Attachment C1 MRC OM IDIQ PWS 251103.pdf

75F40126R00006 Attachment C1 Performance Work Statement (PWS) Muirkirk Road Complex (MRC) Operations and Maintenance Support Services

INDEFINITE DELIVERY, INDEFINITE QUANTITY (IDIQ)

CONTRACT

PERFORMANCE WORK STATEMENT (PWS)

Muirkirk Road Complex (MRC) Operations and Maintenance Support Services

Contract Type: Indefinite Delivery, Indefinite Quantity (IDIQ)

Contract Period: Single 5-year ordering period

Date:November 2, 2025

Contents

PERFORMANCE WORK STATEMENT (PWS)

Muirkirk Road Complex (MRC) Operations and Maintenance Support Services

1.0 PURPOSE AND SCOPE

1.1 Contract Overview

1.2 Contract Type

1.3 Facility Description

2.0 SERVICE CATEGORIES AVAILABLE FOR TASK ORDER

2.1 Category 1: Routine Operations and Maintenance (O&M)

2.2 Category 2: Preventive Maintenance Programs

2.3 Category 3: Repair and Restoration Services

2.4 Category 4: Project and Modification Services

2.5 Category 5: Specialized Technical Services

2.6 Category 6: Emergency and On-Call Services

2.7 Category 7: Specialized Facility Services

3.0 GENERAL REQUIREMENTS APPLICABLE TO ALL TASK ORDERS

3.1 Contractor Qualifications and Capabilities

3.2 Personnel Requirements

3.3 Security and Access

3.4 Safety, Health, and Environmental Compliance

3.5 Quality Control

3.6 Government-Furnished Property and Services

3.7 Contractor-Furnished Items

3.8 Subcontracting

4.0 TASK ORDER PROCEDURES

4.1 Task Order Issuance

4.2 Proposal Requirements

4.3 Task Order Award and Modification

4.4 Task Order Performance Period

4.5 Ordering Procedures for Common Service Types

5.0 PERFORMANCE REQUIREMENTS SUMMARY (PRS)

5.1 Purpose

5.2 Performance Surveillance Approach

5.3 Remedies and Corrective Action Framework

5.4 Performance Tier Definitions

5.5 Performance Requirements and Standards

5.5.1 Tier 1 – Mission-Critical Performance Requirements

5.5.2 Tier 2 & Tier 3 – High & Routine Performance Requirements

6.0 STANDARD TERMS AND CONDITIONS

6.1 Applicable Contract Clauses

6.2 Performance Monitoring and Evaluation

6.3 Invoicing and Payment

6.4 Warranties

6.5 Insurance Requirements and Regulatory Compliance

6.6 Compliance with Federal, State, and Local Regulatory Requirements

6.7 Intellectual Property and Data Rights

6.8 Disputes and Claims

7.0 STANDARD DELIVERABLES AND REPORTING

7.1 Management and Administrative

7.2 Operations and Maintenance (O&M Task Orders)

7.3 Technical Reports and Documentation

7.4 Specialized Deliverables (As Specified in Task Order)

7.5 Submission Requirements

8.0 PLACE OF PERFORMANCE

8.1 Primary Location

8.2 Additional Locations

8.3 Site Access and Logistics

9.0 CONTRACT ADMINISTRATION

9.1 Key Government Personnel

9.2 Contractor Key Contacts

9.3 Communication Protocols

9.4 Meetings and Conferences

10.0 TRANSITION REQUIREMENTS

10.1 Phase-In / Transition-In

10.2 Phase-Out / Transition-Out

11.0 ORDERING PERIOD

11.1 Contract Ordering Period

11.2 Pricing Orders Across Ordering Periods

11.3 Effect on Task Orders

12.0 PRICING AND COST STRUCTURE

12.1 Pricing Structure

12.2 Task Order Pricing Methods

13.0 ACRONYMS AND DEFINITIONS

13.1 Acronyms

13.2 Key Definitions

14.0 APPLICABLE DOCUMENTS AND STANDARDS

14.1 Regulatory and Code Compliance

14.2 Reference Documents

APPENDICES

Appendix A: Facility Maps and Layouts Appendix B: Equipment Lists (Representative) Appendix C: Labor Category Descriptions Appendix D: Sample Task Order Format

1.0 PURPOSE AND SCOPE

1.1 Contract Overview

This Performance Work Statement (PWS) establishes an Indefinite Delivery, Indefinite Quantity (IDIQ) contract vehicle for operations and maintenance (O&M) support services at the U.S. Food and Drug Administration's (FDA) Muirkirk Road Complex (MRC) in Laurel, Maryland.

The Government will order services as needed through individual task orders issued under this IDIQ contract in accordance with FAR 16.505. This PWS describes the types of services available for ordering and establishes the general requirements, qualifications, and terms applicable to all task orders.

1.2 Contract Type

This is an IDIQ contract with:

• Minimum Guarantee:1,000,000 in services over the 5-year ordering period and the first order will meet the guaranteed minimum. The Government guarantees to order at least $

• Maximum Contract Ceiling:49,000,000 over the 5-year ordering period without bilateral contract modification Total orders shall not exceed $

• Task Order Types: Fixed-price, time-and-materials, or labor-hour as specified in individual task orders

• Ordering Period: 5 years from date of IDIQ contract award

1.3 Facility Description

The FDA Muirkirk Road Complex (MRC) is a 198-acre, Government-owned campus consisting of approximately 432,000 square feet of research laboratory space located in Laurel, Maryland. The facility includes:

Module I (8301 Muirkirk Road)

• 246,853 gross square feet

• Built 1984, dedicated 1990

• Houses Human Foods Program (HFP) and Office of Inspections and Investigations

(OII)

• AAALAC-accredited animal research facility

• BSL-1, BSL-2, and BSL-3 laboratories

Module II (8401 Muirkirk Road)

• 100,406 gross square feet across 18 buildings

• Center for Veterinary Medicine (CVM)

• AAALAC-accredited

• Animal testing and research facilities

Beltsville Research Facility (8501 Muirkirk Road)

• 35,061 gross square feet

• Operational since 1964, renovated 2014

• CVM research programs

• Includes mechanical, storage, maintenance, and hazmat processing buildings

The facilities support mission-critical pharmaceutical, toxicology, veterinary medicine, and food safety research requiring continuous operations, specialized environmental controls, and regulatory compliance.

