ATTACHMENT_1_-_PWS.pdf

ATTACHMENT #1

PERFORMANCE WORK STATEMENT (PWS)

FOR

CLINICAL TRIALS CENTER SUPPORT SERVICES

Single Award-Indefinite Delivery Indefinite Quantity (SA-IDIQ) Contract for

Walter Reed Army Institute of Research (WRAIR)

CONTENTS

1.0 INTRODUCTION

2.0 PURPOSE AND BACKGROUND

3.0 SCOPE & OBJECTIVE

4.0 PERIOD OF PERFORMANCE

5.0 WORK SCHEDULE & LOCATION

6.0 PERFORMANCE REQUIREMENTS

7.0 MANAGEMENT REPORTS AND PLANS

8.0 DELIVERABLES

9.0 QUALITY ASSURANCE

10.0 TRANSITION SUPPORT

11.0 KEY PERSONNEL

12.0 TRAVEL

13.0 GOVERNMENT/CONTRACTOR FURNISHED PROPERTY

14.0 GOVERNMENT & CONTRACT MANAGEMENT

15.0 COMPLIANCE DOCUMENTS

16.0 OTHER TERMS, CONDITIONS, AND PROVISIONS

17.0 TRAINING AND SECURITY REQUIREMENTS

18.0 OTHER DIRECT COSTS (ODCs)

19.0 SPECIAL REQUIREMENTS

20.0 CONTRACT ADMINISTRATION DATA

21.0 ACRONYMS

PERFORMANCE WORK STATEMENT (PWS)

Title: Clinical Trials Center Support Services

Requiring Activity: Walter Reed Army Institute of Research (WRAIR), Center for Enabling Capabilities (CEC), Clinical Trials Center (CTC)

1.0 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 headquarters is dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland. The Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense. Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

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

2.0 PURPOSE AND BACKGROUND

WRAIR is the largest and most diverse biomedical research laboratory in the Department of Defense (DoD). The main facility, the Daniel K. Inouye building, is located in Silver Spring, Maryland. Other laboratory and clinical facilities carry out research in Asia, Africa, and Europe through cooperative partnerships with a host of governments and militaries through the U.S. State Department. WRAIR’s greatest resources are the dedicated scientists, clinicians, and support personnel who make up the core of WRAIR today. By integrating basic research and advanced technology for the primary goal of protecting the Warfighter, WRAIR serves as the premier biomedical research organization within the DoD. The institute hosts the Centers for Infectious Disease Research (CIDR) and Center for Enabling Capabilities (CEC), and Center for Military Psychiatry and Neuroscience (CMPN) research. Laboratories are also hosted in subordinate directorate locations in Washington state, Thailand, Germany, the Republic of Georgia and Kenya.

A portion of WRAIR’s research, through the enabling capabilities of the CTC, undergoes pre-clinical testing, a phase involving laboratory studies (in vitro) and tests on animals, designed to show that experimental drugs are considered safe and effective. As the Principal Investigators (PI) and other research staff design the clinical study, they consider what they want to accomplish for each of the different clinical research phases and begin the non-commercial Investigational New Drug (IND) process, which is a regulatory process they must go through before clinical research begins. After 30 calendar days during which the Food and Drug Administration (FDA) reviews to assure that research subjects will not subjected to unreasonable risk, the sponsor may initiate the clinical trial (Phase I) where the CTC begins evaluating interventions (medical, surgical, or behavioral) to be tested in humans (first in humans). CTC’s knowledge capacity extends beyond Phase I upward to Phase IV (for drugs or devices taking place after the FDA approves their use). Clinical trials, Phases I thru IV, which may include safety testing, effectiveness, dosing, and population safety, must be performed in accordance with applicable Federal law, DoD and Command regulations, and policies. The objective is to obtain FDA approval and maintain this status at each phase with the ultimate objective of licensure for commercial application.

Clinical trial efforts have been primarily focused at WRAIR, and within the National Capitol Region (NCR), an increasing number of collaborations have been requested throughout the military healthcare system (MHS) as a result of its long-standing expertise and productivity. Projections for our Continental United States-based (CONUS) network expansion include a number of existing Military Treatment Facilities (MTF) with active departments of clinical investigation and/or infectious disease or epidemiology staff as well as other military clinical research entities. The volume and composition at each site will determine the expected staff capability mix (e.g., physician investigator, clinical research coordinator, laboratory technician, etc.) with overall project coordination and analyses continuing through the CTC.

Our clinical trial network capitalizes on the existing capabilities and track record of the WRAIR CTC and is aligned with the approaches taken by other successful federal and academic institutions. Multisite trials also allow for a diversity of study participants, efficiency of study completion (e.g., can fill studies earlier when carried out at more than one location) and meeting regulatory compliance requirements.

