Stacey Drant and Vivekanand Allada The Children’s Hospital of Philadelphia, Philadelphia, PA, USA With continued advances in ultrasound technology and accreditation requirements, establishing and maintaining a pediatric echocardiography laboratory (echo lab) has become progressively more complex. Echo labs have become increasingly “digital” requiring sophisticated information technology for digital acquisition, reporting, and archiving. Lab accreditation has become more widespread to establish consistency within and amongst pediatric echo labs in an effort to assure quality. Guidelines and recommendations for pediatric echo labs have been published and incorporated into the requirements for accreditation. This chapter serves as a reference guide to establishing and maintaining a pediatric echo lab. A variety of published recommendations exist pertaining to the organization and function of a pediatric echo lab from several medical societies including the American College of Cardiology (ACC), American Heart Association (AHA), American Academy of Pediatrics (AAP), and the American Society of Echocardiography (ASE). These recommendations have substantial overlap and form the basis for the requirements of the Intersocietal Accreditation Commission (IAC) necessary to achieve accreditation of a pediatric echo lab. For more detailed information, readers are referred to the applicable references and websites cited. Pediatric echo labs vary substantially in size and composition of the staff, from individual office practices performing outpatient echocardiograms to large hospital‐based labs that combine inpatient and outpatient imaging. In general, pediatric echo labs include physical space, ultrasound machines, pediatric cardiologists, and sonographers. Most pediatric echo labs – including all IAC accredited labs – have medical and technical directors to provide administrative functions. The performance and interpretation of transthoracic echocardiograms is a requirement for cardiology fellowship training. Echocardiography is an operator‐dependent imaging technique that requires skill in both performance and interpretation of studies. The recommendations of the American Society of Pediatric Cardiology Training Program Directors/ACC/AAP/AHA Training Statement on Pediatric Cardiology Fellowship Training in Noninvasive Cardiac Imaging 2015 represent the most recent guidelines for echocardiography training [1]. These guidelines describe two levels of expertise, core and advanced, that are appropriate for different career goals. Core level training recommendations represent the minimum that should be achieved by all pediatric cardiology fellows during their standard 3‐year cardiology fellowship. Core training allows each fellow to achieve competency to allow for independent use of transthoracic echocardiography to diagnose simple congenital heart disease and acquired pediatric heart disease. Physicians with core level training are not expected to develop expertise in transesophageal and fetal echocardiography; however, exposure to these during core training is recommended as this allows for familiarity with techniques, indications, and limitations, with many fellows becoming competent in these areas. Advanced fellowship (generally requiring an additional year of training) allows for the development of skill and expertise in the echocardiographic diagnosis of complex congenital heart disease, transesophageal, and fetal echocardiography with the goal of assuming positions as independent noninvasive imaging physicians and is also often obtained when a faculty position in academic echocardiography is the goal. While the current guidelines define specific minimum procedure numbers as a guide to achieving core and advanced levels of training, emphasis is placed primarily on competency‐based benchmarks as listed in Tables 2.1 and 2.2 [1]. At present in North America, there is no formal examination that can be used to determine competency in pediatric echocardiography; thus, evaluation is based solely upon an assessment of the trainee’s skills during fellowship training. Continued performance and interpretation of echocardiograms and participation in intramural conferences and continuing medical education is necessary to maintain clinical competency. In order to be accredited by the IAC in pediatric echocardiography, medical staff of the laboratory are required to meet the training guidelines outlined, demonstrate continuing medical education specific to pediatric echocardiography, and to maintain an annual procedure volume sufficient to maintain proficiency in examination performance and interpretation, but no specific benchmarks are defined [2]. Table 2.1 Pediatric echocardiography training: minimal procedural numbers for competency assessment Source: Srivastava S, Printz