- •Foreword
- •Preface
- •Contents
- •1.1 Introduction
- •1.2 Method
- •1.2.1 Databases
- •1.2.2 Dates
- •1.2.3 Keywords
- •1.2.4 Criteria for Inclusion
- •1.2.5 Criteria for Exclusion
- •1.2.6 Selection of Papers
- •1.3 Results
- •1.3.1 Subspecialty
- •1.3.2 Type of Telemedicine
- •1.3.3 Study Design
- •1.3.4 Final Conclusions of Papers
- •1.4 Discussion
- •References
- •2.1 Introduction
- •2.2 The Need for Diabetic Retinopathy Screening Programs
- •2.4 Guidelines for Referring Patients
- •2.7 Program Models for Diabetic Retinopathy Screening
- •2.9 Program Personnel and Operations
- •2.9.1 Primary Care Providers
- •2.9.2 Photographers
- •2.9.3 Clinical Consultants
- •2.9.4 Administrators
- •2.9.5 A Note to CEOs, Operations Directors, and Clinic Managers
- •2.10 Policies and Procedures
- •2.10.1 Sample Protocol 1
- •2.10.1.1 Diabetic Retinopathy Screening Services
- •Policy
- •Background
- •Procedure
- •2.10.2 Sample Protocol 2
- •2.10.2.1 Pupil Dilation Before Diabetic Retinopathy Photography
- •Policy
- •Background
- •Procedure
- •2.10.3 Sample Protocol 3
- •2.10.3.1 Diabetic Retinopathy Photography Review
- •Policy
- •Background
- •Procedure
- •2.11 Technical Requirements
- •2.11.1 Connectivity
- •2.11.2 Resolution
- •2.11.3 Color
- •2.11.4 Stereopsis
- •2.11.5 Compression
- •2.11.6 Enhancement
- •2.11.7 Pupil Dilation
- •2.11.8 Early California Telemedicine Initiatives Diabetic Retinopathy Screening
- •2.11.9 The American Indian Diabetes Teleophthalmology Grant Program
- •2.11.10 Central Valley EyePACS Diabetic Retinopathy Screening Project
- •2.12.1 Diabetic Retinopathy
- •2.12.1.1 ADA Guidelines Terms
- •2.12.1.2 Vitrectomy
- •References
- •3: Stereopsis and Teleophthalmology
- •3.1 Introduction
- •3.2 History of Stereopsis and Stereopsis in Ophthalmology
- •3.3 Technology and Photography
- •3.3.3 Imaging Fields
- •3.3.4 Image Viewing Techniques
- •3.3.5 Image Compression
- •3.4 Stereoscopic Teleophthalmology Systems
- •3.4.1 University of Alberta
- •3.4.4 Joslin Vision Network
- •3.5 Conclusion
- •References
- •4.1 Introduction
- •4.2 Methods
- •4.2.1 Main Outcome Measures
- •4.3 Results
- •4.3.1 Retinal Video Recording Versus Retinal Still Photography
- •4.3.2 Video Compression Analysis
- •4.4 Discussion
- •References
- •5.1 Introduction
- •5.1.1 Automated, Remote Image Analysis of Retinal Diseases
- •5.1.2 Telehealth
- •5.2 Design Requirements
- •5.2.1 Telehealth Network Architecture
- •5.2.2 Work Flow
- •5.2.3 Performance Evaluation of the Network
- •5.3 Automated Image Analysis Overview
- •5.3.1 Quality Assessment Module
- •5.3.2 Vascular Tree Segmentation
- •5.3.3 Quality Evaluation
- •5.4 Anatomic Structure Segmentation
- •5.4.1 Optic Nerve Detection
- •5.4.2 Macula
- •5.4.3 Lesion Segmentation
- •5.4.4 Lesion Population Description
- •5.4.5 Image Query
- •5.5 Summary
- •References
- •6.1 Introduction
- •6.3 Optical Coherence Tomography to Detect Leakage
- •References
- •7.1 Introduction
- •7.2 Patients and Methods
- •7.2.1 Participants
- •7.2.2 Methods
- •7.2.3 Statistics
- •7.3 Results
- •7.3.1 Reliability of Image Evaluation
