Home

National Standards for Blood Transfusion Service

1. ANNEX 16 BASIC REAGENTS REQUIREMENTS AT CENTERS S No Name of the reagents NBC RBC BSC Combi pack of pre diluted monoclonal Anti D IgG antibody reagent and red cell preservative 2 Alsevers Solution for preservation of red blood cell 3 Anti A monoclonal antibody 4 Anti A1 lectin monoclonal antibody 5 Anti AB monoclonal antibody 6 Anti B monoclonal antibody 7 Anti C monoclonal antibody x 8 Anti c monoclonal antibody 9 Anti D IgG antibody 10 Anti D IgM and IgG antibody 11 Anti E monoclonal antibody xX 12 Anti e monoclonal antibody xX 13 Anti Fy antibody x 14 Anti Fy antibody X 15 Anti H lectin monoclonal antibody xX 16 Anti Human Globulin poly specific anti IgG and anti C3 H 17 Anti Jk monoclonal antibody x 18 Anti Jk monoclonal antibody x 19 Anti K monoclonal I antibody xX 20 Anti Le monoclonal antibody xX 21 Anti Le monoclonal antibody xX 22 Anti Lutheran antibody x 23 Anti Lutheran antibody x 24 Anti M monoclonal antibody xX 25 Anti Mi antibody X 26 Anti N monoclonal antibody x 27 Anti P1 antibody x 28 Anti S antibody X 29 Anti s antibody x 30 Antibody panel cells for antibody identification x
2. 64 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 31 Antibody screening cells x 32 Adult blood administration set 33 Blood bag single CPDA1 350ml 34 Blood bag double CPDA1 450ml x 35 Blood bag triple CPDA1 450ml X 36 Blood bag quadruple top and bottom x 37 Bovine serum Albumin 22 solution H 38 Column Agglutination Technology ID cards or cassettes for ABO Rh and DAT test for newborns 39 ane Agglutination Technology ID cards cassettes for m oombs Cross match 40 Column Agglutination Technology ID cards for antibody x screening and antibody identification 41 Hemocue micro cuvettes for Hb estimation specific to equipment 42 Plasma Over wrap 43 Platelet administration set 44 Printed sticker for Blood group A positive in yellow 45 Printed sticker for Blood group AB positive black 46 Printed sticker for Blood group B positive in pink 47 Printed sticker for Blood group O positive in blue 48 Rh Control 49 Transfer bag capacity 300ml 50 Volumetric Blood administration set for pediatric patients 51 Temperature recorder chart equipment specific if required 52 Temperature recorder pen for chart equipme
3. Once the sterility of the component is compromised by use of open system packed red cells prepared from that unit must be transfused within next 24 hours and platelet concentrates prepared must be transfused within next 6 hours from the time of compromised sterility All the prepared components shall have integrally connected segments filled with the final product for subsequent compatibility testing and quality checks All the components prepared from whole blood shall bear the same unit number as that of the whole blood unit The final label on the blood component unit shall have all the details as mentioned in standard 3 5 Labeling of a blood unit The blood bank shall develop SOPs to perform periodic quality control checks on prepared components The national standards for quality control of blood and blood component including testing parameters frequency of testing and quality requirements have been developed and shall be followed Principles of good manufacturing practice must be followed to provide blood components of required specifications 26 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Table 3 Standard requirements for storage transport expiry of blood and blood components Components Properties Storage Transport Expiry 4 ji m l oa 35 days in a In a blood transported y Hct 35 50 closed system bank For next 24hrs Whole
4. Anemia s other than iron deficiency anemia Asthma on steroid treatment Cancers Diabetes on treatment with insulin or with complications Alaj Ajuwon Epilepsy 48 National Standards for Blood Transfusion Service 2013 2013 National Standards for Blood Transfusion Service 2013 7 Hypertension with complications or heart diseases 8 Individuals with Hepatitis B Hepatitis C or HIV AIDS 9 Hyperthyroidism or thyrotoxicosis 10 Chronic kidney diseases or liver diseases C SPECIAL CONDITIONS SPECIAL CONDITIONS ACCEPT 1 Medicines Antibiotics Aspirin Accept three days after stoppage 2 Vitamins contraceptive pills Accept the donor on same day 3 Vaccines e Hepatitis A Hepatitis B e Accept after 48 hours recombinant Rabies Human diploid Tetanus Toxoid e Accept after four weeks e Rubella Vaccine e Accept after 12 months e Hepatitis B immunoglobulin e Tattooing ear piercing or any body e Accept after 12 months part piercing e History of syphilis or gonorrhea e Accept after 12 months from completion of treatment e Any individual who has been in a Accept after 12 months correction institution like jails or prisons for more than 72 hours 49 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 4 SAMPLE ONLY BLOOD REQUEST FORM NATIONAL BLOOD TRANSFUSION SERVICE BH
5. 2 9 Blood is a public resource and access should not be restricted Wastage of blood and blood components should be avoided at all times 2 10 A profit motive shall not be the basis for the establishment and running of future private blood banks or blood service in the country 14 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Hospital transfusion practice 2 11 2 12 2 13 2 14 2 15 There should be no financial incentive or motive of personal gain nor any coercion from the patient s party to prescribe a blood transfusion Rational clinical needs should be the basis of prescribing blood transfusion The prescribing clinician shall inform the patient of known risks and benefits of blood transfusion and of alternative therapies The patient s decision to accept or refuse the procedure must be respected In the event that the patient is unable to give prior informed consent or in case of a minor the clinician shall discuss with the patient s family and decide to transfuse blood in the best interest of the patient Transfusion therapy must be carried out under the overall responsibility of a registered medical practitioner or other qualified and authorized health care professional As far as possible only those components cells plasma or plasma derivatives shall be prescribed that are need based clinically appropriate and provide optimal safety to the p
6. Preparation of the veni puncture site The veni puncture site shall be cleaned and prepared with locally available anti septic agent to minimize risk of bacterial contamination Veni puncture Successful veni puncture must be carried out at first attempt If the first veni puncture fails a second veni puncture shall be attempted only if the donor permits In some cases a new blood bag may have to be used Anti coagulant CPDAI shall be the anticoagulant used in the blood bag The volume of anti coagulant shall be in the proportion of 1 7 to the volume of blood collected for adequate anticoagulation Blood collection time Total blood collection time should be between 8 to 12 minutes If the time exceeds 12 minutes the blood collected shall not be used for platelet preparation Pilot samples 3 4 9 1 Pilot samples are blood donor samples collected at the time of donation for conducting laboratory tests 3 4 9 2 Pilot samples shall be taken when the needle is in situ and not from the blood bag 18 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 3ml of blood shall be collected in EDTA tube and 6ml in plain tube 3 4 9 3 The tubes containing pilot samples shall be appropriately labeled immediately after blood collection 3 4 9 4 Hermetic sealing of the blood bag tubing shall be done to ensure sterility of the blood collected 3 4 10 Blood volume collected
7. 60 hours e Cooling Down Time A full load of blood packs at 37 C takes a maximum of 8 hours for all the packs to reach below 6 C e Temperature Monitoring Digital temperature LED display with 0 1 amp C graduation e Temperature recording device Audible and visual alarm system indicating unsafe temperatures Battery back up for alarm and temperature recording device e Capacity 100 to 150 blood bags of 450ml volume e Necessary Spare parts to be made available e Voltage stabilizer is needed then to be provided with the equipment 85 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 20 Semi For blood screening Specifications Automatic using ELISA assays e Open System for programming ELISA any ELISA test UV Screening Advanced kinetics End point curve fit shaking e Programmable time and speed e Measurement channels amp Ref channel present e Variable Wave length and filters present e Absorbance range 0 to 4 0 OD e Accuracy and precision 0 005 OD e Resolution 0 001 OD e Throughput to suite Lab Requirement e Software capable for self test and calibration e Help menu available e Residual volume per well 2 1 e Suitable for U V amp flat bottom microplates etc e Printer attachable Software capable for self test and calibration e Many methods stored for easy recall e Crosswise opera
8. 76 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Incubator As above Sr No 1 Plasma thawing device Thawing liquefaction of the frozen plasma at controlled temperature of 37 C 2 C and controlled time duration thus maintaining the properties of clotting factors in the plasma Specifications Easy loading and removal of the plasma packs Easy to empty water when Accessories voltage stabilizer to be included with the equipment plastic wraps for holding the bags during thawing Type of equipment At 37 C water bath Plasma packs held in special containers and constantly agitated uniformly in the bath until thawing is complete Packs remain dry Construction Internal Corrosion resistant material easy to clean and no staining Electrical Characteristics Nominal input voltage 220V 240V 50 Hz Equipment meets internationally accepted electrical safety specifications such as that IEC Internal Temperature Control Tamper resistant temperature control set at 37 C _1 C External Ambient Temperature Performs in an ambient temperature of 10 C to 30 C Thawing Time A full load of flat plasma packs approx 250ml volume with a core temperature of 30 C is thawed completely in less than 20 minutes Warning Systems Digital temperature LED display with 0 1 C graduation Visual and audible alarm system i
9. Annex 11 Annex 12 Annex 13 Annex 14 Annex 15 Annex 16 Annex 17 Annex 18 Annex 19 Annex 20 5 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 GLOSSARY Autologous blood The blood drawn from the patient recipient for re transfusion into him her at later date Apheresis Procedure whereby whole blood is separated by physical means into components and one or more of them returned to the donor Blood Human blood drawn from a donor and mixed with anti coagulant Blood center A facility or centre that performs all the following functions e Recruiting blood donors e Screening and selecting blood donors e Blood collection e Testing and processing of blood units e Transportation receiving and storage of blood units e Pre transfusion tests on patients blood samples e Issue of blood or blood components for clinical transfusion Blood storage center A center that is involved in the following functions only e Receiving and storing screened blood and blood components from another authorized blood establishment e Performing compatibility tests e Blood issue for transfusion Blood component Any therapeutic constituent of blood that is separated by physical or mechanical means e g red cells platelets plasma It is not intended to capture plasma derived products Blood collection A procedure whereby a single donation of blood is collected in an anticoa
10. National Standards for Blood Transfusion Service 2013 Chapter 4 TESTING OF DONATED BLOOD 4 1 Blood Group Serology All tests shall be performed in accordance with the standard operating procedures developed 4 1 1 Determination of ABO group of all blood units collected 4 1 1 1 ABO blood group shall be determined by both cell and serum grouping methods 4 1 1 2 Cell grouping shall be done with anti sera anti A anti B and anti AB by tube method 4 1 1 3 Serum grouping shall be done with standard A cell B cell and O cell 4 1 2 Determination of Rh type of all blood units collected 4 1 2 1 This shall be carried out with anti D IgM IgG reagent If the initial test is negative AT method to detect weak D shall be carried out If Weak D test is positive the unit shall be labeled as Rh D Positive 4 2 Blood screening for Transfusion Transmissible Infections TTIs 4 2 1 All donated blood units shall be tested mandatory for four infections transmissible by transfusion 4 2 1 1 Screening for HIV shall include anti HIV 1 2 antibodies as the minimum required screening target 4 2 1 2 Screening for viral hepatitis shall include Hepatitis B surface antigen HBsAg for Hepatitis B and anti HCV anti body for Hepatitis C as the minimum required screening targets 4 2 1 3 Test for Syphilis shall include specific treponemal antibodies as the minimum required screening target 4 2 1 4 Test for
11. Saline level detection alarm system Electrical Requirements 220 V Easy to clean housing Accessories required 1 Centrifuge head with No 1 to 12 test tube holders of 12mm tube diameter Aspiration tube 1 meter PVC tube between saline pump and NaC detector 1 meter Ballast for tube NaCl H20 Polypropylene connector right angled connecting piece for tubes Waste tube 1 meter Fan filter Replacement fuses 100 240VAC 79 National Standards for Blood Transfusion Service 2013 2013 National Standards for Blood Transfusion Service determination of Hb in whole blood using a specially designed analyzer with specially designed microcuvettes containing dried reagents It is the method of choice for measuring Hb of blood donors in blood banks mobile camps for its eay to use machine consumables and quick measuring time 11 Electronic To determine the Specifications Blood weight volume Input supply 220 to 240 V 50 Hz measuring of various blood e Weighing range up to 1 kg scale components during e Resolution 1Gm the process of e Zero set provision to account for blood component weight of the empty bag preparation e Alarm when the programmed volume is reached e Provisions for six key keyboard for power on off weight volume conversion zero set e Led indications for zero set and volume measurement 12 Blood Special spring scale Special spring scale for measuring the
12. C g with any std cell tests For vial of 3ml each Anti Jk monoclonal phenotyping 16 IgM antibody for tube the respective and storage at method red cell 2 to 8 C antigens For vial of 3ml each Anti Le monoclonal phenotyping 17 IgM antibody for tube the respective and storage at method red cell 2 to 8 C antigens For vial of 5ml Anti K monoclonal phenotyping 3 each and 18 IgM antibody for tube the respective storage at 2 to method red cell 8 C antigens For vial of 3ml each Anti Le monoclonal phenotyping 19 IgM antibody for tube the respective and storage at method red cell 2 to 8 C antigens For vial of 3ml each 21 Anti Lutheran phenotyping the respective red cell antigens 20 IgM antibody for tube the respective and storage at method red cell 2 to 8 C antigens For vial of 3ml each and storage at 2 to 8 C 90 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 For phenotyping vial of 5ml each 22 Anti Lutheran the respective and storage of red cell 2 to 8 C antigens For Anti M monoclonal phenotyping vial of 5ml each 23 IgM antibody for tube the respective and storage of method red cell 2 to 8 C antigens For Anti Mi antibody phenotyping vial
