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International institute of Health Management Research, Delhi

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1 International institute of Health Management Research, Delhi
T ransfusion Services International institute of Health Management Research, Delhi Minakshi Gautam Assistant Professor

2 History of Blood Bank Early development leading to establishment of banks dates back to 1915. It was when Richard Lewison of Mount Sinai Hospital, New York initiated the use of sodium citrate as an anticoagulant. This discovery transformed the blood transfusion procedure from direct (vein to vein) to indirect. The introduction of a citrate-glucose solution by Francis Peyton Rous and JR Turner 2 years later permitted storage of blood in containers for several days. Thus opening way for the first “blood Depot” established in Britain during World War I.

3 History of Blood Bank Within a few years, hospital and community blood banks were established across United States. Willem Johan Kolff organized the first blood bank in Europe (in 1940) An important breakthrough came in when Karl Landsteiner, Alex Wiener, Philip Levine, and R. E. Stetson discovered the Rh Blood group system, which was found to be the cause of majority of transfusion reactions upto that time.

4 History of Blood Bank Three years later, the introduction by J.F. Loutit and Patrick L. Mollison of acid-citrate-dextrose (ACD) solution, which reduces the volume of anticoagulant, permitted transfusions of greater volumes of blood and allowed longer term storage. An anticoagulent preservative, CPDA-1 was introduced in 1979. It decreased wastage from expiration and facilitated resource sharing among blood banks. Newer solutions contain Adenine and extend the shelf life of red cells to 49 days.

5 Definition The transfusion services can be defined as “A medical facility, designed, equipped and staffed, to procure, draw, process, and store and distribute human blood and its derivatives.” (American Association of Blood Banks)

6 Some Facts Millions of lives are saved each year through blood transfusions. In many countries, people still die due to an inadequate supply of blood and blood products. To maintain an adequate blood supply, 1-3% of the population needs to be blood donors.

7 Some Facts More than 92 million units of blood are collected globally every year. (WHO 2012) Nearly 50% of these blood donations are collected in high-income countries, home to 15% of the world’s population. However only 45% of these are donated in developing and transitional countries where more than 80% of the world’s population lives. Where blood is available, it is often unsafe.

8 Some Facts WHO estimates that the lack of effective screening results in up to 16 million new infections with hepatitis B, 5 million new infections with hepatitis C 16,000 cases of HIV infections every year Overall, 5-10% of HIV infections worldwide are the result of transfusions of contaminated blood or blood products.

9 Some Facts Hence every country has a common need to ensure;
Availability of adequate supplies of blood and blood products and their accessibility to all patients requiring transfusion; Safety of blood and blood products; Safe and appropriate clinical use of blood and blood products

10 Some Facts During last two decades there has been an increased awareness in the field of blood transfusion medicine. This is due to advances in basic medical sciences such as immunology, biotechnology, genetics, cryobiology, physiology as well as technical progress. Greater stress has been laid on voluntary blood donation.

11 Some Facts The major aim of blood transfusion has been to make transfusion safe. Other aims have been in prolongation of the shelf life of blood. It’s optimum utilization. Development of synthetic substances to supplement human source.

12 Some Facts Through better understanding of red cell metabolism, the red cell preservatives can preserve the red cells upto 49 days as against 21 days earlier. The emphasis is now rightly put on the use of various components of blood This helps to utilize one unit of donated blood for more than one patient.

13 Some Facts Therapeutic applications of cell separators have also enabled clinicians to reduce morbidity and mortality. More sensitive methods for screening have helped in prevention of diseases like hepatitis B, C and HIV/AIDS. Methods of HLA (leukocyte antigens) typing have been useful for transplant surgeries.

14 Some Facts Efforts are being made for use of artificial substitute for specific components of blood. Genetic engineering techniques have isolated recombinant DNA clones for adequate and safe production of plasma proteins especially factor VIII. The most important managerial issue of a blood bank is the donor recruiter and bleeding donors.

