UAE Healthcare / Pharma LawCabinet Resolution No. (28) of 2008 Regarding the Blood Transfusion Regulations

Article (5) This Resolution shall be published in the Official Gazette. All previous resolutions that contradict or conflict with the provisions of this Resolution shall be repealed. It shall enter into force from the date of its publication. Mohamed bin Rashid Al Maktoum Prime Minister Issued by us in Abu Dhabi: Dated: 3 Rajab 1429 A.H. Corresponding to: 6 July 2008 A.D.

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Cabinet Resolution of 2008 Regarding the Blood Transfusion Regulations 3 Table of Contents: Section One: Administrative Regulations for the Technical Aspects of Blood Transfusion Service Centers Chapter One: Blood Transfusion Service − Definition 7 − Classification of blood transfusion service centers 7 − Main functions of blood transfusion service center 7–11 − Competences of the laboratory department at the Central Blood Center 11 − Conducting Viral laboratory Diagnostics 11 − Blood components separation 12 − Storage of blood and blood components 12 − Monitoring of medical equipment 12 − Preserve donor result records 12 − Conducting confirmation tests for positive cases and for all tests via Enzyme-Linked Immunosorbent Assay (Elisa) 13 − Satellite Blood Bank (located within hospital laboratory departments 13 − Main functions of the Satellite blood bank 13–16 − Semi-fixed mobile blood banks 16–17 − Mobile blood banks 17 Chapter Two: Indications for the Optimal Use of Blood and It’s Main Components − Definition of blood 18 − Components of blood 18 a- Blood cells 18 1. Red Blood Cells (RBCs) 18 2. White Blood Cells (WBCs) 19 3. Platelets 19 b- Plasma 19–20

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Cabinet Resolution of 2008 Regarding the Blood Transfusion Regulations 4 c- Methods for Preserving Blood and Its Components: 20 1. Chemical Substances Used for preserving Whole Blood and the preservation Duration: 20  CPD 20  CPDA 20  CPDA-1 20  ADSOL or SAG-M 20–21  GLYCEROL 21 2. Biochemical Changes in Whole Blood and Its Components During Storage from Initial Collection up to 35 Days 22 3. Laboratory Diagnostic Tests on Blood Unit after Donation 22–23 d- Indications for Optimal Use of Blood and its Main Components: 23–25 e- Use of Blood and its Components in Blood Group Incompatibility: 25 1- As per ABO system 1/1- Transfusion of packed red blood cells 25 1/2- Blood Plasma Transfusion 26 1/3- Platelet transfusion 26 2- As per Rhesus (RH) System 2/1- Transfusion of packed red blood cells 26 2/2- Blood plasma transfusion 27 2/3- Transfusion of Platelet Concentrates 27 f- Role of blood banks in reducing the transmission of diseases 27–28 g- Blood transfusion risks 28–29 Chapter Three: Principles of Handling Blood and its Components: Introduction 30 Sterility 30–31 Gamma-Irradiation 31 Blood and Blood Components 1- Whole Blood 31–32 1-1- Modified Whole Blood

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Cabinet Resolution of 2008 Regarding the Blood Transfusion Regulations 5 1-2- Irradiated Whole Blood 1-3- Low Volume Whole Blood 2- Red Blood Cells and their Components 32–34 2-1- Red Blood Cells (RBCs) 2-2- Frozen Red Blood Cells 2-3- Washed Red Blood Cells 2-4- Leucodepleted Packed Red Cells 2-5- Rejuvenated (activated) red blood cells 2-6- Irradiated Red Blood Cells 2-7- Low Volume Red Blood Cells 3- Plasma Derivatives 34 3-1- Fresh Frozen Plasma (FFP) 3-2- Cryoprecipitate (Antihemophilic Factors) 3-3- Plasma frozen within 24 hours of donation 3-4- Liquid Plasma 3-5- Cryoprecipitate-Poor Plasma 4- Platelets 35 Laboratory tests conducted on donated blood 35 o ABO group Testing o Rh type Testing − Previous Blood Group Records 35 − Screening for Red Blood Cell Antibodies 36 − Screening for Infectious Diseases Associated with Blood Transfusion 36 − System for Disposal of Blood Units or Components Unsuitable for Transfusion 36 − Labeling process for blood and blood components 1- General conditions 36–37 2- Identification of Blood Unit or its Components 37 3- Labeling during collection or preparation 37

