Attachment R1 MRC OM Routine TO PWS 251102.pdf

STATEMENT OF WORK

OPERATIONS AND MAINTENANCE SERVICES

FDA Muirkirk Road Complex (MRC)

The U.S. Food and Drug Administration’s (FDA) laboratory research and animal testing facilities located at: - 8301 Muirkirk Road (Module I) - 8401 Muirkirk Road (Module II) -

8501 Muirkirk Road (Beltsville Research Facility)

Laurel, Maryland 20708

U.S. Food and Drug Administration

November 2, 2025

75F40126R000006

PLACEHOLDER IDENTIFICATION GUIDE

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APPENDIX D – PERFORMANCE REQUIREMENTS SUMMARY (PRS)

Contract/Order No.: [Insert] • Appendix D PRS • Page 2

Statement of Work - Operations and Maintenance Services

FDA Muirkirk Road Complex (MRC)

Table of Contents

PLACEHOLDER IDENTIFICATION GUIDE

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SECTION 1 - EXECUTIVE SUMMARY & PROJECT IDENTIFICATION

1.0 INTRODUCTION

1.1 BACKGROUND

1.1.1 Site Overview

1.1.2 Module I (Mod I)

1.1.3 Module II (Mod II)

1.1.4 Beltsville Research Facility (BRF)

1.2 CONTRACT OBJECTIVE

1.2.1 Primary Objective

1.2.2 Facility Performance Requirements

1.2.3 Research Mission Support

1.2.4 Safety and Compliance

1.3 SCOPE SUMMARY

1.3.1 Operations and Monitoring Services

1.3.2 Preventive Maintenance Services

1.3.3 Reactive Maintenance Services

1.3.4 Technical Services by Discipline

1.3.5 Specialized Support Services

1.3.6 Service Delivery Coverage

1.3.7 Contractor-Furnished Resources

1.3.8 Compliance Requirements

1.4 PERIOD OF PERFORMANCE

1.4.1 Contract Periods

1.4.2 Transition Period Requirements

1.5 SITE INFORMATION AND ACCESS

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1.5.1 Site Location

1.5.2 Pre-Proposal Site Visit

1.5.3 Contractor Site Familiarization Requirement

1.5.4 Security and Access Requirements

SECTION 2 - SCOPE & PLACE/HOURS OF PERFORMANCE

2.0 OVERVIEW

2.1 SCOPE OF WORK

2.1.1 General Requirements

2.1.2 Standards and Code Compliance

2.1.3 Site Familiarity Requirement

2.1.4 Standard Work Orders and Day-to-Day Operations

2.2 PLACE OF PERFORMANCE

2.2.1 Primary Location

2.2.2 Facility Components

2.2.3 Site Infrastructure

2.2.4 Off-Site Work

2.3 HOURS OF OPERATION AND COVERAGE REQUIREMENTS

2.3.1 Service Coverage

2.3.2 Normal Duty Hours

2.3.3 After Hours, Weekends, and Holidays

2.3.4 Federal Holidays

2.3.5 Staffing Flexibility and Coverage

2.4 WORK ORDER RECEPTION AND MANAGEMENT

2.4.1 Single Point of Contact

2.4.2 Work Request Review and Analysis

2.4.3 Work Request Sources

2.4.4 Work Order Documentation

2.5 SCOPE LIMITATIONS AND EXCLUSIONS

2.5.1 Work Not Included

2.5.2 Government Responsibilities

2.6 CHANGES TO SCOPE

2.6.1 Scope Modifications

2.6.2 Changed Conditions

2.6.3 Additional Services

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SECTION 3 - APPLICABLE LAWS/STANDARDS & OPERATING CONSTRAINTS

3.0 OVERVIEW

3.1 FEDERAL LAWS AND REGULATIONS

3.1.1 Occupational Safety and Health Act (OSHA)

3.1.2 Environmental Protection Agency (EPA) Regulations

3.1.3 Americans with Disabilities Act (ADA)

3.1.4 Animal Welfare Act

3.2 NATIONAL CODES AND STANDARDS

3.2.1 National Electrical Code (NEC)

3.2.2 National Fire Protection Association (NFPA) Standards

3.2.3 American Society of Mechanical Engineers (ASME) Standards

3.2.4 American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Standards

3.2.5 American Society for Testing and Materials (ASTM) Standards

3.2.6 International Building Code (IBC)

3.2.7 International Mechanical Code (IMC)

3.2.8 International Plumbing Code (IPC)

3.3 STATE AND LOCAL REQUIREMENTS

3.3.1 Maryland State Requirements

3.3.2 Prince George’s County Requirements

3.3.3 Permits and Licenses

3.3.4 Inspections

3.4 MANUFACTURER REQUIREMENTS

