IRV_Exhaust_Pump_SOW.pdf

Performance Work Statement January 13, 2026

Project Title: Irvine room 2309 Exhaust and Vacuum Pump Replacement

Location: U.S. Food and Drug Administration (FDA); 19701 Fairchild, Irvine, CA

Name of PM: To be provided at time of award

Contract No: TBD

1.0 Description of Work

1.1 Background Information:

The FDA Pacific Southwest Laboratory and District Office, an FDA owned facility located in Irvine, CA. Construction services shall include two portions.

• Replacement of end-of-life, obsolete vacuum pump systems at the FDA facility. Existing system is near 23 years old, does not have replacement parts available on the market for repair, representing a single-point failure risk to the facility's vacuum system, therefore requiring replacement.

• Irvine room 2309 has three isolators. These isolators use vaporized hydrogen peroxide (VHP) during their use. The room has VHP detection which have been alarming indicating that the levels have exceeded the safe levels for humans to be exposed to (>1ppm). A design has been completed to correct this issue and involves directly ducting the isolators to the outside and discharge via exhaust fan to the outside.

1.2 Purpose and Scope of Work

The purpose of this work is to provide construction services for the replacement of vacuum system (currently AES-Dekker Laboratory Vacuum System Model AES-VMX0153MA2-45-DS with capacity for each vacuum pump 23.3 SCFM @ 25 “HGVAC) at FDA Irvine and correct the exhaust in room 2309. The FDA requests the award of construction (Construction, replacement, and installation) contract.

1.2.1 Delivery Type: The project is a Construction Services delivery type that is Firm Fixed Price contract.

2.0 Period of Performance:

2.1 The work shall proceed promptly upon execution of this contract and only after the issuance of the Notice to Proceed (NTP) or contract award by the Government for the activities indicated.

2.2 The actual performance of the work and delivery of the required documents shall be in accordance with the project schedule and shall be completed within 222 calendar days of the NTP or on the negotiated date of completion at time of award otherwise agreed upon by the

3.0 Specific Requirements (PWS):

3.1 The Contractor shall perform all services described in this Scope of Services in accordance with applicable requirements and provisions set forth in this Performance Work Statement (PWS).

The Contractor will be responsible for relocating any electrical, mechanical, commissioning, third party inspections, site walks, surveys, additional engineering, BAS integrations, or structural building system components necessary to perform this work.

The Contractor shall provide all necessary labor, material, insurance, training, and equipment for the following.

3.1.1 Vacuum pump

• Contractor shall provide any necessary survey, study, engineering, or technical expert services to understand the existing conditions of the vacuum system at FDA Irvine.

• Contractor shall provide new equipment with matching capacity, or better. The necessary constraints shall include, but not limited to, vacuum pump HP, new valves, shut offs, and tank capacity.

• Contractor shall provide equipment cutsheet submittals and shop drawings to FDA for review and approval before procurement of materials.

• Contractor shall ensure N+1 redundancy integrated into new system for resilient facility operation.

• Contractor shall assess and provide repairs or additions to any housekeeping pad intended to support new equipment, as needed.

• Contractor shall provide new control panel, field located in an accessible area near the vacuum system. Control panel shall be integrated with existing BAS and include alarms both to BAS and readout local to the panel.

• Contractor shall utilize power feed to existing vacuum system.

• Contractor shall provide independent isolations valves and disconnect means to permit service of each vacuum pump while maintaining the system’s operation.

• Contractor shall keep equipment shutdowns to a minimum and schedule/coordinate all shutdowns with FDA while providing adequate notice. Contractor shall provide temporary utilities for any shutdown lasting longer than three (3) days. Weekend shutdowns are preferred.

• Contractor shall provide all inspection and testing, except where required by code, specification, or detailed elsewhere in the requirements of this document.

