W81XWH22Q0130 (1).pdf

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. ISSUE Date: 24 August 2022

2. CLOSE Date: 07 September 2022 11:00 AM EST

3. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler Street, Fort Detrick, MD 21702

4. Requiring Activity: Walter Reed Institute of Research (WRAIR) Veterinary Services Program (VSP) located at Robert Grant Avenue, Bldg 503, Silver Spring, MD 20910

5. Subject: Tunnel Washer

6. Request for Quote: W81XWH22Q0130

7. Description of Requirement: Tunnel Washer

7.1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in the Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, as a written solicitation will not be issued.

7.2 This combined synopsis/solicitation W81XWH22Q0130 is issued as a Request for Quote (RFQ).

7.3 Provisions and clauses are those in effect through Federal Acquisition Circular 2022-07; 10 Aug 2022 are incorporated.

7.4. The North American Industry Classification System (NAICS) code is 339112 Surgical and Medical Instrument Manufacturing, with a size standard of 1,0000 employees. This acquisition is set aside for Small Business.

7.5. The Contract Line Items Number (CLINs) and item, quantities units of measure, and description are identified under the Supplier/Services Section of the RFQ.

7.6. The anticipated date of delivery is within 1 year after contract award (ADC) with shipping Free On Board (FOB) Destination IAW FAR 52.247-34. The delivery address is Walter Reed Institute of Research, Bldg. 503, Robert Grant Avenue, Silver Spring, MD 20910.

7.8. FAR provision 52.212-1 Instruction to Offerors – Commercial Items including the Addendum applies to this acquisition and the attached RFQ.

7.9. FAR provision 52.212-2 Evaluation – Commercial Items applies to this acquisition including the Addendum located in the RFQ. Contract award will be made on a competitive best value basis using “Lowest Price, Technically Acceptable (LPTA)” approach.

7.10. Offerors responding to this combined synopsis/solicitation shall include a completed copy of the provision at 52.212-3 Offeror Representations and Certifications-Commercial Items with its quote.

7.11. FAR Clause 52.212-4 Contract Terms and Conditions – Commercial Items applies to this acquisition.

Additional contract requirements, terms, and conditions are identified in the attached RFQ.

7.12. FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statue or Executive Order – Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and market which are applicable to this acquisition.

7.13. All equipment and accessories shall be new from the manufacturer and include OEM Warranty. Used or refurbished equipment, or equipment obtained from a third party shall not be accepted.

8. Point-of-Contact: The point-of –contact for this acquisition is Rebecca Wisner; rebecca.c.wisner.civ@mail.mil.

AND rebecca.c.wisner.civ@health.mil No phone calls will be accepted.

9. Instructions for the Preparation and Submission of Quotes

9.1. Quotes shall be prepared in accordance with this solicitation and FAR provision 52.212-1 Instructions to Offeror-Commercial Items including the Addendum which is included at the bottom of the Provision.

9.2. The Government reserves the right to reject any or all quotes, and to award no contract at all, depending on the quality of the quote(s) submitted and the availability of funds.

9.3. Questions: Questions shall be submitted via e-mail to Rebecca Wisner; rebecca.c.wisner.civ@mail.mil no later than 30 August 2022 at 11:00 AM EST. Questions received after this date will not be accepted. An Amendment to this RFQ will be posted to SAM.Gov with responses to the question received. Only one set of questions per Contractor will be accepted.

9.4. Quotes: Quotes in response to this RFQ are due via e-mail no later than 07 September August 2022, at 11:00 AM EST to Rebecca Wisner; rebecca.c.winser.civ@mail.mil.

9.5. The Offeror shall agree to honor proposed prices for 60 calendar days from the due date for receipt of quotes.

mailto:rebecca.c.wisner.civ@mail.mil mailto:rebecca.c.wisner.civ@health.mil mailto:rebecca.c.wisner.civ@mail.mil mailto:rebecca.c.winser.civ@mail.mil

MINIMAL ESSENTIAL CHARACATERIS

Minimum Essential Characteristics (MEC) for Tunnel Washer

1. The tunnel washer shall be furnished and installed shall as a minimum be steam heated, pass-through, washer designed for thorough, efficient cleaning and sanitization of cages and equipment. Washer shall have left to right flow with the capability to washing up to 1500 rodent cages per hour.

