Egyptian National Blood Standards 2nd Edit. 2011

Egyptian National BloodTransfusion Standards

Ministry of Health

Second Edition

Egypt - 2011

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IInnttrroodduuccttiioonnThe senior management team of NBTS is an umbrella committee whose primary role is tooversee the creation, development and revision of all Egyptian National standards to ensureharmonization and consistency in Egyptian National standards-setting activities.

The QMS develops and reviews quality standards and guidance to ensure that all qualitymanagement concepts in corporate a consistent message.

The Egyptian National Blood Transfusion Services developed this 2nd edition of Standardsfor Blood Transfusion Services used an evidence-based decision making process, whenpossible, to modify existing requirements or create new specific requirements.

These Standards are based on input from a variety of sources, including GMP guidelines,standards of AABB, standards of practice for blood transfusion in South Africa as well ascomments from heads of departments, Regional Blood Transfusion Centers Directors & thestaff working in NBTS and recognized experts in blood transfusion medicine.

With this edition, the quality management system remains the frame work of the publication,resulting in the 11 chapter headings representing the Quality System Essentials of theNational Blood Transfusion Services, which were first identified.

The guiding principle of this document is to be consistent with available scientificinformation while focusing on patient advocacy and optimal care for donors who provideblood and components.

We are trying to make the requirements simple, clear and practical. The use of theseStandards should aid materially in developing and maintaining policies, processes andprocedures that will provide safe and effective transfusion, as well as a safe work environmentfor blood bank and transfusion service personnel.

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Contributors:

Dr. Faten MoftahGeneral Director of the NBTSThe Egyptian head of task group TAPDr. Sabah RasmyDeputy of the General Director ofNBTC & the National Laboratory Manager

Dr. Afaf AhmedNational Quality ManagerHead of Quality Department, NBTC

General Engineer Mohamed LabibNational IT ManagerHead of IT Department, NBTCDr. Hiedi GobranNational Procurement ManagerHead of Serology Department, NBTCDr. Wessam Gad El HakHead of Issuing Department, NBTCDr. Mohamed NabeelDonor Care Department, NBTC

Dr. Alan KitchenHead of the Microbiology Lab of NBS in NorthLondon & the External Expert of TAP projectMrs Jenny WhiteDeputy Scheme Manager UKNEQAS for Blood TransfusionLaboratory Practice Watford, UKDr. Nehad Mohamed MahmoudNational Blood Donor Recruitment & collectionManagerHead of the Donor Care Department, NBTCDr. Tarek MetwalyTechnical Advisor of ACUBHead of RCRL, NBTCDr. Lamiaa YehiaHead of Component Department, NBTC

Dr. Ahmed Abd El-AziemHead of the Therapeutic Unit, NBTCDr. Mohamed FaroukSerology Department, NBTC

Dr. Mahmoud SalehDirector of Tanta RBTC

Dr. Mervat DossACUB, NBTC

Dr. Fatma El- AnsaryDirector of Alexandria RBTC

Dr. Nadia AytaDirector of Mansoura RBTC

Dr. Rania IsmailHead of Issuing Department, AlexandriaRBTC

Dr. Magda MohmedHead of component Department, Tanta RBTC

Dr. Rasha KhalifaQO of Mansoura RBTC

Eng. Hanan AbadyIT Department, NBTC

Quality Management Task Group:

Dr. Heba Abu Bakr NasrQuality Department, NBTC

Dr. Shereen ShabayakQuality Department, NBTC

Dr. Belal Mohamed MohamedQuality Department, NBTC

Dr. Mohamed MagdyQuality Department, NBTC

Dr. Amal ZakariaQuality Department, NBTC

Dr. Enas FathyQuality Department, NBTC

Dr. Dalia RifaieQuality Department, NBTC

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Description Page No.

Definitions 1

Section I: Organization of Blood Transfusion Services 6

Section II: Quality Management System 10

Section III: Blood Collection 16

Section IV: Blood Component Processing 21

Section V: Testing for Red Cell Serology and TTIs 26

Section VI: Issuing and Compatibility Testing 30

Section VII: Documents and Records 41

Section VIII: Human Resources 46

Section IX: Purchasing & Incoming Receipt, Inspection andTesting

48

Section X: Safety Health and Environment 50

Section XI: Information Technology 52

Annex I: Egyptian National Donor Selection Criteria 56

Annex II: Egyptian National Processing Specifications 63

Annex III: Blood components suitable for use in intrauterine andexchange transfusion and neonates and infants underone year, specific requirements

67

Annex IV: Volumes &Weights Specifications for Whole BloodProcessing

68

Annex V: Adverse Transfusion Reactions 69

Abbreviations 74

Glossary of QMP Terms 76

National Standards for Blood Transfusion Services, 2nd Edition 1

DDeeffiinniittiioonnss Allogeneic Donation: Blood collected from an individual and placed in the general

blood supply for the purpose of transfusion to another person.

Antibody Screen: Serological test by which donor serum/plasma is tested with reagentred cells of known antigenic profile to determine if unexpected clinically significantantibodies are present. "Clinically Significant" refers to antibodies that may causeadverse reactions in the recipient due to incompatibility.

Aphaeresis: means removal of one component of blood and the return of the remainingcomponents to the donor.

Autologus Donation: Blood collected from an individual for the purpose of transfusionback to the same individual.

Blood: Whole blood collected from a single donor and processed either for transfusionor further manufacturing. The term is often used to describe blood components ingeneral.

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

Blood Donation: means the act of withdrawing blood or plasma from a blood donor andmay also refer to the unit of blood so collected.

Blood Donor: means any living, voluntary, non-remunerated person from whom Bloodis withdrawn for the subsequent administrating thereof to another living person or tohimself or for the processing into blood products.

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

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

Compatibility test: means a procedure whereby a donor blood component is tested toensure serological compatibility with the intended recipient.

Contract Facility: Organization performing work associated with the manufacturingprocess for the manufacturer.

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


Crossmatch: means a procedure whereby the donor red blood cells are directly mixedwith the recipient serum to detect ABO and/or other red cell antigen compatibility.

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

Document: means all written instructions and records involved in providing a productor service.

Document Control: means the control of the issue, use and review of authorizeddocuments within the quality management system.

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

Firewall: It’s a security software or hardware used to protect the network. It is a part ofa network that is designed to block unauthorized access to a user’s PC or a privatenetwork, while permitting authorized communications.

General Director: means the general director appointed by undersecretary of statespecialized medical centers as the director ultimately responsible for the overalleffective functioning of the blood service.

Good laboratory Practices (GLP): means ensuring that laboratory functions arecarried out in accordance with regulatory requirements and may include planning,performance, recording and reporting of laboratory functions.

Good Manufacturing Practices (GMP): means ensuring that products are consistentlyproduced and controlled in accordance with appropriate standards and regulatoryrequirements.

Hemoglobin: means the constituent of red blood cells responsible for the oxygencarrying capacity.

Hematocrit: means the proportion of red blood cells in the blood.

Hardware: A computer system consists of a group of physical components known ashardware, such as monitor, hard disk, etc. upon which operating system can be installedand other software desired by the user. All physical components of a computer systemreceive instructions from the software to perform the functions required by the user.

Integration testing: In software development integration testing is done gradually.First test the coordination between the root module and a subordinate module. Whenthis test succeeds, add one or two subordinate modules, and so on till the entire programis tested.


Leukapherasis: Separation of leucocytes by removing whole blood from the donor,separating the leukocytes, and returning the formed elements and plasma back to thedonor.

Leukoreduced Components: component units that have been treated by centrifugation,filtration or other methods to reduce the amount of leukocytes per unit to a level below astandard acceptable value.

Local Area Network (LAN): It is a computer network covering a small physical areasuch as home, office, a group of small buildings such as school.

Log off: This is a security measure, where the user closes his/her access to a computersystem when they finish their work, or move away from their workstation. This actionis very useful on computer systems with multiuser to protect each user data. In order tolog off, the user should have previously logged into the system with their username andpassword.

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

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

Medical Director: means the director qualified by training and/or experience in bloodtransfusion and related disciplines, who has the responsibility and authority for allmedical and technical policies and procedures and for all support services which relateto the safety of donors and the recipients of blood products.

NBTS: “National Blood Transfusion Service” means the national blood transfusionservice establishment licensed in terms of the regulations to withdraw blood from blooddonors, to process blood into blood components to health care professionals foradministration to patients; the national fractionation establishment and other approvedinstitutions.

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

Operating System: It is system software installed on the computer that manages howdifferent programs use the hardware. It also regulates how the user interacts with thecomputer system.

Peripherals: These are auxiliary devices distinct from a computer's central processingunit and working memory, and often connected externally. They are connected to thecomputer for input (keyboard, mouse, scanner, etc.), output (printer, loudspeakers,monitor, etc.) communication (NIC, modem), storage (floppy drive, CD drive) andothers.


Plasma: The fluid portion of whole blood collected, stabilized against clotting andseparated from the red blood cells.

Plasmapheresis: Separation of plasma from whole blood and the continuous orintermittent return of red blood cells and formed elements to the donor. Plasma collectedby Plasmapheresis may be used either as source plasma or further manufacturing orfresh frozen plasma for transfusion.

Plateletpheresis: Separation of platelets from whole blood and the continuous orintermittent return of red blood cells, with or without platelet-reduced plasma, to thedonor. If plasma is collected as a final product during Plateletpheresis, the regulationsfor Plasmapheresis apply.

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

Prototype: One approach of software development applies this concept for userdemonstration. It is the process where system requirements are converted to a workingsystem that is continually revised with the user. Any modifications or additions madeby the user are made during this stage.

Quality Assurance (QA): Part of quality management focused on providing confidencethat quality requirements are fulfilled ─ ISO9000 (2000).

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

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

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

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

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

Regulations: means the regulations relating to blood and blood products.

Router: It is a network device that determines the next network point to which a packetshould be forwarded toward its destination. It connects two separate networks.

Sample: means a small quantity of blood taken from a blood donor, donation or apatient for testing purposes.

Serum: The liquid portion of clotted blood.


Sharing peripherals: Organizations with a LAN connecting a group of users, it ispossible to share peripheral devices as printers. For example, network printer can beused by any PC connected to the LAN.

Software: It is a set of instructions written by one of the programming languages thatinstruct the hardware to perform certain tasks. Software is classified into manycategories: operating systems, system programs, database management systems,applications and others.

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

Standard: Minimum level required.

Standard Operating Procedure (SOP): Written instructions for the performance of aspecific procedure.

Switch: It is a computer network device that joins multiple devices within one LANtogether.

System testing: Last step of software development is bringing together all of theprograms that make up the system for testing purpose.

Unit testing: In software development each module is tested separately to find out anyerror in the code.

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

Withdrawal of blood: means the taking of a blood sample or donation.

Organization of Blood Transfusion Services


Section I

Organization of Blood TransfusionServices



1.1 Structure of the Blood Transfusion Services

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

1.1.2 The Blood Transfusion services (BTS) must develop a well-defined structure thatclarifies the relationship and interactions between operations, support services andquality.

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

1.1.4 Job descriptions must be periodically reviewed and updated when necessary.

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

1.1.5.1 General Director (Head)1.1.5.2 National Laboratory Manager1.1.5.3 National Quality Manager1.1.5.4 National Blood Donor recruitment and Collection Manager1.1.5.5 National Head of the Information Technology1.1.5.6 Finance and Administration Manager1.1.5.7 Director of Regional Blood Transfusion Centers (RBTCs)

1.2 General Director

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

1.2.1.1 The overall strategy and development of the BTS.1.2.1.2 Providing adequate cost effective supply of blood to Egyptian Population.1.2.1.3 The overall performance and direction of the BTS.1.2.1.4 Ensuring adequate and sustainable funding for the BTS.1.2.1.5 Ensuring acceptance and compliance with the national quality standards.1.2.1.6 Ensuring compliance with applicable national laws and regulations.1.2.1.7 Advising the Advisory Body of the Ministry of Health (MoH) in all aspects

of transfusion activities in Egypt.1.2.1.8 Heading of NBTS team consisting of the director of finance and

administration, national technical manager and Director of RBTCs.

1.3 National Laboratory Manager

1.3.1 The National Laboratory Manager is responsible for:

1.3.1.1 Developing national testing strategy.1.3.1.2 Developing national processing strategy.1.3.1.3 Developing national issuing strategy.1.3.1.4 Defining a national plan for laboratory training.1.3.1.5 Defining specifications of laboratory equipment, consumables and disposables.



1.4 National Quality Manager

1.4.1 The National Quality Manager is responsible for:

1.4.1.1 Ensuring the proper management, development, implementation andmaintenance of the national quality system.

1.4.1.2 Ensuring NBTS meets the appropriate regulatory standards for all its activitiesand across all of its sites.

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

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

1.5 National Blood Donor Recruitment and Collection Manager

1.5.1 The National Head of Blood Donor Recruitment and Collection is responsible for:

1.5.1.1 Development and implementation of national donor recruitment and retentionstrategy and plans.

1.5.1.2 Ensuring donor recruitment strategies are in line with current knowledge anddevelopments in the areas of motivation and recruitment through applyingbasic research techniques. Strategies should be adapted to local culture andfacilities.

1.5.1.3 Establishing and maintaining a communication system that ensure effectiveliaison between the donor care department and other areas of operation.

1.6 National Head of Information Technology

1.6.1 The National Head of IT is responsible for:

1.6.1.1 The management of all IT staff in accordance with BTS guidelines.1.6.1.2 Ensuring close cooperation between platform and application engineers in

order to achieve the most effective use of staff resources.1.6.1.3 Preparation of the NBTS strategic plan through the NBTS management team.1.6.1.4 Leading an IT Council of Senior Managers to develop strategic IT planning

and to oversee major projects and operations.1.6.1.5 Maintaining an overall awareness of the business process and the use of IT.1.6.1.6 Ensuring a rapid and efficient escalation procedure to ensure major problems

are identified and managed effectively.1.6.1.7 Working in close cooperation with Key System Users to ensure that IT

solutions are meeting user needs.1.6.1.8 Ensuring that critical activities are carried out effectively in accordance with

good practice and are properly documented.1.6.1.9 Ensuring effective security of IT system through the implementation of robust

and regularly updated security protocols.

1.7 Finance and Administration Manager

1.7.1 The NBTS Director of Finance and Administration is responsible for:

1.7.1.1 The overall financial management of NBTS.1.7.1.2 Finance and administration planning of the NBTS.1.7.1.3 Preparing strategic, financial and administration plans in cooperation with the

NBTS management team.1.7.1.4 The overall financial control of the NBTS and follows governmental financial

management and accountability guidelines.



1.7.1.5 The provision of appropriate local support services to NBTS sites in:- Accounting- Purchasing and Contracting- Human resources management- Legal affairs- Marketing- Housekeeping- Stores- Engineering

1.8 Director of Regional Blood Transfusion Center

1.8.1 The RBTC Director is responsible for:

1.8.1.1 Day-to-day management of the BTS.1.8.1.2 Ensuring that the RBTS meets its quality and supply targets.1.8.1.3 Ensuring that financial transparency is maintained and that there is full costing

of all activities.1.8.1.4 Ensuring that the National QMS is supported fully across all sites.1.8.1.5 Chairing the national management team.1.8.1.6 Maintaining continuous communication with hospitals and other users within

the region.1.8.1.7 Coordination and cooperation with the local health authorities and relevant

external stakeholders.

