A02-PWS_Pharmacological_Studies_on_Anti-Parasitic_Drugs.docx

PERFORMANCE WORK STATEMENT

Contents

PWS

PERFORMANCE WORK STATEMENT (PWS)

Title: Pharmacological studies on anti-parasitic drugs

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Experimental Therapeutics (ET) Branch

1. INTRODUCTION

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

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

2. PURPOSE AND BACKGROUND

The Experimental Therapeutics (ET) Branch is part of the Walter Reed Army Institute of Research (WRAIR). The mission of the ET Branch is to discover and develop new pharmaceutical agents to protect military members from death, disease, and injury. The ET Branch is the nation’s primary developer of new drugs to prevent and/or treat malaria and leishmaniasis. Collectively, ET engages in drug discovery, drug efficacy and mechanism evaluation, and formal preclinical and clinical development.

This requirement under the Department of Drug Discovery specifically involves research of pharmacokinetics, efficacy, and toxicity of antiparasitic drugs in animals for the novel prophylactic and therapeutic drugs to prevent and treat various malarias. The rodent studies address efficacy and toxicities of the selected drug candidates, and the relationship of their dose levels with their efficacy and toxic effects.

3. SCOPE

This requirement includes assisting investigators with the performance of efficacy, pharmacokinetics and toxicity studies of various prophylactic or therapeutic drugs of antimalarial agents carried out through in vivo efficacy, pharmacokinetics, acute and subacute toxicity in rodents. The blood and selected tissue samples from animals shall be assayed by in vivo image system (IVIS) and flow cytometry system for efficacy projects. The contractor shall conduct pharmacokinetics and toxicity studies and shall use the information obtained to choose doses for repeat-dose studies, providing preliminary identification of target organs of toxicity and occasionally revealing delayed toxicity. The proposed study in rodents addresses efficacy and toxicities of the selected candidates and the relationship of their dose levels with their efficacy and toxic effects. The contractor shall also provide operational support for laboratories to include but not limited to developing reports and publication, dissecting mosquitoes, taking biological samples, and collecting and analyzing data.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows: One (1) twelve month base period for twelve (12) Months and four (4) twelve (12) month option periods.

5. WORK SCHEDULE AND LOCATION

The main work location is at the Walter Reed Army Institute of Research, Experimental Therapeutics Branch, Department of Drug Discovery at 503 Robert Grant Avenue, Silver Spring, MD 20910. The contractor’s workweek shall be the normal forty (40) hours per week, eight (8) hours per day, between the hours of 0800 and 1700, with flexibility based on experimental time points, excluding vacation and sick time. The lunch period shall not exceed one hour and shall be taken between the hours of 1100 and 1300. Work may be required on weekends due to schedule of protocols and animal monitoring needs. If this is to occur the contractor shall notify the COR in advance to request approval.

5.1. Telecommuting

Telecommuting is not authorized under this contract.

5.2. Working During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Managers to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, including base closures, the Contractor Manager shall promptly open an effective means of communication with the COR to verify:

a. Key points of contact (Government and Contractor)

b. Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

c. Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

d. Essential duty personnel for emergency and contingency operations

e. Essential work products expected to continue production by priority

The Contractor Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

5.3. Federal Holidays

The contractor shall not work on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander unless preapproved by the COR and deemed necessary to monitor protocols or ongoing experiments (i.e. animal studies, etc.).

Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays:

· New Year’s Day

· Birthday of Martin Luther King, Jr.

· Washington’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

· Christmas Eve

5.4. Post Closure

On-site contractor personnel will not be designated as Mission Essential and will not work during post closures unless preapproved by supervisor and deemed necessary to monitor protocols (i.e. animal studies, etc.). All non-mission essential contract employees shall not report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

The objective is for the contractor to assist the ET branch with the execution of efficacy, pharmacokinetics, and toxicity studies of various prophylactic or therapeutic drugs of antimalarial agents.