15 Some Facts Ideally no blood or blood components should be allowed to outdate. Every effort should me made to reduce the waste of blood. As per the available data, the wastage due to outdating of blood is to the tone of about 10%, which is a significant in the light of such a scarce commodity.

16 General Considerations
The blood transfusion centre should be located where it provides easy access for donor and staff, And allow quick and safe transportation of blood and components to hospitals Tasks of Transfusion Centre and Planning a facility Total amount of blood to be taken The level at which centre will operate (national, regional, district)

17 Functions of Blood Bank
The main functions of the blood bank are; Recruitment of donors and maintenance of donor’s record. Collection, preservation, and distribution of blood and blood components. Laboratory procedures like, testing for hepatitis B, Hepatitis C, HIV, VDRL for Syphilis and Malaria Parasite. Teaching, training and research Clinical and therapeutic functions like transfusion and daycare service.

18 Functions of Blood Bank
Organizing of outreach programs for blood donation camps in the community on a regular basis. Community Awareness programmes in close liaison with mass media for motivating people to donate blood. Awareness program for treatment of hematological disorders like Hemophilia, Thalessemia, etc. Community Awareness Programs for transfusion transmitted diseases. Maintaining a database for various types of blood groups; particularly rare blood groups; with details of contact telephone numbers or ID, etc.

19 BLOOD COMPONENTS Packed Cells Fresh Frozen Plasma Single Donor Plasma
Cryoprecipitate Hemoglobin Factor VIII concentrate Factor IX concentrate Platelet rich plasma Platelet concentrate

20 How long can the blood be stored at blood bank?
Whole blood can be stored for 35 days. The various blood components can be stored as under; * Platelet Concentrate - 5 days * Packed Cells - 42 days *Fresh Frozen Plasma – 1 year * Cryo Anti Hemophilic Factor – 1 year Deep Freezer (-40°C and -80°C) are used to preserve plasma, related blood components while platelets are store in agitator machine at 20°C for proper storage.

21 Indications Packed Cells: Severe Anaemia and edema, chronic leukemia, hemolytic anemias, etc. Fresh frozen plasma: Inborn deficiency of coagulation factors, DIC, Thrombocytopenic purpura Cryoprecipitates: Chronic Renal failures, congenital platelet disorders, Haemophilia Specific Immunoglobuliins: passive immunization for Hepatitis B, Varicella, Tetanus Fresh Blood: Massive transfusion, Bleeding Disorders Note: Fresh blood is especially ordered as certain components of blood deteriorate rapidly on storage and these are: Platelets, Factor V and VIII, Granulocytes

22 Exercise List major functions of BTS
Advantages of using disposable plastic bags List areas which blood bank should have Criteria for accepting and rejecting blood donor Blood transfusion committee in hospital and its role Statutory requirements for BTS

23 Level of Blood Banks Category I Category II Category III
3-7 units of blood/ hospital bed/ yr. Units of blood consumed per year like District Hospital Blood Bank (100 – 400 beds hospital) 8-15 UOB/ bed/ year. UOB consumed per year ( bed hospital) 16 UOB/ bed/ year More than UOB consumed per year (more than 1000 bed hospital) like medical college hospital blood banks

24 Physical Facilities LOCATION Ideally on the ground floor.
Direct access from main entrance. Signage system for easy visibility Close to emergency department Close proximity with/accessibility to hospital’s clinical service departments

25 Physical Facilities Donor Recruitment Office Bleeding Complex
Physical facilities and space of a Blood Bank can be grouped under the following areas; Donor Recruitment Office Bleeding Complex Therapeutic Area Laboratories Administration Area Teaching and Training Facility

26 The Path of the Donor Entrance Exit Waiting Room Donor Records
Donor Laboratory Medical Examination Resting Room Blood Collection Donor Cafeteria

27 The Path of the Blood Blood Collection Distribution
Refrigeration and Freezing Distribution Preparation of blood components Plasma Fractionation Path of Blood Components Path of Whole Blood Path of Plasma and Plasma Fractions

28 The Path of the Blood Samples
Blood Grouping Blood Collection Labeling Testing for transmissible diseases Discarding after agreed period Results Blood Samples Path of Plasma and Plasma Fractions

