|Year : 2020 | Volume
| Issue : 1 | Page : 9-16
Quality management or the need for a quality culture in transfusion medicine
Cees Th Smit Sibinga1, Farrukh Hasan2
1 IQM Consulting for International Development of Quality Management in Transfusion Medicine, Zuidhorn, Netherlands
2 National Hematology Centre and Blood Bank, Karachi, Pakistan
|Date of Submission||26-Dec-2019|
|Date of Decision||06-Feb-2020|
|Date of Acceptance||25-Feb-2020|
|Date of Web Publication||17-Apr-2020|
Cees Th Smit Sibinga
IQM Consulting for International Development of Quality Management in Transfusion Medicine, Zuidhorn
Source of Support: None, Conflict of Interest: None
With the development of safe blood supply and transfusion comes the introduction of managing quality as a culture. This is implemented through the introduction of a quality system (QS) and a related quality management system (QMS). In many situations in the world the idea is that when instructions are written (SOPs) a QS is in place; one just has to follow the instructions and “that is it, we're done”! However, quality does only partly depend on following instructions at the operational level. What is generally not understood is the importance of designing and implementing QS management as an institutional culture, based on the five key elements (1) organization and (infra) structure; (2) standards (technical and quality); (3) documentation to allow traceability and evidence; (4) education through continued teaching and training; (5) assessment through continued monitoring and evaluation. There are a number of QMSs available which can be applied to procurement and clinical use of blood. Some are “process”- and “operations-oriented” while others deal more with the management aspects, securing a quality environment and culture, necessary for consistency and reliability of the operational processes. The EU European Foundation for Quality Management and Canadian ISQua system are based on fundamental concepts of excellence. To achieve an optimal understanding of the values of quality in transfusion medicine, vein-to-vein, a culture has to be created through ownership development, and commitment to and implementation of the principles of fitness for purpose, the supplier-producer-customer continuum, and customer-orientation and satisfaction.
Keywords: European Foundation for Quality Management, excellence, quality culture, quality management, transfusion medicine
|How to cite this article:|
Smit Sibinga CT, Hasan F. Quality management or the need for a quality culture in transfusion medicine. Glob J Transfus Med 2020;5:9-16
|How to cite this URL:|
Smit Sibinga CT, Hasan F. Quality management or the need for a quality culture in transfusion medicine. Glob J Transfus Med [serial online] 2020 [cited 2020 Aug 11];5:9-16. Available from: http://www.gjtmonline.com/text.asp?2020/5/1/9/282750
| Introduction|| |
The practice of medicine, as with any other profession, should be based on evidence and well-defined criteria which relate to the benefit and safety of patients and the personnel involved, the principle adagio being the Hippocratic “primum est non nocere.” The criteria or the guidelines should not hamper the personal responsibility and accountability of the medical practitioner toward each and every patient. While too restrictive, regulatory criteria may have a negative effect on the quality of medical practice. However, it does not exclusively depend on the individual practitioner but intimately relates to: (1) the code of practice, (2) the specifically defined criteria and guidelines of practice or standards, their implementation, documentation, and audit. In any medical discipline, the responsibility to safeguard the quality and standard of practice, setting up and acceptance of a code of practice, updating of the criteria, standards, and guidelines in accordance with the state-of-the art and the ongoing developments as well as accountability, lies with the group of professionals in their specific field.
The field of transfusion medicine as a bridging science integrally deals with that part of the health-care system that undertakes the appropriate provision and use of human blood resources, whether whole blood, plasma, or cellular components. The group of professionals involved is explicitly multidisciplinary, including medicine, pharmacy, biochemistry, virology, and medical sociology. If we assume that transfusion practice is that collective action that links the community (donor) with the clinical bedside (patient), then it follows that transfusion medicine occupies those areas, in which it is deemed important or even essential that a specialized medical practitioner contributes to this bridging process. To avoid any misunderstanding, a defined and documented quality system (QS) management should be in place as the cader within which this multidisciplinary and bridging science is being practiced.