3.4.1 Manufacturer Instructions

3.4.2 Warranty Preservation

3.4.3 Factory-Authorized Service

3.5 OPERATING CONSTRAINTS

3.5.1 Research Operations

3.5.2 Animal Care Facilities

3.5.3 Good Laboratory Practices

3.5.4 Security Requirements

3.6 ORDER OF PRECEDENCE FOR CONFLICTING REQUIREMENTS

3.6.1 Hierarchy of Requirements

3.6.2 Most Stringent Requirement

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3.6.3 Conflict Resolution

3.7 CHANGES TO APPLICABLE REQUIREMENTS

3.7.1 Monitoring Changes

3.7.2 Notification of Changes

3.7.3 Implementation of Changes

SECTION 4 - GOVERNMENT-FURNISHED RESOURCES

4.0 OVERVIEW

4.1 GOVERNMENT FURNISHED PROPERTY (GFP)

4.1.1 Definition and Scope

4.1.2 Tools and Test Equipment

4.1.3 Office Equipment and Furniture

4.1.4 Computers and Information Technology Equipment

4.1.5 Safety Equipment

4.1.6 Vehicles

4.1.7 Property Accountability

4.2 GOVERNMENT FURNISHED EQUIPMENT (GFE)

4.2.1 Definition and Scope

4.2.2 Equipment Categories

4.2.3 Equipment List

4.2.4 Equipment Additions and Deletions

4.2.5 Contractor Maintenance Responsibility

4.2.6 Equipment Manuals and Documentation

4.3 GOVERNMENT FURNISHED FACILITIES (GFF)

4.3.1 Definition and Scope

4.3.2 Buildings and Structures

4.3.3 Site Infrastructure

4.3.4 Contractor Work Space

4.4 GOVERNMENT FURNISHED SERVICES (GFS)

4.4.1 Definition and Scope

4.4.2 Utilities

4.4.3 Information Technology Support

4.4.4 Badging and Access Control

4.4.5 Waste Disposal Services

4.5 LIMITATIONS AND CONTRACTOR RESPONSIBILITIES

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4.5.1 Government Liability Limitations

4.5.2 Service Interruptions

4.5.3 Proper Use Requirements

4.5.4 Security and Protection

4.5.5 Return at Contract End

SECTION 5 - CONTRACTOR-FURNISHED ITEMS & STAFFING

5.0 OVERVIEW

5.1 CONTRACTOR-FURNISHED MATERIALS AND SUPPLIES

5.1.1 General Requirements

5.1.2 Material Quality Standards

5.1.3 Spare Parts Inventory

5.1.4 Hazardous Materials

5.1.5 Refrigerants

5.1.6 Water Treatment Chemicals

5.2 CONTRACTOR-FURNISHED TOOLS AND EQUIPMENT

5.2.1 General Tools

5.2.2 Specialized Equipment

5.2.3 Test and Measurement Equipment

5.2.4 Safety Equipment

5.2.5 Vehicles

5.2.6 Communication Equipment

5.3 KEY PERSONNEL

5.3.1 Definition and Requirements

5.3.2 Project Manager

5.3.3 Alternate Project Manager

5.3.4 Safety Manager

5.3.5 Quality Control Manager

5.3.6 Key Personnel Changes

5.4 STAFFING REQUIREMENTS

5.4.1 General Staffing Requirements

5.4.2 Required Positions and Coverage

5.4.3 Qualifications and Certifications

5.4.4 Staffing Summary Table

5.5 PERSONNEL REQUIREMENTS

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5.5.1 Background Checks and Badging

5.5.2 Conduct and Performance Standards

5.5.3 Subcontractor Personnel

5.6 CONTINUITY OF OPERATIONS

5.6.1 Coverage During Absences

5.6.2 Succession Planning

5.6.3 Knowledge Transfer

SECTION 6 - MANAGEMENT & WORK CONTROL

6.0 OVERVIEW

6.1 MANAGEMENT STRUCTURE

6.1.1 Contractor Organization

6.1.2 Management Responsibilities

6.1.3 Government Interface

6.2 WORK CONTROL SYSTEM

6.2.1 System Requirements

6.2.2 Work Order Types

6.2.3 Work Order Processing

6.2.4 Work Order Documentation

6.2.5 Equipment History

6.3 SCHEDULING AND COORDINATION

6.3.1 Master Schedule

6.3.2 Preventive Maintenance Scheduling

6.3.3 Outage Coordination

6.3.4 Access Coordination

6.4 EMERGENCY RESPONSE

6.4.1 Emergency Response Plan

6.4.2 Emergency Notification

6.4.3 Emergency Response Requirements

6.4.4 After-Hours Response

6.5 MEETINGS AND COMMUNICATION

6.5.1 Progress Meetings

6.5.2 Coordination Meetings

6.5.3 Safety Meetings

6.5.4 Daily Communication

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6.6 SUBCONTRACTOR MANAGEMENT