2. Load and unload opening shall be no less than 37 inches across and 18 inches high

3. The washer shall include an inline cartridge filter and back-flushed to an existing holding tank. The machine shall be equipped with a pressure monitoring system that notifies the user of a clog at the interface panel.

4. The drying system will include high speed warm air blown over the load through a set of air knives.

5. The conveyor belt shall be constructed of chemical-resistant fiberglass filled PPA material. The user shall be have the ability to remove sections of the belt for replacement or to retrieve fallen objects.

6. The washer belt shall pause automatically when not in use and go in stand-by mode after a set period of inactivity.

7. The washer shall include a programmable self-start function to automatically turn on the unit at a set time.

8. The washer shall include a cycle option to rinse the chamber and flush the lines and tanks.

9. All parts exposed to water or chemicals shall be constructed of a minimum AISA 304 stainless steel where applicable. Belt, viewing ports, and interior curtains are exempt from this requirement, but shall be constructed of material resistant to water and chemical exposure.

10. Interior compartment/chamber size shall not be less than: 70” W x 185” L x 96” H (inside door to door) with the overall exterior dimensions no greater than 110”W x 198”L x 115”H

11. The interior of the tunnel washer shall be all stainless steel construction. All wetted parts shall be stainless steel or appropriate polymeric materials. All structural support including sump support frame shall be stainless steel.

12. The chamber shall be insulated to reduce hot surfaces and heat loss.

13. Tunnel washer shall provide a visual indication of machine status during wash phases.

14. Washer shall consist of five modules; loading, wash, pre-rinse and rinse, dryer, and unload.

15. Treatment schedules and cycle selections shall be made through an Operator Interface Terminal (OIT) and shall include supervisory access code security. The OIT shall provide process times, temperatures and sequence information during equipment operation.

16. All recirculated treatment phases shall have temperature set-point capability. Wash and rinse phases shall have temperature set-point guarantee capability. If temperature set-point guarantee is selected for any phase, that phase shall not begin timing until the set point is reached. Should the solution temperature drop below the set point the timer shall stop and begin again when the temperature rises above set point.

17. The tunnel washer shall be controlled by a touchscreen display, which shall control all times, temperatures, treatment cycles and operational control.

18. Treatment schedules and cycle selections shall be made through an Operator Interface Terminal (OIT) and shall include supervisory access code security. The OIT shall provide process times, temperatures and sequence information during equipment operation and control all times, temperatures, treatment cycles and operational control.

19. Contractor shall install a photo-electric conveyor stop on the government-provided discharge roller table.

20. Contractor shall align the unload end of the washer with a government provided discharge roller table.

21. Washer shall include an emergency stop feature at the load and unload end that can be easily access by the user. Emergency stop will immediately stop all washer operations. Washer shall also immediately stop operations when chamber access doors are opened.

22. All mechanical, piping, and electrical components will be readily accessible for maintenance. Doors shall be equipped with spring loaded, explosion relief type safety latches that open readily when pushed from inside the chamber.

23. Treatment schedules shall be configurable for their respective cycles. A minimum of ten (10) configurable cycles shall be provided.

24. Washer drain shall connect to an existing dedicated effluent drain line or in to a Government-furnished (GFE) effluent holding/treatment tank located within 10 feet of equipment location.

25. Shall contain dosing pump for a minimum of three chemicals with ability to add additional pumps.

26. The sump shall contain a stainless steel, steam heat exchanger to maintain recirculated solution temperatures complete with steam supply and condensate controls and be easily removable for maintenance and cleaning.

27. The washer shall be inter-piped and inter-wired so that only one connection is required for each service utility.

28. Pump discharge, steam and water supply lines shall have pressure gauges and steam, water and condensate return lines shall terminate with unions and shut-off valves.

29. Hot and cold water supply lines shall include water hammer arrestors.

30. If requirement is greater than building-supplied compressed air, an integral air compressor shall be provided to operate the pneumatic components. The air compressor shall have ample capacity to provide for all compressed air requirements and be fitted with air dryer, automatic drains and filter/regulator/lubricator.

31. A stainless steel modular wall shall be provided as required for isolation between the clean and dirty sides of the washer.