3.1.2 Room 2309 Exhaust

• The Contractor shall utilize the design drawings and specifications dated August 15, 2025, in the performance of this scope of work. All references to the General Services Administration (GSA) within the drawings, specifications, or related documents shall be interpreted as references to the Food and Drug Administration (FDA) for purposes of required approvals, submittals, and deliverables.

3.2 The Contactor shall ensure compliance with NIH Design Requirements Manual (DRM). Section 12.4 is most applicable to this project. Variances allowed by FDA prior approval.

3.3 Execution

3.3 Project Goals & Objectives

3.3.1 GOALS

a. Provide a safe working environment.

b. Maintain operations for the FDA through construction, with minimal interruption as possible.

c. Ensure a safe work environment during construction for workers and authorized visitors on the construction site.

d. Complete the project with no security violations or safety incidence.

3.3.2 OBJECTIVES

a. Build dynamic partnerships and a cohesive team with all contracted parties and FDA, aligning goals and vision to successfully deliver this project’s scope on-time and on- budget.

b. Select systems and materials of high performance, comfortable, aesthetically pleasing, cost effective to operate and maintain, with durability and extended service life.

c. Provide best value to FDA’s customer agencies and the American taxpayer.

d. Deliver the project efficiently and effectively – keeping the project on time and on budget.

e. Execute the scope of work of the building within the timeframe and budget limits established by the Government, minimizing cost and optimizing life-cycle cost to the facility.

3.3.3 Project Delivery Approach

FDA envisions a highly collaborative approach for this project, with the outcome that the Contractor must work closely with the FDA to deliver a final project that meets the needs and expectations as defined within the supporting documents.

The Contractor must perform commissioning-related tasks.

3.3.4 Contractor Team

2. STAFFING

The Contractor must provide experts in disciplines listed in the Facilities Standards for the Public Buildings Service (Core Building Standards), and as otherwise required in this section, with credentials as indicated, as they apply to this project. The Contractor must provide sufficient staff of project managers, superintendents, inspection and testing engineers, scheduling specialists, cost engineers, clerical and accounting personnel, etc. to perform the required work.

3. KEY PERSONNEL

The Government anticipates and expects that the Contractor will rely on and use key personnel listed, if any, in its proposal submitted to the Government as part of the underlying procurement process to perform the work required by the Contract. The Contractor may substitute any such personnel only with the advance written approval of the Contracting Officer within 30 days of departure.

Any such substitution must be at no additional cost to the Government and the replacement must have equal or greater experience, expertise, and qualifications as the substituted personnel. The Contractor must provide any information as may be reasonably requested by the Contracting Officer such as a resume or curriculum vitae for review to determine acceptance.

OTHER PERSONNEL

In addition to the key team members identified within this document, the Contractor must provide administrative, clerical, and technical personnel as necessary to perform the services required under this contract.

4. EXPERTISE

At a minimum, the Contractor’s team members should include the following experts to provide expertise (a single individual may be assigned more than ONE of the responsibilities / expertise listed below) as and when needed for efficient and effective operations:

Within 10 days after the Notice to Proceed (NTP) the Contractor must edit and the Communications Plan and complete the team entries.

a. Project Executive

b. Project Manager

c. Quality Control

d. Construction Superintendent

5. CONTRACTOR TEAM SUBSTITUTION

During the performance of the services required under this contract, the Contractor must obtain FDA written consent from the Contracting Officer before making any substitution for sub-contractors and outside associates or consultants specifically identified and agreed to in the request for qualifications, proposal, contract, and any contract modifications.

3.3.5 Project Stages, Phases and Work Sequence

This PWS is organized to identify the scope of services that are to be performed in a sequential manner however the Contractor may propose a schedule of design and construction activities that overlap a.k.a. Fast-track delivery strategy of beginning construction before the design is completed.

