Attachment_1_-_Performance_Work_Statement.pdf

PERFORMANCE WORK STATEMENT (PWS)

Title: Histology and Immunohistochemistry for Brain Injury

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

1. BACKGROUND

The Brain Trauma Neuroprotection and Neurorestoration (BTNN) Branch at Walter Reed Army Institute of

Research (WRAIR) conducts preclinical research identifying the pathophysiology processes of mild-severe traumatic brain injury (TBI), as well as, evaluating novel therapeutic strategies to diagnose and/or treat TBI occurring in military centric environments. The ultimate goal of these studies is to identify drugs or other forms of therapy which can transition to clinical products (i.e. biomarkers discovery and drug development). This bench-to-bedside strategy relies on the use of clinically, and militarily relevant, animal models of penetrating and concussive brain injury, e.g. the rat penetrating ballistic-like brain injury (PBBI) model and the rat projectile concussive impact

(PCI) brain injury model. In both of these TBI models, the occurrence of histological, cellular, and/or molecular changes in the brain are believed to be responsible for the underlying mechanisms of the secondary injuries, which are considered targets for therapeutic treatments. In order to identify and quantitatively measure brain injury induced histopathology (e.g. tissue tearing, lesion, or cavity) and cellular/molecular pathology (e.g.

neuroinflammation, axonal injury, blood brain barrier damage, etc.), the brain samples must be carefully prepared and processed for histopathology and immunohistochemistry analysis. Since our PCI and PBBI models represent different etiologies and severities, it is critically important to acquire a histological service known for its expertise in neuroanatomy, neurohistopathology and immunohistopathology. This service will be responsible for processing severely injured brain samples, containing lesions and cavities, while preserving the anatomical architecture for volumetric and immunohistopathological analysis (e.g. in the PBBI model), as well as, detecting subtle cellular and molecular changes in the brain which may not show gross tissue damage (e.g. for the PCI model).

The Blast-induced Neurotrauma (BINT) Branch use models to validate and characterize scaled experimental blast exposure conditions and assessments of outcomes relevant to blast-injured Warfighters. Investigators in this program conduct basic and applied research on the mechanisms of primary and secondary injury resulting from exposure to blast. Although most studies address the mechanisms of closed-head injury, much effort is also focused on the complex interactions among head injury, hemorrhage, and other body trauma. Through a variety of animal and other laboratory experiments and mathematical modeling techniques, program scientists work to develop standardized models of blast injury allowing better coordination of research across diverse laboratories, to develop high-fidelity simulations of head injury to speed research while limiting the need for animals studies, to better understand whether cellular and organ level processes in head trauma are a unique form of injury, and to develop recommendations for better Soldier protection, such as improved helmet design. The research priorities include:

develop a nationally and internationally recognized animal model of blast concussive injuries and determine if explosions produce a unique form of brain injury. Similar to BTNN, BINT will require immunohistochemistry to identify occurrence of histological, cellular, and/or molecular changes in the brain are believed to be responsible for the underlying mechanisms of the secondary injuries.

2. SCOPE

This Performance Work Statement (PWS) defines the requirements of procurement of technical expertise and support services necessary to perform histopathology and immunohistochemistry in support of the Brain Trauma, Neuroprotection and Neurorestoration Branch and Blast-inducted Neurotrauma, Center for Military Psychiatry and

Neuroscience, Walter Reed Army Institute of Research (WRAIR). The Contractor representative shall secure the provisions necessary to meet the government (BTNN, BINT) objectives and perform the tasks described in this

PWS. The Government will use a single-award, IDIQ contract type.

3. OBJECTIVES

The objective of this Performance Work Statement (PWS) is to establish and define the government’s requirements for histology and immunohistochemistry services provided by the contractor. These services include: rat, ferret, swine, and/or non-human primate tissue processing (brain and peripheral organs), various histological and immunohistological staining/labeling, and storage and preservation of spare tissues for later use. The tasks required for task orders are detailed below.

