Attachment_A_Perfromance_Work_Statement_OC_2025_130285.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 define the technical requirements and performance expectations to support a competitive acquisition. Specifically, this PWS outlines the scope of services for the purchase, maintenance, AHA-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 Public Access Defibrillation (PAD) Program, which supports employee and visitor safety by providing and maintaining Automated External Defibrillators (trAEDs) 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 2025, FDA intends to 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 2026, FDA intends to 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

3.2 Future Inventory

At this time, the FDA does not plan to expand the AED inventory, and 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 4.8).

All services and equipment provided by the Contractor shall meet applicable industry, FDA, AHA, OSHA, and Department of Transportation (DOT) requirements and best practices.

4.0 Requirements

4.1 AED Product Specifications

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 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 & Batteries

· AED Secondary PAD PAK & Batteries

· AED Pediatric PAD PAK & Batteries

· Minimum 8-year manufacturer's warranty.

· Minimum of 4-year battery life.

· Minimum 2-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.

4.2 Delivery and Installation

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

Travel is not anticipated under this contract.

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

If on-site services are required, the Contractor may utilize local subcontractors or service providers. All shipping and subcontractor costs shall be included in the fixed-price proposal.

State locations are:

4.3 AED Maintenance and Monitoring

The Contractor shall:

· Perform 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.

· Remedy device deficiencies within 24 hours of notification.

· Submit written service reports to the COR within 7 days.

4.4 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. This list shall include names, contact information, assigned site(s), and training certification status. This information should be maintained on a secure site with access to the COR and PAD Program Administrator.

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.

4.5 Training

The Contractor shall provide American Heart Association (AHA)-certified Cardiopulmonary Resuscitation (CPR) and AED training at all or most of the locations listed Section 3.1.

This training will be provided in accordance with the standards and guidelines established by the American Heart Association (AHA). 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 an AHA certification card, valid for two years, verifying their competence in CPR and AED use per AHA guidelines.

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 in sessions of no more than 10 people per year.

The Contractor shall:

· Coordinate training locations, dates, and delivery methods with the COR and/or FDA PAD Program Administrator.

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

4.6 Technical Support

The Contractor shall provide:

· Telephone-based technical support during business hours.

· 24/7 online support for AED device troubleshooting and software/system issues.

4.7 Event Data and Reporting

Following AED use and notification, the Contractor shall:

· Retrieve event data within 24 hours, including ECG and summary reports.

· Provide PHI-compliant access to AED data.

· Allow access to all post-event reports and data to the FDA Occupational Health Physician and PAD Program Administrator.

· Provide training on the event data tool annually, or as needed.

5.0 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.

6.0 Proposal Evaluation Criteria

Proposals will be evaluated using a best-value tradeoff methodology. Evaluation factors include:

· Technical Approach: Demonstrated understanding of the FDA PAD Program goals and execution plan.

· Past Performance: Relevant experience with Federal Government AED programs.

· Personnel Qualifications: AHA-certified instructors and experienced technical support personnel.

· Price: Reasonableness and cost realism of proposed rates and equipment.

The Government may conduct discussions or request clarifications. A technical evaluation panel (TEP) will make award recommendations to the Contracting Officer.

image1.png