Quality

Abstract

There is a thread of quality running through all sections of this publication. This is because the quality system in a blood transfusion service includes all aspects of transfusion practice; including the education, identification, screening and selection of blood donors; the actual collection of blood; the preparation of components; appropriate and accurate laboratory testing, including the storage and transportation of blood products; the identification and testing of recipients; and the documentation of all results. It also includes the selection, validation and maintenance of equipment used in these processes; the design and provision of a suitable working environment; and the appropriate storage and maintenance of laboratory and other records. A commonly quoted definition of quality is ‘fitness for purpose’. This is an appropriate definition to use in the blood transfusion service, where the main objective of the quality system is to ensure the transfusion of safe and effective blood and blood components, i.e. components that are fit for the purpose for which they are intended. The quality system should be designed to deliver a sufficient supply of blood and blood components with maximum efficacy and with minimum risk to donors and recipients alike, and to ensure that the components and services delivered meet expected requirements. Effective quality management is achieved by adopting good manufacturing practice (GMP), good laboratory practice (GLP) and good hospital and clinical practice. Personnel involved at any stage of the blood transfusion chain should be aware of the importance of quality management and their role in achieving it successfully. Good record keeping, the adherence to well-designed standard operating procedures and laboratory worksheets, and following well-conceived safety guidelines will further improve the quality of the work produced. By the end of this section the student should be able to describe the quality management system in a blood transfusion service, with the focus on the following elements: Quality management system organizational structure premises equipment and materials management of processes and procedures documentation and record keeping quality assurance and quality control management of non-conforming product or material waste management – overview monitoring and evaluation of the quality system process improvement ethical guidelines A quality management system may be defined as the set of policies and procedures for establishing and implementing the intentions of the organization with respect to quality. The factors that can affect the quality of the products and services delivered by the blood transfusion service are numerous, yet all must be taken into account in the development of the quality management system. They include the following: Equipment and reagents used in the various processes Personnel carrying out these processes Environment in which personnel work Environment to which blood products are exposed during testing, storage and transportation Methods, equipment and techniques used to carry out the numerous procedures. The management of each of these aspects is important if quality requirements are to be met. The principle elements of a quality management system include: Organizational structure Premises Equipment and materials Management of processes and procedures Documentation and record keeping Quality assurance and quality control Management of non-conforming product Waste management Monitoring and evaluation of the quality system Process improvement Ethical principles. The general elements constituting a good quality system are sometimes referred to as ‘good laboratory practice’ (GLP) or ‘good manufacturing practice’ (GMP) and these terms are often used when referring to overall quality within an organization. Figure 16·1 shows the elements of the quality system. Elements of the quality system. The blood transfusion service must be organized and structured in a way that will maximize the effective implementation of the quality system. Senior management, and in particular the individual in overall charge, such as the medical director or chief executive officer (CEO), are responsible for the design and implementation of the quality system. They are also responsible for documenting the organizational structure and defining the roles and responsibilities of each individual within the organization with respect to quality. Ideally this structure would include one individual, independent of all production activities, and reporting directly to the CEO or medical director, with the overall responsibility for the management of the quality system. In smaller organizations it may not be feasible to dedicate one individual to this function. In such cases, care should be taken to arrange the duties of the designated individual so that he/she has sufficient time to devote to the required quality activities. If this is not done, then quality may be the first aspect of the job to suffer should workload increase. The organizational structure is usually documented in the form of an organizational chart or organogram. This shows the reporting lines within the organization and suggests the following: Personnel should be available in sufficient numbers. Personnel should have the appropriate education and training to perform the tasks to which they are assigned. Job descriptions should be available for all personnel and should clearly define responsibilities with respect to quality as well as required qualifications and experience, general responsibilities and reporting relationships of the position. Figure 16·2 gives just one example of the many different ways in which a blood transfusion service could be set up, in terms of its organizational structure. Example of organizational chart for blood transfusion service. A concerted effort should be made to create a ‘quality consciousness’ within the organization, and to build an