Staffing at these sites may be accomplished in coordination with other funded DoD investigative efforts, or provide stand-alone support for project enrollment and completion. Regulatory or subject matter expertise support may also be provided to WRAIR’s subordinate Outside the Continental United States (OCONUS) laboratories. Projections for the first five (5) years include five (5) CONUS (MTFs) and one

(1) OCONUS MTFs. Individual Memorandums of Understanding (MOUs) will be developed for each site at the task order level as required.

The following CONUS MTFs have been identified as potential trial sites:

Military Treatment Facilities (MTF) Location 1 WRAIR, U.S. Medical Research Directorate (USAMRD-W) –

Joint-based Lewis McChord 9933A West Johnson Street Tacoma, WA 98431

2 U.S. Medical Research Directorate (USAMRD) - Madigan Army Medical Center (MAMC)

9040 Jackson Avenue Tacoma, WA 98431

3 William Beaumont Army Medical Center (WBAMC) 5005 North Piedras Street El Paso, TX 79920

4 Womack Army Medical Center (WAMC) 2817 Reilly Road Fort Bragg, NC 28310

5 Tripler Army Medical Center (TAMC) 1 Jarrett White Road Honolulu, HI 96859

6 Brooke Army Medical Center (BAMC) 3551 Roger Brooke Drive Fort Sam Houston, TX 78234

7 United States Army Medical Research Institute of Infectious Diseases (USAMRIID)

1425 Porter Street Frederick, MD 21702

OCONUS site support would likely begin with offering centralized statistical support at the WRAIR CTC followed by project-specific on-site tasks supported by Principal Investigator, Clinical Research Coordinator and Laboratory Technician augmentation.

The following OCONUS subordinate laboratories for statistical support include, other laboratories could be added as WRAIR’s mission changes:

WRAIR Subordinate labs Location

8 WRAIR, United State Medical Research Directorate (USAMRD) Armed Forces Research Institute of Medical Sciences (AFRIMS)

Bangkok, Thailand

9 WRAIR, United State Medical Research Directorate – Republic of Georgia (USAMRD-G)

Tbilisi, Georgia

10 WRAIR, United State Medical Research Directorate –Africa (USAMRD- A)

Nairobi, Kenya

3.0 SCOPE & OBJECTIVE

This Performance Work Statement (PWS) provides for regulatory, clinical, and technical clinical trial support services. These support services cover the full range of clinical, manufacturing, and regulatory professional disciplines necessary to perform the work efforts specific in this PWS. Except for government furnished property, the Contractor shall provide support services to include but not limited to all personnel, supplies, tools, equipment, materials, and supervision necessary to perform regulatory, clinical, and technical clinical trial support services.

4.0 PERIOD OF PERFORMANCE

The estimated period of performance is:

Period of Performance Dates Base Period (5 years) 22 Jul 2019 – 21 Jul 2024 Option Period 1 (12 months) 22 Jul 2024 – 21 Jul 2025 Option Period 2 (12 months) 22 Jul 2025 – 21 Jul 2026

5.0 WORK SCHEDULE & LOCATION

5.1 Performance Location. WRAIR, Silver Spring, MD (prime location), Contractor facility and additional performance locations based on mission need.

5.2 Additional estimated performance locations:

Military Treatment Facilities (MTF) Location 1 WRAIR, U.S. Medical Research Directorate (USAMRD-W) –

Joint-based Lewis McChord 9933A West Johnson Street Tacoma, WA 98431

2 U.S. Medical Research Directorate (USAMRD) - Madigan Army Medical Center (MAMC)

9040 Jackson Ave Tacoma, WA 98431

3 William Beaumont Army Medical Center (WBAMC) 5005 North Piedras Street El Paso, TX 79920

4 Womack Army Medical Center (WAMC) 2817 Reilly Road Fort Bragg, NC 28310

5 Tripler Army Medical Center (TAMC) 1 Jarrett White Road Honolulu, HI 96859

6 Brooke Army Medical Center (BAMC) 3551 Roger Brooke Drive Fort Sam Houston, TX 78234

7 United States Army Medical Research Institute of Infectious Diseases (USAMRIID)

1425 Porter Street Frederick, MD 21702

WRAIR Subordinate labs Location

8 WRAIR, United State Medical Research Directorate (USAMRD) Armed Forces Research Institute of Medical Sciences (AFRIMS)

Bangkok, Thailand

9 WRAIR, United State Medical Research Directorate – Republic of Georgia (USAMRD-G)

Tbilisi, Georgia

10 WRAIR, United State Medical Research Directorate –Africa (USAMRD- A)

Nairobi, Kenya

5.3 Telecommuting. In accordance with FAR 7.108 “Additional requirements for telecommuting,” telecommuting is permitted. The Contractor is authorized to enable contract staff to telecommute when onsite presence is not required. The Contractor shall provide adequate oversight of work products to ensure contract adherence. Contractors shall have formal telework policies in place if telework is employed. The Contractor shall ensure that all of its employees, including subcontractor employees, working under this contract are informed of the substance of this Section. If the Contractor believes any action or communication has been given that would create a business ethic or conduct violation, the Contractor shall notify the Contracting Officer (KO) immediately of this communication or action. Reference WRAIR’s telework Policy (Attachment 10).

5.3.1 Telework arrangements shall commence with the Contracting Officer Representative’s

(COR) concurrence the following conditions:

Telecommuting on the part of the company is voluntary.

Telecommuting shall not result in an increase in contract price.

The Contractor is responsible for continuity of performance in accordance with the terms of the contract.

Company requests to telework shall first be approved by the Contracting Officer and/or the COR.

The Contractor shall safeguard all Government-furnished property and information for the duration of the contract and abide by WRAIR’s Virtual Private Network Policy (see Attachment 9).

At the end of each telework day, the Contract employee shall summarize completed work/tasks and submit to the Project Manager, which shall be made available to the COR upon request.

Teleworkers must exercise care in transporting and storing all non-public information, ensuring it is safeguarded. Controlled unclassified information, including personally identifiable information (PII) and Privacy Act information, shall be transported and stored only in encrypted form using WRAIR-approved hardware and software encryption solutions. Non-public government information shall NOT be stored on personally-owned equipment, devices, or storage media. Telecommuters shall apply approved safeguards to protect Government property, records, and non-public information from unauthorized access, disclosure, sharing, transmission or damage and will comply with the Privacy Act requirements set forth in the Privacy Act of 1974, Public Law 93-579, codified at Section 552a, Title 5 U.S.C. Violation can result in adverse action, fines, and/or criminal prosecution.

5.4 Federal Holidays

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

5.4.2 Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday;

holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed:

New Year’s Day, 1 January Martin Luther King’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, last Monday in May Independence Day, 4 July Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, 11 November Thanksgiving Day, 4th Thursday in November Christmas Day, 25 December

5.5 Duty Hours

5.5.1 Contractor personnel shall perform services during normal duty hours, which are defined as those between 6:00am and 6:00pm, Monday through Friday. However, the Contractor may need to adjust the work schedule of its employees to minimize delays meeting trial deadlines or on an “as needed” basis during the duration performance in order to meet specific protocol requirements. On-site contract personnel shall perform services during normal duty hours.

5.5.2 Contractor personnel shall perform services during a 24-hour period, not to exceed 12 consecutive hours, to accommodate study requirements (e.g., challenge trials that require overnight study participant stays).

5.5.3 Overtime. It is expected that the contractor shall manage its work schedule within the forty-hour work week. Overtime, should it be required, must be pre-approved by the Contracting Officer. The contractor shall provide all documents to support the need for overtime in a specific situation to the COR and Contracting Officer.

5.6. Contractor Identification.

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

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

6.0 PERFORMANCE REQUIREMENTS

The contractor shall provide services in support of CTC ’s clinical trials capacity, phases I through IV, which may include safety testing, effectiveness, dosing, and population safety, must be performed in accordance with applicable Federal law, DoD and Command regulations, and policies. The objective is to obtain FDA approval and maintain this status at each phase with the ultimate objective of licensure for commercial application.

OVERARCHING TASK. The contractor shall develop, implement, maintain, and insure compliance with the Standard Operating Procedures (SOPs), be knowledgeable and compliant with all Human Subjects’ Protection, FDA, and Current Good Clinical Practice (cGCPs) regulations as well as ensure its personnel remain trained and up-to-date in their prospective field(s). The integration of the SOPs, rules, procedures, and guides provides the regulatory basis over each awarded task order for clinical trials/ research protocols and shall be part of the FDA approval submissions.

The following tasks are likely components of each clinical trial/research protocol. These task are determined during the planning phase of each clinical trial/protocol. Clinical trials/research protocols may involve one or more of the tasks:

Task 1: Technical Support Services The contractor shall provide qualified personnel to implement all aspects of clinical trial activities in compliance with human subjects’ protection regulations and provide a level of quality that will result in successful regulatory submissions for product development. The Contractor shall prepare and manage submissions to regulatory agencies in support of the product development process. Submissions and document management practices shall comply with all regulatory requirements and be performed to a level of quality that will result in successful advancement of products in the development process. Additional assistance to support the mission in the form of staffing or specialized services may occur on an as needed basis. The Contractor shall provide qualified staff to prepare and manage the documents required for submissions to the Sponsor and Food and Drug Administration (FDA), provide support for general administrative activities, technical services, laboratory work, SOP preparation, internal quality reviews, and document preparation required for human subjects’ protection purposes.

Task 2: Protocol Compliance The Contractor shall ensure that all clinical trial protocols are compliant with regulatory standards and ethical principles. Documents and management processes shall comply with regulatory requirements, both Federal and DoD-specific. Submissions shall be made in coordination with the integrated product teams (IPTs) when appropriate, sponsor representatives, and participating scientists. Prepared documents shall be appropriate for the purpose, accurate in content, and timely in submission. Records of the processes and archives of the products shall be maintained according to quality and applicable standards such as Current Good Clinical Practice (cGCPs), Current Good Manufacturing Practices (cGMP), and Current Good Laboratory Practices (cGLP) regulations. Information provided about regulatory processes and practices shall be accurate, timely, and delivered with good customer service practices. The contractor shall ensure that all sponsor documents are in compliance with SOPs, including training requirements.

