ �لصالحيا] ��لعالقا].*

منظمة / مؤسسة

Organizational Structure:

Orderly arrangement of responsibilities, authorities and relationships between people.*

• ترتيب منظم من �لمسؤليا] �لسلطا] ��لعالقا] فيما بين �

*.Áلنا�

�لهيكل �لتنظيمي

Policy: A high-level overall document embracing the goals and intentionsof the organization.

• �ثيقة على مستو� عالى من ¤��إل�� تحتو� على �هد

�مقاصد عامة للمنظمة.

سياسة

Precision: Reproducibility of the quantifiable outcomes of processes andprocedures.

• تكر�� نتائج �لعمليا] .Áلقابلة للقيا� [��إلجر�ء�

�لدقة

Preventive Action: Action taken to eliminate the causeof a potential non- conformity or other potentially undesirablesituation.*

• �جر�ء يتخذ للحد من سبب عد� �لتطابق �لمحتمل ��

Ëموقف محتمل غير مرغوفيه.*

�جر�ء مانع / �جر�ء �قائى

Procedure: Specified way to carry out an activity or aprocess.*

• طريقة محد�� للقيا� بعملية �� نشاÊ ما.*

�جر�ء

Process: System of activities which uses resources to transform inputs intooutputs.*

• مجموعة من �ألنشطة تستخد� �لمو�� لتحويلها من

مدخال] �لى مخرجا].*

عملية

Product: Result of a process.* • نتيجة �لعملية.* منتج/ناتج

Project: Unique process consisting of a set of coordinated and controlled activities with start and finish dates undertaken to achieve an objective conforming to specific requirements including the constraints of time, cost and resources. *

• عملية فريد� تتكو� من مجموعة من �ألنشطة �لمنظمة

�لمحكمة �] تا�يخ بد�ية ��تا�يخ نهاية يتم �جر�ئها

لتحقيق هد¤ مو�فق لمتطلبا] معينة تتضمن حد�� لوقت

*.��لتكاليف ��لمو�

مشر�


English Term English Definition Arabic Definition Arabic TermQuality Objective: Something sought, or

aimed for, related to quality.*

• شيء يبحث عنه �يهد¤ �ليه، متعلق بالجو��.*

+��ليل/هد� �لجو

Quality Officer: An individual who works within the quality department of an organization and who is primarily concerned with the day-to-day operation and maintenance of the quality system.

�لشخص �لذ� يعمل بد�خل •قسم �لجو�� فى �لمنظمة

�لذ� يكو� �هتمامه �ألساسى ��لتطبيق ��لصيانة �ليومية

لنظا� �لجو��.

+�ممثل �لجو

Quality Plan: Document specifying the Quality Management System (QMS) elements and the resources to be applied in a specific case.*

• �ثيقة تحد� عناصر �لجو�� مو�� نظا� ��للتطبيق على حالة معينة.*

+�خطة �لجو

Quality Planning: Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives.*

�لجو�� يركز ��• جزء من ��على تحديد �هد�¤ للجو�� تحديد �لعمليا] ��لمو

�لضر��ية لتحقيق هذ¸ *.¤��ألهد

+�تخطيط �لجو

Quality Policy: Overall intentions and direction of an organization related to quality as expressed by top management.*

�لنو�يا ��لتوجيها] �لعامة •للمنظمة �لمتعلقة بالجو��

�لعليا.* ��لمحد�� من �إل��

+�سياسة �لجو

Quality Requirement:

Requirement for inherent characteristics of a product, process or system.*

• متطلبا] من �جل خصائص مال}مة للمنتج �� للعملية ��

للنظا�.*

+�متطلبا< �لجو

Quality System: Organizational structure, procedures, processes, and resources needed to implement quality requirements.

،��لهيكل �إل� •�لعمليا] � [��إلجر�ء�

�لضر��ية من �جل ��لمو�تحقيق متطلبا] �لجو��.

+�نظا# �لجو

English Term English Definition Arabic Definition Arabic TermQuality Evaluation: Systematic examination

of the extent to which an entity is capable of fulfilling specified requirements.Progression in the principles of a quality system from inspection, QC, quality assurance, TotalQuality Management.

