SEARCH

SEARCH BY CITATION

Keywords:

  • haemovigilance;
  • quality management;
  • quality systems

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Quality principles
  5. Quality systems
  6. Haemovigilance
  7. Quality assurance and quality control
  8. Suggested reading
  9. Disclosures

Quality systems and principles are essential aspects of high quality clinical transfusion laboratory practice. Many frameworks provide the structure for quality systems, some of which are specific to transfusion laboratory practices such as codes of practice and others are more general including ISO9001 and ISO15189. All these systems follow the same core principles incorporating quality assurance activities, quality control and continual quality improvement processes. The application of quality principles may be divided into five categories: processes, people, material, equipment and management. Specifically these categories must encompass laboratory procedures and analysis, storage and transportation of blood products, documentation of all results, selection, validation and maintenance of equipment used in these processes; the design and provision of a suitable working environment, appropriate storage and maintenance of laboratory and other records, internal and external audits and quality control. Personnel involved at any stage of clinical transfusion laboratory practice should be aware of the importance of quality principles, quality systems and quality management and their role. The strict adherence to well designed standard operating procedures and following definitive safety guidelines further enhances quality systems. Together, application of these principles ensures that all products, processes and facilities meet the required standards and specifications. If quality principles are not applied and errors are not addressed, then the consequences can be far reaching.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Quality principles
  5. Quality systems
  6. Haemovigilance
  7. Quality assurance and quality control
  8. Suggested reading
  9. Disclosures

Quality systems and principles are essential aspects of high quality clinical transfusion laboratory practice ensuring consistent and reliable performance of services or provision of blood or blood products in conformity with specified standards. The approach used to ensure that patients receive the highest quality transfusion therapy has been described as a “Vein to Vein” process covering all aspects of donor and recipient procedures incorporating and addressing aspects of a quality system. In many cases the quality systems applied to blood collection services and in clinical practice have been separate to those in clinical (hospital) transfusion laboratory practice. The difficulty has been to bring the three together.

Now the emphasis has widened to include developments in systems thinking and management systems. Application of Quality Management (QM) is now much broader. While it includes quality planning, as well as Quality Control (QC) and Quality Assurance (QA), it also includes Quality Improvement (QI) and extends beyond just QA and QC to a systems approach looking at the quality management system as a whole (Fig. 1). The systems approach considers the various elements of the entire system which comprises five main components:

image

Figure 1.  Total quality management system and levels of quality.

Download figure to PowerPoint

  •  the system as a whole and its processes
  •  management responsibilities
  •  management of resources
  •  management of the service and
  •  management of measurement, analysis and improvement.

Application of these systematic elements sets the standards for analysis, patient identification and preparation, collection, transportation, storage, processing and examination of patient samples. From the clinical transfusion laboratory perspective safe blood transfusion requires a correct and appropriate transfusion request, donor and patient identification, sample collection and labelling, laboratory activities, patient and component identification and infusion and is reliant on well developed quality systems. In short the right blood for the right patient for the right reason. Therefore the responsibility for implementing and maintaining these quality systems must be seen as an organisation wide responsibility.

Quality principles

  1. Top of page
  2. Abstract
  3. Introduction
  4. Quality principles
  5. Quality systems
  6. Haemovigilance
  7. Quality assurance and quality control
  8. Suggested reading
  9. Disclosures

The terms Quality Control (QC) and Quality Assurance (QA) are often used synonymously, however each has its own purpose and specific application. Quality can be seen as a hierarchical structure (Fig. 1) with Total Quality Management (TQM) at the apex and at the base, QC. Quality management (QM) includes all the management activities required to achieve the quality objectives whereas Quality Systems (QS) and QA integrate QC and QA into a co-ordinated documented process that meets pre-defined regulations through a planned and systematic approach.

Quality management ensures that laboratory practices are consistent at the required level of performance building in quality assurance at every stage of a process and not relying on an end point check to verify performance acceptability. Implementation of total quality management is dependent on well trained staff, an organised and well managed laboratory, validated and well maintained equipment, quality systems, documentation, safe procedures and reliable, quality reagents.

