N0018924RZ0140002.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to answ er additional questions and extend this RFP.

1. CONTRACT ID CODE PAGE OF PAGES

S 1 33

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 14-Mar-2024

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X N0018924RZ014

X 9B. DATED (SEE ITEM 11)

08-Feb-2024

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

14-Mar-2024

CODE

NAVSUP FLC NORFOLK CONTRACTING

NORFOLK OFFICE

ATTN: S SOLLENBERGER

5450 CARLISLE PIKE BOX 2020

MECHANICSBURG PA 17050-2411

N00189 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

N0018924RZ014

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

ADDITIONAL Q&A

Q1. Section B of the RFP at page 12 now includes a Program Manager labor category as noted in Answer 14.

However, the position descriptions at C.5 Labor Categories and Education/Experience/Other Requirements and Duties were not updated to include this position which is needed for pricing purposes. Would the government please provide a position description for the Program Manager labor category?

A1. Description Added Q2. Answer 63 clarifies that this contract is not subject to the DOL wage determination under the Service Contract Labor Standards (SCLS). However, Section III.2 (Cost Proposal), Paragraph (i) on page 46 still states: “Offerors are responsible for determining which of their proposed labor categories are covered by the SCLS and they shall specify if any SCLS covered labor categories in their cost proposal along with providing the applicable wage determination schedule and revision number.” Given the government’s determination that the SCLS does not apply to this contract, would the government please remove this requirement from the solicitation?

A2. Requirement Removed Q3. Please confirm, as long as the offerors can meet the scope of the project, we can use Past Performances of less than $5 million per year.

A3. This is acceptable.

Q4. Please confirm that the prime and subcontractor team is defined as the “offeror” in this solicitation.

A4. Offeror is refering to prim and subcontractor team.

Q5. Per A53 and A60, to clarify in an unpopulated, SBA-approved mentor-protégé, joint venture situation, the managing member is the protégé. Please confirm that as an unpopulated, SBA-approved mentor-protégé joint venture, the mentor which has an approved DCAA accounting system (documentation provided), and a protégé without a DCAA accounting system, can meet the requirements of the RFP by the protégé providing a third-party CPA firm verification stating that the protégé’s accounting system has been audited and has been determined adequate for determining costs. In addition, does the joint venture also need to provide the DCAA Pre-Award Survey of Prospective Contractor Accounting System Checklist?

A5. For an SBA mentor-protégé JV, the special account where all payments will be deposited and all expenses incurred will be paid from must utilize have a DCAA approved accounting system or they can meet the requirement a DCAA Pre-Award Survey. You must complete the Survey if you do not currently have an approved system, the third-part CPA firm verification is recommended but not required.

Q6. Given the substantial changes released per the amended RFP and Q&A, we would request the government consider extending the due date by March 25, 2024.

A6. RFP has been extended as requested.

SECTION A - SOLICITATION/CONTRACT FORM

The required response date/time has changed from 18-Mar-2024 12:00 PM to 25-Mar-2024 12:00 PM.

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

PWS

STATEMENT OF WORK/PERFORMANCE WORK STATEMENT

NAVAL HEALTH RESEARCH CENTER (NHRC) OPERATIONAL INFECTIOUS DISEASES (OID)

RESEARCH & SURVEILLANCE SUPPORT SERVICES INDEFINITE DELIVERY INDIFINITE QUANTITY

(IDIQ)

C.1. GENERAL INFORMATION

C.1.1. This Statement of Work (SOW)/Performance Work Statement (PWS), located in Section C of the base contract, applies to all subsequent task orders issued under this base contract.

C.1.2. Naval Health Research Center (NHRC) is a Navy Medical Research and Development (R&D) Command charged with conducting medical research, development, testing infectious disease samples, evaluation, and surveillance to enhance deployment readiness of Department of Defense (DOD) personnel worldwide.

C.1.3. Infectious diseases are a constant threat to the readiness of US military forces at home and abroad. Given the dynamic nature of global pathogenic transmissibility, diseases that may have once been confined to remote areas of the world are carried to new areas with relative ease. Expeditionary forces are especially susceptible due to their exposure to areas/regions of high risk and the potential for rapid, high volume transmission among close quartered personnel. In support of disease risk assessment and prophylactic clinical responses such as vaccine and drug therapeutics, research efforts require basic and applied research support for understanding etiologic agents underlying infectious diseases, epidemiological investigations following outbreaks, advanced characterization methods and validation of methods for rapid diagnoses, and developing and testing new technologies for pathogenic detection and viral mutagenic prediction. The recent prevalence of newly emerging, highly publicized novel disease pandemics has further strengthened the demand for expanding surveillance efforts.