environment that encourages practices relating to quality. Although it may be difficult to achieve, having an environment where personnel have quality in the forefront of their thinking at all times is the most effective way of ensuring that the programme is successful. It costs the same, and takes very little time and effort to ensure that labels are fixed to blood bags in the correct places and at the correct angles; that photocopies are squarely positioned and clearly legible by being copied from the original and not from a fading copy, and so on. Yet it is these simple actions, which contribute to the quality consciousness. Accepting shoddy work in relatively minor items such as laboratory worksheets can very quickly become the norm and this should be discouraged. In the effort to build a quality organization, senior management should take the lead by formulating a policy statement that clearly states their total commitment to quality, and this statement should be displayed in all work areas. Senior management should also formulate a more detailed quality policy that includes a description of how the quality policy will be implemented within the organization, and also sets some of the guidelines for the ethical operation of the blood transfusion service. Many organizations have a separate ‘Code of Ethics’ in which the ethical principles by which they operate are clearly stated. Specific training on the quality management system should be provided for all personnel at all levels within the organization, at least once a year, and such training should be compulsory. For example, the CEO/medical director should be trained to support the system, as should junior personnel responsible for the transport of blood, waste management, handling of blood samples and other tasks that can have a profound effect on the quality of the final products and services. Ongoing awareness may be created by the use of posters with slogans such as: ‘Quality is everybody's responsibility, Quality starts with me.’ It is important that all personnel understand the quality system and acknowledge their role in delivering a quality product. The quality system, however well designed, is really only as good as those who implement it. It is the responsibility of the organization to provide a safe and healthy workplace for all employees, and also for visitors such as donors, patients and others. All premises, including laboratories, should be constructed and maintained in a way that suits the activities to be carried out. They must be designed to allow effective cleaning to minimize the risk of contamination and to provide a safe working environment. It is important to give consideration to the flow of work, arranging procedures in a logical sequence in order to reduce congestion and the risk of errors. Work areas should provide adequate space and be well lit, well ventilated, kept at a comfortable temperature, and be free of excessive noise. The provision of adequate water, toilet and washing facilities is, of course, essential. Procedures should be in place to address general safety, such as that relating to electrical hazards, fire safety and preparedness to deal with disasters. Laboratories may require that attention be paid to more specific issues such as biological safety, particularly with respect to blood-borne pathogens, chemical safety and possibly radiation safety, and the management of biohazardous waste. Entry to storage areas for blood and blood products should be limited and controlled, and these areas should be used only for their intended purpose. Conditions in these storage areas should be controlled and monitored. High and low temperature alarms, preferably both audible and visual, should be fitted and checked regularly to ensure that they are functioning correctly. Alarms should be set at temperatures that will alert personnel in sufficient time to carry out appropriate corrective action before the temperature of the products reaches an unacceptable level. Standard operating procedures (SOPs) should describe the action to be taken if the temperature should be out of the acceptable range. Equipment should be selected and validated to suit its intended purpose. Maintenance, cleaning and calibration should be performed regularly and recorded. SOPs should be written describing the correct use, cleaning and servicing of the equipment, and also describing the action to be taken when malfunctions or failures occur. Properly cleaned and maintained equipment should last longer and deliver more accurate results more reliably than equipment that is less cared for. Prior to being taken into routine use, reagents and other materials should be evaluated thoroughly to ensure that, under the particular conditions of the laboratory, they perform satisfactorily. Materials that could directly affect the quality or safety of products or services (critical materials) should be obtained only from approved suppliers. Certificates of compliance or certificates of analysis for each batch of materials should be requested from suppliers if appropriate. All new procedures and the equipment used in the procedure should be validated before being adopted for routine use. This validation should be carefully designed and carried out to ensure that the procedure is capable of reliably and consistently delivering expected results. Laboratories should have documented SOPs for all procedures that may affect the health or safety of donors and recipients of blood products and also personnel handling products or associated samples. Written procedures are essential to prevent errors that may arise from verbal instruction and to limit unintentional variation. SOPs should include an accurate description of each step in the method, taking into account any local constraints and limitations. Generally, the responsibility for the preparation and authorization of SOPs lies with the head of the work area in which the SOP is to be used. SOPs should also