16-236-SOL-0004_RFP.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

Rockville MD 20852 801 Thompson Ave, TMP605 Division of Acquisition Policy Indian Health Service

CODE 16. ADMINISTERED BYCODE

X

X

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED OR196

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

12/10/2015 1600 ET

11/23/2015

301-443-6749MICHAEL FISCHER

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

16-236-SOL-00004

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 79 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Rockville MD 20852 801 Thompson Ave, TMP 605 Division of Acquisition Policy

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

Indian Health Service

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

IHS Tele-Retina Program (IHS-TR) Services Request for Proposal.

Questions Questions relating to this acquisition shall be submitted to Michael Fischer via electronic mail using the question template document (see table below) at Michael.Fischer@ihs.gov no later than 12:00pm EST December 1, 2015. All e-mail inquiries shall have "Question - RFP 16-236-SOL-000XXX" included in the subject line.

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED

MICHAEL FISCHER

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDEND

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Submission Deadline

Your quote is due no later than 4:00PM EST on

December 10, 2015 electronically to Contract

Specialist Michael Fischer via email ONLY.

1 Base Period

Period of Performance: 01/01/2016 to 12/31/2016

2 Option Period One

Period of Performance: 01/01/2017 to 12/31/2017

3 Option Period Two

Period of Performance: 01/01/2018 to 12/31/2018

4 Option Period Three

Period of Performance: 01/01/2019 to 12/31/2019

5 Option Period Four

Period of Performance: 01/01/2020 to 12/31/2020

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

79 2 of

16-236-SOL-0004 IHS Tele-Retina Program RFP

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 CONTRACT PRICING

The pricing provided in this contract is Firm-Fixed Price. As a result, the Contractor is hereby obligated to the pricing and quantities provided in Section B.

B.2. BASE PERIOD (JANUARY 01, 2016 THROUGH DECEMBER 31, 2016)

Item #

SERVICES

Description

Services: Quarterly Support

Quantity

Price

Total

2 Services: IHS-TR/RPMS Integration and web development 4

3 Services: Repairs 10

Subtotal

EQUIPMENT

1 IAS Camera with one year warranty 10

2 IHS-TR Camera and IA Workstation Repair 4

3 MegaVision/Topcon NW6S annual warranty and maintenance 1

4 Software: Oracle 1

5 Software: WebLogic 1

6 Software: Lead Tools 1

7 Software: Stereo OpenGL 1

8 Software: MyDicom.Net 1

9 Software: VS2010 1

B.2.1 BASE PERIOD OPTIONAL SUPPLIES/SERVICES (JANUARY 01, 2016 THROUGH

DECEMBER 31, 2016)

SERVICES

Services: Reader Training

2 Deployment/On-site Support Logistics 1

3 JVN Service and Support Logistics 1

4 IHE Eye Care Connectathon and TF Integration 1

5 Advanced Camera Identification, testing, validation 1

SUPPLIES

Item # Description Quantity Price Total

1 IAS Workstation 1

2 Mobile Deployment Equipment Package 1

3 Deployment Table (w/shipping) 1

4 Advanced Camera System 1

5 MegaVision camera upgrades with 3 Year Warranty 1

6 Portable IHS-TR CPU 1

7 IHS-TR Mobile Reader (desktop) w/shipping 1

8 IHS-TR Mobile Reader (laptop) w/shipping 1

9 Miscl Equipment- IHS-TR CPU w/shipping 1

10 Miscl Equipment- IHS-TR Networking w/shipping 1

B.3. OPTION PERIOD ONE (JANUARY 01, 2017 THROUGH DECEMBER 31, 2017)

SERVICES

3 Services: Repairs 8

1 IAS Camera with one year warranty 10

2 IHS-TR Camera and IA Workstation Repair 4

3 MegaVision/Topcon NW6S annual warranty and maintenance 1

4 Software: Oracle 1

5 Software: WebLogic 1

6 Software: Lead Tools 1

7 Software: Stereo OpenGL 1

8 Software: MyDicom.Net 1

B.3.1 OPTION PERIOD ONE OPTIONAL SUPPLIES/SERVICES (JANUARY 01, 2017

THROUGH DECEMBER 31, 2017)

SERVICES

4 IHE Eye Care Connectathon and TF Integration 1

5 Advanced Camera Identification, testing, validation 1

SUPPLIES

Item # Description Quantity Price Total

1 IAS Workstation 1

2 Mobile Deployment Equipment Package 1

3 Deployment Table (w/shipping) 1

4 Advanced Camera System 1

7 IHS-TR Mobile Reader (desktop) w/shipping 1

8 IHS-TR Mobile Reader (laptop) w/shipping 1

9 Miscl Equipment- IHS-TR CPU w/shipping 1

B.4. OPTION PERIOD TWO (JANUARY 01, 2018 THROUGH DECEMBER 31, 2018)

SERVICES

2 IHS-TR Camera and IA Workstation Repair 4

3 MegaVision/Topcon NW6S annual warranty and maintenance 1

4 Software: Oracle 1

5 Software: WebLogic 1

6 Software: Lead Tools 1

7 Software: Stereo OpenGL 1

8 Software: MyDicom.Net 1

B.4.1 OPTION PERIOD TWO OPTIONAL SUPPLIES/SERVICES (JANUARY 01, 2018

THROUGH DECEMBER 31, 2018)

