<< - STRENGTHENING CAIN WAN NOE SVSUEMS IN BLOOD LANKS TRAINING MANUAL Ministry of Health and Family Welfare Government of India©NACOINBTC, 2016 The contents in this module are solely for the purpose of training blood bank staff. This Publication can be reproduced/copied with prior intimation and reference to NACO/NBTC The mention of specific companies, organization or of certain manufacturers’ products does not imply that they are endorsed or recommended by the NBTC in preference to others of a similar nature that are not mentioned. All reasonable precautions have been taken by the NBTC to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the NBTC be liable for damages arising from its use. Readers are expected to regularly visit the websites and other publication materials for updated information. Scientific knowledge has been simplified for ease of explanation and understanding, and efforts have been made to retain accuracy. However this document may not be cited for technical reference. Feedback may be provided to nbtemohfw@gmail.com Development of this publication was supported by cooperative agreement 5U2G GHO01103-02 with the Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily reflect the official views of the Department of Health and Human Services and Centers for Diseases Control and Preventionren red STRENGTHENING QUALITY MANAGEMENT SYSTEMS IN BLOOD BANKS TRAINING MANUAL FOR BLOOD BANK STAFF 2016 © NBTC Ministry of Health and Family Welfare Government of India‘Oo sare ed afar Bean ace NA nha gu fis 0H 9a Ae, aogettes fafa, 26 arora, art Kecetl -110001 Government of Inia St AA. oat wa em ae Ministry of Health & Family Welfare age aia National AIDS Control Organisation th Floor, yhandralok Building, 36 Janpath, New Delhi - 110 001 Dr. C. V. Dharma Rao Joint Secretary Foreword Blood Transfusion Service is an essential component of health care system that has a responsibilty of ensuring availabilty, accessibility, adequacy, quality and safety of blood supply. The availabilty and safety of blood depends on multiple steps in the transfusion chain. This starts with @ healthy and motivated population, retention of voluntary non-remunerated repeat donors, processing and testing of all donated blood, availabilty of blood and blood products, ‘ational use of blood and its components and post-transfusion monitoring of the patient. At every ‘step, any lowering of quality would reflect adversely on the final product. Therefore, capacity building for strengthening the Quality Management Systems of Blood Banks is very important \wherein emphasis is laid on ensuring consistency in performing various activities so that the Safety and quality of blood is guaranteed. The performance of any procedure will yield desired Quality resuits only if Standard Operating Procedures (SOP's) are followed. The recently Conducted baseline assessment of NACO supported Blood Banks revealed that many Blood Banks in the country are not aware of the Standard Quality Management practices for various Procedures that are commonly performed in Blood Transfusion Services, hence NBTC/ NACO has developed this Module. Individual Blood Banks need to adapt these and develop their own blood bank-specific Quality Policy and Quality Manual based on the infrastructure available. test procedures to be followed and availabilty of reagents. | am sure the Blood Banks will find this Module of Quality Management System useful to help them in achieving their objective of Continuously providing adequate, safe and quality blood, Des Le (Or. C.V. Dharma Rao) ‘ty Fler, Chaneralok Building, $6 Janpath, New Delhi 110007, Phones: 011-2392594%, Fax 011-29731766 smal: dharma raa@nicin,s@naco.govin, jt seeynaco@gmal com eh qeamdg) sewer on, Prozan aram® orerares A gv wae a ita one Know Your HIV status, goto the nearest Government Hospital for free Vowntary Counselling and Testingawe zac aaa aleve NBTC zara ea afta epee area ‘ag a aie ate Tee BOR’ er etn " National Blood Transfusion Council Director weet Ministry of Health and Family Welfare so nameen Government of India Etna fxenonteggma cam Preface ‘A Quality Management System can be described as a set of key quality elements that must be in place for an Organization's work operations to function in a manner that meets the Organization's stated quality objectives. This system provides the means to direct and control the Organization with regard to quali. The purpose of this Quality Module is to define and document a Blood Bank's Quality Management Systern. ‘There has been growing awareness about quality in Blood Transfusion Services with the objective of releasing only those blood products and blood which full the desired standards in terms of safety and efficacy. Consistency is the hallmark of quality and can be achieved only by implementing standard Quality procedures by all staff engaged in Blood Banks at all times. Following Quality procedures is also essential for licensing and accreditation. Each Blood Bank has to develop its own set of Quality Policy and Quality Manual matching their requirement and resources. To attain maximum safety, the requirements of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), use of Standard Operating Procedures (SOP) and ‘moving towards total Quality Management is vital for organization and management of Blood Transfusion Services. ‘The Strengthening Quality Management System in Blood Banks Module is intended to act as @ ‘guide and help all Blood Banks in writing and validating their own Quality Policy and Quality Manual. We are hopeful that these Modules will also stimulate Blood Transfusion Services in ‘adapting Standard Quality procedures strengthening their Quality Systems. ‘9th Floor, Chandralok Building, 6 Janpath, New Delhi 110001, Website _wirw nbtc govinAcknowledgement Blood Transfusion is a lifesaving intervention that has an essential role inthe total patient management within the health care delivery. Based on the principle of delivering quality healthcare services, the National Blood Transfusion ‘Counell(NBTC) and Blood Transfusion Services Division, NACO has developed a Module on “Strengthening Quality Management Systems in Blood Banks" with an objective to maintain and enhance the qualiy and safety of Blood ‘Transfusion Services in India. This Quality Module is based on interationally-accepted standards and focuses on {900d quality principles and best practices. it shall be a template to provide guidance to Blood Banks on writing Policies and procedures that support a Quality Management System Keoping in mind the guiding principle of consistency, this Module emphasizes on the adherence to Quality Standards in the entire Transfusion chain from "Donor to Recipient’, encompassing the selection of Blood donors {rom 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 othe recipients. ‘The constant encouragement of Shri N.S. Kang, President NBTC / Secretary NACO, Dr C.V. Dharma Rao, Joint Secretary, NACO and Dr R.S.Gupta, Director NBTC/DDG (BTS), NACO have greatly helped in undertaking this importantactivty. ‘A special thanks to Dr Shanoo Mishra PO (QC), NBTC and other team members for their constant effort and hard ‘work in overall supervision and guidance for development ofthis module, Itis commendable to note that the document has been prepared and compiled by Dr Veena Doda and reviewed with the coordinated and concerted efforts of various experts from the Transfusion Medicine fraternity especially Dr Gajendra Gupta, Or Joy Mammen, Dr Sunita Upadhyaya and Dr Sarika Mohan. I gratefully acknowledge the contributions made by all he experts. lextend my sincere thanks to the U.S. Centers for Disease Control and Prevention, Division of Global HIVIAIDS & TB (CDC-DGHT), India and Christian Medical Association of India (CMA\) for supporting the development and printing ofthis publicationContributors & Reviewers Key Contributors (in Alphabetical Order): Dr. Gajendra Gupta - Santokba Durlabhji Memorial Hospital, Jaipur Dr. JoyMammen - Christian Medical College, Vellore Dr. Sarika Mohan - Christian Medical Association of India Dr. Shanoo Mishra - Programme Officer (Quality Control) BTS, NBTC/NACO, MoHFW Dr. Shobini Rajan. - Assistant Director General (BTS), NACO, MoHFW Dr. Sunita Upadhyaya - US Centers for Disease Control & Prevention-DGHT India Dr. Veena Doda - Transfusion Medicine Expert, New Delhi Reviewers (in Alphabetical Order): Dr. Anjali Hazarika -AIIMS, Cardio Neuro Centre, New Delhi Dr. Aseem Tiwari -Medanta, the Medicity Hospital, New Delhi Dr.CharusmitaModi —_- King Edward Memorial Hospital, Mumbai Dr.LathaJagannathan —_—- Rotary TK Blood Bank, Bangalore Dr. M.D. Gajjar -B.J Medical College, Ahmedabad Dr.PrasunBhattacharya _-Medical College Hospital, Kolkata Dr. Sangeeta Pathak -Max Super Speciality Hospital, New Delhi Dr.SunilRajadhyaksha —_- Tata Memorial Hospital, Mumbai Dr.ZarinS.Bharucha _- Federation of Mumbai Blood Bank. MumbaiContents Foreword Preface ‘Acknowledgement Contributors & Reviewers Table of Contents Purpose And Scope Agenda Terms and Defini Abbreviations Chapter1 Objectives of Quality Management Systems Training for Blood Banks 1 Chapter2 National Blood Policy, Regulatory Requirements, Standards and 5 Guidelinesin Blood Banking Chapter3 _ National Program Reporting 9 Chapter4_ Importance of Quality in Blood Banks 23 ChapterS Quality Management Systemsin Blood Transfusion Service 31 Chapteré Organization & Management 37 Chapter? Quality Policy 43 Chapter8 Documentation and Document Control 45 Chapter? Writing Quality Manual 53 Chapter10 _ HowtowriteanSOP 59 Chapter11 Accommodation and Environment nm Chapter12___ Biomedical Waste Management and Infection Control 81 Chapter13 Personnel 93 Chapter14 Equipment Management 103 Chapter15 _ External Supplies and Services 113, Chapter16 Process Control 17 Chapter17__ Identification of Deviations and Adverse Events, 321 Chapter18 Quality control of Immunohaematology 129 Chapter19 _Qualitycontrol of blood components 143, Chapter20 Quality Controlof TT! Testing 151 Chapter21 External Quality Assurance (EQA) 163 Chapter22 Performance improvement 169 Chapter23 Internal Audit 181 Chapter24__ Management Review 187 Chapter25 Accreditation Process- National Accreditation Board for Hospitals 191 ‘and Healthcare Providers (NABH) 26 References 153 27 Annexures 195Purpose And Scope Quality management systems in Blood transfusion service are essential to ensure safe blood. One of the fundamental objectives of this initiative is to help participants to develop a realistic plan of action for establishing an effective quality system in their own Blood banks. This Training manual provides information on all the essential elements of quality and is designed as a road map to establish and adopt quality management systems in blood banks. This manual is directed to the staff working in blood banks for creating awareness on the importance of quality management systems, strengthening their existing skills and planning ways of introducing improved and systematic approaches and procedures for safe and efficacious blood.Det ns and Terms ee ‘Accreditation’: A process of external review of the quality of the healthcare being provided by ahealth care organization. ‘Accuracy of measurement’ means closeness of the agreement between the result of a measurement and a true value of the measured. ‘Agreement’: A contract, order, or understanding between two or more parties, such as between facility and one of its customers. ‘Agreement Review’: Systematic activities carried out before finalizing the agreement to ensure that requirements are adequately defined, free from ambiguity, documented, and achievable. ‘Apheresis' means the process by which blood drawn from a donor, after separating plasma or platelets or leucocytes, is transfused simultaneously into the said donor. ‘Autologous blood’ means the blood drawn from the patient for re-transfusion into him/her later on. logical reference interval’ means central 95% interval of the distribution of reference values. ‘Blood’ means and includes whole human blood, drawn from a donor and mixed with an anti- coagulant. "Blood bank’ means a place or organisation or units or institutions or others arrangements made by such organisation, unit or institution for carrying out all or any of the operation for collection, apheresis, storage, processing and distribution of blood drawn from donors and/or for preparation, storage and distribution of blood components. "Blood bank Director’ means competent person (s) with responsibility for, and authority over, a Blood bank ‘Blood bank Management’ means person (s) who manage the activities of a Blood bank headed by a blood bank director. "Blood component’ means a drug, prepared, obtained, derived or separated from a unit of blood drawn froma donor. ‘Blood product’ means a drug manufactured or obtained from pooled plasma of blood by fractionation, drawn from donors. ‘Closed System’: A system, the contents of which are not exposed to air or outside elements during preparation and separation of components. ‘Collection Facility':A facility that collects blood, components or tissue from a donor. ‘Competence’: Ability of an individual to perform a specific task according to the procedure ‘Conformance’: Fulfillment of requirements. Requirements may be defined by customers, practice standards, regulatory agencies, or law.Defi ns and Terms ee ‘Corrective Action’: An activity performed to eliminate the cause of an existing non- conformance, or other undesirable situation in order to prevent recurrence. "Customer/Recipient': The receiver of a product or service. A customer may be internal (i.e., another department within the same organisation) or external (i.e., another organisation) 'Disaster': An event (internal, local, or national) that can affect the blood supply or the safety of staff, patients, volunteers, and donors. ‘Document (noun): Written or electronically generated information and work instructions. Examples of documents include quality manuals, procedures, or forms, "Document (verb): To capture information for use in documents through writing or electronic media. ‘Equipment’: A durable item, instrument, or device used in a process or procedure. ‘Event’: A generic term used to encompass the terms ‘incident’, ‘error’, and accident. ‘Executive Management’: The highest level personnel within an organisation, including employees and independent contractors, who have responsibility for the operations of the organisation and who have the authority to establish or change the organisation's quality policy. Executive management may be an individual or a group of individuals. ‘Incident’ : an unplanned deviation from a facility's estal hed policy, process or procedure. 'Label': An inscription affixed to a unit of blood, component, tissue, derivative, or sample for identification ‘Labelling’: Information that is required or selected to accompany a unit of blood, component, tissue, derivative or sample, which may include content, identification, description of processes, storages requirements, expiration date, cautionary statements or indications for use. 'Leucapheresis' means the process by which the blood drawn from a donor, after leucocyte concentrate have been separated, is re-transfused simultaneously into the said donor. ‘Maintain’: To keep in the currentstate. ‘Material’: A good or supply item used in the manufacturing process. Materials are a type of input product. Reagents are a type of material. ‘Measurement’ means set of operation having the object of determining a value ora quantity. 'Non-conformance': Failure to meet requirement. ‘Open System’: A system, the contents of which are exposed to air and out side elements during preparation and separation of components. ‘Organisation’: An institution, or part thereof, that has its own functions and executive management,Defi ns and Terms ee 'plasmapheresis' means the process by which the blood drawn from a donor, after plasma has been separated is re-transfused during the same sitting into the said donor 'Plateletpheresis' means the process by which the blood drawn from a donor, after platelet concentrates have been separated, is re-transfused simultaneously into the said donor. ‘Policy’: Adocumented general principle that guides present and future decisions. 