Nursing_Informatics_Consultant_SOW_Final.docx

Statement of Work (SOW)

Nursing Informatics Consultant

National Institutes of Health (NIH) National Institute of Nursing Research (NINR) Project Officer: Erica Vass

Bldg. 31, Suite 5B10 Bethesda, MD 20892

Background The National Institute of Nursing Research (NINR) is one of the 27 Institutes and Centers that comprise the National Institutes of Health (NIH). The mission of the National Institute of Nursing Research (NINR) is to promote and improve the health of individuals, families, communities, and populations. NINR supports and conducts clinical and basic research and research training on health and illness across the lifespan to build the scientific foundation for clinical practice, prevent disease and disability, manage and eliminate symptoms caused by illness, and improve palliative and end-of-life care. NINR's research programs, both extramural and intramural, incorporate a broad range of interdisciplinary approaches designed to promote scientific exploration that will lead to better health outcomes and health services. Such approaches include: clinical intervention studies; translational and implementation research.

Under this Statement of Work (SOW), the offeror will provide resources to plan and aid the development clinically relevant and appropriate immersive visualization scenarios to be used in human subjects’ research for application of these scenarios in efforts to improve patient self-care and self- management. It is intended that the resulting contract vehicle will be a Level of Effort (LOE) on a Labor Hour and other direct costs (ODC) basis. The estimated timeframe of the engagement is 12 months from date of award, plus for up to 1 additional option year.

Scope This SOW defines the scope of work to be accomplished by the contractor. The objectives for this project are:

· To obtain expertise to facilitate development of clinically relevant requirements into the design of immersive visualization simulations of routine health tasks commonly managed by patients in non-clinical environments.

· To convene and conduct focus-group discussion with appropriate subject area experts.

· To provide the following primary deliverables:

· Written medical literature reviews following traditional/narrative literature review summaries for topics specified by the NINR investigators framing the clinical issues.

· Draft language for clinical scripts, storyboards, and requirements for assets to be integrated into the immersive simulations.

The project is divided into phases for each simulation. This procurement action is for the scope of work for full development of two simulations (initial year; for option years, an equivalent number of deliverables would be expected for each year period) and contribution to limited phases of development for up to an additional six simulations. The approach section provides information describing deliverables expected at the completion of each phase. The offeror will not be directly involved in the technical development of visualization simulations.

Approach The Contractor shall identify a single key personnel, hereafter identified as the consultant to perform most of the work and will take full responsibility for the deliverables as outlined in the Contractor Responsibilities section below. The following documents a few key assumptions:

General

· The NINR AVB Chief Investigator will prioritize the work to be done during kick-off and assess progress to adjust prioritization during at least monthly meetings including providing the consultant research direction and expectations for deliverables required for each simulation;

· The NINR AVB Chief Investigator shall provide the consultant with the general topic for literature review summaries;

· The NINR Contracting Officer Representative (COR) provides active project management;

· The NINR AVB provides NIH Library resources to the consultant and literature access requests will be used whenever possible;

· Novel review/research direction will be approved in advance by NINR AVB Chief Investigator;

· The consultant will be provided necessary security badges and computers for use during performance of tasks;

· The consultant will obtain information from other subject matter experts in clinically appropriate fields – expected to primarily be from nurse case managers or others with experience/expertise in the field of post-acute care patient management;

· The consultant will conduct the work at the contractor’s site with the possibility for work at the NINR site one or two times during the expected performance for this contract (travel requirements and work-location are further clarified below).

Hardware and software

· Cost, purchase, and delivery of hardware and software are covered by NINR AVB.

· NINR shall obtain licensed copies of all required third-party software products with the anticipated required software installed on the hardware prior to delivery.

· NINR is responsible for the support for data processing such as hardware configuration, and software installation; instructions for consultant assisted maintenance and security procedures are required.

Deliverable Phases In general, deliverables promote clinical awareness among the NINR AVB staff to aid in establishing clinically meaningful and relevant simulation design requirements for integration into research plans. Simulations developed by the AVB staff use technology to create immersive visualization scenarios for display on head-mounted display devices (HMDs). These simulations are designed to evaluate whether VR simulations can be leveraged to improve patient self-care and/or self-management outcomes for patients with a variety of clinical care issues in non-clinical settings. The consultant applies clinical nursing knowledge to research the clinical contexts for proposed simulations, develops proposals for clinically based outcome measures and methodologies, and contributes to the development of other key deliverables as outlined below. Full activities/deliverables include, but are not limited to two for each of the following:

Literature Reviews The consultant will be responsible for up to 10 literature review summaries. All simulations are expected to have at least one literature review summary, so this phase is considered a minimum deliverable for all simulations developed. Some simulations may involve more than one literature review.

Simulation Outline Clinical scenario design and development proposals (outline) established – this outline is intended to provide the clinical details for the proposed disease/condition health tasks are associated with for proposed simulation development. This outline should contribute to the establishment of a hypothesis for individuals’ rehearsal of relevant health tasks into immersive visualization simulations and frame potential secondary outcomes/endpoints for further exploration/development in future research study applications of the proposed simulations to be developed. Addition elements to include are specific targeted patient outcome improvement(s) recommendations with proposed measurement/evaluation criteria and the asset requirements explained in the following section.

Asset Requirements The consultant will contribute to discussion of required elements (assets) to be incorporated into the simulations. The consultant shall provide information for all medical equipment and supplies which are expected to be included in routine patient self-care and/or self-management health tasks. Emphasis on items which may hinder patients’ ability to comply with medical advice should also be considered when developing requirements recommendations. The consultant’s literature review will focus on the ways health information is utilized by patients/care givers and methods for improving patient outcomes. The synthesis of information from more technology focused literature reviews (conducted by AVB staff) will be used collectively with the information summarized by the consultant to inform scenario development and planning of constructed environments. Reviewed medical literature will also focus on identifying ways to improve patients’ health experience in non-clinical settings. This literature shall include patient education/training best practices which can further inform the development of scenarios that are designed to actively engage the participant in completion of interactive health tasks within virtual environments.

Storyboards The consultant will lead storyboard development for patient tasks for developed simulations involving the patients’ self-directed health tasks. Storyboard development is a collaborative effort between the consultant and the AVB staff. Storyboards for at least two simulations is expected.

Scripting The consultant will draft the clinically relevant scripts for use in the simulations. Again, a minimum of two complete script drafts is expected.

Other Direct Costs Focus Group Administration The contractor is expected to administrate and convene expertise from outside consultants (primarily anticipated to be nursing or health-care case management experts) for participation in focus groups to validate clinical accuracy, thoroughness, and validation of tasks expected to be part of patients’ health-task related routines appropriate to the simulations being developed. All costs associated with convening these groups should be coordinated and administered by the offeror. Prior to convening any focus groups, a summary of methodology and brief bio statement for proposed participants will be validated by the contract officer representative or designated staff of the NINR AVB as to the appropriateness of the participants in the convened focus group.

Travel The consultant shall travel at least once to the NINR site. All travel arrangements shall be directed by the offeror and are subject to terms consistent with travel regulations as outlined in the Federal Travel Regulations (FTR). The consultant is not expected to incur travel expense for more than two visits to the NINR site. All requests for travel will be provided at least one month prior to expected travel date.

Note: These deliverables are subject to adjustment with mutual agreement between the consultant and the AVB as based upon level of effort required for the implementation of the tasks required. This is intended to be an initial phase effort and a larger project may result from the initial project described here.

Consultant description The work outlined utilizes the consultant’s expertise to combine knowledge of patient care, informatics concepts, and system design/system requirements for the development of patient education tools. The consultant will be expected to come with a range of experience which can be validated on their submitted CV/Resume at time of contract bid. Experience to be documented includes the following:

· Evidence of successful development and implantation of technology-driven tools for health-care topics on platforms which include on-line tools, mobile apps, and/or head mounted devices

· Evidence of ability to communicate health information to a range of healthcare professionals and patients as demonstrated by participation in presentations to and/or publications for professional healthcare or health technology societies

· Evidence of leadership in healthcare informatics as demonstrated by chief and/or director level positions with primary focus on nursing informatics of three years or greater and a minimum of a masters in nursing informatics, public health with health information focus, or a closely related field of study.

Duty Station The Consultant shall perform all work at the contractor site or another location permitted by the offeror. Routine meetings and deliverables are anticipated to be via technology connections and may include web-ex meetings (NINR to coordinate) and secure file transfer (NINR to initiate).

Period of Performance Work is time sensitive. The period of performance shall be 12 months from date of award. This contract may optionally be renewed annually for up to one year. The expected work-load is requested to be spread throughout the expected period of performance to enable continuation of simulation development as the projects are implemented throughout the award phase. A few restrictions apply:

· The consultant should be generally expected to complete an average of 10 hours/week for efforts, but the number of hours per week can be adjusted during the at least monthly AVB lab meetings. Fewer than 5 hours/week and greater than 20 hours/week will require advanced written approval from the AVB staff or the Contract Officer Representative (COR).

· All established meetings should be conducted during routine business hours (M-F 8:30 to 5:00 pm – eastern standard time).

· Work will be assumed to be no less than 5 hours’ work per week. If the consultant is unable to meet the 5 hours’ work request for a full business week or more, the consultant should notify NINR AVB staff of the anticipated timeline for resuming work at the earliest convenient time, but no longer than three business days.

Key Personnel (Consultant)

1. Skilled and experienced technical and clinical personnel are essential for accomplishing the work to be performed. Consultant shall be identified by name and title/job classification in offeror proposals. Consultant for this contract are permitted to be subcontractors.

a. Required qualifications for consultant:

i. Current and active RN license

ii. Minimum of Bachelor’s degree in nursing

iii. High level of understanding of clinical areas and patient education

iv. Minimum of 7 years of experience in nursing informatics

v. Experience in working with the establishment and implementation of patient education tools for use on-line, on a mobile app, or for display in head mounted devices (Virtual Reality – specific devices).

vi. Ability to be adaptive and flexible to work with a range of collaborative work models

vii. Excellent written and verbal communication skills

viii. Proven track record of successful project implementation for at least two projects

ix. Able to sense and envision technology needs in relation to organization’s strategy and priorities.

b. Preferred qualifications:

i. Masters informatics, nursing informatics, or public health with at least two years’ experience with technology project consultation

ii. Advanced knowledge of patient self-management in home setting (as demonstrated by at least 5 years’ experience working with patients for home-based care or transitional care settings).

2. The Contractor (offeror) agrees that the above consultant shall not be removed from the contract effort, replaced or added to the contract without a compelling reason and without compliance with paragraphs (3) and (4) hereof. The Government will not approve substitutions for the sole convenience of the contractor.

3. If any change to the consultant position becomes necessary (substitutions or additions), the Contractor shall immediately notify the Contracting Officer in writing, accompanied by the resume of the proposed replacement personnel who shall be of at least substantially equal ability and qualifications as the individual currently approved for that category.

4. No substitution or replacement of the consultant shall be approved within the first ninety (90) days after contract award.

5. All requests for approval of changes hereunder must be in writing, via email, and provide a detailed explanation of circumstances necessitating the proposed change. Request for changes should be made whenever the need is identified. In addition to the resume for the proposed replacement consultant, the request must also provide:

a. A comparison of skills and qualifications to those set forth from the qualifications for the original consultant;

b. Number of hours the contractor will provide at his/her own expense to train the proposed replacement, and

c. Any other information requested by the Contracting Officer to reach a decision.

Management Requirements The Contractor (and any sub-contracted consultant) shall guarantee strict confidentiality of the information/data discussed with the NINR AVB during the performance on this contract as well as the information provided in the specified deliverables. The Contractor must commit to protecting non-public Departmental (Department of Health and Human Services) information and data. The Contractor and any subcontractor(s) performing work under this contract shall not release or publish non-public Departmental information to unauthorized personnel and shall protect such information in accordance with provisions of the following laws and any other pertinent laws and regulations governing the confidentiality of such information:

· 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records)

· 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information)

· Public Law 96-511 (Paperwork Reduction Act) Disclosure of the information/data, in whole or in part, by Contractor can only be made after the Contractor receives prior written approval from the contracting officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the NINR COR.

All computer code, data, and information obtained or produced during this project will be the property of the NINR.

Privacy and Security Requirements All personnel and activities must conform to all applicable Federal, HHS, and NIH, and NINR policies and guidelines regarding security, confidentiality, and privacy.

Information Security is applicable to this SOW. The SOW requires the contractor to perform one, or any combination, of the following on behalf of the government:

1. Develop, have the ability to access, and maintain a Federal information system(s).

2. Remotely access federal information or physically remove sensitive federal information beyond agency premises or control.

Pursuant to Federal and HHS Information Security Program Policies the following requirements apply to this task order:

Federal Information Security Management Act of 2002 (FISMA), Title III, E-Government Act of 2002, Pub. L. No. 107-347 (Dec. 17, 2002); http://csrc.nist.gov/drivers/documents/FISMA-final.pdf Security Categories and Levels The security level for this task order is:

Position Sensitivity Designations The following sensitivity level(s), clearance type(s), and investigation requirements apply to this contract:

Level 1: NACI The Contractor shall submit a roster by name, position, e-mail address, phone number, and responsibility of all staff (including subcontractor staff) working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain federal information system(s). The roster shall be submitted to the Project Officer, with a copy to the Contracting Officer, within 14 calendar days of the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change; however, in the event of proposed change to consultant, the notification should be made prior to departure of the current consultant. The Contracting Officer will notify the Contractor of the appropriate level of investigation require for each staff member. An electronic template, “Roster of Employees Requiring Suitability Investigations,” is available for contractor use at https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Archive/SuitabilityRoster_10-15-12.xlsx).

