W81XWH-20-R-0024 FINAL.pdf

Section A - Solicitation/Contract Form

REQUIREMENT DETAILS

A.1 U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), has a requirement for diagnostic testing services for its research animal colonies at Fort Detrick, MD, and any other locations that houses any part of its research animal colony. Laboratory testing for animals includes but not limited to mouse, rat, hamster, guinea pig, rabbit, macaque, African green monkey and marmoset.

A.2 The Government anticipates this solicitation will result in the award of single Indefinite-Delivery-Indefinite-

Quantity (IDIQ) contract.

A.3 The “not to exceed” overall ceiling value of all task orders to be issued under the single award IDIQ contracts is $249,854.00. The ordering period consists of one five-year ordering period.

A.4 The North American Industry Classification System (NAICS) code is 541713, Research and Development in

Nanotechnology, and the size standard is 1,000 employees.

A.5 The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) shall be the primary customer for the single award IDIQ contract.

A.6 Copies of the Exhibits and Attachments listed in this solicitation may be downloaded from the Federal

Business Opportunities website ww.fbo.gov.

A.7 All questions should be directed to Arjun Bhalla, Arjun.bhalla.civ@Mail.mil no later than 13 August, 2020.

A.8 Orders placed by the GPC Ordering Officers using a GPC will not exceed $25,000.00.

GOVERNMENT PURCHASE CARD ORDER

INDEFINITE DELIVERY INDEFINITE QUANTITY (IDIQ) TASK ORDERS AND GOVERNMENT

PURCHASE CARD (GPC) ORDERING

1. DESCRIPTION

(a) The Contractor shall furnish services, if and when requested by the Contracting Officer or his authorized representative during the period specified in the clause below entitled "Effective Period". Purchases (which may be referred to as orders) made hereunder may be written or oral. The purchases shall reference this agreement and be numbered in accordance with DFARS Part 204, Subpart 204.70. Such orders shall include a description of the supplies or services being ordered; prices therefore; delivery schedule; FOB point; place of inspection and acceptance; preservation, packaging and marking requirements; designation of appropriations chargeable together with such other specifics covered elsewhere herein.

(b) Services will be identified on individual purchases issued in accordance with paragraph (a) above. Services purchased under this IDIQ shall be limited to the Performance Work Statement and Attachment 01 – Test Pricing.

2. EXTENT OF OBLIGATION

The Government is obligated only to the extent of authorized orders actually placed against this IDIQ.

3. PURCHASE LIMITATION

mailto:Arjun.bhalla.civ@Mail.mil

No individual order under this agreement shall exceed the simplified acquisition threshold. The anticipated collective maximum amount of all Task Orders/GPC issued against the IDIQ for the five (5) year ordering period will not exceed $249,854.00. The contractor agrees that the work performed under this IDIQ shall be accomplished within the specified ceiling price. Unless and until the Contracting Officer has notified the contractor in writing that the ceiling price has been increased and the amount of the increase, any costs incurred in excess of the ceiling price shall be borne by the contractor. Contractor entitlement to the monies specified as the IDIQ ceiling is derived solely from the issuance and successful performance of Orders against that ceiling amount.

Orders placed by the GPC Ordering Officers using a GPC will not exceed $25,000.00. All orders above

$25,000.00 must be issued by a Task Order.

The ceiling amount for this IDIQ is $249,854.00 which includes the maximum collective amount of all

Orders for the ordering period identified in Section 1.4, Table 1. Any costs incurred in excess above the ceiling amount of $249,854.00 will be borne by the Contractor. The Contractor agrees all supplies delivered under this

IDIQ will be accomplished within the ceiling amount.

4. INDIVIDUALS AUTHORIZED TO PLACE ORDERS AND DOLLAR LIMITATIONS

A list of names of individuals authorized to place orders under this agreement, identified by organizational component, and the dollar limitation per order for each individual shall be furnished to the contractor by the

Contracting Officer.

The following individuals are authorized to make purchases under this IDIQ:

a. Contracting Officer, U.S. Army Medical Research Acquisition Activity (USAMRAA)

b. Government Purchase Card (GPC) Ordering Officers for the USAMRIID.

5. INVOICES

An invoice shall be submitted at least monthly or upon expiration of this IDIQ, whichever occurs first, for all deliveries made during a billing period, identifying the delivery tickets covered therein, stating their total dollar value, and supported by receipt copies of the delivery tickets, depending the type of IDIQ order issued. If less than

$25,000, the invoice can be paid using a Government Purchase Card (GPC), if greater than $25,000, please follow the instructions in the IDIQ task order.