6.6.1 Subcontractor Use

6.6.2 Subcontractor Approval

6.6.3 Subcontractor Supervision

6.6.4 Subcontractor Coordination

6.7 CHANGE MANAGEMENT

6.7.1 Contract Changes

6.7.2 Change Requests

6.7.3 Out-of-Scope Work

SECTION 7 - PROGRAMS & PLANS

7.0 OVERVIEW

7.1 TRANSITION PLAN

7.1.1 Purpose and Scope

7.1.2 Transition Plan Contents

7.1.3 Transition Activities

7.1.4 Assumption of Full Responsibility

7.2 PREVENTIVE MAINTENANCE PROGRAM

7.2.1 Program Objectives

7.2.2 PM Program Plan

7.2.3 PM Scheduling and Execution

7.2.4 PM Compliance

7.3 TRAINING PROGRAM

7.3.1 Training Requirements

7.3.2 Training Program Plan

7.3.3 New Employee Orientation

7.3.4 Job-Specific Training

7.3.5 Safety Training

7.3.6 Certification and License Maintenance

7.4 SAFETY PROGRAM

7.4.1 Safety Program Requirements

7.4.2 Safety Program Plan

7.4.3 Safety Program Implementation

7.5 QUALITY CONTROL PROGRAM

7.5.1 Quality Control Requirements

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7.5.2 Quality Control Plan

7.5.3 Quality Control Implementation

7.6 ENVIRONMENTAL MANAGEMENT PROGRAM

7.6.1 Environmental Compliance Requirements

7.6.2 Environmental Management Plan

7.6.3 Waste Management

7.6.4 Spill Prevention and Response

7.7 ENERGY MANAGEMENT PROGRAM

7.7.1 Energy Management Objectives

7.7.2 Energy Management Activities

7.7.3 Energy Reporting

7.8 WATER MANAGEMENT PROGRAM

7.8.1 Water Management Requirements

7.8.2 Water Management Plan

7.8.3 Water System Monitoring

7.9 EMERGENCY PREPAREDNESS PROGRAM

7.9.1 Emergency Preparedness Requirements

7.9.2 Emergency Response Plan

7.9.3 Business Continuity

7.10 RECORDS MANAGEMENT PROGRAM

7.10.1 Records Management Requirements

7.10.2 Record Retention

7.10.3 Records Access

7.10.4 Records Turnover

7.11 CONTINUOUS IMPROVEMENT PROGRAM

7.11.1 Continuous Improvement Philosophy

7.11.2 Improvement Identification

7.11.3 Improvement Implementation

SECTION 8 - TECHNICAL REQUIREMENTS BY SYSTEM/DISCIPLINE

8.0 OVERVIEW

8.1 ARCHITECTURAL AND STRUCTURAL SYSTEMS

8.1.1 General Requirements

8.1.2 Roofing Systems

8.1.3 Exterior Walls and Building Envelope

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8.1.4 Doors and Hardware

8.1.5 Windows

8.1.6 Interior Finishes

8.1.7 Painting

8.2 HEATING, VENTILATION, AIR CONDITIONING AND REFRIGERATION

(HVACR)

8.2.1 General Requirements

8.2.2 Environmental Control Standards

8.2.3 Air Handling Units and Distribution Systems

8.2.4 Exhaust Systems

8.2.5 Terminal Units and Local Equipment

8.2.6 Refrigeration Equipment

8.2.7 Controls and Instrumentation

8.2.8 Testing, Adjusting, and Balancing

8.2.9 Lubrication

8.2.10 Compressors

8.3 BOILER PLANT OPERATIONS AND MAINTENANCE

8.3.1 General Requirements

8.3.2 Operational Requirements

8.3.3 Water Treatment

8.3.4 Daily Maintenance Requirements

8.3.5 Periodic Maintenance

8.3.6 Annual Boiler Inspections

8.3.7 Steam Distribution Systems

8.4 CHILLER PLANT AND COOLING SYSTEMS

8.4.1 General Requirements

8.4.2 Chiller Operations

8.4.3 Chiller Maintenance

8.4.4 Cooling Towers and Condensers

8.4.5 Chilled Water Distribution

8.4.6 Condenser Water Systems

8.5 ELECTRICAL SYSTEMS

8.5.1 General Requirements

8.5.2 Electrical Distribution Equipment

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8.5.3 Lighting Systems

8.5.4 Emergency Lighting and Exit Signs

8.6 EMERGENCY POWER SYSTEMS

8.6.1 General Requirements

8.6.2 Emergency Generator Maintenance

8.6.3 Transfer Switch Maintenance

8.6.4 UPS Systems

8.7 PLUMBING SYSTEMS

8.7.1 General Requirements

8.7.2 Domestic Water Systems

8.7.3 Sanitary Sewer Systems

8.7.4 Specialized Water Systems

8.7.5 Wastewater Pretreatment

8.8 FIRE PROTECTION SYSTEMS

8.8.1 General Requirements

8.8.2 Fire Sprinkler Systems

8.8.3 Fire Alarm Systems

8.8.4 Fire Extinguishers

8.8.5 Special Suppression Systems

8.9 BUILDING AUTOMATION AND CONTROL SYSTEMS

8.9.1 General Requirements

8.9.2 BAS Monitoring and Operation

8.9.3 BAS Maintenance

8.9.4 Controls Programming

8.10 ELEVATOR SYSTEMS

8.10.1 General Requirements

8.10.2 Elevator Maintenance

8.10.3 Elevator Testing

8.10.4 Emergency Service

8.11 LABORATORY SUPPORT SYSTEMS

8.11.1 Laboratory Gas Systems

8.11.2 Laboratory Vacuum Systems

8.11.3 Biological Safety Cabinets

8.11.4 Vivarium Equipment

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8.12 SITE INFRASTRUCTURE

8.12.1 Grounds and Exterior

8.12.2 Exterior Lighting

8.12.3 Site Utilities

SECTION 9 - ITP MATRIX (INSPECTION, TESTING, AND PREVENTIVE

MAINTENANCE)

9.0 OVERVIEW

9.1 ITP MATRIX ORGANIZATION

9.1.1 Matrix Structure

9.1.2 Frequency Definitions

9.1.3 Task Scheduling

9.1.4 Task Documentation

9.2 ITP MATRIX BY SYSTEM

9.2.1 ARCHITECTURAL AND STRUCTURAL SYSTEMS

Roofing Systems

Building Envelope

Doors and Hardware

9.2.2 HVACR SYSTEMS

Air Handling Units

Exhaust Systems

Terminal Units

Refrigeration Equipment

9.2.3 BOILER SYSTEMS

Boiler Operations

Steam Distribution

9.2.4 CHILLER AND COOLING SYSTEMS

Chillers

Cooling Towers

Pumps (Chilled Water and Condenser Water)