29 Path of Materials Source of Supply Central Store Non Sterile Sterile
Waste Department for use Cleaning Sterilization Department for use Waste

30 Designing a Blood Transfusion Centre
Building must be designed so that closed working areas (e.g. aseptic rooms) are not exposed to strong sunshine. Climatic conditions to be considered, like, if wind carries dust ventilation by filtered air may be required Donor, blood and outpatients shoud follow separate paths Stand by generator

31 Designing a Blood Transfusion Centre
If a transfusion centre is not located within a hospital, the following supporting facilities must be needed; Sterilizing Room Laundry Garage Store Rooms Changing room Canteen for the staff of the centre Workshop for maintenance of building and equipment Suggested that a separate room be available for sterilizing equipment and stills

32 Designing a Blood Transfusion Centre
District level Transfusion Centre A district centre with 50 donors per day needs floor space of 120 m sq Regional Level Transfusion Centre If daily bleedings number is 200, donor department floor space should be 300 m sq. This assumes that more than half of the total donations taken by mobile teams National Level transfusion Centre Approx. 900 sq m

33 Physical Facilities Donor Recruitment Office
Most vital activity for any blood bank. Recruiting voluntary donors requires spread of public awareness through mass media or community approach. It should have following facilities; Donor Organizer’s space Space for clerical staff Space for type writer/ printer/ fax machine/ photocopier machine Telephone with intercom facility Computer for database management for recording and retrieval of data Facility for printing and publicity material.

34 Physical Facilities Bleeding Complex
It should be close to the front entrance, to ensure easy visibility, it will consist of following rooms; Reception Room Examination Room Bleeding Room and Aphaeresis Room Rest Room Kitchen / Pantry Daycare Room/ Treatment Room

35 Physical Facilities Therapeutic Area
Consists of the facilities required for blood transfusion of those patients who require frequent transfusion of blood or blood components like patients of thalessemia and hemophilia.

36 Physical Facilities Laboratory
Minimum movement of the persons in the corridor of the laboratory Minimum access to the outsiders The processing, typing and cross matching of blood is performed in this area

37 Physical Facilities Laboratory
The laboratories of the blood banks are of following types Laboratory for processing donor’s blood Blood component laboratory Basic Work Fresh Frozen Plasma Cryoprecipitate Platelets Packed RBCs Leukocytes poor RBCs Relevant Coagulation Work

38 Physical Facilities Laboratory Advance Work
Freeze dried and heated coagulation factors Plasma Fraction Donors Serological laboratory ABO and Rh Grouping Antibody Screening Labeling Donor’s Blood Storing of tested blood

39 Physical Facilities Laboratory Infectious Diseases Laboratory
The laboratory will have provision for testing of: HIV Malaria Parasite Syphilis HBV Hepatitis C Virus Special Laboratory The laboratory will do platelet and granulocytes serology.

40 Physical Facilities Laboratory Patient’s Serological Laboratory
The laboratory will do following functions: ABO and Rh Grouping Antibody Screening Cross matching of blood Antenatal work up

41 Physical Facilities Administrative Area Consultant’s Chambers
Departmental office Administrative and Clerical Office Rooms Staff’s Common Room Store Room Wash Room and Toilet Housekeeping Room PRO’s Room Medico Social Worker Room Voluntary Counseling and Testing Center (VCTC)

42 Physical Facilities Teaching and training Facilities
If the blood bank is a part of teaching/ training institution it will participate in teaching and training program. In some of the hospitals blood bank is the part of Transfusion Medicine It will have facilities of; Conference Room Demonstration Room Departmental Library Reading Room

43 Other Physical Facilities
Water Supply: It should be pyrogen free water Electricity Supply: round the clock, uninterrupted to maintain cold storage temperature. Sewage Disposal System: Effluent Treatment Plant Storage System: separate facility for blood and blood components Steam: for cleaning of glassware, equipments and sterilizers Supply of Distilled Water: Especially deionized, for blood transfusion center High Pressure Air Vacuum Intercom System Mobile Van for conducting blood donation camps as community programs

