Safety Is No Accident PDF 2019

Safety is No Accident A FRAMEWORK FOR QUALITY RADIATION ONCOLOGY CARE DEVELOPED AND SPONSORED BY Safety is No Accident A FRAMEWORK FOR QUALITY RADIATION ONCOLOGY CARE DEVELOPED AND SPONSORED BY: American Society for Radiation Oncology (...

Safety is No Accident A FRAMEWORK FOR QUALITY RADIATION ONCOLOGY CARE DEVELOPED AND SPONSORED BY Safety is No Accident A FRAMEWORK FOR QUALITY RADIATION ONCOLOGY CARE DEVELOPED AND SPONSORED BY: American Society for Radiation Oncology (ASTRO) ENDORSED BY: American Association of Medical Dosimetrists (AAMD) American Association of Physicists in Medicine (AAPM) American Board of Radiology (ABR) American Brachytherapy Society (ABS) American College of Radiology (ACR) American Radium Society (ARS) American Society of Radiologic Technologists (ASRT) Society of Chairmen of Academic Radiation Oncology Programs (SCAROP) Society for Radiation Oncology Administrators (SROA) TARG E T I NG C A NC E R C A RE The content in this publication is current as of the publication date. The information and opinions provided in the book are based on current and accessible evidence and consensus in the radiation oncology community. However, no such guide can be all-inclusive, and, especially given the evolving environment in which we practice, the recommendations and information provided in the book are subject to change and are intended to be updated over time. This book is made available to ASTRO and endorsing organization members and to the public for educational and informational purposes only. Any commercial use of this book or any content in this book without the prior written consent of ASTRO is strictly prohibited. The information in the book presents scientific, health and safety information and may, to some extent, reflect ASTRO’s and the endorsing organizations’ understanding of the consensus scientific or medical opinion. ASTRO and the endorsing organizations regard any consideration of the information in the book to be voluntary. All radiation oncology medical practice management and patient care decisions, including but not limited to treatment planning and implementation; equipment selection, maintenance and calibration; staffing and quality assurance activities, are exclusively the responsibility of duly licensed physicians and other practitioners, based on relevant information not available to the authors. Neither this book nor its content is a substitute for professional medical advice, diagnosis or treatment. The ultimate determination regarding the practices utilized by each provider must be made by the provider, considering any local, state or federal laws and certification and/or accreditation standards that apply to the provider’s practice, the applicable policies, rules and regulations of third-party payers, their own institution’s policies, procedures, and safety and quality initiatives, and their independent medical judgment. The information and opinions contained in the book are provided on an “as-is” basis; users of the information and opinions provided by the book assume all responsibility and risk for any and all use. ASTRO and all the endorsing organizations expressly disclaim all representations and warranties, expressed or implied, regarding the accuracy, reliability, utility or completeness of any information or other material provided here or in response to inquiry, including any warranty of merchantability and/or fitness for a particular purpose. Neither ASTRO, nor any endorsing organization, nor any ASTRO or endorsing organization’s officers, directors, agents, employees, committee members or other representatives, shall have any liability for any claim, whether founded or unfounded, of any kind whatsoever, including but not limited to any claim for costs and legal fees, arising from the use of this material. Copyright. American Society for Radiation Oncology. 2019. All Rights Reserved.  Acknowledgements Safety is No Accident was first issued in 2012. The first edition of this book was based on an intersociety meeting where various representatives of sister radiation oncology societies came together to draft these safety recommendations. At the time, it was noted that technologic advances and systemic changes in health care delivery meant that the field of radiation oncology and its processes of care are in continuous evolution. These changes must be reflected in this framework so timely review and revision was envisioned. In 2017, an effort to update the recommendations began by ASTRO’s Multidisciplinary Quality Assurance Committee (MDQA) that includes physicians, physicists, and other members of the radiation oncology team. A special thank you to the following MDQA members: Phillip Beron, MD, University of California, Los Angeles Joseph Bovi, MD, Medical College of Wisconsin Bonnie Bresnahan, RT, Anne Arundel Medical Center Derek Brown, PhD, University of California, San Diego Bhisham Chera, MD, University of North Carolina Michael Dominello, DO, Karmanos Cancer Center Suzanne Evans, MD, Yale University Shannon Fogh, MD, University of California, San Francisco Gary Gustafson, MD, William Beaumont Hospital Mark Hurwitz, MD, Thomas Jefferson University Ajay Kapur, PhD, Northwell Health System Teamour Nurushev, PhD, 21st Century Oncology Michael O’Neill, MD, Radiation Oncology Associates of Lynchburg Kelly Paradis, PhD, University of Michigan Lakshmi Santanam, PhD, Washington University Jing, Zeng, MD, University of Washington Members of the MDQA suggested revisions and then the revised draft was posted for comment to the sister societies, giving them the opportunity to provide additional updates. The suggested revisions from the sister societies were reviewed by MDQA leaders and ASTRO’s Clinical Affairs and Quality Council leaders, Jim Hayman, MD, University of Michigan; Todd Pawlicki, PhD, University of California, San Diego; Benjamin Smith, MD, University of Texas MD Anderson Cancer Center; and Eric Ford, PhD, University of Washington. The revised draft was approved by the ASTRO Board in January 2019 and endorsed by sister societies by March 2019.  TABLE OF CONTENTS Safety Is No Accident Chapter 1. The Process of Care in Radiation Oncology 1 1.1. PATIENT EVALUATION 1 1.2. RADIATION TREATMENT PREPARATION 2 1.2.1. Clinical Treatment Planning 2 1.2.2. Therapeutic Simulation, Fabrication of Treatment Devices and Preplanning Imaging 2 1.2.2.1. Therapeutic Simulation for External Beam Radiation Therapy 2 1.2.2.2. Therapeutic Simulation for Brachytherapy 3 1.2.3. Dosimetric Treatment Planning 3 1.2.4. Preparation for Radiation Therapy Using Unsealed Sources 4 1.2.5. Pretreatment Quality Assurance and Plan Verification 4 1.3. RADIATION TREATMENT DELIVERY 5 1.3.1. External Beam Radiation Therapy 5 1.3.2. Brachytherapy 5 1.3.3. Calibration Procedures, Ongoing Equipment Quality Assurance and Preventive Maintenance 7 1.4. RADIATION TREATMENT MANAGEMENT 7 1.5. FOLLOW-UP EVALUATION AND CARE 7 Chapter 2. The Radiation Oncology Team 8 2.1. ROLES AND RESPONSIBILITIES 8 2.2. QUALIFICATIONS AND TRAINING 9 2.2.1. Medical Director 10 2.2.2. Radiation Oncologist 10 2.2.3. Nonphysician Providers 10 2.2.4. Physicist 10 2.2.5. Dosimetrist 10 2.2.6. Radiation Therapist 10 2.2.7. Radiation Oncology Nurse 11 2.3. CONTINUING EDUCATION AND MAINTENANCE OF CERTIFICATION 11 2.4. STAFFING REQUIREMENTS 11 Chapter 3. Safety 12 3.1. THE NEED FOR A CULTURE OF SAFETY 12 3.2. LEADERSHIP AND EMPOWERING OTHERS 12 3.3. EVOLVING STAFF ROLES AND RESPONSIBILITIES 14 3.4. EXAMPLES OF TOOLS AND INITIATIVES TO FACILITATE SAFETY AND SAFETY CULTURE 14 3.4.1. Staffing and Schedules 14 3.4.2. Communication and Facilities 14 3.4.3. Standardization 14 3.4.4. Lean Methods 15 3.4.5. Risk Analysis 15 3.4.6. Hierarchy of Effectiveness 15 3.4.7. Systems and Human Factors Engineering 16 3.4.8. Automated Quality Assurance Tools 16 3.4.9. Peer Review 16 3.4.10. Daily Morning Huddles 18 3.4.11. Safety Rounds 18 3.4.12. Routine Public Announcements and Updates 18 3.4.13. Incident Learning 18 3.4.14. Quality Assurance Committee 18 3.4.15. Credentialing and Training of Staff 19 3.5. INGRAINING SAFETY INTO EVERYDAY PRACTICE 19 3.6. COLLABORATION BETWEEN USERS AND VENDORS 20 3.7. INVOLVING THOSE BEYOND RADIATION ONCOLOGY 21 Chapter 4. Quality Management and Assurance in Radiation Oncology 22 4.1. QUALITY