13. before blood donation by authorized BTS personnel Assessment of blood donors shall include the following steps a Donor interview Refer to Annex 2 for Donor questionnaire and consent form b Physical examination for any jaundice swollen glands skin rashes tattoos needle or body piercing marks c Check for body weight temperature and blood pressure d Check for hemoglobin content and ABO Rh blood group The interviewer then decides on the fitness of the donor based on the national donor selection criteria 16 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 3 2 2 3 2 2 1 3 2 2 2 332 2 3 3 2 2 4 3 2 2 5 3 2 2 6 3 2 2 7 3 2 2 8 3 2 2 9 Criteria for blood donor acceptance The donor shall be in the age group of 16 to 60 years For 16 or 17 aged individuals a written consent from parents guardians should be obtained before blood donation Elderly donors between 60 65 age group must be assessed by a doctor for suitability to donate Minimum acceptable body weight shall be 45 kg for 350ml and 50 kg for 450ml blood collection In an case blood volume collected should not exceed 10ml kg body weight Minimum hemoglobin level must be 12 0 gm Blood pressure Systolic reading between 90 mmHg and 180mmHg Diastolic reading between 50 mmHg and 100mmHg The donor shall be having normal body temperature on the day of donation The donor shall be
14. blood donor and safety of the recipients of your blood please read the information leaflet and answer the questions correctly In case of any queries please seek help from the blood center staff All information provided by you shall be kept confidential Name of Donor Age Sex QUESTIONS YES NO Remarks Have you been feeling well today Have you eaten some food in the last 8 hours Have you donated blood before If Yes when was your last donation Have you been advised not to donate blood for some reason In the last three days have you taken medicines like aspirin antibiotics or any vaccines like TT hepatitis B or had any tooth extraction done Have you ever suffered from major disease of the heart lungs kidney thyroid skin liver jaundice epilepsy high blood pressure allergy stomach ulcers swollen glands continuous fever unexplained weight loss continuous diarrhea continuous cough TB If Yes please provide details Have you undergone any operation in last 6 months If Yes please give details In last one year have you had a tattoo ear or body piercing done In last one year have received rabies vaccination or blood transfusion Has your blood ever been tested POSITIVE for Hepatitis B Hepatitis C or for any Sexually Transmitted Disease OR In last one year have you been treated for syphilis gonorrhea or any sexually transmitted disease In the last one year have you
15. calibration and maintenance Quality controls of reagents and test kits shall be performed periodically All BTS personnel shall be trained on the use and maintenance of the equipment Records of all installed equipment shall be maintained Refer to Annex 17 for details Quality Assurance QA Blood and blood components are intended for use in the cure treatment or prevention of diseases in humans and have been classified as medicinal products by the Bhutan Medicines Board Hence all blood products shall be regulated and controlled under the Medicines Act of the Kingdom of Bhutan 2003 In order to ensure that blood and blood components maintain consistent quality and safety standards all blood centers shall implement the following elements of QA esr Quality Control QC It refers to all the activities undertaken by the staff at periodic intervals to monitor the 34 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 quality of the materials reagents equipment methods blood and blood components prepared to assure that they meet their minimum requirements Quality control QC shall be conducted for o Reagents o Equipment o Techniques o Whole blood and blood components 7 5 1 1 Quality control of reagents anti sera shall include a Checks for titer antibody specificity and avidity on every new batch or lot received b These checks shall b
16. collection for measuring the blood volume from 0 to 500m1 with spring scale blood volume from accuracy 0 to 500ml collected in the bag Used during mobile blood donation camps 13 Hemocue Hemocue machine is Specifications Blood Hb used for quantitative Measuring range 0 25 6gm dl e Samples can be capillary venous or arterial blood for Hb estimation e Battery operable and with power supply e Voltage 6 9 VDC e Current input 100mA e Pollution degree 2 e Over voltage category II e Weight 350gm e 4 batteries type AA e Dimensions 85x 160x43mm Transformer CE marked 230VAC 50 Hz output is 6VDC 350 mA Consumables required e Microcuvettes specific to the machine e Liquid Hemocue controls High Low and normal range e Hemocue cleaner 80 National Standards for Blood Transfusion Service 2013 2013 National Standards for Blood Transfusion Service 2013 14 Hand tube A multi functional Hand Tube stripper roller cutter stripper instrument for squeezing tubing and cutting the tubing 15 Donor couch Ensuring safety Specifications and comfort to e Width of the arm rest 15cm the donor and the e Length ofarmrest 60cm phlebotomist Enables Lifting capacity 135 kg the phlebotomist e Power 230V 50Hz to tilt the couch by e Weight 80 kg operating a simple e Seat height 56cm switch e Length ofseatand 100 cm leg rest e Length of backrest 90cm e Width 67 cm e Upholstery Sof
17. free from any skin disease at the phlebotomy site on the arm The last blood donation must be at least three months ago The donor shall be in good health and mentally alert on the day of donation The donor shall not be a jail inmate or a drug alcohol addict 3 2 2 10 The donor should have eaten something in the last 8 hours and had 5 hours sleep 3 3 Donor Deferral Donors shall be deferred based on national donor deferral guidelines Refer to Annex 3 3 3 1 3 4 3 4 1 The following individuals must not be allowed to donate blood as they are at risk of contracting HIV AIDS Hepatitis B Hepatitis C or syphilis due to their risky lifestyles Intravenous drug users or individuals sharing sharp injectable objects Persons with multiple sex partners Commercial sex workers Persons who had paid casual or unsafe sex Individuals with homosexual behaviors Sex partners of all the above hopos The following steps shall be followed when a donor is not accepted for donation a The donor shall be explained in a clear and understandable language the reason for deferral b The donor shall be informed whether the deferral is temporary or permanent If temporary encourage the donor to come after the deferral period is completed The donor shall be referred to a doctor for consultation if required All records of deferred donors shall be maintained e Reassure the donors and encourage them to ask questions or clarify any doub
18. patient s health Administration of blood and blood components shall be under the supervision of a health staff trained in clinical transfusion process who can manage adverse events appropriately National Guidelines on Clinical Use of Blood for Clinicians and Nurses shall be followed by all prescribing and administering blood All requests shall be sent to the blood centre using standard Blood Request Form and accompanied by the recipient s blood sample Refer to Annex 4 Patient identification must be done using his full name age sex and hospital registration identification number OPD or inpatient hospital registration number No telephonic requests shall be entertained by blood centres except in a dire EMERGENCY situation Pre transfusion tests shall include Determination of ABO group of the patient e ABO blood group shall be determined by both cell and serum grouping methods e Cell grouping shall be done with anti sera anti A anti B and anti AB by tube method e Serum grouping shall be done with standard A cell B cell and O cell Determination of Rh D type group of the patient e This shall be carried out with anti D IgM IgG reagent If the initial test is negative the patient shall be typed as Rh D negative Major cross match test between patient s serum plasma and donor red cell National and regional blood centers shall perform additional antibody scree
19. that bear on its ability to meet requirements Fit for its purpose Quality System The organizational structure responsibilities policies processes procedures and resources established by executive management to achieve quality Quarantine To isolate nonconforming blood component or materials Reaction In reference to a transfusion a suspected or proven unexpected response to a blood transfusion manifested by signs and or symptoms 8 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Reagent A substance used to perform an analytical procedure A substance used as in detecting or measuring a component or preparing a product because of is biological or chemical activity Replacement family donation donation given by an individual who gives blood when it is required by a member of the patient s family or community This may involve a hidden paid donation system in which the donor is paid by the patient s family Service An intangible result of a process or procedure Shall A term used to indicate a requirement Supplier Individual or organization that provides an input material or service Supplier Qualification An evaluation method designed to ensure that input materials and services e g materials blood component patient blood sample obtained from a supplier meet specified requirement Traceability The ability to follow all steps of a process
20. using same sample and same assay For emergency screening only If using ELISA repeat in duplicate if using RAPID repeat singly If repeated A1 is Positive report as Repeat Reactive result Discard the blood unit and refer blood donor to VCT unit If repeated A1 is Negative report as Repeat Non Reactive result Blood or blood components can be released for transfusion If both repeated tests are Negative Al Al report as Repeat Non reactive result Blood or blood components can be released for transfusion If one or both repeated tests are Positive Al Al or Al Al report as Re peat Reactive result Discard the blood unit and refer blood donor to VCT unit 25 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 General principles 5 1 5 2 59 5 4 5 5 5 6 5 1 5 8 5 9 All blood components shall be prepared from whole blood from donors who meet national donor selection criteria The volume of whole blood collected for blood component preparation shall be 450ml Sterility of all components shall be maintained during processing and storage Fresh frozen plasma shall be prepared within 8 hours after collection Platelet concentrates shall be prepared within 8 hours after collection of whole blood that is stored at temperature of 22 C 2 C
21. while delivering services to the clients Your little bit of extra efforts will definitely go a long way in improving health care services to our people Our quest is to improve quality of health care services to the people of Bhutan I wish all health family members TASHI DELEK in our common endeavour DR WGEN DOPHU Director General 1 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Blood transfusion is a life saving intervention that has an essential role in the total patient management within health care delivery It is therefore important that the health authority takes appropriate and adequate measures to ensure that the blood banks in the country have the basic requirements in terms of human and financial re sources and the necessary infrastructure and other support to provide service in accordance with the set standards For better adherence to the standards special areas to focus on are self sufficiency in blood and blood products based on voluntary non remunerated blood donation continued medical education of all the health personnel involved in the blood transfusion chain periodic auditing of blood banks and development of quality management system in the blood transfusion service Keeping in mind the guiding principle of consistency the manual on National Standards for Blood Transfusion Service has been prepared on the basis of Good Laboratory P
22. 4 1 8 4 2 8 4 3 8 4 4 8 4 5 8 4 6 8 4 7 8 4 8 8 4 9 8 4 10 8 4 11 8 5 All BTS personnel shall be trained in national bio safety guidelines handling blood and well informed of the hazards including transmission of viral infections Incidental exposures to infected samples like bag breakage splash and needle stick injury shall be immediately reported and recorded with the concerned authorities and action taken as per the guidelines on post exposure prophylaxis Immunization against hepatitis B infection shall be mandatory before joining service after which their immune status will be determined The following safety instructions shall be followed at all times All staffs are adequately trained in safety measures Staff must behave in a safe and responsible manner Access to the blood bank must be restricted to authorized personnel only Appropriate protective clothing must be worn including apron mask and gloves Eating must be prohibited inside the laboratory Care must be taken to avoid formation of aerosols or splashing of materials All work surfaces must be decontaminated before and after the routine work is begun and after any spillage All contaminated waste or reusable materials must be appropriately decontaminated before disposal or reuse In case of needle stick injury squeeze out the blood wash the hand with soap and water or anti septic and prepare an incident report National guidelines on waste ma
23. 6 to 7 of expiry prepared platelets whichever is higher Minimum of 4 units per month or 1 of Sterility No growth prepared platelets whichever is higher nits before issue Physical Swirling phenomenon Minimum of 4 units per month or 1 of examination demonstrated prepared platelets whichever is higher Table 16 Fresh frozen plasma 75 of the units tested should meet the below requirements Parameters Quality requirement Frequency of check Volume 220 to 250ml Minimum of 4 units per month Factor VIIIc 0 7 IU ml Minimum of 4 units per month Fibrinogen 200 to 400 mg Minimum of 4 units per month Visual inspection Ne peace nana sa All units before issue 7 5 2 Documentation All BTS activities shall be documented including all the tests performed and quality data Confidentiality of both blood donors and blood recipients shall be ensured Different sets of documents that shall be developed and controlled are reflected in Annex 18 All records shall be maintained for period of 5 years Accessibility to the information shall be restricted and a document control system wherein development approval validation review revision and authorization shall be done by authorized personnel only 38 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 ID 7 5 4 Proficiency testing Proficiency testing scheme shall assess and monito
24. 9 4 5mm Inner diameter 2 9 3 1mm e Tubing material Polyvinyl Chloride PVC that is the tubing of the blood bags Leukocyte reduction filters apheresis kits e Operating conditions Temperature 10 to 40 C humidity 10 to 80 e Storage conditions Temperature 10 to 50 C e Electrical requirements AC 100 to 240V 50 to 60 Hz e Weight 5 to 7 kg approx e External dimensions W224 x H177 X D342mm Consumables required TSCD II Wafers model number SC WO017 Pack size one cassette contains 70 number of wafers 82 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 17 Refrigerated blood processing centrifuge For separation of blood by centrifugation into various blood components under controlled temperature speed and time Specifications High capacity floor standing centrifuge with temperature controlled refrigeration Microprocessor driven and programmable memory up to minimum 20 programmes for speed RCF acceleration deceleration temperature and time and functions like RCF pre selection quick run automatic rotor recognition imbalance detection and soft touch lid lock Maintenance free induction motor Should have provision or capacity to centrifuge 8 blood bags of 450ml volume double triple and quadruple blood bags Power 220 50 Hz Speed range 300 to 10 000 rpm adjustabl