The aim of QS management in transfusion medicine is to provide and assure vein-to-vein safe and effective hemotherapy. Fundamental to the introduction and implementation of a QS management program, are definitions of the various concepts used.
The consistent and reliable performance of processes and procedures leading to products and services in conformity with specified standards, preferably national or international.
That part of a QS management program that consists of retrospective tests or measures that must be completed with satisfactory results or outcomes before proceeding further in a given process and that shows compliance with defined limits and specifications.
The creation and operation of standards, program, and effective management systems to ensure quality to be achieved by the application of current good manufacturing practices.
Good manufacturing practice
All (current) elements in an established practice, which collectively will lead to final products or services that consistentlymeet the expected standards and specifications.
Standards or references
The criteria against which outcomes of processes and procedures can be measured quantitatively and/or qualitatively.
Recommendations that as part of a QS management program are not binding or compulsory, but embody optimal approaches and considerations.
Document stating requirements.
Quality monitoring and evaluation
That documented part of the QS management program that is concerned with maintenance and improvement of quality. It deals with the identification and use of indicators to detect relevant variations from standards or specifications.
That part of the QS management program that evaluates in advance the steps involved in managerial and operational processes and procedures to ensure consistency (reproducibility) and quality, effectiveness, and reliability.
Errors or deviations
Inadvertent or unauthorized deviations from standard processes and/or procedures.
Total quality management
Management approach of an organization centered on quality, based on the participation of all members and aiming at long-term success through customer satisfaction and benefit to all members of the organization and to society.
Audit and inspection
The formal and objective review of managerial and operational processes and procedures according to the adopted standards within the QS management program to identify problems and approaches to their resolution and improvement.
These are regarded to be the most essential definitions in quality management, though there are more.
| Quality System Management|| |
There are a number of quality and quality management systems (QMSs) available, which can be applied to procurement and clinical use of blood. Some are “process-oriented” and “operations-oriented” while others deal more with the management aspects, securing a quality environment and culture, necessary for consistency and reliability of the operational processes. The most appropriate QS for a Blood Establishment is Good Manufacturing Practice (GMP) and for the Hospital, Good Hospital Practice (GHP). The prototype system was developed in the USA after the so-called Thalidomide affair. It was first published as part of the Food, Drug, and Cosmetics Act Amendments in 1962, and was implemented for the manufacture of human drugs in 1963. The U. S. Congress amended the Biologics Act in 1970 to include blood and blood components or derivatives, and in 1975, FDA published GMP regulations for the collection, processing, and storage of human blood and blood components. It took some time to establish the first GMP rules in Europe, and since 1992 there is the EU Directive about the “GMP for Proprietary Medicinal Products for Human and Veterinary Use.” Blood products have a therapeutic purpose and should, therefore, be considered to be produced in accordance with pharmaceutical principles. The reason being that, in many cases, a regulatory framework for biologics, came into existence after regulations for pharmaceuticals, approaching GMP rules, requires an understanding of the similarities and differences between blood products and pharmaceuticals. The procurement of an active starting material whole blood, which is living tissue – is completely different from the purchasing of active ingredients of medicinal products. Human blood or plasma is collected under aseptic conditions and these have to be guaranteed also, during processing. The batch size of blood components is limited to each whole blood donation and the production of a few blood components thereof. In the pharmaceutical industry, the starting materials are raw and need to be processed into aseptic or sterile finished products through usually large batch sizes.
To manage such “operations-oriented” QS, there are several approaches, such as the ISO 9001 series, and the European Foundation for Quality Management (EFQM), both of which in their current version, are explicitly customer-oriented, leading to total quality management.
| The Concept of Excellence|| |
The EFQM [Figure 1] and Canadian ISQua systems is based on fundamental concepts of excellence.
|Figure 1: EFQM quality management scheme. Quality processes (centre) depend on leadership (left) steering policy and strategy, people (human resource) and partnerships and resources. Quality processes lead to key performance results (right) through customer results (satisfaction), people results (competent and satisfied human resource) and society results (embedding and full acceptance)|
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The current EFQM Model structure [Figure 2] is based on the simple but powerful logic of asking three questions:
- “Why” does this organization exist? What purpose does it fulfill? Why this particular Strategy (direction)?
