W81XWH17T0351Amendment1.pdf

COMBINED SYNOPSIS/SOLICITATION

1. Issue Date: 08/11/2017 Close Date: 09/13/2017 12:00 PM EST

2. Solicitation Number: W81XWH-17-T-0351

3. Requiring Activity: Walter Reed Army Institute of Research (WRAIR)

4. Contracting Office: US Army Medical Research Acquisition Activity (USAMRAA)

820 Chandler Street

Fort Detrick, MD 21702

5. Point of Contact: Sharew Hailu

(301) 619-9201 sharew.hailu.civ@mail.mil

6. Subject/Description:

This is a non-personal services contract to provide Laboratory Information Management System (LIMS), Consultant

Support to the Walter Reed Army Institute of Research.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart

12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

This combined synopsis/solicitation is issued as a request for proposal (RFP).

This solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular 2005-95.

This an Unrestricted procurement. The relevant NAICS code is 541519 with a small business size standard of $27.5M.

Questions should be addressed to Sharew Hailu at sharew.hailu.civ@mail.mil and are due no later than 12:00 p.m. EST on Monday, August 21, 2017. Answers will be posted via amendment. Questions will not be accepted by telephone.

It is preferred that quotations be sent electronically to sharew.hailu.civ@mail.mil.

Please include your DUNS Number and CAGE Code with your offer.

The resulting contract is expected to be firm-fixed-price.

mailto:sharew.hailu.civ@mail.mil mailto:sharew.hailu.civ@mail.mil mailto:sharew.hailu.civ@mail.mil

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job

WRAIR Assessment (GEIS)

FFP

Bacterial Diseases Branch (MRSN)

FOB: Destination

PURCHASE REQUEST NUMBER: 0011039703

NET AMT

0002 1 Job

WRAIR Assessment (Corporate)

FFP

Translational Medicine (Pilot Bioproduction Facility)

Military Malaria Research Program

Military HIV Research Program

Center for Military Psychiatry and Neurosciences

Viral Disease Branch

Entomology

Veterinary Services Program

0003 1 Job

WRAIR Assessment (OCONUS)

FFP

AFRIMS-Thailand

USAMRD-Kenya

USAMRD-Georgia

USAMRD-West

0004 1 Job OPTION USAMRIID Assessment

FFP

United States Army Medical Research Institute of Infectious Diseases

(USAMRIID)

AMOUNT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

0005 1 Job OPTION USAISR Assessment

FFP

United States Army Institute of Surgical Research (USAISR)

AMOUNT

OPTION USACEHR Assessment

FFP

United Staes Army Center for Environmental Health Research (USACEHR)

0007 1 Job OPTION USARIEM Assessment

FFP

United States Army Research Institute of Environmental Medicine (USARIEM)

0008 1 Job

WRAIR ODC - (GEIS)

FFP

Travel: Bacterial Diseases Branch (MRSN)

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE

0006 1 Job

0009 1 Job

WRAIR ODC - (Corporate)

FFP

Travel:

Translational Medicine - PBF

MMRP

MHRP

CMPNS

VDB

Entomology

VSP

0010 1 Job

WRAIR ODC (OCONUS)

FFP

Travel:

AFRIMS-Thailand

USAMRD-Kenya

USAMRD-Georgia

USAMRD-West

0011 1 Job

OPTION USAMRIID - ODC

FFP

Travel

0012 1 Job

OPTION USACEHR- ODC

FFP

0013 1 Job

OPTION USAISR - ODC

FFP

0014 1 Job

OPTION USARIEM - ODC

FFP

0015 1 Each

CMR

FFP

Contract Manpower Reporting

Peformance Work Statement

Contents

1. BACKGROUND

2. SCOPE

3. OBJECTIVES

4. PERIOD OF PERFORMANCE

5. TASKS

6. DELIVERABLES……………………………………………………………………………………………….5

7. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

8. TRANSITION SUPPORT

9. QUALITY CONTROL

10. KEY PERSONNEL

11. TRAVEL

12. GOVERNMENT FURNISHED ITEMS

13. WORK SCHEDULE AND LOCATION

15. COMPLIANCE DOCUMENTS

16. REFERENCE DOCUMENTS

17. OTHER TERMS, CONDITIONS, AND PROVISIONS

18. ATTACHMENTS

PERFORMANCE WORK STATEMENT (PWS)

Title: Laboratory Information Management System (LIMS), Consultant Support to the United States Army Medical

Research and Materiel Command (USAMRMC)

Requiring Activities Name: This is a collective requirement for USAMRMC headed by the Walter Reed Army

Institute of Research (WRAIR) along with its detachment and OCONUS laboratories. The requirement will also support the following activities: United States Army Medical Research Institute for Infectious Diseases

(USARMRIID), United States Army Institute for Surgical Research (USAISR), United States Army Center

Environmental Health Research (USACEHR), United States Army Research Institute for Environmental Medicine

(USARIEM).

1. BACKGROUND

The U.S. Army Medical Research and Materiel Command is the Army's medical materiel developer, with responsibility for medical research, development, and acquisition and medical logistics management. The

USAMRMC's expertise in these critical areas helps establish and maintain the capabilities the Army needs to fight and win on the battlefield. Ensuring our armed forces remain in optimal health and are equipped to protect themselves from disease and injury, particularly on the battlefield, is the job of the U.S. Army Medical

Research and Materiel Command. The Command is headquartered at Fort Detrick, MD, with 12 subordinate commands located throughout the world.

Six medical research laboratory commands execute the science and technology program to investigate medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense, and clinical and rehabilitative medicine (See Attachment 4 for a description of each research activity). The

Command manages a large extramural research program with numerous contracts, grants, and cooperative research and development agreements to provide additional science and technology capabilities from leading academic, private industry, and other government organizations. Six additional commands focus on medical materiel advanced development, strategic and operational medical logistics, and medical research and development contracting, to complete the full life cycle of medical materiel acquisition. The Command is staffed with highly qualified scientists, program managers, logisticians, contracting experts, and support personnel.

Because of MRMC’s research and collaboration diversity, implementation of a Laboratory Information

Management System (LIMS) and Electronic Laboratory Notebook (ELN) is necessary to remain competitive with the leading research industries, effectively streamline workflow and business practices, and to provide accurate and meaningful data back to research stakeholders and collaborators. Current approaches to data management are antiquated and error-prone. Additionally, implementation of a LIMS/ELN across the MRMC enterprise will enable researchers to store data in a useful manner, provide data continuity for rotating personnel, improve operational throughput, and improve overall quality assurance to those activities that require

FDA/CAP/CLIA regulatory oversight.

Market research has shown that commercial off the shelf (COTS) LIMS/ELN products exist that may satisfy

MRMC’s requirements. A thorough analysis of work processes and the development of user specific requirements is crucial in ensuring MRMC’s scientists are provided with a useful product. Therefore, in order to effectively and accurately select a LIMS/ELN that can best serve the unique needs of each research activity under the MRMC’s purview, an assessment by a vendor-neutral LIMS/ELN consultant is essential in highlighting and developing the functional, user, and business requirements necessary to procure a meaningful

LIMS/ELN solution.

2. SCOPE

This Performance Work Statement (PWS) describes the performance requirements for contractor services in support of the following MRMC research activities: The Walter Reed Army Institute of Research (WRAIR), United States Army Medical Research Institute for Infectious Diseases (USAMRIID), United States Army

Institute for Surgical Research (USAISR), United States Army Center for Environmental Health Research

(USACEHR), United States Army Research Institute for Environmental Medicine (USARIEM). Detachment laboratories and OCONUS laboratories will need to be assessed for the WRAIR. Their laboratories are located in Kenya (USAMRD-K), Georgia (USAMRD-G), Thailand (AFRIMS), and Joint Base Lewis-McCord, WA

(USAMRD-W). The MRMC and research activities require the assessment of research processes by a vendor neutral LIMS/ELN consultant with expert knowledge and experience in implementation of a configurable and expandable commercial off the shelf (COTS) web-based LIMS/ELN with features that support a modern research laboratory's operations.

3. OBJECTIVES

The objective of this effort is to provide MRMC research activities with a vendor neutral team of LIMS/ELN subject matter experts who have successfully deployed an enterprise wide LIMS/ELN solution within the

Department of Defense or Federal Government and who can provide technical and programmatic expertise and support to each MRMC research activity to, perform a gap analysis of current systems, develop project management plans, conduct market analysis studies and assessments for LIMS/ELN systems considered by

MRMC; analyze and support the development of functional, user and business requirements for the LIMS/ELN project, and the testing and evaluation of considered systems. The contractor shall provide MRMC with a list of available COTS LIMS/ELN products that will work on the existing DoD network and comply with DoD Risk

Management Framework (RMF) regulations as well as be expandable and configurable enough for other groups within MRMC to utilize in the future.

4. PERIOD OF PERFORMANCE

Base Period – 30 September 2017 – 29 March 2018

5. TASKS

The Contractor shall furnish the necessary services, personnel, and labor to perform the following:

5.1. Task 1 – Kick-Off Meeting

The contractor shall prepare for and attend a start-of-work meeting with the Government Contracting

Officer Representative (COR) and MRMC personnel (from all CONUS and OCONUS laboratories) within ten business days of contract award. The contractor shall support a final analysis of alternatives after validations to support COTS selection. As part of the analysis, the contractor shall identify COTS

LIMS/ELN products that satisfies MRMC’s identified requirements along with a detailed program plan that includes a work schedule and estimated cost of the anticipated The program plan shall include a personnel section that explains the personnel involved in executing the tasks and the activities required. A technical section shall explain the activities required to execute the task requirements and to maintain and sustain the normal laboratory functions. (Deliverable 1)

5.2. Task 2 – Laboratory Information Management System (LIMS)/Electronic Laboratory Notebook (ELN) –

The contractor shall perform gap analyses and a needs assessment including risk analysis of various alternatives.

5.2.1. On-Site LIMS/ELN Requirements Assessment – The contractor shall conduct a thorough

LIMS/ELN requirements assessment to fill in potential gaps in requirements documents provided by the Government which were developed through previous efforts. The assessment process will include site visits to the following MRMC Commands and Subordinate Directorates:

Table 1

Command &

Subordinate Directorates Location Department/Branch/Program for Assessment

WRAIR Silver Spring MD Bacterial Diseases Branch (MRSN)

Translational Medicine (Pilot Bioproduction

Facility)

Military Malaria Research Program

Military HIV Research Program

Center for Military Psychiatry and Neurosciences

Viral Disease Branch

Entomology

Veterinary Services Program

AFRIMS Bangkok, Thailand AFRIMS

USAMRD-K Kenyan cities of Nairobi, Kisumu, and Kericho

USAMRD-K

USAMRD-G Tbilisi, Republic of

Georgia

USAMRD-G

USAMRD-W Joint Base Lewis-McCord, Washington State

USAMRD-W

USAMRIID (Optional) Fort Detrick, MD USAMRIID

USACEHR (Optional) Fort Detrick, MD USACEHR

USARIEM (Optional) Natick, MA USARIEM

USAISR (Optional) San Antonio, TX USAISR

In addition to conducting assessments at representative laboratories, the contractor shall interview personnel from the eIT/PMO and G-6 offices located at Fort Detrick, MD. The contractor shall work with the laboratory staff, management, and users of the respective Commands’ analytical data to identify the requirements for a LIMS/ELN in the operating environment. Features to be considered will pertain to virtually every aspect of laboratory operations including planning, sample receiving and processing, work scheduling, analytical processes, quality control, data reporting, internal monitoring, control charting, etc. The contractor shall evaluate the operations and practices within each of the functional research programs, subordinate directorates, department/branch, and document each management practices into a LIMS/ELN Survey Analysis Report (Deliverable 2.)

5.2.2. Development and Analysis of As-Is and To-Be Workflows: The contractor shall capture the current state of the entire business context, upstream and downstream processes and roles, and the exact business problems/inefficiencies/limitations that are driving the need to change processes and/or implement a new technology solution. The contractor shall capture this data in an “as-is” summary document which will include high level work flow diagrams of key laboratory processes, interfaces with key systems and customers, inputs and outputs, etc. Additionally, the contractor shall identify opportunities where work processes can be optimized and standardization between common research groups can be applied. The contractor shall capture this data in a “to-be” workflow document. (Deliverable 3)

5.2.3. LIMS/ELN Market Analyses: The contractor shall develop and deliver a LIMS/ELN Vendor

Market Analysis Report utilizing user requirements developed during the assessment process. This report will match WRAIR’s requirements to the current COTS LIMS/ELN product market and individual LIMS/ELN vendor capabilities. The analysis shall provide the top LIMS/ELN products most closely matching WRAIR’s requirements. Software performance, integration capabilities, and previous experience with enterprise solutions will be assessed and a list of COTS LIMS/ELN products meeting the WRAIR’s objectives/requirements and the DoD’s RMF compliance shall be provided. (Deliverable 4).

5.2.4. Develop User Requirements Specifications (URS)-: The contractor shall develop a User

Requirements Specification document (Deliverable 5) that will enable testing the application for adherence to the requirements once it is configured for use. The URS is a comprehensive document that captures the requirements that support the laboratory’s ability to complete its work functions. It specifies what functions the user expects the LIMS/ELN to do.

5.2.5. Vendor Demonstration Scripts: The contractor shall provide vendor demonstration scripts based on the list of COTS LIMS/ELN vendors meeting WRAIR’s objectives/requirements. Demonstration

(data call and user testing) from potential LIMS/ELN software vendors will support collation of data submitted. The contractor will combine this data with the data from the market survey effort, and incorporate all data into a MRMC recommendations document along with the number of LIMS/ELN software licenses WRAIR will need to procure. (Deliverable 6)

5.2.6. Analysis of Alternatives: The contractor shall support a final analysis of alternatives after validations to support COTS selection. The analysis shall identify COTS LIMS/ELN products that satisfies MRMC’s identified requirements.

5.2.7. LIMS/ELN Project Reviews and Weekly Meetings Support: It is expected that a number of project reviews as well as weekly meetings will be conducted during the period of performance of this contract. The contractor shall support those meetings and reviews by arranging and presenting information created as part of the evaluation of Market Survey Reports or other investigations they may undertake as directed by the MRMC and/or COR. Meeting and review support shall include development of meetings agendas and meeting minutes and may include handouts, read-ahead packages or briefing slides as may be necessary to describe the work performed by the contractor. All meeting materials shall be delivered for Government review at least twenty –four (24) hours ahead of its associated meeting start time. All minutes shall be delivered no later than forty-eight (48) hours after conducting the meeting. Meeting support may be accomplished remotely or onsite as necessity dictates. (Deliverable 7)

5.2.8. Weekly Progress Reports: The contractor shall prepare and deliver written weekly progress reports and shall submit them no later than the Friday of each week. The weekly progress reports shall include task expenditures versus planned expenditures, technical progress made, schedule status, travel conducted, meetings attended, COR approved equipment/material procured, issues and recommendations. The weekly progress report shall be emailed to the COR in Microsoft Word or

Adobe PDF format.

5.2.9. Final Technical Comprehensive Report: The Contractor shall provide a final Technical Report

(Deliverable 8) documenting all work performed under this effort, including task background, purpose, objectives, assumptions, data collected, technology surveys, analyses conducted, the results of all analyses, summary of deliverables, lessons learned, and as appropriate, conclusions and recommendations.

6. DELIVERABLES

6.1. Delivery Address

All deliverables should be submitted to the COR designated in the COR appointment letter CORT System.

6.2. Method of Delivery

Electronic copies are to be delivered using Microsoft Office suite 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.

6.3. Government Acceptance Period

The COR will have ten (10) workdays to review draft deliverables and make comments. The Contractor shall have five (5) workdays to make corrections. Upon receipt of the final deliverables, the COR will have two (2) workdays for final review prior to acceptance or providing documented reasons for non-acceptance.

Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) work days the Government notifies the

Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in thirty (30) calendar days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted quote. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The

Contractor shall have five (5) workdays to correct the rejected deliverable and return it per delivery instructions.

6.4. Delivery Schedule Abbreviations

Abbreviation Definition

COR Contracting Officer's Representative

CS Contract Specialist

DA Days after

DACA Days after contract award (award of this order)

DAEOM Days after the end of the month

Days Calendar Days unless otherwise specified

DID Data Item Description

E Electronic Copy

H Hard Copy

NLT Not Later Than

PWS Ref Performance Work Statement Reference (paragraph number)

WDA Working Days After

6.5. Deliverable/Delivery Schedule:

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E), and/or hard copy (H).

Deliverables Table

PWS Ref Title Dist. E H Initial Subsequent

Deliverable 1 5.1 Kickoff

Meeting and

Program Plan

COR 1 Ten (10) business days after task award

Deliverable 2 5.2.1 LIMS/ELN

Survey

Analysis

Report

COR 1 NLT 60 days prior to contract end

NLT 30 days prior to contract end

Deliverable 3 5.2.2 Development and Analysis of

As-Is and To-

Be Workflows

COR

CS

1 NLT 60 days prior to contract end

NLT 30 days prior to contract end

Deliverable 4 5.2.3 LIMS/ELN

Vendor Market

Analysis

Report

COR 1 NLT 60 days prior to contract end

NLT 30 days prior to contract end

Deliverable 5 5.2.4 User

Requirements

Specification

COR 1 NLT 60 days prior to contract end

NLT 30 days prior to contract end

Deliverable 6 5.2.5 Vendor

Demonstration

Scripts

COR 1 NLT 60 days prior to contract end

NLT 30 days prior to contract end

Deliverable 7 5.2.7 Weekly

Progress

Reports

COR 1 Weekly

Deliverable 8 5.2.8 Technical

Report COR 1 NLT 60 days prior to contract end

NLT 30 days prior to contract end

Deliverable 9 Attachment Non- COR 1 1 Signed statements are due, from 5 Disclosure CS 1 1 each employee assigned, prior to

Agreement performing ANY work on this task.

Deliverable 16.13.14 SHARP COR 1 1 At the start of At the start of 10 CS 1 1 work the any new contract employee’s first day of work

6.6. 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.

6.7. 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 Work Statement and all terms and conditions of this order, including all modifications.

7. 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

Standard Acceptable Quality

Level Performance

Measurement Incentive

1 6.1 Provide accurate deliverables on time Deliver the deliverables on or before the due date

The contractor shall deliver the deliverables on time

100% of the time

Date deliverables are provided

Positive past performance grade, renewal of option period(s) 2 6.2 Meeting with

CONUS Labs Conduct preliminary meetings/interviews with all of the CONUS labs for all MRMC labs listed in this PWS within 10 days of contract award

The contractor will meet with all of the

CONUS labs 100% of the time

Review of report/weekly progress reports

Positive past performance grade, renewal of option period(s) 3 6.2 Meeting with

OCONUS Labs Conduct preliminary meetings/interviews with 4 of 4 of the

OCONUS labs within

10 days of contract award

The contractor will meet with 4 of 4

OCONUS labs 100% of the time

Review of report/weekly progress reports

Positive past performance grade, renewal of option period(s)

8. TRANSITION SUPPORT

8.1. Incoming Transition Plan

This is a new requirement and does not require an incoming transition plan.

9. QUALITY CONTROL

The contractor shall develop and maintain an effective Quality Control (QC) program which includes a documented Quality Control Plan (QCP) to ensure services are performed in accordance with this PWS. The

Contractor shall define a process that supports the execution of the tasks delineated in this contract and develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The program shall include method of surveillance, inspection, validation, evaluation, corrective action and procedures necessary to affect QC of all performance and products including those of sub-contractors and members of the contractor’s team. The QC program is the means by which the contractor assures their work complies with the requirement of the contract. After acceptance of the contractor’s QC program by the Government, the contractor shall require the Government’s acceptance in writing before making any proposed changes to the QC program.

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. Resumes shall be provided at least two weeks (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.

KEY PERSONNEL TABLE

Key Personnel Position Minimum Requirements

1. Senior LIMS/ELN

Consultant

a) See Attachment 3

11. TRAVEL

Worldwide contractor travel may be required for some tasks. Contractor will be authorized travel expenses consistent with the substantive provisions of the FAR Part 31 and the limitation of funds specified in this contract. All travel requires Government prior approval/authorization by the COR. The format below shall be used to convey estimated travel requirements:

Origin Destination Number of People

Traveling Number of Days

Traveling Washington, D.C. Kisumu, Kenya 1 5 Washington, D.C. Bangkok, Thailand 1 5 Washington, D.C. Tbilisi, Georgia 1 5 Washington, D.C. Takoma, Washington 1 5 Washington, D.C. San Antonio, TX 4 20 Washington, D.C. Natick, MA 4 20

Silver Spring, MD 8 10

Frederick, MD 4 20

12. GOVERNMENT FURNISHED ITEMS

The Government will provide the equipment/information/property shown below as Government Furnished

Equipment/Information/Property. Government Furnished Property includes: desks and telephones for support personnel onsite. Equipment issued at time of contract award will be annotated in a separate attachment. The

Government will provide any current local templates, SOPs, and policies. The Contractor shall maintain a detailed inventory accounting system for Government Furnished Equipment/Material. The inventory accounting system must specify, as a minimum: product description (make, model), Government tag number, date of receipt, name of recipient, location of receipt, current location, and contract/order number under which the equipment is being used. The Contractor shall attach an update inventory report to each Weekly Progress

Report (Deliverable 7) by the 15th of each month for the preceding month. The Contractor’s inventory listing must be available for Government review within one business day of COR request.

13. WORK SCHEDULE AND LOCATION

13.1. Federal Holidays

The following are Federal Holidays:

New Year’s Day

Birthday of Martin Luther King, Jr.

Washington’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving Day

Christmas Day

13.2. Work Schedule

The Contractor shall perform the functions and tasks under this PWS as defined by the COR. The normal hours of operation are from 0730-1600 (7:30 A.M. - 4:00 P.M.). Actual hours of operation may increase considerably for emergencies, unforeseen delays/problems, or increased customer workload. Hours may be adjusted with fourteen (14) days’ notice to the Contractor to accommodate changes in the customer support environment and peak work periods. Any overtime shall be approved in advance by the Contracting

Officer (KO).

13.3. Work Locations

Work on this task shall take place at Government offices CONUS/OCONUS. However, the main sites will be at the Walter Reed Army Institute of Research, in Silver Spring, Maryland and Fort Detrick in

Frederick, Maryland. Travel will be required to San Antonio, Texas (USAISR); Natick, Massachusetts

(USAREIM); Nairobi, Kisumu and Kericho, Kenya (USAMRD-K); Tbilisi, Georgia (USAMRD-G);

Bangkok, Thailand (AFRIMS), and Takoma, Washington (JBLM). Work will also be performed at the

Contractors location for report writing and information management.

14. TYPE OF CONTRACT

Firm-Fixed Price (FFP)

15. COMPLIANCE DOCUMENTS

15.1. General Compliance

15.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Material Command

(USAMRMC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The

International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

15.1.2. 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 http://www.dtic.mil/whs/directives/corres/dir.html

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) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011.

http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

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

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

g) Department of Defense (DOD) Instruction 8500.01 Cybersecurity

h) Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For

DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy

Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

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

j) 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

k) 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.

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

m) Clinical Laboratory Standards Institute. Standards and Guides for Laboratories:

http://clsi.org/standards

n) 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

o) 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

p) ICH Guideline for Good Clinical Practice, Consolidated Practice (E6) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html http://www.dtic.mil/whs/directives/corres/dir.html http://www.army.mil/usapa/epubs/340_Series_Collection_1.html http://www.army.mil/usapa/epubs/340_Series_Collection_1.html http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf http://www.cms.gov/Regulations-and-http://www.ecfr.gov/cgi-bin/text-http://www.dtic.mil/whs/directives/corres/pdf/64402m.pdf http://www.dtic.mil/whs/directives/corres/pdf/64402m.pdf http://www.cap.org/ http://clsi.org/standards http://clsi.org/standards http://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf

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

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

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

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

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

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

v) 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

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

x) 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_nu mber=1910

y) 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

z) 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

aa) Dangerous Goods Regulations of the International Air Transport Association.

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

bb) 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

15.2. Information Technology Compliance

15.2.1. Army Regulation 25-1, Information Technology

Compliance information regarding Army Information Technology may be found at:

15.2.2. Army Regulation 25-2, Information Assurance

Compliance information regarding Army Information Assurance may be found at:

https://ia.signal.army.mil/docs/AR25-2.pdf

15.2.3. Cyber-security

Department of Defense (DOD) Instruction 8500.01 Cybersecurity http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showF http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_nu http://www.gpo.gov/fdsys/granule/CFR-2007-title42-vol1/CFR-2007-http://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol2/pdf/CFR-2015-title49-vol2-sec173-http://www.iata.org/Pages/default.aspx http://www.iata.org/Pages/default.aspx http://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-

15.2.4. Risk Management Framework

Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD

Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program

15.3. Medical and Laboratory Compliance

15.3.1. Human Subjects

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The

International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

15.3.2. 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

15.3.3. 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

15.3.4. DOD Health Information Privacy

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

January 2003.

15.3.5. Research Integrity and Misconduct

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

15.3.6. 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

15.3.7. 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

15.3.8. 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.

15.3.9. Pathology Inspection

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

15.3.10. Laboratory Standards

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

15.3.11. 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

15.3.12. Clinical Laboratory Practice Standards

http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf http://www.army.mil/usapa/epubs/340_Series_Collection_1.html http://www.army.mil/usapa/epubs/340_Series_Collection_1.html http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf http://www.cms.gov/Regulations-and-http://www.ecfr.gov/cgi-bin/text-http://www.dtic.mil/whs/directives/corres/pdf/64402m.pdf http://www.dtic.mil/whs/directives/corres/pdf/64402m.pdf http://www.cap.org/ http://clsi.org/standards http://www.gpo.gov/fdsys/granule/CFR-2011-

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

15.3.13. Clinical Practice

ICH Guideline for Good Clinical Practice, Consolidated Practice (E6)

15.3.14. Clinical Practice

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

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

15.3.15. 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

15.3.16. 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

15.3.17. Institutional Review Boards

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

15.3.18. 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

15.3.19. 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

15.3.20. Protection of Human Subjects

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

15.3.21. 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 0

15.3.22. 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

15.3.23. 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

15.3.24. Dangerous Goods Regulations of the International Air Transport Association

Dangerous Goods Regulations of the International Air Transport Association.