be approved by the quality manager and, when appropriate, by the medical director or CEO. It is important that SOPs are kept up-to-date and a procedure should be in place for the regular review (and revision if necessary) of each procedure, preferably by the management personnel with direct authority over the process. It is also good practice for an appropriate member of the quality department to provide input before the SOP is finalized. An important step before an SOP is finalized is validation of the process, i.e. carrying out the procedure exactly as documented to check that in doing so, the correct result is obtained. If this step is omitted the SOP is very likely to contain errors or steps that are not in the correct sequence. It is particularly important to validate procedures when it is difficult to inspect the finished product in order to confirm conformance with specifications, such as the procedures for the preparation of blood components. Process validation also provides an important opportunity to optimize the performance of each process, e.g. in establishing ideal centrifugation speeds and times in procedures for the preparation of blood products. When a procedure is changed, or when a major piece of equipment or a reagent that is used in the procedure is changed, it is necessary to revalidate the procedure to ensure that the change has not resulted in a degrading of the performance of the process. If the validation process shows that the procedure does not produce the expected result, the procedure should be corrected and this corrective action documented, after which the validation procedure should be repeated. When a procedure has been validated, finalized and released, personnel required to perform the procedure should be trained to the SOP and allowed to perform the procedure without supervision only when found to be competent to do so. The validation of computer systems is especially challenging. Computer systems are often critical components of the quality system, and are useful in the management of donor and laboratory records. They are useful for record keeping and in the analysis and interpretation of data. The use of bar-coded identification labels on blood units and their related samples, together with the use of barcode scanners to read these labels electronically, virtually eliminates transcription errors and provides a fast and accurate method for dealing with large numbers of samples in a busy work area. Most modern sample-handling equipment, such as automated pipetting systems and enzyme linked immunosorbent assay (ELISA) processors, have integrated barcode scanners and data management software to provide fast and accurate linkage of samples and results. It is very important that any computer system is properly evaluated and validated within the laboratory in which it is to be used to ensure that it is delivering the results and manipulating the data in the expected way. This is especially important when linking equipment or systems from different suppliers together as data are not always recorded or handled in the same way. For example, if data originating from an ELISA system are incorporated into the main database, care should be taken to ensure that the data are interpreted by the main database as expected, and that the results are assigned to the correct sample or donor records. All computer data should be backed-up in a systematic and organized way in order to provide a high level of assurance that data is not lost in the event of equipment failure. With all equipment it is not so much a question of if it will fail, but more a question of when it will fail, and a good back-up system will ensure that a minimum amount of data is lost when this happens. Back-up systems should be validated and tested regularly. If an automated system of testing or data management is used, it is important to have an alternative system, usually manual, that can be used in the event of the main system failing. This alternative system should be tested regularly to ensure that personnel know how to use it effectively and without increasing the risk of errors. The organization should ensure that the hardware, software and peripheral devices such as printers and barcode scanners function reliably and accurately in the environment in which they will be used. Validation should include verification of data capture and manipulation, security and safety. If the computer system is used in the final release of product, this feature should be thoroughly tested and challenged to ensure that under all conditions and when presented with any permutation of results, the system will respond as expected. For example, a system designed to prevent the labelling of blood units with a reactive marker for a transfusion transmissible infection (TTI) may work perfectly on the original whole blood unit, but may not prevent the labelling of processed or pooled units when the original pack identification number has been changed by the addition of a suffix or the assignment of a pool number. It is also important to establish that personnel who use the computer system are able to do so accurately and reliably in the context of their normal workload. Problems are often experienced with the entry of free text, such as names and phone numbers, where it is not practical for the computer to perform extensive checks that the data are entered correctly, but of course significant problems can arise when the data are retrieved, often months later, and found to be inaccurate. This can result in a great deal of frustration; a waste of time and effort in tracing the correct information, which could lead, for example, to the loss of contact with valuable donors. Also, attention should be paid to the operator's ability to respond to messages and warnings generated by the computer system, and not to accept whatever message is presented without due consideration of the implications. An operator may often be requested to confirm a procedural step such as ‘Please confirm the discard of RCC no. 123456’. If the ‘Confirm’ choice is selected without the information being properly checked, and it is later found that it was FFP no. 123456 (not RCC no. 123456) that should have been discarded, it may be extremely difficult to ‘undo’ the incorrect step. Worse still, if such an error is not detected, serious problems of traceability could result. Quality documentation should provide a framework for the effective communication of the quality management system throughout the organization, ensuring proper understanding and effective implementation at all levels. There should be policies and procedures in place that define clearly and unambiguously how various processes are intended to work, the relationships between them and how, and by whom, they are to be implemented. Written policies, SOPs or work instructions, laboratory worksheets and forms, records and labels are all important parts of the documentation system. SOPs, in particular, are often supported through the use of flowcharts that show, in a simplified way, the major steps in the procedure. Flowcharts are also very useful in the design of procedures and, if used correctly, will assist in highlighting ambiguities and missed steps in the procedure. It is common, for example, for an SOP to include a step such as ‘Check that the patient's details on the pack label and the blood requisition form correspond’ followed by the instruction to ‘Issue the unit’. The critical step that is omitted is what to do if the patient's details do not correspond. A carefully compiled flowchart will highlight this omission. Policies and procedures generally provide a description of what is intended. Records provide the evidence of what actually happened. Worksheets and forms must be designed to ensure that all essential information is recorded. Another important quality principle that may be used in the form of a poster ‘If it isn't written down, it didn't happen!’ In many quality systems, documentation is assigned to different ‘levels’ in order to accentuate the relationships between the various documents, and to emphasize the importance of each. Figure 16·3 shows the levels of documentation in a quality system. Policies are the highest-level documents that define overall quality policy. Procedures form the next level, documenting ‘how things will be carried out’. SOPs are the actual work instructions and records show that work was performed and results that were achieved. Levels of documentation. Accurate and complete records enable each step in a procedure to be traced, providing evidence that the procedure was carried out correctly. This is necessary for monitoring that SOPs are followed correctly and are producing the intended results in complex processes such as component preparation and laboratory testing. By examination of the laboratory and other records, it should be possible to trace the sequence of events from the collection of a unit of blood, through all the processes until it is issued, revealing who was responsible for each step and gaining the assurance that each step was properly controlled. This audit trail should allow for the traceability of each unit from the donor to the recipient or recipients. Accurate records can also help to identify possible sources of error, and enable appropriate corrective and preventive action to be taken to prevent a recurrence. When a donor presents at a collection centre, it is important that he/she is properly identified and that the results of the health check are accurately recorded at the time the checks are carried out. Even in a busy collection area, recording the results of these checks should never be deferred until personnel have more time, as this will increase the chances of errors. The records, even if reviewed years after the event, should clearly identify the donor as the donor of a particular unit, and should reveal all the information related to the donation, including the date, time and venue of the collection, the personnel involved in the evaluation and collection of blood from the donor, and the type and lot number of the blood pack used. In the laboratory, recording test results accurately and immediately the test is read is important to avoid errors, and to ensure that results are linked to the right sample. The results of tests performed manually should be recorded in a format that shows the results in a clear and understandable way, preferably on a standard laboratory worksheet, and both the observed laboratory result and the interpretation of the results should be recorded whenever applicable. When performing an ABO group on a red cell sample, for example, the results of the anti-A, anti-B and (if used) anti-A,B should be recorded as well as the group interpreted from those results. The identity of individuals performing the work together with the date and time it was carried out should also be recorded on the worksheet. It needs to be emphasized that technologists must record the results produced by the actual tests that they have carried out and must under no circumstances record ‘expected’ results. This is particularly important in a test such as an ABO group, where a particular pattern of results is expected for a particular blood group. Records of blood collections, including the records of health checks and the record of the donor's agreement (informed consent) to donate, and laboratory records, particularly the records of tests carried out on donors and recipients, should be filed and retained in a document archives for a period of time determined by the organization, but usually not less than 30 years. In view of this length of time and because many records are paper records, the archives area should be dry, dustproof, free of rodents and other harmful pests, and protected from fire. Access should be limited and procedures should be in place for the management of documents entering the archives and for