Regular assessments or routine audits of the quality management system will help identify practices that are no longer effective or could be improved through the use of new technology or procedures.

The key principles of QM include:

  •  organisation and a quality management system
  •  clearly defined processes/procedures for
  • o
     pre-examination prerequisites
  • o
     examination requirements and
  • o
     post examination requirements

Quality systems

  1. Top of page
  2. Abstract
  3. Introduction
  4. Quality principles
  5. Quality systems
  6. Haemovigilance
  7. Quality assurance and quality control
  8. Suggested reading
  9. Disclosures

Therefore as part of the quality system transfusion safety depends on recruitment, selection and retention of healthy donors, good manufacturing practices in blood collection, processing, labelling, storage and release, suitability and quality of all related reagents, equipment, test kits and adverse event monitoring of both donors and patients (Table 1).

Table 1.   Elements of vein to vein donor, laboratory and patient quality system requirements
DonorLaboratoryPatient
Donor selection criteriaPatient testingPatient identification
PhlebotomyReagentsSpecimen collection
Donor testingSpecimen handlingTransfusion triggers
Inventory managementInventory managementEvidence based orders
TransportationTransportationInfusion protocols
ProcessingAppropriate product selectionMassive transfusion protocols
Component productionCompatibility testing 
StorageAdverse event reporting 
Distribution  
Haemovigilance

The role of quality systems in clinical transfusion laboratory practice is becoming more formalised through the need to comply with an increasingly growing regulatory framework of regulations and legal requirements, some of which are specific to transfusion laboratory practices such as codes of practice, and others which are more general including ISO15189:2007 Medical laboratories – particular requirements for quality and competence and ISO9001. ISO15189:2007 specifies requirements for quality and competence particular to medical laboratories and requires laboratories to establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the standard. Also ISO15189:2007 is for use by accreditation bodies in confirming or recognising the competence of medical laboratories. Therefore a laboratory or clinical Quality System must identify its:

  •  responsibilities
  •  required documentation
  •  required resources

and be controlled by a Quality Manual which is a statement of intent defining:

  •  management responsibilities
  •  control of purchasing
  •  documentation including standard operating procedures
  •  document control policy which defines
    • o
       unique identification
    • o
       document history and validity
    • o
       document review history
  •  equipment maintenance and calibration
  •  product monitoring, handling, storage and traceability
  •  records
  •  staff training and competency maintenance

All of these systems follow the same core principles incorporating quality assurance activities, quality control, continual quality improvement processes and regulatory functions. Within these schemes there is considerable emphasis on processes, people, material, equipment and management guidelines, standard operating procedures, internal and external audits and haemovigilance. Particularly, the quality system encompasses the organisational structure, staff responsibilities and competencies, procedures, activities, capabilities and outcomes that together aim to ensure that products, processes and services will meet requirements and specifications.

Specifically these categories must encompass

  •  laboratory procedures and analysis
  •  storage and transportation of blood products
  •  documentation of all results
  •  selection, validation and maintenance of equipment used in these processes
  •  the design and provision of a suitable working environment
  •  appropriate storage and maintenance of laboratory and other records
  •  internal and external audits and
  •  quality control

Haemovigilance

  1. Top of page
  2. Abstract
  3. Introduction
  4. Quality principles
  5. Quality systems
  6. Haemovigilance
  7. Quality assurance and quality control
  8. Suggested reading
  9. Disclosures

Beyond assuring established standards, regulatory policy-making for blood safety is needed to address emerging threats (e.g. from new infectious agents), to consider the risks and benefits of new products and technologies, and to capture and respond to adverse event data. In this setting haemovigilance has a role and must be seen as an integral part of the quality system within the blood transfusion process. Haemovigilance is a set of surveillance procedures covering the whole transfusion chain, including the collection of donor blood and its components and their testing, pre-transfusion testing of patient’s samples, transfusion and the follow-up of the recipient, that are intended to collect and assess information on unexpected or undesirable effects and to prevent their occurrence or recurrence.

