DRAFT-TCRT-Task-Order-PWS-for-RFI-23Dec2024.docx

PERFORMANCE WORK STATEMENT (PWS)

DEFENSE HEALTH AGENCY (DHA) AIR FORCE MEDICAL SERVICE ENTERPRISE-WIDE

TECHNICAL CLINICAL RESEARCH TEAM (TCRT)

59th Medical Wing (59 MDW)

Part 1 General Information

1. General: This is a non-personal services task order under which the personnel rendering the service(s) are not subject, either by the base contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

1.1 Description of Services/Introduction: This is a non-personal services task order to provide support to the 59 MDW located within the continental United States (CONUS) and throughout Joint Base San Antonio to include the Science and Technology Headquarters (ST HQ), Clinical Investigations and Research Support (CIRS), and Center for Advanced Molecular Detection (CAMD).

The ST HQ mission is to conduct clinical studies and translational research and apply knowledge gained to enhance performance, protect the force, and advance medical care and capabilities across the global health system. ST HQ continues to facilitate development of innovations for advancing the care and rehabilitation of the combat wounded and support for Food and Drug Administration (FDA) regulated trials supporting activities Enterprise-Wide. In order to support the required research, the ST HQ office requires support from a Technical Clinical Research Team (TCRT).

CIRS is the largest Clinical Investigation Facility in the Air Force Medical Service (AFMS) and is a free-standing facility and vivarium. The division supports health sciences education to develop the Military Health Service Force and clinical investigations for the advancement of medical science and its military and nonmilitary application toward patient care. The CIRS’ mission is to support the 59 MDW mission by providing centralized administrative, technical, and scientific support, as well as regulatory oversight to researchers across the AFMS in the development, performance and dissemination of clinical research. This support is provided through the CIRS’ Clinical Investigations Program and the 59 MDW Chief Scientists portfolio of programmatic research and development (R&D). CIRS directly supports 59 MDW readiness and certification training requirements for staff providers, residents, fellows, nurses, and other allied healthcare professionals, training over 1,500 students annually.

CAMD is a unique research unit within the 59 MDW Science and Technology (ST) Office. CAMD provides integrative solutions for the advancement of molecular diagnostics, biomaterial development, tissue engineering, and precision medicine needs for internal Department of Defense (DoD) organizations and supports collaborative opportunities with external academic and industry partners. As part of the Joint Integrative Clinical Medicine (JICM) portfolio, research efforts at the CAMD are divided into two major focus areas, (1) Clinical Molecular Research and Support (CMRS) and (2) Advanced Engineering Research and Development (AERD). The goal of these areas is to support the Military Health System and external partners in their molecular, genetic, and proteomic requirements, while applying innovative engineering principles and approaches to improve existing diagnostic, therapeutic, and clinical capabilities. Furthermore, the CAMD serves as the coordination arm to support internal and extramural collaborators in translating cutting-edge concepts and technologies into material and knowledge products.

1.2 Background: The 59 MDW ST office advises and conducts clinical and translational research under the guidance of the Air Force Surgeon General (AF/SG), the Secretary of the Air Force (SAF), Air Force Chief of Staff, and the Office of Assistant Secretary of Defense for Health Affairs (ASD/HA) on matters pertaining to the medical aspects of the Air Expeditionary Force and the health of Air Force (AF) personnel and beneficiaries. In order to support the required research, ST offices conduct translational research in the areas of emergency medical care, combat casualty care, force health protection, restorative medicine, clinical and rehabilitative medicine and specialty centers.

1.3 Scope: The Contractor shall provide technical and professional services in support of DHA and the AFMS. The contractor shall provide the services as outlined in this PWS in support of the clinical and translational research activities in all capacities ranging from providing personnel services to developing research execution plans and protocols. The contractor may be asked to provide consultation, support, and/or execution services on all aspects of the R&D process from concept development through FDA approval and market/field introduction.

1.4 Objectives: The primary objective of this task order is to provide administrative, financial, regulatory, clinical, and non-clinical support services.

1.5 General Information:

1.5.1 Quality Control Plan (QCP): The Contractor shall develop and maintain a QCP to ensure services are performed in accordance with this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor's QCP is the means by which it assures that the work provided complies with the requirements of the task order.

The Contractor’s Proposed QCP shall be submitted to the Contracting Officer (KO) through the Contracting Officer’s Representative (COR) for review within 15 days after date of task order award.

