IHS Request for Proposal (RFP) 75H70421R00004 for JVN Tele-Retina(01-05-2021 Final).pdf

Section A

Indian Health Service (IHS) Request for Proposal

(RFP) 75H70421R00004

For

IHS Tele-Retina Program Support Services and Equipment Purchase

You are invited to submit a proposal in accordance with the requirements of the following

Solicitation.

Proposals must be received by the Government no later than the local time on the Due Date stated in the table below.

Issue Date: 01/05/2021

Due Date: 01/26/2021

Time: 4:00pm EST

Points of Contact:

Paul Premoe, Paul.Premoe@ihs.gov

Javier Medina-Velazquez, Javier.Medina-Velazquez@ihs.gov mailto:Paul.Premoe@ihs.gov mailto:Javier.Medina-Velazquez@ihs.gov

SECTION B – PRODUCTS OR SERVICES AND PRICES/COSTS

B.1. BACKGROUND/PROGRAM OVERVIEW

The Indian Health Service 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 (DR). 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), Resource and Patient Management System/Electronic Health Record

(RPMS/HER) interoperability, and Digital Imaging and Communications in Medicine (DICOM) image management. As such, the CDMP serves as the platform for clinical operation of the JVN in the Indian Health Service (IHS).

Deployment and use of the JVN system in the IHS allows participating facilities to image the retina 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/AN’s. This is a critically important program from both a clinical and regulatory vantage:

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%. In FY 2018 the IHS-TR program captured 29,065 studies of American Indians/Alaska Native (AI/AN) patients that would have been at risk for progressing to blindness due to undetected high risk DR.

The first clinical deployments of the IHS-TR began in 2000 and have continued incrementally over the subsequent 20 years with implementations currently at 123 sites in 25 states in Indian country as the IHS-JVN Tele-ophthalmology Program. With 14 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/AN’s.

Evaluation of these images by IHS readers at the IHS-TR National Reading Center using the reading and reporting software that 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. 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.

Purpose

The general purpose of this contract is to maintain ongoing development, implementation, and support of the Indian Health Service Tele-Retina activities in Urban Indian Health Care clinics, Tribal Health Clinics and Indian Health Services hospitals and clinics with software, services and equipment. These software, services and equipment are provided by the vendor in accordance with the directed spending language contained in IHS congressional appropriations.

B.2. TYPE OF CONTRACT (FAR 52.216-1 (APR 1984))

The Government desires to award a single, Time-and-Material (T&M) contract, resulting from this solicitation. The government reserves the right to award to multiple offers, depending on the need at the time of award, available funding, and the quality of proposals received. This requirement is

Total small business set-aside.

B.3. CONSIDERATION AND PAYMENT

The Contractor shall provide the services described in Section C: Performance Work Statement

(PWS). Except as otherwise specified in the contract, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise provide all tasks necessary for or incident to the performance of the work set forth herein.

B.4. CONTRACT PRICE

The government intends to award a Time-and-Material (T&M) contract with one, 12-month base and four (4), 12-month option periods.

All rates proposed for this RFP shall be proposed for support services and equipment for a period of

12-months, including the base and all option periods. For evaluation purpose, Contractor shall propose a total contract price which includes all labor and equipment for the base and all option contract line item numbers (CLINS), including travel and applicable Per Diem.

Upon delivery and acceptance of the services described in the PWS of the resultant contract and identified in the schedule of charges below, the Government shall pay to the Contractor the charges as specified below per the following CLINs with the attached, Appendix F: Offeror’s Pricing Sheet:

Schedule of Charges.

SECTION C- PERFORMANCE WORK STATEMENT (PWS)

2 SCOPE

2.1 Description of Work

The general purpose of this contract is to maintain ongoing development, implementation, and support of the Indian Health Service-Teleretina activities in Urban Indian Health Care clinics, Tribal Health

Clinics and Indian Health Services hospitals and clinics with software, services and equipment. These software, services and equipment are provided by the vendor in accordance with the directed spending language contained in IHS congressional appropriations.

2.2 - Task 1 – OPERATIONS (SERVICE ITEM 1)

Description of Work

Provide primary infrastructure support for all ongoing operations. Set all critical requirements, test, and certify all imaging and reading workstations for compatibility with IHS-Teleretina’s GRI (Global

Retinal Imager) software and all other IHS-Teleretina technology, for safe and effective clinical use.