25. Blood centers and Transfusion Services 1st edition 2007 NABH India 2 WHO Recommendations on Basic Requirements for Blood Transfusion Services WHO EHT 06 05 advanced draft 3 AABB Standards for Blood Banks and Transfusion Services 21st edition 4 Manual on the management maintenance and use of the blood cold chain equipment WHO Geneva 2005 5 Framework for standard of practice and service standards developed by QASD Ministry of Health Dr Mahrukh Getshen Transfusion Medicine Specialist Blood Bank JDW National Referral Hospital Thimphu 3 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Blood Safety Program Ministry of Health would like to appreciate and thank the valuable contributions and the hard work put in by the technical experts laboratory specialists and personnel from the national regional and district health facilities health officials from Quality Assurance and Standardization Division Drug Vaccine and Equipment Division in the ministry and also to officials from Bhutan Medical And Health Council and Drug Regulatory Authority The Ministry of Health would like to specially acknowledge Dr Nani Nair WHO Representative Country office Bhutan Dr Neelam Dhingra Co ordinator Blood Safety WHO Geneva Dr Rajesh Bhatia Director Department of Communicable Diseases WHO SEARO and Dr Zarin Bharucha WHO Short Term Consultant for pr
26. ING PROCEDURES Sr No Names of the test procedures Blood donor management 1 Donor selection criteria 2 Hb estimation of donors by Hb colour scale method 3 Hb estimation of donors by HaemoCue method 4 Preparation for phlebotomy 5 Selection of blood bags 6 Blood collection procedure 7 Management of donor adverse reaction 8 Relating product to donor Immuno hematology 9 Washing of red cell manual method 10 Preparation of 3 5 red cell suspension 11 Reading grading and recording reactions 12 Preparation of Std Ac Bc and Oc for serum grouping 13 Preparation of Coombs Control cells 14 ABO blood grouping 15 Rh D typing 16 Weak D test 17 Direct Antiglobulin test 18 Antibody Screening test for unexpected antibodies optional 19 Antibody Identification test optional 20 Red cell antigen testing against the identified antibody 21 Patient sample acceptance and registration 22 Compatibility testing 23 Investigation of a transfusion reaction 24 Antibody titration Labeling storage issue of blood and blood components 25 Labeling of blood bags 26 Proper Storage of blood and blood components 27 Inventory of blood and blood components 67 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 28 Issue of blood and blood components 29 Reissue of returned unused blood 30 Storage of reagent
27. NENTS Patient Information Namerno p AE E i R z ADG eiaa ee DEX aa needs National Blood Transfusion Service i Bhutan DNO ete Parent Name icc3223seeecces ieaie Hospital Reg NO cece cece eee eeeee I PATIENT STATEMENT I the undersigned CONSENT to undergo the procedure of transfusion of blood or blood components with full knowledge of the need the benefits possible risks side effects and the alternatives to a transfusion I have also been informed about the risks and consequences of not receiving this therapy and been given an opportunity to ask questions regarding transfusion and have received answers to my questions and concerns in a language understandable to me Signature Thumb Imprint amp Name Il PATIENT REPRESENTATIVE INTERPRETER S STATEMENT 1 Thepatientisunabletoconsentbecause whereapplicable 2 1 therefore consent for the patient Signature and Name Relationship to Patient 3 Interpreter s attestation where applicable The translation has been provided by me Signature and Name IH DOCTOR S AFFIRMATION I declare that I have personally explained the above information in detail to the patient and or the patient s representative and have answered the entire patient s questions to the best of my knowledge Signature and Name 51 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Servi
28. National Standards for Blood Transfusion Service 2013 e suspended in such a way as to ensure minimum noise for the life of the agitator e Amplitude 3 6 to 4 0cm 65 to 75 strokes minute e Electrical characteristics Nominal input voltage 220 240V 50Hz Equip ment meets electrical safety specifications such as that of the IEC e Internal Temperature Control Fan cooling Electronic temperature control to maintain even temperature 22 C 2 C at all shelves and temperature display unit at 0 1 C graduation e Microprocessor controlled LCD display of the inside tempearture at any given time e Audiovisual alarm when temperature out of range open door low battery and power failure warning with battery backup e External Ambient temperature Incubator performs in an ambient tempera ture of 43 C 1 C and relative humidity of 60 e Capacity for storage of approximately 24 to 36 bags of platelet concen trates e Temperature recording mechanism like a seven day recorder chart or an in built printer Accessories i Seven day temperature recorder chart for continuous temperature re cording optional ii Ink stylus pens optional 75 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 6 Upright Plasma freezer Rapid freezing process of the liquid plasma and subsequent storage of the plasma in the frozen stat
29. UTAN Hospital Date of request PATIENT DETAILS Name Age Sex Wt Hospital reference no Ward Blood group documented earlier ABO Rh HISTORY Diagnosis Previous transfusion Yes No Reason for transfusion Any reactions Yes No Hemoglobin result if WB PRC requested Previous pregnancies Yes No___ Platelet count if Platelets requested REQUEST FOR URGENCY 1 Cross matched Blood Whole blood units a Routine Packed Red Cells units b Urgent blood needed in one hour Plasma units c Hold for surgery GSH Protocol CrossMatch Platelets units 2 Un Cross matched blood tick in the blank space Date time required a Group O PRC b Group specific blood c Abbreviated cross matched blood Name of the doctor requesting blood LABORATORY USE ONLY Compatibility testing Patient s Reference No Patient s Blood Group P Antibody Screening POSITIVE NEGATIVE Unit PRC ABO Date amp IS 37 C IAT ICCC Result Name of Date amp time No FFP Rh time of of cross staff cross of issue and PC cross match match matching name of staff WB unit 50 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 5 SAMPLE ONLY INFORMED CONSENT FORM FOR TRANSFUSION OF BLOOD amp BLOOD COMPO
30. VR World Health YY Organization NATIONAL STANDARDS FOR BLOOD TRANSFUSION SERVICE Edition 1 2013 Blood Safety Program Health Care and Diagnostic Division Department of Medical Services Ministry of Health Thimphu Bhutan National Standards for Blood Transfusion Service 2013 Ministry of Health over a period of time has been focusing on consolidation of health care services by improving quality enhancing sustainability improving accessibility and strengthening human resource development and deployment Based on the principle of delivering quality health care services the Blood Safety Program under the Department of Medical Services has developed a manual on National Standards for Blood Transfusion Service based on Good Manufacturing Practices GMP with objective to maintain and enhance the quality and safety of blood transfusion in the health facilities The standards address the entire low risk population selection of donor blood collection testing screening services equipment reagents and human resources The efforts of the program are commended and appreciated since this standard has come at a critical juncture where our efforts are geared towards providing quality health care services Besides adhering to blood transfusion standards I would urge all health care providers to make use of this and other clinical standards guidelines standard operating procedures handbook on universal precaution etc
31. a 350ml in single bags for whole blood transfusion b 450ml in double or triple bags for preparation of packed red cells fresh frozen plasma and platelet concentrates 3 4 11 Therapeutic phlebotomy It shall be performed when ordered by a physician Units drawn shall not be used for transfusion Records of therapeutic phlebotomy should be maintained 3 5 Post donation care All blood donors shall be made to rest for at least 15 minutes post donation and shall be provided with oral fluids and post donation advice and instructions in the form of Information note 3 6 Donor adverse event 3 6 1 All the BTS personnel shall be trained in identification and management of donor adverse event 3 6 2 Standard procedures shall be followed to identify and manage donor adverse reactions 3 6 3 In the advent of a severe reaction a doctor should be informed urgently 3 6 4 Records of all donor adverse events shall be maintained 3 7 Autologous transfusion procedure 3 7 1 Preoperative autologous donation a Done prior to elective surgery b All the donor screening criteria has to be applied as in a homologous donor Minimum Hb should be 11gm 1 unit can be collected every 5 7 days d First donation should be 35 days prior to surgery and last donation 72 hours before surgery date e Oral iron supplement to be given to the donor patient Q 19 National Standards for Blood Transfusion Service 2013 National Standards for Blood Tran
32. aints Therefore in line with the blood policy and the vision national blood safety program has proposed consolidation of the service in its medium to long term strategic plan In this proposal critical functions like donor recruitment blood collection screening for transfusion transmitted infections TTIs processing and distribution shall be limited to few strategic blood banks that shall be referred to as blood centers in each region rest of the blood banks shall function as blood storage centers and the service to be collectively termed as Blood Transfusion Service BTS Hence this document reflects the minimum requirements the service and quality standards based on the new organizational and functional structure of BTS in line with the proposed consolidation strategy 12 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Vision To have a well organized coordinated standardized and quality national blood transfusion service that ensures adequate safe and timely blood supply to all the health facilities practicing clinical blood transfusions Goals 1 To provide the best possible care to the donor before during and after donation 2 To ensure that the best rational use of the donated blood is made by the prescribers 3 To implement quality management system in the service 13 National Standards for Blood Transfusion Service 2013 Nat
33. and 30 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 7 2 4 7 2 5 7 2 6 7 2 8 7 2 9 coordinating the quality system and directly reporting to the head of the center The technical in charge supervisor of each section shall be responsible for the technical operation and to ensure quality assurance The staff shall receive on the job orientation induction briefing and training specific to quality assurance and quality management for services offered Personal records of all staff shall be maintained with details on educational qualifications job description trainings received and competency evaluation reports All staff shall participate in continued medical education programs and regular updates on recent advances in blood banking and clinical transfusion as mandated by Bhutan Medical and Health Council All staff performing TTI testing and processing blood units shall undergo a periodic competency evaluation This activity shall enable in deciding the training needs of the staff Table 4 Human Resource requirement for consolidated BTS until 2023 Eines Posi mon Qualification Designation HR Remarks center Title requirement Transfusion sas ae PG qualification in Medicme Transfusion Medicine nead l specialist B Sc Medical Laboratory Technology Quality Technologist with training in Quality Manager National Management in BTS Blood M
34. antibody for tube antigen c storage at 2 to method 8 C Aia Dil Only For a weekly vial of 10 ml 8 antibody only for D testin each tube method 6 Anti D IgM and IgG combination vial of 10ml 9 Monoclonal IgM and For Rh blood each and Titre 2 1 256 with D IgG blood typing typing storage at 2 to positive cell antibodies for slide 8 C and tube method Anti E Monoclonal vial of 2ml Rh hr typing IgM For typing each and 10 antibody for tube antigen E storage at 2 to method 8 C Anti e Monoclonal vial of 2ml Rh hr typing IgM For typing each and 11 s antibody for tube antigen e storage at 2 to method 8 C For phenotyping vial of 2ml each 12 Anti Fy antibody the respective and storage at red cell 2 to 8 C antigens For phenotyping vial of 2ml each 13 Anti Fy antibody the respective and storage at red cell 2 to 8 C antigens Anm ti lecu vial of 5ml each monoclonal IgM 14 and storage of antibody for tube 2 to 8 C method 89 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 To detect IgG AHG should give Anti Jk monoclonal phenotyping Anti Human Globulin antibodies vial of 10ml ie 2 3 4 reaction Green polyspecific as in each and 15 ne with CCC and containing anti IgG Crosmatching storage at 2 to n ratvereacioh and anti C34 DAT and IAT 8
35. aterials used Outer casing galvanized sheet steel Heat sink aluminum Inner chamber shelves and components fitted in the inner chamber stainless steel Glass door toughened with sodium silicate Door seal Seasoned silicone rubber Door handle PA glass fiber reinforced Control unit ABS Thermal insulation Mineral fiber wool Leads PVC sheathed copper wire Filling medium over temperature protection device polydimethyldisiloxane equipped with an electronic upper limit cut out device of protection class 3 1 2 Blood Bank 1 For spinning the Specifications Centrifuge test samples to detect Silent centrifuge head for 12 tubes Serofuge antigen antibody of dimensions 10 x 75 mm and 12 x reactions during the 75mm immunohematogy e Max RCF 3000 rpm 1006g testing e Adjustable parameters 10 different parameters e Time display in seconds e Voltage requirement 220 to 240 V 50 Hz e Dimensions 260mm width 305mm depth 175mm height e Weight 4 to 5 kg Accessories_required e Centrifuge head for 12 tubes of dimensions 10 x 75 mm and 12 x 75mm e Centrifuge head for 6 tubes of 15 x 100mm e Necessary stabilizer to be included with the equipment 72 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 3 Blood collection monitor with shaker 1 Accurate collection of blood volume during the blood donation process S
36. atient 15 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 3 1 3 1 1 3 2 3 2 1 Donor recruitment All blood establishments in the country shall collect blood from voluntary non remunerated donors recruited from low risk safe and healthy population within the community No payments shall be made to any donor Pre donation information shall be provided Basic information on following topics shall be included e Blood science e Importance of voluntary blood donation e General information about blood donation process and pre and post donation care e Importance of honest answers during the donor interview procedure e The tests conducted on donor and donated unit e HIV transmission and HIV risk reduction Pre donation counseling shall be provided to all potential donors by authorized staff in a private and confidential manner It shall include information on e High risk behaviors and mode of transmission of infections like HIV and hepatitis e Signs and symptoms of HIV AIDS hepatitis and other sexual transmitted infections e Importance of true answers and self exclusion or self deferral by unsuitable donors e Mandatory tests done on all donated blood e Confidentiality of test results e Obtaining an Informed Consent e Available testing options or sites for HIV test Donor selection All potential blood donors shall be assessed
