Developing a clinical pediatric interventional practice: a joint clinical practice guideline from the Society of Interventional Radiology and the Society for Pediatric Radiology.
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Page 1
STANDARDS OF PRACTICE
Developing a Clinical Pediatric Interventional
Practice: A Joint Clinical Practice Guideline from
the Society of Interventional Radiology and the
Society for Pediatric Radiology
Kevin M. Baskin, MD, Mark J. Hogan, MD, Manrita K. Sidhu, MD, Bairbre L. Connolly, MB,
Richard B. Towbin, MD, Wael E.A. Saad, MD, Josee Dubois, MD, MSc,
Manraj K.S. Heran, MD, FRCPC, Francis E. Marshalleck, MD, Donald L. Miller, MD,
Derek Roebuck, MBBS, Michael J. Temple, MD, FRCP, T. Gregory Walker, MD,
John F. Cardella, MD, and members from the Society of Interventional Radiology Standards of
Practice Committee and Society for Pediatric Radiology Interventional Radiology Committee
PREAMBLE
The membership of the Society of Interventional Radiology (SIR) Stan-
dards 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 litera-
ture 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 practitio-
ners 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 prac-
titioner who employs an approach substantially different from these guide-
lines 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.
From the Department of Radiology (K.M.B.), Children’s Hospital of Pittsburgh,
University of Pittsburgh Medical Center, Pittsburgh; Department of Radiology
(J.F.C.), Geisinger Health System, Danville, Pennsylvania; Section of Vascular
and Interventional Radiology, Department of Radiology (M.J.H.), Nationwide
Children’s Hospital, The Ohio State University, Columbus, Ohio; Department
of Radiology (M.K.S.), Seattle Children’s Hospital, University of Washington,
Seattle, Washington; Center for Image Guided Therapy (B.L.C., M.J.T.), Hos-
pital for Sick Children, University of Toronto, Toronto, Ontario; Department of
Medical Imaging (J.D.), Centre Hospitalier Universitaire Sainte-Justine, Mon-
treal, Quebec; Department of Radiology (M.K.S.H.), British Columbia Chil-
dren’s Hospital; Department of Radiology (M.K.S.H.), Vancouver General
Hospital Vancouver, British Columbia, Canada; Department of Radiology
(R.B.T.), Phoenix Children’s Hospital, Phoenix, Arizona; Department of Radi-
ology (W.E.A.S.), University of Virginia Health System, Charlottesville, Vir-
ginia; Department of Radiology (F.E.M.), Riley Hospital for Children, Indiana
University School of Medicine, Indianapolis, Indiana; Department of Radiology
(D.L.M.), Uniformed Services University of the Health Sciences; Department
of Radiology (D.L.M.), National Naval Medical Center, Bethesda, Maryland;
Department of Radiology (D.R.), Great Ormond Street Hospital, London,
United Kingdom; and Division of Vascular Imaging and Intervention (T.G.W.),
Massachusetts General Hospital, Boston, Massachusetts. Final revision re-
ceived and accepted July 18, 2011. Address correspondence to K.M.B., c/o
SIR, 3975 Fair Ridge Dr., Suite 400 N., Fairfax, VA 22033. E-mail: kevin.
baskin@chp.edu
W.E.A.S. is a paid consultant for Boston Scientific (Natick, Massachusetts),
has research funded by Siemens (Forchheim, Germany), and serves on the
Speaker’s Bureau for Atrium (Hudson, New Hampshire). None of the other
authors have identified a conflict of interest.
The views expressed in this article are those of the authors and do not
necessarily reflect the official policy or position of the Department of the
Navy, Army, Department of Defense, nor the United States Government.
This article is being published concurrently in Pediatric Radiology, volume
41(12), 2011. The articles are identical except for minor stylistic differences
in keeping with each journal’s style. Either citation can be used when citing
this article. Permission to reproduce this article can only be granted by the
copyright holder, the Society of Interventional Radiology. To request per-
mission to print this article in a journal, Web site, or other publication,
please contact the SIR at dkatsarelis@sir.org
© SIR, 2011
J Vasc Interv Radiol 2011; 22:1647–1655
DOI: 10.1016/j.jvir.2011.07.010
Page 2
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 Interven-
tional Radiology, with permission of the publisher (1). The special skills
of the interventional radiologist include both major and minimally
invasive procedures performed in whole or in part with image guid-
ance. The terms “interventionalist,” “intervention,” or “interventional”
will be used throughout this document to represent interventional radi-
ology 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 nonphy-
sician 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 radi-
ology 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 clin-
ical 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 manage-
ment plans (1,2).
