Facilitating the Implementation of Perioperative Patient Blood Management: Education, Infrastructure, Process Descriptions, Quality Indicators and Patient Information

Abstract

Background: Patient Blood Management (PBM) is a collection of evidencebased interventions before, during and after major surgery that aim to avoid anemia, reduce blood loss, reduce allogeneic blood transfusions, and improve patient outcome. Despite global, international, and national recommendations of various stakeholders for systematic clinical application of PBM, implementation of the bundle concept is slow. The aim of this article is to propose a shopping list-like summary of medicinal interventions as well as of educational and managerial aspects to facilitate the implementation of perioperative PBM.

Methods: Barriers to uptake PBM have been identified und summarized from the perspective of a clinician, teacher, guidelines collaborator, organizer of an international PBM master course.

Results and Discussion: Main barriers to uptake PBM may include misconceptions surrounding PBM, lack of knowledge and skills, infrastructure and process descriptions, sensitive quality indicators as well as poor communication about the vision for PBM and its benefits. In chapter 1, a list of perioperative interventions may clarify the scope of work. Chapter 2 describes aspects of sustained knowledge transfer and skill training from post-graduate education to professional development of all involved healthcare professionals in order to overcome uncertainty. Chapter 3 lists the role of public authorities and managerial pre-requisites including infrastructures, process descriptions, and quality outcome assessment. Role and responsibilities of laypersons are defined in the last chapter. Increased public research funds will have to advance scientific evidence in perioperative PBM.

Keywords: Patient Blood Management; Anesthesia; Health Care

Introduction

Patient Blood Management (PBM) is a collection of evidencebased interventions before, during and after major surgery that aim to avoid anemia, and reduce blood loss and allogeneic blood transfusions [1]. PBM has been recommended by the World Health Organization WHO since 2010 [2], and international and national governments support its implementation because of obvious benefits in terms of quality of care, patient outcome, and reductions in health care costs [3,4]. Nevertheless, implementation of all aspects of perioperative PBM is slow worldwide. Patient advocates require healthcare professionals to deliver perioperative PBM [5], while international scientific societies may focus only on single interventions in the bundle concept of PBM [6]. The main barriers to uptake may include misconceptions surrounding PBM, lack of knowledge, skills, and attitude towards using PBM, a need for more scientific evidence, lack of infrastructure and process descriptions, insensitive quality indicators as well as poor communication about the vision for PBM and benefits afforded by PBM. The aim of this article is to propose a shopping list-like summary of medicinal interventions as well as of educational and managerial aspects to facilitate the implementation of perioperative PBM.

Clinical Concept of Perioperative PBM

Perioperative PBM should be applied in major surgery with a relevant risk of bleeding. PBM is not applicable in minor surgery without relevant risk of bleeding.

The bundle concept of PBM have been described elsewhere in detail [1,4-6]. When anchoring PBM in the hospital’s culture a frequently encountered question is when to do which intervention. The following list may serve as an implemental tool and displays the requirement for interdisciplinary cooperation at various time points.

Preoperative interventions

Considering the axis of time, the following medicinal interventions are part of PBM before major surgery.

Optimizing hemostasis:

• Patient assessment including a standardized bleeding questionnaire

• Indication and interpretation of laboratory tests

• Detection of pre-existing coagulopathy

• Correction of pre-existing coagulopathy

• Patient- and procedure-specific withdrawal of antithrombotic drugs (with eventual bridging)

Management of anemia:

• Anemia detection

• Anemia correction, including support of hematopoiesis by administration of iron, folic acid, erythropoietin stimulating agents

• Diagnostic interventions for detecting reasons for iron deficiency anemia including gastrointestinal endoscopy, gynecological investigation

• Enhancing adaption to anemia, including increasing oxygen supply by correcting or at least optimizing cardiopulmonary disease

• Calculations, e.g. blood volume, tolerable blood loss

Blood conservation modalities:

• Planning less invasive surgical technique in patients at risk for increased bleeding, anemia, transfusion

• Planning autologous transfusion technique, e.g. cell saver

Patient-centered decision-making:

• Patient information including benefits and risks of PBM and alternatives

• Documentation of patient’s preferences and patient consent

Intraoperative interventions

The following medicinal interventions are indicated during major surgery.