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within 15 days. If the Government has provided comments, the Contractor shall then have 15 days to submit a Final QCP. After receipt of the Final QCP, the Contractor may receive the KO’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the KO no later than 15 days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:

(a) A chart showing the organizational structure and lines of authority, the names, qualifications, duties, responsibilities, and classification of each member of the Contractor's Quality Control Team;

(b) How the Contractor will monitor work to ensure performance complies with all deliverables (etc. timelines, deadlines, and goals);

(c) How the Contractor will monitor work to ensure performance complies with all specifications and requirements of the task order, including the base contract’s/task order’s clauses;

(d) How the Contractor will monitor and ensure staff qualifications remain current and valid including DoD Contractor Personnel Office (DOCPER) processes/approvals throughout task order performance;

(e) How the Contractor will ensure all keys issued will remain controlled items (Paragraph 1.7 Key Control);

(f) How the Contractor will inventory and track maintenance of all Government Provided Equipment / Materials;

(g) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

(h) How the Contractor will file and save all Quality Control related documents for the life of the task order plus five years.

1.5.1.1 An analysis of Quality Control and timeliness of submittals (i.e. deliverables) shall be provided to the COR within 15 days upon completion of each option period or Task Order.

1.5.1.2 The Contractor shall inform the COR of issues or potential issues that might affect the performance within 24 hours of identifying those issues. Verbal reports shall be followed up by written reports within 10 days.

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this task order in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds). The QASP provides the COR with a proactive way to avoid unacceptable or deficient performance, and provides verifiable input for the required Contractor Performance Assessment Reports (CPARS). The QASP will be finalized immediately following award and a copy provided to the Contractor after award. The QASP is a living document and may be updated by the Government as necessary.

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g. deliverables, submittals, etc.) deadlines fall on a holiday, the closest work day prior to the holiday will apply as the deadline for submittal.

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

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

1.5.4 Operating Hours: The Government facility operating hours and the Contractor support hour requirements often coincide, however, they may differ. Please refer to the following.

1.5.4.1 Government Facility Operating Hours: The Government facility operating hours occur between the hours of 0630-1630 CT, Monday through Friday. The Government facility may close due to local or national emergencies, administrative closings, or similar Government directed facility closings and will be communicated by the KO to the Contractor.

1.5.4.3 Contractor Support Hours: The Contractor shall provide support between the hours of 0630-1630 CT, Monday through Friday unless the Government facility is closed during local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor shall maintain an adequate workforce at all times for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential.

1.5.4.3.1 Contractor Work Plan: The Contractor shall prepare and maintain a Work Plan. The plan, as a minimum, shall identify regularly scheduled work (to include location, work to be completed, timeline, etc.) and how the Contractor intends to address and meet increased operations tempo. The Contractor’s proposed Work Plan shall be submitted to the KO via the COR for review within 30 days after date of task order award. The Government will review and either accept or return their comments to the Contractor within 10 days. The Contractor shall then have three days to submit a Final Work Plan. Any proposed change to the accepted Final Work Plan is required to be resubmitted via the COR for review and acceptance by the KO at a minimum 30 days prior to implementation. The timeline noted above shall apply for review and acceptance for proposed changes.

1.5.5 Place of Performance: The work to be performed under this task order will be performed at the Government’s facilities on Joint Base San Antonio, Texas and in the surrounding areas. Any variation from this will be determined by the program/project specific needs.

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

1.6.1 Security Program: Contractor personnel performing work under this contract must have a Tier 1 (T1) at time of the proposal submission and must maintain the level of security required for the life of the contract. The security requirements can be obtained from the Contract Personnel Management Office, Ms. Elizabeth Howe, Elizabeth.a.howe12.civ@health.mil, 210.292.6418.

1.6.2 Installation Access: Access to U.S. installations, buildings, and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings, and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this task order comply with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

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

The Contractor shall return installation passes to the issuing IACS office when the task order is completed or when a Contractor employee no longer requires access.

1.6.3 Common Access Cards (CAC): Before CAC issuance, the Contractor personnel and working at a U.S. Government facility requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (T1) or an equivalent or higher investigation in accordance with Homeland Security Presidential Directive 12 (HSPD-12). The Contractor personnel will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of six months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the Federal Bureau of Investigation (FBI) fingerprint check and a successfully scheduled T1 at the Office of Personnel Management. The Contractor shall provide the following information: Last, First and Middle Names, Government issued personal identifier (e.g. Social Security Number, Federal Identification Number, or Tax Identification Number), date of birth, primary email address (this email address will be used to contact the individual) and any other necessary information required to obtain a CAC or installation access card, to the COR within first 30 calendar days after task order award (unless circumstances require otherwise and as directed by the KO). The Contractor shall ensure safeguarding of Personally Identifiable Information (PII).

Submission of a satisfactorily completed Standard Form 85, Questionnaire for Non-Sensitive Position, and Optional Form 306, Declaration for Federal Employment, to the Security Manager is required prior to the contract employee being fingerprinted. Contractor or contract employee will coordinate with the Security Manager to have an FBI fingerprint check appointment to be completed no later than 14 days prior to the required in-place date. If an unfavorable fingerprint check is returned, the contract employee will not be issued a CAC. Since the CAC is required by the contract employee for installation and network access and is essential to the performance of duties, the contract employee’s ineligibility to receive a CAC will result in the Contractor being required to provide a replacement candidate.

The Government has full and complete control over granting, denying, withholding, or terminating security clearances for employees. The granting of a clearance shall not prevent, preclude, or bar the withdrawal or termination of any such clearance by the Government.

Note - CACs are Government property and must be accounted for. The Contractor shall collect CAC the same day employment of an individual has expired or has been terminated and shall return them to the issuing office within one day.

1.6.4 Background Checks: Contractor is not permitted to bill until the contractor’s personnel are fully able to perform the requirements of the task order PWS. The Contractor employee may begin performance of the contract after receiving a favorable local background check. The Contractor agrees to replace the employee should results of the background check, if required, be unfavorable as determined by the COR. The Contractor shall also replace employees whose background check, during their tenure of employment, renders them with an unfavorable local or stateside background check, as determined by the COR.

1.6.5 Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use.

1.7 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The KO, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the KO will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

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

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

1.9 Key Personnel:

a. Solicitation Requirement:

1.9.1 Solicitation Requirement: The Government has identified the following positions to be filled by Key Personnel. The offeror may propose alternate and/or additional positions as Key personnel.

· Project/Contract Manager who shall be responsible for the performance of the work on TO

· Bio-Scientific and Statistical Subject Matter Expertise

· Intellectual Property and Licensing Manager

1.9.1.1 For all Key Personnel positions, provide an attachment naming the individuals proposed to fill Key Personnel positions along with a description of the portion of the solicitation’s Performance Work Statement that each individual is being proposed to perform.

1.9.1.2 A resume is required for all individuals proposed to fill Key Personnel positions.

1.9.1.3 The resumes must provide thorough and detailed documentation of the experience, abilities, and background for proposed Key Personnel or equivalent statements of qualifications. Such documentation shall include but not be limited to: name, curriculum vitae, type and description of experience.

1.9.2 Contract Requirement:

The following positions have been identified to be filled by Key Personnel proposed for this award.

Position Title: To be completed at task order award.

1.9.2.1 The approved Personnel identified to fill the Key Personnel positions shall be utilized as necessary to fulfill the requirements of this contract.

1.9.2.2 The contractor agrees that during the contract performance period substitution for Key Personnel shall not be permitted unless such substitution is necessitated by sudden illness, death, or change in employment conditions (e.g. termination, change in position, etc.). In any of these events, the contractor shall promptly notify the KO in writing and provide the information required by paragraph 3 below.

1.9.2.3 All requests for substitutions must provide a detailed explanation of the circumstances necessitating the proposed substitution(s), a complete resume for the proposed substitute(s), and any other information requested by the KO needed to approve or disapprove the proposed substitution(s). Any proposed substitute or replacement key personnel shall have qualifications comparable to the individual being replaced, taking into account the requirements of the PWS. The KO or his authorized representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof.

1.9.2.4 If any of the listed Key Personnel are subcontractor personnel, the contractor shall flow down the substance of this instruction in any subcontract which is awarded in support of this contract.

1.10 Identification of Employees: All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties must identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.11 Contractor Identification Badges: Contractor personnel shall be easily identifiable through the display of badges. When contractor personnel perform the services required in this contract on a Government installation they are required to possess and wear an identification badge that displays his or her name and the name of the Company. The contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

While performing in a contractor capacity, contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

The Contractor shall collect all ID Badges upon completion of the contract/task order or termination of employee.

1.12 Contractor Travel: In support of task orders to be awarded off this contract, contractor personnel may be required to travel (CONUS and OCONUS) to various locations and work in excess of 40 hours/week on occasion. The Contractor may be authorized travel expenses at rates no higher than the substantive provisions of the Joint Travel Regulation (JTR), IAW FAR Part 31.205-46, and the limitation of funds specified in this contract. All travel requires Government approval and authorization forty-five (45) days prior to scheduled travel. After travel is incurred, documentation/receipts shall be sent to the COR (with the invoice submittals). NO PAYMENT WILL BE MADE WITHOUT DOCUMENTATION and RECEIPTS. All travel shall be coordinated and approved on a Consent to Purchase (CTP) form.

1.12.1 DOD Contractor Foreign Travel: Approval of Foreign Travel. Foreign travel under this contract is defined as any travel outside of the continental United States and its territories and possessions. The cost of foreign travel is allowable only when specific written approval of the KO is obtained prior to the commencement of the travel. This is a requirement for all DoD contractors traveling on official DoD business.

1. The following requirements will be accomplished by the contractor(s) prior to foreign travel on approval of the KO. Allow 90 days for completion of training requirements and approval of the application process. Detailed information can be found on the U.S. Army Medical Research and Development Command (USAMRDC) website: https://mrdc.health.mil/index.cfm/resources/mrdc_resources/oconus. Select all the links under “Contractor Travel Requirements” and comply with the instructions. Consult the DoD Foreign Clearance Guide https://www.fcg.pentagon.mil

2. Mandatory training and minimum requirements must be met and a copy provided to the KO at least 15 days prior to scheduled departure.

3. Costs incurred by contractor personnel on official company business, whether foreign travel and/or domestic/local travel, are allowable subject to the limitations in the Federal Acquisition Regulation (FAR clause 52.216-7 Allowable Cost and Payment); incorporated into this contract.

1.13 Other Direct Costs (ODCs): Before an ODC may be included in the awarded task order, the ODC must satisfy the criteria expressed in the scope of the task order and be critical to the scope of the services being provided.

ODCs anticipated over the period of performance are as follows (but subject to change): Gift cards (to be used as incentives for study participants), research supplies (i.e., genetic sequencing kits, extraction kits, etc.), office supplies, animals, and research equipment to be used to support individual research.

When purchasing ODCs, the Contractor must use the CTP form to obtain prior authorization and approval before purchasing the ODCs. Contractor shall keep a log of CTPs submitted. The deliverable should be submitted to COR monthly.

A material handling fee will not be included. Shipping and transportation cost of the material will be directly reimbursed and must be itemized and labeled on the CTP form prior to purchase of the ODC.

1.14 Data Rights: The Government has unlimited rights to all documents and materials produced under this task order. All documents and materials, to include the source codes of software, produced under this task order shall be Government owned and are the property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the Contractor without written permission from the KO. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights. All deliverables become the sole property of the United States Government. The Government, for itself and such others as it deems appropriate, will have unlimited rights to all information and materials developed under this task order and furnished to the Government including reports, listings, and all other items pertaining to the work and services pursuant to this agreement including any copyright. Unlimited rights under this task order are rights to use, duplicate, or disclose data and information, in whole or in part, in any manner and for any purpose whatsoever without compensation to or approval from the Contractor. The Government will at all reasonable times have the right to inspect the work and will have access to and the right to make copies of the above-mentioned items. All digital files and data and other products generated under this task order shall become the property of the Government.

Copyright: Any software and computer data/information developed, as a component of this task order shall have the following statement attached to documentation:

“This computer program is a work effort for the United States Government and is not protected by copyright (17 U.S. Code 105). Any person who fraudulently places a copyright notice on or does any other act contrary to the provisions of 17 U.S. Code 506(c) shall be subject to the penalties provided therein. This notice shall not be altered or removed from this software or digital media and is to be on all reproductions.”

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

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

1.17 Non-Disclosure Statements: The Contractor shall provide signed non-disclosure agreements to the Government no later than five days prior to commencement of work under awarded task order. Disclosure of information by Contractor personnel may result in removal of Contractor personnel from performance under this task order.

1.18 Organizational Conflict of Interest (OCI): The FAR Part 9.5 prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving Organizational Conflict of Interest (OCI), provides examples to assist KOs in applying these rules and procedures to individual contracting situations; and implements section 8141 of the 1989 Department of Defense Appropriation Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a Contractor's judgment and preventing unfair competitive advantage. An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses –

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing, or mitigating organizational conflicts of interest.

It is the Contractor’s responsibility to notify the KO of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the KO prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the KO, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

Contractors shall sign a Non-Disclosure Agreement (Attachment XX) at the start of their performance on the contract and resultant task orders.

If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractor’s act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the KO.

The KO has significant discretion as to the acceptability of any mitigation plan offered.

Contractors are encouraged to present their best strategy for mitigation of any potential OCI under this contract. Contractors shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

The KO (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the KO that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined eligible for award. If the KO reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Performance Work Statement, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

1.19 Environmental Compliance: The following provides information on Environmental Compliance.

1.19.1 Environmental Compliance Plan and Program: The Contractor shall ensure that all contract personnel have received appropriate levels of training in the handling, use, storage, and disposal of hazardous material. In addition, the Contractor shall ensure that all Contractor controlled activities on Joint Base San Antonio, Texas and in the surrounding areas installations are conducted in accordance with the 59th Medical Logistics and Readiness HAZMAT Spill Prevention and Response Plan, Solid Waste Policy.

1.20 Required Training: Below is an overview of AT/OPSEC training requirements that may be required. Specific requirements will be defined at the task order level.

1.20.1 Anti-Terrorism (AT) Level I Training: All Contractor employees who are employed under any resultant contract/task order, shall complete AT Level I Training within 30 after contract/task order start date or effective date of incorporation of this requirement into the contract/task order, whichever applies, or 30 days after employment of new personnel. Contractor personnel travelling overseas shall complete area of responsibility (AOR) specific AT awareness training for U.S. based Contractor employees and associated subcontractor employees. The Contractor shall submit certificates of completion for each affected Contractor to the COR within 5 days after completion of this training. AT Level I awareness training is available at https://jkodirect.jten.mil. Contractor personnel shall complete refresher training every 12 months except AOR specific AT Level I training which shall be completed as required by local AT policies.

1.20.2 OPSEC Training: All Contractor employees shall complete Level I OPSEC training within 30 calendar days of employment under this contract. Verification of the training shall be provided to the COR within five days after completion of the training. OPSEC Level I training is available at https://jkodirect.jten.mil/. Contractor personnel must complete refresher training every 12 months.

1.20.3 Information Assurance (IA) Training: All Contractor employees requiring access to Government information systems shall complete the DoD IA Cyber Awareness Training within seven calendar days after contract/task order start date or effective date of incorporation of this requirement into the contract/task order, whichever applies, or seven calendar days after employment of new personnel. Verification of the training shall be provided to the COR within five days after completion of the training. Cyber Awareness training is available at https://lms-jets.cce.af.mil/moodle/ . Contractor personnel must complete refresher training every 12 months.

1.20.4 Health Insurance Portability and Accountability Act (HIPAA) and Privacy Act Training: Contractor employees performing services under this contract/resultant task orders with access to Government networks shall complete HIPAA training within 30 calendar days of employment. Contractor personnel shall complete refresher training every 12 months from initial completion. The Contractor shall provide the COR a copy of the training certificates for its employees no later than five days after completion. Training is available at https://jkodirect.jten.mil/

1.20.5 Military Treatment Facility (MTF) Orientation: All personnel assigned to the 59 MDW will complete base and facility orientation within 30 duty days of assignment. The MTF Orientation will familiarize the contract employee with the policies and procedures of the MTF and will be scheduled by the COR, or the designated government representative. Orientation attendance shall be required of the contractor employee during government paid duty time.

1.20.6 MTF Standards: All contract employees are required to in-process through the 59 MDW Contract Personnel Management Office upon reporting for duty. As part of in-processing, the contract employee should bring their basic life support training card (BLS), and a copy of their Immunization Record with them. A MTF checklist will be provided to ensure all necessary areas are completed. Upon termination or expiration of the contract/task order, the contract employee shall be required to out-process through the same office and return the CAC, facility ID badge, Restricted Area Badges, and key(s).

1.20.7 Occupational Health: Contract employees supporting animal work are responsible for all Occupational Health assessments, examinations, vaccinations, and reporting changes in health status if it changes the ability to perform the contracted work requirements.

1.20.8 Immunizations: Prior to contract/task order performance, the contract employee shall provide proof of immunization, or immunity from or screening for the following diseases according to Air Force guidelines equivalent to that provided to active work Armed Forces: Hepatitis B, MMR (Measles, Mumps, and Rubella), Varicella, Tdap (Tetanus, Diphtheria, and Pertussis), Tuberculosis (TB), HIV (Contract employee who has direct patient care) and influenza for all personnel. Contract employee shall control and prevent disease in accordance with AFI 48-105 Surveillance Prevention and Control of Diseases and Conditions of Public Health or Military Significance, and the American Public Health Association Publication, Control of Communicable Diseases Manual, and the Centers for Disease Control and Prevention (CDC) publication, Morbidity and Mortality Weekly Report, Air Force Policy (as applicable) and its supplements. For the TB screening, contract employees shall provide proof of negative TB 2-step skin testing in accordance with the CDC. If an individual has a past positive TB skin test, the contract employee shall provide proof of a negative chest X-ray within 12 months prior to personnel performing. The Government reserves the right to require more frequent TB testing of personnel based on the facility annual TB risk assessment. Additional vaccines as they are made mandatory for health care workers may also be required in unusual circumstances. In summary, Contract employees should have and maintain all requirements. The Contract employee shall not obtain medical tests or procedures at the MTF, with the exception of initial evaluation and testing performed under the Medical Employee Health Program. The Contract employee shall be responsible for the cost of any emergency medical services received. Contract employee shall receive the current influenza immunization, at contractor’s expense, unless contraindicated by allergy; as an example, to eggs as evidenced by hives, difficulty breathing, itching, and other symptoms of anaphylactic hypersensitivity, this exemption requires a Physicians diagnosis. Proof of vaccination will be required.

1.21. Contractor Performance Assessment Reporting System (CPARS)

A CPARS assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Completed CPARS performance evaluations are used by government agencies to assess contractor past performance for future acquisitions. The contractor shall appoint a Contractor Representative (CR) and provide this information to the KO (KO) within 10 calendar days of award. The contractor POC shall have the authority to comment on the CPARS assessment on behalf of their company and within the timeframes established.

A CPARS assessment must be completed within 120 calendar days after the evaluation. The CR has a total of 60 calendar days to concur/non- concur with the assessment. After 60 days, the CR can either concur/non-cur. The CR has the authority to: access the Government evaluation; review/comment/concur or non-concur with the assessment within 60 calendar days after notification of the government’s assessment. The CR has the right to request a meeting (in writing) with the government within 7 calendar days of notification of an assessment. If the CR fails to respond within 60 days, the assessment will be finalized. Training for CPARS can be found on the CPARS website: https://www.cpars.gov/index.htm.

To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate.

1.22 Service Contract Reporting

1.22.1 System for Award Management (SAM) Service Contract Report (SCR): The Contractor shall report all Contractor labor hours (including subcontractor labor hours) required for performance of services provided under applicable task orders for the DHA and 59 MDW via a secure data collection site. The Contractor is required to completely fill in all required data fields through the following web address: www.sam.gov. Reporting inputs will be for the labor executed during the period of performance during each Government FY, which runs from October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. Contractors may direct questions to the help desk by clicking “View Assistance for SAM.gov” which is located at the top of the SAM.gov website. From there, you can the select “Contact Our Service Desk” which will allow you to contact SAM.gov directly. If contract period of performance ends prior to September 30, the Contractor has 30 calendar days from end date of the contract to complete the SAM SCR requirement.

Steps for Submitting a Service Contract Report (SCR)

1. Go to www.sam.gov and log in.

2. Select Entity Registrations and then select Service Contract Reporting.

3. SAM displays your entities which have service contracts and meet the reporting criteria. Select View by entity to see the service contracts for each entity.

4. Next, select Add for the service contract against which you want to create a Service Contract Report. Each service contract which meets the FAR Subpart 4.1703 reporting thresholds is displayed.

5. You will be taken to the Complete Service Contract Report page. SAM displays the contract details and allows you to report. You are required to enter the following information:

· Total Amount Invoiced: Total dollar amount invoiced for services performed during the previous Government fiscal year under the contract (this amount should include the prime and any subcontract amount).

· Prime Contractor Hours Expended: Prime contractor direct labor hours expended on the services performed during the previous Government fiscal year. The amount you enter is automatically divided by 2,080 hours to calculate a Full Time Employee (FTE) equivalent, displayed under the Prime Contractor Hours Expended as Prime Contractor FTEs.

6. Report any required Tier 1 subcontractor information by selecting the Add Tier 1 Subcontract Information button.

7. When you are ready to submit the report, select Submit. This saves your report and returns you to the Select Service Contract page where you can create other SCRs or edit an existing SCR.

Steps for Editing a Submitted Report

1. Follow steps 1-4 above. Any previously submitted SCR will have a View/Edit button instead of an Add button.

2. Select View/Edit. You will be able…