FOOD AND DRUG ADMINISTRATION

The Office of Facilities Engineering and Mission Support Services (OFEMS) Division of Operations Management and Community Relations (DOMCR)

Facilities Maintenance & Operations Branch (FMOB)

Preventative Maintenance of Above Standard Equipment at the

FDA White Oak Campus

Task Order 1 – Program Planning and Management

DRAFT Date: 5 March 2026 Version Number: 0.2

Contents

1. BACKGROUND

2. OBJECTIVE

3. SCOPE

3.1. APPLICABILITY

3.2. ORDER TYPE

4. APPLICABLE DOCUMENTS

5. PERFORMANCE DETAILS

5.1. PERIOD OF PERFORMANCE

5.2. PLACE OF PERFORMANCE

5.3. HOUR OF OPERATIONS ........................................................... Error! Bookmark not defined.

5.3.1. INCLEMENT WEATHER ....................................................... Error! Bookmark not defined.

5.3.2. NOTICE TO THE GOVERNMENT OF DELAYS ................. Error! Bookmark not defined.

6. DESCRIPTION OF WORK

6.1. PROGRAM PLANNING AND MANAGEMENT

6.1.1. PROJECT MANAGEMENT PLAN

6.1.2. PROGRAM MANAGEMENT REPORTING

6.1.2.1. LOGS AND RECORDS ....................................................... Error! Bookmark not defined.

6.1.2.2. EQUIPMENT MAINTENANCE REPORT AND CERTIFICATIONS

6.1.3. OPERATIONS MANAGEMENT MANUAL ......................... Error! Bookmark not defined.

6.1.4. COMMUNICATIONS PLAN .................................................. Error! Bookmark not defined.

6.1.5. RISK MANAGEMENT PLAN ................................................ Error! Bookmark not defined.

6.1.6. FINANCIAL MANAGEMENT PLAN .................................... Error! Bookmark not defined.

6.1.7. RESOURCE MANAGEMENT PLAN .................................... Error! Bookmark not defined.

6.1.8. TRANSITION ACTIVITIES AND PLANNING ..................... Error! Bookmark not defined.

6.1.8.1. TRANSITION-IN ................................................................. Error! Bookmark not defined.

6.1.8.2. TRANSITION-OUT ............................................................. Error! Bookmark not defined.

7. GOVERNMENT FURNISHED EQUIPMENT/INFORMATION (GFE) /(GFI)

7.1. MATERIALS, EQUIPMENT & LOCATIONS

7.1.1. GOVERNMENT FURNISHED PROPERTY

7.1.1.1. EQUIPMENT

7.1.1.2. EQUIPMENT ACCOUNTABILITY

7.1.1.3. FORMS AND PUBLICATIONS

7.1.2. CONTRACTROR-ACQUIRED PROPERTY

7.1.3. FACILITIES

7.1.3.1. CONTROLLED ENTRY

7.1.3.2. RESTRICTED USE OF GOVERNMENT FACILITIES AND PROPERTY

7.1.3.3. KEYS

7.1.4. WARRANTY

7.2. BADGES, PHYSICAL SECURITY, & SAFETY REQUIREMENTS

7.3. OPERATIONAL SAFETY & HEALTH

7.3.1. LOCAL, STATE AND FEDERAL SAFETY & HEALTH REQUIREMENTS

7.3.2. CHEMICAL HAZARDS

7.3.3. FIRE SAFETY

7.3.4. SAFETY DATA SHEETS (SDS)

7.3.5. MARKINGS, GUARDS AND BARRIERS

7.3.6. STORAGE AND DISPOSAL

7.3.7. OCCUPANT EMERGENCY EVACUATION PLAN

7.3.8. EXISTING DRAWING AND TECHNICAL DATA

8. PERSONNEL

8.1. KEY PERSONNEL

8.2. SECURITY REQUIREMENTS

9. TASK ORDER DELIVERABLES AND MEETINGS .................... Error! Bookmark not defined.

10. SITE SCAN ...................................................................................... Error! Bookmark not defined.

11. FDA POINTS OF CONTACT (POCs) ......................................... Error! Bookmark not defined.

1. BACKGROUND

The U.S. Food and Drug Administration (FDA) White Oak Campus, located at 10903 New Hampshire Avenue, Silver Spring, Maryland, consists of 710 acres of developed land in addition to 130 acres of land planned for continued development. The campus is comprised of state-of-the-art laboratories, office buildings and support facilities. As demonstrated within Attachment I – Site List, the FDA houses over 4,400 pieces of specialty equipment. Subsequently, the purpose of this requirement is to obtain a Contractor specialized equipment maintenance and repair services to support FDA’s mission to protect public health by ensuring laboratory specialty equipment located at the White Oak Campus, are maintained, and repaired according to local, state, federal and industry standards, and regulations (i.e. including BSL3, ISO and AAALAC standards).

This Statement of Work (SOW) seeks to establish a new IDIQ contract to provide Site Scan services/support to over 4,400 pieces of specialty equipment.