As the Navy hub for the Armed Forces Health Surveillance Division, Global Emerging Infections Surveillance Department (AFHSC-GEIS), the NHRC Operational Infectious Diseases (OID) Directorate conducts on-going, laboratory-based surveillance of US military populations in unique environments to quantify and study the etiology of infectious illnesses. Test specimens are collected from ongoing surveillance programs and from special investigations of febrile illnesses and pneumonia among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, and border populations). In addition to the utilization of portable, rapid assay technologies to identify pathogens in the field, test specimens and limited epidemiologic data, when approved by the Institutional Review Board (IRB), are provided to the NHRC laboratory where diagnostics and, in some instances, in-depth pathogen characterization is conducted. Results are provided to sponsors, the Armed Forces Health Surveillance Center, local investigators and collaborators and, when applicable, county health units in order to guide proper responses that ultimately affect both the readiness of US forces and the safety of public health.

The OID Directorate supports NHRC’s mandate as a Navy Medical Research and Development Command to conduct medical research, development, testing, evaluation, and surveillance to enhance deployment readiness of DOD personnel worldwide. OID researchers use existing administrative data to investigate deployment-related and operationally-relevant health, career, and occupational issues, as well as health care systems and processes, that impact Warfighter readiness.

The Contractor shall provide all personnel, supervision, and other items necessary to provide laboratory technical services, statistical analysis, study coordination, fiscal analysis, quality control and assurance, safety and logistics, sample collection, administrative and program management support for operational infectious disease surveillance, accredited clinical laboratory testing, diagnostic evaluations, clinical research support and scientific research services as defined in this SOW/PWS except for those items specified as government furnished property and services. The Contractor shall perform to the standards in this contract.

This acquisition will involve comprehensive scientific research and development services over the full period of performance. The required acquisition may involve, but will not be limited to: developing, refining, and executing the full spectrum of data-related tasking; examining the impact of case management services and source of delivered health care services on health care costs, patient outcomes, and health care system efficiencies; understanding injury prevention, injury identification, and injury reduction across a military career; investigating the longitudinal medical and career outcomes of en route care providers and patients; and identifying and then understanding other deployment health-related concerns.

C.2. ASSUMPTIONS AND CONSTRAINTS

C.2.1. All task orders issued under this base Indefinite Delivery Indefinite Quantity (IDIQ) - contract will be Cost Plus Fixed-Fee (CPFF) or Firm-Fixed-Price (FFP). All task orders issued under this contract will be for non-personal services.

C.2.2. Over the course of the contract period of performance (POP)/ordering period, the Government will issue task order proposal requests (TOPRs). Either level of effort severable or non-severable task orders may be issued under this contract. Non-severable task orders will be issued for services that must continue from start through completion in order for the Government to receive a benefit. Severable task orders are for services where the Government receives a benefit during the period for which services are performed, regardless of when or if the services are severed. Each task order will include the task order type deemed appropriate by the Government. The TOPRs will also include the required assurances for human subject research (HSR), if applicable.

C.2.3. Contractor personnel are recognized as Non-Critical Sensitive [ADP/IT-II] positions when the contract scope of work requires physical access to a federally controlled base, facility or activity and/or requires access to a DoD computer/network, to perform unclassified sensitive duties. At a minimum, each Contractor personnel must be a US citizen and have a favorably completed NACLC or T3 or T3R equivalent investigation to obtain a favorable determination for assignment to a non-critical sensitive position. Refer to SUPTXT204-9400 (9-18) herein. It is not anticipated that access to classified material will be required under this base contract or resulting task orders. As a result, notwithstanding the required background investigation, a facility level clearance (FCL) is not required. Per DoD 5220.22-M - NISPOM – if access to classified material becomes required after the execution of any resulting task order, a task order modification may be executed to require a SECRET FCL.

C.2.4. No later than fifteen days after contract award, the Contractor’s Security Representative shall submit to the Command Security Manager, via the Contracting Officer’s Representative (COR), the necessary documents to obtain the appropriate Federal background investigation.

C.2.5. Orientation: Contractor personnel providing services under this contract or resultant task orders shall attend and complete Orientation at the first available opportunity. On a case-by-case basis, the Government may waive orientation sessions if the contractor personnel is currently or has previously worked at the Command. Contractor personnel shall complete all command required training, which may include but is not limited to Diversity, HIPAA, and Navy Knowledge Online courses.