• �ختبا� منظم لمد� قد�� حد�/جهة ما على تحقيق

متطلبا] محد��.

�لتقد� فى �ساسيا] نظا� ��•�لجو�� من فحص �تحكم

�تأكيد �� جو��.

+�تقييم �لجو

Quality Improvement (QI):

Part of quality management focused on increasing effectiveness and efficiency.*

�لجو�� يركز ��• جزء من ��على }يا�� لفعالية ��لكفاء�

*.��بأستمر

+�تحسين �لجو

Quality Loop or Quality Spiral:

Conceptual model of interacting activities that influence quality at the various stages from identification of the needs to the assessment of satisfaction.

• نموÂ تصو�� من �لنشاطا] �لمتد�خلة لها

تأثيرعلى �لجو�� فى مر�حل مختلفة تتر��Å من تحديد�إلحتياجا] �لى تقييم

��ضاء �لعميل.

+��ئر+ �لجو

Quality Management:

Coordinated activities to direct and control an organization with regard to quality.*

• �نشطة متكاملة لتوجيه �لتحكم في �لمنظمة من جهة �

�لجو��.*

+��!+ �لجو�

Quality ManagementSystem (QMS):

System to establish a quality policy and quality objectives and to achieve thoseobjectives.*

• نظا� إلنشاء سياسة جو�� ئإنشاء �هد�¤ للجو�� لعمل

*. ¤�لتحقيق هذ¸ �ألهد

+�نظا# ��!+ �لجو

Quality Manager: The appointed, responsible and authorized individual within an organization with the responsibility for developing and managing the quality system.

�لشخص �لمعين �لمسئو² •�لذ� يمتلك صالحية ��خل

�لمنظمة ��لذ� يقع على عاتقه تطوير �� نظا� �لجو��.

+�مدير �لجو

Quality Manual: Document specifying the Quality Management System (QMS) of an organization.*

��• �ثيقة تحد� نظا� �لجو�� لمؤسسة ما.*

+��ليل �لجو


English Term English Definition Arabic Definition Arabic TermSoftware: Intellectual product

consisting of information on a support medium.*

• منتج فكر� يتكو� من معلوما] على �سط حامل. منتج فكر� يتكو� من �سط

حامل للمعلوما].*

برمجيا<

Specifications: Document stating requirements.*

• �ثيقة تحد� �لمتطلبا].* مو�صفا<

Standard Operating Procedure (SOP):

Written instructions for the performance of a specific procedure.

• خطو�] موثقة ألجل �لقيا� بعملية محد��.

Åتعليما] مكتوبة تشر �� •طريقة �لقيا� بإجر�ء محد�.

طر� �لعمل �لقياسية

Standard: Minimum level required.

�لمستو� �أل�نى من •.Ëلمطلو�

معيا!/مقيا�

Supplier: Organization or person that provides a product.*

�لمنظمة �� لشخص �لذ� •يقد�/يوفر منتج ما.*

�لمو!�/ �لممو�

System: Set of interrelated or interacting elements.*

• مجموعة من �لعناصر �لمتد�خلة �� لمتفاعلة.*

نظا#

Technical Expert: Person who provides specific knowledge or expertise with respect to a particular subject field to be audited.*

• شخص � معرفة �� خبر� عن موضو� �� حقل معين

ستتم مر�جعته.*

�لخبير �لتقنى

Statistical Process Control (SPC):

The continuous monitoring and charting of a process while it is operating, to warn when the process is moving away from predetermined limits. Typically the upper and lower control limits will be three standard deviations away from the mean. All points outside the control limits should be investigated and corrected.

�لمتابعة ��لتخطيط �لبياني •�لمستمر لسير �لعملية،

للتحذير من �� نحر�¤ عن �لحد�� لمقر�� مسبقًا، يكو�

مقد�� بعد �لحد �ألعلى � �لحد �أل�نى عن �لمتوسط ثالثة �نحر�فا] معيا�ية. جميع �لخا�جة عن هذ¸ Êلنقا�

�لحد�� يجب �� يتم �لتحر� عنها �تصحيحها.

