Supplementary Appendix

Supplementary Appendix Supplement to: Leahy MF, Hofmann A, Towler S, et al. Improved outcomes and reduced costs associated with a health-system-wide Patient Blood Management Program: A retrospective study in four major adult tertiary-care hospitals

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Table of Contents Information on Australian and Western Australian Health System...................................................... 3 Summary table of application of the three-stage eight-step Kotter model to practice change and implementation of the Western Australia Patient Blood Management Program .................................. 4 Patient Blood Management Program Leadership Structure Showing the Four Major Tertiary Institutions’ Structure at Hospital Level ............................................................................................... 7 Duties and Responsibilities of the State Patient Blood Management Medical Director ......................... 8 Duties and Responsibilities of the State Patient Blood Management Clinical Nurse Coordinator......... 9 Duties and Responsibilities of the Patient Blood Management Medical Directors .............................. 11 Duties and Responsibilities of the Patient Blood Management Nurse Coordinators ........................... 12 Functions of the Patient Blood Management Committees ................................................................... 14 The Five Drivers Establishing Urgency for Change ............................................................................ 16 Modifying the triad of independent risk factors for adverse patient outcomes by application of the three pillars of patient blood management .......................................................................................... 17 The Three-Pillar Nine-Field Matrix of Patient Blood Management .................................................... 18 The Three-Pillar Nine-Field Matrix of Patient Blood Management with the National (Australia) Patient Blood Management Guidelines – Module 2 Perioperative Evidence-based Recommendations, Practice Points and Supplementary Material. ..................................................................................... 19 Western Australia Patient Blood Management Program Consumer Information Fact Sheet ............. 20 Blood Product Costs ............................................................................................................................ 23 Blood Product Information ................................................................................................................. 24 Elements of a Comprehensive Patient Blood Management Program .................................................. 26 References: .......................................................................................................................................... 47

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Information on Australian and Western Australian Health System Australia has three levels of government: federal, state and territory, and local. All three levels of government play a role in the Australian health-care system.1 This health care system is a mixed model of public and private health services, with responsibilities for the public health system shared between the Federal Government and the State and Territory Governments as defined by the National Healthcare Agreement.2 The public health system is based on the principle of universal access and is funded through taxation. This system provides free hospital services for public patients admitted to public hospitals and is regulated by the State and Territory Governments. The public hospital system makes up 68% of hospital beds in Australia and is the major provider of emergency health care and high cost/ high complexity procedures and interventions. The private health-care sector, which accounts for approximately 32% of hospital beds in Australia, is funded independent of government with ownership by both for-profit and charitable providers for which funding comes from private health insurers, governments and patients.3,4 Within this system, where funding arrangements and costs are kept relatively separate, blood products whether used in the public or private sectors - are provided free to the patient. As a consequence, all blood products are free on the order of a medical practitioner and there is virtually no price signal in the health sector regarding blood. At the level of the provision of blood products, the Federal Government is the major funder, providing 63% of the costs to support the procurement and distribution of blood products, with the State Governments providing the balance. Against this backdrop, the Australian state of Western Australia was both uniquely positioned and uniquely challenged. Representing nearly one third of the land mass of Australia – 2.5 million square kilometres – Western Australia has a population of approximately 2.6 million persons. Between 2008/2009 and 2012/2013 Western Australia recorded the greatest growth in inpatient activity in Australia,4 likely due to its rapidly growing and aging population. Nearly 74% of the population live in the State’s capital city, Perth. The health community is relatively isolated with the major opinion leaders largely restricted to this single major city. Perth has 13 public hospitals, including the five major tertiary hospitals (four adult and one paediatric) and these sites consume nearly 60% of the blood products used in the State. The city also hosts all the major private hospitals in the State and clinicians often have appointments in both hospital systems. Furthermore, the administration of the State budget and policy on the use of blood products co-exist within the Western Australia Department of Health. These unique characteristics of size and distribution of the health services, combined with the establishment of Australia’s first comprehensive blood conservation program in 19905 and a long history of lower dependence on the use of blood products but sustained quality in patient outcomes, meant Western Australia represented a major opportunity for the implementation of a comprehensive, sustainable, coordinated patient blood management program.

