Attachment 1 - Revised Performance Work Statement - WRAIR DQA Tanzania_22 December 2021.pdf

PERFORMANCE WORK STATEMENT

Conducting Data Quality Assessments (DQAs) at DoD/WRAIR-supported facilities in Tanzania

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

9. TRANSITION SUPPORT

10. KEY PERSONNEL

11. TRAVEL/TEMPORY DUTY (TDY)

12. GOVERNMENT FURNISHED PROPERTY

13. CONTRACT MANAGEMENT

14. COMPLIANCE DOCUMENTS

15. OTHER TERMS, CONDITIONS, AND PROVISIONS

16. ATTACHMENTS

PERFORMANCE WORK STATEMENT (PWS)

Title: Conducting Data Quality Assessments (DQAs) at DoD/WRAIR-supported facilities through funding from the

US President's Emergency Plan for AIDS Relief (PEPFAR) in Tanzania

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), United States Army Medical Research

Directorate – Africa (USAMRD-A).

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed

Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense.

Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host three Centers of Excellence for Military

Psychiatry and Neuroscience Research, Military Infectious Disease Research, and Enabling Capabilities Research;

each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

The purpose of this requirement is to contract a Tanzanian local organization to assist the DoD/WRAIR-Tanzania team located at the United States Mission in Dar es Salaam with ensuring the accuracy of reported accomplishments by conducting external Data Quality Assessments (DQAs) specified in the annual Country Operational Plan (COP) guidance and approved in the annual Tanzania COP, at facilities supported by funding from the US President's

Emergency Plan for Acquired Immunodeficiency Syndrome (AIDS) Relief (PEPFAR).

MHRP, under WRAIR, conducts research to develop an effective HIV vaccine and integrates prevention, diagnosis, treatment, and monitoring as part of an international effort to protect US and Allied troops and reduce the impact of

HIV infection worldwide. In 2004, the program began to collaborate on HIV prevention, care and treatment services, funded by the State Department/Office of the Global AIDS Coordinator and Global Health Diplomacy (S/GAC), PEPFAR, with African militaries and in the communities where MHRP conducts research. The integration of prevention, care, and treatment services has helped MHRP build strong and trusting relationships with the communities, while providing an ethical framework for the conduct of HIV clinical research. The Department of

International HIV Prevention and Treatment (IHPT) under MHRP executes PEPFAR programs around its civilian research sites in Kenya, Tanzania, and Uganda and with militaries in Kenya, Tanzania and Nigeria. The military programs are conducted in collaboration with the Department of Defense HIV/AIDS Prevention Program (DHAPP).

To develop and implement HIV/AIDS care and treatment aspects, MHRP through DoD Health Affairs, established an interagency agreement with the US Department of State to receive PEPFAR funds, which direct the implementation of effective HIV/AIDS care and treatment programs in Africa. Each country seeking support under PEPFAR negotiates for and develops a detailed annual COP. MHRP has secured PEPFAR funds for HIV/AIDS prevention, care and treatment programs in Kenya, Tanzania, Uganda, and Nigeria.

Monitoring and evaluation (M&E) of interventions are critical for demonstrating the effectiveness of health programs but are dependent on the data reported by health facilities that are often of poor quality. These DQAs are helpful not only for a comprehensive program monitoring, but also for focusing on improving program specific indicators, if needed. Frequent DQAs conducted by an independent organization will improve data quality through triangulation, reduce program under performance caused by data-issues, and help address challenges/shortcomings that affect data quality. These challenges range from but are not limited to indicator reporting, physical set up of data-related infrastructures, knowledge gap for service providers and SI teams, documentation of M&E tools, data discrepancies, challenges in uniquely identifying clients through the continuum of care, and gaps in quality, accuracy, and timeliness of reporting. These DQAs will be a collective process led by the DoD/WRAIR-Tanzania team in collaboration with the Strategic Information and Continuous Quality Improvement (CQI) teams of the programs supported by

DoD/WRAIR-Tanzania. These DQAs will also serve to ensure that USG agencies and their implementing partners are demonstrating program performance and good stewardship in maximizing the efficiency of US funds that are used to support public health priorities.

