TATRC-17-0001_W81XWH-17-T-0093_SOLICITATION.doc

Section SF 1449 - CONTINUATION SHEET

Base Year - Labor

FFP

Administrative Research Support Services

FOB: Destination

PURCHASE REQUEST NUMBER: 0010959584

NET AMT

Base Year - Other Direct Costs (ODCs)

COST

ESTIMATED COST

Base Period - CMR

FFP

See PWS Section 6.6 for Further Details.

NET AMT

FFP

Administrative Research Support Services

NET AMT

COST

ESTIMATED COST

FFP

ISee PWS Section 6.6 for Further Details.

NET AMT

FFP

The Contractor shall provide a plan for 30-Days of outgoing transition for transitioning work from an active task order to a follow-on contract/order or Government entity. See attached the Performance Work Statement, Section 2.5.4 Option Item for details

NET AMT

PERFORMANCE WORK STATEMENT

Performance Work Statement

Telehealth 2.0 Project Research Support Services at Carl R. Darnall Army Medical Center (CRDAMC)

1.0 Scope of Work.

The scope of work for this contract is limited to research support services for the Telehealth 2.0 Research Project at Carl R. Darnell Army Medical Center (CDRAMC) at Fort Hood, Texas. Specific tasks for the Telehealth 2.0 Research Project Support Services include:

(a) Administrative preparation of CDRAMC Behavioral Health Service and Fort Hood line units for the Telehealth 2.0 research activities.

(b) Technical preparation of the CDRAMC Behavioral Health Service and Fort Hood line units for the Telehealth 2.0 research activities.

(c) Direct research support services to CDRAMC Behavioral Health Service and Fort Hood line units for conducting an open pilot of mHealth technology for the Telehealth 2.0 research project.

1.1 Background.

The Telehealth 2.0 Research Project is a collaborative effort between the United States Army Medical Research and Materiel Command (USA MRMC) Telemedicine and Advanced Technology Research Center (TATRC), the Defense Health Agency (DHA) National Center for Telehealth and Technology (T2) and CDRAMC at Fort Hood, Texas.

This research project is the result of a successful, peer reviewed, intramural grant award from the Joint Program Committee-1 (JPC-1) Health Information Technology / Informatics Portfolio (see Appendix A for the JPC-1 approved research grant SOW) .

The Telehealth 2.0 Research Project is significant because mobile telehealth has the ability to extend continuity-of-care and helps to address the availability and access to care that service members (SMs) have within a deployed setting. In the deployed/operational environment, the number of BH providers is limited which can limit the range and availability of behavioral health services during a critical time period.

Furthermore, there are unique challenges for BH care in the deployed environment:

(a) smaller units that have limited skill sets/resources available to address behavioral health issues;

(b) there may be a need to hold patients longer due to limited and/or absence of air superiority, resulting in delayed access to care and;

(c) the projected shift of future conflicts to the Pacific region, which creates a huge burden on provider availability and has implications for 'burn-out'.

1.2 Objectives.

The Contractor shall provide research support services at CDRAMC for the Telehealth 2.0 project. The specific contract services are as follows:

(a) Administrative preparation of CDRAMC Behavioral Health Service and Fort Hood line units for the Telehealth 2.0 research activities.

(b) Technical preparation of the CDRAMC Behavioral Health Service and Fort Hood line units for the Telehealth 2.0 research activities.

(c) Direct research support services to CDRAMC Behavioral Health Service and Fort Hood line units for conducting an open pilot of mHealth technology for the Telehealth 2.0 research project.

1.3 Technical Requirements. Technical requirements this contracting action are as follows, and are specifically outlined in Appendix A:

1.3.1 Administrative Research Support Preparation Services.

1.3.2 Technical Research Support Preparation Services.

1.3.3 Direct Research Support Services.

1.4 Non-Personnel Services.

This award identifies services that are strictly non-personnel in nature.