SERVICES

4 IHE Eye Care Connectathon and TF Integration 1

5 Advanced Camera Identification, testing, validation 1

Subtotal

SUPPLIES

Item # Description Quantity Price Total

1 IAS Workstation 1

2 Mobile Deployment Equipment Package 1

3 Deployment Table (w/shipping) 1

4 Advanced Camera System 1

7 IHS-TR Mobile Reader (desktop) w/shipping 1

8 IHS-TR Mobile Reader (laptop) w/shipping 1

9 Miscl Equipment- IHS-TR CPU w/shipping 1

B.5. OPTION PERIOD THREE (JANUARY 01, 2019 THROUGH DECEMBER 31, 2019)

SERVICES

3 MegaVision/Topcon NW6S annual warranty and maintenance 1

4 Software: Oracle 1

5 Software: WebLogic 1

6 Software: Lead Tools 1

7 Software: Stereo OpenGL 1

8 Software: MyDicom.Net 1

B.5.1 OPTION PERIOD THREE OPTIONAL SUPPLIES/SERVICES (JANUARY 01, 2019

THROUGH DECEMBER 31, 2019)

SERVICES

4 IHE Eye Care Connectathon and TF Integration 1

5 Advanced Camera Identification, testing, validation 1

Subtotal

SUPPLIES

Item # Description Quantity Price Total

1 IAS Workstation 1

2 Mobile Deployment Equipment Package 1

3 Deployment Table (w/shipping) 1

4 Advanced Camera System 1

5 MegaVision camera upgrades with 3 Year Warranty 1

6 Portable IHS-TR CPU 1

7 IHS-TR Mobile Reader (desktop) w/shipping 1

8 IHS-TR Mobile Reader (laptop) w/shipping 1

9 Miscl Equipment- IHS-TR CPU w/shipping 1

B.6. OPTION PERIOD FOUR (JANUARY 01, 2020 THROUGH DECEMBER 31, 2020)

SERVICES

3 Services: Repairs 10

3 MegaVision/Topcon NW6S annual warranty and maintenance 1

4 Software: Oracle 1

5 Software: WebLogic 1

6 Software: Lead Tools 1

7 Software: Stereo OpenGL 1

8 Software: MyDicom.Net 1

B.6.1 OPTION PERIOD FOUR OPTIONAL SUPPLIES/SERVICES (JANUARY 01, 2020

THROUGH DECEMBER 31, 2020)

SERVICES

4 IHE Eye Care Connectathon and TF Integration 1

5 Advanced Camera Identification, testing, validation 1

Subtotal

SUPPLIES

Item # Description Quantity Price Total

1 IAS Workstation 1

2 Mobile Deployment Equipment Package 1

3 Deployment Table (w/shipping) 1

4 Advanced Camera System 1

5 MegaVision camera upgrades with 3 Year Warranty 1

6 Portable IHS-TR CPU 1

7 IHS-TR Mobile Reader (desktop) w/shipping 1

8 IHS-TR Mobile Reader (laptop) w/shipping 1

9 Miscl Equipment- IHS-TR CPU w/shipping 1

SECTION C: DESCRIPTION/SPECIFICATION/WORK STATEMENT

C.1 Description-Background The IHS Tele-Retina Program (IHS-TR) uses the Joslin Vision Network (JVN) system, which is a specialized tele-ophthalmology modality for the remote diagnosis and management of diabetic retinopathy. Any awarded contractor as a result of this solicitation will be required to interface their solution with the processes and equipment currently implemented in IHS offices. The current JVN is a proprietary telemedicine system developed by the Joslin Diabetes Center (JDC) in Boston. The JDC is a not for profit organization, and an affiliate of the Harvard Medical School. The JVN operates within the Comprehensive Diabetes

Management Program (CDMP), 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 clinical record management, database maintenance, clinical and administrative reporting, quality assurance (QA), RPMS/EHR interoperability, and DICOM image management. As such, the CDMP serves as the platform for clinical operation of the

JVN in the Indian Health Service (IHS) and also is being used in a similar fashion by other IHS telemedicine modalities for remote health monitoring. Both the JVN and CDMP were developed as a collaboration of the JDC, DoD, VHA, and the IHS in the late 1990’s, and continuously updated since then with multiple version level upgrades of the software and hardware. The software is owned by JDC, but federal funding of its development established the basis for royalty/license free use in perpetuity by federal and federally affiliated users.

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) to allow timely diagnosis and treatment, thereby reducing avoidable vision loss among AI/ANs. This is a critically important program from both a clinical and regulatory vantage:

1. DR is the leading cause of blindness among working age adults but serious vision loss can very nearly be eliminated by timely diagnosis and treatment of high risk disease. Before the

IHS-TR was implemented the sustained annual DR examination rate in Indian country was

~50%. Now it is 60% but would be ~44% without the IHS-TR, and with only conventional eye clinic examinations for DR surveillance. In FY 2014 that difference equates to more than 1,400 additional AI/AN patients that would have been at risk for progressing to blindness due to undetected high risk DR.

