Draft PWS Simulated Patients v1.5.docx

Draft Performance Work Statement (PWS)

Simulated Patient Services

Part 1 General Information

1.0 General: Implement the use of Simulated Patients (SP) to enhance Telemedicine and Advanced Technology Research Center’s (TATRC) ability to provide multimodule simulations for military medical research focused on casualty care.

1.1 Description of Services/Introduction: This is a non-personal service(s) contract to provide personnel, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Simulated Patient Services as defined in this Performance Work Statement (PWS)

1.2 Background: Telemedicine and Advanced Technology Research Center (TATRC) facilitates medical research and development that focuses on new medical technologies to optimize Warfighter performance and casualty care. Medical Modeling Simulation Information and Visualization (MMSIV), a division within TATRC, provides high-fidelity simulations to integrate medical sensors that collect patient data from the simulated casualties. Simulated Patients (SP) play a vital role in the data collection research efforts that measure vitals using physiological recording equipment being that they are live participants. SP participation not only helps tests the utilization of a sensor, but also provides another modality of simulation to create a more realistic and immersive experience for the Warfighter participating in the research.

Simulated Patients (SP) are expected to role play as casualties in various combat environments where they portray behaviors that correlate with a given scenario. This includes but is not limited to acting out different levels of consciousness, providing appropriate responses to medic participant interventions, and operating simulated prosthesis.

In a simulated combat environment, SPs are subject to loud noises, different levels of lighting and varying temperatures. SPs will be made-up with moulage or medical makeup to portray various injury patterns that may be graphic in nature.

TATRCs simulation events concentrate on combat medicine necessitating SPs to have the appearance of military-aged personnel and military weight standards. As active participants in research, a consistent group of SPs is imperative for the purposes of standardization.

There are no targets for specific genders, races, or ethnicities. TATRC is seeking to make the data collected as generalizable to actual patient care scenarios as possible.

1.3 Scope: The Contractor shall provide non-personal service(s). The Contractor shall provide Simulated Patients recruitment and payroll. Supply Telemedicine and Advanced Technology Research Center (TATRC) with qualified and vetted Simulated Patients that correlate with given scenarios or simulation events put on by TATRC with notice from the MMSIV Division.

1.4 Objectives:

a. Contractor shall provide Simulated Patients (SP) that meet the demographic criteria of a given scenario or simulation event.

b. Contractor shall provide Simulated Patients for TATRC scheduled events with notice no later than two weeks out from MMSIV Division.

c. Contractor shall curate, maintain, and provide a portfolio of Simulated Patients for the purposes of standardization and consistency.

1.5 General Information:

1.5.1 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).

1.5.2. Holidays: Work Shall not be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer. When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

1.5.4 Operating Hours: The Contractor is responsible for conducting business Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The Core hours are 8:00 AM to 4:00 PM The Contractor must at all times maintain and adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.5.6 Place of Performance: The work to be performed under this contract will be performed:

On-site services shall be performed at Telemedicine and Advanced Technology Research Center,1078 Patchel Street Fort Detrick, MD 21702, Off-site services shall be performed within a travel radius of 50-miles from TATRC.

1.6 AT-OPSEC - Security Requirements: The following information is provided on security related matters.

Access and general protection-security policy and procedures. This standard language is for contractor employees with an area of performance within Army controlled installation facility or area. Contractor and all associated sub-contractors’ employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office Director of Emergency Services or Security Office.

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

For contractors that do not require CAC but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05-AR 190- 13) applicable installation facility and area commander installation-facility access and local security policies and procedures (provided by government representative) or at OCONUS locations in accordance with status of forces agreements and other theater regulations. Contractor personnel must be always escorted by a U.S. DoD Service Member or civilian employee they are inside a U.S. government facility.

1.6.1 Installation Access:

The Contractor shall be aware of and comply with the requirements associated with Installation Access Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements. Contractors will be escorted on and off post and through their time on post.

1.6.1.1 Installation Pass Log: In addition, the Contractor shall provide the Contracting Officer, via the COR a list of personnel entering post 3 days prior to work.

1.6.1.2 Common Access Cards (CAC) – No CAC cards will be issued to contractors.

1.6.2 Background Checks: The contractor shall execute background checks on personnel to make sure that they can access Fort Detrick, Md

1.6.2.1 U.S. Citizen: The Requiring Activity Manager will determine the extent of background checks required. The Contractor employee may begin performance of the contract after receiving a favorable local background check. The Contractor agrees to replace the employee should results of the background check, if required, be unfavorable as determined by the Requiring Activity Manager. The Contractor’s replacement of the employee with the unfavorable background check shall be within a timeframe provided by the Requiring Activity Manager. The Contractor shall also replace employees whose background check, during their tenure of employment, renders them with an unfavorable local or stateside background check, as determined by the Requiring Activity Manager. The Contractor shall forward a copy to the Contracting Officer via the COR and the Requiring Activity Manager of each favorable background check within 30 days of receipt by the Contractor, identifying such with the appropriate contract number. The Contractor shall forward a copy to the Contracting Officer via the COR and the Requiring Activity Manager of each unfavorable background check within 7 days of receipt by the Contractor, identifying such with the appropriate contract number When the Government awards a non-personal services contract directly to an individual, the failure of the individual to provide a favorable background check would be grounds for termination.

1.6.3 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel.

1.7 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the Contracting Officer 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. These meetings shall be at no additional cost to the Government.

1.7.1 The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the Government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

1.8 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. The designation letter states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including Government drawings, designs, specifications, monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.9 Data Rights: The Government has unlimited rights to all documents and materials produced under this contract. All documents and materials, to include the source codes of software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the Contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.10 Non-Disclosure Requirements: Performance under this contract may require the Contractor to access data and information proprietary to a Government agency, another Government Contractor, or of such nature that its dissemination or use other than as specified in this work statement would be averse to the interests of the Government or others. The Contractor and Contractor personnel shall not divulge, or release data or information developed, or obtained under performance of this PWS, except to authorized Government personnel or upon written approval of the Contracting Officer. The Contractor shall not use, disclose, or reproduce proprietary data, which bears a restrictive legend, other than as specified in this PWS. All documentation showing individual names or other personal information shall be controlled and protected under the provisions of the Privacy Act of 1974, Public Law 93-579, 5 United States Code (U.S.C.) Section 552a.

1.11 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at www.dimoc.mil/resources/limitations/ , the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.12 Non-Disclosure Statements: The Contractor shall provide signed non-disclosure agreements to the Government no later than 5 days (Deliverable) prior to commencement of work under the contract. Disclosure of information by Contractor personnel may result in removal of Contractor personnel from performance under this contract.

1.13 Phase In /Phase Out Period: To minimize decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the 5 days phase in/ phase out periods. During the phase in period, the Contractor shall become familiar with performance requirements to commence full performance of services on the contract start date.

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer – means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local terminology can be COR, Contracting Officer’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line-item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the Contracting Officer as alternate CORs.”

Deliverable – means anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, Government-furnished Property “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract

Government Property - means all property owned or leased by the Government.Government property includes both Government-furnishedand Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

Property Administrator - means an authorized representative of the Contracting Officer appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance – (or Government contract quality assurance) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – means the key Government-developed surveillance process document and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the Performance Work Statement (PWS). It provides specific details on how the Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Simulated Patient - A simulated patient is an induvial who is trained to portray a real patient to simulate a set of symptoms or problems used for healthcare education, evaluation, and research.

Subcontractor – means one that enters a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Workday - The number of hours per day the Contractor provides services in accordance with the contract.

Work Week - Monday through Friday.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

MMSIV Medical Modeling Simulation Information and Visualization

SP Simulated Patient SIGE Safety and Health Protection Plan TATRC Telemedicine and Advanced Technology Research Center TE Technical Exhibit USAG United States Army Garrison

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: The Government will NOT provide Government Furnished Services in support of this contract.

3.2 Facilities: The Government will provide restrooms and water fountains but will not provide workspace for contractors.

3.3 Utilities: The Government will NOT provide Utilities in support of this contract.

3.4 Equipment: The Government will not provide any equipment.

3.5 Materials: The Government will NOT provide Materials in support of this contract/task order.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: The Contractor shall furnish all supplies, equipment, facilities, and services required to perform work listed under Section 5 of this PWS.

4.2 Secret Facility Clearance: Not required. The contractor personnel will need a government issued ID (Drivers Licenses, Passport etc) to access Fort Detrick via Visitor’s Center. No CAC issued. Vendors will be escorted on and off post and will be escorted throughout the day.

4.3 Materials: None.

4.4 Vehicles and Equipment: None.

4.5 Background Checks: The Contractor shall provide Background Checks in accordance with this PWS and as determined by the Government.

PART 5

SPECIFIC TASKS

5.1 Services: The Contractor shall provide personnel for Simulated Patients (SP). The Contractor’s SP Staff will be individually assigned to an event by the contracting company with notice from MMSIV Division (Deliverable 1 &2).

5.1.1 Recruitment. The contractor shall provide personnel for simulated patients scenarios that meet the criteria listed:

a. Gender, race, ethnicity-Unimportant

b. Meet military age requirement of 18-45 years old.

c. Meet military height and weight requirements, and be able to lift 50 lbs.

d. Meet requirements to enter a Military Post.

5.1.2 The contractor shall be responsible for curating and maintaining a roster of SP’s that have trained and participated in TATRC simulation research events. This will help with the process of standardization and performance consistency.

a. Vetting. The contractor will ensure that a background check is conducted on each SP to ensure that they are not a security risk and that they will be permitted on base.

b. Scheduling. The contractor will provide SPs for TATRC scheduled events with notice no later than two weeks out from MMSIV Division. The contractor will be responsible for contacting SP’s and providing them with dates, time, and location of events that have been provided by the MMSIV Division.

5.2 Simulated Patients Performance: The Vendor shall provide personnel to perform the following task:

5.2.1 Have the appearance that they meet military weight requirements and restrictions.

a. Physical ability:

b. Ability to carry 50lbs.

c. Ability to portray an injured casualty on the ground for up to 30mins.

e. Ability to work outdoors in varying temperature and conditions.

5.2.2 Provide SPs that can:

a. Interact with staff and participants in a professional manner.

b. Master the role and personality of the scripted casualty from a given scenario.

c. Learn scenarios and change presentation based on interventions completed or not completed on a given timeline.

d. Follow direction with setup and resetting of scenarios.

5.2.3 Ensure that SPs agree to all research procedures prior to participation, including data collection of video and physiological signatures/Personal Health information (PHI) by signing a volunteer assent/consent form.

5.2.4 Ensure that the SPs do not have any preexisting conditions that would negatively impact their ability to work outside (i.e., extreme allergies, extreme reactions to sun exposure, etc.), and cannot have preexisting health conditions that would interfere with data collection (i.e., abnormal vitals that could interfere with physiological signals captured).

5.2.5 Participated in TATRC simulation research events. This will help with the process of standardization and performance consistency.

5.2.6 The Contractor shall invoice monthly. (Deliverable 3).

5.3 Planned Simulations:

Monthly Totals

Monthly Totals

Monthly Totals

Monthly Totals

Monthly Totals

Monthly Totals

Monthly Total

Monthly Total

Monthly Total

Monthly Total

Monthly Total

Monthly Total

Yearly Total Hours

PART 6

Deliverables

6. The following table provides a listing of the actual deliverables the Contractor shall be required to provide:

1. 5.1 List of SP to perform

3. 5.2.6 Monthly invoice.

7. Quality Assurance Surveillance Plan (QASP) The Government intends to utilize a QASP to monitor the quality of the Contractor’s performance. The oversight provided in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance and provides verifiable input for the required Past Performance Information Assessments.