Abstract

Preamble
The American Telemedicine Association (ATA) brings together diverse groups from traditional medicine, academia, technology and telecommunications companies, e-health, allied professional and nursing associations, medical societies, government, and others to overcome barriers to the advancement of telemedicine through the professional, ethical, and equitable improvement in healthcare delivery.
ATA has embarked on an effort to establish practice guidelines for telemedicine to help advance the science and to assure the uniform quality of service to patients. They are developed by panels that include experts from the field and other strategic stakeholders and are designed to serve as both an operational reference and an educational tool to aid in providing appropriate care for patients. The guidelines generated by ATA undergo a thorough consensus and rigorous review, with final approval by the ATA Board of Directors. Existing products are reviewed and updated periodically.
The purpose of these guidelines is to assist practitioners in pursuing a sound course of action to provide effective and safe medical care that is founded on current information, available resources, and patient needs. The guidelines recognize that safe and effective practices require specific training, skills, and techniques, as described in each document. The resulting products are properties of the ATA, and any reproduction or modification of the published guideline must receive prior approval by the ATA.
The practice of medicine is an integration of both the science and art of preventing, diagnosing, and treating diseases. Accordingly, it should be recognized that compliance with these guidelines alone will not guarantee accurate diagnoses or successful outcomes. If circumstances warrant, a practitioner may responsibly pursue an alternate course of action different from the established guidelines. A divergence from the guidelines may be indicated when, in the reasonable judgment of the practitioner, the condition of the patient, restrictions or limits on available resources, or advances in information or technology occur subsequent to publication of the guidelines. Nonetheless, a practitioner who uses an approach that is significantly different from these guidelines is strongly advised to provide documentation, in the patient record, that is adequate to explain the approach pursued.
Likewise, the technical and administrative guidelines in this document do not purport to establish binding legal standards for carrying out telemedicine interactions. Rather, they are the result of the accumulated knowledge and expertise of the ATA Working Groups and other leading experts in the field, and they are intended to improve the technical quality and reliability of telemedicine encounters. The technical aspects of and administrative procedures for specific telemedicine arrangements may vary depending on the individual circumstances, including location of the parties, resources, and nature of the interaction.
Scope
This guideline is intended to cover clinical applications of telepathology only. For this document, telepathology is defined as the electronic multimedia communication across a network of pathology-related information, between two or more locations for use-cases between pathologists and/or qualified laboratory personnel, and may include involvement by clinicians and/or patients. Examples of clinical applications include primary diagnosis, intraoperative consultations, secondary consultations, and quality assurance that may result in amended cases. The scope of this guideline excludes use-cases specifically for research or education purposes. The recommendations apply to all types of telepathology configurations, regardless of the hardware device used, including static (store-and-forward), dynamic (synchronous), and hybrid static–dynamic implementations.
For this document there are several terms that need to be defined specifically: • “
• Telemedicine. Telemedicine is defined as the use of medical information exchanged from one site to another via electronic communications to improve a patient's clinical health status. Telemedicine includes a growing variety of applications and services using two-way video, e-mail, smartphones, wireless tools, and other forms of telecommunications technology. • Telepathology. Telepathology is a form of communication between medical professionals that includes the transmission of pathology images and associated clinical information for the purpose of various clinical applications including, but not limited to, primary diagnoses, rapid cytology interpretation, intraoperative and second opinion consultations, ancillary study review, archiving, and quality activities.
Introduction
The term “telepathology” was introduced into the English language in 1986 by Weinstein 1 (see Kaplan et al. 2 ), and since then there have been many advances and publications. 3 –13 The practice of telepathology involves obtaining macroscopic and/or microscopic images for transmission along telecommunication links to obtain a remote interpretation (telediagnosis), second opinion or consultation (teleconsultation), quality assurance, education (tele-education), teaching, self-study, and research (tele-education). Various terms have been used interchangeably to refer to telepathology, including digital microscopy, remote robotic microscopy, teleconferencing, teleconsultation, telemicroscopy, video microscopy, virtual microscopy, and whole slide imaging (WSI). 9,11,14
With advances in technology and widespread access to the Internet, telepathology is increasingly being used around the world, improving rapid sharing of cases and access to expert pathologists. Telepathology can be used for remote-site interpretation of all types of pathology material including, but not limited to, hematoxylin and eosin–stained paraffin tissue sections, frozen sections, cytology or hematology slides, microbiology specimens, clinical fluids (e.g., urine), electron micrographs, electrophoresis gels, and cytogenetics images. 2,15 –24 In practice, these digital images are typically linked to patient information, including identification/medical record numbers, clinical history, and relevant laboratory and radiology data. 25
Table 1 summarizes milestones of the many technological advances in telepathology. The primary modes of telepathology include static imaging, dynamic imaging, hybrid static/dynamic telepathology and WSI:
Telepathology System Classification 14
• Static (store-and-forward) image telepathology: asynchronous capture of image files for subsequent viewing 26
• Robotic (dynamic) telepathology: the ability to remotely control an image acquisition device (e.g., microscope, whole slide scanner) that is used to view glass slides 27,28
• Video microscopy (dynamic): real-time transmission (streaming) of images from a video camera for telepathology purposes 29 –31
• WSI: digitization (scanning) of a glass slide to generate a digital file that allows the entire slide to be viewed in a manner that simulates microscopy 32 –34
• Multimodality telepathology: simultaneous utilization of more than one mode of technology (e.g., hybrid robotic microscopy and WSI) 35
Despite many advances and increased utilization of telepathology, barriers exist that have limited its widespread use. These include cost, legal and regulatory issues, technology barriers (e.g., limited resolution, large image files), resistance from pathologists, and above all a lack of standards. Previously, the ATA published guidelines for telepathology in 1999. 36 This revision is an update to the original ATA guideline. More recently, the Canadian Association of Pathologists 37 and the Royal College of Pathologists 38 have also published guidelines for telepathology. The purpose of this document is to provide new and updated guidelines to offer guidance on specific applications, practice, benefits, limitations, and regulatory issues that may arise in the practice of telepathology.
Clinical Guidelines
Technology
The selection of digital imaging systems for clinical use
The facility
Technical Specifications
Image acquisition
One
Displays
One
The consistent presentation of images is essential and is influenced by software, graphic controllers, and display devices. Good visualization of displayed images is achieved when the diagonal dimension of the display distance is about 80% of the viewing distance.
Zoom (magnification) and pan functions
Viewing devices
For the practice of telepathology one can select from a variety of mobile devices,
43,44
including tablets and smartphones, and
Transmission and storage
For the transmission of telepathology images, appropriate connectivity, bandwidth, and computing capabilities
Information technology infrastructure for telepathology systems
Adequate storage capacity
Compression technology
Software
Clinical Applications
Telepathology can be used for any of these applications:
Primary diagnosis
Primary diagnosis can be successfully rendered using a variety of telepathology modes on a variety of substrate materials. 48 –52 There are studies that indicate that there is not always 100% concordance between digital versus glass slide interpretations; however, there is not always 100% concordance between glass versus glass slides, and both inter- and intrareader variability can vary as a function of case complexity. 19,53 –55 There are also some studies that show that certain cases (cytopathology in particular) are more challenging to interpret using digital imaging and may therefore not be quite ready for primary diagnosis. 20,56,57
Intraoperative consultation (frozen section)
Intraoperative consultation, with or without use of frozen section, can be accomplished by telepathology using a variety of models, including fixed images, robotic dynamic telemicroscopy, video microscopy, and WSI. If an intraoperative consult is performed on a resection specimen or large biopsy specimens, access to imaging of the gross specimen
Rapid cytology
Rapid cytologic assessment of cytologic samples (e.g., fine-needle aspiration) requires sufficient speed and image resolution to assist with a patient management decision such as whether to obtain further samples or to direct specimen management. Speed and resolution used
Secondary consultation
Secondary consultation refers to any situation where a primary or initial review (with or without a formal diagnosis) has been performed on the primary materials (gross specimen, glass slides, etc.) and further opinion is sought by means of telepathology tools. Secondary consultation
Special studies
Telepathology can be successfully used to expand access to specialized services not otherwise available on a cost-effective basis in a given location. These include but are not limited to specialized staining processes such as immunohistochemistry, fluorescence in situ hybridization, chromogenic in situ hybridization, etc., and their appropriate controls if required. Other technical procedures requiring physician interpretation are also amenable to remote interpretation via telepathology tools. Digital images of special studies
Archival review
Archival review for clinical purposes occurs when a case is being reviewed in the context of a new specimen from the same patient or other clinical reassessment of that patient. Availability of digitized materials for archival review
Quality activities
Telepathology tools
Quality assurance of glass slides can be facilitated by digital pathology. Standardization of histology lab output can benefit from the rigor required for slide digitization. Digital imaging when used for visual management of quality control materials
Consensus Conference
Telepathology enables consensus review peer activity from multiple sites, either contemporaneously or asynchronously. The method used
Multidisciplinary interactions (tumor boards)
Telepathology enables review of cases for tumor boards and subspecialty conferences at the primary site or remote sites. Telepathology tool-facilitated pathologist–clinician interactions can enhance care by lowering the barriers to slide or other information sharing.
Patient consultation
Telepathology allows for the remote view of a patient's pathology images either solely by the patient or in consultation with the clinical team including the pathologist. Patients' access to their digital pathology materials
Clinical Responsibilities
Sending (referring) and receiving (consulting) individuals
Referring and consulting parties
The referring individual • Include all relevant clinical information for the consulting pathologist. • Ensure that the consulting pathologist has access to any necessary and/or relevant current and prior diagnostic material. • Take responsibility that the correct image is being sent, as well as appropriate metadata.
Appropriately trained personnel
A laboratory medical director
Other clinical staff who may be impacted
Prior to the implementation of novel telepathology, pathologists
Facility Responsibilities
Standard of care. The standard of care of the facility
The facility
Technical support
Information technology support personnel
Technical support personnel, including vendors with an adequate understanding of the telepathology systems (hardware, software),
A technical support plan
Functional verification of equipment
The facility
Accreditation
The laboratory
Privileges
The pathology department, and specifically the Clinical Laboratory Improvement Amendments Laboratory Director [or equivalent] and/or her or his pathologist designee,
Licensure
The facility performing telepathology
Validation
• Technical
○ All laboratories implementing a telepathology service for clinical diagnostic purposes
○ The validation
○ Validation
○ Revalidation
○ Validation
○ A pathologist(s) who has been adequately trained to use the telepathology system
○ The validation process
○ The validation process
○ The validation process
○ Validation
○ Validation documentation
• Diagnostic
○ A validation process
Training
Personnel responsible for performing telepathology, using telepathology technology, and following telepathology procedures
The training and competency assessment of the staff
Training procedures
Training
Documentation and Archiving
Reporting of pathologic findings
A diagnostic consultation by telepathology
The referring pathologist
Disclaimer statements
Any disclaimer statements added to the formal report of the telepathology encounter
Logs
Logs of telepathology interactions
Retention policy
The retention of associated artifacts of the telepathology event, including telepathology documentation, reports, and captured images,
Images
Quality Management
Technical
An ongoing quality management program
Examples of quality metrics that
Diagnostic
A quality management program
Examples of quality metrics that
A pathologist knowledgeable in telepathology
Operations
Maintenance
The maintenance of the system
The maintenance records
Technical support
The facility
The facility
Physical facilities
Institutions
Security and privacy
Organizations and health professionals providing telepathology services
All data transmission
Individuals in charge of technology
When providers use a mobile device, special attention
Providers
Mobile devices
Protected health information and other confidential data
Regulatory compliance
Telepathology programs
Footnotes
Disclosure Statement
No competing financial interests exist.
