B.08 PWS-FMD for W81XWH20Q0028.pdf

PERFORMANCE WORK STATEMENT

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

9. TRANSITION SUPPORT

10. PERSONNEL

11 TRAVEL/TEMPORY DUTY (TDY)

12 GOVERNMENT FURNISHED PROPERTY

14 COMPLIANCE DOCUMENTS

15 REFERENCE DOCUMENTS

16 OTHER TERMS, CONDITIONS, AND PROVISIONS

17 ATTACHMENTS

PERFORMANCE WORK STATEMENT (PWS)

Title: Facility Management Technical Support Services

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Division of Logistics, Facilities Management Department

1. INTRODUCTION

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

With the headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense. Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

The WRAIR vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

The Facilities Management Department (FMD), Walter Reed Army Institute of Research (WRAIR) is responsible for operations and maintenance of Medical Research facilities occupied by WRAIR and the Navy Medical Research Center (NMRC) located at Forest Glen Annex (FGA), Silver Spring, Maryland to include oversight and management of Army Medical Research facility construction and renovation projects.

WRAIR FMD has a requirement to acquire non-personal services in support of WRAIR's facilities management program to support the initiatives and mission of FMD, to maintain continuity of facility operations and allow for continued facilities service support for the WRAIR/NMRC client-base.

3. SCOPE

The scope of the requirement is to acquire Facility Management Technical Support services for the Facilities Management Department (FMD), Division of Logistics, Walter Reed Army Institute of Research (WRAIR). The FMD requires Facilities Management Technical Support Services to accomplish a range of activities in support of current work priorities. Facilities Management Technical Support Services to be provided on-site include Project Management (PM) / Quality Assurance (QA) for WRAIR FMD supporting WRAIR/NMRC.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract is as follows:

Base period 15 May 2020 – 14 May 2021 Option period 1 15 May 2021 – 14 May 2022 Option period 2 15 May 2022 – 14 May 2023 Option Period 3 15 May 2023 – 14 May 2024 Option Period 4 15 May 2024 – 14 May 2025

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work location is 503 Robert Grant Avenue, Silver Spring, MD 20910.

5.1.1. Telecommuting

Telecommuting is not feasible for the services provided under this contract.

5.1.2. Working During Emergency Situations

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.

5.2. Federal Holidays

5.2.1. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander

5.2.2. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed

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

5.3. 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.

5.4. Work Schedule

The contractor shall provide technical support services during standard business hours of 0700 to 1800 Eastern Time. The work week shall be a normal forty (40) hours per week, excluding vacation and sick time. Any deviation from the normal work schedule must be approved in advance by the COR. (e.g. Evening or weekend scheduling of utility outages in order to minimize disruption to WRAIR personnel.)

6. PERFORMANCE REQUIREMENTS

The contractor shall provide on-site, non-personal Project Management (PM), Quality Assurance (QA) and Operational Support technical services to the FMD, Division of Logistics, WRAIR FGA, Silver Spring, MD.

Contractor personnel shall work independently and in association with various Government staff on assigned projects that are within the Scope of Work and shall provide the technical assistance necessary to accomplish the assigned tasks in the performance of this contract at the WRAIR/NMRC FGA. The WRAIR/NMRC facility includes, but is not limited to, six (6) buildings, ranging in size from 22,140 Sqft to 527,481 Sqft, their surroundings, and connections to municipal support, i.e. water, sewer, power, etc.

6.1. Specific Tasks / Requirements

6.1.1 Project Management (PM) Support

The contractor shall perform on-site Project Management support services at the Walter Reed Army Institute of Research (WRAIR)/Naval Medical Research Center (NMRC) located at Forest Glen Annex, Silver Spring, Maryland. Tasks include:

a) Participate in the development of the WRAIR/NRMC project priority list;

b) Gather input from department end users, and evaluate the overall common area requirements for project development;

c) Coordinate actions daily with the on-site point of contacts (POC), to include the COR and Facility Manager.

d) Coordinate with the US Army Corps of Engineers (USACE), the Directorate of Public Works and the US

Army Medical Research and Development Command (USAMRDC) personnel as required;

e) Review and scope Facility Engineering Work Requests (FEWR);

f) Participate in pre-construction, staff, in-progress-review, and other project meetings;

g) Coordination with WRAIR/NMRC end users to ensure proper reviews of contractor submitted documentation, notification of project status and emergency/scheduled utility outages.

