Amend_3_Performance_Work_Statement_OC-2025-130285_10_03_2025.docx

Title FDA Public Access Defibrillation (PAD) Program – Automated External Defibrillator (AED) Equipment and Maintenance Services

1.0 Purpose

The purpose of this Performance Work Statement (PWS) is to outlines the scope of services for the purchase, maintenance, certified training, and management of existing Automated External Defibrillator (AED) units and associated components at FDA facilities nationwide, as part of the FDA’s Public Access Defibrillation (PAD) Program.

2.0 Background

The FDA’s Office of Occupational Safety and Health (OOSH) oversees the PAD Program, which supports employee and visitor safety by providing and maintaining AEDs across FDA facilities nationwide.

3.0 Scope

3.1 Current In-Scope Inventory

The FDA currently maintains approximately 399 AED units, consisting of 389 HeartSine devices, 6 Cardiac Science units, and 4 of unknown brand (Note: Usage of a specific brand is not an endorsement by the FDA). These devices are deployed across 87 cities in 34 states. Note that these numbers are provided for cost estimation and are subject to change based on corrected inventory records, site needs, or program adjustments.

Each unit is supported by associated components such as wall cabinets, signs, responder kits, and maintenance tags.

In the base year, the contractor shall replace:

· 237 AED Units (59%)

· 385 AED Primary PAD PAK & Batteries (96%)

· 375 AED Secondary PAD PAK & Batteries (94%)

· 2 AED Pediatric PAD PAK & Batteries (100%) In Option Year 1, the contractor shall replace:

· 162 AED Units (41%)

· 14 AED Primary PAD PAK & Batteries (4%)

· 16 AED Secondary PAD PAK & Batteries (6%)

· 0 AED Pediatric PAD PAK & Batteries In Option Year 2, the contractor shall provide:

· AED Maintenance & Monitoring for apprx 400 units

· CPR/AED Training & Certification (class up to 10 students; for a total of 500 students)

· Transition and close-out.

3.2 Future Inventory

This contract will focus solely on the replacement, maintenance, training, and management activities necessary to support the existing program infrastructure.

3.3 In-Scope Activities

The Contractor shall provide all labor, equipment, materials, and services necessary to support the FDA PAD Program, including:

· Supply, delivery, and installation of replacement biphasic escalating waveform AED units and components (Sections 4.1 and 4.2).

· Proactive service checks, maintenance, and component replacement on existing AED units (Section 4.3).

· Maintain the AED Site Coordinator and Point of Contact List (Section 4.4).

· Training (Section 4.5).

· 24/7 technical support and post-event data retrieval (Sections 4.6 and 4.7).

· Transition support and closeout documentation (Section 4.9).

All services and equipment provided by the Contractor shall meet applicable industry, FDA, American Heart Association (AHA), Occupational Safety and Health Administration (OSHA), and Department of Transportation (DOT) requirements and best practices.

4.0 Tasks

4.1 Replacement of AED

In the base year, the contractor shall replace:

· 237 AED Units (59%)

· 385 AED Primary PAD PAK & Batteries (96%)

· 375 AED Secondary PAD PAK & Batteries (94%)

· 2 AED Pediatric PAD PAK & Batteries (100%) In Option Year 1, the contractor shall replace:

· 162 AED Units (41%)

· 14 AED Primary PAD PAK & Batteries (4%)

· 16 AED Secondary PAD PAK & Batteries (6%)

· 0 AED Pediatric PAD PAK & Batteries

Product Specifications for Replacement The Contractor shall furnish and install replacement AED units and components meeting or exceeding the following specifications:

· Replacement FDA-approved biphasic escalating waveform AED units with real-time Cardiopulmonary Resuscitation (CPR) feedback (visual and audio) and self-diagnostic capabilities.

· Integrated AED electrode pad cartridge (battery and electrode pads combined) to include, as needed:

· AED Primary PAD PAK

· AED Secondary PAD PAK

· AED Pediatric PAD PAK

· Minimum 8-year manufacturer's warranty.

· Minimum 4-year AED electrode pad life.

· Compact and portable: no larger than 4” H x 9.5” W x 11” D and no heavier than 7.5 lbs.

· AED components to include carry case, data cable, spare AED electrode pad, responder kit, cabinet with alarm (if not present or functional at a site), signage (if not present or functional at a site), and inspection/maintenance tag.

The Contractor shall ensure timely delivery and installation of AED units and components at designated FDA locations across 87 cities in 34 states. See Appendix A.

Travel is not anticipated under this contract.

All AED units, components, and materials shall be shipped or brought directly to FDA sites. The Contractor is responsible for all shipping and delivery costs and shall provide advance delivery tracking.

On-site services are required for physical service checks (see Section 4.2). Anyhipping costs shall be the responsibility of the contractor.

AED locations are listed in Appendix A.