Haemovigilance serves a number of objectives of which the primary one should be to improve patient safety, through feedback and education to enable system improvement. As a quality surveillance system focused on improvement of processes, procedures, and practices and on prevention of recurrence of adverse events, haemovigilance can be effective only if there is a comprehensive and well managed quality system in place.

For example, the safety measures that are proposed to stimulate blood saving strategies will have to be taken into account along with surveillance of appropriate or optimal blood use through collection of data within the system. Reports from haemovigilance programs have identified non-infectious hazards as the leading cause of transfusion-related mortality and serious morbidity in many countries. These are often preventable events, frequently related to clerical errors in patient identification and sample handling, and other problems related to the environment in which the transfusion is occurring. Avoidance of unnecessary transfusions, appropriate management and review of adverse events can improve outcomes for patients and reduce risks. Haemovigilance data can be used to place the risks of transfusion in perspective for clinical staff, transfusion laboratories and the public, to inform policy, and to show that action is being taken to minimise risk. All hospitals and transfusion laboratories should accumulate their own haemovigilance data as part of their quality system. This will allow meaningful analysis and identification of trends and patterns which can be used as part their continual quality improvement program.

Quality assurance and quality control

  1. Top of page
  2. Abstract
  3. Introduction
  4. Quality principles
  5. Quality systems
  6. Haemovigilance
  7. Quality assurance and quality control
  8. Suggested reading
  9. Disclosures

Quality Assurance and Quality Control are often thought of as interchangeable terms which is incorrect. QC is the most basic level of quality (Table 1) and commences with activities whose purpose is to control the quality of products or services by detecting problems and defects.

QC can take many forms including process and product control, individual staff assessment, equipment monitoring and reagent control. These activities can be readily incorporated into testing processes to verify that the end results are acceptable. At its simplest, QC involves inspecting; testing or checking services or products to make sure they are satisfactory. The intent is to identify non-conformances and either correct or eliminate them, or to ensure they conform to the required specifications, and perform as required. Therefore QC can be defined as a procedure or set of procedures intended to control the testing environment to ensure that products, processes and performed services meet stated quality requirements and specifications and those tests are reproducible, accurate and sensitive. In these circumstances the controls provide assurance that the run/assay/test has performed as per specification and the test results may be accepted as valid.

Incorporation of QC activities in transfusion laboratory practice is relatively easy to manage and monitor and is able to be incorporated into 100% of tests or test batches. Quality control of reagents must be a regular part of clinical transfusion laboratory practice and should encompass tests for avidity, specificity and sensitivity. Reagent QC should challenge the limitations of the reagent and always include controls that give both weak positive reactions and negative reactions to demonstrate appropriate sensitivity and specificity. With the advent of column technology there is little or no manipulation of the reagents or their volumes however checking of the quality of the reagents is still required. The challenge is with the introduction of automation into laboratories and how we QC the results output.

QC activities for blood product production processes on the other hand are more complex, as unlike testing activities, not all products can be QC tested prior to release to verify compliance with relevant specifications or standards. The blood product is tested at the collection centre but there is little or no way to measure the product immediately prior to infusion (ie are the platelets still physiologically active).

Overall, QC is a useful monitor or indicator of process or test performance but cannot be solely relied on to provide assurance. Any problems identified by QC failure should result in a full investigation of the processes to determine all possible causes. All potential causes (direct or indirect) should be reviewed as part of the corrective action for a non-conformance, including those that are obvious and those that may not be immediately apparent. Therefore QC data should be used to monitor medium and long-term trends, performance and compliance which may lead to corrective actions being taken as part of overall continual quality improvement.

Quality Assurance developed from the realisation that quality could be improved by looking at all processes and is aimed at preventing non-conformities or defects. The management, monitoring, reviewing and control of the entire process including all steps of the transfusion process from the decision to transfuse, specimen collection, laboratory testing through to the final outcome of the transfusion contributes to overall Quality Assurance.

QA still has QC at its core to control the quality of service/product, but it goes beyond testing or inspection to also consider related activities or processes (such as training, document control and audits) that may be resulting in defects in any part of the system. QC could be seen as undertaking periodic checks on a procedure to see if they are within specifications, whereas QA would aim to make sure that the procedures and processes work properly and that all staff are trained and aware of the need to follow standard operating procedures.

Examples of QA include establishment of document control, training programs, management of equipment and participation in external and internal quality assurance programs. QA is concerned with implementing systems designed specifically to prevent the chance of problems occurring in the first place (as compared with QC which relies on detecting any problems after they occur). Effective QA should involve:

  •  an external quality assurance program to allow performance to be compared to other external laboratories
  •  an internal QA system
  •  change control processes for methods, equipment, reagents and staff

The incorporation of QA activities provides added confidence that systems are in control and are designed and managed to minimise errors.

Good control of processes provides better control of laboratory processes and leads to standardised procedures. Process control includes all the resources and activities that convert an input to an output and thus managing a process should address all the interrelated activities, inputs, outputs and resources. Written and approved policies, processes and procedures must exist for all critical functions performed and must be carried out under controlled conditions. Areas that must be considered include:

  •  personnel
  •  equipment
  •  materials and reagents
  •  methods (documents and records)
  •  environment
  •  evaluation

The quality system should describe how to monitor and evaluate laboratory processes. To implement any new technology, test protocols or reagents the change must be managed stringently with formal validation, verification and acceptance plans to verify that performance is as expected and to confirm suitability for their intended use. Similarly it is important that regular checks are performed on critical pieces of equipment such as automated equipment, pipettes and temperature monitoring equipment. Failure of testing must result in removal of that piece of equipment from routine use, minor changes may be managed less formally and reviewed at audit for compliance.

A further significant component of any quality system is continual quality improvement which encompasses the processes the laboratory or organisation uses to continually assess what practices it does and how to identify ways in which they can be improved. Laboratories must learn from errors and develop solutions to reduce errors such as the use of technology and training. Formalised feedback mechanisms may be utilised and include internal and external audits and non-conformance reporting systems. Audits can be internal or external, following local or national guidelines and include evaluation of process outputs, the activities that make up a process or a group of related processes and outputs.

Non-conformities identified at audit or by self reporting must be formally reviewed. Any deficiencies are highlighted through investigation including a root cause analysis and corrective actions implemented. The systematic review or investigation and subsequent application of preventative measures are then aimed at improving the process making it more effective. In effect, continual quality improvement should be seen as a plan, do, check and act cycle where planning analyses the problem and determines the course of action; doing leads to implementation of the planned activities; checking ensures review of the effectiveness of the action taken and acting leads to changes in ineffective plans.

Personnel involved at any stage of clinical transfusion laboratory practice should be aware of the importance of quality principles, quality systems and quality management and their role. Adherence to well designed standard operating procedures and following definitive safety guidelines further improves the quality of the work produced. Together application of these principles ensures that all products, processes and facilities meet requirements and specifications. If quality principles are not applied and errors are not addressed, then the consequences can be far reaching.

Suggested reading

  1. Top of page
  2. Abstract
  3. Introduction
  4. Quality principles
  5. Quality systems
  6. Haemovigilance
  7. Quality assurance and quality control
  8. Suggested reading
  9. Disclosures
  •  ISO 15189:2007 Medical laboratories - Particular requirements for quality and competence.
  •  AS/NZS 9001:2008 Quality Management Systems - requirements
  • http://www.shotuk.org– SHOT Annual Reports.
  •  Recommendations for evaluation, validation and implementation of new techniques for blood grouping, antibody screening and crossmatching. Transfusion Medicine 1995; 5: 145–150.
  •  ISBT Guidelines for Validation of Automated Systems in Blood Establishments. ISBT Science Series 2010; 98 (Suppl 1): 1–19
  •  Roback, J, Combs, M, Grossman, B, Hillyer, C, ed.; Technical Manual, 16th edn. AABB, Bethesda, USA, 2008.