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Summary table of application of the three-stage eight-step Kotter model to practice change and implementation of the Western Australia Patient Blood Management Program

Stage

Step

Stage 1: Defrost a hardened status quo

Step 1: Establish a sense of urgency Identify a crisis or potential crisis that jolts people out of complacency and galvanises to do something - 50% of organisations fail in change because of not establishing a sense of urgency.

Step 2: Creating the guiding coalition – leadership Leadership an essential driving force. Powerful (influential) coalition to lead and implement the change.

Step 3: Developing a vision and strategy A simple concise statement of where the organisation 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 Use every vehicle possible to constantly communicate (educate) the vision and strategies

Application Literature review identified drivers for urgent change: Blood supply pressures; burgeoning cost of blood; blood safety challenges; limited evidence for benefit; adverse outcomes associated with transfusion; wide practice variation. Three independent but modifiable risk factors for adverse outcomes: anaemia and iron deficiency, blood loss (iatrogenic) and bleeding (coagulopathic), and transfusion State-level leadership including: executive endorsement from state health executive body; executive sponsorship (state Chief Medical Officer); expert PBM implementation group; faculty of international experts in PBM to participate in clinical education; 71-member multidisciplinary clinical reference group of state key opinion leaders; PBM steering committee; PBM research committee; State PBM Medical Director; State PBM Clinical Nurse Coordinator; Hospital-level leadership including: PBM Medical Directors; PBM Nurse Coordinators; hospital-based PBM committees. What: Improving outcomes while reducing cost Why: Quality, safety and effectiveness issue with resource and economic implications How: Changing the transfusion paradigm (culture) from a product focus to a patient focus and implementing a comprehensive multidisciplinary multimodal patient blood management program Multiple ongoing education and communication strategies for all stakeholders including: Program launch educational symposium Introductory series of presentations to hospital Executives, Administrators, and Executive Committees and symposia by international faculty at all tertiary public hospitals, some private hospitals, transfusion nurse groups, and the Australian Red Cross Blood Service One-on-one presentations and meetings with executives, administrators, Clinical Reference Group members, and department heads Bimonthly literature reviews conducted, compiled into a digest and distributed Multicentre, multidisciplinary PBM workshops and symposia A preceptorship and demonstration surgery with an experienced PBM cardiothoracic surgeon Study tours for PBM staff Educational PBM roadshows at over 60 major hospital departments including departments of surgery, anaesthesia, critical care, obstetrics,gynaecology, trauma/emergency, haematology, oncology, cardiology, gastroenterology, general medicine, nephrology, and paediatrics/neonatology. Presentations included Program and PBM definition and

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rationale, drivers for urgent change in practice, the triad of independent risk factors for adverse patient outcomes, the three pillars of PBM to modify these risk factors, updates on current specialty-specific literature on PBM, evidence-based PBM guidelines and department-specific benchmarking PBM hemostasis workshops at the Clinical Training and Evaluation Centre (CTEC), The University of Western Australia which included didactic classroom sessions, practical laboratory sessions and workshop discussions An educational website with information for health professionals and patients including a patient PBM factsheet Informed consent/refusal for transfusion Educational workshops and sessions with general practitioners Additional PBM CMEs, grand rounds, and in-service programs presented by PBM staff and the Australian Red Cross Blood Service Including PBM elements in the medical school curriculum Stage 2: Introducing many new practices

Step 5: Empowering a broad base of people to change Encouraging non-traditional approaches and practices

Step 6: Generating short- term wins Collecting data and providing feedback on results

Development of a three-pillar nine-field matrix of periintervention PBM strategies for clinical implementation (figure 2) Dissemination and implementation of the national evidencebased Patient Blood Management Guidelines modules upon release Conducting gap-analysis surveys of PBM strategies at all major institutions Identified and engaged clinical champions in various disciplines Convened a workshop of national and international experts to design a pre-operative anemia and iron deficiency detection, evaluation, and management program Re-engineered pre-admission clinics to facility timely hemoglobin and iron stores optimization and bleeding risk assessment and management Integration of PBM within the State Elective Joint Replacement Model of Care Piloted alerts within the Computerised Prescriber Order Entry system Introduction of minimal volume blood sampling Viscoelastic coagulation testing guided management Introduction of a single-unit RBC transfusion policy in symptomatic non-actively bleeding patients Intravenous iron therapy protocols for anemic/iron deficient patients Identified and sourced key data elements from core hospital databases Developed of a comprehensive fully automated data system with analysis tools Clinical consultation sessions to identify and categorize key patient groups for benchmarking Quarterly feedback of clinical practice to hospitals and departments Interactive dashboards to allow comparison between hospital/department/physician across key indicators Benchmarked reports developed and tailored to key audiences, eg. State-wide, Area Health Service level, hospital administration, PBM staff, departments, and individual