Task 3: Professional Licensures, Certifications and Medical liability Insurance (Deliverable 20) The contractor shall indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance by maintaining medical liability insurance.

The contractor shall provide credentialed Registered Nurses licensed to practice in the state of Maryland (or applicable duty location), who are skilled and qualified in nursing procedures to include, but not limited to phlebotomy and the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314. The contractor shall provide Physicians with unrestricted licenses to practice in the state of Maryland (or applicable duty location) in support of all clinical trials. All qualified personnel shall meet all credentialing requirements in accordance with Clinical Trial Monitoring of FDA Regulated Clinical Trials Policy (Command Policy Memorandum 2011-59), Army Regulation (AR) 40-68, Clinical Quality Management, issued 26 Feb 2004, WRAIR Command Policy Memorandum 2017-45, “Walter Reed Army Institute of Research Quality Policy,” and U.S. Army Medical Research Material Command (USAMRMC) Command Policy 2010-07, “Licensure, Credentialing and Privileging (LCP)” issued 10 Mar 2015, or revisions thereof. The contractor shall ensure all licenses and certifications are current, active, and valid.

All certifications shall be valid in each duty location and must be valid at the time of contract award. The Contractor shall ensure that all personnel maintain their licensure, certification, and/or registration throughout contract performance. The contractor shall maintain and document all specified certifications, licenses, and continuing education requirements to ensure the Contractor staff maintains the quality of their technical skills. The contractor shall make available, upon request by government personnel and as needed for protocol submissions, records of mandatory training, certifications, and licensures.

Task 4: Recruiting and Advertising The contractor shall enroll sufficient numbers of healthy, qualified volunteers to meet the requirements of all clinical studies. The Contractor shall devise and implement recruiting strategies to identify potential research volunteers and provide valid estimates of their cost. The contractor shall have the capability of designing and producing effective advertising products to be used in modern media venues. Advertising shall be done within defined study budget parameters as well ethical and legal guidelines. All advertising materials shall be approved by WRAIR’s Public Affairs Office in accordance with WRAIR Command Policy Memorandum 2014-27, “Publication-Presentation Clearance,” or revision thereof.

Task 5: Volunteer Compensation The contractor shall provide payment to volunteers with funds that reside in U.S. dollars and are Federal Deposit Insurance Corporation (FDIC)-insured, for screening or participating in ongoing research studies in accordance with the amounts and schedule(s) specified in each protocol. Payments shall be tracked and auditable in accordance with all applicable Internal Revenue Service (IRS) reporting requirements.

Volunteers shall receive full payment authorized for study visits at the completion of the visit in a form that each volunteer can access their payment immediately, do not need a bank account to use, and can be accepted universally. Payments to volunteers shall be made by the contractor Monday through Friday, between 6:00am and 3:00pm Eastern hours. The Contractor shall track payments with a method that is conveniently accessed by the COR and Principal Investigators (PIs) to document correlation between actual visit date and payment date, payment amount, and specific study visit. The contractor shall have or shall develop a volunteer payment tracking system that provides complete transparency to the Sponsor, Clinical Research Organization (CRO), PI, COR as well as Defense Contract Audit Agency (DCAA).

Task 6: Post-donation and Post-vaccination Snacks and Beverages The contractor shall provide snack-sized food items and beverages to all volunteers approved to participate in randomized, control trials and blind studies. For screening trials involving laboratory tests that check blood, urine, and other body fluids and tissues, the contractor shall furnish beverages and snacks (e.g., water, juice, coffee, cookies, and pastries) to ensure the donor’s blood pressure has adjusted and blood sugar levels are elevated prior to the donor departing. Additionally, in the event of extended observation periods, offsite residential studies, and/or post-vaccination, the contractor shall provide an adequate supply of food and water to ensure volunteers are rid of any and all pollutants resulting from the study and are not subject to excess time without nourishment.

Task 7: Arrange Offsite Residential Accommodations The contractor shall arrange for offsite accommodations (e.g., hotel, leased space, etc.) necessary to implement residential research studies. The Contractor shall make all appropriate arrangements to secure the needed accommodations to house the volunteers and support personnel required to fully comply with protocol procedures. All offsite locations shall be preapproved by the COR and USAMRAA Contracting Officer. The contractor shall ensure all offsite facilities are clean, in a safe location, and can be conveniently accessed by all volunteers and support staff.

Task 8: Clinical Laboratory Services The contractor shall provide College of American Pathologists (CAP) / Clinical Laboratory Improvement Amendments (CLIA) certified clinical laboratory testing to support research studies with turnaround times and reporting methods equivalent to a standard clinical setting (reference 21 CFR 11, 50, 54, 56, 312, and 314). The contractor shall obtain supplies and equipment essential to conducting cGLP testing in a cost-effective and timely manner. The contractor shall provide, either directly or through subcontracting, CAP/CLIA certified laboratory support services and the necessary supplies to carry out clinical laboratory testing as described in protocols, to include routine clinical tests and highly specialized laboratory tests.

The contractor shall provide all CAP/CLIA certifications annually to the COR.

Task 9: Design Study Forms The contractor shall provide source documents and case report forms for studies meeting data collection needs of each protocol. When required for a study, the contractor shall work with teams of investigators and Sponsor personnel to design study forms that collect the required data for each study. The contractor shall provide printed or electronic forms in a format that promotes efficient and accurate data entry. The contractor shall ensure processes exist to quickly revise forms when required and provide printed or electronic replacements. The contractor shall ensure that all study forms meet Sponsor specifications for data entry and FDA regulations for submission.

Task 10: Statistical Support Services The contractor shall develop a Statistical Analysis Plan (Deliverable 1) and Program Validation Plan (Deliverable 2) that contain statistical programming specs and the statistical programs used to produce the tables, listings and figures (TLFs) as well as all ad hoc analyses and reports requested by the Sponsor and/or the FDA. The contractor shall consider coding conventions and formats used in the statistical programs.

The plan shall include data populated TLFs (for the study clinical study report, the data monitoring committee, the FDA annual reports, and other sponsor/FDA statistical requests) and all required components for the submission of data to FDA in the FDA-required format. The document shall be in Clinical Data Interchange Standards Consortium (CDISC) format and shall include define.xml (define.pdf), Study Data Tabulation Model (SDTM), Analysis Data Model (AdaM), and the Reviewer’s Guide. The statistical programs used to create the CDISC data sets shall be provided along with the programming specs.

The Standard for Exchange of Nonclinical Data (SEND) for all non-clinical data submission is required and shall be used for all communications and/or statistical products for sponsor requests/queries; all communications and/or statistical products for FDA requests/queries; statistical review of protocol;

statistical review of clinical study report, biostatistics project management; and review of TLFs prior to database lock.

Task 11: Records Management The contractor shall be responsible for the management of clinical study records (e.g., Clinical Trial Master File) through final archival, ensuring compliance with current regulatory requirements such as FDA and Army guidelines. With a focus on inspection readiness, the Contractor shall receive, catalog, organize, digitize, and retire archival holdings and shall be responsible for preparation of documentation required for regulatory agency inspection, internal requests, and audits. The Contractor shall establish and develop active, continuing records management by performing lifecycle management of CTC regulatory records.

Review and keep current on relevant laws, rules, and regulations. Coordinate with external and internal monitors, maintain compliance with specific protocol, SOPs, regulations and guidelines. Develop and/or edit appropriate SOPs/policy letters/finding aids as well as provide periodic quality assessments and document management oversight.

Task 12: Clinical Monitoring The contractor shall review information related to the site qualification, review issues at the study site, perform a site initiation visit with the Sponsor/Investigator, conduct an interim monitoring visit and perform close-out visits. The information shall be provided to the COR prior to qualifying the site for a clinical trial as a Clinical Monitoring Plan (Deliverable 3). The contractor shall provide clinical monitoring staff who are knowledgeable in investigational product, protocol, consent form and any other written information given to the participant, sponsor’s SOPs, and GCP and the relevant regulatory requirements.

Task 13: Subject Matter Experts (SMEs) and Consultants The contractor shall be responsible for hiring subject matter experts (SMEs) and Consultants for professional consultation services to support the successful development and execution of clinical trials, which shall be pre-approved/coordinated with the COR. The Contractor shall provide SMEs and Consultants who are an experts in their field and are able to advise clinical trial staff members and participate at the professional level on scientific studies.

Task 14: Phlebotomy The contractor shall perform phlebotomy for simple and full blood unit collections using standard techniques (e.g. straight and/or butterfly needles) and universal precautions for approved research protocols as well as for specimen preparation. The contractor shall ensure phlebotomy personnel adhere to universal precautions and infection control guidelines in the performance of all phlebotomy activities, to include gloving, disposal of needles and contaminated waste, and patient isolation requirements. The contractor shall follow proper procedures in the storage and disposal of needles and syringes. The contractor shall prepare, package and ship clinical specimens according to regulations, local policies and procedures.

Task 15: Regulatory Affairs The contractor shall prepare regulatory submissions required for product development and marketing new therapeutic modalities in both domestic and international markets. The contractor shall develop and implement strategies with the goal of regulatory submission approval. The contractor shall obtain all necessary approvals and marketing permits from the FDA as well as other pertinent regulatory offices in a timely manner that complies with product timeline goals. The contractor shall provide regulatory guidance and review as well as prepare related reports and briefs.

Task 16: Mobile Therapeutic Apheresis Services The contractor shall provide mobile apheresis services upon the request of WRAIR Government staff clinicians. The contractor shall provide all appropriate equipment, disposable supplies and skilled technician(s). The equipment shall be safe, effective, reliable, and shall be maintained by the contractor in accordance to the manufacturer’s expectations. Mobile Apheresis services shall include Plasmapheresis, Cytapheresis, Photopheresis, low density lipoproteins (LDL) Apheresis, and Hematopoietic Progenitor Cell (HPC) harvest.

Task 17: Financial Management The Contractor shall provide cost estimating and analysis support and guidance for projects. Support may include, but not limited to independent cost assessments of programs and projects and update trials estimates. The Contractor shall have or the ability to develop and maintain an integrated system of financial services including accounting, budgeting, and financial reporting. The contractor shall formulate, justify, and monitor the execution of trial budget plans, develop detailed estimates and narrative justifications as well as plan and monitor funds for program goals. The contractor shall have a system capable of tracking all clinical trial’s full cost and associated cost drivers. The contractor shall forecast clinical sites, subjects and project expenses.

Task 18: Microscopy Services The contractor shall provide advanced microscopy services. The contractor shall utilize appropriate microscopy standard operating procedures (SOPs), study specific procedures (SSPs), standard techniques and universal precautions for all research protocols. The Contractor shall work closely with the clinical research coordinator staff to ensure all laboratory needs of the study sponsor are in place before, during, and after all clinical trials. The contractor shall maintain a safe workplace ensuring that he/she practices all appropriate safety and occupational health rules and regulations.

Task 19: Clinical Trial Management System The Contractor shall provide access to electronic scheduling tool capable of meeting all volunteer scheduling needs, screening logs, screening status, appointment status, and be capable of providing reports necessary for clinical trial regulatory filings. In addition, the system shall be accessible to all clinical research monitors and have appropriate privacy safeguards to satisfy the Health Insurance Portability and Accountability Act (HIPAA) requirements. Data from any previously existing system shall be extracted/obtained and merged with any new/replacement systems in a timely, complete, and confidential manner.

Task 20: Administrative Support Services The contractor shall provide general administrative support which includes, but is not limited to processing travel requests, regularly update accountability reports, and conduct market research on consumable purchase requests. Assisting the government staff with formatting various memorandums and disseminating message notifying staff of specific milestones and deadlines. Greet and escort volunteers and provide direction as needed. Schedule and track study volunteer appointments and make reminder phone calls to volunteers regarding upcoming appointments. Prepare and/or assist in the design and update of various study documents. Maintain and update front desk and MS Outlook calendars as needed. Enter required data on Case Report Form (CRFs) and audit records for accuracy, resolve discrepancies, edit various documentation as necessary. Coordinate with external and internal monitors, maintain compliance with specific protocol, SOPs, regulations and guidelines. Regularly update personnel accountability reports. Enter required data in eCRFs and audit records for accuracy, resolve discrepancies, correct as necessary. Oversee and manage laboratory notebook distribution.

7.0 MANAGEMENT REPORTS AND PLANS

7.1 Contract Manpower Reporting (Deliverable 4).

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

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the WRAIR via 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), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2019. Contractors may direct questions to the help desk at: http://www.ecmra.mil/.

The Unit Identification Code (UIC) of the Requiring Activity for this contract is: W03KAA

The Department of Defense Activity Accounting Code (DODAAC) is: W74MYF

7.2 Quality Control Plan (QCP) (Deliverable 5)

The Contractor shall provide a QCP with their proposal. The QCP shall document how the Contractor will meet and comply with the PWS. At a minimum, the QCP should include: (a) self-inspection plan, which includes management of government furnished property (i.e. GFP) (b) an outline of the procedures that the Contractor will use to maintain quality, timeliness, deliverable timelines, responsiveness, and customer satisfaction, and (c) how their quality control approach identifies processes, procedures, and metrics, which are likely to result in successful outcomes within cost and on schedule. Additionally, the QCP shall indicate a strategy for recruiting, retaining, and backfilling qualified personnel to continuously meet government requirements.

7.3 Program Management Plan (Deliverable 6)

The Contractor shall develop a Program Management Plan. This plan is pre-approved by the COR and shall be applied by the Contractor to manage, track, and evaluate contract performance. The Program Management Plan shall consist of control policies and procedures in accordance with standard industry practices for project administration, execution, and tracking as well as policies and procedures specific to contract tasks and deliverables (i.e. training requirements, Contractor Manpower Reporting, monthly reports, etc.). The Program Management Plan shall be due thirty (30) calendar days post-award and shall contain, at a minimum, three (3) parts: Milestones, Management Approach, and Staffing Plan.

7.4 Task Order Management Plan (Deliverable 7)

The contractor shall create and maintain a Task Order Management Plan, per task order, which shall be used as a baseline for control of the project(s)/clinical trials. This plan shall be used to manage, track, and self-monitor contractor performance. The task order management plan shall document control policies and procedures for project administration, execution, surveillance (for quality control) and tracking. The task order management plan shall address: tasks; deliverables; quality control; schedules; security; risk strategy, management, and mitigation; and staffing. If the task order management plan is updated, it shall reflect changes from the prior task order plan and identify reasons for the change.

7.5 Contingency Operations Plan (Deliverable 8).

7.5.1 The Contractor shall prepare and submit a Contingency Operations Plan (COP). The

Contingency Operations Plan shall be due sixty (60) calendar days after the award of the base contract, and will be updated on a semi-annual basis. The COP shall document Contractor plans and procedures to maintain WRAIR support during an emergency to include situations when WRAIR facilities are not unavailable for use. The Contingency Operations Plan shall include the following:

A description of the Contractor’s contingency management procedures and policy;

A description of how the Contractor will account for their employees during a contingency situation;

Planned temporary work locations and/or alternate facilities;

Planned off site clinical trials support capabilities and timeline (to include proposed location, facility size, equipment, cost, exit strategy, and if government funded- Contractor operated or wholly Contractor owned);

How the Contractor will communicate with WRAIR during a contingency situation; and

A list of primary and alternate Contractor points of contact, each with primary and alternate:

1. Telephone numbers,

2. E-mail addresses;

3. Procedures for protecting Government furnished property (if any); and

4. Procedures for safeguarding sensitive and/or classified Government information (if applicable).

7.6 Meetings

7.6.1 Kick-off Meeting. The Contractor shall participate in the kick-off meeting in coordination with the Government within seven (7) business days after base contract award. The objective of the kick-off meeting is to review contract requirements, invoice, deliverables, points of contact, and answer contractor questions.

7.6.2 Program Review Meetings. The Contractor shall plan and conduct regular, routine meetings with a frequency of not less than quarterly with the Government to review progress and status of activities under this contract. Each review shall provide insight into expenditures, staffing, progress, risks, and status of GFP, including Contractor purchased, Government owned items. The Contractor shall provide project briefings addressing cost/price, schedule, performance, and status of each key element of this contract/task orders, noting any problems or risks and alternative and recommended solutions. The Contractor shall ensure that meeting materials are provided to Government participants prior to the meeting and that data presented at program reviews is current within ten (10) calendar days. The Government will provide a template for Program Review meeting materials after contract award.

7.6.3 Contract Discrepancy Meetings. The Government will issue a written Contract Discrepancy

Report (CDR) (reference Attachment 2 - QASP) when the contractor’s performance is found to be unacceptable. The COR will, within two (2) business days of discovery of a discrepancy, may call a meeting between the Program Manager, and any others, as appropriate, to address the unacceptable performance. The Government will, within two (2) business days of the meeting, prepare a CDR that explains the issue and documents the meeting discussion. This report will be sent to the Program Manager and to the Contracting Officer.

Within five (5) business days of receipt of the CDR, the contractor shall provide, to the COR and the KO, a written statement of the planned corrective action. The contractor shall take corrective action within two (2) business days after receipt of the Government-approved corrective action. If the contractor disagrees with the Government-issued CDR, the contractor shall explain, in writing, areas of disagreement to the COR and KO within five (5) business days of receipt of the Government-issued CDR receipt. Upon receipt of the contractor’s written disagreement, the KO will recommend action.

7.7 Reports.

7.7.1 Task Order Monthly Progress Report (Deliverable 9). The Contractor shall provide a monthly progress report, for each task order, detailing all work, including the subcontractor’s work, and where there is critical or significant data related to the provided support. The report shall be in accordance with content as identified in the specific task order. The report shall be submitted within 10 calendar days prior to invoice submission via e-mail using Microsoft Office products, e.g. MS Word, Excel, and PowerPoint, as needed. Each task order monthly report shall include the following:

Task Order number Name of COR Task completed Each employee’s name and position title Activities related to primary job responsibilities Summary of any other general operational or management problem areas and recommendations Presentations / Publications (if any) Milestone achievements (if any) Contract CLIN burn rate percentages List of official travel performed during the preceding billing period

7.7.2. Annual Report (Deliverable 10). The Contractor shall provide an annual report detailing all work, including the subcontractor’s, completed from the previous twelve (12) month period. The report shall be submitted via e-mail using Microsoft Office products, e.g. MS Word, Excel, and PowerPoint, as needed. Although there is no page limitation for the annual report, each report shall be of sufficient length to provide a thorough description of the accomplishments with respect to the PWS. Submission of the report in electronic format (PDF only) shall be submitted to the COR. The annual report shall have the following elements, in this order:

a. FRONT COVER

b. TABLE OF CONTENTS

c. INTRODUCTION: Narrative that briefly (one paragraph) describes the subject, purpose and scope of the support services.

d. BODY: This section of the report shall describe the accomplishments associated with each task order. At a minimum, the annual report must include the following:

i. Administrative Information.

1. Subcontractors. Identify and maintain subcontractor list. Identify sub-contractor(s) organization, cage code and technical point of contact. Identify newly added subcontractors and the date of KO approval.

2. Contract/Administrative POCs: Identify the name, organization, business address, business phone, business fax, and e-mail address of the administrative point of contact.

3. Accounting POCs. Identify the name, organization, business address, business phone, business fax, and e-mail address of the contact for financial data.

ii. Financial Information.

1. Incurred Expenses. Specify the expenses incurred during this reporting period

(direct and indirect costs on the awardee’s accounting system including labor, overhead, G&A, equipment purchases, travel, material, and any subcontract charges known by the prime).

2. Invoices. Specify the invoice date, number, and amount of each invoice submitted.

3. Indirects. Pursuant to FAR 42.705-1, Contracting Officer Determination Procedures and FAR 52.216-7, Allowable Cost and Payment, provide the projected date or timeframe when final indirect cost rate proposal will be provided to the KO (or cognizant Federal agency official) and to the cognizant auditor.

4. Provide confirmation that the Contractor’s Accounting, Purchasing, and Estimating systems are remain adequate in accordance with FAR and DFARS.

Reference Section H of the base contract.

iii. Deliverables.

1. Include a list of the following deliverables and the date they were provided:

Clinical Monitoring Plan Quality Control Plan, if updated Program Management Plan, if updated Contingency Operations Plan

CPARS

Transition Out plan Employee Participate Agreement, for newly added personnel HIPAA Training Copy of Medical Liability Insurance Policy

iv. Other Relevant Information

5. Issues or Concerns. Summarize any funding, technical, programmatic and other issues or concerns as well as recommended actions for Government consideration. Indicate if an anticipated funding increment has not been received.

6. Meetings and Presentations this Period. List all meetings (conferences, workshops, demonstrations, and other coordination meetings) participated in during the reporting period that were sponsored fully or in part by this contract.

For each meeting, specify the:

Meeting Name Meeting Purpose Meeting Start and End Dates Meeting Location (place and name of facility) Meeting Attendees from this project

8.0 DELIVERABLES

Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR. Note: Some task order deliverables may be required to be submitted in Contract Data Requirement List (CDRL) format/DD from 1423. This will be determined and specified at the task order level.

Deliverable No. & Attachment No.

PWS Reference

Description

Deliver To

Required at Base or T.O. level

Delivery Schedule

Deliverable 1 6.0, Task 10 Statistical Analysis Plan

COR T.O. level Five (5) calendar days

(includes stat programs used to create CDISC data set & programming specs) after Government request

Deliverable 2 6.0, Task 10 Program Validation Plan

(includes stat programs used to create CDISC data set & programming specs)

COR T.O. level Five (5) calendar days after Government request

Deliverable 3 6.0, Task 12 Clinical Monitoring Plan

COR Base level Prior to qualifying any location for a clinical trial

Deliverable 4 7.1 Contract Manpower Reporting (CMR)

CMR

website and confirmation to COR and

KO

T.O. Level Due by 31 Oct, annually

Deliverable 5 7.2 Quality Control Plan

(QCP)

With proposal submission

Base level With proposal submission and update, as needed, thereafter.

Deliverable 6 7.3 Program Management Plan

COR and KO Base level Thirty (30) calendar days after base contract award.

Deliverable 7 7.4 Task Order Management Plan

COR and KO T.O. level T.O. level

Deliverable 8 7.5 Contingency Operations Plan

COR and KO Base level Due sixty (60) calendar days after award of base contract, and shall be updated on a semi-annual basis.

Deliverable 9 7.7.1 Task Order Monthly Progress Report

COR and KO T.O. level Monthly and within ten (10) calendar days prior to invoice submission

Deliverable 10 7.7.2 Annual Report COR Base level Annually Deliverable 11 9.2 CPARS CPARS website Base level Annually

Deliverable 12 10.1 Transition-in Plan With proposal submission

Base level With proposal submission

Deliverable 13 0 Transition-out Plan COR and KO Base level Sixty (60) calendar days from end date of contract.

Deliverable 14 0 Travel Claims/Trip Report

COR T.O. level Ten (10) calendar days after travel

Deliverable 15, Attachment 4

16.4 Organizational

Conflict of Interest

(OCI)

With proposal submission

Base level With proposal submission (if applicable).

Deliverable 16, Attachment 8

16.5 Employee

Participation Agreement

COR and KO T.O. level Prior to beginning work under this IDIQ contract.

Deliverable 17 17.1.1 Training Certifications

COR Base level Within five (5) calendar days of completion

Deliverable 18 17.2.1 Information Security Program Training

COR Base level Due within 30 calendar days after contract performance start.

Deliverable 19 17.2.2 HIPAA Training COR Base level Within 30 calendar days after contract award and annually thereafter.

Deliverable 20 6.0, Task 3 Copy of Medical Liability insurance Policy

COR and KO T.O. level Annually

9.0 QUALITY ASSURANCE.

9.1 Quality Assurance Surveillance Plan (QASP) (Attachment 2) The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance both at the base and task order level. The QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term.