37. ational External Quality Assessment Schemes IEQAS 2 10 Conduct Hemovigilance system 56 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 FUNCTIONAL STRUCTURE OF NATIONAL BLOOD CENTER Headed by a specialist Clerical anit QA section headed by Quality Manager DR section BC section TH amp TTI Comp Storage Issue Dispatch Laboratory section section section Other services Research Training QA Quality assurance DR Donor Recruitment BC Blood Collection IH amp TTI Immuno hematology and Transfusion Transmitted Infection Comp section Blood component preparation 57 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 12 REGIONAL BLOOD CENTER RBC I Staff at Regional Blood Center 1 1 Head 1 2 Quality Manager 1 3 I C Donor section and full time dedicated staff 1 4 T C Red cell serology and full time dedicated staff 1 5 I C TTI laboratory and full time dedicated staff 1 6 I C Component section and full time dedicated staff 2 Functions of a Regional Blood Center 2 1 Blood Donor recruitment 22 Blood donor selection 2 3 Blood collection 2 4 Blood component preparation 2 5 Red cell serology testing 2 6 TTI Testing 2 7 Issue Transport amp distribution o
38. be cooled and maintained at 10 C while transporting from mobile sites to the blood center The blood units for platelet preparation shall be cooled up to 20 C and transported within 6 hours to the blood center Processed blood shall be stored using appropriate storage equipment in the appropriate temperature range until the date of expiry 20 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Table 1 Transportation and Storage Requirements Blood Condition Temperature Transportation Storage range Storage time equipment Whole blood For pransportanon Well insulated and Packed red transportation to 2 C to 10 C container with less than 24 i cell another center ice packs hours Whole blood and Packed red Ror orage i 2 C to 6 C 35 days Blood Dani cell blood center refrigerator Well insulated Platelet Por container transportation to 20 C to 24 C 24 hours concentrates without ice another center packs Platelet For storage in 420 C to 424 C Sdays Platelet agitator concentrates blood center with incubator For Transported Well insulated Fresh Frozen i SA transportation to Frozen state until maintained container with Plasma i another center in frozen state ice packs 3 11 Storage of donor blood samples Long term archiving of the donor s serum samples can be useful for look back facility in ca
39. been in sexual contact with anyone having jaundice or anyone with HIV Hepatitis B Hepatitis C or had sex with a commercial sex worker a drug addict or done any payment in return for sex In last one year have you had casual unprotected sex with one or multiple partners 44 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 In the last three years have you suffered from malaria or taken treatment for malaria In the last six months have you visited high malaria risk region Have you suffered from any abnormal bleeding tendency like easy bruising or heavy blood loss after minor cuts In case you are a woman are you pregnant breast feeding a child of less than one year old or had an abortion in the last six months Statement of consent I the undersigned have understood the importance and have given the correct answers to the best of my knowledge I also give consent to screen my blood for infections like HIV Hepatitis B and C and syphilis Blood donor s signature Hb ABO Rh ____ Body weight Temp rature BP Alcohol smell Yes No IV drug use marks Yes No Infected wounds Yes No Jaundice Yes No Outcome Donor accepted Temporary deferred Permanently deferred Tick appropriate answer Date of donation Blood unit no Type of blood bag Single Double Triple bag Blood volume
40. blood Dosage 10ml kg f at body wt refrigerator at if maintained at 24 hours if 2 C to 6 C 1 C to Increases Hb 10 C open system by 1 1 5gm Vol 250ml1 30m1 Hct 60 to 70 Packed hed Powe like Same as above Same as above Same as above Cells body wt Increases Hb by 1 1 5gm Vol 200 220ml1 Contains stable amp Ina plasma Fresh Frozen 70 unstable freezer Transported in Pye Plasma FFP clotting factors at below frozen state y Dosage 15ml kg 30 C body wt o y p o Maintain FFP Thawed Same as FFP blood bank between 4 6 hours R 1 C to 10 C refrigerator Vol 200 220m1 2 C to 6 C ee Contains only ina ieee Liquid Plasma between 40 days stable clotting blood bank 1 C to 10 C factors refrigerator Vol 50 to 70ml Contains 3 5 In a platelet 4 4 5x10 platelets incubator with days dosad unit agitator at syster Platelet Dosage lunit 10 20 C to 5 y f 20 C to 24 C concentrate kg body wt 24 C with 6 hours if Increases the continuous o platelet count gentle P by 10 000 to agitation 20 0000 ul blood 27 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 6 1 6 1 1 6 1 2 6 1 4 6 2 6 2 1 6 2 2 6 2 3 6 2 4 Transfusion requests Transfusion of blood and blood components shall be advised by authorized health personnel based on definite clinical benefits to the
41. ce 2013 Annex 6 SAMPLE ONLY TRANSFUSION REPORT to be filled for each transfusion Name of patient Hospital Age Sex Registration No Ward Pt s Blood Bank Ref No Pt s blood group Unit No Blood group of the unit Compatibility label checked Y N circle Type of component circle one PRC WB FFP Platelet concentrate Pooled platelets Volume of the unit ml Name of the doctor advising Details of the nursing staff performing the checks and starting the transfusion Name Signature Date time of starting the transfusion Any IV Fluid joined Y N Any pre medication given Y N Vitals to be noted as below Vitals Time i Temperature Pulse rate Blood Pressure Respiratory rate Outcome of the transfusion Completed Transfusion reaction occurred tick the appropriate If reaction occurred is it reported and are blood samples sent to the Blood Center Y N Is the blood bank in charge or blood center staff informed Y N Details of the nursing staff completing the transfusion reporting the reaction Name Signature 52 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 8 Figure 1 ORGANOGRAM OF CONSOLIDATED BLOOD TRANSFUSION SERVICE Ministry of Health BMB DoPH PHL DRA NBT Co
42. collected Time Taken Any reaction during after blood donation Yes No If yes please mention the type of reaction Name of the blood center staff Information Note to be provided to donor Name of donor Age Sex Date of donation Unit No 45 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 You should follow the instructions mentioned below after donating blood e Take plenty of oral fluids on the day of donation e Continue your routine work avoid any type of heavy or risky activity on that day Do not smoke for the next one hour e Keep the band aid plaster on the donation arm for the whole day e Incase after donating blood if you feel that your blood may be unsafe to the patient who receives it you may please inform the concerned blood bank at the earliest for its timely discard Donated blood shall be screened for HIV Hepatitis B Hepatitis C syphilis and if indicated for malaria Thank you for your support Kindly come again and donate the GIFT of BLOOD Your next date of donation is around Name and Signature of the blood center staff Date 46 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 3 DONOR DEFERRALS A LIST OF TEMPORARY DEFERRALS CONDITIONS PERIOD OF DEFERMENT e Abortion e Accept after 6 months e A
43. e conducted as below Table 5 Frequency of testing for reagents and solutions Reagents and supplies Frequency of testing with controls Blood grouping anti sera Each day of use Standard cells for serum grouping Each day of use Anti Human Globulin Each day of use Coombs control cells Each day of use Bovine albumin Each lot Syphilis serology assays Each run HIV test assays reagents Each run Hepatitis test assays Each run Normal saline Each day of use c Minimum quality requirements for anti sera and red cell reagents are as follows Table 6 Anti sera anti A anti B and anti A B Parameters Quality requirement Appearance on visual inspection No turbidity no particle or precipitates Specificity with positive and negative controls and required strength of reactions For Anti A hemolysis or positive reaction of grade 3 4 with A cell negative reaction with B cell For Anti B hemolysis or positive reaction of grade 3 4 with B cell negative reaction with A cell For Anti AB hemolysis or positive reaction of grade 3 4 with A cell and B cell negative reaction with O cell 35 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service Avidity Macroscopic agglutinates seen in 10 seconds with whole blood on slide test Acceptable titer 3 reaction at 1 256 titer to be carried out with
44. e for 6months to year at below 20 C Plasma Freezers Equipment meets internationally accepted electrical safety speci fications such as that IEC Specifications Type of equipment Compression freezer with CFC free refrigerant gas and elec tricity supply from the national grid e Construction Internal Stainless steel External corrosion resistant e Upright type e Solid door with roll out type drawers e Electrical Characteristics Nominal input voltage 220V 240V 50 Hz e Internal temperature Control Electronic temperature control e Operating temperature 35 C to 40 C with setting accuracy of 1 C what ever the load e Fan air cooling automatic defrost within safe temperature control e External ambient temperature Performs in an ambient temperature of 10 to 43 C e Hold over time A full load of plasma packs at 36 C takes atleast 1 hour to rise to above 20 C A full load of plasma packs at 36 C takes atleast 32 hours to rise above 5 C e Capacity To store 200 approx plasma bags of 250 ml volume e Temperature Monitoring Digital temperature LED display with 0 1 LIC graduation e Temperature recording device e Visual and audible alarm system indicating unsafe temperatures e Battery back up for alarm and temperature recording device Accessories Transparent poly carbonate material rack to hold 25 units of frozen plasma per rack Dimension of the rack are 105x125x648mm
45. e in 10 rpm increments Max RCF 15 320g Drive Brushless induction drive Acceleration deceleration 9 9 profiles Program memory 9 1 centrifugation programs Run time 0 to 99minutes plus load Temperature range 9 C to 40 C CFC refrigerant free Temperature 2 digit adjustable in 1 C interval Safety Features Lid lock and lid interlock automatic imbalance cut out and steel armored chamber and provision for unlocking the lid incase of power failure and quick stop at any time using a special key also during the deceleration phase 83 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Accessories Required ROTOR Windshield and double blood bag buckets 6 pieces For centrifuging capacity of 8 blood bags x 450ml 1 2 J 4 5 6 Should display the error of lid not closed imbalance malfunction of the centrifuge operating errors over temperature Maximum Speed 4 400 rpm Maximum RCF 5 480g Maximum Capacity 8x 500 ml Adapter for 450 500m1 quad triple XL set of 6 Volume Adjustment Plates blue rubber set of 12 Taring sticks 4 each of 6gm and 15gm a limited electric supply They should hold the temperature below 10 C for up to 72 hours following a power cut and at 4 C in presence of power supply 18 Manual The stand is used Specifications plasma to extract manually e Sp
46. e potential blood donors Blood collection with minimum risk of contamination or errors Refreshment cum post donation care of donors including management of donors with adverse events Laboratory for screening of blood units for transfusion transmitted infections TTIs Laboratory for blood group serology and immunohematology testing Processing of whole blood into components in a manner that prevents contamination and loss of potency Separate storage of quarantined and finished products Separate storage of reagents supplies and equipment Sterilization cum washing optional room Documentation recording and storage of data on the donor the blood units and the blood recipients Quality control and assurance activities Administrative room with computer internet connection and printer It shall cover a minimum area of 100 sq m for its above operations and an additional area of 50 sq m for having facilities for blood component preparation An area of10 sq m shall be included for aphaeresis services Mobile blood donation The premises used may not comply with the above 7 3 4 requirements they must be adequate to ensure safety of the donor collected blood and the staff participating in the camp and the subsequent users of the premises For holding a mobile blood donation camp the following requirements shall be fulfilled a The premises shall have sufficient space and shall be hygienic b Electric supply made available for equ
47. ection blood units IH Immuno hematology laboratory Mx Management 60 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 14 STANDARD TESTS AT CENTERS Tests NBC RBC BSC Blood Donor Management Area ABO grouping RhD typing Weak D test Test for Donor Hemoglobin Screening of donated blood for HIV HBV ot HCV syphilis and malarial for all malarial endemic regions em 1K mK KL a Donor Red cell phenotyping x Compatibility tests ABO grouping Rh typing Cross matching test 4 Antibody screening test to detect unexpected F X anti bodies Antibody identification test T x Recipient Red cell phenotyping x Quality Control tests QC tests on blood group serology reagents QC tests on TTI reagents T T x QC tests on blood components x Other tests Tests for transfusion reaction investigation Prenatal testing 61 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 ANNEX 15 BASIC EQUIPMENT REQUIREMENT AT CENTERS S No Name of the equipm
48. edical Laboratory Center Technician or Health Donor recruitment Assistant trained in Donor 2 health education blood Recruiter personnel science and donor recruitment Medical Certificate in general Bloodcent r Laboratory Medical Laboratory staff 15 technicians Technology 31 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Atleast at Tanu oi PG qualification in Mo ggar Medicine a Head 1 and are Transfusion Medicine specialist Gelephu RBCs B Sc Medical Laboratory Technology se Technologist with 6 months training Head 1 eng in blood banking and clinical transfusion Regional B Sc Medical Blood j Laboratory Technology Quality Center Technologist with training in Quality Manager i Management in BTS Medical Certificate in general Blood center Laboratory Medical Laboratory staff 10 technicians Technology Medical Laboratory Technician or Health Donor recruitment assistant trained in 1 health education blood personnel science and donor recruitment Rotated Blood Meical Certificate in Medical from storage Laboratory Laboratory Technolo l neral center technicians y 8y gene laboratory 7 3 Premises Requirements 7 3 1 The premises shall be of suitable size construction and location to facilitate its proper operation cleaning and maintenance and at the same time minimi
49. ell Lewis Lutheran blood group system To detect unexpected antibodies 3X10ml pack and storage at 2 to 8 C To be procured on monthly basis maintaining cold chain and have shelf life of 4 weeks 31 Bovine serum Albumin 22 solution for serological applications protein concentration and pH should be adjusted to 22 and 7 1 respectively To enhance immunological reactions and increase test sensitivity vial of 10ml each and storage at 2 to 8 C 92 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 32 Rapid test kit for blood donor screening for Malarial Antigens to all four species lt should comprise of monoclonal anti Pan specific pLDH IgG antibody conjugated with gold sol in conjugate pad which facilitate high specificity and monoclonal anti Pan specific pLDH IgM antibody in test line area of chromatography membrane which facilitate high sensitivity for the antigen pLDH detection Rapid test kit for blood donor screening for Malarial Antigens to all four species which detects pan specific pLDH High sensitivity for antigen detection should detect very less parasitaemia 150 parasites ul have no cross reactivity 25 test kits in one pack and storage at 2 to 8 C 33 Rh hr Control fortified with Bovine serum Albumin To be used in parallel to confirm t