3. SCOPE

The contractor shall support the DoD/WRAIR-Tanzania team located at the United States Mission in Dar es Salaam with ensuring the accuracy of reported accomplishments and any other activities related to data quality, reporting and use, by conducting external DQAs specified in the COP guidance and approved in the annual Tanzania COP at facilities supported by funding from PEPFAR. Specifically, the contractor shall provide experienced, technical support for assessing the quality of data for the selected DoD/WRAIR-Tanzania supported HIV/AIDS programs in the

Southern Highlands regions of Mbeya, Rukwa, Katavi, Songwe, and Ruvuma as well as the Tanzania Peoples Defense

Forces (TPDF) facilities countrywide. The DQA process will include preparation, methodology review, desk review, field review, documentation, and a mitigation plan to address data limitations as needed at 40 facilities in base period and 80 facilities in each option period that will be selected in conjunction with the DoD/WRAIR-Tanzania team.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

Base period 01 April 2022 - 30 September 2022

Option period 1 01 October 2022 - 30 September 2023

Option period 2 01 October 2023 - 30 September 2024

Option Period 3 01 October 2024 - 30 September 2025

Option Period 4 01 October 2025 - 30 September 2026

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

Work will be performed at DoD/WRAIR-supported civilian facilities in the Southern Highland regions (Mbeya, Songwe, Ruvuma, Rukwa and Katavi) and selected military facilities for the TPDF in all regions of Tanzania.

The assessment has to be executed on-site but all other work can be completed remotely.

5.1.1. Telecommuting

Telecommuting is feasible for portions of the services provided under this contract. Data quality assessments must be performed at health care facilities in the Southern Highland regions (Mbeya, Songwe, Ruvuma, Rukwa and Katavi) and military facilities for the TPDF in all regions of Tanzania.

5.1.2. Working During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the

Contractor Manager to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, including

Embassy closures, the Contractor Manager shall promptly open an effective means of communication with the WRAIR Activity Manager and COR to verify:

a. Key points of contact (Government and Contractor)

b. Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

c. Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

d. Essential duty personnel for emergency and contingency operations

e. Essential work products expected to continue production by priority

The Contractor Manager, in coordination with the WRAIR Activity Manager, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances.

Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

Contractor shall not report to work on those days the Government or installation is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the Chief of Mission for any other reason. During these periods of closure, the contractor employees that are not designated as essential

IAW this contract shall not report for work. Essential personnel tasks include the following:

5.2. Federal Holidays

5.2.1.

The contractor shall not perform services on days designated as a local country holiday. The following is a list of local country holidays that services shall not be performed.

The following are Tanzanian Holidays:

New Year’s Day

Zanzibar Revolution Day

Karume Day

Good Friday

Easter Monday

Union Day

Worker’s Day

Eid-al-Fitr

Saba Saba

Eid al-Adha

Peasants' Day

Mwalimu Nyerere Day

Maulid day

Independence Day

Christmas Day

Boxing Day

5.3. Work Schedule

The contractor shall work 40 hours per week, Monday to Friday, with no more than a one hour lunch break per day, as per work schedule approved by the COR.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

The objective of this requirement is to conduct DQAs for DoD/WRAIR-Tanzania-supported, PEPFAR-funded HIV/AIDS programs in the Southern Highlands regions of Mbeya, Rukwa, Katavi, Songwe, Ruvuma as well as the selected TPDF facilities countrywide. The contractor shall meet the following objectives:

Introduce a component of triangulation between program data and other data sources (surveys, research, National routine data systems, Joint United Nations Program on HIV/AIDS UNAIDS Estimates etc.)

Introduce Strength, Weakness, Opportunity, and Threat (SWOT) analyses to identify strengths, weaknesses, opportunities and threats at all levels of data collection, management, reporting and use within the

DoD/WRAIR-Tanzania programs.

Produce comprehensive technical DQA reports that have recommendations on technical steps to be taken to improve data quality, reporting, and use.

Improve the accuracy and reliability of future data submissions to the DoD/WRAIR, PEPFAR and the

Ministry of Health (MOH).

Use and integrate Continuous Quality Improvement (CQI) and QA (Quality Assurance) methodology at the site level to address barriers; identify and remediate bottlenecks and improve quality of data and eventually services and the client experience.

6.2. Specific Tasks / Requirements

In support of the Objectives identified in Section 6.1, the contractor shall:

6.2.1

Conduct DQA Visits: After comprehensive planning in conjunction with DoD/WRAIR-Tanzania team, the contractor shall conduct site visits to review clinic charts, patient cards, registers, reports, databases and logs to assess if recording, storing, processing and reporting of data meets all dimensions of quality as defined in the PEPFAR Monitoring and Evaluation (MER) Guidance and MoH Tanzania

HIV/AIDS Data Quality Guideline, while following strategies approved in the annual work plan and quarterly work plan updates.