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Cabinet Resolution of 2008 Regarding the Blood Transfusion Regulations 6 4- Renewing blood component validity prior to the labeling process 38 5- Final Label prior to distribution 38 6- Cases for Special Labeling 38–39 − Storage, Transport, Receipt and Expiry Process: − Storage process 39–40 − Transportation process 40 − Receipt process 40 − Expiry date 40 − Method of storage, transport and expiry 41–46 − Documents and Records of blood transfusion centers 46–47 − Blood storage policy: The specified duration of blood storage is the retention duration of various records: 47–48  Permanent records  Records to be kept for a minimum of five years − Quality assurance requirements for blood and blood components 48–55 Section Two: Ensuring Safety of a Patient Receiving Blood Transfusion 56 Chapter One: Responsibilities of the Blood Bank 57–59 Chapter Two: Responsibilities of the physician ordering the blood transfusion 60–61 Chapter Three: Responsibilities of the Physician Supervising the Transfusion of Blood and Blood Components 62–64 Chapter Four: Rules and Regulations Governing Blood Transfusion Services 65–66 Key regulatory requirements for the work of blood banks 66-70 − Blood Banks Basic and administrative Regulation. − Comprehensive quality system applied in blood banks. − Hospitals Blood Transfusion Committees. − Tasks of the Hospital Blood Transfusion Committee

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Cabinet Resolution of 2008 Regarding the Blood Transfusion Regulations 7 Annex 1 Blood Transfusion regulation 2008 Regulation Contents Section One: Administrative Regulations for the Technical Aspects of Blood Transfusion Service Centers Chapter One Blood Transfusion Service Definition: Blood transfusion service center is the designation given to a center specialized in dealing with the public for the purpose of collecting blood, preserving it, conducting laboratory diagnostics, and dispensing it as per international regulations. Blood Transfusion Service Centers shall be classified as follows: 1. Central blood transfusion service center 2. Satellite Blood Banks (located within hospital laboratory departments) 3. Semi-fixed mobile blood banks 4. Mobile blood bank Main functions of blood transfusion service center: 1. Reception of blood donors, ensuring each donor is properly selected to exclude individuals with unsafe behavior, thereby monitoring the safety of the blood transfused to patients. 2. Verification of the donor’s identity shall be conducted by means of personal identification. The individual must possess a UAE-issued personal identification document bearing the holder’s photograph; no other form shall be accepted for blood donation. A Personal identification document refers to a passport, UAE health card, UAE Labour card, driving license issued within the state, or any other government

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Cabinet Resolution of 2008 Regarding the Blood Transfusion Regulations 8 issued ID that includes the holder’s photograph, UAE blood banks ID with photograph, or a work card issued by local departments. 3. The donor shall fill in the blood-donation questionnaire by providing accurate information for the items specified therein. 4. Inquiring about the donor via the computerized system, or from the blood center’s records if the system is not available, to find all relevant information regarding the number of donations (donations shall not exceed four times per year with at least three months interval between donations), and to obtain all relevant information about the donor, to avoid collecting blood from donors suffering from diseases or from any donor who has donated within a period shorter than the specified donation interval, and other important information. 5. Collecting a blood sample from the donor to perform the necessary medical tests such as the hemoglobin test, white blood cells and platelets count, and conducting a blood- grouping test at each visit to prevent repeated errors in blood-group determination. Blood group identification shall be conducted using ABO or Rh systems. 6. A physician shall be continuously present at each centralized blood center. In satellite blood banks, if no physician is available on-site, the donor may, if necessary, be referred to an internist or an emergency physician. 7. The clinical examination shall consist of measuring blood pressure and pulse rate, and conducting a private personal interview with the donor to inquire about matters related to the donor’s health condition as specified on the donation form. 8. After the physician approves the donation questionnaire, the donor is referred to blood collection halls or rooms, where the questionnaire is assigned a sequential number. The blood unit is then numbered, labeled, and prepared, and the donor undergoes psychological and physical preparation to ensure readiness for the blood- collection procedure. The volume collected is approximately 400-450 ml. 9. Measurement of blood pressure and pulse rate, and the personal interview shall be conducted by the physician, in the physician’s absence, by the nurse; and if the nurse is also unavailable, by the technician, in descending order of precedence. 10. The physician and technicians shall immediately discontinue the blood collection