Quality Management System


Section II




2.1 Quality System

2.1.1 The quality management system (QMS) must be defined, documented and maintained.

2.1.2 The National Quality Department shall be a distinct and independent BTS unit withinthe NBTS.

2.1.3 The National Quality Department must develop a national quality policy and plan thatmust be available to all staff and all staff must be able to understand the policy and itsimplication.

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

2.1.5 Operational policies, processes and procedures must be developed and implemented toensure that requirements of these standards are satisfied.

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

2.2 Management Review

2.2.1 Top management shall review the QMS at regular intervals to ensure continuedsuitability and effectiveness and taking into account outcomes of external bodies'assessments, internal audits, outcomes of the monitoring of component conformanceto specifications and feedback from donors, patients and physicians.

2.2.2 The management review must be recorded and records must be maintained.

2.3 Process Control2.3.1 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.

2.3.2 The Blood Transfusion Services should identify the processes that need statisticalanalysis for monitoring and control, using acceptable and appropriate statisticaltechniques, with documentation and maintained records.

2.3.3 The quality management system in place must ensure continuous cleaning,maintenance and calibration of equipment in collecting, processing and testing ofblood and blood components in accordance with documented Standard OperatingProcedures (SOPs) and time schedules. Cleaning, maintenance and calibration ofequipment must be recorded and records must be maintained.

2.3.4 The QMS must ensure appropriate handling and storage of materials used incollection, production and testing of blood and blood component (e.g. blood bags,reagents, labels etc.)

2.3.5 General Elements:

2.3.5.1 Control of Change The Quality management system must ensure appropriate planning, control,

approval, documentation and review of any changes that may affect thequality of products or service.

The blood transfusion service shall have a process to develop new processesand procedures or change existing ones.

This process shall include identification of specifications and verificationthat specifications have been met.



Prior to implementation, the new or changed processes and procedures shallbe validated.

The blood transfusion service shall ensure that the implementation of new orchanged processes and procedures are controlled.

2.3.5.2 Quality Control A program of quality control shall be established that is sufficientlycomprehensive to ensure that reagents, equipment and methods function asexpected.

Results shall be reviewed and corrective action taken, where appropriate.2.3.5.3 External Quality Assessment Scheme

Where applicable the Blood Transfusion Services shall have policies,processes and procedures to ensure that external assessment of operationsand quality systems are conducted and scheduled.

When this is not available, there shall be a system for determining theaccuracy and re liability of test results.

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

When corrective action is needed its development, implementation andevaluation shall be reviewed by the quality department and in the case ofserious events, by the Quality Manager together with other appropriatesenior management.

2.3.5.4 Use of Materials

All materials (including containers and solutions used for collection, preservation andstorage of blood and components and all reagents used for required tests on bloodsamples) shall be used in accordance with the manufacturer’s written instructions andshall meet specified requirements.

2.4 Product Status and Traceability

2.4.1 The Quality management system must ensure that the status of each donation and anyassociated blood products can be identified at all times.

2.4.2 hThe Blood transfusion services must maintain records showing the history of eachdonation from collection to the distribution to end user of all products prepared fromeach donation.

2.5 Internal Quality Audits

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

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

2.5.3 The assigned internal auditor must prepare reports about the audit outcomes includingnonconformance points, corrective actions needed, due dates and the personresponsible for each corrective action.

2.5.4 The reports must be reviewed and signed by head of the relevant department, auditor,head of quality and general director.



2.5.5 Follow up internal audits must be performed when necessary.

2.5.6 Management of Audit Results

2.5.6.1 The results of internal and external audit shall be reviewed by personnelhaving responsibility for the area being audited.

2.5.6.2 When corrective action is taken, it shall be developed, implemented andevaluated in accordance with process improvement through corrective andpreventive Action.

2.5.6.3 The results of internal and external audit and associated corrective andpreventive action shall be reviewed by the general director.

2.6 Process Improvement through Error Reporting System2.6.1 The blood transfusion services must develop, apply and implement policies, processes

and procedures for capturing, assessing, investigating and monitoring adverse events,events that deviate from accepted policies, processes and procedures, or event thatresult in the failure to meet the Blood Transfusion Service’s defined requirements;this include the discovery of nonconforming products, complaints and services, aswell as adverse reactions to blood donation and transfusion.

2.6.2 The blood transfusion services policies, processes and procedures must clearly definewhat is:

2.6.2.1 Corrective Action

The blood transfusion service shall have a process for corrective action that includes thefollowing elements:

Documentation of incident, error and accident reports; reports nonconformances and complaints.

Investigation of the cause of non conformances relating to blood,components, critical materials and services.

Investigation of customer complaints. Determination of the corrective action needed to eliminate the cause of nonconformances and incidents, errors and accidents.

Evaluation to ensure that corrective action is taken and that it is effective.

2.6.2.2 Preventive Action

The blood transfusion service shall have a process for preventive action that includes thefollowing elements:

The review of appropriate sources of information, including assessmentresults, external quality assessment scheme results, quality control recordsand complaints, to detect and analyze potential causes of non conformances.

Determination of steps needed to deal with potential problems requiringpreventive action.

Initiation of preventive action and application of controls to ensure that it iseffective.

2.7 Quality Monitoring

The blood transfusion service shall have a process to collect and evaluate quality indicatordata on a scheduled basis.



2.8 Equipment

2.8.1 Selection of EquipmentThe blood transfusion service shall have a process to define the selection criteria forequipment.

2.8.1.1 All equipment shall be qualified for its intended use.2.8.1.2 All devices and equipment shall be validated by the blood bank or transfusion

service.2.8.1.3 Unique Identification of Equipment.

Critical equipment shall have unique identification.2.8.1.4 Equipment maintenance and calibration:

The blood bank or transfusion service must have policies, processes andprocedures to ensure that calibration, maintenance and monitoring ofequipment conform to the standards required for each item of equipment.

Equipment used or intended to be used in whole blood (WB) collection,aphaeresis procedures and component production should be designed andmaintained to suit its intended purpose and shall not present any hazard todonors, products or operators.

All equipment must be maintained and calibrated on a regularly scheduledbasis according to established procedures and the needs of the equipment asdescribed in the standard operating procedures (SOPs) and/or equipmentmanual.

2.8.2 Monitoring of Critical Equipment

2.8.2.1 The blood bank or transfusion service shall identify the equipment that iscritical to the provision of blood and blood components.

2.8.2.2 The blood bank or transfusion service must have a process for scheduledmonitoring and maintenance of all critical equipment. The process shallinclude: frequency of checks, check methods, acceptance criteria and action tobe taken for unsatisfactory results.

2.8.2.3 Critical equipment must be calibrated and adjusted at the manufacturer’sprescribed intervals, as determined by the Blood Transfusion Services and afteractivities that may affect the calibration (e.g. servicing/maintenance).

2.8.3 Equipment MalfunctionsInvestigation and follow-up of equipment malfunctions or failures shall include:

2.8.3.1 Assessment of the conformance of blood and blood components whenequipment is found to be out of calibration.

2.8.3.2 Steps to ensure that the equipment is removed from service.2.8.3.3 Investigations of the malfunction.2.8.3.4 Steps for re-qualification of the equipment.2.8.3.5 Reporting the nature of malfunction or failure to the manufacturer, when

indicated.

2.8.4 Storage of Blood Components

2.8.4.1 Storage devices must have the capacity and design to ensure that the propertemperature is maintained.



2.8.4.2 There must be a process to monitor the temperature of refrigerators, freezersand platelet incubators continuously and to record the temperature at leastevery 4 hours.

2.8.5 Alarm SystemsStorage devices with alarms must conform to the following standards:

2.8.5.1 The alarm must be set to activate under conditions that will allow proper actionto be taken before blood and blood components reach unacceptable conditions.

2.8.5.2 Activation of the alarm must initiate a process for immediate investigation andappropriate corrective action.

2.8.6 Back up Power Supply

2.8.6.1 Equipment used for blood and blood components storage should be connectedto an emergency power supply to ensure a continuous power supply ismaintained.

2.8.6.2 Equipment used for processing and testing of donations should be connected toan emergency power supply that is sufficient for work currently in progress tobe completed and the equipment shut-down correctly. If significant periods ofpower loss are expected, a continuous power supply is needed to enable bloodto be processed and tested effectively and with no delays that may result in theunavailability of blood or products.

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

2.8.6.4 It is the responsibility of biomedical engineering department, users and qualitydepartment to determine for each item of equipment the frequency of thesechecks and its documentation.

2.8.6.5 The blood bank or transfusion service must have ‘emergency plan’ for storedblood components during down time.

Blood Collection


Section III

Blood Collection

Blood Collection


3.1 Donor Qualifications

3.1.1 All phases of the selection of the blood donor, collection, processing and transfusionof blood are the responsibility of a qualified, licensed physician.

3.1.2 This physician should have thorough knowledge of the problems of blood transfusionbased upon, training and experience.

3.1.3 Allogenic donors:

3.1.3.1 Blood is collected only from voluntary non remunerated blood donors.3.1.3.2 Prior to donation all donors must complete the donor questionnaire.3.1.3.3 Donor ID must be checked using their national ID card or any official ID card.3.1.3.4 Donors should be identified using their full name (till the 4th grand father), date

of birth and official ID number.3.1.3.5 Donor confidentiality should be maintained throughout the donation

procedure.3.1.3.6 The donor health check must be performed by an appropriately trained medical

officer and the donor must fulfill the national donor selection criteria (refer toannex I).

3.1.4 Plateletpheresis donors:

3.1.4.1 Must have given whole blood donation within the same institute.3.1.4.2 With the exception of the donation interval, the standards that apply to

allogeneic W.B donor qualification shall apply to the selection ofplateletpheresis donors.

3.1.4.3 No history of analgesic intake (5 days for Aspirin, 48 hours for NAID) prior tothe procedure.

3.1.4.4 Prominent anti-cubital veins.3.1.4.5 No serious complications during their last whole blood or plateletpheresis

donation.3.1.4.6 Complete blood count shall be done for every donor prior the donation

process.3.1.4.7 The interval between procedures for plateletpheresis donations shall be at least

3 days but not more than twice per week; and the total number ofplateletpheresis donations must not exceed 24 times per year.

3.1.4.8 The total amount of plasma taken from the donor shall not exceed 15 liters peryear.

3.1.4.9 The total amount taken from the donor shall not exceed 700 ml per procedure.

3.1.5 Autologous donors:

3.1.5.1 Autologous pre-deposit donations must be collected according to the samerequirements as allogeneic donations but the deferral criteria vary.

3.1.5.2 Deferral criteria.

The two main deferral criteria for donors of autologous pre-deposit donations are:

Serious cardiac disease (where the clinical setting of the blood collectionmust be taken into account).

Active bacterial infection.

3.1.5.3 These autologous donations must be labeled and clearly identified.

Blood Collection


3.1.5.4 Separate storage must be used securely to be segregated from allogeneicdonations at all stages from collection to issue avoid inappropriate issue.

3.1.6 All blood donors must be non-remunerated volunteer donors. These selectionguidelines have two purposes:

3.1.6.1 Firstly, to protect donors from any potential harm.3.1.6.2 Secondly, to protect recipients of blood transfusions from adverse effects, such

as transmission of infectious diseases.

3.2 Donor Consent

3.2.1 Informed consent:

3.2.1.1 Before each donation every donor must provide written consent.3.2.1.2 Written consent should cover the whole donation process including

information about risks of the procedure and tests performed. It should beavailable in the questionnaire.

3.2.1.3 The donor shall have an opportunity to provide or refuse consent.3.2.1.4 If consent is refused the pre-donation process must be stopped immediately.

3.3 Donor Notification of Abnormal Findings and Test Results

3.3.1 Post donation counseling system:

3.3.1.1 Is the responsibility of the Donor Care Department.3.3.1.2 Ensures that donor is notified appropriately about any abnormal test results.3.3.1.3 Ensures that the appropriate education, follow up based on second sampling

(except with NAT technique no need for second sample) and referral areprovided.

3.4 Donor Call - Up

3.4.1 The recall system is based on:

3.4.1.1 Phone call system.3.4.1.2 Automated and Manual (card) system record keeping.3.4.1.3 The recall system is responsible for building up a panel of regular voluntary

nonremunerated blood donors, aphaeresis blood donors and phenotyped donorswith rare blood groups.

3.4.1.4 Regular and lapsed donors recall.

3.5 Donor Care

3.5.1 The collection team ensures that donor qualification process is private andconfidential.

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

3.5.3 The collection team shall deal professionally with any donor adverse reactions andemergency medical care if necessary.

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

3.5.5 Presence of an effective and maintained donor retention strategy.

Blood Collection


3.6 Blood Collection

3.6.1 Blood bags must be:

3.6.1.1 Sterile and for single use only.3.6.1.2 Inspected before use for any visible abnormality or other problem.

3.6.2 The blood bag and sample tubes must be labeled with the unique donation numberprior to performing the venepuncture.

3.6.3 The collection team must ensure that no air enters the blood bag at any stage of thedonation process. The bag must be properly sealed at the end of the donation process(maintain closed system).

3.6.4 Staff involved in phlebotomy must be trained appropriately prior to practising.

3.6.5 Prior to venepuncture checks must be made to ensure that the identity of the donormatches the identification on the blood bag and associated documents and that thedonation number on the blood bag matches that on all samples tubes and any otherassociated documents.

3.6.6 The collection team must ensure that prior to venepuncture the site is properly cleanedusing a disinfectant swab.

3.6.7 If the venepuncture is initially unsuccessful, ask the donor for another attempt. If heagreed, no further attempts using the same needle are permitted. If the collectionprocess has started and the flow then stops, repositioning of the needle WITHOUTcomplete withdrawal is allowed. If the flow does not re-start, the collection processmust be stopped.

3.6.8 Samples shall be collected after completion of the donation process using vacuumtubes and in a way that would prevent external contamination of the donation.

3.6.9 The volume of blood collected shall be proportional to the amount of anticoagulantsolution in the primary blood pack (follow manufacturer instructions).

3.6.10 During collection, the staff shall ensure that there is continuous mixing of the bloodwith the anticoagulant through the whole process either using a shaker balance or bymanual mixing.

3.6.11 All donations main blood bag, sample tubes, donor register and the donorquestionnaire must be properly identified with the bar-coded donation number (ISBT128) and date of collection (except sample tubes without date).

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

3.6.13 Additional labels, e.g. antibody screening, phenotyping, should be added as necessary.

3.6.14 Inspection:

3.6.14.1 Prior to release from the blood collection session, the blood bag and itsassociated tubing must be re-inspected for defects.

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

3.7 Aphaeresis Collections

3.7.1 All equipment must be regularly maintained and calibrated. The operating softwareshould be kept up-to-date by the supplier.

Blood Collection


3.7.2 All operators must be well trained, competent and able to deal appropriately with anyproblems that might arise during the collection procedure.

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

3.7.4 A full blood count must be performed prior to every plateletpheresis procedure.

3.7.4.1 The platelet count must not be less than 150,000 /mm3.3.7.4.2 The hematocrit must not be less than 38%.3.7.4.3 The hematological profile must be checked carefully for any other

abnormalities.

3.7.5 We could collect plasma and packed red blood cells on the cell separators during thecollection of the single donor platelets.

3.8 Blood Storage during Mobile Sessions

3.8.1 All donations must be stored at the appropriate temperatures prior to processing at theBTC.

3.8.2 All donations and their associated samples must be transported and stored undertemperature controlled conditions, ensuring that, if ice packs are used, there is nodirect contact between the ice packs and the blood bags or the sample tubes.

3.8.3 Donations to be used for platelet production must be stored and transported attemperature not less than 20°C until processed.

3.8.4 Data loggers should be available to monitor temperature of all donations duringmobile sessions.

Blood Component Processing


Section IV




4.1 Starting Materials for Preparation

4.1.1 The source for processing may be:

4.1.1.1 Whole blood donations collected manually from individual donors.4.1.1.2 Aphaeresis donations.

4.1.2 Donations must not be processed if there is:

4.1.4.1 Any visible abnormality as haemolysis.4.1.4.2 Overweight, small volume.

4.1.3 Blood bag intended for collection of certain volume must maintain the ratio betweenblood and anticoagulant (10:1.4) according to the volume of anticoagulant in theprimary bag:

Whole blood volume:Weight of whole blood unit – Weight of empty bag containing anticoagulant

Density of component4.1.3.1 The ideal volume of whole blood unit with 70ml anticoagulant is 450 - 550ml.4.1.3.2 The ideal volume of whole blood unit with 63 ml anticoagulant is 405 - 495ml.4.1.3.3 If outside the normal range (refer to Annex II).

4.1.4 Whole blood is collected into primary bag intended to be processed according to thenumber and type of satellite bags attached.

If configurations of bags need to be changed:

4.1.4.1 Transfer bags with different capacities can be connected to the original bag set.4.1.4.2 It is preferable to connect the two bags by using a sterile docking device to

maintain close system.4.1.4.3 If sterile docking device is not available WB is processed in an open system

and must be maintained at temperature 2 -6 C and transfused within 24hoursOR maintained at room temperature and transfused within 6 hours.

4.1.4.4 All bags must be properly identified and matched.

4.1.5 Whole blood intended to be processed is stored between 10-24 C but in case ofplatelet production WB must be stored in temperature not less than 20C.

4.1.5.1 Donations to be used for the preparation of fresh frozen plasma,cryoprecipitate and platelets:

Must be collected within 10 minutes of the venepuncture. Must be processed within 8 hours of collection. For platelets preparation: Aspirin should not be taken for 5 days before

donation.

4.1.5.2 Freezing of plasma components is done by using Blast freezer (if available)which freezes plasma within 35 minutes leading to preservation of labilecoagulation factors.

4.1.5.3 Unprocessed blood older than 8 hours may only be used to prepare frozenplasma and packed RBCs.

4.1.5.4 Additive solution must be added to red cells within 72 hours of collection.4.1.5.5 Donations for leukocyte reduction must not exceed 3 days from collection.4.1.5.6 Before expiry date of fresh frozen plasma Cryoprecipitate can be prepared.



4.2 Component Preparation Procedures

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

4.2.2 Component specifications must be defined in line with international specifications(refer to component annex II).

4.2.3 The quality of the blood components produced must be regularly monitored and theresults must be documented:

4.2.3.1 PRBC: 1-2 % of the daily production depending on the number of processedunits.

4.2.3.2 Platelets: 1-2 % of the daily production depending on the number of processedunits.For platelet count: minimum 3 units daily.For PH meter: minimum 2 units weekly.If bacterial detection system is available: minimum 2 units weekly.

4.2.3.3 Cryoprecipitate and FFP production: 2-6 units of the monthly productiondepending on the number of processed units.

4.3 Handling and Storage of Processed Components

4.3.1 SOPs must be developed and followed for storage areas.

4.3.2 Blood component storage temperatures:

4.3.2.1 Whole blood may be stored immediately after collection at the refrigerator(2˚C - 6˚C). Alternately, it may be placed in a controlled room temperature(20˚C - 24˚C) up to 24 hours. Whatever option is used after the first 24 hoursall whole blood donations must be maintained at (2˚C - 6˚C).

4.3.2.2 Blood and blood products need to be stored under the right conditions toensure that they remain viable, safe and clinically effective.For more details on storage of components refer to component annex II.

4.3.3 The equipment used for the storage of all clinical products should:

4.3.3.1 Ensure all products are stored within the correct temperature ranges.4.3.3.2 Ensure the safe segregation of quarantined and released products.4.3.3.3 Provide adequate space for storage.4.3.3.4 Be secure.4.3.3.5 Be fitted with a temperature monitoring and alarm system (visual and

acoustic).4.3.3.6 Have an uninterrupted power supply.

4.3.4 Each product must be clearly and appropriately labeled, using high quality labelswhich are:

4.3.4.1 Self-adhesive using a non-invasive adhesive.4.3.4.2 Smear-resistant.4.3.4.3 Resistant to water and humidity.

4.3.5 The labels should provide, as appropriate, the following information and ensuring thatthis complies, as necessary, with the relevant national legislation and internationalagreements:

4.3.5.1 Donation number (eye readable and barcode)



4.3.5.2 ABO group and Rh type4.3.5.3 Date of collection4.3.5.4 Expiry date4.3.5.5 Product type4.3.5.6 Storage temperature4.3.5.7 Volume4.3.5.8 The producer’s identification (text or code)4.3.5.9 Anticoagulant solution4.3.5.10 Warning:

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

appears abnormal in any other way.

The shelf-life of all components must be defined individually (refer to components annex II).

4.4 Irradiating Products and Source of Irradiation

4.4.1 SOPs must be developed and followed for irradiation.

4.4.2 The preferred irradiation source is gamma radiation (Cesium 137).

4.4.3 Blood irradiator must be used for irradiation.

4.4.4 The recommended minimum dose of irradiation is 25 Gy, maximum of 50 Gy.

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

4.4.6 Storage and regulations for irradiated red cell components (refer to annex II).

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

4.4.8 The blood component dosimeter must be regularly monitored.

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

4.5 Release of Components from Quarantine

4.5.1 All components are kept in the quarantine area until the completion of the laboratoryscreening.

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

4.5.2.1 Donation department

Low volume High volume Donor selection criteria not fully met Any other situations where the collection process has resulted in an

unsuitable donation Self deferral notification by the donor

4.5.2.2 Blood components department

Reddish plasma or platelets Interrupted close system Lipaemic units Icteric unit



Haemolysis Punctured or leaking bags Any component which does not meet specifications

4.5.2.3 Screening laboratories

TTI screen reactive Unidentified high titre irregular antibodies Presence of antibodies DAT positive

4.5.2.4 Issuing department

Mishandled blood units Open system Expired units Haemolysed units

4.5.3 Dedicated staff in the Components Department is responsible for discarding units.

4.5.4 The reasons for discard must be documented thoroughly.

4.5.5 Statistical data on discard rates should be collected and analyzed regularly.

4.5.6 Components must be released from quarantine to the stock after meeting the releasecriteria.

4.5.7 The components released from the quarantine storage areas upon meetingspecifications must be documented:

4.5.7.1 Donation number4.5.7.2 ABO and Rh groups4.5.7.3 Component type released4.5.7.4 Signature of both Components and Issue Area staff performing and authorizing

the release4.5.7.5 Date and time of release

Testing for Red Cell Serology and TTIs


Section V




5.1 General Standards for Donation Samples for Screening

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

5.1.2 All samples are identified with eye & scanner readable bar-coded donation number,attached at donation and which links the sample to the donation and the donor.

5.1.3 Two samples obtained from each donation, at least 5ml on EDTA for blood groupingand 7ml plain for screening of serological markers. A third 7ml plain sample isobtained for NAT (if available).

5.1.4 Serum is the sample of choice for infectious disease serology.

5.1.5 Samples should fulfill the basic quality requirements.

5.1.6 Severely haemolysed or lipaemic samples should not be tested.

5.1.7 Samples must be tested within 7 days of collection.

5.1.8 Samples must otherwise be suitable for use and stored as defined in the manufacturer’sinstructions and guidelines for the test kits or reagents used.

5.2 Blood Group Serology

5.2.1 The ABO group shall be determined for each donation, irrespective of the previousdonation history of the donor.

5.2.1.1 Sensitive techniques suitable for testing large numbers of donations must beused (column agglutination technique / tube technique/microplate technique).

5.2.1.2 The red cells must be tested against anti-A and anti-B reagents.5.2.1.3 The plasma must be tested against standard A1, B cells and Ab screening cells.5.2.1.4 Appropriate controls must be used and give the expected results.

5.2.2 The Rh (D) type shall be determined for each donation, irrespective of the previousdonation history of the donor.

5.2.2.1 Sensitive techniques suitable for testing large numbers of donations must beused (column agglutination technique / tube technique / microplate technique)

5.2.2.2 The red cells must be tested with anti-D reagent.5.2.2.3 Donations initially Rh (D) negative must be tested further for weak D antigen

by IAT.5.2.2.4 If the red cells reaction is positive by IAT, the donation is classified as Rh (D)

Positive.5.2.2.5 If the red cells reaction is negative against the anti-D reagent and the IAT for

weak D, the donation is classified as Rh (D) Negative.5.2.2.6 DAT is done for IAT positive weak D testing as a control for the donor cells, if

DAT is positive; the IAT is invalid.5.2.2.7 Appropriate controls must be used and give the expected results.

5.2.3 The plasma of each donation should be screened for the presence of irregular red cellantibodies:

5.2.3.1 By CAT or tube IAT using AHG.5.2.3.2 Using pooled Ab screening cells.5.2.3.3 Positive and negative quality control samples must be used.



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

5.2.4.1 Only a test reagent based on micro tube system or anti sera (Tube technique)approved by an internationally recognized accrediting system e.g. CE markedetc must be used.

5.2.4.2 The test reagent used must be evaluated and validated by the Red CellReference Laboratory of NBTC before acceptance and use.

5.2.5 The blood grouping performed must be performed according to defined standardoperating procedures:

5.2.5.1 Samples should fulfill the basic quality requirements.5.2.5.2 All samples must be tested according to the mandatory requirements described.5.2.5.3 All samples must be centrifuged prior to testing and checked for suitability for

automated testing.5.2.5.4 Samples unsuitable for automation should be tested using manual methods

(tube technique) or semi automated (CAT).5.2.5.5 Appropriate control and QC samples must be included with each batch of tests

and must give the expected results for the run to be considered valid.5.2.5.6 Discrepant results should be resolved by senior staff, if still not resolved;

samples should be referred to the RCRL.5.2.5.7 Blood and components must not be released from quarantine for clinical use

until all of the mandatory grouping tests have been completed, documentedand authorized.

5.2.6 Quality control procedures must be in place:

5.2.6.1 To assess the day to day performance of all reagent and kits used.5.2.6.2 To assess the performance of all equipment used.5.2.6.3 Including both internal and external quality controls.5.2.6.4 Included in each batch of tests.5.2.6.5 The results monitored to ensure standards are maintained and look for any

trends.5.2.6.6 To assess the performance of all new manufacturer’s lots of reagents prior to

their acceptance and use.5.3 TTI Screening

5.3.1 All donations must be screened for the following markers (using EIA technique)before considered suitable for release for clinical use:

5.3.1.1 Hepatitis B surface antigen (HBsAg)5.3.1.2 Antibody to hepatitis C virus (anti-HCV)5.3.1.3 HIV 1/2 antigen/antibody (HIV Ag/Ab)

5.3.2 All donations must be screened for the following markers (using EIA technique/Column agglutination technique) before considered suitable for release for clinicaluse:

5.3.2.1 Syphilis antibodies (anti-Treponema pallidum)

5.3.3 All donations should be tested by Nucleic acid Amplification Technology (ifavailable).

5.3.4 MPX format is the most suitable for donor screening either tested individually or inmini pools of 6 using either TMA or PCR techniques.



5.3.5 Only screening assays which are approved by an international accreditation/regulatorysystem must be used (e.g. CE marked under the IVD Directive or FDA approved).

5.3.5.1 The assay must be evaluated and validated by the recognized and suitablyqualified and experienced Microbiology Reference Laboratory of NBTC priorto their introduction for use in blood screening.

5.3.6 TTI screening must be performed according to defined procedures:

5.3.6.1 TTI screening using EIAs is either to be performed on fully automated systemsor semi automated systems.

5.3.6.2 Samples should be centrifuged and checked for suitability for automatedsystems prior to starting the testing.

5.3.6.3 Samples unsuitable for automated screening should be tested by semiautomated systems (except for NAT).

5.3.6.4 The validity of the results of each single microplate or test run is determinedby the manufacturer's control samples which should meet the manufacturer’scriteria.

5.3.6.5 Additional QC samples should be included with each test run for monitoringthe process and must give the expected results. These samples can be used asgo-no-go samples for the results of the test run to be released.

5.3.6.6 Initially non reactive donations are considered to be suitable for release.5.3.6.7 Initially reactive donations are retested, in duplicate using the same assay

(except if they are reactive by NAT).5.3.6.8 Repeatedly reactive donations, with 2 or more out of 3 screen results reactive

with high absorbance, are considered to be unsuitable for release and thedonations should either be discarded or stored securely for subsequentreagent/QC use.

5.3.6.9 Repeatedly reactive donations with equivocal results should be referred toMRL for supplementary screening.

5.3.6.10 Samples referred to MRL are tested 2 times by supplementary screening assayseither another 2 different EIA's or another EIA and CLIA for viral markers,and by CLIA and/or TPHA (for syphilis).

5.3.6.11 Products must not be released from quarantine for clinical use until all of themandatory TTI screening tests have been completed and the results areauthorized.

5.3.7 Quality control procedures must be in place (refer to clause 5.2.6).

Issuing and Compatibility Testing


Section VI




6.1 Blood and Blood Products Transfusion Requests

6.1.1 Blood Transfusion Requests:A working instruction for the acceptance of a standard request form must be followed.These requests must include:

6.1.1.1 Request for a general stock which must specify:

Numbers and types of the products required. Blood grouping of the products requested concerning ABO and Rh blood

groups. Any additional specific needs e.g. irradiation, filtration, wash, aliquoting,

pediatric units if needed.

6.1.1.2 Request for a specific patient which must include:

In case of individual patients complete patient identification should be done.

Full name (till the 4th generation). Diagnosis and reason of transfusion. Hemoglobin percentage (Hb %). Date of birth, age, gender & weight (neonates). The number and type of products required. The date and time that the blood is required. Previously transfused or not, if yes the date of last transfusion should be

known. Any other requirements e.g. irradiated/ leucocytes reduced/washed products. Previous pregnancy& history of drug intake. The occurrence of any adverse transfusion reactions in a previous

transfusion. Signature of the physician request.

6.1.1.3 Urgent requests:

There must be a record signed by the requesting physician indicating thatthe urgency of the clinical situation was sufficient to require release of redcells before completion of compatibility testing.

The product must be clearly labeled with a warning statement thatcompatibility testing had not been completed at the time of issuing.

Blood should 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 cellcomponents before other tests for compatibility have been completed.

When the Rh type is unknown, only Rh(D) negative should be issued toa female prior to or during childbearing years, otherwise Rh(D) positiveor negative may be given.



6.2 Reception of Samples

The SOP for sample reception should be strictly followed concerning:

6.2.1 A fresh EDTA sample of sufficient volume (5 ml) must be submitted with therequest form to perform the investigations (grouping, crossmatching &any otherinvestigations if needed).

6.2.2 The sample must be labeled correctly and clearly with the following minimuminformation:

6.2.2.1 Full name (till the 4th generation)6.2.2.2 Hospital name6.2.2.3 Date of collection (not more than 72 hours)6.2.2.4 Signature of sample collector

6.2.3 Samples received for testing must be checked prior to booking.Poor quality samples must not be accepted. Visual inspection to determine thesuitability for testing should consider the following in relation to the equipmentmethods and samples used:

6.2.3.1 The presence of visible haemolysis6.2.3.2 The presence of clots in an anti-coagulated sample6.2.3.3 A low sample volume6.2.3.4 Diluted Samples6.2.3.5 Insufficient labeling data

6.2.4 Accepted samples:

6.2.4.1 Suitable samples must be recorded, labeled & given a unique identification lab.number prior to investigation. The request form must also be labeled with thesame lab. number.

