Attachment_1._Scope_of_Work.docx

SCOPE OF WORK

Background

The Joslin Vision Network (JVN) is a specialized teleophthalmology modality for the remote diagnosis and management of diabetic retinopathy. JVN is a proprietary telemedicine system developed by the Joslin Diabetes Center (JDC) based in Boston. The Comprehensive Diabetes Management Program (CDMP) is a suite of software applications residing on the IHS JVN/CDMP server that provides multiple functions critical to the clinical operation of the JVN including patient management, database maintenance, reporting, quality assurance (QA), RPMS/EHR interoperability, and DICOM image management. The CDMP serves as the platform for clinical operation of the JVN in the IHS and also is being used in a similar fashion by other IHS telemedicine modalities for remote health monitoring.

Equipment and Service deployment and use of the JVN system in the IHS allows participating facilities to image the fundi of patients with diabetes for the purpose of remote diagnosis and management of diabetic retinopathy (DR). The IHS-JVN Teleophthalmology Program (IHS-JVN) uses the JVN technology to acquire and transmit retinal images from AI/AN’s with diabetes. Evaluation of these images by readers at the IHS-JVN National Reading Center allows the remote diagnosis of level of DR and diabetic macular edema (DME) with development of a treatment plan consistent with established standards of care.

The program is validated at the American Telemedicine Association (ATA) Category 3, and retinal evaluations by this program qualify for IHS GPRA tallies for annual DR examinations in Indian country. The IHS-JVN retains control of all deployed equipment and is responsible for operational support, maintenance, repairs, and replacement. The IHS-JVN also provides onsite deployment services, training, support, reporting, and QA for all its telemedicine operations.

Specifications:

The general purpose of this contract is to maintain ongoing development and operation of the IHS-JVN teleophthalmology activities in Indian country with services and equipment.

Contract Features This contract with the Joslin Vision Network provides for the following major categories of product and services:

· Hardware

· Image Acquisition Station (IAS) that is deployed to various sites across the IHS incrementally during the year

· JVN DD hardware: IAS Camera; Deployment Table; Advance Camera System; IAS Workstation;

· Mobile Deployment Equipment Package

· Miscellaneous hardware- cases, CPU’s, camera tables, etc

· Support

· Deployment / On-site Support

· JVN Service and Support Logistics

· JVN Reading Training

· Advance Camera Identification, Testing, Validation

Deliverables- Supplies or Services and Price/Cost

SERVICES

NTE*

Quantity Opt Yr.

NTE

Quantity

SUPPLIES

NTE

Quantity Opt Yr.

NTE

Quantity

*NTE: Not-to-Exceed

Services Deliverables:

Services: Deployment/On Site Logistics:

For New Optos Daytona system deployments, the selected contractor shall:

1. Manage each imaging site deployment from site identification through go live.

2. Coordinate execution of the standard Memorandum of Understanding / Agreement.

3. Provide pre-deployment consulting and support for each site.

4. Verify site readiness.

5. Order all necessary deployment hardware and peripherals.

6. Coordinate site visit and make necessary travel arrangements.

7. Travel to site.

8. Inspect and document purchased equipment.

9. Uncrate, assembly and apply IHS asset/inventory tags to purchased equipment.

10. Install and configure all required software.

11. Work with local IT support to approve system and add to the local domain/network.

12. Conduct a trial study and confirm quality with the National Reading Center.

13. Package any excess equipment and arrange for shipping.

14. Provide Differences Training to onsite staff.

15. Arrange for the disposal of packing materials.

The Optos Daytona cameras will be deployed at large facilities already hosting an IHS-NN system using the Topcon NW6S device, and the remainder will be sent to new deployments. These replaced systems will then be redeployed to new facilities with smaller populations of patients with diabetes. This requires a technical specialist to travel to the deployment/re-deployment/upgrade site. Onsite technical support by this specialist may also be required for non-deployment service issues at any of the existing IHS-TR sites. The actual cost for logistic support of a specific deployment or service visit varies based upon location and other market variables so logistic costs estimates for the deployment technical specialist consider the average historical expense of deploying at a broad range of possible locations (see deployment location table and map) associated with a broad range of possible costs. The deployment specialist logistic expenses are reimbursed with the spending threshold applied in accordance with the Federal Travel Regulation. All reimbursable expenses are to be reported using the vendor travel reimbursement form and then billed against this line item without profit applied.

Any particular I/TIU site deployed, re-deployed, upgraded, or receiving onsite technical service under this contract is determined on an ad hoc basis during the term of this contract so a precise timeline for this activity cannot be established in advance.

