PWS_for_Solicitation.pdf

STATEMENT OF WORK

FOR

ON-SITE LABORATORY TECHNICIAN SUPPORT

FOR THE NAVY EXPERIMENTAL DIVING UNIT

14 February 2017

1.0 SCOPE

This statement of work identifies contractor tasks required to provide non-personal services support of the Navy Experimental Diving Unit (NEDU), Panama City, FL. The contractor shall provide support of basic integrative physiology research related to the mechanisms of human performance degradation following exposure to hyperbaric and extreme environments, and understanding of human heat exchange during cold water diving exposures.

2.0 APPLICABLE DOCUMENTS

None

3.0 REQUIREMENTS

The Navy Experimental Diving Unit requires full-time on-site non-personal contract services to perform the tasks as listed below:

3.1 Warfighter Human Performance Laboratory Technician Support

The Contractor shall support two tasks to 1) evaluate human performance parameters following long-duration hyperoxic dives and 2) determine physiological heat exchange in cold water using direct regional calorimetry and other measurements of thermal exchange.

3.1.1 The contractor shall coordinate and execute physiological experimentation to include, but not limited to human performance testing, pulmonary function testing, examination of the effects of hyperbaric and extreme environments on thermoregulation and cardiovascular, autonomic, respiratory, and muscular physiology.

3.1.2 The contractor shall maintain laboratory organization, equipment, and required supplies for project execution.

3.1.3 The contractor shall build, test, troubleshoot, and repair developmental and production electronic components and systems in biomedical instrumentation. If needed, the contractor shall coordinate development and repair with appropriate vendors.

3.1.4 The contractor shall perform data entry and analysis using statistical and graphing software, as well as specialized software to measure physiological variables such as body temperature, peripheral blood flow, oxygen consumption, lactate threshold, and hemodynamic status.

3.1.7 Services will be requested and controlled by means of Government Furnished Information (GFI), which will delineate specific objectives, deliverables, and constraints. The contractor shall be responsible for delivering all end items specified in the GFI as well as the work control documentation to the Contracting Officer or his/her designee. GFI will be provided by the Principal Investigator to the contractor. The requested services in the GFI will be prioritized according to the short term (i.e. daily/weekly) and long-term (monthly) project objectives, and may be modified as necessary by the Principal Investigator or Contracting Officer to best achieve the milestones of the project.

3.2 Special Requirements

3.2.1 The contractor shall assign to the contract those persons whose resumes or personnel qualification statements were submitted as required to fill the requirements of the contract. No substitution or addition of personnel shall be made except in accordance with this special requirement.

3.2.2 The contractor shall not substitute personnel during the purchase order period of performance unless such substitutions are necessitated by an individual’s sudden illness, death or termination of employment. In any of these events, the contractor shall promptly notify the Contracting Officer and provide the information required by paragraphs below.

3.2.2.1 Personnel substitutions shall be submitted, in writing, to the Contracting Officer at least 15 work days (30 work days if a security clearance must be obtained), prior to the proposed substitution. Each request shall provide a detailed explanation of the circumstances necessitating the proposed substitution, a complete resume for the proposed substitute and any other information required by the Contracting Officer to approve or disapprove the proposed substitution. All proposed substitutes (no matter when they are proposed during the performance period) shall have qualifications that are equal to or higher than the qualifications of the person being replaced.

3.2.3 Contractor employees shall be U.S. citizens able to read, write, communicate and understand the English language. No employee or representative of the Contractor shall be admitted to the work site unless satisfactory proof of U.S. citizenship is furnished. Contractor employees shall conduct themselves in a proper, efficient, courteous and businesslike manner. The Contractor shall remove from the site any individual whose continued employment is deemed by the Government to be contrary to the public interest or inconsistent with the best interests of National Security.

3.2.4 All work will be conducted onsite at NEDU.

3.3 Technical Point of Contact

The Technical Point of Contact for this purchase order is John Florian, Ph.D. Dr. Florian is the Principal Investigator (PI) for this purchase order.

