Attachment_1_-__PWS.pdf

Attachment 1

PERFORMANCE WORK STATEMENT

for

Clinical, Epidemiological, Administrative and Logistical Support Services

Armed Forces Research Institute of Medical Sciences (AFRIMS) Bangkok, Thailand

INTRODUCTION & BACKGROUND

SCOPE

PERIOD OF PERFORMANCE

WORK SCHEDULE AND LOCATION…………………………………………………………..4

PERFORMANCE REQUIRMENTS

QUALITY CONTROL

DELIVERABLES

OTHER DIRECT COSTS (ODCs)

QUALITY ASSURANCE SURVELLIANCE PLAN (QASP)

KEY PERSONNEL

TRAVEL

GOVERNMENT FURNISHED ITEMS

COMPLIANCE DOCUMENTS

CONTRACT MANAGEMENT

OTHER TERMS, CONDDITIONS, AND

PROVISIONS……………………….........................Error! Bookmark not defined.3

PERFORMANCE WORK STATEMENT (PWS)

Title: Clinical, Epidemiological, Administrative and Logistical support services

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Armed Forces Research Institute of Medical Sciences (AFRIMS).

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 two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

The mission of the Walter Reed Army Institute of Research (WRAIR) and its subordinate organization the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Bangkok, Thailand is to conduct and support biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers lifesaving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the war fighter. This is a requirement for research services in support of the AFRIMS division of WRAIR.

The United States Army Medical Directorate - Armed Forces Research Institute of Medical Sciences (USAMD- AFRIMS) is an overseas laboratory of the WRAIR. USAMD-AFRIMS maintains field stations in both Manila and Cebu, Philippines, known collectively as the Philippines - AFRIMS Virology Research Unit (PAVRU) which conducts biomedical research and surveillance in support of the WRAIR mission. PAVRU executes biomedical surveillance and research projects focusing on emerging infectious diseases of importance to the U.S. Army. These diseases include but not limited to dengue, influenza and zika.

Projects conducted by PAVRU are done in conjunction with several institutions native to the Philippines, including, but not limited to Chong Hua Hospital in Cebu and the V. Luna Medical Center of the Armed Forces of the Philippines in Manila. Projects range from prospective investigations for drug resistance to epidemiology studies and seroprevalence studies related to diseases of interest to the U.S. military.

3. SCOPE

The contractor shall provide clinical, epidemiological, administrative and logistical support for biomedical surveillance and research projects for emerging infectious diseases being conducted by PAVRU in the Philippines.

Supported research projects include but are not limited to “Sentinel human surveillance for influenza in the Philippines,” “Surveillance for Influenza and Other Emerging Acute Respiratory Infections in Patients Seeking Admission in Chong Hua Hospital in Cebu, Philippines,” “Febrile and Vector-Borne Illness Surveillance (FVBI) in the Philippines and “Acute and Chronic Infectious Diarrhea: Etiology, Pathogenesis, and Correlates of Clinical Outcome.”

4. PERIOD OF PERFORMANCE

The ESTIMATED periods of performance for this contract are as follows:

Base period 24 Sep 2018 – 25 Sep 2019 Option period 1 24 Sep 2019 – 25 Sep 2020 Option period 2 24 Sep 2020 – 25 Sep 2021 Option period 3 24 Sep 2021 – 25 Sep 2022 Option period 4 24 Sep 2022 – 25 Sep 2023

OPTION: FAR 52.217-8 “Option to Extend Services” “The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed six (6) months. The Contracting Officer may exercise the option by written notice to the Contractor within thirty (30) calendar days.”

In accordance with FAR 52.217-8, the vendor shall have the ability to provide continuation of these support services for up to a period of six (6) months after the period of performance end date.

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

Services will be performed at the hospitals and/or city health centers in Manila or Cebu, Philippines where the projects are being implemented.

