Draft Statement of Work - OC-2024-123376_Replacement Vacuum Pump.pdf

STATEMENT OF WORK

Vacuum Pump Replacement FDA Project: OC-2024-120971 FDA Los Angeles District Office

Pacific Southwest Food and Feed Laboratory Irvine, CA 92612

1.0 Description of Work

1.1 Background Information:

The U.S. Food and Drug Administration’s Los Angeles District Office and Pacific Southwest Food and Feed Laboratory, herein referred to as FDA Irvine, is an FDA owned facility located in Irvine, CA. Construction services for replacement of end-of-life, obsolete vacuum pump systems at the Irvine FDA facility is required. The existing system is nearly 23 years old, does not have replacement parts available on the market for repair, and represents a single-point failure risk to the facility's vacuum system. Therefore, this critical system requires replacement.

1.2 Purpose and Scope of Work

The purpose of this Statement of Work (SOW) is to provide construction services for the vacuum pump system replacement at FDA Irvine.

2.0 Period of Performance:

2.1 The work shall proceed promptly upon execution of the resultant contract and only after the issuance of the Notice to Proceed (NTP) 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 approved project schedule and shall be completed within 222 calendar days of the NTP unless otherwise agreed upon by the Project Officer (PO) and Contracting Officer (CO).

3.0 Place of Performance

U.S Food and Drug Administration Los Angeles District Office Pacific Southwest Food and Feed Laboratory 19701 Fairchild Irvine, CA 92612

3.0 Specific Requirements:

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 Statement of Work. The Contractor will be responsible for relocating any electrical, mechanical, or structural building system components necessary to perform this work. If so, this will be noted in this Scope of Work and such work may only be performed after approval from FDA. The Contractor shall provide all necessary supervision, labor, material, insurance, training, and equipment to:

Sheneil.Green Draft

3.1.1 Contractor shall provide any necessary survey, study, 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 and tank capacity.

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

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

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

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

3.1.6 Contractor shall utilize power feed to existing vacuum system.

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

3.1.8 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) calendar days. Weekend shutdowns are preferred.

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

3.2 The Contractor shall ensure compliance with National Institutes of Health (NIH)’s Design Requirements Manual (DRM). Section 12.4 is the most applicable to this project.

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, Energy Policy Act (EPACT), Energy Independence and Security Act (EISA), Sustainable design and Federal Regulations; Local City, County, and State building codes and regulations; National Electrical Code (NEC), American Society of Mechanical Engineers (ASME), National Fire Protection Association (NFPA), Occupational Safety and Health Administration (OSHA), Underwriters Laboratories (UL), American National Standards Institute (ANSI), and Institute of Electrical and Electronics Engineers (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 (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 the resultant contract, unless otherwise denoted, the Contractor shall provide all services necessary to perform the following activities as related to completing the FDA Irvine Vacuum Replacement mentioned above:

• 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

• Progress Meetings

• Meeting Minutes for review and approval by PO (within five business days)

6.2 Deliverables: The Contractor shall provide all deliverables in accordance with the project schedule and NIH DRM Appendix E, FDA Policy Guidelines, and compliant with Section 508 requirements.

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

1. Two (2) copies of the Operations and Maintenance (O&M) Manuals shall be provided physically in binders and electronically per Compact Disc and Digital Versatile Disc (CD/DVDs) (if applicable).

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.

CD/DVDs shall have printed labels.

5. CD/DVDs shall be placed in CD/DVD page holders with slaps (like Avery 75263 or Avery 73721) when associated with a binder. Avery 75263 for multiple discs and Avery 73721 for a single disc.

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

7. One (1) equipment submission.

8. Four (4) physical copies of as-built marked-up drawings, documentation, etc. for review and discussion. Also, provide electronic copies of the drawings, etc. All electronic drawings shall be provided in portable document format (PDF) and Computer-aided Design (CAD). Deliverables are to be submitted to the COR and/or PO, unless otherwise stated.

9. Four (4) copies of Final Drawings shall be provided in PDF and CAD.

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