9.2.5 ELECTRICAL SYSTEMS

Electrical Distribution

Lighting Systems

9.2.6 EMERGENCY POWER SYSTEMS

Emergency Generators

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UPS Systems

9.2.7 PLUMBING SYSTEMS

Domestic Water Systems

Sanitary and Storm Systems

Specialized Water Systems

9.2.8 FIRE PROTECTION SYSTEMS

Fire Sprinkler Systems

Fire Alarm Systems

Fire Extinguishers

9.2.9 BUILDING AUTOMATION SYSTEMS

9.2.10 ELEVATOR SYSTEMS

9.2.11 LABORATORY SUPPORT SYSTEMS

Laboratory Gases

Laboratory Vacuum

Biological Safety Cabinets

9.3 SCHEDULE MANAGEMENT AND COMPLIANCE

9.3.1 PM Schedule Development

9.3.2 PM Schedule Balancing

9.3.3 PM Completion Tracking

9.3.4 PM Schedule Adjustments

9.4 EQUIPMENT ADDITIONS AND DELETIONS

9.4.1 New Equipment

9.4.2 Equipment Removal

9.4.3 ITP Matrix Updates

SECTION 10 - SAFETY, HEALTH, AND ENVIRONMENTAL REQUIREMENTS

10.0 OVERVIEW

10.1 SAFETY PROGRAM REQUIREMENTS

10.1.1 Written Safety Program

10.1.2 Safety Responsibility

10.1.3 Safety Meetings

10.1.4 Safety Performance Monitoring

10.2 OSHA COMPLIANCE

10.2.1 General OSHA Requirements

10.2.2 Hazard Communication (OSHA 1910.1200)

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10.2.3 Lockout/Tagout (OSHA 1910.147)