1.5 Severable/Non-Severable Services.

This award identifies services that are severable in nature.

1.6 Inherently Governmental Functions.

This requirement has been reviewed and contains no services that are inherently governmental functions.

2.0 Statement of Work

2.1 Task Management.

The Contractor shall provide sufficient management to ensure that this contract is performed efficiently, accurately, on time, and in compliance with the requirements of this document.

Specifically, the Contractor shall designate a single manager to oversee this contract and supervise staff assigned to this contract.

The Contractor shall prepare monthly progress reports which outline the expenditures, billings, progress, status, and any problems/ issues encountered in the performance of the required tasks.

2.2 Incoming Transition Plan:

The Contractor shall provide a plan for 30 days incoming transition from contract to contract. The Contractor shall coordinate with the Government in planning and implementing a complete transition to the Contractor's support model. The Contractor shall collaborate with the Government to develop and deliver an Incoming Transition Plan (Deliverable 9). The Government will designate a transition period for the incoming Contractor to coordinate and work with the incumbent Contractor. This transition plan shall include, but is not limited to the following items as applicable:

· Coordination with Government representatives

· Review, evaluation and transition of current support services

· Transition of historic data to new Contractor system

· Completion of the government-approved training and certification process

· When applicable, transfer of all documentation, to include, at a minimum, user manuals, training materials, and other documents required to conduct, maintain and administrate research support services.

· Orientation phase to introduce government personnel programs and users to the contractor’s team, tools, methodologies and business processes.

· When applicable, distribution of contractor purchased government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc

· Transfer of government furnished equipment (GFE), and government furnished information (GFI) and GFE inventory management assistance.

· Applicable government (CRDAMC) briefing and personnel in-processing procedures

· Coordinate with the government to account for government keys, ID/access cards and security codes.

2.3 Quality Control Plan.

The Contractor shall prepare and adhere to a Quality Control Plan (QCP) for this contract.

The QCP shall document how the Contractor will meet and comply with the quality standards established in this statement of work.

At a minimum, the QCP must include a self-inspection plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

2.4 Kick Off Meeting.

The contractor shall participate in a telephonic kick-off meeting with the Government within 10 business days after contract award.

2.5 Monthly Reports.

The contractor shall provide a Monthly Status Report describing activities of those assigned to the project, problems encountered, actual or recommended corrective actions and a summary of the funding activity.

2.6 Specific Tasks. The Contractor shall provide the following tasks:

2.6.1 Administrative Research Support Preparation Services.

2.6.1.1 Append the existing Master Cooperated Research and Development Agreement (CRADA) between Army and the contractor with a specific Statement of Work for the Telehealth 2.0 research project to ensure that the contractor personnel are authorized to perform the necessary research support services at CDRAMC and Fort Hood in accordance with the approved JPC-1 research grant proposal (see Appendix A)

2.6.1.2 Refine eligibility criteria, exclusion criteria, screening protocol for the Telehealth 2.0 pilot from the approved JPC-1 research proposal by introducing the research project to the CDRAMC Behavioral Health Service and Fort Hood line units and finalizing the details provided in the research proposal to meet the specific requirements of the site location in accordance with criteria set by the Department of Clinical Investigations (DCI), Brooke Army Medical Center (BAMC)

2.6.1.3 Develop a final draft of the formal human subject research protocol and participant consent form(s) for the Telehealth 2.0 research project in accordance with the most recent criteria set by DCI, BAMC and the US Army Medical Research and Materiel Command (USA MRMC) Human Research Protection (HRPO) office at the time of the contract award

2.6.1.4 Provide a draft of the formal human subject research protocol and participant consent forms to the USA MRMC HRPO office for pre submission review and provide appropriate administrative tracking of their review, revision and approval process to the Telehealth 2.0 PI(s)

2.6.1.5 Edit the formal human subject research protocol and participant consent forms based on formal guidance from the MRMC HRPO office at the conclusion of their pre submission review and provide revisions to the Telehealth 2.0 PI(s)

2.6.1.6 Provide the CDRAMC Behavior Health Service with a first level IRB functions for the Telehealth 2.0 final research protocol and consent forms, in accordance with the criteria set by the DCI, BAMC and DoDI 3216.02 Subpart 3a(7).

2.6.1.7 Submit the first level IRB Approvals for final USA MRMC HRPO review and approval of the Telehealth 2.0 research project in accordance to the most recent criteria set by DCI. BAMC and USA MRMC HRPO at the time of the contract award.

2.6.1.8 Identify the contract support staff from existing, embedded resources at CDRAMC and Fort Hood to execute the requirement of the research project in accordance with the USA MRMC HRPO approved research protocol to the Telehealth 2.0 PI(s).

2.6.2 Technical Research Support Preparation Services.

2.6.2.1 Verify the installation of Desktop VTC Technology and mHealth Platform at CRDAMC by visual inspection within the CDRAMC Behavior Health Service provider offices and Fort Hood line units defined in the USA MRMC HRPO approved research protocol. Report findings to the Telehealth 2.0 PI(s) and/or Defense Health Agency Video Network Center (DHA VNC) as applicable and appropriate.

2.6.2.2 Provide the technical support required to for a TATRC/T2 site visit to test the mHealth Prototype connects at CDRAMC. This will include, at a minimum scheduling specific meeting places, coordinating with CDRAMC Behavioral Health Service staff participants and Fort Hood line units, providing audio visual support and technical training services as required.

2.6.2.3 Conduct a technical kick-off meeting at CRDAMC to train PIs and key study staff on technology. This training will be specific to the use of the mHealth Prototype technology and the necessary steps to participate in the research study in accordance with the USA MRMC HRPO approved protocol requirements.

2.6.2.4 Maintain appropriate levels of communication, coordination and outreach with all Telehealth 2.0 participants and research partners through email, teleconference and face to face meetings as required.

2.6.3 Direct Research Support Services.

2.6.3.1 Face to face recruitment of provider participants in the Telehealth 2.0 research project within the CDRAMC Behavioral Health Service.

2.6.3.2 Ensure that provider participants at CDRAMC Behavioral Health Service are properly consented, complete pre-test(s) and enrolled in the Telehealth 2.0 research project in accordance with processes outlined in the final, approved research protocol from USA MRMC HRPO office.

2.6.3.3 Post the approved marketing and advertisement materials within the designated line units at Fort Hood that were approved as part of the final research proposal from the USA MRMC HRPO office to identify and recruit service member participants for the Telehealth 2.0 research project in accordance with the methods outlined and approved by the USA MRMC HRPO office in the final research protocol

2.6.3.4 Ensure that SM who volunteers to participate in the Telehealth 2.0 research project are properly consented, complete pre-test(s) and are enrolled in the Telehealth 2.0 research project in accordance with the processes outlined in the final approved research proposal from USA MRMC HRPO office.

2.6.3.5 Ensure that participating SM are properly trained on the use of the mHealth mobile interface on their personal mobile devices to ensure that they are able to properly login to the secure mobile application, connect to their assigned providers through a video teleconference session on their mobile device, and can properly disconnect when the session is completed.

2.6.3.6 Conduct post-pilot assessment (+12 weeks from pretest) for all Telehealth 2.0 participants (e.g. providers and SMs) in accordance with the processes outlined in the final, approved research protocol from USA MRMC HRPO office.

2.6.3.7 Conduct statistical analysis of the quantitative and qualitative data generated by the Telehealth 2.0 research project, as defined in the approved USA MRMC HPRO research protocol

2.6.3.8 Maintain regulatory compliance with IRBs/HRPO to include initial review and approval, amendments, continuing review, adverse event and deviation reporting and closure reports. Participate in an Executive Committee sessions, as identified by the government representatives as required throughout the period of performance. During these sessions, the contractor will be expected to oversee dissemination activities including developing publication protocol for disseminations of findings through professional and scholarly venues (e.g. peer-reviewed publications, scientific conferences etc.)

2.6.3.9 Develop draft research articles for consideration by the Telehealth 2.0 PIs for Department of Defense (DoD) and civilian peer review publications, as required during the period of performance. Author a draft final report for the Telehealth 2.0 project activities at CDRAMC and Fort Hood within 6 months of project completion in accordance with the final report template provided by the JPC-1 Committee.

3.0 Inspection and Acceptance.

The Contracting Officer’s Representative (COR) for the Task Order is a Government official who has been delegated specific technical, functional and oversight responsibilities for this task order.

The COR is designated in the COR appointment letter, issued by the Contracting Officer, and is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

3.1 Acceptance Criteria.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Requirements Summary Matrix (PRSM) (Section 6.1.3) and all terms and conditions of this order, including all modifications.

3.2 Contractor Payment Processing.

The Contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment.

The Contractor shall invoice in accordance with Section B of the task order. The Contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs).

Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum.

Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report.

For any items purchased under ODCs which exceed $3,000, appropriate competition is required. When the Wide Area Workflow – Receipt and Acceptance (WAWF-RA) application is able to be used, it is the preferred method of submission. (See paragraph 3.4 below.)

3.3 Invoicing and Receiving Report Instructions – Fixed Price Contracts.

The Contractor is responsible for submitting invoices and initiating receiving reports electronically through WAWF-RA for goods and services rendered under this Contract. For fixed price contracts, the WAWF 2 IN 1 format (for services), and the COMBO format (only for supplies or equipment), are the preferred methods of processing electronic invoices and receiving reports within TMA.

Back up documentation (such as timesheets, etc.) can be included and attached to WAWF documents as requested by the responsible COR. Attachments created in any Microsoft Office product are attachable to the invoice in WAWF.

Contractor personnel (WAWF Vendor role) shall self-register at the web site: https://wawf.eb.mil/, and be activated by the Contractor’s designated Electronic Business Point of Contact.

WAWF training is available on the internet at http://wawftraining.com. The Contractor shall submit invoices for payment and initiate receiving reports every month. The Government shall process invoices for payment and associated receiving reports every month. Prior to submitting the first WAWF-RA electronic form for a given task order, Contractors should first coordinate with the assigned MRMC TATRC COR.

4 Deliverables.

4.1 Delivery Address.

All deliverables shall be submitted to the COR designated in the COR appointment letter and the USAMRAA Contract Specialist. Contact information will be provided at the time of award.

4.2 Method of Delivery.

Electronic copies shall be delivered using Microsoft (MS) Office Suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format), unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

4.3 Deliverable/Delivery Schedule.

A summary of deliverables follows. These deliverables are based on the approved deliverables for the Telehealth 2.0 research project, which can be found in Appendix A. Copies are to be provided to the Government officials indicated in electronic format and/or hard copy.

5 CONTRACT ADMINSTRATION DATA

5.1 Place of Performance.

The Contractors shall perform primary activity at CDRMC, Fort Hood, Texas with frequent coordination and meetings to take place virtually, and as required at the MRMC TATRC offices located at Fort Gordon, Georgia and/or the T2 offices on the Joint Base Lewis McCord, Washington military installations.

5.2 Other Direct Costs (ODCs).

5.2.1 Travel.

Local travel will be required. CONUS travel arrangements for costs of all travel, transportation, meals, lodging and incidentals are the responsibility of the Contractor.

Travel costs shall be incurred and billed in accordance with the FAR Part 31. Costs for these expenses will be reviewed, certified and approved by the COR.

All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the government.

The Government will not pay for business class or first-class travel.

Lodging and meals shall be reimburse in accordance with regulations defined in FAR PART 31. Estimated travel is indicated below. Travel costs not to exceed $4,800/year.

*for internal kick off meeting at vendor headquarters

5.2.2 Travel outside of the U.S.

Not applicable.