'Pre-donation procedures’ include the process and activity done mandatorily before proceeding for bleeding the donor. ‘Post donation procedures’ all the activities, procedures and instructions carried out after bleeding the donor. ‘Preventive Action’: an action taken to reduce the potential for non-conformance or other undesirable situations. ‘Procedure’: A series of tasks usually performed by one person according to instructions. "Process': A set of related tasks and activities that accomplish a work goal ‘Process Control’: The efforts to standardize and control processes in order to produce predictable output. "Product': A tangible result of a process or procedure. ‘Proficiency Testing’: The structured evaluation of laboratory methods that assesses the suitability of processes, procedures, equipment, materials, and personnel. ‘Quality’: Characteristics of a unit of blood, component, tissue, derivative, sample, critical material, or service that bear on its ability to meet requirements, including those defined during agreement review. ‘Quality Control’: Testing routinely performed on materials and equipment to ensure their proper function. ‘Quality System’: The organisational structure, responsibilities, policies, processes, procedures, and recourses established by executive management to achieve quality. ‘Quantity’ means attribute of a phenomenon, body or substance that may be distinguished qualitatively and determine quantitatively. ‘Quarantine’: To isolate nonconforming/ untested blood, components, tissue, derivatives, or materials to prevent their distribution or use, "Reference Standards’: Reference standards define how or within what parameters an activity shall be performed and are more detailed than quality system requirements. "Sample! means one or more parts taken from a system and intended to provide information on the system, often to serve asa basis for decision onthe system or it's production.Defi ns and Terms ee ‘Supplier’: An activity that provides an input material or service, ‘Supplier Qualification’: An evaluation method designed to ensure that input materials and services (e.g. material, blood components, tissue and derivatives, patient blood samples) obtained froma supplier meet specified requirements. ‘Traceability’ means property of the result of a measurement or the volume of a standard where by it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties. “Transfusion Service’: A facility that performs one or more of the following activities: compatibility testing, storage, selection, and issuing of blood and components to intended recipients. Transfusion services do not routinely collect blood or process whole blood into components. "True Positive’: A positive result on both the initial test and the confirmatory test. "Uncertainty of measurement’ means parameter, associated with the result of ameasurement that characterized the dispersion of the values that could reasonably be attributed to the measurement. ‘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. Validation’: Establishing recorded evidence that provides a high degree of assurance that a specific process will consistently produce an outcome meeting its predetermined specifications and quality attributes. Verification’: Confirmation by examination and provision of objective evidence that specified requirements has been met ‘Voluntary Blood Donor' means a person who voluntarily donates blood after he/she has been declared fit after a medical examination, for donating blood, on fulfilling the criteria given hereinafter, without accepting in return any consideration in cash or kind from any source, but does not include a professional or a paid donor.List of Abbreviations BMW Bio Medical Waste CAPA Corrective and Preventive Actions DMLT Diploma in Medical lab Technology ELISA Enzyme Linked Immunosorbent Assay FM Format HOD Head of the Department HR Human Resources HRD Human Resource Development IA Internal Audit ICM Infection Control Manual ID Identification IH Immunohaematology Iso International Organization for Standardization IT Information Technology Lis Laboratory information System LU Chart Levey Jennings Chart MD Doctor of Medicine (Applies to specialty) Mgt Management MKT Marketing MRM Management Review Meeting NABH National Accreditation Board for Hospitals and Healthcare Providers NACO National AIDS Control Organisation NBTC National Blood Transfusion Council NC Non Conformity ac Quality Control Ql Quality indicator aM Quality Manual ams Quality Management System MT Quality Management Training asp Quality Supporting Procedure RCA Root Cause Analysis soP Standard Operating Procedure TT Transfusion Transmitted InfectionsCHAPTER 1 Objectives of Quality Management Systems Training for Blood Banks The training module on strengthening Quality management system: blood banks has been designed to train blood bank staff (Technical managers and quality managers) in the basic principles of quality, quality systems and quality management toimprove blood safety. The basic aim of the course is to enable the participants to strengthen quality management systems in their Blood Banks as well as build capacity acting as focal points in the establishment of Quality management systems at National and Central level. This course has been designed by amalgamation of previous QMS resource material developed by NACO, |SO15189:2012 and NABH standards. The specific objective of the training course is to enable participants to acquire and enhance knowledge, understanding and skills of introducing quality systems into their Blood Banks. The course will assist the participants to gain experience on the subject and develop realistic action plan for the implementation of quality management systemsin their Blood Banks. Purpose of the course: Implementation of Quality Management Systems (QMS) in the blood banks to: Improve blood safety. . Standardize processes and procedures for quality output, . Ensure optimum utilization of resources for maximum efficacy of blood and blood products. Ensure that blood and products benefit and cause no harm to the patient, prevent transfusion of unsafe blood or blood products to patients and minimize the risk of adverse effects of transfusion. It also reduces the seroprevalence of infection among donors ,increasing the credibility of the blood bank 5. Reduce the possibility of errors in the transfusion chain from vein-to-vein thereby reducing the potentially serious or fatal consequences of blood transfusion Benefit of QMS Quality management systems in blood blanks improve consistency in all its activities for safety and quality ofblood. ‘An enhancement in quality of the blood bank increases the motivation of all staff that develops more confidence in their own abilities which improves donor, patient, clinician and community satisfaction. The donors also develop confidence in the Blood Banks, are satisfied, become regular donors and promote voluntary non-remunerated blood donation (VNRBD). ‘An adequate and timely supply of products of defined standards builds for patients confidence of the clinician in the blood bank. Improved clinical outcomes with no adverse reactions in the patient, posttransfusion also contributes towards the same. Similarly the community at large seeing the performance of blood bank, actively partners with it for voluntary blood donation camps, augmenting blood safety. Pre-course assessment: The aim of pre-course assessment is to generate baseline information about participants, determine their current levels of knowledge and understanding about quality and the range of knowledge within the group in order to plan an appropriate level of training. It is to help facilitators to focus the course on areas of particularneed Stakeholders in QMS In order to achieve the quality objectives, the stakeholders for implementation of QMS in Blood Banks are as follows: Pecicd Sacs /SBTC or octet Cr or ei 1, NACO/NBTC/SACS/SBT countrywide have formulated the training program and will facilitate the training courses for implementation of QMS. :- By taking initiative and drive for improving the quality of Blood Banks 2. Head of institution- for Administrative and Financial support to Blood Banks with willingness to improve quality in Blood Banks. 3. Drug controller: -for strict regulation on Blood Banks and to ensure statutory and regulatory requirements are fulfilled by Blood Banks before grant of license. 4, Head of blood bank and staff :- for taking management commitment, making action plan, and motivation of blood bank staff forimplementation of QMS. 5. Donor community:- to provide support to blood bank by promoting voluntary blood donation for safe blood 6. Trait ing centres: by providing infrastructure and resources for imparting knowledge to participants on QMS.The broad outline of course is modular to ensure active learning-using a combination of formal presentations anda series of activities. Role of the trainers Mentoring and hand holding of the participants to make them learn QMS. Promote active discussion and make a simple, easy to follow approach to QMS for the participants. Boost confidence of participants and enable them to applyalll requirements of QMS and standards in their Blood Banks. Role of the participants Role of the Participants is to work hard and actively take part in discussions and deliberations. QMT course does not train on technical issues in Blood Banks but trains the participants on understanding the elements of quality systems that improve the quality and safety of blood. Most of the content of the course is group work which is interactive, to enhancing the learning process. The contribution of each and every participant will be important during the training program as sharing and exchange of knowledge will take place amongstall during group work and discussions, It is anticipated that the participants will develop a vision and view their Blood Banks intently for quality systems, analyze their problems and then apply acquired knowledge wherever appropriate and assist in cross training of their own BB staff to facilitate implementation of QMS in their Blood Banks. The course participants will have a central role in this process and stimulate the interest and enthusiasm for quality culture in their staff, because contribution of each staff is important in developing and maintaining the quality system. Participants are expected to prepare an action plan during the training course and implement their action plans by taking appropriate administrative support from their Medical Directors and authorities of their titutions to improve their blood transfusion services. The indicators of the training program will be the level of Participants’ knowledge and understanding assessed throughout the course. Post-training assessment will be conducted using a standardized questionnaire and feedback on QMT will also be taken for analyzing the effectiveness of training course. QMT Trainees are therefore expected to outline the structure and content of QMS with full attention and identify theirimportant role and responsibilities in implementation of QMS in their Blood Banks. The current and progressive status of quality systems will be assessed on a later date via a questionnaire on key performance indicators. A comparison of the baseline data with later reports will definitely ascertain and assess progress in implementation of quality systems in their Blood Banks.CHAPTER 2 National Blood Policy, Regulatory Requirements, Standards and Guidelines in Blood Banking, It is essential that the blood bank staff are aware, have knowledge and understand the National blood policy, all statutory requirements, regulations, standards and guidelines before operating a blood bank and implementing quality in their Blood Banks. Itis important to also understand the commitment of State to provide access to safe and quality-assured blood. In response to a public Interest litigation (PIL in 1992), Supreme Court of India in 1996 directed Government of India to establish National Blood Transfusion Council at National level (NBTC) and State Blood Transfusion Councils (SBTC) at State levels. The mandate of these council was to formulate a comprehensive National blood policy to address critical concerns of human resource, technology, quality, availability of blood ete. The National Blood Policy aims to ensure easily accessible and adequate supply of safe and quality blood and blood components collected / procured from a voluntary non-remunerated regular blood donor in well-equipped premises, which is free from transfusion transmitted infections (TTI), and is stored and transported under optimum conditions. Transfusion under supervision of trained personnel for all who need it irrespective of their economic or social status through comprehensive, efficient and a total quality management approach will be ensured under the policy. Objectives of National Blood Policy: Toachieve the aim, the following objectives are drawn 1. To reiterate firmly the Govt. commitment to provide safe and adequate quantity of blood, blood components and blood products. 2. To make available adequate resources to develop and reorganise the blood transfusion services in the entire country. 3. To make latest technology available for operating the blood transfusion services and ensure functioning in an updated manner. 4, To launch extensive awareness programmes for donor information, education, motivation, recruitment and retention in order to ensure adequate availability of safe blood. 5. Toencourage appropriate clinical use of blood and blood products. 6. Tostrengthen the manpower through human resource development 7.To encourage Research & Development in the field of Transfusion Medicine and related technology. 8. To take adequate regulatory and legislative steps for monitoring and evaluation of blood transfusion services and to take steps to eliminate profiteering in Blood Banks, Modifications in National blood policy 1. Union Ministry of Health & Family Welfare made a major modification in 2015 in the NationalBlood Policy, toallow Blood Banks to borrow units from one another in case of a shortage. 2. The ministry also made modification in the policy to fix an exchange value for surplus plasma available at some Blood Banks in the country. Blood Transfusion Safety and Regulatory Requirements Blood bank is a vital part of National Health Services. Regulations are necessary to ensure safety and efficacy of blood and its components and also the diagnostic reagents and devices used by the blood establishment. Human blood is covered under the definition of “Drugs” under sec 2A(b) of Drugs and Cosmetics Act (D & C Act). Blood Banks are regulated under the Drugs and Cosmetics Act and license granted for operating it by the State Licensing and Central License Approving Authorities after inspection. Note: Relevant portions from the D&C Act-PartX-B, 122 and XII Bof Schedule F for grant of license. General Requirements of Blood bank (as per D&C Act, 1945): 1. Premises shall be well lighted, ventilated and screened (mesh), wherever necessary. 2. Walls and Floors of the rooms shall be smooth & washable, 3. Drains shall be of adequate size and equipped with traps to prevent back siphonage. 4. Permit operation under hygienic conditions Accommodation: A blood bank shall have an area of 100 sq.mt for its operation and an additional area of SO sq.mt. for preparation of blood components as detailed below: 1. Registration & Medical Examination Room. Blood Collection Room (A/C). Blood Component Preparation Room (A/C). Laboratory for Blood Group Serology (A/C). Laboratory for Blood Transmissible Diseases (A/C) Sterilization-cum-Washing Room Refreshment-cum-rest Room (A/C) 2S NTH RYN Store-cum-records Room Premises ‘The premises shall be maintained in a clean and proper manner to ensure: 1. Privacy of donorsatthe time of Medical examination 2. Prevent contamination at the time of blood collection 3. Proper storage of blood and components before tests 4, Proper storage of contaminated products and reagents before disposal 5 . Proper storage of finished products prior to distribution6. Provision for safe and sanitary disposal of blood & blood components not suitable for use Personnel 1. Medical Officer with qualification of MD (Pathology/Transfusion Medicine) or MBBS with diploma in pathology or MBBS with one year experience in Blood Bank during regular service. 2. Blood Bank Techni year experience in the testing of blood or its components. 3. Registered Nurse 4, Technical Supervisor (for Blood components) with degree in MLT with six months experience or sn with degree in MLT with six months exper Diploma in MLT with one year experience in the preparation of Blood components. Equipment Equipment used in the collection, processing, testing, storage and sale /distribution of blood and its components shall be maintained in a clean and proper manner and so placed so as to facilitate cleaning and ied intervals. maintenance. Equipment shall be observed, standardized and calibrated at spe: Supplies & Reagents All supplies and reagents used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be stored at proper temperature in a safe and hygienic place in a proper manner Standard Operating Procedures (SOPs) Written standard operating procedures shall be maintained and shall include all steps to be followed in the collection, processing, compatibility testing, storage and sale or distribution of blood and/ or preparation of blood components for homologous transfusion, autologous transfusion and further manufacturing processes. Such procedures shall be available to the personnel for use in the concerned areas of Blood Banks: 1. Criteria for blood don: General equipment & instruments ion Special reagents Testing of whole blood Records 2. 