10.2.4 Personal Protective Equipment (OSHA 1910 Subpart I)

10.2.5 Confined Space Entry (OSHA 1910.146)

10.2.6 Fall Protection (OSHA 1910.28 and 1926 Subpart M)

10.2.7 Respiratory Protection (OSHA 1910.134)

10.2.8 Electrical Safety (OSHA 1910 Subpart S and NFPA 70E)

10.2.9 Ladder Safety

10.2.10 Machine Guarding

10.3 ACCIDENT AND INCIDENT RESPONSE

10.3.1 Accident Notification

10.3.2 Accident Investigation

10.3.3 Emergency Medical Response

10.3.4 Corrective Actions

10.4 SPECIFIC HAZARD CONTROLS

10.4.1 Asbestos

10.4.2 Lead Paint

10.4.3 Biological Hazards

10.4.4 Chemical Hazards

10.4.5 Hot Work

10.4.6 Overhead Work and Falling Objects

10.5 SAFETY TRAINING REQUIREMENTS

10.5.1 General Safety Training

10.5.2 Task-Specific Training

10.5.3 Refresher Training

10.5.4 Training Documentation

10.6 ENVIRONMENTAL REQUIREMENTS

10.6.1 Environmental Compliance

10.6.2 Pollution Prevention

10.6.3 Waste Management

10.6.4 Spill Prevention and Response

10.6.5 Air Quality Protection

10.6.6 Water Quality Protection

10.6.7 Noise Control

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10.7 COORDINATION WITH GOVERNMENT SAFETY AND ENVIRONMENTAL

PERSONNEL

10.7.1 Government Safety Personnel

10.7.2 Government Environmental Personnel

10.7.3 Facility Emergency Response

SECTION 11 - PERFORMANCE MANAGEMENT

11.0 OVERVIEW

11.1 PERFORMANCE REQUIREMENTS SUMMARY (PRS)

11.1.1 PRS Organization

11.1.2 Performance Objectives

11.1.3 Acceptable Quality Levels

11.2 RESPONSE TIME REQUIREMENTS

11.2.1 Emergency Response

11.2.2 Urgent Service Calls

11.2.3 Routine Service Calls

11.2.4 Preventive Maintenance Completion

11.2.5 Callback Response

11.3 PERFORMANCE MONITORING AND SURVEILLANCE

11.3.1 Surveillance Methods

11.3.2 Performance Metrics

11.3.3 Performance Trending

11.4 QUALITY ASSURANCE

11.4.1 Contractor Quality Control

11.4.2 Government Quality Assurance

11.4.3 Deficiency Correction

11.4.4 Acceptance of Work

11.5 PERFORMANCE ISSUES AND REMEDIES

11.5.1 Performance Deficiencies

11.5.2 Corrective Action Plans

11.5.3 Performance Improvement Plans

11.5.4 Remedies

11.6 PERFORMANCE EXCELLENCE

11.6.1 Recognition of Excellence

11.6.2 Continuous Improvement

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11.6.3 Innovation

11.7 PERFORMANCE EVALUATION

11.7.1 Ongoing Performance Assessment

11.7.2 Formal Performance Evaluations

11.7.3 Contractor Input

11.8 PERFORMANCE REPORTING

11.8.1 Monthly Performance Reports

11.8.2 Performance Reviews

11.8.3 Annual Performance Summary

SECTION 12 - DELIVERABLES AND REPORTING

12.0 OVERVIEW

12.1 DELIVERABLE SUMMARY TABLE

12.2 INITIAL DELIVERABLES

12.2.1 Transition Plan

12.2.2 Organizational Chart

12.2.3 Subcontractor List

12.2.4 Preventive Maintenance Program Plan

12.2.5 Training Program Plan

12.2.6 Safety Program Plan

12.2.7 Quality Control Plan

12.2.8 Environmental Management Plan

12.2.9 Emergency Response Plan

12.2.10 Water Management Plan

12.3 MONTHLY REPORTS

12.3.1 Monthly Performance Report

12.3.2 Monthly Energy Report

12.3.3 Work Order Status Report

12.3.4 Safety Report

12.4 PERIODIC REPORTS

12.4.1 Quarterly Equipment Inventory Updates

12.4.2 Annual Property Inventory Report

12.4.3 Annual Performance Summary

12.5 EVENT-DRIVEN REPORTS

12.5.1 Emergency Notifications

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12.5.2 Accident and Incident Reports

12.5.3 Spill Reports

12.5.4 Out-of-Spec Conditions

12.6 REPORT FORMAT AND SUBMISSION

12.6.1 Format Requirements

12.6.2 Electronic Submission

12.6.3 Data Format

12.6.4 Timeliness

12.7 RECORD RETENTION AND AVAILABILITY

12.7.1 Retention Requirements

12.7.2 Government Access

12.7.3 Contract Closeout

SECTION 13 - QUALITY CONTROL AND RECORDKEEPING

13.0 OVERVIEW

13.1 QUALITY CONTROL PROGRAM

13.1.1 Quality Control Organization

13.1.2 Quality Control Inspection Plan

13.1.3 Three-Phase Inspection Process

13.2 INSPECTION REQUIREMENTS BY WORK TYPE

13.2.1 Preventive Maintenance Inspections

13.2.2 Corrective Maintenance Inspections

13.2.3 Critical System Inspections

13.2.4 New Installation Inspections

13.3 DEFICIENCY MANAGEMENT

13.3.1 Deficiency Identification

13.3.2 Deficiency Tracking

13.3.3 Deficiency Correction

13.3.4 Deficiency Trending

13.4 WORK ORDER DOCUMENTATION

13.4.1 Work Order Completion Requirements

13.4.2 Required Work Order Information

13.4.3 Photographs and Attachments

13.4.4 Work Order Quality Review

13.5 EQUIPMENT HISTORY RECORDS

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13.5.1 Equipment History Purpose

13.5.2 Equipment History Contents

13.5.3 Equipment History Maintenance

13.5.4 Equipment History Analysis

13.6 RECORD TYPES AND REQUIREMENTS

13.6.1 Maintenance Records

13.6.2 Safety Records

13.6.3 Environmental Records

13.6.4 Training Records

13.6.5 Quality Control Records

13.6.6 Property Records

13.6.7 Administrative Records

13.7 RECORDKEEPING SYSTEM

13.7.1 Electronic Records

13.7.2 Hard Copy Records

13.7.3 Record Organization

13.7.4 Record Protection

13.8 GOVERNMENT ACCESS TO RECORDS

13.8.1 Right of Access

13.8.2 Record Copies

13.8.3 On-Site Review

13.9 AUDITS AND INSPECTIONS

13.9.1 Internal Audits

13.9.2 Government Audits

13.9.3 Regulatory Inspections

APPENDIX A - DEFINITIONS & ACRONYMS

APPENDIX B – EQUIPMENT LISTING

See IDIQ PWS Attachment B

APPENDIX C - FACILITY DRAWINGS AND MAPS

APPENDIX D - REQUIRED STAFFING TABLE

APPENDIX E - STANDARDS AND CODES REGISTER

APPENDIX F - PERFORMANCE REQUIREMENTS SUMMARY (PRS)

Contract/Order No.: [Insert] • Appendix D PRS • Page 19

SECTION 1 - EXECUTIVE SUMMARY & PROJECT IDENTIFICATION

1.0 INTRODUCTION

This Statement of Work (SOW) establishes the requirements for comprehensive operations and maintenance (O&M) support services at the U.S. Food and Drug Administration’s (FDA) Muirkirk Road Complex (MRC) located in Laurel, Maryland.

The contractor shall provide all necessary labor, materials, equipment, and management to ensure the continuous, safe, and efficient operation of all buildings and facilities on a 24 hours per day, 7 days per week basis throughout the period of performance.

The contract title is Standard Work Orders Operations & Support Services, Muirkirk Road Complex (MRC). The FDA Project Number will be assigned by the issuing office, which is the U.S. Food and Drug Administration (FDA) Office of Facilities Engineering and Property Management.

Definitions of key terms and acronyms used in this SOW are provided in Appendix A.

1.1 BACKGROUND

1.1.1 Site Overview

The FDA Muirkirk Road Complex (MRC) is a 198-acre FDA-owned site located in Laurel, Maryland between U.S. Route 1 and the Baltimore Washington Parkway (I- 295). The complex consists of 432,000 square feet of research laboratory space supporting mission-critical research for the U.S. Food and Drug Administration and its program research offices. The site comprises 195 acres of land with three principal facilities located at 8301, 8401, and 8501 Muirkirk Road.

