FY19_CPR.AED_Statement-of-Work.docx

STATEMENT OF WORK (SOW)

BASE YEAR

SEPTEMBER 5, 2019 THRU SEPTEMBER 6, 2020

CARDIOPULMONARY RESUSCITATION/AUTOMATED EXTERNAL DEFIBRILLATOR /FIRST AID SERVICES

(CPR/AED/FA)

CENTERS FOR MEDICAID & MEDICARE

7500 SECURITY BOULEVARD

BALTIMORE, MD 21244

POC: ELIAS BOULOUBASSIS

PH.: 410-786-5514

DATE

MAY 24, 2019

TABLE OF CONTENTS

INTRODUCTION/BACKGROUND

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

Vendor will provide all maintenance and service for 46 AEDs located in the CMS Regional Offices Nationwide.

Vendor will conduct yearly American Heart Association accredited CPR/AED/FA training classes for CMS sites, monthly inspections, operability, and readiness testing of AEDs, and other emergency related trainings available by the vendor.

SCOPE OF WORK

Vendor will provide Medical Direction, Oversight, Prescription and maintenance for each AED installed. Vendor must have the ability to provide & sell new Defibtech AED’s to CMS, if requested. AED’s will come equipped with a second set of electrode pads and a ready kit containing a bag mask, razor, gauze pads, scissors, nitrile gloves, and wipes.

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

CMS’ 46 AED’s: are located:

33 in Baltimore Based Buildings 3 in Region 1 (Boston, MA) 1 in Region 2 (New York, NY) 2 in Region 3 (Philadelphia, PA) 2 in Region 4 (Atlanta, GA) 0 in Region 5 (Chicago, IL) 0 in Region 6 (Dallas, TX) 1 in Region 7 (Kansas City, MO) 3 in Region 8 (Denver, CO) 0 in Region 9 (San Francisco, CA) 1 in Region 10 (Seattle, WA) 0 in Satellite Site Santa Ana, CA 0 in Satellite Site Miami Lakes, FL

Vendor will provide 40 CPR/AED/FA training’s annually, to be held in CMS training rooms of CMS furnished facilities. The contractor will supply all necessary training materials to certify attendees that meet or exceed CPR/AED/FA American Heart Association, Heartsaver guidance, and shall issue each student an American Heart Association certification card good for two years. CMS reserves the right to reduce the number of trainings.

CMS will recruit and advertise the availability of classes that the contractor will provide to CMS building population.

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

PERIOD OF PERFORMANCE

This contract is a base award, plus two option years, following a successful review of contract year. The period of performance for the CPR/AED/FA contract is one year (365 days) beginning on 6 September 2019 to 5 September 2020. 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.

PLACE OF PERFORMANCE

The vendor will be required to meet at CMS’ facility, located at 7500 Security Boulevard, Baltimore, Md, 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 will provide vendor date and times NLT 30 days prior to training. Vendor must have capability to service CMS Regional offices listed below.

CMS training sites:

CMS Baltimore Based buildings

1508 Woodlawn 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

CMS Regional offices Region 1 Boston 15 New Sudbury Street Boston, MA 02203

Region 2 New York Jacob K. Javits Federal Building 26 Federal Plaza, Room 3811 New York, NY 10278-0063

Region 3 Philadelphia 801 Market Street Suite 9400 Philadelphia, PA 19107-3134

Region 4 Atlanta Sam Nunn Atlanta Federal Center (SNAFC) 61 Forsyth Street SW - Rm. 4T20 Atlanta, GA 30303-8960

Region 5 Chicago 233 N. Michigan Avenue, Suite 600 Chicago, IL 60601-5519

Region 6 Dallas 1301 Young Street, Rm 833 Dallas, TX 75202

Region 7 Kansas City 601 E. 12th Street, Suite 355 Kansas City, MO 64106

Region 8 Denver 1961 Stout Street, Room 08-148 Denver, CO 80294

Region 9 San Francisco 90 7th Street San Francisco, CA 94015

Region 10 Seattle 701 Fifth Avenue, Suite 1600 Seattle, WA 98104

CMS Satellite Sites

WORK REQUIREMENTS

Task 1: 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 ensure 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

Task 2: Training Vendor will provide:

40 CPR/AED/FA classes 20 classes in Baltimore Based buildings 20 classes in Regional Offices

· Up to 12 students each class

· CPR/AED/FA training sessions will last no more than 4 ½ 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 has the option to substitute CPR/AED/FA training classes for other trainings that the vendor has available.

CMS will provide:

· A television and 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.

Task 3: 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 features and benefits will include:

· Designed for use by lay responders

· Loud, clear voice instructions

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

· Device must consist have pads pre-connected

· 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, which will be replaced on or before the expiration date.

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

Vendor will be responsible for ensuring the AED installed is in good working order. Vendor will replace batteries and pads prior to the expiration date. If the AED experiences a malfunction the vendor will replace the AED within 24 hours.

AED must perform 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

Task 4: Vendor accessibility

Vendor must be able to undergo a CMS background check, or possess a commensurate Government issued badge/credential to have the ability to perform monthly inspections of the AED’s.

Vendor must be able to produce a government issued form of identification upon arrival, or possess a commensurate Government issued badge/credential.

Task 5: Record keeping

The Contractor shall submit to the COR a Monthly Progress Report that reflects the previous month’s effort that supports the monthly invoice submission. The Contractor shall submit the Monthly Progress Report to the COR on the 15th calendar day of each month or the next business day if the 15th occurs on a holiday or weekend. The COR and the Contractor shall agree upon the content and format of the Monthly Progress Report if information is required other than described below. Monthly Progress Reports shall include, but not be limited to, the following elements:

· Report/Invoice Number;

· Contract number and related task number;

· Date, location and cost of services provided;

· Prior month’s completed activities by task;

· Summaries of meetings including time, location, participants, and contact information;

· Areas of concentration for the upcoming month;

· Issues of concern that require CMS action;

· Any unresolved issues from the prior month, as well as the applicable timeline of submission and potential resolution;

· Identified risks including level of impact and mitigation strategy;

· Projected tasks/activities for the upcoming month; and,

· Report of any continuous quality/improvement activities and findings;

· Electronic copies of trainees sign in sheets, monthly inspections and/or replacement of equipment

Vendor is to keep all class rosters on file and will contact the CMS COR to inform of participants who are due for recertification classes at the appropriate 2 year mark.

The Contractor shall coordinate with the COR for full reporting requirements which will cover each task listed in the SOW.

SCHEDULE/MILESTONES

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

SCHEDULE MILESTONES:

Scheduled at CMS request (Base Year):

Scheduled at CMS request (Option Year 1):

Scheduled at CMS request (Option Year 2):

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 vendor will move AED cabinet and install AED for a set price.