BF, Geva T, et al. Task Force 2: Pediatric Cardiology Fellowship Training in Noninvasive Cardiac Imaging. J Am Coll Cardiol 2015;6:687–98. © Elsevier. * Numbers are in addition to those obtained during core training. † Fetal echocardiogram: 50 should have congenital heart disease and/or abnormality of fetal circulation. TEE, transesophageal echocardiogram; TTE, transthoracic echocardiogram. With continued advances in cardiac ultrasound, performing a pediatric echocardiogram continues to become increasingly sophisticated. This places added educational and professional demands on sonographers. The ASE has published minimum qualifications for cardiac sonographers [3,4], which are reflected in the IAC standards for technical staff summarized in Table 2.3. Despite the fact that training in cardiac sonography has historically been heterogeneous, current standards mandated for credentialing reflect the importance of a formal verifiable education in cardiac sonography. This guarantees that new sonographers have adequate knowledge and technical skills to be competent in contemporary pediatric echocardiography. Current IAC guidelines recommend that each sonographer achieves and maintains minimum standards in education and credentialing in pediatric and/or fetal echocardiography within 1–2 years of the start of employment. Current IAC requirements for credentialing and maintenance of competence are listed in Table 2.4 [2]. The facility must meet the standards set out by the Occupational Safety and Health Administration and by the Joint Commission where applicable. The ASE [5] and the IAC [2] recommend that echo laboratories should be large enough to accommodate an area for scanning, a designated space for the interpretation and preparation of reports, and space for the storage of images and reports to remain compliant with state laws (Figure 2.1). The scanning space needs to be large enough to accommodate a patient bed that allows for position changes, an echocardiography imaging system, and patient privacy; a scanning room is generally recommended to be at least 150 square feet [2]. In addition, a sink and antiseptic soap must be readily available and used for hand washing in accordance with the infection control policy of the facility. For the practice of transesophageal echocardiography, space must be available to perform high‐level disinfection and to store transesophageal echocardiography probes. Pediatric echo labs require a variety of equipment to function effectively (Table 2.5) including a specialized bed, gel warmer, and blood pressure machine in addition to the ultrasound systems. Forms of distraction such as DVD players or televisions are also recommended to entertain young children during the performance of the studies. All imaging equipment should be tested on a regular basis; the manufacturer’s recommendations regarding preventative maintenance should be followed. Echo labs that perform special procedures, including transesophageal echocardiography (TEE), stress echo, and sedated echocardiograms, should also have written procedures in place to handle acute medical emergencies including maintaining a fully equipped crash cart and other pediatric‐specific medical equipment in a variety of sizes to accommodate patients of varying sizes [2]. Ultrasound systems dedicated to echocardiography must include the hardware and software to perform M‐mode and 2D imaging, color flow and spectral Doppler, along with electrocardiogram (ECG) gating [2,5,6]. There should also be a system setting for tissue Doppler imaging [2]. Many echo labs have added routine 3D imaging and speckle tracking echocardiography into their protocols. The image display may include the name of the institution, patient name, date and time of the study, the ECG tracing, and range and depth markers. Echocardiography has specific transducer requirements, including the ability for the transducer head to fit between rib spaces for a variety of patient sizes as well as the wedge‐shaped sector display. Transducers ranging from 2.0 to 12 MHz, providing both low‐ and high‐frequency imaging, are required for pediatric imaging due to the range in patient size from premature infants to adults with congenital heart disease. In addition, a dedicated nonimaging continuous‐wave Doppler transducer (Pedoff) must be available. All machines should have harmonic imaging capability and other instrument settings that enable the optimization of both standard and contrast‐enhanced ultrasound examinations. Table 2.2 Core competencies and evaluation tools for noninvasive imaging Source: Srivastava S, Printz BF, Geva T, et al. Task Force 2: Pediatric Cardiology Fellowship Training in Noninvasive Cardiac Imaging. J Am Coll Cardiol 2015;6:687–98. © Elsevier. CHD, congenital heart disease; MR, magnetic resonance; TEE, transesophageal