2. OBJECTIVE

As a result of this task order, the FDA requires:

• Centralized, ongoing program management for specific task orders awarded under this IDIQ to ensure consistent management of Above Standard Equipment delivery and maintenance throughout the program and for the duration of the period of performance.

• Consolidation of FDA supervision by providing a primary point of contact for ongoing operations, and reduction of government administrative burden.

• Integrated and efficient operational plans and operations to assure resource leveling and optimized execution of all Above Standard Equipment activities.’

3. SCOPE

The Contractor shall provide Preventative Maintenance of Above Standard Equipment (WOASE) program and project management support services as required by the FDA throughout the period of performance.

The scope includes program planning and management that is necessary to assure optimal efficiency in the delivery of comprehensive WOASE technical support, labor support, standard conference supplies, equipment repair, and maintenance services. The activities within this Task Order includes WOASE management, transition planning, development of operations procedures, implementation of operations procedures, an operations management manual, and daily oversight of operations management.

3.1. APPLICABILITY

This TO effort SOW is within the scope of Section 5.1 “Program Planning and Management” of the Preventative Maintenance of Above Standard Equipment at the FDA White Oak Campus

IDIQ SOW.

3.2. ORDER TYPE

This is a Fixed Price TO.

4. APPLICABLE DOCUMENTS

The Contractor shall comply with all applicable documents, terms, and conditions included within the base IDIQ contract.

5. PERFORMANCE DETAILS

5.1. PERIOD OF PERFORMANCE

The period of performance period for this Task Order shall consist of one (1) twelve-month Base Period with four (4) twelve-month Option Periods. The anticipated period of performance is as follows:

Base Year: April 1, 2027, through March 31, 2028

Option Year 1: April 1, 2028, through March 31, 2029

Option Year 2: April 1, 2029, through March 31, 2030

Option Year 3: April 1, 2030, through March 31, 2031

Option Year 4: April 1, 2031, through March 31, 2032

5.2. PLACE OF PERFORMANCE

Locations will be FDA sites primarily located in the eastern United States and set forth in Attachment I, “Metropolitan Area Site List.” However, the Contractor shall primarily perform activities at the White Oak Campus (WO), located at:

10903 New Hampshire Ave, Silver Spring, Maryland 20993

No work shall be performed on Contractor sites or outside of the Continental United States

(OCONUS).

6. DESCRIPTION OF WORK

6.1. KICK-OFF MEETING

The Contractor shall attend a task order kick-off meeting no later than ten (10) working days after task order award. The purpose of the kickoff meeting is for the Contractor to familiarize itself with the Government’s facilities, introduce the Contractor staff to the Government, review roles and responsibilities of all parties involved in the contract, and review and discuss the tasks and deliverables required by the task order (i.e. including the Contractor’s approach to meeting the requirements of the SOW).

The Contractor shall submit kick-off meeting minutes following the kick-off meeting. At a minimum, the meeting minutes shall include a record of all discussion topics covered during the kick-off meeting. The kick-off meeting minutes shall further be incorporated within the Monthly Progress Report and be approved by the COR and or CO. (i.e. Task 2).

Deliverable:

A. Kickoff Meeting Minutes

6.2. PROJECT MANAGEMENT PLAN

The Contractor shall establish and maintain an integrated project management plan. The project management plan shall be the basis for receipt of work, planning, estimating, material acquisition, facility inspection, work assignment, and scheduling. The project management plan shall facilitate accomplishment of all requirements identified herein and shall provide supervision, recording, and evaluation of work performance to ensure timeliness, completeness, and efficiency.

At a minimum, the project management plan shall include an identification of Contractor resources and track task progress and deliverables. The project management plan shall further include the following areas:

1) Project Planning

a. The project planning area of the project management plan shall include, at a minimum, the Contractor’s tracking methodology for all task orders. The project planning area shall further include a list of all task order deliverables (i.e., completed, and outstanding).

2) Schedule Management

a. The schedule management area of the project management plan shall include, at a minimum, the Contractor’s scheduling process to accomplish Government due dates (i.e., milestones) for all task orders.

3) Financial Management

a. The financial management area of the project management plan shall include, at a minimum, the Contractor’s financial tracking of all task orders (i.e., including minor repair orders – up to $2,500.00). The Contractor shall enable Finance Administration control procedures to ensure that actual costs are consistently within five (5) percent (5%) of planned costs throughout the Period of Performance.

4) Quality Management

a. The quality management area of the project management plan shall include, at a minimum, the Contractor’s management of all inspection records that the Government requires.

5) Resource Management

a. The resource management area of the project management plan shall include, at a minimum, the resumes of the IDIQ Key Personnel. The Key Personnel resumes shall clearly display academic qualifications, length, and variety of experience relevant to the requirements in the IDIQ SOW. The Contractor shall clearly indicate whether the resumes submitted are those of current staff (prime or sub-contractor).

b. The Contractor shall further include a copy of all active certifications pertinent to foster successful completion of the contract and in accordance with the minimum qualifications required by the base IDIQ SOW.