Reader Training:

This line item is to fund formal IHS-JVN Reader instruction and certification. Reader certification is an essential aspect of the IHS-JVN program and helps ensure the accuracy, quality and consistency of image evaluation. The selected contractor shall:

1. Work with IHS program leadership to identify candidates.

2. Contract with the Joslin Diabetes Center (Boston, MA) to enroll candidates into their JVN Reader Training program.

3. Coordinate with all parties and assist with travel planning. Note: Any IHS staff travel costs shall not be included in this line item.

JVN Services and Support Logistics:

This line item is intended to fund travel and shipping costs related to the legacy system deployments and National Reading Center visits/reading station support.

For Existing Topcon systems requiring on-site service:

1. Accept and triage the service request.

2. Attempt to repair the system remotely.

3. Confirm site location, contacts and make travel arrangements.

4. Order replacement hardware (as appropriate).

5. Travel to the site.

6. Preform necessary repairs.

7. Work with local IT support to approve system and add to the local domain/network (as appropriate).

8. Conduct a trial study and confirm quality with the National Reading Center.

9. Package any excess equipment and arrange for shipping.

10. Provide Differences Training to onsite staff (as appropriate).

11. Arrange for the disposal of packing materials.

For New Topcon systems deployments:

1. Manage site deployment from site identification through go live.

2. Coordinate execution of the standard Memorandum of Understanding / Agreement.

3. Provide pre-deployment consulting and support for each site.

4. Verify site readiness.

5. Order all necessary deployment hardware and peripherals.

6. Coordinate site visit and make necessary travel arrangements.

7. Travel to site.

8. Inspect and document purchased equipment.

9. Uncrate, assembly and apply IHS asset/inventory tags to equipment.

10. Install and configure all required software.

11. Work with local IT support to approve system and add to the local domain/network.

12. Conduct a trial study and confirm quality with the National Reading Center.

13. Package any excess equipment and arrange for shipping.

14. Provide Differences Training to onsite staff.

15. Arrange for the disposal of packing materials.

For National Reading Center systems support:

1. Accept and triage the service request.

2. Attempt to repair the system remotely.

3. Confirm site location, contacts and make travel arrangements.

4. Order replacement hardware (as appropriate).

5. Travel to the site.

6. Preform necessary repairs or deploy new stations (as appropriate).

7. Work with local IT support to approve system and add to the local domain/network (as appropriate).

8. Package any excess equipment and arrange for shipping.

9. Provide Differences Training to onsite staff (as appropriate).

10. Arrange for the disposal of packing materials.

Logistic support of onsite service and support of the IHS-NN at 96 current sites and anticipated new sites in Indian country for site inspections, staff orientation and training, maintenance, repairs, and equipment updates that cannot be accomplished remotely. These events occur incrementally throughout the contract year and the incremental costs vary with the location, neither of which can be precisely predicted. The anticipated aggregate cost for the contract year is reflected in the value of this line item. The actual logistic costs are invoiced incrementally as they occur using the same rules and reporting system described in Deployment/On-site Support.

Advance Camera Identification, Testing, Validation:

The selected contractor shall work with program leadership to validate additional imaging systems.

For camera validation:

1. Arrange with potential vendor for use of an evaluation unit.

2. Preform internal team testing and imaging to confirm potential suitability

3. Contract with an independent Institutional Review Board (IRB) to provide Validation Study ethical oversight.

4. Develop a system specific validation protocol to ensure equivalence / superiority to existing systems and the Early Treatment of Diabetic Retinopathy (ETDRS) study.

5. Once IRB approved, execute the planned study.

6. Collect and analyze date, publish results.

7. Finalize program and closeout protocol with the IRB.

IAS Camera with one-year warranty:

a. Optos Daytona System with AF - White body with dark blue trim.

i. Optos, Inc. 500 Nickerson Road, Suite 201, Marlborough, MA 01752

b. To Include:

i. Scanhead

ii. Auto Fluorescence

iii. Touchscreen Tablet and Stand

iv. Image Server with Monitor (Optos Vantage)

v. Shipping

vi. One-year warranty

Deployment Table:

Each mobile deployment requires a table to support the camera for clinical operations. A common pattern for a mobile deployment is for additional imaging locations to be added. Since the site has all the remaining components, all that is required is an additional power camera table. This equipment item is an electric Camera Table with Power Lift with shipping. This deployment occurs on an ad hoc basis for which a precise timeline for acquisition cannot be established in advance. The motorized tables are shipped directly from the manufacturer to the deployment site where Biomed inspection/tagging and property management inventory intake then occurs as per HHS/IHS policy and the MOU with the deployment site.