2.0 SERVICE CATEGORIES AVAILABLE FOR TASK ORDER

The Contractor shall be prepared to provide the following categories of services when ordered by the Government. Each task order will specify the exact scope, performance period, deliverables, and pricing structure for the services ordered.

2.1 Category 1: Routine Operations and Maintenance (O&M)

Continuous, comprehensive facility operations and maintenance services including:

Building Systems:

• HVACR systems operation, maintenance, and repair

• Electrical distribution systems and emergency power

• Plumbing and domestic water systems

• Fire protection and life safety systems

• Building envelope maintenance

• Interior and exterior maintenance

Utility Systems:

• Steam generation and distribution (boiler plant operations - 24/7/365)

• Chilled water production and distribution

• Compressed air systems

• Natural gas and fuel oil systems

• High-purity water systems (RO, DI, distilled)

Specialized Systems:

• Laboratory gas distribution (oxygen, nitrogen, nitrous oxide, argon, vacuum)

• Building Automation Systems (BAS) and controls

• Animal support equipment and environmental controls

• Laboratory safety equipment: Biosafety cabinets (Class I, II, III), fume hoods, autoclaves and sterilizers (including those serving BSL-3 suites), cage washers and wash-down stations. Maintenance shall include HEPA filter testing and replacement, airflow verification, and certification in accordance with NSF/ANSI standards and manufacturer recommendations.

• Biosafety systems and cleanrooms

• Humidification and air quality control systems

Service Characteristics:

• 24/7/365 coverage with on-site personnel

• Preventive maintenance programs

• Emergency response capability

• Regulatory compliance maintenance

• Equipment lifecycle management

2.2 Category 2: Preventive Maintenance Programs

Scheduled, proactive maintenance services designed to optimize equipment performance and extend asset life:

• Development and execution of PM schedules per manufacturer specifications, GSA standards, and applicable codes

• Inspections, testing, calibration, and certification services

• Consumables replacement (filters, belts, lubricants, etc.)

• Performance trending and predictive maintenance

• Documentation and reporting

Services may be ordered:

• As standalone PM-only contracts for specific systems

• As components of comprehensive O&M task orders

• On scheduled or on-call basis

2.3 Category 3: Repair and Restoration Services

Corrective maintenance and repair services including:

Minor Repairs:

• Service calls for equipment malfunctions

• Component replacement and adjustment

• Troubleshooting and diagnostics

• Routine repair work (typically <$5,000 per incident)

Major Repairs:

• Equipment overhauls and rebuilds

• System restoration following failures

• Emergency repairs requiring specialized expertise

• Complex, multi-trade repair projects

Repair Types:

• Time-and-materials

• Fixed-price for defined scope

• Emergency call-out services

2.4 Category 4: Project and Modification Services

Capital improvements, renovations, and facility modifications:

• System upgrades and modernizations

• Equipment replacement projects

• Facility modifications and alterations

• Energy efficiency improvement projects

• Code compliance upgrades

• Integration of new systems with existing infrastructure

Each project task order will include:

• Detailed scope of work and specifications

• Design requirements (if applicable)

• Construction/installation schedules

• Testing and commissioning requirements

• As-built documentation

2.5 Category 5: Specialized Technical Services

Expert services requiring specialized qualifications:

Engineering Services:

• System assessments and condition surveys

• Energy audits and conservation studies

• Failure analysis and root cause investigations

• Forensic investigations

• Life-cycle cost analyses

• Capacity studies

Testing and Certification:

• NETA electrical testing

• Eddy current tube testing

• Thermographic inspections

• Air balance (TAB) services

• Water treatment analysis

• Legionella testing programs

• AAALAC compliance testing

Environmental Services:

• Environmental monitoring and reporting

• Waste management support

• Regulatory compliance assistance

• Spill response and remediation support

• Testing, Adjusting, and Balancing (TAB): Comprehensive TAB services for HVAC systems, particularly for AAALAC-accredited areas including BSL-1/2/3 laboratories, animal housing, vivarium spaces, equipment rooms, and critical environmental areas.

Services include initial TAB for new systems, annual recertification, and TAB following system modifications or prior to AAALAC inspections. All work shall conform to manufacturer specifications and Associated Air Balance Council (AABC) National Standards.

2.6 Category 6: Emergency and On-Call Services

Rapid response services for urgent situations:

• Emergency repair response (1-hour callback)

• After-hours emergency services

• System failure emergency stabilization

• Natural disaster response

• Backup and temporary system support

• Emergency equipment rentals

2.7 Category 7: Specialized Facility Services

Grounds and Site Services:

• Snow and ice removal

• Grounds maintenance

• Tree removal and landscaping

• Parking lot maintenance

• Site utilities maintenance

Building Services:

• Mechanical room cleaning

• Equipment room maintenance

• Specialized cleaning services

• Waste handling support

3.0 GENERAL REQUIREMENTS APPLICABLE TO ALL TASK

ORDERS

3.1 Contractor Qualifications and Capabilities

The Contractor shall demonstrate and maintain throughout the contract period:

Corporate Qualifications:

• Minimum 5 years' experience in comprehensive facility O&M for research/laboratory facilities

• Experience with AAALAC-accredited facilities (preferred)

• Experience with biosafety level laboratories (BSL-2/BSL-3 preferred)

• Proven track record with Federal Government contracts

• Financial stability and adequate bonding capacity

Technical Capabilities:

• Qualified workforce across all required trades and disciplines

• Access to specialized equipment and instrumentation

• Established vendor relationships for parts and materials

• Quality control and safety management programs

• 24/7/365 emergency response capability

Regulatory Compliance:

• Knowledge of applicable FDA, OSHA, EPA, NFPA, ASME, ASHRAE standards

• Understanding of Good Laboratory Practices (GLP)

• Familiarity with animal care regulations and AAALAC requirements

• Environmental compliance expertise

3.2 Personnel Requirements

Minimum Personnel Standards:

All Contractor personnel shall meet the following minimum requirements:

Qualifications:

• Appropriate trade licenses, certifications, and credentials for assigned work

• Minimum experience levels as specified in individual task orders

• Ability to obtain and maintain required security clearances

• Medical clearance for work in animal facilities (as applicable)

• English language proficiency

Key Personnel:

Task orders requiring continuous on-site presence shall designate Key Personnel positions per HHSAR 352.237-75. Typical Key Personnel may include:

• Project Manager,

• Assistant Project Manager,

• Chief Engineer,

• Stationary Engineers,

• High Voltage Electrician,

• Building Automation System (BAS) Controls Technician, and

• Office Administrator.

Key Personnel substitutions require Government approval per contract clause.

Training Requirements:

• OSHA safety training appropriate to assigned work

• FDA site-specific orientation and security training

• Asbestos awareness training

• Confined space entry (as applicable)

• Bloodborne pathogen awareness (as applicable)

• IT security awareness (for GFE users)

3.3 Security and Access

Clearance Requirements:

• All personnel requiring facility access must undergo FDA background investigation

• PIV card issuance per HSPD-12

• Compliance with FDA security policies and procedures

• Visitor management and escort procedures as specified

Facility Access:

• Access limited to areas necessary for task order performance

• Escort requirements for sensitive areas (BSL-3 labs, vivarium areas, server rooms)

• After-hours access procedures

• Key control and accountability

3.4 Safety, Health, and Environmental Compliance

General Safety Requirements:

Contractor shall comply with all applicable safety regulations including:

• OSHA 29 CFR 1910 (General Industry)

• OSHA 29 CFR 1926 (Construction, as applicable)

• EPA 40 CFR (Environmental regulations)

• FDA site-specific safety requirements

• State and local safety codes

Required Safety Programs:

Task orders requiring on-site work shall include:

• Site-Specific Safety Plan

• Confined Space Entry Program (if applicable)

• Lockout/Tagout (LOTO) procedures

• Hazard Communication Program

• Personal Protective Equipment (PPE) Program

• Emergency Response procedures

• Incident Reporting procedures

Environmental Compliance:

• Proper handling and disposal of hazardous materials

• Waste stream segregation and management

• Spill prevention and response

• Air quality protection

• Water quality management

3.5 Quality Control

Quality Requirements:

All work shall meet or exceed:

• Manufacturer specifications and recommendations

• Industry best practices and standards

• Applicable codes and regulations

• Government acceptance criteria

Quality Control Plan:

Task orders may require submission of a Quality Control Plan including:

• Inspection procedures and frequency

• Quality control personnel and organization

• Acceptance criteria and testing methods

• Deficiency identification and correction procedures

• Documentation and recordkeeping

Government Quality Assurance:

The Government reserves the right to:

• Conduct inspections at any time

• Reject non-conforming work

• Require re-performance at Contractor expense

• Evaluate Contractor performance

3.6 Government-Furnished Property and Services

Typical Government-Furnished Items (Task order specific):

• Facility access and workspace

• Utilities (electric, gas, water, telecom)

• Government equipment and systems requiring maintenance

• Existing drawings, manuals, and technical documentation

• Government computers and IT access (for designated personnel)

• Protective equipment for restricted areas (e.g., animal facility PPE)

Contractor Responsibilities:

• Proper care and use of Government property

• Reporting of damages or deficiencies

• Return of GFP at task order completion

• Compliance with Government property management procedures

3.7 Contractor-Furnished Items

Contractor shall provide (unless otherwise specified in task order):

• All labor, supervision, and management

• Tools, equipment, and instrumentation

• Consumable materials and supplies

• Vehicles for on-site transportation (if required)

• Uniforms and company-provided PPE

• Administrative supplies and IT equipment (except GFE)

• Off-site facilities for storage, staging, or fabrication

3.8 Subcontracting

Subcontracting Policy:

• Subcontracting is permitted with Government consent

• Prime contractor remains fully responsible for all subcontractor performance

• Subcontractors must meet all requirements applicable to prime contractor

• Government reserves right to approve/reject subcontractors

4.0 TASK ORDER PROCEDURES

4.1 Task Order Issuance

Ordering Authority:

Task orders shall be issued by the Contracting Officer or authorized Ordering Officer in accordance with FAR 16.505.

Task Order Format:

Each task order shall include:

• 1. Task Order Number

• 2. Performance Work Statement (specific to the task order)

• 3. Performance Period and schedule

• 4. Place of performance

• 5. Deliverables and acceptance criteria

• 6. Government-furnished property/services (if any)

• 7. Pricing structure (FFP, T&M, or LH)

• 8. Contract Line Item Numbers (CLINs)

• 9. Price, estimated price, or not-to-exceed (NTE) value

• 10. Any task-order-specific clauses or requirements

Ordering Methods:

• Negotiated Task Orders: Selected task orders may be negotiated

• Direct Task Orders: May be issued directly for specialized or time-sensitive requirements

• Urgent Requirements: Expedited ordering procedures for emergencies

4.2 Proposal Requirements

When a task order requires a proposal, the Contractor shall submit:

Technical Proposal:

• Understanding of requirements

• Technical approach and methodology

• Personnel qualifications (resume for Key Personnel)

• Management approach

• Quality control procedures

• Schedule and milestones

• Risk mitigation strategies

Price Proposal:

• Detailed cost breakdown by CLIN

• Labor rates and hours by category

• Materials and equipment costs

• Subcontractor costs (if any)

• Overhead and profit breakdown

• Basis of estimate (BOE)

• Cost or pricing data (if required)

Submission Deadlines:

• Proposals due per task order request

• Standard: 10 business days (routine task orders)

• Expedited: 3-5 business days (urgent requirements)

• Emergency: Same-day response capability

4.3 Task Order Award and Modification

Award Process:

• Government evaluation of proposal

• Discussions/negotiations (if required)

• Best value determination

• Task order award notification

• Post-award conference (if applicable)

Task Order Modifications:

Modifications to existing task orders may be issued for:

• Scope changes

• Period of performance extensions

• Price adjustments

• Administrative corrections

Note: Significant scope increases may require new task order.