1.1.2 Module I (Mod I)

1.1.2.1 Facility Characteristics

Module I is located at 8301 Muirkirk Road, Laurel, Maryland 20708. The facility was constructed in 1984 and dedicated in August 1990, consisting of 246,853 gross square feet. Module I houses research programs for the Human Foods Program (HFP) and Office of Inspections and Investigations (OII).

1.1.2.2 Research Mission

Research conducted at Module I is designed to provide credible scientific information upon which informed decisions can be based. These facilities permit the Agency to improve its science base and prepare for the challenges of the 21st century. Animal studies are conducted according to contemporary scientific standards and in accordance with the Animal Welfare Act and the Guide for the Care and Use of Laboratory Animals, with the flexibility to keep pace with technological developments.

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1.1.2.3 Research Areas

Research is directed to assess significant health questions in areas that include pharmaceuticals, drug interaction, toxicology, drug chemistry, and food nutrition.

The facility is accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC).

1.1.3 Module II (Mod II)

1.1.3.1 Facility Characteristics

Module II is located at 8401 Muirkirk Road, Laurel, Maryland 20708. The facility consists of 18 buildings totaling approximately 100,406 gross square feet and is designed with the most modern equipment available to facilitate the research mission. Module II houses the Center for Veterinary Medicine (CVM).

1.1.3.2 Mission and Responsibilities

CVM is responsible for assuring the safety and efficiency of food, drugs, and food additives that will be given to animals. These include animals from which human foods are derived, as well as companion animals. This component of the regulatory testing group performs bioassays using animals. CVM is presently AAALAC accredited.

1.1.4 Beltsville Research Facility (BRF)

1.1.4.1 Facility Characteristics

The Beltsville Research Facility is located at 8501 Muirkirk Road, Laurel, Maryland 20708. Operational since 1964, the facility consists of 35,061 gross square feet. The facility houses research programs for CVM.

1.1.4.2 Facility Components

The BRF includes the main research building which was renovated in 2014, a mechanical equipment building, a small block storage building, a maintenance building, three Hazmat containment units used for processing hazardous waste, one machine shop/fitness center building, and one steel storage building.

1.1.4.3 Special Considerations

Certain systems at the Beltsville Research Facility (BRF), including abandoned piping and heating distribution systems, contain asbestos. The Contractor shall immediately notify the COR upon discovery of any friable suspect material. The COR and CO may direct asbestos abatement through a work order.

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1.2 CONTRACT OBJECTIVE

1.2.1 Primary Objective

The objective of this contract is to ensure the continuous, safe, and efficient operation of all buildings and facilities located at the U.S. Food and Drug Administration’s Muirkirk Road Complex (MRC). The Contractor shall provide comprehensive operations and maintenance (O&M) support services on a 24 hours per day, 7 days per week basis to maintain optimal facility performance and readiness throughout the period of performance.

1.2.2 Facility Performance Requirements

The Contractor shall maintain optimal facility performance throughout the period of performance, ensure facility readiness to support mission-critical research, and maintain all systems in safe and operational condition.

1.2.3 Research Mission Support

The Contractor shall support ongoing laboratory research activities, maintain environmental conditions required for animal care and use, ensure compliance with good laboratory practices, and maintain AAALAC accreditation standards.

1.2.4 Safety and Compliance

The Contractor shall maintain compliance with all applicable codes and regulations, ensure safe working conditions for government and contractor personnel, maintain life safety systems in operational readiness, and protect the environment and prevent pollution.

1.3 SCOPE SUMMARY

1.3.1 Operations and Monitoring Services

The Contractor shall provide 24/7 operation and monitoring of building automation systems, boiler plant operations and monitoring, chiller plant operations and monitoring, emergency generator operations and testing, utilities monitoring and energy management, water treatment operations, and wastewater pretreatment operations.

1.3.2 Preventive Maintenance Services

The Contractor shall provide a comprehensive preventive maintenance (PM) program for all equipment, building and structures preventive maintenance, mechanical systems preventive maintenance, electrical systems preventive maintenance, specialized systems preventive maintenance, and PM documentation and recordkeeping.

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1.3.3 Reactive Maintenance Services

The Contractor shall provide service calls and work order response, emergency repairs and callbacks, routine repairs and maintenance, and equipment troubleshooting and repair.

1.3.4 Technical Services by Discipline

The Contractor shall provide architectural and structural maintenance, site and exterior maintenance, mechanical systems including HVAC, steam, boilers, chillers, and compressed air, electrical systems including distribution, emergency power, and lighting, building automation and control systems, fire protection and life safety systems, vertical transportation including elevators, and plumbing and water systems.

1.3.5 Specialized Support Services

The Contractor shall provide laboratory support equipment maintenance, animal facility environmental controls, laboratory gas systems, specialized water systems including reverse osmosis, de-ionized, and distilled water systems, and wastewater pretreatment operations.

1.3.6 Service Delivery Coverage

The Contractor shall provide 24 hours per day, 7 days per week service coverage, holiday and weekend coverage as required, and emergency callback capability.

1.3.7 Contractor-Furnished Resources

The Contractor shall provide all labor including skilled trades, technicians, operators, and management staff, all materials and supplies, all tools and equipment, all vehicles and transportation, all permits and licenses, all certifications and training, and all supervision and management necessary to perform the services required by this SOW.

1.3.8 Compliance Requirements

All work shall comply with local, county, state, and federal codes and regulations, ASTM standards, OSHA requirements, National Electrical Code (NEC), ASME standards, manufacturer recommendations, and industry best practices. In the event of conflicting requirements, the more stringent code or standard shall apply.

1.4 PERIOD OF PERFORMANCE

1.4.1 Contract Periods

The period of performance consists of a Transition Period from date of award through sixty (60) days, a Base Period after the transition period of sixty (60) days continuing for ten (10) months thereafter, Option Period 1 from Month 13 through

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Month 24, Option Period 2 from Month 25 through Month 36, Option Period 3 from Month 37 through Month 48, and Option Period 4 from Month 49 through Month 60.

1.4.2 Transition Period Requirements

During the sixty (60) day transition period, the Contractor shall mobilize personnel and resources, complete required training and badging, conduct facility and equipment walkdowns with incumbent contractor if applicable, develop and submit required plans and procedures, establish work management systems and processes, and assume full operational responsibility by day 60. Detailed transition requirements are specified in Section 7 (Programs & Plans).

1.5 SITE INFORMATION AND ACCESS

1.5.1 Site Location

The primary address is FDA Muirkirk Road Complex, 8301-8501 Muirkirk Road, Laurel, Maryland 20708. The site is located between U.S. Route 1 and the Baltimore Washington Parkway (I-295), approximately 15 miles northeast of Washington, DC and approximately 20 miles south of Baltimore, MD.

1.5.2 Pre-Proposal Site Visit

A pre-proposal site visit will be scheduled for all potential offerors. Details regarding date, time, and registration requirements will be provided in the solicitation. Offerors are strongly encouraged to attend the site visit to familiarize themselves with the facility layout and conditions, observe existing equipment and systems, understand access requirements and restrictions, and ask questions about the facility and requirements.

1.5.3 Contractor Site Familiarization Requirement

The Contractor acknowledges that they have visited the site or have had the opportunity to visit the site and are aware of all aspects of the existing conditions, needs, and requirements stated in this SOW. The Contractor shall be responsible for determining all requirements including materials, tools, and equipment needs, supply requirements, regulatory compliance requirements, required certifications and licenses, vehicle and transportation needs, workforce requirements including engineers, technicians, tradesmen, and support personnel, subcontractor needs, and management staff requirements.

1.5.4 Security and Access Requirements

1.5.4.1 Badging Requirements

All contractor personnel require FDA-issued identification badges for facility access.

Badge requirements and processes are detailed in Section 5 (Contractor-Furnished Items & Staffing).

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1.5.4.2 Restricted Areas

Certain areas of the facility have restricted access due to ongoing research activities, animal care facilities subject to AAALAC requirements, secure storage areas, and sensitive research equipment. The Contractor shall coordinate with the COR and Center Managers before accessing restricted areas.

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SECTION 2 - SCOPE & PLACE/HOURS OF PERFORMANCE

2.0 OVERVIEW

This section defines the complete scope of work, place of performance, hours of operation, and coverage requirements for operations and maintenance services at the Muirkirk Road Complex. The Contractor shall provide all necessary materials, labor, permits, hauling, equipment, shipping, delivery, and supervision for protecting existing equipment and all other Government property.

2.1 SCOPE OF WORK

2.1.1 General Requirements

The Contractor shall provide comprehensive operations and maintenance support services to ensure the continuous, safe, and efficient operation of all buildings and facilities at the MRC. The scope encompasses all systems, equipment, and infrastructure necessary to support the mission-critical research activities conducted at the facility.

2.1.2 Standards and Code Compliance

The Contractor shall be certified and ensure all work adheres to local, county, ASTM, OSHA, NEC, ASME, and other applicable codes and specifications as listed and identified in Section 3 (Applicable Laws/Standards & Operating Constraints) or the overall contract Statement of Work. In the event a conflict arises over workmanship, the more stringent code shall be adhered to.

2.1.3 Site Familiarity Requirement

The Contractor has visited the site and is aware of all aspects of the existing conditions, needs, and requirements stated in this SOW. The Contractor shall be responsible for all requirements in the SOW to determine materials, tools, equipment, supplies, regulatory compliance, certifications, licenses, vehicles, and a fully trained workforce of engineers, technicians, tradesmen, support personnel, subcontractors, and management staff to ensure continuous and satisfactory operational performance on a 24 hours per day, 7 days per week basis.

2.1.4 Standard Work Orders and Day-to-Day Operations

The Contractor shall deliver the full range of operational and maintenance services throughout the period of performance. The scope of work identifies key day-to-day operations that are standard orders to the contract in Operations and Maintenance support services. This includes preventive maintenance, operations, and support services that will be standard to the contract with detailed requirements per section as specified in Section 8 (Technical Requirements by System/Discipline).

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2.2 PLACE OF PERFORMANCE

2.2.1 Primary Location

All work under this contract shall be performed at the FDA Muirkirk Road Complex located at 8301-8501 Muirkirk Road, Laurel, Maryland 20708. The place of performance includes all buildings, structures, grounds, and infrastructure within the 198-acre site boundaries.

2.2.2 Facility Components

The place of performance encompasses the following facilities as described in Section 1.1 (Background):

2.2.2.1 Module I

8301 Muirkirk Road, Laurel, MD 20708. Total area of 246,853 gross square feet housing Human Foods Program and Office of Inspections and Investigations research programs.

2.2.2.2 Module II

8401 Muirkirk Road, Laurel, MD 20708. Consisting of 18 buildings totaling approximately 100,406 gross square feet housing the Center for Veterinary Medicine.

2.2.2.3 Beltsville Research Facility

8501 Muirkirk Road, Laurel, MD 20708. Total area of 35,061 gross square feet housing Center for Veterinary Medicine research programs.

2.2.3 Site Infrastructure

The place of performance includes all site infrastructure supporting the three facilities including but not limited to central utility plants, distribution systems for steam, chilled water, compressed air, natural gas, electricity, domestic water, wastewater collection and pretreatment, storm water management systems, roads, parking areas, exterior lighting, perimeter fencing and gates, landscaped areas, and other site improvements.

2.2.4 Off-Site Work

The Contractor may perform certain administrative, procurement, or preparatory work at off-site locations. However, all operational, maintenance, and direct support activities shall be performed at the MRC. The Contractor shall maintain an on-site presence as specified in Section 2.3 (Hours of Operation and Coverage Requirements).

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2.3 HOURS OF OPERATION AND COVERAGE REQUIREMENTS

2.3.1 Service Coverage

The Contractor shall provide operations and maintenance services on a continuous basis, 24 hours per day, 7 days per week, 365 days per year including Federal holidays. This continuous coverage is essential to support the mission-critical research activities and maintain facility safety and environmental conditions.

2.3.2 Normal Duty Hours

2.3.2.1 Definition

Normal duty hours are defined as Monday through Friday, 6:00 AM to 6:00 PM, excluding Federal holidays. During normal duty hours, the Contractor shall maintain full staffing levels to support preventive maintenance activities, reactive maintenance, routine operations, administrative functions, and coordination with Government personnel.

2.3.2.2 Staffing During Normal Duty Hours

During normal duty hours, the Contractor shall ensure that all positions identified in Section 5 (Contractor-Furnished Items & Staffing) are filled and that personnel are available to respond to service calls, emergency conditions, and routine operational needs. The Contractor’s on-site Project Manager or designee shall be available during all normal duty hours.

2.3.3 After Hours, Weekends, and Holidays

2.3.3.1 Continuous Operations Coverage

The Contractor shall provide continuous staffing for critical building systems that require 24/7 monitoring and operation. This includes but is not limited to boiler plant operations, chiller plant operations, building automation system monitoring, water treatment operations, wastewater pretreatment operations, and emergency response capability.

2.3.3.2 Callback and Emergency Response

The Contractor shall maintain callback capability 24 hours per day, 7 days per week to respond to emergency conditions outside normal duty hours. The Contractor shall provide contact information for emergency response and shall respond to emergency callbacks within the timeframes specified in Section 11 (Performance Management) and detailed in Appendix F (Performance Requirements Summary).

2.3.3.3 Preventive Maintenance Scheduling

Due to ongoing research activities, the Contractor shall be prepared to schedule preventive maintenance and other work outside normal duty hours. The Contractor

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2.3.4 Federal Holidays

Federal holidays observed by the FDA are not considered normal duty hours.

However, the Contractor shall maintain continuous operations coverage on Federal holidays as specified in Section 2.3.3.1. The Federal holidays are New Year’s Day, Martin Luther King Jr. Day, Presidents’ Day, Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day. When a holiday falls on a Saturday, it is observed on the preceding Friday. When a holiday falls on a Sunday, it is observed on the following Monday.

2.3.5 Staffing Flexibility and Coverage

2.3.5.1 General Staffing Requirements

The Contractor shall ensure that all positions are fully staffed at all times. To meet this requirement, the Contractor may utilize part-time rovers, cross-trained personnel, or subcontractors to provide coverage during employee absences, extended leave, weekends, and holidays. The use of rovers or part-time staff does not relieve the Contractor of the responsibility to maintain required service levels and response times.

2.3.5.2 Building Automation System Coverage

In addition to general facility operations coverage, the Contractor shall provide a Building Automation System (BAS) operator on site three (3) days per week. The BAS operator must be employed by a company independent of the on-site contractor to ensure objective system monitoring and optimization.

2.3.5.3 Controls Contractor Coverage

The Contractor shall provide a Phoenix-authorized contractor on-site one (1) day every week to perform service calls and programming for the Phoenix control systems. This specialized coverage ensures that proprietary control systems are maintained by factory-authorized technicians.

2.4 WORK ORDER RECEPTION AND MANAGEMENT

2.4.1 Single Point of Contact

The Contractor shall maintain a single point of contact continuously during normal working hours on-site at the facility for reception of all work requests and orders. A Contractor representative shall reside in the Project Manager’s Office during normal hours to receive, process, and otherwise manage all incoming work requests

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2.4.2 Work Request Review and Analysis

The Contractor shall review each work request for completeness, understanding, and clarity. The Contractor shall analyze each work request thoroughly, breaking all tasks down to the simplest elements possible. This analysis shall include identification of required labor skills, materials, tools, estimated duration, and any special requirements or constraints.

2.4.3 Work Request Sources

Service calls shall be placed directly to the Contractor via telephone or email by the COR or Government Center Managers. Miscellaneous Utility Work Orders will be issued to the Contractor by the COR or designated Government Representative.

Emergency work orders may be initiated by any authorized Government personnel and shall be responded to immediately regardless of source.

2.4.4 Work Order Documentation

The Contractor shall document all work orders in accordance with the requirements specified in Section 6 (Management & Work Control) and Section 13 (D