Suitability investigations are required for contractors who need access to NIH information systems. However, Contractors who do not need access to NIH physical space will not need an NIH ID Badge. Each contract employee needing a suitability investigation will be contacted via e-mail by the NIH Office of Personnel Security and Access Control (DPSAC) within 30 days. The DPSAC e-mail message will contain instructions regarding fingerprinting as well as links to the electronic forms contract employees must complete. Additional information can be found at the following website: http://idbadge.nih.gov/background/index.asp All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract. Contractors may begin work after the fingerprint check has been completed.

Personnel Security Responsibilities The Contractor shall perform and document the following actions:

The contractor shall notify the Contracting Officer, the NINR Project Officer, and the Security Investigation Reviewer within five working days before a new employee assumes a position that requires a suitability determination or when an employee with a suitability determination or security clearance stops working under this acquisition. The Government will initiate a background investigation on new employees requiring suitability determination and will stop pending background investigation for employees that no longer work under this acquisition.

· New employees: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability determination level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate suitability level.

· Departing employees: Provide the name, position title, and suitability determination level held by or pending for the individual.

All documentation shall be made available to the Project Officer and/or Contracting Officer upon request.

Information Security Training Contractors/subcontractors shall receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements.

The Contractor shall ensure that each contractor/subcontractor employee has completed the following training (located at http://irtsectraining.nih.gov/) prior to performing any task order work, and thereafter completing the NIH-specified fiscal year refresher course during the period of performance on this acquisition:

1) Information Security Awareness Training course (including agreement to NIH Rules of Behavior),

2) Securing Remote Computers, and

3) Privacy Awareness Course The Contractor shall maintain a list by name and title of each Contractor/Subcontractor employee working under this acquisition who has completed the NIH required training. The list (along with any subsequent updates to the list) shall be provided to the Project Officer. Any additional security training completed by Contractor/Subcontractor staff shall be included on this list. Additional security training requirements commensurate with the position may be required as defined in NIST Special Publication 800-16, Information Technology Security Training Requirements (http://nvlpubs.nist.gov/nistpubs/Legacy/SP/nistspecialpublication800-16.pdf). This document provides information about information security training that may be useful to the Contractor.

Contractor/subcontractor staff may be required to complete additional training prior to performing any work under this acquisition as directed by the NINR ISSO, CIO, or Executive Officer. The list of completed training shall be included in the first status report submitted to the Project Officer. Any revisions to this list as a result of staffing changes shall be submitted with the next required status report.

The Contractor shall include in the “Information Security” section of its Technical Proposal, the name and title of its official who will be responsible for all information security requirements should the Contractor be selected for an award.

Contractor Employee Non-Disclosure Agreement Each Contractor/subcontractor employee who may have access to non-public Department information under this task order shall agree to the NIH Non-Disclosure Agreement (NDA). The NDA is now part of the Information Security Awareness Training. Upon reviewing and agreeing to the slide within the training, the contractor has completed the NIH NDA requirement.

Data Encryption The following applies to all Contractor/subcontractor computers containing HHS data at rest and/or HHS data in transit:

1. All computers used on behalf of the government shall be secured using a Federal Information Processing Standard (FIPS) 140-2 compliant whole-disk encryption solution. The cryptographic module used by an encryption or other cryptographic product must be tested and validated under the Cryptographic Module Validation Program to confirm compliance with the requirements of FIPS PUB 140-2 (as amended). For additional information, refer to http://csrc.nist.gov/groups/STM/cmvp/documents/140-1/140val-all.htm.

2. All mobile devices, including non-HHS computers and portable media, that contain sensitive HHS information shall be encrypted using a FIPS 140-2 compliant product. Data at rest includes all HHS data regardless of where it is stored.

3. A FIPS 140-2 compliant key recovery mechanism shall be used so that encrypted information can be decrypted and accessed by authorized personnel. Use of encryption keys which are not recoverable by authorized personnel is prohibited. Key recovery is require by “OMB Guidance to Federal Agencies on Data Availability and Encryption,” November 26, 2001, http://csrc.nist.gov/groups/ST/toolkit/documents/ombencryption-guidance.pdf.

4. Encryption keys shall comply with all HHS and NIH policies https://www.hhs.gov/ocio/policy/20080007001s.html and shall provide adequate protection to prevent unauthorized decryption of the information.

5. All media used to store information shall be encrypted until it is sanitized or destroyed in accordance with NIH procedures. Contact the NIH Center for Information Technology https://ocio.nih.gov/ITGovPolicy/Documents/SanitizationPolicy.doc.

6. NIH Web Page Privacy Policy (NIH Manual Chapter 2805): https://policymanual.nih.gov/2805.

7. NIH Manual 1745 – NIH Information Technology (IT) Privacy Program: https://policymanual.nih.gov/1745.

8. Information Security Program Policy: http://intranet.hhs.gov/infosec/docs/policies_guides/ISPP/Information_Security_Program_Policy.pdf

9. Federal Information Security Management Act of 2002 (FISMA), Title III, E-Government Act of 2002, Pub. L. No. 107-347 (Dec. 17, 2002) http://csrc.nist.gov/drivers/documents/FISMA-final.pdf Using Secure Computers to Access Federal Information

1. The Contractor shall configure its computers that contain HHS data with the applicable United States government Configuration Baseline USGCB (http://USGCB.NIST.gov), (formerly Federal Desktop Core Configuration, FDCC, http://nvd.nist.gov/fdcc/index.cfm) and ensure that its computers have and maintain the latest operating system patch level and anti-virus software level.

2. The Contractor shall ensure IT applications operated on behalf of HHS are fully functional and operate correctly on systems configured in accordance with the above configuration requirements. The Contractor shall use Security Content Automation Protocol (SCAP)- validated tools with USGCB Scanner capability to ensure its product operate correctly with USGBC configurations and do not alter USGCB settings – see https://nvd.nist.gov/scap/validated-tools. The Contractor shall test applicable product version with all relevant and current updates and patches installed. The Contractor shall ensure currently supported versions of information technology products met the latest USGCB major version and subsequent major versions.

3. The Contractor shall ensure that its subcontractors (at all tiers) which perform work under this contract comply with the requirements contained in this clause.

4. As needed, the Government shall provide logical access to NIH resources via a terminal server solution to the Contractor.

5. A Privacy Act Notification Statement (NS) and NINR disclaimer must be posted on all websites, paper and electronic forms which collect information in identifiable form (IIF), that is, information that is personal in nature and which ay be used to identify an individual. NOTE: The Acronyms IIF and PII (Personally Identifiable Information) mean the same thing.

NIH Physical Access Security In accordance with OMB Memorandum M-05-24, background investigations must be completed for all contractor/subcontractor personnel who have (1) access to sensitive information, (2) access to Federal information systems, (3) regular or prolonged physical access to Federally-controlled facilities, or (4) any combination thereof.

The SOW requires the Contractor/subcontractor to have regular or prolonged access to sensitive information and/or access to Federal Information Systems, thereby requiring compliance with the following regulations/polices:

1. HHS Information Security Program Policy: http://intranet.hhs.gov/infosec/docs/policies_guides/ISPP/Information_Security_Program_Policy.pdf

2. Homeland Security Presidential Directive/HSPD-12, Policy for a Common Identification Standard for Federal Employees and Contractors (08-27-04): http://www.dhs.gov/xabout/laws/gc_1217616624097.shtm#1

3. OMB Memorandum M-05-24, Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors (08-05-05): https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2005/m05-24.pdf.

4. Federal Information Processing Standards Publication (FIPS PUB) 201-1 (Updated June 26, 2006): http://csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf

5. HHS Interim Policy: Contractual Implementation of Homeland Security Presidential Directive (HSPD) 12, Policy for a Common Identification Standard for Federal Employees and Contractors [Draft]

6. HHS Office of Security and Drug Testing, Personnel Security/Suitability Handbook (02-01-05): https://www.hhs.gov/sites/default/files/hr-resource-library-731-1.doc.

Privacy Act This Statement of Work required the Contractor to have incidental or administrative access to data covered under the following, but not all inclusive Privacy Act System of Records.

The Contractor agrees to comply with the policies and practices defined in the System of Records listings for this data and any other Privacy Act system the contractor may have access to, and the Privacy Act clauses for FAR 52.224.1 and 52.224-2, herein incorporate by reference.

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