6. PRE-AWARD OFFEROR PROPOSAL PREPARATION STAGE

7. CONTRACT AWARD

8. PROCUREMENT PHASE OWNER COMMENTS

9. CONSTRUCTION STAGE

10. CLOSEOUT AND TURNOVER STAGE

11. FINANCIAL CLOSEOUT STAGE

3.3.6 COMMISSIONING PROVIDER (CX)

The Cx Scope of Services

a. For this contract the Cx is a subconsultant to the Contractor.

b. The Cx is responsible for developing the commissioning requirements for incorporation into the PWS.

c. The Cx must develop the Cx plan, testing requirements and performance specifications, and propose/coordinate failure criteria.

d. The Cx manages and leads the Cx meetings.

e. The Cx advises FDA on issues involving the commissioning process, emphasizing the long-term performance and maintainability of the systems included in the commissioning scope of work.

f. The Cx must advise FDA of deficiencies involving the design, construction, testing, adjusting and balancing, or other deficiencies that would compromise the ability of the facility to meet the needs of

FDA.

g. The Cx is authorized to recommend to FDA the acceptance, modification, or rejection of all materials, procedures, schedules, tests, reports, or other required commissioning submittals.

h. The Cx is not authorized to change the Contractor’s Contract Documents, schedules, costs, or scope of work.

3.3.7 SCHEDULE MANAGEMENT

FDA effective scheduling practices to execute this project. These practices involve detailed project schedule combinations, development, and maintenance.

3.3.8 Change Management

Change Management is the procedure by which the CO and PM process all change orders. Change orders add or delete work from the PWS; serve as a written record of a technical change; modify the contract duration; and may authorize a change in cost of construction.

The PM does not have authority to approve change orders and obligate the government; they provide technical expertise to the CO. The CO has the authority to obligate the government to change orders.

1. The Contractor must submit all requests or recommendations for change(s) to the project scope to the CO for approval. Requests must include a rationale, cost and impact to the schedule.

2. In the event of a significant change in contract value as determined by the PM, the Contractor must update the Cost Allocation tabulation.

3.3.9 Shop Drawings Review

The Government will require copies of all submittals, and the FDA will approve a list of those submittals that require FDA review and feedback in advance of approval.

3.3.10 Closeout & Turnover Stage

1. PUNCH LIST

a. After the FDA certification that the work for each designated portion thereof is substantially complete, the Contractor must assist FDA in conducting a final inspection and in preparation of a Punch List documents the remaining work.

b. Contractor pre-punch to identify and correct items before the Government is requested to walk the project for the formal Punch List.

c. Government/Tenant Punch List to identify items requiring correction. The Government and occupying tenants will walk the project together and generate one Punch List.

d. Contractor activity to correct the Punch List.

e. Participate with FDA in conducting follow-up inspections to administer resolution of Punch List items acceptance.

2. ACCEPTANCE

Although the Punch List will occur by area, warranties for building systems will not begin until the final acceptance of the building by the Government.

The project will not be accepted by the Government until the letter of Substantial Completion has been issued by the Contracting Officer.

3. SUBSTANTIAL COMPLETION

a. Prior to substantial completion, assist FDA in conducting a pre-final walk-through with the occupant agency.

b. The Contractor must provide time within their schedule for this inspection as well as time for any corrections to be made in order to receive the approval for Occupancy.

3.3.11 Travel, Reproduction, and Delivery

Unless otherwise indicated in this PWS, the Contractor is responsible for travel costs to support the requirements contained in this PWS, including all progress meetings, reviews, and site visits. The Contractor must assume all travel must be within the vicinity of the project site except as specifically indicated otherwise in the PWS.

Printing, reproduction and delivery costs necessary for execution of this contract must be included in the base contract price.

3.3.12 Security Clearance and Management

1. The Contractor shall comply with the HHS and FDA Security Clearances requirements. The Contractor shall comply with the policies outlined in the HHS and FDA Security Standards and Requirements.

2. Application for HSPD-12 clearance includes an electronic application process, in-person fingerprinting at a federal facility, and in-person pickup of the badge. For any individual whose Initial Fitness Determination requires that the applicant wait for Final Fitness Determination, the Contractor shall promptly provide a qualified replacement.

3. No extensions for schedule will be given for failure to get personnel credentialed in a timely manner.

4. Building badges must be worn above the waist and below the neck in a visible fashion at all times by the Contractor while in the subject facility.

5. All Contractor personnel not authorized to be unescorted shall be escorted at all times in compliance with the HSPD-12 escorting requirements.

4.0 General Requirements:

4.1 The Contractor shall:

4.1.1 Adhere to Project Management responsibilities as defined herein.

4.1.2 Appoint a Project Manager who shall be the Government’s primary point of contact and provide all necessary project representation for the successful accomplishment of the said work. The project manager shall be thoroughly familiar with all requirements and schedules. The project manager shall be identified in the firm’s proposal prior to contract award.

4.1.3 Coordinate all project related activities including documentation through the Project Officer (PO) for approval unless otherwise denoted.

4.1.4 Bring any questions and/or industry specification additions to the attention of the PO for direction.

4.1.5 Perform all work in a skillful and workmanlike manner as deemed applicable to this project.

4.1.6 Provide appropriate communication and coordination efforts with the facility department and the PO to avoid disruption of facility operations while performing contract work such as meetings, proposed phasing plans, outage notifications, etc.

(where applicable).

4.1.7 Obtain necessary badges per FDA policies and guidelines (if applicable). FDA binding process is to be anticipated of 1 month. All badging must be completed prior to start of on-site construction.

4.1.8 Provide (to the PO) a list of possible employees and sub-contractors who may require access to the FDA premises per the project being administered.

4.1.9 Provide utility outage notifications per facility department requirements (if applicable).

4.1.10 Perform all necessary measurements and sizing associated with the work assigned.

4.1.11 Confirm existing conditions of work assigned.

4.1.12 Perform all associated project work in accordance with FDA and NIH Guidelines;

Executive orders, EPACT, EISA, Sustainable design and Federal Regulations; Local City, County, and State building codes and regulations; NEC, ASME, NFPA, OSHA, UL, ANSI, and IEEE rules and regulations and standards; and all other applicable industry standards.

4.1.13 Restore all affected areas back to pre-project conditions or better by the completion of the specified project including necessary patching, repairing and/or replacing.

4.1.14 Provide all necessary drawings, documentation, and literature for all recommended items where applicable.

4.1.15 Provide all labor and equipment necessary to accomplish the above specified tasks.

4.1.16 Assume all risk and shall be liable for any damages to persons or property caused by the contractor.

4.1.17 Be solely responsible for the quality of his/her work. Deficiencies and omissions shall be corrected prior to Government acceptance of work.

4.1.18 Be responsible for removing construction and demolition debris daily from site. The contractor shall provide the dumpster for the debris.

5.0 Government Furnished Material and Resources:

5.1 The Government shall provide, but are not limited to, the following items:

• Site Utility Drawings (Upon request-PDF)

• Point(s) of contact at the FDA Site (at Kickoff Meeting)

• Photographs of work-site conditions and others as needed

• Irvine Lab specification report volume 2 (Section 15486) (Upon request-PDF)

6.0 Submittals:

6.1 General: Under this contract, unless otherwise denoted, the Contractor shall provide all services necessary to perform the following activities as related to completing the FDA IRV Exhaust Lab and Vacuum Replacement mentioned above:

• Communication Plan

• Project Kick-Off Meeting

• Project Schedule (with earned value and loaded dollar values)

• Plan of action (Plan shall include names of Team members and PM – and phone/email)

• Point-of-contact, Project Manager

• Safety and Hazardous Material Plan

• Shop Drawings: Coordinated drawings showing physical characteristics, installation details, and layouts for various systems (HVAC, Electrical, etc.).

• Equipment cutsheet submittals

• Progress Meetings

• Meeting Minutes for all meetings for review and approval by PO (within three business days)

• Deliverables contain in the Document “251226 IRV Room 2309 Exhaust Spec” o Site Logistics, Accident Prevention, and Quality Control Plans: To be submitted for review and approval before the Notice to Proceed (NTP).

o Construction Safety and Health Plan (CSHP): A site-specific plan to be submitted at least

7 days prior to the pre-construction meeting.

o Hazard Communication Plan (HCP): Submitted with the CSHP, including a list of all chemical products to be used.

o Waste Management Plan: To be submitted within 14 days of the NTP, detailing waste identification, reduction, and disposal methods.

o Construction Indoor Air Quality (IAQ) Management Plan: A draft must be submitted 7 days prior to the pre-construction meeting for approval.

o Testing, Adjusting, and Balancing (TAB) Plan: A pre-construction phase plan to be submitted at least two weeks before TAB work begins.

o Schedules: Including a proposed schedule for work during unoccupied hours, a schedule for temporary utilities, and a detailed schedule of selective demolition activities.

o Substitution Requests: Formal requests for any products or methods that deviate from the contract documents. (If required) o Field Correction Requests: Submitted upon discovery of any need to deviate from the contract documents. (If required) o Qualification Data: For demolition firms, testing agencies, training facilitators, and instructors.

o Technical Data and Drawings o Product Data: Manufacturer's descriptive literature for all products and equipment.

o Samples: Physical samples of patching materials, finishes, and other products as requested. (If required) o Test Reports: Including reports for VFDs, ground resistance, cable insulation, and other quality control tests.

o Manufacturer's Instructions & Field Reports: Installation instructions for all equipment and field reports from manufacturer's representatives.

o Demolition Inventory: A list of items to be removed and salvaged.

o Photographs/Videotape: Detailed images of existing conditions before work begins.

6.2 Deliverables: Provide all deliverables in accordance with the project schedule and NIH Design

Requirements Manual (DRM) Appendix E.

6.2.1 Physical Deliverables (Format): The documentation process shall be compiled and provided per the following per submission unless otherwise denoted:

1. Two (2) copies of the O&M Manuals shall be provided physically in binders and electronically.

2. Non-Stick, Locking Slant D-Style, three ring view binders, 8 1/2x 11 inches.

3. Title, FDA Logo, Contract and Project Number, Submission % (if applicable), etc.

shall be located on the front cover and spine of binder(s).

4. CD/DVDs shall contain electronic copies of any Reports, Calculations, Modeling(s), Drawings, Videos, Photos and O&M Manuals per final submission Electronically.

5. Three (3) signed copies of all warranties shall be provided in binders and electronically. Warranty start date shall begin no earlier than the date of installation acceptance.

6. One (1) equipment submission.

7. Four (4) physical copies and Electronic copies of the following, (All electronic drawings shall be provided in PDF and CAD.)

• Record as-built marked-up drawings, documentation, etc. for review.

• Record Specifications

• Record Product Data

• Warranties and Guarantees: All manufacturer and special warranties, including a two-year guarantee for roofing work. All warranties must be registered in the owner's name.

• Final Reports: Including the final Testing, Adjusting, and Balancing (TAB) report, commissioning reports, and final waste diversion reports.

• Demonstration and Training: A complete instructional program for the owner's personnel on the operation and maintenance of all new systems. This includes:

• Complete Training Manuals.

• Video recordings of all training sessions in .mp4 or a similar universal electronic format.

6.2.2 Electronic Deliverables (Format): Provide electronic deliverables in the following format using the latest version of software unless otherwise denoted or agreed upon:

Reports: MS Word and Adobe PDF Presentation: MS PowerPoint

Spreadsheets: MS Excel Schedule: MS Project (saved to PDF) with schedule of values Drawings: AutoCAD 2015 or later version and PDF Catalog Cut Sheets: PDF Modeling: PDF

6.3 Project Schedule: The IRV Exhaust Lab and Vacuum System Replacement Project shall be completed per the Period of Performance (or earlier) starting with the NTP or in accordance with the approved contractor project schedule incorporated at time of contract award, and per the following key milestones:

Submittal/Phase/Activity Task Time Interval Cumulative Duration Kick-off Meeting 07 calendar days (from NTP) 07 days Plan of Action (including schedule) 14 calendar days 21 days Proposed Equipment – Submittal 30 calendar days 51 days Proposed Equipment – FDA Review 14 calendar days 65 days Comment Resolution/Approval 7 calendar days 72 days Order material/lead times 30 calendar days 102 days Construction (Demo and New Work) 60 calendar days 162 days Inspection, Commissioning, Acceptance 30 calendar days 192 days Close-Out (O&M Manuals, As-Builts) 30 calendar days 222 days

6.4 Project Contacts:

All technical questions shall be submitted to:

1. Darrel Wilmoth Engineering Management Branch Office of Facilities Engineering and Mission Support U.S. Food and Drug Administration 301-529-2755 Darrel.Wilmoth@fda.hhs.gov mailto:Darrel.Wilmoth@fda.hhs.gov

6.5 Communication and Coordination:

6.5.1 The Contractor shall prepare a detailed schedule for the project and provide to the

Project Officer and Contracting Officer.

6.5.2 The Contractor shall appoint a Project Manager (PM), who shall be the Government's single point of contact, and provide all necessary project representation for the successful accomplishment of the work.

6.5.3 The Contractor shall hold weekly progress meetings unless otherwise denoted or agreed upon by the PO. Meetings shall be scheduled as required to satisfy the complete understanding and concurrence of stakeholders regarding the services to be rendered.

The progress meetings shall be held virtually (MS Teams, Zoom) or per conference call unless otherwise denoted or agreed upon. The contractor shall participate in additional meetings (such as on-board reviews) when prevailing issues require their input or resolution.

6.5.4 The progress meetings shall focus on the various task denoted in the contract; and shall cover project progress, timelines, existing and potential impediments, personnel, and delivery of services.

6.5.5 The Contractor shall take minutes of each meeting and distribute a narrative summary to each person in attendance within three (3) business days of any such meeting for review and comment prior to finalization. Meeting minutes shall be approved by the FDA PO prior to finalization or distribution.

6.5.6 The Contractor shall notify the government in writing 15 business days prior to utilities shutdowns. Shutdowns shall be performed after hours or on weekends unless otherwise notified or agreed upon.

6.5.7 The Contractor shall issue submittal for signature, Catalog Cut Sheets, as-built marked-up drawings, and O&M manuals to the government for review and allow 10 business days for review (where applicable). The Contractor shall provide responses to FDA comments within five (5) business days of receipt.

6.6 Liability: The Contractor shall assume all risk and shall be liable for any damages to persons or property in connection with the above-mentioned project.

6.7 Progress Payments: The government shall only approve invoices for progress payments that reflect the percentage of the task completed (earned value) and submitted in accordance to contract requirements. The contractor shall be responsible for furnishing the government with the appropriate documentation to justify the invoice. The contractor shall provide a detailed cost breakdown per invoice. The cost breakdown shall only include cost incurred during the invoice period.

6.8 Working Hours: All field work shall be performed Monday through Friday from 6 A.M. to 5 P.M.

unless otherwise denoted or agreed upon (where applicable). No work shall be performed on Federal holidays or on days that the Government is closed unless otherwise denoted or agreed upon.

6.9 Contract Numbers: The contract number assigned to this project shall be used on all reports, invoices, and any other related correspondence.

6.10 Quality Control: The Contractor shall be solely responsible for the quality of his work. Deficiencies and omissions shall be corrected prior to FDA’s acceptance of work at no cost to the Government.

6.11 Cost Proposal: The cost proposal should be in the CSI format with detailed breakdown (labor, material, equipment per line item).

6.12 Release of Information: All documentation shall be the property of FDA. Documentation and information shall not be released to any other agency (government, private, or individual) without the prior approval of the Contracting Officer and PO.

6.13 Attachments

• 251226 IRV Rm 2309 Drawings

• 251226 IRV Room 2309 Exhaust Spec