Change Delayed is Change Denied: The Challenge of Patient Blood Management Implementation

See Article, page 950, 956, 964, and 975 The World Health Organization’s (WHO) 2021 patient blood management (PBM) Policy Brief and 2025 Guidance on implementing patient blood management to improve global blood health status point to “evidence, economics, and ethics” as compelling drivers of PBM and emphasize that there is an urgent need for global implementation at all levels of health care.1–3 It is, indeed, time to translate the vision of PBM into transformation of how we approach anemia, bleeding and blood loss, coagulation disorders, and the blood health of our patients and our communities. The themed issue of Anesthesia & Analgesia in September 2022 demonstrated clearly that our collective information has changed.4,5 Our challenge now is, what do we do in response? As the renowned economist John Maynard Keynes is often quoted as saying, “When my information changes, I alter my conclusions. What do you do sir?” Real change is no small task. The history of change in medical practice demonstrates the challenge is formidable, and the timeline, unfortunately, often painfully long. The extended lag times in health research translation are well documented, as are concerns regarding the lengthy delays in getting research into practice at the bedside.6 What are the barriers to change, and what can we do to ensure that many years do not pass before comprehensive PBM is not only adopted as the standard of care but implemented as the standard of care? The challenges to implementation are well known, though this by no means makes them less challenging.1,7 They can be summarized as follows: Cultural, behavioral, and educational barriers, including an entrenched medical culture that has long relied on transfusions as a primary treatment. Lack of standardized guidelines for PBM programs. Existing guidelines have focused on transfusion indications and “optimal blood use.” Infrastructure challenges and logistical and resource constraints - issues in health care in all countries but creating unique burdens in low- and middle-income countries. Resistance to change, a significant hurdle in any human endeavor, and particularly relevant to hierarchical structures such as health care systems, especially in high- and middle-income countries. This issue’s PBM high-impact bundle (HIB) offers perspectives and strategies on how these barriers might be overcome. It is timely in that it follows the very recent publication of the 200-page WHO PBM Guidance (https://iris.who.int/handle/10665/380784).2 The authors recommend that readers download and review this comprehensive guide for national implementation of PBM leveraging the work of hospitals and health systems at the local and regional level. Taken together, this HIB extends the messaging of the 2022 Anesthesia & Analgesia PBM-themed issue and, coupled with the WHO PBM Guidance, provides practical support and direction on how to successfully implement PBM using the proven strategies of change management.8,9 CULTURAL, BEHAVIORAL, AND EDUCATIONAL BARRIERS Tackling this entrenched medical culture begins with education – education of patients, to be sure, so that they can become active partners and advocates for change.2,9 But education must occur at all levels of health professions: undergraduate training, postgraduate training, and reeducation of physicians, pharmacists, nurses, and community health workers already in practice. The article by Ozawa et al10 is an excellent introduction to a modern reconceptualization of blood as an organ and part of an integrated organ system. The WHO PBM Guidance has identified patients’ blood as the most neglected organ.2 This has led to the concept of “blood health,” analogous to “heart health” and “gut health.” To achieve blood health, PBM aims to improve patient outcomes by managing and preserving the patient’s own blood like any other organ or organ system.4,10 The concept of blood health provides a shared language for educating patients and the health care profession and understanding how it is cared for through the 5 levels of prevention.10 For blood, primordial and primary prevention will play an essential role in reducing the incidence and prevalence of anemia and iron deficiency. Ozawa et al point out that “the ease with which blood can be collected from altruistic donors, stored, and transfused, has contributed to a medical culture of expendability and replaceability.” As physicians, we do not tolerate such a care paradigm for any other organ or organ system. The medical culture that blood is easily replaceable must change. In fact, “replaceability” is a flawed concept since donor blood is not equivalent to a patient’s own blood. Further, the ready availability of donor blood is a reality only in high- and upper-middle-income countries. Understanding blood as an organ, the health of which must be protected, maintained, and improved whenever possible, is fundamental to PBM. From the perspective of a health minister, an understanding of blood as an organ and blood health as a population health imperative calls for PBM to be adopted as a national standard of care.2 The WHO PBM Guidance, recognizing the importance of empowering the public through education on blood health, created a distinct step in the implementation process dedicated to education. This includes creating public awareness, promoting blood health in the public domain, promoting blood health through patient empowerment including community and patient education, shared decision-making, and informed consent and choice, and promoting PBM as a patient safety initiative. Resources exist to facilitate patient education and empowerment.11 We are well advised to keep in mind that, among other examples, public outcry over blood safety during the HIV crisis caused major changes in transfusion medicine and the blood industry beginning in the 1980s. Similarly, patient empowerment is key to PBM implementation. LACK OF STANDARDIZED GUIDELINES Many published transfusion guidelines and transfusion utilization audit tools exist to improve the use of transfusion as a medical intervention. These are distinct from PBM guidelines, several of which have been published.12 However, there has been a pressing need for tools to assess PBM program implementation if we are to successfully implement PBM as a standard of care. In this HIB, Farmer