The updated clinical guidelines for telepathology released in August 2014 by the American Telemedicine Association (ATA) define telepathology as a form of communication between medical professionals that includes the transmission of pathology images and associated clinical information for 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.[1] The modalities that can be used in telepathology include static imaging, static-dynamic robotic microscopy, video microscopy, whole slide imaging (WSI), and combinations of the above, all of which represent forms of digital pathology. Well-known barriers to the adoption of telepathology have included the cost of implementing and operating the technology, information technology-related challenges, pathologist perception of inferior performance relative to light microscopy, insufficient speed of these systems for high-volume clinical environments, as well as regulatory and licensure issues.[2] Another major challenge to the widespread adoption of telepathology has been a lack of standards and best practice guidelines from governing bodies of pathology. However, these barriers are being steadily addressed.
During the last 2 years, we have witnessed the release of clinical guidelines from several sources including the College of American Pathologists (CAP) on the validation of WSI systems for diagnostic purposes,[3] Guidance on telepathology from the Royal College of Pathologists in the United Kingdom,[4] Guidelines from the Canadian Association of Pathologists on establishing telepathology services in anatomic pathology,[5] and most recently, the revised clinical guidelines for telepathology from the ATA.[1] In 2005, guidelines were established for practical telepathology in Japan.[6] While the Food and Drug Administration in the United States has not yet approved WSI systems for primary diagnosis, Health Canada has granted Class II Medical Device Licensure to two WSI vendors for creating, managing, storing, annotating, measuring, and viewing digital images for routine pathology use including primary diagnosis.[7] The appearance of guidelines based on published evidence and current experience, the emergence of regulatory approval, and a growing body of literature showing that WSI is not inferior to light microscopy[8,9,10,11] represent major steps forward with respect to enhancing the adoption of telepathology for patient care.
The development of initial guidelines on any new technology necessarily draws heavily on the experience of early adopters. While such guidelines are not “standards of care” and are by no means all-encompassing, they nonetheless provide new and prospective users with a helpful list of issues, duties, and responsibilities to consider when implementing and using the technology of interest in their own practice. It also follows that such guidelines will need to be revised over time to accommodate advances in technology and the experience of an increased number of adopters. The 2014 clinical guidelines for telepathology released by the ATA are an update to guidelines originally developed in 1999. A committee comprised primarily of pathologists with extensive experience in various aspects of telepathology/digital pathology was assembled by the ATA in 2012. The committee also included a vendor representative with experience implementing clinical telepathology systems and senior ATA personnel to ensure proper guideline development protocols were followed. Several ATA committee members were also involved in the development of other telepathology guideline documents.[3,5]
The process began with a review of the 1999 ATA document to define the scope of the 2014 update, specific elements to be covered and terms for a literature search for relevant publications. A guideline consensus workshop was held on October 5, 2013 in Washington DC-where individual committee members developed guideline statements for accepted outline elements. These were discussed, revised, and voted upon by the group. To enhance the efficiency of the workshop, the meeting was led by professional facilitators who employed ThinkTank software (Group Systems, Denver, CO) and a local computer network allowing the committee to build the guideline as the workshop proceeded. This 1-day workshop resulted in the production of an advanced first draft that was shaped into a final guideline with supporting telepathology literature by E-mail and follow-up teleconferences. The final draft was subject to open public review and commentary, endorsed by several other organizations (CAP, Association for Pathology Informatics, Digital Pathology Association), and subsequently approved by the ATA Board of Directors prior to its official release in August 2014. Compared to the 1999 ATA Telepathology Guideline, the 2014 version standardizes terms that have been used interchangeably in telepathology and includes newer technology such as WSI that was not commercially available in 1999. The 2014 update also provides detailed advice on many different clinical applications of telepathology, highlights the need for user training and system validation, identifies facility responsibilities for sending and receiving sites, discusses regulatory, legal and patient confidentiality issues as well as the use of mobile viewing devices such as smartphones and tablets.
Table 1 compares the elements covered in the 2014 ATA, 2013 Royal College of Pathologists in the United Kingdom and 2013 Canadian Association of Pathologists Guidelines on telepathology. While the same core elements are covered in each of these documents, there are notable differences. The ATA and Royal College of Pathologists Guidelines both represent revised versions while the Canadian Guideline is the first such document developed in Canada. The Canadian Guideline focuses only on WSI, as the committee members felt that WSI was the most promising modality for certain telepathology applications.[5] The ATA guideline is unique for its inclusion of a comprehensive glossary of terms. It also provides important advice on technical specifications and the use of mobile viewing devices, as well as addressing the use of telepathology for rapid assessment of cytologic samples such as fine-needle aspiration specimens. The ATA and Canadian Guidelines were developed by committees, whereas the Royal College of Pathologists’ document has a single author supported by input from a Royal College committee and general members during a 1-month online consultation period. The ATA and Canadian Guidelines emphasize the importance of system validation before using telepathology in live patient-care situations. The Royal College Guideline discusses the need for double reporting of representative proportions of cases by conventional microscopy and telepathology. Unlike the ATA Guideline, the Royal College of Pathologists and Canadian guidelines provide more extensive discussion on the benefits of telepathology, recognized problem areas, and the communication responsibilities for all stakeholders in telepathology encounters. All guidelines cover legal liability issues specific mainly to practicing in the countries where they were developed.
Table 1
Comparison of the ATA, UK and Canadian telepathology guidelines
There will certainly be more topics to address in revised versions of these telepathology guidelines. It is likely that there will be a need for specific guidance concerning the retention of images used clinically in telepathology. Specifically, should all images be retained or only those deemed to be diagnostically relevant by the consultant pathologist? For how long should these images be retained? No guideline to date offers advice on the use of third party commercially-operated cloud solutions to share protected health information, such as scanned slides and clinical notes with patient names and/or barcodes, between pathologists. Widely publicized “hacking” episodes in recent years illustrate the potential vulnerability of these solutions and underscore the importance of security in our current “upload-it-to-the-cloud” culture.
The venues where telepathology activities are carried out, particularly when mobile viewing devices are involved, represents another potential topic for refining of guidelines. Hopefully, common sense dictates that activities involving protected health information like telepathology should be carried out in venues with some semblance of privacy as opposed to open public areas such as the food court at a shopping mall or an airport departure lounge. Guidelines from other clinical specialties such as radiology and psychiatry have already started dealing with these issues both from the technological and security/privacy perspectives so revisions to the telepathology guidelines will have other documents to refer to. Finally, there will likely be situations when a pathologist would feel more confident if he/she could review the glass slides along with telepathology images. A dilemma is created if the institution or country requesting the telepathology diagnosis has policies prohibiting the release of the original glass slides. As these and other issues surface, pathologists will certainly look to future iterations of telepathology guidelines for advice in these situations.
The three guideline documents discussed above provide an excellent resource for those considering the use of telepathology in their practice. The development and revision of these guidelines are an obligation for early adopters whose collective experience (good and bad) is crucial for the safe evolution of telepathology. This is especially true in an era where medical practice is becoming increasingly anchored to evidence-based guidelines.[12]