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clinicians Step 7: Consolidating gains and producing even more change Building on incremental changes and improvements

Benchmarking data feedback on clinical practice to departments identifying gains and areas for improvement Informal benchmarking with international centers of excellence Outcomes research projects as part of improving health-care and translating research into clinical practice

Stage 3: Step 8: Institutionalizing the new approaches Developed Program and institutional policies, procedures, Grounding in the culture protocols, and algorithms the changes in the culture PBM = patient blood management; CME = Continuing medical education.

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Patient Blood Management Program Leadership Structure Showing the Four Major Tertiary Institutions’ Structure at Hospital Level

PBM Program Leadership Structure CMO Executive Sponsor to SHEF

PBM Research Committee

State PBM Steering Committee

CRG

State PBMP Medical Director

PBM Implementation Consultants & DoH

State PBMP Clinical Nurse Coordinator

Hospital PBMP Medical Director




Haem

Haem & Anaesth

Haem & Anaesth

Haem & Anaesth

Hospital PBMP Clinical Nurse Consultant

Hospital PBMP Committee







Abbreviations: PBM = Patient Blood Management; PBMP = Patient Blood Management Program; CMO = Chief Medical Officer; SHEF = State Health Executive Forum; DoH = Department of Health; Haem = Haematologist; Anaesth = Anaesthetist. At one hospital the PBMP Medical Director was a haematologist, at three hospitals the role was a Co-Director position shared between a haematologist and an anaesthetist. The original PBM Program design had a PBM Medical Director and PBMP Clinical Nurse Consultant at the major metropolitan paediatric hospital and the Western Australia Country Area Health Service covering public hospitals outside the city of Perth. The PBMP Medical Directors and Clinical Nurse Consultants at the five major metropolitan hospitals were to also service the three metropolitan area health services covering all public hospitals in the Perth metropolitan area.

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Duties and Responsibilities of the State Patient Blood Management Medical Director Responsible for ensuring the development, implementation and management of the Patient Blood Management (PBM) program in Western Australian Hospitals. Provides advice and support to the PBM Medical Directors and the PBM State Clinical Nurse Coordinator in relation to the implementation and management of the Western Australia (WA) PBM Program. Provides effective leadership in the development of a data system within each hospital and project wide.

1. Provides state-wide leadership and direction in the management of the Patient Blood Management (PBM) program. 2. Supervises the initiation and operation of each local program within each of the Area Health Services 3. In collaboration with the PBM State Clinical Nurse Coordinator, ensures benchmarking of blood products utilisation for each hospital that can be used project wide. 4. In conjunction with the PBM State Clinical Nurse Coordinator and PBM Medical Directors, develops policies and procedures for patient throughput and management that can be used project wide. 5. Establish annual targets as set for each department and overall for hospitals to be used project wide. 6. Implements a periodic data analysis for progress report. 7. Establishes a feedback system to communicate progress against targets for each hospital. 8. Maintains an arbitration system through the medical staff process to address issues that may impact on clinical practice (ethical/moral issues, patient negative outcomes etc) 9. Develops a uniform data collection system in each hospital that will be underpinned by the project wide data system. 10. Ensures there is an educational program for each department involved in PBM that provides information specific to that department as well as at large. 11. Is a member of the PBM Committees in each hospital 12. Chairs periodic meetings of PBM Medical Directors and PBM Clinical Nurse Consultants 13. Maintains a comprehensive data collection of hospital progress as set by goals and targets. 14. Reports back to local hospitals, implementation board oversight committee and to the CMO. 15. Represents the PBM on behalf of the CMO at relevant conferences, events, boards and committees. 16. Develops investigator initiated research and/or other projects. 17. Supervises the initiation of each additional local program. 18. Any other duties as requested by the Chief Medical Officer

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Duties and Responsibilities of the State Patient Blood Management Clinical Nurse Coordinator PRIME FUNCTION / KEY RESPONSIBILITIES: This position plays a key role in the enactment of the PBM Program from the time of Implementation through to its integration and sustainability. During the Implementation period the State Coordinator works closely with the WA PBM Implementation Board in assuring that activities planned and organised are carried out. The State Coordinator provides leadership, expertise and support to the PBM Clinical Nurse Consultants (PBM CNCs). The State PBM Coordinator communicates progress to the PBM CNCs from the WA PBM Implementation Board, regulatory agencies, and the State PBM Clinical Director.