4. PERIOD OF PERFORMANCE

Base Period: 28 May 2018 – 27 May 2019

Option Period 1: 28 May 2019 – 27 May 2020

Option Period 2: 28 May 2020 – 27 May 2021

Option Period 3: 28 May 2021 – 27 May 2022

Option Period 4: 28 May 2022 – 27 May 2023

5. REQUIRED TASKS

The contractor shall accept government (BTNN and BINT) provided rat, ferret, swine, and/or non-human primate brain and peripheral organ samples for the required tasks described herein and process them in adherence to the

Quality Assurance Surveillance Plan (QASP). The contractor shall provide all services under Section 5.0.

The contractor shall deliver prepared, processed, and stained tissue each task listed below within 2-3 weeks after the contractor receives a Task Order with instructions from the government (BTNN and BINT).

5.1. Preparation and Processing

Rat, ferret, swine, and/or non-human primate brain or peripheral organs (including liver, kidney, heart, lung, urinary bladder and muscles) preparation for histological or immunohistochemicaly processing. (The cerebrum, cerebellum, brain stem, and olfactory bulbs are processed separately).

5.2. Hematoxylin & Eosin or Nissl Staining

Hematoxylin & Eosin (H&E) or Nissl staining of rat, ferret, swine, and/or non-human primate brain or organ tissues for evaluation of gross histopathology. The brain samples to be processed under this task are approximately 800 annually.

5.2.1. Upon receipt of instructions from the government, the contractor shall perform H&E staining or

Nissl on selected series of brain or organ sections prepared under Task 5.1 in accordance with standard or approved protocols and coverslip for delivery.

5.3. Colorimetric Immunohistochemical and Immunofluorescence Staining

The contractor shall provide colorimetric Immunohistochemical and immunofluorescence staining of rat, ferret, swine, and/or non-human primate brain or organ tissues for evaluation of cellular and molecular changes in the brain or peripheral organs after brain injuries. The tissue samples to be processed under this task are approximately 500 annually.

5.3.1. Upon receipt of instructions from the government, the contractor shall preform colorimetric immunohistochemical staining and immunofluorescence staining labeling (including immunofluorescence double or triple labeling as needed) on selected free-floating brain sections or paraffin-embedded organ sections prepared under Task 5.1 using standard or approved immunohistochemistry protocols and techniques to stain or label cellular and molecular markers for different aspects of brain or organ injuries. After staining each section, the contractor shall mount the stained sections on slides (2 sections per slide) and coverslip for delivery. The antibodies to be used for this task will be determined by the government as studies proceed. The contractor shall perform the following tasks:

a. The contractor shall perform immunohistochemical staining on brain sections (cerebrum, cerebella, brain stem, and olfactory bulb) or paraffin-embedded organ sections prepared under

Task 5.1.1 - 5.1.2 with 1 primary antibody.

b. The contractor shall perform immunofluorescence labeling (including double or triple labeling) on brain sections (cerebrum, cerebella, brain stem and olfactory bulb) or paraffin-embedded organ sections prepared under Task 5.1.1 - 5.1.2.

c. If necessary, the contractor shall perform testing and titration of primary antibodies for colorimetric and immunofluorescence staining requested by the government, using selected brain sections or organs prepared under task 5.1.

5.4. Other Neurohistological Staining

Other neurohistological staining may be performed to detect cellular and molecular markers in the brain after brain injuries upon receipt of instructions from the government. The brain samples to be processed under this task are approximately 200 annually.

5.4.1. The contractor shall perform histochemical stains on selected free-floating brain sections prepared under Task 5.1 using standard or approved protocols and techniques to stain or label cellular and molecular markers of different aspects of brain injuries. After staining, the contractor shall mount the stained sections on slides with a coverslip for delivery. The markers to be used for this task will be determined by the government as studies proceed.

5.4.2. The contractor shall perform Amyloid Plaque detection using Hirano Zimmerman method in the rat, ferret, swine, and/or non-human primate brains using the selected silver stained sections from task

5.4.1. After staining, the contractor shall mount the stained sections on slides with a coverslip for delivery.

5.4.3. The contractor shall perform Golgi staining on freshly collected rat, ferret, swine, and/or non-human primate brains. The contractor will provide all the necessary reagents that is required for processing the freshly dissected brains at the government site. The contractor will deliver ready to view slides after sectioning, staining and cover slipping the Golgi-Cox impregnated brain blocks.