C.2.6. Emergency Preparedness: Contractor personnel shall participate in emergency preparedness drills, training, and exercises as required by the Command or Activity. The Contractor will cooperate with the Command or Activity to ensure that personnel can be promptly accounted for, during real-world emergencies. The Contractor shall make arrangements to ensure mission continuity of work activities, in the event of an emergency. Should an emergency occur that affects the worker’s shift, the designated Contractor representative and the Contractor personnel will be contacted.

C.2.7. Environmental Standards: Contractor personnel shall comply with DoD, city, and county environmental health policies and requirements, when conducting work activities that potentially impact program initiatives related to air quality, water quality, waste water, hazardous material control, hazardous and universal waste, solid waste, recycling, biological material transport, and biological waste management. Contractor personnel shall complete related annual and refresher environmental trainings, when required by the Command or Activity. Contractor personnel who are assigned biological material transport duties or biological waste transport duties must complete initial and refresher training provided by the Army Public Health Center as required by the DoD, or complete a federally equivalent course if DoD training options are unavailable.

C.2.8. Occupational Health Requirements: Certain work activities present an inherent risk of injury and/or illness to the Contractor personnel. The Contractor personnel may be exposed to physical, chemical, biological, and radiological hazards in the workplace.

The Contractor will conduct regular risk assessments of the Contractor personnel’s work activity, and cooperate with the Command or Activity to establish procedures that mitigate identified workplace hazards. This can be accomplished in conjunction with local Industrial Hygiene (IH) surveys. The Contractor personnel may be required to wear personal protective equipment (PPE) such as outer clothing, gloves, respirators, hearing and eye/face protection, as a hazard mitigation measure. Prescription eyewear PPE or other PPE that requires custom fitting, shall be provided by the Contractor.

Contractor personnel baseline medical surveys, periodic medical surveys, ad-hoc medical surveys, termination medical surveys, and fit-testing appointments shall be provided by the Contractor and completed when required by the Command or Activity. Contractor personnel shall notify the Contractor when there is a change in health status or job status, which impacts their medical surveillance data. Records shall be made available to the Command or Activity, upon request.

Contractor personnel who are exposed to biological hazards shall comply with applicable immunization requirements and medical clearances, as recommended and/or required by OSHA and the CDC. Contractor personnel who travel OCONUS as part of their duties, shall consider CDC immunization recommendations for the destination country, prior to travel departure. Contractor personnel shall seek immunization services through their designated occupational health provider. Immunization records shall be made available to the Command or Activity, upon request. Declinations for required immunizations, within applicable regulation, shall be documented in writing.

All Contractor personnel occupational health expenses are the responsibility of the Contractor and shall not be approved as ODCs.

C.2.9. Bloodborne Pathogen Program: Contractor personnel who are involved in work activities that include potential exposure to bodily fluids or other potentially infectious material (OPIM) shall participate in a local Blood borne Pathogen Program.

The Contractor shall complete personnel exposure evaluation rosters and provide resources for Contractor personnel immunization, booster doses, or titers, as required by OSHA BBP standards.

The Contractor personnel shall complete annual and periodic training requirements, related to the BBP. The Contractor shall ensure that Contractor personnel are provided with appropriate technical training related to their BBP activities (i.e. venipuncture training and certification, medical waste and safe sharps handling).

C.2.10. Onsite Safety: Contractor personnel shall follow all local safety policies and procedures established by the Command or Activity. Contractor personnel shall assist with corrective action items that are identified during local safety inspections, when required by the Command or Activity.

Contractor personnel who work with hazardous material shall comply with training, labeling, transport, storage, and disposal requirements of the Command or Activity.

Contractor personnel who are assigned to laboratory work areas shall follow safety and facility guidelines, as specified in the latest edition of the CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL). Any Contractor personnel performing research involving recombinant nucleic acid and/or organisms and viruses containing recombinant nucleic acid molecules agrees by acceptance of this contract to comply with the NIH guidelines for research involving recombinant DNA molecules.

C.2.11. Training: The Contractor shall ensure that Contractor personnel complete initial and annual training as required by the Command or Activity. This includes but is not limited to orientation training for new Contractor personnel, refresher safety training, and job-specific safety training.

General safety topics that the Contractor will complete include but are not limited to fire/life safety, general ergonomics awareness, risk management, hazard communication/global harmonization, and reproductive hazard awareness.

Job-specific safety training will be completed by applicable Contractor personnel as required by the Command or Activity, to include but not limited to weight-handling management, hearing conservation, respiratory protection, basic life safety, PPE use, hazardous material control, waste management, radiological safety, and biological safety.

New Contractor personnel shall complete initial safety training within the timelines specified by DoD policy. All training records will be made available to the Command or Activity upon request.

The Contractor shall ensure that all Contractor personnel assigned to this requirement have and maintain all training, certifications, credentialing/privileging (if applicable) and medical requirements, including, but not limited to vaccinations, medical exams, and other medical care at no additional cost to the government. ODCs will not be authorized to pay for such expenses. These types of training and certification will vary depending on the position.

The Contractor shall provide the government with verification of such requirements for each applicable Contractor personnel.

C.2.12. Mishap Reporting: All accidents which may arise out of or in connection with the performance of services required herein, and which result in injury, illness, death, or property damage, shall be reported to the Command Safety Office and the COR immediately. Fatalities, in-patient hospitalizations, amputations, or eye-loss shall be reported and recorded within the required timelines established by Occupational Health and Safety Administration (OSHA) and DoD regulations. If any claim is made by a third party against the Contractor on account of any accident which occurs in connection with the performance of this contract, the Contractor shall promptly report the facts in writing.

The Contractor will ensure that injured/exposed Contractor personnel receive appropriate medical care, counseling, and that mishap reporting requirements are met.

C.2.13. This effort is considered a new requirement; there is not a legacy contract and therefore the right of first refusal concerning incumbent personnel does not apply.

C.2.14. Intramural HSR is expected under the task orders that will be issued under this base IDIQ contract. Research with human subjects shall not begin until the Contractor (and all subcontractors) obtains a Federal Wide Assurance (FWA) issued by the Department of Health and Human Services (DHHS). A Human Research Protection Officer (HRPO) review must be in place before any funding can be placed on a task order (or on any Option CLIN where HSR is segregated from the remainder of the task order).

C.2.15. Intramural HSR can include interaction with study participants. When interaction with study participants is required, the Contractor shall possess medical liability and indemnity insurance. The Federal Tort Claims Act does not apply. The requirement for medical liability and indemnity insurance will be delineated at the task order level.

C.2.16. Travel is expected in support of the research efforts at NHRC. Travel approval must be processed in accordance with NHRC procedures, in accordance with Joint Travel Regulations, documented and submitted with monthly reports and correlated with a corresponding line item in the invoice for payment. The number of Contractor personnel required will be determined at the discretion of the Contracting Officer’s Representative (COR). All travel must be approved by the COR in writing prior to the Contractor incurring any costs.

C.2.17. Shipboard Stays. Whenever work assignments require temporary duty aboard a Government ship, the Contractor will be reimbursed at the per diem rates identified in the Joint Travel Regulations (JTR) “Other Circumstances Impacting a Traveler's Per Diem” section while aboard a Government Ship.

C.2.18. The Government retains the right to direct the mode of travel including the availability and size of rental cars. It should be noted that vendors are not obligated to extend discounted Government rates to Contractors working on behalf of the Federal Government.

C.2.19. An estimated travel cost will be delineated at the task order level. The estimated travel cost shall not include fee or Contractor burdens unless applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

C.2.20. Other Direct Costs (ODC) are expected in support of the research efforts at NHRC. ODCs may include, but are not limited to: equipment, research supplies, shipping/transportation fees, dry ice, consulting services, invited travel, training/certification fees not previously listed in the contract/task orders as required by the work sponsor to meet the needs of a research project, and incentives for research participation (i.e. gift cards). All ODC costs must be processed in accordance with NHRC procedures and approved/endorsed by the COR in writing prior to the Contractor incurring any costs.

C.2.21. An estimated ODC amount will be delineated at the task order level. The ODC amount shall not include fee or Contractor burdens unless applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

C.2.22. Subcontracts: Subcontracts are expected in support of the research efforts at NHRC. The awardee must have the capacity to award subcontracts as needed to meet research and development needs. Subcontracts could include (but are not limited to): rent of space for sample storage, rent of office space or research facility with a security system (to execute clinical trials or field research activities, such as performing subject recruitment, initial evaluation, and follow up visits), support from clinical research organizations (CRO), data analysis and management, clinical monitoring and data quality assurance and regulatory filing and support.

C.2.23. An estimated subcontracts amount will be delineated at the task order level. The subcontracts amount shall not include fee or Contractor burdens unless applied in accordance with the offeror’s accounting system and Forward Pricing Rate Agreement(s) (if applicable).

C.2.24. The identified potential or perceived Organizational Conflict of Interest (OCI) within this effort is that Contractor personnel performing work under this requirement may also have access to include, but not limited to, budgetary information; research program design; sensitive, personal information; personnel information;

procurement information; support acquisition tasks; support development of research proposals; and support development of research protocols which may create a current or subsequent OCI as defined in FAR Subpart 9.5. As such, all offeror’s proposals shall include OCI Mitigation Plan for review/approval by the Command/Contracting Officer. Acceptance of a contract by the Contractor shall not create an OCI condition, either for legacy work being performed or future work to be bid or performed. The OCI Mitigation Plan shall include Non-disclosure Agreements (NDAs) signed by the Contractor personnel performing on this requirement and counter-signed by their management. The OCI Mitigation Plan and NDAs shall state: “This document does not authorize access to another company’s proprietary or sensitive information.” The mitigation plan shall address the possibility (of the offeror) of reviewing (1) its own research such that a bias in favor of itself may be perceived or (2) a competitor’s research such that a bias against the competitor may be perceived. Subject to Contracting Officer discretion, the Contracting Officer may deem an Offeror’s proposal invalid if the OCI has not been or cannot be adequately mitigated.

C.2.25. All financial, statistical, personnel, and technical data, which are furnished, produced, or otherwise available to the Contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of work under this contract. Such data shall not be released by the Contractor without prior written consent of the COR. Any presentation of any statistical or analytical materials, or any reports based on information obtained from studies covered by this contract, will be subject to review and approval by the COR before publication or dissemination. All inquiries from the media shall be forwarded to the Command Public Affairs Officer via the COR. All records produced in the performance of this contract are the property of, and subject to the exclusive control of, the Government. The Contractor may retain a copy of all such records or evaluations, but may not provide further copies or disclose the information from such records or evaluations to third parties. All requests from other Commands, treatment facilities or other individuals for research data shall be handled in accordance with procedures specified by applicable Command instructions.

C.2.26. The Government estimates a full time equivalent (FTE) at 1912 hours (One FTE = 1912 hours (2080 hours – 88 hours holidays – 80 hours PTO)) for the purposes of the estimated level of effort that is provided at the task order level. The Government estimate is provided so that all offerors are aware of the Governments’ estimated level of effort for each task order. Positions may be requested at less than a full time status.

C.2.27. Government Vehicle Use: There may be circumstances requiring Contractor personnel to ride in a Government vehicle in the performance of conducting various research study requirements, including but not limited to travel to field or remote sites, relocation of research equipment, or transportation of research subjects.

Government vehicle use will be on official business for non-personal service in accordance with NHRC’s instruction.

C.2.28. Work Location and Schedule: NHRC is headquartered in San Diego, California at 140 Sylvester Road, San Diego, CA 92106.

C.2.29. Other locations where research support services may be required include, but are not limited to:

Army, Navy, Marine Corps, Air Force and Coast Guard training commands

Marine Corps Recruit Depots (East/West) School of Infantry (East/West) Special Operations Training Commands Fort Leonard Wood, MO Newport, Rhode Island All others not listed

Naval Base San Diego, CA United States Naval Hospital (USNH) Yokosuka, Japan Guam Naval Hospital Camp Pendleton, CA El Centro Regional Medical Center, El Centro, CA Naval Medical Center San Diego Naval Health Clinic Lemoore, CA Great Lakes VA Hospital, IL Robert E. Bush Naval Hospital Twentynine Palms, CA Shipboard (Naval vessels or similar) Remote Field Environment

The locations provided above are examples and the exact locations will be delineated at the task order level.

C.2.30. The normal work schedule for on-site Contractor personnel is during NHRC’s normal business hours of 0630-1800 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. Due to the nature of this support, work outside of core hours is authorized, on an as-needed basis, and at the discretion and approval of the Government.

C.2.31. Overtime will be authorized at the task order level and shall be approved by the Government prior to the commencement of overtime work.

C.2.32. Telework may be authorized at the task order level. Telework may be granted on a case-by-case basis and must be endorsed by the COR prior to the commencement of teleworking. Telework requires the Contractor to have the infrastructure/equipment to perform the duties remotely, therefore, ODCs are not authorized for procuring telework items.

C.2.33. Government Furnished Property (GFP): NHRC will provide, without cost, the facilities, computers, laboratory equipment, safety equipment, and necessary office supplies and materials required to perform the duties outlined under this requirement. Government-furnished property (GFP) shall only be used in the performance of this order. The Government will provide routine scheduled maintenance and repair of Government-provided equipment according to NHRC Instructions. Upon Contractor’s request, through the COR, the Government will provide repairs of government-provided equipment in accordance with command instructions. The Contractor will be responsible for implementing property management procedures for accountability and reporting of GFP issued to Contractor personnel, including subcontractor personnel. The Contractor is liable for loss of or damage to supplies and equipment if such loss or damage is due to negligence or willful misuse. The Contractor shall ensure efficient and economical use of supplies. At no time during the term of this contract shall the Contractor remove Government-furnished supplies or equipment from the Command facilities without prior COR approval. GFP will be delineated at the task order level.

C.2.34. Contractor Furnished Items: The Contractor must provide any ergonomic evaluations and supply furniture necessary for ergonomic support.

C.2.35. Publications and Forms: The Government will furnish all forms and publications required for the contract.

The Contractor is required to comply with various instructions, directives and regulations covering routine administrative, safety and security matters in the same manner as other members of the staff. Such data shall not be released by the Contractor without prior written consent of the COR. Such compliance does not constitute a material expense to the contract.

C.2.36. Options on Task Orders: Task orders may contain option periods. The Contracting Officer may exercise options only after determining that (1) funds are available, (2) the requirement covered by the option fulfills an existing Government need and (3) successful performance of the Contractor in the preceding performance period.

C.3. MANAGEMENT

C.3.1. The Contractor shall provide direct on-site supervision of all personnel and provide direct on-site management functions for Contractor personnel such as timekeeping, leave, pay, benefits, performance reporting, and all related human resourcing, supervision, and management functions. The Contractor shall ensure all Contractor personnel are aware that all such functions are to be performed by the Contractor’s management and issues or problems related to these areas should not be discussed with Government employees. The Contractor will clearly communicate to Contractor personnel who their point of contact is for these matters.

C.3.2. The Government retains no direct control of the Contractor or its personnel and how they render services.

The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or personnel. The Contractor will assume all responsibility and liability for any and all personal injuries or death and/or property damage or losses suffered due to the negligence of the Contractor’s personnel in the performance of services under this contract. The Contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government.

C.3.3. The Commanding Officer of NHRC maintains administrative and operational responsibility for all activities within the Command and may take such actions as necessary to preserve and maintain the integrity of the Command, subject to the limitations prescribed by law and U.S. Navy Regulations.

C.4. SCOPE OF WORK

C.4.1. The Contractor shall provide R&D and support services for the OID Directorate at NHRC, NHRC military, and NHRC civilian staff members.

C.4.2. This acquisition represents a mix of on-site (NHRC) and off-site Contactor personnel. Approximately 85% of Contractor personnel will be at NHRC and 15% will be off-site.

C.4.3. The Contractor shall perform the following General tasks using industry best practices, Military Standards (MIL-STD), DOD practices, policies, procedures, instructions, etc., as outlined in this contract and subsequent task order(s). Requirements associated with tasks will flow down to the task order level and may be further restrictive at the task order level. All tasks are subject to GS or military review/approval and may not include inherently Governmental functions.

C.4.3.1. Support logistic and administrative tasks as needed to ensure that the directorate can successfully meet its mission. Including assisting in the maintenance of a calendar, coordinate events and travel, schedule appointments, make arrangements for meetings and conferences, and make arrangements and prepare itineraries for distinguished visitors.

C.4.3.2. Provide research and general administrative support to prepare and edit routine correspondence and perform routine and specialized administrative duties.

C.4.3.3. Complete Command and Directorate training and medical exams, vaccinations, and blood work, as required by assigned job duties.

C.4.3.4. Submit recommended changes to protocols and research SOPs, to appropriate GS or military personnel, as needed.

C.4.3.5. Take and transcribe minutes of meetings, correspondence, reports, and telephone conversations involving both technical and specialized medical and scientific terminology related to the performance of this requirement.

C.4.3.6. Assist in the maintenance of a database to record, track, and locate official correspondence, personnel files, training records, instructions, directives, recurring reports, and other documents as required.

C.4.3.7. Input and track Contractor personnel throughout multiple places of performance (during periods of travel) to ensure personnel are appropriately tracked and accounted for. Coordinate system compliance via monthly reports.

C.4.3.8. Assist Government personnel with tracking accounting and financial information spreadsheets related to research projects.

C.4.3.9. Assist Government personnel with tracking monthly budgeting/accounting spreadsheets and report findings to the Government.

C.4.3.10. Assist Government personnel with the review of budget estimates/adjustment for completeness, accuracy, and conformance with procedures, regulations, and Government-directed program changes.

C.4.3.11. Provide technical assistance with research/protocol related data and reports such as costs, fiscal allocation, and preparation of project budget reports.

C.4.3.12. Assist with the computer and database programming systems for internal functioning of all aspects within the directorate to include tracking laboratory and clinical trial samples and corresponding results, supplies, maintenance, and costs.