4.2 AED Maintenance and Monitoring

The Contractor shall:

· Perform battery replacement, diagnostic inspections and physical service checks on all AED units, covering approximately 20–30% of devices each quarter to ensure 100% completion annually.

· Proactively replace expired or used AED components as part of routine maintenance and monitoring.

· Remedy device deficiencies within 24 hours of notification.

· Submit written service reports to the Contracting Officer’s Representative (COR) within 7 days.

4.3 Technical and Program Management Support

4.3.1 AED Site Coordinator List

The Contractor shall maintain an up-to-date list of approximately 400 FDA AED Site Coordinators that support the PAD Program in Archibus. This list shall include names, contact information, assigned site(s), and training certification status. The information shall be stored on a secure site provided by the Government.

The list shall be updated monthly to reflect personnel changes, training status, or new site assignments. This list will be used to support communication, scheduling, and tracking of training records for designated personnel.

4.3.2 Technical Support

The Contractor shall provide:

4.3.3 Event Data and Reporting

Following AED use and notification, the Contractor shall:

4.4 Training

The Contractor shall provide both CPR/AED training and certification at all or most of the locations listed Section 4.2.

CPR/AED training and certification shall be obtained from either the AHA or the American Red Cross (ARC).

The following approved Basic Life Support (BLS) training options:

· American Heart Association (AHA) Basic Life Support for health care providers

· AHA Advanced Cardiac Life Support (ACLS) for officers who maintain currency in another basic life support class listed in the requirements

· American Red Cross CPR/AED for the professional rescuer

· American Safety and Health Institute (ASHI) CPR and AED for healthcare providers and professional responders

· AHA Resuscitation Quality Improvement (RQI)

· Instructor certification for any of the above courses For any training not explicitly listed, pre-approval from the Surgeon General is required to ensure equivalency with the established standards.

This training includes:

· Recognition of cardiac arrest and emergency response procedures,

· Instruction and practice in delivering high-quality chest compressions and rescue breaths,

· Safe and effective use of an AED, and

· Scenario-based skills practice and evaluation Upon successful completion, participants receive a certification card, valid for two years, verifying their competence in CPR and AED.

This training shall be delivered as blended or hybrid learning, which combines online instruction with an in-person, instructor-led skills assessment session to no more than 500 FDA employees per year, with class sizes not to exceed 10 participants per session.

The Contractor shall:

· Communicate training locations, dates, and delivery methods with the COR, OOSH Office Director and Deputy Director, PAD Program Administrator, and all the AED site coordinators at least one month prior to classes occurring.

· Ensure that instructor-to-student ratios and class sizes comply with applicable standards.

· Maintain accurate training records and update the AED Site Coordinator List.

· Submit a monthly training summary to the COR and PAD Program Administrator, including participant names, course type, certification dates, and expiration dates.

4.5 Transition and Closeout

The Contractor shall support a smooth transition at contract closeout, including data handoff, reporting of all open activities, and return of any government-furnished equipment (GFE).

5.0 Security and Government Furnished Property

5.1 Government-Furnished Property (GFP) and Information

To facilitate performance under this contract, the Government will furnish certain property to designated contractor personnel. Specifically, the Government will provide the following:

· Personal Identity Verification (PIV) cards

· FDA-issued laptops These items are necessary to access FDA internal systems, email, and secure portals related to AED program management and communications. Use of this property is required for execution of contract tasks and to maintain compliance with FDA cybersecurity and records management policies.

The government will provide existing FDA-managed internal tracking systems. The internal tracking system used is Archibus. Access to these systems will be granted by the FDA upon award, subject to completion of applicable onboarding, training, and security requirements.

5.2 Timing and Conditions of Property Issuance

GFP will be provided post-award, only after contractor personnel have successfully completed background investigations and received clearance from FDA Security. The COR will coordinate property issuance and retrieval. All GFP will be provided in functional condition and suitable for use in support of contract performance.

6.0 Quality Assurance

The government will monitor contract performance through the COR using a combination of the following methods:

· Review of records for completeness and accuracy.

· Inspection of delivered equipment and service reports.

· Verification of timely component replacement and maintenance schedules.

· Evaluation of training delivery, participation, and certification outcomes.

· Review of contractor response times and issue resolution records.

Nonconforming deliverables may result in corrective action requests, invoice rejection, or contract termination.

7.0 Place and Period of Performance

Performance will occur at various U.S. Food and Drug Administration (FDA) locations across 87 cities in 34 states and U.S. territories. Specific sites for AED delivery, installation, maintenance, and training will be coordinated directly with the Government after award. Remote support may also be required, as applicable.

The period of performance will be a 12-month base period and two 12-month option periods.

8.0 Deliverables

ALP: OC-2025-130285

Attachment 1, Performance Work Statement Revised October 03, 2025

APPENDIX A

Provided as separate attachment.