5.2. Federal Holidays

5.2.1. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander. In addition, PAVRU has their own set of approved holidays, and as such, the contractors will follow that holiday schedule in addition to the list of Federal Holidays that are designated by Federal Status.

5.2.1.1. The Philippine government often declares national holidays (not listed below) at the very last moment and the site must sometimes give up a day that might be in the schedule and exchange it for another, because Philippine national law dictates there cannot be more than twenty (20) national holidays in one (1) calendar year.

5.2.2. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall be performed

The following are Federal Holidays from which the site selects no more than 20:

New Year’s Day Post New Year’s Day Chinese New Year Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day Arawng Kagitingan/Day of Valor

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Christmas Eve Maundy Thursday Good Friday

Eidul Fitr/End of Ramadan Ninoy Aquino Day National Heroes’ Day Pre-All Saint’s Day All Saint’s Day Bonifacio Day

Independence Day Substitute for Quezon City

Day (only in Manila) Eidul Adha/Feast of

Sacrifice All Soul’s Day

5.3. Work Schedule

The contractor normal/core duty hours are 0800 to 1700 local time Monday through Friday. Normal duty contractor work-week shall be forty (40) hours per week, eight (8) hours per day, however staggered shifts, may be required for some positions. Dependent upon mission requirements, work for some positions may consist of overlapping shifts that exceed 8 hours in duration (e.g., 12-hour shifts) and may occur at any time around the clock. Evening and weekend work may also be required. However, total hours shall not exceed 80 hours biweekly per contract employee. The Contractor shall not work Federal Holidays unless necessitated by mission requirements. The Contractor shall not be designated as “essential” and will not be required to work during post closures unless authorized by the COR and or KO.

5.3.1. Telecommuting

In accordance with FAR 7.108, Telecommuting shall not be discouraged by the Government/Contractor.

However, it is not feasible for the services provided under this requirement to be performed by way of telecommuting and therefore, all contract support shall be performed on-site.

5.4 Working During Emergency Situations/Contingency Operations Plan

The Contractor shall prepare a Contingency Operations Plan for the Government. Contingency operation plans shall be activated immediately after determining that an emergency has occurred, and 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 the grounds affected by the emergency. When any disruption of normal, daily operations occurs, the Contractor Manager shall promptly open an effective means of communication with the COR. Contingency Operations Plan shall include the following:

a. A description of the Contractor’s emergency management procedures and policy

b. A description of how the Contractor will account for their employees during an emergency

c. Planned temporary work locations or alternate facilities

d. How the Contractor will communicate with USAMRIID during emergencies

e. A list of primary and alternate Contractor points of contact, each with primary and alternate:

(1) Telephone/cell numbers

(2) E-mail addresses

f. Procedures for protecting Government furnished equipment (if any)

g. Procedures for safeguarding sensitive and/or classified Government information (if applicable)

The Contractor Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract.

Contractor shall not report to work on those days the Government controlled facility is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the WRAIR Commander or AFRIMS Director for any other reason. During these periods of closure, the contract employees who are not designated as “essential” in accordance with the contract, shall NOT report for work nor will they be compensated for those days. NO CONTRACT EMPLOYEE IS CONSIDERED “ESSENTIAL”

UNDER THIS CONTRACT.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives/Tasks

6.1.1. Contractor shall maintain files (electronic and hardcopy) for work products, associated reference material, and data for the duration of the contract. Develop, implement, and maintain a database of files accessible and reportable to the government (and government designees) relevant to PAVRU biomedical surveillance and research projects.

6.1.2. Contractor shall provide scientific/technical, administrative, logistical and laboratory support to PAVRU personnel in conducting biomedical surveillance and research projects. These activities include collection, processing, storage, and shipment of biological samples and data collected in the Philippines.

6.1.3. Contractor shall provide quarterly reports indicating the support provided to AFRIMS/PAVRU biomedical surveillance and research projects in the Philippines as outlined in this PWS (Deliverable 1).

6.1.4. Contractor shall collect specimens through biomedical research projects with approved protocols or as part of AFRIMS public health services.