50. ent NBC RBC BSC Blood donor management section 1 Automatic Blood Collection Monitor with Shaker x 2 Blood collection spring scale 3 Portable Hemoglobin testing machine Hemocue machine x 4 Donor Couch x 5 Hand tube stripper with roller and cutter 6 Dielectric tube sealer 7 Apheresis machine x x Immunohematology laboratory 8 Blood Bank Bench top centrifuge serofuge 9 Automatic Cell Washer x 10 Microscope 11 Dry Incubator 12 Column Agglutination Test system Incubator Centrifuge X X and work station Blood component preparation amp storage section 13 Refrigerated blood processing centrifuge x 14 Double pan blood bag weighing balance x 15 Standard blood bank refrigerator 16 Platelet agitator and incubator x 17 Plasma Storage freezer x 18 Plasma thawing bath x 19 Manual Plasma expresser H 20 Sterile connecting device xX 21 Cryobath x x 22 Laminar air flow xX 23 pH meter xX TTI laboratory 24 ELISA system washer and reader x 62 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 25 Micropipettes x Blood cold chain 26 Blood transport boxes with data loggers x 27 Cool boxes H 63 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013
51. erwise they must be discarded 36 National Standards for Blood Transfusion Service 2013 2013 National Standards for Blood Transfusion Service 2013 A cell positive reaction of grade 3 4 with anti A negative reaction with anti B Specificity with positive and B cell positive reaction of grade3 4 with negative controls and required anti B strength of reactions negative reaction with anti A O cell negative reaction with anti A and anti B CCC Grade 2 3 4 reaction with AHG negative reaction with normal saline 7 5 1 2 Quality control of BTS equipment a For all new equipment installation and operational qualification must be performed After it is qualified for use an ongoing quality control checks should be performed b All critical equipment must be calibrated and adjusted e before use that is on installation e after activities that may affect the calibration e at prescribed intervals c Safeguards are to be implemented to prevent adjustments that would invalidate the calibration setting and calibration equipment must have adequate accuracy and precision Table 11 Quality Control Performance Intervals Equipment Performance Frequency Blood collection monitor with f ceeds Day or ise shaker Time displayed Monthly Volume displayed Monthly Spring ee Hor hood Volume displayed Day of use collection Electronic balance for blood bags Weig
52. etection should be able to detect very less parasitaemia 150 parasites ul and NO Interference protected from heterophile antibodies no cross reactivity Test that It should be a can detect gs double antibody pan sperite sandwich assa Rapid test kits pLDH which Y pa for detection of for blood donor facilitate to i 42 i active malaria screening for malaria detect active a ae infection comprising antigens infection i e of monoclonal viable para y sites of all anti Pan specific pLDH IgG antibody malaria conjugated with gold sol in conjugate pad which facilitates high specificity and monoclonal anti Pan specific pLDH IgM antibody in test line area of chromatography membrane which facilitates high sensitivity for the antigen pLDH detection 95 National Standards for Blood Transfusion Service 2013
53. every new lot and with new annual procurement supply Table 7 Anti D anti sera Parameters Appearance on visual inspection Quality requirement No turbidity no particle or precipitates Specificity with positive and negative controls and required strength of reactions positive reaction of 3 4 with D ve cell negative reaction with D negative cell Avidity Macroscopic agglutinates seen in 10 seconds with whole blood on slide test Acceptable titer 3 reaction at 1 64 titer to be carried out with every new lot and with new annual procurement supply Parameters Table 8 Anti Human Globulin AHG Quality requirement Appearance No turbidity no particle or precipitates Specificity and strength of reactions Table 9 Bovine Albumin positive reaction of 2 3 4 with CCC negative reaction with any standard cell Parameters Quality requirement Appearance No turbidity no particle or precipitates to be done daily Reactivity with negative control only Negative reaction with any standard cell to be done with each new lot Table 10 Red cell preparations A cell B cell O cell and Coombs Control Cells Parameters Quality requirement Appearance on visual inspection No hemolysis in the supernatant If a single saline wash removes the hemoglobin stained supernatant fluid the red cells are appropriate for use Oth
54. f blood and components to blood storage centers 2 8 Hemovigilance 2 9 Transfusion audits amp monitoring 58 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 FUNCTIONAL STRUCTURE OF REGIONAL BLOOD CENTER Headed by a specialist technologist QA section headed by Quality Manager Clerical unit BC section IH amp TTI Comp Storage Dispatch Laboratory section Issue section section QA Quality assurance DR Donor Recruitment BC Blood Collection IH amp TTI Immuno hematology And Transfusion Transmitted Infection Comp section Blood component preparation 59 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 13 BLOOD STORAGE CENTERS BSC 1 Staff at Blood Storage center El Technicians from laboratory service on rotation 2 Functions of a Blood Storage Center 2 1 Receipt and storage of screened blood amp components 2 2 Blood inventory management 2 3 Maintenance of storage equipment 2 4 Grouping amp cross matching compatibility tests 2 5 Issue of blood 2 6 To participate in Hospital Transfusion Committee HTxC meetings FUNCTIONAL STRUCTURE OF A BLOOD STORAGE CENTER BSC Headed by a laboratory technician Storage amp inventory IH Laboratory Blood Issue Mx of screened s
55. gulant solution Blood product Any therapeutic substance derived from human blood including whole blood blood components and plasma derived products Calibrate To set measurement of equipment against a known standard Clinically Significant Antibody Any allogenic or autologous antibody that is capable of producing a significant adverse reaction to transfused blood or component Closed System A system for collecting and processing blood in containers that have been connected together by the manufacturer before sterilization so that there is no possibility of bacterial or viral contamination from outside after collection of blood from the donor 6 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Corrective Action An activity performed to eliminate the cause of an existing nonconformance or other undesirable situation in order to prevent recurrence Competence Ability of an individual to perform a specific task according to standard procedure Conformance Fulfillment of requirements as defined by standards Critical Capable of affecting quality Document noun Written or electronically generated information involved in providing a product or service Examples are policies standards standard operating procedures work instructions reports and records Document verb To capture information for use in documents through writing or electronic media Don
56. he specific reaction with Rh antigen and Rh antibody vial of 5ml each and storage of 2 to 8 C 34 35 Rapid test kits for anti HIV antibody Rapid test kits for anti HCV antibody WHO evaluated Sensitivity 299 5 and specificity gt 98 WHO evaluated Sensitivity 299 5 and specificity gt 98 93 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 F WHO evaluated Rapid test kit for Sensitivity 299 5 36 Hepatitis B Surface sade Anngen specificity gt 98 WHO qualified sensitivity 299 5 37 ELISA test for anti HIV and specificity 1 2 antibody gt 99 8 Antibody IgG and IgM detection WHO qualified sensitivity 299 5 38 ELISA test for anti and specificity HCV antibody gt 99 8 Antibody IgG and IgM detection WHO qualified ELISA test for sensitivity 299 5 39 Hepatitis B Surface specificity 99 8 Antigen Antibody IgG and IgM detection TPHA Sensitivity 100 40 ile E specificity 99 8 test kit Antibody IgG and IgM detection Sensitivity 100 and specificity RPR flocculation test 99 8 Directions for 41 ithe kits both qualitative and quantitative method serial dilution 94 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 It should be highly sensitive antigen d
57. ht Volume displayed Monthly Di electric tube sealer Adequate sealing Day of use Hemoglobinometer Hb value with known control sample Day of use 7 5 1 4 Quality control of blood and blood components Table 13 Whole blood 100 of the units tested should meet the below requirements Parameters Quality requirement Frequency of check Volume 350ml 450ml 10 Minimum of 4 units per month Het 30 to 40 Minimum of 4 units per month Sterility No growth Minimum of 4 units per month 37 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Table 14 Packed red cell 100 of the units tested should meet the below requirements Parameters Quality requirement Frequency of check Volume 280ml 50ml Minimum of 4 units per month Hematocrit value 65 to 75 Minimum of 4 units per month Sterility No growth Minimum of 4 units per month Table 15 Platelet concentrate 75 of the units tested should meet the below requirements Parameters Quality requirement Frequency of check Minimum of 4 units per month or 1 of a aa prepared platelets whichever is higher gt 3 5 x 10 platelet per bag in at least 75 of the Minimum of 4 units per month or 1 of units tested at the end of prepared platelets whichever is higher the storage period Platelet count pH at the time Minimum of 4 units per month or 1 of
58. ional Standards for Blood Transfusion Service 2013 Blood transfusion service and hospital transfusion practice established by national health authority shall function in compliance with the below mentioned code of ethics Blood donors and blood donation 2 1 All matters related to blood donation should be in accordance with the National Blood Policy 2007 2 2 Blood donation shall be on a voluntary basis and no remuneration shall be given to the donors There shall be no compulsion made on an individual to donate blood 2 3 The donor should understand the risks of donating infected blood to others and his her ethical responsibility to the recipient 2 4 The donor should provide informed consent to the donation of blood and to the subsequent use of the blood by the transfusion service 25 Blood donation shall be based on the donor selection criteria laid down and must not entail discrimination of any kind including gender nationality or religion BTS personnel 2 6 The BTS personnel shall explain the donor of the risks connected with the donation procedure The donor s health and safety shall be the ethical responsibility of the staff 2 7 Blood should be collected under the overall responsibility of either a registered medical practitioner or an authorized BTS personnel who can manage a donor adverse reaction 2 8 Anonymity between the donor and the recipient must be ensured and the confidentiality of donor information assured
59. ipment used in the blood donation camp c Adequate lighting 33 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 7 4 7 4 1 7 4 2 7 4 3 7 4 4 7 4 5 7 4 6 7 4 1 7 4 8 7 5 d Facilities for confidential examination of donors e Hand washing facilities f Basic furniture like chairs and tables g Couches beds that can be arranged within the available space h Refreshment facilities for donors and staff i Proper disposal of waste Standard tests equipment and reagents Each center shall perform the required tests as shown in Annex 14 The list of standard equipment and standard reagents are provided in Annex15 and Annex 16 respectively Standard specifications developed for all BTS equipment and reagents shall be used for floating quotations to registered suppliers Only those that meet the criteria shall be selected and purchased Annex 19 and Annex 20 provide the specifications for blood bank equipment and reagents respectively Prior to selection all immuno hematology reagents and supplies shall be evaluated by national blood center and TTI test kits by Public Health Laboratory PHL All BTS equipment shall be validated on installation and before use jointly by manufacturer competent technical staff Quality Assurance and Standardization Division and Bio Medical Engineering unit Equipment control process shall be in place for periodic
60. istry of Health The national blood transfusion service NBTS under the Department of Medical Services DMS Ministry of Health shall be the key planning agency The department shall be responsible to make available to NBTS all the necessary resources human and financial for the operations of the NBTS NBTS shall define clear lines of authority responsibility and accountability for all health personnel involved in blood safety and blood transfusion It shall work in co ordination with clinical services for appropriate use of blood for patient care The composition and roles of NBTS are reflected in Annex 10 The composition and functions of various levels of consolidated BTS are reflected in Annex 11 12 and 13 Personnel The BTS shall have adequate number of personnel qualified by education training and or experience The blood center should have a written dated and signed organogram organisational structure clearly defining the reporting structures and hierarchies of the management and staff BTS technicians shall be competent and full time possessing a certificate diploma degree of medical laboratory technology and blood banking The head of major blood centers shall be a doctor with post graduate qualification in transfusion medicine with responsibilities including professional consultative or advisory organizational administrative and educational matters The quality manager shall be designated staff responsible for directing
61. l 2 7 Co ordinate with DVED in the procurement of equipment reagents and supplies 2 8 Coordinate with DRA 2 9 Monitor blood centers by conduct periodic supervisory visits audits 2 10 Manage blood safety data through collection compilation and analysis of reports from all blood Centers 2 11 To co ordinate with national blood center to organize National External Quality Assurance scheme in blood group serology and TTIs 2 12 Organize National Hemovigilance System 55 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 11 NATIONAL BLOOD CENTER NBC 1 Staff at National Blood Center 1 1 Head 1 2 Quality Manager 1 3 In charge Donor section and dedicated staff 1 4 In charge Red cell serology and dedicated staff 1 5 In charge TTI laboratory and dedicated staff 1 6 In charge Blood Component section and dedicated staff 2 Functions of National Blood Center 2 1 Perform all routine operations of a blood center 2 2 Provide technical advice to NBTS 2 3 Assist NBTS in national awareness and multi media campaigns for Voluntary blood donations VBD 2 4 Preparing all technical documents 2 5 Introduction of new technologies 2 6 Support NBTS in procurement of reagents consumables and equipment 2 7 Conduct training of all categories of staff involved in blood transfusion chain 2 8 Organize National External Quality Assessment Schemes NEQAS 2 9 Participate in Intern
62. malaria antigens to all four species shall be done on all donations collected in endemic districts Table 2 TTIs and Serological Markers Mandatory TTI s Serological Markers Human Immunodeficiency Virus Antibodies to HIV 1 and 2 Hepatitis B Hepatitis B surface antigen HBsAg Hepatitis C Anti HCV antibody Syphilis Specific treponemal antibody Malaria Malaria antigen 4 3 Screening assays All blood centers shall screen 100 blood units for TTIs using ELISA assays In emergency situations when blood is needed urgently but not readily available in 24 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 inventory screening with rapid assays could be done But the unit shall be retested with the ELISA assay 4 4 National screening algorithm All blood centers shall follow the screening algorithm shown in Figurel when screening blood units for HIV HBV and HCV infections 4 5 Personnel TTI testing shall be done by only authorized laboratory personnel and National Guidelines on screening donated blood for TTIs shall be followed Figure 1 Screening Algorithm If Al is Negative Perform initial If Al is Positive report as Non a Screening test EIA __ record as Initial reactive or Rapid A1 Reactive Blood or blood components can be released for transfusion Repeat test
