Draft_SON_Small_Animals_V1_04-15-2019.pdf

DRAFT

Statement of Need

Small Laboratory Animals for the

U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), U.S. Army Medical Research Institute of Chemical Defense (USAMRICD), U.S. Army Research Institute of Environmental Medicine (USARIEM), U.S. Army Institute of Surgical Research (USAISR), and the

Walter Reed Army Institute of Research (WRAIR)

15 APRIL 2019 - VERSION: 1

**DRAFT**

STATEMENT OF NEED

Small Laboratory Animals

1. Introduction

The U.S. Army Medical Research and Materiel Command (USAMRMC) is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition and medical logistics management. The USAMRMC’s expertise in these areas establish and maintain the capabilities the Army requires to fight and win on the battlefield. There are six (6) medical research laboratory subordinate commands that execute the science and technology program to investigate medical solutions for the battlefield. Five (5) of those subordinate commands are identified below to include their individual missions.

a. U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) with a mission to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents.

b. U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) with a mission to discover and develop medical products and knowledge solutions against chemical threats through research, education and training, and consultation.

c. U.S. Army Research Institute of Environmental Medicine (USARIEM) with a mission to optimize warfighter health and performance through medical research.

d. U.S. Army Institute of Surgical Research (USAISR) with a mission to provide combat casualty care medical solutions and products for wounded warriors, from self-aid through definitive care across the full spectrum of military operations; provide statement of the art trauma, burn, and critical care to Department of Defense (DoD) beneficiaries and civilians, and provide Burn Flight Teams.

e. Walter Reed Army Institute of Research (WRAIR) with a mission to conduct biomedical research that is responsive to DoD and Army requirements and delivers lifesaving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the warfighter.

The USAMRMC five (5) subordinate commands requirements for small laboratory animals are included in this Statement of Need (SoN). The term “subordinate commands” is used throughout this document and when used is to mean the five (5) subordinate commands identified above.

1.1. Background

1.1.1. Currently, the small laboratory animals are purchased through four (4) Blanket Purchase Agreements (BPAs) as identified in Table 1. The Government intends to recompete the current BPAs as the subordinate commands continue to require small laboratory animals. This Multiple Award (MA) BPA will encompass the same scope of the current BPAs.

Table 1: Current Small Laboratory Animal BPAs BPA # Ordering Period Ends Contractor

1. W81XWH-15-A-0008 7 July 2020 Charles River Laboratories, Inc.

2. W81XWH-15-A-0009 7 July 2020 Covance Research Products, Inc.

3. W81XWH-15-A-0010 7 July 2020 ENVIGO RMS, Inc.

4. W81XWH-15-A-0011 7 July 2020 The Jackson Laboratory

1.1.2. This opportunity represents full and open competition in accordance with (IAW) Federal Acquisition regulation (FAR) 6.1. This MA-BPA will replace the current BPAs for small laboratory animals when the ordering period ends on 7 July 2020.

1.2. Scope

1.2.1. This MA-BPA is for the purchase of small laboratory research animals to support basic research and Good Laboratory Practices/Food and Drug Administration (GLP/FDA) studies for the USAMRMC and subordinate commands. The small laboratory animals are targeted for use in Animal Biosafety Level 2 (ABSL-2) through Animal Biosafety Level 4 (ABSL-4).

1.2.2. The small laboratory animals required under this MA-BPA include the following:

a. Mice

b. Rats

c. Rabbits

d. Guinea Pigs

e. Hamsters

f. Gerbils

1.2.3. The Government has determined the services required by this MA-BPA for the small laboratory animals are considered incidental to include vascular catheterization, device implants, electroencephalogram (EEG) / electrocardiogram (EKG), tattoos, and diagnostic services.

1.2.4. The Minimum Essential Characteristics (MECs) for the small laboratory animals are found in Attachment A of the SoN and will be defined for each Call Order.

1.2.5. The Contractor must ensure all animals delivered test negative for standard host specific protozoa, viral, and bacterial agents specific for each species, reference the MECs. The animals must be monitored by the Contractor and if the results of the tests are positive, the Contractor shall notify the Contracting Officer and the COR in writing within five (5) business days upon confirmation (Deliverable 1).

1.2.6. The Contractor prior to contract award shall have a facility that is certified by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) or Canadian Council on Animal Care (CCAC) in addition to U.S. Federal, State, and local regulations, laws and ordnances. The Contractor shall maintain accreditation and compliance with regulations, laws, and ordinances throughout the ordering periods of the BPA. The Contractor is to provide the Contracting Officer and the Contracting Officer’s Representative (COR) with a copy of the certification at the time of contract award and when recertification occurs thereafter (Deliverable 2). If AAALAC or CCAC accreditation becomes lapsed, suspended, or is terminated during the BPA ordering periods, the Contractor shall notify the COR in writing within three (3) business days of the event. The Contractor cannot perform under this MA-BPA or resultant Call Orders if the AAALAC is revoked.

1.2.7. The small animals must be from a domestic, qualified U.S. Department of Agriculture (USDA) licensed dealer or commercial breeder. The Government requires the Offeror to provide proof of certification of USDA licensed dealer or commercial breeder for the small animals at the time of BPA award and annual thereafter (Deliverable 3).

1.2.8. This SoN has been reviewed and contains no supplies or services that are inherently governmental functions, as defined in FAR Part 2.1.

1.2.9. Organizational Conflicts of Interest (OCI)

The U.S. Army Medical Research and Materiel Command (USAMRMC) has categorized all supply procurements into one (1) of the following three (3) as defined below, for purpose of identifying, avoiding or mitigating against Organizational Conflicts of Interests (OCIs) IAW FAR Subpart 9.5. These categories are defined as follows:

Category 1 - Program and/or Administrative Support. 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. 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.

Category 2 - Program Management Support. Services which assist in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business, process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3 - Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS Procurement and integration, internal development testing, deployment, installation, operations, and maintenance. 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.

This MA-BPA for small laboratory animals is identified as OCI Category 3 – Product Support. The Contractor shall perform a thorough comparative analysis of the potential new supply effort against all current and previous supply efforts performed in support of the subordinate commands and ascertain whether there is a possible conflict of interest.

If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide an OCI Mitigation Plan (Deliverable 4) as a means of preventing, avoiding, and mitigating each OCI identified.

2. General Requirements

a. Delivery. The Call Orders placed against the BPA shall identify the delivery address for the required small laboratory animals by the USAMRMC subordinate commands.

b. Ordering Periods. This MA-BPA will include five (5) ordering periods with an approximate start in July 2020 through July 2025.

2.1. Business Relations

The Contractor shall manage the timeliness, completeness, and quality of problem identification. The Contractor shall provide timely identification of issues and effective management of subcontractors (as applicable). The Contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all Contractor personnel providing support the resultant BPAs to include the Call Orders.

2.2. Contract Administration and Management

The following subsections specify requirements for BPA management and administration.

2.2.1. BPA Management

The SoN provides two distinct activities and functions: (1) Base BPA activities and (2) Individual Call Order activities. The Contractor shall appoint a single point-of-contact with the overall responsibility for BPA management including all Call Orders.

2.2.1.1. BPA Management Activities

a. Government Management of the BPA. The Contracting Officer will officially designate (in writing) a Contracting Officer’s Representative (COR) to oversee the base BPA. The Government’s BPA COR will have responsibility for:

(1) Ensuring evaluations are developed for performance of delivery for Call Orders.

(2) Providing advice and assistance in resolving any delivery issues that may arise from the award of the Call Orders.

(3) Initiating and coordinating global BPA changes such as changes in the paying office.

(4) Conducting other activities as specified in the COR appointment memorandum.

(5) Elevating to the Contracting Officer any problems that cannot be addressed by the COR.

b. Contractor Management of the BPA. The Contractor shall designate a single point-of-contact between the Government and the Contractor to oversee the Base BPA. The Contractor’s designated single point-of-contact shall be responsible for addressing BPA issues, quality issues, and overall Contractor performance. This may include coordination with the Contracting Officer, Contract Specialist, and the COR to resolve any issues that may arise, trends relating to the Base BPA or proposed changes or modifications to the BPA.

2.2.1.2. Call Order Management Activities

a. Government Management of the Call Order. The Contracting Officer will designate a Call Order COR at the USAMRMC subordinate command level for all Call Orders. This Call Order COR will serve as the primary point-of-contact for all activities and issues that occur under each Call Order issued for that USAMRMC subordinate command. The Call Order COR is responsible for:

(1) Serving as the primary technical point-of-contact for the Call Order, as required.

(2) Identifying the need for and sending Call Order modification requirements to the Contracting Officer, as required.

(3) Reviewing, and accepting or rejecting all Contractor deliveries provided under the Call Order.

(4) Serving as the approval and disapproval authority for receiving reports and invoices.

(6) Conducting Call Order surveillance activities.

(7) Conducting other activities as specified in the Call Order COR appointment memorandum.

(8) Elevating to COR any problems that cannot be adequately addressed by the Call Order COR.

2.3.1. BPA Administration

The Contractor shall establish processes and assign appropriate resources to effectively administer the requirement.

The Contractor shall respond to Government requests for contractual actions in a timely fashion. The BPA Administration Team will consist of the following members:

2.3.1.1. The Contracting Officer will have overall responsibility for administering the BPA. The Contracting Officer is the only person authorized to obligate the Government and make changes to the BPA. The Contracting Officer will manage BPA administration and performance delivery surveillance supported by BPA administrators and the COR.

2.3.1.2. The COR will be appointed in writing and will be directly responsible to the Contracting Officer. The COR serves as the Government’s point-of-contact for BPA-level coordination of administration and performance matters.

The COR will assist the Call Order COR in overseeing the administrative and performance of Call Orders as appropriate; assist the Call Order COR in resolving performance issues; initiate Call Order-level changes; notify the Contracting Officer of any disputes, performance issues, or contractual issues that cannot be resolved at the Call Order-level; and conduct other activities as specified by appointment.

2.3.1.3. The Call Order COR will be appointed in writing by the Contracting Officer and has specific technical, functional and oversight responsibilities for individual Call Orders. The Call Order COR will serve as the official point-of-contact for coordination for the Call Order; approve or disapprove Contractor invoices; approve executed invoices and receiving reports to the paying office designated in the Call Order; and conduct other activities as may be specified by the Contracting Officer.

2.4. Subcontractor Management

The Contractor shall be responsible for any subcontract management necessary to integrate work performed on this BPA and shall be responsible and accountable for subcontractor performance. The prime Contractor will manage the supply requirement to ensure there are no OCI considerations. Contractors may add subcontractors to their team and notification must be sent to the Contracting Officer and COR within 30 days of the agreement.

2.5. Federal Holidays

The following Federal holidays are observed and no supply deliveries shall occur on the dates specified. Any of the below holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday.

a. New Years Day, 1 January

b. Martin Luther King’s Birthday, 3rd Monday in January

c. President’s Day, 3rd Monday in February

d. Memorial Day, last Monday in May

e. Independence Day, 4 July

f. Labor Day, 1st Monday in September

g. Columbus Day, 2nd Monday in October

h. Veteran’s Day, 11 November

i. Thanksgiving Day, 4th Thursday in November

j. Christmas Day, 25 December

3. Inspection and Acceptance

3.1. The Government shall provide certification of satisfaction upon receipt the general laboratory supplies, chemicals, scientific and laboratory equipment, and animal supplies in accordance with the terms and conditions of the base BPA and all Call Orders issued against the BPAs. If the delivery fails to meet the specifications defined in the Call Orders, the delivery will be returned to the Offeror.

3.2. The COR or Call Order COR may reject or require correction of any deficiencies found in the invoice or receiving report. In the event of a rejected invoice or receiving report, the Offeror will be notified in writing with the specific reasons for rejection.

4. Government Purchase Card

The Contracting Officer and Government Purchase Card (GPC) Ordering Officer(s) are the only authorized buyers under this multiple award BPA. The position titles of the appointed GPC Ordering Officers will be defined at the time of BPA award. Call Orders issued by anyone other than the Contracting Officer and GPC Ordering Officer(s) will not be honored without prior written approval from the Contracting Officer.

5. Contractor Monthly GPC Order Report

The Contractor shall deliver a Monthly GPC Order Report (Deliverable 5) via e-mail to the Contracting Officer of all GPC Orders within five (5) calendar days after the close of each month. The reports shall include all GPC orders placed from the first day of the month to the last day of the month. Reports shall reflect, at a minimum, the following information:

Unique Order Number Date of Order Item Description(s) Total Dollar Amount of Each Order Authorized Ordering Official’s Name

6. Deliverables

6.1. The Contractor shall provide electronic copies of the deliverables as identified in Table 2 for the Base BPA.

Deliverables shall be specified by the Government.

Table 2: Base BPA Deliverables

E: Electronic H: Hard Copy TBD: To be determined

Del # SoN Reference Title Distribution E H Initial Subsequent

2 1.2.6. AAALAC or CCAC Certification

Contracting Officer and

COR

1 0 Contract award At the time of recertification

3 1.2.7. Certification of USDA License

Contracting Officer and

COR

1 0 Contract award Annual

4 1.2.9. OCI Mitigation Contracting Officer and

COR

1 0 Reference Section 1.2.9.

5 5. Monthly GPC Order Report

Contracting Officer and

COR

1 0 Reference Section 5.

6.2. BPA Call Orders. The Contractor shall provide electronic copies of the deliverables as identified in Table 3 for all Delivery Orders issued under the Contract.

Table 3: Call Order Deliverables E: Electronic H: Hard Copy TBD: To be determined

Del # SoN Reference Title Distribution E H Initial Subsequent

1 1.2.5. Test Results COR 1 0 IAW individual Delivery Order

7. Contractor Manpower Reporting (CMR) (SEP 2017)

The Contractor shall report ALL contractor labor hours (including subcontractor labor) required for performance of services provided under this BPA for the USAMRMC subordinate commands via a secure data collection site. The Contractor is required to completely fill in all required data fields using the following web address: 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.

The four Service-specific CMRA systems have been merged into one combined application. All user accounts and system data were transferred to the new consolidated Enterprise Contractor Manpower Reporting Application (ECMRA) at www.ecmra.mil.

Contractors may direct questions to the new ECMRA Support Desk at dod.ecmra.support.desk@mail.mil or obtain detailed instructions from the CMR Contractor Manpower Reporting User Guide available on the new eCMRA website www.ecmra.mil.

The Order Data tab on the CMRA Contractor Data Entry website will ask for the “Requiring Activity Unit Identification Code” (UIC). The Unit Identification Code (UIC) of the Requiring Activity that would be performing the mission if not for the contractor. This is not necessarily the Contracting Office, Contracting Administrative Office, or Funding Source. The UIC is not the same as the Department of Defense Activity Address Code (DODAAC).

The UIC of the Requiring Activity for this contract is TBD.

https://www.ecmra.mil/ https://www.ecmra.mil/ mailto:dod.ecmra.support.desk@mail.mil https://www.ecmra.mil/