3. 4, 5. 6 Standards for Blood Banks Standards is a document that provides requirements, specifications, guidelines or characteristics that can Labelsbe used consistently to ensure that materials, products, processes and services are fit for their purpose. Relevant and appropriate standards are required to provide framework for development of quality systems in Blood Banks. The existing standards for Blood Banks and Blood Transfusion Services (NACO, NBTC-2007) must be acknowledged and incorporated into the framework of quality. ‘These standards have been divided into 19 sections: . General Guidelines Donor Selection . Collection of Blood from donors . Testing of Donated blood . Preparation of Blood components . Labeling . Apheresis . Storage, transportation and expi |. Compatibility Testing 10.Recipient 11.|ssue of Blood for Transfusion 12.Transfusion of blood and Components 13.Transfusion Complications 14.Autologous Blood 15.Documentation in Transfusion Service 16.Histocompatibility Testing 17.Biosafety and Waste disposal 18.Quality Control of Reagents 19. Equipment Maintenance ion of Blood and its Components eernanewneCHAPTER 3 National Program Reporting 1 Strategic Information Management System (SIMS) ‘At the Blood Bank there is a report that must be submitted on the Strategic Information Management System (SIMS) platform to the Ministry of Health and Family Welfare. But in addition, the Blood Bank team would find it advisable to maintain some additional records to improve its functioning and its response to the local community needs. This chapter will discuss both aspects. Good records at Blood Banks can hel; + Improving day-to-day functioning of the blood bank. * Developing donor profiles. + Mor but + Establishing stock requirements for test kits and other consumable items. ingavailability, di Nand utilization of blood. + Contributing to.an epidemiological profile of the district or state SIMS Monthly Report This monthly report is submitted under the name of the official in-charge of the Blood Bank, the information will be collated by different team members - you may not information about different aspects of Blood Bank work. that each section requires Basic details about the Blood Bank Name of Blood Bank: Sub Type Category Location ‘Address of Blood Bank District Block city Pin Code Blood Component Separation Facility Avalable? (1=¥es, 2=No) | Aachedo any Strge Unis? ives Zoned | Stats oicense Voll Up [ps ow] lense Nomber Reporting Period Month(MM) Year(YYYY) Blood bank Supported by NACO? (1=Yes, Name of Officer in-chargeWhat to fill red Ceara Name of Blood Bank Name of the institution (hospital/ medical college as applicable) where the Blood Bankis located Subtype Subtype as Government, Voluntary/ Charitable, Private, NA Category Model Blood Bank, Major Blood Bank, Blood Component Separation Unit (BSCU), District-level Blood Bank, Blood Storage Centre Location Medical Hospital, District or sub district hospital, CHC, PHC etc Address of Blood bank Complete Address of Blood bank including state, city, district, Block/mandal and pin code Blood Component Separation Facility Whether Blood Component Separation facility is available in the Blood bank. Mark as 1=Yes or 2=No Attached to any Storage units Whether Blood bank is attached to any Storage Unit. Mark as 1=Yes or 2=No Status of License The date till which the license is valid (dd/mm/yyyy) License Number The current valid license number Reporting period Reporting month and year. Example: the data for the month January, 12 would be reported in Feb 12. So the reporting monthis Jan and yearis 2012. Blood bank supported by NACO Whether blood bank supported by NACO. Mark as 1=Yes or 2=No Name of the Officer in-charge Name of the medical officer who is in-charge of the Blood BankDetails about Blood Units collected by the Blood Bank per month ‘Section 1 : Blood Units collected during the Month ae cee nation (ut at Blood | Blood Donation oe Bank Camps 328 | seg | Male |Femate| Male | Female ls.No] 2 | 282 | Dono] Doners| Donors | Donors | Male | % | Female | % | Total | Total% 223 |228| a] oe) © | oO Voluntas ‘Blood ° o 0 | 000 | Noluntary | Donor Blood Donation | Family Blood ° 0 0 | 000 Donor 2 Total 0} of} o | o ° a 0 | 0.00 Replacement Blood 3 scone ° a 0 | 000 4 Grand Total 0 0 ° 0 ° 0 0 0.00 5 | Number of Donors coming for repeat dation ° 6 | Number of Blood Donars Counseled 0 before Donation 7. | Number of Blood Donors Deferred because of following reasons (Total = 7a+70+7c+7d+7e) 0 0 o Ta | Anaemia 0 Th | Underweight / underage 0 Te | Medical'surgical causes ° 74 | High risk history 0 Te | Others ° 8 | Number of Voluntary Blood Donation Camps OrganizedWhat to fill eae CEE Type of Donors Voluntary donors ‘person who gives blood, plasma or other blood components of his/her own free will and receives no payment for it, either in the form of cash or in-kind, which could be considered a substitute for money is known as Voluntary Blood Donor. Any person can walk-in voluntarily any time round the clock at their own convenience to donate blood in a licensed blood bank. The number of voluntary blood donors in the reporting month is recorded for licensed blood banks as well as for blood donation camps. The number of donors calculated separately for male and female under voluntary and family donor. Family d A person who gives blood when it is required by a member of the od family and isa first degree blood relation or spouse is a family donor. Total This is auto calculated in software. The total gives total voluntary blood donation made during the month Replacement A donor who gives blood when it is required by a member of the Gano patient's family or community is known as Replacement Blood Donor. The number of replacement blood donors in the reporting month is recorded for licensed blood banks. Grand total This is auto calculated in software. The total gives total blood donation made during the month. Repeat donation ‘A person who donates blood at least two — four times in one year i.e (regular donor) the second donation is known as repeat donor. The number of repeat donors is recorded combined for blood banks as well as voluntary blood donation camps and also separately for males and females. Blood donors Blood donor counseled are numbers of donors coming for counseled pre donation counseling Blood donors Blood donation should be deferred if it could be detrimental to the deferred donor/recipient. Write the number of deferred donations due to ‘Anaemia, underweight/ underage, medical/surgical cause, high risk history and other condition combined for blood banks as well as voluntary blood donation camps among male and female donors separately. Number of Voluntary These are pre-fixed venues arranged by organizers like educational blood donation camps institutions, industrial and commercial houses etc. Blood banks organised organize camps in these sites/premises on fixed days as decided by SBIC (State Blood Transfusion Council) i.e. ina house, camp can be organized by a blood bank on pre fixed dates in coordination with the organizers and blood bank in-chargeDetails about Status of Testing Itis mandatory to test each and every collected unit of blood for HIV, Hepatitis 8, Hepatitis C, Malaria and Syphilis. All mandatory tests should be carried out on blood samples in pilot tubes taken at the time of collection. The whole blood or components from any unit that tests positive should be discarded. This indicator is obtained by counting voluntary and replacement collecting units in the reporting month in the columns: number tested and positive and referral to ICTC and STI clinics. et me ees Cocca aa Teoma Poreont Postive Number | Number Positve | Tested | Positive Tests | Number | Number conducted | Tested | Postive a fav 2 | Hepatitis-B 3 4 5 | Malaria What to fill Oey TE All blood units collected should be tested for HIV | & Il antibodies HIV using ELISA/rapid which is a validated method. Any alternative technology with similar or higher sensitivity may be used. Donor found to be HIV positive should be referred to ICTC. A test for hepatitis B (HBsAg) by ELISA/rapid test which is a validated method should be done on each unit of blood. Any technology with similar or higher sensitivity may be used additionally to improve blood safety A test for Hepatitis C (anti-HCV) by ELISA/rapid test which is a validated method should be done on each unit of blood. Any technology with similar or higher sensitivity may be used additionally to improve blood safety. Each