REQUIREMENTS FOR RADIATION ONCOLOGY PRACTICES 22 4.1.1. Physical Requirements for Practices 22 4.1.2. Radiation Safety 23 4.1.2.1. Radioactive Source Procedures 23 4.1.2.2. Equipment Safety 23 4.1.2.3. Safety for Imaging Devices 23 4.1.3. Program Accreditation 23 4.1.4. Monitoring Safety, Quality and Professional Performance 23 4.1.4.1. Safety, Quality and Error Monitoring 24 4.1.4.2. Morbidity and Mortality Rounds 24 4.1.4.3. Minimizing Time Pressures 24 4.1.4.4. Monitoring Professional Performance 25 4.1.4.5. Peer Review 25 4.2. PATIENT-CENTERED QUALITY MANAGEMENT 25 4.2.1. General Medical Issues 25 4.2.2. Patient Access to Multidisciplinary Care and Technique Specialists 25 4.2.3. Outcome Assessment 26 4.2.4. Outcomes Registry 26 4.2.5. Quality Assurance for the Standard Treatment Process 26 4.3. EQUIPMENT AND DEVICE QUALITY MANAGEMENT 28 4.3.1. Equipment, Devices and Systems 28 4.3.1.1. System Specification, Acceptance Testing, Clinical Commissioning and Clinical Release 28 4.3.1.2. Process Quality Assurance 28 4.3.1.3. Maintenance 29 4.3.1.4. Interconnectivity and Interoperability of Devices and Systems 29 4.3.1.5. External Review 29 4.3.1.6. Equipment Replacement, Upgrades and Additions 30 4.3.2. External Beam Radiation Therapy 30 4.3.2.1. Qualification of External Beam Radiation Therapy Personnel 30 4.3.2.2. Minimum Device Requirements 30 4.3.2.3. Minimum Quality Assurance Requirements 30 4.3.2.4. Intensity-modulated Radiation Therapy and Volumetric-modulated Arc Therapy 31 4.3.2.5. Particle Therapy 31 4.3.2.6. Specialized Techniques and Devices 32 4.3.3. Brachytherapy 33 4.3.3.1. Qualification of Brachytherapy Personnel 33 4.3.3.2. Minimum Device Requirements 33 4.3.3.3. Minimum Quality Assurance Requirements 35 4.3.4. Imaging Devices 35 4.3.5. Commissioning and Quality Assurance of the Treatment Planning and Delivery Process 35 4.3.6. Treatment Planning Systems 36 4.3.6.1. Minimum Device Requirements 36 4.3.6.2. Minimum Quality Assurance Requirements 36 4.3.7. Treatment Management Systems 37 4.3.7.1. Minimum Device Requirements 37 4.3.7.2. Minimum Quality Assurance Requirements 37 4.4. DOCUMENTATION AND STANDARDIZATION 38 4.4.1. Medical Record Documentation 38 4.4.2. Policies and Procedures 38 References 39 Appendix I. Abbreviations 45 Appendix II. Illustrative Safety Staffing Model 46 2019 Forward I n 2012, as part of its Target Safely initiative, ASTRO spearheaded the effort among our specialty societies to update the “Blue Book.” During the 20 years prior to its previous update, major advances had been made in treatment planning and delivery resulting in increased technical complexity. At the same time, cancer care was becoming much more multidisciplinary both within and outside our departments, resulting in the need for improved communication. These issues, along with several others, led us to refocus our efforts to improve the quality and safety of the care we deliver. The recommendations in Safety Is No Accident provided an updated framework for achieving that goal. Since 2012, many additional efforts have been undertaken by our specialty societies to improve quality and safety. In the last five years, with the support of several other societies, ASTRO has initiated the RO-ILS: Radiation Oncology Incident Learning System®, one of the few specialty-specific national safety event reporting and shared learning systems. ASTRO has also launched its Accreditation Program for Excellence (APEx®), a comprehensive program based on a series of standards with a focus on continuous quality improvement. AAPM has also released reports and guidelines focused on quality and safety. For example, Task Group 263 focused on standardizing nomenclatures with a key goal to enhance future safety and quality efforts; Medical Physics Practice Guideline 4.a. focused on development, implementation, use and maintenance of safety checklists, and Task Group 100 focused on quality management and risk assessment. At the same time, there have been major advances in our specialty including increased use of MRI and PET-based simulation, knowledge-based planning, re-treatment, hypofractionation, surface imaging and MRI-guided treatments, particle therapy and immunotherapy. In light of what we have learned from these new initiatives and advances, it is a logical time to update Safety is No Accident to incorporate this new knowledge. Given the extent of the revisions undertaken six years ago, it is not surprising that some updates have been made to clarify the standardization of routine processes and procedures. One major point of emphasis in this update is to make clear that quality and safety are not just the responsibility of departmental leadership but the entire treatment team. Other areas where the bar has been raised involve certification of dosimetrists and radiation therapists, radiation safety, and supervision of stereotactic treatments. Over the next five years, it is likely that emerging technologies will continue to become part of routine practice and result in new unexpected challenges to quality and safety. In addition, we are entering an era where efficiency will be increasingly important, requiring us to reassess the usual way of doing things and focus only on those activities that add value. Going forward, we need to take what we have learned about quality and safety, combine it with the most effective technologies and activities such as automation, simplification and standardization, and incorporate them into a continuous quality improvement cycle to give our patients what they deserve, the best care possible. Todd Pawlicki, PhD, FASTRO Benjamin Smith, MD James A. Hayman, MD, MBA, FASTRO Eric Ford, PhD, FAAPM 2012 Forward D uring the latter part of the twentieth century, the “Blue Book” had a unique importance in defining the shape of a modern radiation oncology department. It set standards regarding personnel, equipment and quality assurance and has been an invaluable guide for department chairs and practice leaders. Twenty years have elapsed since the last edition was published and during that time the world of radiation oncology has changed beyond measure. These two decades have seen an unprecedented expansion in the technological tools at our disposal with clear benefits to our patients. At the same time, however, the “Great Expansion” has added the challenge of deep complexity to our planning and treatment delivery. These decades have also been associated with a vigorous awareness of safety in medicine generally and radiation oncology in particular. This movement is pushing the practice of medicine toward integrated teamwork and effective, simple, quality assurance procedures. The safe delivery of radiation therapy was never a simple matter and is now exceedingly complex. This new document is designed to address the specific requirements of a contemporary radiation oncology facility in terms of structure, personnel and technical process in order to ensure a safe environment for the delivery of radiation therapy. It was developed through collaboration between all of the major societies in the field representing physicians, medical physicists, radiation therapists, medical dosimetrists, nurses and administrators. It explicitly sets a high bar below which no radiation oncology facility should operate, and it foresees that the bar will be raised further in the years ahead. This book is unapologetic in its strong stance because, as the title states, safety is no accident. It comes from well-run facilities with good processes operating harmoniously within their capabilities. We recognize that some with smaller facilities may find the standards set here hard to achieve but we do not believe that they are impossible. We recognize that, in a declining economy, these high bars may prove a challenge but we believe this interdisciplinary document will help facility leaders advocate on behalf of patients from a position of strength. The authors wish this book to be a living manifesto of the specialty’s dedication to patient safety and, after initial publication, will place it on the web with regular updating to follow. Anthony L. Zietman, MD Jatinder R. Palta, PhD Michael L. Steinberg, MD 2011-2012 “Safety Is No Accident” Writing Chairmen  CHAPTER 1 The Process of Care in Radiation Oncology T he “process of care” in radiation