echocardiogram; TTE, transthoracic echocardiogram. Echo lab personnel, including sonographers, trainees, and physicians, must be able to adjust the system settings for image optimization; thus, an in‐depth familiarity with each system is ideal. Pediatric echocardiography often incorporates significantly more vascular imaging than in adult labs to evaluate the systemic venous return, pulmonary veins, branch pulmonary arteries, coronary arteries, and aortic arch. These static structures benefit from different system settings than those for the more mobile intracardiac structures, and thus the ability to readily adjust the depth and gain along with the persistence, log compression, sector angle, gate, and Doppler filters becomes imperative. Most vendors have systems specialists who can provide training in the utilization and adjustment of the system settings in order to create optimal preset packages for each machine according to the institutional preferences. Sufficient time should be allotted for each study according to the procedure type. Performance time for an uncomplicated complete pediatric transthoracic echocardiogram is generally 45–60 minutes from patient encounter to departure. Additional time may be required for: (i) patients with complex disease; (ii) when other modalities such as 3D imaging or speckle tracking imaging are required; or (iii) studies performed on sedated patients. An “urgent” study must be performed in the next available time slot while a “stat” study must be performed as soon as possible, pre‐empting routine studies. Qualified personnel and equipment must be available for urgent or “stat” studies outside normal working hours in inpatient facilities or somewhere appropriate. Routine inpatient echocardiograms should be performed on the same working day as they are ordered unless otherwise specified, while outpatient studies should be assigned priority as defined by the referring physician and/or indication of the study [2,5,6]. Many busy pediatric echo labs have systems that schedule patients in time slots during the course of the day while others use a “first come, first served” type of schedule. The echocardiogram order and requisition must clearly indicate the type of study to be performed, the reason(s) for the study, and the clinical question to be answered, and the signed order/requisition must be present in the patient’s medical record. Table 2.3 American Society of Echocardiography (ASE) guidelines for pediatric cardiac sonographers Table 2.4 Intersocietal Accreditation Commission (IAC) guidelines for credentialing and maintenance of competence in pediatric echocardiography Figure 2.1 Echocardiography reading room with live imaging displayed on wall screens and dual screen work stations for efficient review of images and reporting. Table 2.5 Pediatric echocardiography laboratory equipment A permanent record of both echocardiographic images and the final echocardiographic report must be produced and retained in accordance with applicable state and federal guidelines. Federal guidelines fall under the Healthcare Insurance Portability and Accountability Act (HIPAA) passed in 1996 and directs that facilities retain records for 6 years from the date of creation [7]. State laws also govern the length of time medical records need to be retained and vary from state to state; however, HIPAA requirements supersede state laws if the state law requires shorter retention periods. Images must be archived as moving images in the original format that they were acquired. The current standard format has changed from analog media utilizing videotape to digital storage. The ASE has published guidelines for digital echocardiography [8] which describe digital archiving in detail. The DICOM (Digital Imaging and Communications in Medicine) standard was created through a collaboration of the National Electrical Manufacturers’ Association and various professional organizations and serves to standardize the exchange of digital images allowing interoperability within and between echo labs. In order to accommodate the large storage requirements, both clinical and digital compression is often required. Clinical compression is at the discretion of the imager and can be accomplished by limiting the time length of a clip or the number of clips. Digital compression is accomplished utilizing JPEG compression, currently the only compression approved by the DICOM committee, which provides more efficient storage of individual frames and loops without significant distortion of the images. Quantitative image analysis has shown little degradation at compression ratios as high as 20 : 1 [9]. DICOM standards now also need to be applied to 3D echocardiograms. Thus, the DICOM Working Group is rewriting the standard to allow exchange of multidimensional datasets.
CHAPTER 2
Instrumentation, Patient Preparation, and Patient Safety
Introduction
Structure and organization
Personnel and supervision
Physicians
Level of training
Number of studies
Core training
TTE perform and interpret
150
TTE review and interpret
100
Advanced training *
TTE perform and interpret
100
TTE review and interpret
100
TEE perform and interpret
50
Fetal echocardiogram perform and interpret†
50
Fetal echocardiogram review and interpret†
50
Sonographers
Facility
Space requirements
Equipment
Ultrasound systems
Medical knowledge
Know the physical properties of ultrasound and Doppler principles
Know the principles of echocardiographic image construction and factors that influence image composition
Know the ultrasound imaging devices, including “knobology,” appropriate transducer and settings to optimize images, and proper and safe use of the ultrasound equipment
Know the proper use of different echocardiographic techniques (2D, M‐mode, 3D, color, and spectral Doppler) to thoroughly evaluate cardiac anatomy, physiology, and function
Know the standard transthoracic imaging planes (subxiphoid, apical, parasternal, suprasternal)
Know the effects of patient positioning on image acquisition and how to move them to optimize echocardiographic images
Know the indications for a pediatric TTE
Know the hemodynamic and physiologic changes from fetus to adult
Know the full spectrum of pediatric cardiac surgical procedures, including the components of a complete preoperative and postoperative echocardiographic assessment, as well as potential postoperative complications of each procedure
Know the techniques for imaging abnormal situs and dextrocardia, as well as the associated terminology of complex disease
Know the basic TEE imaging views and indications, including the use of TEE for guidance of intraoperative and catheter‐based interventions, and be aware of the limitations of TEE imaging
Know the basic fetal imaging views and indications and limitations of fetal echocardiographic imaging
Know the basic principles used to generate MR images
Know the indications and contraindications for cardiac MR in patients with CHD, including children and adults
Know the indications and contraindications for cardiac MR in children with acquired heart disease
Evaluation tools: direct observation, conference participation and presentation, and in‐training examination
Patient care or procedural skills
Have the skills to do a clinical history, know the indications for study, review prior studies, and interim procedures
Have the skills to identify the goals of each study
Have the skills to consistently obtain adequate images from all planes on a standard TTE in a timely manner
Have the skills to identify cardiac structures displayed by echocardiography and how echocardiographic images correlate with cardiac anatomy
Have the skills to recognize imaging artifacts
Have the skills to obtain appropriate measurements of ventricular, valvar, and vascular dimensions
Have the skills to obtain appropriate measurements of ventricular function
Have the skills to evaluate valvar stenosis and regurgitation with spectral (pulsed and continuous wave) and color Doppler
Have the skills to identify and describe common lesions: atrial septal defect, ventricular septal defect, patent ductus arteriosus, aortic stenosis, and pulmonary stenosis
Have the skills to complete a full examination of patients with simple congenital defects, including full Doppler assessment, along with a detailed, concise report
Have the skills to perform a comprehensive 2D and Doppler examination of a newborn with previously undiagnosed complex CHD and be able to assess the need for prostaglandin without assistance. Complete description of complex anatomic details is encouraged, but not required, of a trainee completing core fellowship; accurate imaging/interpretation of complex CHD may require advanced training and/or post‐fellowship experience
Have the skills to identify and describe pericardial disease
Have the skills to demonstrate familiarity with indications, use, and limitations of TEE
Have the skills to demonstrate familiarity with indications, use, and limitations of basic imaging skills for fetal echocardiography
Have the skills to read basic cardiac MR images acquired in infants, children, and young adults with either structurally normal or abnormal hearts
Evaluation tools: conference participation, direct observation, and procedure logs
Scheduling
Comprehensive understanding of:
Cardiovascular and thoracic anatomy, pathophysiology, hemodynamics, and embryology
Congenital and acquired heart defects
Segmental approach to the diagnosis of congenital heart defects
Surgical procedures for repair and palliation of congenital heart defects
Ultrasound physics
Instrumentation
Tissue characteristics
Biological effects of ultrasound
Measurements of cardiac structures and blood flow
Making appropriate quantitative calculations from echo measurements
Communication and safety‐related skills:
Ability to interact and communicate effectively both orally and in writing
Be well versed in medical terminology
Capable of explaining the purpose of the echo exam to the patient and answer questions
Utilize proper infection control procedures
Comply with patient confidentiality and privacy laws
Competent in first aid and basic life support
Familiar with other types of diagnostic tests
Credentialing and education
Credentialing includes:
Provisional staff employed in an accredited facility:
Technical expertise
Must be able to properly display cardiac and/or vascular structures and blood flow in each of the imaging views within a standardized protocol
Proficiency in 2D, M‐mode, and Doppler echocardiography
Ability to accurately document abnormal echocardiography and Doppler velocities indicative of abnormal cardiovascular pathophysiology
Demonstrate knowledge and competency in specialty areas of echocardiography when required in practice
Maintenance of competence
Annual procedure volume sufficient to maintain proficiency in examination performance
Document at least 15 hours of echocardiography‐related continuing medical education over a period of 3 years 
Ultrasound system:
Digital image storage method
Imaging bed with dropout section of mattress
Gel warmer
Blood pressure machine (including age‐appropriate cuff sizes)
Distraction equipment (e.g., TV, DVD player, music player)
Contrast agents and intravenous supplies
Equipment to treat medical emergencies (e.g., suction, oxygen, code cart)
Storage
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