donation of whole blood should be subjected to a serological ‘Syphilis test for syphilis (e.g., RPR/VDRL). Donor found to be reactive should be referred to STI Clinic Hepatitis-c Malaria All blood units should be tested for malaria parasite using a validated and sensitive antigen test/slide examinationBlood Component Details These columns give the details of blood and blood componentsi.e. their collection / preparation during the month, units that are supplied, discarded and the number of units left as a balance with blood bank. Opening stock and balance at the end of the month are auto-calculated by the software, Ce ee red Supplied Dieca at the end ee! Co Opening Sock 1 | Whole Blood 2_| Packed Cells 3 _| Platelet Concentrate 4_| Fresh Frozen Plasma 5 _| cryoprecipitate 6 | Plasma 7 | oF Blood Unit processed for Component separation ZZ “ | What to fill ean Beare The whole blood contains 450245 ml or 350235ml of donor blood plus anticoagulant solution Whole Blood Packed or red blood cells are prepared by removing most of the Packed Cells plasma from a unit of whole blood This is a concentrate of platelet prepared after removal of packed Platelet Concentrate cells and most of the plasma. It is responsible for normal haemostasis in the body Fresh Frozen Plasma is plasma obtained from a single donor Fresh Frozen Plasma either by normal donation or by plasmapheresis and rapidly frozen within 6 to 8 hours of collection Cryoprecipitate is a concentrated source of specific plasma proteins Cryoprecipitate and is rich in fibrinogen, factor Vill, Xill, von, Willibrand factor and fibronectin Plasma is the fluid component of blood prepared from whole blood Plasma after removal of packed cellsDetails of Blood Units Discarded These columns give the details of the blood units discarded for various reasons. Details of Blood Units Discarded Number of % SNNo, | Cause of Discard unter aed + | outdated Units 0.00% 2 | Sero-Reactive Units 0.00% a | others 0.00% What to fi eee CE Outdated units Fill the number of blood units after date of expiry Fill the number of blood units found positive for any Sero-Reactive Units of the five infectious diseases (HIV, Hep-B, Hep-C, Syphilis and Malaria) Fill the number of blood units discarded due rupture of Others Blood bags, bacterial contamination of Blood, Hemostasis, of blood etc Total Fill the total number unit discardedStock Position of Test kits and Consumables These columns provide stock position of test kits (ELISA Kits, Rapid Test kits, Hepatitis B & C, VDRL and Malaria test Kits) and consumables (blood bags and antibody reagents) to keep a track of consumption, wastage, requirement and when to place order. Note: Reporting should be based on number of tests not kits. Perea Ped Estimated | Balance atine| number | Number Used | Number damaged stoek emst Requirement | begining of | Received | duringthe | Masted during. | galance | sufficient |Comments forteWonh | “thetonn [During the Month] Montn(tumber| Month Aoraprox| (atest (Number of test} (Number of test} (Number of test) of test) (Number Of Test) months | Expiery) HIV ELISA Kit (Number of tests) 0 0.00 HIV Rapid Test Xt (Number of test) cee ay Hepatitis 8 EUSA KR (Number of tests) 0 0.00 Hepatitis 8 Rapid Test kit 0 | 000 Hepatitis CEUSA KE (Number of tests) 0 9.00 Hepatitis C Rapid Test Kit 0 | 000 Syphilis Test Ke (Number of tests) 0 | 0.00 Malaria Test kt (Number of tests) 0 | 0.00 es . Estimated Number | Number Used | Number damaged Stock | comments hams Reauireent Received | during the | Wasted during. | Balance | suicient [east fortteMonth Duingtne Ment] “oan orth ersppon| er Single Blood bags a | 000 Double Blood bags a) “Tape Blood bags a 000 SAGM Blood bogs a [000 AREA (20m a_[_000 ‘AneEB (LO [000 “AngPAB (10 mi) a) AND HOM [000 ‘Anti Human Globulin a 000 22% Bovine Albumin a [000 Wafers a _|_000 Anti At (5 mi a [000 ‘ai (mi a | 000What to Balance at the beginning | This refers to the total stock available at the beginning of the of the month month or the stock at the end of previous month is auto generated Number received during i the month Refers to number received in the current month Number damaged / wasted/control during the | Refers to number consumed in the reporting month. month Balance at the end Refers to the wastages, damages and controls in the of the month reporting month Gives the position at the end of the month. This is an auto calculated field. This is calculated as balance at the end of the month = Balanced at the beginning of the month +Number received during the month - Stock sufficient for Number used ~ Wastage during the month approx. months Gives the position of the stock at the end of the month sufficient for approximate number of months. This is an auto calculated field This is calculated as stock sufficient for approx. month = Balanced at the end of the month / Number used during the month, provided there is some consumption ‘Comments: Write the expiry date of the test kit and consumables in a lot of the (Earliest expiry) closing stock having the earliest expiry date in MM/YYYY Blood storage centre and Blood Units supply details The following table refers storing of blood units at different storage units. There are four basic blood groups i.e. A, B, AB & O, depending upon the presence of antigens on red cells and reciprocal presence or absence of antibodies in the serum. een ect Looe ae linked to the Blood Banks: co the Blood a Be ABs oF & 8 ae. ° rage Units What to fill Number of Blood Storage Total number of blood storage units linked to the blood bank. Units linked to the Blood Banks| (in absolute number) Number received during This refers to the centre linked to mother blood bank which the month receives screened blood and blood components (A+, B+, AB+, O+, A-, B-, AB-, and O-)Status of Equipment These columns provides the status of equipment in terms of their availability in numbers, their working condition, number under which the equipment is covered for annual maintenance contract (AMC), number of equipment condemned and who has procured them. Pee east an Pra Dey Dr Coo oy coe du Condemned Pgs rs Blood Bank Refrigerator Donor Couches 1 2 3 | Bio Mixer 4 | Tube Seater, stripper with cutter 5_| Dielectric sealer 6 1 8 9 Domestic Refrigerator Bench top centrifuge Dry Incubator Serological water bath 410 | Auto clave 11 | Binocular microscope 12 | Micropipettes (2ut- 1000 ul) 13 | Multi channe! Pipette 14 | _Distited water stil 45 | Digital analytical balance 416 |_ Computer ‘Tal _Elisa System (Washer ) 417b| Elisa System (Reader) 18 | Cell counter 19 | Refrigerated Centrifuge 20 | -800C Deep freezer 24 | -400C Deep freezer 22 | Laminar Air flow bench 23 | Plasma expresser (Manual 24 | Plasma expresser (Automated) 25 | Platelet incubator with agitator 26 | _ Refrigerated water bath (Cryobath) 27 | Cell counter 28 | Coagulometer 29 | pH meterWhat to ear} Te Mention here the number of particular equipment availability at the blood bank Number Available Number in working Mention here the numbers of equipment which are in good condition working condition from the available equipment at blood bank. Mention here the number of AMC under which the equipment LES AC covered for maintenance Number of Equipment This refers that number of Equipment condemned from condemned the total available Procured by SACS/ Mention who has procured the Equipment i.e. SACS, NACO NNACO/ State or State Other Documentation Toimprove the functioning of the Blood Bank, you may want to consider adding the following records: Organisational Directory These are lists of social, educational and religious organisations in your locality which might serve as sites for your blood collection drive. Sometimes such lists are already prepared for particular cities. But you will wanttoaddtoit. Make sure you have details of the contact persons at these organisations such as name and telephone number, Orga nal List While, in each monthly report, you are mentioning the number of blood drives, here you will want to maintain a list of the blood drive by name of organization, date and number of units collected. These are Useful for compiling the monthly report. But by analyzing your data here, you will learn when to contact the organization for another blood drive, You can also make an informal note of any issues that were associated with that institution, For instance, did you initially do a lecture? Were there any donors who were felicitated? Donor Directory Here the Blood Bank team should compile a list of donors with the name, telephone number, email address, blood group and birthday. If you compile this in Microsoft Excel, you will be able to sort it out according to the blood group in case you need units of rare blood. You can sort it out by month and senda congratulatory email or sms onthe donor's birthday.References: National AIDS Control Organisation (nd). A guide to recruitment and retention of voluntary blood donors. New Delhi, india: Ministry of Health and Family Welfare. National AIDS Control Organisation (nd). Strategic Information Management System (SIMS) data definition for blood safety. New Delhi, India: Ministry of Health and Family Welfare. 2. National Health Portal (NHP): National Blood Transfusion Council in pursuit of e governance initiatives is partnering with National Health Portal, Centre for Health Informatics, Ministry of Health and Family Welfare to develop web presence for Blood Transfusion Services of India through making available information pertaining to licensed blood banks on line. The website for NBTC in India for Blood transfusion Services (BTS) is conceptualized to be a dynamic site providing an up to date consolidated Blood Bank stock positions and locations. The citizen centric interface of the NHP platform so as to bring uniformity in data display from across the country has been developed in the following manner. + Alllicensed Blood Banks are enrolled on the NHP through a user name + and password. + On facility log in page, the blood banks have filled in the required details as a onetime activity including authentic information, contact detail, phone no., Google coordinate etc. of the respective blood banks, In addition, blood banks must report on this portal on a daily basis to update the availability of blood group wise status of stock status of blood and blood components. Note: + The information on NHP has to be completed/verified/ corrected and up to date as this would be in publicdomain and has to be fruitful to the end user. The steps for login and entrvon the NHP olatform are as given below e ‘Steps for entering data at the Facility Level Step1 * Logontowww.nhp.gov.in Step2 + Clickonthe B| Icon on NHP homepage and it will redirect user to the E-Blood Banking microsite. * Clickon the Facility Login Button and enter username and password Step3 + Kindly verify the information uploaded especially the PIN CODE & Google Coordinates as data on mobile app requires the same. Kindly ensure that all the information is authentic and updated also that no columns are left blank3. Haemovigilance + The term “Haemovigilance” is derived from the Greek word ‘hema’ meaning blood and the Latin word ‘vigilans' meaning watchful + Theyare: 1. Asetof surveillance procedures . Covering the whole transfusion chi . From the collection of blood and its components . Tothe follow-up of its recipients . Intended to collect and assess information on . Unexpected or undesirable effects . Resulting from the therapeutic use of labile blood products . To prevent their occurrence and recurrence exnanewn + The ultimate goal of a Haemovigilance systemis to improve the safety of blood transfusion | + The Haemovigilance Programme of India ( HvPI) was launched on 10th December, 2012 in the country. Enrollment 1, Head/In Charge of Transfusion Medicine Department /Blood Bank provides the necessary details to the National Coordinating Centre (NCC) - Haemovigilance Programme of India (HvP!) by sending the duly filled Enrollment Form 2. NCCverifies the details provided by the Center 3. After verification, NCC issues the User Id and Password to the Head/In Charge of Transfusion Medicine Department /Blood Bank to access the Haemo-Vigil Software for onward transmission of Transfusion Reactions Reports to NCC. * HvPIReporting 1. Transfusion Reactions Reporting Form (TRRF) for blood and blood products can be downloaded and filled up «Transfusion Reactions Reporting Recipient Haemovigilance 1. Head of the Department opens the Haemo-Vigil software 2. Usesthe User Idand password 3. Fillsup the form online and submits Donor Adverse Reactions Reporting 1, Head of the Department opens the Donor-Vigil software 2. Usesthe User Id and password 3. Fills up the form online and submitsCHAPTER 4 Importance of Quality in Blood banks It is essential to understand the definitions of terminologies required for understanding and implementation of Quality Management Systems in blood banks. Quality is defined as the degree to which a set of inherent characteristics fulfills requirements. (ISO 9000:2005). Quality is conformance to requirements. In simpler terms, quality means fitness for purpose and the purpose is safe blood transfusion. The definition of quality used by WHO is the consistent and reliable performance of services or products in conformity with specified standards. The term “quality” can be used with adjectives such as poor, good or excellent. A quality based approach in all procedures of blood bank ensures maximum safety, for recipients, donors and staff and maximum clinical effectiveness of the products. Achieving a 99% level of quality means accepting 1% failure rate. It is acceptable in blood bank? Quality is a continual process of striving for improvement to ensure consistently high quality. Need for quality The quality of Blood Banks is directly influenced by the quality of Blood transfusion chain from vein to vein ! To ensure that products and services meet the customer’s needs. To ensure the maximum efficacy of blood and blood products. The Blood Transfusion Chain Frcgase Bg) THe strength of he cain conuarot depends onthe weakest Seve inks Tne ot the strangest nk (primary processes) ‘The quality ofthe BTS is lnfuenced by the quality ‘ofeach ofthe inks Scored na | Stake holders in Blood transfusion chaBlood Transfusion is a bridging science that spans the healthy community and clinical care of those in need for supply of good quality blood and products have their own needs and responsibilities. The interface is between community as supplier of blood, blood bank as the producer and patient/clinician as the consumer of blood . The donors from the community provide the raw material and should be treated properly to ensure that the donation of blood causes them no harm, their blood is not wasted and their goodwill is maintained and developed. The society as a whole wants the best service, availability of blood and no wastage of resources. Producer i.e Blood Bank staff wants to provide high quality products and to be able to work to provide safe blood efficiently and effectively. The patients and clinicians require the right product, at the right place, in the right strength, at the right time. Even with highest level of standards, best of equipment and trained personnel, there exists a possibility of error and possible serious or fatal consequences in the transfusion chain from vein-to-vein. These errors affect the health and safety of blood donors, recipients or staff. ‘Some of the risks of transfusion should be preventable but some are beyond control in the transfusion chain from donor to the recipient if quality systems are not in place. Any failure in the quality system in blood transfusion chain in Blood Banks could lead to potentially dangerous situations such as: 1. Failure to identify the donor/patient correctly . Wrong blood unit/sample labeling . Mix-up of results amongst different donors/patients . Poor techniques or incorrect reagents being used . Incorrect test results . Issue of unscreened blood due to faulty processes or procedures Noveen . Variation in test results in terms of accuracy, precision, reliability Challenge for Blood Banks: To provide Safe Blood & components and therefore, quality oriented approach is of paramount in all aspects of Blood Banks. To avoid unsafe blood to be issued, itis essential that quality systems are designed, implemented and monitored in Blood Banks to ensure consistency , availability of safe and effective blood and its products Safe bloods blood thatis 1. Free from risk of infection 2. Free from other contamination 3. Correctly labelled 4. “Indate” Effective blood should 1. Contain required bioactive substances 2. Give clinical benefit to the patients. Quality is therefore essential to ensure that blood transfusion is safe and clinically effective and consistentfor the patients. Quality in Blood Banks should also prevents the transfusion of unsafe blood or blood products to patients and minimizes the risk of adverse effects of transfusion. Importance of quality management systems in Blood Banks Quality