Clinical Guidelines for Telepathology

Table of Contents

Pream ble……………………..……………………………………………………………………………………………….………….4

Scope………………………………………………………………………………………………………………………………..………5

Int roduct ion………………………….……………………………………………………………………..…..... . .. ... . . . . . . . . . . .5

Clinical Guidelines for Telepathology……………………………………………………...….... ... ... . . . .7

Technology .………………………………………………………………………..………………………………………7

Technical Specificat ion .…………………………………………………………………..………………………..7

Clinical Applicat ions…………………………………….………………………………………………………………8

Clinical Responsibilit ies…………………….………………………………………………………….……………10

Facilit y Responsibilit ies…………………………………………………………………………………..…………10

Training……………………………………………….……………………………………………………………….……12

Docum entat ion & Archiving…………………….……………………………………….………………………12

Qualit y Assurance…………………………………..………………………………………………………..………13

Operat ions……………………………………………….…..……………………………………………………………13

Appendix……………………………………………………………………………………………………………………………..…..16

A: Definit ions/ Abbreviat ions…………………………………………………………………………….….….…16

B: References………………………………………….……………………………………………….…………….…18

2

Pream ble The Am erican Telem edicine Associat ion (ATA) br ings together diverse groups from t radit ional m edicine, academ ia, technology and telecom m unicat ions com panies, e-health, allied professional and nursing associat ions, m edical societ ies, governm ent and others to overcom e barriers to the advancem ent of t elem edicine through the professional, ethical and equitable im provem ent in health care delivery. ATA has em barked on an effort to establish pract ice guidelines for t elem edicine to help advance the science and to assure the uniform qualit y of service to pat ients. They are developed by panels that include experts from the field and other st rategic stakeholders, and are designed to serve as both an operat ional reference and an educat ional tool to aid in providing appropriate care for pat ients. The guidelines generated by ATA undergo a thorough consensus and rigorous review, with final approval by the ATA Board of Directors. Exist ing products are reviewed and updated per iodically. The purpose of these guidelines is to assist pract it ioners in pursuing a sound course of act ion to provide effect ive and safe m edical care that is founded on current inform at ion, available resources, and pat ient needs. The guidelines recognize that safe and effect ive pract ices require specific t raining, skills, and techniques, as described in each docum ent . The result ing products are propert ies of the ATA and any reproduct ion or m odificat ion of the published guideline m ust receive prior approval by the ATA. The pract ice of m edicine is an integrat ion of both the science and art of prevent ing, diagnosing, and t reat ing diseases. Accordingly, it should be recognized that com pliance with these guidelines alone will not guarantee accurate diagnoses or successful outcom es. I f circum stances warrant , a pract it ioner m ay responsibly pursue an alternate course of act ion different from the established guidelines. A divergence from the guidelines m ay be indicted when, in the reasonable judgm ent of the pract it ioner, the condit ion of t he pat ient , rest r ict ions or lim its on available resources, or advances in inform at ion or technology occur subsequent t o publicat ion of the guidelines. Nonetheless, a pract it ioner who uses an approach that is significant ly different from these guidelines is st rongly advised to provide docum entat ion, in the pat ient record, that is adequate to explain the approach pursued. (1) Likewise, the technical and adm inist rat ive guidelines in this docum ent do not purport to establish binding legal standards for carrying out telem edicine interact ions. Rather, they are the result of the accum ulated knowledge and expert ise of the ATA work groups and other leading expert s in the field, and they are intended to im prove the technical quality and reliabilit y of telem edicine encounters. The technical aspects of and adm inist rat ive procedures for specific telem edicine arrangem ents m ay vary depending on the individual circum stances, including locat ion of the part ies, resources, and nature of the interact ion.

3

SCOPE This guideline is intended to cover clinical applicat ions of telepathology only. For this docum ent , telepathology is defined as the elect ronic m ult im edia com m unicat ion across a network of pathology- related inform at ion, between two or m ore locat ions for use-cases between pathologists and/ or qualified laboratory personnel, and m ay include involvem ent by clinicians and/ or pat ients. Exam ples of clinical applicat ions include prim ary diagnosis, int raoperat ive consultat ions, secondary consultat ions, and qualit y assurance that m ay result in am ended cases. The scope of this guideline excludes use-cases specifically for research or educat ion purposes. The recom m endat ions apply to all t ypes of telepathology configurat ions, regardless of the hardware device ut ilized, including stat ic (store and forward) , dynam ic (synchronous) and hybrid stat ic-dynamic im plem entat ions. Acronym s and term s that are com m only used in telepathology are defined in Appendix A. For this docum ent there are several term s that need to be defined specifically:

• “Sha ll, Should, May” – this docum ent contains requirem ents, recom m endat ions, or act ions that are ident ified by text containing the keywords “shall,” “ should,” or “m ay.” “Shall” indicates a required act ion whenever feasible and pract ical under local condit ions. These indicat ions are found in bold throughout the docum ent . “Should” indicates an opt im al recom m ended act ion that is part icularly suitable, without m ent ioning or excluding others. “May” indicates addit ional points that m ay be considered to further opt im ize the healthcare process. “Shall not ” indicates that this act ion is st rongly advised against .

• Telem edicine : The use of m edical inform at ion exchanged from one site to another via elect ronic com m unicat ions to im prove a pat ient ’s clinical health status. Telem edicine includes a growing variety of applicat ions and services using two-way video, em ail, sm art phones, wireless tools and other form s of t elecom m unicat ions technology. • Telepathology: A form of com m unicat ion between m edical professionals that includes the t ransm ission of pathology im ages and associated clinical inform at ion for the purpose of various clinical applicat ions including, but not lim ited to, prim ary diagnoses, rapid cytology interpretat ion, int raoperat ive and second opinion consultat ions, ancillary study review, archiving, and qualit y act ivit ies.

