Revised_PWS_14_Sep_2018.pdf

PERFORMANCE WORK STATEMENT

“Virtual reality for alleviation of peripheral IV placement‐associated discomfort”

SCOPE OF Work:

1.1: General

1.1.1 Overview: The purpose of this study is to evaluate efficacy of immersive virtual reality (iVR) software during peripheral IV (PIV) placement for alleviation of procedure‐associated discomfort.

1.1.2 Description of effort: Research Coordinator and Principal Investigator will collect data for the prospective randomized controlled trial comparing self‐ reported discomfort during PIV placement in subjects receiving PIVs while using iVR with those who receive PIVs according to standard of care. Subjects will be consented and intervened upon only in the immediate pre‐ surgical environment, with all data collected in the peri‐operative suite immediately prior to surgery.

Specifically, any patient about to undergo surgery will require intravenous access and may be screened for basic inclusion/exclusion criteria. If the patient is eligible for participation the consent process would be executed in the peri‐operative suite prior to surgery. Participants will be randomized into two groups; conventional PIV placement, or PIV placement with iVR.

Subjects will be interviewed after PIV placement prior to surgery, to provide pain scores according to the validated Graphic Rating Scale for pain and discomfort associated with procedures while using iVR.

It is anticipated that 50 patients in each group will be needed to determine if there is a statistically significant difference in discomfort associated with the procedure between groups, powered to 80%. This number was selected to allow a sample size of 86 after an estimated 10% drop out/withdrawal rate. Two‐tailed T‐test will be performed to assess difference in ratings between groups.

1.1.3 Research Hypothesis/Objective: Patients who undergo distraction with immersive virtual reality (iVR) during peripheral IV catheter placement will rate their pain as less unpleasant than those who do not receive iVR during PIV placement

1.1.4 Period of Performance: 6 months from the date of award

1.1.5 Scope of Work: Contracted research coordinator will provide administrative services and research support according to protocol as determined by PI.

1.1.6 Contractor Personnel: n/a

1.1.7 Equipment/Supplies‐ Item:

Personnel: research nurse (Julie Garcia, MSN), $2,000 (0.3125 FTE)

Samsung Gear virtual reality headset, software, disposable foam liners for hygiene package deal

(AppliedVR), $800 each mobile device (x10 headsets) = $8000.00

Healthcare VR Subscription Software $4,200.00 each (x10) = $42,000.00

TDY funds $4,000 each (x2 investigators) = $8,000

Computerware for data entry and analysis will be provided by the Department of Defense

1.1.8 Travel: Travel will not be required to complete investigation protocols. Funds are budgeted for the research coordinator and PI to attend one national conference per year to present results and to interact with others in the field.

1.1.9 Other Direct Costs: Printing services for participant recruitment materials, courier services, postage costs, communication services necessary to successfully conduct clinical investigation protocols in accordance with the Performance Work Statement during the performance period will be procured by the PI. Funds have also been budgeted to support online and print advertisement of the research coordinator position. Finally, funds have been budgeted to support costs associated with submission fees for publication of findings in peer‐reviewed journals.

2.1: General requirements

2.1.1: Necessary services of personnel, professional services, research administration of the study entitled, “Virtual reality for alleviation of peripheral IV placement‐associated discomfort,” may be obtained within existing SAMMC infrastructure.

2.2: Research personnel

2.2.1: The PI will be responsible for day‐to‐day conduct of the project and will execute routine functions of research study, providing administrative oversight to ensure that it is executed successfully.

2.2.2: The PI will be responsible for daily coordination and administration of the study site, which includes participant recruitment, data collection, and tracking deadlines and reporting requirements.

2.2.3: The PI shall be responsible for the initial set‐up and close‐out of study/studies files and databases, data collection and data entry, and on‐going organization and maintenance of all research study/studies records and data in a computerized format.

2.2.4: The PI, Assistant Investigator, and Research Coordinator shall execute study protocol(s) according to the methods and procedures as outlined in the approved protocols.

2.2.5: The Research Coordinator shall assist with preparation of interim and final reports, as well as manuscripts for publication.

2.2.6: Assistant investigator shall collaborate and contribute to study outcome peer‐reviewed journal articles, professional meeting presentations, or abstracts in support of and under direction of PI.

2.2.7: The Research Coordinator will communicate frequently with the research team concerning the study via email, team meetings, and phone contact.

3.1.0: Qualifications

3.1.1: PI, AI, Research Coordinator all possess required qualifications for the research protocol

4.1.0: Deliverables

4.1.1: Written reports of work accomplished will be provided in accordance with the funding party’s requirements

5.1.0: Operational security (OPSEC):

Investigation Requirements. The Contractor shall ensure all personnel performing under the contract are required to maintain a minimum of a favorably adjudicated Tier 1 (T1) formerly known as National Agency Check with written Inquires (NACI) for IT Level III access or Tier 3 Formerly known as a National Agency Credit and Law Check (NACLC) for IT‐II access. The contractor must coordinate with the Contracting Officer Representative (COR) to initiate the Request for Personnel Security Action prior to performance start date. U.S. Citizenship will be verified by presenting original or certified copy of birth certificate, certificate of citizenship/naturalization issued by INS, or born aboard certificate (Form FS‐240 or DS‐1350) or a valid U.S. Immigration Form 1‐151 and Alien Registration Card ("Green Card") and is completed investigation document(s) to the BAMC Personnel Security Office at the time of in processing for all contract personnel assigned to the contract. In order to maintain the security requirements any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues must be reported to the COR and to the BAMC Personnel Security Office.

5.2. 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 Contracts That Require Handling or Access to Classified Information. Contractor shall comply with FAR 52.204‐2, Security Requirements. This clause involves access to information classified "Confidential," "Secret," or "Top Secret" and requires contractors to comply with‐ The Security Agreement (DD Form 441), including the National Industrial Security Program Operating Manual (DoD 5220.22‐ M); any revisions to DOD 5220.22‐M, notice of which has been furnished to the contractor. A Secret security clearance is required for the contract employee to perform the scope of work. The Contractor shall have a proper Facility Clearance (FCL). The Contractor's employee shall report to the workplace with a favorable National Agency Check with Law and Credit/T3/T3R and a Secret or Interim Secret clearance in order to gain access to the workplace. DD254 shall be processed at no added cost to the contract.

5.3. 1.2.7.6. Freedom of Information Act Program (FOIA and Privacy Act). The contractor shall comply with DOD Regulation 5400.7‐R, DOD Freedom of Information Act Program requirements. The Freedom of Information Act sets policy and procedures for the disclosure of records to the public and for marking handling transmitting and safeguarding For Official Use Only materials.

5.4. 1.2.7.7. Reporting Requirements. The contractor shall comply with DoD 5200.2‐R, January 1987, Personnel Security Program and AR 380‐67, 9 September 1988, Department of the Army Personnel Security Program Regulation. Contractor shall report to the BAMC Security Manager any information or circumstances which may pose a threat to DOD or contractor personnel, resources, or DOD information.

5.5. 1.2.7.8. Removal of contract employee. The government reserves the right to require immediate temporary or permanent removal of any individual whose actions raise reasonable suspicion that patient care or services may be compromised in any way or that pose a threat of harm to other contractor/government personnel or self. The employee may be required to submit to drug/alcohol testing. The government reserves the right to require temporary or permanent removal of any individual who refuses testing. Notification of all removals will be made by the Contracting Officer Representative (COR). Removal of any individual does not relieve the contractor of any performance requirement

5.6. 1.2.7.9. Physical Security. The contractor shall comply with all Force Protection Condition (FPCON) procedures, Random Antiterrorism Measures (RAMS) and local search/identification requirements.

5.7. 1.2.7.11. Government Computer Access Requirements. If this contract requires contractor personnel to have access to government computers, contractor personnel requiring access to government computers shall successfully complete, Tier 1 (T1) formerly known as National Agency Check with written Inquires (NACI) for IT Level III access or Tier 3 formerly known as a National Agency Credit and Law Check (NACLC) for IT‐II access to the computer. These investigations shall be submitted by the government at no additional cost to the contractor.

Common Access Cards (CACs) for Contractor Personnel are required which is hereby incorporated by reference if not otherwise included. The contractor shall comply with Homeland Security Policy Directive (HSPD)‐12, Army Directive 2014‐05 “Policy and Implementation Procedures for Common Access Card Credentialing and Installation Access for Uncleared Contractors”, Policy for Common Identification Standard for Federal Employees and Contractors and Federal Information Processing Standard 201

5.8 1.2.7.12. Keys and Lock Combinations. The contractor shall abide by all current BAMC key control and lock combination procedures The Contractor shall be responsible for any keys issued to the employee. The keys shall not be duplicated. The Contractor shall ensure that its employee’s not allow government‐issued keys be used by personnel other than those currently authorized. No unauthorized personnel shall be allowed entry into the locked area. Keys shall not be used to open work areas for personnel other than personnel engaged in performance of their duties, unless authorized by the Government functional area chief. The employee shall use keys issued to them to secure/open areas only as directed by the COR and/or functional area chief. Lost keys and/or locks shall be reported to the issuing party and COR immediately upon recognition of the loss. The COR shall notify the PMO of the lost key. The employee shall be responsible for the replacement costs of any lost keys and any associated locks. Reimbursement shall be provided before the Government replaces lost keys or performs re‐keying.

5.9 1.2.7.12.1. Key Control. The contractor shall safeguard all keys issued by the government and insure they are used only by authorized contractor personnel.

The contractor shall not duplicate issued keys and shall report lost keys to the contracting officer immediately the contractor will be charged for lost keys, re‐ keying, and lock replacement as applicable