et al7 report on the structure and impact of a project to design and pilot a comprehensive PBM Program Implementation and Assessment Tool (PIAT). This tool was developed based on the 6 modules of the Australian PBM Guidelines,12 the Spanish PBM maturity assessment tool,13 and a comprehensive list of updated literature. The assessment tool follows the widely accepted Donabedian method for health care quality assessment by being built around 3 sections: Structure, Process, and Outcomes. Since culture has been identified as one of the greatest barriers to PBM implementation, successful PBM programs have incorporated implementation science and change management methodology.1,2,14 For culture change, key elements of the Kotter Model for Change were included in the PIAT (Table). Any assessment tool must serve several functions to be of value: Guide those interested in starting a program on the basic structures and processes needed; Allow for performance of a gap analysis; Provide a means to measure incremental improvement, implementation progress, and maturity; and, Allow existing programs to assess their effectiveness and benchmark themselves against other similar programs establishing the possibility of identifying centers of excellence that might serve as reference centers for others. Finally, one should never conclude that “the job is done.” Without ongoing drivers such as periodic assessment, practice inevitably regresses to old practice habits. The PIAT developed by Farmer et al serves these functions and succeeds admirably in all these areas. Table. - Kotter Model for Change as Used in Successful Patient Blood Management Program Implementation Stage Step Stage 1: Defrost a hardened status quo Step 1: Establish a sense of urgencyIdentify a crisis or potential crisis that jolts people out of complacency and galvanizes to do something–50% of organizations fail in change because of not establishing a sense of urgency. Step 2: Creating the guiding coalition – leadershipLeadership an essential driving force. Powerful (influential) coalition to lead and implement the change. Step 3: Developing a vision and strategyA simple concise statement of where the organization wants to go/be and why.Essential to direct, align, and inspire the actions of large numbers of people.Strategies for how to achieve the vision. Step 4: Communicating the change vision – educationUse every vehicle possible to constantly communicate (educate) the vision and strategies. Stage 2: Introducing many new practices Step 5: Empowering a broad base of people to changeEncouraging nontraditional approaches and practices. Step 6: Generating short-term winsCollecting data and providing feedback on results. Step 7: Consolidating gains and producing even more changeBuilding on incremental changes and improvements. Stage 3: Grounding the changes in the culture Step 8: Institutionalizing the new approaches in the culture The existence of standardized guidelines and appropriate assessment tools is necessary but insufficient to bring about change. It is critical that there be a system for data collection, agreed-upon metrics, and ongoing reporting.15 Trentino et al16 provide a narrative review and practical guidance on data collection and metrics to support PBM. In our experience, most health care organizations have fallen into the trap of only counting what is easiest to count. In the case of PBM, there is overrepresentation of transfusion-related metrics. While a reduction in blood utilization often occurs as a corollary of PBM implementation14 especially in high-utilization, high-income countries, transfusion utilization is not a substitute for data collection and metrics for PBM and can lead to fuzziness in distinguishing between optimal blood use and true, comprehensive PBM.3 We must create and agree on a common set of PBM data elements and metrics as this is essential if we are to establish benchmarks. While developing these data sets and PBM metrics, we must consider the needs of middle- and lower-income countries. Resource constraints limit the ability to collect data electronically, and therefore meaningful metrics should be developed that can be determined by survey. It is in low-income countries, where access to blood for transfusion may be severely limited, that transfusion-related metrics may have the least relevance. The WHO PBM Guidance2 provides instruction on data collection, metrics, and a structure for reporting, after the Donabedian quality framework in the context of establishing PBM as a standard of care. It recommends mandated, measurable national PBM standards with institutional PBM accreditation and PBM auditing. Farmer et al provide a tool with measurable PBM standards that might support an accreditation process. INFRASTRUCTURE CHALLENGES, AND LOGISTICAL AND RESOURCE CONSTRAINTS The last 2 articles in this HIB may seem to be unrelated.17,18 However, both deal directly, or indirectly, with how we structure the care of our patients in a continuum of care predicated on blood health and PBM. When does PBM begin? Is it with the healthy person in the community as part of our duty to improve population health, prevent iron deficiency, and improve long-term health outcomes? Does it begin in the prehospital setting when a patient has been identified as needing a surgical intervention? How do we structure the care journey of our patients? What is the role of the primary care provider? Does preoperative iron deficiency/anemia management begin with the hospital provider or before? Crispell et al17 describe the staged growth of a preoperative anemia clinic (PAC) in a tertiary care center. Enough specific details are provided that the article can be used as a guide for the construction of similar clinics in comparable organizations. It also serves as a reminder that, even in well-resourced institutions, progress in implementing a PBM program, or even constituent parts of a program, can be quite slow. A high prevalence of preoperative anemia was identified in an audit of data from adults undergoing elective cardiac surgery in 2016 and 2017. These data were presented to appropriate department chairs in 2018. Approval to execute a plan for a PAC was received in July 2019, the program launched in December 2020, and the program was deemed fully mature in December 2022. We can applaud the development of this high-functioning PAC but still be dismayed by the long timeline