4.4 Task Order Performance Period

Period Limits:

• Task orders may be issued at any time during the 5-year IDIQ ordering period

• Individual task order performance periods may extend beyond the IDIQ ordering period for services already ordered

• No restriction on task order performance period length, subject to appropriations

Types of Task Orders:

• Short-term: Days to weeks (emergency repairs, specialized services)

• Moderate-term: Months (project work, seasonal services)

• Long-term: 1-2 years (annual recurring services)

• Multi-year: 3-5 years (continuous O&M, spanning most of IDIQ period)

4.5 Ordering Procedures for Common Service Types

Routine O&M Task Orders:

• Typically annual recurring task orders with option periods

• Fixed monthly or annual pricing

• Detailed PWS included in task order

• Key Personnel designations required

• Government right to reduce or discontinue services with notice

Emergency Services:

• Verbal authorization by CO for life-safety emergencies

• Written confirmation within 24 hours

• Immediate response required (typically 1 hour)

• Time-and-materials or labor-hour pricing

• Documentation of emergency conditions required

Repair Services:

• May be ordered via:

- Standing repair task order with NTE ceiling

- Individual repair task orders

- As part of comprehensive O&M task order

• Contractor provides quote for repairs >$2,500

• Government approval required before commencing work

Project Services:

• Formal RFTOP process for task orders >$2,500

• May require separate design services task order

• Detailed specifications and drawings

• Fixed-price preferred

• Warranty requirements

5.0 PERFORMANCE REQUIREMENTS SUMMARY (PRS)

This Performance Requirements Summary (PRS) establishes the minimum performance expectations for services ordered under this Indefinite Delivery, Indefinite Quantity (IDIQ) contract. The PRS provides a standardized framework for measuring contractor performance across Task Orders (TOs), ensuring that service delivery supports the continuous, safe, compliant, and mission-critical operations of the FDA Muirkirk Road Complex (MRC). Task Orders may refine, tailor, or supplement the performance standards in this PRS to address specific requirements.

5.1 Purpose

The PRS:

• Establishes performance objectives, standards, and acceptable quality levels (AQLs) for key services ordered under the IDIQ.

• Ensures consistent oversight and evaluation across Task Orders.

• Supports transparent and fair performance monitoring, recognition of strong performance, and corrective action when required.

• Provides a common reference for the Government, Contractor, Contracting Officer’s Representative (COR), and technical stakeholders.

5.2 Performance Surveillance Approach

The Government will use a Balanced Surveillance approach, including scheduled and unscheduled inspections, performance data reviews, customer feedback, and trend analysis.

5.3 Remedies and Corrective Action Framework

If performance does not meet AQLs, the Government may initiate corrective actions, require contractor Improvement Plans, or pursue remedies per contract clauses.

5.4 Performance Tier Definitions

Performance requirements in this PRS are organized into three tiers based on the level of mission risk associated with service performance.

The higher the tier, the more critical the service is to safety, animal welfare, regulatory compliance, and research continuity.

Tier Tier Name Definition / Expectation Examples

Tier 1 – Mission Critical

Highest importance

Services essential to life safety, regulatory compliance, animal welfare, or critical research continuity. Failures have immediate mission, safety, or compliance impact. Strictest AQLs apply.

Boiler & steam plant operations; HVAC & environmental control for labs/vivarium; BAS;

electrical & backup power; life safety systems; animal facility support systems

Tier 2 – High Significant importance

Services that impact facility operations, research efficiency, or regulatory readiness. Failures may inconvenience operations or increase risk if not corrected promptly.

Corrective maintenance; PM for non-critical systems; waste handling support; engineering studies

Tier 3 – Routine

Standard importance

Services that support general facility operations without direct mission or safety impact. Failures cause minimal risk and can be managed with flexibility.

Grounds, snow removal, routine service calls, non-critical cleaning

5.5 Performance Requirements and Standards

The performance standards in this section define the minimum levels of acceptable performance for services ordered under this IDIQ. Each performance objective includes a performance standard, acceptable quality level (AQL), mission impact, surveillance method, and a brief plain-language explanation to promote shared understanding. Task Orders may refine or tailor these standards to fit their specific requirements.

5.5.1 Tier 1 – Mission-Critical Performance Requirements

Performance Objective

Performance Standard AQL Mission Impact Surveillance Method

Plain Language Summary

Maintain Critical System Uptime

(HVAC, BAS,

Boilers/Steam, Electrical/EP/UPS, Systems shall operate continuously and within required parameters as defined in the TO, applicable codes, and manufacturer specifications.

≥ 99.5% uptime per system per month

Research disruption, animal welfare risk, safety hazards, and regulatory non-compliance

Automated monitoring, COR inspection, system logs, incident reports

These systems must stay running almost all the time to protect research, animals, and safety.

Performance Objective

Performance Standard AQL Mission Impact Surveillance Method

Plain Language Summary

Life Safety, Vivarium Systems)

Emergency Response for Mission-Critical Systems

Respond to emergency service calls within the following timeframes:

Response ≤ 1 hour;

Stabilization ≤ 4 hours (unless otherwise approved).

≥ 95% on-time response and stabilization

Escalating safety risk, lab shutdown, compromised research or animal welfare

COR call logs, incident reports, after-action reviews

Emergencies for critical systems must be answered fast and made safe quickly.

Tier 1 Preventive Maintenance Completion

Complete PMs according to the approved schedule to prevent system failures.

≥ 98% on-time; 100% within 15 days of due date

Increased risk of system failure or compliance breach

CMMS/Archibus data, PM logs, COR review

PMs for critical systems must almost never be late to prevent failures.

Life Safety System Compliance

Maintain full compliance with NFPA, OSHA, State/Local codes; Zero missed inspection intervals.

100% completion by due date

Immediate life safety and liability risk

Inspection reports, compliance audits, COR inspection

Fire and safety systems must always be inspected and compliant.

Animal Facility Environmental & Equipment Support

Maintain vivarium environmental conditions (temp, humidity, airflow, cleanliness) per AAALAC and TO standards.

99% compliance;

0 repeat deviations

Animal welfare harm, AAALAC findings, research impact

BAS logs, environmental monitoring, facility reports

Conditions for research animals must be in required ranges to protect health and accreditation.

Critical System Notifications & Reporting

Notify COR immediately of critical system failures;

written report required within 24 hours.

100% compliance

Delayed response increases mission and safety risk

Incident reports, communication logs

Critical failures must be reported right away and documented quickly.

5.5.2 Tier 2 & Tier 3 – High & Routine Performance Requirements

Performance Objective

Performance Standard AQL Mission Impact Surveillance Method

Plain Language Summary

Non-Critical System Uptime

Maintain continuous operation of systems per TO requirements.

≥ 97% uptime per month

Facility disruptions, increased workload, reduced efficiency

System reports, COR inspection

These systems should run reliably with occasional acceptable downtime.

Routine Service Call Response

Respond within TO-defined timelines (typical: 4 hours).

≥ 90% on-time resolution

User frustration, delayed work, minor disruptions

Service tickets, feedback surveys

Non-urgent issues should still be handled in a timely manner.

Tier 2 & 3 PM Completion

Complete PM tasks per approved schedule.

≥ 95% on-time; 100% within 30 days

Increased likelihood of breakdowns over time

PM logs, CMMS data

PMs keep equipment working well and should be done mostly on time.

Deliverables & Reports

Submit accurate, complete, timely deliverables per TO requirements.

100% on-time; max 1 resubmission per quarter

Delays in decision-making, delayed payments, admin burdens

Document reviews, COR acceptance

Reports must be accurate and submitted when due.

Customer Service & Communication

Maintain professional communication; respond to inquiries within 1 business day.

95% positive feedback

Reduced trust and satisfaction

Surveys, COR feedback

Communicate clearly, professionally, and quickly.

6.0 STANDARD TERMS AND CONDITIONS

6.1 Applicable Contract Clauses

All task orders issued under this IDIQ contract shall incorporate by reference:

• FAR clauses incorporated in base IDIQ contract

• HHSAR clauses incorporated in base IDIQ contract

• Any task-order-specific clauses identified in the task order

6.2 Performance Monitoring and Evaluation

Performance Assessment:

• Government will monitor and evaluate Contractor performance

• Performance may be documented in Contractor Performance Assessment Reporting System (CPARS)

• Past performance on IDIQ task orders may affect future task order awards

Performance Metrics:

Task orders may include specific performance metrics such as:

• Response times

• System uptime/availability

• Preventive maintenance completion rates

• Customer satisfaction scores

• Safety record

• Quality deficiency rates

6.3 Invoicing and Payment

Standard Payment Terms:

• Monthly invoicing typical for recurring services

• Progress payments for project work , as applicable and negotiated at the task order level

• Final invoice due within 30 days of task order completion

Invoice Requirements:

• Submitted via Government electronic invoicing system

• Proper backup documentation required

• Labor hours by category (T&M/LH task orders)

• Materials receipts and invoices

• Compliance with prompt payment requirements

6.4 Warranties

Standard Warranties:

• Labor: Minimum 1 year on all installation and repair work

• Materials: Manufacturer's standard warranty (pass-through)

• Equipment: Per manufacturer or as specified in task order

Extended Warranties:

May be required for:

• Major equipment replacements

• System installations

• Renovation/construction projects

• Specialized equipment

6.5 Insurance Requirements and Regulatory Compliance

The Contractor shall, at its own expense, obtain and maintain all insurance necessary to protect the Government’s interests and to support safe performance of Operations & Maintenance (O&M) services under this IDIQ and any issued Task Orders. Insurance shall meet or exceed the minimum requirements established by applicable Federal, State, and local laws, regulations, and the Federal Acquisition Regulation (FAR) Part 28.

At a minimum, the Contractor shall maintain the following insurance coverage for the duration of the contract and any exercised option periods:

• Workers’ Compensation and Employer’s Liability Insurance, As required by Federal and State statutes covering all employees engaged in the performance of work under this contract, including subcontractor personnel.

• Commercial General Liability Insurance, Covering bodily injury (including injury to Government personnel), personal injury, property damage, completed operations, and contractual liability. Coverage shall apply to all O&M activities performed in Government-occupied buildings or on Government property.

• Automobile Liability Insurance, Covering all owned, hired, leased, and non-owned vehicles used in performance of services under this contract.

• Pollution / Environmental Liability Insurance (as applicable), Required when performing work involving hazardous materials, asbestos, refrigerants, chemicals, fuel systems, or environmental waste handling or transport.

• Professional Liability / Errors and Omissions Insurance, Required when the Contractor performs engineering, design, testing, commissioning, or other technical professional services.

• Additional Task-Order–Specific Insurance, The Government may require additional insurance (e.g., boiler & machinery insurance, cyber liability for BAS or OT systems, laboratory contamination coverage) when dictated by the nature of the work.

The Government reserves the right to review and approve insurance coverage, limits, and carriers to ensure compliance with contract requirements. Upon request, the Contractor shall provide certificates of insurance to the Contracting Officer (CO) and shall notify the CO in writing at least thirty (30) calendar days prior to cancellation or material change in coverage.

6.6 Compliance with Federal, State, and Local Regulatory Requirements

The Contractor shall comply with all applicable Federal, State, territorial, Tribal, and local laws, codes, ordinances, regulations, directives, and industry standards governing performance of O&M services at Government facilities. This includes, but is not limited to:

• Occupational Safety and Health Administration (OSHA) and State OSHA requirements

• National Fire Protection Association (NFPA) codes and standards

• Environmental Protection Agency (EPA) and State environmental regulations

• Local jurisdiction facility, mechanical, electrical, boiler, plumbing, and building codes

• U.S. Department of Transportation (DOT) regulations for transport of hazardous materials

• Required professional trade certifications/licensing (e.g., stationary engineers, electrical, HVAC, water treatment, boiler operators)

• Applicable laboratory biosafety, chemical hygiene, radiation safety, and hazardous waste regulations, where relevant

Energy Management:

The Contractor shall implement energy conservation measures and practices in accordance with applicable federal energy management requirements including Agency initiatives and applicable Executive Orders. Contractor shall identify opportunities for energy savings, recommend efficiency improvements, and operate systems in an energy-conscious manner while maintaining required environmental conditions for research operations. Task orders may require periodic reporting on conservation activities and recommendations.

The Contractor is responsible for obtaining and maintaining all required licenses, permits, registrations, and certifications for personnel, equipment, and work activities. All required credentials shall be current, valid, and verifiable prior to personnel performing work.

The Contractor shall ensure:

• Personnel maintain qualifications required by Federal, State, and local law to operate equipment such as boilers, chillers, pressure vessels, generators, fuel systems, and Building Automation Systems (BAS).

• Subcontractors meet the same standards and regulatory requirements required of the prime Contractor.

• All work, including emergency and after-hours work, is performed by fully qualified and appropriately licensed personnel.

Failure to maintain insurance or regulatory compliance may result in suspension of work, withholding of payment, task order termination, or other remedies available to the Government.

6.7 Intellectual Property and Data Rights

Deliverables:

All deliverables produced under task orders become Government property:

• Reports, studies, and analyses

• Drawings and specifications

• Operating procedures and manuals

• Inspection and test records

• Electronic data and files

Pre-existing Materials:

Contractor may use proprietary methods, tools, and materials but shall grant Government:

• License to use deliverables

• Rights to reproduce for Government purposes

• Access to data for verification and validation

6.8 Disputes and Claims

Disputes shall be resolved per:

• FAR 52.233-1 Disputes

• Contract Disputes Act

• Agency-level resolution procedures

Contractor shall continue performance during dispute resolution unless directed otherwise.

7.0 STANDARD DELIVERABLES AND REPORTING

Task orders shall specify required deliverables. Common deliverables include:

7.1 Management and Administrative

• Task Order Management Plan - Due 10 days after task order award (for complex task orders)

• Progress Reports - Monthly or as specified

• As-built Drawings - For project work, due at completion

• Closeout Report - Within 30 days of task order completion

• Transition Documentation - For recurring services, at contract end

7.2 Operations and Maintenance (O&M Task Orders)

• O&M Work Management Plan - Initial and annual updates

• Preventive Maintenance Schedules - Initial and as revised

• Daily/Weekly Operations Logs - Continuous

• Monthly Status Reports - By 10th of following month

• Equipment Inventory - Initial and annual updates

• Deficiency Reports - As identified

• Emergency Response Reports - Within 24 hours

7.3 Technical Reports and Documentation

• Inspection Reports - Per schedule or as required

• Test Results - Upon completion of testing

• Calibration Records - Upon completion

• Safety Inspection Reports - Per OSHA/safety plan requirements

• Incident Reports - Immediate notification + written report within 24 hours

• Energy Conservation Reports - Quarterly (if applicable)

7.4 Specialized Deliverables (As Specified in Task Order)

• Engineering studies and reports

• Condition assessment reports

• Life-cycle cost analyses

• Failure analysis reports

• Water treatment analysis results

• Environmental monitoring reports

• Training completion certificates

• Warranty documentation

7.5 Submission Requirements

Standard Formats:

• Electronic submission in PDF format (unless otherwise specified)

• Submitted via Government SharePoint, email, or designated system

• Naming convention per Government standards

• Version control for updated documents

Review and Approval:

• Government review within 30 days of submission

• Contractor resubmission of rejected deliverables within 15 days

• Final acceptance by Contracting Officer's Representative (COR) or designated official

8.0 PLACE OF PERFORMANCE

8.1 Primary Location

FDA Muirkirk Road Complex

8301, 8401, and 8501 Muirkirk Road

Laurel, Maryland 20708

8.2 Additional Locations

Task orders may require work at:

• Off-site testing facilities (for specialized testing)

• Vendor facilities (for equipment fabrication/testing)

• Training locations

• Other FDA facilities (if task order specifies)

8.3 Site Access and Logistics

Normal Operating Hours:

Monday - Friday, 6:00 AM - 6:00 PM ET

24/7 Facility Operations:

Research and animal care operations continue around-the-clock. Task orders requiring continuous presence or after-hours access will specify requirements.

1.3.1 Unique Facility Considerations

Maintenance and operations at MRC must account for specialized requirements including:

(1) coordination with ongoing research protocols to minimize disruption, (2) strict adherence to contamination control procedures, (3) compliance with animal welfare requirements, (4) maintenance of critical environmental parameters (temperature, humidity, pressure differentials), and (5) specialized training for work in biosafety and animal care areas. All work shall be performed to ensure minimal disruption to research operations and animal welfare activities.

Parking and Transportation:

• On-site parking available

• Contractor vehicles permitted

• Site speed limits and traffic rules apply

• Loading dock access coordination required

9.0 CONTRACT ADMINISTRATION

9.1 Key Government Personnel

Contracting Officer (CO):

• Overall contract authority

• IDIQ contract modifications

• Task order awards (or designation of ordering officers)

• Final decision authority

Ordering Officer(s):

• Authority to issue task orders within delegated limits

• Task order negotiations and modifications

• Designated per warranted authority

Contracting Officer's Representative (COR):

• Technical oversight of task order performance

• Acceptance of deliverables

• Performance monitoring

• Designated per individual task order

9.2 Contractor Key Contacts

Contractor shall designate:

• Corporate Contract Manager - IDIQ contract administration

• Task Order Managers - Per individual task order

• Emergency Contact - 24/7 availability

9.3 Communication Protocols

Routine Communications:

• Email preferred for non-urgent matters

• Scheduled meetings (weekly/monthly per task order)

• Progress reports and status updates

Urgent Communications:

• Phone contact for urgent issues

• Emergency hotline (if applicable)

• Immediate notification requirements (safety, security)

Formal Communications:

• Contract modifications - via CO

• Task order awards - via CO or ordering officer

• Disputes and claims - per FAR procedures

9.4 Meetings and Conferences

Post-Award Conference:

• Within 30 days of IDIQ award

• Discuss contract administration procedures

• Clarify roles and responsibilities

Task Order Kickoff Meetings:

• Within 10 days of task order award (for significant task orders)

• Review task order requirements

• Establish communication protocols

Periodic Reviews:

• As specified in task orders

• Typically monthly or quarterly for long-term task orders

10.0 TRANSITION REQUIREMENTS

10.1 Phase-In / Transition-In

For task orders requiring transition from incumbent contractor:

Transition Period:

• Duration:15-30 days typical, as specified in task order

• May be concurrent with incumbent or sequential

Transition Activities:

• Knowledge transfer from incumbent

• Review of facility systems and documentation

• Staff hiring and training

• Security clearance processing

• Equipment procurement and staging

• Development of operating procedures

• Demonstration of capability

Transition Deliverables:

• Transition Plan (due 10 days after task order award)

• Staffing plan and personnel qualifications

• Readiness certification

• Final transition report

10.2 Phase-Out / Transition-Out

At task order completion or termination:

Transition-Out Period:

• 15-30 days prior to task order end

• Cooperation with successor contractor

Transition-Out Activities:

• Documentation turnover

• Knowledge transfer to successor

• GFP inventory and return

• Final inspections

• System condition documentation

• Spare parts inventory transfer

Transition-Out Deliverables:

• Transition-out plan (120 days prior to end)

• Final equipment inventory and condition report

• All contract-generated documentation

• Final closeout report

11.0 ORDERING PERIOD

11.1 Contract Ordering Period

This IDIQ contract has a single 5-year ordering period from date of contract award.

Note: Individual task orders issued during the ordering period may have performance periods that extend beyond the 5-year ordering period for services already ordered.

11.2 Pricing Orders Across Ordering Periods

Labor rates used for task orders may cross ordering periods if the task order period of performance crosses ordering periods.

11.3 Effect on Task Orders

Task Order Timing:

• Task orders may be issued at any time during the 5-year ordering period

• Performance periods for individual task orders are specified in each task order

• Task order performance periods may extend beyond the IDIQ ordering period

• Long-term task orders (e.g., multi-year O&M services) may be issued during the ordering period

Example: A 3-year continuous O&M task order issued in Year 4 of the IDIQ ordering period would have a performance period extending 2 years beyond the IDIQ ordering period end date.

12.0 PRICING AND COST STRUCTURE

12.1 Pricing Structure

IDIQ Contract Pricing:

The IDIQ contract shall establish ceiling rates for labor categories and pricing mechanisms for task orders:

Labor Hour Rates (Ceiling Rates):

Contractor shall propose fully-burdened hourly rates by labor category for time-and-materials and labor-hour task orders:

• Licensed Stationary Engineer (First Class)

• Licensed Electrician (Journeyman/Master)

• HVAC Mechanic (Journeyman)

• Plumber (Journeyman)

• Controls Technician

• General Mechanic

• Laborer

• Project Manager

• Engineer

• [Additional categories as required]

Material Handling:

• Cost plus [___]% markup (T&M task orders)

• Or: Materials at cost (no markup)

Equipment:

• Cost plus [___]% markup

• Or: Equipment at cost (no markup)

12.2 Task Order Pricing Methods

Fixed Price:

Firm-fixed-price for well-defined scope:

• Preventive maintenance programs

• Specific repair projects

• Installation projects

• Recurring monthly services

Time and Materials (T&M):

For work where scope cannot be precisely defined:

• Emergency repairs

• Troubleshooting and diagnostics

• General labor support

• Variable-scope repair work

Labor Hour (LH):

For professional services where materials are minimal:

• Engineering studies

• Technical consulting

• Training services

• Inspection services

13.0 ACRONYMS AND DEFINITIONS

13.1 Acronyms

• AAALAC - Association for Assessment and Accreditation of Laboratory Animal Care

• ASHRAE - American Society of Heating, Refrigerating and Air-Conditioning Engineers

• ASME - American Society of Mechanical Engineers

• BAS - Building Automation System

• BSL - Biosafety Level

• CFR - Code of Federal Regulations

• CLIN - Contract Line Item Number

• CO - Contracting Officer

• COR - Contracting Officer's Representative

• CPARS - Contractor Performance Assessment Reporting System

• CVM - Center for Veterinary Medicine

• DI - Deionized (water)

• EPA - Environmental Protection Agency (or Economic Price Adjustment)