6) Communications Management

a. The communications management area of the project management plan shall document, at a minimum, the Contractor’s approach to communicating with FDA stakeholders throughout the period of performance of the contract. The FDA stakeholders shall include all agents that operate in the Above Standard Equipment ecosystem, to include FDA employees, General Services Administration (GSA) employees, as well as other contractors.

b. The communications management area shall further document the different categories of FDA stakeholders that will be part of the Above Standard Equipment ecosystem. The communications management area shall also detail the key messages that shall be articulated to the stakeholders, as well as the timing associated with the delivery of those messages. The communications management area shall identify the Contractor as the designated point of contact for all Contractors entering the Government buildings for work associated with Above Standard Equipment. The communications management area shall also contain the desired outcomes for the communications, as well as the vehicles for communications between FDA Stakeholders and all related sub-contractors.

7) Organizational Change Management

a. Note: In the event of company name changes, the contract will be bilaterally modified to reflect such name change(s) in accordance with Federal Acquisition Regulation (FAR) 42.12.

8) Risk Management

a. The risk management area of the project management plan shall include, at a minimum, the Contractor’s risk management program that identifies, analyzes, prioritizes and mitigates program risks from a technical, cost, and schedule perspective.

9) Safety & Security. At a minimum, the safety and security area of the project management plan shall include the Contractor’s Safety & Security protocols and shall clearly document how the Contractor will implement and ensure its Safety & Security protocols are adhered by any applicable subcontractors.

The Contractor shall provide the Contracting Officer (CO) with a comprehensive Project Management Plan which shall be the basis for receipt of work, planning, estimating, material acquisition, facility inspection, work assignment, and scheduling, within 30 days after contract award date. This plan shall facilitate accomplishment of all items of work necessary to accomplish the various tasks described in this SOW and shall provide supervision, recording, and evaluation of work performance to ensure timeliness, completeness, and efficiency.

A. Project Management Plan

6.3. PROGRAM MANAGEMENT REPORTING

Monthly Progress Reports (MPRs)

The Contractor shall submit MPRs to the FDA Project Manager (PM) and COR no later than the fifth (5th) working day of every month. The MPR shall be submitted in electronic form (i.e.

Microsoft Word, Microsoft Project, or Microsoft Excel) as required by the COR.

At a minimum, the MPR shall include, but not be limited to the following:

• Total dollars awarded against the IDIQ contract ceiling

• Deliveries (Amount and Types)

• ARCHIBUS Tickets o At a minimum, the MPR shall document the number of ARCHIBUS tickets submitted, the number of ARCHIBUS tickets completed, and the number of ARCHIBUS tickets pending within each monthly reporting period.

• Task Orders Completed, Pending, and Ongoing. At a minimum, the MPR shall include a status update for each Task Order for each respective monthly reporting period. The Task Order status shall be documented within a Microsoft Excel spreadsheet.

• Risks

• Damage/Loss

• Logistical Challenges o Incorrect Delivery Location o Intended Destination Not Found

• Accidents

• Injuries

• Chemical/Environment Spills

• Repairs below $2,500.00 (Completed, Pending, and Ongoing). The repairs below

$2,500.00 shall be documented within Microsoft Excel spreadsheet for each respective reporting period.

A. MPR

6.4. STATUS MEETINGS

The Contractor shall attend weekly status meetings (i.e., every Tuesday) to discuss the MPR for the given month in detail. The duration of the status meetings shall be no more than 90 minutes in length.

At a minimum, the Contractor shall submit meeting minutes following each status meeting. The meeting minutes shall include a record of all discussion topics covered during each respective status meeting.

Meetings may take place face-to-face on-site at FDA or via a virtual means such as Zoom or via telephone. The COR will coordinate and provide notification to the Contractor in advance of each weekly meeting.

6.5. OPERATIONS MANAGEMENT MANUAL

The Contractor shall develop an operations management manual, which clearly describes how the equipment and life safety systems will be most efficiently operated and maintained. The Contractor shall meet with FDA stakeholders and review the document to capture current FDA equipment service procedures as well as establish the basis for the development of future standard operating procedures. Such meetings are anticipated to take place on a quarterly basis.

Unless otherwise specified herein, the operations management manual shall include, but is not limited to:

• Formal documentation of business processes based on the FDA-provided Staff Manual Guide, available upon request

• Ecosystem (stakeholders/programs/locations)

• A complete description of operating procedures, including Reliability-Centered

Maintenance (RCM)

• Personnel organization and schedules reporting methodology; operational testing, measuring, recording, and reporting of operating data, to include operation logs;

operator inspections and services and their frequencies

• Identification and reaction to operational emergencies

Upon the Government’s review and acceptance of the Contractor’s operations management manual, the Contractor shall support the institutionalization of the document as the standard operating model during the period of performance of the task order.

Logs, records, inspection services and other documentation maintained by the Contractor shall be available during all normal working hours for Government review. Proposed revisions shall be provided to the Government for approval within 15 working days after their need is identified.

Deliverable:

A. Operations Management Manual Draft B. Operations Management Manual Final

6.6. TRANSITION ACTIVITES AND PLANNING

6.6.1. TRANSITION-IN

The Contractor shall transition and assume the responsibility for activities and duties from the prior Contractor in a manner that does not interrupt or negatively impact FDA’s mission critical operations and activities. The purpose of the transition-in requirement is to provide an orderly transition from the incumbent Contractor. The new Contractor shall work with the incumbent Contractor to affect a smooth and efficient transition of work from one vendor to the other.