2. The Government Performance and Reporting Act requires the IHS to perform against a variety of clinical quality measures, one of which is the DR annual examination rate. The minimum performance requirement under IHS-GPRA for DR examinations in GY15 is 60.2%.

The IHS rate in FY14 was 59.8% but would have been ~44% without the IHS-TR, resulting in non-compliance under GPRA.

The first clinical deployments of the IHS-TR began in 2000 and have continued incrementally over the subsequent 14 years with implementations currently at 96 sites in 25 states in Indian country as the IHS-JVN Teleophthalmology Program (IHS-JVN). In addition there are 7 portable deployments of the IHS-TR that provides services with additional outreach to small or remote locations. The IHS-TR uses the JVN technology to acquire, transmit, store/retrieve, interpret, and report retinal images from AI/AN’s with diabetes. These images are maintained on servers that operate on the IHS wide area network (WAN), and are routinely visible only by

IHS reader staff to insure the privacy of AI/ANs. Evaluation of these images by IHS readers at the IHS-TR National Reading Center using the reading and reporting software (currently JVN) 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. As a contingency of its use in the IHS, the system has been validated and operated at the American

Telemedicine Association (ATA) Category 3. Since this provides a DR diagnostic accuracy equal or better than a conventional dilated retinal examination, examinations by this program qualify for IHS GPRA tallies for annual DR examinations. More importantly, this allows patients to be managed remotely until they progress to high risk DR, thereby minimizing inconvenience and expense for the patient and increasing efficiencies for the hosting site. The imaging and reading service is generally reimbursable by Medicare, Medicaid, and private insurance companies. A MOU between the program and the deployed sites defines the relationship and responsibilities of the respective parties. The IHS-TR retains ownership and control of all deployed equipment and is responsible for operational support, maintenance, repairs, and replacement as needed. The IHS-TR also provides onsite deployment services, training, support, reporting, and QA for all its telemedicine operations. The local site hosting the deployment must appropriately use and protect the equipment, and adhere to all required

HHS/IHS property management requirements. As proscribed in the MOU between the IHS-TR and the deployment facility, failure to strictly adhere to all aspects of the MOU results in return of the equipment to the IHS-TR program, whereupon it may be redeployed to another site.

The IHS-TR Teleophthalmology Program operates through recurring funding stemming from appropriations containing directed spending language for tele-retinal surveillance of DR among

AI/AN. The original congressional direction also included the use of the JVN technology in collaboration with the JDC. As a result, this mature and widely distributed telemedicine program utilizes the proprietary JVN technology exclusively. This contract continues that legacy pattern for operational, fiscal, and regulatory reasons, and to maximize quality and minimize cost to the US government/IHS. The contractor provides all hardware, software, accessories, and other components necessary for the efficient deployment and effective operation of the IHS-TR technology. In the case of computer workstations and related equipment that support imaging or reading activities the vendor specifies all critical hardware, firmware, and software and certifies them for clinical use. The vendor also supplies operational support, maintenance, and IHS specified development of the IHS-TR software and hardware in collaboration with the IHS. This includes development and maintenance of all supporting software (currently CDMP), and all RPMS/EHR integration/interoperability. Imager modifications, repairs, and preventative maintenance of the legacy Topcon NW6S imager is also provided by the vendor. IHS-TR related software development limited to RPMS/EHR and other IHS specific applications and devices, such as interfaces, is generally available only within the federal sector, and therefore is supplied by IHS OIT or OIT contractors.

Description of Work

The general purpose of this contract is to maintain ongoing development, implementation, and support of the IHS-TR activities in Indian country with services and equipment. These services and equipment are provided by the vendor in accordance with the directed spending language contained in IHS congressional appropriations to support the following telemedicine based activities.

Create and maintain a standards based electronic medical record associated with each image that interfaces with the IHS RPMS/EHR system, currently using the CDMP hosted interface engine

Development and deployment of an integrated Reader QA system that allows seamless expansion to accommodate program growth.

End-to-end QA of the IHS-TR at the National Reading Center

Collaborate with OIT software development teams to optimize bi-directional

RPMS/EHR interoperability including additional telehealth service delivery modules such as Remote/Home Monitoring, and creation of interfaces between

RPMS/EHR/VI and IHS-TR technology.