6.2.1.1.

In support of these DQAs, the contractor shall:

6.2.1.1.1

Conduct quarterly DQA visits to sites selected in consultation with the DoD/WRAIR-Tanzania team as well as follow up visits to sites that score poorly. The results of follow up visits will be used to monitor improvements in data quality at these facilities.

6.2.1.1.2

Provide recommendations and work with DoD/WRAIR-Tanzania Implementing Partner program staff to address gaps in data quality and develop improvement plans for M&E system and Data

Quality at Program, Regional, District, community and site levels.

6.2.1.2

In support of DQA Visits, the contractor shall adhere to the following reporting requirements:

6.2.1.2.1

Submit a completed Data Quality Review Tool (softcopy) with findings of the DQA to the COR and the DoD/WRAIR Activity Manager immediately following each site visit. (Deliverable 1).

6.2.1.2.2

Submit a comprehensive feedback on the status of visited sites via e-mail to the COR and the

WRAIR Activity Manager on a monthly basis. (Deliverable 2)

6.2.1.2.3

Review and analyze findings of the DQA. Implement capacity building plans through trainings, on-site and off-site mentoring, and provision of tools and resources and follow up on these capacity building plans. Facilitate review and update of capacity-building plans with the implementing partner staff, as needed. Continue on- and off- site mentoring, including working with the Implementing Partner leadership on institutionalizing the DQA process.

6.3. Management Reports and Plans

Annual Work Plan (Deliverable 3). The contractor shall develop a detailed costed Annual Work Plan in accordance with the COP guidance. This Work Plan shall include a schedule of all the planned activities including DQA visits for the year. The Work Plan must demonstrate how the outcomes, strategies, activities, timelines, and staffing will take place and shall be developed at the start of each fiscal year and be updated on a quarterly basis thereafter.

Quarterly Operational and Financial Tracking Reports (Deliverable 4). The contractor shall provide a quarterly report detailing all work and where there is critical or significant data related to the provided support.

The report shall include a detailed list of workload accomplished, to include writing assignments in support of all tasks. The contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN). The report is due 15 days after the end of each quarter.

Quality Control Plan (Deliverable 5). The contractor shall provide a draft Quality Control Plan (QCP) no later than (NLT) 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance

Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and performance satisfaction.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

PWS

Ref.

Number Title/Description Due

6.2.1.2.1 Deliverable 1

A Softcopy of DQA Tool

The contractor shall submit a completed Data

Quality Review Tool (softcopy) to the COR and the WRAIR Activity Manager immediately following each site visit

Immediately upon conclusion of each program/site visit

6.2.1.2. Deliverable 2

Monthly Site Visit Feedback

The contractor shall submit a comprehensive feedback on the status of visited sites via e-mail to the COR and the WRAIR Activity Manager on a monthly basis.

15th day of each month for the preceding month

6.3 Deliverable 3

Annual Work Plan

The contractor shall develop an Annual Work

Plan in accordance with the COP guidance. This

Work Plan shall include a schedule of all planned activities for the year

NLT 45 days after the start of the fiscal year, each year.

Updates shall be provided on a quarterly basis.

6.3 Deliverable 4

Quarterly Operational and Financial Tracking

Reports

The contractor shall complete an Operational and

Financial Report on a quarterly basis. This should include:

-Data quality capacity-building plans

-Technical assistance log documenting training and on-site/off-site mentoring provided

-DQA follow-on report presentation with results of DQAs and comparison to baseline

-List and descriptions of progress implementing partners have made toward institutionalizing the

DQA process.

NLT than 15 days the end of each quarter, for the preceding quarter

6.3 Deliverable 5 Quality Control Plan

NLT 15 days after contract award

7.1. Technical Reports and Documents

Technical reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable DFAR clause 252.227-7013, Rights in Technical Data-

Noncommercial Items. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with

(IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

7.2. Inspection and Acceptance

The COR delegated for oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

7.3. COR Information

To be determined upon award.

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the

Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance

Requirements Summary Matrix” (PRS Matrix).

Performance Requirements Summary Matrix

PWS

Ref.

Performance Objective

Performance

Measurement

Acceptable

Quality

Level

Method of

Surveillance Incentive

1 6.2.1 Conduct Data Quality

Assessment (DQA)

Visits

Conduct quarterly DQA visits to selected

Tier 1 &2 and selected TPDF sites.