h) Coordination of construction activities/schedule with various WRAIR/NMRC end users to ensure that

Government operations and services are not adversely impacted

i) Provision of facility management support to monitor and provide oversight during construction contractor scheduled utility outages.

j) Update of FMD weekly status worksheet;

k) Provide record maintenance within the Defense Medical Logistics Standard Support (DMLSS) database for

WRAIR/NMRC projects that shall include, but not be limited to; all pertinent data fields including project title, project location, project contract information, project superintendent and project QC representative contact information, project dollar value, and scheduled completion date of projects.

6.1.2 Quality Assurance (QA) Support

The contractor shall perform on-site Quality Assurance (QA) support services at the Walter Reed Army Institute of Research (WRAIR)/Naval Medical Research Center (NMRC) located at Forest Glen Annex, Silver Spring, Maryland. Tasks include:

a) Conduct field surveys to investigate existing layouts and conditions;

b) Provide on-site facilities management support and oversight during construction contractor scheduled utility outages;

c) Participate in pre-construction, staff, in-progress-review, and other project meetings;

d) Evaluate schedules, work performance quality, safety oversight, and coordination effectiveness to identify deficiencies;

e) Perform documentation reviews for all repair and construction work in progress or in planning stages at above-referenced facilities

f) Monitor noise and vibrations to prevent disruption of research and take measures to minimize the level of noise and vibration and the impact it has on individuals and equipment;

g) Attend all construction meetings pertaining to projects; meet, at a minimum, daily with on-site contractors performing construction and adhere to the requirements of all US Army Corps of Engineers (USACE) Quality Assurance Engineering and Regulations, including but not limited to ER-1180-1-6 and all MEDCOM guidance on QA reporting;

h) Ensure conformance with National Fire Protection Association (NFPA) codes, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), safety standards, and other agency criteria;

i) Participate in final on-site inspections of completed projects, provide input/recommendations as to acceptability/non-acceptability of completed work along with recommendations for corrective action, if necessary;

6.2. Status Meeting and Reporting Requirements

Weekly Status Meetings (Deliverable 1). The contractor shall participate in a weekly meeting with FMD Management and the COR to discuss key findings, issues and concerns identified during the week and present recommended solutions or remedies. These meetings will be held on the Monday following the reporting week.

Monthly Progress Report (Deliverable 2). The contractor shall provide a monthly report that includes levels of effort, expenditure levels for other direct costs (ODC’s), and a summary of results for activities conducted during the reporting period.

Quality Control Plan (Deliverable 3). The contractor shall provide a Quality Control Plan (QCP) within 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

Contract Manpower Reporting Application (CMRA) (Deliverable 4). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the 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 2020. Contractors may direct questions to the help desk at http://www.ecmra.mil/.

7. DELIVERABLES

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

DELIVERABLES TABLE

PWS

Ref.

Number Title/Description Due

6.2 1 Weekly Status Meetings Each Monday following the reporting period

6.2 2 Monthly Progress Report Within 7 days of the end of the reporting period

6.2 3 Quality Control Plan To be included in contractor’s proposal

6.2 4 Contractor Manpower Reporting Application

As required by the contract

9.1 5 Incoming Transition Plan Within 3 days of contract award

9.2 6 Outgoing Transition Plan Not less than 30 days prior to contract completion

12.3 7 Updated Inventory Report With monthly status report

14.1.2 8 OSHA 300A

The contractor shall complete and deliver the

OSHA 300A.

1 February of each year.

16.9.12 9 Threat Awareness Reporting Program The contractor shall ensure all service providers receive Threat Awareness Reporting Program (TARP) training.

60 days after contractor personnel begin performance under this contract, and annually thereafter.

16.10 10 Information Security Program Training The contractor shall ensure all service providers receive Information Security Program training.

30 days after contractor personnel begin performance under this contract, and annually thereafter.

16.11 11 Health Insurance Portability and Accountability Act (HIPAA) Training The contractor and all of its employees working on this contract must complete the annual HIPAA training.

Within 30 days after contract award, and then annually thereafter for the remainder of the contract.