�لتحكم �إلحصائى للعملية

Test: Technical operation that consists of the determination of one or more characteristic of a given product, process or service according to a specified procedure.*

• عملية تقنية تتكو� من تحديد خاصية �� كثر من خصائص

منتج �� عملية �� خدمة ما تبعًا إلجر�ء محد�.*

�ختبا!

English Term English Definition Arabic Definition Arabic TermQuarantine: Non-authorization to

proceed to next stage of a process until specified standards/ conditions are met.

�النتقا² �لغير �سمى •للمرحلة �لتالية لحين �لوصو²

لمعايير معينة.• �� عد� �جو� �لصالحية/

�لسلطة لالنتقا² �لى �لمرحلة �لتالية من �لعملية لحين Êستيفاء مقاييس/شر��

محد��.• �� منع �النتقا² للمرحلة

�لتالية من �لعملية لحين تحقق معايير �� ظر�¤ معينة.

�لحجر

Record: Document stating results achieved or providing evidence of activities performed.*

• �ثيقة تبين �لنتائج �لمحققة �� توفر �ليل على �ألنشطة �لتي

تم �لقيا� بها.*

سجل

Recruitment: The process of educating, motivating and selecting prospective blood donors.

�لعملية �لتى يتم عن طريقها •تعليم �تحفيز �جذË متبرعي

�لد� �لمحتملين.

�ستقطا§ �تحفيز �لمتبر

Release: Authorization to proceed to next stage of a process.*

• صالحية �النتقا² للمرحلة �لتالية لعملية ما.*

�فر�¨

Requirement: Need or expectation that is stated, customarily implied or obligatory.*

• حتياÂ �� توقع معين للمنظمة، يكو� متعا�¤ عليه

ضمنيًا �� يكو� �جبا��.*

متطلبا<

Responsible Person: An individual formally designated as being responsible for the quality of defined operations or outcomes within an organization.

• شخص مكلف �سميا ليكو� مسئوًال عن جو�� عمليا]

محد�� نتائج معينة بد�خل �لمؤسسة.

�لشخص �لمسؤ�

Review: Activity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of the subject matter to achieve established objectives.*

• نشاÊ يتم �لقيا� به لضما� مالئمة �كفاية �فعالية �كفاء� Ãلمتاحة من �جل بلو��لما��

�لموضوعة.* ¤��ألهد

مر�جعة

Service: Intangible product that is the result of at least one activity performed at the interface between the supplier and customer.*

• منتج غير ملموÁ يكو� �حد على �ألقل � Êحصيلة نشايتم عند �لو�جهة �لمشتركة بين

�لمو�� لعميل.*

خدمة

National Standards for Blood Transfusion Services, 1st Edition 72

English Term English Definition Arabic Definition Arabic TermTop Management: Person or group of

people who direct and control an organization at the highest level.*

• شخص �� مجموعة من �ألشخاÍ تقو� بإ��/ توجيه

�لتحكم فى �لمنظمة على ��على مستو�.*

�إل��!+ �لعليا

Traceability: Ability to trace the history, application or location of that which is under consideration.*

• �مكانية تتبع تا�يخ �� ستخد�� مكا� �� شىء

تحت �إلعتبا�.*

�قتفاء �ألثر

Validation: Confirmation and provision of objective evidence that the requirements for a specific intended use or application have been fulfilled.*

• جزء من نظا� توكيد �لجو�� يحث على �لتقييم

�لعمل [��لمبكرلخطولتحضير منتج معين من �جل

تأكيد فاعليته �ثقته.• �� توكيد �توفير �ليل

ملموÁ على تحقق �لمتطلبا] �لمقصو� ��لال}مة لإلستخد�لمحد� للمنتج �� لعملية. �

(�فقا لمو�صفة مما�سة �لتصنيع �لجيد)*

�قر�!/تقرير�لصالحية

Work Environment: Set of conditions under which a person operates.*Set of conditions under which a person operates.*

• مجموعة من �لظر�¤ يعمل �لشخص تحت �طئها.*• �� مجموعة �لظر�¤

�لمحيطة بالشخص ��لتي تؤثر عليه �ثناء ��ئه للعمل.*

بيئة �لعمل

* ISO 9000 : 2000 0002 : 0009 +�* �فقًا للمو�صفا< �لعالمية للجو