oncology refers to Other team members involved in the patient’s planning and a framework for facilitating the appropriateness, treatment regimen include the medical physicist (physicist), quality and safety of all treatments received by medical dosimetrist (dosimetrist), radiation therapist, nursing patients undergoing radiation therapy (RT).1 staff and ancillary services. The radiation oncologist is responsible for coordinating care with other specialists. The process of care can be separated into the following five operational categories: Many of the procedures within each phase of care in radiation oncology should be completed before moving to the next phase Patient Evaluation in the patient’s care. Other processes will occur and recur Radiation Treatment Preparation during the course of treatment for various reasons (e.g., patient o Clinical Treatment Planning tolerance to treatment, changes in treatment) as dictated by o Therapeutic Simulation (simulation) the clinical scenario. Specific processes of patient care may o Dosimetric Treatment Planning vary between practices. While the process of care involves o Pretreatment Quality Assurance (QA) and Plan close collaboration between a team of qualified individuals, Verification the attending radiation oncologist is ultimately accountable Radiation Treatment Delivery for all aspects of patient care. Most RT practices use standard Radiation Treatment Management operating procedures (SOPs) to describe the treatment Follow-up Evaluation and Care approach and provide consistent protocols for staff. These SOPs are an essential component of any practice. There will A course of RT is a function of the individual patient be certain clinical scenarios which may require modification situation, composed of a series of distinct activities of varying of the SOPs to optimally treat the patient, and they should complexity. All components of care involve intense cognitive be documented. Collaboration between clinical staff helps medical evaluation, interpretation, management and decision- determine how treatment options outside of an SOP might be making by the radiation oncologist and other members of the tailored to a particular patient’s situation. clinical team. Each time a component of care is performed, it should be appropriately documented in the electronic health 1.1. PATIENT EVALUATION record (EHR). The clinical team, led by the radiation oncologist, provides At the request of another physician or patient, a radiation the medical services associated with the process of care. oncologist may be asked to evaluate the patient and Safety is No Accident 2019 | 1 recommend treatment or care for a specific condition/ of RT delivery (e.g., intensity-modulated radiation therapy problem, including further work-up. As part of this process, [IMRT], proton beam therapy, intensity-modulated proton the radiation oncologist obtains and reviews a clear, accurate therapy, three-dimensional [3-D] conformal radiation therapy and detailed description of the patient’s pertinent history, [CRT], two-dimensional [2-D] CRT, low-dose-rate or high- current and recent symptoms, physical findings, imaging dose-rate [HDR] brachytherapy, stereotactic radiosurgery studies, pathology and laboratory results, as appropriate. If [SRS], stereotactic body radiation therapy [SBRT]); specifying treatment is recommended, the goals of treatment, including areas to be treated, dose, dose fractionation and treatment curative or palliative intent, should be clearly established schedule. In developing the clinical treatment plan, the and discussed with the patient. The radiation oncologist radiation oncologist may use information obtained from and the patient (and family, as appropriate) should engage the patient’s initial clinical evaluation, as well as additional in shared decision-making about the appropriate course of tests, studies and procedures that are necessary to complete action, including a detailed discussion of the treatment risks treatment planning. Studies ordered as part of clinical and benefits. Following the radiation oncologist’s evaluation, treatment planning may or may not be associated with studies discussions with other members of the multidisciplinary care necessary for staging cancer. Imaging studies and laboratory team may ensue, as indicated. Potential combination and tests are often reviewed to determine the treatment volume optimal sequencing of treatment modalities, including surgery and relevant critical structures, commonly referred to as and systemic therapy (e.g., chemotherapy, hormonal therapy, organs at risk (OARs), in close proximity to the treatment immunotherapy, or molecular targeted therapy) should be area or more distant but receive radiation that needs to be considered. All factors pertinent to treatment decision-making monitored. Toxicities and tolerances associated with the (e.g., prior radiation and/or systemic therapy, implanted intent of treatment, including the time intervals between any devices and pregnancy status) must be documented as part retreatment, should be evaluated. of RT preparation and made available to the clinical team. Full details of the patient evaluation and consent process are Clinical treatment planning results in a complete, formally beyond the scope of this safety document.2 documented and approved directive/order for simulation or any pretreatment preparation. 1.2. RADIATION TREATMENT 1.2.2. Therapeutic Simulation, Fabrication of PREPARATION Treatment Devices and Preplanning Imaging Simulation is the process by which the patient’s anatomy is 1.2.1. Clinical Treatment Planning defined in relation to the geometry of the treatment device to Clinical treatment planning is a comprehensive, cognitive develop an accurate and reproducible treatment delivery plan. effort performed by the radiation oncologist and clinical team For this purpose, radiographic and photographic images of for each patient undergoing RT. The radiation oncologist the patient in the preferred treatment position are typically is responsible for understanding the natural history of the necessary. In general, the simulation procedure shows the patient’s disease process, conceptualizing the extent of relationship between the position of the target(s) and the disease relative to the adjacent normal anatomical structures, surrounding critical structures. For treatment techniques not and integrating the patient’s overall medical condition and requiring dosimetric planning, volumetric simulation is not associated comorbidities. Knowledge of the integration necessary as the pretreatment preparation may be completed of systemic and surgical treatment modalities with RT is via clinical setup and/or manual calculation. essential for appropriate care coordination in a safe and high- quality multidisciplinary approach. 1.2.2.1. Therapeutic Simulation for EBRT The simulation directive/order guides the procedure Clinical treatment planning for all modalities (e.g., external performed by the radiation therapist(s). It is helpful to beam radiation therapy [EBRT], brachytherapy or unsealed think of the simulation step as the patient position and sources) is an important step in preparing for treatment. imaging needed to inform the dosimetric treatment The timing of certain preparation components may vary planning process. Modern simulators, like the computed depending on patient requirements and a practice’s preference tomography (CT) simulator (less commonly magnetic and workflow. These components include: determining the resonance or position emission tomography (PET) disease-bearing areas based on the imaging studies and simulator), have the ability to produce volumetric data pathology information; identifying the type and method in addition to 2-D images. Intravenous, intracavitary or Safety is No Accident 2019 | 2 oral contrast may be used during simulation to improve studies taken with different patient positioning. TPS and visibility of both target and normal tissues/structures. some CT-simulator devices can provide the software for Markers, such as wires, ball bearings or fiducials may be this capability. Use of TPS software shifts this part of the used to facilitate planning. process to the dosimetric treatment planning phase within the overall care process. The radiation oncologist reviews Selecting a reproducible and appropriate patient and verifies the accuracy of the fusion on the clinically treatment position is an important part of the simulation relevant region prior to proceeding to target delineation process. The selected patient position should consider and normal tissue definition. the location of the target and anticipated orientation of the treatment beams as well as the comfort of the 1.2.2.2. Therapeutic Simulation for Brachytherapy patient. This may involve the construction or selection For certain brachytherapy procedures, treatment of certain immobilization devices used to facilitate preparation is similar to the procedure described for treatment but should not restrict the treatment technique. EBRT. The simulation portion for this treatment modality A personalized approach is required, taking into is also typically imaging based and can involve planar consideration each patient’s unique anatomy and other X-rays, CT scans, or ultrasound images, sometimes in case-specific concerns to promote accurate treatment, combination with MRI scans. Other imaging modalities provide support and enhance reproducibility. Some may be important for some brachytherapy procedures; devices (e.g., vaginal dilators/obturators, mouth opening/ obtaining these studies is part of the preplanning imaging tongue position devices and prostate-rectal spacers) may process. assist with reducing doses to adjacent normal tissue. 1.2.3. Dosimetric Treatment Planning Preparing for EBRT treatment can also depend on The computer-aided integration of the patient’s unique other imaging modalities that are directly or indirectly anatomy, the desired radiation dose distribution to the introduced in the simulation process. In some cases, extra target(s), dose constraints to normal tissues and the technical time and effort are required to directly incorporate the specifications of the treatment delivery device yield a work information available from other imaging modalities. product referred to as the dosimetric treatment plan. The plan Treatment planning systems (TPS) that include image is a programmed set of instructions for the linear accelerator registration capabilities allow the fusion of multiple or brachytherapy device whereby a combination of external imaging modalities, such as magnetic resonance imaging beams or internal source positioning administers the intended (MRI) and/or PET, with the standard CT dataset dose of radiation to the target volume while limiting the obtained during simulation in appropriate situations. In exposure of normal tissues. addition, it is possible to produce image datasets that quantify the motion of structures and targets due to Accordingly, before the dosimetrist begins the dosimetric respiration, cardiac motion and physiologic changes in planning process, the radiation oncologist communicates and the body. These four-dimensional (4-D) datasets include documents relevant clinical information and any additional time as the fourth dimension and are used for motion instructions regarding treatment planning and treatment management techniques like respiratory tracking or delivery in the planning directive/order. Additionally, the gating. Other motion management techniques (e.g., radiation oncologist has the following responsibilities: assisted or voluntary breath hold) may be used to help promote accurate treatment delivery and these are Confirm registration, when applicable; considered and included during simulation as needed. Define the target volumes on the images obtained during simulation; In some cases, patients require imaging from outside Specify the normal tissues requiring segmentation; of the radiation oncology practice. On such occasions, Specify dosimetric objectives and priorities for the the exact patient positioning may not be duplicated for target(s) and OARs; these images and therefore clinical considerations should Identify patients with prior radiation history and be made to compensate for variations. Most image other patient-specific considerations documented registration is still performed manually with rigid datasets. during the initial consultation; and However, more practices are utilizing tools including Detail the total desired dose, fractionation, treatment deformable image registration for co-registering imaging technique, energy, time constraints, on-treatment Safety is No Accident 2019 | 3  imaging and all other aspects of the radiation 1.2.5. Pretreatment QA and Plan Verification prescription. In some cases, the prescription may For safe and high-quality RT, a pretreatment QA program be modified based on the results of is required. The QA steps taken after treatment planning the treatment planning process. is completed and before starting treatment is critical to maximize patient safety. An important initial step is an The dosimetrist and physicist must be appropriately trained in independent check of the dose calculation (monitor units) for the efficient and effective use of the complex TPS hardware EBRT or dose (source strength and temporal pattern) and and software. They must also understand the clinical aspects implant geometry for brachytherapy. Monitor units or dwell of radiation oncology in order to interact with the radiation times can be manually verified by a point dose calculation oncologist during the planning process. Treatment planning in a high-dose region. Alternatively, verification may be tools are evolving, and various systems may be used to performed with computer-assisted software, using the patient’s optimize the treatment plan. planning image data set in a separate software program along with the plan parameters. In either case, confirmation The radiation oncologist reviews treatment plan(s) generated of linear accelerator output settings or brachytherapy source during the dosimetric planning process using a combination of strengths/dwell times by an independent method is required graphic visual representations of the radiation dose distribution to reduce the risk of an input mistake in the primary treatment inside the patient and quantitative metrics describing the dose planning software. If an independent calculation method is to the target(s) and OARs (e.g., dose-volume histograms). The not available, then an appropriate measurement technique plan evaluation should include a review of OARs delineated by should be used. Under the supervision of the physicist and/or planning staff for accuracy. Additionally, these plans may be radiation oncologist, appropriately trained clinical staff may compared against a documented standard, such as output from approve such QA documents. a knowledge-based planning system or practice’s protocol. The radiation oncologist then decides whether to accept or reject a Secondary checks and a collaborative team environment are given plan. This process may be iterative and require multiple important for a comprehensive QA program. The physicist revisions and adjustments to the initial plan to achieve a dose reviews the physician-approved plan, which includes analysis distribution that is both clinically acceptable and technically of the dose distribution, coverage of targets, protection of feasible. The radiation oncologist is responsible for selecting critical OARs and appropriate fusion of additional treatment and formally approving the plan ultimately chosen for planning imaging (i.e., MRI, PET) to the planning CT, treatment, verifying that it satisfies the clinical requirements and many other checks. Additional checks are required and prescription(s) and that it can be carried out accurately. for brachytherapy plans, such as appropriate dwell time distribution and correct source activity. These are covered in 1.2.4. Preparation for Radiation Therapy Using more detail in Chapter 4. Unsealed Sources For clinical situations where therapy using unencapsulated Plan verification is accomplished in several different ways radionuclides is indicated, a distinct treatment planning depending on the technique and complexity of treatment. process is necessary due to its multidisciplinary execution. The One component of verification is to ensure that the intended process involves calculating the anticipated dose distribution target is being irradiated. Historically, this consisted of field to the target organ or tumor(s), and