Support expansion of the IHS-JVN Program

Requirements

Vendor must meet all of the American Telemedicine Association’s (ATA) – Ocular Telehealth-

Diabetic Retinopathy Practice Guidelines (3rd Edition) – at the Category 3 level or higher. The following excerpt summarizes those requirements:

Category 3 validation indicates a system can identify the Early Treatment Diabetic Retinopathy Study

(ETDRS) defined levels of Non Proliferative Diabetic Retinopathy (mild, moderate, or severe), Proliferative Diabetic Retinopathy (early, high-risk), and Diabetic Macular Edema with accuracy sufficient to determine appropriate follow-up and treatment strategies. Category 3 validation allows patient management to match clinical recommendations based on clinical retinal examination through dilated pupils.

The vendor must follow an ISO 13485 certified and registered Quality Management System (QMS) for vendor management, software development and program management.

The vendor’s offering must have a current FDA medical device (510k) clearance. Support regulatory compliance (ex. FDA registration).

The vendors offering must conform to relevant portions of both the DICOM and IHE (Integrating the

Healthcare Enterprise) Eyecare file format and messaging standards.

The vendor’s offering must be listed on the Department of Veterans Affairs (VA) VistA Imaging approved list for Ophthalmic Photography image acquisition devices.

The vendor must have conducted research and published evidence that their tele-retinal surveillance offering is as effective as an in-clinic evaluation for Diabetic Retinopathy.

The vendor must have conducted research and published evidence that their proposed retinal images are equivalent to the clinical “gold standard” Early Treatment of Diabetic Retinopathy Study’s

(ETDRS) Seven Standard Field Photography imaging protocol.

Deliverables/Tasks and Subtasks

Subtask 1.1 - Quality Assurance – (Deliverable)

Support end-to-end Quality Assurance (QA) of the IHS-Teleretina program at the National Reading

Center with on-going review of System, Imager, and Reader performance.

Subtask 1.2- Quality Improvement- (Deliverable)

Utilizing the data monitoring tools developed for the quality assurance module the vendor team shall, upon the request of the IHS-Teleretina Director, collaborate with the IHS team to perform data analyses and identify specific areas where quality improvement is indicated.

Subtask 1.3- Risk Management (Deliverable)

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.

Subtask 1.4 -Ongoing Program Analysis (Deliverable)

The vendor shall conduct ongoing scientific evaluation and review of the program. The vendor shall develop all required Internal Review Board (IRB) materials, extract and process relevant datasets, develop reports and peer-reviewed academic manuscripts. The vendor’s research and data scientists shall present cleared materials at conferences and other forums as directed. Provide continuous program improvement through outcome analysis and epidemiologic review.

Program specific, Institutional Review Board (IRB) supervised research publications on key public health and tele-ophthalmology topics relevant in Indian country:

Subtask 1.5 - Emerging Clinical Technologies

Provide support and development of emerging clinical technologies (ex AI, Machine Learning, etc.)

The vendor shall maintain expertise in Diabetic Retinopathy identification and surveillance techniques including emerging technologies such as computer aided image review, Artificial Intelligence/Machine

Learning based image assessments, and automated treatment planning.

As directed, the vendor shall conduct vendor assessments, technology reviews and software development to integrate new technologies into the IHS-Teleretina program.

Subtask 1.6 -Program Expansion/Growth

The vendor shall assist the IHS-Teleretina program leadership to identify and recruit additional clinics.

As directed, the vendor shall participate in relevant conferences, develop and distribute program materials, and work with clinic leadership to adopt the IHS-Teleretina program.

Subtask 1.7 -Web Services:

Develop and maintain both an externally and internally pointing Web site for the IHS-TR Teleretina program in collaboration with the IHS OIT web development division and to support end-users of the program

Subtask 1.8 –Training:

The vendor shall work with the IHS clinical team to provide ab initio IHS-Teleretina Reader training;

provisional certification, full certification and recertification.

All training provided by the vendor shall be supplied at a location mutually agreed by the IHS-

Teleretina program and the vendor.

2.3 - Task 2 - LOGISTICAL SUPPORT (SERVICE ITEM #2)

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

Upgrade existing and end of life hardware and software with program validated components. Provide customer support. Provide a mechanism for users of imaging workstations at IHS-Teleretina sites to view reports and retinal images in a non-diagnostic presentation state for program patients at their site.

Inventory management and reporting. Provide support to the National Reading Center.

Deliverables/Tasks and Subtasks:

Subtask 2.1 Deployment/On-site support logistics:

The vendor shall have primary responsibility for ensuring all participating sites have the necessary equipment to participate in the IHS-Teleretina program.

New JVN approved equipment will be deployed at facilities already hosting an IHS-JVN system that currently use the Topcon NW6S device, and at all new deployments.

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.

Subtask 2.1.1 –New Site Deployment (Typical) Service Item #2a (Deliverable)

All new sites have the necessary equipment and software to participate in the IHS-Teleretina program.

Subtask 2.1.2 – Existing System Support – Service Item #2b (Deliverable)

All participating sites have the necessary equipment and software to continue participating in the IHS-

Teleretina program.

Subtask 2.1.3 -Support Services Vendor will provide comprehensive IHS-Teleretina customer support for the IHS as well as IHS-Teleretina's management of third- party vendors on behalf of the IHS.

IHS-Teleretina Support or Help Desk shall be staffed weekdays between the hours of 8 AM and 8 PM ET to interact seamlessly to manage the entire service environment for the IHS systems.

RPMS/EHR-IHS-Teleretinal technology Interface support: The vendor shall collaborate with IHS OIT to ensure appropriate interface support and documentation of issues and their resolution.

Account Management: The vendor and IHS shall collaborate on identifying and documenting technical, clinical, and administrative issues that arise from IHS-Teleretina program operations.

IHS-Teleretina Tools Support: These tools would include Quality of Service tools for performance expectations

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

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-Teleretina program.

Advanced grading studies: The vendor team shall work the IHS team to identify and validate emerging grading technologies that may improve the accuracy and/or efficiency of grading operations.

Subtask 2.1.4-Repairs – Service Item #2c (Deliverable) Vendor Technical Team shall provide repairs to IHS-Teleretina program technology as needed and requested, including responsibility for image evaluation workstations and ancillary Reading Center equipment

(faxes, shredder, etc.)

2.4 -Task 3 - SOFTWARE MAINTENANCE AND ENHANCEMENT (Service Item #3a)

(Deliverable)

Reader integrated system to allow for seamless expansion and accommodation of program growth.

Collaborate with OIT software development teams to support interoperability of additional telehealth service delivery modules such as Remote/Home Monitoring, and creation of interfaces between IHS

Medical Record systems and IHS-TR technology. Develop, test, and provide ongoing enhancements of an interface between the programs validated camera systems and IHS-TR imaging software - Global

Retinal Imager (GRI). Provide maintenance and updates of third-party software and renewal of third-party software as needed for data and image management. Conduct continuous research and development to ensure the program utilizes the most current and effective clinical solutions.

Deliverables/Tasks and Subtasks:

Subtask 3.1 -Integration Services:

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

RPMS/EHR/VI.

Subtask 3.2.-Image transmission

Vendor shall develop, maintain and enhance image capture and transmission processes of stereoscopic color digital retinal images and software to ensure all patient images are delivered to the National

Reading Center using store-and-forward mode through the IHS-Teleretina program software platform

(currently GRI/JVN)

Subtask 3.3. - Reading Software

Vendor shall develop, maintain and enhance image review and analysis software to ensure accurate human and/or technology-based image review. The vendor shall ensure efficient and compliant production of patient imaging session reports and treatments plans.

Subtask 3.4.-Imaging software

Vendor shall develop, maintain and enhance image acquisition software to efficiently support patient imaging workflows. The vendor shall ensure the imaging software supports all deployed program validated camera systems.

Subtask 3.5. - Integration Services

In coordination with national and local clinical IT staff, the vendor shall develop, maintain and enhance IHS-Teleretina technology/RPMS Integration. Integration shall minimally include patient registration/scheduling and final report submission.

Subtask 3.6 - Additional related tele-health integrations

The vendor shall work with other IHS programs as directed to support, advise, develop, maintain and deploy other related integrations.

Subtask 3.6.1 - Special Requirements of Support Activities:

At all times, all the vendor staff with access to federal information systems must have all required certification and clearances

2.5. – Task 4 - EQUIPMENT & SUPPLIES (ITEMS# 3b - 5)

The nature of telemedicine in general and the IHS-Teleretina program 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).

The Contractor shall provide the following equipment and supplies and have on file a reseller/partnership certificate from the camera vendor that evidences the company’s eligibility and capability to provide the IHS-Teleretina program approved products.