• FAR - Federal Acquisition Regulation

• FDA - Food and Drug Administration

• FFP - Firm Fixed Price

• FTE - Full-Time Equivalent

• GFE - Government Furnished Equipment

• GFP - Government Furnished Property

• HFP - Human Foods Program

• HHSAR - Health and Human Services Acquisition Regulation

• HVAC - Heating, Ventilation, and Air Conditioning

• HVACR - Heating, Ventilation, Air Conditioning, and Refrigeration

• IDIQ - Indefinite Delivery, Indefinite Quantity

• LH - Labor Hour

• MRC - Muirkirk Road Complex

• NETA - National Electrical Testing Association

• NFPA - National Fire Protection Association

• NTE - Not to Exceed

• O&M - Operations and Maintenance

• OII - Office of Inspections and Investigations

• OSHA - Occupational Safety and Health Administration

• PM - Preventive Maintenance

• POP - Period of Performance

• PPE - Personal Protective Equipment

• PWS - Performance Work Statement

• RO - Reverse Osmosis

• SOW - Statement of Work (general term)

• T&M - Time and Materials

• TAB - Testing, Adjusting, and Balancing

13.2 Key Definitions

Base IDIQ Contract - The overarching contract establishing terms, conditions, and pricing structure for ordering services.

Ceiling Rate - Maximum hourly rate established in IDIQ contract for each labor category.

Task orders may use lower rates but not exceed ceiling.

Contractor - The entity awarded the IDIQ contract and responsible for performance of task orders.

Deliverable - A tangible or intangible output required under a task order (reports, services, equipment, etc.).

Emergency - An unforeseen condition requiring immediate action to prevent injury, loss of life, property damage, or mission failure.

Government - The U.S. Food and Drug Administration acting on behalf of the United States Government.

Key Personnel - Contractor personnel identified in a task order as critical to performance, whose removal or substitution requires Government approval.

Minimum Guarantee - The minimum dollar value the Government commits to ordering over the contract period.

Ordering Officer - Government official with warranted authority to issue task orders under the IDIQ contract.

Ordering Period - The time during which the Government may issue task orders (typically the base and option periods).

Performance Period - The time allocated for performance of a specific task order.

Task Order - An individual order for services issued under the IDIQ contract, establishing specific scope, price, and performance period.

Task Order Manager - Contractor's designated manager responsible for a specific task order.

14.0 APPLICABLE DOCUMENTS AND STANDARDS

14.1 Regulatory and Code Compliance

Work performed under this IDIQ contract shall comply with all applicable Federal, State, and local regulations, codes, and standards, including but not limited to:

Federal Regulations:

• 21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies

• 29 CFR 1910 - OSHA General Industry Standards

• 29 CFR 1926 - OSHA Construction Standards

• 40 CFR - EPA Environmental Regulations

• FDA Staff Manual Guides (as applicable)

Industry Codes and Standards:

• NFPA Codes (National Fire Protection Association)

• ASME Codes (American Society of Mechanical Engineers)

• ASHRAE Standards and Guidelines

• NEC (National Electrical Code - NFPA 70)

• SMACNA Standards (Sheet Metal and Air Conditioning National Association)

• CTI Guidelines (Cooling Technology Institute)

• AABC Standards (Associated Air Balance Council)

Laboratory Animal Care:

• Guide for the Care and Use of Laboratory Animals (NIH/NRC)

• AAALAC International standards

• Animal Welfare Act regulations

Biosafety:

• Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH), 5th Edition or later

Other Standards:

• GSA Public Buildings Maintenance Standards Guide

• State of Maryland licensing and regulatory requirements

• Local county codes and ordinances

14.2 Reference Documents

The following documents are provided for reference and may be made available to the Contractor:

• MRC Facility Drawings (as-built drawings and schematics)

• Equipment Manuals and Technical Documentation

• Previous Inspection and Maintenance Records

• Existing Standard Operating Procedures

• Environmental Permits and Compliance Documents

APPENDICES

Appendix A: Facility Maps and Layouts

[To be provided separately]

Appendix B: Equipment Lists (Representative)

Appendix C: Labor Category Descriptions

APPENDIX C

LABOR CATEGORIES, DUTIES, AND QUALIFICATIONS

1.0 PURPOSE

This appendix defines the labor categories, duties, responsibilities, and minimum qualifications for personnel performing Operations and Maintenance (O&M) services under this Indefinite Delivery, Indefinite Quantity (IDIQ) contract and task orders issued thereunder.

The labor categories specified herein establish the minimum qualifications for:

• Key Personnel positions requiring Government approval and notification of changes

• Non-Key Personnel positions supporting task order execution

• Quality control and supervision requirements

• Minimum staffing levels by labor category

Task orders issued under this IDIQ may:

• Select applicable labor categories from this appendix

• Specify the number of personnel required in each category

• Add task-order-specific labor categories not listed herein

• Establish labor rate ceilings by category

• Define specific work schedules and coverage requirements

2.0 DEFINITIONS AND ABBREVIATIONS

2.1 Reference to IDIQ PWS Definitions

For general contract terms, acronyms, and key definitions, refer to IDIQ PWS Section 13.0 - Acronyms and Definitions, which includes:

• General contract acronyms (IDIQ, CLIN, CPARS, FFP, etc.)

• Contract-level definitions (Task Order, Ceiling Rate, Ordering Period, etc.)

• Common terms applicable across all task orders

The following definitions in Section 13.0 of the IDIQ PWS are particularly relevant to this appendix:

• Contractor - The entity awarded the IDIQ contract and responsible for performance of task orders

• Key Personnel - Contractor personnel identified in a task order as critical to performance, whose removal or substitution requires Government approval

• COR - Contracting Officer's Representative

• CO - Contracting Officer

• PWS - Performance Work Statement

• O&M - Operations and Maintenance

2.2 Labor Category-Specific Definitions and Abbreviations

The following terms are specific to labor categories and technical operations under this…