32. If required, existing exhaust hoods at load and unload end shall be modified to capture exhaust from load and/or unload doors when opened.

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

Title: Tunnel Washer

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 and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With our headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense.

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

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

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

2. PURPOSE AND BACKGROUND

The Veterinary Services Program (VSP) provides comprehensive animal care, protocol consultation, support, and pathology services to the Walter Reed Army Institute of Research (WRAIR). To meet this mission VSP, provides quality veterinary medical care and environmental enrichment programs for all animals, representing nine different species. VSP provides guidance for regulatory compliance issues related to animal-based research, comprehensive animal research support through scientific consultation with investigators and medical/surgical care to the research animal colony. VSP conducts training for laboratory animal techniques and animal handling workshops for investigators, research support staff, veterinary staff, and animal care personnel. VSP trains military veterinarians chosen by a selection board for the DoD Laboratory Animal Medicine Residency Training Program.

3. SCOPE

The contractor shall furnish all labor, materials, equipment and supervision required for the demolition and off site removal of an existing Lynx model 542LXi tunnel washer and furnish and install a newly manufactured tunnel washer. Location of the performance requirement is room GE03, Building 503, Walter Reed Army Institute of Research, Forest Glen Annex, Silver Spring Maryland. The intent of this contract is for the contractor to provide a fully operational tunnel washer.

4. PERIOD OF PERFORMANCE

Installation of tunnel washer is contingent upon completion of a secondary cage wash facility located on site in building 511. Tunnel washer removal and install may be delayed up to one year from time of award. The contractor shall store the equipment at their site until a date is coordinated with the. Contracting Officers Representative (COR). The period of performance for this contract are as follows:

Base period 30 September 2022 – 29 September 2023

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work location is GE03, 503 Robert Grant Avenue, Silver Spring, MD 20910.

5.1.1. Telecommuting

Telecommuting is not feasible for the services provided under this contract. Medical equipment maintenance, administrative, and professional support services must be performed on site.

5.1.2. Working During Emergency Situations

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

5.1.3. Federal Holidays

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

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 Juneteenth Independence Day

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

5.1.4. 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.

5.1.5. Work Schedule

The contractor shall provide support from 0700 to 1530 Eastern Time.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

The following general requirements apply to all activities involved with the removal of existing equipment and installation and testing of new equipment:

• To minimize down time, the contractor shall schedule and coordinate with the Technical Point of Contact

(TPOC) the installation and testing of the new system to ensure that minimal delays in operation are experienced between the shutdown of the old system and full operation of the new system. The schedule may be modified on a periodic basis as required by project activities. The COR will be responsible for approving all schedule modifications.

• All mechanical, piping, and electrical components will be readily accessible for maintenance.

• Prior to the use of any welding or cutting torches, compliance with regulatory requirements and coordination with the COR is the responsibility of the contractor. The contractor shall insure that all safety requirements regarding the use of the freight elevator size and weight capacities are adhered to.

• Equipment shall comply with all industry and government design, testing, assembly, and fabrication requirements for specified equipment.

6.2. Specific Tasks / Requirements

6.2.1. Delivery of New Equipment

The contractor shall deliver a fully operational tunnel washer, which conforms to all of the identified Minimum Essential Characteristics. (Deliverable 1)

6.2.2. Removal of Existing Equipment

The contractor shall disconnect, disassemble, and remove the existing Lynx tunnel washer from the premises and turn it in to nearest Defense Reutilization Marketing Office (DRMO) facility (Fort Meade, MD) (Deliverable 2). The contractor shall allow the WRAIR facilities no less than 80 hours to make repairs to the mechanical space, prior to installation of new equipment.

6.2.3. Installation of New Equipment

The installation is intended to be turn-key. If current utilities are not adequate for proposed equipment, contractor will ensure proposal includes all costs to provide utilities (electrical, plumbing, HVAC) necessary for normal operation of equipment.

Available utilities:

• HVAC: 500 – 1500 CFM (2 exhaust ducts)

• Electrical: 3 phase, 60 cycle, 460 volt, 45 amp

• Steam: 2 ½” NPT, 40 – 80 PSI, 1800#/HR

• Hot Water: 1 ½” NPT, 50 GPM flow rate @ 70 psi @ 130oF

• Cold Water: Located in area

• Drain: 3” NPT drain to transfer tank

• Compressed Air: Maximum 75 PSI

6.2.4. Transition of Equipment

The contractor shall be responsible for ensuring equipment can be moved from loading dock to installation location. Any damage or changes to door openings shall be the responsibility of the contractor to repair to existing condition.

6.2.5. Equipment Testing

• The contractor shall commission the newly installed washer by testing all equipment following the completion of installation and ensure that the equipment is operating in accordance with OEM performance specifications.

• Prior to equipment testing, the contractor shall provide the COR with a 48 hour notice so the government can witness the testing.

• Contractor shall document all testing and provide a report to the Government with the testing results.

6.2.6. Installation of Information Plate (Deliverable 3)

Vendor shall supply an information plate permanently affixed to the tunnel washer with the following information:

• Name and Address of Manufacturer

• Serial number and Unit Identification

6.2.7. Warranty (Deliverable 4)

The contractor shall propose as a separate item a two-year warranty and service/maintenance agreement providing a “next business day” response time. If accepted, this will commence from the last day of the standard commercial warranty.

6.2.8. Training

The contractor shall provide one 4-hour on site user training session to include basic operation, operator level maintenance and troubleshooting. An additional 4-hour training session will be provided to the medical maintenance staff on maintenance procedures. Contractor shall provide biomedical training for one technician at the manufacturer training site within a year after the unit is certified and fully operational. The training will include preventive maintenance schedules and procedures, calibration instructions, piping and electrical schematic diagrams, and cycle descriptions that describe the sequence of events controlling the individual cycles during each session. Training dates and times shall be coordinated with the Government appointed TPOC.

6.2.9. Equipment Specific Documentations (Deliverable 5)

The contractor shall provide three full sets of Operation and Maintenance manuals for each piece of equipment. At a minimum, manuals shall include Programmable Logic Controller (PLC) ladder diagrams and Operator Interface Terminal (OIT) diagrams. In addition, a complete list of purchased parts including original manufactures’ part numbers, descriptive information and where the parts were purchased shall be included in the manuals. Operation manuals shall also include a description of operator-level periodic (e.g.

daily, weekly, monthly) maintenance requirements as well as a trouble-shooting guide for common problems.

Software copies of the PLC and OIT programs shall be supplied. Maintenance manuals shall include preventive maintenance schedules and procedures, calibration instructions, piping and electrical schematic diagrams, and cycle descriptions that describe the sequence of events controlling the individual cycles.

6.2.10. Supporting Imagery

Fig 1: Load end of existing tunnel washer Fig. 2: Unload end of existing tunnel washer

Room GE03 Cage Wash Diagram

6.3. Management Reports and Plans

Quality Control Plan (Deliverable 5). The contractor shall provide a draft Quality Control Plan (QCP) no later than (NLT) 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

7. DELIVERABLES

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

DELIVERABLES TABLE

PWS Ref. Number Title/Description Due

6.3.1 Deliverable 1

Delivery of New Equipment The contractor shall deliver a fully operational tunnel washer, which conforms to all of the identified Minimum Essential Characteristics Upon start of contract PoP

6.3.2 Deliverable 2

Removal of Existing Equipment. The contractor shall disconnect, disassemble, and remove the existing

Lynx tunnel washer from the premises and turn it in to nearest Defense Reutilization Marketing Office

DRMO facility (Fort Meade,MD)

Upon removal of existing equipment

6.2.6 Deliverable 2 Installation of Information Plate Vendor shall supply an information plate permanently affixed to the tunnel washer

Upon completion of installation

6.2.7 Deliverable 3

Warranty The contractor shall propose as a separate item a two-year warranty and service/maintenance agreement providing a “next business day” response time

Upon start of contract PoP

6.2.9.4 Deliverable 4 The contractor shall provide three full sets of Operation and Maintenance manuals for each piece of equipment.

Upon completion of installation

6.3 Deliverable 5 Quality Control Plan NLT 15 days after contract award

6.4 Deliverable 6 Contract Manpower Reporting Application

The contractor shall complete and deliver the CMRA.