Subtask 4.1- TELEOPHTHALMOLOGY PLATFORM –ITEM #3b (Deliverable)

The vendor shall provide a complete platform with functionality that can be verified to support all of the requirements for clinical use. A core server with electronic medical record capabilities. A unified retinal imaging platform with a single stream image review. A Reading Center Operations and Study

Evaluation System. Remote sites with access to a Web Accessible Telemedicine Reporting Service.

A functional, real-time displayable Operations Dashboard. Reading and Imaging work stations, IHS-

TR server, and bi-directional HL7 EMR interfaces. All required foundation software to include; Oracle

RDBMS, WebLogic, LeadTools, and Visual Studio 2019 or better.

Subtask 4.2– STATIONARY CAMERA DEPLOYMENT PACKAGE - ITEM #4 (Deliverable)

IHS-Teleretina program approved camera and one-year maintenance agreement.

Subtask 4.3- MOBILE DEPLOYMENT PACKAGE - ITEM #5 (Deliverable)

IHS-Teleretina program approved camera and one-year maintenance agreement with Travel Case

Subtask 4.4 - MISCELLANEOUS EQUIPMENT & SUPPLIES – ITEMS #6a – 6g

Subtask 4.4.1-Desktop Imaging Workstation (Deliverable)

Computer Workstation, LCD monitor, computer, keyboard, etc and all IHS-JVN software. A workstation is needed for each imaging system.

Workstation is certified, standardized, compatible with the IHS-Teleretina imaging software, and compatible with the interoperability applications used for clinical and business operations, and for support and remote diagnostics.

Subtask 4.4.2-Portable Imaging Workstation (Deliverable)

Ruggedized laptop with no camera or microphone. A workstation is needed for each imaging system.

Subtask 4.4.3-IHS-Teleretina Reader (desktop) (Deliverable)

The IHS-Teleretina Mobile Reader (desktop) is a small format workstation for use by an IHS-

Teleretina Reader or Adjudicator for performing IHS-Teleretina image review from fixed locations other than the National Reading Center.

This workstation will have dual monitors with NVIDIA Quadro P620 - Graphics card - Quadro P620 -

2 GB GDDR5 - PCIe 3.0 x16 low profile – for stereo retinal image review.

Subtask 4.4.4- Uninterruptable Power Supply (UPS) (Deliverable)

The IHS-JVN program occasionally encounters imaging and evaluation locations which have electrical service inconsistencies. For those locations the program typically deploys a UPS system.

Subtask 4.4.5-Instrument Table (Deliverable)

Each deployment requires a table to support the camera for clinical operations. This equipment item is an electric Camera Table, Power Lift and Wheelchair Access.

Subtask 4.4.6-Advanced Camera System (Deliverable)

Minimal Retinal Imager device description: low light level, stereo, non-mydriatic, retinal imaging device with a format appropriate for desktop, hybrid, or portable applications. Emerging technologies such as SLO / OCT integrated units or systems designed for use with Artificial Intelligence / Machine

Learning augmented grading systems are of particular interest during this contract period.

Subtask 4.4.7 -Miscellaneous Networking Equipment (Deliverable)

The value is set at an approximate level of functional capacity but without technical specifics since that will depend on the specific item needed and the state of the technology at the time of need and as directed by the Phoenix Area Office Data Center staff.

3. GOVERNMENT FURNISHED PROPERTY/INFORMATION

Government Furnished Property (Material, Equipment, and/or Information), is to be provided together with required performance under this effort. As determined by mutual agreement, the Government will provide additional property that may be required in the performance of this effort. At the request of the

Government, or at completion of this effort, the Contractor shall immediately return any Government-provided property, including any equipment, specialized or off the shelf software, and all other property provided by the Government for the Contractor to use to complete this effort.

Upon commencement of this effort, unless otherwise indicated, the Government will provide the following property to the Contractor:

Government-Furnished Materials/Information:

Quarterly Patient Volume Reports, Site and Imager Reports, Deployed Inventory List (with timestamp confirmation photos), Stored Inventory List, Program Contact List, Quality Assurance Imaging Systems and Workstations, Copies of Memorandums of Understanding and related program agreements, Helpdesk user support case history and standard FAQ responses, Research datasets, IRB protocols and links to published works.

Government Furnished Equipment (GFE)

NONE

The Contractor shall have full access to GFE and software to perform the duties on the project while performing duties in government space. The government shall furnish the computer hardware, software, and supporting GFE and facilities, as required, in support of the tasks requested in this order.

Access to Government Facilities: The Contractor will be allowed limited access to the Government facilities, as specified below: Access will be allowed to government facilities and computer systems.

SECTION D – PACKAGING AND MARKING

D.1. PACKAGING

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

a. Contract Number: TBD

b. Proposal Title: TBD

D.2. MARKING

Each electronic submission shall be delivered to the address shown in Section G.1.3 entitled

“Contracting Officers’ Representative Appointment and Authority” and shall be clearly marked containing the following information:

A. Name of Contractor

B. Contract Number

C. Description of Contract Line Item Numbers Contained Therein

D. Consignee’s Name and Address including Email

E. Deliverable Item Reference Number

F. Date of Deliverable Submission

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

Inspection and Acceptance Term under the contract is FOB Destination. All work under this contract is subject to inspection and final acceptance by the Contracting Officer (CO) or the duly authorized representative of the government. The Contracting Officer’s 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

Contractor, and performing final inspection and acceptance of all deliverables and services called for by the contract.

SECTION F – DELIVERIES AND/OR PERFORMANCE

F.1 PERIOD OF PERFORMANCE

The base year period of performance (POP) for this contract shall be for a total of 12 months (one year from the award date). If exercised, all option periods will be for one year (12-months) for each year.

If exercised, services under this contract may be extended to provide ongoing maintenance and support for this requirement up to a maximum of 6 months past the Option Period Four (OP4) POP end date in accordance with FAR 52.217-8 – Option to Extend Services (NOV 1999).

Base: 2/28/2021 through 2/27/2022

Option Period One: 2/28/2022 through 2/27/2023

Option Period Two: 2/28/2023 through 2/27/2024

Option Period Three: 2/28/2024 through 2/27/2025

Option Period Four: 2/28/2025 through 2/27/2026

F.2. PLACE OF PERFORMANCE – See Appendix A: Schedule of Deliverables and IHS

Locations

The location for all JVN Tele-Retina program sites where JVN Tele-Retina support services and equipment deployment shall be provided may be found in Appendix A: Schedule of Deliverables and IHS Locations.

F.3. REQUIRED DELIVERABLES - See Appendix A Schedule of Deliverables and IHS

Locations

a. The Contractor shall submit the required deliverable items in accordance with the Schedule of

Deliverables.

b. The U.S. Government reserves the right to accept or reject services in accordance with

Inspection and Acceptance clause and the Appendix A: Schedule of Deliverables and IHS

Locations.

F.4. CONTRACTOR PAYMENT

The COR is responsible for documenting and communicating performance deviations, corrective actions, and performance improvements to the Contractor and the CO. If the Contractor fails to perform required services at the acceptable quality level, payment may be withheld until Contractor makes corrections. If performance is below the government’s expectations, IHS will document concerns on Appendix E: Contract Discrepancy Report. In accordance with Appendix E, the

Contractor’s actions taken or not taken to mitigate concerns may be recorded on past performance

CPARS evaluations. If performance is below acceptable quality levels on the attached, Appendix B:

Quality Assurance Surveillance Plan (QASP).

SECTION G – CONTRACT ADMINISTRATION

G.1. AUTHORITIES OF GOVERNMENT PERSONNEL

Notwithstanding the Contractor’s responsibility for total management during the performance of this Contract, the administration of the Contract will require maximum coordination between the

Government and the Contractor.

The following individuals will be the Government’s points of contact during the performance of this Contract.

G.1.1. Contracting Officer (CO)

The CO for this contract is:

Mr. Paul Premoe

Indian Health Services

Division of Acquisition Policy (DAP) 5600 Fishers Lane, Suite 09E32

Rockville, Maryland 20857

E-Mail: Paul.Premoe@ihs.gov

Phone: 301-443-4470

The CO is the only person authorized to approve changes to any of the terms and conditions of this contract. In the event the Contractor effects any changes at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract’s price to cover any increase in costs incurred as a result thereof. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract, or to modify any term or condition of the contract. The CO is the only individual who can legally obligate Government funds. No cost chargeable to the proposed contract can be incurred before receipt of a fully executed contract, which includes any subsequent modifications or other specific written authorization from the CO.

The Contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the CO or is pursuant to specific authority otherwise included as a part of this contract. No order, statement, or conduct of Government personnel, other than the CO, who visit the Contractor’s facilities or in any other manner communicate with

Contractor personnel during the performance of this contract shall constitute a change under the

Changes clause of the contract.

All communications pertaining to contractual and/or administrative matters under the contract shall be sent to the CO noted above.

All communications pertaining to contractual and/or administrative matters under the contract shall also be sent to the following Contract Specialist and Contracting Officer Representative (COR):

G.1.2. Contract Specialist (CS)

Contract administration shall be performed by:

Javier Medina-Velazquez

Indian Health Service/Division of Acquisition Policy (DAP)

5600 Fishers Lane, Mailstop 09E70 Rockville, MD 20857

Phone: 240-474-8769

Email: Javier.Medina-Velazquez@ihs.gov

G.1.3. Contracting Officer’s Representative (COR) mailto:Paul.Premoe@ihs.gov mailto:Javier.Medina-Velazquez@ihs.gov

The name and address of the COR assigned to this project is: TBD

G.1.3.1. Technical Monitoring – Responsibilities of the COR

a) Performance of work under this contract will be subject to the technical direction of the COR identified above, or a representative designated in writing. The term “technical direction” includes, without limitation, direction to the Contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that task areas outlined in the PWS and Contractor PWS, are accomplished satisfactorily.

b) Technical direction must be within the scope of the specification(s) PWS and Contractor PWS.

The Contracting Officer’s Representative does not have authority to issue technical direction that:

1. Constitutes a change of assignment or additional work outside the specification(s)/ PWS and Contractor PWS

2. Constitutes a change as defined in the clause entitled “Changes”;

3. In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

4. Changes any of the terms, conditions, or specification(s) of the contract, PWS, or

Contractor PWS

5. Interferes with the Contractor's right to perform under the terms and conditions of the contract; or

6. Directs, supervises or otherwise controls the actions of the Contractor's employees.

c) Technical direction may be oral or in writing. The COR shall confirm oral direction in writing within five (5) work days, with a copy to the CO.

d) The Contractor shall proceed promptly with performance resulting from the technical direction issued by the COR. If, in the opinion of the Contractor, any direction of the COR, or his/her designee, falls within the limitations in (b), above, the Contractor shall not proceed and immediately notify the Contracting Officer no later than the beginning of the next Government work day.

e) Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled “Disputes.”

G.2 INVOICE SUBMISSION AND PAYMENT

The Contractor may submit invoices monthly, but upon acceptance of the deliverables by the COR.

A complete invoice with all required back-up documentation shall be sent electronically via e-mail to:

Indian Health Service – Office of Finance & Accounting EMAIL: HQInvoices@ihs.gov, copying the following points-of-contacts:

mailto:HQInvoices@ihs.gov

1. Contracting Officer (CO): Mr. Paul Premoe

2. Contract Specialist (CS): Mr. Javier Medina-Velazquez

3. Contracting Officer’s Representative (COR): TBD

* No other non-invoice related documents (i.e. deliverables, reports, balance statements) shall be sent to the CO/CS or OFA. Failure to submit directly to the offices listed above will delay prompt payment of your invoice.

For invoices submitted by email: the subject line of your email invoice submission shall contain the

Contractor’s name, contract number, and invoice. Invoicing and Payments shall be done no less often than monthly. If more frequent invoicing and payments apply, that information will be contained in the contract. The email may have multiple invoices for the contract. Invoices must be in one of the following formats: PDF, TIFF, or Word. No Excel formats will be accepted. The electronic file cannot contain multiple invoices; example, 10 invoices requires 10 separate files

(PDF, TIFF, or Word).

Additionally, the Contractor is required to include its Data Universal Numbering System (DUNS) number on each invoice. For additional information about the Dun & Bradstreet (D&B) DUNS number, please visit http://fedgov.dnb.com/webform.

Invoices shall be submitted in accordance with the contract terms, i.e. payment schedule, progress payments, partial payments, deliverables, etc.

All information set forth in FAR Clause 52.212-4(g), Invoice, must be included in all invoices for it to constitute a proper invoice.

FAR 52.212-4(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, contract line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi)Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic

Funds Transfer—Central Contractor Registration, or 52.232-34, Payment by Electronic Funds

Transfer—Other Than Central Contractor Registration), or applicable agency procedures.

http://fedgov.dnb.com/webform

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and

Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315.

In accordance with OMB Memorandum, M-11-32, Agencies shall make payments to small businesses as soon as practicable, with the goal of making payments within 15 days of receipt of a proper invoice. If a small business contractor is not paid within this (15 day) accelerated period, the contractor will not be given a late-payment interest penalty. Interest penalties, as prescribed by the

Prompt Payment Act, remain unchanged by means of this memorandum. All small businesses shall label all invoices as “Small Business.”

Additionally, in accordance with OMB Memorandum, M-12-16, all prime contractors are encouraged to disburse funds received from the Federal Government to their small business subcontractors in a prompt manner. To assist prime contractors in expediting contractor payments to small business subcontractors, Agencies shall, to the full extent permitted by law, temporarily establish an earlier, accelerated date for making agency payments to all prime contractors.

Consistent with OMB Memorandum M-11-32 above, Agencies shall have a goal of paying all prime contractors within 15 days of receiving proper documentation. In an effort to support small business growth, drive economic activity and job creation, the Contractor is encouraged to accelerate payments to their small business subcontractors.

Failure to submit directly to the offices listed above will delay prompt payment of your invoice.

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1. CONTRACTOR PERFORMANCE EVALUATION REPORT

During the life of this contract, Contractor performance will be evaluated on an interim and final basis for the contract, pursuant to FAR Subpart 42.15. This evaluation shall become a part of the contract file and shall be used as past performance information in evaluating the Contractor’s, and any significant subcontractors’ or affiliates, past performance on future contracts. Contractor

Performance Assessment Report System (CPARS) is an on-line reporting system https://www.cpars.gov/. The Contractor Performance Report is completed by the COR electronically and sent to the Contractor for review and approval at the end of each performance period as an interim report and at the end of the contract performance as a final report. After review by the Contracting Officer, the report becomes a permanent record of the Contractor’s past performance.

H.2. HHSAR 352.239-73 ELECTRONIC AND INFORMATION TECHNOLOGY

ACCESSIBILITY NOTICE (DEC 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the

Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance

Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc%2Buscview%2Bt29t32%2B1665%2B30%2B%2B%2831%29%20%20AND%20%28%2831%29%20ADJ%20USC%29%3ACITE%20%20%20%20%20%20%20%20%20 https://www.cpars.gov/ comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS

EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and- standards/communications-and-it/about-the-section- 508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product

Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the

Contractor at its expense.

H.3. HHS SECTION 508 ACCESSIBILITY STANDARDS NOTICE (SEPTEMBER

2009)

This contract is subject to Section 508 of the Rehabilitation Act (the Act) of 1973 (29 U.S.C.794d), as amended by the Workforce Investment Act of 1998, and the Architectural and Transportation

Barriers Compliance Board (Access Board) Electronic and Information Accessibility Provisions (36

CFR Part 1194). Section 508 of the Act requires that, unless an exception applies, all communications products and services that require a contractor or consultant to produce content in any format that is specifically intended for publication on, or delivery via, a federally owned or federally funded website permit the following:

(1) Federal employees with disabilities to have access to and use information and data that is http://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.hhs.gov/web/508 comparable to the access and use of information and data by federal employees who are not individuals with disabilities.

(2) Members of the public with disabilities seeking information or services from a federal agency to have access to and use of information and data that is comparable to the access and use of information and data by members of the public who are not individuals with disabilities.

(Note: Information about Section 508 of the Act is available at http://www.section508.gov/ . The complete text of Section 508 can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and- it/about-the-section-508-standards/section-508-standards. )

Accordingly, regardless of format, all web content or communications materials specifically produced for publication on, or delivery via, HHS websites, including text, audio, or video, under this contract shall conform to applicable Section 508 accessibility standards. Remediation of any materials that do not comply with the applicable accessibility standards of 36 CFR Part 1194 as set forth herein shall be the responsibility of the Contractor.

The following Section 508 accessibility standards apply to the content or communications material identified in this PWS:

(NOTE: The DDTP Program Manager shall list the applicable accessibility standards of the Access

Board Final Rule (36 CFR Part 1194) (e.g., “36 CFR 1194.21(a)-(j).” Most web-based text and communication must meet the accessibility standards in 36 CFR 1194.22, “Web-based intranet and

Internet information and applications.” Additionally, 36 CFR 1194.41, “Information, documentation and support,” and 36 CFR 1194.24 “Video and multimedia products” apply to all written, graphical, or broadcast video materials or products produced for HHS, including training.

36 CFR 1194.41(c) specifies that support services for products shall accommodate the communication needs of end-users with disabilities.)