6.1.5. Contract shall provide various administrative and accounting services including reimbursement of research study volunteers for attending study-related activities.

6.1.6. Contractor shall process payment for licensing and permits in accordance with local and legal requirements for the activities as well as specimens being collected, transferred and/or sent.

6.1.7. Contractor shall provide clinical research services as outlined in research protocols (e.g., informed consent procedures, clinical data collection, phlebotomy, lab studies) and other related functions as relevant to the execution of study protocols.

6.1.8. Coordinate and work with in country partners, detailed below:

Cebu City Health Department General Maxilom Ave Ext.

Cebu City 6000 Philippines WEBSITE: https://www.cebucity.gov.ph/index.php/calendar-of-activities/day.listevents/2008/11/25/16 POC: Dr. Alma S. Corpin EMAIL: almacorpin116@yahoo.com

PHONE: (+63 32) 415-5170

Chong Hua Hospital (CHH) Don Mariano Cui Street, Cebu City 6000 Philippines WEBSITE: http://www.chonghua.com.ph/ POC: Dr. Mary Noreen Cabalfin-Chua EMAIL: mncchuamd@gmail.com

PHONE: (+63 32) 255-8000

Armed Forces of the Philippines Health Service Command (AFPHSC) – Victoriano Luna Medical Center (VLMC) Barangay Pinyahan, V. Luna Avenue, Quezon City 1100 Metro Manila, Philippines No Website Available POC: MAJ Cynthia U. Liao MC

EMAIL: inchay2000@yahoo.com

PHONE: (+63 2) 273-3342/ (+63 922) 834-3467

6.2. Management Reports and Plans

6.2.1. Quarterly Report (Deliverable 1). The contractor shall provide a quarterly report detailing all tasks, including the subcontractor’s work, completed and in process. The quarterly report shall include, at a minimum, the following:

- Workload accomplished (i.e. the number of biological specimens and data collected and shipped/sent to AFRIMS in support of biomedical research and surveillance projects conducted in conjunction with AFRIMS in the Philippines)

- Biological samples in tabular format with the number of samples reflecting the relative incidence of infections compared to previous years

- Project milestones that conform with the approved human subjects research protocols.

- A list of Other Direct Costs (ODCs) purchased, date of purchase, WAWF invoice number, price, and quantity of each

6.2.2. Quality Control Plan (Deliverable 2). The contractor shall provide a Quality Control Plan (QCP) no later than 30 business days after contract award for COR approval. 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 Quality Assurance Surveillance Plan (QASP) and timely receipt of deliverables. 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 customer satisfaction.

6.2.3. Contract Manpower Reporting Application (CMRA) (Deliverable 3). This is a mandatory requirement in accordance with Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the AFRIMS via 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 2018. Contractors may direct questions to the help desk at: http://www.ecmra.mil/.

6.2.4. Training (Deliverable 4). Contractor shall complete on-line Human Subjects Protection training.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below.

DELIVERABLES TABLE

PWS

Ref.

Number Title/Description Due

Distribution:

6.2 Deliverable 1 Quarterly Reports 5th of each quarter (i.e. Mar 5th, Jun

5th, Sep 5th, and Dec 5th)

COR

6.2 Deliverable 2 Quality Control Plan 30 business days after date of contract

COR and Contracting

Officer

6.2 Deliverable 3 Contract Manpower Reporting

Application

The contractor shall complete and deliver the CMRA.

31 Oct annually http://www.ecmra.mil email confirmation to COR and Contracting Officer

6.2 Deliverable 4 Training Certificates Upon completion for each applicable contract employee

COR and Contracting

Officer

N/A Deliverable 5 Copies of current Licensures, Credentials, Prior to any work performed. COR and Contracting

Officer

N/A Deliverable 6 Letter of Intent AND resume for

Key Personnel (i.e. Principal

Investigator)

With proposal submission COR and Contracting

Officer

14.1.1. Deliverable 7 A copy of the Assurance of

Compliance and/or IRB approval

(obtain from Office of Research

Protection (ORP)), for work under the Performance Work Statement

Immediately upon ORP approval is completed.

COR and Contracting

Officer

6.3. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the FAR clause 2.101, “Definitions.” 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. (Reference Sections 5.4 and 6.2).

6.4. Inspection and Acceptance

The COR delegated 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. OTHER DIRECT COSTS (ODCs)

7.1. ODCs shall be billed on a cost reimbursable basis. Costs are defined as the purchase price of materials or service plus General and Administrative (G&A) charges or material and handling charges (M&H).

7.2. All ODCs shall be fully supported in compliance with all competition requirements of the FAR part 6.

7.3. All ODCs shall be reported in the Quarterly Progress Report (reference Section 6.2)

Estimated ODCs are as follows:

Description Quantity

ODC (Training/Meeting Cost) $40.00/Year

ODC (Office Supplies) $1,000.00/Year

ODC (Laboratory testing) $12,500.00/Year

ODC (Clinical Supplies) $1,000.00/Year

ODC (Ethics Review Fees) $420.00/Year

ODC (Administrative costs) $1,000.00/Year

ODC (Volunteer Compensation) Base Yr:

Op Yr 1:

Op Yr 2:

Op Yr 3:

Op Yr 4:

TOTAL:

$10,800.00 $11,100.00 $11,400.00 $11,400.00 $12,000.00 $56,700.00

TOTAL ODCs: $136,500.00

8. 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 by the COR 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 and the contractor with a proactive way to avoid unacceptable or deficient performance. The QASP will be finalized immediately following award and a copy provided to the Contractor. The QASP is a living document and may be updated by the Government as necessary.

9. KEY PERSONNEL

Principal Investigator (PI)

10. TRAVEL/TEMPORY DUTY (TDY)

Not applicable for this requirement.

11. GOVERNMENT FURNISHED PROPERTY

Not applicable for this requirement.

12. CONTRACT MANAGEMENT

12.1. Government Management

The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will provide technical direction only, receive deliverables, review/approve invoices, and complete monthly Contractor performances assessments. The COR does NOT have the authority to obligate money, supervise the contractor, and/or make contract changes and/or modifications. Only the USAMRAA Contracting Officer has the authority to obligate funds and make changes to the contract.

12.2. Contractor Management

The contractor shall designate a single Program/Contract Manager to be the contract’s authorized point of contact (POC) with the COR and KO. The Program/Contract Manager shall be responsible for formulating and enforcing performance standards, assigning contractor schedules, verify licensures and credentials are current and remain current throughout contract performance, completion of required training, completion and implementation of Contingency Operations Plan, timely submission of ALL deliverables, reviewing performance quality, communicating policies, purposes, and goals to contract employees. This will include coordination with the KO and the COR to resolve issues and/or proposed changes or modifications to the contract.

12.3. 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.

12.4. Contractor Vacant Positions

Contractor shall fill positions within 45 calendar days from official notification of a vacancy and/or a new requirement by the Contracting Office (USAMRAA) unless an exception is provided by the Contracting Officer.

Key Personnel - Substitutions or replacement of proposed Key Personnel shall not be allowed for a period of six

(6) months after contract award, except under extreme circumstances. Any substitutions or replacement of Key Personnel shall have qualifications equal to or greater than the qualification of the vacant position. For substitutions or replacement of Key Personnel, the Contractor shall provide a resume for proposed personnel to the COR. Contractor personnel must submit all required documentation (i.e. licensure/credentials, etc.) prior to contract performance. Resumes shall be provided at least 15 calendar days (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Substitution and/or replacement of Key personnel shall be fulfilled within 45 calendar days of exiting contract employee.