5.4.4. The contractor shall perform neuronal apoptosis detection with in situ DNA nick end-labeling technique (TUNEL) in selected sections from Task 5.1.1. The government will provide unfixed-fresh frozen tissue and the contractor will section, stain and deliver ready to view TUNEL stained slides.

5.4.5. The contractor shall perform Fluoro-Jade staining in selected sections from Task 5.1.1. The government will provide brain tissue processed according to the companies protocol and the contractor will section, stain and deliver Fluoro-Jade stained slides.

5.4.6. The contractor shall perform Timm’s staining in selected sections from Task 5.1.1. The government will provide brain tissue processed according to the companies protocol and the contractor will section, stain and deliver Timm stained slides.

5.4.7. The contractor shall perform histological examination of mitochondrial enzymes or other mitochondria specific metabolic / oxidative / inflammatory biomarkers assays to detect in situ enzymatic activity / content in selected sections from Task 5.1.1. The government will provide unfixed-fresh frozen tissue and the contractor will section, stain and deliver ready to view mitochondria enzyme activity-stained slides.

5.5. Shipping and Handling

The contractor shall deliver the processed brain slides in slide boxes by commercial carriers or in person to the government facility outlined at the Task Order level.

5.6. Quality Control

The Offeror shall submit a Quality Control Plan (QCP). At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Offeror will use to maintain quality, timeliness, responsiveness, customer satisfaction, and any other requirements set forth in this solicitation. The QCP must include how it will ensure a high level of quality for all work performed in support of the performance work statement (PWS) and all deliverables. The QCP must also explain how the Offeror will handle any issues should they arise that include but are not limited to (1) proper tissue processing variables that must be addressed in order for the outcome to be consistent and free of artifacts and (2) incomplete fixation, which in turn may lead to improper dehydration, clearing, and infiltration. The QCP shall address potential issues that may arise when initial samples are sent to the laboratory, stored, and returned to the WRAIR scientists and meet the Quality Standards identified in the

PWS related to Pathology and Histological standards and Staining standards.

All laboratory technicians assigned to perform procedures in the laboratory shall be trained on SOPs for specific methods and all instruments are evaluated for peak shapes, sensitivity and proper run conditions prior to sample analysis as well as completed appropriate lab safety.

6. DELIVERABLES

6.1. The contractor shall complete and submit deliverables in accordance with the “Deliverables Table”.

DELIVERABLES TABLE

PWS

Ref.

Number Description Due

Erro r!

Refe rence sourc e not foun d.

Deliverable 1 OSHA 300A

The contractor shall complete and deliver the

OSHA 300A.

1 February of each year.

6.5 Deliverable 2 Government Purchase Card (GPC) Task

Order Reports

Monthly

6.2. 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.

6.3. Acceptance Criteria

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.

6.4. Task Order Deliverables

A Performance Work Statement (PWS) will be provided at the Task Order level with specific tasks based on section 5.0 of this document defining research objectives, description, quantity, anticipated delivery time and address.

6.5 GPC Task Order Reports (Deliverable 2)

Contractor shall provide monthly purchasing information to the COR and the contracting officer detailing products ordered by:

a. Order number and GPC Ordering Officer

b. Services Provided and catalog number (if applicable)

c. Services ordered per month and total dollar

d. Cumulative total of all orders

7. 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 performance requirements to measure the performance of the contractor at the Task Order level. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within a defined

“Performance Requirements Summary Matrix” (PRS Matrix).

8. TRAVEL

The contractor is not required or authorized to travel at Government expense as part of this contract.

9. GOVERNMENT FURNISHED EQUIPMENT

The government will furnish all rat brain and peripheral organ samples to be processed under this task order. The bio-samples must be approved by the accepting contractor prior to processing. Once accepted, the samples are in the custody, but not the ownership, of the receiving contractor. Data ownership is solely that of the government.

The government will furnish the antibodies which are required for specified tasks that are not commonly used by the vendor.

The government will coordinate all shipping and transportation of the samples to the contractor.

The government will expect all data to be archived by the contractor prior to acceptance by the government representative (COR).

10. WORK SCHEDULE AND LOCATION

10.1. Federal Holidays

The following are Federal Holidays:

New Year’s Day

Birthday of Martin Luther King, Jr.

Washington’s Birthday

Memorial Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving Day

Independence Day Christmas Day

10.2. Work Schedule

The WRAIR business hours are 8:00 am to 4:30 pm, Eastern Time.

10.3. Work Locations

The work location is contractor site.

11. CONTRACTING OFFICER’S REPRESENTATIVE

TBD

12. COMPLIANCE DOCUMENTS

NOT APPLICABLE

13. OTHER TERMS, CONDITIONS, AND PROVISIONS

13.1. Non-Personal Services

This award identifies services that are strictly non-personal in nature.

13.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

13.3. Inherently Governmental Functions

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

13.4. Organizational Conflict of Interest

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

Subpart 9.5. These categories apply to all enterprise laboratories (Armed Forces Research Institute of Medical

Sciences (AFRIMS), United States Medical Research Directorate – Kenya (USAMRD-K), and United States

Medical Research Directorate – Georgia (USAMRD-G). These categories are defined as follows:

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

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

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

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

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of

WRAIR rather than the WRAIR enterprise.

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

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

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

Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of

Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective

Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an CCI 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.

13.5. Invoices

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

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and

Acceptance application is the required method of submission.

13.6. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub

Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer. Business Program Management Office (PMO) approval for publication will require provisions that protect the intellectual property and patent rights of both

Business PMO and the Contractor.

13.7. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

13.8. 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.

13.9. Use of Military Rank by Contractor Personnel

Contractors may not use or allude to former or current military rank during the performance of this work.

13.10. Data Rights

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

13.11. Section 508 Requirement

The Contractor shall comply with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d). Specifically, the procurement, development, maintenance, or integration of electronic and information technology (EIT) under this contract must comply with the applicable accessibility standards issued by the Architectural and

Transportation Barriers Compliance Board at CFR part 1194.

13.12. Contractor Manpower Reporting

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

http://www.ecmra.mil/

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY); this runs October 1 through September 30. While inputs may be reported any time during the FY, all http://www.access-board.gov/sec508/508standards.htm http://www.ecmra.mil/ data shall be reported no later than October 31 of each calendar year, beginning with 2016. Contractors may direct questions to the help desk at help desk at: http://www.ecmra.mill.

Register under the "All Other Defense Components" module. The Walter Reed Institute of Research (WRAIR)

Unit Identification Code (UIC) is W03KAA.

13.13. Anti-Terrorism and Operational Security

13.13.1. AT Level I Training.

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

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

13.13.2. Access and General Protection/Security Policy and Procedures.

This standard language text is for contractor employees with an area of performance within an Army controlled installation, facility or area. Contractor and all associated sub-contractors employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements 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.

14. ATTACHMENTS

Attachment 1 – Acronyms List

Attachment 2– WRAIR Organization Chart

Exhibit A – Price Sheet

Exhibit B – Participation Agreement http://www.ecmra.mill/ http://jko.jten.mil/

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 Information

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

NCIC-III National Crime Information Center Interstate Identification Index

NLT No Later Thank

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

SHARP Sexual Assault Prevention and Response Program

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-K United States Medical Research Directorate – Kenya

WAWF Wide Area Work Flow

WRAIR Walter Reed Army Institute of Research

ATTACHMENT 2– WRAIR ORGANIZATION CHART

Command Group

Command Staff

Overseas Operations Liaison

USAMC- AFRIMS,

Bangkok, Thailand

USAMRD-W,

Tacoma, Washington

USAMRD-K, Nairobi, Kenya

USAMRD-G, Tbilisi, Georgia

Science Education & Strategic

Communication

Support Divisions

Business Management

Human Resources

Human Subjects Protection

Logistics

Operations & Security

Information Management

Resource Management

Information Management

Center for Military Psychiatry and Neuroscience

Behavioral Biology

Military Psychiatry

Brain Trauma Neuroprotection & Neurorestoration

Blast Induced Neurotrauma

Research Transition Office

Center for Infectious Disease

Research

Military HIV Research Program

Military Malaria Research Program

Bacterial Diseases

Entomology

Preventive Medicine

Viral Diseases

Capabilities

Clinical Trials Center

Pilot Bioproduction Facility

Veterinary Services

Education