PWS_BiostatisticsW81XWH18Q0243.pdf

PERFORMANCE WORK STATEMENT (PWS)

Title: WRAIR Biostatistician Research and Analysis

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

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense (DoD) 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 DoD. Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

2. PURPOSE AND BACKGROUND

The purpose of this requirement is to provide the personnel, management support and other items necessary to provide bio-statistician research and analysis to the WRAIR.

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.

3. SCOPE

The primary objective of this contract is to provide bio-statistical consultation, data analysis, and interpretation of results and statistical methods. The Contractor shall provide:

• Interpretation of results

• Manuscript and grant preparation

• Statistical aspects of study design

• Choosing statistical methods

• Multivariable modeling

• Other statistical analyses

• Sample size planning

• General biological data mining

• Statistical analysis for results reporting

• Database consultation and generation

4. PERIOD OF PERFORMANCE

September 30, 2018 – September 29, 2023, or when the total aggregate BPA Call amount is reached, whichever occurs first

5. WORK SCHEDULE AND LOCATION

5.1. Work Schedule

The Contractor shall provide support during normal work hours (6:30 a.m.-6:30 p.m. (EST)); Monday through Friday. 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.

5.2. Work Location

The contractor shall perform this work both at the contractor’s office location(s) and at the WRAIR government site at:

WRAIR

503 Robert Grant Ave Silver Springs, MD 20910 Hours of operation: Monday – Friday, 0700 – 1700

The Government, when required, will provide access to Government controlled facilities, equipment, and materials for daily business use of staff. This shall include office space, desk, telephone, chair, computer, shared printer, and requisite consumable materials.

5.2.1. 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 Managers 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 base closures, the Contractor Manager shall promptly open an effective means of communication with the 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 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. 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 Installation Commander 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 nor will they be compensated for those days.

5.3. Federal Holidays

5.3.1. The contractor shall not perform services on days designated as a Federal Holiday by

Federal Status, Executive Order, Presidential Proclamation or Installation Commander

5.3.2. 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 not be performed

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

5.4. Post Closure

All non-mission essential contract employees shall not report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation. During these periods of closure, the mission essential contractor personnel shall report for work.

5.5. Labor Categories:

The Government anticipates Call Order periods of performance to be from as little as one week to as much as several months. The estimated level of effort for required biostatisticians will vary per Call Order depending upon project complexity and number of projects. Varying levels of the complexity of requirements will determine the level(s) of biostatistician required.

Suggested Labor Categories:

Biostatistician I Conducts statistical studies to generate data and insights used to innovate, plan and support improved healthcare outcomes and processes. Prepares analysis plans to ensure the best statistical methods are developed and utilized. Writes specifications for files, consistency checks, tables, and calculations used to collect and analyzes data from a variety of sources.

Interprets analyses and prepares exhibits for reports and presentations. Interfaces with non-technical users to assist with data interpretation and understanding of results. Proficient with statistical computer applications like SAS and R. A master's degree (recommended) of biostatistics, statistics, mathematics or related field. Typically reports to a supervisor or manager. Works on projects/matters of limited complexity in a support role. Work is closely managed. Typically requires 0-2 years of related experience.

Biostatistician II Conducts statistical studies to generate data and insights used to innovate, plan and support improved healthcare outcomes and processes. Prepares analysis plans to ensure the best statistical methods are developed and utilized. Writes specifications for files, consistency checks, tables, and calculations used to collect and analyzes data from a variety of sources.

Interprets analyses and prepares exhibits for reports and presentations. Interfaces with non-technical users to assist with data interpretation and understanding of results. Proficient with statistical computer applications like SAS and R. A master's degree (recommended) of biostatistics, statistics, mathematics or related field. Typically reports to a manager or head of a unit/department. Gaining exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work. Typically requires 2 to 4 years of related experience.

Biostatistician III Conducts statistical studies to generate data and insights used to innovate, plan and support improved healthcare outcomes and processes. Prepares analysis plans to ensure the best statistical methods are developed and utilized. Writes specifications for files, consistency checks, tables, and calculations used to collect and analyzes data from a variety of sources.

Interprets analyses and prepares exhibits for reports and presentations. Interfaces with non technical users to assist with data interpretation and understanding of results. Proficient with statistical computer applications like SAS and R. A master's degree (recommended) of biostatistics, statistics, mathematics or related field. Typically reports to a manager or head of a unit/department. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. Typically requires 4 to 7 years of related experience.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

The objective of this contract is to provide biostatistician services on an as-needed basis for WRAIR to support various research projects.

6.2. Specific Tasks / Requirements

6.2.1. Biostatistician Research Services:

The Contractor shall assist in the conduct of clinical research studies with experimental medical products under the principles of current Good Clinical Practices (cGCP), Good Laboratory Practices (cGLP), and Good Manufacturing Practices (cGMP). All of the work for this research must be performed in accordance with the Federal, DoD, and Command laws, regulations, and policies.

Clinical research studies require production of experimental products, conduct of research studies, laboratory analysis of samples, analysis of resulting data, and submission of study findings. The Contractor shall:

6.2.1.1. Provide statistics and biostatistics leadership for clinical trials.

6.2.1.2. Provide technical assistance to the staff, including assisting staff with design or analysis tasks and/or jointly meeting with clients seeking statistical and computing services.

6.2.1.3. Assist in the development of the statistical portion of human protocols. Calculate the appropriate number of subjects needed for varying levels of statistical power. Make recommendations on statistical power calculations to investigators.

6.2.1.4. Provide expert consultation in the development of a statistical analysis plan (SAP) to meet the objectives of the protocol.

6.2.1.5. Provide clear oral and written advice in English with regard to statistical procedures.

6.2.1.6. Provide clearly written technical edits that improve statistical aspects of documents, such as research protocols or manuscripts.

6.2.1.7. Draft clearly written data, statistical design, sample size, and analysis sections for documents such as research protocols or manuscripts from clients.

6.2.1.8. Co-author scientific/technical manuscripts.

6.2.1.9. Assist in the development, analysis, or review of formal protocols subject to national and international regulations.

6.2.1.10. Document critical reviews at an appropriate level for the intended audience. Reviews are conducted for manuscripts and publications written by others with regard to good statistical practices.

6.2.1.11. Produce products free of obvious errors and consistent with statistical methods published in peer reviewed literatures. In all cases, reports, statistical algorithms, computer programs and data used to generate results shall be provided in digital formats.

6.2.1.12. Call Orders may consist of, but are not limited to:

• Sample size estimation, calculations of effect size and power, & written justifications of same for use in IACUC protocols (as well as signing approval of IACUC protocol) o 3-5 per Call Order

• Consultation and open communication regarding experimental design and data analysis considerations and statistical interpretations o Up to 20 consultations of various degrees of consultation.

• Stochastic and deterministic epidemiological and clinical models.

o Up to 3-5 per Call Order

• Test for differences among groups, or relative to a control/mock/placebo group, using parametric and non-parametric analyses o Up to 20 study or project based with multiple data

• Correlations, regressions, and other relatedness assessments of various data in pursuit of biomarkers, correlates, etc., including PCA and tSNE\ o Up to 10 per Call Order

• Assistance with / production of publication-ready graphical representation of data, particularly in the case of PCA, tSNE, heat map, and other similarly cumbersome data sets o Up to 10 per Call Order

• Analysis of significance among extremely large data sets, i.e., RNAseq, including necessary corrections, transformations, and post-hoc analyses o Up to 5 per Call Order

6.2.1.13. The Contractor shall provide the appropriate level biostatistician support personnel within

10 business days of receipt of the Governments call order.

7. Contract Management Activities

7.1. Management Reports and Plans

The Contractor shall ensure that a Monthly Progress Report (MPR) (Deliverable 2) is submitted outlining the expenditures, billings, progress, status, and any problems/ issues encountered in the performance of this contract. The MPR shall include but not be limited to:

• Activities completed in reporting period

• Activities anticipated for the next reporting period

• New and ongoing issues/ problems

• Identified risks and mitigation

• Sub-contractor Expenditures (see section 13.4)

• Any government action needed

• Government furnished equipment issued during the reporting period. Government shall provide a format for the GFE list required

• Labor hours expended, by labor category for each task/sub-task

• Monthly Performance Metrics

• Lessons learned

• Trip Report (See Section 11.2)

• A separate section for optional Contract Line Item Numbers (CLINs) exercised for surge support with the same information as discussed above

Quality Control Plan The contractor shall provide a draft Quality Control Plan (QCP) no later than 15 days after contract award. (Deliverable 4) 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 customer satisfaction.

Contract Manpower Reporting Application (CMRA) (Deliverable 3).

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the WRAIR via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

The contractor shall register under the "All Other Defense Components" module. The WRAIR Unit Identification Code (UIC) is W03KAA.

Delivery Order Procedures: The majority of the Call Orders will be placed by WRAIR utilizing a Government Purchase Card (GPC). However, the Contracting Activity reserves the right to write Call Orders from the BPA. All BPA’s will support Orders that are awarded by agencies within The Department of Defense Medical Community.

8. 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.

8.1. Delivery Address

All deliverables shall be submitted to the COR designated in the COR appointment letter CORT system.

http://www.ecmra.mil/ http://www.ecmra.mil/

8.2. Method of Delivery

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

8.3. Shipping:

The Contractor will use the U.S. Postal Service standard delivery for delivery of materials, equipment, or required hardcopy documents. The COR must approve all exceptions to this requirement. The Contractor shall deliver all deliverables to the Contracting Officer’s Representative at 503 Robert Grant Avenue, Silver Spring, MD 20910-7500.

8.4. Government Acceptance

The COR delegated oversight of specific technical, functional and oversight responsibilities 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.

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.

8.5. Delivery Schedule Abbreviations

Abbreviation Definition

COR Contracting Officer's Representative for the Task order

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

8.6. 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).

Deliverable # PWS Ref Title Dist. E H Initial Subsequent

Deliverable 1 Attachment

Non-Disclosure Agreement

COR

CS

Signed statements are due, from each employee assigned, prior to performing ANY work on this task.

Deliverable 2 7.1 Monthly Progress Report

COR 1 NLT 45

DACA

NLT 15th of each month

Deliverable 3 7.1 CMRA COR 1 1 By October 31 or on the last day of contract performance – whichever is first.

Annually

Deliverable 4 7.1 QCP COR 1 NLT 45

DACA

As needed

Deliverable # PWS Ref Title Dist. E H Initial Subsequent

Deliverable 5 9.1 Outgoing Transition Plan

COR 1 NLT 45 prior to contract end

As needed

Deliverable 6 Reports COR 1 TBD per Call Order

Deliverable 7 16.12 Sexual Assault or Sexual Harassment Reporting

COR 1 1 Conditional Deliverable due only in the event of an incident

Conditional Deliverable due only in the event of an incident

Deliverable 8 16.12 Sexual Assault and Harassment Training Completion Reporting

COR 1 1 60 days after contractor personnel begin performance under this contract

Annually

Deliverable 9 16.13 ISP Training COR 1 1 60 days after contractor personnel begin performance under this contract

Annually

Deliverable

16.11.13 TARP Training COR 1 1 60 days after

contractor personnel begin performance under this contract

Annually

Deliverable

16.14 HIPAA Training COR 1 1 60 days after

contractor personnel begin performance under this contract

Annually

8.7. 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 applicable FAR clause 52.227-14, Rights in Data. 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.

Contractor Performance Assessment Reporting System (CPARS). CPARS is the DoD mandatory system to electronically capture assessment data and manage the evaluation process. CPARS is used to assesses a Contractor’s performance and provide a record, both positive and negative, on a given contract during a specific period of time. The CPARS process is designed with a series of checks and balances to facilitate the objective and consistent evaluation of Contractor performance. Both Government and Contractor program management perspectives are captured on the CPAR form and together make a complete CPAR. Once the Assessing Official completes the proposed assessment for the period of performance, the CPARS is released to the appropriate Government Contractor Representative for their review and comments. User ID and password will be provided to the designated Government Contractor Representative upon issuance of a call order. The Contractor has 30 days after the Government's evaluation is completed to comment on the evaluation. The Government Contractor Representative must either concur or non-concur to each CPAR. If the Contractor concurs with the proposed assessment and the Reviewing Official does not wish to see the CPAR, the Assessing Official may close out the CPAR. Otherwise, they must forward the CPAR to the Reviewing Official for them to review, enter comments if appropriate, and close out. The Reviewing Official may at their option direct the Assessing Official to forward every CPAR to them for review.

8.8. COR Information

The COR for the contract is a Government official who has been delegated specific technical, functional and oversight responsibilities for this contract. The COR is identified in the COR appointment letter, issued by the Contracting Officer, and will serve as the Government’s primary technical point of contact for all contract activities and issues. The COR will manage the contract on a day-to-day basis, will review Contractor performance and deliverables, and will receive and review all Contractor invoices.

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

# Task Performance Objective Acceptable Quality Level

Method of Surveillance Incentive

1 8.0 Provide accurate deliverables, on-time

95% of deliverables will be delivered accurately and on-time

Date deliverables are provided

Positive CPARS review, renewal of option period(s)

2 7.1 Invoices and MPRs are submitted timely and accurately

95% of invoices and MPRs submitted accurately and on-time

Date submitted Positive CPARS review, renewal of option period

3 16.5, Attachment 1 / Attachment

Organizational Conflict of Interest and Non- Disclosure Agreements are in place for each contractor personnel prior to starting any work on this contract

100% complete as required prior to start and provided via email to the COR.

Date submitted Positive CPARS review, renewal of option period

4 6.2.1.13 Provide the appropriate level biostatistician support personnel within 10 business days of the Governments call order/request

Provide the proper level of support within 10 business days 95% of the time

COR

observation/MPR

Positive CPARS review, renewal of option period

5 6.0 Provide accurate statistical analysis for research projects

Provide accurate statistical analysis 98% of the time

COR

observation/MPR

Positive CPARS review, renewal of option period

9. TRANSITION SUPPORT

9.1. Outgoing Transition Plan:

The Contractor shall develop and deliver an outgoing transition plan for 45 days of outgoing transition (Deliverable 5) for transitioning work from an active award to a follow-on contract/order or Government entity. This transition may be to a Government entity, another Contractor or to the incumbent Contractor under a new contract/order. In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract to a successful provider. This shall include formal coordination with Government staff and successor staff and management. It shall also include delivery of copies of existing policies and procedures, and delivery of required documents, metrics and statistics. This transition plan shall include, but is not limited to:

a. Coordination with Government representatives,

b. Review, evaluation and transition of current support services,

c. Government-approved training and certification process,

d. Transfer of hardware warranties and software licenses (if applicable),

e. Transfer of all necessary business and/or technical documentation,

f. Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes,

g. Disposition of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.,

h. Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance.

i. Applicable WRAIR debriefing and personnel out-processing procedures.

j. Turn-in of all government keys, ID/access cards, and security codes.

10. KEY PERSONNEL – Not Applicable

11. GOVERNMENT FURNISHED PROPERTY

Government Furnished Property (GFP) will be determined on a call order basis and includes: WRAIR network laptops and docking stations, and mobile devices for support personnel onsite and laptops and mobile devices for support personnel offsite. Government provided Laptops will be profiled for WRAIR network access, will be CAC enabled, and will have VPN access.

Equipment issued at time of contract award will be annotated in a separate document.

Government Furnished Information/System Access includes: WRAIR Network access to the shared drives as required; and the SharePoint collaboration site. The Government will provide any and all current local templates, SOPs, and policies.

The Contractor shall maintain a detailed inventory accounting system for Government Furnished Equipment/Material or Contractor-Acquired-Government Owned Property (CAP). 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, purchase cost (if CAP), and contract/order number under which the equipment is being used. The Contractor shall attach an update inventory report to each Monthly Progress Report 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.

11.1. Return of Government Furnished Equipment

The contractor shall return any CACs, WRAIR Picture ID Card, keys, and key fobs for employees no longer supporting the contract and/or on contract expiration. Specifically, the contractor shall, within two business days of employee no longer supporting the contract and/or on contract expiration, return:

a) CACs to WRAIR Security office;

b) WAIR Picture ID Card to WRAIR Security office;

c) Keys to the WRAIR key custodian; and

d) Key Fobs to the WRAIR key custodian.

If the contractor does not returned items a-d within 2 business days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

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 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.

12.2. 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.

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. Subcontract management

The Contractor shall prepare and deliver a Subcontract Expenditures Report as part of the MPR (Deliverable 2) that discloses actual subcontract expenditures by company name, business size standard (i.e. Woman Owned Business, Veteran Owned Business, etc.), and other socioeconomic programs (i.e. Indian Incentive Program, Historically Black Colleges and Universities and Minority Institutions, etc.).

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

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

• The contractor is responsible to manage task distribution to ensure there are no OCI considerations

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

• Privy of contract is with the contractor and the subcontractor…..

12.5. Foreign Nationals

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform. A background investigation must be completed in its entirety before unescorted access to the facility is granted. Government computer access will not be approved until a background check is done in accordance with para 18.9. Typically, a background check cannot be performed on a foreign national unless the individual has lived in the United States for three (3) of the last five (5) years.

13. COMPLIANCE DOCUMENTS

13.1. General Compliance

14.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, 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.

14.1.2. DoD Compliance Documents

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

A complete list of DoD 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) DoD (DOD) 6025.18 Regulation, DOD Health Information Privacy Regulation, 24

January 2003.

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

f) DoD (DOD) Instruction 8500.01 Cybersecurity

g) DoD (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT DoD (DoD) Instructions 5400.11-R, Privacy Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

h) 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

i) 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 DoD and Health and Human Services.

j) College of American Pathologists Inspection Checklists. http://www.cap.org http://www.dtic.mil/whs/directives/corres/dir.html http://www.dtic.mil/whs/directives/corres/dir.html http://www.army.mil/usapa/epubs/340_Series_Collection_1.html http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf http://www.cms.gov/Regulations-and-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.cap.org/

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

http://clsi.org/standards

l) 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

m) National Institutes of Allergy and Infectious Diseases, DAIDS Guidelines for Good

Clinical Laboratory Practice Standards, https://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/g clp.pdf

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

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

14. REFERENCE DOCUMENTS

a) DoD Directive 6485.01, Human Immunodeficiency Virus, June 7, 2013.

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

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

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

d) US Medical Entrance Processing Command Regulation 40-8, DoD (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

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.

http://clsi.org/standards http://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-http://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/g http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56 http://www.dtic.mil/whs/directives/corres/pdf/648501p.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

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

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 DoD cannot reasonably be made available to perform these functions. However, appropriate military or civilian personnel of the DoD 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.

Performance by the successful offeror shall be in compliance with the following constraint:

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

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 (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. 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 GLOBAL 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

BPA Call Orders:

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 Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

Government Purchase Card (GPC) Orders:

Call Orders placed by authorized Ordering Officers, the payment will be made by the GPC.

The GPC invoice shall include order number, date of order, services provided and name of Ordering Officer.

15.7. 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.

15.8. 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.

15.9. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order.

Contractor personnel shall make their contractor status known during introductions.

15.10. Data Rights

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

15.11. Anti-Terrorism and Operational Security

15.11.1.AT Level I Training.

All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable.

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

http://jko.jten.mil/

15.11.2. AT Awareness Training for Contractor Personnel Traveling Overseas.

Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. (Requirement will be determined per call order)

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.

a) For contractors requiring CAC. Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

b) For contractors that do not require CAC, but require access to a DoD facility or installation.

Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014- 05/AR 190-13); applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative);

or, at OCONUS locations, in accordance with status-of-forces agreements and other theater regulations.

15.11.3 This standard language requires U.S.-based contractor employees and associated subcontractor employees to make available and to receive Government-provided area of responsibility (AOR)– specific AT awareness training as directed by AR 525-13. Specific AOR training content is directed by the combatant commander, with the unit ATO being the local point of contact.

15.11.4 iWATCH Training.

The contractor and all…