6.2.4.2 The information on the sample and on the request form must match.6.2.4.3 Differences between sample and request must be resolved before any

investigations are started.

N.B:If the sample is rejected for any of the previous reasons. The sender should be notifiedon the spot to bring another sample with justification to the reason of rejection.

6.3 Pre-Transfusion Testing of Patient Samples

6.3.1 Blood Grouping:

6.3.1.1 Every unit of blood intended to be transfused should be tested for ABO, Dtyping.

6.3.1.2 The ABO blood group determination is the first step in the pre-transfusiontesting of the patient sample and this could be done by: Column agglutination technique / tube technique:

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 Micro-plate technique



6.3.1.3 The Rh(D) type of each patient shall be determined by testing the patient redcells with anti-D serum and this could be done by:

Column agglutination technique / tube technique Micro-plate technique

Red cells reactive with anti-D by direct agglutination test must be transfused as positiveblood group units and red cells non-reactive with anti-D by direct agglutination test shouldbe transfused as negative blood group units.

6.3.1.4 Any previous records for patients must be cross-checked to ensure that thecurrent findings are consistent with the previous ones.

6.3.2 Compatibility testing:The purpose of pretransfusion compatibility testing is to prevent incompatible red bloodcell transfusions that may be caused by clinically significant antibody (reacting at 37°C-AHG) leading to immune mediated hemolytic transfusion reactions. Some hemolytictransfusion reactions may have serious sequelae including hemoglobinemia, disseminatedintravascular coagulation, renal failure and death.

6.3.2.1 Cross matching could be done by:

Tube technique Column agglutination technique Microplate technique

6.3.2.2 Age of the sample:

The sample for cross matching should be obtained within 3 days of thescheduled transfusion especially if a recipient has been exposed to red cellantigens within the preceding 3 months.

6.3.3 Abnormalities in testing results:

6.3.3.1 ABO discrepancies:

Any discrepancies between forward and reverse blood grouping, that couldoccur (due to clerical error in registration of the sample, or the presence ofsignificant irregular antibodies, etc…), must be investigated immediatelyfirstly by repeating the test once more and if the problem persisted, thesample should be sent to the reference laboratory for resolving the problemprior to the cross-matching and release of products.

Uncertain reactions in the Rh(D)typing suspecting weak or partial D, thesample should be sent to the reference laboratories to resolve the problemand if partial D is suspected, the patient should receive D-negative bloodunit.

6.3.3.2 Positive cross-match:

Take good history from the patient concerning any previous transfusion, thetiming for the last one or any transfusion reactions that could have occurredduring these transfusions.

Perform anti-body screening.



6.3.3.3 Positive antibody screening:

Refer to the red cell reference laboratory to resolve the problem byperforming antibody identification studies before issuing RBC products.

Antibody identification procedures outlines any clinically significant.Selected units must be typed antigen-negative.

Patients with a history of previously identified clinically significantantibodies must receive antigen negative units whether or not the antibodiesare currently demonstrable.

Clinically significant antibodies are those antibodies that are reactive at37°C-AHG and are known to affect survival of transfused red cells. Bloodmay be issued when antibody identification studies and compatibility testingis completed.

6.3.3.4 Positive Direct Antiglobulin Test:

Patients with a positive DAT (with anti-IgG) should be tested to determinethe cause of the positive reaction.

6.4 Selection of Units for Neonates

An initial pre-transfusion sample must be tested from both the mother and the baby in order todetermine ABO group and Rh (D) type and to guide the physician to any sort ofincompatibility between the two samples (ABO or Rh incompatibility).

6.3.4 Investigations on the maternal sample:

6.4.1.1 ABO and RhD group.6.4.1.2 Screen for the presence of atypical red cell antibodies.

6.4.2 Investigations on the infant sample:

6.4.2.1 ABO and RhD group (a reverse group would detect passive maternalantibodies).

6.4.2.2 Direct antiglobulin test (DAT) performed on the neonate’s red cells.6.4.2.3 In the absence of maternal serum, screen infant’s serum for atypical antibodies

by an indirect antiglobulin technique (IAT).6.4.2.4 A positive DAT of the neonate’s red cells or an atypical red cell antibody in

maternal or neonatal serum suggests possible hemolytic disease of the newborn(HDN).

6.4.3 Selection of blood component

6.4.3.1 If the antibody screening for the mother and the DAT of the baby is negativecross matching of the unit to be transfused should be done with both (mother &neonate) using an ABO, Rh compatible unit.

6.4.3.2 If the initial antibody screen demonstrates clinically significant irregular redcell antibodies, these antibodies should be detected accurately and thetransfused unit must not contain the corresponding antigen and compatibilitytest is fully done (full antiglobulin compatibility test).

6.4.3.3 The plasma that would be transfused should the same blood group or ABplasma.



6.5 Selection and Labeling of Compatible Blood and Components for Transfusion

6.5.1 All red cell products should normally be cross-matched prior to transfusion.

6.5.2 The NBTS must ensure that recipients receive ABO group compatible products.

6.5.3 The NBTS must ensure that Rh(D) negative recipients receive Rh(D) negativeproducts, except when Rh negative blood is in short supply and an appropriatelyqualified and experienced medical officer has approved the use of Rh(D) positiveproducts.

6.5.4 Rh(D) negative blood must always be issued to Rh(D) negative females and femaleswhere there is any uncertainty over their Rh(D) type, prior to or during thechildbearing years.

6.5.5 Plasma and platelet products should be ABO compatible, especially in the case ofinfant.

6.5.6 A label must be attached securely to each component bearing:

6.5.6.1 Recipient’s full name (till the 4th generation)6.5.6.2 Name of the hospital6.5.6.3 Hospital identification number6.5.6.4 Compatibility testing results

6.5.7 For patients needing special products e.g. leucodepleted blood, washed red cells,irradiated red cells etc., the components should undergo the additional processing aftercompatible units have been identified and relabeled accordingly.

6.6 Archiving of Samples

6.6.1 Samples used for blood grouping, cross-matching, antibody screening should be welllabeled according to days received on & archived for 7 days. This is important formedico-legal reasons, traceability and hemovigilance in case of occurrence of adversetransfusion reactions.

6.7 Quality Control in Issuing Laboratory

6.7.1 Quality control is done in issuing laboratory 3 times a day (morning shift, after shift,night shift).

6.7.2 Quality control should be done for:

6.7.2.1 Blood grouping (done by already known blood groups).6.7.2.2 Cross-matching (positive & negative control).6.7.2.3 Samples for quality control are received from the reference laboratory labeled

with their manufacture and expiry dates.

6.8 Temperature Monitoring in Issuing Laboratory

6.8.1 Temperature monitoring is done in issuing laboratory 3 times a day (morning shift,after shift, night shift).

6.8.2 It is done using temperature monitoring sheets to all devices present in lab to insurethe efficacy of their performance and to insure the optimum storage temperature foreach product.

6.8.3 Each device is having an emergency plan sheet guiding the user to which place thecomponents of this device is going to be transfused in case of down time.



6.9 Transportation of Blood and Blood Products

6.9.1 Products must be packaged appropriately for transportation.Packaging must be secure and strong enough to protect the contents.

6.9.2 All components must be packaged and transported securely and be maintained at thecorrect temperature until arrival at their destination.

6.9.2.1 Red cell products must be stored and transported between 1-10ºC (using icepacks with insulator).

6.9.2.2 Frozen plasma products must be stored and transported below -18ºC.6.9.2.3 Platelets must be stored and transported between 20-24ºC and agitated for half

an hour before transfusion.

6.9.3 Transport containers must be cleaned and disinfected regularly.

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

6.9.5 Transportation times must be monitored and recorded.

6.9.6 The condition of the products upon arrival at their destination must be monitored andrecorded.

6.9.7 Transportation time should not exceed 24 hours.

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

6.9.8.1 The name, address and telephone number of the BTC that issued the product(s)unit.

6.9.8.2 The instruction that the contents must be maintained within a temperaturerange stipulated for the specific products at all times during storage,transportation and immediately prior to transfusion.

6.10 Transfusion Practice

6.10.1 A blood transfusion record must be completed for each product transfused indicatingthe:

6.10.1.1 Intended recipient’s name6.10.1.2 Hospital name and identification number6.10.1.3 Recipient ABO group and Rh D type6.10.1.4 Donor identification number6.10.1.5 Donor ABO group and Rh D type6.10.1.6 Interpretation of compatibility tests if performed

6.11 Administration of Blood and Products

6.11.1 Each hospital transfusion committee should ensure that transfusion practice is definedwithin the hospital and that the instructions are followed at all times.

6.11.2 Each product must be carefully inspected prior to transfusion.

6.11.2.1 For any abnormalities, unusual appearance or other irregularities.6.11.2.2 That the expiry date of each product has not passed.6.11.2.3 The product has not been opened or entered in any way unless for the purpose

of preparing for the transfusion and in which case immediately prior to thetransfusion.



6.11.3 The recipient is identified properly.

6.11.3.1 Bedside checking of all information before transfusion.

6.11.4 The recipient has been informed fully about the transfusion process.

6.11.4.1 Benefits.6.11.4.2 Risks.6.11.4.3 Any appropriate alternatives.6.11.4.4 Their right to refuse transfusion.6.11.4.5 Full informed consent has been obtained from the recipient and recorded.

6.11.5 Full records of each transfusion are kept.

6.11.5.1 The type and donation numbers of all products transfused.6.11.5.2 The date and time each product was transfused.6.11.5.3 The volume transfused.6.11.5.4 The person prescribing the transfusion.6.11.5.5 The person setting up each product.6.11.5.6 Pre- and post-transfusion vital signs.6.11.5.7 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 thetransfusion and their subsequent management.

6.11.6 Transfusion should be prescribed and monitored under medical observation.

6.11.7 Blood and components should be transfused through a sterile, pyrogen free transfusionset.

6.11.8 Except for 0.9% sodium chloride, drugs or medications should not be added to bloodor blood products.

6.11.9 If home therapy is allowed, e.g. haemophilia, clear instructions must be provided withthe products, including additional instructions on the management of reactions outsideof a healthcare institution.

6.11.10 The NBTS shall have a strategy for Rh Immune Globulin prophylaxis for Rh (D)negative patients who have been exposed to Rh (D) positive red cells in case oftransfusing Rh-D positive platelets to Rh-D negative recipients.

6.11.11 Routine warming of red cell components is not recommended, except in situationswhere there is rapid infusion of large volumes of blood (massive transfusion: generallyoccurring in the operating room or trauma settings) or in patients with identified coldagglutinins. Warming must only be undertaken using approved blood warmers.

6.12 Detecting, Reporting and Investigating Possible Adverse Events followingTransfusion6.12.1 Each hospital must develop and implement a system for the monitoring of all

transfused patients to identify record and investigate any adverse incidents followingthe transfusion of any products.

6.12.1.1 The patient must receive the appropriate care following any adverse reaction.6.12.1.2 All incidents must be reported to the NBTS as soon as possible.

6.12.2 The NBTS must develop and implement a system for the investigation of any reportedadverse events following transfusion.



6.12.2.1 The responsible physician should be notified once an adverse reactionhappened.

6.12.2.2 Records of the event shall be maintained in the patient’s medical record.6.12.2.3 The hospital shall notify the NBTS to record the event, providing full details of

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

6.12.3 All suspected transfusion complications reported shall be evaluated and reviewed bythe NBTS Quality Department together with appropriate medical and technical staff todetermine if the transfusion could have been the cause/source of the problem.

6.12.3.1 Full records of the review and the outcome must be kept.6.12.3.2 The archive samples from the implicated donations should be recovered and

investigated accordingly.6.12.3.3 As necessary the donor(s) implicated should be re-called and investigated

further.6.12.3.4 Any additional work needed to resolve the issue should be determined and

undertaken.6.12.3.5 A full report of the incident, investigations and outcomes must be prepared as

soon as possible and the hospital/ the responsible physician informed of theoutcomes.

6.13 Re-Issue of Products

Red cell components returned to the blood bank may only be re-issued if:

6.13.1 They are returned within half an hour of issue.

6.13.2 The product has not been opened.

6.13.3 There is sufficient bleed line for further compatibility testing, unless to be re-issued tothe same recipient within 72 hours of the initial transfusion.

6.13.4 There is satisfactory evidence that the unit of blood has been maintained at atemperature of 1-10ºC.

6.13.5 There is a clear record that the component is being re-issued.

6.13.6 The compatibility label attached to the product is cancelled and replaced with a newone, unless the product is to be re-issued to the same recipient within 72 hours and it isconfirmed that the patient has not been transfused within that time.

N.B:If a returned product is deemed as not safe for re-issue, it must immediately have alabel attached indicating that the product must not be used for transfusion and thendiscarded.

6.14 Blood Stock Management

6.14.1 Ideal inventory level

6.14.1.1 Optimum number of blood units, no shortage & no outdates, this could be donethrough estimation of needs using the stock card used in the laboratory andthis could be done by two methods:

Daily estimation. Weekly estimation (more accurate).



6.14.1.2 Ideal inventory level could be reached if the practical consideration (type ofactivity and the power of the medical institute) and logistics (enough space forthe blood units stored in) are kept in mind.

6.14.1.3 Rearrangement of the blood unit should be done daily according to the expirydate of the unit (the older blood unit should be issued first).

6.14.2 Methods of storage:

6.14.2.1 By expiry date order.6.14.2.2 According to ABO or Rh.

The number of blood units present in the stock card should be revised with that present inthe refrigerator three times daily (morning shift, after shift, night shift).

6.14.3 Types of blood stock:

6.14.3.1 Routine stock: calculated as previously mentioned.6.14.3.2 Emergency stock: calculated as 20% of the routine stock.

6.14.4 Outdated unit: (indicator of performance)In order to get use of all blood units many points should be taken in consideration such as:

6.14.4.1 The size of service of the medical institute requesting blood from the supplier.6.14.4.2 The shipping distance from the supplier.6.14.4.3 The shelf-life of the blood unit.6.14.4.4 The ordering &issuing policies (the number of units requested and issued

should be optimum to the patient according to the diagnosis and clinicalestimation of the case).

6.14.5 Monitoring of the blood stock:

6.14.5.1 Theoretical monitoring (stock card).6.14.5.2 Physical count (actual counting of the blood bags, 3 times/24hrs).6.14.5.3 Daily blood bank report.

6.15 Therapeutic Phlebotomy

6.15.1 Therapeutic vein section:Therapeutic Vein section is a treatment whereby a prescribed amount of blood iswithdrawn for medical reasons.

6.15.1.1 Therapeutic Vein section medically necessary for any of the followingindications:

Hemochromatosis (including hereditary hemochromatosis) Polycythemia vera Porphyria cutanea tarda Polycythemia secondary to arterio-venous (A-V) fistulae Polycythemia secondary to cyanotic congenital heart disease Polycythemia secondary to cor pulmonale Sickle cell crisis Persons with hematocrit greater than 60%

6.15.1.2 Phlebotomy for treatment of hemochromatosis typically involves removing aunit of blood-or 250 mg of iron-once a week.



6.15.1.3 Phlebotomy sessions are required until iron levels return to a consistentlynormal level, which may take several months to several years.

6.15.1.4 Phlebotomy for polycythemia vera removes enough blood to keep the patient'shematocrit below 45%. The frequency and duration of sessions depends on thepatient's individual needs.

6.15.2 Therapeutic aphaeresis:For a few rare blood disorders, phlebotomy is performed as a medical interventionfor disease management. Cells, plasma or plasma constituents may be removed fromthe circulation and replaced by normal plasma or solutions, to reduce the patient’s loadof some pathologic substance to levels that will allow improvement in the course ofthe disease or for alteration of the antigen-to-antibody ratio, modification of mediatorsof inflammation or immunity, or for clearance of immune complexes:

6.15.2.1 Hematology/oncology conditions

Paraproteinemias Hyperleukocytosis Thrombocythemia Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome Sickle cell disease Post-transfusion purpura

6.15.2.2 Neurology conditions

Acute Guillain-Barré syndrome Chronic inflammatory polyneuropathy Myasthenia gravis

6.15.2.3 Other conditions

Cryoglobulinemia Rapidly progressive glomerulonephritis associatated with antibody to

neutrophil cytoplasmic antigen Homozygous Type II familial hypercholesterolemia Refsum’s disease

6.15.2.4 Avoiding overuse or underuse of therapeutic aphaeresis requires considerablemedical knowledge and judgment.

6.15.2.5 The patient should be evaluated for the treatment by his physician and by thephysician in charge of the aphaeresis team.

6.15.2.6 Close consultation between these physicians is important, especially if thepatient is young or elderly.

Documents and Records


Section VII




7.1 Document Control System

7.1.1 The NBTS shall have a policy that defines the strategy, processes and proceduresrequired to ensure that documents are appropriately controlled throughout the BloodTransfusion Services.

7.1.2 The Blood Transfusion Services must develop, validate and maintain a documentcontrol system, including all the procedures needed for protecting the integrity of alldocuments and data contained within them.

7.2 Documents

7.2.1 A master list of documents, including policies, processes, procedures, labels and formsthat relate to the requirements of these standards.

7.2.2 The document control system must ensure proper validation and approval of newdocuments before use, including defining who should produce documents.

7.2.3 There must be standard format defined for all documents.

7.2.4 A continuously updated master list of all documents in use must be maintained,ensuring that approved, current editions of appropriate documents are available at allrelevant locations.

7.2.5 The current revision status of each document must be recorded, ensuring the periodicalrevision of approved documents, along with the identification, withdrawal andappropriate archival of invalid or obsolete documents.

7.3 Records

7.3.1 The document control system must ensure the proper indexing, storage, access andwhere appropriate, disposal of all records.

7.3.1.1 All records must be complete.7.3.1.2 Able to be retrieved within an appropriate time.7.3.1.3 Records must be protected from accidental or unauthorized destruction, access

or modification.7.3.1.4 The Blood Transfusion Services must develop, apply and maintain a system to

ensure confidentiality of records.

7.3.2 The record system must ensure the full traceability of all products from donor torecipient, including the results of all performed tests and all donor details.

7.3.3 Where appropriate there shall be processes and procedures to support the managementof electronic records on computer systems including routine back-up and appropriateretrieval of all critical data.

7.4 Record Retention

7.4.1 All records must be retained in accordance with any Egyptian legal or regulatoryrequirements as well as NBTS requirements.The retention times for critical documents are detailed below.



Record Retention

ItemNo. Standard Record to be Retained

MinimumRetention Time

(years)

1. 3.4 Donor recall forms 5

2. 3.8 Financial transportation records 10

3. 3.8 Other transportation records 5

4. 4.56.5

Identification of individuals performing eachsignificant step in collection, processing and

compatibility testing.5

5. 6.1Final disposition of each unit of blood or blood

components and if issued by the facility fortransfusion, identification of the recipient

5

6. 4.5 اعام ض 5

7. 4.5 Preparation of specific components 5

8. 5.2 Determination of ABO group and Rh type for allcollections 5

9. 5.2 Ab screening for donor 5

10. 5.3 Serological test results for TTIs 5

11. 5.2 Serologic confirmation of donors ABO/Rh 5

12. 3.4 RBCs Phenotyping of the Donor 5 years from lastdonation

13. 6.15 Therapeutic phlebotomy 5



14. 6.3 Patient's ABO group and Rh type 5

15. 6.3patient testing to detect unexpected antibodies to red

cell antigens 5

16. 6.3

Comparison of patients’ previous test results forABO group and Rh type for the last 12 months, if

comparison is not performed electronically 5

17. 6.3 Clinically significant antibodies Life-long

18. 6.3 RBCs Phenotyping of the patient Life-long

19. 6.3 Interpretation of serologic cross match 5

20. 6.8 Recipient consent 5

21. 6.1

Physician consent indicating that the clinicalsituation was sufficiently urgent to require release ofblood before completion of compatibility testing or

infectious disease testing5

22. 6.7

Patient’s medical record: Verification of patientidentification before transfusion, transfusion order,component name, donor unit or pool identificationnumber, date and time of transfusion, pre-and post-

transfusion vital signs, amount transfused andidentification of the transfusionist.

5

23. 6.9 Transfusion adverse events Life-Long

24. 6.9 Evaluation of suspected transfusion adverse events 5

25. 6.8Look-back to identity recipients who may have been

infected with HCV,HBV, Syphilis or HIV 5

26. 2.8 ع ع إالغ ذجBreak Down Notification Form Life-long

27. 2.8 هز إصالح Repair Report Life-long

28. 2.8 هز وكب إسرةInstallation Record Life-long



29. 2.8 هز إصالح وى دراسFeasibility Analysis Life-long

30. 2.8 Equipment PM and CAL form(Daily/Weekly 2

31. 2.8 Equipment PM and CAL form 2

32. 11.2 Hardware Log Books (PC’s, Scanners, Printers andData show) Device lifetime

33. 11.2 Internet Service Lifetime

34. 11.3 Application Development Request Lifetime

35. 11.3 Joining domain Request ضاال شطب م Lifetime

Billing system

36. اا 5

37. 33ال 5

38. ام صف سالت 5

39. ق ن 3

40. ا ا ام شت د اي و اشهي ان 3

Human Resources


Section VIII

Human Resources

Human Resources


8.1 Qualification

8.1.1 The Blood transfusion services shall have a process to ensure the employment of anadequate number of individuals qualified by education for each job position.

8.2 Training

8.2.1 The training needs of the staff must be identified and properly met throughdocumented training programs.

8.2.2 The records of the staff training must be maintained.

8.3 Competence

8.3.1 Evaluations of continued competence shall be preformed at specified intervals.

8.4 Personal Records

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

Purchasing & Incoming Receipt, Inspection and Testing


Section IX

Purchasing & Incoming Receipt,Inspection and Testing

Purchasing & Incoming Receipt, Inspection and Testing


SUPPLIER AND CUSTOMER ISSUES

The blood transfusion service (BTS) shall have policies, processes and procedures to evaluatethe ability of suppliers of critical materials and services to consistently meet agreed uponrequirements.

9.1 Supplier Qualification

9.1.1 The blood transfusion service shall evaluate and participate in the selection ofsuppliers, when possible, prior to acceptance of an agreement.

9.1.2 When a supplier fails to meet specified requirements, it shall be reported tomanagement with contracting authority.

9.1.3 Testing or services required by these Standards shall be performed in a laboratory.

9.2 Purchasing Requirements

9.2.1 The BTS must develop specific requirements for all items purchased that influence theoverall quality of the blood and blood products produced and supplied by the NBTS.

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

9.3 Incoming Receipt, Inspection and Testing

9.3.1 Different departments of the BTS perform the evaluation and validation & must keeprecords of acceptance testing of incoming materials such as blood bags, reagents andlabels etc.

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

9.3.3 Incoming blood components and critical materials must be received, inspected andtested, as necessary, before acceptance or use.

9.3.4 Each container used for collection, preservation and storage including those used forblood and components, must be inspected to ensure that it is intact.

9.3.5 The label must be complete, affixed and legible.

9.3.6 Critical materials must meet specified requirements.

9.3.7 All containers and solutions used for collection, preservation and storage of bloodcomponents and all reagents used for required tests on blood samples shall meet orexceed applicable criteria.

Safety and Occupational health


Section X




10.1 General Requirements

10.1.1 The BTS shall establish, document, implement, maintain and continually improve asafety & occupational health management system in accordance with the requirementsthat ensure adequate safety and the appropriate environmental conditions in the workarea.

10.2 OH & S Policy

10.2.1 Top management shall define and authorize the BTS’s safety & occupational healthpolicy that ensure the commitment to prevention of injury and ill health and continualimprovement in safety & occupational health performance.

10.2.2 The policy is communicated to all staff members of the BTS with the intent that theyare made of their individual safety & occupational health obligations.

10.2.3 It is reviewed periodically to ensure that it remains relevant and appropriate to theBTS.

10.3 Hazard Identification and Safe Environment

10.3.1 The BTS shall establish, implement and maintain a procedure(s) for the ongoinghazard identification, risk assessment, and determination of necessary controls.

10.3.2 The BTS shall have processes to minimize environmentally related risks to safety &occupational health of staff, donors & patients. Suitable quarters, environment &equipment shall be available to maintain safe operations.

10.3.3 The BTS shall have a process for monitoring adherence to biological, chemical, &radiation safety regulations.

10.3.4 Blood components & any biological waste shall be handled & discarded in a mannerthat minimizes the potential infection hazard.

10.4 Implementation and Operation

10.4.1 Top management shall take ultimate commitment for safety & occupational healthmanagement system. Ensuring the availability of resources essential to establish,implement, maintain and improve the safety & occupational health managementsystem.

10.4.2 The BTS shall ensure that any person(s) under its control performing tasks that canimpact on safety & occupational health is (are) competent on the basis of appropriateeducation, training or experience and shall retain associated records.

10.5 Emergency Preparedness and Response

10.5.1 The BTS shall establish, implement and maintain a procedure(s) to:

10.5.1.1 Identify the potential for emergency situation.10.5.1.2 Respond to such emergency situation.

10.5.2 The BTS shall also periodically test its procedure(s) to respond to emergencysituations, where practicable, involving relevant interested parties as appropriate.

10.5.3 The BTS shall periodically review and where necessary, revise its emergencypreparedness and response procedure(s), in particular, after periodical testing and afterthe occurrence of emergency situations.

Information Technology


Section XI




11.1 IT Department

11.1.1 IT department is a business support department. It gives appropriate support to theorganization through:

11.1.1.1 Supporting the different departments with the appropriate services and devicesthat help them in performing their daily work and in turn achieving theorganization’s vision and strategy.

11.1.1.2 Providing suitable technology based services to the different departments inorder to improve their level of performance at a cost effective manner.

11.1.2 There should be processes and procedures to support the management of computersystem.

11.1.3 There should be a process in place for routine back-up of all critical data.

11.2 Services

11.2.1 Local Area Network should be built in every RBTC to provide network access forusers to shared files, printers, e-mail and internet services.

11.2.2 Application Development:Suitable applications shall be developed whenever possible according to end userneeds. This is done through what is called "Software Development Life Cycle."

11.2.3 The developed system should be adjustable for modification to meet the changesrequested by the user and to meet the expanding business needs.

11.2.4 The labeling system:

11.2.4.1 The labeling system for retrieved blood and blood products:

Donation identification number label: a label bearing donation numberbarcode. Produced in sets, these labels ensure the accurate and uniquelabeling of all donations and samples. Allocated at the point of donation,this number is fundamental to the secure audit trail for Blood.

This label will bear the title of the Blood Transfusion Service supplying theBlood. The label will also bear the nationally defined identifier and otherdonation specific information, e.g. year of donation & donation site.

General Requirements

Label QualityLabels used for blood and sample labeling must be:

Self-adhesive using a non-invasive adhesive. Tamper-evident (i.e. removal must deface the label). Smear-resistant and non-fading. Resistant to water and humidity. Capable of being affixed readily to paper or other base label material, plastic

surfaces, glass (particularly glass tubes of 12 mm diameter) without winging('winging' is defined as the lifting of a label from the surface to which it isapplied.

Capable of withstanding a temperature range of –80°C to +56°C afterapplication to the blood container.

Capable of being applied without slippage to tubes. Non-flaking when read using a hand-held light-pen touching the label.



Printing requirements: eye-readable information.

11.2.5 There shall be processes and procedures to support the management of computersystems.

11.2.6 There shall be a process in place for routine backup of all critical data. Proceduresshall be in place to ensure that data are retrievable and usable.

11.2.7 Hardware and software security measures must prevent unintended deletion of data oraccess by unauthorized persons.

11.2.8 There must be adequate protection against unintended data loss (eg, when a storagedevice is full).

11.2.9 A backup disk or tape should be maintained in the event of unexpected loss ofinformation from the storage medium.

11.2.10Information SecurityTo apply security rules, next steps are taken:

11.2.10.1 The network should be protected using firewall and other secure networkdevice and/or applications.

11.2.10.2 Insuring that PC users are protected by having a suitable antivirus that is up-to-date.

11.2.10.3 Insuring that users with Internet access has no access to prohibited accesswebsites that might steal information and pirated sites that containdownloadable viruses which can destroy their computers.

11.2.10.4 Users aren’t allowed to add or remove programs without assistance of ITspecialist.

11.2.10.5 Users should understand and apply backup and archiving policy of their data onregular basis.

11.2.10.6 Computers with sensitive information shouldn’t be left unattended. The usershave to log off or lock the PC.

11.3 Infrastructure

There should be a rigid infrastructure that supports these operations and services. Thisincludes:

11.3.1 Desktop Support:11.3.1.1 The users will receive pc/laptop according to their working conditions and

needs. These workstations will be loaded and configured with officeapplications, as well as network services. Each of the devices should have a logbook, where each maintenance, update or change to the equipment orapplication installed recorded.

11.3.1.2 The hardware devices will be maintained and monitored on regular basis.11.3.1.3 In case of any device failure, the technical support at the IT department should

determine if this malfunction is due to software or hardware problem.11.3.1.4 Other Hardware:

The concerned person will have to determine if the device problem canbe solved internally by replacing spare part (i.e. change printer inkcartridge) or it needs to be sent to specialized company where there arebetter capabilities.

11.3.1.5 Software: The device needs to reinstall a fresh OS copy.



The software application needs to be updated or modified.

11.3.2 Network Infrastructure:11.3.2.1 The Network is comprised of the computer hardware and wired connectivity

that allows the members of the organization to communicate with each other,as well as with higher level.

11.3.2.2 The infrastructure consists of cables modems, routers, switches, etc.11.3.2.3 Maintenance must be provided to keep the network functioning especially at

peak time.(heavy traffic).11.3.2.4 Troubleshoot errors that arise.


Annex IEgyptian National Donor Selection Criteria

Basic criteria AcceptabilityAge 18-60 years may be up to 65 years if regular donorWeight >50 kgPulse Regular rhythm (60-100 beat/minute)Blood pressure 90/60 up to 180/100Hemoglobin level 13 – 18 g/dl for male donors

12 – 18 g/dl for female donors

Condition AcceptabilityAbortion Six monthsAcne 4 weeks if on Ruoaccutaine (Isotretinoin)

or 12 months if on Tigason (Actitretin)Acupuncture, tattooing, earpiercing, accidental needle prick.

6 months deferral

AIDS/HIV Patient - permanent deferralContact - 6 months from last contact

Alcohol Accepted exceptIntoxicated, regular use or addict (alcoholism) - deferred

Allergies Severe - permanent deferralSeasonal - accepted during symptom free periodSteroids/desensitization injections - permanent deferral

Anemia Iron deficiency - accepted 3 months after recoveryAccept - donors with

thalassaemia traits, provided they are well andtheir haemoglobin level is above the requiredlower limit.

haemophilia A or B carrier states provided theyhave normal coagulation and have not receivedtreatment with clotting factors.

previously treated haematinic deficiency(including those on maintenance treatment forpernicious anaemia with Vitamin B12)

past history of acute autoimmunethrombocytopenia.

sickle trait, provided their haemoglobin isabove the required lower limit, but note thattheir blood is not suitable for neonatal exchangetransfusion.

G-6-PD deficiency, without history ofhaemolysis, but not suitable for neonatalexchange transfusion

Other causes - permanent deferralAntibiotic intake Deferral for 7 days following completion of treatmentAngina pectoris Permanent deferral


Ankylosing spondylitis Permanent deferralArthritis Accepted unless acuteAutoimmune disorders Permanent deferral if severe debilitating such as systemic

lubus erytheematosis, dermatomyositis or severerheumatoid disease

Babesiosis Permanently defer individuals with history of infectionBiopsy Benign and healed deferred for 6 monthsBlood donation 90 days for males

120 days for femalesBlood transfusion Transfusion is defined as any product containing red cells,

platelets, granulocytes, fresh frozen plasma,cryoprecipitate and intravenous human normalimmunoglobulin.6 months deferral for recipients of blood components andderivatives and their sexual contacts and for antibodyscreening

Boils Deferred for 3 weeksBrain injury Permanent deferralBilharziasis Active (infection or lake contact) - 1 month after

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

Bronchial Asthma Mild (< 7 attacks/week) - acceptedModerate (7-14 attacks/week) - acceptedSevere (> 14 attacks/week) - permanent deferralDuring an acute exacerbation - deferredOn steroids - permanent deferral

Brucellosis Permanent deferralBurns (minor) Acceptable if no sepsisCancer Permanent deferralCeliac disease Accepted if treatedCerebro-vascular disease Permanent deferralChagas’ disease (Trypanosomiasis) Permanent deferralChikungunya Defer Visitors to endemic areas(Africa, Asia, Indian

subcontinent) for 28days, or 6 months if febrile illnessCholecystitis Acceptable after recoveryColitis (ulcerative) Accept if in long term remissionConcussion Deferred for 3 monthsCoronary artery disease Permanent deferralCystitis Deferred for 3 weeksCytomegalovirus Refer to Herpes virusesDementia Permanent deferralDengue Defer Visitors to endemic areas (SE Asia & W

Pacific,areas of Africa, Americas, E Mediterranean. )for28days, or 6 months if febrile illness

Dental intervention Accepted after 6 monthsDiabetes Accepted if controlled by diet or hypoglycaemic

medicationPermanent deferral if controlled by insulin


Diphtheria Acceptable 3 months after recoveryDysentery Accepted 1 month after recoveryEmbolism Permanent deferralEmphysema Permanent deferralEncephalitis Accepted 6 months after recoveryEndoscopy Accepted after 6 monthsEpilepsy or seizure disorder Permanent deferralGall stones Accepted after recoveryGastroenteritis Accepted after 1 monthGastro-oesaphageal reflux AcceptedGerman measles Accepted 3 weeks after recoveryGlandular fever Accepted 6 months after recoveryGonorrhea Deferred for 12 months following completion of treatmentGout Acceptable if quiescent and not on systemic treatmentHaemochromatosis Accept donor with Hg (13 – 18) and fulfill other selection

criteriaHemorrhoids Accepted if no severe bleedingHeart disease Permanent deferralHepatitis A Patient - accepted after 12 months from full recovery

Contacts - accepted after 6 monthsHepatitis B Patient - permanent deferral

Contacts - accepted after 6 monthsHepatitis C Patient - permanent deferral

Contact - accepted after 6 monthsHepatitis E As for HAVHepatitis of unknown origin As for HAVHerpes simplex Refer to Herpes virusesHerpes viruses (Includes Herpessimplex, varicella-zoster, Epstein-Barr Virus (EBV),cytomegalovirus (CMV), roseola,HHV-8)

Individuals with active infection – deferred until completerecoveryHistory of HHV-8 or active infection - permanent deferralContacts - deferred for 28 days

HHV-8 Refer to Herpes virusesHiatus hernia AcceptedHTLV-1 and 2 Individuals with known positive markers and their current

sexual partners are deferredHypertension Accepted if only stable uncomplicated and controlled by

medicationHyperthyroidism Permanent deferralHypotension Accepted minimum 90/60Hypothyroidism Defer - individuals who are hypo-thyroid, individuals

under investigation for thyroid diseaseAccept - individuals with benign disorders who areeuthyroid such as asymptomatic goitre, history of viralthyroiditis, autoimmune hypothyroidism

Immunosuppression Permanent deferralInfectious mononucleosis (Epstein-Barr Virus),

Refer to Herpes viruses


Influenza (including newlyemergent strains)

Defer individuals with active infection until 2 weeks afterfull recoveryDefer contacts for 7 days

Injecting drug use Permanent deferralIrritable bowel syndrome AcceptedJaundice As for HAV if viral or unknown etiology hepatitisLeishmaniasis Permanently defer individuals with history of infectionLyme disease(Borrelia burgdorferi) Defer individuals with active or chronic infectionMalabsorption syndromes Accept if well and in long-term remissionMalaria Travelers to endemic areas 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 deferral

History of malaria - permanent deferralMeasles Contact - accepted 3 weeks after recovery unless donor has

previously suffered from measlesPatient - accepted 3 weeks after recovery

Medications Retinoids: Etretinate Permanent deferralActitretin 12 monthsIsotretinoin 4 weeks

Dutasteride: 6 monthsFinasteride: 4 weeksAspirin and non-steroidal anti-inflammatory drugs:platelet components should not be prepared usingdonations from donors who have taken aspirin within 5days or NSAIDs within 48 hours.Human pituitary derived growth hormone: permanentdeferralInjected medications: accepted if given under medicalsupervision using safe techniques

Meningitis Accepted 6 months after recoveryMenstruation AcceptedMigraine AcceptedMultiple sclerosis Permanent deferralMultiple sexual partners,homosexuals, extramarital sexualrelationships

Permanent deferral

Mumps Contact - accepted 3 weeks after recovery unless donor haspreviously suffered from mumpsPatient - accepted 3 weeks after recovery

Nephritis Acute - accepted 6 months after recoveryChronic - permanent deferral

Neurodegenerative disease Permanent deferralNon-injected recreational drugs Accepted except

Intranasal cocaine – deferred


Intoxicated, regular use or addict - deferredOccupation 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)

Organ and tissue transplantation Permanent deferralOsteomyelitis (acute) Accepted 6 months after recoveryPancreatitis Accepted 6 months after recoveryPeptic 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 recoveryPoliomyelitis Accepted 6 months after recoveryPolycythemia vera Permanent deferral, and for therapeutic bleedingPregnancy Deferred until after delivery (see below)

Normal labour and caesarian section - accepted 6 monthsafter delivery unless breast feedingBreast feeding - accepted 1 year after delivery

Prion-associated diseases includingsporadic Creutzfeldt-Jakob Disease(CJD) , Iatrogenic CJD and variantCJD (vCJD)

Permanent deferralDefer donors who have visited UK for a cumulative periodof at least 3 months (up to 6 months) between 1980 and1996.

Psoriasis Accepted if without systemic symptoms and thevenepuncture site is unaffected

Psoriatic arthropathy Permanent deferralPsychiatric disorders Permanent deferralQ Fever Permanent deferralRape Victim:12 months

Assailant: Permanent deferralRaynaud's disease Permanent deferralRenal disorders Accepted if acute self-limiting when fully recovered

Deferred if severe chronic renal disease with chronic orrecurrent infection.

Respiratory infections Acute respiratory infections – Accepted when fullyrecovered 7 days after completion of antibiotic treatmentSevere, chronic or recurrent respiratory infections –permanent deferred

Rheumatic fever Permanent deferralRheumatoid arthritis Accepted if mild without systemic symptomsRoseola Refer to Herpes virusesSarcoidosis Permanent deferralScabies Deferred until clearedScarlet fever Accepted after 3 monthsSciatica AcceptedSepticaemia Accepted 6 months after recoverySevere acute respiratory syndrome Probable cases; 3 months after full recovery.


(SARS) Suspected cases; 1 month after full recoveryClose contact; 3 weeksTravel to endemic region; 3 weeks

Shingles Permanent deferralSkin diseases Accepted except generalised skin diseases with systemic

symptoms or on systemic medicationSnake bite Accepted 3 months after recoveryStab injuries Accepted after 6 monthsSurgery Accepted after 6 monthsSyphilis Permanent deferralTetanus Accepted 6 months after recoveryThrombophlebitis Accepted 6 months after recoveryThyrotoxicosis Permanent deferralTick bite fever Accepted 2 months after recoveryTonsillitis Accepted after recoveryToxoplasmosis Defer for 6 months after resolution of acute infectionTuberculosis Defer patient and contact for 24 months following

confirmation of cureTyphoid Patient - accepted 6 months after recovery

Contact - accepted after 1 monthTyphus Accepted 6 months after recoveryWest Nile Virus Defer Visitors to endemic areas(N & S America May to

Nov)for 28days, or 6 months if febrile illnessUnder weight (below 50 kgs) Permanent deferralVaccination Anti-D Rhogam - accepted after one year

BCG – accepted after 4 weeks Cholera – accepted Diphtheria toxoid - accepted Hepatitis A - accepted Hepatitis B - 7 days after routine immunization.

12 months after post-exposureprophylaxis

(Post-exposure prophylaxis (PEP) is treatment thatcan be used after possible exposure to the HepatitisB virus through sex, drug injecting equipment orinjury such as needle stick injury. PEP is given todecrease the risk of infection with the Hepatitis Bvirus. )

Hepatitis B Ig - accepted after one year Human immunoglobulins derived from UK plasma

1980-1996 - deferred Influenza - accepted Live attenuated vaccines - defer donors for 4 weeks

following immunization Live attenuated cholera - accepted after 4 weeks Measles - accepted after 4 weeks Mumps - accepted after 4 weeks Non-live vaccines and toxoids – accepted Non-specific Ig - accepted after one year


Pertussis - accepted Polio (Salk) - accepted Polio (Sabine) oral drops - accepted after 4 weeks Rabies (no exposure to bite) – accepted Rabies (after bite) - accepted after one year Rubella - accepted after 4 weeks Smallpox - accepted after 8 weeks TAB - accepted Tetanus - accepted Varicella - accepted after 4 weeks

Varicella-zoster Refer to Herpes virusesVitiligo Accepted if without systemic symptoms


Annex IIEgyptian National Processing Specification

Com

pone

nt

Technicalinformation

Stor

age

tem

p.(°

C)

Max. storageperiod (days)

Tra

nspo

rtte

mp.

(°C

)

Parameter specification

Wholeblood

A unit of bloodcollected intoapproved containercontaininganticoagulant.WB unit consistingof 450 ml ±10% ofblood plus 63 mL ofanticoag OR500 ml ±10% ofblood plus 70 mL ofanticoagulant

4 ± 2 CPD =21dCPDA-1=35 dACD=21 d

Interrupted closesystem24hoursin 4 oC

2-10

Volume (ml)

450 45ml plus63ml anticoag.500 50ml plusanticoag. 70ml

Haemoglobinlevel

Minimum 12%(♀)& 13% (♂)

Hematocritvalue (Hct)

37-39 %

Haemolysis No visual signdetected

PRBCs

Red cell componentprepared byremoving aproportion of theplasma from wholeblood

4 ± 2 CPD =21dCPDA-1=35 dACD=21 dInterrupted closesystem24hoursin 4 oC

2-10 Volume 280 + 50 mlHematocritvalue (Hct)

60-75 %


PRBCs inadditivesolution

A red cellcomponent preparedby removing aproportion of theplasma from wholeblood andsuspending in anapproved additivesolution

4 ± 2 SAGM orAdditive solution42dInterrupted closesystem24hoursin 4 oC

2-10 Volume 280 + 50 plus100ml SAGM

Hematocritvalue( Hct)

50-70 %


WashedPRBCs

Red cell component,which has beenwashed with 0.9%w/v sodium chloridefor injection.Then add approvedadditive solution forre- suspension.

4 ± 2 Interrupted closesystem24hoursin 4 oC

2-10 Volume Variable


60-75 %


Leucocytescount

2.9×108

Residualprotein

<1.0 g/unit


Com

pone

nt


Stor

age

tem

p.(°

C)


Tra

nspo

rtte

mp.

(°C

)


Leuco-depletedPRBCs

A red cellcomponent preparedby removing aproportion of theplasma fromleucocyte depletedwhole blood or byremoving aproportion of theplasma from wholeblood, followed byleucodepletion of thered cells.

4 ± 2 CPD =21dCPDA-1=35dACD=21dInterrupted closesystem 24hoursin 4 oC

2-10 Volume 280 + 50 ml


65-75 %


ResidualLeucocytes

< 5×106 /unit

IrradiatedPRBCs

Packed red cells canbe irradiated at anytime up to 14 daysafter collection.

4 ± 2 It is stored for upto 14 days afterirradiation

2-10 Indicator To determine doseof irradiation


RandomDonorPlatelets

The component mustbe prepared atambient temperaturebefore the red cellcomponent is cooledto its storagetemperature.

Appropriate packspecified forplatelets should beused

22 ± 2 5 days incontinuous gentleagitation

According toinstructionsrecorded on thebag.

Interrupted closesystem 6 hours inthe roomtemperature

20-24 Volume 50-60 ml

Platelet count Minimum 5×1010/unit

PH at the endof therecommendedshelf life

6.4-7.4


Com

pone

nt


Stor

age

tem

p.(°

C)


Tra

nspo

rtte

mp.

(°C

)


Leuco-depletedRandomPlatelets

Post processingleucodepletion of therandom platelets.


According tomanufacturer’sinstructionsrecorded on thebag.


20-24 Volume 50-60 mlPlatelet count Minimum5×1010PH at the endof therecommendedshelf time

6.4-7.4

ResidualLeucocytes

<0.3 ×10 6 /unit

SDP(Apha-eresis)

Platelets Apheresis,Leucocyte Depletedmay be collected bya variety ofaphaeresis systemsusing differentprotocols.

Appropriate packspecified forplatelets should beused


According tomanufacturer’instructionsrecorded on thebag.


20-24 Volume Variable accordingto session

Platelet count >3 ×1011 /unit

PH at the endof therecommendedshelf life

6.4-7.4

ResidualLeucocytes

<5×106/leucodelpeted unit


Com

pone

nt Technicalinformation

Stor

age

tem

p.(°

C) Max. storage

period (days)

Tra

nspo

rtte

mp.

(°C

)


Freshfrozenplasma

Plasma obtainedeither from wholeblood or byapheresis.The plasma has beenrapidly frozen to atemperature that willmaintain the activityof labile coagulationfactors.The Plasma must befrozen within 8 hoursof collection.

<-30 Minus 18C 3 months Fluctuatingbetween minus23-30C 6months <minus3012 months

<-30 Volume >170 ml

Factor VIII >0.7 IU/ml

RBCs Trace or not

Visualchanges

No abnormal color

Freshfrozenplasmapoorplatelets

Supernatant plasmathat has beenobtained during thepreparation ofplatelets fromplatelet rich plasma

<-30 Minus 18 C 3 months Fluctuatingbetween minus23-30C 6months <minus3012 months

<-30 Volume >150 mlFactor VIII >0.7 IU/mlRBCs Trace or notVisualchanges

No abnormal color

Cryo-ppt

Cryoprecipitate isthe cryoglobulinfraction of plasmaobtained by freezing-thawing – refreezingtechnique of a singledonation of FFP at4°C ± 2°C.

<-30 Minus 18 C 3 months Fluctuatingbetween minus23-30C 6months <minus3012 month

<-30 Volume 20-30 ml

Factor VIII >80 IU/unit

Fibrinogen >140mg/unit

Content Von willebrandfactor.Fibrinogen&Fibro-nectin.FXIII

Cryo-depletedfrozenplasma

The supernatantplasma removedduring thepreparation ofCryoprecipitate.

<-30 Minus 18 C 3 months Fluctuatingbetween minus23-30C 6months <minus3012 month

<-30 Volume >170 mlcontent Stable coagulation

factorsAlbuminIgs


Annex III

Key: = Mandatory;

- = not mandatory (Unless clinically required.)

Blood components suitable for use in intrauterine and exchange transfusion and neonates andinfants under one year, specific requirements

Free fromclinically

significantred cell

antibodies

CMVnegative

Gammairradiated

Preparedfrom

previouslytesteddonors

Mandatorytesting

required

Leucocytedepleted

Requirement

Red Cells forIntrauterineTransfusion (IUT),Leucocyte DepletedWhole Blood forExchangeTransfusion,Leucocyte DepletedRed Cells forExchangeTransfusion,Leucocyte Depleted

-Red Cells forNeonates andInfants, LeucocyteDepleted

-Red Cells inAdditive Solutionfor Neonates andInfants, LeucocyteDepletedPlatelets for IUT,LeucocytesDepleted

-Platelets forNeonatal Use,Leucocyte Depleted

--Fresh FrozenPlasma, NeonatalUse, MB Treatedand Removed,Leucocyte Depleted


Annex IVVolumes & Weights Specifications for Whole Blood Processing

Weight of the component pack – Weight of the pack (including anticoagulant)

Volume of any component =Density of that component

Weight of any component pack = Volume of the component x Density of the Component+ Weight of the empty pack

Density of plasma = 1.03 Density of RBCs = 1.09 Density of Platelet = 1.03 Density of WB = 1.06

With 70ml anticoagulant With 63ml anticoagulantVolume Weight Volume Weight

Ideal 500ml ± 50ml(450-550ml) 565gm - 671 gm 450ml ± 45ml

(405-495ml) 509gm - 605 gm

Low VolumeProcess PRBCs &discard plasma

400 - 449ml 512 gm to564gm 300 - 404ml 398gm- 508gm

Discard whole bloodunit

Over 550mlBelow 400ml

Over 671gmBelow 512gm

Over 495mlBelow 300ml

Over 605gmBelow 398gm


Annex V

Classification ofAdverse Transfusion

Reactions

Acute transfusionreaction

Immunologic

Hemolytic

Allergic&

Anaphylactic

Febrile

TRALI

Non Immunologic

Mechanical

Bacterial sepsis

Circulatoryoverload

Hypocalcemia

Hypothermia

Delayed transfusionreaction

Immunologic

Hemolytic

PTP

GVHD

Non Immunologic

Iron overload

Disease transmission

(Viral &bacterial& Parasitic)


Adverse Transfusion Reactions

Type Cause Symptomsand Signs Prevention Treatment

AcuteHemolytic

- Incompatibilitydue to clericalerrors, involveABOincompatibility

- Anxiety- Dyspnea- Flushing- Fever, rigors- Pain at infusionsite, lumbarspine and flanks- In case ofanaesthetizedpatient signs arehypotension andbleeding

- Avoid clericalerrors- Insure propersample andrecipientidentification

- Stoptransfusion- Give fluids tomaintainurinary output- Diuretics- Mannitol- Treatment ofDIC and shock

Non-Hemolytic(Febrile)

- Antibodies toLeucocytes

- Chills- Fever- Rigors

- Pre transfusionAnti pyreticLeucodepletionof the bloodcomponent

- Stoptransfusion andgiveantipyretics

Allergic

- Antibody todonor plasmaproteins

- Urticaria- Pruritis- Flushing

- Pre transfusionAntihistaminicWashing of theRed cell bloodcomponents

- GiveChlorophenera-mine 10 mgslowly I.V- Adrenaline 0.3mg dilution(1:1000)subcutaneous- Commenceoxygen andSalbutamolnebulizer (5mg)

AnaphylacticReaction

- IgA Antibodyin patient withIgA deficiency

- Hypotension- Urticaria- Bronchospasm(respiratorydistress,wheezing)- Laryngealeodema- Loss ofconsciousness

- Closeobservationduring the firstquarter hour ofinfusion

- Hydrocortisone- Chlorphenera-mine- Adrenaline S.C(1:1000) or I.Vdil(1:10,000)


TransfusionRelated AcuteLung Injury(TRALI)

- Anti-WBC’santibodies indonor reactwith recipient'sgranulocytes

- Hypoxemia- Cyanosis- Respiratoryfailure- Hypotension- Tachycardia- Bilateralpulmonaryodema

- Ab screeningfor donors'blood ifpositivediscard theplasma unit.- Avoid donationfrommultiparouswomen ormultipletransfuseddonors

- IV steroids,- 100% oxygenventilate ifhypoxia

MechanicalHemolysis

- Physical orchemicaldestruction ofblood (heating,freezing,hemolytic drugor solutionadded to blood)

- Hemoglobinuria - Inspect allunits and neveradd solutionsto blood

- Stopimmediatelyand give IVfluids

BacterialContamination

- Bacterialcontaminationof bloodcomponents

- Rapidlyincreasing fever,rigors- Hypotension- Nausea,vomiting withabdominalcramps and ifsevere willpresent withcrash(cardiovascularcollapse) withinthe first 15 min.

- Care in bloodcollection andstorage

- Oxygen,- IV fluidsupport- Commencebroad spectrumantibiotic as anemergency assoon assuspected

CirculatoryOverload

- Volumeoverload whenthe rate oftransfusion istoo rapid

- Dyspnea- Cyanosis- Orthopnea- Cough- Tachycardia- Hypertension- Severe headache

- Avoid rapid orexcessivetransfusion

- Place patient inupright position- Diuretics(frusemide) 40-80 mg I.V ,- Reduce fluidsand considerphlebotomy


Hypocalcemia

- Rapid citrateinfusion- Delayedmetabolism ofcitrate- Massivetransfusion ofcitrated blood- Apheresisprocedures

- Parathesia- Tetany- Arrhythmia

- Avoid rapid orexcessivetransfusion- Ca supplementby mouthduringapheresisprocedures

- Slow calciuminfusion whilemonitoringionized Calevel in severecases

Hypothermia

- Rapid infusionof cold blood

- Cardiacarrhythmia

- Warming ofbloodcomponent incase of massivetransfusion

- Stoptransfusion

DelayedHemolyticReaction

- Alloimmuniza-tion to red cellAgs

- Fever- Jaundice- Chills- Pain or dyspena- Rarely RF- Low Hb highLDH and lowhaptoglobinhaemoglobinuria

- Screening forRed cell Abs- Transfusion ofphenotypedblood

- Many patientstolerate withouttreatment,- Fluids anddiuretics are notindicated unlessrenal failure,- IVIG may help

PostTransfusionPurpura

- Recipientplateletantibodyusually anti-HPA1-a whichdestroyautologusplatelets

- GeneralizedpurpuraThrombocytopen-ic purpura ,bleeding 8-12days (range of 1-24 days posttransfusion )- Usually occur inmultiparouswomen- Cerebralhaemorrhagemay occur

- HPA1- anegativeplateletstransfusion

- Self limitedwith fullrecovery within21 days- IVIG- Plasmaexchange- High dosesteroids


Graft VersusHost Disease

- Donorlymphocyteengrafted,clonally,expanded inimmunecomponentrecipient andattacks histissues.

- Erythroderma- Maculopapularrash

- Anorxia- Nausea,vomiting

- Diarrhea- Hepatitis- Pancytopeniaand fever

- High mortalityrate

- Irradiation ofthe bloodcomponent inimmunocompri-mizedpatients.

- Methotrexateandcorticosteroids

Iron Overload

- Multipletransfusionwith obligateiron load intransfusiondependentpatients

- Diabetes- Cirrhosis- Cardiomyopathy- Organ failure

- S. Ferritinshould be doneevery 6 monthin transfusiondependentpatients

- If elevatedchelator isgiven.

- Fe - chelators


AABBBBRREEVVIIAATTIIOONNSS

Ab AntibodyACD Adenine Citrate DextoroseACUB Appropriate Clinical Use Of BloodAIDS Acquired Immunodeficiency SyndromeAg AntigenAHG Anti-Human GlobulinAnti-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 PlasmaCJD Creutzfeldt-Jakob DiseaseCLIA Chemiluminescence immuno-assayCPD Citrate Phosphate DextroseCPDA-1 Citrate Phosphate Dextrose AdenineCryo-ppt CryoprecipitateDAT Direct Antihuman globulin TestDIC Disseminated Intravascular CoagulopathyEIA Enzyme immuno-assayEmail Electronic MailERD Entity Relationship DiagramFFP Fresh Frozen PlasmaFNHR Febrile Non-Hemolytic ReactionFDA Food and drug administrationGMP Good Manufacturing Practice.GvHD Graft Versus Host DiseaseHb HemoglobinHBB Hospital Blood BankHBsAg Hepatitis B surface AntigenHBV Hepatitis B VirusHct HematocritHCV Hepatitis C VirusCMV CytomegalovirusHIV Human Immunodeficiency VirusHLA Human Leucocyte AntigenHR Heart RateHTC Hospital Transfusion CommitteeIAT Indirect Agglutination TestIg ImmunoglobulinIgA Immunoglobulin A


IgG Immunoglobulin GIgM Immunoglobulin MIM IntramuscularIT Information TechnologyIUT Intra-Uterine TransfusionIV IntravenousLAN Local Area NetworkNIC Network Interface cardMPX MultiplexMPX format Multiple screening in single test (HBV, HCV, HIV)MRL Microbiology Reference LaboratoryNSAIDs Nonsteroidal anti-inflammatoryNAT Nucleic acid amplification technologyNBTS National Blood Transfusion ServiceOH & S Occupational health & safetyOS Operating SystemPC Personal ComputerPlt PlateletsPRBCs Packed Red Blood CellsQC Quality ControlQMS Quality Management SystemRBCs Red Blood CellsRBTC Regional Blood Transfusion CentreRDP Random Donor PlateletRh Rhesus FactorSAGM Saline Adenine Glucose MannitolSDP Single Donor PlateletSOP Standard Operating ProcedureTTIs Transfusion Transmissable InfectionsvCJD variant Creutzfeldt-Jakob DiseaseWB Whole BloodWHO World Health Organisation


Glossary of Terms

ا اماصطحت خت فى

English Term English Definition Arabic Definition ArabicTerm

Accreditation: Procedure by which anauthoritative bodygives formalrecognition that a bodyor person is competentto carry out specifictasks.

م اي اإلاء ،م م شص أو ظ إلد

.ارف م ط ا أوا

ر ء الح ذاتاءة ك شص أو ن

م م الزا. شص ر أوم

آلداء ر ء ظ أو.دة

وث/إد

Accuracy: Agreement betweenthe results obtainedand the true value.

ال ا ائج اا ا.

ا

Audit: Systematic,independent anddocumented processfor obtaining evidenceand evaluating itobjectively todetermine the extent towhich audit criteria arefulfilled.*

ث / إذا ط و ن ئا اطت

دة .ظمث أو/و

ط و لأد دح األد ه

اا اة *.ادة/ى

اا

Audit Client: Person or organizationrequesting an audit.*

اب اص أو ؤااا.*

ه ااع

AuditConclusions:

Outcome of an auditdecided by the auditteam afterconsideration of all theaudit findings.*

اا ا ائج إت را

اا.*

اا ئج

Audit Criteria: Set of policies,procedures orrequirements againstwhich collected auditevidence is compared.*

اءاتواإل ات األد ا وات

أ اا ا.*

ي/أساا

Audit Evidence: Records, verifiedstatements of fact orother informationrelevant to the audit.*

أي أو ؤة ئا أو االت أخى ت

اا.*

اا أد


English Term English Definition Arabic Definition Arabic Term

Audit Findings: Identified compliancesand non-compliancesagainst the standardsused for the audit

Results of theevaluation of thecollected auditevidence against auditcriteria.*

أوم ا ر

اا.

اا ئج ر أواا/س *.

اا ئج

Audit Program: Set of audits to becarried out during aplanned timeframe.*

ت /أو ام ا اا

ز .*

اا بج

Audit Scope: Extent or range of agiven audit.*

اا أوق .*ى طق/لاا

Audit Team: One or more auditorsconducting an audit,one of whom isappointed as leader.*

ن أ أو ائ اح و اا

*.

اا يف

Auditee: Organization beingaudited.*

ا ظا أو ا أو ا ا.

اا ظا .*أو

ه ااع

Auditor: Person qualified andcompetent to conductaudits.*

التؤا ك اي اصاا م .*واءة

ااع

Benchmarking: Audit Evidence:records verifiedstatements of fact orother informationrelevant to the audit.- ISO 9000 (2000)

و ج دراأ رت اآلداء غض اس

ا ا.

اآلداء ر

Blood ColdChain:

The maintained storageof blood and productsat the appropriatestorage temperatureand conditionsfrom the point ofcollection to the pointof use – ‘from vein tovein’.

و أو ام ئإ ح .اع

در و ام أو ا اظوف و اارة

االام و ح ا و.

اردة اام زين



Calibration: The set of operationswhich establish, underspecified conditions,the relationshipbetween valuesindicated by ameasuring instrumentor measuring system,or values representedby a material measure,and the correspondingknown values of areference standard.

الا ر م ا اتز اام ا ا ا وا وا

ا.

م ا ات أو ا ا الا ءوا س دة أو ظم أو آداة ا وا

ا.

ية

Capability: Ability of anorganization, system orprocess to realize aproduct that fulfils therequirements for thatproduct.*

ا أو اظم أو ظا رةت إخاج

ا .*ا

رة

Chief ExecutiveOfficer[CEO]:

Chief executive officer ىا ا اذى يا

Characteristic: Distinguishingfeature.*

ةا *.ات خئص

ClinicalInterface:

The relationshipbetween the producersand users of blood andblood productsMeeting requiredstandards.

و الماا ا ه أو

ا.

ييا هاا/اإلك

Compliance: Meeting requiredstandards.

ا//ا ا.

اإلام

Concession: Authorization to use orrelease a product thatdoes not conform tospecifiedrequirements.*

)ا اا)االتاإلاج أو اام ئاات ال

ا ا ا*.

زل

Conformity: Fulfillment of arequirement.*

اا .ت أو

.*ادة



Consistency: Doing the same thingtime after time, whichmakes the outcomemore predictable andallows for reducedvariation in productsand processes?

ا ارإاءا ت ن ى

و ا وا ئا ا.اإلخالف

،ة ة ا أوارئا اات ا و أك ه

وات .ات

اساري/ات

ContinuousQualityImprovement:

The ongoingimprovement processat the centre of allquality systems: plan,do, check and act, asencapsulated in theDeming Cycle.

دةا ظأ ا اخ /أ//ك ل

د دائة رك .

أسارادة

Contract: Formal agreement ofintention to supply aproduct or service inaccordance withagreed specifications.

اإلاد ر اقا ا ع ش خ أو

.

/

Contract Review: Systematic activitiescarried out by thepurchaser to ensurethat contractualrequirements havebeen met.