- •7.3.2 Prevalence of Glaucomatous Optic Nerve Atrophy
- •7.4 Discussion
- •7.5 Perspectives
- •References
- •8.1 Introduction
- •8.1.2 Homology Between Retinal and Systemic Microvasculature
- •8.1.3 Need for More Precise CVD Risk Prediction
- •8.2.1 Retinal Microvascular Signs
- •8.2.2 Retinal Vessel Biometry
- •8.2.3 Newer Retinal Imaging for Morphologic Features of Retinal Vasculature
- •8.3 Associations of Retinal Imaging and CVD Risk
- •8.3.1.1 Risk of Pre-clinical CVD
- •8.3.1.2 Risk of Stroke
- •8.3.1.3 Risk of Coronary Heart Disease
- •8.3.2.1 Risk of Hypertension
- •8.3.2.2 Risk of Stroke
- •8.3.2.3 Risk of Coronary Heart Disease
- •8.3.2.4 Risk of Peripheral Artery Disease
- •8.3.3 Newer Morphologic Features of Retinal Vasculature
- •8.4 Retinal Imaging and Its Potential as a Tool for CVD Risk Prediction
- •References
- •9.1 Alzheimer’s Disease
- •9.2 Treatments
- •9.3 Diagnosis
- •9.6 Conclusions
- •References
- •10.1 Introduction
- •10.1.1 Stroke
- •10.1.2 Heart Disease
- •10.1.3 Arteriovenous Ratio
- •10.2 Purpose
- •10.3 Method
- •10.3.1 Medical Approach
- •10.3.2 Technical Approach
- •10.3.3 Output of Medical Data
- •10.4 Patients
- •10.5 Results
- •10.5.1 Medical History
- •10.5.2 Telemedical Evaluation of Retinal Vessels
- •10.5.2.1 Prevalence of Retinal Microangiopathy
- •10.5.2.2 Arteriovenous Ratio
- •10.5.2.3 PROCAM-Index
- •10.6 Discussion and Perceptive
- •10.6.1 Estimation of “Stroke Risk” Estimated by the Stage of Retinal Microangiopathy
- •References
- •11.1 Introduction
- •11.2 System Requirements
- •11.3 Fundus Camera
- •11.4 Imaging Procedure
- •11.4.1 Reading Center Procedure
- •11.5 Detection of Macular Edema
- •11.6 Implementation
- •11.7 Unreadable Images
- •11.7.1 Impact on Overall Diabetic Retinopathy Assessment Rates
- •11.7.2 Compliance with Recommendations
- •11.7.3 Challenges
- •11.7.4 Summary
- •References
- •12.1 Screening
- •12.2 Background
- •12.3 Historical Perspective in England
- •12.4 Methodology
- •12.4.1 The Aim of the Programme
- •12.5 Systematic DR Screening
- •12.6 Cameras for Use in the English Screening Programme
- •12.7 Software for Use in the English Screening Programme
- •12.9 Implementation in England
- •12.11 Quality Assurance
- •12.12 The Development of External Quality Assurance in the English Screening Programme
- •12.13 Information Technology (IT) Developments for the English Screening Programme
- •12.14 Dataset Development
- •12.15 The Development of External Quality Assurance Test Set for the English Screening Programme
- •12.16 Failsafe
- •12.17 The Epidemic of Diabetes
- •References
- •13.1 Introduction
- •13.2 Burden of Diabetes and Diabetic Retinopathy in India
- •13.3 Diabetic Retinopathy Screening Models
- •13.4 Need for Telescreening
- •13.5 Guidelines for Telescreening
- •13.6 ATA Categories of DR Telescreening Validation
- •13.7 Yield of Diabetic Retinopathy in a Telescreening Model
- •13.8 How Are Images Transferred
- •13.10 How Many Fields Are Enough for Diabetic Retinopathy Screening
- •13.11 Is Mydriasis Needed While Using Nonmydriatic Camera?
- •13.12 Validation Studies on Telescreening
- •13.12.1 Accuracy of Telescreening
- •13.12.2 Patient Satisfaction in Telescreening
- •13.12.3 Cost Effectivity
- •13.12.4 Telescreening for Diabetic Retinopathy: Our Experience
- •13.13 Future of Diabetic Retinopathy Screening
- •References
- •14.1 Introduction
- •14.2 Methods
- •14.3 Discussion
- •14.4 Conclusion
- •References
- •15.1 Introduction
- •15.1.1 Description of the EADRSI
- •15.5 State Support of Screening in the Safety Net
- •15.7 Screening Economics for Providers
- •15.8 Patient Sensitivity to Fees
- •15.9 Conclusion
- •References
- •16.1 Introduction
- •16.2 Setting Up the New Screening Model
- •16.2.1 Phase 1: Training
- •16.2.2 Phase 2: Evaluation of Agreement
- •16.2.3 Phase 3: Implementation of the Screening Model
- •16.3 Technologic Requirements
- •16.3.1 Data Management
- •16.3.2 Data Models
- •16.3.2.1 Data Scheme for Patient-Related Information
- •16.3.2.2 Data Scheme for Images
- •Fundus Camera VISUCAM Pro NM
- •PACS Server
- •ClearCanvas DICOM Visualizer
- •16.4 Results
- •16.4.1 Phase 2: Agreement Evaluation
- •16.4.2 Phase 3: Implementation of the Screening Model
- •16.5 Discussion
- •16.5.1 Evaluation of the Screening Model
- •16.5.2 Prevalence of DR
- •16.5.3 Quality Evaluation
- •16.6 Conclusion
- •References
- •17.1.3 Examination and Treatment
- •17.1.4 Limitations of Current Care
- •17.2 Telemedicine and ROP
- •17.2.2 Accuracy and Reliability of Telemedicine for ROP Diagnosis
- •17.2.3 Operational ROP Telemedicine Systems
- •17.2.4 Potential Barriers
- •17.3 Closing Remarks
- •17.3.1 Future Directions
- •References
- •18.1 Introduction
- •18.2 Neonatal Stress and Pain
- •18.3 ROP Screening Technique
- •18.4 Effect of Different Examination Techniques on Stress
- •18.5 Future of Retinal Imaging in Babies
- •References
- •19.1 Introduction
- •19.2 History of the Program
- •19.3 Telehealth Technologies
- •19.4 Impact of the Program
- •Selected References
- •Preamble
- •Introduction
- •Background
- •The Diabetic Retinopathy Study (DRS)
- •Mission
- •Vision
- •Goals
- •Guiding Principles
- •Ethics
- •Clinical Validation
- •Category 1
- •Category 2
- •Category 3
- •Category 4
- •Communication
- •Medical Care Supervision
- •Patient Care Coordinator
- •Image Acquisition
- •Image Review and Evaluation
- •Information Systems
- •Interoperability
- •Image Acquisition
- •Compression
- •Data Communication and Transmission
- •Computer Display
- •Archiving and Retrieval
- •Security
- •Reliability and Redundancy
- •Documentation
- •Image Analysis
- •Legal Requirements
- •Facility Accreditation
- •Privileging and Credentialing
- •Stark Act and Self-referrals
- •State Medical Practice Acts/Licensure
- •Tort Liability
- •Duty
- •Standards of Care
- •Consent
- •Quality Control
- •Operations
- •Customer Support
- •Originating Site
- •Transmission
- •Distant Site
- •Financial Factors
- •Reimbursement
- •Grants
- •Federal Programs
- •Other Financial Factors
- •Equipment Cost
- •Summary
- •Abbreviations
- •Appendices
- •Appendix A: Interoperability
- •Appendix B: DICOM Metadata
- •Appendix C: Computer-Aided Detection
- •Appendix D: Health Insurance Portability and Accountability Act (HIPAA)
- •Appendix F: Quality Control
- •Appendix H: Customer Support
- •Level 1
- •Level 2
- •Level 3
- •Appendix I: Reimbursement
- •Medicare
- •Medicaid
- •Commercial Insurance Carrier Reimbursement
- •Other Financial Factors
- •Disease Prevention
- •Resource Utilization
- •American Telemedicine Association’s Telehealth Practice Recommendations for Diabetic Retinopathy
- •Conclusion
- •References
- •Contributors
- •Second Edition
- •First Edition
- •Index
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¥Availability Ð requires methods for disaster recovery, backup, and access to data under all conditions
Appendix E: Privileging
and Credentialing
Many healthcare facilities use the Joint CommissionÕs (JC) Elements of Performance for privileging and credentialing providers, even when not strictly required. At one time, Elements of Performance allowed privileging and credentialing telemedicine providers by proxy under speciÞc conditions. This policy allowed the originating site to import privileging and credentialing materials from the distant site if certain criteria were met (i.e., the distant site was JC accredited), staff were privileged for the activity at the distant site, and peer review was conducted and reported to the originating site with other quality information. CMS had planned to require JC to conform to more restrictive criteria effective July 15, 2010, eliminating privileging and credentialing by proxy as described by JC MS.13.01.01. CMS reversed its position in May 2010, however, with a proposed rule deÞning conditions for a proxy method of privileging and credentialing telemedicine providers [151]. As of October 2010, this decision is still under review.
MS.13.01.01, EP 1 Ð Licensed independent practitioners responsible for patient care, treatment, and services via telemedicine are credentialed and privileged at the originating site according to standards MS.06.01.03 through MS.06.01.16. Standards allow medical staff to use information another hospital gathers for physician credentialing provided the other hospital is a Medicare-participating hospital. Data includes:
¥Licensure
¥Training
¥Board certiÞcation veriÞcations
¥National Practitioner Data Bank queries
¥Sanction queries
¥References
¥Other information gathered during the credentialing process
Appendix F: Quality Control
The following are major categories of performance to be evaluated; evaluation of all categories below may not be applicable to some programs:
¥Originating site
ÐAdministrative
Primary care provider and nursing surveys Patient surveys
DR surveillance rate for catchment area of the program
Successful patient enrollment rate (sustained vs. initial)
Successful referral completion rate
ÐImager
Ungradable study rate Field deÞnition Focus
Stereo Imaging time
Continuing Quality Improvement (CQI) Continuing education
ÐEquipment
Preventative maintenance schedule Out of service rate
¥Reading center
ÐAdministrative
Average acquisition to reading center time Average time to read standard study Average time to read stat study
Average acquisition to report delivered time
Exception rate and time
ÐTechnical Ð network, servers, software, etc.
ÐReader
Average time per read
Assessment program of peer review or over reads at appropriate levels of detail and including ungradable and exception rates
Interobserver agreement, if multiple readers are used
Intraobserver agreement External review
Test set performance
Agreement with live exam, if appropriate Assessment fallout/outlier review and evaluation
CQI
Continuing education
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Interactive |
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• Case Review |
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Full certification
• Recent (last read)
•Current (volume of reads/time)
•Proficient (QA outcome)
Recurrent certification
Training/certification
QA analysis
Feedback loops
Fig. F.1 Example of a quality assurance and continuous quality improvement ßow diagram
Multiple feedback loops allow continuing education (CE) programs to adapt to changing conditions. Reviews allow CE performance and cost-effectiveness to be continuously enhanced (Fig. F.1). The following are examples of training and quality assurance method:
Standardized training for imager, imager trainers, readers, and reader trainers [152].
¥Structured, self-study, pretraining of imager and reader to provide minimum background knowledge.
¥Structured curriculum training with deÞned endpoints to assure knowledge and skills proÞciency.
¥Provisional certiÞcation followed by full certiÞcation based on experience with a mini-
mum number of patients over a minimum period of time. Experience should demonstrate required levels of proÞciency documented by formal quality assurance (QA) review of a Þxed number of cases.
¥Time-limited certification of imagers and readers. Recertification should be based on the period since last clinical encounter, number of clinical encounters over a period of time, and proficiency as documented by formal QA review. Ocular telehealth programs should create certification methods that are formally defined and relevant to the
program.
Ongoing sampling of imager and reader performance by formal criteria based on QA review
214 |
Appendix |
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should be performed. A review of trends in fallout from outcome analyses can be used to assess:
¥ProÞciency
¥Opportunities for program improvement
¥Need for changes in initial or recurring training
¥Need for additional training of an imager or reader
CE is an important component of any QA/CQI
(Continuous Quality Improvement) program and a fundamental method of ensuring current competency [153]. CE should be dynamic and sensitive to patient and staffÕs changing needs. The following are considerations:
¥Adjust CE content by end-to-end program testing through data sampling and outcome analysis
¥Adjust CE program to maintain temporal relevance to aggregate and individual clinical populations
¥Deliver CE in formats to achieve desired outcome with maximum efÞciency and effectiveness. Format examples include periodic self-study curriculum with preand poststudy testing, newsletters, and e-mail ÒTips of the Day.Ó A variety of interactive CE sessions using telehealth technology are available such as group-based or one-on-one case reviews, morbidity and mortality (M and M) conferences and conferences patterned on Clinical Pathological Conference (CPC) concepts.