5.2.3 Other Direct Costs (ODCs).

ODCS shall be billed on a cost reimbursable basis. Costs are defined as the purchase price of materials or service plus the General and Administrative (G&A) or material handling charges. All ODCs shall be fully supported in compliance with all competition requirements of the FAR PART 31. All ODCs shall be reported in the Monthly Process Reports.

Specific ODCs for the Telehealth 2.0 project are limited to hardware, software and supplies, specifically:

· Laptop computer (1 ea) for capturing de-identified research data for vendor analysis

· Transcription services

· server space/maintenance services for de-identified research data for statistical analysis

· Consumable research / office supplies

6 Other Terms, Conditions, and Provisions.

6.1 Access Requirements.

6.1.1 Contractor Access to the CDRMC Network.

Contractor access to the CDRMC network is required, and will be sponsored by the Government, specifically the CDRMC Principal Investigator (PI) for the Telehealth 2.0 research study. This includes Common Access Card (CAC) sponsorship.

6.1.2 Contractor Access to Classified Information.

The Contractors will NOT require access to classified data to perform this contract.

6.1.3 Contractor Access to Military Installations.

Contractor access to military installations will require a National Agency Check (NAC) background investigation.

6.2 Quality Assurance.

The Government will review Monthly Progress Reports and will attend regular task performance review meetings with the Contractor to survey quality of products and services.

6.2.1 Quality Assurance Surveillance Plan (QASP).

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance. The oversight provided for in the order and in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term.

Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance, and provides verifiable input for the required Past Performance Information Assessments.

The QASP will be developed by the Government in conjunction with the performance work statement.

A copy of the QASP will be provided to the Contractor at the time of contract award.

The QASP is a living document and may be updated by the Government as necessary.

6.2.2 Performance Requirements Summary Matrix (PRSM).

By monitoring the Contractor, the COR will determine whether the performance levels set forth in contract have been attained. Performance standards are specified in the following:

Task 2.5.1 Administrative Research Support Preparation Services

Key staff and research participants at CDRAMC understand the objectives of the Telehealth 2.0 research project. IRB protocols are prepared, submitted and approved as appropriate

Accurate and complete documentation.

All products and actions requested by the government are completed on time

Monthly Reports;

Progress Meetings;

Government Acceptance of Documentation

Vendor participates and engages with all Telehealth 2.0 participants and research partners, and attends all key meetings and site visits.

Accurate and complete companion documentation.

Monthly Reports;

Progress Meetings;

Government Acceptance of Documentation

Task 2.5.3

Direct Research Support Services Participants are successfully recruited, consented and enrolled in the Telehealth 2.0 research project at CRDAMC.

Research participants are able to use the VTC software as required for the Telehealth 2.0 research project at CDRAMC

Data collection and analysis for the Telehealth 2.0 research project is conducted in a timely, accurate fashion.

Draft reports and peer review articles are prepared in a timely, accurate fashion.

Accurate and complete companion documentation.

Observation;

Monthly Reports;

Progress Meetings;

Government Acceptance of Documentation

6.3 Government Furnished Facilities / Information.

6.3.1 Government Furnished Equipment

The Government (specifically the CDRAMC PI for the Telehealth 2.0 research study) will provide the follow equipment, as required:

· Desktop Computer

· Computer Monitor

· Desktop Video Teleconference (VTC) camera

6.3.2 Government Furnished Facilities (GFF).

The Government (specifically the CRDAMC PI for the Telehealth 2.0 research study) will provide office space, workstation furniture, utilities and housekeeping services as required.

6.3.3 Government Furnished Information (GFI).

Detailed technical requirements and/or specifications for the Telehealth 2.0 research project will be provided by the Government at the initial contract kick off meeting. In addition, information related to conducting consulting support services in support of this contract will also be provided by the Government, as required.