from identifying a need until full implementation. Their eventual success highlights the logistical challenges to implementation in large, complex organizations. Given the evidence, economics, and ethics of PBM,1,2 the need for implementing PBM is urgent, and we must find strategies to accelerate the process. Continued delays prolong preventable risks to patient’s blood health worldwide.10 In their discussion of the successful design of their PAC, the authors note that more than 70% of their treated patients received their recommended treatment within 1 week of their surgical date. They state: “Despite this short interval, improvements in hemoglobin concentrations were observed in most patients who had their hemoglobin rechecked before surgery.” The authors do not discuss the reasons for this short lead time. Possibilities include resource and facility constraints, delay in identifying anemic patients quickly after the decision to schedule surgery, urgent or emergent need for surgery, or a short lead time from the surgical decision to the scheduled procedure. Regardless, there is a need to lengthen the lead time between diagnosis of preoperative anemia and the date of surgery if surgical preparedness and blood health are to be optimized.19 This speaks directly to the intersection of Crispell and Jayasuriya et al18 and importantly, the pivotal role that primary care plays if PBM is to become the standard of care across the full care continuum.2 Jayasuriya et al point out that the “essential attributes of primary care, including access, continuity, coordination, and comprehensiveness align well with PBM” even as the majority of existing formal PBM programs originate at the secondary and tertiary hospital level with little involvement by primary care. We believe, like Jayasuriya et al and as attested to in the WHO PBM Guidance, that primary care must be in a position of centrality in the social and medical network that will drive the adoption, implementation, and practice of PBM, both at the community level and at the individual patient level. The importance of reducing the burden of anemia, both for the community and the individual, cannot be overemphasized. When anemia, iron deficiency anemia, and nonanemic iron deficiency are considered, as much as 30% of the patients seen in primary care will be affected, with a profound impact on quality of life and health outcomes.20 Health systems with a strong primary care base are best equipped to meet this challenge if PBM is conceptualized as a care paradigm that begins in the community health center and primary care provider’s office. The short lead time between identification of preoperative anemia and surgery that limited the impact of the PAC program of Crispell et al becomes a nonissue since primary care, as a matter of good PBM practice, is engaged in early recognition, diagnosis, and treatment of iron deficiency/anemia. PBM exists across the full continuum of care before, during, and after hospital inpatient encounters and when no hospital encounter is anticipated. It is this PBM infrastructure that must be built to ensure comprehensive PBM.2 Such an approach will facilitate patient education and awareness because of the influential role of the general practitioner within the community. An often-neglected aspect of comprehensive PBM is the importance of postdischarge follow-up. The continuum of care begins and ends with the primary care provider. PBM protocols should ensure effective care and seamless “hand-offs” from primary care provider to specialist, to inpatient care, to rehabilitative care, and finally back to primary care. Jayasuriya et al emphasize advocacy as a core competency for primary care professionals, helping their individual patients navigate their health system. They rightly emphasize that advocacy extends to advocating for the population they care for, and “actively collaborating with the community, government organizations, and policy makers to promote population health initiatives and educate about the importance of PBM.” Thus, primary care helps complete the circle of both a “top-down” and a “bottom-up” implementation of PBM.2 RESISTANCE TO CHANGE Resistance to change is perhaps PBM’s biggest challenge. The HIB in this issue of Anesthesia & Analgesia is 1 step forward in providing guidance in how to bring about the changes in care that PBM represents and requires. This guidance is necessary but not sufficient. John P. Kotter, in his book, A Sense of Urgency, is clear that the first and toughest step in change management is overcoming resistance by creating a sense of real urgency.2,21 The global anemia crisis and our inattention to blood health, guided by the evidence and our ethical obligations, should provide that sense of urgency. This urgency was emphasized by the WHO PBM Policy Brief.1 Communicating that sense of urgency will encourage engagement with health system leaders and policy makers, and help ensure that PBM advances to “a global standard of care.”2 In partnership with their patients, health care providers can drive a change to health care delivery systems that strengthens interconnectedness, values relationships, and emphasizes synthesis over isolated analysis. They can push hard to design systems that deliver the highest quality PBM to as many in the world community as possible. Health care is highly complex. Individuals doing heroic work will still fail when the structures and systems that support their work are flawed. If PBM is to succeed, we must design systems where the average person can consistently perform exceptional work.11 DISCLOSURES Conflicts of Interest: I. Gross received consulting fees from CSL Vifor, hc1+ Accumen, is an author of a book on PBM, and was Co-chair of the WHO External Steering Committee for PBM Implementation, L. Shore-Lesserson received advisory board fees from Werfen, Haemonetics, and CSL Behring, S.L. Farmer received consulting fees from the International Foundation for Patient Blood Management, lecture honoraria from Ethicon Biosurgery, travel support from the National Blood Authority (Australia), International Foundation for Patient Blood Management, and World Anemia Awareness, is a lead author of two books on PBM, and had a leadership role in the WHO External Steering Committee for PBM Implementation and the Executive Committee of the Western Australia Patient Blood Management other authors Conflicts of This was