6. EFFECTIVE PERIOD

The ordering period for this IDIQ is five (5) years as identified in Table 1.

Table 1: IDIQ Ordering Periods

Ordering Period 1 02 October 2020 – 01 October 2025

7. The following named individuals are authorized to place individual orders, not to exceed the simplified acquisition threshold, under this agreement:

U.S. Army Medical Research Acquisition Activity (USAMRAA)

8. The following name individuals/organizations are authorized to place individual orders, using the Government

Purchase Card up to $25,000 or less:

USAMRIID with approval from the Contracting Officer

9. IDIQ ORDER ISSUANCE:

9.1. All services under this IDIQ will be set forth in Task Orders and/or GPC orders. All Orders will be issued in accordance with (IAW) the requirements and all clauses listed in this IDIQ. The Contracting Officer will order against the IDIQ through issuance of the Task Orders signed by the Contracting Officer. The Government will award Firm Fixed Price Task Orders under this IDIQ. IDIQ Task Orders will be executed in writing by the

Contracting Officer and transmitted either via facsimile or electronically via e-mail. The contractor shall acknowledge receipt via e-mail. Note that in the event of a GPC Order, the Contractor will be contacted directly by the Authorized GPC Ordering Officer.

10. IDIQ ORDERS/REPORTING:

10.1 Each IDIQ Task Order will require the minimum required documentation as listed in the USAMRAA Contract

Requirements Matrix as applicable.

10.2 Each Order will contain at a minimum the following information:

a. The date of order

b. Contract number and order number

c. Description of the requirement

d. Pricing Information

e. The anticipated period of performance/ delivery date

f. Accounting and appropriations data

g. Payment office address

h. Invoicing and acceptance instructions

i. Any other pertinent data

10.3 IDIQ Order Reports

Offeror shall provide monthly purchasing information to the COR and the contracting officer detailing services ordered by:

a. Order number and ordering/contracting officer

b. Services Provided

c. Services ordered per month and total

IDIQ ADMINISTRATION

1. PAYMENT

Payment procedures will be indicated on each Order.

2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The COR for the resultant IDIQ will be assigned via a separate appointment letter. A COR is anticipated for this requirement.

3. IDIQ MANAGEMENT

It is the contractor’s responsibility to notify the Contracting Officer (KO) immediately if there are any administrative changes such as contact information. Additionally, the contractor shall immediately contact the KO to request clarification when a question arises regarding the authority of any person to act for the KO under the resultant IDIQ.

4. INTERPRETATION OR MODIFICATION

No verbal or written statement by any person other than the KO, or his/her authorized representative acting within the scope of his/her authority, shall be interpreted as modifying or otherwise affecting the terms of this solicitation and the resultant IDIQs. All requests for amendments/modifications shall be made in writing to the KO or Contract

Specialist.

5. ORGANIZATIONAL CONFLICT OF INTEREST (OCI)

If any OCI arises during the Period of Performance, the vendor shall notify the Contracting Officer in writing.

Please be advised that the Government may not make an award that would result in a prohibited OCI. Therefore, offerors shall identify any and all potential OCI that arises from performing any aspects of the requirement as detailed in the SON and MECs, and include proposed means of preventing, avoiding or mitigating each OCI identified.

6. ORDERS

6.1. The contractor shall perform in accordance with the agreement schedule and as called for by Orders issued in accordance with the following procedures.

6.2. The DD 1155 or SF 1449 will be used to issue Task Order assignments and to signify Contracting Officer notification to commence work under the individual Task Orders. The contractor shall not proceed with the Task

Order assignments until notification is received from the Contracting Officer or authorized GPC Ordering Officers.

6.3. The Task Orders, and modifications to Task Orders, will be numbered by the issuing office. Modifications to the Task Order will be designated by the modification number and contain the original Task Order number.

6.4. The contractor shall identify all correspondence, reports, drawings, and other pertinent papers in connection with the IDIQ by imprinting thereon the Task Order and the IDIQ number, plus any other references furnished by the Contracting Officer.

6.5. The total of all completed and outstanding Task Orders will at no time exceed the current amount obligated.

6.6. Procedures:

6.6.1. Prior to issuance of a Task Order and upon definition of the Government requirement, either

a. the Contract Specialist will, in writing, issue to the contractors a Task Order Proposal Request (TOPR), or

b. an authorized GPC Ordering Officer will, in writing or verbally, issue to the contractors a Task Order TOPR

6.6.2. The contractor shall provide its Task Order quote to the Contract Specialist or authorized GPC Ordering

Officer by a date mutually agreed upon but no later than five (5) working days after receipt of the TOPR, unless otherwise specified.

6.6.3. The Government will award a Task Order to the offeror whose proposal is deemed most advantageous to the

Government based upon the evaluation factors defined in the Task Order TOPR.

7. IDIQ CEILING

The cumulative ceiling price of all IDIQ orders issued against this solicitation will be $249,854.00. The contractor agrees that the work performed under the resultant IDIQs shall be accomplished within the specified ceiling price. Unless and until the Contracting Officer has notified the contractor in writing that the ceiling price has been increased and the amount of the increase, any costs incurred in excess of the ceiling price shall be borne by the contractor. Contractor entitlement to the monies specified as the IDIQ ceiling is derived solely from the issuance and successful performance of Orders against that ceiling amount.

CLAUSES INCORPORATED BY REFERENCE

52.203-18 Prohibition on Contracting With Entities That Require Certain

Internal Confidentiality Agreements or Statements--

Representation

JAN 2017

52.203-19 Prohibition on Requiring Certain Internal Confidentiality

Agreements or Statements

JAN 2017

Section B - Supplies or Services and Prices

MAXIMUM CONTRACT VALUE

The maximum contract value = $249,854.00

ITEM NO SUPPLIES/SERVICES MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

0001 9,999 Job Lab Animal Sample Testing

FFP

See Attachment 1 - List of Tests

FOB: Destination

PSC CD: AN11

MAX

NET AMT

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

Laboratory Testing for Animals Including, but not limited to Mouse, Rat, Hamster, Guinea Pig, Rabbit, Macaque, African Green Monkey, Marmoset.

CORE SCIENCES, UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASE

SECTION 1, PURPOSE

1.1. Introduction

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Comparative Medicine Division houses and cares for thousands of animals per year. The USAMRIID Comparative Medicine Division is seeking

Clinical and environmental testing to be conducted on these animals and their housing facilities to ensure healthy research subjects are available for biomedical research and GLP and FDA studies

1.2. Mission

USAMRIID works closely with other The U.S. Army Medical Research & Development Command (USAMRDC) organizations, DoD, the Interagency (including Interagency Laboratories), and private companies to accomplish its mission of protecting the Warfighter from biological threats and being prepared to investigate disease outbreaks or threats to public health.

1.3. Background

The USAMRIID Comparative Medicine Division houses and cares for thousands of animals per year. Clinical and environmental testing is regularly conducted on these animals and their housing facilities to ensure healthy research subjects are available for biomedical research and GLP and FDA studies.

Optimum veterinary care is required for a research facility housing animals. Data are necessary to make medical and research decisions as well as support GLP and FDA studies. USAMRIID is obligated to meet these testing requirements, but has little current capabilities in this area.

Veterinarians at USAMRIID require many tests to ensure the animals are free from specific diseases. Due to the uniqueness of the animal species housed and their associated diseases, a contract with a commercial laboratory capable of testing for animal illnesses is necessary.

1.4. Scope of Work

The USAMRIID will use an Single Award (SA) Indefinite Delivery Indefinite Quantity (IDIQ) contract which will include Task Orders and/or Government Purchase Credit (GPC) orders. The orders awarded from the IDIQ will be

Firm-Fixed Price (FFP).

The USAMRIID requirement is for diagnostic testing services for its research animal colonies at Fort Detrick, MD, and any other locations that houses any part of its research animal colony.

The objective is to identify microorganisms associated with animals and to evaluate the status of the laboratory animals’ colony health or other environmental factors to ensure the animal colony’s good health.

The deliverables are test results and reference ranges from submitted samples.

The Contractor shall provide diagnostic testing services for USAMRIID’s laboratory animal colony include but not limited to chemistry testing, clinical pathology testing, colony antibody survey panels, customer assay development, environmental testing, hematology testing, histopathology testing, immunology testing, microbiology testing, molecular biology testing, plenum filter testing, and premortem health assessment.

Species for that testing may be required, including but not limited to:

Mouse

Rat

Hamster

Guinea Pig

Rabbit

Macaque

African Green Monkey

Marmoset

1.5. Organizational Conflict of Interest

1.5.1 Organizational Conflict of Interest (OCI) (Deliverable 1, Exhibit 1). This contract will be used to procure

U.S. Army Medical Research and Material Command products/services that falls within the scope of the PWS. The contractor shall provide an OCI certification with their proposal. If there is an OCI, the contractor shall provide a draft OCI Mitigation Plan with their proposal.

1.5.2 Non-Disclosure Statement (NDS) (Deliverable 2, Exhibit 2). The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor personnel may be required to sign specific non-disclosure statements as required by the contract. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

1.5.3. Organizational Conflict of Interest Requirements:

1.5.3.1. The Federal Acquisition Regulation (FAR) 9.5 (Organizational and Consultant Conflicts of Interest) prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving Organizational

Conflict of Interest (OCI), provides examples to assist Contracting Officers in applying these rules and procedures to individual contracting situations; and implements Section 8141 of the 1989 Department of Defense Appropriation

Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a Contractor's judgment and preventing unfair competitive advantage. An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses --

1.5.3.1.1. Proprietary information that was obtained from a Government official without proper authorization; or

1.5.3.1.2. Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract.

1.5.3.2. The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

1.5.3.2.1. It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the

Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

1.5.3.2.2. Contractors shall sign a Non-Disclosure Agreement (Deliverable 2, Exhibit 2) at the start of their performance on the contract.

1.5.3.2.2. If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/02.htm#P10_603 connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

1.5.3.2.3. If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractors act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

1.5.3.2.4. If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service, unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

1.5.3.2.5. If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services, unless proper safeguards are established to ensure objectivity.

1.5.3.2.6. If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer.

1.5.3.3. The Contracting Officer has significant discretion as to the acceptability of any Mitigation Plan

(Deliverable 1, Exhibit 1) offered.

1.5.3.3.1. Contractors are encouraged to present their best strategy for mitigation of any potential OCI under this contract. Contractors shall submit a Mitigation Plan (Deliverable 1) at the Contract level and update it as often as necessary throughout the life of the Contract.

1.5.3.3.2. The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan (Deliverable

1), in accordance with the requirements of FAR Subpart 9.5 to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan

(Deliverable 1) adequately protects the interests of the Government in the event of award to that Offeror, the

Offeror will be determined eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or Avoidance/Mitigation Plan (Deliverable 1), or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

1.5.3.3.3. If the Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI

(Deliverable 1) status and submit the certification with its proposal and any later award, if awarded the contract.

The Contractor shall also obtain a similar certification of OCI (Deliverable 1) status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

1.5.3.4. For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the

Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

1.5.3.5. Prior to a contract modification involving a change to the Performance Work Statement (PWS), or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

SECTION 2 GENERAL REQUIREMENTS

2.1. Performance

2.1.1. Period of Performance.

The ordering period for this IDIQ consists of five (5) years. The ordering period for this IDIQ consists of five (5) years. The Laboratory Testing services ID/IQ contract will have an ordering period consisting of one five-year base ordering period and one option in accordance with Federal Acquisition Regulation (FAR) 52.217-8, Option to

Extend Services. The ordering period for is as follows:

02 October 2020 – 01 October 2025

The ordering activity will use GPC to place orders during the ordering period.

2.2. 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.

2.3. Contract Management

2.3.1. Government Management. The Contracting Officer’s Representative (COR) and Alternate Contracting

Officer’s Representative (ACOR) 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. In the event that the COR is not available, the ACOR will assume the COR’s responsibilities.

2.3.2.1. 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.

2.3.2.4. The contractor shall provide a draft Quality Control Plan (QCP) (Deliverable 4) with their proposal and a final QCP no later than 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.

2.4. Reports

2.4.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered

Technical Data as defined in the applicable FAR clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

SECTION 3 PERFORMANCE REQUIREMENTS

The Contractor shall provide all labor, materials, equipment, and facilities (unless otherwise stated herein) to receive samples and complete the following tasks:

3.1 Chemistry testing

3.1.1. TASK: The contractor shall perform chemistry testing on furnished samples from the USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 4)

3.1.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.1.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15. Deliverables and Reports are in conformance with this PWS.

3.2 Clinical pathology testing

3.2.1. TASK: The contractor shall perform clinical pathology testing on furnished samples from the USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 4, 7)

3.2.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.2.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15. Deliverables and Reports are

3.3 Colony antibody survey panels

3.3.1. TASK: The contractor shall perform colony antibody survey panels on furnished samples from the

USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 3)

3.3.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.3.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15. Deliverables and Reports are

3.4 Customer assay development

3.4.1. TASK: The contractor shall perform customer assay development on furnished samples from the USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 10)

3.4.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.4.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15. Deliverables and Reports are

3.5 Environmental testing

3.5.1. TASK: The contractor shall perform environmental testing on furnished samples from the USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 5, 8, 9)

3.5.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.5.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15. Deliverables and Reports are

3.6 Hematology testing

3.6.1. TASK: The contractor shall perform hematology testing on furnished samples from the USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 4, 7)

3.6.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.6.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15. Deliverables and Reports are

3.7 Histopathology testing

3.7.1. TASK: The contractor shall perform histopathology testing on furnished samples from the USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 5, 7, 8)

3.7.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.7.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15. Deliverables and Reports are

3.8 Immunology testing

3.8.1. TASK: The contractor shall perform immunology testing on furnished samples from the USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 3, 5)

3.8.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.8.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15. Deliverables and Reports are

3.9 Microbiology testing

3.9.1. TASK: The contractor shall perform microbiology testing on furnished samples from the USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 4, 7, 8, 9)

3.9.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.9.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15. Deliverables and Reports are

3.10 Molecular biology testing

3.10.1. TASK: The contractor shall perform molecular biology testing on furnished samples from the USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 8, 9)

3.10.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.10.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15 Deliverables and Reports are

3.11 Plenum filter testing

3.11.1. TASK: The contractor shall perform plenum filter testing on furnished samples from the USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 5, 7, 8, 9)

3.11.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.11.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15 Deliverables and Reports are

3.12 Premortem health assessment

3.12.1. TASK: The contractor shall perform premortem health assessment on furnished samples from the

USAMRIID laboratory animal colony and/or its environment to evaluate the laboratory animals’ colony health status and ensure good health. (Deliverable 3, 5, 6, 7, 8)

3.12.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible reports that includes reference ranges for all values in conformance with industry standards when applicable.

3.12.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel may conduct periodic site visits of the laboratory and review reports to determine that all test results include reference ranges for all values in conformance with industry standards when applicable and outputs under Section 3.15 Deliverables and Reports are

3.13 OTHER TESTS

3.13.1. The contractor shall provide the any other tests on the published test list provided.

3.14 Invoices

3.14.1. TASK: The contractor shall provide invoices for services conducted to ensure timely payment. Invoices will be paid using the Government Purchase Card. (Deliverable 10)

3.14.2. TASK MEASUREMENT: Successful completion of this task requires the vendor to submit legible invoices that include purchase order number, item number, total due, and due date for each batch of samples submitted.

3.14.3. ACCEPTABLE QUALITY LEVEL: The appropriate Government personnel will conduct periodic site visits of laboratory or financial assessments to review reports and determine that test results include purchase order number, item number, total due, and due date.

The projected sample submission is 10-750 per month with seasonal variation.

The Government reserves the right to inspect the contractor’s facilities to verify the performance and to ensure compliance with all Federal, state, and local regulations, laws, and ordinances.

The Government, specifically the Comparative Medicine Division at USAMRIID, will request pick-ups as needed, Monday through Friday, by notifying the Vendor by phone or email by no later than 3:30 p.m. on the day prior to the date the pick-up is to occur. Please note that there will be no charge to USAMRAA for these courier services in support for this Contract.

3.15 DELIVERABLES AND REPORTS

The data will test results from different animal systems on a set of standardized laboratory equipment. The data will be analyzed to find the sources of variability and bias between the different animals.

The variability the results of tests will be reported with potential sources of variability from pathologist when applicable.

The automated instruments, training records of individuals performing these services, and SOPs used in the laboratory will be documented and verified.

3.16 DELIVERABLE DUE DATES

1. Serology – 7 days (may include colony antibody survey panels, immunology testing, and premortem health assessment) (Deliverable 3)

2. Comprehensive animal health services – 48 hours (may include chemistry testing, clinical pathology testing, hematology testing, and molecular biology testing ) (Deliverable 4)

3. PCR – 7 days (may include environmental testing, histopathology testing, immunology testing, plenum filter testing, and premortem health assessment) (Deliverable 5)

4. Histopathology – 21 days (may include premortem health assessment ) (Deliverable 6)

5. Parasitology services – 14 days (may include clinical pathology testing, hematology testing, histopathology testing, microbiology testing, plenum filter testing, and premortem health assessment) (Deliverable 7)

6. Microbiology services – 12 days (may include environmental testing, histopathology testing, microbiology testing, molecular biology testing, plenum filter testing, and premortem health assessment) (Deliverable 8)

7. Environmental sample testing – 12 days (may include environmental testing, microbiology testing, molecular biology testing, and plenum filter testing) (Deliverable 9)

8. Invoices – 10 days (Deliverable 10)

3.17. Performance Requirement Summary Matrix

PWS Ref Indicator Standard Acceptable

Quality Level

Method of

Surveillance Incentive

3.1 -

Chemistry

Testing

Perform chemistry testing services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.2 -

Clinical

Pathology

Testing

Perform clinical pathology testing services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.3 -

Colony

Antibody

Survey Panels

Perform colony antibody survey panels services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.4 -

Customer Assay

Development

Perform customer assay development services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.5 -

Environmental

Testing

Perform environmental testing services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.6 -

Hematology

Testing

Perform hematology testing services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.7 -

Histopathology

Testing

Perform histopathology testing services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.8 -

Immunology

Testing

Perform immunology testing services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.9 -

Chemistry

Testing

Perform microbiology testing services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

3.10 -

Molecular

Biology Testing

Perform molecular biology testing services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.11 -

Plenum Filter

Testing

Perform plenum filter testing services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.12 -

Premortem

Health

Assessment

Perform premortem health assessment services on samples furnished on

USAMRIID’s behalf to evaluate the status of the research animal colony’s health

Submit legible reports that includes reference ranges for all values in conformance with industry standards

All (100%) test results include reference ranges for all values in conformance with industry standards

User Survey, Random inspection, Potential periodic site visits

Past performance rating

3.14

(Invoices)

Provide invoices for services conducted

Submit legible invoices that include all pertinent information for payment processing

All (100%) invoices are submitted in a timely manner to ensure timely payment

Random inspection, Periodic Site

Visits

3.18. Quality Assurance Surveillance Plan. Every DoD contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality

Assurance. A QASP is a plan that specify the particular services the COR will inspect and the method(s) used to complete that surveillance. Each offeror shall digest the PWS in this RFP and offer a QASP associated therewith.

The QASP shall be submitted as part of the offeror’s technical proposal. It will not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

SECTION 4 SPECIAL REQUIREMENTS

4.1. Government Furnished Property

N/A

4.2. Maintain Safety, Security, and Biosecurity Standards

Established in 1969, USAMRIID has decades of experience operating containment laboratories and has provided extensive training and consultation to other agencies setting up their own facilities. USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity

Program is governed by a broad set of Federal, DoD and US Army regulations and policies. The program, which enables USAMRIID to safeguard both the biological materials we use in our laboratories and the personnel who work here, consists of the four key areas of biological safety, physical security, personnel reliability, and agent accountability.

There are four levels of biological containment, ranging from BSL-1, the lowest, to BSL-4, the highest. BSL-1 would be comparable to an open bench laboratory found in a school classroom—no special precautions would be needed. At BSL-2, USAMRIID employees wear laboratory coats and observe other basic precautions. For BSL-3 work, personnel are required to wear approved PPE and comply with established biosafety standards.. Other personal protective equipment may be required as well, depending on the tasks to be performed. BSL-4 is the highest level of containment, and employees wear positive-pressure encapsulating suits and breathe filtered air as they work.

In addition, a combination of rigorous training, meticulous procedures, tight security, carefully designed structures, and elaborate and redundant operating systems is in place to protect laboratory workers. These measures also ensure the safety of those outside the suites. Investigators working in USAMRIID laboratories are and must be highly trained to follow and comply with established safety, biosafety and biosecurity procedures.

Investigators in the laboratories study tiny amounts of infectious agents and the diseases they cause in order to develop vaccines, treatments and diagnostic tools. USAMRIID's research involving infectious agents is reviewed and approved by the Institutional Biosafety Committee, the Animal Care and Use Committee, the Portfolio Review

Committee, and other internal and external reviewers as applicable. No studies can take place without careful examination of all protocols to assess risks.

Personnel with the appropriate, government-required training and certification to operate in biocontainment environments are not readily available in the commercial marketplace and are unique to the extremely small number of laboratories worldwide that perform research in BSL-3 and -4. As described above, approved work in biocontainment suites and using biological select agents and toxins requires stringent background checks, health screening, enrollment in specialized reliability programs, and mentored hands-on training. It takes an extensive amount of time and government effort for a new staff member to become fully trained and operational, and there is inherent risk that new personnel will not meet the stringent security and reliability program requirements.

Security

Security

USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority.