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W2020008515 abstract "The membership of the Society of Interventional Radiology (SIR) Standards of Practice Committee represents experts in a broad spectrum of interventional procedures from both the private and academic sectors of medicine. Generally, Standards of Practice Committee members dedicate the vast majority of their professional time to performing interventional procedures; as such, they represent a valid expert constituency of the subject matter under consideration for standards production. Technical documents specifying the exact consensus and literature review methodologies as well as the institutional affiliations and professional credentials of the authors of this document are available upon request from SIR, 3975 Fair Ridge Dr, Suite 400 N., Fairfax, VA 22033. These guidelines are an educational tool designed to assist practitioners in providing appropriate radiologic, procedural, and clinical care for patients. They are not inflexible rules or requirements of practice and are not intended, nor should they be used, to establish a legal standard of care. For these reasons and those set forth later, the SIR and the Society of Pediatric Radiology caution against the use of these guidelines in litigation in which the clinical decisions of a practitioner are called into question. The practitioner, in light of all the circumstances presented, must make the ultimate judgment regarding the propriety of any specific procedure or course of action. An approach that differs from these guidelines does not, of itself, imply that the approach was below the standard of care. To the contrary, a conscientious practitioner may responsibly adopt a course of action different from that set forth in the guidelines when, in the reasonable judgment of the practitioner, such course of action is indicated by the condition of the patient, available resources, or advances in knowledge or technology subsequent to publication of the guidelines. However, a practitioner who employs an approach substantially different from these guidelines is advised to document in the patient record information sufficient to explain the approach taken. The practice of medicine involves not only the science but also the art of the promotion of health and the prevention, diagnosis, alleviation, and treatment of disease. The variety and complexity of human conditions make it impossible to always reach the most appropriate diagnosis or to predict with certainty a particular response to treatment. Therefore, it should be recognized that adherence to these guidelines will not assure an accurate diagnosis or a successful outcome. All that should be expected is that the practitioner will follow a reasonable course of action based on current knowledge, available resources, and the needs of the patient to deliver effective and safe medical care. The purpose of these guidelines is to assist practitioners in achieving this objective. This guideline document was developed and written collaboratively by the SIR and the Society of Pediatric Radiology. It consists in part of adaptations from the general Clinical Practice Guidelines for Interventional Radiology, with permission of the publisher (1Cardella J.F. Kundu S. Miller D.L. Millward S.F. Sacks D. Society of Interventional Radiology clinical practice guidelines.J Vasc Interv Radiol. 2009; 20: S189-S191Abstract Full Text Full Text PDF PubMed Scopus (185) Google Scholar). The special skills of the interventional radiologist include both major and minimally invasive procedures performed in whole or in part with image guidance. The terms “interventionalist,” “intervention,” or “interventional” will be used throughout this document to represent interventional radiology in its broadest sense, inclusive of all disease processes, body systems, means of access, imaging modalities, equipment, and devices concerned. However, jurisdictions may differ on a variety of issues, including requirements of informed consent, scope of practice of nonphysician providers, and procedural coding and reimbursement practices. It is recommended in all cases that local regulatory agencies, medical boards, and hospital administration be consulted regarding the specific parameters applicable to a given practice. Pediatric interventional radiology is a clinical subspecialty of radiology whose focus spans the range of pediatric health and disease. This document has been prepared specifically for interventional radiologists who wish to develop within their practice a clinical focus on the treatment of children. Within this context, these guidelines are intended to be as inclusive as possible of all practice locations, inside and outside of the United States. An interventionalist interacts directly with patients and their families and guardians and counsels them regarding diagnostic and therapeutic options for their medical conditions. Interventional care is a longitudinal continuum, beginning with an initial consultation either formalized in a clinic setting or originating from discussion with a referring clinician, defining a plan of care that may include a diagnostic or therapeutic intervention, through to eventual resolution of the clinical problem or establishment of an alternative care plan. To achieve these ends, it is often necessary for the interventional radiologist to see patients in clinical practice settings and to create and execute management plans (1Cardella J.F. Kundu S. Miller D.L. Millward S.F. Sacks D. Society of Interventional Radiology clinical practice guidelines.J Vasc Interv Radiol. 