6.3.4 Other Special Considerations. The COR will provide the Contractor with access to all pertinent technical requirements to achieve the deliverables. The contractor will also be authorized to engage, as necessary with other supporting contractors.

6.4 Information Assurance (IA).

All work products and services provided by the Contractor shall conform to current US Army and DoD standards and requirements, including the following:

6.4.1 General Security Requirements.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data, to ensure the confidentiality, integrity, and availability of government data.

At a minimum, this shall include provisions for personnel security, electronic security and physical security as listed in the sections that follow.

6.4.2 Health Insurance Portability and Accountability Act (HIPAA).

The contractor shall comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (P.L. 104-191) requirements, specifically the administrative simplification provisions of the law and the associated rules and regulations published by the Secretary, Health and Human Services (HHS) and the published by the DHA (formerly the TRICARE Management Activity [TMA] implementation directions. This includes the Standards for Electronic Transactions, the Standards for Privacy of Individually Identifiable Health Information and the Security Standards. It is expected that the contractor shall comply with all HIPAA-related rules and regulations as they are published and as DHA requirements are defined (including identifiers for providers, employers, health plans, and individuals, and standards for claims attachment transactions).

6.4.3 Personnel Security.

The contractor shall comply with DoD Directive 8500.1, "Information Assurance (IA)," DoD Instruction 8500.2, "Information Assurance (IA) Implementation," DoD Directive 5400.11, "DoD Privacy Program," DoD 6025.18-R, "DoD Health Information Privacy Regulation," and DoD 5200.2-R, "Personnel Security Program Requirements." Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

i. Initiate, maintain, and document personnel security investigations appropriate to the individual's responsibilities and required access to Military Health System (MHS) Sensitive Information (SI).

ii. Immediately report to the MRMC Privacy Office and deny access to any automated information system (AIS), network, or MHS SI if a contractor employee filling a sensitive position receives an unfavorable adjudication, if information that would result in an unfavorable adjudication becomes available, or if directed to do so by the appropriate government representative for security reasons.

iii. Ensure that all contractor personnel receive information assurance (IA) training before being granted access to DoD AISs/networks, and/or MHS SI information.

6.5 Contractor Employees.

6.5.1 Contractor Identification. The contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, providing any type of written correspondence or working in situations where their actions could be construed as official government acts.

6.5.2 Attendance at Meetings. Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their Contractor status know during introductions.

6.5.3 Use of Military Rank by Contractor Personnel. Contractor personnel, while performing in a Contractor capacity, are prohibited from using their retired or reserve component military rank or title in all written or verbal communications associated with the contracts under which they provide services.

6.5.4 Personally Identifiable Information (PII) and Protected Health Information (PHI). The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data, to ensure the confidentiality, integrity, and availability of Government data.

6.5.5 Protection of Human Subjects and Adherence to Ethical Standard in Department of Defense (DoD) Supported Research. While providing consulting support services, the contractor may be required to provide support to MHCE Research activities. Therefore, in accordance with DFARS 252.235-7004-PROTECTION OF HUMAN SUBJECTS (JUL 2009):

i. Definitions.

a) “Assurance of compliance” means a written assurance that an institution will comply with requirements of 32 CFR Part 219, as well as the terms of the assurance, which the Human Research Protection Official determines to be appropriate for the research supported by the Department of Defense (DoD) component (32 CFR 219.103).

b) “Human Research Protection Official (HRPO)” means the individual designated by the head of the applicable DoD component and identified in the component’s Human Research Protection Management Plan as the official who is responsible for the oversight and execution of the requirements of this clause, although some DoD components may use a different title for this position.

c) “Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information (32 CFR 219.102(f)). For example, this could include the use of human organs, tissue, and body fluids from individually identifiable living human subjects as well as graphic, written, or recorded information derived from individually identifiable living human subjects.

d) “Institution” means any public or private entity or agency (32 CFR 219.102(b)).

e) “Institutional Review Board (IRB)” means a board established for the purposes expressed in 32 CFR Part 219 (32 CFR 219.102(g)).

f) “IRB approval” means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements (32 CFR 219.102(h)).

g) “Research” means a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to general knowledge. Activities that meet this definition constitute research for purposes of 32 CFR Part 219, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities (32 CFR 219.102(d)).

ii. The Contractor shall oversee the execution of the research to ensure compliance with this clause. The Contractor shall comply fully with 32 CFR Part 219 and DoD Directive 3216.02, applicable DoD component policies, 10 U.S.C. 980, and, when applicable, Food and Drug Administration policies and regulations.

iii. The Contractor shall not commence performance of research involving human subjects that is covered under 32 CFR Part 219 or that meets exemption criteria under 32 CFR 219.101(b), or expend funding on such effort, until and unless the conditions of either the following paragraph (a) or (b) have been met:

a) The Contractor furnishes to the HRPO, with a copy to the Contracting Officer, an assurance of compliance and IRB approval and receives notification from the Contracting Officer that the HRPO has approved the assurance as appropriate for the research under the Statement of Work and also that the HRPO has reviewed the protocol and accepted the IRB approval for compliance with the DoD component policies. The Contractor may furnish evidence of an existing assurance of compliance for acceptance by the HRPO, if an appropriate assurance has been approved in connection with previous research. The Contractor shall notify the Contracting Officer immediately of any suspensions or terminations of the assurance.

b) The Contractor furnishes to the HRPO, with a copy to the Contracting Officer, a determination that the human research quoted meets exemption criteria in 32 CFR 219.101(b) and receives written notification from the Contracting Officer that the exemption is determined acceptable. The determination shall include citation of the exemption category under 32 CFR 219.101(b) and a rationale statement. In the event of a disagreement regarding the Contractor’s furnished exemption determination, the HRPO retains final judgment on what research activities or classes of research are covered or are exempt under the contract.

c) DoD staff, consultants, and advisory groups may independently review and inspect the Contractor’s research and research procedures involving human subjects and, based on such findings, DoD may prohibit research that presents unacceptable hazards or otherwise fails to comply with DoD procedures.

d) Failure of the Contractor to comply with the requirements of this clause will result in the issuance of a stop-work order under Federal Acquisition Regulation clause 52.242-15 to immediately suspend, in whole or in part, work and further payment under this contract, or will result in other issuance of suspension of work and further payment for as long as determined necessary at the discretion of the Contracting Officer.

e) The Contractor shall include the substance of this clause, including this paragraph (f), in all subcontracts that may include research involving human subjects in accordance with 32 CFR Part 219, DoD Directive 3216.02, and 10 U.S.C. 980, including research that meets exemption criteria under 32 CFR 219.101(b). This clause does not apply to subcontracts that involve only the use of cadaver materials.

6.5.6 Public Key Infrastructure Authentication and Encryption.

Contractors shall follow the DoD standards, policies, and procedures related to the use of Public Key Infrastructure (PKI) certificates and biometrics for positive authentication including authentication to DoD private web servers or applications. Where interoperable PKI is required for the exchange of unclassified information, including the encryption of e-mail containing sensitive information, between DoD and its Contractors, industry partners shall obtain all necessary certificates if they are not eligible for a DoD Common Access Card (refer to http://iase.disa.mil/pki/eca/ and http://www.cac.mil/ ).

6.6 Contractor Manpower Reporting.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the DoD TATRC is (UIC W03JAA) via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/ Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at help desk at: http://www.ecmra.mil/.