44 Staffing Staff Blood Bank Category I II III Bleeding Complex
1. Junior Doctor 1 1-2 2 2. Nurses 3 4 3. Social Worker 4. Lab Attendant

45 Staffing Staff Blood Bank Category I II III Laboratory
1. Technical Supervisor - 1-2 4 2. Technical assistant 2 8 3. Laboratory Technician 11 13 4. Laboratory Assistant 1 5. Lab Attendants 5

46 Staffing Staff Blood Bank Category I II III Donor Organizer
1. Associate/ Classical Staff Part Time 1 2 2. Social Worker (mobile team) 5 10 3. Vehicle + Driver

47 Staffing Staff Blood Bank Category I II III Service Staff
1. Clerks / Typist Part Time 1 2 2. Store Keeper 3. Housekeeping Attendant

48 Staffing Staff Blood Bank Category I II III Medical Director Professor
- 1 2. Associate Professor 3. Lecturer 2 3

49 EQUIPMENTS Can be grouped as following: Equipments for Routine Work
Refrigerator – for maintaining temperature to 1-4 degree with audio-visual alarm, temperature display, temperature recording, 24 hr power supply. Minimum number of refrigerator should be 3 For untested blood -1 For tested blood – 1 Tested and Cross matched blood – 1 Centrifuge table top Water bath Incubators Hot Air Oven Binocular Microscope

50 EQUIPMENTS Weighing Scale for blood bags Domestic Refrigerator
Ph Meter VDRL Agitator Weighing Machine for donors Distillation Plant Analytical Balance

51 EQUIPMENTS Additional Equipments Dielectric Sealer – 2 Vortex Mixer
Plasma Separation Stand Magnetic Stirrer Laminar Air Flow Micro Plate Agitator Platelet Agitator Cryoprecipitate Thawing Bath ELISA System with washer, incubator and reader kits for HIV/ HBV/ HCV/ VDRL tests for screening of blood equipments Apheresis System when procedure is carried out

Blood Collection Monitor is a compact instrument to provide smooth and gentle rocking for homogeneous mixing with anticoagulant without clot formation of blood cells during collection of blood from a donor.

53 BLOOD BAG TUBE SEALER Blood Bag Tube Sealer is a compact equipment to seal the Blood Bag pilot tube by radio frequency sealing system. Sealing can be achieved in less than 1.5 seconds per tube by simple operation. Sealed tube can be easily separated by pulling the sealing section by both sides.

54 PLASMA THAWING BATH Micro controller based Plasma Thawing Bath is a tabletop model, for quick thawing of plasma at 37.0 °C. Temperature is controlled by micro controller based temperature controller.

Microcontroller based Plasma Freezers are designed for quick freezing and storing of plasma and related blood components at desired low temperature up to -35 ºC. The System includes temperature controller with digital temperature display, Temperature recorder, Temperature alarm system with adjustable high / low alarm limits, includes audio visual alarm on temperature deviation.

56 Platelet Incubator Micro controller based platelet incubators are designed to store Platelet concentrates in continuous motion at controlled temperature. The platelet Incubators are constructed of double walls the exterior is made of mild steel and the inner chamber is fabricated of imported stainless steel medical-grade.

57 Blood Bank Refrigerator
Blood Bank Refrigerators are designed to fit a variety of space and storage requirements Combine Superior refrigeration technology and precise temperature control to ensure reliable blood storage. Blood Bank Refrigerators are equipped with Heavy-duty compressors and direct air flow cooling system to maintain a vital operation temperature of 4 °C.

58 Donor’s Couch Micro-controller based donor couch is designed to provide a comfortable position for the donor. Donor's position can be easily shifted from upright body position.

59 Plasma Extractor Micro-controller based Plasma Extractor is designed for automatic separation of blood components from the blood bag.

60 Plasma Expresser High Volume Centrifuges are designed & developed for centrifuging larger volume centrifuge tubes, bottles, blood bags etc. The unit is provided with control panel with speed control, digital speed indicator, and 0-99 minutes digital timer with a bypass switch for operating beyond 99 minutes and automatic switching off alarm signal and digital temperature control cum indicator.

