RFI - SS Attachment 1 Draft PWS - HSP Personnel Management and Support Services - USAMRDC OHARO.pdf

DRAFT PERFORMANCE WORK STATEMENT

Title: Human Subjects Protection (HSP) Personnel Management and Support Services

Requiring Activity Name: U.S. Army Medical Research and Development Command (USAMRDC), Office of Human and Animal Research Oversight (OHARO)

1.0 INTRODUCTION

The U.S. Army Medical Research and Development Command (USAMRDC) provides medical materiel development and has responsibility for medical research, development, and acquisition. The USAMRDC’s expertise in these critical areas helps establish and maintain the capabilities the DoD needs to remain ready and lethal on the battlefield.

Ensuring our armed forces remain in optimal health and are equipped to protect themselves from disease and injury, particularly on the battlefield, is the job of the USAMRDC. The Command is headquartered (HQ) at Fort Detrick, MD, with eight (8) subordinate commands located throughout the world. Six (6) medical research laboratory commands execute the science and technology program to investigate medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense, and clinical and rehabilitative medicine. The Command manages a large extramural research program with numerous contracts, grants, and cooperative research and development agreements to provide additional science and technology capabilities from leading academic, private industry, and other Government organizations.

The USAMRDC Office of Human and Animal Research Oversight (OHARO) serves as the principal advisor to USAMRDC for human and animal research regulatory compliance and oversight of Army cadaver use activities. The Office of Human Research Oversight (OHRO) is one of two specialized offices within OHARO.

1.1. Mission

1.1.1. USAMRDC’s mission is to responsively and responsibly create, develop, acquire, and deliver capabilities for the warfighter.

1.1.2. OHARO’s mission is to provide USAMRDC oversight to ensure the protection of human subjects, welfare of animals, and human cadavers in DoD-supported research.

1.1.2.1 OHARO’s vision is to provide effective oversight of intramural and extramural human and animal research programs and efforts, facilitate DoD-relevant, scientifically valid, ethical research that is responsive to emerging needs, and create a culture of research ethics and compliance among stakeholders.

1.2. Background

Human subjects research funded, conducted, or supported by the USAMRDC is governed by DoD Instruction (DoDI) 3216.02; 32 Code of Federal Regulations (CFR) 219; 45 CFR 46 Subparts B, C, D, and E; 45 CFR 160; and 45 CFR 164. The USAMRDC also adheres to the Food and Drug Administration (FDA) Regulations 21 CFR 11 (Electronic Records; electronic signatures), 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards), 312

(Investigational New Drug Application), 314 (Applications for FDA Approval to Market a New Drug or Antibiotic Drug), 601 (Licensing), 812 (Investigational Device Exemptions), and 814 (Pre-Market Approval of Medical Devices) for research involving investigational drugs or devices. FDA “Guidance for Industry” publications provide additional directions in the research, development, test, and evaluation of regulated products. All research involving cadaver specimens must comply with the Department of Army (DA) policy, “Army Policy for Use of Human Cadavers for Research, Development, Test and Evaluation, Education or Training.” All research conducted outside of the continental United States (OCONUS) must comply with host nation laws and regulatory requirements.

1.2.1. OHARO

The OHARO provides component-level oversight of the USAMRDC and subordinate institutions’ Human Research Protection Programs, and serves as the proponent for implementation and oversight of the Army Cadaver Policy. The OHARO federal staff consists of a Director, a Chief, Intramural Human Research and Cadaver Activities Oversight, and an Office Manager. OHARO also includes a Human Subject Protection Scientist (HSPS) I, II and III contractor staff. An intermittent consultant subject matter expert also supports the OHARO for cadaver activity oversight.

1.2.2. OHARO Composition

The OHRO consists of five teams, overseen by the Director, OHRO which will consist of 27.5 contractor FTEs (PWS Attachment A – Organizational Chart):

Four teams support the DoD-required Human Research Protection Official administrative human subjects protection regulatory review, approval, and post-approval oversight of USAMRDC-supported research conducted by non-DoD organizations. These teams consist of three review teams and one administrative support team. Each review team is comprised of one federal HSPS, who serves as Governmental OHRO Approval Authorities (AA) for review and approval of regulatory actions that are Inherently Governmental, at least three contractor HSPS IIIs, two HSPS IIs and one HSPS I with functions described in this PWS. The administrative support team consists of two federal employees and five contract staff.

The fifth team, OHRO Intramural Research Review (IRR), supports the USAMRDC’s subordinate institutions human subjects research and the activities of the HQ USAMRDC IRB to provide federally required IRB review, approval, and oversight for human research conducted by customers of the USAMRDC IRB. The IRR staff consists of a federal Chief, Deputy Chief, and an IRB Coordinator. IRR also includes two HSPS III contractor personnel with functions described in this PWS. Additionally, the USAMRDC is supported by consultant subject matter experts as appointed IRB members.

1.3. Scope

The Contractor shall provide all personnel, training, materials, supervision, and non-personal services necessary to provide HSPS support for the OHARO and the OHRO. The Contractor shall also provide HSPS Subject Matter Expert and program management support for the OHARO and the OHRO operations, including workload management and administrative support, operating procedure development, quality assurance, and process improvement initiatives. The Contractor shall provide HSPS onsite supervision for personnel that support the OHARO and the OHRO.

The OHARO requires support for the USAMRDC Human Research Protection Program (HRPP), specifically for the USAMRDC OHARO and OHRO extramural and intramural activities. Research protocols funded, conducted, or supported by the USAMRDC must be reviewed for compliance with

DoD, federal, state, host national, and local human subjects’ protection regulations and human research ethical standards. The general scope of the OHARO’s requirements is organized into fourteen (14) support areas as listed below:

1.3.1. Area 1: Initial Administrative Review. Initial Administrative Review includes review of all types and risk levels of protocol submissions received by OHRO. Initial Administrative Review means timely review of proposal submissions (and associated documents such as research protocols, consent forms, IRB approvals, and recruitment materials) submitted to the USAMRDC to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection regulatory and cadaver use requirements. This includes completing regulatory-based written review of initial submissions using standardized checklists, delineating deficiencies, and areas of noncompliance, and making recommendations to the OHRO federal AAs regarding regulatory and ethical issues.

1.3.2. Area 2: Limited Initial Administrative Review. Limited Initial Administrative Review includes reviews only of minimal risk and exempt human subjects research, and research not involving human subjects submissions received by OHRO. Limited Initial Administrative Review means timely review of proposal submissions (and associated documents such as research protocols, consent forms, IRB approvals, and recruitment materials) submitted to the USAMRDC to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection regulatory and cadaver use requirements. This includes completing regulatory-based written review of initial submissions using standardized checklists, delineating deficiencies, and areas of noncompliance, and making recommendations to the OHRO federal AAs regarding regulatory and ethical issues.

1.3.3. Area 3: Post-Approval Oversight. Post-Approval Oversight means real-time oversight of USAMRDC-supported research protocols through timely documented reviews of protocol lifecycle submissions to assure ongoing compliance with all applicable Federal, DoD, state, host nation, and USAMRDC human subjects protection regulatory requirements. This includes completing regulatory-based written review of post-approval submissions using standardized checklists, delineating deficiencies and areas of noncompliance, and making recommendations to the OHRO federal AAs regarding regulatory and ethical issues.

1.3.4. Area 4: Administrative Support. Administrative Support means timely customer service and support to the OHARO and OHRO Team staff, OHARO and OHRO Approval Authorities, Principal Investigators, and other OHARO and OHRO customers.

1.3.5. Area 5: Human Research and Cadaver Use Compliance Oversight. Human Research and Cadaver Use Compliance Oversight means HSPS support for staff assistance visits designed to monitor and ensure compliance with human subjects protection regulations and cadaver use requirements and make recommendations for improvement.

1.3.6. Area 6: IRB Research Protocol Pre-review. IRB Research Protocol Pre-review includes review of initial and lifecycle submissions to the USAMRDC IRB. IRB Research Protocol Pre-review means using Government provided policies, procedures, checklists, guidance, and information systems, to facilitate investigators’ pursuit of USAMRDC IRB approval of DoD-conducted research through comprehensive pre-review of protocol actions prior to their review, approval, and oversight by the

USAMRDC IRB.

1.3.7. Area 7: Human Subjects Protection Policies and Procedures Development Support. Human Subjects Protection Policies and Procedures Development Support means assisting the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations and to update investigators, research managers and administrators, and administrative staff on human subjects protection and regulatory compliance policies and procedures as they apply to DoD-conducted and -supported research.

1.3.8. Area 8: Human Subjects Protection Education and Training. Human Subjects Protection Education and Training means routine review and update of all internal orientation and training materials for OHARO and OHRO staff to ensure they reflect current Federal, DoD, DA, state, host nation, and USAMRDC regulatory requirements related to the protection of human subjects in research and cadaver use.

1.3.9. Area 9: Quality Assurance. Quality Assurance means actively manage and update protocol files and the information management systems used to track information related to protocol review, i.e., contractor personnel must master entry of protocol-related information into automated information management systems and keep protocol status and event information complete and up to date.

1.3.10. Area 10: Performance Improvement. Performance Improvement means participate in performance improvement activities and task contract personnel to participate in specific working groups to improve and streamline the protocol review and approval processes and provide support for formulating and writing OHARO and OHRO standard operating procedures and work instructions.

1.3.11. Area 11: IRB Member Consultant Protocol Review. The IRB Member Consultant Protocol Review means consideration of DoD-conducted research protocols and protocol lifecycle actions for approval or disposition by the convened HQ USAMRDC IRB at routine or ad-hoc meetings. The HQ USAMRDC IRB requires IRB Member Consultants whose primary concerns are in scientific, non-scientific, affiliated, and non-affiliated areas, as determined by the need of the OHRO IRB Office.

1.3.12. Area 12: Cadaver Use Activity Consultation. Cadaver Use Activity Consultation means providing SME to support initial and post-approval cadaver activity oversight and review, as needed.

1.3.13. Area 13: Management of On-Site Personnel and Reporting. Management of On-Site Personnel and Reporting means providing on-site supervision of contract personnel assigned to the

OHARO.

1.3.14. Area 14: Additional Contract Personnel (SURGE). Additional Contract Personnel (SURGE) means providing additional contractor personnel if the OHARO or OHRO research review workload increases due to a variety of reasons.

1.4. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined in Federal Acquisition Regulation (FAR) Part 37. The Government shall neither supervise Contractor employees nor control the method by which the Contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual Contractor employees. It shall be the responsibility of the Contractor to manage its employees and to guard against any actions that are of the nature of personal services, or given 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 Contracting Officer (KO) immediately.

1.5. Inherently Governmental Functions

This PWS has been reviewed and contains no services that are inherently Governmental functions, as defined in FAR Part 2.1.

1.6. Organizational Conflict of Interest (OCI)

a. OCI Certification Form (Attachment B) (Deliverable 1). The Contractor shall perform a thorough comparative analysis of the potential new support services effort against all current and previous support service efforts performed in support of USAMRDC and ascertain whether there is a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide an OCI Mitigation Plan as a means of preventing, avoiding, and mitigating each OCI identified.

The Contractor shall complete the OCI Certification at time of proposal submission.

b. Mitigation Plans. When an OCI mitigation plan is submitted, the KO shall document the evaluation of the plan and obtain USAMRDC Staff Judge Advocate (SJA) concurrence on the plan evaluation. This evaluation shall be filed in the Virtual Contracting Enterprise (VCE) Paperless Contract File (PCF).

1.6.1. System for Award Management (SAM) Exclusion Checks. The U.S. Army Medical Research Acquisition Activity (USAMRAA) will verify the Contractor’s SAM registration by saving a copy of the registration as a Portable Document Format (PDF). The SAM verification will include the Contractor’s name, address, Unique Entity ID (UEI) number, and CAGE code along with the date stamp the verification occurred. The results of the verification will be uploaded to VCE-PCF. In the absence of a date stamp, the date the registration was uploaded to the contract file will be considered the date stamp.

1.6.2. Representations and Certifications Checks. USAMRAA is required to review and include a copy of the Contractor's Representations and Certifications (accessible through SAM) in the contract file for the following situations: (1) For any prospective Contractor selected for award, (2) Prior to exercising an Option, (3) Prior to extending the term of the award, and (4) Annually for Research and Development awards (non-severable services). For modifications specifically, USAMRAA is reviewing the Representations and Certifications for positive certifications regarding FAR 52.209-5 and FAR 52.209- 11.

1.6.3. Certification Regarding Responsibility Matters. The KO is responsible for immediately providing an official notification of referral on letterhead to the Army Suspension Debarment Official (SDO) if a Contractor submits a positive certification to FAR 52.209-5. The KO must notify their immediate Supervisor, who will be responsible for notifying the USAMRAA Senior Leadership. In accordance with (IAW) FAR 52.209-5, the KO may proceed with award to the Contractor, they must however follow-up on the referral to the SDO and shall document the contract file with all related correspondence.

1.6.4. Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. The KO is responsible for immediately providing an official notification of referral on letterhead to the Army SDO if a Contractor submits a positive certification to FAR 52.209-11.

The KO must notify their immediate Supervisor, who will be responsible for notifying the USAMRAA Senior Leadership. IAW FAR 52.209-11, the KO may NOT proceed with award to the Contractor, until they have received official authorization in writing from the SDO. The KO will follow-up on the referral to the SDO and shall document the contract file with all related correspondence.

2.0 GENERAL REQUIREMENTS

2.1. Contract Site Access

2.1.1. The Government will provide access to the Government controlled facilities, equipment, and materials for daily business use for Contractor personnel assigned to the contract. This will include office space, desk, telephone, chair, computer, shared printer, and requisite consumable materials. Reference Section 4.7.1. Government Furnished Facilities (GFF) and Section 4.7.2. Government Furnished Property

(GFP).

2.1.2. Contractor personnel assigned to the contract will be provided a Common Access Card (CAC) and a building access badge which are coded badges for access to secured buildings via a card-key system.

The CAC and building access badges are Government property and thus are controlled and tracked by the Government and Contractor employees in possession of the badges should protect at all times. Upon contract completion, termination, or when a Contractor employee no longer requires access to Fort Detrick, all CAC and access badges to the Government facility shall be turned in to the Contracting Officer’s Representative (COR).

2.2. Business Relations

2.2.1. The Contractor shall successfully integrate and coordinate all activity needed to execute the requirements of this PWS. The Contractor shall manage the timeliness, completeness, and quality of problem identification. The Contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The Contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all Contractor personnel.

2.3. Protection of Information/Public Releases

2.3.1. The Contractor shall coordinate and discuss with the COR all corporate publications (e.g., news releases, abstracts from meetings, or other correspondence) that contain references to this contract.

Additionally, prior to releasing any of the above, the Contractor shall provide a copy of the release to the KO for comments and approval to release.

2.3.2. All OHARO documents, information, files, and projects are sensitive to the public and are proprietary to OHARO and must be securely maintained. The Contractor is strictly prohibited from releasing or discussing all documents, information, files, and projects outside of OHARO without prior consent by the COR or OHARO Director.

2.3.3. The Contractor shall refer all inquiries for OHARO project information to the COR.

2.3.4. The Contractor shall destroy unused documents by shredding to maintain adequate security.

2.4. Contract Management

The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the contract. The Contractor must maintain continuity between the support operations on-site and off-site at the Contractor’s corporate offices.

2.4.1. Contract Management Activities

a. Government Management of the Contract. The KO will officially designate (in writing) a COR to oversee the contract. The Government’s COR will have responsibility for:

(1) Serving as the primary point-of-contacts for contract level coordination of administration and technical performance matters.

(2) Identifying the need for generating contract modification requirements, as required.

(3) Inspection, accepting, or rejecting all Contractor technical deliverables and invoices provided under the contract.

(4) Serving as the approvals and disapproval authorities for receiving reports and invoices.

(5) Managing Government Furnished Materials (GFM).

(6) Conducting contract surveillance activities.

(7) Elevating to the KO any problems that cannot be addressed by the COR.

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

b. Contractor Management of the Contract. The Contractor shall designate the senior member of the on-site team to also serve as the Program Manager (PM) or Technical Lead to oversee the contract. The Contractor’s designated PM/Technical Lead shall address contract issues, quality issues, and overall Contractor performance. This may include coordination with the KO and the COR to resolve any issues that may arise, or proposed changes or modifications to the contract. The Contractor PM/Technical Lead shall ensure the contract is performed efficiently, accurately, on time, and in compliance with the requirements of this PWS. In addition, the Contractor PM/Technical Lead shall ensure timely and accurate submission of invoices and ensure the following actions are completed:

(1) The Contractor shall ensure the Non-Disclosure Agreement (NDA) (Attachment C) (Deliverable 2) is signed by all Contractor and subcontractor employees assigned to or performing under this contract before commencement of the required support services. A Contractor corporate official shall sign the NDA. The Contractor shall ensure all Contractor and subcontractor employees understand and adhere to the terms of the NDA, protecting the procurement sensitive information of the Government and the proprietary information of other Contractors. Assignment of Contractor employees who have not signed the NDA or failure to adhere to signed NDA may constitute default on the part of the Contractor. Requiring activity must ensure the NDA has been approved by its supporting Staff Judge Advocate (SJA).

(2) Quality Control Plan (QCP) (Deliverable 3). The Contractor shall develop and maintain an effective QCP to ensure services are performed IAW this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. An initial QCP shall be submitted to the COR 15 days after contract award and shall be finalized 30 calendar days after contract award. The Contractor’s QCP is the assurance that the work products comply with the requirement of the contract. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor shall use to maintain quality, timeliness, responsiveness, and customer satisfaction. After the COR accepts the QCP, the Contractor shall receive the KO’s acceptance in writing of any proposed changes.

2.4.2. Contract Administration

The Contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The Contractor shall respond to the Government requests for contractual actions by the suspense date. The Contractor’s PM/Technical Lead shall serve as the point-of-contact (POC) between the Government and Contractor personnel assigned to provide support under this contract. The Contractor shall assign work effort and maintain proper and accurate time keeping records of personnel assigned to the contract. The Contract Administration Team will consist of the following members:

2.4.2.1. The KO will have overall responsibility for administering the contract. The KO is the only person authorized to obligate the Government and make changes to the contract. The KO will manage contract administration and quality assurance surveillance functions supported by contract administrators and the COR.

2.4.2.2. The COR will be appointed in writing and will be directly responsible to the KO. The COR serves as the Government’s POC for contract coordination of administration and technical performance.

The COR will also have the overall responsibility for administration of GFM.

2.4.3. Personnel Administration

The Contractor shall provide for employees during designated Government non-workdays or other periods where Government offices are closed due to weather or security conditions. The Contractor shall maintain the currency of their employees by providing initial and refresher training on Government financial systems and program management systems as required to meet the PWS requirements. The Contractor shall provide administrative support to employees such as time keeping, leave processing, pay, and emergency needs.

2.5. Subcontractor Management

The prime Contractor shall be responsible for any subcontract management necessary to integrate work performed under the contract and shall be responsible and accountable for subcontractor performance.

The prime Contractor shall manage work distribution to ensure there are no OCI considerations.

2.6. Location and Hours of Work

2.6.1. Location of Work. Accomplishment of the results contained in this PWS requires work to be performed on-site at Fort Detrick (Frederick), MD.

2.6.1.1 Telecommuting. IAW FAR 7.108, telecommuting is permitted; however, if telecommuting may adversely affect OHARO’s mission readiness and Operations Security (OPSEC) requirements, it may be limited at the discretion of the COR and subject to security requirements specified under the contract.

2.6.2. Hours of Operation. The Contractor shall perform services during regular duty hours from 0700 through 1700 hours, Monday through Friday with up to 60 minutes (non-paid) lunch period, except U.S.

Federal Holidays. The 60-minute lunch period shall be between the hours of 1100 and 1300. Contractor personnel requesting flextime shall not start earlier than 0600 and no later than 0900. Approval of alternate work schedules (to include telework) will be at the discretion of the COR and shall include a total of 80 hours over a period of two workweeks. Any alternate work schedules shall be coordinated between the Contractor PM (not individual contract employees) and the Government COR. The Contractor must maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

2.6.2.1. Federal Holidays. The Contractor shall not perform services on the recognized holidays identified below. If any of the listed holidays fall on a Saturday, the holiday is observed on the preceding Friday and if the holiday falls on a Sunday, the holiday is observed on the following Monday.

a. New Year’s Day, 1 January

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

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

d. Memorial Day, last Monday in May

e. Juneteenth Day, 19 June

f. Independence Day, 4 July

g. Labor Day, 1st Monday in September

h. Columbus Day, 2nd Monday in October

i. Veteran’s Day, 11 November

j. Thanksgiving Day, 4th Thursday in November

k. Christmas Day, 25 December

2.6.2.2. Contractor shall not report to work on the days the Government or installation is closed due to local determination relating to safety conditions, inclement weather conditions, national emergencies, energy conservation, or other conditions that require closure. During these periods of closure, the Contractor employees that are not designated as essential shall not report to work nor will they be compensated for the days of closure, unless telework is approved by the COR.

2.6.2.3. Early Dismissal. On the days the Government is dismissed early from regular duty hours for ad hoc reasons, Contractor employees are not dismissed early and shall continue to work regular duty hours.

Telework may be approved by the COR. Should the Contractor dismiss employees early as a result of the Government dismissal, the Contractor shall report the dismissal to the COR and the Contractor will not be compensated for the hours not worked as a result of the early dismissal.

2.7. Contractor Identification

The Contractor shall ensure all employees properly identify as a Contractor when attending meetings, answering Government telephones, on all written correspondence including e-mail, or working in situations where their actions could be construed as official Government acts.

2.8. Use of Military Rank by Contractor Personnel

All Contractor employees are prohibited from using a retired or reserve component military rank or title in all written, including e-mail, or verbal communications associated with the contract.

2.9. Post Award Conference / Contract Progress Meetings

2.9.1. The Contractor shall attend the Post-Award Conference to be scheduled within five (5) days after contract award. The USAMRDC Contracting Activity, USAMRAA, will convene the Post-Award Conference.

2.9.2. The Contractor shall attend quarterly contract progress meetings to be held with the KO, COR, or other Government personnel, as appropriate, to review the Contractor’s performance. During the quarterly meetings, the KO in conjunction with the COR will apprise the Contractor of how the Government views the Contractor’s performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

2.10. Business Casual Attire

All Contractor and subcontractor employees assigned to this contract shall dress appropriately in business casual attire when on-site. The OHARO work environment serves customers across USAMRDC and a professional business casual attire is essential. Examples of appropriate business casual attire include a polo shirt with khaki pants, a sweater and a shirt with slacks, a jacket with a skirt or slacks and a blouse or a sweater with a skirt or pants. Jeans, t-shirts, shirts without collars and footwear such as flip-flops and sneakers are not appropriate and should not be worn. The Contractor PM/Technical Lead shall ensure all employees and subcontractors assigned to the contract are aware of the business casual attire policy and 100% compliance is required. This does not apply when contractors are teleworking. Contractor employees arriving to work that are not compliant with this policy will be asked to return home and change into appropriate business casual attire and the Government will not be charged for the time the Contractor employee is away from their duty station.

2.11. Contingency Operations Plan

The Contractor shall prepare and submit a Contingency Operations Plan to the COR. The Contingency Operations Plan is due thirty (30) calendar days after the award of the contract and shall be revised on a semi-annual basis (Deliverable 4). The Contingency Operations Plan shall document the Contractor’s plans and procedures to maintain USAMRDC support during an emergency. The Contingency Operations Plan shall include the following:

a. A description of the Contractor’s emergency management procedures and policies.

b. A description of how the Contractor will account for their employees during an emergency.

c. Planned temporary work locations or alternate facilities.

d. How the Contractor will communicate with USAMRDC during emergencies.

e. A record of primary and alternate Contractor POCs, with primary and alternate telephone numbers and e-mail addresses.

f. Procedures for protecting all GFP and information.

2.12. Operations 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 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 contact the Contractor PM/Technical Lead to ascertain the status of any Contractor employees who were in Government controlled space affected by the emergency. When any disruption of normal, daily operations occurs, the Contractor PM shall promptly open an effective means of communication with the COR and verify:

a. Key points of contact (Government and Contractor)

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

c. Means of communication available under the circumstances (e.g. e-mail, webmail, telephone, facsimile, courier)

d. Essential work products expected to continue by priority

The Contractor PM/Technical Lead, 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. Regardless of work location, Contractors performing work in support of authorized tasks within the scope of this contract shall charge those hours accurately IAW the terms of this contract.

2.13. Monthly Progress Report (MPR) (Deliverable 5)

The Contractor shall deliver to the COR a MPR (Deliverable 5) detailing the progress, vice review of the key tasks in Section 3, target completion, labor hours expended by labor category for each task, invoices, and any problems/issues encountered in the performance of this PWS. The Contractor shall work with the COR on the MPR format. The Contractor shall require all subcontractors to provide input to the MPR where there are critical or significant tasks related to the prime contract. Critical or significant tasks shall be defined by mutual agreement between the Government and Contractor. The initial MPR is due NLT 45 calendar days after contract award (DACA) and on the 20th of each month thereafter.

2.14. Subcontractor Expenditures Report (Deliverable 6)

The Contractor shall prepare and deliver a Subcontract Expenditures Report (Deliverable 6) that discloses actual subcontract expenditures by company name, business size standard (i.e. Woman Owned Business, Veteran Owned Business, etc.), and other socioeconomic programs (i.e. Indian Incentive Program, Historically Black Colleges and Universities and Minority Institutions, etc.). The initial Subcontractor Expenditures Report is due NLT 90 DACA and quarterly thereafter.

2.15. Program Management Plan

The Contractor shall develop a Program Management Plan (Deliverable 7) that shall require Government approval. It shall be used to manage, track, and evaluate the Contractor’s performance. The Program Management Plan shall consist of control policies and procedures in accordance with standard industry practices for project administration, execution, and tracking.

The Program Management Plan shall include the following:

• Identification of milestones where Government information/activity is required and timeline dependencies for subsequent Contractor activities.

• An Integrated Master Management Plan describing the Contractor’s overall management approaches, policies and procedures including suggested project metrics.

2.16. Combat Trafficking in Persons (CTIP)

The DoD has a zero-tolerance policy for human trafficking. IAW FAR 52.222-50(c)(10) Combating Trafficking in Persons, the Contractor shall educate all employees assigned to this contract of the Government’s policy prohibiting trafficking in persons and the actions that will be taken against employees for violating to include but not limited to, removal from the contract, reduction in benefits, or termination of employee. As the COR monitors the Contractor and its employees, CTIP is a priority.

COR do not have the authority to investigate suspected incidents of CTIP, instead, forward all reported or suspected violations to the KO immediately. The table below identifies how the COR will monitor the Contractor for CTIP.

Task Standard Acceptable

Quality Level

Surveillance Method Incentive

Has the Contractor informed employees including subcontractor employees assigned to this contract of the DoD / Army zero tolerance CTIP policy, including informing employees of the actions that will be taken against them for violations of this policy?

Reference: FAR Subpart 52.222- 50, Para (c)(10)

Contractor shall inform employees of policy immediately.

100% Compliance

The Contractor shall attest to informing employees in its Monthly Progress Report provided to the COR.

Positive Past Performance Evaluation.

Has the Contractor informed the COR about any information it receives that alleges a Contractor employee or subcontractor employee has engaged in conduct violating the CTIP policy?

50(d)(1) report such information to the COR immediately.

100% Compliance

The Contractor shall include language in the Monthly Progress Report to the

COR.

Positive Past Performance Evaluation.

Has the Contractor informed the KO about any actions taken against Contractors, or subcontractor employees pursuant to CTIP policy?

50(d)(2) report such information to the COR and

KO

immediately.

100% Compliance

The Contractor shall include language in the Monthly Progress Report to the

COR.

Positive Past Performance Evaluation.

2.17. Other Direct Costs (ODCs)

2.17.1. ODC’s – Travel

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Travel costs shall be incurred and billed in accordance with FAR Part

31. Costs for these expenses will be reviewed, certified, and approved by the COR. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the Government. The Government will not pay for business class or first-class travel. Lodging and meals shall be reimbursed in accordance with regulations defined in FAR PART 31.

The Government will be providing a “Plugged” Not to Exceed (NTE) amount of $10,000.00 during base and for each option period to cover anticipated travel costs for employees assigned to OHARO.

As locations, durations and number of personnel can vary; estimated travel is indicated below:

Duty Assignment

From To Round Trip (Y/N)

# of Trips # of People

# of Days

OHARO To be determined

To be determined

Y Up to 5/year

Unknown Unknown

OHRO To be determined

To be determined

Y Up to 5/year

Unknown Unknown

2.17.2. Travel Outside of the U.S.

Travel outside of the United States is not anticipated. If travel outside of the U.S. is needed, the Contractor shall ensure that assigned participants allow sufficient lead-time to obtain valid passports, country clearances, and immunizations to support project activities. Additional contract provisions will be needed, if travel outside of the U.S. is required.

2.17.3. Other ODCs

ODCs shall be billed on a cost reimbursable basis. Costs are defined as the purchase price of materials or service plus General and Administrative charges or material and handling charges.

All ODCs shall be fully supported in compliance with the competition requirements of the FAR PART 6.

All ODCs shall be reported as stated in the Monthly Progress Report Section 2.14. Estimated ODCs are as follows:

No “Other” ODCs are anticipated during the performance of this contract.

2.18. Transition-In Plan (Deliverable 8)

The transition-in plan should identify the tasks to be accomplished, in coordination with Government personnel for transitioning work from the incumbent Contractor to the contract because of this solicitation. The Contractor shall coordinate with the KO and the COR to finalize the transition-in plan after contract award. The Contractor shall designate an overlap period to coordinate with the incumbent Contractor and/or Government personnel. The transition-in plan shall include, but is not limited to:

2.18.1. Coordination with Government representatives.

2.18.2. Review, evaluation and transition of current OHARO support services.

2.18.3. Transition of historic data to new Contractor.

2.18.4. Government approved training and certificate process.

2.18.5. Orientation to introduce Government personnel and programs to the Contractor’s team, tools, methodologies, and business processes.

2.18.6. Distribution of Contractor purchased Government owned assets (if applicable).

2.18.7. Transfer of Government Furnished Equipment (GFE) and Government Furnished Information

(GFI).

2.18.8. Coordination and transfer of staff Government keys, ID/security badges to include CAC and building access badges, and security codes.

2.18.9. Recruitment of incumbent staff or hiring of new staff.

2.19. Transition-Out Plan (Deliverable 9)

The transition-out plan should identify the tasks to be accomplished for transitioning work from this contract to the follow-on contract/order or Government entity. The transition-out plan should include how the Contractor shall support the Government in planning and implementing the transition to the follow-on contract/order or Government entity. The transition-out plan shall include, but not limited to:

2.19.1. Formal coordination with Government representatives and the follow-on provider’s team and management.

2.19.2. The delivery of copies of existing policies and procedures.

2.19.3. The delivery of required metrics and statistics

2.19.4. Transfer of incumbent Contractor employees to the follow-on provider.

2.19.5. Applicable USAMRDC debriefing and employee out-processing procedures.

2.19.6. Return of all Government keys, ID/security badges cards (CAC and building access badges), and security codes.

3.0 PERFORMANCE REQUIREMENTS/TASKS

The Contractor shall provide all necessary personnel required to perform the services in the areas defined in Section 1.3 of this PWS. The Contractor shall adhere to all OHARO and OHRO Standard Operating Procedures (SOPs), work instructions (WI), and policies during the performance of the contract. The following identifies the performance objectives and key tasks for the contract.

3.1. Objective 1 – Initial Administrative Review

3.1.1. Key Task 1: The contractor shall accelerate an investigator’s pursuit of OHRO approval through using Government-provided policies, procedures, checklists, and information systems, and through timely review of proposal submissions (and associated documents such as research protocols, consent forms, IRB approvals, and recruitment materials) submitted to the USAMRDC to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection regulatory and cadaver use requirements.

3.1.2. Key Task 2: The contractor shall provide comprehensive, timely, professional quality and fully documented initial reviews of research supported by the USAMRDC.

3.1.3. Key Task 3: The contractor shall have the expertise to provide reviews of all types of research supported by the USAMRDC, including, but not limited to, research involving human subjects, cadavers, human data, and biospecimens. The purpose of these reviews is to assure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection and cadaver use regulatory requirements and to delineate deficiencies and areas of noncompliance. These reviews provide recommendations regarding regulatory and ethical issues for submission that are provided to the Principal Investigator following review and approval by the OHRO Approval Authority.

3.1.4. Key Task 4: The contractor shall provide regulatory-based written initial reviews of protocols using standardized checklists. (Deliverable 10) (Deliverable 11)

3.1.5. Key Task 5: The contractor shall formulate and recommend potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects research and cadaver use. This includes identification and assessment of noncompliance when the research is conducted prior to OHRO approval.

3.1.6. Key Task 6: The contractor shall provide human subjects protection regulatory consultation on selected proposals and pre-reviews of draft protocols as tasked by the Program Manager.

3.1.7. Key Task 7: The contractor shall complete administrative review actions for protocols in post-approval oversight per the Project Manager, as needed.

3.1.8. Key Task 8: The contractor should interpret and apply federal human subjects’ protection requirements and make regulatory review recommendations for any OHRO administrative review action required, from initial submission through lifecycle oversight to study closure.

3.1.9. Key Task 9: The contractor shall prioritize submissions for initial review to complete review and submission to approval authority based on assignment date, award status, regulatory complexities, international collaborators, and anticipated start date.

3.1.10. Key Task 10: The contractor shall provide accurate information, assistance, and documents to customers and OHRO federal personnel when requested with appropriate professionalism in a timely manner. This requires active management and updating of the protocol files and the information management systems used to track information related to protocol review. This also requires active backup of HSPS working materials to the OHRO’s shared computer drive to facilitate review of future actions by team members.

3.1.11. Key Task 11: The contractor shall responsively engage in email and telephone communication with the Principal Investigator, OHRO Approval Authority, and key study personnel to address questions, concerns, and outstanding issues.

3.1.12. Key Task 12: The contractor shall provide comprehensive, timely, professional quality and fully documented initial pre-reviews of USAMRDC and DoD-supported protocols limited to the following categories of submissions: exempt and minimal risk human subjects research, research not involving human subjects and exempt human subjects research, OHRO determinations, deferrals, and requests for protocol withdrawal.

The Government may require changes in contractor labor mix to accommodate changes in Federal and Department of Defense human subjects’ protection regulatory requirements.

3.2. Objective 2 - Limited Initial Administrative Review

3.2.1. Key Task 1: The contractor shall provide comprehensive, timely, professional quality and fully documented initial reviews of USAMRDC and DoD-supported protocols limited to the following categories of submissions: exempt and minimal risk human subjects research, OHRO determinations, deferrals, addition of protocol sites as an amendment, and requests for protocol withdrawal.

3.2.2. Key Task 2: The contractor shall use Government-provided policies, procedures, checklists, and information systems, and through timely review of proposal submissions (and associated documents such as research protocols, consent forms, IRB approvals, and recruitment materials) submitted to the USAMRDC to ensure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection regulatory and cadaver use requirements.

3.2.2. Key Task 2: The contractor shall provide comprehensive, timely, professional quality and fully documented initial reviews of research supported by the USAMRDC.

3.2.3. Key Task 3: The contractor shall have the expertise to provide reviews of all types of research supported by the USAMRDC, including, but not limited to, research involving human subjects, cadavers, human data, and biospecimens. The purpose of these reviews is to assure compliance with all applicable Federal, DoD, DA, state, host nation, and USAMRDC human subjects protection and cadaver use regulatory requirements and to delineate deficiencies and areas of noncompliance. These reviews provide recommendations regarding regulatory and ethical issues for submission that are provided to the Principal Investigator following review and approval by the OHARO or OHRO Approval Authority.

3.2.4. Key Task 4: The contractor shall provide regulatory-based written initial reviews of protocols using standardized checklists. (Deliverable 10) (Deliverable 11)

3.2.5. Key Task 5: The contractor shall formulate and recommend potential solutions to complex problems that would help bring protocols in compliance with the various laws, regulations, policies, procedures, and guidelines governing human subjects research and cadaver use. This includes identification and assessment of noncompliance when the research is conducted prior to human research protection official approval.

3.2.6. Key Task 6: The contractor shall conduct pre-reviews of projects submitted to the OHRO for determination of the applicability of the human subjects protection regulations. On an as-needed basis, the Program Manager may task the contractor to complete administrative review actions for protocols in post-approval oversight.

3.2.7. Key Task 7: The contractor shall prioritize submissions for initial review to complete review and submission to approval authority based on assignment date, award status, regulatory complexities, international collaborators, and anticipated start date.

3.2.8. Key Task 8: The contractor shall provide accurate information, assistance, and documents to customers and OHARO and OHRO federal personnel when requested with appropriate professionalism in a timely manner. This requires active management and updating of the protocol files and the information management systems used to track information related to protocol review. This also requires active backup of HSPS working materials to the OHARO’s shared computer drive to facilitate review of future actions by team members.

3.2.9. Key Task 9 The contractor shall…