NON-Key Personnel - Substitutions or replacement of proposed NON-Key Personnel shall not be allowed for a period of six (6) months after contract award, except under extreme circumstances. Any substitutions or replacement of NON-Key Personnel shall have qualifications equal to or greater than required for vacant position. Contractor personnel must submit all required documentation (i.e. licensure/ credentials, etc.) prior to contract personnel performance. Substitution and/or replacement of NON-Key personnel shall be fulfilled within 45 calendar days of exiting contract employee.

12.5. Subcontract management

12.5.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

12.5.2. The contractor is responsible and accountable for subcontractor performance on this contract

12.5.3. The contractor is responsible to manage task distribution to ensure there are no Occupational

Conflict of Interest to be considered

12.5.4. Contractor my add subcontractors to their team after notification and written approval from the

KO.

12.5.5. Privy of contract is with the contractor and the subcontractor.

13. COMPLIANCE DOCUMENTS

13.1. Human Research Protections

13.1.1. Research Involving Human Subjects (Deliverable 7)

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 USC. 980, and, when applicable, FDA policies and regulations.

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 (c)(1) or (c)(2) have been met:

a) The Contractor shall furnishes a copy of the assurance of compliance and/or IRB approval (obtain from Office of Research Protection (ORP)), for work under the Performance Work Statement as well as confirmation that ORP has reviewed the protocol and accepted the IRB approval for compliance with the DoD component policies. The Contractor shall notify the KO immediately of any suspensions or terminations of the assurance (Deliverable 7).

b) (2) The Contractor furnishes to the ORP, with a copy to the KO, a determination that the human research proposed meets exemption criteria in 32 CFR 219.101(b) and receives written notification from the KO 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 ORP retains final judgment on what research activities or classes of research are covered or are exempt under the contract.

c) The Contractor shall adhere to all applicable DoD regulations pertaining to Human Subjects Protection and Ethical Standards. Specifically, 32 Code of Federal Regulations (CFR) 219, National Defense, Protection of Human Subjects; Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011; Army Regulation (AR) 70-25 (under revision): Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990. Applicable US CFR regulations are: Title 21, CFR Part 50 Protection of Human Subjects, Title 21 CFR Part 56, Institutional Review Boards; Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014; Title 32 CFR Part 219, Protection of Human Subjects; Title 45 CFR 46, Protection of Human Subjects, April 1, 2014.

13.2. Medical and Laboratory Compliance

13.2.1. Army Regulation 340-21, Army Privacy Program

Compliance information regarding Army Privacy program may be found at:

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

13.2.2. Protection of Human Subjects

Compliance information regarding Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011, may be found at: http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

13.2.3. DOD Health Information Privacy

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

13.2.4. Research Integrity and Misconduct

DOD Instruction 3210.7, Research Integrity and Misconduct, 14 May 2004.

13.2.5. Volunteers as Subjects of Research

Army Regulation (AR) 70-25: Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990 – currently under revision

13.2.6. Clinical Laboratory Improvement

Clinical Laboratory Improvement Amendments, 2013. https://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/CLIA_Regulations_and_Federal_Register_Documents.html. Specific guidance: http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5

13.2.7. Clinical Laboratory Improvement Program

Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014.

http://www.dtic.mil/whs/directives/corres/pdf/64402m.pdf (this document is codified Title 42 Part 493 under Memorandum of Agreement between the US Department of Defense and Health and Human Services.

13.2.8. Pathology Inspection

College of American Pathologists Inspection Checklists. http://www.cap.org

13.2.9. Laboratory Standards

Clinical Laboratory Standards Institute. Standards and Guides for Laboratories: http://clsi.org/standards

13.2.10. Laboratory Requirements

Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html

13.2.11. Clinical Laboratory Practice Standards

National Institutes of Allergy and Infectious Diseases, DAIDS Guidelines for Good Clinical Laboratory Practice Standards, https://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf

13.2.12. Clinical Practice

ICH Guideline for Good Clinical Practice, Consolidated Practice (E6) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

13.2.13. Clinical Practice

Title 21, CFR Part 11 Electronic Records: Electronic Signature.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