2009; 20: S189-S191Abstract Full Text Full Text PDF PubMed Scopus (185) Google Scholar, 2Schor E.L. Family pediatrics: report of the Task Force on the Family.Pediatrics. 2003; 111: 1541-1571PubMed Google Scholar). In order to treat patients in a hospital setting, it is necessary that the interventionalist obtain the required hospital privileges. Furthermore, a clinical pediatric interventional radiology practice benefits from both appropriate procedural areas and traditional clinical office space. In addition to the necessary infrastructure requirements, there are benchmarks that define an interventional clinical practice. These benchmarks should be used as goals for developing the practice. Depending on the clinical complexity of the case and the practice environment, a clinical interventional radiologist should be in a position to: 1Independently accept referrals for diagnostic or therapeutic interventions as the responsible physician or as a consultant for the disease process;2Inform patients referred for services of the spectrum of diagnostic and therapeutic options that might benefit them and provide interventional treatment if they desire;3Establish treatment plans and implement them;4Admit patients who require inpatient services related to therapeutic interventions;5Consult specialists as indicated for opinions regarding aspects of care outside the regular scope of practice of the interventional radiologist;6Perform and bill for consultations for patients before and after planned or elective interventions; and7Provide longitudinal patient care. The following guidelines should be used to develop an interventional clinical practice for inpatient and outpatient clinical services. Recommendations will include processes for dealing effectively with pediatric clinical care issues, handling referrals, the physician–patient relationship, scheduling of invasive procedures, staffing, clinic space, time dedicated to clinical duties, interventional suites and equipment needs, administrative and clerical services, practice development, and continuous quality improvement programs. Maintaining a family-centered approach is a core value of pediatrics (2Schor E.L. Family pediatrics: report of the Task Force on the Family.Pediatrics. 2003; 111: 1541-1571PubMed Google Scholar) that should be fully supported by a pediatric interventional radiology practice and the hospital or health care system within which it operates. The foundation of family-centered care is a partnership between families and professionals that acknowledges and respects the integral role the family plays in the child's wellbeing, illness, and recovery. It affects the time and detail required for sharing information and obtaining consent, permitting parental presence during certain procedures, scheduling, and the provision of family-suitable facilities (eg, waiting rooms, play areas, space), to mention just a few examples. Informed consent has several essential features that must be provided or assured by the interventional radiologist (1Cardella J.F. Kundu S. Miller D.L. Millward S.F. Sacks D. Society of Interventional Radiology clinical practice guidelines.J Vasc Interv Radiol. 2009; 20: S189-S191Abstract Full Text Full Text PDF PubMed Scopus (185) Google Scholar). The patient or substitute decision-maker must understand the critical elements of the planned procedure, including its potential risks and benefits, expected outcomes, and the comparative risks and benefits of any alternatives. A detailed discussion of informed consent is beyond the scope of this document. When feasible, having this discussion at a time and place removed from the procedure will help the decision-maker be more relaxed and attentive, such as in a clinic setting, a multidisciplinary patient/family conference, or during a bedside visit. Ideally, the consenting individual will have full access to all relevant information in a form that is accessible and sensitive to the consenter's language and comprehension. The pediatric patient is often not legally capable of consent, although the age and conditions for consent vary from one jurisdiction to another. Even when the patient cannot legally consent, he or she should be afforded every opportunity to participate in the plan of care. The child who understands and assents to a procedure is more able to cooperate. When parents or guardians wish to limit the child's access to information about a medical condition or interventional procedure, the interventional radiologist must balance the parents' decision with the child's need for, or right to, information. Conflicts between parents and patients with regard to a plan of care can be very difficult to resolve, and may require the assistance of patient care representatives, medical ethicists, and legal staff. The sedation and analgesia needs of pediatric patients can vary widely and can be difficult to predict. A plan for patient comfort must be individualized to each patient and for each procedure, and may range from general anesthesia or intravenous or oral sedation to minimal anxiolysis. There are several models currently in use for the safe delivery of sedation, including the following: 1Sedation administered by an interventional radiologist or other interventional radiologic clinical provider;2Sedation administered by an anesthesiologist, intensivist, or other specialist not involved in the primary procedure;3A hospital-wide sedation service; and4A combination of the aforementioned determined on a case-by-case basis. There are published guidelines detailing the necessary requisites (3Wraith A. Sedation of children SIGN guidelines.SAAD Dig. 2002; 19: 3-13PubMed Google Scholar, 4ACR-SIR Practice Guideline for Sedation/Analgesia, Revision 2010. American College of Radiology, Reston, VA2010Google Scholar). There is general agreement that the sedation team must have the training, skills, and equipment necessary to resuscitate the patient. The interventional suite must be capable of monitoring critically ill patients and patients under deep intravenous sedation and analgesia or general anesthesia. The ability to monitor heart rate, electrocardiography, venous and arterial pressures (noninvasively or invasively), and pulse oximetry must be available at minimum. The ability to measure simultaneous pressures from multiple inputs can be helpful during certain procedures. It is also useful to be able to create a permanent record of any selected physiologic parameter. In order to adhere to the “As Low as Reasonably Achievable” principles of radiation protection, it is important to balance the need to limit radiation dose on a moment-by-moment basis against the need to image effectively and advance a successful procedure efficiently (5Connolly B. Racadio J. Towbin R. Practice of ALARA in the pediatric interventional suite.Pediatr Radiol. 2006; 36: 163-167Crossref PubMed Scopus (63) Google Scholar). A variety of free resources are available to assist in this process (and can be found at www.imagegently.com). Appropriate radiation protection in pediatric interventional radiology is important because of the increased sensitivity of children to radiation effects and the number of years of life during which to express any potential effects (6Hall E.J. Radiation biology for pediatric radiologists.Pediatr Radiol. 2009; 39: S57-S64Crossref PubMed Scopus (95) Google Scholar, 7Miller D.L. Balter S. Schueler B.A. Wagner L.K. Strauss K.J. Vanó E. Clinical radiation management for fluoroscopically guided interventional procedures.Radiology. 2010; 257: 321-332Crossref PubMed Scopus (141) Google Scholar, 8Kleinerman R.A. Cancer risks following diagnostic and therapeutic radiation exposure in children.Pediatr Radiol. 2006; 36: 121-125Crossref PubMed Scopus (421) Google Scholar). It is also important to manage exposure of interventional staff and other participants (9Faulkner K. Ortiz-Lopez P. Vano E. Patient dosimetry in diagnostic and interventional radiology: a practical approach using trigger levels.Radiat Prot Dosimetry. 2005; 117: 166-168Crossref PubMed Scopus (11) Google Scholar, 10Staniszewska M.A. Jankowski J. Personnel exposure during interventional radiologic procedures.Med Pr. 2000; 51: 563-571PubMed Google Scholar, 11Amis Jr, E.S. Butler P.F. Applegate K.E. et al.American College of Radiology white paper on radiation dose in medicine.J Am Coll Radiol. 2007; 4: 272-284Abstract Full Text Full Text PDF PubMed Scopus (717) Google Scholar, 12Miller D.L. Vañó E. Bartal G. et al.Occupational radiation protection in interventional radiology: a joint guideline of the Cardiovascular and Interventional Radiology Society of Europe and the Society of Interventional Radiology.Cardiovasc Intervent Radiol. 2010; 33: 230-239Crossref PubMed Scopus (194) Google Scholar). In brief, the radiation dose to the child may be reduced by carefully selecting such technical parameters as focal spot size, pulse width, pulse rate, field size, air-gap magnification, choice of screens, filter thickness and position, and antiscatter grid systems to match the size of the patient and the needs of the procedure. The operator should be judicious in the use of ionizing radiation, and should limit fluoroscopy time and the number of images obtained in angiographic and radiographic acquisitions. Appropriate use of nonionizing imaging modalities such as ultrasound during portions of suitable procedures may reduce the radiation dose. Additional dose reduction can be achieved through such software features as last image hold, storage of dynamic fluoroscopy, flexible automated detection systems, radiation-free patient positioning and collimation, and postprocessing magnification. Appropriate pediatric settings and protocols should be considered throughout the equipment work cycle, including at the time of purchase and equipment setup and during ongoing interventional radiology staff education (13Strauss K.J. Kaste S.C. ALARA in pediatric interventional and fluoroscopic imaging: striving to keep radiation doses as low as possible during fluoroscopy of pediatric patients--a white paper executive summary.J Am Coll Radiol. 2006; 3: 686-688Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar, 14Sheyn D.D. Racadio J.M. Ying J. et al.Efficacy of a radiation safety education initiative in reducing radiation exposure in the pediatric IR suite.Pediatr Radiol. 2008; 38: 669-674Crossref PubMed Scopus (54) Google Scholar, 15Strauss K.J. Pediatric interventional radiography equipment: safety considerations.Pediatr Radiol. 2006; 36: 126-135Crossref PubMed Scopus (49) Google Scholar). As recent Digital Imaging and Communications in Medicine standardization will make radiation dose information archival universal, it is important to assure that relevant information (eg, dose–area product or estimated skin entry dose) be reported in the medical record (16Miller D.L. Balter S. Wagner L.K. et al.Quality improvement guidelines for recording patient radiation dose in the medical record.J Vasc Interv Radiol. 2009; 20: S200-S207Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar) and considered during the informed consent process (7Miller D.L. Balter S. Schueler B.A. Wagner L.K. Strauss K.J. Vanó E. Clinical radiation management for fluoroscopically guided interventional procedures.Radiology. 2010; 257: 321-332Crossref PubMed Scopus (141) Google Scholar, 14Sheyn D.D. Racadio J.M. Ying J. et al.Efficacy of a radiation safety education initiative in reducing radiation exposure in the pediatric IR suite.Pediatr Radiol. 2008; 38: 669-674Crossref PubMed Scopus (54) Google Scholar). Each team member brings vital training and experience to the clinical interventional team. Team members need to work within and across conventional job descriptions to assist each other in meeting the demands of patient care, and to assure patient safety and comfort and procedural efficacy. They must also understand their specific individual roles in the care of the child. These include, but are not limited to, maintaining appropriate laboratory, imaging, and physiologic parameters (eg, body temperature, hydration, ventilation, and oxygenation); ensuring proper positioning, padding, and restraint; and correctly labeling and dosing medications so that the procedure is optimized to the individual. Appropriate pediatric life support certification (eg, Pediatric Advanced Life Support or equivalent) is strongly recommended. Ideally, pediatric image-guided interventions should be performed by or under the supervision of a pediatric interventional radiologist or an interventional radiologist with a special interest in and experience with pediatric interventions. Again, in ideal terms, highly specialized procedures require an interventional radiologist with additional specific training and experience. For example, pediatric interventional radiologists with relevant experience in neurologic interventions may perform neurointerventional procedures in children or they may be performed by neurointerventional radiologists with relevant experience treating children. Hybrid solutions may be necessary when the volume of such procedures is not sufficient to maintain currency of specific skills by a single individual. For example, in some centers, an interventional neuroradiologist and a pediatric interventional radiologist may jointly perform head and neck and neurologic vascular interventions. It is essential that interventional radiologists caring for pediatric patients be familiar with the relevant spectrum of pediatric disease, and be well versed in the principles of pediatric interventions and related care. Specific requirements for credentialing and privileges will vary from institution to institution. As part of the interventional team, other practitioners may assist the interventional radiologist in providing clinical care. These practitioners can help to improve the efficiency of the clinical practice, especially with regard to routine follow-up care in the hospital or in the office. Partnership with pediatric hospitalists may assist the interventional radiologist in timely consultation, development of a management plan, and follow-up for complex medical problems in pediatric interventional patients (17Connolly B. Mahant S. The pediatric hospitalist and interventional radiologist: a model for clinical care in pediatric interventional radiology.J Vasc Interv Radiol. 2006; 17: 1733-1738Abstract Full Text Full Text PDF PubMed Google Scholar). Midlevel practitioners (eg, advanced practice nurses, nurse practitioners, and physician assistants) work within the scope of practice of their supervising physicians as regulated by law (18Beach D. Swischuk J.L. Smouse H.B. Using midlevel providers in interventional radiology.Semin Intervent Radiol. 2006; 23: 329-332Crossref PubMed Scopus (12) Google Scholar, 19Rosenberg S.M. Rosenthal D.A. Rajan D.K. et al.Position statement: the role of physician assistants in interventional radiology.J Vasc Interv Radiol. 2008; 19: 1685-1689Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar). These individuals are specifically trained to function in the inpatient and outpatient clinical settings and are equipped with the skills needed to perform clinical duties (20Hong K. Georgiades C.S. Hebert J. et al.Incorporating physician assistants and physician extenders in the contemporary interventional oncology practice.Tech Vasc Interv Radiol. 2006; 9: 96-100Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar). They can perform histories and physical examinations, educate patients and families regarding informed consent (21Davies L. Laasch H.U. Wilbraham L. et al.The consent process in interventional radiology: the role of specialist nurses.Clin Radiol. 2004; 59: 246-252Abstract Full Text Full Text PDF PubMed Scopus (21) Google Scholar), and participate with the interventional radiologist in forming a clinical assessment and plan. Within an interventional practice, midlevel practitioners may develop particular areas of expertise and may perform as a first-line resource to patients and families. They may triage problems, provide education, take off-hour telephone queries, and manage minor problems or complications. Their clinical training makes them valuable complementary members of the interventional clinical team. A licensed independent practitioner employed by a radiology group can function as an independent member of the interventional team. In most settings, the licensed independent practitioner can perform selected interventional procedures, thereby increasing clinical productivity. There are clear differences in the way different midlevel practitioners can practice, as determined by various third-party payers, regulatory agencies, and health care centers. In some jurisdictions, appropriately trained nurses and radiologic technologists (ie, radiographers) can take on advanced roles in the interventional practice. Interventional radiologists are advised to consult with their local regulatory agencies and hospitals regarding the modes of practice that are acceptable in their regions. Radiology practitioner assistants are advanced practitioners with extended training in radiologic technology. They have a much different scope of practice than nurse practitioners or physician assistants, and, like registered nurses, are not recognized as independent providers, but work under the direct supervision of the interventional radiologist. Registered nurses and radiologic technologists play a critical role during interventional procedures; in addition, they can augment clinical services and provide care adjunctive to that provided by the practitioner. Many tasks require significant overlap of the roles of all team members. Other tasks are more specific to particular certification and training. The role of the radiologic technologists and nurses frequently include other responsibilities, such as performing as a “scrubbed-in” assistant during interventional procedures, procedural coding, inventory management, and workflow management. Extended training with advanced skills may also be included, with appropriate credentialing or certification. Nurses should be appropriately licensed with documented training and expertise in care of pediatric patients, although no specific certification pathway exists for pediatric interventional nurses. Nurses may administer intravenous sedation and analgesia under the supervision of the interventional radiologist or another physician or other licensed independent practitioner, within the credentialing standards of the institution and the scope of practice as defined by local authorities. Nurses frequently play a role in screening or triaging referrals, gathering laboratory values and historical information, speaking with family members, and assisting with research protocols. In the outpatient setting, adjunctive nursing care might include obtaining a history, systems review, and vital signs; drawing blood; and providing patient education, telephone consultation, and follow-up with patients. Radiologic technologists should be certified and licensed and should have documented training and experience in pediatric interventional procedures. No specific single certification pathway currently exists for pediatric interventional radiologic technologists. Technologists bring expertise in radiation protection techniques and their application in children. With the increasing complexity of imaging equipment and postprocessing software, it is helpful if the interventional radiologic technologist has a working knowledge of various imaging modalities (eg, US, fluoroscopy, digital subtraction angiography, and rotational and conventional computed tomography [CT]) and associated software. With the heavy reliance on US in many pediatric interventional radiology practices, it is helpful if a technologist is available who is familiar with and able to optimize sonographic imaging. Auxiliary services can assist the patient and family, decreasing frustration and anxiety while improving satisfaction. For example, child life specialists or play therapists can significantly improve patient comfort and decrease reliance on pharmacologic therapies to achieve patient comfort and adequate immobility. They may help to engage patients with nonpharmacologic interventions (eg, distraction, imagery and visualization, hypnosis, lighting, music, décor, three-dimensional goggles, and DVD players) (22Towbin A.J. Towbin R.B. Interventional radiology in the treatment of the complications of organ transplant in the pediatric population—part 2: the liver.Semin Intervent Radiol. 2004; 21: 321-333Crossref PubMed Scopus (3) Google Scholar). This information has been extrapolated from the adult data, as there are no pediatric data available. Similarly, patient and family liaisons can facilitate accurate communication; update patients, families, and referring clinicians regarding delays and scheduling changes; and comfort families during procedures and recovery. All these measures have the ability to decrease perceptions of pain and anxiety, increase comfort and satisfaction, and decrease procedure time. Administrative support and coordination are most helpful when they align interventional radiology within the institution's clinical pathway. It is important that the hospital administration understands and supports the broader clinical nature of pediatric interventional radiology and how it differs from an entirely diagnostic service. The administrative resources required to run an inpatient and outpatient clinical practice effectively include transcriptional services, information technology, office management, dedicated interventional scheduling, and clinical documentation. In certain jurisdictions, coding, billing, insurance precertification, and compliance may require administrative resources and support. In addition, personnel who can perform data management and quality improvement are required. A single individual may fill the responsibilities of more than one position. Often many of these services are already available within an institution and may therefore be expanded or modified to meet the additional requirements of the clinical service. The outpatient interventional clinic should become a routine entry point to the interventional clinical practice. An outpatient clinic is important for facilitating longitudinal care, including monitoring and surveillance of disease progression or recurrence. Patients and referring physicians have general expectations of a clinical practice. It is instrumental to the growth and future success of an interventional service that it meets such expectations. In the outpatient clinic setting, the interventional radiologist and support staff should perform the following duties while providing evaluation and management services: 1Determine an appropriate plan for diagnostic workup;2Determine need for and arrange consultation with other physicians;3Schedule interventional procedures;4Obtain informed consent and assent;5Order or prescribe appropriate medications and laboratory or imaging studies;6Provide follow-up care, including testing and evaluation after a procedure; and7Provide counseling visits. Currently, provision of a full clinical service represents a culture change in practice for some interventional programs and in the perception of many administrators (23Siskin G.P. Bagla S. Sansivero G.E. Mitchell N.L. The interventional radiology clinic: key ingredients for success.J Vasc Interv Radiol. 2004; 15: 681-688Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar). Provision of this service requires acknowledgement and endorsement of the importance of this activity for good clinical care. Clinic visits for outpatients, like ward rounds for inpatients, are the medium through which longitudinal care is delivered and quality of care is achieved. The interventional radiologist who is involved with the continuing care of a patient is following a conventional model of clinical care. The interventionalist is the health care professional most knowledgeable about interventional options and most capable of providing interventional management for a patient whose problem falls within the interventional radiologist's scope of practice. Clinicians typically pr" @default.
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W2020008515 title "Developing a Clinical Pediatric Interventional Practice: A Joint Clinical Practice Guideline from the Society of Interventional Radiology and the Society for Pediatric Radiology" @default.
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