By October 31 or on the last day of contract performance

– whichever is first

14.1.2 Deliverable 7 OSHA 300A

The contractor shall complete and deliver the OSHA 300A. 1 February of each year.

7.1. Technical Reports and Documents – Not Applicable

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

To be determined upon award.

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor.

The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

Performance Requirements Summary Matrix

# PWS

Ref.

Performance Objective Performance Measurement

Acceptable Quality Level

Method of Surveillance Incentive

1 6.3.2. Equipment Removal

The contractor shall disconnect, disassemble, and remove the existing Lynx model 452LXi tunnel washer from the premises. The contractor shall allow the WRAIR facilities no less than 80 hours to make repairs to the mechanical space, prior to installation of new equipment.

Meets:

97%

Direct observation by COR

Positive Past

Performance

2 6.3.3 Turn Key Installation

The installation is intended to be turn-key. If current utilities are not adequate for proposed equipment, contractor will ensure proposal includes all costs to provide utilities

(electrical, plumbing, HVAC) necessary for normal operation of equipment.

Meets:

97%

Review by

COR

Positive Past

Performance

3 6.3.4 Transition of Equipment

The contractor shall be responsible for ensuring equipment can be moved from loading dock to installation location, and for repairing any damage

Meets:

97%

Review by

COR

Positive Past

Performance

4 6.3.5 Equipment Testing

The contractor shall test all equipment following the completion of installation and ensure that the equipment is operating in accordance with OEM performance specifications.

Meets:

97%

Review by

COR

Positive Past

Performance

5 6.3.8 Training

The contractor shall provide one 4-hour on site user training session to include basic operation, operator level maintenance and troubleshooting. An additional 4-hour training session will be provided to the medical maintenance staff on maintenance procedures.

Meets:

99%

Review by

COR

Positive Past

Performance

6 16.11.12

Installation Access -

Contractor shall follow installation access procedures.

Sum of all incidents in which contractor personnel did not follow installation access procedures

< 1 incident per month

Direct observation by COR and installation security.

Past Performance

9. TRANSITION SUPPORT – Not Applicable

10. KEY PERSONNEL – Not Applicable

11. TRAVEL/TEMPORY DUTY (TDY) – Not Applicable

12. GOVERNMENT FURNISHED PROPERTY – Not Applicable

13. CONTRACT MANAGEMENT

13.1. Government Management

The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract.

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

13.2. Contractor Management

The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

13.3. Contractor Organization

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

13.4. Contractor Vacant Positions

The contractor shall fill vacant positions within 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.

13.5. Subcontract management

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

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

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

13.5.4. Contractor may add subcontractors to their team after notification and written approval from the

KO.

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

13.6. 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 Development 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 7).

14.1.3. DoD Compliance Documents – Not Applicable

14.2. Human Research Protections – Not Applicable

14.3. Research Involving Animals – Not Applicable

14.4. Information Technology Compliance – Not Applicable

14.5. Cybersecurity Management – Not Applicable

14.6. Medical and Laboratory Compliance – Not Applicable

15. REFERENCE DOCUMENTS – Not Applicable

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 non-severable in nature.

16.3. Inherently Governmental Functions

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

16.4. Acquisition Functions Closely Associated with Inherently Governmental Functions

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

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

16.5. Organizational Conflict of Interest

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart 9.5. These categories apply to all enterprise laboratories AFRIMS, USAMRD-A, and USAMRD-G.

These categories are defined as follows:

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

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

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

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

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

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

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

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

Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an OCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

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

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

This requirement is categorized as ISOLATED SUPPORT.

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

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

16.6. 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.

16.7. 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.

DFARS 252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting. The contractor shall implement National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, “Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations.”

16.8. Contractor Identification

When contractor personnel perform the services required in this contract on a Government installation they are required to possess and wear an identification badge that displays his or her name and the name of the Company. The contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

While performing in a contractor capacity, contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

16.9. 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.

16.10. Data Rights – Not Applicable

16.11. Anti-Terrorism and Operational Security

16.11.1. 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.

DFARS 204.7202 Contractor personnel who, as a condition of contract performance, require routine physical access to a Federally-controlled facility or military installation are required to complete Level I antiterrorism awareness training within 30 days of access and annually thereafter.

Include the clause at DFARS 252.204-7004 DoD Antiterrorism Awareness Training for Contractors, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, when contractor personnel require routine physical access to a Federally-controlled facility or military installation.

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.

16.11.2. Installation Access.

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.

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. – Not Applicable

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.

16.11.3. AT Awareness Training for Contractor Personnel Traveling Overseas. – Not Applicable

16.11.4. iWATCH Training. This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area. – Not Applicable http://jko.jten.mil/

16.11.5. Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to Government information systems. – Not Applicable

16.11.6. For Contracts That Require an OPSEC Standing Operating program. – Not Applicable

16.11.7. For Contracts That Require OPSEC Training. – Not Applicable

16.11.8. For IA/IT training. – Not Applicable

16.11.9. For Information Assurance (IA)/Information Technology (IT) Certification. – Not Applicable

16.11.10. For Contractors Authorized to Accompany the Force. – Not Applicable

16.11.11. For Contract Requiring Performance or Delivery in a Foreign Country. – Not Applicable

16.11.12. For Contracts That Require Handling or Access to Classified Information. – Not Applicable

16.11.13. Threat Awareness Reporting Program (TARP). – Not Applicable

16.12. Information Security Program Training – Not Applicable

16.13. System Security Plan and Associated Plans of Action – Not Applicable

16.14. Identification, Tracking, and Restricted Flow Down of all Covered Defense Information, and for

Requesting the Contractor’s Record of Tier 1 Level Subcontractors, Vendors, and/or Suppliers who Receive or Develop Covered Defense Information – Not Applicable

16.15. Compliance with Relevant DoD, Service, and Institutional Policy Regulations. – Not Applicable

16.16. Personally Identifiable Information (PII) and Protected Health Information (PHI) – Not

Applicable

16.17. Public Key Infrastructure Authentication and Encryption – Not Applicable

16.18. Network Security – Not Applicable

16.19. Workplace Safety

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

The Contractor will be required to ensure compliance with Occupational Health physicals or vaccinations in support of the PWS. These shall be documented and charged as an ODC.

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

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

17. ATTACHMENTS

Attachment 1 – Acronyms List Attachment 2 – Organizational Conflict of Interest

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition

AFARS Army Federal Acquisition Regulation Supplement AFRIMS Armed Forces Research Institute of Medical Sciences

AKO Army Knowledge Online AOR Area Of Responsibility

AT OPSEC Antiterrorism and Operational Security ATCTS Army Training Certification Tracking System

CAC Common Access Card CFR Code of Federal Regulations

CONUS Continental United States COR Contracting Officer Representative

DFARS Defense Federal Acquisition Regulation Supplement DoD Department of Defense EIT Electronic and Information Technology FAR Federal Acquisition Regulation FBI Federal Bureau of Investigation

FPCON Force Protection Condition FSC Federal Supply Code FSS Federal Supply Schedule GFE Government Furnished Equipment GFI Government Furnished Information GSA General Services Administration IA Information Assurance ID Identification

ID/IQ Indefinite Delivery / Indefinite Quantity IPT Integrated Product/Process Team IT Information Technology

NAC National Agency Check NACI National Agency Check with Inquiries

NCIC-III National Crime Information Center Interstate Identification Index NLT No Later Than OCI Organizational Conflict of Interest

OCONUS Outside Continental United States OPSEC Operational Security PMO Project Management Office PRS Performance Requirements Summary PWS Performance Work Statement

QASP Quality Assurance and Surveillance Plan QCP Quality Control Plan SOP Standing Operating Procedure

TARP Threat Awareness and Reporting Program

U.S.C. United States Code UIC Unit Identification Code US United States

USAMRAA United States Army Medical Research Acquisitions Activity USAMRD-G United States Medical Research Directorate – Georgia USAMRD-A United States Medical Research Directorate – Africa

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

W81XWH22Q0130

ATTACHMENT 2: ORGANIZATIONAL CONFLICT OF INTEREST

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

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

9.5. These categories apply to all enterprise laboratories (Armed Forces Research Institute of Medical Sciences (AFRIMS), United States Medical Research Directorate – Kenya (USAMRD-K), and United States Medical Research Directorate – Georgia (USAMRD-G). These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary…