PERFORMANCE WORK STATEMENT (PWS) - DRAFT

Title: Intermediate Medical Acquisition Course (IMAC)

Requiring Activity: Defense Health Agency (DHA) / Operational Medicine (OPMED)

1.0 Background

The Defense Health Agency (DHA) / Operational Medicine (OPMED) requires delivery of the Intermediate Medical Acquisition Course (IMAC), a medically focused DAU‑aligned acquisition course supporting FDA‑regulated product development. This training equips DHA personnel with medical acquisition fundamentals necessary for medical R&D, lifecycle management, and program execution. In the past the OPAA, the USAMRDC, and the entire U.S. Army Medical Department as well as other services has needed medically focused Defense Acquisition University (DAU)-certified course on program management since the establishment of the medical research, development, and acquisition (RDA) process within the USAMRDC known as Decision Gate in 2009 and other DHA training to ensure all members are certified. This unique acquisition process integrates the Department of Defense (DOD) acquisition system based on the DOD Instruction 5000 series with the FDA’s medical product development process and medical industry best practices. As a result, OPMED as the lead for medical acquisition in the DHA needs expertise to guide leadership who lack medical and PM experience through the complicated process by which products move through the development pipeline within the OPMED and other agencies within DHA.

Training for acquisition personnel. Significant numbers of Army and DOD staff that are members of Integrated Product Teams (IPT) are not under the PM acquisition career track, but rather under other career tracks, such as Science & Technology Manager, Contracting, and Lifecycle Logistics. The IPT members and medical acquisition staff should have an appreciation and understanding of PM in the context of defense acquisition. Also, IPT positions need PM training to better appreciate the entire lifecycle acquisition process. A medically focused DAU-certified medical acquisition course has in the past been extremely instrumental in facilitating PM understanding and IPT functions and the acquisition lifecycle. The DHA has a requirement through the RDA process that all IPT members have training, which is best achieved through a medically focused course not offered directly by DAU. The contractor shall administer the course.

This primary course should focus on the goals and objectives of DAU’s Level II Certification for PM (with a second course, DAU Certified and non-DAU Certified geared towards leadership (truncated version of the DAU Certified Course), which focuses on IPTs by providing an overview of systems acquisition, principles, policies, and processes. These courses, however, must be medical centric and focus on medical acquisition and the development of medical products such as drugs, vaccines, and medical devices with consideration for requirements of the FDA.

1.01 Non‑Personal Services

All services under this contract are strictly non‑personal. No contractor employee shall be supervised or controlled as a Government employee.

1.02 Severable Services

This requirement is severable. Each IMAC class is a distinct and complete unit of service.

1.03 Inherently Governmental Functions

No inherently governmental functions are included in this requirement.

1.04 Acquisition Functions Closely Associated With Inherently Governmental Functions This requirement does not include acquisition functions closely associated with inherently governmental functions.

2.0 Scope (Task 1 and Task 2)

2.01. Objective (Task 1):

The Contractor shall deliver six (6) offerings annually of the 40‑hour Intermediate Medical Acquisition Course (IMAC). The course must:

• Align with DAU PM Level II learning objectives

• Be medically focused (FDA pathways, medical devices, drugs, vaccines)

• Support Integrated Product Teams (IPTs)

• Provide medically relevant acquisition scenarios and instruction

• Delivery may be in‑person or Virtual Instructor‑Led Training (VILT). Although in-person is the preferred teaching method for this course virtual offerings will be permitted with Government POC approval. The Contractor shall make provisions for both in-person and virtual learning due to any events they may hinder on site governmental class. The contractor would deliver via MS Teams. The COR would make available Government Furnished Equipment (computers), system access, and a Teams profile so they can manage the course. [NOTE: for DAU VILT for ACQ2030 virtual classes are conducted via MS Teams.] - The instructors should still travel to Fort Detrick to conduct the VILT course at an on-site location if required.

2.0.2 Expected Performance

The contractor shall provide, via email, the designated Government Point of Contact (POC) with proof that it is certified to provide the DAU equivalent. (Deliverable 2). This is a mandatory requirement.

The contractor shall furnish all necessary personnel and training materials required for virtual delivery of the course, except for laptops and internet connection for each attendee. The contractor personnel shall be qualified and experienced to teach the course. The contractor personnel shall be well-versed in the subject matter to provide the course attendees with real-life experiential examples and suggestive feedback during virtual interactive dialog.

The contractor shall provide the training course with a 40-hour course to a minimum of twenty-five (25) attendees, through a maximum of thirty (30) attendees. Although in-person is the preferred teaching method for this course virtual offerings will be permitted with Government POC approval. The Contractor shall make provisions for both in-person and virtual learning due to the any pandemic or uncontrollable reasons by the Government.

The course will include location, student recruitment, registration, trainers, presentation media, student text, tests, and certification for the course. The course materials shall be virtually delivered to the designated Government POC and course attendees no later than 15 calendar days prior to the class start date (Deliverable 3).

The training course shall occur once with a duration of five (5) consecutive business days.

Date(s) for this training course is TBD as of time of award but shall take place within the POP identified in this contract. The designated Government POC shall coordinate with the Contractor on dates that are mutually agreeable to both parties.

The class hours shall be from 0800-1630. Any changes shall be coordinated between the contractor and designated Government POC.

The Contractor shall maintain attendance through a class roster (Deliverable 4) and administer a course evaluation/survey to attendees at each course completion date (Deliverable 5). The Contractor shall email the class roster and evaluations/surveys to the designated Government POC within 10 business days after course completion (Deliverables 4 and 5). The Contractor shall also issue and email a Certificate of Training (Deliverable 6) to each attendee within 15 business days after students have completed the final exam. The Contractor shall also email the designated Government POC copies of all attendee Certificates of Training (Deliverable 6).

2.0.3. Place of Performance

Location of course will be conducted at DOD facilities at Fort Detrick and other CONUS DOD sites or non-DOD sites. The course may also be held through Virtual Instructor Led Training (VILT) with Government POC approval. The contractor shall provide all necessary technical information as it relates to the VILT training to include instructions on how to access training, links to training resources, online class materials, and tech support for the class. The contractor should also provide the course attendees with a direct telephone number and email to provide technical support for the duration of the training.

2.1. Scope (Task 2).

The objective of this requirement is to provide a medically focused course that is a truncated (but non-certified) version of the DAU - certified course as described in PWS Section 2.01.

2.1.1. Objective.

Task 2: This course will be geared toward senior leaders that do not have time for the full course, but that would benefit from the information presented. The course objectives will be a selection of the objectives from the course noted in 2.01 as determined by the DAU but will be presented at a high/senior level and not delve into the details. The OPAA will review and approve the objectives to be presented in the truncated senior-leader course. The course material will be selections from the DAU-course developed by the contractor and approved by the OPAA. The truncated version of the course does not have to be DAU-certified. The contractor liaises with the OPAA for student selection. The Government is requesting no less than two (2), but up to four (4) offers (at the Government’s discretion) of this course of each 12-month period of performance with the option for up to an additional two (2) offerings (at the Government’s discretion) for each 12-month period of performance.

2.1.2. Expected Performance

The contractor shall furnish all necessary personnel and training materials required for virtual delivery of the course, except for laptops and internet connection for each attendee. The contractor personnel shall be qualified and experienced to teach the course. The contractor personnel shall be well-versed in the subject matter to provide the course attendees with real-life experiential examples and suggestive feedback during virtual interactive dialog.

The contractor shall provide a truncated version of the DAU-certified course noted in Task 2.01 for senior leaders. The training course should be at least 16-hours in duration, but no more than 22-hours in duration. Although in- person is the preferred teaching method for this course virtual offerings will be permitted with Government POC approval. The Contractor shall make provisions for both in-person and virtual learning.

The course will include location, student recruitment, registration, trainers, presentation media, and student text. The course materials shall be virtually delivered to the designated Government POC and course attendees no later than 15 calendar days prior to the class start date (Deliverable 3).

The training course shall occur once with a duration of two (2) to two-and-a-half (2.5) consecutive business days.

Date(s) for this training course are TBD as of time of award, but shall take place within the POP identified in this contract. The designated Government POC shall coordinate with the Contractor on dates that are mutually agreeable to both parties.

The class hours shall be from 0800-1630. Any changes shall be coordinated between the contractor and designated Government POC.

The Contractor shall maintain attendance through a class roster (Deliverable 4) and administer a course evaluation/survey to attendees at each course completion date (Deliverable 5). The Contractor shall email the class roster and evaluations/surveys to the designated Government POC within 10 business days after course completion (Deliverables 4 and 5).

2.1.3 Place of Performance

Location of course will be conducted at DOD facilities at Fort Detrick and other CONUS DOD sites or non-DOD sites. The course may also be held through a Virtual Instructor Led Training (VILT) with Government POC approval. The contractor shall provide all necessary technical information as it relates to the VILT training to include: instructions on how to access training, links to training resources, online class materials, and tech support for the class. The contractor shall also provide the course attendees with a direct telephone number and email to reach technical support for the duration of the training.

2.1.4 Other Direct Costs (ODCs)

Other Direct Costs (ODCs) shall be proposed for this contract. They shall be for including (but not limted to):

· Travel

· Other ODCs (Materials, etc.)

2.1.4.1. 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.

For planning purposes, estimated travel is indicated below:

· Travel to and from Contractor location and Course Location (if non-virtual and in-person).

2.1.4.2 Other Direct Costs (ODCs) – Non-Travel ODCs (to include but not limited to course materials, etc.)

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 (G&A) or material and handling charges (M&H).

All materials generated will be provided to the COR/Government in both print and digital format. In addition, all materials will be compiled into a single CD and folder to be presented to the COR at the end of the base and all option years.

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 (G&A) or material and handling charges (M&H). All ODCs shall be fully supported in compliance with all competition requirements of FAR PART 31. All ODCs shall be reported as stated in the Monthly Progress Report Section 2.1.2.

Contract Period

Base Period

Option Period 1 (OP1)

Option Period 2 (OP1)

Option Period 3 (OP3)

Option Period 4 (OP4)

All ODCs shall proposed in sufficient detail and shall be fully supported in compliance with all competition requirements of the FAR PART 31.

2.2 Virtual Pre-Platform Test

In the event face to face courses cannot be scheduled due to pandemic or other contingencies, the contractor shall provide a virtual pre-platform test with the designated Government POC NLT 20 calendar days prior to the first VILT course delivery. (Deliverable 12)

Fort Detrick, MD, or other CONUS locations approved by DHA/OPMED. Virtual (VILT) courses may be delivered in emergency circumstances at government discretion.

3.0 Deliverables:

3.01 Delivery Address

All deliverables shall be submitted to the designated Government POC: Name: Mr. Daniel J. Duke Title: OPMED Project Analyst/COR E-Mail: daniel.j.duke2.civ@health.mil

3.02 Method of Delivery

Electronic copies shall be delivered using Microsoft (MS) Office suite of tools (for example, MS Word, MS Excel, MS PowerPoint, MS Project, or MS Access format), unless otherwise specified by the designated Government POC. Electronic submission shall be made via email, unless otherwise agreed to by the designated Government POC.

3.03 Government Acceptance Period

Not Applicable

3.04 Delivery Schedule Abbreviations

The following abbreviations are used in the delivery/deliverable schedule:

3.05 Deliverable/Delivery Schedule

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E), and/or hard copy (H).

Ref

& 2.02.01

& 2.02.01

& 2.02.01

Course Attendees

4.0 Other Terms, Conditions, and Provisions

4.01. Non-Disclosure Agreement – Deliverable 1

The Contractor shall ensure that the Non-Disclosure Agreement (Attachment 1 to SOW) is signed by all employees assigned to or performing on this contract before performing any work, including all subcontractors and consultants. The Non-Disclosure Agreement shall be co-signed by a corporate official (Contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other Contractors. Assignment of personnel who have not executed this statement or failure to adhere to this statement may constitute default on the part of the Contractor.

4.02 Protection of Information/Public Releases

The Contractor shall coordinate and discuss with the designated Government POC all corporate publications (e.g., news releases, abstracts from meetings, etc.) 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 Contracting Officer for comments and approval to release.

4.03 Contractor Employees/Contractor Identification

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

Contractor personnel, while performing in a Contractor capacity, are prohibited from using their retired or reserve component military rank or title in all written or verbal communications associated with the contract under which they provide services.

5.0 Quality Assurance Surveillance Plan (QASP)

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance. The oversight provided for in the contract and in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term. Further, the QASP provides the designated Government POC with a proactive way to avoid unacceptable or deficient performance and provides verifiable input for the required Past Performance Information Assessments. The QASP will be finalized immediately following award, and a copy provided to the Contractor after award. The QASP is a living document and may be updated by the Government as necessary.