management System is defined as the management system to direct and control an organization with regard to quality. (ISO 9000:2005). Quality management is an organized, coordinated and systemic approach to planning and management of activities in Blood Bank. The organizational structure, processes and procedures, resources are needed to implement quality systems to ensure that the final blood product meets the basic quality requirement of safety and efficacy. Development of quality management system is the foundation of a quality based approach to prevent failure of quality in Blood Banks. Important terminologies to be understood for QMS: Quality Assurance Defined as "part of quality management focused on providing confidence that quality requirements will be fulfilled” (ISO 9000). Quality assurance is creation and operation of standards, programs and effective management systems to ensure quality. Quality assurance is concerned with every aspect of transfusion practice and applies to all activities of a blood transfusion service from donor identification to appropriate use of blood by taking measures to maintain the standards of all the critical factors at a specified optimal level as per defined standards. Quality assurance determines whether the overall processis reliable, accurate, correct and controlled. It basically identifies errors in the processes that need to be addressed and corrected immediately for further improvement . The common examples in Blood Banks are review of records, monitoring of quality indicators, and internal assessments. Quality Control : Defined as_ part of quality management focused on fulfilling quality requirements (ISO 9000).Quality Control is the monitoring system that ensures that specifications are met and errors do not occur. Itchecks the effectiveness of quality assurance by testing the quality of final products. Quality control (QC) provides feedback to Blood Bank staff about the state of a process that is in progress and whether everything is acceptable or a problem exists which needs to be resolved before proceeding further. Simple QC examples followed in Blood Banks include OC of reagent, visual inspections, and measurements such as temperature recordings of storage equipment and volume or cell counts of components prepared. Accuracy is defined as the closeness of agreement between the result of a measure and the true value of measurement. Calibration Calibration means a process to control and maintain precision of measurement of an equipment as compared toa known standard. All equipment/instruments which measure weight, volume,temperature, speed, pressure and time need calibration is essentially used to achieve accuracy of instruments and equipments inthe Blood Bank. Precision is defined as the closeness of agreement between the results of successive measurement of a defined procedure several times under prescribed conditions. Precision means exact and accurate reproducibility and repeatability, the degree to which repeated measurements show same value. High precision is achieved by running Internal Quality Controls in analytical procedures. Accuracy vs Precision Inaccurate Accurate (systematic error) Precise Imprecise {reproducibility error) fined as set of interrelated or interacting activities which transform inputs into outputs (ISO Procedures: Defined as specified way to carry out an activity ora process that is documented, implemented and maintained (ISO 9000:2005). Procedure is a specific activity that forms the basic unit of a process. Blood transfusion service activities consists of various processes and procedures from donor registration to issue of a unit of blood and the quality system is designed around these processes and procedures. Factors Affect 1g Quality of processes and procedures in Blood Banks Each process in Blood Banks has an input and an output, and in its most generic form, includes all of the resources and activities that transform an input into an output. An understanding of how to manage and control processes in the blood bank or transfusion service is based on the simple equation:Right Right Reagent Equipment Personne! —— ouTPUT Procedures The different factors affecting quality of each process include the 5 M's : Man, Material, Machinery, Methodology, Mother nature viz Personnel, Equipment, Reagents and Consumables, procedures, and Environmental conditions. These factors that affect quality of processes need to be identified, validated and ensured that they do what they are supposed to do for quality output as output of one process is the Input of another processin Blood Banks. Quality of Equipment: ‘The specifications should be appropriate as per the need of Blood Banks to meet the applicable regulatory requirement for all quality parameters, calibrated and validated taking into consideration the certifications for acceptability which are important for quality of equipmentin Blood Banks. ‘The performance of the equipment should be as per defined protocol of installation qualification (10), operational qualification (0Q) and performance qualification (PQ) to suit the purpose. The equipment should be maintained under Annual/Comprehensive maintenance contract (AMC/CMC), calibrated for quality control purposes forts appropriate functioning Quality of Reagents: The external supplies are an integral determinant of the quality of Blood Banks. It is well known that quality of the input is always the quality of the output. Only reagents and materials from approved suppliers meeting documented requirements should be used for quality results. Reagents used should be maintained at right temperature for viability and effectiveness as per protocol after quality control checks. Inventory stock management should be in place to ensure appropriate resource utilization and continuous availability with no stockouts as each and every itemis critical in Blood Banks.Quality of Personnel: Right personnel for right job at the right time should be available to ensure quality of blood and blood products. Adequate induction, in-service trainings as well as competency assessment of technical staff is essential for safe and effective service to patients in Blood Banks. All staff in donor area should be also appropriately trained on basic life support procedures and equipment to respond to any emergency situation. Pre employment, regular health check ups, training on personal hygiene, use of personal protective gear and immunization against Hepatitis B for all staff is paramount to ensure health safety and prevent risks of occupational hazards for laboratory staff. Quality of Documents: Documentation isa core of any quality system. “Write what you do. Do what you write” Blood Banks should have a quality manual, quality policy, standard operating procedure, flow charts, records as key documents for quality management system to provide consistent results. All formal documents need to have certain identification. Timely review of documents, amendments, control of I elements of quality systems. Any change in document should be acted upon promptly with record keeping forall practical purposes. documents are criti Quality of Environment: Good lab environment minimizes risk of errors. Right temperature/humidity/adequate space/safety measures should be adapted and maintained for all activities in logical sequence. Air conditioning and availability of power back up are of utmost importance in maintaining temperatures of storage equipment. Proper cleaning and maintenance of equipment minimizes risk of contamination to equipment. Management commitment centered on quality based upon participation of all staff with an aim for long term success through customer satisfaction and benefit to all staff and society is the need of the hour. Once quality systems are established, Quality Assessment is performed to ensure if quality systems are in place. The assessment results give confidence to the Blood Banks about their quality status, Quality assessment is done by internal quality control and participating in external assessment schemes which are both essential and complementary activities. Internal quality control (1Qc): The assessment of quality management system in a blood bank should be done by regular monitoring of the tests. It is necessary for continuous monitoring to demonstrate whether there is any variation in the reagent used or decline in the performance of a test for evaluation and taking corrective measures for improvement. This applies to all analytical procedures.