Integrate the IHS-TR technology into RPMS/EHR through bidirectional standards based interoperability (DICOM, HL7, IHE), including all existing image acquisition devices (Topcon NW6S and Optos Daytona)

Maintain and demonstrate IHE-Eye Care conformance with relevant profiles through the IHE Eye Care Connectathon including all software development, testing, and demonstration leading to a published IHE Eye Care conformance statement. This includes expansion of the scope of IHE Eye Care conformance as appropriate and needed by IHS-TR customers as communicated to the vendor by the IHS-TR Director

Develop, test, and provide ongoing enhancements of an interface between the Optos

Daytona SLO fundus camera and IHS-TR imaging software [currently Global Retinal

Imager (GRI)]

Develop and maintain an externally pointing Web site for the IHS-TR

Teleophthalmology program in collaboration with the IHS OIT web development division

Develop and maintain an internally pointing Web site for the IHS-TR

Teleophthalmology program to support end-users of the program

Onsite service and support including introduction, orientation, staff training (clinical, technical, business), deployment, logistics, and troubleshooting of operational problems following deployment

Ongoing program support and maintenance including training, mult-tier help desk, troubleshooting, IAS and DD deployment, and software and hardware development

Transmit stereoscopic color digital retinal images to an IHS staffed reading center using store-and-forward mode through the IHS-TR software platform (currently

CDMP)

Set all critical requirements, test, and certify all imaging and reading workstations for compatibility with IHS-TR imaging software (currently JVN IA4, GRI) and other

IHS-TR technology, for safe and effective clinical use

Reader and Imager Trainer training as needed to meet staffing changes

Training of IHS-TR staff (if needed) to provide entry level field based support of the

Optos Daytona SLO retinal camera

QA/CQI support through outcome analysis and epidemiologic review

Purchase, delivery, and onsite setup of Optos Daytona SLO retinal camera for targeted replacement and redeployment of Topcon NW6S units

Maintain and upgrade the diagnostic display stations, including both fixed and mobile platforms onsite at existing sites by:

o Upgrade by replacement o Upgrade by modification

Upgrade of existing Imaging Workstations to include the latest version of Mobile

Reader system (HIPAA conformant and limited to read only) to allow IHS-TR sites to view their retinal images in a non-diagnostic presentation state

Upgrade of existing Imaging Workstations with WinXP to Win7 in conformance with

HHS and IHS IT policy.

Repairs to imaging devices, cameras, workstations, and other IHS-TR equipment and related devices, including repair by replacement with logistic support

Refurbish existing Topcon NW6S cameras and TL-301 relay lenses to new service limits and warranty as needed

Maintain the loaner equipment program (Topcon NW6S with MegaVision camera back and TL 301 relay lens) with logistic support

Provide software solutions for standardized multi-mode (stereoscopic, red-free, thumbnail, isolated, standards comparison, image rendering, etc.) grading/reading of the images using integrated diagnostic tools (measuring rule, lesion size/area, c/d ratio, etc) yielding a computer assisted diagnosis and treatment/follow-up plan based upon the standards of the Early Treatment Diabetic Retinopathy Study (ETDRS) and other evidence based models

Maintenance and version updates of third party software and renewal of third party software as needed for data and image management

Maintain a Business Partner Interconnection Security Agreement (BIPSA) with the

IHS to allow vendor connection to the IHS IT resources for IHS-TR support

The major components of the current IHS-TR clinical system include:

Imaging workstation

Reading workstation

IHS-TR server (currently JVN®/CDMP®)

IHS-TR imaging and reading software

IHS WAN

SECTION D: PACKING AND MARKING

D.1. PACKAGING

All deliverables shall be packaged and packed in accordance with normal commercial practice to meet the packing requirements of the carrier, including that which is necessary to prevent deterioration and damage due to the hazards of shipping, handling and storing.

D.2. DELIVERY AND MARKING

All deliverables shall be delivered to the address shown in Section F.2. , entitled “Place of

Performance” and shall be marked as follows:

1. Name and address of the Contractor;

2. Contract Number TBD

3. Description of item contained therein; and

4. Consignee’s name and address.

SECTION E: INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

The Contracting Officer Representative (COR), as a duly authorized representative of the

Contracting Officer, shall assume the responsibilities for monitoring the Contractor’s performance, evaluating the quality of services provided by the Closeout Contractor, and performing final inspection and acceptance of all deliverables.

E.2. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es): “http:\\www.arnet.gov/far/”.

FEDERAL ACQUISITION REGULATIONS (48 CFR CHAPTER 1) CONTRACT

CLAUSES

52.246-4 INSPECTION OF SERVICES--FIXED-PRICE AUG 1996

52.246-2 INSPECTION OF SUPPLIES-FIXED PRICE AUG 1996

52.246-16 RESPONSIBILITY FOR SUPPLIES APR 1984

E.3 REVIEW AND APPROVAL

Review and evaluation of the overall performance of this contract is the responsibility of the

Contracting Officer. Unless otherwise stated in writing, the COR is delegated the authority to accept or reject services delivered under the contract following necessary review. Acceptance shall be affected in the manner described herein, otherwise as directed by the Contracting

Officer.

E.4 EVALUATION

1. The COR shall evaluate services performed under this contract during the term of the contract, and the results of such evaluation shall be made a part of the contract file.

The evaluation report shall be directed toward the progress made in meeting the contract Scope of Work.

2. Progress of Contractor’s performance shall be measured in terms of successful deployment of Imaging Stations and upgrades based on a mutually agreed to, deployment schedule.

3. Evaluation of performance shall occur as a standing report item in the IHS/JVN

Diabetes Eye Care Program monthly report. These evaluations shall consider suitability of the hardware and software, quality of the images, usefulness of the images, and quality of the support. The rate of deployment shall be determined by the capacity of IHS to s elect/recruit, deploy, support and fund these sites. Evaluation conferences shall occur quarterly with site visits as needed by the COR.

SECTION F: DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The period of performance shall be for a basic period of 12 months with four 12-month option periods. The Government may exercise options to extend the period of performance in accordance with FAR 52.217-9, upon written notification by the

Contracting Officer within 30 days of contract expiration or within 30 days of funds becoming available for that fiscal year.

F.2. PLACE OF PERFORMANCE

The Contractor shall perform the required services at the locations listed in Section J, Attachment 2.

F.3. DELIVERABLE SCHEDULE

The Contractor shall prepare and deliver the following items in the quantities specified to the Contracting Officer Representative (COR). This individual will be identified upon contract award. (See Section G.1.)

Any deliverable or products produced under this contract will be accepted or rejected in writing by the (COR). To complete this contract, the Contractor must furnish the deliverables specified below:

F.4 DELIVERABLES

This contract provides for the following major categories of product and services:

Services o Development

Hardware- identification, development/modification, testing, and validation of advanced retinal imaging devices

Software- QA, RPMS/EHR/VI interface to IHS-TR technology, IHE TF conformance, computer assisted decision support, diagnostic image display, etc

IHS-TR technology/RPMS/EHR/VI integration programming (IHS-TR side)

IHS-TR Website(s) o Support

Deployment of IHS-TR imaging and reading technology

Operational- multi-tier help desk

Software/Technical

Hardware/Technical

Logistics for onsite activity

Training- reader, imager trainer, Optos upgrade staff

QA- clinical, technical, business

Equipment/supplies o Hardware

Image Acquisition Station (IAS) deployed to various sites across the IHS incrementally during the year as needed

IHS-TR reader and imaging workstations certified for technical compatibility with the IHS-TR technology and highly standardized across the IHS-TR enterprise to facilitate cost efficient support and maintenance

Upgraded MegaVision cameras for legacy IAS’s (if any; planned and deployed)

IHS-TR DD hardware

Mobile Reader hardware

Camera and workstation repairs

Advanced retinal imaging device (if available)

Miscellaneous hardware- cases, CPU’s, workstation subcomponents, camera tables/table tops, cables, etc o Software

IHS-TR imaging, reading, reporting, and RPMS/EHR interface software

Acquisition and Maintenance of miscellaneous third party software

Maintenance of third party software licenses

Some of the service items and most of the equipment items are needed on an ad hoc basis with the schedule only grossly estimated during the term of the contract. Invoices are submitted for services and equipment on a per unit or cost basis as contract line items.

Equipment items are to be invoiced incrementally, singly or in batches as they occur, and may include bundled services immediately relevant to the equipment, e.g.

shipping/logistic costs, warranty agreements, etc. The support charges consider development and direct deployment activities, as well as ongoing support of the deployments throughout the entire contract year, and are invoiced quarterly.

SERVICES

Services Deliverables:

Quarterly Support Services: (item# 1)

The objective of the quarterly support is to provide a wide range of services that allows for IHS-TR operations and development. The major categories of this service item are described below:

Site Deployment Services: Pre-Deployment

Step 1- Participate in Pre-Deployment Call/Meeting

Tasks:

Notified by IHS-TR Director of planned deployment sites and appropriate contacts

Receipt of pre-deployment call/meeting agenda from IHS-TR Director

Participate in scheduling of the pre-deployment call/meeting

Output:

Acknowledge pre-deployment call/meeting schedule

Resources:

IHS Program Management

Related Documentation:

Pre-Deployment Questionnaire

IHS-RPMS Implementation Checklist

Step 2- Gather Pre-deployment Information

Tasks:

Conduct Pre-Deployment Call

Identify scope of clinical program

Identify group members and roles

Review Pre-Deployment Questionnaire

Discuss site preparation

Imaging Room

Connectivity

Review IHS-TR installation tasks

Review RPMS tasks

Review Support Procedures

Review Property Inventory Management

Review Biomed Property Inspection

Review IT access

Schedule deployment

Schedule imager training

Establish communication plan

Conduct Follow-up sessions to collect remaining information

Pre-Deployment Questionnaire Complete

Local Site Contacts (MOU)

Vendor Deployment Specialist

OHS-Site MOU

Step 3 — Procure and Deliver Equipment

Order all equipment based on output from Pre-Deployment Conference Call

Output:

Equipment delivered at pre-staging area of the deployment site

Equipment remains unopened

Vendor Program Manager

Procurement Information

Steps 4 and 5- Off-Site Technical Pre-Deployment Prep Work and Local Readiness

Confirmation

Tasks:

Arrange for Travel Logistics for Deployment Specialist

Pre-Stage Equipment

Ship Equipment to Sites

Confirm Receipt of Equipment at Sites

Confirm with IHS Program Management readiness of local site

Ready for On-Site Deployment

Resources:

Vendor Program Manager

Workstation Configuration/Installation Document

Inventory Tracking and Workstation Information Forms

Steps 6 & 7 & 8 - Prepare Local Site and Confirm Readiness

Ensure location for system is appropriate and ready for deployment

Ensure connectivity of IHS-TR Workstation by pinging IHS-TR server from workstation data drop with local IT staff assistance as needed