Layout FRONT OF THE HOSPITAL BLOOD BANK Donor Recruitment Office Bleeding Complex Therapeutic Area Issuing Counter Emergency lab Department Admin. and Clerical Offices Component Basic laboratory Donor Serology Storage Refrigerator Platelets Serology Antenatal Workup Doctor’s office Component Stores Infection Test Laboratory Special Lab RBC Serology Platelet Serology Leukocyte Serology Store Room Trainee’s office Components Advanced laboratory Toilets Wash Room Library & Conference Room Staff Record Room Distillation Plant

62 Schedule of Accommodation
Room/ Space Area in sq m Public Access Areas (Bleeding Complex) Reception 40 Medical Exam Room 12 Bleeding Room 20 Refreshment Room Kitchen/ Pantry 8 Aphaeresis 30 Daycare/ Therapeutic

63 Schedule of Accommodation
Room/ Space Area in sq m Laboratory Areas Routine Donor Work – up 20 Patient Sample and ANC Work up Specialized Lab Work 30 TTI Lab (Transfusion Transmissible Infection) Component Separation Wash Room Emergency Lab 15 Issue Counter 10

64 Schedule of Accommodation
Room/ Space Area in sq m General and Administrative Areas Doctor Office 12 Donor Recruitment 10 Office Stores 15 Technicians Common Room Toilets (separate for male and female) 4 Training and Seminar room 20 Library/ Conference 30

65 Other Specifications According to existing statutory provisions, the blood bank should have an area of 100 m sq for its operations and an additional area of 50 m sq for preparation of blood components.

66 Other Specifications It should consist of at least a room each for
Registration Medical examination Blood collection Component Preparation Lab for transfusion transmissible infections Sterilization cum washing Refreshment cum rest room Store cum records

67 Other Specifications Licensing authorities have to record reasons in writing, if relaxation is to be provided in respect of testing laboratories and sterilization cum washing room Temperature should be maintained between degree C and recommended air changes are / hour

68 Movement of Each Unit of Blood
Bleeding Room Blood Collected in blood bags and pilot tubes Stored untested in refrigerator Issued to patients Cross-matched blood in issue counter Pilot tubes sent to Blood bank sent to Cross-matched blood stored in Components Room Components Refrigerator in patient lab, for cross match Infectious disease lab Donor lab Blood bags shifted each day to Donor Blood labeling Area Labeled, tested blood stored in tested stock refrigerator in donor lab

69 Policy and Procedures Every blood bank should develop and maintain the written policy and procedures in form of SOPs NACO, under GOI, Ministry of Health and family welfare has designed various procedures and step by step approach while dealing with transfusion services of the hospital. It is available in document prepared by NACO, “Standards for Blood Bank and Blood transfusion Services.”

70 Policy and Procedures Selection of donor and Bleeding Donor
Whenever a decision is made regarding acceptance or rejection of a blood donor, these two things should be kept in mind, i.e. Safety of Donor Safety of Recipient Each blood donor must be screened by medical history and appropriate physical examination

71 Policy and Procedures The donor should have
Age between 18 yrs to 65 yrs Body weight of 110 pounds or more for 450 ml of blood collected Body temperature should be less than 37.5 degree C or 99.5 degree F Pulse rate should be between 50 – 100 beats per minute.

72 Policy and Procedures Blood Pressure: The systolic BP between mm Hg: diastolic between mmHg Haemoglobin estimation: It should be 13.5 gm/ dl (male) and 12.5 gm/ dl (female): or minimum haematorcit: 41% male and 38% female Specific Gravity: It should be > (male) and >1.053 (female)

73 Policy and Procedures Deferral of Donor for Donation of Blood
It can be a permanent or temporary Deferral, depending upon the situation. Permanent Deferral History of Viral Hepatitis, History of jaundice of unknown cause, malignant cases, Leukemia, convulsions, fainting spells, abnormal bleeding tendency, non positive HBsAg (Australia Antigen Test), serious Cardiopulmonary Disease , high risk behavior, drug addicts etc.