- “How” does it intend to deliver its Purpose and Strategy (execution)?
- ”What” has it actually done, to date? 'What' does it intend to achieve tomorrow (results)?
- Achieving results as desired, that delights all the organization's stakeholders (result oriented)
In the fast-changing environment of today's world, excellent organizations are agile, flexible, and responsive to stakeholder's needs and expectations, often frequently. Excellent organizations measure and anticipate the needs and expectations of their stakeholders, monitor their experiences and perceptions, and at the same time, review the performance of other organizations. Information is gathered from both current and future stakeholders. This information is used to set, implement, and review their policies, strategies, objectives, targets, measures, and plans for short, medium, and long term. The information gathered also helps the organization to develop and achieve a balanced set of stakeholder results.
• Creating sustainable customer value (customer focus)
Excellent organizations know and intimately understand their customers. They understand that customers are the final arbiters of product and service quality. They also understand that customer loyalty, retention, and market share gain is maximized through a clear focus on the needs and expectations of both existing and potential customers hence are responsive to their present needs and expectations. Where appropriate they segment their customers to improve the effectiveness of their response, monitor competitor activity, and understand their competitive advantage. They effectively anticipate the customer's future needs and expectations and act immediately to meet and where possible to exceed them. They monitor and review the experiences and perceptions of their customers and where things go wrong they respond quickly and effectively. They build and maintain excellent relationships with all their customers.
• Visionary and inspirational leadership, coupled with the constancy of purpose (leadership and consistency of purpose)
Excellent organizations have leaders who set and communicate a clear direction for their organization. In doing so, they unite and motivate other leaders to inspire their people. They establish values, ethics, culture, and a governance structure for the organization that provides a unique identity and attractiveness to stakeholders. Leaders at all levels within these organizations constantly drive and inspire others toward excellence and display both role model behavior and performance, by example, recognizing their stakeholders and working with them on joint improvement activities. During times of turbulence, they display a constancy of purpose and steadiness that inspires confidence and commitment with their stakeholders. At the same time, they demonstrate the capability to adapt and realign the direction of their organization in the light of a fast-moving and constantly changing external environment, and in so doing, carry their people with them.
• Managing the organization through a set of independent and interrelated systems, processes and facts (management by processes and facts)
Excellent organizations have an effective management system based upon and designed to deliver, the needs and expectations of all stakeholders. The systematic implementation of policies, strategies, objectives, and plans of the organization are enabled and assured through a clear and integrated set of processes. These processes are effectively deployed, managed, and improved on a day-to-day basis. Decisions are based on factually reliable information relating to current and projected performance, process and systems capability, stakeholder needs, expectations and experiences, and the performance of other organizations, including, where appropriate, that of competitors. Risks are identified based on sound performance measures and effectively managed. The organization is governed in a highly professional manner, meeting and exceeding all corporate external requirements. Appropriate preventive measures are identified and implemented, inspiring, and maintaining high levels of confidence with stakeholders.
• Maximizing the contribution of employees through their development and involvement (people development and involvement)
Excellent organizations identify and understand the competencies required, both at present and in future, to implement the policies, strategies, objectives, and plans of the organization. They recruit and develop their people to match these competencies and actively and positively support them throughout. Personal development is promoted and supported, allowing people to realize and unleash their full potential. They prepare people to meet and adapt to the changes required of them both in terms of operational changes and personal capabilities.
They recognize the increasing importance of the intellectual capital of their people and use their knowledge for the benefit of the organization. They seek to recognize, care, and reward their people in a way that would build their commitment and encourage their loyalty toward the organization. They maximize the potential and the active involvement of their people through shared values and a culture of trust, openness, and empowerment. They utilize this involvement to generate and implement ideas for improvement.
• Challenging the status quo and effecting change by utilizing learning to create innovation and improvement opportunities (continuous learning, innovation, and improvement)
Excellent organizations continuously learn, both from their own activities and performance and from those of others. They rigorously benchmark, both internally and externally. They capture and share the knowledge of their people to maximize learning across and within the organization. There is an openness to accept and use ideas from all stakeholders. People are encouraged to look beyond today and present capabilities. They are careful to guard their intellectual property and to exploit it for commercial gain, where appropriate. Their people constantly challenge the status quo and seek opportunities for continuous innovation and improvement that add value.
• Developing and maintaining value-adding partnerships (partnership, coordination, and collaborative development)
Excellent organizations recognize that in today's constantly changing and increasingly demanding world, success may depend on the partnership that they develop. They seek out and build partnerships with other organizations that enable them to deliver enhanced value to their stakeholders through optimized core competencies. These partnerships may be with customers, society, suppliers, or even competitors and are based on clearly identified mutual benefit. Partners work together to achieve shared goals, supporting one another with expertise, resources, and knowledge and build a sustainable relationship based on mutual trust, respect, and openness.
• Exceeding the minimum regulatory framework, in which the organization operates and striving to understand and respond to the expectations of their stakeholders in society (corporate social responsibility).
Excellent organizations adopt a highly ethical approach of being transparent and accountable to their stakeholders for their performance as a responsible organization. They give consideration to and actively promote social responsibility and ecological sustainability both at present and in future. The organization's Corporate Social Responsibility is expressed in its values and integration within the organization. Through open and inclusive stakeholder engagement, they meet and exceed the expectations and regulations of the local and where appropriate, the global community. By managing risks, they seek out and promote opportunities to work on mutually beneficial projects with society inspiring and maintaining high levels of confidence with stakeholders. They are aware of the organization's impact, both on the present and future community and take utmost care to minimize any adverse impact.
The nine model criteria of excellence
Excellent leaders further develop and facilitate the achievement of the mission and vision. They promote organizational values and systems required for sustainable success and implement them through their actions and behaviors. During periods of change, they retain a constancy of purpose. Such leaders are able to change the direction of the organization and are an inspiration for others.
- Leaders develop the mission, vision, values, and ethics and are role models of a culture of excellence
- Leaders are personally involved in ensuring the organization's management system is developed, implemented and continuously improved
- Leaders interact with customers, partners, and representatives of the society
- Leaders reinforce the culture of excellence with the organization's people
- Leaders identify and champion organizational change.
Policy and strategy
Excellent organizations implement their mission and vision by developing a stakeholder focused strategy that takes account of the market and sector in which it operates. Policies, plans, objectives, and processes are developed and deployed to deliver the strategy.
- Policy and strategy are based on the present and future needs and expectations of stakeholders
- Policy and strategy are based on information from performance measurement, research, learning, and external related activities
- Policy and strategy are developed, reviewed, and updated
- Policy and strategy are communicated and deployed through a framework of key processes.
Excellent organizations manage, develop, and release the full potential of their people at an individual, team-based, and organizational level. They promote fairness and equality and involve and empower their people. They care for, communicate, reward, and recognize in a way that motivates staff and builds commitment to utilizing their skills and knowledge for the benefit of the organization.
- People resources are planned, managed, and improved
- People's knowledge and competencies are identified, developed, and sustained
- People are involved and empowered
- People and the organization have a dialogue
- People are rewarded, recognized, and cared for.
Partnership, coordination, collaboration, and resources
Excellent organizations plan and manage external partnerships, suppliers, and internal resources to support policy and strategy and the effective operation of processes. During the planning and while managing partnerships and resources, they balance the current and future needs of the organization, the community, and the environment.
- External partnerships are managed
- Coordination and collaboration are managed
- Finances are managed
- Buildings, equipment, and materials are managed
- Technology is managed
- Information and knowledge are managed
- Communication is managed.
Excellent organizations design, manage, and improve processes to fully satisfy and generate increasing value for customers and other stakeholders.
- Processes are systematically designed, documented, and managed
- Processes are improved, according to requirements, using innovation to fully satisfy and generate increasing value for customers and other stakeholders – change management.
Products and services are developed based on customer needs and expectations.
- Products and services are produced, delivered, and serviced
- Customer relationships are managed and enhanced.
The above five are fundamental for the achievement of satisfactory results or outcomes.
Excellent organizations comprehensively measure and achieve outstanding results with respect to their customer satisfaction.
- Perception measures
- Performance indicators.
People/human resource results
Excellent organizations comprehensively measure and achieve outstanding results with respect to their people.
- Perception measures
- Performance indicators.
Excellent organizations comprehensively measure and achieve outstanding results with respect to society (environment).
- Perception measures
- Performance indicators.
Key performance results
Excellent organizations comprehensively measure and achieve outstanding results with respect to the key elements of their policy and strategy.
- Perception measures
- Performance indicators.
| the Five Stages of Development in Quality Management|| |
The five stages of development mentioned are
Activity or product oriented
Each and every employee strives to do his work optimally. Craftsmanship is highly appreciated and supported by education and training. In case of any complaint, the organization shall try to correct it. The focus is on the product as an outcome without really observing the need for input and the process leading to the product as an output.
The production or primary process is controlled. The mutual dependence of the successive steps or procedures is getting clear. The single process steps from input to output are identified; tasks and responsibilities are laid down. Achievement indicators serve as guidance. Processes are improved based on noticed nonconformances.
Improvement of the total organization is a matter of all levels. The Deming Cycle (Plan, Do, Check, Act) is applied to primary, supporting, and guiding processes. The supplier-customer principle is built on and focused on satisfaction and the complaints are dominant for the policy that is focused to prevent problems rather than to correction.
The organization strives together with partners in the production chain to maximize the additive value. The organization is embedded in its environment and has developed a continuous interaction in a question and answer principle.
Recognized for excellence or total quality management
In its market segment, the organization is on top. The process of continuous improvement is anchored in the organizational structure and culture. Based on long-term vision, changes are implemented in time to start new activities and to prepare the organization which is customer oriented and has become a major partner in its environment.
| Self Assessment|| |
To advance from activity or operation orientation to Recognized for Excellence self-assessment is required from time to time. For this purpose, EFQM has developed a special system of assessment. For the first five of the nine criteria, it must be determined how of the five stages the various subranges can be classified [Table 1].
The average stage is plotted in a “spider net.” For the last four criteria (customer result, people/human resource result, society/environment result, and key performance results) matrices are developed to calculate the score of these criteria, enabling bench-marking over time, and between organizations.
This example [Figure 3] illustrates in the five sections a progress tracking of a specific 5S progress system for cleaning (Sort, Set in Order, Shine, Standardize and Sustain) where the sections B, D, and E are weak points that need improvement.
The average stages and scores can also be plotted, as in [Table 2].
| Directions for the Future|| |
Recent developments in QMS paradigms have placed an increased emphasis on standardized documentation that allows continuous traceability and standardized procedures and a focus on customer satisfaction.
There has been a shift toward focusing on customer satisfaction and relationships, and this will likely continue to develop and mature. An example can be found in the ISQua approach to quality management for blood establishments and patient blood management programs. Within the EU, much attention is being given to inter-country harmonization and standardized approaches in both the procurement (EUBis) and clinical transfusion practice (EUBUP) in addition to attempts through DOMAINE to harmonize donor management. However, the continued use of terminology that may be perceived as aggressive, terms like “recruitment,” “donor camps” and the like, stemming from a period of enduring shortages and lack of public awareness, are still used. This may demonstrate a poor understanding of the perceptions of the public. In the age of social marketing, it is easy to imagine that blood collection establishments should be able to present a more collaborative and customer-friendly image where potential donors see themselves as critical partners in patient care rather than suppliers of raw biological materials (despite the attitudes of some regulatory bodies on this point). The key in social marketing for blood donation is in motivation and the retention thereof. The culture and related attitude might change from the demanding and finger-pointing “I NEED YOU” into a partnering through a supporting and offering – “IF YOU NEED US, HERE WE ARE.”
These developments are part of an ongoing process of refinement and review. The current emphasis is on the promising though challenging development of comprehensive bio-vigilance and patient blood management, placing the patient in the center of the transfusion medicine universe. However, the application of QMSs to transfusion medicine is limited by the growing gap between the advanced and developing parts of the world. This gap is largely due to differences in cultures, and the knowledge and skills available to the establishment. Increasing reliance on technology can create barriers to promoting a culture of quality that views human skills and intelligence as fundamental building blocks that are supported by the appropriate tools and systems. With the “touch screen and push-button” culture that increasingly is replacing human awareness and understanding, the intellectual understanding of what a process and related procedures mean, or their purpose and intent of performance, and their place in an intelligent production chain from input into the output can all be lost. This phenomenon already has led to a decline in the basic understanding of physiologic and pathophysiologic processes of human blood and its elements to be used for clinical use.
Building a culture of quality may, therefore, require building human capacity and should be viewed as a high priority. Quality is a multifaceted phenomenon with the sky as a limit. The potential for a culture of quality is universally present, but the deployment of QMSs remains to be realized. In many instances, quality is not discovered, not observed, not identified, not applied, and above all not entirely owned by the transfusion world to the extent needed to achieve real excellence – total quality management.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Smit Sibinga CT, Abdella YE. Review - Transfusion medicine - A bridging science. Intern Med Rev 2018;4:1-30.
Report of the WHO Global Blood Safety Initiative (GBSI) Informal Consultation on “Collaboration in Training in Transfusion Medicine”, Geneva, CH; 23-27 September 1991.
Smit Sibinga CT, editor. Annex 3 – Quality Terminology. In: Quality Management in Transfusion Medicine. New York, USA: Nova Sciences Publishers Inc.; 2013. p. 466-500.
Smit Sibinga CT, Seidl C, Nunes E, AuBuchon JP. Quality and quality management systems applicable in transfusion medicine. In: Smit Sibinga CT, editor. Quality Management in Transfusion Medicine. New York, USA: Nova Sciences Publishers Inc.; 2013. p. 55-130.
Hutt PB, Merrill RA, Grossman LA. Food and Drug Law. 3rd
ed. New York, USA: Foundation Press; 2007. p. 918, 924.
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use. Official Journal of the European Union, L193; 1991. p. 30-3.
Quality Management Systems – Requirements ISO 9001:2015. Brussels, BE: CEN European Committee for Standardization; 2015.
Smit Sibinga CT, Seidl C, Nunes E, AuBuchon JP. Quality and quality management systems applicable in transfusion medicine. 2.3 ISQua. In: Smit Sibinga CT, editor. Quality Management in Transfusion Medicine. New York, USA: Nova Sciences Publishers Inc.; 2013. p. 73-6.
de Kort W, Veldhuizen I. Donor Management Manual, 2010.ISBN 978-90-815585-1-8 DOMAINE project Nijmegen, NL. Available from: http://www.domaine-europe.eu/
. [Last retrieved on 2012 Jun 07].
Los APM, Mutegombwa S, Kit CL. Quality management at the societal interface. In: Smit Sibinga CT, editor. Quality Management in Transfusion Medicine. New York, USA: Nova Sciences Publishers Inc.; 2013. p. 315-55.
Murphy MF, Saxena S, Smit Sibinga CT. Patient safety and quality management. In: Smit Sibinga CT, editor. Quality Management in Transfusion Medicine. New York, USA: Nova Sciences Publishers Inc.; 2013. p. 283-312.
[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]