Check for/Install RPMS Environment for required applications and patches

Provide local RPMS access and Area VPN access to vendor QA Personnel

Establish remote Health Summary print devise

Back-up RPMS installation

Confirm Imager training by IHS Imager training scheduled

Local Site Ready for On-Site installation

IHS-RPMS Implementation Checklist complete

Local site contacts

OIT

Related Documentation

IHS-RPMS Implementation checklist

Site Deployment Services: On-Site Deployment

Step 9 — Perform On-Site Set-up of Equipment

Set-up Camera

Set-up and configure Workstation

Final Imager Orientation to camera, imaging software, and RPMS interface

Camera and Workstation Function locally

Imager able to operate related RPMS and IHS-TR software

Imager able to capture IHS-TR image series

Imager able to transmit health summary

Site Imager

Deployment Toolkit Checklist

Deployment Test Procedures

Step 11 — Integration Testing

Ensure test patients scheduled in RPMS appear in IHS-TR work list without error

Ensure that test studies are stored locally and in the IHS-TR server, and can be retrieved from IHS-TR without error

Deployment Test Procedures Complete

Deployment Test Procedures

Step 12 — Provide On-Site Admin Training to Local Technical Contact(s)

Review maintenance procedure

Virus protection

Windows Updates

Review procedures if network configuration changes are necessary

Review support process/procedures

On-site Training Sign-off complete

IHS On-site technical contact(s)

IHS-TR On-site Maintenance Procedures

Site Deployment Services: Post-Deployment

Steps 13 & 14 — Create Post-Deployment Summary

Document on-site tasks completed, not completed, and open issues remaining

Complete IHS-TR equipment tracking database including make/model, serial numbers/manufacturer’s service tags, etc.

IHS Program Management to review and suggest edits

Post-Deployment Summary complete and distributed to appropriate parties

Resources

IHS-TR Post-Deployment Summary Template

Support Services

The following describes the plan to provide comprehensive IHS-TR customer support for the IHS as well as IHS-TR's management of third-party vendors on behalf of the

IHS. It contains a brief overview of the support plan, workflow and procedures of the support infrastructure for both the central IHS-TR Help Desk as well as Field Support.

Support Escalation Workflow

IHS-TR Support or Help Desk shall be staffed weekdays between the hours of 8 AM and

8 PM ET. It will consist of three levels of service that will interact seamlessly to manage the entire service environment for the IHS systems.

Level 1: The Help Desk Liaison is the first point of contact for IHS customer support.

This occurs at the level of the IHS and is usually not performed by the vendor except in a fail-over condition. All inbound issues will be logged, recorded and then passed off to either Level 1 or Level 2 support personnel. IHS clinical personnel at the IHS-TR offices shall provide Level 1 clinical support, which is primarily associated with clinical and camera use issues and other problems requiring entry level technical support. Level 1 support issues will typically be resolved by the end of the phone call or via email response. Any issue that cannot initially be resolved by Level 1 support shall immediately be escalated to Level 2 support.

Level 2: All technical problems associated with computer hardware, operating systems and IHS-TR software that cannot be addressed by Level 1 are elevated to Level 2 vendor

Technical support. Support issues at the IHS level are triaged and routed to appropriate support personnel. If Level 2 cannot resolve the issue within 24 hours of assignment, it will be forwarded to Level 3 support.

Level 3: Level 3 Support consists of both IHS-TR software application support as well as third-party vendor management. Any technical problem associated with vendor-supplied products is escalated to Level 3 support. Vendor Level 2 support personnel shall contact the appropriate third-party vendor(s) on behalf of the IHS and continue to manage the issue until it is resolved. In the case of third-party vendor issues, Level 3 support resolution shall be dependent upon the various service contracts negotiated by Vendor.

Resolutions for IHS-TR software issues will be dependent upon the determined level of severity.

Other Specific Support Services:

1. RPMS/EHR-IHS-TR technology Interface support: The vendor shall collaborate with IHS OIT to ensure appropriate interface support and documentation of issues and their resolution. The vendor is expected to have sufficient RPMS/EHR expertise to perform basic troubleshooting and vendor side interface management. Only those cases requiring more advanced RPMS/EHR expertise should involve IHS OIT or contractor staff.

2. Account Management: The vendor and IHS shall collaborate on identifying and documenting technical, clinical, and administrative issues that arise from IHS-TR operations. The identified contact person shall establish a liaison between the vendor and IHS to ensure that issues are resolved expeditiously and that issues are documented as part of the IHS-TR Lessons Learned documentation process.

3. IHS-TR Tools Support: These tools would include Quality of Service tools for performance expectations. The vendor shall collaborate with IHS in establishing these tools to provide performance enhancement of the clinical program.

4. IHS-TR Deployment Support: The vendor team shall coordinate with IHS team to coordinate deployments and triage of support issues.

5. Telecom support: the vendor team shall work with IHS team to ensure that appropriate telecom support is available for the IHS-TR program

6. Epidemiologic studies: The vendor team shall work with the IHS team to identify epidemiologic trends among AI/AN’s using existing data derived during the normal operation of the IHS-TR.

Special Requirements of Support Activities:

During the provision of support services the vendor shall occasionally have access to federal information and/or information systems. At all times the vendor must satisfy applicable provisions of the Health Insurance Portability and Accountability Act

(HIPAA), The Privacy Act, Federal Information Security Management Act (FISMA), HHS/IHS Rules of Behavior (as applicable) and the Homeland Security Presidential

Directive (HSPD-12) to insure the identity of the staff with access and to protect the confidentiality, integrity, and availability of sensitive federal information and/or information systems. At all times, all the vendor staff with access to federal information systems must have a current and active IHS Division of Information Security

Interconnection Security Agreement in place.

Quality Assurance

Preliminary work has been done to develop a data set for QA purposes. Reader testing and data monitoring for quality assurance metrics will be accomplished through the use of the IHS-TR software (currently JVN/CDMP). The vendor QA team shall work closely with the IHS team to complete the work required for measuring reader quality to establish a robust QA program for the IHS-TR.

Quality Improvement

Utilizing the data monitoring tools developed for the quality assurance module the vendor team shall, upon the request of the IHS-TR Director, collaborate with the IHS team to perform data analyses and identify specific areas where quality improvement is indicated. Once a particular area of quality improvement has been identified the hypothesis can be tested through a study that will be facilitated through the use of the

IHS-TR studies management module (currently JVN-CDMP). The data collected will allow an evaluation of a particular quality improvement hypothesis with respect to clinical or business case scenarios within the IHS program.

Risk Management

Maintain records for identifying and tracking technical risks to the program and actively participating with the IHS to mitigate these risks in compliance with IHS risk management requirements.

Integration Services: (item# 2)

IHS-TR technology/RPMS Integration comprises all software requirements for operational integration of the IHS-TR technology into the IHS HIT including interoperability with RPMS/EHR/VI.

Prior to the capture of retinal images of a patient, demographic information about the patient is sent from the Resource and Patient Management System (RPMS) utilizing the

RPMS-Generic Interface System (GIS), or its operational equivalent. The RPMS GIS supports the development and implementation of interfaces using multiple messaging protocols such as Health Level 7 (HL7) and HLO, and distributed as patches to the

RPMS GIS. A GIS RPMS interface for the IHS-TR technology (currently JVN/CDMP) was developed, verified, and is in use to support the information exchange described.

Specific Integration Services

1. Information technology project management and support: The vendor team shall collaborate with IHS-TR and OIT team to identify and prioritized new interoperability use cases and management issues and formulate procedures for resolution.

2. Architectural Support: The vendor team shall collaborate with IHS-TR and

OIT to define technical specifications as they evolve with respect to the IHS-TR imaging and reading application and IHS-TR shall provide the associated quality systems documentation.

3. Standards and Messaging Support: The vendor team shall collaborate with the

IHS-TR and OIT teams to ensure that IHS-TR requirements continue to be supported by IHS IT and RPMS/EHR infrastructure.

4. RPMS Interface development: the vendor team shall collaborate with IHS to coordinate bilateral software development for functional integration of the IHS-TR technology applications and workflow with RPMS/EHR. The prime outcome of this collaboration is to ensure that IHS-TR technology software development will continue to meet RPMS/EHR interfacing requirements including specified standards based automated workflow, Meaningful Use (as required by the current stage specified by ONC), and other interfaces as specified by the IHS-TR Director.

5. Facilitate potential integration of the IHS-TR technology with other existing and planned IHS HIT entities, such as VistA Imaging (VI) and other telemedicine acquisition modalities, and provide vendor qualification services and technology validation for potential system vendors or adoption of new technologies such as different retinal imaging cameras.

6. Interim programming comprises all ad hoc programming needed to deal with unplanned development issues. By definition, an anticipated volume, scope, and timeline cannot be provided. The estimated value for this service is based upon IHS-

JVN historical experience.

Web Services: (item# 2)

Internal marketing and customer education is an important feature for competent telemedicine operations and should be included in the IHS-TR Teleophthalmology

Program. This web-based communication platform includes an online description of the program in a context relevant, culturally sensitive, and regulatory compliant fashion. This support is provided by the vendor web development staff in collaboration with the IHS-

TR director and the IHS OIT Web Manager. OIT is the predominant resource for this externally pointing site, but the vendor participation is required for operational consistency and content management. This is an ongoing process that is documented by the web posting of an externally pointing web site with content development occurring collaboratively by IHS and the vendor, and approved by the IHS-TR Director.

Development and maintenance of an internally pointing IHS-TR web site is needed to facilitate cost efficient, effective, and regulatory conformant operations. This web site must contain document repository, broadcast communication, education/training, and

QA/CQI functions. The basic architecture of this site has been developed but other developmental tasks remain. While the OIT Web Manager is a resource in this effort, the predominant source of the web site development and support is the vendor. This is done in close association with the IHS-TR Director and vendor Program Manager.

Repair Services: (item# 3)

Vendor Technical Team shall provide repairs to IHS-TR technology as needed and requested. It is understood that the cost of repairs during the contract year can be only estimated based upon historical levels and anticipated event rate and the relative impact of operational idiosyncrasies as they become manifest. In certain circumstances the nature of the failure, and economic and time line dependencies drive a decision for repair, temporize, or defer repairs. Historically the demand for these services is rate limit by the budget, so there is no expectation that any of these services will go undelivered due to insufficient demand.

These support services are provided on an IHS preferred hourly rate that represents a discount from the commercial rate.

Training: (item# 4)

Item #6- The vendor shall work with the IHS clinical team to provide ab initio IHS-TR

Reader training and provisional certification of optometrist reader trainees as needed to accommodate new hire IHS reading staff. It is understood that there may be no need to replace or expand the IHS-TR Reader staff, but this option is provided to accommodate attrition or unanticipated growth. IHS-TR readers will also undergo evaluation and recertification as needed to ensure that the expectations of clinical excellence are maintained throughout the program.

The vendor and IHS clinical teams shall review curricula for training course to ensure that evolving clinical guidelines are met and that training material is appropriate for the IHS.

Deployment/On-site support logistics: (Item# 5)

Most of the new Optos Daytona cameras will be deployed at large facilities already hosting an IHS-JVN 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 by the standard vendor travel rules that define expense limits and reporting. Air travel shall be by coach and lodging in standard/mid-level hotels. Per

Diem reimbursement is per standard vendor policy and shall not be in excess of industry norms. All reimbursable expenses are reported using the vendor travel reimbursement form (see example below), and then billed against this line item without indirect costs or profit. The anticipated aggregate cost for the contract year is reflected in the value of this line item.

Any particular I/T/U 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.

JVN Service and Support Logistics (item# 6)

Logistic support of onsite service and support of the IHS-JVN 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 (item #5) above.

IHE Eye Care Connectathon and TF Integration: (item# 7)

Demonstrate standards based HIT interoperability by software development, testing, and successful participation at the IHE Eye Care Connectathon leading to a published IHE

Eye Care conformance statement describing IHS-TR IHE-Eye Care conformance. This is an important operational feature anticipating Meaningful Use Stage 2 and 3 requirements.

Advanced camera system identification, testing, validation: (item# 8)

Currently there is no retinal imaging device commercially available that is specifically designed for telemedicine duty. Instead, imagers designed primarily for an eye clinic setting are adapted to telemedicine operations. This results in cameras that generally too heavy, too big, too expensive, too complicated, and don’t capture all the data needed for remote diagnosis and management of DR. Previous retinal imager development efforts continue but no production ready device is currently available. Vendor and IHS-TR will collaborate to define requirements for a proper telemedicine retinal imager, and then maintain market vigilance for a new device that satisfies these requirements. Upon identification of a possible new advanced retinal camera appropriate for clinical deployment in the IHS-TR program the vendor will explore its potential through testing and validation in collaboration with IHS-JVN.

EQUIPMENT/SUPPLIES

The nature of telemedicine in general and the IHS-TR in particular requires strict attention to evolution of technology and its clinical application (new technology, new use cases for existing technology, orphaned technology, new operational requirements, etc).

Such changes have occurred during every year of this contract. Changes in hardware

(camera, diagnostic workstation and display), hardware availability, new/ongoing programming needs, and HQ expectations for the program have driven changes in previous IHS-TR contracts. This contract reflects those changes, but is substantially the same as the previous year. In this context the following are key features that established the equipment/supplies deliverables.

The RIC MegaVision camera was integrated into IHS-TR imaging software (JVN

Image Acquisition (IA) 4.0, and subsequently Global Retinal Imager) Upgrade of existing IA 3.0 units began five years ago and is complete except for inactive deployments. The need for upgrades in this contract year is growing to an end, but the residual demand is uncertain. For this reason the MegaVision camera line item is retained as optional.

Currently there is no retinal imaging device commercially available that is specifically designed for telemedicine duty. Instead imagers designed for eye clinic use are adapted to telemedicine operations. This results in telemedicine retinal imagers that generally too heavy, too big, too expensive, too complicated, and don’t capture all the data needed for ATA Category 3 performance and remote management of DR. Previous retinal imager development efforts continue but no production ready device is currently available. Therefore, an optional line item for a new advanced retinal imaging system has been continued to allow identification, testing, and validation of devices in anticipation of broader deployment for replacement of the existing Topcon NW6S that is no longer commercially available.

The legacy imaging device of the IHS-TR program is the Topcon TC-NW6S. It has been modified under previous IHS-TR contracts to fit the operational needs of the program and requirements of the IHS. This device has not been manufactured for several years and has orphan status with its manufacturer. To date there has been no other commercially available fundus camera that meets all the clinical needs and technical requirements for the IHS-TR system. Since the current vendor provides repair/maintenance/overhaul services for the Topcon TC-NW6S, and since this camera remains uniquely suited for ATA category 3 clinical performance the existing NW6S units will be maintained and refurbished as needed through the vendor until an appropriate new imaging device is available.

Depending on the condition of a specific camera, repair may occur by…