Transfusion Services and Quality Assurance: A Critical Component
Transfusion services or Blood Banking plays a major role in clinical medicine. With the advances in transfusion medicine, the services rendered need to be of the highest quality. Many techniques and processes are currently involved in the transfusion services and a high degree of vigilance is required to maintain the same.
As we all know, modern transfusion therapy is a central and often indispensable part of many significant advances in medicine. Many success stories are based on the ever accelerating technological developments in transfusion medicine. Blood is considered as a life-saving fluid. Without the help of hemotherapy, many surgical procedures would not have been possible. Aggressive oncology regimens are heavily dependent on the availability of blood components and blood products. The role of blood transfusion in salvaging trauma victims is well known. Long term replacement support has significantly altered the quality of life for patients with inherited defects of red cells and coagulation factor deficiencies.
James Blundell performed the first human to human transfusion in 1818. The discovery of the ABO blood groups in 1901 by Karl Landsteiner won him a Nobel prize and gave a new insight into transfusion practice. Among the key advancements in transfusion practice are the availability of sterile and inert plastic collection systems, long term preservative solutions, blood collection monitors, component separation by centrifugation an apheresis, advanced refrigerators for storage, and reagents and techniques for blood grouping, cross-matching, identification of unexpected antibodies and testing for transfusion transmissible diseases. With the marked developments in this field, blood banking is currently known as the discipline of transfusion medicine.
Why are blood components instead of whole blood desired? They allow optimal survival of each constituent, allow specific transfusion as per patient requirement with the transfusion of the unnecessary component being avoided thus minimizing complications and the risk of transmission of infections, allow optimal use of every unit of donated blood, overcome the shortage of blood, increase the shelf life of individual blood components and minimize complications.[1-9]
The PRIMARY GOAL of blood banks and transfusion services is to promote high standards of quality in all aspects of production, patient care, and service. Quality of blood transfusion services is to ensure safe transfusion of blood and its components.[2,6,10] Blood banks in our country are stringently governed by the Drugs & Cosmetics Act as well controlled by the National AIDS Control Organisation (NACO).
A quality system includes the organizational structure, responsibilities, policies, processes, procedures, and resources to achieve quality. The purpose of quality control (QC) is to provide feedback to operational staff about the state of a process that is in progress. It gives information on whether the process is acceptable or if a problem has been detected which needs to be resolved immediately. Quality control is based on monitoring the procedures that are performed in the Blood Bank. It includes measurements as well as statistical analysis. It is important to develop quality assurance programs and procedures as defined by national policy, keeping in mind that the available resources are used in the most efficient, cost-effective and ethical manner.[2,6,10]
It is necessary to know certain fundamental definitions critical to understanding transfusion medicine. Whole blood is the unseparated blood collected into an approved container with an anticoagulant-preservative solution. A blood product is any therapeutic substance prepared from human blood. A blood component is a constituent of blood separated from whole blood by differential centrifugation or by apheresis and includes cellular and plasma components.
WHO has defined QUALITY as consistent and reliable performance of services and products in conformity with specific standards. Quality Assurance is a consistent and reliable performance of services and products in conformity with specific standards. Quality Control is the process by which the product standards are established and met. Quality Audit is the evaluation of a quality assurance program to identify problems and approaches to their resolution. A quality assurance program has the following components – Internal quality control, External quality assessment, Standardization & Proficiency surveillance. It must ensure adequate control of pre and post analytic stages from blood collection to timely issue of blood.[2,6,10]
The process of standardization refers to both materials and procedures. A material standard or reference preparation is used to calibrate analytic instruments and to assign a quantitative value to calibrators. A reference method is an exactly defined technique which provides sufficiently accurate and precise data so that it can be used to assess the validity of other methods. The main international authority concerned with material standards (reference preparation) is the WHO. Controls are preparations which are used for quality control. Standardization of methods and devices are the concern of the international council for standardization.[2,6,10]
Proficiency Surveillance is concerned with pre-analytical and post-analytical parts of the process that requires controls if tests are to be reliable and effective. This is the major component of audit. This includes blood collection with blood bags containing correct type and amount of anticoagulant, and phlebotomy by a standardized procedure, adequate identification of all specimens and request forms with appropriate indication, proper storage, transportation of blood without delay and maintenance at appropriate temperature, accurate testing and regular contact with users to ensure optimal use during clinical management.
Organisation wise quality assurance consists of Quality council for Policy making, Resource support and Prioritizing, Quality management board (Steering Committee) for implementation and monitoring, and Process Improvement Teams for process improvement and problem solving.[2,6,10]
Quality control involves quality of donor selection, type of container and anticoagulant preservation used for blood collection, storage and transport conditions, procedure involved in preparation of components and administration to the patient. This includes personnel, premises, standard operation procedures (SOPs), laboratory testing techniques, reagents, equipment, documentation.
The staff in each section should be adequately trained so as to undertake his/her responsibility correctly. The working of all technical staff should be monitored regularly and cross checked. There should be provision for regular development programmes for the staff to upgrade their knowledge in the latest techniques.
The premises should be clean, air conditioned with adequate light and ventilation. The various sections required are as follows: donor registration and selection, blood collection and refreshment, blood component preparation hemapheresis room, storage area of blood and blood components awaiting the completion of the tests (quarantine storage), laboratory for blood grouping and typing, serology and compatibility testing, laboratory for testing blood transfusion transmissible diseases i.e. hepatitis B & C, syphilis, malaria, and HIV, store and record room, sterilization and washing room, and adequate clean and conventional hand washing and toilet facilities.
Every blood transfusion service should have its own procedural manual called the SOP. It should cover every significant action which affects the quality of products or services including record keeping, validation and documentation. Preparation of the SOP should be a team effort and the senior technologist of each section, authorized by the director / in-charge of blood transfusion services should be involved in its preparation. The manual must be regularly (preferably annually) reviewed and updated. It should be available in all the sections of the department for use to all personnel. SOPs ensure that specified standards are met uniformly and at all times, helps to monitor the performance of the task in more effective way, standardizes all staff members to do their job more effectively and helps to reduce adverse effects on performance when staff changes or absence occurs.
The aim of Quality Assurance in testing is to ensure that the blood and its components meet the specified standards of safety and efficiency. All the tests should be conducted as per the national policy or according to well validated and documented techniques. All mandatory lab tests as per the national policy should be done on the blood before releasing from the quarantine. The result must be documented and the blood or blood components labelled to show that the individual donation has been tested and conforms to national or local policy. All blood and blood components should be labelled appropriately. Internal quality control is meant to allow the technical staff in the lab to check their performance by themselves & to evaluate the reliability of their techniques.[2,6,10]
The blood grouping should be performed using quality reagents. All the reagents should be used according to the manufacturer’s instruction. Routine quality control of antibody reagents is based on the use of positive and negative controls with each batch in order to see that the reagent is specific and potent. All the new reagents should be introduced into routine working only after assessment and confirming that the new reagents are satisfactory. Polyclonal reagents are mixture of antibodies, thus directed against different epitopes, and can give nonspecific reactions. Monoclonal reagents are obtained from culture of the cells secreting antibodies called hybridomas. These monoclonal have significant advantages over polyclonal reagents, in terms of specific potency, potency (avidity, intensity, titre), stability, batch to batch consistency, absence of non specific antibodies and freedom from viruses such as hepatitis and HIV.[2-6]
The kits used for various serological tests for testing blood transmissible diseases should be strictly used as per the instructions of manufacturers and controls both positive and negative provided with the kit should be run along with the test. No tests should be considered acceptable unless the manufacturers and local/national quality tests have satisfactorily met the criteria.[2-6]
All equipment should be checked and assessed when first installed and after any repairs or adjustment. All equipments need preventive maintenance including cleaning, regular calibration and periodic verification of performance accuracy. The refrigerator for storage of blood requires special attention, the temperature should be maintained in the range of 2 -6 0C and it should be recorded continuously on a graph. The refrigerator should have alarm system battery operated without any electric supply. The alarm is set in such a manner so as to make sound when temperature is outside the normal ranges of 2 -6 0C.
The quality control of blood and blood components begins with collection of blood from the donor and ends with its administration or disposal. There should be separate areas for storage of blood during the quarantine period. It is important to check every unit of blood or its components before issue for any evidence of hemolysis in the plasma or discoloration of red cells.
The record of donor blood collection should have date of collection donor identification number, name and address with telephone number, demographics, physical examination record, and laboratory tests done. The record of recipient should include recipients name and identification number, hospital ward and bed number, name of attending physician, indication for transfusion, and number of units required. Other important records are compatibility test record, and blood/ blood components issue register.
The procedure of transfusion is equally important. The procedure should begin and end with the patient safety in mind. Administering blood and blood products is similar to administering any parenteral drug and due care should be taken. Transfusion should be undertaken only if the anticipated benefits outweigh the potential risks.
Auditing is an important management tool for managing the quality assurance system. Audit may be either Quality Audit or Medical Audit.
Quality Audit is a comprehensive quality audit, should cover each and every aspect of blood transfusion should asses the relations between various components and services. The Quality Audit can be selective and specific at times. The procedures may be internal or external.
Medical Audit is carried out through the hospital transfusion committee. The committee should have representatives from surgical disciplines, internists, hematologists, anesthesiologists, hospital administration, and nursing staff. The hospital management has an important role to play in checking the effectiveness of quality assurance by monitoring and evaluation, participation in external quality assessment scheme, training of staff, and identifying errors and taking appropriate remedial actions to their recurrence. Auditing is the valuable way of assessing the quality assurance. Efficient collection, communication and follow up are important for achieving the success in external quality assessment programmes.[2,6,7,10]
The functions of the hospital transfusion committee include monitoring the source and supply of blood components, monitoring the adverse effects of blood transfusion and decision upon the appropriate actions and their implementation, establishing maximum surgical blood order schedules for surgical procedures, reviewing the current practices with a view to their possible up gradation and make recommendation whenever necessary, promote continuing medical education programmes for medical and paramedical staff, and identifying the priority issues. The indicators of blood transfusion monitoring are the total number of units of blood or component transfused during a definite period and the ratio of whole blood used to red cell concentrate The frequency of the hospital transfusion committee meeting should be decided as per local policies.[2,6,7,8,10]
The role of biosafety in blood transfusion services is not to be ignored. Universal precautions must be practiced by the laboratory staff with all samples at all times. All the disposable material used in laboratory must be properly decontaminated before disposing either by autoclaving or incineration.
It is as important to analyze, clarify errors and take remedial action as it is to detect them. There are two types of errors, consequential and inconsequential (discrepancies).Consequential errors have serious consequences and may lead to litigation. Inconsequential errors are often pointed out either during or just after the completion of routine procedures and should be corrected immediately. The major sources of error include Clerical, Organizational & Technical. Clerical errors are often due to inadequate or incorrect labelling of blood that is the recipient’s pre-transfusion sample, blood bag or pilot tube. Mostly it has been seen that clerical errors are not due to lack of knowledge or skill. Organizational errors can be due to internal or external factors, like excess work load or insufficient staff can lead to problems at times. Technical errors can be caused by staff, reagent or equipment. It is important to investigate the technical errors fully as it often reveals a breakdown in quality assurance measures. All errors (failures) should be corrected as soon as possible, whatever the cause of error may be so that the patient may not suffer.
Transfusion medicine is currently a multidisciplinary specialty and the term emphasizes its role in patient care and clinical outcomes. Safe transfusion is the principal goal of transfusion practice.
- Sazama K, DeChristopher PJ, Dodd R, et al. Practice Parameter for the Recognition, Management, and prevention of Adverse Consequences of Blood Transfusion. Arch Pathol Lab Med; 2000 : 61-70.
- Brecher ME, ed. Technical Manual. 15th ed. Bethesda, American Association for Blood Banks, United States: 2005.
- Davenport RD, Mintz PD. Transfusion medicine. In: McPherson, Pincus MR, eds. Henry’s Clinical Diagnosis and Management by Laboratory Methods. 22nd ed. Elsevier Saunders: 2011.
- Galel SA, Fontaine MJ, Viele MK. Transfusion Medicine. In: Greer JP, List AF, Rodgers GM, et al, eds. Wintrobe’s Clinical Hematology. 13th ed. Lippincott Williams & Wilkins: 2014.
- Klein HG, Anstee DJ, eds. Mollison’s Blood Transfusion in Clinical Medicine. 11th ed. Blackwell Publishing Ltd: 2005.
- Makroo RN.Compendium of Transfusion Medicine: 2nd ed. Alps Printer, New Delhi:1999
- Petz LD, Swisher SN, Kleinman S, Spence RK, Strauss RG, eds. Clinical practice of Transfusion Medicine. 3rd ed. New York: Churchill Livingstone: 1996.
- Shiraz Kareem. Manual of Blood Transfusion in Clinical Medicine.1st ed. All India Publishers and Distributors: 1992
- The Clinical use of Blood. WHO Blood Transfusion Safety Geneva 2003
- Harmning DM. Modern Blood Banking and Transfusion Practices. 3rd ed. Jaypee Brothers : 1998