Meets: 95% Monitored via

DQA site visit reports

Past

Performance

2 6.2.1.1.1 Conduct follow up visits for sites that score poorly

Conduct follow up visits for all sites (100%) that score poorly

Meet:

>99.9%

Monitored via follow up visit reports

Past performance

3 6.2.1.1.2 Develop and implement improvement plans for

M&E system and Data

Quality at Program, Regional, District and sites levels.

Develop improvement plans for M&E system and Data

Quality at

Program, Meets: 95% Monitored via submitted improvement plans and

Implementatio n reports

Past

Performance

9. TRANSITION SUPPORT

9.1. Incoming Transition Plan – Not Applicable

9.2. Outgoing Transition Plan – Not Applicable

10. KEY PERSONNEL

The contractor shall provide Key Personnel in accordance with the minimum requirements listed within the Key

Personnel table.

Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have the necessary experience and knowledge required to perform the duties defined herein. For temporary and/or permanent replacement of Key

Personnel, the Contractor shall provide a resume for each individual to the COR and the WRAIR activity Manager.

Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes.

The contractor agrees that during the contract performance period substitution for Key Personnel shall not be permitted unless such substitution is necessitated by sudden illness, death, or change in employment conditions (e.g. termination, change in position, etc.).

The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance.

Substitution or replacement personnel shall be replaced with 60 days.

Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

KEY PERSONNEL TABLE

Key Personnel Position Minimum Requirements

DQA Manager Degree in Statistics or Degree in Monitoring and Evaluation (M&E)

11. TRAVEL/TEMPORY DUTY (TDY)

There will be 40 sites selected within Tanzania that will be analyzed for data quality assessments in base period. There will be 80 sites within Tanzania that will be selected for data quality assessment in each option period. Sites will be determined by the WRAIR-TZ team based on data, however, it is estimated that 16 trips shall be conducted during the base period and 32 trips in each option period. The COR is the travel order approval authority as designated in writing by the KO. All travel requirements (including plans, agenda, itinerary, or dates) shall be pre-approved by the COR and is on a strictly cost reimbursable basis. The Contractor shall be authorized travel expenses OCONUS within

Tanzania consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract.

Regional, District and site levels for the DoD/WRAIR-

Tanzania-supported, PEPFAR

Programs

Costs for travel shall be billed in accordance with the regulatory implementation of Public Law 99-234 and FAR

31.205-46 Travel Costs, subject to local policy and procedures.

11.1. Travel Arrangements

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. The Contractor shall remain current on applicable regulations, policies, and procedures that may impact processes for travel and modify their processes accordingly. No later than 30 calendar days prior to scheduled travel date, the Contractor will prepare the estimate, which shall include airline ticket costs, car rental, per diem, and any other allowable costs associated with the travel request. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the government. The Government will not pay for economy plus, business class or first-class travel or items of personal preference. The COR will provide the Contractor approval of travel (via e-mail) before the Contractor is authorized to travel from one site in Tanzania to another site in Tanzania. All travel is

OCONUS and will be completed within Tanzania. There will be 16 trips for base period and 32 trips for each option period that consist of 7 days per trip. Estimated travel is indicated below:

Period From To Round

Trip

(Y/N)

# of

Trips

# of

People

Base Contractor’s operation base in Tanzania

DoD-WRAIR-supported facilities

Y 16 4

Option

Period 1

Contractor’s operation base in Tanzania

DoD-WRAIR-supported facilities

Y 32 4

Option

Period 2

Contractor’s operation base in Tanzania

DoD-WRAIR-supported facilities

Y 32 4

Option

Period 3

Contractor’s operation base in Tanzania

DoD-WRAIR-supported facilities

Y 32 4

Option

Period 4

Contractor’s operation base in Tanzania

DoD-WRAIR-supported facilities

Y 32 4

11.2. Travel Claim Procedures, Approval, and Reimbursement

Travel shall be reimbursed after the COR has determined fair and reasonable cost reimbursement IAW the JTR and FAR Part 31.205-46. The Contractor shall submit an estimate for travel to COR no later than 30 calendar days prior to the first day of travel; in order for the Contractor to obtain economical travel arrangement and cost.

The COR and WRAIR Activity Manager will verify the travel receipts are valid and match the travel requirements identified in the PWS. The Contractor shall provide a trip reports to include costs associated with the travel to the

COR within fifteen (15) calendar days after the completion of travel trip. All travel costs shall be billed within 30 days after travel is complete unless an approval for later billing is approved by COR or KO. All travel cost reimbursement requests must detail all authorized expenses associated with the travel and all receipts including ticket stubs (booked airline, hotel receipts, etc.) shall be provided to substantiate claims for costs of all expense items.

11.3. DOD Contractor Foreign Travel / OCONUS – Not Applicable

11.4. Estimated Other Direct Cost (Travel/Lodging/Per Diem/Taxi/Fuel/Vehicle Hire)

Period Estimated Cost (PLUG NUMBERS FOR QUOTE)

Base Period $181,608.00

Option Period 1 $381,376.80

Option Period 2 $400,445.64

Option Period 3 $420,467.92

Option Period 4 $402,281.61

12. GOVERNMENT FURNISHED PROPERTY – Not Applicable

13. CONTRACT MANAGEMENT

13.1. Government Management

The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer

(KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract.

Only the KO has the authority to enact changes to this award.

13.2. Contractor Management

The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact

(POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

13.3. Contractor Organization

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

13.4. Contractor Vacant Positions

The contractor shall fill vacant positions within sixty (60) business days. If contractor positions are vacant for more than thirty (60) days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

13.5. Subcontract management – Not Applicable

13.6. Foreign Nationals – Not Applicable

14. COMPLIANCE DOCUMENTS

14.1. General Compliance

14.1.1. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program.

http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-1, Information Technology.

http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

c) Army Regulation 25-2, Information Assurance.

d) Department of Defense (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24 January 2003.

15. OTHER TERMS, CONDITIONS, AND PROVISIONS

15.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition

Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the

Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

15.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

15.3. Inherently Governmental Functions

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

15.4. Acquisition Functions Closely Associated with Inherently Governmental Functions

Not applicable for this award

15.5. Organizational Conflict of Interest

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR

Subpart 9.5. These categories apply to all enterprise laboratories AFRIMS, USAMRD-A, and USAMRD-G.

These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating.

These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of

WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI exists.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information.

Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of

Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective

Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an OCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under

FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple

Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR services solicitation will therefore be designated as falling within one of the above defined categories. The applicable OCI category will be set forth in each award.

This requirement is categorized as ISOLATED SUPPORT.

Organizational and consulting conflicts of interest may arise by performing advisory or consulting support services. Organizational conflicts of interest include providing services or performing advisory or consulting work for private companies that participate or will participate in future services or contract activities

(solicitations and award). See FAR subpart 9.5.

The Contractor shall ensure that the Participation Agreement, either A and / or B as identified on each award, is signed by all staff assigned to or performing on each award before performing any work, including all subcontractors and consultants. The Participation Agreement shall be cosigned by a corporate official

(contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor and the COR will immediately initiate a CDR.

15.6. Invoices

The contractor shall submit invoices to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding the invoice and receiving report for payment to the COR. 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. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

15.7. Dissemination of Information/Publishing

There shall be no dissemination or publication of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting

Officer.

15.8. Contractor Identification

When contractor personnel perform the services required in this contract on a Government installation they are required to possess and wear an identification badge that displays his or her name and the name of the

Company. 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.

15.9. Attendance at Meetings

Contractor personnel may be required to attend meetings. Contractor personnel shall make their contractor status known during introductions.

15.10. Anti-Terrorism and Operational Security

15.10.1. AT Level I Training.

Not applicable for this contract

15.10.2. Installation Access.

Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation Embassy access requirements to be accomplished by the

Security Office.

Contractor workforce must comply with all personal identity verification requirements (CFR clause

52.204-9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the

Government may require changes in contractor security matters or processes.

15.10.3. For Contract Requiring Performance or Delivery in a Foreign Country.

Not applicable for this contract

15.11. Compliance with Relevant DoD, Service, and Institutional Policy Regulations.

The Contractor shall comply with HIPAA and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data and PHI. In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g. Public Affairs clearance and Operational Security clearance for dissemination).

15.12. Personally Identifiable Information (PII) and Protected Health Information (PHI)

The contractor shall comply with the DHA Procedures, and Information (PGI) 224 – Protection of Privacy and

Freedom of Information, revised 17 May 2015. The contractor may access PII in the course of task response to the requirements of this contract, as such the contractor shall comply with the document entitled “Personally

Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

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

Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFAR Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD

Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health

Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the

HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January

24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

IT services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C. (Reference (aa)), DoD 5400.11

(Reference (ab)) and DoD 5400.11-R (Reference (ac)). DoDI 5400.16 (Reference (ad)) established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title

44, U.S.C. (Reference (ae)).