74 Policy and Procedures Deferral of Donor for Donation of Blood
Temporary Deferral Conditions requiring rest or medication, cold, flu, diabetes, TB, sexually transmitted diseases like syphilis, etc.

75 Policy and Procedures Deferral of Donor for Donation of Blood
The period of deferral may vary for many other conditions like various vaccination, major surgery, termination of pregnancy or delivery, dental or minor surgery and symptomatic asthma. A minimum of 72 hrs deferral is made for a donor who has consumed aspirin. Under the directive of Honorable Supreme Court of India it is unlawful to take blood from any professional donor.

76 Policy and Procedures Other Important Considerations
Identification Details: Full Name Address Contact Details Telephone Number Age, Sex and Race Consent: A written consent of the prospective donor is required

77 Policy and Procedures Other Important Considerations
Preparation before donation Eat a regular meal, avoid fatty food, and no alcohol within 12 hrs prior to donation Exceptions A physician can make exceptions specially for therapeutic bleeding, auto transfusions, immunization and specially rare blood donors.

78 Policy and Procedures Phlebotomy
Bleeding of the donor should be smooth and painless Strict aseptic procedures must be followed and only disposables used. The vein-puncture site should be free of skin lesions of an infectious nature. The donor blood bank, sample tube and donor record should be properly identified and labelled before drawing blood

79 Policy and Procedures Phlebotomy
Plastic blood bags with additional satellite bags should be selected according to need. For instance single bag may be used for whole blood, double bags for RBC concentrates, triple bags for platelets, and quadruple bags for both platelets and cryoprecipitate. Universal precautions must be followed in each case Thorough inspection of bags for defects and anticoagulant inside

80 Policy and Procedures Phlebotomy
Thorough mixing of blood in the bag and tubing is essential It should be ensured that there is no leaking from the puncture site and that the donor is in satisfactory condition before leaving the room. An adhesive bandage should be applied to the phlebotomy site Donor should be made to rest for minutes before being asked to get up

81 Policy and Procedures Phlebotomy
He should be then taken to the refreshment room for light refreshment. In case the donor complaints of giddiness or faints, immediately make him lie down with foot-end raised. Check his BP and other vitals Give necessary post donation advice to the donor Every donor must be thanked before he leaves the blood bank

82 Policy and Procedures Labeling and Storage of Donor Blood
Donor blood should be stored at 1-4 degree in proper blood bank refrigerator. Untested, tested and cross matched blood should be stored in separate refrigerators. These should never be allowed to mix under any case Standard colored labels should be used for labelling the donor units

83 Policy and Procedures Labeling and Storage of Donor Blood
The donor bag number, date of collection, date of expiry, blood group and other relevant information should be properly and boldly mentioned on every bag. It must be ensured that correct information being made available on the cross-matched label, so that the blood goes to the correct patient.

84 Policy and Procedures Tests on Donor Blood ABO and Rh Typing
Every donors blood must be tested in infectious deseases laboratory for HIV I and II, hepatitis B, HCV, VDRL, and malaria.

85 Policy and Procedures Pre transfusion testing of the Recipient's blood
Recipient’s first and last name, age and sex, bed no. and hospital registration no. and other relevant details available must identify the recipient Specimens must be labeled at the bedside; with the full name of the patient, date, identification no., initials of the person drawing blood. If the blood sample has to be drawn from the intravenous tubing it should be flushed with saline and the first 5 ml of blood discarded.

86 Policy and Procedures Pre transfusion testing of the Recipient's blood
When additional transfusions are requested, a new specimen should be obtained at each 48 hr interval to identify an incompatibility from an antibody developed . Hemolyzed blood samples should be avoided. ABO and Rh typing should be done on every recipient before blood is issued. Cross matching should be done on every unit of blood to be transfused to the patient

87 General Guidelines The provision of safe and adequate blood is the responsibility of government. The formation of a nationally organized and managed blood program should be an integral part of each country’s national health care policy and health care infrastructure. The Blood Transfusion Services should be established in accordance to National Blood Policy and plan within the legislative framework. The blood bank should function under the direction of licensed physician qualified by training and experience as Transfusion Medicine Specialist All blood banks should be licensed by State Drug Controller and approved by Drugs Controller General, India.

