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U.S. Securities and Exchange Commission

AUTOMATED EXTERNAL DEFIBRILLATORS

MEDICAL OVERSIGHT AND PROGRAM MANAGEMENT

STATEMENT OF WORK

1. BACKGROUND

The U.S. Securities and Exchange Commission (SEC) was established by Congress in 1934 to enforce the Securities Act of 1933 and the Securities Exchange Act of 1934. Detailed information about the SEC mission, activities, and office locations is published at www.SEC.gov. Central functions are housed at the SEC Headquarters in Washington, DC as well as eleven (11) regional offices locations across the United States. As part of the Commission’s commitment to the health and safety of all staff and visitors, Automated External Defibrillators (AEDs) are located in all facilities.

2. OBJECTIVES

The purpose of the contract is to provide medical oversight and program management to support the SEC’s Public Access Defibrillation (PAD) program and protect the health and safety of all building occupants and visitors.

3. SCOPE

The scope of this contract would be to provide up to five (5) years of administrative and technical oversight and program management to ensure that all of the SEC’s 88 AED devices (currently HeartSine Samaritan PAD 350p, purchased in 2016) are in proper working order, lay responders are appropriately trained and certified, and proper protocols are followed when responders assist a sudden cardiac event victim. The Vendor shall provide training and program policy documents needed to comply with all applicable federal guidelines and medical standards, as well as provide an optional means of acquiring equipment and supplies.

4. TASKS

4.1. Medical Oversight and Program Management: Vendor will provide medical oversight by an AED Medical Director who is board-certified in emergency medicine, internal medicine, occupational medicine, preventive medicine, or family practice for eighty-eight (88) devices throughout SEC facilities. The Vendor AED program will support the designated SEC AED Administrative Coordinator and SEC AED On-site Coordinators. The Vendor AED Program oversight will meet the criteria for compliance with the Department of Health and Human Services Guidelines for Public Access to Defibrillation Programs in Federal Facilities, American Heart Association (AHA) guidelines, and current medical and industry standards.

RFQ Enclosure 1

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STATEMENT OF WORK

Vendor will perform the following:

Monitor the AED literature and alert SEC Administrative Coordinators about advances and changes in AED protocols.

Provide a written prescription for each FDA-approved device that is under the oversight of the Vendor AED Program. The prescription will identify the AED serial number, location, and useful life expectancy.

Coordinate the registration of the device with local emergency medical services and manufacturers, when required by local regulations and upon SEC request

Communicate AED Program changes in writing that are required to remain in compliance with current medical and industry guidelines and standards.

Approve acceptable CPR/AED protocols for the public access defibrillator program.

Evaluate Mock Cardiac Arrest Drills and issue recommendations for improvement to ensure successful completion of this required exercise.

Collect and analyze data provided by the SEC and from the AED following a sudden cardiac arrest and provide a written Vendor AED Investigation Report.

The analysis and report will be completed by the Vendor AED Program Medical Director after any event in which responders use the AED. The report shall be issued within five (5) business days of receipt of the Event Documentation Form and AED rhythm data.

SEC Responsibility: SEC program personnel will provide routine maintenance to ensure AEDs are in working order, including the following:

Perform monthly AED checks to ensure status indicator, supplies, and expiration dates are all current and fully functional.

Provide equipment status information to the Vendor twice each year (using a checklist provided by the Vendor) in like-new condition.

Purchase/replace any AED supplies (batteries and defibrillator pads) that are expired or have been used. The Vendor may offer a unit cost for limited quantities of these supplies.

Confirm the number of devices and device serial numbers for the AEDs that are covered under the Vendor AED Program within 30 days of the beginning of each the fiscal year.

Submit completed AED Checklists to Vendor for each device covered by the Vendor AED program within 30 days of placement of a new device and then twice each fiscal year (by October 30 and April 30).

Submit information about newly acquired AEDs for which the SEC requests coverage under the Vendor AED Program within 30 days of purchase.

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4.2. Additional Equipment, Supplies and Services: Vendor will provide the following services or products on a reimbursable cost basis, unless otherwise noted:

Provide consultation about device selection (up to 5 hours/year without an additional fee).

Make available devices and supplies that the SEC can procure.

Register devices with manufacturers that are purchased by the SEC, upon request.

Consultation and guidance about the type of AED to purchase, when requested by the SEC.

4.3. Training: Lay responder training is required for compliance with federal PAD program guidelines and is critical for maximizing the potential for successful resuscitation of a sudden cardiac arrest victim.

Vendor will perform the following:

Secure a training vendor who can provide on-site American Heart Association, Red Cross, or American Safety and Health Institute classes.

Provide a date for the training class for lay responder within 2 weeks of training request receipt from the SEC.

Identify and approve suitable online training classes that can be used as a component of practice sessions.

Provide SEC feedback on customer (lay responder) satisfaction regarding training classes.

SEC Responsibility: SEC program personnel will perform the following training-related activities:

Ensure that all lay responders have CPR/AED certification from a CPR/AED training program that contains an AHA curriculum.

Provide required information for lay responder training that is obtained from a non-Vendor for approval by the Vendor AED Program Medical Director.

5. REPORTING AND DELIVERABLES

The following program documents will be provided by Vendor to the SEC AED Administrative Coordinator and SEC AED On-site Coordinators:

Standardized monthly reports, to include the following:

o Percentage of compliant devices.

o Notification when AED batteries and pads will expire within 3 months.

o Alert notification at least 6 months prior to the date when devices will exceed their useful life.

o Summary of responder certification and mock drill compliance.

AED MEDICAL OVERSIGHT AND PROGRAM MANAGEMENT Page 4 o Summary of SEC funding status

Ad-hoc customized SEC reports, upon customer request at a fee based on the AED

Program consultation rates.

Vendor AED Program Handbook (revised annually) which defines required SEC AED staff and their program responsibilities.

Site Specific protocols for each AED location.

Quality Assurance Plan.

Sudden Cardiac Arrest (SCA) event reports.

Mock Drill forms defining scenarios to be used for required annual mock drill exercises.

Vendor staff directory, including identification of an administrative staff member as the

Vendor point of contact.

Monthly status and financial reports, including monthly invoices and an itemized statement of services by the 10th day of the following month.

Quarterly report that itemizes AED equipment/supplies purchases and training conducted by location.

6. GOVERNMENT-FURNISHED PROPERTY (GFP)

The SEC will continue to use 88 HeartSine Samaritan PAD 350p AED units; and will purchase separately new pad-pak replacement accessories once during the Period of Performance.

7. SECURITY CONSIDERATIONS

The Vendor shall comply with all security requirements of the SEC and the Federal Government regarding authorizing personnel to be on-site. Some of the SEC’s leased space is located in Federal buildings and the Contractor shall comply with any additional requirements of the security agency in charge of securing the building and the building’s perimeter. Extra time may need to be planned for the scanning of all items entering into SEC facilities.

The Vendor shall provide a list of all proposed personnel to the SEC AED team point of contact a minimum of 48 hours prior to start of work. For Federal buildings, the notification must occur a minimum of one week in advance of work.

8. TRAVEL

The Government will not reimburse for any local travel. In the event long distance travel is required to Regional Offices not in proximity to the Vendor, the Vendor shall comply with the Federal Travel Regulations (FTR) and are subject to the limitations contained in FAR

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STATEMENT OF WORK

Part 31.205-46. Anticipated travel costs to provide base contract services to all SEC locations should be clearly identified as part of the Vendor’s proposal.

9. SPECIAL MATERIAL REQUIREMENTS

All materials shall be new, not refurbished, and meet all applicable industry and medical standards.

10. PLACE OF PERFORMANCE

There are a total of 88 AED units, with the highest concentration (43 units) located at the SEC Headquarters, 100 F Street NE, Washington, DC 20002. The remaining 45 units are dispersed throughout the SEC’s 11 Regional Offices (https://www.sec.gov/page/sec-regional-offices).

At the time of issue of the solicitation, these are the current addresses of each of the SEC Regional Office locations. These are subject to change.

SEC Regional Offices:

Atlanta Regional Office 950 East Paces Ferry, N.E., Suite 900 Atlanta, GA 30326

Boston Regional Office 33 Arch Street, 24th Floor Boston, MA 02110

Chicago Regional Office 175 W. Jackson Boulevard, Suite 1450 Chicago, IL 60604

Denver Regional Office 1961 Stout Street, Suite 1700 Denver, CO 80294

Fort Worth Regional Office 801 Cherry Street, Suite 1900, Unit 18 Fort Worth, TX 76102

SEC Regional Offices:

Los Angeles Regional Office 444 South Flower Street, Suite 900 Los Angeles, CA 90071

Miami Regional Office 801 Brickell Ave., Suite 1800 Miami, FL 33131

New York Regional Office 200 Vesey Street, Suite 400 New York, NY 10281

Philadelphia Regional Office 1617 JFK Boulevard, Suite 520 Philadelphia, PA 19103

Salt Lake Regional Office 351 S. West Temple St., Suite 6.100 Salt Lake City, UT 84101

San Francisco Regional Office 44 Montgomery Street, Suite 2800 San Francisco, CA 94104

11. PERIOD OF PERFORMANCE

The contract will be awarded for one (1) 12-month base period and four (4) one-year ordering periods.