6.2. Animal Studies

The contractor shall assists Investigators with the following animal studies:

6.2.1. Assist and conduct animal studies of 8 antimalarial drugs in rodents on toxicity

6.2.2. Assist and conduct animal studies of 50 antimalarial prophylactic drugs in rodents on efficacy

6.2.3. Assist and conduct animal studies of 32 antimalarial drugs in rodents on pharmacokinetics (PK)

6.2.4. Assist and conduct animal studies of 6 long-term release formulations in rodents on efficacy and PK, respectively

6.2.5. Perform animal studies of antimalarial drugs with prophylactic effect on liver-stage efficacy with new animal model of in vivo imaging system (IVIS) with intravenous infection in mouse tail vein with C3H, C57BL/6 and ICR mice models

6.2.6. Perform animal studies of antimalarial drugs with therapeutic effects on blood-stage efficacy (Thompson Test) with single or multiple dose therapies in rodent.

6.2.7. Perform various animal studies of antimalarial drugs on pharmacokinetics

6.2.8. Perform various animal studies of antimalarial drugs on acute and subacute toxicity

6.3. Pharmacokinetics, Toxicity, and Efficacy Projects

The contractor shall work on three projects related to pharmacokinetics, toxicity and one project related to efficacy by using in vivo image system in animals. The contractor shall perform the following tasks:

6.3.1. Assist and perform animal studies on efficacy, bioavailability and pharmacokinetics of novel and best selected antimalarial drugs (new prophylactic agent to malaria) in rodents following single or multiple intravenous and intragastric administrations.

6.3.2. Assist and perform pre-GLP acute and subacute toxicity and toxicokinetics studies of novel and best selected antimalarial drugs (new prophylactic agent to malaria) in mice or rats following single or multiple intravenous and intragastric studies.

6.3.3. Assist and use the in vivo image system (IVIS) and flow cytometer (FCM) to measure sporozoites infection and blood parasitemia samples. Report initial statistics and data to PI for drug suppression, partial, and full curative activities.

6.3.4. Assist and perform the high-performance liquid chromatography (HPLC) and to measure drug concentration from various bio-samples (urine, blood, plasma and tissues). Report initial statistics and data to PI for drug PK parameters and profile.

6.3.5. Perform in vivo imaging system (IVIS) every other day to evaluate all liver-stage antimalarial drugs

6.3.6. Perform flow cytometry machines (FCM) to evaluate all blood-stage antimalarial drugs

6.3.7. Perform high-performance liquid chromatograph (HPLC) machines to analyze pharmacokinetic samples

6.3.8. Maintain and run IVIS machine and flow cytometry to evaluate drug effects on malaria parasites in rodent liver and blood stages

6.3.9. Maintain and run HPLC system for measuring PK samples and analysis

6.3.10. Perform infection, dosing, and surgery on the rodents.

6.4. Research Support Tasks

Throughout the period of performance, the contractor shall perform the following tasks:

6.4.1. Provide operational support for 3 laboratories, maintaining and callibrating equipment, handling all chemicals and reagents, and assisting the principal investigators, technicians, fellows, and students in various projects;

6.4.2. Train new lab fellows, technicians and students;

6.4.3. Take various bio-samples during all studies for clinical and pathological tests

6.4.4. Fill data in computer database and report to PI for further developments

6.4.5. Collect data, analyze data, and report study results. Analyze the biological results, tabulate results, and graphically represent the data, thus facilitating the formulation of conclusions.

6.4.6. Establish Standard Operation Procedures (SOP) for each study, new equipment, and new experiment. Develop laboratory SOPs for safety monitoring and report any safety issues.

6.4.7. Assist and perform mosquito dissection, including dissecting 80 mosquitos weekly to obtain one million of malaria parasites (sporozoites) for infection

6.4.8. Provide inspection support (quarterly and yearly) on study SOPs and safety monitoring while work is in process, and maintains complete records of inspections.

6.4.9. Develop research and project reports and provides support writing manuscripts and reports for publication. Provide statistical results or for various projects, gives oral or poster presentations in scientific conferences, and presents manuscripts for peer review publications

6.5. Reporting Requirements

6.5.1. Study and Data Research Reports (Deliverable 1): The contractor shall produce study research reports as needed for conferences, meetings, and scientific publications (reference CDRL A001).

6.5.2. Monthly Report (Deliverable 2): The contractor shall provide a monthly report detailing all work performed, and where there is critical or significant data related to the provided support. The report shall include a progress report on each project, inspection reports, all study data and results, final versions of any documents created (e.g. SOPs), and a detailed list of all hours worked and workload accomplished in support of all tasks.

6.5.3. Annual Report (Deliverable 3): On a yearly basis, the contractor shall provide a report which outlines the status of all project milestones including the following:

a. Animal studies worked on during the reporting period

b. Status of ongoing pharmacokinetics, toxicity, and efficacy projects as outlined in the performance requirements above;

c. Problem Areas encountered and appropriate resolutions;

d. Other Relevant Issues: Any other detail necessary to adequately assess performance will be reviewed and input will be shared with the contractor to the extent required to resolve any outstanding issues.

e. Mitigation plan to resolve issues identified.

6.6. Contract Manpower Reporting Application (CMRA) (Deliverable 4).

This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the Contractor will report ALL Contractor manpower (including sub- Contractor manpower) required for performance of this contract. The Contractor is required to completely fill in all the information in the format using the following web address: (You will need to create a login user-ID and password) https://Contractormanpower.army.pentagon.mil. The required information includes:

1. Contracting Office, Contracting Officer, Contracting Officer's Technical Representative

2. Contract number, including task and delivery order number;

3. Beginning and ending dates covered by reporting period;

4. Contractor name, address, phone number, e-mail address, identity of Contractor employee entering data;

5. Estimated direct labor hours (including sub-Contractors);

6. Estimated direct labor dollars paid this reporting period (including sub-Contractors);

7. Total payments (including sub-Contractors);

8. Predominant Federal Service Code (FSC) reflecting services provided by Contractor (and separate predominant FSC for each sub-Contractor if different);

9. Estimated data collection cost;

10. Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the Contractor with its UIC for the purposes of reporting this information);

11. Locations where Contractor and sub-Contractors perform the work (specified by zip code in the United States and nearest city, country, when in an overseas location, using standardized nomenclature provided on website);

12. Presence of deployment or contingency contract language; and

13. Number of Contractor and sub-Contractor employees deployed in theater this reporting period (by country) As part of its submission, the Contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not to exceed twelve (12) months ending 30 September of each government fiscal year and must be reported by 31 October of each calendar year.

Contractors may use a direct XML data transfer to the database server or fill in the fields on the website. The XML direct transfer is a format for transferring files from a Contractor's system to the secure web site without the need for separate data entries for each required data element at the web site. The specific formats for the XML direct transfer may be downloaded from the web site.

7. DELIVERABLES

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

DELIVERABLES TABLE

7.1. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable DFAR clause 252.227-7013, Rights in Technical Data-Noncommercial Items. . All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

7.2. Inspection and Acceptance

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

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

7.3. COR Information

TBD at time of award

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

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

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

Performance Requirements Summary Matrix

Frequency: On the due date of each report as outlined in the deliverables table.

Past Performance

6.2, 6.3, 6.4

Frequency: Monthly Past Performance

9. TRANSITION SUPPORT

9.1. Incoming Transition Plan

The Contractor shall provide support for 30 days of incoming transition. The Contractor shall coordinate with the Government in planning and implementing a complete transition to the Contractor's support model. This transition support shall include, but is not limited to the following items as applicable:

a. Coordination with Government representatives,

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

c. Transition of historic data to new Contractor system,

d. Government-approved training and certification process,

e. Transfer of hardware warranties and software licenses,

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

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

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

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

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

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

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

9.2. Outgoing Transition Plan

The Contractor shall provide outgoing transition support for 45 days of outgoing transition for transitioning work from an active award to a follow-on contract/order or Government entity. This transition may be to a Government entity, another Contractor or to the incumbent Contractor under a new contract/order. In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract to a successful provider. This shall include formal coordination with Government staff and successor staff and management. It shall also include delivery of copies of existing policies and procedures, and delivery of required documents, metrics and statistics. This support shall include, but is not limited to:

a. Coordination with Government representatives,

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

c. Transition of historic data to new Contractor system,

d. Government-approved training and certification process,

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

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

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

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

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

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

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

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

m. Summarized final report

10. KEY PERSONNEL

The contractor shall provide Key Personnel in accordance with the minimum requirements listed within the Key Personnel table.

Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have the necessary experience and knowledge required to perform the duties defined herein. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance. Substitution or replacement personnel shall be replaced with 30 days.

Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

KEY PERSONNEL TABLE

· The contractor shall have the ability to operate and manage in vivo animal studies of antimalarial and antileishmanial drugs.