16.16 12 Sexual Assault Prevention Response (SAPR) Reporting The contractor shall immediately report the incident in writing to the Government's COR or Contracting Officer.

Within 24 hours of a SAPR related incident

16.16 13 Sexual Assault Prevention Response Training

Number of calendar days after contract award that the contractor submits documentation to COR

7.1. 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 DFAR clause 252.227-7015, Technical Data-Commercial Items. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

Contractor Performance Assessment Reporting System (CPARS). The Contractor 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 task 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.

7.2. Inspection and Acceptance

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

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

7.3. COR Information

TBD

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 as discussed in Section 6.2.

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).

# PWS

Ref.

Performance Objective

Acceptable Quality Level

Performance Measurement

Method of

Surveillance Incentive

1 6.2 Weekly Status Meetings 100% Completion of Meeting Direct observation and participation by

COR

Past performance

2 6..2 Monthly Progress Report

100% Receipt of Monthly Progress Report

Receipt and acceptance of report by COR

Past performance

3 6.2 Quality Control Plan 100% QC Plan included in Proposal

Receipt and acceptance of report by COR

Past performance

4 6.2 Contractor Manpower Reporting

100% Review of Annual Report Receipt and acceptance of report by COR

Past performance

5 9.1 Incoming Transition Plan

100% Approval of Plan Receipt and acceptance of report by COR

Past performance

6 9.2 Outgoing Transition Plan

100% Approval of Plan Receipt and acceptance of report by COR

Past performance

7 12.3 Updated Inventory Report

100% Submittal of Report Receipt and acceptance of report by COR

Past performance

8 14.1.2 OSHA 300A 100% Report submitted by February 1 of each year of the contract

Receipt and acceptance of by

COR

Past performance

9 16.9.12

TARP Training

< 90 calendar10 days after contract award

Number of calendar days after contract award that the contractor submits documentation to COR

COR receipt of documentation of completed training

Past Performance

10 16.10

Information Assurance

– Contractor information assurance workforce personnel are trained in accordance with DoD and Army policy

< 30 calendar days

Number of calendar days after contract award in which the contractor submits training certifications for all personnel requirement information assurance training

COR receipt of all certifications

Past Performance

11 16.11 Health Insurance Portability and

Accountability Act (HIPAA) Training

100% Completion of annual required HIPAA training

COR receipt of documentation of completed training

Past performance

12 16.16 Sexual Assault Prevention Response

(SAPR) Reporting The contractor shall immediately report the incident in writing to the Government's COR or Contracting Officer.

100%

Within 24 hours of a SAPR related incident

COR or KO receipt of documented incident.

Past performance

13 16.16 Sexual Assault

Prevention Response Training

< 60 calendar days after contract award

Number of calendar days after contract award that the contractor submits documentation to COR

COR receipt of documentation of completed training

Past Performance

9. TRANSITION SUPPORT

9.1. Incoming Transition Plan

The Contractor shall provide a plan for 15 days of incoming transition. The plan shall be completed within 3 days of contract award.

The Contractor shall develop a detailed transition plan, in accordance with the current contractor, describing the contractor’s plans for assuming housekeeping duties and responsibilities. The transition plan should address schedules, tasks and activities necessary for the successful transition of operations between Contractors. The transition plan‘s intent is to ensure that there is no lapse in service during the shift from the incumbent Contractor to the successful offeror. Concepts that should be considered as part of the transition plan include:

Coordination with Government representatives; Review, evaluation and transition of current services; Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance; Inventory and control practices for all government keys, ID/access cards, and security codes. For planning purposes, the transition from the incumbent Contractor to the successful offeror shall be accomplished in a two (2) week period in accordance with the end of current contract.

The Contractor shall coordinate with the Government in planning and implementing a complete transition to the Contractor's support model. The Contractor shall develop and deliver a Transition-in Plan (Deliverable 5).