Similar guidance comes from broadly dis-
tributed programs outside the USA. The UK National Screening Committee adopted digital photography in 2000 for a systematic national risk reduction program [154]. Their model incorporates trained professionals, recorded outcomes, targets and standards, quality assurance, and promotion to increase screening rates. Criteria and minimal/achievable standards were proposed for each quality assurance objective [155]. Other ongoing quality assurance programs are publishing measures and outcomes. For example, a UK diabetes center regraded a percentage of images to determine appropriateness of referrals for clinic examination [156]. Other programs have reported outcomes
measuring image quality, intragrader reliability, and percentage of grader-generated reports within 48 h of grading images [157].
Appendix G: Operational Specifications
Possible components of an ocular telehealth operations manual include
¥Company overview and history
¥Organization chart
¥Mission statement
¥Opening procedures
¥Closing procedures
¥Cash handling
¥Daily tasks
¥Alarm system operations
¥Safe opening and closing procedures
¥Contact numbers for emergencies or information
¥Employee shift coverage
¥Website procedures
¥Customer service procedures
¥Marketing
¥Sales procedures
¥Sales quotas
¥Commission payments
¥Order processing
¥Special orders
¥Shipping and receiving
¥Equipment handling
¥Imaging site deployment
¥Reading center operations
¥Quality assurance
¥Privileging and credentialing (originating and distant site)
¥Equipment maintenance (ofÞce, clinical, I.T., etc.)
¥Security procedures
¥Emergency procedures
¥Services pricing and discounts
Additional details and examples that may not
be applicable to all programs:
¥Prospect engagement
ÐSales representative receives prospect information from sales/marketing representative
Appendix |
215 |
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ÐContacts prospect via telephone, e-mail, letter, etc.
ÐDocuments contact in CRM software (Customer Relationship Management)
ÐUpdate status of prospect after each contact
ÐProspect closes and becomes client
¥Contract
ÐSend approved contract and lease agreement to prospect
ÐCustomer returns agreement with signature and deposit check or signature and lease document
ÐSubmit lease document to leasing company
ÐReceive notiÞcation of lease approval or equipment paid in full
¥Setup new customer
ÐComplete the Customer Deployment Prerequisite Datasheet
ÐIdentify static external IP address (may require IT liaison)
ÐIdentify internal DNS server, Default Gateway, and Subnet Mask
ÐIdentify user details. Assign new unique clinician identiÞer for each clinician. Assign a new locally unique user ID for that user
ÐIdentify primary care clinician information. Assign new unique clinician identiÞer for each clinician
¥Stage equipment
ÐReceive application update CD and shipment checklist and installation checklist from Hosted Solution Management Team
ÐNotify admin of expected ship date
ÐAdmin notiÞes customer of expected ship date
ÐAssemble equipment Camera back Fundus camera Table
PC
Desktop reference book
ÐApply the software image to the PC
ÐApply the application update to the PC
ÐRun a local photography test using the customer photography instructions
ÐDisassemble and repackage for shipment
¥Customer installation and test
ÐValidate training personnel and room availability prerequisites and installation date with customer
ÐValidate static IP prerequisites
ÐComplete relevant parts of installation checklist (carry out install as per installation document)
ÐSchedule/conduct deployment test
ÐComplete relevant parts of installation checklist
ÐStore in appropriate customer folder
¥Imager training
ÐEnsure that all staff due for training are present.
ÐProvide introduction to fundus camera Ð startup, calibration, conÞguration, imaging, shutdown.
ÐProvide introduction to imaging software Ð log on, conÞguration, patient registration, image storage and transmission, shutdown, log off.
ÐStep through photography process using training scripts, tests, and real patients.
ÐObtain sign-off from all trained staff. Complete relevant parts of installation checklist and store in appropriate customer folder.
¥Photography
ÐAdministrator
Diabetic patient presents at front desk Verify that the patient has not had retinal photographs within 12 months by checking records
Add retinal photography to their routing slip for the day
ÐPhotographer
Diabetic patient presents for photography Drop the patient in to todayÕs clinic according to the instructions
ÐMonitor messaging
Run the ÒDaily ReportÓ for all locations Inspect the report to validate it conforms to the business rules (see exceptions)
ÐMonitor message resend