· The contractor shall have knowledge of the development, execution, and interpretation of animal models for drug discovery, lead optimization, and development.

· The contractor shall have the ability to maintain and perform analysis on pharmacokinetic samples using HPLC machines.

· The contractor shall have knowledge of drug development and specific knowledge of IVIS system in malaria, pharmacokinetic, and toxicity with technical skills and competencies in animal research models requiring intravenous injection to small animals and performance of pharmacokinetic and toxic animal models (rodents and dogs)

11. OTHER DIRECT COSTS (ODCs) Not Applicable

12. GOVERNMENT FURNISHED PROPERTY

Government Furnished Equipment (GFE) includes a computer. Government provided computers will be profiled for WRAIR network access, will be CAC enabled, will have VPN access, and will have access to any relevant software, shared drives, and SharePoint sites.

The Government will also provide the contractor with access to the needed facilities, SOPs and policies, supplies, and equipment (e.g. HPLC, FCM, IVIS) needed to carry out the tasks in this PWS.

The Contractor shall maintain a detailed inventory accounting system for GFE. The inventory accounting system must specify, as a minimum: product description (make, model), Government tag number, date of receipt, name of recipient, location of receipt, current location, and contract/order number under which the equipment is being used. The Contractor’s inventory listing must be available for Government review within one business day of COR request.

12.1. Return of Government Furnished Equipment

The contractor shall return CACs, WRAIR Picture ID Card, keys, and key fobs for employees no longer supporting the contract and/or on contract expiration. Specifically, the contractor shall, within two business days of employee no longer supporting the contract and/or on contract expiration, return:

a) CACs to WRAIR Security office;

b) WAIR Picture ID Card to WRAIR Security office;

c) Keys to the WRAIR key custodian; and

d) Key Fobs to the WRAIR key custodian.

NOTE: If the contractor does not returned items a-d within 2 business days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

13. CONTRACT MANAGEMENT

13.1. Government Management

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

13.2. Contractor Management

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

13.3. Contractor Organization

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

13.4. Contractor Vacant Positions

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

13.5. Foreign Nationals

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform. A background investigation must be completed in its entirety before unescorted access to the facility is granted. Government computer access will not be approved until a background check is done. Typically, a background check cannot be performed on a foreign national unless the individual has lived in the United States for three (3) of the last five (5) years.

14. COMPLIANCE DOCUMENTS

14.1. General Compliance

14.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Material Command (USAMRMC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

14.1.2. Occupational Safety and Health Administration (OSHA)

The contractor shall comply with Occupational Safety and health Administration Standard Number 1904.32. The contractor shall deliver the 300A by February 1 of each year (Deliverable 5).

14.1.3. DoD Compliance Documents

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

14.2. Research Involving Animals

The WRAIR/NMRC Institutional Animal Care and Use Committee (IACUC) must review and approve all animal use before starting work in accordance with (IAW) DoDI 3216.01 Use of Animals in DoD Programs, and other applicable regulations and policies.

14.2.1. DoD 3216.01, Use of Animals in DoD Programs

14.2.2. Army Regulation 40-33, The Care and Use of Laboratory Animals in DOD Programs

14.2.3. Animal Welfare Act (AWA) (USC Title 7, Ch 54, Sect 2139-2159)

14.2.4. Animal Welfare Regulations (CFR 9, Ch 1, Parts 1-4)

14.2.5. Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals

14.3. Information Technology Compliance

14.3.1. Army Regulation 25-1, Information Technology

Compliance information regarding Army Information Technology may be found at: http://armyhpubs.army.mil/epubs/25_Series_Collection_1.html

14.3.2. Army Regulation 25-2, Information Assurance

Compliance information regarding Army Information Assurance may be found at: https://ia.signal.army.mil/docs/AR25-2.pdf

14.3.3. Cyber-security

Department of Defense (DOD) Instruction 8500.01 Cybersecurity

14.3.4. Risk Management Framework

Department of Defense (DOD) Instruction 8510.01 Risk Management Framework (RMF) For DOD Information Technology (IT Department of Defense (DoD) Instructions 5400.11-R, Privacy Program http://www.dtic.mil/whs/directives/corres/pdf/540011p.pdf

14.4. Medical and Laboratory Compliance

14.4.1. Army Regulation 340-21, Army Privacy Program

Compliance information regarding Army Privacy program may be found at: http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

14.4.2. Research Integrity and Misconduct

DOD Instruction 3210.7, Research Integrity and Misconduct, 14 May 2004.

14.4.3. Pathology Inspection

College of American Pathologists Inspection Checklists. http://www.cap.org

14.4.4. Laboratory Standards

Clinical Laboratory Standards Institute. Standards and Guides for Laboratories: http://clsi.org/standards

14.4.5. Laboratory Requirements

Title 42 Part 493 Laboratory Requirements, 1 October 2011 https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html

14.4.6. Financial Disclosure by Clinical Investigators

Title 21 CFR Part 54 Financial Disclosure by Clinical Investigators https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

14.4.7. Bloodborne Pathogens

Title 29 Part 1910.1030 Bloodborne Pathogens; 1910.1200, Hazard Communication; 1910.132 Personal Protective Equipment https://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910

14.4.8. Category B Infectious Substances

Title 49 CFR Part 173.199 Category B Infectious Substances https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol2/pdf/CFR-2015-title49-vol2-sec173-199.pdf

15. REFERENCE DOCUMENTS

a) Department of Defense Directive 6485.01, Human Immunodeficiency Virus, June 7, 2013. http://www.dtic.mil/whs/directives/corres/pdf/648501p.pdf

b) Department of Defense Instruction 6440.02, Clinical Laboratory Improvement Program (CLIP) Manual, May 29, 2014. http://www.dtic.mil/whs/directives/corres/pdf/644002p.pdf

c) Department of Defense Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standard in D00D-Supported Research. http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf

d) Army Regulation 600-110, Identification, Surveillance, and Administration of Personnel Infected with Human Immunodeficiency Virus, 22 April 2014. http://www.apd.army.mil/pdffiles/r600_110.pdf

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

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

g) US Medical Entrance Processing Command Regulation 40-8, Department of Defense (DOD) Human Immunodeficiency Virus (HIV) Testing Program and Drug and Alcohol Testing (DAT) Program http://www.mepcom.army.mil/ASP/pubnform.asp?topic=Regulations&sort=pubNo

16. OTHER TERMS, CONDITIONS, AND PROVISIONS

16.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

16.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

16.3. Inherently Governmental Functions

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

16.4. Acquisition Functions Closely Associated with Inherently Governmental Functions Not Applicable for this Award.

16.5. Organizational Conflict of Interest

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

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

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

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

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

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

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

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

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

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

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

This requirement is categorized as ISOLATED SUPPORT.

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

For the purposes of this contract, the contractor shall complete and sign the organizational conflict of interest document (Exhibit 2) if the contractor is a co-author or contributor to a publication or is named in a patent application.

The Contractor shall ensure that the Participation Agreement (see Exhibit 3) either A and / or B as identified on each award, is signed by all staff assigned to or performing on an award before performing any work, including all subcontractors and consultants. The Participation Agreement shall be cosigned by a corporate official (contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor and the COR will immediately initiate a CDR.

16.6. Invoices

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

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

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

16.7. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

16.8. Contractor Identification

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

16.9. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

16.10. Data Rights

The Government will retain rights to all data produced during this contract.

16.11. Anti-Terrorism and Operational Security

16.11.1. AT Level I Training

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

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

16.11.2. Access and General Protection Policy and Procedures

Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office.

Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204-9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

a) For contractors requiring CAC. Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

b) For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014-05/AR 190-13); applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative); or, at OCONUS locations, in accordance with status-of-forces agreements and other theater regulations.

16.11.3. iWATCH Training. This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area.

The contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance, with the results reported to the COR NLT 30 calendar days after contract award.

16.11.4. Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to Government information systems.

All contractor employees with access to a Government info system must be registered in the ATCTS at commencement of services and must successfully complete the DoD Information Assurance Awareness prior to access to the information system and annually thereafter.

16.11.5. For Contracts That Require an OPSEC Standing Operating program.

The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan within 90 calendar days of contract award, to be reviewed and approved by the responsible Government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it, and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander. In addition, the contractor shall have an identified certified Level II OPSEC coordinator per AR 530-1.

16.11.6. For Contracts That Require OPSEC Training.

Per AR 530-1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

16.11.7. For IA/IT training.

All contractor employees and…