C.4.4. The Contractor shall perform the following Logistical, Supply, and Safety tasks using industry best practices, Military Standards (MIL-STD), DOD practices, policies, procedures, instructions, etc., as outlined in this contract and subsequent task order(s). Requirements associated with tasks will flow down to the task order level and may be further restrictive at the task order level. All tasks are subject to GS or military review/approval and may not include inherently Governmental functions.

C.4.4.1. Make entries to various paper and computer files to assist with controlling receipt, follow-up actions, backorders, stock record changes, requisition files, and related supply records.

C.4.4.2. Assist with recording information from requisitions, contracts, and shipping documents.

C.4.4.3. Assist with examining items received, note overages, shortages, or any damages incurred in shipping, and prepare detailed reports as required.

C.4.4.4. Assist with monitoring and tracking inventories of Contractor owned/acquired tools, equipment, and supplies needed as well as notate corrective and preventative maintenance.

C.4.4.5. Assist in supporting the logistics of receiving specimens including archiving and entering the samples into the laboratory database.

C.4.5. The Contractor shall perform the following Non-Specific Technical tasks using industry best practices, Military Standards (MIL-STD), DOD practices, policies, procedures, instructions, etc., as outlined in this contract and subsequent task order(s). Requirements associated with tasks will flow down to the task order level and may be further restrictive at the task order level. All tasks are subject to GS or military review/approval and may not include inherently Governmental functions.

C.4.5.1. Provide technical and editorial support and assist with oversight of all correspondence, logistics, facilities and the central filing system for OID research efforts at NHRC.

C.4.5.2. Assist with recording the status and location of all documents and maintaining the integrity and security of all documents in the appropriate database.

C.4.5.3. Support surveillance of infectious diseases that affect DoD personnel in coordination with federal agencies, local governments, research organizations, and universities at locations around the world.

C.4.5.4. Provide operational support, to include analytical evaluations and prospective clinical evaluations, for diagnostic evaluations, clinical studies, and/or clinical trials sponsored by Federal Agencies or private companies.

C.4.5.5. Provide rapid assessment, which may require deployment/TAD travel outside of the local 50 mile radius, in cases of national emergency or infectious disease outbreaks, as they occur and provide appropriate personnel and response task forces with information that can be used to develop effective short term and long term solutions. In cases of national emergency or infectious disease outbreaks, the COR will notify the Contractor and the Contracting Officer.

C.4.5.6. Provide support to the USN and DoD in the case of a pandemic or otherwise large-scale health event where NHRC’s resources can be leveraged.

C.4.5.7. Assist with setting up, operating, modifying, and maintaining study and/or laboratory equipment and apparatus.

C.4.5.8. The Personnel Reliability Program (PRP) is a United States Department of Defense security, medical and psychological evaluation program, designed to permit only the most trustworthy individuals to have access to nuclear weapons (NPRP), chemical weapons (CPRP), and biological weapons (BPRP). Reference: OPNAVINST 5530.16A- Minimum Security Standards for Safeguarding BSAT, 2011. Contractor will support BPRP efforts as directed by the Government.

C.4.5.9. Assist with supporting efforts across the full research project cycle, including, but not limited to: reviewing relevant literature; project conceptualization; proposal development and submission; project documentation and compliance (e.g., IRB protocol, data-sharing agreements, survey approval, etc.); data collection; data management;

data analysis; presentation of results; and preparation of manuscripts.

C.4.5.10. Assist the Government with drafting institutional agreements including but not limited to memorandums of understanding/agreement (MOU/MOA), Cooperative Research & Development Agreements (CRADAs), and data sharing agreements.

C.4.6. The Contractor shall perform the following Laboratory and Quality Assurance (QA) tasks using industry best practices, Military Standards (MIL-STD), DOD practices, policies, procedures, instructions, etc., as outlined in this contract and subsequent task order(s). Requirements associated with tasks will flow down to the task order level and may be further restrictive at the task order level. All tasks are subject to GS or military review/approval and may not include inherently Governmental functions.

C.4.6.1. Assist with maintaining Good Laboratory Practices (GLP) standards during performance of laboratory testing infectious disease samples, including, but not limited to, respiratory and enteric samples in accordance with GLP Regulations – 21 CFR Part 58 (FDA).

C.4.6.2. Assist with maintaining an ongoing Quality Assurance (QA)/Quality Control (QC) program that meets accreditation standards (such as College of American Pathologists (CAP)) and improves the safety and quality of the laboratory.

C.4.6.3. Via a licensed medical director, assist the government in the overall operation and administration of the laboratory, including the employment of competent qualified personnel to ensure all duties are properly performed and applicable Clinical Laboratory Improvement Amendments (CLIA) regulations are met to ensure ongoing CAP laboratory accreditation. This includes but is not limited to ensuring testing systems in the laboratory provide quality services in all aspects of test performance, review of new test procedures, physical and environmental conditions of the laboratory are adequate, and ensuring appropriate training of Contractor personnel.

C.4.6.4. Assist the government with providing oversight for and execution of the performance of high and moderate complexity laboratory testing as required by CLIA.

C.4.6.5. Assist Government personnel in the development and implementation of measures to enhance quality assurance and proficiency testing for laboratory operations.

C.4.6.6. Collect, test, analyze and archive specimens from ongoing surveillance programs and special investigations for environmental samples and human samples among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, DoD dependents and border populations); this may entail being on board a Naval vessel.

C.4.6.7. Assist with providing laboratory sample handling, including check-in, aliquoting, and database entry.

C.4.6.8. Facilitate shipment of test specimens and/or shipping of Category A Infectious Substance affecting humans (UN 2814) in accordance with U.S. Department of Transportation’s Hazardous Materials Regulations and the International Air Transport Association Dangerous Goods Regulations.

C.4.6.9. In accordance with DoN (Department of Navy), DoD regulations, and federal law, contract support staff working with Biological Select Agents and Toxins (if/when applicable) will be required to be enrolled in a Biological Personnel Reliability Program (BPRP), should such a program be initiated at NHRC. This requirement affects the Research Coordinator I, Senior Clinical Research Coordinator, Laboratory Manager, Molecular Supervisor, Senior Research Associate, and Research Associate labor categories.

C.4.7. The Contractor shall perform the following Clinical Trial tasks using industry best practices, Military Standards (MIL-STD), DOD practices, policies, procedures, instructions, etc., as outlined in this contract and subsequent task order(s). Requirements associated with tasks will flow down to the task order level and may be further restrictive at the task order level. All tasks are subject to GS or military review/approval and may not include inherently Governmental functions.

C.4.7.1. Coordinate the implementation of sponsored and Principal Investigator (PI) initiated clinical and scientific research studies, including maintenance of study records. All activities associated with internal and external audits in coordination with the PI are subject to final GS or military approval and submission.

C.4.7.2. Collect specimens from subjects enrolled in surveillance protocols including but not limited to nasal washes, nasal swabs, nasopharyngeal swabs, and blood samples through venous phlebotomy or capillary finger stick.

C.4.7.3. Provide subjects information on how to self-collect stool samples and rectal swabs.

C.4.7.4. Assist the government with establishing and coordinating with new or renewed research sites for the execution of surveillance programs and special investigations among military personnel or civilians (recruits, forces afloat, deployed forces, outbreaks of concern, DoD dependents and border populations); this may entail being on board a Naval vessel.

C.4.7.5. Provide support for Institutional Review Board submissions, edits, and continuity for programs across the Directorate.

C.4.8. The Contractor shall perform the following Science tasks using industry best practices, Military Standards (MIL-STD), DOD practices, policies, procedures, instructions, etc., as outlined in this contract and subsequent task order(s). Requirements associated with tasks will flow down to the task order level and may be further restrictive at the task order level. All tasks are subject to GS or military review/approval and may not include inherently Governmental functions.

C.4.8.1. Support government scientists in reviewing relevant literature, writing protocol‐driven research proposals, human use protocols, technical reports, final reports, and peer‐reviewed manuscripts and submitting Government cleared manuscripts to local, federal, and international databases.

C.4.8.2. Assist with securing research funds and identifying funding sponsors in support of government scientists for the successful execution of the mission of the OID Diseases Directorate.

C.4.8.3. Assist with the following tasks: organizing and evaluating Government collected or Contractor collected data sets, developing presentation materials, developing research Standard Operating Procedures (SOP), presenting findings at technical and professional meetings, assisting with project documentation and compliance and reviewing and submitting research protocols to Institutional Review Boards (IRB) and/or funding agencies.

C.4.8.4. With Principal Investigator (PI) oversight and in accordance with the NHRC Authored Work Instruction, review and assist in preparation of scientific publications and reports that inform customers and partners of surveillance, clinical study or trial, and scientific research findings.

C.4.8.5. Assist in measures designed to strengthen local and regional capacity for surveillance of emerging and reemerging diseases.

C.4.9. The Contractor shall perform the following Population Health tasks using industry best practices, Military Standards (MIL-STD), DOD practices, policies, procedures, instructions, etc., as outlined in this contract and subsequent task order(s). Requirements associated with tasks will flow down to the task order level and may be further restrictive at the task order level.