15.13. Workplace Safety

The contractor employee must be able to maintain a safe workplace and comply with occupational health and safety rules and regulations. Contractor employees are required to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the COR immediately.

16. ATTACHMENTS

Attachment 1 – Acronyms List

Attachment 2 – Organizational Conflict of Interest

Attachment 3 – Participation Agreement

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition

AFARS Army Federal Acquisition Regulation Supplement

AFRIMS Armed Forces Research Institute of Medical Sciences

AKO Army Knowledge Online

AOR Area Of Responsibility

AT OPSEC Antiterrorism and Operational Security

ATCTS Army Training Certification Tracking System

CAC Common Access Card

CFR Code of Federal Regulations

CONUS Continental United States

COR Contracting Officer Representative

DFARS Defense Federal Acquisition Regulation Supplement

DoD Department of Defense

EIT Electronic and Information Technology

FAR Federal Acquisition Regulation

FBI Federal Bureau of Investigation

FPCON Force Protection Condition

FSC Federal Supply Code

FSS Federal Supply Schedule

GFE Government Furnished Equipment

GFI Government Furnished Information

GSA General Services Administration

IA Information Assurance

ID Identification

ID/IQ Indefinite Delivery / Indefinite Quantity

IPT Integrated Product/Process Team

IT Information Technology

NAC National Agency Check

NACI National Agency Check with Inquiries

NCIC-III National Crime Information Center Interstate Identification Index

NLT No Later Than

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States

OPSEC Operational Security

PMO Project Management Office

PRS Performance Requirements Summary

PWS Performance Work Statement

QASP Quality Assurance and Surveillance Plan

QCP Quality Control Plan

SOP Standing Operating Procedure

TARP Threat Awareness and Reporting Program

U.S.C. United States Code

UIC Unit Identification Code

US United States

USAMRAA United States Army Medical Research Acquisitions Activity

USAMRD-G United States Medical Research Directorate – Georgia

USAMRD-A United States Medical Research Directorate – Africa

WAWF Wide Area Work Flow

WRAIR Walter Reed Army Institute of Research

ATTACHMENT 2: ORGANIZATIONAL CONFLICT OF INTEREST

Walter Reed Army Institute of Research (WRAIR) Acquisition Operational Support

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart

9.5. These categories apply to all enterprise laboratories (Armed Forces Research Institute of Medical Sciences

(AFRIMS), United States Medical Research Directorate – Kenya (USAMRD-K), and United States Medical

Research Directorate – Georgia (USAMRD-G). These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating.

This services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of

WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area. An unfair competitive advantage exists where a contractor competing for award of any Federal contract possesses –

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that contractor in obtaining the contract.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent

OCI’s with respect to requirements in the other category and or may give rise to an CCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs;

and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award

Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under

Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR services solicitation will therefore be designated as falling within one of the above defined categories.

The applicable OCI category will be set forth in each task order. Contractors may submit a proposal for task orders in either of the OCI categories.

WRAIR will administer this clause for purposes of award eligibility for each solicitation as follows:

The offeror shall provide a listing of all contracts performed for the WRAIR and any enterprise laboratories

(USAMRD-G, USAMRD-A, and AFRIMS) as well as with other MRDC laboratories (i.e. U.S. Army Medical

Research Institute of Infectious Diseases (USAMRIID), U.S. Army Medical Materiel Development Activity

(USAMMDA), the Telemedicine and Advanced Technology Research Center (TATRC) or MRDC) in the last three

(3) years. A single-category Offeror/Contractor wishing to submit an offer in the other category, or any

Offeror/Contractor which now provides or previously has provided support in both categories, must include the following as part of its offer:

Perform a comparative analysis of the potential new work against all current and previous work performed in support of WRAIR in any category. The comparative analysis must be included in the proposal for the new work, and must include a statement certifying whether the Contractor believes that its performance of the proposed new work would create a real or apparent OCI. If the Contractor believes that no real or perceived OCI will result from an award of the proposed work, no additional action by the Contractor is required, unless the Contracting Officer specifically requests an OCI mitigation Plan.

If the Offeror/Contractor believes that a real or apparent OCI may exist as a result of an award, the

Contractor shall also submit an OCI Mitigation Plan with its proposal.

Inclusion of the comparative analysis and OCI Mitigation Plan will not be counted against any offer page limitations otherwise stated in the solicitation.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

It is the contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the

Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

Contractors shall sign a Non-Disclosure Agreement at the start of their performance on the contract.

If, under this contract, the contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer.