Guidelines for the Surgical Practice of Telemedicine

Disclaimer

Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.

Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.

SECTION 1. OVERVIEW

SAGES has established guidelines for post residency surgical education in its Framework for Post-Residency Surgical Education & Training. [1] That document provides a format for obtaining appropriate training, attaining competence, and gaining privileges for advanced surgical procedures not learned during a formal residency program. It is upon the foundation laid by that document that this Guidelines for the Surgical Practice of Telemedicine has been constructed. The two instruments are designed to be complementary and not exclusionary; both are intended to promote high quality patient care.

Telemedicine has been practiced for over 30 years. [2] Recent technological advances, however, have expanded the scope of medical interaction that may be achieved. Whereas consultative services, examination of still documents (photos, x-rays, slides, or ECGs), and interactive voice sessions previously defined the state of the art, the telemedical event may now involve “live” manipulations of patients and/or tissues “at a distance”. In fact, there are now many levels of health care-related interaction that may take place in the telecommunications medium: physician-to-physician consultation, physician-tostudent (physician, nurse, other care giver) teaching, physician-to-patient examination and consultation, and physician-to-patient treatment. [3-10] This document provides guidelines for establishing policies and procedures to promote safe, high quality application of telemedicine technology to the practice of surgery.

The implementation of enhanced high speed, broadband communications (Internet2), immersive feedback and nanotechnology will continue to drive the rapid development of telemedicine. SAGES anticipates this document to be a vibrant resource for those interested in the field and to evolve as the state of the art evolves. [11-13a]

Both surgeons and telemedicine facilities involved in the practice of intrastate, interstate, international and/or transcontinental telemedicine are responsible for compliance with appropriate state and federal and global licensing requirements. Complex issues relating to patient privacy, medical licensure and malpractice liability continue to evolve. Current expert opinion should be verified. [14,15, 15a-c]

SECTION 2. EXISTING DEFINITIONS and CONCEPTS

Skills:

Practical ability and dexterity based on talent and knowledge usually derived from a period of education and training.

Skills Laboratory:

A facility in which a practicing physician acquires, refines or improves his/her ability to perform specific medical/surgical tasks or procedures. Skills are the building blocks upon which procedures are constructed. A skills laboratory may teach one skill or the entire set of skills required to perform a procedure. A skills laboratory is usually a continuing resource that can be revisited.

SECTION 3. NEW DEFINITIONS and CONCEPTS

The following definitions and concepts regarding surgical practice and telemedicine have been formulated after a review of the literature on telemedicine, with an intent to provide continuity relative to the principles defined in SAGES’ Framework for Post-Residencv Surgical Education & Training document.

Some of the items in this section are derived from the history of telemedicine; others are natural extensions of concepts presented in SAGES’ parent document. The purpose here is to develop a framework for understanding and categorizing basic telemedicine concepts and activities, and to establish guidelines for the safe surgical practice of telemedicine.

TELEMEDICINE

Definition:

The practice of medicine and/or teaching of the medical art, without direct physical physician-patient or physician-student interaction, via an interactive audio-video communication system employing tele-electronic devices.

Appropriate Use:

Some applications of consultation, diagnosis and teaching with the potential for treatment as defined below.

REMOTE SITE (SITE OF THE PRIMARY ACTIVITY)

Definition:

The site or location of the primary activity. This location may be the originating site of a conference, the laboratory where a new technique, instrument, or technology is being demonstrated, the facility where a patient is being evaluated or treated, or the operating theater where a surgical procedure is being performed.

CENTRAL LOCATION (CENTRAL SITE)

Definition:

The site of the teacher, demonstrator, evaluator, student, or clinician which is not immediately adjacent or proximate to the primary site of the activity or procedure. The central or offsite location may be as little as 100 feet or as distant as several thousand miles from the primary site of a conference or patient interaction. The basic assumption here, is that the individual at the central site is not able to physically intervene immediately in the primary procedure without the telecommunications interface.

Comments:

The concept of interaction at a distance implies that some form of telecommunications medium is employed. The participants, facilities, and telecommunication service vendors involved in the event should coordinate their efforts so that the telecommunications interface is suitable for the planned activity.

TELECONFERENCING

Definition:

A real time and live interactive program in which one set of participants are at one or more locations and the other set of participants are at another location. The teleconference allows for interaction, including audio and/or video, and possibly other modalities, between at least two sites.

Appropriate Use:

Teaching (e.g. didactic lectures, demonstration of surgical or other medical procedures, and demonstration of uses of equipment), consultation, diagnosis, or deliberations. (See: Teleconsulting)

Comments:

Teleconferencing may be a useful adjunct to hands-on experience in the instruction of new procedures but is not a substitute for on-site supervised hands-on training in the development of competency.

TELEPROCTOR

Definition:

An expert surgeon, at a central site, who undertakes to impart his/her clinical knowledge and skills in a defined setting to a student. The teleproctor must be appropriately privileged, skilled, and experienced in the procedure(s) and/or technique(s) in question. In order to serve as a teleproctor in a specific procedure or technique, the surgeon (teleproctor) must be a recognized authority (e.g. publications, presentations, extensive clinical experience) in the particular field of expertise. The teleproctor, by definition, does not have the ability to physically intervene on-site in the primary activity without the telecommunications interface.

TELEPROCTORING

Definition:

A real time and live interactive teaching of techniques or procedures by a teleproctor to a student. The teleproctor is in one location and the student is in another. The teleproctor must have the ability to see the performance of the procedure or technique being executed by the student in real time. The teleproctor and the student must have the ability to verbally communicate during the session. Implicit in the definition of teleproctoring is that the teleproctor does not have the ability to physically intervene on-site and can therefore not assume primary patient care responsibility.

Appropriate Use:

  • Demonstration and/or teaching technique or procedures using inanimate trainers.
  • Demonstration and/or teaching techniques or procedures using animate ex vivo models.
  • Demonstration and teaching techniques or procedures on patients as an adjunct teacher when a qualified preceptor is on-site with the student.

Comments:

Teleproctoring is not an acceptable substitute for an on-site preceptorship but may be a useful adjunct.

TELEMONITOR / TELEPROCTOR

Definition:

A person who supervises or monitors students from a central location. As defined here, a teleproctor differs from a consultant or a preceptor in that (s)he functions as an observer and evaluator, does not directly participate in patient care, and receives no fees from the patient. The teleproctor acts as an agent of the privileging committee of the sponsoring hospital. The teleproctor, by definition, does not have the ability to physically intervene on- site without the telecommunications interface and therefore cannot assume primary patient care responsibility.

A teleproctor must be a physician/surgeon who has recognized proficiency or documented expertise in the specialty area being monitored. The teleproctor should be free of perceived or actual conflicts of interest, which might create a bias against, or in favor of, the applicant. A teleproctor may work at the same or at another institution.

TELEPROCTORING

Definition:

A real time and live interactive monitoring (evaluation) of technique(s) or procedure(s) of an applicant seeking privileges, or a surgeon seeking to certify or document his competence in a specific technique or procedure(s). The teleproctor is in one location and the surgeon to be evaluated is in another. The teleproctor must have the ability to see the performance of the procedure or technique being executed by the student in real time. The teleproctor and the applicant must have the ability to verbally communicate during the session.

Appropriate Use:

Teleproctoring may be used as an adjunct to proctoring in the privileging process but should not alone be a substitute for proctoring to determine competency. Integration of teleproctoring into the proctoring process may reduce, but not eliminate, the number of on-site proctored cases required.

Comments:

The term-teleproctoring is sometimes used to define remote patient surveillance. For the purposes of this document, teleproctoring is not used in that context, but rather as described above. Remote patient surveillance is an activity that is included in the concept of telemanagement.

Teleproctoring assumes that the ability of the teleproctor to physically intervene at the site of the primary procedure is not possible without the telecommunications interface.

TELECONSULTANT

Definition:

A physician at a central location who evaluates a patient, and/or patient data, and who presents an opinion of his or her findings and/or recommendations for further evaluation or treatment to the patient or other health care provider at the remote site, using a telecommunications interface.

TELECONSULTING (REMOTE PATIENT EVALUATION & CONSULTATION)

Definition:

Evaluation of patient(s), and/or patient data, and consultation regarding patient management, from a distant site, using a telecommunications interface. The teleconsultant, by definition, does not have the ability to physically interact with the patient, except through the telecommunications interface.

Appropriate Use: [16]

  • Initial urgent evaluation of patients, triage decisions, and pretransfer arrangements for patients in an urgent/emergency situation
  • Intra-operative consultations
  • Supervision and consultation for primary care encounters in sites where an equivalently qualified physician/surgeon is not available
  • Routine consultations and second opinions based on history, physical findings, and available test data
  • Public health, preventive medicine, and patient education

Comments:

Teleconsulting has heretofore represented the pinnacle of achievement in telemedicine applications. Its use in the fields of radiology and pathology has stimulated the development of specific guidelines regarding the minimum and suggested interface requirements for reliable interpretation of transmitted patient information. [17,18] In other disciplines, minimum requirements for the telecommunications interface remain to be defined. However, teleconsulting with telesurgical presence should include high speed, uninterrupted transmission, similarity of operating room environments with necessary instruments previously agreed upon and an absence of language barriers between the consultant and the operating team. Utilizing these criteria expert telesurgical consultation has been provided for even complex surgical problems. [18a, 18b]

Remote patient evaluation assumes that a remote health care provider, who is familiar with, and capable of using the telecommunications interface equipment, is present with the patient or that the patient has been instructed in the mechanics of, and is capable of applying the diagnostic and telecommunications instrumentation necessary to provide clinical information to the teleconsultant.

TELEMANAGEMENT (REMOTE PATIENT MANAGEMENT)

Definition:

Remote evaluation and non-operative treatment of a patient, using a telecommunications interface.

Appropriate Use: [16]

  • Medical and surgical evaluation, follow-up, and medication checks
  • Management of chronic diseases and conditions requiring a specialist not available locally
  • Public health, preventive medicine, and patient education

Comments:

Telemanagement of a patient assumes that the central physician has evaluated the patient, and/or patient data, concurrently with the management activity.

Because it involves a level of physician-patient interaction comparable to, or more intense than teleconsulting, telemanagement requires that a remote health care provider, who is familiar with, and capable of using the telecommunications interface equipment, is present with the patient, or that the patient has been instructed in the mechanics of, and is capable of applying the diagnostic and telecommunications instrumentation necessary to provide clinical information to the central site physician.

TELESURGERY (REMOTE SURGERY)

Definition:

Surgery, procedure or intervention performed on an inanimate trainer, animate model, or patient, in which the surgeon or operator is not at the immediate site of the model or patient being operated upon. Visualization and manipulation of the tissues and equipment is performed using teleelectronic devices.

Appropriate Use:

  • Demonstration and/or teaching technique or procedures using inanimate trainers as the objects of the procedure.
  • Demonstration and/or teaching techniques or procedures using animate model for purposes of testing technology.
  • Demonstration and teaching techniques or procedures on patients under strict guidance of an IRB and only when a qualified surgeon is present to intervene in a timely fashion if technical difficulties arise.

Comments:

Remote surgery remains investigational and should be performed with IRB approval and only by surgeons familiar with the technology. The introduction of telerobotic surgery, coupled with improvements in bandwidth and reduction in time has allowed for the remote safe completion of common surgical procedures [19-23].

SAGES strongly urges surgeons to conduct the clinical use of telesurgery and telerobotics under IRB auspices. Quality assurance and outcomes data should be routinely collected. Surgeons utilizing telerobotics should undergo appropriate training and be aware of the anesthetic implications of this technology [24, 25]. All involved participants, facilities, telecommunication and equipment vendors should coordinate their efforts to provide secure visual fidelity and smooth telecommunications interfaces. The development of global standards should be actively pursued.

Since 4/14/03 (Health Insurance Portability And Accountability Act compliance date), protected health information (PHI), needs to be managed in accordance with Federal regulations. Simple de-identification such as removal of the patient’s name or avoidance of facial photography, which was sufficient in the past does not meet all of the requirements today. “Live surgery” by its very nature adds identifiers in two categories that need to be considered under the law. They are “dates of service” which is the day of the transmission and geographic location (less than 20,000 persons) of the procedure, i.e. the hospital. Since these are unavoidable, an authorization from the patient must be obtained. This is the patient’s physician responsibility prior to disclosing PHI outside of the covered entity where the procedure is taking place.

This authorization should indicate:

  1. It is very unlikely that the patient could be identified individually (unless the patient authorizes the disclosure of his or her name or allows the use of facial photography
  2. The nature of the PHI to be disclosed (in most cases this is date of surgery and location of care)
  3. the nature of those persons who will be in receipt of PHI and the fact that federal law does not require those same persons to keep the PHI confidential
  4. the expiration date of the authorization.

SAGES strongly urges surgeons and hospitals to defer clinical implementation of these modalities until the technology has been validated. It is our opinion that current clinical use of this technology should only be conducted under a protocol reviewed by an institutional committee for the protection of patients and should include the collection of quality assurance and outcomes data. The participants, facilities, and telecommunication service vendors involved in these events should coordinate their efforts so that the visual fidelity and telecommunications interface is suitable for the planned activity.

REFERENCES

  1. SAGES. Framework for post-residency surgical education & training. Surg Endosc 8(9): 1137-1142, 1994.
  2. DeBakey ME. Telemedicine has now come of age. Telemedicine Journal, 1(1): 3-4,1995.
  3. Allen A, Cox R, Thomas C. Telemedicine in Kansas. Kans Med, 93(12): 3235, 1992.
  4. Satava RM, Simon lB. Teleoperation, telerobotics, and telepresence in surgery. Endosc Surg Allied Technol, 1(3): 151-3, 1993.
  5. Eide T J, Nordrum I. Current status oftelepathology. APMIS, 102(12): 881-90, 1994.
  6. Belmont JM, Mattioli LF, Goertz KK, et. al. Evaluation of remote stethoscopy for pediatric telecardiology. Telemedicine Journal 1 (1): 133-150, 1995.
  7. Mexrich RS, DeMarco JK, Negin S, et. al. Radiology on the information superhighway. Radiology, 195(1): 73-81, 1995.
  8. Sweet HA, Holaday BA, Leffell 0, et. al. Telemedicine: delivering medical expertise across the state and around the world. Connecticut Medicine, 59(10): 593-602, October, 1995.
  9. Nakamura K, Takano T, Akao C. Assessment of the value of videophones in community model networks for developing a comprehensive home health care system employing multimedia. Paper presented at the Second International Conference on the Medical Aspects of Telemedicine and Second Mayo Telemedicine Symposium, Telemedicine Journal 1(2): 174, 1995.
  10. Darkins A, Gough 0, Opett L, et. al. Inner city telemedicine–management of patients with minor injuries by low cost videoconferencing. Paper presented at the Second International Conference on the Medical Aspects of Telemedicine and Second Mayo Telemedicine Symposium, Telemedicine Journal 1(2): 177, 1995.
  11. Bashshur RL. On the definition and evaluation of telemedicine. Telemedicine Journal, 1 (1): 19-30, 1995.
  12. Houtchens BA, Allen A, Clemmer TP, et. al. Telemedicine protocols and standards: development and implementation. J Med Syst, 19(2): 93-119, 1995.
  13. Sanders JH, Bashshur RL. Challenges to the implementation of telemedicine. Telemedicine Journal, 1 (2): 115-123, 1995.
    1. Versel, N. 3-D, Fast Connection Boosts Telemedicine, Modern Physician, 1 (1): 4, 2003.
  14. Buckler LB, et al. An act to regulate the practice of medicine across state lines. The Federation of State Medical Boards, Euless, Texas, October 16, 1995.
  15. Buckler LB, et al. A model act to regulate the practice of telemedicine or medicine by other means across state lines: Executive summary. The Federation of State Medical Boards, Euless, Texas, October 16, 1995.
    1. Standards for privacy of individually identifiable health information. Final rule. Department of Health and Human Services. Federal Register 65(250): 82461-82829,2000.
    2. Hodge, J.G., Gostin, LO., Jacobson, P.O. Legal issues concerning electronic health information. Privacy, quality and liability. JAMA 282:1466-1471,1999.
    3. Gobis, L An overview of state laws and approaches to minimize licensure barriers. Part 2. Telemedicine Today Magazine. 6:1998
  16. Grigsby J, Schlenker RE, Kaehny MM, et al. Analytic framework for evaluation of telemedicine. Telemedicine Journal, 1(1): 31-39,1995.
  17. Black-Schaffer S, Flotte T J. Current issues in telepathology. Telemedicine Journal, 1(2): 95-106,1995.
  18. Forsberg D. Quality assurance in teleradiology. Telemedicine Journal, 1 (2): 107-114,1995.
    1. Rodas, EB., Latifi, R, Cone, S., etal. Telesurgical presence and consultation for open surgery. Arch. Surg. 137:1360-1363,2002.
    2. Quintero, RA., Munoz, H., Pommer, R etal. Operative fetoscopy via telesurgery. Ultrasound, Obstetrics and Gynecology 20:390-391, 2002.
  19. Cheah, W.K., Lee, B., Lenzi, J.E, Goh Pmy. Telesurgicallaparoscopic cholecystectomy between two countries. Surg Endo 14:1085, 2000.
  20. Marescaux, J., Leroy, J., Gagner, M., etal. Transatlantic Robot-assisted telesurgery. Nature 413: 379-380,2001.
  21. Link, R.E., Schulam, P.G. and Kavoussi, LR Telesurgery. Remote monitoring and assistance during laparoscopy. Urologic Clinics of North America 28(1) 177-88,2001.
  22. Marescaux, J., Leroy, J., Gagner, M., etal. Transcontinental Robot-assisted remote telesurgery: Feasibility and potential applications. Ann. Surgery 235(4) 487-492,2002.
  23. Ballantyne, G.H. Robotic surgery, telerobotic surgery, telepresence and telementoring. Review of early clinical results. Surg. Endo. 16: 1389-1402, 2002.
  24. Chitwood, W.R., Nifong, L.W., Chapman, W.H. etat Robotic surgical training in an academic institution. Ann. Surgery. 234(4) 475-486, 2001.
  25. Parr, KG. and Talamini, M.A. Anesthetic implications of the addition of an operative robot for endoscopic surgery: A case report. J. Clin.Anesth.14:228223, 2002.

This statement was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) on Oct 2010.

This is a revision of a SAGES publication printed Mar 2004, revised Oct 2010.

For more information please contact:

SOCIETY OF AMERICAN GASTROINTESTINAL ENDOSCOPIC SURGEONS (SAGES)
11300 West Olympic Blvd., Suite 600
Los Angeles, CA 90064
Tel:
(310) 437-0544
Fax:
(310) 437-0585
Email:
publications@sages.org

Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.

Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.