I NTRODUCTI ON The term “ telepathology” was int roduced into the English language in 1986 by Weinstein [ Weinstein 1986; Kaplan et al. 2012] , and since then there have been m any advances and publicat ions [ Weinberg 1996; Dervan 1998; Kayser et al. 1999; Wells et al. 2000; Weinstein 2001; Cross et al. 2002; Weinstein 2009; Evans et al. 2010; William s et al. 2010; Della Mea 2011; Pantanowitz et al. 2012] . The pract ice of telepathology involves obtaining m acroscopic and/ or m icroscopic im ages for t ransm ission along telecom m unicat ion links for obtaining a rem ote interpretat ion ( telediagnosis) , second opinion or consultat ion ( teleconsultat ion) , qualit y assurance, educat ion, teaching, self- study, and research ( t ele-educat ion) . A variety of term s have been used interchangeably to refer to telepathology including digital m icroscopy, rem ote robot ic m icroscopy, t eleconferencing, teleconsultat ion, telem icroscopy, video m icroscopy, virtual m icroscopy, and whole slide im aging [ William s

4

2010; Weinstein et al. 2009; Weinstein et al. 2012] . With advances in technology and widespread access to the Internet , telepathology is increasingly being used around the world, im proving rapid sharing of cases and access to expert pathologists. Telepathology can be used for rem ote-site interpretat ion of all t ypes of pathology m aterial including, but not lim ited to, H&E stained paraffin t issue sect ions, frozen sect ions, cytology or hem atology slides, m icrobiology specim ens, clinical fluids (e.g., urine) , elect ron m icrographs, elect rophoresis gels, and cytogenet ics im ages [ Winokur et al. 1998; McLaughlin et al. 1998; Fisher et al. 2001; Evans et al. 2009; Wilbur et al. 2009; Thrall et al. 2011; Nakayam a et al. 2012; Gould 2012; Khurana 2012; Collins 2013; Kaplan et al. 2012] . I n pract ice, these digital im ages are typically linked to pat ient inform at ion including ident ificat ion/ m edical record num bers, clinical history, and relevant laboratory and radiology data [ Hedvat 2010] . Table 1 sum m arizes m ilestones of the m any technological advances in telepathology. The prim ary m odes of telepathology include stat ic im aging, dynamic im aging, hybrid stat ic/ dynamic telepathology and whole slide im aging. • Stat ic (store and forward) im age telepathology: asynchronous capture of im age files

for subsequent viewing [ Weinstein 1996] . • Robot ic (dynam ic) telepathology: the abilit y to rem otely cont rol an im age acquisit ion device (e.g., m icroscope, whole slide scanner) t hat is used to view glass slides [ Dunn et al. 2009; Kaplan et al. 2002] . • Video m icroscopy (dynam ic) : real t im e t ransm ission (st ream ing) of im ages from a video cam era for t elepathology purposes [ Baak et al. 2000; Sinard 1996; Buxbaum et al. 2012] . • Whole slide im aging (WSI ) : digit izat ion (scanning) of a glass slide to generate a digital file that allows the ent ire slide to be viewed in a m anner that sim ulates m icroscopy [ Pantanowitz et al. 2011; Cornish et al. 2012; Ghaznavi et al. 2013] . • Mult i-m odalit y telepathology: sim ultaneous ut ilizat ion of m ore than one m ode of technology (e.g., hybrid robot ic m icroscopy and WSI ) [ Della Mea et al. 2009] .

Table 1 . Telepathology system classificat ion [ Weinstein et al. 2012]

I m aging System Year Rea l - t im e I m a g ing Television m icroscopy Dynam ic- robot ic telepathology

1952 1986

Stat ic I m age Te lepathology Store & Forward telepathology Whole slide im aging (autom ated) Whole slide im aging (operator-directed)

1987 1991 1994

Mult i - Moda lit y Te lepathology Hybrid dynam ic robot ic/ stat ic im aging Whole slide im aging dynam ic robot ic/ stat ic im aging

1989 2011

Despite m any advances and increased ut ilizat ion of t elepathology, barriers exist that have lim ited it s widespread use. These include cost , legal and regulatory issues, t echnology barriers ( e.g., lim ited resolut ion, large im age files) , resistance from pathologists, and above all a lack of standards. Previously, the ATA published guidelines for t elepathology in 1999 [ Yagi et al. 1999] . This revision is an update to the original ATA guideline. More recent ly, the

5

Canadian Associat ion of Pathologists [ Bernard 2014] and the Royal College of Pathologists [ Lowe 2013] have also published guidelines for telepathology. The purpose of this docum ent is to provide new and updated guidelines to offer guidance on specific applicat ions, pract ice, benefit s, lim itat ions, and regulatory issues that m ay arise in the pract ice of t elepathology. CLI N I CAL GUI DELI NES Technology

The select ion of digital im aging system s for clinical use sha ll be determ ined at the discret ion of the m edical director of the pathology facilit y intending to use them . The facilit y shall be responsible for using such devices for FDA-approved clinical applicat ions as claim ed by the m anufacturer. The m edical director shall be responsible for em ploying and validat ing these devices if they are to be used for non-FDA-approved applicat ions. To date the FDA has not provided guidance with respect t o WSI use for prim ary diagnosis, but if guidance is issued it should be followed as appropriate. Technical Specificat ions

I m age acquisit ion: One m ay select from a variety of devices to acquire an im age, including cam eras and scanners. Displays: One m ay use a variety of displays including com puter m onitors, TV screens, and m obile devices. The viewing device and it s associated param eters (e.g., m onitor size, resolut ion and color) shall accurately display the pathology im age to be viewed [ Doolit t le et al. 1997; Krupinski 2010] . The professional j udgm ent of the pathologist m ay be used to determ ine whether or not an im age is sat isfactory to render a diagnosis.

The consistent presentat ion of im ages is essent ial and is influenced by software, graphic cont rollers, and display devices. Good visualizat ion of displayed im ages is achieved when the diagonal dim ension of the display distance is about 80% of the viewing distance. Zoom (m agnificat ion) and pan funct ions should be used for display of the im age at the originally acquired spat ial resolut ions ( i.e., direct presentat ion of acquired pixels on the display pixels) . Viewing devices should be color calibrated. Although there is no accepted calibrat ion standard for color m edical displays, there are a variety of opt ions in the literature and it is im portant to select one that can readily be im plem ented and m aintained on the display of choice [ Krupinski 2010] . Users sh ould be aware that color in digital pathology im ages can also be influenced by staining, im age acquisit ion, and software issues [ Yagi 2011; Baut ista et al 2014] . For the pract ice of telepathology one can select from a variety of m obile devices [ Park et al. 2012; Speiser et al. 2014] , including tablets and sm artphones, and m ay be used as long as they can securely display the pathology im age to be viewed at an acceptable level of qualit y. Transm ission & Storage: For the t ransm ission of telepathology im ages appropriate connect ivit y, bandwidth and com put ing capabilit ies should be in place to support the t ransm it ted im age type [ Rom ero et al. 2013] . Bandwidth for real- t im e viewing of im ages will

6

be higher than for asynchronous t ransm ission. IT infrast ructure for telepathology system s sha ll facilitate linkage of pathology im ages with necessary m etadata (e.g., ident ifiers, clinical inform at ion and prior pathology findings) . Adequate storage capacity should be in place if im ages used in telepathology are to be retained, m anipulated and ret r ieved. A typical WSI captured with a × 20 object ive lens typically represents 20+ Gb of storage if uncom pressed, but aft er com pression, the size is reduced to an average range of 200-650 Mb. Com pression technology m ay be applied so long as it does not com prom ise the im age for clinical use ( i.e., should be “ visually lossless” in that it does not change resolut ion as visible to the naked eye) [ Marcelo 2000; Krupinski et al. 2012] . Com pression is defined as m athem at ically reversible ( lossless) or irreversible ( lossy) . Reversible com pression m ay always be used as there is no im pact on the im age. I rreversible com pression m ay be used to reduce t ransm ission t ime or storage space only if the result ing qualit y is sufficient to reliably perform the clinical task. Software should support im age acquisit ion, viewing and, if desired, annotat ion and workflow (e.g., side-by-side viewing of m ult iple im ages) . Clinical Applicat ions Telepathology can be used for any of these applicat ions: Prim ary Diagnosis Prim ary diagnosis can be successfully rendered using a variety of t elepathology m odes on a variety of subst rate m aterials [ Pantanowitz et al. 2013; Bauer et al. 2013; Jen et al 2013; Evans et al. 2014; Reyes et al. 2014] . There are studies that indicate that there is not always 100% concordance between digital versus glass slide interpretat ions, however, there is not always 100% concordance between glass vs. glass slides and both inter- and int ra- reader variabilit y can vary as a funct ion of case com plexity [ Wilbur et al 2009; Dangot t & Parwani 2010; Cam pbell et al 2012; Stathonikos et al 2013] . There are also som e studies that show that certain cases ( cytopathology in part icular) are m ore challenging to interpret using digital im aging and m ay therefore not be quite ready for prim ary diagnosis [ Pantanowitz et al 2011b; Thrall et al 2011; Wilbur 2011] . I nt raoperat ive Consultat ion ( frozen sect ion) I nt raoperat ive consultat ion, with or without use of frozen sect ion can be accom plished by telepathology using a variety of m odels, including fixed im ages, robot ic dynam ic telem icroscopy, video m icroscopy and WSI . I f an int raoperat ive consult is perform ed on a resect ion specim en or large biopsy specim ens, access to im aging of the gross specim en should be available in addit ion to m icroscopic im aging m aterials [ Alm argo et al. 1996] . Rapid Cytology Rapid cytologic assessm ent of cytologic sam ples (e.g., fine-needle aspirat ion) requires sufficient speed and im age resolut ion to assist with a pat ient m anagem ent decision such as whether to obtain further sam ple, or to direct specim en m anagem ent . Speed and resolut ion used should be determ ined by the consult ing pathologist based on their experience and expert ise with respect t o the specific sam ples and diagnost ic task.

7

Secondary Consultat ion Secondary consultat ion refers t o any situat ion where a prim ary or init ial review (with or without a form al diagnosis) has been perform ed on the prim ary m aterials (gross specim en, glass slides, et c.) and further opinion is sought by m eans of t elepathology tools. Secondary consultat ion m ay be either form al or inform al, different iated prim arily by whether or not a writ ten or other form al report is rendered on the consultat ion. I nform al secondary consultat ions used to direct pat ient care should not be referenced in the m edical record without the knowledge of the rendering consultant . Secondary consultat ion is dist inct from peer- review act ivit y perform ed for qualit y assurance purposes. Secondary consultat ion via telepathology m ay be used to enhance qualit y of care by providing access to part icular expert ise m ore widely and at a potent ially lower overall cost . Special Studies Telepathology can be successfully used to expand access to specialized services not otherwise available on a cost-effect ive basis in a given locat ion. These include but are not lim ited to specialized staining processes such as im m unohistochem ist ry, FISH, CISH, etc. and their appropriate cont rols if required. Other technical procedures requir ing physician interpretat ion are also am enable to rem ote interpretat ion via telepathology tools. Digital im ages of special studies shall include pert inent pat ient ident ifiers and access to appropriate cont rol m aterials. Archival Review Archival review for clinical purposes occurs when a case is being reviewed in the context of a new specim en from the sam e pat ient or other clinical reassessm ent of t hat pat ient . Availabilit y of digit ized m aterials for archival review should be indicated in som e m anner in the pat ient record. Archival m aterial review should be docum ented to indicate lim itat ions of possible m aterial assessed. ( e.g., only 3 im ages were reviewed even though the case had 20 slides originally) . The lab should em ploy a data m anagem ent system whereby processes and procedures are defined for short and long term im age storage, and accurate and t im ely ret r ieval of im ages. Qualit y Act ivit ies Telepathology tools m ay be ut ilized in accordance with local qualit y m anagem ent plans to m onitor laboratory and or personnel qualit y perform ance on a qualitat ive or quant itat ive basis, and should be reviewed according to laboratory standards. Digital pathology tools m ay be used to provide qualit y assurance of the diagnost ic process it self. This can be done by m eans of regular diagnost ic qualit y cont rol cases, selected (autom at ic, sem i-autom at ic, random , or directed) peer review or other m eans, either prospect ively or ret rospect ively. Qualit y assurance of glass slides can be facilitated by digital pathology. Standardizat ion of histology lab output can benefit from the r igor required for slide digit izat ion. Digital im aging when used for visual managem ent of qualit y cont rol m aterials should allow t rend analysis. Quant itat ive or qualitat ive data obtained from digit ized im ages incorporated into or used as a com ponent of qualit y m anagem ent system s should be retained for an appropriate period as determ ined by the referr ing and consult ing inst itut ions. Consensus Conference Telepathology enables consensus review peer act ivity from m ult iple sites, either contem poraneously or asynchronously. The m ethod em ployed should be determ ined by the situat ion (diagnost ic considerat ions, sam ple type, speed required, m agnificat ions needed,

8

etc.) and resources available. Mult idisciplinary I nteract ions (Tum or Boards) Telepathology enables review of cases for tum or boards and subspecialty conferences at the prim ary site or rem ote sites. Telepathology- tool facilitated pathologist-clinician interact ions can enhance care by lowering the barriers to slide or other inform at ion sharing. Pat ient Consultat ion Telepathology allows for the rem ote view of pat ient 's pathology im ages either solely by the pat ient or in consultat ion with the clinical team including the pathologist . Pat ient access to their digital pathology m aterials sha ll adhere to pert inent privacy and security guidelines. Clinical Responsibilit ies Sending (Referring) and Receiving (Consult ing) I ndividuals Referring and Consult ing part ies should agree on a m inim al acceptable data set that shall accom pany digital m aterial such as accessioning num ber, pat ient nam e and block/ slide I D. The referr ing individual sha ll : • I nclude all relevant clinical inform at ion for the consult ing pathologist . • Ensure that the consult ing pathologist has access to any necessary and/ or relevant

current and prior diagnost ic m aterial. • Take responsibilit y that the correct im age is being sent , as well as appropriate m etadata.

Appropriately t rained personnel should be able to m anage cases and relevant m aterials being t ransm it ted to either the referr ing pathologist or consult ing pathologists. A laboratory m edical director should be responsible for t raining the support personnel including t rainees and sha ll be available to the support personnel as needed; responsibilit ies m ay be delegated. Other Clinical Staff Who May Be I m pacted Prior t o the im plem entat ion of novel telepathology, pathologists should engage non-laboratory clinical personnel to ident ify situat ions that require adaptat ion to change their current pract ice or workflow. Facilit y Responsibilit ies Standard of Care (SOC) The SOC of the facilit y sh a ll be defined by the organizat ion and/ or other accredit ing/ regulatory bodies such as the College of Am erican Pathologists (CAP, The Joint Com m ission (TJC) , or as is appropriate locally. The facilit y should engage the Medical Advisory Com m it tee/ Board to review and approve protocols around telepathology in situat ions where a t radit ional paradigm is substant ially changed.

9

Technical Support IT support personnel shall have a basic understanding of the technical requirem ents for the required workflows and be fam iliar with aspects of networking, interfaces, and the operat ing system s involved. Technical support personnel, including vendors with an adequate understanding of the telepathology system s (hardware, software) , should be available to ensure that the system s are operat ing appropriately. A technical support plan should m atch the urgency and crit ical nature of the use case im plem ented for t elepathology applicat ions. Funct ional Verificat ion of Equipm ent The facilit y shall m ake sure that technology and inst rum entat ion operate in accordance with m anufacturer ’s specificat ions. Accreditat ion The laboratory shall operate in com pliance with applicable accreditat ion criteria. Privileges The pathology departm ent , and specifically the CLIA Laboratory Director [ or equivalent ] and/ or her/ his pathologist designee, sha ll determ ine which individuals will have privileges to pract ice telepathology at the inst itut ion and any applicable pract ice set t ings [ Wiley et al. 2011] . Licensure The facilit y perform ing telepathology shall adhere to the applicable licensure requirem ents, with respect both to facilit ies and to pathologists, for their locat ion(s) and those with which they com m unicate. Validat ion • Technical

All laboratories im plem ent ing a telepathology service for clinical diagnost ic purposes sha ll perform their own validat ion studies [ Pantanowitz et al. 2013] . The validat ion sha ll encom pass the intended use of the clinical case and set t ing ant icipated to be deployed. Validat ion should encom pass all com ponents of the telepathology workflow. These should be validated as a single “system ”. Revalidat ion shall be conducted if there is significant change in a com ponent or use-case. Validat ion should use prepared hum an specim en(s) of the specific type that m atches the type that will be used for the clinical use-case. Validat ion for specific t issues, diseases, m icroscope changes or diagnoses is not necessary.

10

A pathologist (s) who has been adequately t rained to use the telepathology system shall be involved in the validat ion process. The validat ion process should also include all individuals that will use the telepathology system , including laboratory m anagers, laboratory staff, and I T personnel. The validat ion process should confirm that all of the m aterial present , or purposefully selected areas on the glass slide, is included in the digital im age/ video. The validat ion process should confirm that the video/ im age being sent is ident ical to that which is received. However, it should be noted that with lossy com pression, the im age that results from com pression/ decom pression m ay not be ident ical to the start ing im age but should be "visually lossless" with respect to diagnost ic inform at ion and/ or details/ features. Validat ion should com ply with the m ost current accredit ing standards of the facilit ies’ regulatory bodies; including m ethods, m easurem ents, evaluat ions and approvals for the telepathology system . Validat ion docum entat ion should be m aintained for a sufficient period to sat isfy regulatory bodies and legal inst itut ions. • Diagnost ic A validat ion process should include a sufficient num ber and m ix of cases for each applicat ion that reflects the spect rum and com plexity of specim en types and diagnoses likely to be encountered [ Pantanowitz et al. 2013] . Training Personnel responsible for perform ing telepathology, using telepathology technology and following telepathology procedures sha ll be t rained in the correct usage and adhere to any relevant Standard Operat ing Procedures (SOPs) [ Giansant i et al. 2008] . The t raining and com petency assessm ent of the staff should be determ ined by the local SOPs. Training procedures should be standardized. Training should be docum ented. Docum entat ion and Archiving Report ing of Pathologic Findings A diagnost ic consultat ion by telepathology should generate a form al report for the m edical record, com prised of either the pathology report or as a docum ented report of the oral com m unicat ion. I nform al/ internal “ curbside/ hallway” type telepathology consultat ions m ay be docum ented at the discret ion of the pathologists involved and/ or in accordance with departm ental procedures. The referr ing pathologist should docum ent in the form al pathology report that the telepathology encounter occurred, and detail the interpretat ion rendered by the consult ing

11

pathologist at their discret ion, and/ or in accordance with the inst itut ion/ departm ental SOP. Disclaim er Statem ents Any disclaim er statem ents added to the form al report of the telepathology encounter m ay be facilit y specific and determ ined by an organizat ion’s policies. Logs Logs of telepathology interact ions sha ll be t racked as is appropriate to the local requirem ents and regulat ions. These logs can be used for clinical purposes, reim bursem ent records, qualit y assurance, research or any other appropriate reason. Retent ion Policy The retent ion of associated art ifacts of the telepathology event , including telepathology docum entat ion, reports, and captured im ages sha ll be retained as is appropriate to the local requirem ents and applicable regulat ions. Im ages should be retained for an appropriate period as determ ined by the referr ing and consult ing inst itut ions. Quality Managem ent Technical An ongoing qualit y m anagem ent program should address the technical perform ance of a telepathology system such as im age qualit y, m alfunct ion, network perform ance, device calibrat ion, data integrity and im age t racking. Exam ples of qualit y m et rics that m ay be m onitored include the num ber of discordant diagnoses due to poor im age qualit y, re- scan rate as a technical qualit y indicator, and delays in turnaround t im e due to the technology. Diagnost ic A qualit y m anagem ent (QM) program should address the diagnost ic perform ance of the pathologists using the system . Exam ples of qualit y m et rics that m ay be used to assess diagnost ic perform ance include num ber of m isdiagnoses (e.g., discordant glass versus digital diagnoses) , delays in turnaround t im e, and deferral rates (e.g., failure or inabilit y to render a telepathology diagnosis) for users. A pathologist knowledgeable in telepathology should be appointed to oversee the diagnost ic QM program . Operat ions Maintenance The m aintenance of the system shall be in accordance with vendor recom m endat ions and other applicable regulatory standards.

12

The m aintenance records sha ll be retained as per the local regulatory requirem ents. Technical support The facilit y should develop telepathology specific business cont inuity procedures as appropriate for their environm ent , if such procedures are different from com plete downt im e/ system availabilit y procedures. The facilit y should develop downt im e SOPs for telepathology that are appropriate for their inst itut ional needs. Physical Facilit ies I nst itut ions shall ensure that the physical facilit ies and equipm ent provided for telepathology applicat ions are adequate for safe and efficient operat ions; this includes appropriate environm ental cont rols, network infrast ructure, physical space and ut ilit ies. Security and Privacy Organizat ions and health professionals providing telepathology services shall ensure com pliance with relevant local, state and federal (or internat ional if appropriate) legislat ion, regulat ions, accreditat ion and ethical requirem ents for support ing pat ient / client decision-m aking and consent , including protect ion of pat ient health inform at ion. All data t ransmission shall be secure through the use of encrypt ion that m eets recognized standards. I ndividuals in charge of technology should fam iliarize them selves with the technologies available regarding com puter and m obile device security, and should help educate users with respect to such issues as privacy and security opt ions. I f videoconferencing is going to be used (e.g., tum or boards) , privacy features sh a ll be available to all part icipat ing part ies. Privacy features should include audio m ut ing, video m ut ing, and the abilit y to easily change from public to private audio m ode. When providers use a m obile device, special at tent ion should be placed on the relat ive privacy of inform at ion being com m unicated over such technology. Providers sh a ll ensure that access to any pat ient inform at ion stored on any device is adequately rest r icted. Devices sha ll require a passphrase or equivalent security feature before the device can be accessed. I f m ult i- factor authent icat ion is available, it should be used. Devices should be configured to ut ilize an inact ivit y t im eout funct ion that requires a passphrase or re-authent icat ion to access the device after the t im eout t hreshold has been exceeded. This t im eout should not exceed 15 m inutes. Mobile devices should be kept in the possession of the provider when t raveling or in an uncont rolled environm ent . Unauthorized persons sha ll not be allowed access to sensit ive inform at ion stored on any device, or use the device to access sensit ive applicat ions or network resources. Providers should have the capabilit y to rem otely disable or wipe their m obile device in the event it is lost or stolen. Providers and organizat ions m ay consider establishing guidelines for periodic purging or delet ion of telepathology related files from m obile devices. Protected health inform at ion and other confident ial data sha ll only be backed up to or stored

13

on secure data storage locat ions. Cloud services unable to achieve com pliance sha ll not be used for personal health inform at ion or confident ial data. Regulatory Com pliance Telepathology program s shall be m indful of regulatory agencies ( i.e., FDA, CMS/ CLIA, CAP) and their specific policies and guidelines that pertain to telepathology.

14

APPENDI X A: DEFI NI TI ONS/ ABBREVI ATI ONS

Business Cont inuit y Procedures: Procedures established to ensure, t hat in the event of a disaster or adverse condit ions, business will cont inue to funct ion.

CAP: College of Am erican Pathologists

CI SH: Chrom ogenic in situ hybridizat ion

CLI A : Clinical Laboratory Im provem ent Am endm ents

CMS: Centers for Medicare & Medicaid Services

Digit a l Pathology: A dynam ic, im age based environm ent that enables the acquisit ion, m anagem ent , and interpretat ion of pathology inform at ion generated from a digit ized glass slide. [ ht tps: / / digitalpathologyassociat ion.org]

Digit a l Pathology System ( DPS) : An im age-based com puter system that enables the acquisit ion, m anagem ent and interpretat ion of pathology inform at ion generated from a digit ized glass slide [ DPA 2011] .

DPA: Digital Pathology Associat ion

FDA: Food and Drug Adm inist rat ion

FNA: Fine needle aspirat ion

FI SH: Fluorescence in situ hybridizat ion

I ntended Use : The m ethod or m anner in which a product is used on a daily basis [ DPA 2011] .

Metadata: Data about data. This is st ructured inform at ion describing, explaining, locat ing, or otherwise m aking it easier to ret r ieve, use, or m anage inform at ion resources. Metadata includes adm inist rat ive, descript ive, and st ructural data. Exam ples of pat ient ident it y m etadata include nam e, date of birth, m edical record num ber, and so on.

Mobile Plat form : Com m ercial off the shelf (COTS) com put ing plat form , with or without wireless connect ivit y, that is typically handheld in nature. Exam ples of t hese m obile plat form s include m obile com puters such as sm art phones, tablet com puters, or other portable com puters. Also referred to as Mobile Devices [ FDA m obile guidance docum ent 2013] .

Mult i - m odalit y Te lepathology: The sim ultaneous abilit y to ut ilize m ore than one m ode of pract ice for the purpose of t elepathology ( i.e., a hybrid of robot ic m icroscopy and WSI ) .

Qualit y Managem ent System : A set of interrelated processes and/ or m ethods that are used to cont rol how qualit y policies are im plem ented and how qualit y object ives are realized.

Robot ic Te lepathology: The abilit y to rem otely cont rol an im age acquisit ion device (e.g., whole slide scanner) , and review acquired im ages from that device for t he purpose of

15

telepathology. Also referred to as dynam ic telepathology.

SOC: Standards of Care

Standard Operat ing Procedures ( SOP) : A docum ent or inst ruct ion that details all steps and act ivit ies of a process or procedure.

Stat ic Telepathology: The asynchronous capture of im age files for the purpose of telepathology.

Telem edicine : According to the ATA, the use of m edical inform at ion exchanged from one site to another via elect ronic com m unicat ions to im prove a pat ient ’s clinical health status. Telem edicine includes a growing variety of applicat ions and services using two-way video, em ail, sm art phones, wireless tools and other form s of telecom m unicat ions technology.

Telepathology: A form of com m unicat ion between m edical professionals that includes the t ransm ission of pathology im ages and associated clinical inform at ion for the purpose of various clinical applicat ions including, but not lim ited to, prim ary diagnoses, rapid cytology interpretat ion, int raoperat ive and second opinion consultat ions, ancillary study review, archiving, and qualit y act ivit ies.

Telepathology System : The m ode or m odes of pract ice ( i.e. stat ic, robot ic, video, WSI ) used for the purpose of telepathology.

TJC: The Joint Com m ission

Validat ion: An ongoing process to establish docum ented evidence that provides a high degree of assurance, that a process or system will consistent ly perform according to predeterm ined specificat ions and qualit y at t ributes, taking into account the nature of specim ens and techniques that will be encountered [ Long et al 2012] .

Video M icroscopy: The real t im e (dynam ic im aging) t ransm ission of im ages from a video cam era for the purpose of t elepathology.

W hole Slide I m aging ( W SI ) : Digit ized (scanned) pathology glass slide that has been created on a slide scanner. The digit ized glass slide represents a high- resolut ion replica of the original glass that can then be m anipulated through software to sim ulate m icroscope review and diagnosis. Also referred to as a virtual slide [ DPA 2011] .

16

APPENDI X B: REFERENCES

Alm agro UA, Dunn BE, Choi H, Recla DL, Weinstein RS. The gross pathology workstat ion: An essent ial com ponent of a dynam ic- robot ic telepathology system . Cell Vision 1996; 3: 470-473.

Baak JP, van Diest PJ, Meijer GA. Experience with a dynam ic inexpensive video-conferencing system for frozen sect ion telepathology. Anal Cell Pathol 2000; 21: 169-175.

Bauer TW, Schoenfield L, Slaw RJ, Yerian L, Sun Z, Henricks WH. Validat ion of whole slide im aging for prim ary diagnosis in surgical pathology. Arch Pathol Lab Med. 2013; 137: 518-24.

Baut ista PA, Hashim oto N, Yagi Y. Color standardizat ion in whole slide im aging using a color calibrat ion slide.J Pathol I nform . 2014; 5: 4.

Bernard C, Chandrakanth SA, Cornell IS, Dalton J, Evans A, Garcia BM, et al. Guidelines from the Canadian Associat ion of pathologists for establishing a telepathology service for anatom ic pathology using whole-slide im aging. J Pathol I nform at ics. 2014. 5: 15.

Buxbaum JL, Eloubeidi MA, Lane CJ, Varadaraj ulu S, Linder A, Crowe AE, Jhala D, Jhala NC, Crowe DR, Eltoum IA. Dynam ic telecytology com pares favorably to rapid onsite evaluat ion of endoscopic ult rasound fine needle aspirates. Dig Dis Sci. 2012; 57: 3092-7.

Cam pbell WS1, Lele SM, West WW, Lazenby AJ, Sm ith LM, Hinrichs SH. Concordance between whole-slide im aging and light m icroscopy for rout ine surgical pathology. Hum Pathol. 2012; 43: 1739-44.

Collins BT. Telepathology in cytopathology: challenges and opportunit ies. Acta Cytol. 2013; 57: 221-32.

Cornish TC, Swapp RE, Kaplan KJ. Whole-slide im aging: rout ine pathologic diagnosis. Adv Anat Pathol. 2012; 19: 152-9.

Cross SS, Dennis T, Start RD. Telepathology: current status and future prospects in diagnost ic histopathology. Histopathology 2002; 41: 91-109.

Dangot t B, Parwani A. Whole slide im aging for teleconsultat ion and clinical use. J Pathol I nform . 2010; 1. pii: 7. Della Mea V, Cataldi P, Pertoldi B, et al. Com bining dynam ic- and stat ic- robot ic techniques for real- t im e telepathology. I n: Kum ar S, Dunn BE, eds. Telepathology. Ber lin: Springer; 2009. 8: 79-89.

Della Mea V. 25 years of telepathology research: a bibliom et ric analysis. Diagn Pathol. 2011; 6 Suppl 1: S26.

Dervan PA, Woot ton R. Diagnost ic telepathology. Histopathology 1998; 32: 195-198.

Doolit t le MH, Doolit t le KW, Winkelm an Z, Weinberg DS. Color im ages in telepathology: how m any colors do we need? Hum Pathol 1997; 28: 36-41.

17

DPA (Digital Pathology Associat ion) . Validat ion of Digital Pathology In a Healthcare Environm ent . White paper. Lowe A, Chlipala E, Elin J, Kawano Y, Long RE, Tillm an D. 2011. Available online at : ht tps: / / digitalpathologyassociat ion.org/ _data/ files/ DPA-Healthcare-White-Paper- -FI NAL_v1.0.pdf

Dunn BE, Choi H, Recla DL, Kerr SE, Wagenm an BL. Robot ic surgical telepathology between the I ron Mountain and Milwaukee Departm ent of Veterans Affairs Medical Centers: a 12-year experience. Hum Pathol. 2009; 40: 1092-9.

Evans AJ, Chet ty R, Clarke BA, Croul S, Ghazarian DM, Kiehl TR, Perez Ordonez B, I laalagan S, Asa SL. Prim ary frozen sect ion diagnosis by robot ic m icroscopy and v irtual slide telepathology: the University Health Network experience. Hum Pathol. 2009; 40: 1070-81.

Evans AJ, Kiehl TR, Croul S. Frequent ly asked quest ions concerning the use of whole-slide im aging telepathology for neuropathology frozen sect ions. Sem in Diagn Pathol. 2010; 27: 160-6.

Evans AJ, Perez-Ordonez B, Asa SL. Prim ary diagnosis by whole slide imaging (WSI ) telepathology: University Health Network (UHN) goes live. Mod Pathol 2014; 27 (suppl 2) : 399A.

FDA m obile guidance docum ent . 2013. Available online at : ht tp: / / www.fda.gov/ downloads/ MedicalDevices/ .../ UCM263366.pdf

Fisher SI , Nandedkar MA, William s BH, Abbondanzo SL. Telehem atopathology in a clinical consultat ive pract ice. Hum Pathol 2001; 32: 1327-1333.

Ghaznavi F, Evans A, Madabhushi A, Feldm an M. Digital im aging in pathology: whole-slide im aging and beyond. Annu Rev Pathol. 2013; 8: 331-59.

Giansant i D, Cast r ichella L, Giovagnoli MR. Telepathology requires specific t raining for the technician in the biom edical laboratory. Telem ed J E Health. 2008; 14: 801-7.

Gould PV, Saikali S. A com parison of digit ized frozen sect ion and sm ear preparat ions for int raoperat ive neurotelepathology. Anal Cell Pathol (Am st ) . 2012; 35: 85-91.

Hedvat CV. Digital m icroscopy: past , present , and future. Arch Pathol Lab Med. 2010; 134: 1666-1670.

Jen KY, Olson JL, Brodsky S, Zhou XJ, Nadasdy T, Laszik ZG. Reliabilit y of whole slide im ages as a diagnost ic m odalit y for renal allograft biopsies. Hum Pathol. 2013; 44: 888-94.

Kaplan KJ, Burgess JR, Sandberg GD, Myers CP, Bigot t TR, Greenspan RB. Use of robot ic telepathology for frozen-sect ion diagnosis: a ret rospect ive t r ial of a telepathology system for int raoperat ive consultat ion. Mod Pathol 2002; 15: 1197-1204.

18

Kaplan K, Weinstein RS, Pantanowitz L. Telepathology. I n: Pantanowitz L, Balis UJ, Tuthill JM (editors) . Pathology Inform at ics: Theory & Pract ice. ASCP Press. 2012; 16: 257-272.

Kayser K, Szym as J, Weinstein R. Telepathology. I n: Telepathology: Telecom m unicat ion, Elect ronic Educat ion and Publicat ion in Pathology. Berlin: Springer; 1999. Pages 1-186.

Khurana KK. Telecytology and it s evolving role in cytopathology. Diagn Cytopathol. 2012; 40: 498-502.

Krupinski EA. Opt im izing the pathology workstat ion "cockpit " : Challenges and solut ions. J Pathol I nform . 2010; 1: 19.

Krupinski EA, Johnson JP, Jaw S, Graham AR, Weinstein RS. Com pressing pathology whole-slide im ages using a hum an and m odel observer evaluat ion. J Pathol I nform . 2012; 3: 17.

Leung ST, Kaplan KJ. Medicolegal aspects of t elepathology. Hum Pathol. 2009; 40: 1137-42.

Long RE, Sm ith A, Machotka SV, Chlipala E, Cann J, Knight B, Kawano Y, Ellin J, Lowe A. Scient ific and Regulatory Policy Com m it tee (SRPC) paper: validat ion of digital pathology system s in the regulated nonclinical environm ent . Toxicol Pathol. 2013; 41(1) : 115–124.

Lowe J. Telepathology: Guideline from the Royal College of Pathologists. 2013. Available online at ht tp: / / www.rcpath.org/ Resources/ RCPath/ Migrated% 20Resources/ Docum ents/ G/ G026_Telepathology_Oct13.pdf

Marcelo A, Fontelo P, Farolan M, Cualing H. Effect of im age com pression on telepathology. A random ized clinical t rial. Arch Pathol Lab Med. 2000; 124: 1653-6.

McLaughlin WJ, Schifm an RB, Ryan KJ, Manriquez GM, Bhat tacharyya AK, Dunn BE, Weinstein RS. Telem icrobiology: feasibilit y study. Telem edicine J 1998; 4: 11-17.

Nakayam a I , Matsum ura T, Kam ataki A, Uzuki M, Saito K, Hobbs J, Akasaka T, Sawai T. Developm ent of a telederm atopathology consultat ion system using virtual slides. Diagn Pathol. 2012; 7: 177.

Pantanowitz L, Valenstein PN, Evans AJ, Kaplan KJ, Pfeifer JD, Wilbur DC, Collins LC, Colgan TJ. Review of the current state of whole slide imaging in pathology. J Pathol I nform . 2011; 2: 36.

Pantanowitz L, Parwani AV, Khalbuss WE. Digital im aging for cytopathology: are we there yet? Cytopathology. 2011b; 22: 73-4.

Pantanowitz L, Wiley CA, Dem et ris A, Lesniak A, Ahm ed I , Cable W, Cont is L, Parwani AV. Experience with m ult imodalit y telepathology at the University of Pit t sburgh Medical Center. J Pathol I nform at ics. 2012; 3: 45.

19

Pantanowitz L, Sinard JH, Henricks WH, Fatheree LA, Carter AB, Cont is L, Beckwith BA, Evans AJ, Lal A, Parwani AV; College of Am erican Pathologists Pathology and Laboratory Qualit y Center. Validat ing whole slide im aging for diagnost ic purposes in pathology: guideline from the College of Am erican Pathologists Pathology and Laboratory Qualit y Center. Arch Pathol Lab Med. 2013; 137: 1710-22.

Park SL, Parwani AV, Satyanarayanan M, Pantanowitz L. Handheld com put ing in pathology. J Pathol I nform at ics. 2012; 3: 15.

Reyes C, I kpat t OF, Nadj i M, Cote RJ. I nt ra-observer reproducibilit y of whole slide im aging for the prim ary diagnosis of breast needle biopsies. J Pathol I nform . 2014 Feb 25; 5: 5.

Rom ero Lauro G, Cable W, Lesniak A, Tseyt lin E, McHugh J, Parwani A, Pantanowitz L. Digital pathology consultat ions - a new era in digital imaging, challenges and pract ical applicat ions. Journal Digital Im aging 2013; 26: 668-77.

Sinard JH. Pract ical Pathology Inform at ics. New York: Springer; 2006. Pages 265-286.

Speiser JJ, Hughes I , Mehta V, Wojcik EM, Hutchens KA. Mobile telederm atopathology: using a tablet PC as a novel and cost-efficient m ethod to rem otely diagnose derm atopathology cases. Am J Derm atopathol. 2014; 36: 54-7.

Stathonikos N, Veta M, Huism an A, van Diest PJ. Going fully digital: Perspect ive of a Dutch academ ic pathology lab. J Pathol I nform . 2013; 4: 15. Thrall M, Pantanowitz L, Khalbuss WE. Telecytology: clinical applicat ions, current challenges and future benefit s. J Pathol I nform at ics 2011; 2: 51.

Walter GF, Walter KFJP. Legal pit falls in teleneuropathology. Methods Inf Med 2003; 42: 255–9.

Weinberg DS. How is telepathology being used to im prove pat ient care? Clin Chem 1996; 42: 831-5.

Weinstein RS. Prospects for t elepathology. Hum Pathol. 1986; 17: 433-4.

Weinstein RS. Stat ic image telepathology in perspect ive. Hum Pathol 1996; 27: 99-101.

Weinstein RS, Descour MR, Liang C, Bhat tacharyya AK, Graham AR, Davis JR, Scot t KM, Richter L, Krupinski EA, Szym us J, Kayser K, Dunn BE. Telepathology overview: from concept to im plem entat ion. Hum Pathol. 2001; 32: 1283-99.

Weinstein RS, Graham AR, Richter LC, Barker GP, Krupinski EA, Lopez AM, Erps KA, Bhat tacharyya AK, Yagi Y, Gilbertson JR. Overview of t elepathology, virt ual m icroscopy, and whole slide im aging: prospects for the future. Hum Pathol. 2009; 40: 1057-69.

20

Weinstein RS, Graham AR, Lian F, Braunhut BL, Barker GR, Krupinski EA, Bhat tacharyya AK. Reconciliat ion of diverse telepathology system designs. Historic issues and im plicat ions for em erging m arkets and new applicat ions. APMI S. 2012; 120: 256-75.

Wells CA, Sowter C. Telepathology: a diagnost ic tool for the m illennium ? J Pathol 2000; 191: 1-7.

Wilbur DC, Madi K, Colvin RB, Duncan LM, Faquin WC, Ferry JA, Frosch MP, Houser SL, Kradin RL, Lauwers GY, Louis DN, Mark EJ, Mino-Kenudson M, Misdraj i J, Nielsen GP, Pitm an MB, Rosenberg AE, Sm ith RN, Sohani AR, Stone JR, Tam bouret RH, Wu CL, Young RH, Zem bowicz A, Klietm ann W. Whole- slide im aging digital pathology as a plat form for teleconsultat ion: a pilot study using paired subspecialist correlat ions. Arch Pathol Lab Med. 2009; 133: 1949-53.

Wilbur DC. Digital cytology: current state of the art and prospects for the future. Acta Cytol. 2011; 55: 227-38.

Wiley CA, Murdoch G, Parwani A, Cudahy T, Wilson D, Payner T, Springer K, Lewis T. I nterinst itut ional and interstate teleneuropathology. J Pathol I nform . 2011; 2: 21.

William s S, Henricks WH, Becich MJ, Toscano M, Carter AB. Telepathology for pat ient care: what am I get t ing myself into? Adv Anat Pathol. 2010; 17: 130-49.

Winokur TS, McClellan S, Siegal GP, Reddy V, List insky CM, Conner D, Goldm an J, Grim es G, Vaughn G, McDonald JM. An init ial t rial of a prototype telepathology system featuring stat ic im aging with discrete cont rol of the rem ote m icroscope. Am J Clin Pathol. 1998; 110: 43-9.

Yagi Y, Weinstein R, Gilbertson J, and m em bers of the ATA’s telepathology special interest group. Clinical guidelines for t elepathology. Am erican Telem edicine Associat ion. 1999. Available online at ht tp: / / www.am ericantelem ed.org/ docs/ default- source/ standards/ clinical-guidelines- for- telepathology.pdf?sfvrsn= 4

Yagi Y. Color standardizat ion and opt im izat ion in whole slide im aging. Diagn Pathol. 2011; 6 Suppl 1: S15.

For Further I nform at ion or Quest ions: Contact Am erican Telem edicine Associat ion at 202.223.3333 or info@am ericantelem ed.org

21