15.3.25. Records Maintained on Individuals

Title 5, U.S.C section 5A, Records Maintained on Individuals http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/gclp.pdf http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=191 http://www.gpo.gov/fdsys/granule/CFR-2007-title42-vol1/CFR-2007-title42-vol1-sec72-3 http://www.gpo.gov/fdsys/pkg/CFR-2015-https://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-subchapII-sec552a/content-detail.html

16. REFERENCE DOCUMENTS

a) Department of Defense Directive 6485.01, Human Immunodeficiency Virus, June 7, 2013.

http://www.dtic.mil/whs/directives/corres/pdf/648501p.pdf

b) Department of Defense Instruction 6440.02, Clinical Laboratory Improvement Program (CLIP) Manual, May

29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/644002p.pdf

c) Department of Defense Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standard in D00D-Supported Research. http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

d) Army Regulation 600-110, Identification, Surveillance, and Administration of Personnel Infected with Human

Immunodeficiency Virus, 22 April 2014. http://www.apd.army.mil/pdffiles/r600_110.pdf

e) Army Regulation 40-501, Standards of Medical Fitness

f) US Medical Entrance Processing Command Regulation 40-1, Medical Processing and Examinations http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

g) US Medical Entrance Processing Command Regulation 40-8, Department of Defense (DOD) Human

Immunodeficiency Virus (HIV) Testing Program and Drug and Alcohol Testing (DAT) Program http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

17. OTHER TERMS, CONDITIONS, AND PROVISIONS

17.1. Non-Personal Services

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

17.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

17.3. Inherently Governmental Functions

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

17.4. Organizational Conflict of Interest

The Contractor shall complete and submit the Organizational Conflict of Interest (OCI) statement (Attachment 6) as part of the proposal documentation. The OCI statement for this contract is considered Global as services in this contract have a direct impact on the operations of the greater WRAIR enterprise.

17.5. Non-Disclosure Agreement

The Contractor shall ensure the Non-Disclosure Statement (Attachment 5) is signed by all staff assigned to, including all subcontractors and consultants, or performing on this requirement and adhere to the terms of that 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.

17.6. Invoices

http://www.gpo.gov/fdsys/granule/USCODE-2010-title5/USCODE-2010-title5-partI-chap5-subchapII-http://www.dtic.mil/whs/directives/corres/pdf/648501p.pdf http://www.dtic.mil/whs/directives/corres/pdf/648501p.pdf http://www.dtic.mil/whs/directives/corres/pdf/644002p.pdf http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf http://www.apd.army.mil/pdffiles/r600_110.pdf http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

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 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. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and

Acceptance application is the required method of submission.

17.7. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub

Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, 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. Business Program Management Office (PMO) approval for publication will require provisions that protect the intellectual property and patent rights of both

Business PMO and the Contractor.

17.8. 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.

17.9. Data Rights

The Government will retain rights to all data produced in the course of developing, deploying, training, using and supporting MRMC or other federal agencies that utilize this order.

17.10. Section 508 Requirement

The Contractor shall comply with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d). Specifically, the procurement, development, maintenance, or integration of electronic and information technology (EIT) under this contract must comply with the applicable accessibility standards issued by the Architectural and

Transportation Barriers Compliance Board at CFR part 1194.

17.11. 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 MRMC support 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); this 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 2017. Contractors may direct questions to the help desk at help desk at: http://www.ecmra.mill.

http://www.access-board.gov/sec508/508standards.htm http://www.ecmra.mil/ http://www.ecmra.mill/

Register under the "All Other Defense Components" module. The Walter Reed Institute of Research (WRAIR)

Unit Identification Code (UIC) is W03KAA, AFRIMS is W03K04, USAMRD-K is W03K08, USAMRD-G is

W03K07, USAMRD-W is W03K07. The Federal Supply Code (FSC) is R499.

17.12.