General quality measures set forth below shall be applied to each work product received from the contractor under this statement of work:

· Accuracy – Work performed shall be accurate in presentation, technical content, and adherence to accepted elements of style.

· Clarity - Work performed shall be clear and concise.

· Consistency to Requirements - All work must satisfy the requirements of this statement of work.

· File Editing - All text and report files shall be editable by the Government.

· Format - Work Products shall be submitted in hard copy (where applicable) and in media as designated DHA OPMED prior to submission.

· Hard and soft copy formats shall follow Directives, Manuals or formats designated by DHA/OPMED

· Timeliness - Work Products shall be submitted on or before the due date specified by DHA/OPMED.

5.01. Performance Requirements Summary Matrix

By monitoring the Contractor, the designated Government POC will determine whether the performance levels set forth in the contract have been attained. Performance standards are specified in the following Performance Requirements Summary Matrix in the Standard and Acceptable Quality Level (AQL) columns. References which may be used by the designated Government POC to determine whether the performance levels have been attained include the following:

Reference

evaluations of course Positive Past Performance Rating

AQL: 95%

AQL: 98%

and 3.05 Training certificates will be delivered within 15 business days of completed final exam. AQL: 98%

DOD has a zero tolerance policy for human trafficking. As the designated Government POC monitors the contractor and its employees, Combating Trafficking in Persons (CTIP) should rank among the Government POC’s top priorities. Government POCs should not personally investigate suspected incidents of Trafficking in Persons (TIP) but should forward all reported or suspected violations to the contracting officer immediately.

Quality Level

Compliance

exercised.

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

immediately.

100% Compliance

exercised.

FAR Subpart 52.222- 50(d)(1)

Has the contractor informed the contracting officer about any actions taken against contractors, or subcontractor employees pursuant to TIP policy?

FAR Subpart 52.222- 50(d)(2)

Contractor has a duty to report such information to the Government POC and contracting officer immediately.

100% Compliance

ATTACHMENT 1: NON DISCLOSURE AGREEMENT

Non-Disclosure Agreement for Contractor Employees and Subcontractors I, , am an employee of or a subcontractor to [Company Name], a Contractor acting under contract to the [Name of USAMRDC Directorate] under Contract No. . I understand that in the performance of this task, I may have access to sensitive or proprietary business, technical, financial, and/or source selection information belonging to the Government or other Contractors. This information includes, but is not limited to, cost/ pricing data; Government spend plan data; Planning, Programming, Budgeting and Execution (PPBE) documents and information, as defined in DOD Directive 7045.14; Contractor technical proposal data; independent Government cost estimates; negotiation strategies and Contractor data presented in negotiations; contracting plans and statements of work. I agree not to use, discuss, divulge, or disclose any such information or data to any person or entity except those persons directly concerned with the use or performance of this contract. I have been advised that the unauthorized disclosure, use or negligent handling of the information by me could cause irreparable injury to the owner of the information. The injury could be source sensitive procurement information of the Government or proprietary/trade secret information of another company.

I understand that the United States Government may seek any remedy available to it to enforce this Agreement, including, but not limited to, application for a court order prohibiting disclosure of information in breach of this agreement. Court costs and reasonable attorney fees incurred by the United States Government may be assessed against me if I lose such action. I understand that another company might file a separate claim against me if I have misused its proprietary information.

In the event that I seek other employment, I will reveal to any prospective employer the continuing obligation in this agreement prior to accepting any employment offer.

The obligations imposed herein do not extend to information/data which is:

a. in the public domain at the time of receipt or it came into the public domain thereafter through no act of mine;

b. disclosed with the prior written approval of the USAMRDC designated Contracting Officer;

c. demonstrated to have been developed by [Company Name], or me independently of disclosures made hereunder;

d. disclosed pursuant to court order, after notification to the USAMRDC designated Contracting Officer;

e. disclosed inadvertently despite the exercise of the same reasonable degree of care a party normally uses to protect its own proprietary information.

I have read this agreement carefully and my questions, if any, have been answered to my satisfaction.

(Printed Name of Employee or Subcontractor) Date

(Signature) Organization

(Signature of Corporate Official) Date

(Printed Name of Corporate Official) (Printed Title –Task Manager or higher)