Optimizing hemostasis:

• Quick surgical bleeding control

• Topical hemostatic agents

• Detection of acquired coagulopathy, e.g. by viscoelastic hemostatic assays

• Correction of acquired coagulopathy, e.g. by antifibrinolytic drugs, goal-directed substitution of coagulation factor concentrates

• Minimizing diagnostic blood loss

• Avoiding hypothermia

Management of anemia:

• Detection of anemia

• Indication and interpretation of laboratory tests including blood gas analysis, blood counts

• Enhancing adaption to anemia, including increasing oxygen supply by means of perioperative intensive care

• Volume monitoring, volume management, cardiovascular stabilization

• Anesthesia techniques, e.g. controlled hypotension, pain control

• Antibiotic prophylaxis

• Continuous assessment of blood loss (amount and rate)

• Restrictive allogeneic blood products transfusion including red blood cell concentrates, plasma, platelet concentrates

Blood conservation modalities:

• Using autologous cell salvage system

Patient-centered decision-making:

• Attention to patient’s preferences, needs, and concerns

Postoperative interventions

The following medicinal interventions are indicated after major surgery.

Optimizing hemostasis:

• In case of surgical bleeding: quick indication for redo surgery

• Detection of acquired coagulopathy

• Correction of acquired coagulopathy, e.g. by antifibrinolytic drugs, goal-directed substitution of coagulation factor concentrates

• Minimizing diagnostic blood loss

• Avoiding hypothermia

Management of anemia:

• Detection of anemia

• Indication and interpretation of laboratory tests including blood gas analysis, blood counts

• Enhancing adaption to anemia, including optimizing cardiopulmonary reserve by means of perioperative intensive care

• Volume monitoring, volume management, cardiovascular stabilization

• Pain control

• Antibiotic prophylaxis and therapy

• Continuous assessment of blood loss (amount and rate)

• Closed-line system for invasive blood pressure monitoring and blood gas analyses

• Replacing iron upon severe blood loss

• Restrictive allogeneic blood products transfusion including red blood cell concentrates, plasma, platelet concentrates

• Commencing venous thromboembolism prophylaxis

Blood conservation modalities:

• Using autologous cell salvage system for the maximum approved time (eventually including radiation, rhesus immunization)

Patient-centered decision-making:

• Attention to patient’s preferences, needs, and concerns

• Communicating applied PBM options

Post-graduate Education and Professional Development

Knowledge transfer and educational aspects facilitate the implementation of perioperative PBM.

Knowledge transfer during education of doctors, nurses and other healthcare professionals

Medical, economic and healthcare political background and rationale for PBM must be part of the educational program for all stakeholders. In each medical discipline, individual indications and practical performance of appropriate bundle content must be internalized.

Learned content in theory should promote the need to implement PBM in clinical practice.

PBM should be a compulsory component in the training of medical specialists for

• Anaesthesiology and intensive care

• Surgical disciplines including general surgery, orthopedic surgery & traumatology, gynaecology, urology

• Internal medicine

• General medicine

• Laboratory medicine

• Transfusion medicine

Example: PBM is included in the European Training Requirement (ETR) in Anaesthesiology of the European Board of Anaesthesiology (EBA) [7]. This ETR could serve as a model for other curricula in other countries and other medical disciplines as exemplified by the Austrian curriculum, which includes a national adaptation of the ETR [8].

PBM should also be a compulsory component in the training of

• Nurses

• Medical technical assistants.

PBM should be obligatory content in courses and masterclasses for hospital administrators and members of quality assurance committees should have an understanding of these policies.

Examinations

Structured multiple choice questions within diploma exams reinforce knowledge about PBM.

Example: PBM-focused multiple choice questions have been included in the European Diploma Exam in Anaesthesiology and Intensive Care. Questions have been prepared by authors of the guidelines from the European Society of Anaesthesiology (ESA) [6].

Professional development

Theoretical training for doctors and other healthcare providers is a prerequisite for maintenance of work authorization in many countries. PBM-related content is relevant to multiple disciplines and PBM competence levels across all disciplines should be refreshed and increased through recurring hospital internal education programs.

Example: Continuous Medical Education (CME) points can also be gathered in e-learning modules [9].

Professional development should also be compulsory for hospital administration personnel, although the emphasis in these courses should be cost savings and economic aspects of PBM.