the temporary retrieval of documents that may be required for reference purposes. If records are converted to any other medium, particularly to an electronic storage system such as one that stores scanned documents on optical disks, care must be taken to ensure that such records remain legible as technology changes over the storage time of records. Archiving systems should allow for the efficient retrieval of the documents within time frames established by the organization. These time frames should be determined by the urgency and frequency with which the information is likely to be required. The management of written policies and procedures is an important aspect of the quality system, and it is essential that all documentation is controlled in such a way that the documents are available where and when they are required. All older versions should be replaced with updated versions when documents are revised. The distribution of documents should allow time for personnel required to use the procedure to be familiarized with the changes before the changed procedure becomes effective. Document management systems should include at least the following: The verification and validation of the document before approval and release. A system for the regular review of documents that includes a record of changes made in the latest version and the revision status (i.e. an indication of whether this is the first version or a subsequent version of the document). Confirmation that all documents are distributed to those areas that may require them. A system to control the distribution and retrieval of documents that prevents the use of obsolete versions. Quality assurance (QA) is not linked directly to a the performance of a particular process, but deals more with the maintenance of a system to ensure that the overall performance is of the required quality, and to detect shifts or trends in the quality of products or services that may require attention. Quality control (QC) refers to a procedure that is carried out at the time a test is performed and that provides feedback to the blood collection or laboratory personnel about the state of the test. QC should be designed to test the materials, equipment and technique used in the procedure so that the individual carrying it out can determine that everything is as expected and the test result can be accepted. If something is not functioning or behaving as it should, the test result should be disregarded until the matter has been resolved. For example, when carrying out ABO groups, the anti-A, anti-B and anti-A,B should be tested against the appropriate cells of known ABO groups to check that the reagents are both sensitive and specific. Acceptable results for QC should be defined during the process validation, and should be available to personnel performing the procedure so that unacceptable results are immediately apparent to them. QC results should be recorded at the same time as test results whenever possible, although the frequency with which QC is performed will depend to some extent on the type of assay being carried out. For example, QC samples should be assayed with every batch of ELISA assays; IAT and DAT assays are controlled individually through the addition of sensitized cells; but it is probably sufficient under most circumstances to QC ABO test reagents only once a day as the nature of the procedure is such that any problems with the reagents are readily apparent. All QC should be carried out according to a defined plan and the results should be subject to periodic review. If QC results do not satisfy predefined criteria, the product or test results should not be released until the problem has been satisfactorily identified and resolved. A QA programme involves sampling techniques, specifications and testing, as well as organizational, documentation and release procedures that together ensure the satisfactory quality of the process. For example, the accuracy of any test on a blood sample can be assured by a quality programme that: Ensures accurate identification of the patient or donor Assesses the quality and suitability of the specimen for the assay to be carried out Documents the validity of the test method, equipment, and reagents Monitors the performance of the test method, equipment, reagents, and personnel Reviews test results and QC results for errors prior to release. An effective QA programme is dependent on a continuous process of assessment and improvement. It is also important that the performance of tests in the laboratories and blood collection areas be regularly assessed by participation in a formal system of proficiency testing or external quality assessment (EQA). EQA is a system whereby test performance is assessed by an outside agency. Usually a set of unknown samples is sent by the external agency to the laboratory or blood collection area for testing. When the tests have been carried out, the results are returned to the external agency and are compared with those of an approved reference laboratory, and often with other participants in the programme. In this way the laboratory or collection centre is assured of the accuracy (or otherwise!) of the results that are routinely released. If the feedback shows that the results are not within acceptable limits, the cause of the deviation should be established so that corrective action can be implemented immediately. The corrective action should be monitored carefully to ensure that the problem is effectively and reliably corrected. The quality system should include a procedure for dealing with products or services that do not conform to the documented requirements of the organization. This procedure should include the identification and handling of non-conforming products prior to release of the product as well as the response to reported adverse reactions to blood donation and to transfusion. It is important that personnel are trained to recognize and report such events promptly if t