3.4 Monthly Status Report

The contractor shall submit a monthly status report to the Contracting Officer and Contracting Officer Representative by the 10th of each month. At a minimum, the report shall identify ongoing and resolved projects, potential areas of concern, sponsor, and task number, as appropriate. Contractor format is acceptable.

4.0 GOVERNMENT FURNISHED PROPERTY

4.1 Access to Government Facilities

4.1.1 Access to Government buildings is normally from 0600 until 1700 Monday through Friday, except Federal holidays. Access to Government buildings during experimentation is from 0500 until 2100. Contractor personnel shall not work on Federal holidays unless approved by the Procuring Contracting Officer (PCO) to meet schedules.

Telework is not authorized under this purchase order. Compensatory time may be approved by the Contractor. Any overtime requests must be approved by the PCO in coordination with the work site.

4.1.2 When a Government facility is closed and/or early dismissal of Federal employees is directed due to severe weather, a security threat, or a facility-related problem that prevents personnel from working, on-site Contractor personnel regularly assigned to work at that facility should follow the same reporting and/or departure directions given to Government personnel. The Contractor shall not direct charge to the contract for time off, but shall follow parent company policies regarding taking leave (administrative or other). Non-essential Contractor personnel, who are not required to remain at or report to the facility, shall follow their parent company policy regarding they should go, stay home, or report to another parent company facility. Subsequent to an early dismissal and during periods of inclement weather, on-site Contractors should monitor radio and television announcements before departing for work to determine if the facility is closed or operating on a delayed arrival basis.

4.1.3 The contractor shall be provided access to the following equipment and information within five days after award of purchase order.

a) A work station including desk, telephone and computer

b) Access to NEDU Technical Library

4.2 Government Furnished Information (GFI)

GFI in the form of tasking, specific objectives, deliverables, and constraints will be provided throughout the purchase order period of performance. Disposition of GFI will be made at completion of this purchase order.

5.0 DELIVERABLES

All data deliverables shall be submitted in accordance with the attached DD Form 1423.

6.0 SECURITY

This task is UNCLASSIFIED.

6.1 Controlled Unclassified Information (CUI)

Controlled unclassified information (CUI) is official information that requires the application of controls and protective measures for a variety of reasons and has not been approved for public release, to include technical information, proprietary data, information requiring protection under the Privacy Act of 1974, and Government-developed privileged information involving the award of contracts. CUI is a categorical designation that refers to unclassified information that does not meet the standards for National Security Classification under Executive Order 13526, but is (a) pertinent to the national interest of the United States or to the important interests of entities outside the Federal Government, and (b) under law or policy requires protection from unauthorized disclosure, special handling safeguards, or prescribed limits on exchange or dissemination.

6.2 Minimum Requirements for Access to Controlled Unclassified Information

(CUI)

Prior to access, Contractor personnel requiring access to Department of the Navy (DoN) controlled unclassified information (CUI) or "user level access to DoN or DoD networks and information systems, system security and network defense systems, or to system resources providing visual access and/or ability to input, delete or otherwise manipulate sensitive information without controls to identify and deny sensitive information" contractors must have clearance eligibility, or submit an Electronic Questionnaire for Investigation Processing (SF 86) to NSWC PCD Security for processing and subsequent adjudication by the DoN Central Adjudication Facility.

6.3 Minimum Protection Requirements for Controlled Unclassified Information

Security classification guides and unclassified limited documents (e.g., For Official Use Only (FOUO), Distribution Statement Controlled) are not authorized for public release and, therefore, cannot be posted on a publicly accessible webserver or transmitted over the Internet unless appropriately encrypted.

6.4 For Official use Only (FOUO)

FOUO is a document designation, not a classification. This designation is used by Department of Defense (DoD) and a number of other federal agencies to identify information or material, which although unclassified, disclosure to the public of the information would reasonably be expected to cause a foreseeable harm to an interest protected by one or more provisions of the Freedom of Information Act (FOIA). This includes information that qualifies for protection pursuant to the provisions of the Privacy Act of 1974, as amended. FOUO must be marked, controlled and safeguarded in accordance with DoDM 5200.01, Vol. 4, DoD Information Security Program: Controlled Unclassified Information (CUI), February 24, 2012

6.5 Security of Unclassified DoD Information on Non-DoD Information Systems (DoDI 8582.01) DoD Policy

Adequate security shall be provided for all unclassified DoD information on non-DoD information systems. Appropriate requirements shall be incorporated into all contracts, grants, and other legal agreements with non-DoD entities.

Information Safeguards are applicable to unclassified DoD information in the possession or control of non-DoD entities on non-DoD information systems, to the extent provided by the applicable contract, grant, or other legal agreement with the DoD.

6.5.1 Information Safeguards

Unclassified DoD information that has not been cleared for public release may be disseminated by the Contractor, grantee, or awardee to the extent required to further the contract, grant, or agreement objectives, provided that the information is disseminated within the scope of assigned duties and with a clear expectation that confidentiality will be preserved. Examples include:

a. Non-public information provided to a Contractor (e.g., with a request for proposal).

b. Information developed during the course of a contract, grant, or other legal agreement (e.g., draft documents, reports, or briefings and deliverables).

c. Privileged information contained in transactions (e.g., privileged contract information, program schedules, contract-related event tracking).

It is recognized that adequate security will vary depending on the nature and sensitivity of the information on any given non-DoD information system. However, all unclassified DoD information in the possession or control of non-DoD entities on non-DoD information systems shall minimally be safeguarded as follows:

a Do not process unclassified DoD information on publically available computers (e.g., those available for use by the general public in kiosks or hotel business centers).

b. Protect unclassified DoD information by at least one physical or electronic barrier (e.g., locked container or room, logical authentication or logon procedure) when not under direct individual control of an authorized user.

c. At a minimum, overwrite media that have been used to process unclassified DoD information before external release or disposal.

d. Encrypt all information that has been identified as CUI when it is stored on mobile computing devices such as laptops and personal digital assistants, compact disks, or authorized removable storage media such as thumb drives and compact disks, using the best encryption technology available to the Contractor or teaming partner.

e. Limit transfer of unclassified DoD information to subcontractors or teaming partners with a need to know and obtain a commitment from them to protect the information they receive to at least the same level of protection as that specified in the contract or other written agreement.

f Transmit e-mail, text messages, and similar communications containing unclassified DoD information using technology and processes that provide the best level of privacy available, given facilities, conditions, and environment. Examples of recommended technologies or processes include closed networks, virtual private networks, public key-enabled encryption, and transport layer security.

g. Encrypt organizational wireless connections and use encrypted wireless connections where available when traveling. If encrypted wireless is not available, encrypt document files (e.g., spreadsheet and word processing files), using at least application-provided password protected level encryption.

h. Transmit voice and fax transmissions only when there is a reasonable assurance that access is limited to authorized recipients.

i. Do not post unclassified DoD information to website pages that are publicly available or have access limited only by domain or Internet protocol restriction. Such information may be posted to website pages that control access by user identification and password, user certificates, or other technical means and provide protection via use of transport layer security or other equivalent technologies during transmission. Access control may be provided by the intranet (vice the website itself or the application it hosts).

j. Provide protection against computer network intrusions and data exfiltration, minimally including:

(1) Current and regularly updated malware protection services, e.g., anti-virus, anti-spyware.

(2) Monitoring and control of both inbound and outbound network traffic (e.g., at the external boundary, sub-networks, individual hosts), including blocking unauthorized ingress, egress, and exfiltration through technologies such as firewalls and router policies, intrusion prevention or detection services, and host-based security services. Prompt application of security-relevant software patches, service packs, and hot fixes.

k. Comply with other current Federal and DoD information protection and reporting requirements for specified categories of information (e.g., medical, proprietary, Critical Program Information (CPI), personally identifiable information, export controlled) as specified in contracts, grants, and other legal agreements.

l. Report loss or unauthorized disclosure of unclassified DoD information in accordance with contract, grant, or other legal agreement requirements and mechanisms.

m. Do not use external IT services (e.g., e-mail, content hosting, database, document processing) unless they provide at least the same level of protection as that specified in the contract or other written agreement.

6.6 Operations Security

Operations Security (OPSEC) is concerned with the protection of critical information:

facts about intentions, capabilities, operations, or activities that are needed by adversaries or competitors to bring about failure or unacceptable consequences of mission accomplishment.

Critical information includes information regarding:

• Operations, missions, and exercises, test schedules or locations;

• Location/movement of sensitive information, equipment, or facilities;

• Force structure and readiness (e.g., recall rosters);

• Capabilities, vulnerabilities, limitations, security weaknesses;

• Intrusions/attacks of DoD networks or information systems;

• Network (and system) user identifications and passwords;

• Movements of key personnel or visitors (itineraries, agendas, etc.); and

• Security classification of equipment, systems, operations, etc.

The Contractor, subcontractors and their personnel shall employ the following countermeasures to mitigate the susceptibility of critical information to exploitation, when applicable:

• Practice OPSEC and facilitate OPSEC awareness;

• Immediately retrieve documents from printers assessable by the public;

• Shred sensitive and Controlled Unclassified Information (CUI) documents when no longer needed;

• Protect information from personnel without a need-to-know;

• When promulgating information, limit details to that essential for legitimacy;

• During testing and evaluation, practice OPSEC methodologies of staging out of sight, desensitization, or speed of execution, whenever possible.

7.0 DISTRIBUTION LIMITATION STATEMENT

Technical documents generated under this task order shall be marked with Distribution Limitation Statement D. Word processing files shall have the statements included on the cover page of any resultant hard copy. All technical data gathered under this task order shall carry the following Distribution Limitation Statement and handling caveat:

DISTRIBUTION STATEMENT D: DISTRIBUTION AUTHORIZED TO THE DEPARTMENT OF

DEFENSE AND US DOD CONTRACTORS ONLY, ADMINISTRATIVE OR OPERATIONAL

USE, (DATE). OTHER U.S. REQUESTS FOR THIS DOCUMENT MUST BE REFERRED TO

COMMANDING OFFICER, NAVY EXPERIMENTAL DIVE UNIT (NEDU), 321 BULLFINCH

ROAD, PANAMA CITY BEACH, FLORIDA 32407-7012.

DESTRUCTION NOTICE - FOR CLASSIFIED DOCUMENTS, FOLLOW PROCEDURES IN

DOD 5220.22-M, NATIONAL INDUSTRIAL SECURITY PROGRAM OPERATING MANUAL,

CHAPTER 5, SECTION 7 OR DOD 5200.1-R, INFORMATION SECURITY PROGRAM

REGULATION. FOR UNCLASSIFIED, LIMITED DOCUMENTS, DESTROY BY ANY

METHOD THAT WILL PREVENT DISCLOSURE OF CONTENTS OF RECONSTRUCTION OF

THE DOCUMENT.

8.0 RELEASE OF INFORMATION

All technical data provided to the contractor by the Government shall be protected from public disclosure in accordance with the markings contained thereon. All other information relating to the items to be delivered or services to be performed under this contract may not be disclosed by any means without prior approval of the NEDU Commanding Officer.

Dissemination or public disclosure includes, but is not limited to, permitting access to such information by foreign nationals or by any other person or entity; publication of technical or scientific papers; advertising; or any other proposed public release. The contractor shall provide adequate physical protection to such information so as to preclude access by any person or entity not authorized such access by the Government.

9.0 PROTECTION OF HUMAN SUBJECTS

9.1 DEFINITIONS AS USED IN THIS CLAUSE

9.1.1 Assurance of compliance means a written assurance that a institution will comply with requirements of 32 CFR Part 219, as well as the terms of the assurance, which the Human Research Protection Official determines to be appropriate for the research supported by the Department of Defense (DoD) component (32 CFR 219.103).

9.1.2 Human Research Protection Official (HRPO) means the individual designated by the head of the applicable DoD component and identified in the component's

Human Research Protection Management Plan as the official who is responsible for the oversight and execution of the requirements of this clause, although some DoD components may use a different title for this position.

9.1.3 Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information (32 CFR 219.102(f)). For example, this could include the use of human organs, tissue, and body fluids from individually identifiable living human subjects as well as graphic, written, or recorded information derived from individually identifiable living human subjects.

9.1.4 Institution means any public or private entity or agency (32 CFR 219.102(b)).

9.1.5 Institutional Review Board (IRB) means a board established for the purposes expressed in 32 CFR Part 219 (32 CFR 219.102(g)).

9.1.6 IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements (32 CFR 219.102(h)).

9.1.7 Research means a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of 32 CFR Part 219, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities (32 CFR 219.102(d)).

9.2 REQUIREMENTS

9.2.1 The Contractor shall oversee the execution of the research to ensure compliance with this clause. The Contractor shall comply fully with 32 CFR Part 219 and DoD Directive 3216.02, applicable DoD component policies, 10 U.S.C. 980, and, when applicable, Food and Drug Administration policies and regulations.

9.2.2 The Contractor shall not commence performance of research involving human subjects that is covered under 32 CFR Part 219 or that meets exemption criteria under 32 CFR 219.101(b), or expend funding on such effort, until and unless the conditions of either the following paragraph 10.2.2.1 or 10.2.2.2 have been met:

9.2.2.1 The Contractor furnishes to the HRPO, with a copy to the

Contracting Officer, an assurance of compliance and IRB approval and receives notification from the Contracting Officer that the HRPO has approved the assurance as appropriate for the research under the Statement of Work and also that the HRPO has reviewed the protocol and accepted the IRB approval for compliance with the DoD component policies. The Contractor may furnish evidence of an existing assurance of compliance for acceptance by the HRPO, if an appropriate assurance has been approved in connection with previous research. The Contractor shall notify the Contracting Officer immediately of any suspensions or terminations of the assurance.

9.2.2.2 The Contractor furnishes to the HRPO, with a copy to the

Contracting Officer, a determination that the human research proposed meets exemption criteria in 32 CFR 219.101(b) and receives written notification from the Contracting Officer that the exemption is determined acceptable. The determination shall include citation of the exemption category under 32 CFR 219.101(b) and a rationale statement. In the event of a disagreement regarding the Contractor's furnished exemption determination, the HRPO retains final judgment on what research activities or classes of research are covered or are exempt under the contract.

9.2.3 DoD staff, consultants, and advisory groups may independently review and inspect the Contractor's research and research procedures involving human subjects and, based on such findings, DoD may prohibit research that presents unacceptable hazards or otherwise fails to comply with DoD procedures.

9.2.4 Failure of the Contractor to comply with the requirements of this clause will result in the issuance of a stop-work order under Federal Acquisition Regulation clause 52.242-15 to immediately suspend, in whole or in part, work and further payment under this contract, or will result in other issuance of suspension of work and further payment for as long as determined necessary at the discretion of the Contracting Officer.

9.2.5 The Contractor shall include the substance of this clause, including this paragraph, in all subcontracts that may include research involving human subjects in accordance with 32 CFR Part 219, DoD Directive 3216.02, and 10 U.S.C. 980, including research that meets exemption criteria under 32 CFR 219.101(b). This clause does not apply to subcontracts that involve only the use of cadaver materials.

7.0 DISTRIBUTION LIMITATION STATEMENT