1. Networking among multidisciplinary staff in the healthcare field to assist in making change happen within typical clinical practice in the field of Patient Blood Management and transfusion. 2. Direct and assist in the creation and formation of policy and procedure in the field of Patient Blood Management 3. Act as a intermediary between regulatory agencies and the PBM CNC WA staff 4. Responsible for ongoing evaluation of WA PBM CNCs competency in all areas of performance including target KPIs. 5. During Implementation phase, will work with the WA PBM Implementation Board as well as the PBM CNCs, and other PBM staff in the completion and process documentation of the WA Patient Blood Management Program with the intent of expansion to other geographic areas or states. 6. Leads and coordinates the PBM CNCs and the multidisciplinary team to implement the WA Patient Blood Management Program. In collaboration with the Patient Blood Management State Clinical Director, Medical Directors and PBM CNCs, provides clinical leadership and consultancy to nursing, medical, laboratory and allied health care professionals, and providers in the area of Patient Blood Management both within and external to the hospitals/health service. 7. In collaboration with the Patient Blood Management State Clinical Director, Medical Directors and PBM CNCs, initiates and analyses research, including blood utilisation data and benchmarking, to determine clinical best practice; initiates, implements and evaluates best practice activities and provides feedback in order to support the delivery of appropriate clinical care in the area of Patient Blood Management both within and external to the hospitals/health service. 8. Develops, implements and promotes evidence based standards, policies, protocols and guidelines that are compliant with relevant professional, industrial and legislative requirements, which influence Patient Blood Management both internal and external to the hospitals/health service. 9. Provides advanced, complex patient/client care as well as expert consultancy and guidance both within and external to the hospitals/health service. 10. Leads and develops a peri-intervention anaemia/iron deficiency detection, evaluation management program 11. Provides expert consultancy service for a broad range of customers and health professionals, including facilitating the requirements for informed consent/refusal for blood transfusion. 12. Is a member of the multidisciplinary representative Patient Blood Management Committees. 13. Provides leadership in the coordination and implementation of quality improvement activities.

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14. Contributes to the formulation of staffing profiles according to analysis of clinical needs and available resources. Operates within the allocated/available budgets for the area of responsibility. 15. Implements and maintains performance management activities, where applicable. 16. Leads and develops education and training programs both within and external to the hospitals/health service. 17. Regularly disseminates information on clinical research in the area of Patient Blood Management both within and external to the hospitals/health service. 18. Provides a public relations function for the area including, where relevant ,investigation and report preparation for ministerials, enquiries and consumer complaints.

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Duties and Responsibilities of the Patient Blood Management Medical Directors Provides leadership, direction and overall clinical management of the Patient Blood Management (PBM) Program. Responsible for the management and improvement of the Patient Blood Management Program. Chairs the Patient Blood Management Committee. Provides regular reviews of PBM policies, procedures, protocols and guidelines. Provides institutional leadership and, in collaboration with the PBM Clinical Nurse Consultant, direction in the management of the multidisciplinary Patient Blood Management Program.

1. Chairs the PBM Committee. 2. Ensures the development and communication of best practice guidelines to secure consistent, equitable and quality outcomes are achieved across the Patient Blood Management Program. 3. Monitors, analyses and reports on adherence to the best practice guidelines and performance standards. 4. Develops, refines and communicates operational plans resulting from treatment protocols and clinical pathways, and regularly reviews PBM policies, procedures and protocols. 5. Provides medical/clinical supervision and advice when needed in the operation of the Program. 6. Ensures appropriate professional and community education programs are developed and implemented in relation to patient blood management. 7. Recommend to the institution’s administration the use of facility personnel, equipment and general quality standards of patient care in relation to the Program. 8. Maintains clinical skills within the area of patient blood management. 9. Ensures the development of educational programs and resources for all clinical and non-clinical staff within the PBM Program, including orientation for new staff. 10. Monitors and analyses trends for continuous improvement of the Program and proposes/initiates research projects. 11. Maintains an up to date list of all specialists experienced in PBM who are available for consultation. 12. Liaises with other department heads and hospital committees on issues relevant to the PBM program. 13. Represents the PBM on behalf of the CMO at relevant conferences, events, boards and committees. 14. Provides monthly, quarterly and annual financial and clinical reports to the hospital administration, the Implementation Board and the State PBM Clinical Nurse Coordinator. 15. Other duties and special projects as required by the Chief Medical Officer.

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Duties and Responsibilities of the Patient Blood Management Nurse Coordinators PRIME FUNCTION / KEY RESPONSIBILITIES: This position is a specialist role which provides an effective clinical function in improving patient outcomes through the implementation of the WA Patient Blood Management Program (WAPBM). The position holder influences the practice of nursing, medical, laboratory and allied health disciplines in patient blood management both within and external to the health service. Areas of accountability will include the provision of leadership, clinical standard setting and monitoring, policy development, and change management. 1. Leads and coordinates the multi-disciplinary team to implement the WA Patient Blood Management program. 2. In collaboration with the Patient Blood Management Medical Director, provides clinical leadership and consultancy to nursing, medical, laboratory and allied health care professionals, and providers in the area of patient blood management both within and external to the hospital/health service. 3. In collaboration with the Patient Blood Management Medical Director, initiates and analyses research, including blood utilisation data and benchmarking, to determine clinical best practice; initiates, implements and evaluates best practice activities and provides feedback in order to support the delivery of appropriate clinical care in the area of patient blood management both within and external to the hospital/health service. 4. Develops, implements and promotes evidence based standards, policies, protocols and guidelines that are compliant with relevant professional, industrial and legislative requirements, which influence patient blood management both internal and external to the hospital/health service. 5. Provides advanced, complex patient/client care as well as expert consultancy and guidance both within and external to the hospital/health service. 6. Develops and implements a peri-intervention anaemia/iron deficiency detection, evaluation management program 7. Provides expert consultancy service for a broad range of customers and health professionals, including facilitating the requirements for informed consent/refusal for blood transfusion. 8. Promotes and facilitates a multi-disciplinary team approach to decision making. Develops innovative techniques for complex problem solving for patient blood management both within and external to the hospital/health service. 9. Is a member of the multidisciplinary representative Patient Blood Management Committee. 10. Maintains excellence in interpersonal skills and use of leadership to guide appropriate patient blood management. 11. Provides leadership in the coordination and implementation of quality improvement activities. 12. Contributes to the formulation of staffing profiles according to analysis of clinical needs and available resources. Operates within the allocated/available budgets for the area of responsibility. 13. Participates in the recruitment, selection and orientation of staff. 14. Develops and implements business plans and strategies to facilitate effective utilisation of allocated human, financial and physical resources consistent with patient blood management, division and corporate priorities. 15. Implements and maintains performance management activities, where applicable.

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16. Develops, implements and evaluates education and training programs both within and external to the hospital/health service. 17. Regularly disseminates information on clinical research in the area of patient blood management both within and external to the hospital/health service. 18. Provides a public relations function for the area including where relevant investigation and report preparation for ministerials, enquiries and consumer complaints. 19. Uses effective change management strategies to improve patient blood management both within and external to the hospital/health service.

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Functions of the Patient Blood Management Committees Function: This is a multidisciplinary representative committee that takes the lead in developing, implementing, evaluating and progressing the Program. Members of the committee act as role-models for other healthcare professionals in the Program. They address key questions in relation to the functioning of the Program, assist in the development and revision of guidelines and take the lead in their implementation. They assist with the development and evaluation of the benchmarking and monitoring databases, education initiatives and research projects. The Committee’s role is to: 1. Communicate and promote the Program vision throughout the institution facilitating change management 2. Provide forum for discussion and facilitate communication 3. Provide departmental leadership 4. Facilitate development and review of protocols, policies, procedures and guidelines 5. Monitor compliance/ provide feedback on gains and areas for improvement 6. Collect data (baseline, monitoring, feedback, improvement) 7. Benchmark outcomes 8. Initiate educational needs and opportunities 9. Produce educational materials (including newsletters, brochures, posters, website, and e-mail) 10. Interact actively with the hospital 11. Lead by example 12. Integrate EQuIP 4 with the program 13. Develop and review operational policies and protocols 14. Develop and carry out quality improvement activities 15. Act as a resource and provide direction 16. Recommend, develop and review education programs for internal and external customers 17. Initiate proposals for research and clinical trials 18. Compile data for analysis Makeup/representation: • • • • • • • • • • • • •

PBM Medical Director (Chair) PBM Coordinator Medical Administration Executive Administration Surgery (representatives from major surgical specialties) Anaesthesia Intensive Care Unit Haematology/Oncology Emergency General medicine Transfusion committee representative Other institution specific specialty representation Nursing (theatre, intensive care unit and ward)

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• • • • • • •

Pharmacy Accreditation coordinator Environment/infection control Quality assurance Admissions Patient advocate Public relations

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The Five Drivers Establishing Urgency for Change

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Modifying the triad of independent risk factors for adverse patient outcomes by application of the three pillars of patient blood management

Optimise Anaemia Iron deficiency red cell mass

Optimise red cell mass

Blood loss & bleeding

Transfusion

Harness & optimise physiological reserve of anaemia

Minimise Blood loss & bleeding

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The Three-Pillar Nine-Field Matrix of Patient Blood Management

The three-pillar nine-field matrix of patient blood management. The matrix was designed for the Western Australia Patient Blood Management Program to assist in the clinical implementation of the multiple PBM strategies. These strategies are considered in the perioperative period in a patient/procedurespecific context. Reformatted from Hofmann A, Friedman D, Farmer S. Western Australia Patient Blood Management Project 2008-2012: Analysis, Strategy, Implementation and Financial Projections. Perth, Western Australia: Medicine and Economics; 2007. p. 1-215. (Accessed November 11, 2015, at https://www.researchgate.net/publication/281308410_Western_Australia_Patient_Blood_Management_Proj ect_2008-2012_Analysis_Strategy_Implementation_and_Financial_Projections) and reprinted with permission. The principles of this matrix were also applied to non-surgical patients before, during and after treatment. Isbister has adapted this perioperative matrix for wider clinical application, for example medical/haematological patient populations (Isbister J. The three-pillar matrix of patient blood management. ISBT Science Series 2015;10(Suppl. 1):286-94).

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The Three-Pillar Nine-Field Matrix of Patient Blood Management with the National (Australia) Patient Blood Management Guidelines – Module 2 Perioperative Evidence-based Recommendations, Practice Points and Supplementary Material.

1 st Pi l l ar

Optimise blood volume & red cell mass •

Preoperative

• • •

Intraoperative

•

Postoperative

•

•

As early as possible, anaemia should be identified, evaluated and managed; optimise haemoglobin and iron stores (R2,3, PP1,4,5, S3.4) Iron therapy is recommended in patients with or at risk of iron deficiency (R4,PP7) Where an ESA is indicated, it must be combined with iron therapy (R5) Suboptimal iron stores (ferritin level 220) 50 ± 6 (≥ 40) 0.59 ± 0.03 (0.50–0.70) 0.37 ± 0.25 (< 0.8) 0.27 ± 0.07 (< 1.0)

Platelets: Platelet Pooled Leucocyte Depleted Volume (mL) 326 ± 14 (>160) Platelet count (109 /pool) 284 ± 40 (>240) pH (at expiry) 7.0 ± 0.1 (6.4 - 7.4) Leucocyte count (106 /pool) 0.33 ± 0.02 (< 0.8) Platelet Apheresis Leucocyte Depleted Volume (mL) Platelet count (109 /unit) pH (at expiry) Leucocyte count (106 /unit)

180 ± 11 (100–400) 280 ± 34 (> 200 to < 510) 7.0 ± 0.2 (6.4–7.4) 0.21 ± 0.15 (< 1.0)

Apheresis or single-donor platelets in Western Australia account for 75% of supply. Fresh Frozen Plasma Whole Blood Fresh Frozen Plasma Volume (mL) Platelet Count (109/L) Leucocyte Count (109/L) Factor VIIIc (IU/mL)

280 ± 14 (250–310) 5 ± 4 (