7 APPLICABLE DOCUMENTS AND DEFINITIONS. Not applicable.

8 GLOSSARY OF ACRONYMS.

Appendix A. JPC-1 Approved Telehealth 2.0 Research Project – All Parties

STATEMENT OF WORK

(MHIC)

Telemedicine and Advanced Technology Research Center (TATRC)

Medical Research and Materiel Command (MRMC)

Building 38711

Fort Gordon, GA 30905-5650

Defense Health Agency (DHA)

9933 West Hayes Street

Box 339500 MS 34

Joint Base Lewis-McChord, WA 98433-9500

Initiating PI: _______________

Partnering PI: ________________

36000 Darnall Loop

Fort Hood, Texas 76544

Partnering PI: __________________

Timeline

Months

MHIC

(COR)

T2

CRDAMC

Vendor

Specific Aim 1: mHealth Technology Advancement

Specific Aim 2: End User Usability Assessment

X

X

X

X

X

Specific Aim 3: mHealth Technology Refinements

Specific Aim 4: Pilot Investigation of Remote Care Delivery

Major Task 1: Administrative Preparation for Research

X

X

X

X

Major Task 2: Technical Preparation for Research

Major Task 3: Conduct Open Pilot of mHealth Technology

X

X

X

X

X

X

X

X

X

Specific Aim 5: Ongoing Tasks

Task 1: Maintain regulatory compliance with IRBs/HRPO to include initial review and approval, amendments, continuing review, adverse event and deviation reporting and closure reports.

X

Task 2: Outreach

X

Specific Aim 6: Dissemination and Deliverables

Projected Quarterly Enrollment

Target Enrollment

(per quarter)

CRDAMC providers

CRDAMC SMs

Target Enrollment

(cumulative)

SM:10

P:3

SM:20

QASP

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

NONPERSONAL SERVICES FOR

TELEHEALTH 2.0 PROJECT RESEARCH SUPPORT SERVICES AT CARL R DARNALL ARMY MEDICAL CENTER (CRDAMC)

FOR

TELEMEDICINE AND ADVANCED TECHNOLOGY RESEARCH CENTER (TATRC)

MOBILE HEALTH INNOVATION CENTER (MHIC)

FORT GORDON, GEORGIA

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

CONTRACT NUMBER: TBA

Purpose

This Quality Assurance Surveillance Plan (QASP) is a Government developed and applied document used to ensure that systematic quality assurance methods are used in the administration of the Performance-Based Service Acquisition (PBSA) standards included in this contract. The intent is to ensure that the Contractor performs in accordance with the performance standards/acceptable quality levels contained in the performance work statement; that the Government receives the quality of services called for in the contract; and, that the Government only pays for the acceptable level of services received.

Scope

It is important to understand the responsibilities of the parties and distinguish between the quality control plan and the QASP. The contractor is responsible for managing and developing a quality control plan to meet the quality standards established in the performance work statement (PWS). The QASP is put in place to provide the Government surveillance and oversight of the contractor’s efforts in fulfilling the terms of the contract. The QASP is not part of the contract nor is it intended to duplicate the Contractor’s quality control plan. The Government may provide the Contractor with an information copy of the QASP to support the Contractor’s efforts in developing a quality control plan that will interrelate with the QASP.

Government Resources

The following personnel will implement all surveillance activities:

· Contracting Officer - The Contracting Officer ensures performance of all necessary actions for effective contracting, ensures compliance with the terms of the contract and safeguards the interests of the United States in the contractual relationship. It is the Contracting Officer that assures the Contractor receives impartial, fair and equitable treatment under the contract. The Contracting Officer is ultimately responsible for the final determination of the adequacy of the Contractor’s performance.

Assigned Contracting Officer: Justin Pickett Telephone Number: (301) 619-2265

Email Address: justin.h.pickett.civ@mail.mil

· Contract Specialist/Purchasing Agent - is responsible for technical administration of the contract and assures receipt of all proper Government surveillance documentation is received and in the file from the Contracting Officer’s Representative (COR).

Assigned Contract Specialist/Purchasing Agent: Myrsonia Lutz Telephone: (301) 619-8896 Email Address: myrsonia.lutz.civ@mail.mil

· Contracting Officers Representative (COR) - The COR provides detailed technical oversight of the Contractor’s performance and reports his or her findings to the Contracting Officer in a…