63. mation to be Provided to the blood donor shall include a Explanation to the donor on the screen results the non specific reactivity detected by highly sensitive screening assays to ensure blood safety to the recipients b Information on the discard of the reactive unit and the deferral advice on future blood donation c Referral toa VCT center for further counseling and information and consenting for confirmatory testing 22 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 FLOW DIAGRAM OFA POTENTIAL BLOOD DONOR SHALL BE AS FOLLOWS Donor self Reci defers after eceives Intending Reception information mes Fills details donor _ gt materials pap amp educational in donor materials to 3 questionnaire read Donor decides and consent to donate after form reading materials ancien If accepted irei Counselling e under goes donor 4 goes Hemoglobin medical and undergoes blood registration estimation physical check up donation Donor deferred and advised if unsuitable Refreshment rest Donor thanked and post donation and given a gt Donor exists advice and hearty sendoff information note provided 23 National Standards for Blood Transfusion Service 2013
64. mmittee eae Western Region L SC BSC DMS National Blood Transfusion Service Health care amp Diagnostic Division National Blood Center NBC Central Region Eastern Region BSC BSC 2 Rec rec Rec BSC BSC BSC BSC BSC BSC 53 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 9 National Blood Transfusion Committee NBTC l The National Blood Transfusion Committee NBTC shall comprise of the following members 1 1 Chairman Director General Department of Medical Service ex officio 1 2 Dy Chairman Drug controller Chief Regulatory Officer DRA 1 3 Secretary Director Head of NBTS 1 4 Transfusion medicine specialist ex officio 1 5 Head Public Health Laboratory ex officio 1 6 Chief Program Officer QASD ex officio 1 7 Gynecologist nominated by MOH 1 8 Medical specialist nominated by MOH 1 9 Emergency medicine specialist nominated by MOH 1 10 Microbiologist nominated by MOH 2 Roles and Responsibilities of NBTC shall 2 1 Serve as an advisory committee to the Bhutan Medicines Board on matters related to blood and blood products and blood transfusion service 2 2 Guide Bhutan Medicines Board and the Ministry
65. nagement and infection control are strictly followed All the waste produced at the mobile blood donation camps is also to be segregated at source and then transported back to the BTS for proper treatment and disposal The waste that generated within the BTS should always follow an appropriate and well defined process from its point of generation until its final disposal referred to as cradle to grave concept 40 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 This process should consists of following steps a Generation b Segregation at source of generation of waste c Collection d Storage e Transportation f Treatment g Disposal Table 17 Example of waste generated in a BTS Non risk Infectious waste Sharps Chemical waste waste Packages Gloves gauze swabs used Needles from Anticoagulant boxes cuvettes contaminated with blood blood collection solutions Wrappings Blood and blood component units bags blood Copper Sulfate discarded due to TTIs expired and administration disinfectants unsuitability sets and other reagents anti Used blood bags transfer bags disposable sera buffer and accessories for component needles solutions preparations Segments from blood bag tubing IV sets used test tubes micro capillary tubes and glassware used syringes Liquids from cell washers Blood and serum samples Red cell suspen
66. ndicating temperature outside range Audible visual alarm if water level drops Audio Visual alarm if plasma pack leaks during thawing if pack is not in a leak proof container Capacity To thaw 8 plasma bags at a time 77 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Standard upright blood bank refrigerator Heavy insulation for storage of the whole blood and packed red cells at 4 C 2 C with special features of alarm alerts continuous temperature monitoring and display uniform temperature mainatianence throughout the equipment longer holdover time in the event of power failure Specifications Resistant Capacity of three different BBRs are i Terumo penpol 300 litres 144 blood bags of 450ml volume or 168 bags of 350 ml ii Revco I 300 litres Type Compression type CFC free refrigerant gas Construction Internal Stainless steel External Corrosion Glass door and roll out stainless steel drawers Electrical Characteristics Input voltage 220 240 V 50 Hz Internal temperature Control Electronic temperature control range 2 C to 6 C with setting accuracy 1 C Fan air cooling External ambient temperature Performs in an ambient temperature of 10 Cto 43 C Hold Over time A full load of blood packs at 4 C takes at least 30 minutes to rise to above 6 C Co
67. ning identification and antigen tests on the patient s sample Group Screen Hold GSH protocol shall be followed for all elective surgical cases as outlined in the national guidelines document 28 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 6 3 6 3 1 6 4 6 4 1 6 4 2 6 4 3 6 4 4 6 4 5 6 4 6 Blood issue The blood center shall have a process for EMERGENCY issuing of blood blood components before completion of the pre transfusion tests if the treating doctor decides that delay in administering blood transfusion can be detrimental to the patient s survival Blood and blood components that have been returned to the blood center shall be reused only if certain specific criteria have been met These criteria shall be developed by each center Records of patient s details the tests results and issues must be maintained at all times All tests shall be performed in accordance with the standard operating procedures developed Clinical transfusion process CTP Only trained and authorized health personnel shall administer blood blood components to patients A written informed consent shall be obtained from all patients before each transfusion is started Refer to Annex 5 Procedures and protocols for clinical transfusion process as reflected in the national guidelines document shall be followed Positive patient identification check correc
68. nt specific if required 53 Rapid test kits for HIV antibody 54 Rapid test kits for HCV antibody 55 Rapid test kits for Hepatitis B surface antigen 56 ELISA test kits for HIV antibody x 57 ELISA test kits for HCV antibody x 58 ELISA test kits for Hepatatis B surface antigen x 59 Treponema Pallidum Hemagglutination test kit X 60 RPR test kit 61 Rapid test kits for blood donor screening for malaria antigens x 65 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 ANNEX 17 EQUIPMENT RECORD l Name of the equipment 2 Name and contact details of the manufacturer 3 Name and contact details of the supplier 4 Funded by 5 Cost of the equipment if known 6 Date of installation ds Installation certificate 8 Serial Number of the equipment 9 Designated area for installation 10 Electrical Requirement 11 Intended use or purpose of the equipment 12 Operation manual amp Service manual available with 13 Basic Principle on which the equipment works 14 Calibration details 15 Details of preventive maintenance 16 Signature Name of the person performing the QC 66 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 ANNEX 18 STANDARD OPERAT
69. ntibiotics e Accept after completion of antibiotics e Allergies e Accept if mild seasonal allergy e Anemia e Accept only if it is iron deficiency anemia after it is treated e Alcoholism e Accept if donor is sober and not under the influence of alcohol e Arthritis e Accept after acute phase e Asthma e Accept after drug therapy Blood transfusion history Accept 6 months after the date of blood received Bronchitis Accept after 1 month of recovery Defer for 12 months after child birth Accept only if cleared by a medical doctor Breast feeding Chest pain shortness of breath Common cold Accept if there is no fever Cystitis Urinary Tract Infection Accept 3 weeks after recovery Dermatitis skin infection Accept if venipuncture site is clear of any infection and not on any oral medication like antibiotics e Dengue e Defer until 4 weeks after recovery e Diabetes e Accept only if diet controlled or taking single antidiabetic oral drug e Dysentery e Accept month after recovery e Epilepsy e Defer for 3 years after completion of treatment e No deferral needed if H o epilepsy in childhood e Fractures e Minor accept after 3 months Major accept after 6 months Fever flu like illness Accept after 2 weeks Gall stones Accept if no symptoms of acute attack Gastro enteritis Gout Accept after 1 month Accept if asymptomatic and not on treatment 47 National Standards fo
70. of 5ml each 24 the respective and storage at for tube method A red cell 2 to 8 C antigens For Anti N monoclonal phenotyping vial of 3ml each 25 IgM antibody for tube the respective and storage at method red cell 2 to 8 C antigens Ps i vial of of 1ml Anti P1 antibody for p YP 8 each and 26 the respective tube method storage at 2 to red cell ji 8 C antigens ee in vial of 3ml Anti S antibody for p YP ne each and 27 the respective tube method storage at 2 to red cell 7 8 C antigens For Anti antibody for phenotyping vial of 3ml each 28 the respective and storage at tube method A red cell 2 to 8 C antigens 91 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 29 Antibody panel cells for antibody identification for conventional tube method a set of 11 cells of 3 suspension Together the three cell set must possess all the antigens on their red cells for Rh Kidd Duffy P1 MNS Kell Lewis Lutheran blood group system To identify all unexpected red antibodies 11X4ml pack and storage at 2 to 8 C To be procured on monthly basis maintaining cold chain and have a shelf ife of 4 weeks 30 Antibody screening cells for conventional tube method A sets of 3cells of 3 suspension Together the three cell set must possess all the antigens on their red cells for Rh Kidd Duffy P1 MNS K
71. of Health in reviewing and revising the National Blood Policy and in all policy related matters 2 3 Provide technical advice and guidance to Ministry of Health and other relevant agencies on establishment of a national blood program and development of a strategic blood plan 2 4 Review recommend changes and revise the national guidelines and standards for BTS for better implementation by the relevant agencies and enforcement 2 5 Recommend the board for institution of subcommittees as and when required 54 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 10 NATIONAL BLOOD TRANSFUSION SERVICE NBTS 1 Staff at NBTS 1 1 Director Head 1 2 Quality manager 1 3 Programme officer 1 4 Administrative staff and Support staff 2 Functions of NBTS Del Secure annual budget from MoH for all BTS operations 2 2 Perform strategic planning and develop actions plan and implement activities 2 3 Coordinate all operations of Blood Transfusion Service in the country 2 4 Develop national guidelines standard procedures and donor educational materials 2 5 Create national awareness and conduct multi media campaigns on voluntary blood donations VBDs 2 6 Co ordinate with relevant agencies on human resource development capacity building through in service trainings and CMEs for doctors laboratory technicians technologists nurses ACOs and other relevant health personne
72. oling down time A full load of blood packs at 25 C takes a maximum of 13 hrs for all the packs to reach below 6 C Temperature monitoring Digital temperature LED display with 0 1 C graduation Temperature recording device Audible and visual alarm system indicating unsafe temperatures Battery back up for alarm and temperature recording device Mounted on castor wheels Minimum compressor starting voltage 22 below nominal voltage 78 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service iii Revco I 500 litres Accessories Seven day circular chart paper for range of 0 to 40 C chart resolution 1 C Stylus ink pen Automated Cell Washer Multi functions in medical analysis 1 Centrifuging of test samples to detect antigen antibody re actions in immune hematology tests 2 Automatic washing of the test samples with normal saline Specifications Fast acceleration and deceleration Compact and light weight Agitates automatically after each decant agitate cycle also manually operable Digital display of time and wash cycle Single distributor for standard 10mm x 75mm or 12mm x 75mm test tubes 12 test tubes Speed and RCF 500 to 3000rpm and decant speed at 600rpm Controls for Mode Cycle Time and Command Brushless system no need to replace worn brushes Lifetime lubrication of all moving arts
73. olts DC Appropriate Voltage stabilizer RF output frequency 40 68MHz Compliance EN61010 1 Classification Class I Installation category Category H Operation Continuous Provided with a splash guard The sealer to be equipped with a reliable process control that ensures leakage detection Weight Approx 5 to 6 kg 5 Platelet agitator and incubator Storage of platelets for five days at the required temperature of 22 C 42 C in an incubator with continuous agitation of the platelet units for an even suspension of platelets in plasma thereby maintaining the quality of the platelet unit Specifications eType of equipment Flatbed agitator fitted inside a temperature controlled incubator operating in a CFC free refrigerant gas and insulation material and electricity from the national grid Operation Continous Power 60W Construction Internal Stainless steel External Corrosion resistant at least Imm thickness Designed to hold a load of random platelet packs 300ml bag size or apheresis platelet packs 500ml or a mixture of both types Glass door for easy inspection from outside Design of shelves Shelves are made of corrosion resistant material with sufficient clearance to minimize noise Easy loading and withdrawal of platelet packs Shelves cannot be pulled out in error The agitator holding the shelves is 74 National Standards for Blood Transfusion Service 2013
74. on storage at 2 to f reagent and red cell control cells 48 C with AHG and have preserving solution stability of 4 weeks post preparation l vial of 20ml Standard cells Alsevers Solution for prepared should To prepare each and m 2 preservation of red have stability of Cee standard cells storage at 2 to blood cell antigenicity 48 C 4 to 6 weeks post preparation ee Mener anal vialof10ml Titre gt 1 256 with blood grouping IgM For ABO blood 3 and storage at A cell and negative antibody for slide and group ing z i 2 to 8 C with B cell tube method Anti A1 lectin To detect 4 monoclonal IgM Al red cell vial of 5ml each antibody for tube antigen from method A2 Anti AB Monoclonal vial of 10ml Titre gt 1 256 with blood grouping IgM For ABO blood each and f 5 4 A cell and negative antibody for slide and group ing storage at 2to p with B cell tube method 8 C Anti B Monoclonal vial of 10ml Titre gt 1 256 with blood grouping IgM For ABO blood each and 6 B cell and negative antibody for slide and group ing storage at 2to o with A cell tube method 8 C Anti C Monoclonal vial of 2ml 6 Rh hr typing IgM For typing each and antibody for tube antigen C storage at 2 to method 8 C 88 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Anti c Monoclonal vial of 2ml Rh hr typing IgM For typing each and 7