normal tissues, based aperture imaging using radiographic film, referred to as on the patient’s vascular anatomy or biological imaging portal images or port films. These images are now frequently (e.g., nuclear medicine scans). This process should include obtained using electronic portal imaging devices. With the multidisciplinary evaluation of the patient and consideration introduction of IMRT, imaging of individual apertures is not of clinical indications and radiation safety precautions. The always practical. However, the traditional method of verifying American College of Radiology (ACR)/American Society the plan isocenter position using orthogonal imaging is often for Radiation Oncology (ASTRO) practice guideline on used for both 3-D CRT and IMRT. For either portal imaging unsealed radiopharmaceutical sources and Nuclear Regulatory or isocenter verification imaging (using volumetric or planar Commission regulations discuss the special and unique images), a reference image for comparison is necessary. This radiation safety risks and procedures associated with unsealed information is generated from the imaging performed during sources in greater detail.3,4 the simulation step in the process. Safety is No Accident 2019 | 4 For IMRT, this important QA technique is not completely 1.3. RADIATION TREATMENT DELIVERY sufficient to address safety concerns. Additionally, fluence verification should be performed for IMRT and other complex delivery techniques that use inverse treatment planning. 1.3.1. External Beam Radiation Therapy This involves either patient-specific plan QA measurements With treatment planning and pretreatment QA complete, the or other independent calculation checks where appropriate. patient is ready for treatment. The initial step for radiation In the context of brachytherapy, pretreatment verification therapists in treatment delivery is verification of patient by independently verifying the dose calculation at several identity and treatment site. This is followed by patient setup on randomly chosen points is needed. the treatment table using several different techniques, such as simple skin marks and a room laser system that localizes the When organizing the steps in the process of care, integrating treatment unit isocenter. the verification step described in this subsection and the treatment delivery step described in Section 1.3 occurs Prior to the initiation of treatment, the verification of the prior to or on the first day of treatment and whenever the isocenter and/or treatment fields is performed by the imaging treatment plan is changed. While patient-specific plan QA system, as appropriate. IGRT can be used to improve the measurements are obtained prior to the start of treatment, accuracy of patient setup, especially in the context of an dosimeters are sometimes also placed on the patient as a internal target that can move on a daily basis. The radiation verification of correct dose delivery. The information gathered oncologist must review all images and alignments during on the first day of treatment, if within acceptable limits, allows the prescribed course of treatment to confirm the therapy the treatment to continue for all fractions using the same delivered conforms to the original clinical and dosimetric treatment plan. In certain situations, the radiation oncologist plans. and/or physicist may need to assess the in-room setup, for example, to verify light fields for electron setups or bolus Similarly, management of organ motion during treatment placement. delivery, when indicated, is the responsibility of the treating physician (Figure 1.1). A variety of motion management Image-guided radiation therapy (IGRT) equipment is techniques (e.g., assisted or voluntary breath hold, surface available to check the patient setup on the treatment table imaging, and/or surrogate marker tracking) may be used to immediately prior to treatment delivery and then to adjust help promote accurate treatment delivery. the patient position as needed to localize the target volume precisely within the volume that receives the prescription dose. Adaptive techniques can involve a modification to the initial IGRT provides increased setup accuracy allowing for smaller treatment plan to adjust for an observed change. target volumes that spares normal tissue surrounding the tumor. This equipment can be used to verify the patient setup 1.3.2. Brachytherapy daily and can supplement port film information. An advantage Brachytherapy involves the temporary or permanent of IGRT is that it sometimes provides volumetric imaging placement of radiation source(s) (isotopic or electronic) inside capabilities. This process goes well beyond the simple plan or immediately adjacent to a tumor-bearing region (Figure verification process discussed earlier in this section. 1.1). Additionally, brachytherapy may be used alone or in combination with EBRT. For example, permanent seed The QA process must also include steps aimed at verifying implants for prostate cancer can be used either as monotherapy data transfer integrity through the complete chain of systems for early stage or recurrent disease or as a boost before or after (e.g., CT-simulator to TPS to treatment management system ERBT for intermediate- or high-risk disease. As in EBRT, [TMS] to treatment delivery system [TDS]). A robust treatment delivery includes various methods, modalities and information technology infrastructure is a critical requirement complexities. The physicist and physician are responsible for for safe treatment delivery and timely review of imaging and verification and documentation of the accuracy of treatment other data. delivery as related to the initial treatment planning and setup procedure. This includes the accurate identification and localization of catheters or needles immediately prior to treatment delivery. Depending on the treatment site and technique used, this may include ultrasound, CT, and/or MRI. Safety is No Accident 2019 | 5  Figure 1.1. Process of Care for External Beam Radiation Therapy Figure 1.1. Process of Care for EBRT and Brachytherapy Evaluation and Clinical Plan Clinical Coordination Patient Evaluation Overall Clinical Plan Therapeutic Simulation (imaging (Imaging for for planning) Planning) Treatment Preparation Dosimetric Treatment Planning Pretreatment Review and Verification Quality Management for Equipment and n fractions Software Treatment Setup (can include image guidance) Plan Change: Cone-down or Treatment Adaptive Treatment Delivery Techniques (including (including physician management and IGRT Review) review) On-treatment Evaluation (physician on-treatment verification and physics review) Post-treatment Verification Completion Follow-up Care Safety is IGRT, image-guided No Accident: radiation A Framework for Quality Radiation Oncology and Care, Copyright © 2018. American Society for Radiation Oncology. therapy. Safety is No Accident 2019 | 6 1.3.3. Calibration Procedures, Ongoing Equipment tumor response. All evaluations should be documented in the QA and Preventive Maintenance patient’s record. The initial commissioning, ongoing performance evaluation and periodic calibration of RT delivery devices are important It should be emphasized that treatment management requires tasks that are vital to the safe administration of RT. The the integration of multiple medical and technical factors, physicist is primarily responsible for the device evaluations which may be required on any day throughout the treatment necessary for compliance with applicable state and federal course and is performed as often as necessary. While nurses regulations concerning RT delivery technology and is and nonphysician providers effectively participate in managing accountable for calibrating the absolute dose output for patients receiving treatment, typically by helping manage side any therapeutic radiation emitting device. The American effects associated with the treatment, this is not a substitute Association of Physicists in Medicine (AAPM) has for the personal evaluation by a radiation oncologist, who is published extensive guidelines on the conduct of these ultimately responsible for comprehensive patient management. duties and regularly updates its educational materials when new technologies enter into standard clinical practice. The 