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Cabinet Resolution of 2008 Regarding the Blood Transfusion Regulations 9 from the donor, if necessary, especially if the donor experiences fainting or any discomfort, or at the donor’s request. 11. If blood collection is discontinued for any reason after more than 150 mL has been collected from the donor, it shall be considered a complete donation. The donor shall be treated as having donated 450 mL in terms of both the information recorded in the blood center’s records and the utilization of the blood unit. 12. The donor shall be given a rest period of 5 -10 minutes after blood collection and shall be offered glucose-containing substances. The technician shall ensure the safety of the donor before departure from the blood center by enquiring about dizziness, vomiting, or nauseous. The technician should also put a medical bandit on the hand of the donor from the side where the needle pricked it after the end of the drawing process and before the donor exits the blood drawing hall or room. 13. The blood bank shall follow up with the donors (via phone, messages, and other means of communication) and extend thanks and appreciation to donors, especially those who have donated more than ten times, either through donor‐appreciation ceremonies or via certificates of appreciation. Each blood center shall immediately contact any donor whose blood tests yield a positive result, to arrange retesting. If the confirmation test is also positive, the physician at the blood center (in central blood centers) and the center manager at satellite blood banks shall inform the donor via an official letter to whom it may concern, including all donor information and medical test results, for appropriate treatment and preventive measures for the donor’s family. 14. After the collection of blood from donors, the blood units shall be transferred to the laboratory department at the central blood centers to conduct medical tests prior to being distributed to hospitals across the state. As for the satellite blood banks, the blood units are transferred to the hospital’s laboratory department for preservation and, if available, for conducting medical tests. Alternatively, samples from these blood units may be sent to the central blood center for conducting the necessary tests in accordance with the prescribed regulations. 15. Comprehensive information shall be maintained in the electronic record systems for blood donors, including their laboratory test results, donation dates, hemoglobin

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Cabinet Resolution of 2008 Regarding the Blood Transfusion Regulations 10 levels, blood pressure and other important information that is considered essential for each donor. This information shall be easily and promptly retrievable when needed. 16. A comprehensive monthly and annual statistics system shall be established covering the number of collected blood units and their components, the number of units dispensed to hospitals, and those discarded. It shall also include laboratory data related to the results for each donor and for each blood unit and its components. 17. A Quality Assurance and Quality Control program shall be established for all medical units and equipment. 18. A quarterly maintenance program shall be adopted for all the medical equipment used in the blood center to ensure its optimal performance and to avoid errors that could be fatal in blood centers. This maintenance program is known as Preventive Maintenance. 19. A proper program for preventing the transmission of infection during operations shall be established with a designated person responsible for its oversight. This system shall ensure continuous hygiene and sterilization of all used instruments, and require the use of plastic rather than glass tubes for blood samples to avert the risk of injury in the event of breakage. 20. Compatibility (X-matching) tests between the donor’s blood unit and the patient’s serum shall be conducted in accordance with the prescribed regulations as detailed on the blood‑transfusion request questionnaires. The X-matching test shall be conducted on all blood units intended for transfusion, even in emergency situations where units are dispensed before compatibility results are available. Thereafter, the technician shall notify the entity to whom the blood was dispensed to recall any incompatible units, discontinue any incompatible blood already dispensed to the patient, and provide compatible replacement units. 21. The educational level of employees of the blood center shall be enhanced by participating in regular lectures and seminars, attending scientific conferences within and outside the state, and maintaining ongoing communication with international scientific societies specializing in blood centers and transfusion, to stay abreast of the latest developments in blood transfusion.

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Cabinet Resolution of 2008 Regarding the Blood Transfusion Regulations 11 22. The competent administration shall provide blood centers with chemical solutions and supplies for blood transfusion operations, while maintaining a buffer stock sufficient to cover six months’ requirements in advance, to avoid any shortages and cover any unexpected emergencies. Competences of the Laboratory Department at the Central Blood Center: 1- Conducting Viral laboratory Diagnostics as follows: No. Test Name Test Abbreviation 1- Screening for antibodies to Human Immunodeficiency Virus, the causative agent of Acquired Immunodeficiency Syndrome (AIDS) Anti-HIV 1+2 2- Screening for protein 24 antigen of Human Immunodeficiency Virus type 1 (HIV-1) HIV-1 P24 Antigen 3- Screening for Hepatitis B surface antigen HBsAg 4- Screening for antibodies to Hepatitis C Virus Anti-HCV 5- Screening for antibodies to Human T-lymphotropic Virus types 1 and 2 (the causative agents of lymphotropic blood cell diseases) Anti-HTLV 1+2 6- Screening for syphilis (Venereal Disease) Syphilis 7- Screening for antibodies to Hepatitis B core antigen Anti-Hbc 8- Individual screening using nucleic acid testing (NAT) for Human Immunodeficiency Virus type 1 (HIV-1), the causative agent of Acquired Immunodeficiency Syndrome (AIDS), and for Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) during the window period NAT *With the possibility of adding any viral diagnostic test that health authorities may deem necessary to perform in the future.

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Cabinet Resolution of 2008 Regarding the Blood Transfusion Regulations 12 2- Blood components separation 1- Packed red cells 2- Concentrated platelets 3- Fresh frozen plasma 4- Cryoprecipitate 5- Repeat blood group testing on all blood units. 6- Perform blood component collection using apheresis, including plateletpheresis with plasma, plasmapheresis, or any device-specific procedures. 3- Storage of blood and blood components