75. ood bags that are to be discarded should never be opened and the contents poured into the sink or bucket Also never intend to inject disinfectant solution into the blood bags 42 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 1 PROCESS FLOW Registration process Consent form Donor questionnaire lified one amp Vital checks Register and assign the bag amp unit number l Perform blood donation amp collect blood sample Temporary Permanent Deferral with advice Quarantine as WB at 2 C to 4 C till TTI ae results known TTI Nan Reactive Yes Quarantine components at appropriate temperatures ABO TTI Blood to be processed TTI Test TTI Reactive Result Inventory of WB Components Pe Request TTI Non Reactive TTI Reactive Conduct pre transfusion Back to stock tests Blood components to be discarded appropriately Yes No Transfusion process _ Issue for Transfusion 4 Compatible 43 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 BLOOD DONOR QUESTIONNAIRE AND CONSENT FORM NAME of BLOOD CENTER indicate here Thank you for coming forward to donate blood To ensure your safety as a
76. or A person who gives whole blood or one of its components Donor Patient A person whose blood or tissue is collected for possible autologous transfusion or transplantation Expiry The last day on which blood component or tissue is considered suitable for transfusion or transplantation Equipment A durable item instrument or device used in a process or procedure Evaluation It is a specific selection process to determine the suitability of a procedure or material equipment blood bags or reagents Guidelines Documented recommendations Good Laboratory Practice Ensuring that laboratory functions are carried out in accordance with requirements and may include planning performance monitoring recording and reporting of laboratory functions Good Manufacturing Practice Ensuring that products are consistently produced and controlled in accordance with appropriate standards and regulatory requirements Issue To release for clinical use transfusion Internal Quality Control Testing that s routinely performed on material and equipment to ensure their proper function Label An inscription affixed to a unit of blood component or sample for identification Labeling Information that is required or selected to accompany a unit of blood T7 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 component or sample which may include content identification and de
77. or Blood Transfusion Service 2013 ANNEX 19 EQUIPMENT SPECIFICATIONS SL Name of the Description of Operational Requirements no Equipment Function 1 Laboratory For dry heat treatment Specifications Incubator of test samples at e Dimensions WxHxD 37 C 2 C during the Housing 552mm x 685mm x700mm immunohematology Chamber 408x459x390mm procedures Useful space 326x367x312mm incubation of e Volumes Inside 73 litres biological agents Useful sapce 37 4litres Steam space 78litres Weight 40kg e Trays Maximum tray load Lumped 15kg Surfaec 20kg Total 50kg e Number Standard Max 2 9 piece e Dimensions WxD 356x350mm e Thermal data operating temperature 2 5 C to70 C Temperature deviations at 37 C 1 C e Warm up times when unit is empty to 37 C 37minutes e Cool down times from 37 C to when unit is empty to 30 C is 80min e Heat radiation to surrounding areas of 25 C at operating temperature of IS 37 C0 03kW e Rated voltage 1 PE AC 230V e Rated frequency 50 60 Hz e Power consumption 0 32kW e Current load 0 35kVA e Current inputl 4A e Reaction after power failure of more than 20 min to 2 hours and return of power Control unit regulates on set temperature Programme will be stopped inside temperature will be flashing 71 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 e Display accuracy lt 1 C e M
78. or procedure from the beginning to end Unit A container of blood or one of its components in a suitable volume of anticoagulant obtained from a collection of blood from one donor Urticarial Reaction The development of hives maculopapular rash or similar allergic manifestation Validation Establishing recorded evidence that proves a high degree of assurance that a specific process will consistently produce an outcome meeting its predetermined specification and quality attributes Verification Evaluating the performance of a system with regard to its effectiveness based on intended use Voluntary non remunerated donation Donation is considered voluntary and non remunerated if the person gives blood plasma or cellular components of his her own free will and receives no payment for it either in cash or kind which could be considered a substitute for money Small tokens refreshments are compatible with voluntary non remunerated donation Whole blood Blood collected in an anticoagulant solution with or without additives 9 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 AIDS Acquired Immunodeficiency Syndrome BC Blood Centre BMB Bhutan Medicines Board BMHC Bhutan Medical and Health Council CPDA Citrate Phosphate Dextrose Adeninine ccc Coombs Control Cells DMS Department of Medical Services DoPH Department of Public Health DRA Drug Regula
79. ouping for DAT register patients Unit collection sheet Worksheet for Rh typing Weak D test register Don rreaction heei Daily QC of blood grouping District blood receipt reagents register Blood request form Anubar Senet Blood discard register worksheet Transfusion report Aa denat teal Blood inventory register worksheet Transfusion reaction form Worksheet foe PAE Bleed component equipment preparation register Blood bank report Workshest ae Blood issue register antisera Temperature record charts Worksheet for QC of blood Register for manual preparation of red cell components units VCT referring form Woskeher iy uanstusion TTI record register reaction investigation Consent form for blood Worksheet for sterile i VCT register transfusion connecting device Six monthly blood bank Worksheet for ELISA HIV report HCV and HBsAg Monthly siddeisase toii Worksheet for rapid test HIV HCV and HBsAg Stock control card Equipment condemnation Worksheet for rapid malaria test form 69 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 ADMINISTRATION DOCUMENTS Quality manual Quality Policy document Incident report Records for blood bags reagents and test kits Equipment record Personnel records 70 National Standards for Blood Transfusion Service 2013 National Standards f
80. oviding valuable inputs A special thanks to our financial partner OFID OPEC Fund for International Development for supporting the printing of this publication 4 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 TABLE OF CONTENTS Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Annexure Glossary Acronyms Introduction Code of ethics for blood donation and transfusion The blood donor Testing of donated blood Blood and blood components Clinical use of blood and blood component Quality System Waste management in blood transfusion service Process flow Donor questionnaire and consent form Donor deferral Blood request form Informed consent form for transfusion of blood amp blood components Blood transfusion report Transfusion reaction form Transfusion reaction investigation form Organogram of Blood Transfusion Service National Blood Transfusion Committee National Blood Transfusion Service National Blood Center Regional Blood Center Blood storage center Standard tests at centers Basic equipment at centers Basic reagents at centers Equipment record Standard Operating Procedures Equipment specifications Reagents specifications 6 9 9 10 12 13 14 15 16 23 24 25 26 27 28 29 30 39 40 42 Annex 1 Annex 2 Annex 3 Annex 4 Annex 5 Annex 6 Annex 7A Annex 7B Annex 8 Annex 9 Annex 10
81. pecifications e Type of mixing Linear with central support e Volume weighing range 10ml 990ml with minimum variation of 10m1 e Accuracy 2 within the range of 300 to 500 ml e Weight display range 10 990gms e Weight accuracy lgm to 2gm e Time display accuracy lsecond e Power consumption 35VA e Line frequency 50 60 Hz e Power supply 115 230VAC with optional battery pack e Alarming conditions audible and visual e Automatic mixing of the blood with anticoagulant preferably three dimen sions e Voltage input 220 to 240 V 50Hz e Rechargeable battery pack e Weight of the machine 3 kg without battery Accessories required e Re chargeable battery pack e Calibration mass of 500gm 4 Di electric tube sealer Hermetic sealing of the PVC tubing containing blood and blood components ensuring sterility of the blood in the blood bag Specifications e Sealing time 1 to 3 seconds e Indication lamps for power ready and sealing Maximum diameter of the tube that can be sealed 6mm e Tube detection automatic e Power source 220 240 V input frequency 50 60 Hz e Power consumption operating 170W standing 20W e Operating temperature 5 to 40 C RF output power 20W 73 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Accessories Fuse 250V 3 15A 5 20mm Type A Exhaust Fan 12v
82. r Blood Transfusion Service 2013 Blood transfusion is a key component of modern day health care and therefore it is of utmost importance to ensure that blood and blood products meet the appropriate national standards of safety and efficacy for transfusion and benefit blood recipients in their clinical management process National Blood Policy 2007 Mission Statement 1 Ensure adequate timely and easily accessible supply of safe and quality blood and blood products through the establishment of a National Blood Transfusion Service NBTS 2 Ensure adequate resources for the operation of a sustainable National Blood Safety Program 3 Develop effective legislation and a national regulatory body to oversee the operation of the blood service in the country 4 Blood transfusions shall be advised and carried out under the supervision of a registered medical practitioner or other suitably qualified and authorized health care professional Present scenario and future plans The blood supply system in the country functions as part of the laboratory service in all the hospitals and BHU I whereby the individual hospital blood bank is obliged and responsible to undertake the task of recruitment of blood donors blood collection screening of blood units for infections storage and making it available for trans fusion to the respective clinical departments of the hospital Such a fragmented organizational structure poses many challenges and constr
83. r Blood Transfusion Service 2013 National Standards for Blood Transfusion Service e H o Malaria or taken anti e Accept after 3 years malarial drugs e Visited an endemic area e Accept after 6 months of return from malaria area e Hypertension high BP e Defer temporarily and refer to a doctor e Hypothyroidism e Accept if 6 months of therapy have passed and thyroid levels are within normal limits e H o jaundice e Accept after 12 months e Menstruation e Accept after menstruation is over e Migraine e Acceptable Peptic Ulcer gastritis Accept if on diet control or on antacid treatment Surgery Syphilis or gonorrhea Minor surgeries like appendicectomy hernia repair tonsillectomy accept after 3 months Major surgeries like gall stone removal uterus removal thyroidectomy accept after 6 months Accept after 12 months of completion of treatment Sexual contact with HIV Hepatitis B C individual Defer for 6 months multiple partners or with commercial sex worker drug addict prisoner homosexual e Sexual contact with e Defer for 6 months Tattoo body piercing with unsterile sharps Defer for 6months Tonsillitis Defer till completion of treatment with antibiotics Tooth extraction Defer for 1 week Typhoid Accept after 1 month Tuberculosis Accept 5 years after recovery B LIST OF CONDITIONS FOR PERMANENT DEFFERAL Abnormal bleeding tendency
84. r the ability of laboratories to perform immune hematological and TTI test procedures with accuracy through the analysis of unknown samples provided by an external source The national scheme called National External Quality Assessment Scheme NEQAS shall be co ordinated by the National Blood Center for immuno hematology tests and by Public Health Laboratory for TTI tests wherein known samples of undisclosed nature shall be distributed at regular intervals to all the blood centers in the country Deviations non conformances and complications 7 5 4 1 Each BTS management shall review at regular intervals the effectiveness of the quality assurance activities and introduce corrective measures if necessary 7 5 4 2 It shall identify assess investigate and monitor events that deviate or fail to meet the accepted standards 7 5 4 3 This shall include discovery of nonconforming services and products as well as adverse reactions to blood donation and blood transfusion 7 5 4 4 All BTS personnel shall be trained how to e Recognize classify analyze the root cause and document any such occurrence e Prioritize the necessary corrective action needed e Verify that the corrective action is performed e Take preventive action where possible to reduce the likelihood of future recurrence e Report to immediate higher authority when required 7 5 5 Assessment 7 5 5 1 Internal Assessment The operations of all blood centers shall be as
85. ractice and Good Manufacturing Practice with the objective of ensuring quality and safety of blood and blood products in the face of known and emerging threats to public health in the country The standards address the entire transfusion chain from donor to recipient encompassing the selection of blood donors from low risk population safe blood collection testing of donated blood for transfusion transmissible infections and blood group serology preparation storage issue and transportation of blood components for appropriate clinical use and lastly safe administration of blood to the recipients In this document the technical standards appear at the beginning followed by quality requirements for processes and procedures carried out in a center s day to day operations Some terms are specifically designed for the purpose of these standards The term SHALL is used to indicate a mandatory statement and describes the single acceptable activity or method The term SHOULD is used to indicate a commonly accepted activity which may have an effective alternative that can be used also A glossary is included in the manual for the purpose of defining terms to reflect their usage in the context of these standards 2 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 REFERENCES While preparing the document guidance has been taken from 1 Standards on Blood banks
86. ring loaded expresser blood components e Fitted with 8mm plexiglass plate to from a blood give strength while operating the collection bag or function of expression from a satellite bag to To accommodate bags to up to a transfer bag 500ml volume e Rear base designed to wash the blood stains 19 Ice lined A refrigerator for Specifications blood bank storage of whole e Type of equipment Compression refrigerator blood or red cells refrigerator that uses CFC free optional in blood banks with gas and at least 8 hours day of electricity Construction Internal Stainless steel External corrosion resistant Chest type with CFC gas free insulation Upright trays Solid door Net Volume 180 litres Lockable lid 84 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 e Electrical Characteristics Input voltage 220 240V 50 Hz e Equipment meets electrical safety specifications such as that of IEC e Minimum Compressor starting voltage 22 below nominal voltage e Internal temperature Control Electronic temperature control range 2 C to 6 C in refrigerator section with setting accuracy of 1 C whatever the load In freezer section temperature range 20 C to 40 C fan air cooling e External Ambient temperature Performs in an ambient temperature of 10 C to 43 e Hold Over Time during power cut out at 32 C ambient should be
87. s 31 Supply of safe blood for transfusion 32 Use of Sterile connecting device Blood Component preparation 33 Blood component preparation 34 Thawing of Fresh Frozen Plasma Screening of donated blood for TTIs 35 ELISA testing for HBsAg 36 ELISA testing for Anti HIV antibody 1 2 37 ELISA testing for Anti HCV 38 Rapid testing for HBsAg 39 Rapid testing for Anti HIV antibody 1 2 40 Rapid testing for Anti HCV antibody 41 RPR testing 42 TPHA testing 43 Malaria screening 44 Referral of screen reactive donors to VCT Quality control tests 45 QC of reagents anti sera 46 QC of reagents red cell reagents 47 QC of equipment Blood collection monitors Blood bank refrigerator Plasma freezer Platelet agitator and incubator Blood bank centrifuge Plasma thawing device 48 QC of blood component Platelet concentrates Packed red cells FFP Bio hazard 49 Management of blood spill 50 Antigen Phenotyping test worksheet 51 Antibody titration worksheet 68 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 LIST OF FORMS AND WORKSHEETS Forms Sheets Worksheets Registers Blood donor registration Hemaciw OC sheet form Blood donor registers Blood donor questionnaire and consent form Worksheet for cell grouping and serum grouping for Patient sample and d n rs crossmatching register Blood donor deferral Worksheet for cell grouping l she t and serum gr
88. scription of process storage requirements expiration date cautionary or indication for use Maintain To keep in the current state Material A good or supply item used in manufacturing process Materials are a type of input product Reagents are a type of material Neonates A young child less than 4 months of age Organization An institution or part thereof that has its own functions and administration Open System A system the contents of which are exposed to air and outside elements during preparation and separation of components Policy A written statement which guides present and future decisions It determines the future course of action to be established Process A set of related task and activities often performed by one person according to instruction Processing of blood Any procedure that takes place after the blood is collected Process Control The efforts to standardized and control process in order to produce predictable out put Procedure A series of task usually performed by one person according to instructions Pre donation procedure It includes mandatory process and activity done before proceeding with bleeding a donor Post donation procedures All procedures and activities done after bleeding a donor Preventive action An action taken to reduce the potential for an error to occur Product A tangible result of a process Quality Characteristics of a unit of blood component sample or service
89. se of an adverse transfusion event 2ml of serum or plasma sample shall be stored at 20 C or below in a froze state for a year Records of archiving should be maintained 3 12 Labeling of blood units 3 12 1 Each blood bag shall be labeled with following information a Unique unit number b ABO blood group c Rh blood type d Date of collection e Date of expiry f Type of blood component g Volume of the unit h TTI results 21 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 3 12 2 A colored label shall be put on every blood bag The following color scheme for the said label shall be used for different ABO groups of blood Blood group Color of label Color of Letters A Yellow Black B Pink Black O Light Blue Black AB White Black 3 13 Release of blood units for clinical transfusion Only blood units screened Non reactive for all TTI markers and with confirmed ABO Rh blood group shall be suitable for storing in blood inventory and future release for transfusion purpose 3 14 Post test counseling It is recommended that all blood donors are provided with post test counseling 3 14 1 Screened non reactive donors Donors who test non reactive to all TTIs shall be encouraged to donate blood regularly and lead low risk lifestyles 3 14 2 Screen reactive donors Whenever a screening test is reactive to anti HIV anti HCV or and HBsAg markers infor
90. sessed through periodic internal audits or self inspection conducted by trained team or designated staff headed by the Quality Manager The methodology frequencies and areas to be audited as well as quality indicators set shall be made known to the concerned unit at each center At the end of each audit a feedback or an audit report consisting of the findings recommended corrective measures and stipulated time frame to improve shall be provided to the auditees 7 5 5 2 External Assessment It shall be the mandate of the national regulatory authority to oversee the operations of BTS within the legal framework developed This is necessary in order to protect the health of blood donors and blood recipients and to monitor the compliance of blood centers to national standards and good manufacturing and laboratory practices 39 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 The waste management in the blood transfusion service deserves special consideration as Large volume of blood is collected and handled from apparently healthy asymptomatic donors Large volume of blood needs to be discarded due to various reasons like reactive contaminated units outdated or unsuitable units A greater degree of potential hazard among health workers through the use of wide bore needles for blood collection Therefore following standards shall apply 8 1 8 2 8 3 8 4 8
91. sfusion Service 2013 3 8 f Prior consent from the donor patient should be taken for the blood units to be used as homologous do nation if unused by him her g All screening tests shall be carried out on all autologous blood units Donor and donation records Following records shall be maintained 3 9 3 10 3 10 1 3 10 2 a Name of the donor age gender and records of all donations Contact details present address telephone numbers and email address Date of blood collection volume of blood collected and time taken ABO Rh blood group Hemoglobin result of each donor at each time of donation Medical history records TTI results of all donations of each donor Donor deferral records Donor adverse reaction records Records of blood discards if any of a donor org he ae g Quarantine and discard of blood units Until TTI testing is completed and reported as non reactive no unit of blood or blood component shall be used for transfusion The blood bank shall have a process of physical separation of all un screened blood and blood component units Quarantined units shall be stored in appropriate equipment at required storage temperatures All blood and blood components declared as Screen Reactive or Indeterminate on TTI testing shall be disposed in accordance with Hospital infection control and waste management guidelines Transportation of blood Un processed whole blood units shall
92. sion for blood group serology testing Broken test tubes glass slides Broken glassware and ampoules lancets scissors wafers for sterile connecting devices Table 18 Waste segregation Types of Waste Colour of container markings Type of container Infectious waste Red polyethylene bag marked INFECTIOUS or alternatively in plastic bins labelled with the international biohazard symbol Strong leak proof plastic bags or containers capable of being autoclaved domestic waste Sharps Yellow plastic containers Puncture proof and leak proof marked SHARPS containers fitted with covers and Yellow Cardboard boxes made of plastic dense cardboard or metal General Green Plastic bags 41 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 8 6 Treatment and disposal of infectious waste like blood units tested reactive for TTIs 8 6 1 Autoclaving in a waste autoclave operating at a minimum temperature of 121 C for 30 minutes or at 138 C for 18 minutes is the recommended method 8 6 2 After the sterilization the waste should be buried in a secure landfill 8 6 3 The other option is the use of double chamber pyrolytic incinerator with temperatures higher than 1200 C 8 6 4 Where autoclave or incinerator is not available burying of the infectious waste in a secured landfill is the method of choice 8 6 5 Filled bl
93. t upholstery of 2 5inch thickness Base adjustments Back rest tilt 0 to 75 Seat rest tilt 0 to 20 Leg rest tilt to 35 Castor wheels to be provided Tray and stands to be provided Interface for blood collection monitor Confirms to standard and specifications of ISO 9001 CE WHO IDCA 16 Sterile connecting device The system is used for automatically connecting in a sterile manner of the PVC tubing of the blood bags Features The SCD connects PVC tubing of the blood bag of same diameter maintaining a functionally closed system During the wielding process the sterility of cells or fluid in tubes and bags is maintained PVC tubing is connected using wafers that are heated to a high temperature This maintains sterility during wielding The wielding temperature is 81 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 controlled by a sensor assuring the accurate heating and sterility of the SCD wafer e There is no physical contact with the wafer from application to disposal By using the wafer cassette wafer replacement is carried out by pulling the wafer replacement lever Wafers are automatically disposed off after use They are used for single use only e An LCD display indicates operating status guidance for the operators and error messages e Specifications Tubing sizes Outer diameter 3
94. t blood unit identification pre during and post transfusion monitoring of the patient are essential elements of CTP and contributes in minimizing adverse transfusion events These elements shall be followed All transfusions shall be documented using the Transfusion Report form Refer to Annex 6 All transfusion reactions shall be reported by the attending nursing staff to the concerned doctor recorded and investigated by the blood center Refer to Annexes 7A and 7B for Transfusion Reaction form and Transfusion Reaction Investigation form respectively 29 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 7 1 Executive Management In order to provide the required level of safety in blood donation and transfusion service the principles of quality good manufacturing and laboratory practice shall be implemented through a quality management system The new organogram proposed under consolidated BTS is shown in Annex 8 AR 7 2 7 2 1 7 2 2 7 2 3 National Blood Transfusion Committee The National Blood Transfusion Committee NBTC shall be the highest decision making body on all matters related with blood transfusion service blood and blood products It shall serve as a legal advisory committee to the Bhutan Medicines Board BMB on the above matters Refer to Annex 9 for the composition roles and responsibilities of the committee Min
95. tion overflow washing bottom washing e Vacuum power software adjustable e Software capable for self test and calibration 21 Cool boxes Features To carry Specifications whole blood from one Robustness Fitting 2 casing 2 blood bank to another Net capacity 10 to 12 bags e Cold life Maintenance of under 10 C for minimum of 130 hours in an ambient temperature of 43 C 86 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 e Minimum Ice Melting Rate More than 10 hours per kg ice melted during 43 C cold life test e Cold packs To confirm specification E5 IP1 or IP2 Sufficient water filled ice packs for freezing at 20 C are provided to surround blood bags on all sides e Means of handling Two handles for easier lifting carrying by vehicle e Optional specifications The transport box may be designed to operate from the direct current of a motor vehicle battery during long transportation hours 87 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 Annex 20 REAGENTS SPECIFICATIONS Items Function Vol amp storage Remarks Coombs Control Combi pack of pre 2 vials of 10 cells prepared diluted monoclonal To prepare mi schand should give 1 Anti D IgG antibody Coombs 2 3 4 reacti
96. tory Authority DVED Drugs Vaccine and Equipment Division ELISA Enzyme Linked Immuno Assay EQAS External Quality Assessment Scheme FFP Fresh Frozen Plasma GSH Group Screen and Hold Hb Hemoglobin HBsAg Hepatitis B Surface Antigen HBV Hepatitis B Virus HCV Hepatitis C Virus HIV Human Immunodeficiency Virus HR Human Resource IAT Indirect Antiglobulin test IEQAS International external quality assessment scheme IQC Internal Quality Control MT Medical Technologist 10 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 MLT Medical laboratory technician MoH Ministry of Health NEQAS National External Quality Assessment Scheme NBTC National Blood Transfusion Committee NBTS National Blood Transfusion Service NBC National Blood Center OFID OPEC Fund for International Development PHL Public Health Laboratory PRC Packed Red Cell PC Platelet Concentrate QA Quality Assurance QM Quality Manager QS Quality System RBC Regional Blood Centre RGoB Royal Government of Bhutan SOP Standard Operative Procedure TPHA Treponema Pallidum Hemagglutination TTI Transfusion Transmissible Infections VBD Voluntary Blood Donation VCT Voluntary Counseling and Testing VNRBD Voluntary Non remunerated Blood Donors WHO World Health Organization WB Whole Blood 11 National Standards for Blood Transfusion Service 2013 National Standards fo
97. ts before they leave the blood center ao Blood collection donor phlebotomy procedure This procedure shall be conducted by only trained and authorized personnel 17 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 3 4 2 3 4 3 3 4 4 Donor identification and blood unit identification must be confirmed before blood collection Each blood unit shall be assigned a unique unit number which shall be used as an identifier on all blood components blood samples and for documentation purpose e For donations from voluntary blood donors the alphabet letter V shall be prefixed to the unit number e For donations from replacement blood donors the alphabet letter R shall be prefixed to the unit number e For donations collected at mobile sites the alphabet letter M shall be prefixed to the unit number e Donor s name shall not appear anywhere on the blood bag Equipment supplies for phlebotomy 3 4 4 1 Blood bags fulfilling the standard specifications shall be used for blood collection All blood bags and sample collection tubes shall be checked before use for sterility expiry date appearance of the anti coagulant solution any leakage or any defects in the bags 3 4 4 2 Quality control of all blood collection equipment shall be carried out as per the 3 4 5 3 4 6 3 4 7 3 4 8 3 4 9 standard operating procedures and documented
98. ze the risk of occupational injury to the personnel T 32 blood center a The space shall be hygienic and safe away from open sewerage public b c lavatory The following standards shall be followed and kept in mind while constructing a Adequate ventilation and lighting shall be provided for all technical activities that take place The lay out of the service shall take into account the work flow for registration of donors blood donation processing testing of blood and allocate sufficiently large rooms 32 National Standards for Blood Transfusion Service 2013 National Standards for Blood Transfusion Service 2013 d e f g Adequate size and number of rooms for storage of blood and blood components in their respective equipment shall be designed Access to all functional areas except the donor area shall be restricted to authorized personnel only A continuous water supply and un interrupted power supply round the clock shall be made available at all times The walls and floors of the rooms shall be smooth and capable of being easily washable and kept clean 7 3 3 Each blood center shall have provision of a room for the following activities a b c d e f g h i j k D m Registration of blood donors Donor interview counseling and medical examination in private to determine their fitness as donors blood and to provide an opportunity for self exclusion of unsuitabl

National Standards for Blood Transfusion Service

Contents

Download Pdf Manuals

Related Search

Related Contents