13.2.14. Clinical Practice

Title 21, CFR Part 50 Protection of Human Subjects https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1

13.2.15. Financial Disclosure by Clinical Investigators

Title 21 CFR Part 54 Financial Disclosure by Clinical Investigators https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

13.2.16. Institutional Review Boards

Title 21 CFR Part 56, Institutional Review Boards https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56

13.2.17. Investigational Device Exemptions

Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812

13.2.18. National Defense, Protection of Human Subjects

Title 32 CFR Part 219, National Defense, Protection of Human Subjects, http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title32/32cfr219_main_02.tpl

13.2.19. Protection of Human Subjects

Title 45 CFR 46, Protection of Human Subjects, April 1, 2014, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#

13.2.20. Bloodborne Pathogens

Title 29 Part 1910.1030 Bloodborne Pathogens; 1910.1200, Hazard Communication; 1910.132 Personal Protective Equipment https://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=191

13.2.21. Transportation of Materials Containing Certain Etiologic Agents Title 42 CFR 72.3 Transportation of Materials Containing Certain Etiologic Agents; Minimum Packaging Requirements. https://www.gpo.gov/fdsys/granule/CFR-2007-title42-vol1/CFR-2007-title42-vol1-sec72-3

13.2.22. Category B Infectious Substances

Title 49 CFR Part 173.199 Category B Infectious Substances https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol2/pdf/CFR-2015-title49-vol2-sec173-199.pdf

13.2.23. Dangerous Goods Regulations of the International Air Transport Association Dangerous Goods Regulations of the International Air Transport Association.

http://www.iata.org/Pages/default.aspx

13.2.24. Records Maintained on Individuals

Title 5, U.S.C section 5A, Records Maintained on Individuals https://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-subchapII-sec552a/content-detail.html

14. OTHER TERMS, CONDITIONS, AND PROVISIONS

14.1. 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.

14.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

14.3. Inherently Governmental Functions

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

14.4. Acquisition Functions Closely Associated with Inherently Governmental Functions

This award identifies acquisition functions that are closely associated with inherently governmental functions as defined in Section 804 of the FY 2005 National Defense Authorizations Act. Appropriate military or civilian personnel of the Department of Defense cannot reasonably be made available to perform these functions.

However, appropriate military or civilian personnel of the Department of Defense will: (1) oversee Contractor performance of the contract; and (2) perform all inherently governmental functions associated with the functions to be performed under this contract.

14.5. Invoices

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

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information (i.e. receipts) to receiving reports for Other Direct Costs (ODCs). Backup information for ODCs shall list all elements of costs, such as item of purchase, quantity, date of purchase, number of volunteers, payment per volunteer, etc.

Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

Where applicable, contractor will include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.

14.6. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any subcontractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this requirement or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

14.7. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

The contractor shall maintain an OSHA 300a log for all reportable (greater than first aid, lost time, lost days, transfer). The contractor shall provide a quarterly report of all mishaps, regardless of class or reportability.

Annually, the contractor shall provide a 300A (summary) report to the COR and KO.

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 Information

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 Thank OCI Organizational Conflict of Interest

OCONUS Outside Continental United States OPSEC Operational Security PAVRU Philippines - AFRIMS Virology Research Unit

PMO Project Management Office PRS Performance Requirements Summary PWS Performance Work Statement

QASP Quality Assurance and Surveillance Plan QCP Quality Control Plan

SHARP Sexual Assault Prevention and Response Program SOP Standing Operating Procedure

TARP Threat Awareness and Reporting Program U.S.C. United States Code UIC Unit Identification Code US United States

USAMD-

AFRIMS

United States Army Medical Directorate - Armed Forces Research Institute of Medical Sciences (USAMD-AFRIMS)

USAMRAA United States Army Medical Research Acquisitions Activity USAMRD-G United States Medical Research Directorate – Georgia USAMRD-K United States Medical Research Directorate – Kenya

WAWF Wide Area Work Flow WRAIR Walter Reed Army Institute of Research