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 ap-
propriate 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 posi-
tion to:
1. Independently accept referrals for diagnostic or therapeutic interven-
tions as the responsible physician or as a consultant for the disease
process;
2. Inform patients referred for services of the spectrum of diagnostic and
therapeutic options that might benefit them and provide interventional
treatment if they desire;
3. Establish treatment plans and implement them;
4. Admit patients who require inpatient services related to therapeutic
interventions;
5. Consult specialists as indicated for opinions regarding aspects of care
outside the regular scope of practice of the interventional radiologist;
6. Perform and bill for consultations for patients before and after planned
or elective interventions; and
7. Provide longitudinal patient care.
The following guidelines should be used to develop an interven-
tional 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.
ISSUES IN PEDIATRIC CLINICAL CARE
Family-centered Care
Maintaining a family-centered approach is a core value of pediatrics (2)
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.
Consent and Assent
Informed consent has several essential features that must be provided or
assuredbytheinterventionalradiologist(1).Thepatientorsubstitutedecision-
maker must understand the critical elements of the planned procedure, includ-
ing 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 compre-
hension.
Thepediatricpatientisoftennotlegallycapableofconsent,althoughthe
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 infor-
mation about a medical condition or interventional procedure, the inter-
ventional 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.
Sedation, Analgesia, and Anesthesia
The sedation and analgesia needs of pediatric patients can vary widely and
can be difficult to predict. A plan for patient comfort must be individual-
ized 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:
1. Sedation administered by an interventional radiologist or other inter-
ventional radiologic clinical provider;
2. Sedation administered by an anesthesiologist, intensivist, or other spe-
cialist not involved in the primary procedure;
3. A hospital-wide sedation service; and
4. A combination of the aforementioned determined on a case-by-case
basis.
There are published guidelines detailing the necessary requisites
(3,4). 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.
1648 ? Joint Guidelines: Developing a Pediatric Interventional PracticeBaskin et al ? JVIR
Page 3
Radiation Protection
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 (5). 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 in-
terventional 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 (6–8). It is also important to manage
exposure of interventional staff and other participants (9–12). 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 radia-
tion, and should limit fluoroscopy time and the number of images obtained
in angiographic and radiographic acquisitions. Appropriate use of nonion-
izing 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. Ap-
propriate 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 (13–15). 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 (16) and considered during the informed
consent process (7,14).
CLINICAL TEAM
Each team member brings vital training and experience to the clinical inter-
ventional 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 cor-
rectly 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.
Interventional Radiologists
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 interven-
tions. Again, in ideal terms, highly specialized procedures require an inter-
ventional radiologist with additional specific training and experience. For
example, pediatric interventional radiologists with relevant experience in
neurologic interventions may perform neurointerventional procedures in chil-
dren 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.
Other Licensed Independent Practitioners
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.
Hospitalist physicians. 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 (17).
Midlevel practitioners. 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 (18,19).
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 (20). They can perform histories and physical
examinations, educate patients and families regarding informed consent
(21), 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 inter-
ventional 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 con-
sult with their local regulatory agencies and hospitals regarding the modes
of practice that are acceptable in their regions.
Radiology practitioner assistants. 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 inter-
ventional radiologist.
Clinical Interventional Staff
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 manage-
ment, and workflow management. Extended training with advanced skills
may also be included, with appropriate credentialing or certification.
Interventional nurses. 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 labora-
tory 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
Volume 22 ? Number 12 ? December ? 20111649
Page 4
signs; drawing blood; and providing patient education, telephone consul-
tation, and follow-up with patients.
Radiologic technologists. Radiologic technologists should be certi-
fied and licensed and should have documented training and experience in
pediatric interventional procedures. No specific single certification path-
way 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 equip-
ment and postprocessing software, it is helpful if the interventional radio-
logic 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
Auxiliary services can assist the patient and family, decreasing frustration
and anxiety while improving satisfaction. For example, child life special-
ists or play therapists can significantly improve patient comfort and de-
crease reliance on pharmacologic therapies to achieve patient comfort and
adequate immobility. They may help to engage patients with nonpharma-
cologic interventions (eg, distraction, imagery and visualization, hypnosis,
lighting, music, décor, three-dimensional goggles, and DVD players) (22).
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 SERVICES
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 manage-
ment, dedicated interventional scheduling, and clinical documentation. In
certain jurisdictions, coding, billing, insurance precertification, and com-
pliance 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 addi-
tional requirements of the clinical service.
OUTPATIENT CLINIC
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 expec-
tations. In the outpatient clinic setting, the interventional radiologist and
support staff should perform the following duties while providing evalu-
ation and management services:
1. Determine an appropriate plan for diagnostic workup;
2. Determine need for and arrange consultation with other physicians;
3. Schedule interventional procedures;
4. Obtain informed consent and assent;
5. Order or prescribe appropriate medications and laboratory or imaging
studies;
6. Provide follow-up care, including testing and evaluation after a proce-
dure; and
7. Provide 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 (23). Provision of this service requires acknowl-
edgement 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 man-
agement for a patient whose problem falls within the interventional radi-
ologist’s scope of practice.
Space and Equipment
Clinicians typically practice in a traditional physician office setting that
includes standard amenities such as a receptionist, patient and family
waiting area, and private consultation and examination areas. A successful
clinical interventional practice will benefit from quality dedicated clinical
space that will meet outpatient needs and expectations.
Office space for outpatient visits may be most economically achieved
through an office-sharing arrangement within a hospital-owned clinic or in
conjunction with another subspecialty clinic such as a general pediatric
surgical clinic. If interventional radiologists and other colleagues offer
special multidisciplinary services, such as treatment of vascular anomalies
or feeding and nutrition, combining efforts in a multidisciplinary specialty
clinic may help coordinate care more effectively and improve patient and
family satisfaction.
There are potential advantages to establishing an office practice that
is separate from the procedural area. These include increased awareness of
the clinical interventional practice among other doctors in the clinic area,
an increased understanding by potential referring doctors of the practice’s
level of commitment to longitudinal patient care, and an improved status
with the hospital. The examination room(s) should be large enough to
accommodate an examination table, a sink, enough chairs for the patient
and at least one family member, a wheelchair or stroller if needed, as well
as equipment and supplies appropriate to the pediatric population.
Time
Ideally, interventional clinics should be staffed with practitioners not
concurrently scheduled to perform procedures. The time required for the
clinical care of pediatric patients may differ from that required for adult
patients, as additional time is needed for elicitation of history through
parents or guardians, physical examination, obtaining consent, and edu-
cating the patient and relevant caregivers (eg, parents, guardians, blended
families).
Time recommended for evaluating new pediatric interventional pa-
tients and providing adequate follow-up care for patients is in the range of
5–15 hours per week or more, as described later. The exact time required
for nonprocedural evaluation and management encounters will vary de-
pending on the size and nature of the practice.
The time (including physician and ancillary personnel time) allotted
per clinic patient should be 45–60 minutes for each new patient and 20–30
minutes for each follow-up patient (1):
● Practices performing fewer than 1,000 procedures per year may require
5 hours per week;
● Practices performing between 1,000 and 3,000 procedures per year may
require 5–15 hours per week; and
● Practices performing more than 3,000 procedures per year may require
15 hours or more of clinic time per week.
1650 ? Joint Guidelines: Developing a Pediatric Interventional Practice Baskin et al ? JVIR
Page 5
Communication of Clinical Care
Appropriate documentation of the outpatient clinic visit is imperative for
patient care as well as for legal and billing purposes. It should include a
signed and dated record of the initial evaluation and treatment plan and
should document communications with the referring clinician. It should be
coded according to local regulatory requirements and archived appropri-
ately (24–28). A formal consultation report, as opposed to a radiography
report, should be sent to the referring physician in a timely fashion.
Requirements differ depending on the patient and physician setting,
and are often defined by the payer, health system, or national standards
(24–26,29). The medical record must support the scope and level of
service, and match assigned codes where applicable (24–28). In the United
States, adherence to International Classification of Disease codes is re-
quired by the Health Insurance Portability and Accountability Act (24,29).
These codes apply to inpatient services. In addition, Current Procedural
Terminology codes are used to define evaluation and management encoun-
ters (24,25,27). The assigned codes depend upon physician status (treating
vs consulting) and patient status (inpatient vs outpatient) (25). The codes
also differ depending on the time involved in the clinical care and the
complexity of the encounter (25,30). Different coding systems may apply
in other jurisdictions. Proper coding is essential for appropriate billing and
to assure legal and regulatory compliance (25,30). This information has
been extrapolated from the adult data because there are no pediatric data
available.
INPATIENT REQUIREMENTS
Admitting Privileges
It is no longer possible to merely perform technical procedures without
providing ongoing clinical care to patients (31,32). Admitting privileges
signify that the hospital acknowledges the clinical role of the interven-
tional service and that the service is willing and able to assume the primary
responsibility for patients within their scope of practice. It is essential for
a clinical interventional radiology service that desires to admit patients that
the hospital grants the same admitting privileges as those of the surgical
and medical procedural services. Increasingly interventional radiologists
have used these privileges to optimize patient care through personal
inpatient management and treatment (33–36). A clinically competent
interventional radiologist managing the patient minimizes gaps in conti-
nuity of care and potential risks inherent in the system of having different
physicians performing the procedure and managing the patient (37,38).
The interventional service is best informed about preprocedural workup
and preparation, postinterventional care and management of related po-
tential complications, and the appropriate timing of hospital discharge and
outpatient follow-up of patients within their scope of practice. Therefore,
the ability to accept patient referrals for admission and management is
important to the effectiveness and long-term success of any clinical prac-
tice (31,39).
Ideally, the following patients may be admitted to the interventional
service unless a medical condition exists or arises that is best managed by
another service:
● Patients seen in consultation and believed to warrant elective inpatient
interventional therapeutic procedures;
● Patients treated in the interventional suite who develop related compli-
cations warranting admission;
● Patients admitted strictly for interventional diagnostic tests or therapeu-
tic procedures; and
● Urgent referrals from outpatient offices that require interventional ser-
vices and then require admission.
The duties of the interventional radiologist should include daily
clinical rounds (40). Patients to be seen by the interventional practitioners
include:
● Any patient who is admitted to the interventional service, or who has a
significant portion of his or her inpatient care managed by the interven-
tional service, including patients with drains;
● Any patient with a clinical problem that is being managed by the
interventional service in consultation; and
● All patients after a therapeutic intervention before discharge for same-
day patients or within 24 hours of their procedure for inpatients.
The physician inpatient visit can be done in coordination with other
interventional licensed independent practitioner visits. This strategy will
insure the most efficient use of physician time and help reduce costs while
maintaining the all-important personal contact provided to the patient by
the interventional radiologist.
Training and Clinical Privileges
Specific training and experience in the performance of image-guided
interventional procedures in children and in the provision of related
clinical care, including sedation, analgesia, resuscitation, and radiation
protection, are necessary prerequisites for the interventional radiologist
committed to developing a pediatric service. There is no universal pathway to
this end at this time. Training backgrounds, specialization, and subspecializa-
tion of pediatric interventional radiologists vary and include residency in
diagnostic radiology and fellowships in pediatric interventional radi-
ology, interventional radiology, pediatric radiology, neuroradiology,
and neurointerventional radiology. Most current practitioners who an-
swered a survey reported training in more than one of these areas (41).
The group of expert authors and reviewers of this document strongly
recommend certification equivalent to the American Board of Radiology
and adequate exposure to care of the pediatric patient, performance of
interventional procedures in children, and experience with management of
pediatric interventional care, within the scope of the individual interven-
tional radiologist and within the boundaries of appropriate regulatory
agencies.
Clinical privileges arise from the specific training, experience, cer-
tifications, and credentialing of the individual pediatric interventional
practitioner. For pediatric interventional radiologists, such privileges may
specify a wide variety of procedures, use of diagnostic imaging equipment
for diagnostic and therapeutic procedures, and prescription and dispensing
of radiographic contrast media, among other tasks.
The pediatric interventional service and its parent radiology depart-
ment should work carefully to delineate and secure all appropriate clinical
privileges commensurate with the interventional radiologists’ training,
experience, and certification. The health care institution, hospital, depart-
ment, and pediatric interventional service share accountability to assure
that all practitioners are operating within the legitimate boundaries of the
specific clinical privileges they have been granted, and have the appropri-
ate training, experience, certification, and credentialing for the perfor-
mance of procedures (42).
Time Allotment for Inpatient Clinical Duties
Recommended time allocations include the total time spent by the physi-
cian, independent licensed practitioner, and any other ancillary staff that
the interventional radiologist and hospital deem appropriate. The amount
of time required for daily rounds and admissions will also vary with the
size of the practice and procedure mix: practices with less than 1,000
procedures per year, 1–2 hours per day; practices with 1,000–3,000
procedures per year, 2–4 hours per day; and practices with more than
3,000 procedures per year, 4–6 hours per day (1). Practices performing
large volumes of procedures such as arterial interventions, hepatobiliary
procedures, treatment of vascular malformations, chemoembolization, ra-
diofrequency and other ablative therapies, enteric access procedures, mus-
culoskeletal procedures, and abscess/drain management usually require
more admissions and inpatient care.
Call
The number of physicians who provide interventional services and have
admitting privileges should be sufficient to provide 24-hour interventional
call coverage. Coverage responsibilities include management of the clin-
ical problems that fall within the interventional radiologist’s scope of
practice and appropriate referral or consultation when clinical problems
Volume 22 ? Number 12 ? December ? 20111651
Page 6
fall outside that scope. In some health care systems, arrangements for
sharing responsibility between interventional radiologists and other clini-
cians have evolved. Local hospital factors and expertise will influence how
such a system is arranged or organized.
To ensure a stable service, attention to call frequency demands is
suggested to avoid unnecessary burnout and staff turnover. In smaller
programs, the number of staff required for call coverage may exceed the
need based solely on daytime case volume. Interim call support for a small
or growing pediatric interventional service may be provided by cross-
coverage by other individuals with similar training, certification, and
experience performing interventional radiology procedures in children.
Scheduling of Interventional Procedures
It may be acceptable to schedule a few types of invasive diagnostic
radiology procedures (ie, routine low-risk procedures in low-acuity cases),
based on a direct request from a physician to booking personnel. Sched-
uling of more invasive diagnostic and therapeutic procedures should be by
consultation with the interventional radiologist, and may necessitate a
clinic or bedside visit. It is important to provide the opportunity for family
discussion and to obtain informed consent. Complex consultations should
result in a written or electronic documentation of evaluation and manage-
ment recommendations, even if a specific interventional procedure is not
recommended. Electronic scheduling processes can help practice effi-
ciency and communication with the referring physicians (43).
INTERVENTIONAL SUITE REQUIREMENTS
Imaging Requirements
Unlike adult interventional practices, which are often subdivided by sys-
tems and modalities, pediatric interventional practices tend to be less
partitioned, and the pediatric interventional radiologist tends to perform all
image-guided procedures in the pediatric radiology department regardless
of the imaging modality or modalities employed (44).
It is vital to the success of any pediatric interventional service to have
high-quality imaging equipment and sufficient space for the equipment,
personnel, and supplies necessary to safely and effectively complete a
pediatric interventional procedure.
Angiographic or fluoroscopic equipment must be capable of accom-
modating the spectrum of pediatric patients, from 500 g to greater than 150
kg. This poses unique challenges with respect to table positions, location
of the C-arm pedestal, positioning of monitors, accessibility of bedside
controls, immobilization of the patient, integration of other imaging mo-
dalities during multimodality and multidisciplinary procedures, and incor-
poration of equipment necessary for safe delivery of sedation and general
anesthesia. The x-ray–emitting equipment (fluoroscopy, digital subtrac-
tion angiography, CT) must be of high standard and appropriately modi-
fied for pediatric patients (as detailed in “Radiation Protection”).
US is an essential component of a pediatric practice. US-guided
procedures in children require high-quality equipment for the wide range
of procedures and body sizes and target depths. Although CT is less
commonly employed in pediatric practices compared with adult practices,
access to a CT suite in reasonable proximity to the angiographic suite and
adequately equipped and supplied for common CT-guided procedures
should be available, ideally outfitted with CT fluoroscopic capability and
staffed with technologists familiar with the imaging requirements for
pediatric interventional procedures. Rotational (ie, three-dimensional) an-
giography and dynamic CT-capable angiographic suites may reduce reli-
ance on freestanding CT suites for procedures requiring cross-sectional
radiographic guidance.
Interventional Suite
In an ideal situation, a single pediatric interventional suite should have a
digital angiographic unit (single or biplane) and a high-quality US unit. It
should include vacuum suction and medical gases sufficient for general
anesthesia. Ideally, air filtration and lighting should be of a standard
suitable for an operating room and adapted to the needs of pediatric
procedures. Entry to the room should be through a protected clean zone not
accessible to the general public. A dedicated scrub area should be available.
Adequate electrical, medical gas, and monitoring hookups should be available
for provision of general anesthesia or deep intravenous sedation and analgesia
to the sickest patients in an intensive care unit. The room needs to be
sufficiently large (as detailed later) to accommodate the movement of a bed,
multiple teams of health care personnel, general anesthesia, patient monitor-
ing, and support. Immediate access to the patient for emergency personnel
should be assured at all times.
A pediatric “crash cart” with pediatric airway management supplies,
resuscitation and intravenous reversal medications, and related supplies
should be in the suite and familiar to all key personnel. Lock-protected
narcotics and other medications common to interventional procedures
should be readily accessible. Supplies sufficient for completion of most
common cases should be at hand in the interventional suite, with reserve
stocks and supplies for less usual procedures stored in close proximity.
Such an arrangement will commonly support the practice of one or
two full-time equivalent pediatric interventional radiologists with a case-
load of as much as 1,000–1,500 procedures per year and will ideally
require no less than 56 m2(600 square feet) of space in the primary
interventional suite.
As the practice grows to 1,500–3,000 procedures annually, an addi-
tional suite may be needed to support two or three full-time equivalent
interventional radiologists, with a single-plane or biplane angiographic
unit and a second dedicated high-quality US machine. A generalized
pediatric practice performing 3,000–5,000 procedures annually may need
to add a third suite with a single-plane angiographic unit and a third
dedicated US machine to support three or four full-time equivalent inter-
ventional radiologists. Beyond 5,000 procedures annually, consideration
may be given to adding a fourth suite. If facilities are constrained, a “minor
procedure” suite may serve as an alternative to a fourth fully configured
suite. A portable C-arm with a large (eg, 43-cm [17-inch]) detector and
with software capable of dynamic vascular imaging, and a high-quality
portable US machine, may also provide cost-effective alternatives to more
expensive equipment if the potential reductions in flexibility and image
quality can be tolerated. The ratio of patient volumes to the number and
type of interventional radiology suites must reflect the nature of the
specific pediatric practice.
Specialized practices may require additional imaging facilities at
much lower procedure intervals. For example, practices with a large
proportion of vascular malformation interventions, regional oncology in-
terventions or neurologic interventions may fully utilize an interventional
suite at a rate of only 400–500 procedures annually. Practices that more
heavily depend upon general anesthesia under the supervision of an
anesthesiologist will have significantly greater room time needs on a
per-case basis. Alternative imaging modalities may also be useful for
certain types of practice profiles, such as those requiring interventional
magnetic resonance (MR) imaging, interventional positron emission to-
mography/CT, endoscopy or laparoscopy, and optical imaging, and will
depend upon the particular features of an individual practice environment.
Patient Preparation Area and Recovery Room
To optimize utilization of hospital resources, space and personnel need to
be allocated to accommodate inpatients and outpatients who are awaiting
procedures or transport and to provide postprocedure and postsedation
recovery for outpatients as well as for inpatients awaiting transfer. The
amount of space should be two to four beds per interventional suite,
depending on the types of cases and workflow in a particular practice. This
could include space in a dedicated recovery area not necessarily in the
radiology department, provided such space is allocated for and is staffed
with personnel familiar with pre- and postprocedure care of pediatric
interventional patients. Adequate space and privacy are required for inter-
action with the patient and caregivers, for obtaining informed consent if
not already done, and for examination and correct site marking. As
family-centered care is a fundamental guiding principle in a pediatric
practice, appropriate provision for parents and family in the preparation
area, waiting area, and recovery room is an important consideration.
1652 ? Joint Guidelines: Developing a Pediatric Interventional Practice Baskin et al ? JVIR
Page 7
Medical/Surgical Supply Inventory
The dedicated interventional suite must have sufficient space and a control
mechanism to manage the large required inventory located close to the
suite. Integration with central supply or surgical supply facilities within the
institution facilitates economies of scale and decreases the administrative
burden on interventional personnel.
The following items relevant to inventory should be considered when
developing the modern-day interventional practice suite:
● Sufficient facility budgetary commitment to sustain the disposable
equipment needs of the suite;
● Dedicated personnel responsible for inventory management and autho-
rized to replenish stocks at reasonable par levels;
● An inventory control system, possibly with barcode or radiofrequency
identification reading capability for high-end equipment and supplies;
and
● Interventional radiologic representation on hospital committees focused
on innovative procedures, new equipment, product purchasing, and
quality assurance.
Nonradiographic Equipment
The modern interventional suite often requires other invasive and noninvasive
equipment for nonradiographic imaging and interventions, such as radiofre-
quency ablation generators with associated probes, thrombolysis and throm-
bectomy devices, endovascular and endocavitary US devices, and
battery-operated drills and associated hardware, to mention just a few.
The particular equipment necessary to a given practice will depend
upon the local practice profile, the referral base, opportunities for
multidisciplinary collaboration, and the preferences and experience of
the pediatric interventional radiologists.
Staffing Level
Nurse staffing levels should always be sufficient to provide at least one
nurse for each procedure room to prepare, provide, and monitor patient
care, as well as to perform other departmental activities such as quality
assurance. When nurse-administered intravenous sedation and analge-
sia is provided under the supervision of the interventional radiologist,
that nurse must have no other competing duties during the case. Such
regulatory standards may increase the staffing needs of the interven-
tional service. In addition, the recovery room should have at least one,
and preferably two, nurses per patient bed specifically trained in
postsedation or postanesthetic recovery of the pediatric patient. Regu-
latory standards within each jurisdiction will determine minimum staff-
ing for each phase of recovery.
Radiologic technologist staffing levels should be sufficient to always
provide at least one and preferably two technologists per procedure room
to perform imaging functions as well as functions related to inventory,
cleanup, room preparation, film or digital image processing, and data entry
into inventory management, coding and billing, and quality assurance
databases.
If a radiologic technologist or nurse is scrubbed in for procedures, the
necessary number of staff per room will increase accordingly. To achieve
consistent coverage, these staffing recommendations should be considered
in light of local staffing factors and allow for adequate coverage for
off-hours procedures, vacations, sick time, and educational leave.
In ideal circumstances, a pediatric interventional service will build a
team of nurses and technologists that are dedicated to the interventional
area. Many centers may try to have their staff cycle through MR imaging,
CT, or fluoroscopy as part of the day-to-day work. This may dilute the
experience of members of the interventional team and erode their confi-
dence in performing more complex procedures.
The incorporation of independent licensed practitioners into pediatric
interventional practices has been slow to occur, but successful interven-
tional practices generally stabilize with approximately one midlevel prac-
titioner for every two interventional radiologists.
PRACTICE DEVELOPMENT: EDUCATION AND
COMMUNICATION
The overarching concern of the interventional radiologist is the patient’s
health and well being. A practice that does not anticipate and adapt to
changes in its environment will not maintain the ability to deliver patient
care. As part of both a medical and an economic enterprise, a successful
interventional practice must plan its business and market its services
reliably and effectively (45). This planning should be based on the needs
and abilities of each practice.
In order to educate the patients and health-care professionals we
serve, the interventional radiologist needs to effectively establish and
highlight points of differentiation that offer real and lasting benefits over
alternative options. Key advantages of interventional radiology may in-
clude decreased morbidity and invasiveness, a shorter duration of hospi-
talization, greater comfort, timeliness, and accessibility, and decreased
cost. There are areas in which interventional radiologists provide added
value such as salvage procedures for a transplant service, oncologic
interventions, sclerotherapy of vascular anomalies, and percutaneous ce-
costomies, to name a few. Even in areas such as venous access in which
the procedure may not be as obviously differentiated, the ability to dem-
onstrate improved outcomes at lower cost may help sustain the pediatric
interventional radiology practice.
Leadership participation in multidisciplinary and institution-wide
care initiatives (eg, vascular access, vascular malformations, enteral feed-
ing and nutrition programs, pain management, oncology, and palliative
care) is very important and may help enhance the pediatric interventional
radiologist’s ability to provide the most comprehensive and high-quality
care achievable and to maintain access to the relevant patient populations.
Increasing awareness about clinical pediatric interventional radiology
through a multipronged and multimedia approach to education could be
beneficial. Broader educational and public health initiatives on a national
or international scale, such as the Image Gently and Step Lightly cam-
paigns (45–47), or multiinstitutional outcomes registries, can help estab-
lish the concept of pediatric interventional radiology by improving patient
and family awareness of the role interventional radiologists play in patient
care and by improving the awareness of potential referring clinicians of the
added value of specific targeted procedures (48).
QUALITY IMPROVEMENT
An ideal pediatric interventional radiology practice develops plans of care
based upon best practices and peer-reviewed outcomes data appropriate to
the context of that practice and applicable to the given patient problem
(49,50). For many situations, such information is not currently available in
the published literature, and quality improvement in pediatric interven-
tional radiology is therefore in its infancy (51). Within each interventional
practice, quality assurance can be enhanced by conducting dedicated
morbidity and mortality reviews (52), internal audits of key practices,
identification and measurement of specifically chosen determinates and
outcomes (53), and clinical research and reviews (54). In view of the stage
of evolution and growth of the specialty at the time of this writing, it is
necessary to establish a greater knowledge base, to perform outcomes
analysis, and to establish standards. Therefore, evidence-based quality
assurance can be best achieved through multiinstitutional studies, regis-
tries, and collaboration. Electronic databases which facilitate a quality
assurance program are crucial (55). All of these are important approaches
to maintaining and improving quality of care.
ACKNOWLEDGMENTS
Kevin M. Baskin, MD, authored the first draft of this document and served
as topic leader during the subsequent revisions of the draft. Dr. Sanjoy
Kundu, MD, served as chair of the SIR Standards of Practice Committee
during the development of this document and contributed to its content.
John F. Cardella, MD, is Councilor of the SIR Standards Division. Other
members of the Standards of Practice Committee and SIR who participated
Volume 22 ? Number 12 ? December ? 2011 1653
Page 8
in the development of this clinical practice guideline are (listed alphabet-
ically): Anne Marie Cahill, MD, and John Crowley, MD.
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Recent developments in evaluation and management
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Teaching medical documentation
SIR Interventional Radiology Cod-
Pre- and postoperative clinical
Clinical practice of inter-
Inpatient admissions for inter-
Collaborative
Pediatric interventional
The Image Gently campaign:
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The positive effect of targeted
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Mortality and morbidity confer-
Quality improvement
1654 ? Joint Guidelines: Developing a Pediatric Interventional Practice Baskin et al ? JVIR
Page 9
SIR DISCLAIMER
The clinical practice guidelines of the Society of Interventional Radiology attempt to define practice principles that generally
should assist in producing high quality medical care. These guidelines are voluntary and are not rules. A physician may deviate
from these guidelines, as necessitated by the individual patient and available resources. These practice guidelines should not be
deemed inclusive of all proper methods of care or exclusive of other methods of care that are reasonably directed towards the
same result. Other sources of information may be used in conjunction with these principles to produce a process leading to high
quality medical care. The ultimate judgment regarding the conduct of any specific procedure or course of management must be
made by the physician, who should consider all circumstances relevant to the individual clinical situation. Adherence to the SIR
Quality Improvement Program will not assure a successful outcome in every situation. It is prudent to document the rationale
for any deviation from the suggested practice guidelines in the department policies and procedure manual or in the patient’s
medical record.
Volume 22 ? Number 12 ? December ? 20111655