Practical skill training

During medical training, medical simulation centers play a role at the European level [7] and at a national level [8] in the learning of both skills and attitudes. Medical simulation is also increasingly being used for focused professional development. In this context, PBMrelated knowledge can be applied and consolidated in the sheltered environment of a medical simulator, with the best results obtained if interdisciplinary teams are trained in different scenarios.

Example: Medical simulation centers in Linz and Hochegg are accredited by the Austrian scientific society ÖGARI and offer scenarios in PBM in German and English [9].

Preceptorship and visiting programs should be used so that medical personnel can see PBM implemented in daily practice and to allow learning at centers of excellence or centers of competence. It would be desirable for national scientific societies to grant accreditation to PBM-competent centers.

Example: Hospitals with PBM-competence or certification showcase this on their websites and information materials.

Managerial Requirements for PBM

Managerial aspects including infrastructure, process descriptions, and outcome benchmarking facilitate the implementation of perioperative PBM.

Infrastructure

It is within the responsibility of the organization (hospital owner) to provide the infrastructure, personnel, medicinal products and medication required for PBM application according to current standards and definitions. It is also the responsibility of the hospital to organize and keep records of instructions for all healthcare providers on how to use medicinal products according to the national law.

Hospitals performing major surgeries should get (re-) certification as a PBM provider only if the required infrastructure is guaranteed.

Depending on the number of major surgeries, an appropriate number of the following items must be provided in the hospital:

• Workplace equipment for anesthesia according to national regulations

• For surgical disciplines, workplace equipment for surgical bleeding control, e.g. hemostatic bandages, ultrasound for liver surgery, tamponade for peripartum hemorrhage

• Warming systems for patients and infusions

• Autologous cell salvage system

• Volume monitoring, e.g. pulse pressure variation, preload monitoring, echocardiography/doppler monitoring (because heart rate and blood pressure are insufficient for detecting hypovolemia) [6]

• Blood gas analyzer (for hemoglobin level, lactate level, calcium level)

• Coagulation tests including rapidly available viscoelastic hemostatic assays [6] (alternatively: fibrinogen levels, reptilase time)

• For perioperatively acquired coagulation disorders, recommended procoagulant drugs, e.g. fibrinogen concentrate, prothrombin complex concentrate

• Antifibrinolytic drugs, desmopressin, protamine, calcium, buffer solutions

• Crystalloid infusion fluids, colloidal infusion fluids

• Vasoactive medication, e.g. vasoconstrictors, vasodilators

• Heart rate modulating medication, (temporary) pace maker

• Transfusion lines, leukocyte filters

• Blood depot with allogeneic blood products including red blood cell concentrates, plasma, platelet concentrates

• Small-volume cuvettes for blood tests

• Closed-line system for invasive blood pressure monitoring and blood gas analyses

• Standardized bleeding questionnaire [10]

In addition, in hospitals caring for acute trauma patients, the following items must be provided:

• Idaruzicumab (Praxbind)

• As soon as licensed from responsible authorities: andexanet alpha

In addition, the following items could be provided:

• Radiation for autologous cell salvage blood in hospitals performing major cancer surgery

• Medication for rhesus immunization for autologous cell salvage blood in obstetrics

The following items must be provided in the hospital performing major surgery or in cooperation with extramural institutions:

• Laboratory tests including complete blood count, levels of ferritin, vitamin B12, and folic acid, Prothrombin Time (PT), Activated Partial Thromboplastin Time (aPTT), Thrombin Time (TT), fibrinogen level, diluted thrombin time, anti-Xa activity, (von Willebrand factor, platelet aggregation tests)

• Diagnostic interventions for detecting reasons for iron deficiency anemia including gastrointestinal endoscopy, gynecological investigation

The following facilitates the delivery of PBM:

• Pre-anesthesia clinics

Process criteria

It is the responsibility of the organization (hospital owner) to implement all processes in the bundle concept of PBM according to current standards:

• Availability of indicative publications, guidelines and standards in the hospital-internal information system, e.g. the quality standards PBM and the quality standards of preoperative diagnostics from the Austrian Ministry of Health, ESA guidelines on the management of perioperative severe bleeding [4,6].

Availability of process criteria for PBM should be a prerequisite for certification and re-certification of hospitals performing major surgery.

Standard operating procedures (SOP) should be defined and provided to all staff members.

• SOP for preoperative anemia correction

• SOP for pre- and postoperative iron substitution (after severe blood loss)

• SOP for controlled hypotension including definitions of contraindications

• SOP for transfusion triggers (hemoglobin plus physiological parameters, co-morbidities)

• SOP for ordering allogeneic blood products as single unitstrategy; supportive: electronic ordering system linked to laboratory data and in alignment with the individual transfusion trigger in the automated patient medical records

• SOP for bleeding management (acquired coagulopathy)

• SOP for the management of antithrombotic medication

• SOP for volume management (correction of hypovolemia)

• SOP for acute pain therapy including pre-emptive measures, intraoperative parenteral analgesia, nerve blocks, local surgical measures including local anesthetic infiltration, postoperative multi-modal pain therapy and systematic assessment and documentation of pain intensity: prescription of analgesia by the clock and on demand

• SOP for perioperative antibiotic prophylaxis and antibiotic therapy

• SOP for the use of conventional and small-volume cuvettes for blood tests

• SOP for postoperative laboratory testing

The following processes facilitate PBM implementation:

• Outpatient preoperative intravenous administration of iron, erythropoietin

• Outpatient preoperative optimization of the cardiopulmonary reserve (tolerance to anemia)

• Outpatient preoperative optimization of pre-existing coagulopathy

• Assignment of a PBM expert in the hospital with relevant training, e.g. MSc-master course in PBM at Danube University Krems [11]; tasks of the PBM-expert:

Deliver education and increase motivation of doctors, other healthcare providers and hospital administrators in the hospital among doctors.

Stepwise implementation of single interventions in the bundle concept of

PBM performing hospital-internal audits

Organizing means to make PBM

Implementation visible externally

Organizing presentations of PBM to patients and their relatives.

• Data processing related to PBM in the hospital information system

1. Automated calculation of the maximum tolerable blood loss with display at the anesthesia workplace

2. Individualized hemoglobin trigger (e.g. according to the definition in the pre-anesthesia clinic) to be displayed intraoperatively at the anesthesia workplace as well as postoperative at recovery room, intermediate care unit, intensive care unit, and normal ward until discharge from the hospital

3. Automated deposition of pre-existing co-morbidities in the ordering system for allogeneic blood products, e.g. coronary heart disease, obstructive pulmonary disease, heart insufficiency, cerebrovascular insufficiency, previous pneumonectomy

4. Feeding-in parameters during inpatient documentation into the ordering system for allogeneic blood products, e.g. ST dynamics, deterioration in kidney function parameters, increase in lactate levels

5. Automated program for detecting medication interactions should assist in avoiding prescription of drugs promoting anemia or bleeding

• Processing the PBM checklist in addition to the Safe Surgery checklist in order to increase vigilance around perioperative PBM [4]

Outcome quality indicators

It is the responsibility of the organization (hospital owner) to control and audit the implementation status of all processes in the bundle concept of PBM.

Documentation should prove PBM has been implemented according to the relevant quality standards.

At least three of the following parameters could serve as a basis for the annual hospital internal audit report as feedback for medicinal disciplines contributing to PBM, as well as for hospital administrators

1. Anemia at the start of major surgery in relation to the percentage of patients according to the type of surgical intervention

2. Hospital-acquired anemia in relation to the percentage of patients according to the type of surgical intervention

3. Consumption of equipment for the application of PBM in relation to the total case load (infrastructure: medication for anemia correction, sets for autologous cell saving, procoagulant medication)

4. Cost savings by PBM application including indirect costs for e.g. personnel, laboratory tests, process-dependent costs for transfusion, including cross match, storage, bedside testing

5. Percentage of single unit-transfusions in relation to all transfusions

6. Laboratory data before allogeneic transfusions including hemoglobin level, platelet count, INR, fibrinogen levels

7. Deviations from SOPs, e.g. in transfusion strategy

8. Number per year: Allogeneic blood products returned to the blood depot

9. Number per year and surgical intervention: allogeneic blood products provided

10. Number per year and surgical intervention: allogeneic blood products transfused

11. Ratio of provided/transfused allogeneic blood products per year and department

12. Ratio of provided/transfused allogeneic blood products per year and surgical intervention

13. Number and percentage per year of discarded allogeneic blood products

14. Intervention-specific number of transfused patients in relation to the total number of surgical patients

15. Hemovigilance including general transfusion reactions, transfusion-related acute lung injury (TRALI), transfusionrelated immunomodulation (TRIMM), transfusionassociated cardiac overload (TACO)

16. Morbidity in the patient population treated with PBM, including infections, pneumonia, sepsis, acute kidney failure, myocardial infarction and stroke

17. Length of stay in the hospital in the patient population treated with PBM

18. Mortality in the patient population treated with PBM

Hospital-internal ordering strategy for allogeneic blood products:

Red blood cell concentrates should be provided if the likelihood for transfusions in this type of surgery is higher than 10% within a year.

• Nationwide benchmarks should select outcome quality indicators in the field of PBM, e.g. in the Austrian-Inpatient Quality Indicators project (A-IQI).

Overcoming pitfalls in cost calculations:

1. If outpatient and inpatient services are paid out of different health insurance pots, total costs and wins in both pots need to be considered when analyzing cost savings by the implementation of PBM.

2. If cost savings for reductions in allogeneic blood product need are accounted to surgical departments of hospitals and costs for other PBM interventions to anesthesiological departments, interdisciplinary imbalance will arise; instead the net balance from the perspective of the total hospital‘s accounting should be considered.

3. Direct costs for plasma are lower than for coagulation factor concentrates. However, since hypofibrinogenemia in severe bleeding cannot be corrected by plasma but efficiently by fibrinogen concentrate, costs for plasma must be avoided. Direct costs for oral iron pills are lower than for intravenous iron. Again, cost calculations must consider the efficacy of drugs. Thus, costs for oral iron need to include indirect costs for the time laps until surgery.

Layperson Role in PBM Implementation

Historically extreme patient preferences with total avoidance of allogeneic blood challenged doctors to exploit every single intervention aiming to avoid anemia and reduce blood loss. Survival after major surgery including cardiac surgeries proved the concept of ultimate patient-oriented care and stimulated defining the bundle of PBM [1]. Moreover, the mismatch between blood donations and recipients’ needs, exploding costs and risks triggered the constitution of PBM. PBM was not the invention of one research group or one single individual but resulted from experience and scientific evidence from various medicinal fields:

• Risk of allogeneic blood products

• Diagnosis and therapy of acquired perioperative coagulopathy

• Tolerance to anemia

• Surgical technique

PBM will further develop with research in perioperative medicine as well as licensing of medications and technological inventions such as autologous transfusion techniques.

PBM will further develop with increased public research funds in this medicinal field which concerns a relevant proportion of citizen. Establishing urgency for PBM depends on the understanding: Information on aspects of PBM in an easy to read and understand format can increase both the understanding of public and compliance of patients and their relatives. This is important when considering time-consumption and discomfort during preoperative anemia correction. Multi-media material may be used before provision of structured information by the doctor [5]. Information prepared by scientific societies may be used [12]. Fulfilment of legal requirements relating to patient information mandates adequate documentation. Documentation material prepared by scientific societies may be used [13,14].

References

1. Shander A, Javidroozi M. Blood conservation strategies and the management of perioperative anaemia. Curr Opin Anaesthesiol. 2015; 28: 356-363
2. https://apps.who.int/gb/ebwha/pdf_files/wha63/a63_r12-en.pdf
3. https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/2017_
4. https://www.sozialministerium.at/site/Gesundheit/Gesundheitssystem/Gesundheitssystem_Qualitaetssicherung/Qualitaetsstandards/Qualitaetsstandard_Patient_Blood_Management
5. https://youtu.be/cjVYBoqj2sM
6. https://www.transfusion.ru/2017/05-03-1.pdf
7. https://www.uems.eu/__data/assets/pdf_file/0003/64398/UEMS-2018.17-European-Training-Requirements-in-Anaesthesiology.pdf
8. https://www.oegari.at/pruefungsinformationen.asp
9. https://www.perioperativebleeding.org/
10. https://www.oegari.at/web_files/dateiarchiv/editor/anamnesebogen2018_3.pdf
11. https://www.donau-uni.ac.at/de/studium/patientbloodmanagement/index.php
12. https://www.oegari.at/web_files/dateiarchiv/editor/patienten-information_blut-armut2015.pdf
13. https://www.oegari.at/web_files/dateiarchiv/editor/einwilligungsbogen2018_1.pdf