OSSO-393-2016-0042_v2_FY_16_Statement-of-Work.docx

STATEMENT OF WORK (SOW)

CARDIOPULMONARY RESUSCITATION/AUTOMATED EXTERNAL DEFIBRILLATOR /FIRST AID SERVICES

(CPR/AED/FA)

CENTERS FOR MEDICAID & MEDICARE

7500 SECURITY BOULEVARD

BALTIMORE, MD 21244

POC: DALE BROWN

PH.: 410-786-4816

DATE

MAY 2016

TABLE OF CONTENTS

INTRODUCTION/BACKGROUND

The Centers for Medicare & Medicare (CMS) in Baltimore, Maryland has made the decision to obtain a service contract vendor for the CPR/AED/FA program.

Vendor will replace and provide all maintenance and service for 36 AEDs located in the greater Baltimore metropolitan area.

Vendor will conduct yearly American Red Cross accredited CPR/AED/FA training for 13 classes of 12 attendees, monthly inspection, operability, and readiness testing of 36 AEDs.

SCOPE OF WORK

Vendor will provide Medical Direction, Oversight, Prescription and maintenance for each AED installed.

CPR/AED/FA training will be conducted in CMS training rooms in CMS furnished facilities. The contractor will supply all necessary training materials to certify attendees that meets or exceeds CPR/AED/FA American Heart Association, Heartsaver guidance.

Maintenance and inspection of AED’s will be conducted by vendor at a minimum every 30 days.

Records of CPR/AED/FA training, maintenance of AEDs will be kept by vendor and shared with CMS monthly.

CMS will recruit and advertise to CMS building population the availability of up to 13 classes for 12 attendees the contractor will provide.

PERIOD OF PERFORMANCE

The period of performance for the CPR/AED/FA contract is one year (365 days) beginning on 1 August 2016 through 30 July 2017. All work must be scheduled to complete within this timeframe. Any modifications or extensions will be requested through CMS and vendor contracting officers for review and discussion.

Two option years will be extended if contractor meets or exceeds their performance.

PLACE OF PERFORMANCE

The vendor will be required to meet at CMS facility or conference call once per quarter (day and time TBD) for a status meeting. Additionally, all project reviews will be held at CMS’s facility and attended by the vendor. CMS will provide and arrange for meeting spaces within its facility for all required vendor meetings. Once the project reaches the training phase, all training will be conducted in CMS facilities.

CMS Baltimore Based buildings

2520 Lord Baltimore Drive Baltimore MD

2810 Lord Baltimore Drive Baltimore, MD

7111 Security Boulevard Baltimore, MD

7500 Security Boulevard Baltimore, MD

7210 Ambassador Road Baltimore, MD

7501 Wisconsin Avenue Bethesda, MD

WORK REQUIREMENTS

Medical Direction, Oversight and Prescription Vendor will provide medical direction, oversight and prescription for each AED installed. Copies of medical prescriptions will be proved to CMS NLT 30 days after contract award.

Medical direction to include:

· Authorizing the purchase of the AED(s)

· Provide medical consultation and expertise relating to the care and treatment of sudden cardiac arrests, cardiac emergencies and other medical emergencies

· Development and/or approving protocols for the use of an AED and other medical equipment

· Act as a liaison between the early access defibrillation program site and the local Emergency Medical Service (EMS) organization, and assist CMS in responding on site and how to effectively activate CMS local EMS response.

· Approve AED training program and ensuring that rescuers are properly trained

· Review every event in which an AED is used

· Assistance in providing post-event reporting to the local or state EMS, and in analyzing data from your AED to provide you with a thorough understanding of the event and CMS program’s response

· Answer clinical questions about CMS AED and CMS AED program via telephone or email with access 24/7 for urgent calls

Training

Vendor will provide:

· Total of 13 classes annually

· Up to 12 students each class

· CPR/AED/FA training sessions will last no more than 4 hours

· All course materials – booklets, videos, mannequins, AED trainers, etc. will be provided by the vendor.

· Upon completion of the course vendor will supply students with American Heart Association certification cards for CPR/AED/FA.

· Certification will be for 2 years through the American Heart Association.

CMS will provide:

· A television and VCR/DVD or means to display videos shown during training sessions.

· Class rooms for conducting onsite training at CMS.

· Rooms will be a large conference area with ample floor space.

· Provide vendor a schedule of training dates at least 3 weeks in advance of class.

AED specifications

AED must meet or exceed industry standards to include FDA guidance:

ANSUAAMI DF3 9 -Automatic external defibrillators and remote-control defibrillators https://www.federalregister.gov/articles/2015/01/29/2015-01619/effective-date-of-requirement-for-premarket-approval-for-automated-external-defibrillator-systems#h-12

AED must be easy to use by minimally trained CMS personal.

AED features and benefits will include:

· Loud, clear voice instructions, and no ECG display to distract or confuse lay responders.

· LCD screen intuitive to the lay user and display to user what to do and how to do it, while providing visual CPR coaching

· Designed for use by lay responders, have no lids, moving parts or cases

· Device must consist of two buttons with pre-connected pads

· When in use, a clear, calm voice and visual indicators shall prompt the user from start to finish

· Continuous monitoring of the heart and will detect if the patient’s heartbeat recovers, to cancel the shock automatically

· Each AED will be equipped with a battery pack and two sets of adult pads

· Each AED will be equipped/attached with a kit containing a bag mask; razor, gauze pads, scissors, nitrile gloves, and wipes.

· AED batteries and pads will be replaced on or before the expiration date.

Vendor will be responsible for ensuring the AED installed is in good working order. Vendor will replace batteries and pads at no expense to CMS for the life of the contract. If the AED experiences a malfunction the vendor will replace the AED within 24 hours.

AED must preform frequency and types of Self Test listed below:

Daily

· Power up AED

· Test software integrity

· Test basic operation of all electronic circuitry

· Test Battery integrity

Weekly Daily test plus:

· Advanced circuit and battery integrity testing

· Tests patient interface circuitry

· Check that training electrodes are connected

· Partial charge and discharge tests

Monthly Weekly test plus:

· Extensive defibrillation circuitry testing including charge and internal shock at ½ rated output

Quarterly Monthly test plus:

· Charge and internal shock at the maximum energy

Vendor accessibility

Vendor for monthly inspections must be able to undergo a CMS background check, or possess a commensurate Government issued badge/credential.

Vendor for training classes must be able to produce a government issued form of identification upon arrival. Or possess a commensurate Government issued badge/credential.

Record keeping

Electronic copies of trainees sign in sheets, monthly inspections, replacement of equipment. Copies to be emailed within 15 days of class, inspection or equipment replacement. Vendor to keep all class rosters on file and will contact CMS POC to inform participants they are due for recertification classes at the appropriate 2 year mark.

SCHEDULE/MILESTONES

The below list consists of the initial milestones identified for the CMS CPR/AED/FA program:

SCHEDULE MILESTONES

Scheduled at CMS request

ACCEPTANCE CRITERIA

Any discrepancies involving completion of project tasks or disagreement between CMS and the chosen vendor will be referred to both organizations’ contracting offices for review and discussion.

OTHER REQUIREMENTS

All vendor project team members will submit security forms to CMS for clearance and access badges to the facility. Upon completion of CMS forms and background checks vendor will be granted access to CMS common spaces where AED inspections and training will take place.

Vendor will any related shipping cost with CPR/AED/FA program.

Should CMS add, delete, or relocate to another building in the Baltimore metropolitan area vendor will move AED cabinet and install AED for a set price.

CMS buildings to install AEDs

2520 Lord Baltimore Drive Baltimore MD

2810 Lord Baltimore Drive Baltimore, MD

7111 Security Boulevard Baltimore, MD

7210 Ambassador Road Baltimore, MD

7500 Security Boulevard Baltimore, MD

7501 Wisconsin Avenue Bethesda, MD

Out year support

CMS is to expand its CPR/AED/FA program to its Regional offices. Vendor must have capability to service CMS Regional offices listed below.

CMS Regional offices

Region 1 Boston

Region 2 New York

Region 3 DC

Region 4 Atlanta

Region 5 Chicago

Region 6 Dallas

Region 7 Kansas City

Region 8 Denver

Region 9 San Francisco

Region 10 Seattle