88 General Guidelines It should be responsible for establishing and maintaining a national quality system, including; The development of guidelines and standards, staff training, a data/ information management system System for monitoring and evaluation of all the blood transfusion activities

89 General Guidelines All blood banks should be licensed by State Drug Controller and approved by Drugs Controller General, India. It should be regulated by Drugs and Cosmetics Act and rules there under

90 General Guidelines Compliance with laid down rules for recruitment and selection of donors, collection, processing, storage and distribution. (as per drug and cosmetic Act) All blood banks to have their quality policy and prepare quality manual. Each blood bank should maintain a detailed SOP manual as well as records (forms, registers, labels) in a prescribed format by Drug and Cosmetics Rules.

91 General Guidelines Adequate and competent staff as prescribed in Schedule F Part xii B & C of drug and cosmetic Rules. The record of their qualifications, training and competency should be maintained. All containers, anticoagulants and reagents used should meet the standards of Drug and Cosmetics Act.

92 General Guidelines All materials for blood collection and transfusion should be sterile. Pyrogen free and disposable materials should be used and storage should be in an air conditioned area. Aim should be to accept blood from only voluntary non remunerated safe blood donors. Gradual phase out of replacement donors. Blood sellers are banned as per Supreme Court directive.

93 General Guidelines Full time competent staff ensuring proper cadres for both medical and paramedical staff. All medical colleges to have a blood bank or department of transfusion medicine and have faculty as per MCI guidelines. All blood banks collecting more than 10,000 units of blood or having blood component license should employ a diploma or M.D. (TM) or M.D. Pathology with minimum 1 year experience in blood bank.

94 General Guidelines Blood banks collecting < 10,000 units should at least have an MBBS doctor with minimum one year experience in blood bank to manage services. A quality manager should be appointed preferably a medical officer or senior MLT trained in quality management in all blood banks collecting > 10,000 units per year. Training and facilities for implementing universal precautions for HAI

95 Policy for Outdoor Blood Donation Camps
Blood donation camps should be organized to augment blood stocks. Donor organizer/ medical social worker of the blood bank should contact offices, institutions, industries, social and religious organizations, colleges and schools. Adequate publicity and IEC material should be made available to the organizations.

96 Policy for Outdoor Blood Donation Camps
The donation site should be inspected prior to the day of camp. All facilities should be as per drugs and cosmetics rules. Blood bank should maintain quality at each step from donor recruitment, selection and collection to the final product. The methods of collection and management should be as per fixed sites. Predonation counseling procedures should not be compromised.

97 Policy Regarding Aphaeresis
Aphaeresis is a procedure carried out to harvest a particular component and returning the rest of the blood to the donor, by an automated machine. This procedure should be carried out only in a blood bank licensed for this purpose. A medical officer trained in aphaeresis technique should be responsible for the procedure. Provision for emergency medical care, in the event of any adverse reaction to the donor.

98 Policy Regarding Aphaeresis
The staff working on the machine should be trained in aphaeresis procedure and should work directly under supervision of MO. Donor should be asked to sign the consent form in the language, which he understands after being explained the procedure and risk involved. Plasmapheresis: Procedure to harvest plasma from the whole blood and returning the cellular components to the donor.

99 Selection of donor for Aphaeresis
In an occasional plasmapheresis in which donors undergo the process once every 12 weeks the standards for whole blood donation should apply. In higher frequency then stated above, the donor should be tested before every procedure for Hemoglobin and hematocrit. It should be as Hg > 12g/dl and Hct 36%. Total serum protein should not be less than 6 gm/dl.

100 Selection of donor for Aphaeresis
In serial plasmapheresis minimum interval should be of 48 hrs between two procedures. Not more than 2 procedures in week should be allowed. If a participant of such program donates a unit of blood or if it is not possible to return red cells, the donor should not undergo platelet/ plasmapheresis for 12 weeks.