1.5. FOLLOW-UP EVALUATION AND CARE radiation oncologist, physicist and other clinical staff should maintain a clear channel of communication on the issue of At the completion of treatment, the physicist reviews the treatment device performance so that any sign of impending patient’s treatment documents (e.g., dosimetric treatment machine malfunction is quickly recognized and diagnosed, plan, calculation and chart check, record of delivered dose) for and corrective or reparative action taken prior to use of the accuracy and completeness and prepares a technical summary. machine to deliver a clinical treatment to a patient. The radiation oncologist prepares the treatment summary documenting the start and end date of treatment (including 1.4. RADIATION TREATMENT MANAGEMENT any treatment breaks), treatment delivered, frequency of treatment, tolerance and toxicity of therapy, follow-up plan and any ongoing issues.5 A copy of the treatment summary is Treatment management encompasses the radiation oncologist’s shared with other providers of the patient’s care team, which complete oversight of the course of treatment and care for may include the primary care physician and the referring the patient as well as checks and approvals provided by other physician. When details of a patient’s prior treatment are clinical staff (e.g., physicist and therapist weekly chart check). requested from an external provider, the treatment summary This requires the radiation oncologist to provide a minimum of and any other necessary documents should be promptly shared. one patient medical evaluation and examination during their treatment. For treatments consisting of numerous fractions, Continued patient follow-up evaluation and care of those examination and evaluation for each five-fraction treatment who received radiation is necessary to manage acute and period is needed. Treatment management may include the chronic morbidity resulting from treatment, and to monitor following elements: disease status (i.e., free of disease; local, regional or distant relapse). Preferably, follow-up is performed by the treating Review of patient treatment setup; radiation oncologist or a nonphysician provider to obtain the Review of treatment setup verification images (which most accurate information regarding treatment tolerance, side may occur daily for IGRT or surface guided RT); effects and disease status. The radiation oncologist should Review of dosimetry, dose delivery and treatment consult with other clinical staff when unexpected morbidity is parameters; observed or reported to review the delivered plan for accuracy Patient examination, including treatment tolerance and identify potential measures to reduce the risk of toxicity and pain management assessment; and for future patients. Survivorship clinics may play a role in the Response to treatment. management of long-term cancer treatments. The radiation oncologist’s evaluation may vary based on individual patient requirements, technique or treatment The goal of radiation treatment is to achieve the best possible modifications. For example, use of port films may vary based outcome for the patient. Creating a safe environment on certain technical characteristics (e.g., electron beams) and dedicated to continuous quality improvement is an essential modification of dose delivery can vary based on individual part of any practice. This can be accomplished by having patient needs, the patient’s tolerance of therapy, or variation in consistent processes that are formally documented and adhered to for each step in the process of care. Safety is No Accident 2019 | 7  CHAPTER 2 The Radiation Oncology Team 2.1. ROLES AND RESPONSIBILITIES Administrative staff (including IT); Dentists; Clinical social workers; The radiation oncology team works to provide every patient Psychologists/psychiatrists; undergoing RT with the appropriate level of medical, Nutritionists; nutritional, emotional and psychological care before, during Speech/swallowing therapists; and after treatment, through a collaborative multidisciplinary Physical therapists; approach which may include other specialties (e.g., medical Occupational therapists; oncology, anesthesiology, urology). Genetic counselors; Physicist, therapist and nursing assistants; The interdisciplinary radiation oncology clinical team (clinical Patient navigators; team) typically consists of: Integrative medicine specialists; or Pastoral care providers. Radiation oncologists; Medical physicists; Each aspect within the process of care requires knowledge and Medical dosimetrists; training in cancer biology, certain benign disease processes, Radiation therapists; and radiobiology, medical physics and radiation safety that can Oncology nurses. only be demonstrated by board certification in radiation oncology to synthesize and integrate the necessary knowledge The clinical team may include other individuals, such as base to safely render complete care. In addition to knowledge nonphysician providers: and technical skills, clinical staff must function as a cohesive team by communicating and interacting effectively with Nurse practitioners; colleagues and patients.6 Clinical nurse specialists; Advanced practice nurses; or Under the leadership of the radiation oncologist, the Physician assistants. clinical team works together to deliver radiation safely and reproducibly.7 Use of ionizing radiation in medical treatment To meet the complex needs of patients, other staff may provide requires direct physician management and input from the additional services on-site or by consultation including, but not clinical team due to its irreversibility. Team interactions should limited to: be consistent with a culture of safety and should consider the Safety is No Accident 2019 | 8 vital and unique role that each team member contributes. Each The scope of practice of each team member is based on criteria clinical team member is encouraged to ask clarifying questions established by their professional organization and local as needed and to proceed to the next step in the process of care jurisdiction. In addition, each practice must have policies only when any concerns or issues have been addressed. and procedures to define the roles of clinical staff, their appropriate competency assessment, credentialing and periodic Table 2.1 is an attempt to clarify the roles and relative evaluations. responsibilities of the clinical team. Table 2.1. Roles and Responsibilities of the Clinical Team Table 2.1. Roles and Responsibilities of the Clinical Team Oncology Nurse Nonphysician Dosimetrist Providers* Oncologist Radiation Radiation Therapist Physicist Clinical evaluation X X X Ongoing psycho/social evaluation X X X Decision to deliver RT X Patient +/- family education X X X X X Coordination of care X X X X Patient positioning and image acquisition X X X X Fusion and registration X X X Contouring/segmentation X X X Dose-volume constraints X X X Dose calculation X X X X Review of final treatment plan X X X X Patient-specific QA X X X X Treatment delivery X X X X Special procedures (SRS, SBRT, HDR, etc.) X X X X Monitor accuracy of delivery (ports, dose, etc.) X X X X Weekly evaluation X X X X X X Follow-up X X X Survivorship X X X Equipment, software and system acceptance X X testing, maintenance and commissioning *Nonphysician providers include nurse practitioners, clinical nurse specialists, advanced practice nurses and physician assistants. HDR, high-dose-rate; QA, quality assurance; RT, radiation therapy; SBRT, stereotactic body radiation therapy; and SRS, stereotactic radiosurgery. 