م ا ا األات ن اى

ا.

ا ا/ا

Correction: Action taken toeliminate a detectednonconformity.*

أو ات إلزا ا افا .*م

ح

CorrectiveAction:

Action taken toeliminate the cause ofa detectednonconformity or otherundesirable situation.*

ا إلزا ا افأي أو ا م أو ات

أخى ا*.

إاء

Critical ControlPoints:

Those steps in aprocess or procedurethat, without control,will lead to a poorquality outcome.

ا اإلاء أو ا خاتإذا دة ت ا ؤدى

ا .

ا ا طئا أو

Customer: Organization or personthat receives aproduct.*

ا اص أو ظا ىا/ا*.

ا/زن



CustomerDissatisfaction:

Customer’s opinion ofthe degree to which atransaction has failed tomeet the customer’sneeds and expectations.*

نا ى/رأى ا /

ه و .*إه

ا إرء م

CustomerSatisfaction:

Customer’s opinion ofthe degree to which atransaction has met thecustomer’s needs andexpectations.*

نا ى/رأى ا /ح

ه و إه *.

ا إرء

Defect: Non-fulfillment of arequirement related to anintended or specifieduse.*

أوا ا /اءاإلا اات .

تا أ ا أواد الام أوا

.*اد

ب/خ

Deming Cycle: The Plan-Do-Check-ActCycle

خ ←←ا←دائة.ل

ديج دائة

Dependability: Collective term used todescribe the availabilityperformance and itsinfluencing factors:reliability performance,maintainabilityperformance andmaintenance supportperformance.*

م م اؤة اا و اح اآلداءوى اراإل ه

ه .*اإلد

دياإل

Design andDevelopment:

Set of processes thattransforms requirementsinto specifiedcharacteristics and intothe specification of theproduct realizationprocess.*

ل ا ات دة خئص ا ات

اإلج ات .و

يا و ا

Deviation Permit: Authorization to departfrom the originallyspecified requirements ofa product prior torealization, for a limitedquantity of product orperiod of time, and for aspecific use .*

تاا اإلاف ازةة ا أو ا

ض أو *.ودة

اإلاف إزة



Documentation: All the writteninstructions, recordsand actions involved inproviding a product orserviceInformation and itssupport medium.*

التا و وا ات عأو ا ا األ و

ا .*ت

ا/ثقا

DocumentControl:

Formal control of theissue, use and reviewof authorizeddocuments within thequality system.

و إار ا ااة ئا ا و إام

دة ظم داخ.

اثئق ا/االت

Effectiveness: Measure of the extentto which plannedactivities are realizedand planned resultsachieved.*

غو األ ى س ا ئا*.

Efficiency: Relationship betweenthe result achieved andthe resources used.*

ا اارد الوا ا ئا*.

كءة

External QualityAssessmentSchemes[EQAS]:

External qualityassessment scheme

ام ا اآلداء و ذو/ت و

ئ ر و ئاألخى ا.

ادة هجرا

Error: An incident where thequality system hasfailed

دةا ظم ا .ادث خ

Evaluation: The specific selectionprocess to determinethe suitability of aprocedure or material(e.g. reagent, bloodpack, equipment)

م دة إخر أو اإلاء الئ أ

.ادة

/ي

Fitness forPurpose:

Suitability of a productor service for thepurpose for which it isintended

ا الئ/ض اه .اد

غض الئا/هف

Good LaboratoryPractice [GLP]:

Good laboratorypractice

ةا ا را. ا رسااة



GoodManufacturingPractice [GMP]:

Good laboratorypractice

ا اع ر. اع رسا

Guidelines: Document statingrecommendations orsuggestions.*

تا د ئو.*وات

/راتإرشدات

Haemovigilance: The monitoring,reporting andinvestigating ofadverse incidents/nearmisses related to allbloodtransfusion activities

و واإلالغ ا ااادث أو ا اادث

ت ع ا شا.ام

إسات اام

Indicator: Information gathereddirectly or indirectly atthe critical controlpoints in a process orprocedure

ش ا اتش اأو ط

إاء أو ا.

ؤش

Infrastructure: System of permanentfacilities andequipment of anorganization.*

/ ظواالة/ات اا

ظ ا ا*.

ا ا/ساألس

Inspection: Conformity evaluationby observation andjudgmentaccompanied, asappropriate bymeasurement, testingor gauging.*

أوا ا وا ظالا

ار أو أواإلخر اسا*.

ص

Interested Party Person or group havingan interest in theperformance or successof an organization.*

ا ا أو /اصظا ح أو داء ا*.

ا /افا

Internal QualityAssessment[IQA]:

The assessment of alaboratory’s overallquality system by theprocess of halving asample, analyzingeach half in the samemanner and comparingthe results

ا ادة ظم إ و أخ ك ام رو األب ة

ئا.

اخا ادة



InternationalOrganization forStandardization[ISO]:

InternationalOrganization forStandardization

س و ا ا.*ادة

ا ظاقس و ح

ادة

Maintenance Includes preventativemaintenance, normalrepairs, replacement ofparts and structuralcomponents, and otheractivities needed topreserve the asset sothat it continues toprovide acceptableservices and achievesits expected life.

،ئا ا ى و ادة، زاءات

اى أ وأي وتأ ات ظ

ات اإلار از أار و اة

ه اء ااضاال.

ا

Management Coordinated activitiesto direct and control anorganization.*

ت وا ة/اا*.

اإلدارة

ManagementSystem:

System to establishpolicy and objectivesand to achieve thoseobjectives

وا أاف و ء ماالاف ه .ق

اإلدارة ظم

Measurement: Set of operationshaving the object ofdetermining the valueof a quantity.*

ا ف ات *.

اس

MeasurementProcess

Set of interrelatedresources, activities,and influences relatedto a measurement.*

و ات و اارد ا اا اؤات

.*س

اس

Monitoring: The (on-going/continual)collection and analysisof data about anactivity

ت ا وا اع ط ا.

اق/ب

Noncompliance: Not meeting requiredstandards (GMP). Seealso Nonconformity

ال اع.(اا ر و

ا(

اإلزام م



Nonconformity: Non-fulfillment of arequirement.*

با از .مت ق م أو

.*ادة

طبم

ObjectiveEvidence:

Data supporting theexistence or verity ofsomething.*

ءش أو ود .*ت اس ال

Organization: Group of people andfacilities with anorderly arrangement ofresponsibilities,authorities andrelationships.*

قاوا األشص ؤوت

االت/وات.*واالت

ظ/ؤ

OrganizationalStructure:

Orderly arrangementof responsibilities,authorities andrelationships betweenpeople.*

و اؤت واال ات ت

.*اس

اظي ال

Policy: A high-level overalldocument embracingthe goals & intentionsof the organization.

اإلدارة ى و و أاف ى

.

Precision: Reproducibility of thequantifiable outcomesof processes andprocedures.

اءاتاإل و ات ئ ارس ا.

قا

PreventiveAction:

Action taken toeliminate the cause ofa potentialnonconformity or otherpotentially undesirablesituation.*

م إاءاق أوأى ا

غب غ*.

إاء/إاءوقئى

Procedure: Specified way to carryout an activity or aprocess.*

ط أو م دة *.

إاء

Process: System of activitieswhich uses resourcesto transform inputs intooutputs.*

م األ إ الت اارد

.*ت



Product: Result of a process.* ا *. ج/ج

Project: Unique processconsisting of a set ofcoordinated andcontrolled activitieswith start and finishdates undertaken toachieve an objectiveconforming to specificrequirements includingthe constraints of time,cost and resources .*

ن ة ذات ا و ا األ

إائرخ ورخ ا ت اق ف ق

ا و ا ود .*واارد

شوع

Quality: Ability of a set ofinherent characteristicsof a product, system orprocess to fulfillrequirements ofcustomers and otherinterested parties.*

تا رة أو م أو اا أى أو ا ت ق

اى *.

دة

QualityAssessmentSchemes [QAS]:

Quality assessmentscheme

دةا م ادة ظم

Qualification: Combination ofpersonal attributes,minimum education,training, work andaudit experience, andcompetenciespossessed by anauditor.*

:وا، ا ات،روا ،ا األد

،اا وة ،ا واة ا اءات ا الض

.*ااع

اؤهالت

QualityAssurance[QA]:

Part of qualitymanagement focusedon providingconfidence that qualityrequirements arefulfilled.*

ادة إدارة ء ادة ت ن ا

.ا ا واإلج ا وذك دة

ا*.

ادة ك/أك

QualityCharacteristic:

Inherent characteristicof a product, process orsystem derived fromrequirement.*

ا أو ا أ تا ام /أو

ا*.

ادة خئص



Quality Control[QC]:

Part of qualitymanagement focusedon fulfilling qualityrequirements.*

ادة إدارة ءآ و ادة ت ق

اإلج ا*.

ادة ى ا

QualityDepartment:

The identified andauthorized departmentwithin an organizationresponsible for theoverall development,organization andmanagement of qualityand quality systems

ال و ارف ا و اإلدارى و ا ار

ادة و .ادةذو ا ا أو

الا/،ا دا اوإدارة و ال

ادة و .ادة

ادة ق

QualityEvaluation:

Systematicexamination of theextent to which anentity is capable offulfilling specifiedrequirements

Progression in theprinciples of a qualitysystem frominspection, qualitycontrol, qualityassurance, totalquality management

ةو رة ى /إردة ت ق .

دةا م أت ام أوإدارة و و و

.دة

ادة

QualityImprovement[QI]:

Part of qualitymanagement focusedon increasingeffectiveness andefficiency.*

ادة إدارة ءار واءة ا .*زدة

ادة ن

Quality Loop orQuality Spiral:

Conceptual model ofinteracting activitiesthat influence qualityat the various stagesfrom identification ofthe needs to theassessment ofsatisfaction

تا رى ذج ادة اا

أوح اإرضء إ اإلت

ا.

ادة دائة

QualityManagement:

Coordinated activitiesto direct and control anorganization withregard to quality.*

ا و اادة ا*.

ادة إدارة



QualityManagementSystem [QMS]:

System to establish aquality policy andquality objectives andto achieve thoseobjectives.*

ءإ و دة إلء مه ق وا دة أاف

.*األاف

ادة إدارة ظم

Quality Manager: The appointed,responsible andauthorized individualwithin an organizationwith the responsibilityfor developing andmanaging the qualitysystem.

ك اي ال ا اع واى ا دا ال

م وإدارة .ادة

ادة

Quality Manual: Document specifyingthe qualitymanagement system ofan organization.*

دةا ادارة م د و ؤ*.

ادة دل

QualityObjective:

Something sought, oraimed for, related toquality.*

ق ،إ وف ث شء.*دة

ادة/دل هف

Quality Officer: An individual whoworks within thequality department ofan organization andwho is primarilyconcerned with theday-to-day operationand maintenance of thequality system.

ا اى ان واى ا ادة

وا اق األ إادة م ا.

ادة ثل

Quality Plan: Document specifyingthe qualitymanagement systemelements and theresources to be appliedin a specific case.*

م ارد و د و ق ادة إدارة

*.

ادة خط



Quality Planning: Part of qualitymanagement focusedon setting qualityobjectives andspecifying necessaryoperational processesand related resourcesto fulfill the qualityobjectives.*

ك ادة إدارة ء و دة أاف

ورا واارد اتاألاف ه .*ق

ادة ط

Quality Policy Overall intentions anddirection of anorganization related toquality as expressed bytop management.*

ا وات اا وادة دة ا

ا .*اإلدارة

ادة

Qualityrequirement:

Requirement forinherent characteristicsof a product, process orsystem.*

الز ئ أ تم أو أو *.

ادة ت

Quality system: Organizationalstructure, procedures,processes, andresources needed toimplement qualityrequirements.

و اإلاءات و اإلدارى، ا ورا اارد و ات

ادة ت ق أ.

ادة نظم

Quarantine: Non-authorization toproceed to next stageof a process untilspecified standards /conditions are met

ا ر ا االل ال .

الا ود م ا/أو ا ا إ الل اء وط/اش

.دة ا االل أو

أو ق ا .ظوف

ا

Record: Document statingresults achieved orproviding evidence ofactivities performed.*

أو ا ئا وام اي األ د

*.

Recruitment The process ofeducating, motivatingand selectingprospective blooddonors.

و ا اام ي ب و

ا.

ز و إباع



Release: Authorization toproceed to next stageof a process.*

االل الا *.

إفاج

Requirement: Need or expectationthat is stated,customarily implied orobligatory.*

ن ، أو اجن أو ض رف

.*إرى

ت

ResponsiblePerson

An individual formallydesignated as beingresponsible for thequality of definedoperations or outcomeswithin an organization.

ال ن ر شئ أو دة ت دة

ا ا .

اؤل اشص

Review: Activity undertaken toensure the suitability,adequacy,effectiveness andefficiency of thesubject matter toachieve establishedobjectives.*

الئ ن ام طا ادة وكءة و وك

األاف غ أ ضا*.

ا

Service: Intangible product thatis the result of at leastone activity performedat the interfacebetween the supplierand customer.*

ن س األ وا ط

و ارد كا ااا*.

خ

Software: Intellectual productconsisting ofinformation on asupport medium.*

ن ى ت و*.

و ن ى .*ت

ت

Specifications: Document statingrequirements.*

تا د و*. ات

StandardOperatingProcedure [SOP]:

Written instructions forthe performance of aspecific procedure.

ام أل ات.دة

ح ت أود اء .ام

ا ا ق

Standard: Minimum levelrequired.

با األد .اى س/ر



StatisticalProcess Control[SPC]:

The continuousmonitoring andcharting of a processwhile it is operating,to warn when theprocess is movingaway frompredetermined limits.Typically the upperand lower controllimits will be threestandard deviationsaway from the mean.All points outside thecontrol limits shouldbe investigated andcorrected.

ا اي وا اأى ،ا

، ارة اود اافا و األ ا ار ن

ال ا األدر اط.إات

أن اود ه راو اى .

اإلحئى كا

Supplier: Organization orperson that provides aproduct.*

م اى ا أو ا/ *.

ال/ارد

System: Set of interrelated orinteracting elements.*

أو اا ا ا*.

نظم

TechnicalExpert:

Person who providesspecific knowledge orexpertise with respectto a particular subjectfield to be audit.*

ة أو ذو ش أو ضع

ا*.

اى ا

Test: Technical operationthat consists of thedetermination of oneor more characteristicof a given product,process or serviceaccording to aspecified procedure.*

ن أو ئ أك أوإلاء أو

.*د

إخر

Topmanagement:

Person or group ofpeople who direct andcontrol anorganization at thehighest level.*

صاألش أو شدارة /م وا

ى أ ا*.

ا اإلدارة



Traceability: Ability to trace thehistory, application orlocation of that whichis underconsideration.*

أو إام أو رخ إاإلر شء أى .*ن

األث إء

Validation: Confirmation andprovision of objectiveevidence that therequirements for aspecific intended useor application havebeen fulfilled.*

ث ادة ك م ءا اات ا ك أ

و . س د و ك أو

الزا ات إلامق ا أو واد .اد

)ا ر ا وا(

ياالح/إار

WorkEnvironment:

Set of conditionsunder which a personoperates.*Set of conditionsunder which a personoperates.*

اوف و ا.

ا اوف أوأء اي و

.*أداؤه

ا

.دة* ا ات 9000:2000وف* ISO 9000 : 2000

Egyptian National Blood Standards 2nd Edit. 2011

Documents

Transcript of Egyptian National Blood Standards 2nd Edit. 2011