101 RECORDS Records of donor’s like; Periodic examination Laboratory tests
Consent of Donor patient Date of last apheresis procedure Certificate of the attending physician Procedure Volume of product separated Drug used Adverse reaction if any and their treatment

102 Volume of Plasma Volume of plasma from a donor weighing at least 55 kg, should not exceed 500 ml with serum protein within normal limit during one procedure. Or not more than 1000 ml per month with a maximum of 12L/year

103 Cytapheresis Procedure for separation of individual cellular component of blood. Can be achieved by cell separator machine Plateletpheresis is the harvesting of platelets from whole blood using continuous or intermittent flow cell separator. Leukapheresis is harvesting of granulocytes from whole blood.

104 Cytapheresis: Selection of Donor
Donors who undergo cytapheresis, not more than once every 12 weeks should be treated as ordinary blood donors with regards to laboratory studies. More than once in 12 weeks should be examined as in donor selection procedure for apheresis. (Hg, Haematocrit and serum protein) Platelet count should be determined before plateletpheresis and should not be below /dl.

105 Cytapheresis: Selection of Donor
Total and differential white cell count should be normal. Persons who have ingested aspirin or similar antiplatelet drugs in the last 72 hrs should not be suitable for plateletpheresis. Donors with personal and family history of bleeding tendency should not be suitable for plateletpheresis.

106 Cytapheresis: Selection of Donor
Before leukapheresis total WBC counts should be 4000/dl. In serial pheresis minimum interval should be 48 hrs and not more than two procedures in a week. A participant of such program donates a unit of blood or if it is not possible to re-infuse the red cells during a pheresis procedure should not be accepted for cytapheresis for 12 weeks.

107 Supreme Court Judgment and Directions 1996
Establishing national and state councils of blood transfusion. Activities of national and state councils to cover entire range of services related to blood transfusion. Developing good quality technical manpower for transfusion services; Training of technical personnel Post graduate course Drug inspectors training

108 Supreme Court Judgment and Directions 1996
Institution for conducting research on various areas of transfusion medicine. Banning unlicensed blood banks within 1 year. Banning professional donors within 2 years Income tax exemption for donation to councils NACO for coordinating the development of national blood transfusion network in India Hindustan Latex Ltd. engaged to assist NACO in preparation of comprehensive plan for setting up national and state councils.

109 Supreme Court Judgment and Directions 1996
Union government should take steps to establish forthwith a National Council of Blood Transfusion as a society registered under the Society Registration Act. It would be a representative body having representation from; Directorate General of Health Services of GOI Drug Controller of India Ministry of Finance from GOI Indian Red Cross Society Indian Association of blood Banks Major medical institutions NGOs active in field of voluntary blood donations

110 Blood Transfusion Reactions
About 2-4% transfusions lead to minor or major reactions Causes are; Clerical mistakes Upto 80% cases are due to incorrect labeling Errors in writing correct particulars on requisition Confusion in identity of the patient Technical errors Wrong grouping and cross matching Rare blood group Minor cross match errors

111 Investigations in case of Transfusion Reaction
Ranges from minor reactions like rigors to severe reactions of fatal nature. The occurrence should be immediately reported to the blood bank. The reporting authority should send: A post transfusion blood sample A post transfusion urine sample A pre-transfusion blood sample Blood bag along with tubing

112 Role of organizations in blood transfusion services of India

113 To overcome Transfusion Reactions the Blood Bank should maintain
The patient’s original cross match specimen, which should normally be preserved for at least 48 hrs after dispatching the blood or its products. The donor’s pilot tubing/ bottle, which must be preserved; for at least 48 hrs The laboratory and blood bank records The blood bank should take urgent steps to establish the cause of transfusion reaction. The record of transfusion reaction should be maintained.

114 Blood transfusion Committee in Hospital
Medical director/ administrator Blood bank Chief Representatives from clinical department Representatives from nursing staff Blood bank technicians

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