Representative transition-in activities are described as follows:

• Adhere to transition-in plan to ensure full operating accountability and responsibility of the task orders

• Conduct and coordinate all on-boarding activities and obtain secure badging for team personnel

• Review business objectives, processes, and requirements as related to the tasks and activities being performed, and the data, equipment, systems and software being developed, or supported

• Review the current documentation including system design and operations documentation, Concept of Operations (CONOPS) documentation, release documents, project documentation, and any documentation related to current activities

• Participate in transition-in meetings (initially to be held jointly with the incumbent Contractor). The Government anticipates that the duration of each meeting shall be no more than one (1) hour in length. Meetings may be face-to-face on-site at FDA, virtual (e.g. Zoom), or via telephone. The COR will coordinate with the Contractor scheduling of each required transition-in meeting.

• Participate in other technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the incumbent Contractor.

• Ensure Contractor personnel are available to work within 30 days of IDIQ individual task order awards

• Within 60 calendar days of the effective date of the contract, the Government will participate with a Contractor representative to conduct a joint inventory of all equipment and components to validate condition, location, and exact quantities (this must be performed at the beginning of each option year). This will result in a master equipment and components listing and an equipment deficiency listing.

Minor deficiencies easily corrected within the prescribed preventative maintenance labor allowance for each piece of equipment deficiency listing. The equipment deficiency listing shall be submitted to the CO and COR for review and final approval. The COR will prioritize repairs.

• The Contractor shall provide employee training at the request of the Government during the period of performance. The training shall include, at a minimum, (4) hours of client relations and laboratory etiquette training for their employees. This training shall be provided to each newly hired employee through the life of the contract within 10 days of the date of hire and annually thereafter. This training must stress the importance of conflict avoidance, problem resolution, laboratory etiquette, laboratory safety and FDA security procedures. Emphasis shall be placed on grooming, proper attire, appearance and the importance of professionalism and courtesy in day-to-day contact with building occupants and visitors. The Contractor shall maintain a record onsite of all training for Government review.

A. Joint Inventory Listing

6.6.2. TRANSITION-OUT

The Contractor shall facilitate the transition-out of contracted activities and services to the FDA or, to a follow-on Contractor by the end of the contract period of performance.

The Contractor shall provide transition-out activities, to include, but not be limited to, a transition-out plan, leading technical exchange meetings with the successor to impart knowledge of processes, projects, data, systems, and applications, as well as sustainment activities to meet the task. The Contractor shall ensure the technical exchange meetings shall detail the technology used for their activities. During this period, the Contractor shall ensure no degradation in support provided under the task order. Between the turnover date designated by the COR and the end of the contract period of performance, the outgoing Contractor shall ensure all task order activities are closed out and provide sustainment support to complete the transition.

Representative transition-out activities are as follows:

• Providing FDA with current versions of all documentation developed, maintained, or updated under this contract, to include the native format for attachments and diagrams (e.g., Visio), even those embedded in documents, reports, process automations, data, scripts and configurations (not COTS source code) with applicable configuration management information

• Providing FDA with all licensing and renewal information, asset management records, software documentation, and training materials

• Providing FDA with a current inventory of all Government-owned assets used by the Contractor along with full support in the reconciliation of this inventory

• Providing the successor with the ability to “shadow” and participate in technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor

• Provide a transition of the equipment condition index system and the protocols for entering and maintaining data.

• No later than 120 calendar days prior to the contract completion date, the Contractor shall provide a written transition-out plan to the COR for approval. The plan shall identify the proposed method of conducting phase-out, including the level of duration of support to close out any deficiency list.

• No later than 120 calendar days prior to the completion date of the contract, the Contractor and Government shall conduct a systematic joint condition survey of all Government furnished equipment and systems, i.e., mechanical, electrical, plumbing utility, etc., conduct a final joint inventory for the purpose for establishing an inventory and an overall condition assessment. The Contractor is responsible for all equipment provided by the Government. The Contractor and the Government shall jointly determine the working order and condition of all equipment and systems.

Items of equipment missing or not in working order shall be recorded. The Contractor shall be responsible for making adjustments that fall within the scope of this contract.

This includes, but is not limited to, correcting all deficiencies that could be corrected through the preventative maintenance process or any other repair mechanism specified in this contract. The Contractor and the Government shall certify their agreement as to the working order of the equipment. If an item cannot be inspected due to the seasonal nature of the equipment’s operation, inspection can be deferred at the COR’s discretion. Specific rescheduling inventory and/or inspection dates shall be approved by the COR.