H.3.1. The following Section 508 provisions apply to the content or communications material identified in the PWS:

36 CFR 1194.21(a)-(j)

References:

HHS Policy for Section 508 Electronic and Information Technology (E&IT) (January 2005):

http://www.hhs.gov/web/508/

HHS Section 508 Web site: http://508.hhs.gov/

HHS ASPA Web Communications Division Web site:

http://www.hhs.gov/web/policies/index.html

US General Services Administration (GSA) Section 508 Web site: http://www.section508.gov/

H.4. SECURITY (if applicable)

H.4.1. Security Requirements

The contractor and sub-contractor personnel shall be subject to the same Federal laws, regulations, standards and policies as IHS employees regarding information and information system security, http://www.section508.gov/ http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards http://www.hhs.gov/web/508/ http://www.hhs.gov/web/508/ http://508.hhs.gov/ http://www.hhs.gov/web/policies/index.html http://www.section508.gov/ including mandatory training requirements. Contractor personnel may will be exposed to sensitive and unclassified information systems and documents.

(a) To perform the work specified herein, Contractor personnel are expected to have routine (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data or information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

Contracting personnel visiting any Government facility in conjunction with this contract shall be subject to the standards of conduct applicable to Government employees. Site-specific approval regarding access to any IHS facility, sensitive materials, computer facility access, issues of security badges, etc. shall be coordinated with the COR or IHS Project Manager as required.

Health Insurance Portability and Accountability Act (HIPAA):

Work on this contract may require personnel to have access to information covered under The Health

Insurance Portability and Accountability Act (HIPAA) Public Law 104-191, and other public law requirements.

H.4.2. HHS Security and Handling of Data

SECURITY OF DATA

The Contractor shall comply with any security requirements established by HHS to ensure proper and confidential handling of data and information. The Contractor shall refer to “HHS

Cybersecurity Program.”, which is HHS’ Information Security Program Policy, dated June 2010.

The Contractor shall become familiar with the HHS Departmental Information Policies which may be found at http://www.hhs.gov/ocio/policy/index.html.

“HHS Cybersecurity Program” develops policies, procedures, and guidance to serve as a foundation for HHS' information security program. These documents implement relevant Federal laws, regulations, standards, and guidelines that provide a basis for the information security program at the Department. The Contractor must become familiar with ‘HHS Cybersecurity

Program” guidelines as presented at http://www.hhs.gov/ocio/policy/index.html#Security. Data obtained for this contract shall not be used to create databases or any other product not intended for use specifically in this project. All data containing personal identifiers shall be handled in accordance with the Privacy Act of 1974 (Public Law 93-579). No data is to be released to anyone without the specific approval of the COR and the Contracting Officer.

HANDLING OF DATA

The Contractor shall comply with security requirements established by HHS to ensure proper and confidential handling of data and information. The Contractor shall refer to HHS - OCIO Policy for

Information Systems Security and Privacy, which may be found at http://www.hhs.gov/ocio/policy/.

H.4.3. Department of Health and Human Services, Homeland Security Presidential Directive -12

Implementation Policy (HHS HSPD-12 Implementation Policy)

H.4.4. The minimum Government investigation for a non-critical sensitive position is a National

Agency Check and Inquiries (with fingerprinting), which consists of searches of records covering specific areas of a person’s background during the past five years. Those inquiries are sent to current and past employers, schools attended, references, and local law enforcement authorities.

http://www.hhs.gov/ocio/policy/index.html http://www.hhs.gov/ocio/policy/index.html#Security http://www.hhs.gov/ocio/policy/

More restricted positions, above non-sensitive, require more extensive documentation and investigation.

H.4.5. Contractors should ensure that the employees whose names they submit have a reasonable chance for access approval. Delays associated with rejections and consequent reinvestigations may not be excusable.

H.4.6. Language similar to this Security section shall be included in any subcontracts which require subcontractor personnel to have access to an information system, access to sensitive data, regular or prolonged access to a HHS- controlled facility, or any combination of these three.

H.4.7. Inquiries, including requests for forms and assistance, should be directed to the CO or his/her designee, listed in the Contract.

H.4.8. If applicable, within seven (7) calendar days after final acceptance of the work specified herein, the Contractor shall return all identification badges to the CO or his/her designee.

H.4.9. THE SUITABILITY DETERMINATION AND SECURITY CLEARANCE

H.4.9.1 Suitability…