This transition plan shall include, but is not limited to the following items as applicable:

a. Coordination with Government representatives,

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

c. Transition of historic data to new Contractor system,

d. Government-approved training and certification process,

e. Transfer of hardware warranties and software licenses,

f. Transfer of all System/Tool documentation to include, at a minimum: User manuals, system administration manuals, training materials, disaster recovery manual, requirements traceability matrix, configuration control documents and all other documents required to operate, maintain and administer systems and tools,

g. Transfer of compiled and uncompelled source code, to include all versions, maintenance updates and patches,

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

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

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

k. Applicable WRAIR briefing and personnel in-processing procedures,

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

9.2. Outgoing Transition Plan

The Contractor shall develop and deliver an outgoing transition plan (Deliverable 6) for 15 days of outgoing transition 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 be submitted not later than 30 days before the end of the contract and shall include, but is not limited to:

a. Coordination with Government representatives,

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

c. Transition of historic data to new Contractor system,

d. Government-approved training and certification process,

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

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

g. Transfer of compiled and uncompelled source code, to include all versions, maintenance updates and patches (if applicable),

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

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

j. Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and

GFE inventory management assistance.

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

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

10. PERSONNEL

a. The contractor shall be responsible for employing technically qualified personnel to perform the tasks specified in this performance work statement.

b. Contractor personnel shall comply with all specified guidelines regarding safety, security, standard operating procedures, written protocols, technical manuals, and procurement of supplies/equipment as per standing operating procedures or regulations to include, but not limited the following:

Army Regulation 420-1 (Army Facilities Management)

Army Regulation 385-10 (Army Safety Program)

USACE ER 1180-1-6 (Construction Quality Management)

USACE EM 385-1-1 (Safety & Health Requirements Manual)

The contractor personnel must possess current training, licensure and/or certifications necessary to perform the requirements of the PWS. Required Certifications:

USACE Construction Quality Management Certification.

OSHA 30-Hour Course Certification.

10.1 Personnel and Supervision

The Contractor shall furnish supervisory, administrative, and direct personnel to accomplish all work required.

Adequate and competent supervision shall be provided for all work performed by the Contractor's employees to ensure performance and accomplishment in accordance with this specification.

10.2 Unforeseen Facilities Closures

The term "unforeseen facilities closures" as used herein shall include closing due to: the loss of major utilities (water, electricity), inclement weather, and security reasons, etc. When an unforeseen facilities closing occurs on a regularly scheduled day of work, the Government will have the following options:

To require the Contractor to perform the scheduled work on the following day unless the following day is a

Saturday or Sunday.

To reschedule the work on any day satisfactory to both parties.

10.3 Physical Security

The Contractor shall be responsible for safeguarding all Government property provided for Contractor use. The Contractor shall keep all storage areas secured.

10.4 Controlled Entry

The majority of the WRAIR is secured by a card reader security system. All employees must use an identification card/key to obtain access to the work place. The WRAIR is protected by a Master Key control system. The Contractor shall comply with all WRAIR site security policies.

10.5 Identification Card (ID)/key

The Contractor shall obtain a WRAIR Contractor ID/key for each employee before the employee enters on duty.

These ID card/keys may be necessary to activate the card/key locks. Each card/key is programmed for specific card/key locks. The Contractor shall be responsible for assuring that all ID card/keys are returned within two working days to the COR when employees leave employment and on the last day of contract performance. The Contractor shall be held liable for the cost of replacing ID card/keys lost or unaccounted for and for the costs of re-securing areas affected by the loss of security related to card/keys lost or unaccounted for.

Contractor's employees shall prominently display their government issued ID card at all times while inside WRAIR.

The WRAIR ID badge will be hidden from view when outside the building for security purposes. The Contract employees must have their government issued ID badges with them during duty hours. The Contractor shall conduct a quarterly ID card and Key inventory as well as conducting intentional random checks to validate proper security of these items. The Contractor shall notify the COR in writing immediately when a badge is lost and provide a written memo to the COR showing the results and actions taken for any losses. The Contractor shall notify the COR immediately when a badge is lost.

During regular Government work days the facilities are normally unlocked for access between 6:45 a.m. until 5.00 p.m., Monday through Friday. After normal access hours, if required, the card/key will be required to activate the building card readers or unlock doors for access to various areas and buildings.

10.6 Key Control

The Contractor shall establish and implement a procedure for ensuring that any keys and lock combinations issued to its personnel by the Government are not lost or misplaced and are not used by unauthorized persons. Keys issued to the Contractor shall not be duplicated and combinations shall not be disseminated beyond a "need to use" basis among Contractor employees. The Contractor shall report loss of a key or compromise of a combination immediately to the COR. Keys lost by Contractor or Contractor employees will be replaced by the Government and paid for by the contractor. If the lock has to be replaced to reestablish security, the Contractor shall be held responsible for the cost of replacing said locks.

11 TRAVEL/TEMPORY DUTY (TDY)

Travel to Ft. Detrick at the discretion of the COR.

12 GOVERNMENT FURNISHED PROPERTY

12.1 Utilities

The Government will furnish the following utility services at existing outlets for use in those facilities and as may be required for work performed under the contract: electricity, water, sewer service, and refuse collection (from existing distribution and collection points). Use of utilities shall be restricted to that which is specifically needed for contract performance. The Government will furnish telephone service only for personnel, to conduct Government business only, for performance of this PWS.

12.2 Facilities

The Government will furnish, or make available, to the Contractor necessary office space. The Contractor will be expected to appropriately manage their personnel space requirements based on space provided—the Government has limited space available for the Contractor. The Contractor shall be responsible and accountable for such facilities accepted for use and shall take adequate precautions to prevent fire hazards, odors, and vermin. The Contractor shall obtain written approval from the Facilities Management Branch, Logistics Division prior to making any modifications or alterations to the facilities. Any such modifications or alterations approved will be made at the expense of the Contractor. At the completion of the contract, all facilities shall be returned to the Government in the same condition as received, except for reasonable wear and tear. The Contractor shall be held responsible for the cost of any repairs caused by negligence and abuse on their part, or on the part of their employees.

12.3 Other Government Furnished Property

Government Furnished Property may also include: 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 utilize the Procurement Integrated Enterprise Environment (PIEE) system for tracking and accountability for Government Furnished Equipment/Material or Contractor-Acquired-Government Owned Property

(CAP).

12.3.1 Return of Government Furnished Equipment

The Contractor shall return 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.

13 CONTRACT MANAGEMENT

13.1 Government Management

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

The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

13.2 Contractor Management

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

13.3 Contractor Vacant Positions

The contractor shall fill vacant positions within thirty (30) business days. If contractor positions are vacant for more than thirty (30) days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

13.4 Subcontract management

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

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

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

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

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

13.5 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.

14 COMPLIANCE DOCUMENTS

14.1 General Compliance

14.1.1 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 Develo0pment Command (USAMRDC) 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://mrdc.amedd.army.mil/rodorphrpo.asp.

14.1.2 Occupational Safety and Health Administration

The contractor shall comply with Occupational Safety and health Administration Standard Number

1904.32. The contractor shall deliver the 300A by February 1 of each year (Deliverable 8).

14.1.3 DoD Compliance Documents

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

A 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

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

w) 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

x) 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

y) 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

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

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

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

14.2 Information Technology Compliance

14.2.1 Army Regulation 25-1, Information Technology

Compliance information regarding Army Information Technology may be found at:

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

14.2.2 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

14.2.3 Cyber-security

Department of Defense (DOD) Instruction 8500.01 Cybersecurity

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

15 REFERENCE DOCUMENTS

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

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

a) 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

b) 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

c) 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

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

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

f) 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

16 OTHER TERMS, CONDITIONS, AND PROVISIONS

16.1 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.

16.2 Severable / Non-Severable Services

This award identifies services that are severable in nature.

16.3 Inherently Governmental Functions

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

16.4 Organizational Conflict of Interest

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

9.5. These categories apply to all enterprise laboratories AFRIMS, USAMRD-A, and USAMRD-G. These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating. These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

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

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

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

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

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

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

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an OCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs;

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

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

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

The applicable OCI category will be set forth in each award.

This requirement is categorized as ISOLATED SUPPORT.

Organizational and consulting conflicts of interest may arise by performing advisory or consulting support services.

Organizational conflicts of interest include providing services or performing advisory or consulting work for private companies that participate or will participate in future services or contract activities (solicitations and award). See FAR subpart 9.5.

The Contractor shall ensure that the Participation Agreement, either A and / or B as identified on each award, is signed by all staff assigned to or performing on each award before performing any work, including all subcontractors and consultants. The Participation Agreement shall be cosigned by a corporate official (contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor and the COR will immediately initiate a CDR.

16.5 Invoices

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

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information 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.

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

16.6 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.

16.7 Contractor Identification

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

16.8 Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or…