A. Final Transition-Out Plan B. Final Joint Inventory Listing

7. TASK ORDER DELIVERABLES AND MEETINGS

Task Reference Deliverable Quantity Format Due Date Task 6.1 Kick-Off

Meeting Minutes One (1) Microsoft Word via E-mail 10 working days after award

Task 6.2 Project Management Plan

One (1) Microsoft Word or Adobe PDF via E-mail

30 working days after award

Task 6.3 Monthly Progress Report

Twelve (12) Microsoft Word or Microsoft Excel (as applicable) via E-mail

5th working day of each month

Task 6.4 Weekly Status Meeting Minutes

One (1) per week Microsoft Word via E-mail

No later than every Thursday

Task 6.5 Operations Management Manual Draft

One (1) Microsoft Suite (e.g. Word, Excel, etc.) via E-mail

90 working days after award

Task 6.5 Operations Management Manual Final

One (1) Microsoft Suite (e.g., Word, Excel, etc.) via e-mail

120 working days after award

Task 6.6.1 Transition-In;

Joint Inventory Listing

Five (5) Microsoft Excel via e-mail

60 working days upon commencement of each contract period

Task 6.6.2 Final Transition- Out Plan

One (1) Microsoft Suite (e.g., Word, Excel, etc.) via e-mail)

120 working days prior to Task Order expiration

Task 6.6.2 Transition-Out;

Final Joint Listing

One (1) Microsoft Excel via e-mail

120 working days prior to Task Order expiration

Deliverables shall be submitted to the COR for review.

The COR will review Contractor deliverables in accordance with specifications and standards stated in the criteria established and any directives issued during the term of this contract. The COR has the authority to accept or reject deliverables.

The acceptance of deliverables and satisfactory work performance required herein shall be based upon the timeliness, accuracy, craftsmanship, and suitability of the deliverable. The specific deliverables and schedule for delivery shall be as agreed upon and documented.

A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the COR to ensure the services/products provided meet the requirements of the Statement of Work (SOW) at the time of delivery, and the Contractor shall make changes as requested during the inspection and acceptance process.

Inspection and acceptance will occur at the place of performance and take place within ten (10) days of task being completed. The FDA will reject non-conforming products and services. The FDA will provide written notification of acceptance or rejection within ten (10) business days.

Inspection will include review of the deliverables to ensure adequacy. The FDA will accept goods, reports and services only if they conform to all terms and conditions of the SOW and satisfy the performance standards developed under the SOW. The Contractor shall incorporate all FDA feedback and submit revised deliverables within five (5) business days of receipt. If the Contractor cannot correct the deficiencies within the five (5) day cycle, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within five (5) business days.

8. GOVERNMENT FURNISHED EQUIPMENT/INFORMATION (GFE) /(GFI)

8.1. MATERIALS, EQUIPMENT & LOCATIONS

8.1.1. GOVERNMENT FURNISHED PROPERTY

8.1.1.1. EQUIPMENT

The FDA will provide Government-Furnished Property (GFP), consisting of office space, with standard office type set-up (includes desk, chair, credenza, filing cabinet, phone lines). This GFP shall be managed in accordance with the Government Property clause of this contract. The FDA will provide a personal computer with the appropriate telecommunication connections to allow the Contractor to read and receive all incoming email both internally and externally.

The Contractor shall acquire and/or provide any hardware and/or software required to accomplish each TO that is not provided as GFP. Software integrity shall be maintained by the Contractor within the licensing agreement of the producer until such software is delivered to the Government, or otherwise disposed of in accordance with Government direction. Items delivered to the Government shall be approved by the Government in advance of purchase and shall be in compliance with FDA requirements.

8.1.1.2. EQUIPMENT ACCOUNTABILITY

The Contractor shall be responsible for safeguarding all Government property provided for Contractor use in this IDIQ SOW or any other government property provided for the purposes of executing this SOW. At the close of each work period, FDA facilities, equipment, and materials shall be secured. The Contractor shall take all necessary action needed to protect the Government's property against catastrophic events such as major or unusual weather conditions or utility outages. The Contractor shall designate a Security Representative, and which shall be onsite at all times to coordinate or otherwise mange security requirements in accordance with FDA requirements which may be a collateral duty.

Before the completion date of the contract, a joint inventory of Government-Furnished Property (GFP) and Government equipment shall be conducted by the Contractor and an FDA representative. The Contractor shall be liable for loss or damage to GFP beyond fair wear and tear in accordance with the Government Furnished Property clause of the contract. Compensation shall be affected either by reduced amounts owed to the Contractor or by direct payment by the Contractor, the method shall be determined by the Contracting Officer. All equipment in need of repairs or maintenance shall be repaired or maintained by the Contractor within 30 calendar days of discovery.

All repairs or maintenance not performed by the Contractor shall be made by the Contractor or others at the FDA’s option and at the Contractor’s expense. In the case of damaged GFP or government equipment damaged by the Contractor, the amount of compensation due to the FDA by the Contractor shall be the actual cost of repair, including parts, provided such amount does not exceed the economical repair value.

In the case of loss or damage beyond economical repair to equipment, the amount of the Contractor’s liability shall be the depreciated replacement value of the item to be determined by the Contracting Officer. Any failure of the Contractor to agree with such determination shall be treated as a dispute.

8.1.1.3. FORMS AND PUBLICATIONS

The FDA will furnish all required FDA forms and FDA publications to the Contractor, as they are required by the Contract. Government publications include, but are not limited to, written FDA Staff Manual Guides, Federal regulations, and Federal Register issuances.