Portable table specifications:

a. Topcon AIT-16 Automatic Instrument Table w/out top.

vii. Lombart Instrument # TA0T0AIT16 (or equivalent) Salient Requirement: Size has to be close to 29” x 18.5” and must hold the camera system safely

b. Topcon Instrument Table Top – Large

viii. Lombart Instrument # TA1TO25302 (or equivalent) Salient Requirement: Size has to be close to 29” x 18.5” and must hold the camera system safely

IAS Workstation:

Base Unit Dell Mini Tower Workstation, with LCD monitor, and with shipping to sites to be determined (see deployment location table and map). An IAS workstation is need for each new or redeployed Topcon NW6S IAS. The nature of the process is such this occurs on an ad hoc basis for which a precise timeline for acquisition cannot be established in advance. As per the usual deployment process these devices are shipped directly from the manufacturer to the deployment site where they are seemed and remain in their shipping packaging until inspected and accepted by the deployment specialist. Biomed inspection/tagging and property management inventory intake then occurs as per HHS/IHS policy and the MOU with the deployment site.

The Dell workstation is produced by design details defined by the vendor and certified to be compatible with the IHS-TR software. All of the constituent parts are commercially available, but their specificity in aggregate produce a workstation that is standardized, compatible with the IHS-TR imaging software, and compatible with the interoperability applications used for clinical and business operations, and for support and remote diagnostics. The specifications for this workstation contain critical hardware and firmware that is specified by the vendor and included in their certification, and not included in common computer specifications used for ordinary workstation ordering. These specifications are dynamic as various other components change due to market availability. As such, this certified workstation is unique and there is no other device that is acceptable for use in the IHS-TR. In general, the workstation has the following specifications:

a. Dell Optoplex 3050 or equivalent Salient Requirement:

· Intel Core i5-6500 or better

· Windows 7 Pro English (w/ Windows 10 Pro included)

· At least 4GB Memory

· At least 500GB Hard Disk Drive

b. Global Retinal Imager (GRI) Software v1.2 or greater.

Advanced Camera System:

Retinal Imager device: low light level, stereo, non-mydriatic, retinal imaging device with a format appropriate for desktop, hybrid, or portable applications.

Specifications: CenterVue EIDON True Color Confocal Scanner CenterVue, Inc. 43301 Osgood Road, Fremont, CA 94539.

AMFUNME001 – Scanner with dust cover, lens cloth, operator manual (English).

WEEIDCRU12 – EIDON 12 month warranty

Mobile Deployment Equipment Package:

The legacy Topcon retinal imager is a desk-based unit that must be used in a fixed (non-portable) manner. This and other operational and business features make it impractical for use at smaller or remotely located sites with small diabetic populations. IHS-TR has developed unique cases and other associated technology that renders the Topcon NW6S device appropriate for portable operations at very small and/or remote facilities. A complete portable system consists of a re deployed Topcon TRC-NW6S Non-mydriatic retinal camera with MegaVision camera back, Firewire interface, Peace of Mind maintenance agreement, custom hardened cases for camera and laptop workstation, Dell laptop workstation with specification details set by the vendor to insure IHS-TR technology compatibility, Windows 7, Mobile Reader software, and shipping. An estimated 2 of these units will be deployed during FY15 as appropriate sites are identified. The Topcon NW6S retinal camera is no longer produced so deployments using this technology will use existing devices that have undergone required MRO, therefore no new equipment purchase for this item is needed. The Mega vision Camera is the only camera back used by the IHS-TR and is proprietary and not available from any other source. The laptop workstation is a vendor certified dell unit and has the same requirements and dependencies as the full form workstation described above (IAS Workstation- item #10). This equipment package includes shipping to sites to be determined (see deployment location table and map). These items have the following specifications:

a. Deployment Table (see Item 2 above)

b. Dell Latitude 5580 or equivalent Salient Requirement:

· Intel Core i5-6300 or better

· Windows 7 Pro English (w/ Windows 10 Pro included)

· At least 4GB Memory

· At least 250GB Solid State Hard Drive

c. Shipping for refurbished Topcon NW-6S / MegaVision Imaging System from MRO Division (Santa Barbara, CA).

d. Custom Portable Imaging System Case CaseTech or equivalent Salient Requirement:

· ½” LT-Extreme reinforced polypropylene cellular tri-laminate.

· Clam shell, split lid design (black with stenciling).

· 8 Recessed padded handles

· 6 tie-down shackles

· Inner bearing plate on base cushion