2.2. QUALIFICATIONS AND TRAINING The primary consideration for establishing proper In addition, the clinical team and nonphysician providers qualifications and training for clinical staff and nonphysician must meet requirements for obtaining a state license, where providers is board certification. The respective certifying applicable, as shown in Table 2.2. bodies establish the eligibility requirements to sit for a board exam, including education, training and clinical requirements. Safety is No Accident 2019 | 9  Table 2.2. Certification Table and Licensure Requirements* 2.2. Certification and Licensure Requirements* Profession Relevant State Licensure Information Resources Certifying Required? Body Radiation ABR Yes www.theabr.org Oncologist AOBR https://certification.osteopathic.org/radiology/ RCPSC www.royalcollege.ca/rcsite/home-e Physicist ABR Yes www.theabr.org CCPM (In four states [FL, www.ccpm.ca NY, TX, HI] as of 2018)8 Dosimetrist MDCB No www.mdcb.org Radiation ARRT Yes www.arrt.org Therapist (In most states)9 Nurse AANP Yes www.aanp.org Practitioner ANCC Yes www.nursecredentialingancc.org Oncology ANCC Yes www.nursecredentialing.org Nurse ONCC www.oncc.org Clinical Nurse ANCC Yes www.nursecredentialingancc.org Specialists Physician NCCPA Yes www.nccpa.net Assistant *Information in this table is subject to change and is current as of the date of publication. *Information in this table is subject to change and is current as of the date of publication. AANP, American AANP, Academy AmericanofAcademy Nurse Practitioners; ABR, AmericanABR, of Nurse Practitioners; Board of Radiology; American BoardANCC, American Nurses of Radiology; ANCC, Credentialing American NursesCenter; AOBR, AmericanCredentialing Osteopathic Board of Radiology; ARRT, American Registry of Radiologic Technologists; CCPM, Canadian College Center; AOBR, American Osteopathic Board of Radiology; ARRT, American Registry of Radiologic of Physicists in Medicine; FL, Florida, HI, Hawaii; MDCB, Medical Dosimetrist Certification Board; NCCPA, National Commission on Certification of Physician Technologists; CCPM, Canadian College of Physicists in Medicine; FL, Florida, HI, Hawaii; MDCB, Medical Assistants; NY, New York; ONCC, Oncology Nursing Certification Corporation; TX, Texas; RCPSC, Royal College of Physicians and Surgeons of Canada. Dosimetrist Certification Board; NCCPA, National Commission on Certification of Physician Assistants; NY, New 2.2.1. Medical Oncology Nursing Certification Corporation; TX,www.aanp.org; Director York; ONCC; American Texas; RCPSC, Royal Nurses College Credentialing of Physicians and Center, The Medical Director Surgeons is a radiation oncologist who is of Canada. www.nursecredentialing.org; National Commission on responsible for oversight of the practice and for establishing Certification of Physician Assistants, www.nccpa.net; American clinical policies and procedures. They are also accountable for Academy of Physician Assistants, www.aapa.org). the quality of patient care. 2.2.4. Physicist 2.2.2. Radiation Oncologist Physicists should be certified in accordance with the The radiation oncologist has American Board of Radiology appropriate qualification for the designation of Qualified (ABR) certification in Radiation Oncology, Therapeutic Medical Physicist (as published at www.aapm.org), Radiology or equivalent certification (www.theabr.org/). Therapeutic Medical Physicist (as published at www.theabr.org) Alternatively, the radiation oncologist can be certified by the or equivalent certification. Royal College of Physicians and Surgeons of Canada (www.royalcollege.ca/rcsite/home-e) or the American 2.2.5. Dosimetrist Osteopathic Board of Radiology (https://certification. Dosimetrists should be certified in accordance with the osteopathic.org/radiology/). appropriate qualification for the designation of Certified Medical Dosimetrist through the Medical Dosimetrist 2.2.3. Nonphysician Providers Certification Board at www.mdcb.org. The roles, qualifications, licensure requirements and maintenance of credentials for these individuals should be 2.2.6. Radiation Therapist determined by their professional organizations, applicable Radiation therapists should be certified and registered scope of practice laws and regulations, rules of individual in accordance with the appropriate qualification for the practices’ and licensure regulations within individual designation of Radiation Therapist, published by the American jurisdictions (American Academy of Nurse Practitioners, Registry of Radiologic Technologists at www.arrt.org. Safety is No Accident 2 0 1 9 | 10 2.2.7. Radiation Oncology Nurse Many specialty societies offer opportunities for clinical A qualified oncology or radiation oncology nurse has oncology staff to satisfy the requirements of MOC. For example, certification, in addition to basic educational preparation to ASTRO offers live and online courses with self-assessment function as a registered professional nurse, as determined continuing medical education to fulfill the lifelong learning by the individual jurisdiction. Oncology certification can requirements. To help radiation oncologists fulfill their be obtained through the Oncology Nursing Certification practice quality improvement requirements, ASTRO provides Corporation (www.oncc.org), American Nurses Credentialing several templates to be used with various ASTRO programs, Center (www.nursecredentialing.org), or National Association including the Accreditation Program for Excellence (APEx®) of Clinical Nurse Specialists (www.nacns.org). and RO-ILS: Radiation Oncology Incident Learning System®. ACR has the R-O PEER program and the AAPM offers similar initiatives for physicists, such as an online 2.3. CONTINUING EDUCATION AND library of self-assessment modules. Clinical staff should take MAINTENANCE OF CERTIFICATION advantage of these opportunities. The applications, technologies and methodologies of RT continue to expand and develop, therefore lifelong 2.4. STAFFING REQUIREMENTS learning is vital to incorporating new knowledge into clinical practice. Each member of the clinical team should The staffing needs of each practice are unique and can vary participate in available Continuing Medical Education and, greatly based upon the patient mix and the complexity of where applicable, Maintenance of Certification (MOC) or the services offered. Patient load, number of machines, staff Continuing Qualifications Requirements programs. absences (planned and unplanned) and satellite/affiliated practices can impact the management and staffing of full- With guidance from the American Board of Medical time equivalent (FTE) employees (Table 2.3). As such, it is Specialties (ABMS), medical specialties developed MOC impossible to prescribe definitive staffing levels. programs to provide greater oversight of physicians and other health care providers. The ABMS defined four components The practice must have a qualified radiation oncologist on-call of MOC: professional standing, lifelong learning and 24 hours a day, seven days a week, to address patient needs self-assessment, cognitive expertise and practice quality and/or emergency treatments. An adequate number of other improvement. MOC is considered a critical component clinical staff should be available to deliver urgent treatments of good clinical practice, even if not mandatory in some regardless of operating hours, or the practice must arrange for situations. referral of emergency patients for timely treatments. Table 2.3.Personnel Table 2.3. Minimum MinimumRequirements Personnel Requirements for Clinical for Clinical Radiation Radiation Therapy Therapy Category Staffing Medical Director One per practice Radiation Oncologist Minimum of one radiation oncologist present during treatment hours* Physicist Minimum of one physicist available during treatment hours* Administrator One per practice (in some practices this function may be filled by clinical staff) Dosimetrist As needed, ~ one per 250 patients treated annually† Radiation Therapist As needed, ~ one per 90 patients treated annually†‡ Mold Room Technologist As needed to provide service Other staff (e.g., nurse, social As needed to provide service worker, dietician) * Refers to minimum requirements for treatment to take place. The number of clinical staff required to safely provide clinical care for patients is likely to be higher. † This number may be higher or lower depending upon the complexity of patients and treatments. ‡ It is recommended Table 3.2.that a minimum Examples of at least two qualified of Intradisciplinary Peerindividuals Review be present and for any Quality external beam Assurance treatment. Items* Safety is No Accident Team Member Peer Review Quality Assurance 2019 | 11 Physician Target definition Verify appropriate nomenclature and  CHAPTER 3 Safety 3.1. THE NEED FOR A CULTURE OF SAFETY Furthermore, all clinical staff must be open to having any member of the team (whether in leadership positions or not) raise concerns about safety and suggest changes. Indeed, it is Given the complex and rapidly evolving nature of RT, its often the frontline staff that are more likely to understand the safe delivery requires a concerted and coordinated effort by limitations of current procedures and propose improvements. many individuals with varied responsibilities. Furthermore, In a safety-minded culture, all staff are encouraged to suggest efficiency also impacts safety. Inefficient systems lead to staff * and effect change to improve safety, quality and efficiency. frustration, rushing and sometimes cutting corners, thus, all staff should work together to create a safe and efficient clinical environment and workflow. 3.2. LEADERSHIP AND EMPOWERING OTHERS The need for efficiency is heightened by the increasing demands being placed on all clinical staff. Changes (e.g., The practice’s leadership (headed by the Medical Director structural, financial) in health care systems and increasing or Chair, working in conjunction with other radiation levels of administrative burden (e.g., documentation oncologists, physicists, other clinical and administrative staff) requirements) require clinical staff to search for ways to must create a culture of safety and empower all staff to actively improve efficiency. It is essential to provide time for clinical participate in improving clinical processes without fear of staff to perform critical safety-related activities. reprimand or reprisal. This empowerment is a meaningful way to provide staff with a feeling of responsibility, thereby As the field advances, traditional approaches, processes and increasing job satisfaction, raising expectations and enhancing workflows should be continually challenged and reassessed. performance. Each member of the clinical team needs to accept that optimal approaches are not static but may be modified to accommodate Although leadership has the ultimate responsibility to be the evolving practice. champions of safety, all clinical staff should be empowered to operate as advocates for safety-related initiatives. Additionally, Change is essential for continual improvement, but difficult for the patient should be empowered to play an active role in the many individuals and organizations. Good clinical practices culture of safety program. usually evolve over years if not decades, so change should be carefully implemented. It is important that the culture accepts *For simplicity, the term ‘staff’ is used when referring to clinical staff, and implements change, thereby facilitating safety and quality. nonphysician providers and administrative staff. Safety is No Accident 2 0 1 9 | 12  Table 3.1. Examples* of Safety-related Roles and Challenges – Radiation Oncology Staff Team Member Traditional Role Evolving Role Challenges Physician Patient care Team leader for patient safety Relinquish some autonomy to other personnel Supervise RT (e.g., set dose/ Coordination with Engaging others in safety mission volume criteria, approve multidisciplinary team Education in advanced process analysis tools for plan and treatment images, Continuous education (e.g., image patient safety manage toxicity) evaluation/segmentation, new Communication software/technology) Physicist Assure the safe and Incorporating technological Education in advanced process analysis tools for effective delivery of innovations to improve patient/ patient safety radiation as prescribed staff safety Broaden view of role beyond task-specific QA Assess safety of treatment duties processes (e.g., failure mode Communication analysis, fault trees) Dosimetrist Perform treatment planning Changing modalities involved in Adequate instruction in anatomy image cataloging/manipulation Proper utilization of emerging (e.g., PET/MRI fusion/registration/ imaging/segmentation tools segmentation) Communication Assist physicist in IMRT/IGRT equipment QA Evolution in planning (e.g., knowledge-based planning, particle therapy planning, biological modeling) Radiation Provide safe and effective Assessment of 2-D/3-D images to Safe and proper use of imaging and TDS (DIBH, Therapist delivery of radiation as make decisions concerning patient prone positioning, SGRT, etc.) prescribed alignment Communication Perform daily equipment Utilization of various motion and new patient treatment management equipment QA Adapting to changing modalities for IGRT and treatment (MRI linacs, surface imaging, particle therapy) Nurse Assist with patient Patient pain Adequate instruction in evolving technologies care/education Assist in multidisciplinary Knowledge of evolving systemic agents Manage toxicity coordination Communication Nonphysician Assist physician with patient Coordination with Legal or regulatory restrictions Providers care multidisciplinary team Adequate instruction in evolving technologies Knowledge of evolving systemic agents Administrator Oversight of regulatory Support patient safety program Resource allocation compliance Funding and supporting safety- critical operations IT Specialist Provide desktop support Connectivity Resources Data archiving/recovery Space Vendor interoperability All Clinical Staff Proper patient identification QA/QI Identification/discussion of near-misses Peer review Increased documentation in EHR Continuous education Evolving peer review Increased reliance on EHR Compliance with evolving Adequate instruction with regulatory requirements software/technological advances Dedicating time for safety initiatives Minimizing distractions 621 *This is not an exhaustive list. *This is not an exhaustive list. 622 DIBH, deep inspiration breath hold; EHR, electronic health record; IGRT, image guided radiation therapy; IMRT, intensity 623 DIBH, modulated radiation deep inspiration therapy; breath IT, information hold; EHR, technology; electronic health MRI, image-guided record; IGRT, magnetic resonance radiationimaging; therapy;PET, IMRT,positron emission radiation intensity-modulated therapy; IT, information technology; MRI, magnetic resonance imaging; PET, positron emission tomography; RT, radiation therapy; SGRT, surface guided radiation therapy; TPS, treatment planning system; TDS, treatment delivery system; QA, quality assurance; and QI, quality improvement. 20 Safety is No Accident 2 0 1 9 | 13 3.3. EVOLVING STAFF ROLES AND multifaceted and costly investment for a practice; however, there are clear benefits in terms of retrieving documentation RESPONSIBILITIES and communication.14 Clinical staff must keep pace with changes in practice. Table For practice layout, centrally locating dosimetry and/ 3.1 summarizes some safety-related changes and associated or establishing dedicated time for radiation oncologists challenges to the rapidly changing clinical teams’ roles and and dosimetrists to work together facilitates the iterative responsibilities. “directive-segment-computation-review-repeat” cycle. This is a challenge when physicians and planning staff rotate between facilities. 3.4. EXAMPLES OF TOOLS AND Enhanced tools are needed to enable efficient and accurate INITIATIVES TO FACILITATE SAFETY AND communication and the transfer of complex 3-D data between practices. A well-defined communication pathway between SAFETY CULTURE clinical staff will verify messages are sent/received and reduce the need for ad hoc and variable solutions. The rationale for assessing quality is to be able to improve it in a measurable way. Assessment of outcomes, however, is challenging as they may not be realized immediately, and 3.4.3. Standardization Standardization is widely recognized as a means to reduce co-factors (e.g., multidisciplinary care, sample sizes, evolving errors. Due to personal preference, clinical staff may utilize technologies and patient characteristics) complicate risk diverse approaches to processes to reach the same end goal. adjustment models.10,11 Having too many diverse approaches may lead to confusion, particularly given the numerous interactions between staff. The following is not an exhaustive list of quality and safety Additionally, rotating between different physical locations tools and initiatives. Given varying degrees of supportive and/or equipment may exacerbate misunderstandings. evidence, the tools needed, and how to effectively use and Adopting consistent practices agreed upon by staff establishes assess the tools may be at the discretion of the individual consistent expectatio