The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies and standards at the government-wide, HHS and FDA levels.

8.1.2. CONTRACTROR-ACQUIRED PROPERTY

The Contractor shall acquire and/or provide any hardware required to accomplish each Task Order that is not provided as GFP. Items delivered to the Government shall be approved by the Government in advance of purchase and shall be in compliance with FDA requirements.

8.1.3. FACILITIES

8.1.3.1. CONTROLLED ENTRY

The FDA will provide access to all of the facilities noted in Attachment I “Metropolitan Area Site List.” Entrance to the White Oak Campus is controlled though the guard station entrance. Contractor visitors are required to “sign in and sign out” at the entrance of each building and shall be escorted by the WOASE Contactor or designated Representative. Permanent workforce personnel with a valid FDA Contractor ID Badged are required to badge into each building. The Contractor shall also provide the COR with a roster of visitors at least one duty day in advance of their expected arrival.

The Contractor shall comply with all FDA Security and Laboratory protocols. Pending an approved background check, the Government will provide picture ID badges to be renewed annually, for the security purposes. The Contactor and its employees shall comply with all security procedures for access to the grounds. Badges shall be displayed at all times. In addition, the Contractor shall comply with the Security Clearance Requirements Clause specified in Attachment J.4, FDA 1335 Personnel Security Clearance Requirements. Failure to comply may result in non- issuance of badge and or dismissal from the FDA. The Contractor is required to maintain a sign-in sheet for all sub-contractor and non-badged visitors. This must always be in plain sight in the Contractors office and made available for COR review and emergency personnel.

8.1.3.2. RESTRICTED USE OF GOVERNMENT FACILITIES AND PROPERTY

The Contractor is advised that Government owned facilities, property, and utilities shall only be used in the performance of official duties required by this contract. No Government owned facilities, property, and utilities may be used for private benefit at any time.

8.1.3.3. KEYS

Keys issued to the Contractor shall not be duplicated or redistributed; combinations shall not be disseminated beyond “need to know” basis. The Contractor shall provide a list to the COR of personnel that have need to have issued keys, combinations and shall update the list quarterly and submit the update to the COR. The COR shall be the only personnel to issue all keys and combination. All keys shall be returned to the COR.

The Contractor shall report loss of keys or compromise of a combinations immediately to the COR. The Government shall replace all keys lost by the Contractor. The Contractor shall be responsible for all costs associated with key replacement and or rekeying of locks.

8.1.4. WARRANTY

Items acquired under this contract may require warranty protection. Commercial warranties shall be transferred to the Government. The type of warranty and extent of coverage shall be determined on an individual Task Order basis.

8.2. BADGES, PHYSICAL SECURITY, & SAFETY REQUIREMENTS

Employees working at a Government facility may be required to display, on their person, a Government-provided identification badge, that shall include the full name of the employee and the legal name under which the Contractor is operating. It is the responsibility of the Contractor to request and obtain badges from the Government prior to the first workday on Government facility of any Contractor employee. If Contractor employee must visit a Government facility prior to receipt of badge, Contractor employee will follow on-site visitor requirements of Government facility. The Contractor shall return all badges to the COR, or designee, promptly upon an individual’s employment is terminated and upon termination of the contract. The Contractor shall notify the Government Task Lead, or designee, immediately of any lost badges.

The Contractor and their personnel shall follow all FDA policies, standard operating procedures, applicable laws and regulations while on FDA property. Violations of FDA regulations and policies may result in citation and disciplinary measures for persons violating the law.

1. The Contractor and their personnel shall wear visible identification at all times while they are on the premises.

2. FDA does not provide parking spaces at the work site; the Contractor must obtain parking at the work site if needed. It is the responsibility of the Contractor to park in the appropriate designated parking areas. FDA will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

3. The Contractor shall obtain all necessary licenses and/or permits required to perform the work. The Contractor shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract.

8.3. OPERATIONAL SAFETY & HEALTH

8.3.1. LOCAL, STATE AND FEDERAL SAFETY & HEALTH REQUIREMENTS

The Contractor shall adhere to all Local, State and Federal requirements identified in the Health and Human Services (HHS) Occupation Safety and Health Manual. Reference

Attachment J.6 and the Biosafety in Microbiology and Biomedical Laboratories (BMBL) 5th Edition.

The Contractor shall have a proactive environmental management program that not only ensures compliance with Federal, State, Local requirements, but also emphasizes operational improvement to reduce environmental impacts.

The Contractor shall appoint a Safety Manager, which may be a collateral duty.

8.3.2. CHEMICAL HAZARDS

The COR will be responsible to inform the Contractor of:

A. Related precautionary measures to protect contract employees during normal conditions at the workplace and in foreseeable emergencies.

B. Any FDA chemical hazards which the Contractor’s personnel may encounter in the normal course of work on the premises.

The Government reserves the right to investigate accidents involving Contractor personnel and bodily injury, suspected occupationally acquired illness, or death of Contractor personnel while in the performance of official duties, damage to Government property, or loss of Government property caused by the Contractor, its agents, or employee.

In the event of an accident the Contractor shall immediately notify the COR. The Contractor shall prepare a full written report of the events and steps that were performed to resolve the accidents. The contractor shall submit any additional processes request by the Government.

8.3.3. FIRE SAFETY

The Contractor shall include fire safety precautions and procedures in its safety and accident prevention plans. All fires shall be reported immediately by the most expeditious means.

The Contractor will be responsible for obtaining burn permits any time that an open flame or as required by the COR.

8.3.4. SAFETY DATA SHEETS (SDS)

The Contractor shall maintain an accurate file of Safety Data Sheets (SDS) on site for all chemicals used to accomplish this SOW. Within 30 days of the execution of this contract, the Contractor shall establish an accurate file on-site of Safety Data Sheets (SDS) of applicable materials in current use in the execution of this SOW. Any changes to this file will be provided in writing to the COR immediately. The Contractor is to provide SDS’s 3 days prior to all work being performed in the facility, in-order to meet union regulations and must post SDS on project job sites. This is subject to change to remain in compliance with government union requirements.

8.3.5. MARKINGS, GUARDS AND BARRIERS

The Contractor shall ensure that all signs, equipment, machinery, and hazards are marked or painted to identify the hazard. The colors and markings used shall conform to Occupational Safety and Health Administration (OSHA) regulations specified at 29 CRF

1910.144 - Safety Color Code for Marking Physical Hazards and other State and Local statutes, as applicable.

The Contractor shall ensure that all operating equipment and tools have guards, which conform to the provisions of OSHA regulations, specified at 29 CFR 1910 Subpart O (Machinery and Machine Guarding), and Subpart P (Hand and Portable Powered Tools and Other Hand-Held Equipment).

The Contractor shall use barriers as needed whenever a slippery floor condition is identified.

Contractor employees shall avoid blocking the hallways with supplies or equipment.

8.3.6. STORAGE AND DISPOSAL

The Contractor shall store and dispose of all waste (as defined in Title 40 of the Code of Federal Regulations) generated by the Contractor in accordance with Local, State, and Federal regulations. FDA specific waste management system shall dispose of water materials under the White Oak EPA ID number.

8.3.7. OCCUPANT EMERGENCY EVACUATION PLAN

The Contractor will participate in the Occupant Emergency Evacuation Plans and the Contingency/Emergency Plans established in each area of the facility. The Government will make routine fire safety inspections, and the Contractor shall perform corrective actions on any or all fire hazards noted by the Government.

8.3.8. EXISTING DRAWING AND TECHNICAL DATA

Existing drawings and technical data are maintained by the Government and will be made available to the Contractor on an as needed basis. Original copies of these will not be removed from the premises but can be made available for Contractor use. At the conclusion of the contract period, drawings and technical data shall be returned to the COR.

The equipment operating manuals and suppliers catalogs presently maintained by the Government (or copies thereof) will be provided to the Contractor during the Start-Up Phase. All files, daily, weekly, and monthly logs, data sheets, records, manuals and worksheets, or any other technical materials generated by the Contractor during this contract shall remain or become the property of the Government and shall be submitted to the COR at the expiration of the contract. The Government will have the right to inspect or copy any files, daily, weekly, and monthly logs, records, reports, maps, worksheets, or any other technical material generated by the Contractor during this contract.

9. PERSONNEL

The Contractor shall ensure that all Contractor support personnel are adequately trained, possess the credentials specified in the appropriate labor categories, and are otherwise fully qualified to provide the high level of support required by this Task Order SOW.

The personnel employed by the Contractor shall meet the following criteria:

1. All contractor personnel working at the FDA campus and performing under this contract shall sign a non-disclosure agreement (NDA) authorized by FDA

2. Program Planner and Program Manager employed through this task order shall perform all duties required at the FDA Campus at White Oak

3. Program Manager and Chief Engineer will meet with the COR on a monthly basis to provide program status and shall be available to resolve critical issues during business hours identified in this Task Order

4. Contractor personnel shall not have conflicts of interest in regard to being employed by the US Government.

5. Program Manager and Chief Engineer shall have experience in the execution of all tasks associated with the SOW.

6. Contractor shall ensure appropriate staff participation in any training scheduled by the Government during normal Federal working hours.

7. Contractor assumes the responsibility for all work accomplished in an unacceptable manner which is assigned to personnel under its employment.

8. Contractor personnel shall conduct themselves in a professional and appropriate manner at all times. Each Contractor employee is expected to adhere to standards of conduct that reflect credit on themselves, their employer, the FDA, and the Federal Government.

9. The government reserves the right to direct the Contractor to remove an employee from the work site for failure to comply with the standards of conduct.

10. Contractor’s employees shall observe and comply with all FDA rules and regulations concerning general employee conduct. The Contractor shall be responsible for controlling the Contractor employees’ conduct and ensure that employees and visitors of the FDA are treated with discretion, respect, and courtesy at all times.

9.1. KEY PERSONNEL

Key personnel are vital staff to the contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Contractor shall provide thirty (30) days written notice to the Contracting Officer and COR for a change in key personnel. The FDA, at its discretion, may modify the contract to add or delete key personnel at the request of the Contractor. The following labor categories are deemed as key personnel:

1. Program Manager

2. Chief Engineer

3. Assistant Chief Engineer

4. Refrigerant Journeymen

9.2. SECURITY REQUIREMENTS

Contract staff shall complete a background check which meets all FDA security policies, regulations, protocols. FDA will assist the Contractor with this process after award. Failure to obtain and maintain satisfactory background check may result in the termination of the contract or the removal of employee(s) from the contract. All personnel shall obtain a public trust clearance.

10. SITE SCAN

10.1. OBJECTIVE

10.2. The objective for Site Scan is to provide administration, monitoring, preventive maintenance, troubleshooting, and technical support services for the FDA White Oak Campus Veritiv Site Scan system.

The Site Scan system is an equipment monitoring and scanning platform used to monitor and manage specialty laboratory equipment and associated assets across the White Oak Campus.

The Contractor shall ensure the system remains secure, operational, compliant, and optimized in accordance with applicable Federal IT, laboratory, and security standards.

10.2.1. APPLICABLE STANDARDS AND REGULATIONS

10.2.1.1. The Contractor shall comply with all applicable Federal, State, and agency-specific requirements including: Federal Information Security Modernization Act (FISMA) NIST SP 800-53 (current revision) HHS Information Security and Privacy Policy FDA IT Security policies Manufacturer maintenance guidelines. Any applicable BSL-3 or laboratory safety interface requirements

10.2.1.2. If the system processes or stores controlled information, the Contractor shall comply with applicable Federal privacy and security requirements as specified by the Government.

10.3. SYSTEM INVENTORY

10.3.1. The system components covered under this contract include, but are not limited to:

Tag No Model Serial Desc.

1755232 SITETPI‐E C15H861054 SITETPI‐E ASSEMBLY

1755238 VSSW‐4E C15H861339 SITELINK‐4E ASSEMBLY

1755239 VSSW‐4E C15H861341 SITELINK‐4E ASSEMBLY

1755236 VSSW‐2E C15H862063 SITELINK‐2E ASSEMBLY

1755235 VSSW‐12E C15I863546 SITELINK‐12E ASSEMBLY

1878138 VSSW‐4E C17L861508 SITELINK‐4E ASSEMBLY

1878137 VSSW‐4E C17L861510 SITELINK‐4E ASSEMBLY

1878136 VSSW‐2E C17L862386 SITELINK‐2E ASSEMBLY

1878139 VSSW‐2E C17L862390 SITELINK‐2E ASSEMBLY

1756056 SSWEB SOFTWARE SITESCAN WEB

1870796 VSSW‐2E SITELINK‐2E ASSEMBLY

10.3.2. The Contractor shall verify the inventory during the initial survey.

10.4. PERFORMANCE REQUIREMENTS

10.4.1. Initial System Survey. Within 30 calendar days of task order award, the Contractor shall:

Conduct a full system inventory validation. Identify deficient components. Assess software and firmware versions. Identify cybersecurity vulnerabilities. Submit a written survey report to the CO and COR. If requested, the Contractor shall submit a separate quote for corrective actions beyond routine maintenance.

10.5. SECURITY REQUIREMENTS

10.5.1. If system connects to FDA network:

10.5.2. Contractor personnel must comply with FDA IT security requirements. Access must be authorized. Security incidents must be reported within 1 hour of discovery. Contractor shall cooperate with FDA cybersecurity officials

10.6. CONFIGURATION MANAGEMENT

10.6.1. The Contractor shall:

10.6.2. Maintain configuration documentation. Document all system changes. Obtain COR approval prior to implementing configuration changes

10.7. END-OF-LIFE PLANNING

10.7.1. The Contractor shall:

10.7.2. Identify components approaching end-of-life. Provide written recommendations 12 months prior to manufacturer support expiration. Hardware replacement is not included in the base contract and shall be addressed via separate task order unless otherwise specified.

10.8. REPORTING REQUIREMENTS

10.8.1. The Contractor shall provide:

10.8.2. Monthly Performance Report. Submitted within 10 business days after month end including: System uptime percentage, Incident summary, Resolution metrics, Patch status, Security findings, Recommendations

10.8.3. Annual System Health Report Comprehensive system performance assessment including lifecycle planning.

11. TRAINING

11.1.1. The Contractor shall provide: Initial user orientation (within 60 days of award), Refresher training annually, Updated user documentation, Training materials shall be delivered electronically.

12. MEETINGS

12.1. The Contractor shall attend: Monthly performance review meetings (virtual or onsite).

Quarterly strategic planning meetings (if requested)

13. GOVERNMENT ROLES

13.1. Contracting Officer (CO), Sole authority to modify contract, approves task orders, authorizes additional costs, Contracting Officer’s Representative (COR), Technical oversight. Approves configuration changes. Validates performance, Receives reports

14. QUALITY ASSURANCE

15. Performance will be monitored in accordance with the Government’s QASP. Failure to meet performance standards may result in: Corrective action, Increased surveillance, Payment adjustments, Termination remedies per FAR clauses.