V797D-40135-005.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C776-20-AP- 2068

(1) Contracting Activity: The Contracting Activity for this requirement is the Department of Veterans Affairs, Program Contracting Activity Central (PCAC), 6150 Oak Tree Blvd., Suite 300, Independence, OH 44131

(2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). PCAC will execute a firm-fixed price contract for Defibrillators with all necessary expendables and accessories off of the NAC FSS VHA Schedule for Defibrillators to Zoll Medical, Large Business, in support of COVID-19 National Emergency. This contract will be in direct support of the COVID-19 response for VAMCs nationally pursuant to the guidance and limitations set forth in the memo, Emergency Acquisition Flexibilities – Emergency Assistance Activities in Support of Global Pandemic for Coronavirus Disease 2019 (COVID-19), dated March 15, 2020, and invoked via memo dated March 26, 2020 by the Executive Director, Regional Procurement Office Central to support the President’s declared National Emergency in response to

COVID-19.

Order against: FSS Contract Number: V797D-40135

Name of Proposed Contractor: Zoll Medical Corporation

Street Address: 269 Mill Road

City, State, Zip: Chelmsford, MA 01824

Phone: (724) 212-6490 Pat Eastman

(3) Description of Supplies or Services:

The value of the action is $ 8,839,832.11

This contract will procure Defibrillators for VAMCs within VHA as they will be required to fulfil the demand needed to meet the urgent requirements throughout VHA medical facilities. COVID has an estimated mortality rate of 2% of infected individuals, however the ease of transmission combined with the lengthy incubation period before infected individuals begins to display symptoms could skyrocket the estimated mortality rate. Defibrillators deliver a high-voltage electrical impulse to the heart in order to restore normal rhythm and contractile function in patients who are experiencing ventricular fibrillation (VF), ventricular tachycardia (VT), or another shockable rhythm. An ECG monitor included with the unit is used to verify the presence of a shockable rhythm and the effectiveness of treatment.

Defibrillator/pacemakers include an external noninvasive pacemaker. The requirement received was for 400 Defibrillators with an option for 100 more, to prepare the VHA as the situation develops. This requirement must be split between multiple vendors in order to meet the quantity required, given the

VHAPM Part 808.405-6 Limiting Sources Page 2 of 5

Revision 02 Eff Date: 02/21/2020 market conditions. The VHA currently uses Physio-Control and Zoll Medical defibrillator units in the medical centers and clinics across the nation. This Limited Sources justification covers Zoll Medical only.

Zoll Medical was contacted to provide a quote for 280 defibrillators with an option to order an additional 70, to include all necessary expendable supplies and attachments.

The total contract value for all 280 units (with supplies and attachments): $7,131,467.70 Zoll X Series Defibrillator – quantity 180 Zoll R Series Defibrillator – quantity 100

Expendable supplies and attachments include Rechargeable Lithium Io Battery Packs, SurePower Charging Stations, Adult Reusable Sensors, Reusable Patient Cables, carry cases, and Pads/electrodes

Option to purchase an addition 70 units (with supplies and attachments): $1,708,364.41

Grand Total: $8,839,832.11

Delivery is to start as soon as possible, through the end of July.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

The requirement for 400+ Defibrillators was requested directly from the COVID-19 response team for VHA, as this acquisition is in direct support of the COVID-19 National Emergency. The supplies described in paragraph 3 are an immediate need to support the COVID-19 pandemic, which was declared a National Emergency. This requirement meets the statutory definition of having an urgent and compelling need, as the impact of not having this contract in place immediately, is as follows:

While VHA’s primary mission is providing coordinated healthcare to Veterans, VHA is also a critical component of the national federal response framework. The VA’s “fourth mission” is to absorb non- Veteran civilian or military patients if hospitals overflow in an emergency, such as a pandemic.

Since starting in China in late 2019, COVID-19 is now present on every continent except Antarctica, and as of the time this justification is written, there are more than 3,042,444 cases worldwide and over 211,216 deaths. On March 1, 2020, there were approximately 100 confirmed cases in the United States (US), that number is now 1,011,006 cases, including 56,752 deaths, with an upward trajectory.

COVID-19 has over-whelmed the medical systems of every country unable to “flatten the curve” of infections. This resulted in global competition for countries seeking resources (e.g., clinical personnel, medical equipment, and personal protective equipment – PPE). VHA requires a deployment ready capability to support life-and-death decision-making today, otherwise patients could be seriously injured without immediate action.

VHAPM Part 808.405-6 Limiting Sources Page 3 of 5

Revision 02 Eff Date: 02/21/2020

The immediate impact of VHA not having the Defibrillators at VHA Medical Centers and clinics, to handle the significant increase, now and in the immediate future, would negatively impact our ability to perform our mission successfully.

According to the Director of VHA Non-Expandable Program, Mr. Jason Newman, Zoll Medical are dominant manufacturers of defibrillators in VHA Medical Centers and Clinics. Utilizing models currently in use will eliminate the need and time to re-train healthcare providers and staff on other manufactured life-support units. Zoll Medical are approved manufacturers per the Food and Drug Administration. Zoll was contacted by the Contracting Officer following receipt of this urgent requirement. Zoll Medical can supply the needed equipment in the timeframe required, to align with both current and projected needs.

Based upon the above, and pursuant to the statute, Zoll Medical Corporation, 269 Mill Road, Chelmsford, MA. 01824 is awarded the task order for a total of 280 units plus an option to order 70 additional.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

Zoll Medical is a NAC Federal Supply Schedule holder. All items were found in the Zoll Medical FSS Price Book and on the NAC website for the MedSurg List. The prices have already been determined fair and reasonable at the IDIQ level. Communication with the NAC Contracting Officer, Mr. Heath Krida, revealed that while there are maximum order limitations per SINS, the contractor is not obligated to honor any single order which exceeds the maximum order amount designated per SIN. There is no ceiling limitation on the ordering vehicle itself.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

See Attached P02 Market Research Report for detailed Market Research efforts.

(7) Any Other Facts Supporting the Justification:

In accordance with VAAR Subpart 819.70, a search on Vetbiz.gov was conducted to locate Veteran- Owned-Small-Business, to include Service-Disabled-Veteran-Owned-Small-Business (SDVOSB) concerns utilizing NAICS code 339112 and a keyword “Defibrillator”. The search produced 5 results, however none were manufacturers of defibrillators, only distributors.

The manufacturer is a large business. Per the non-manufacturing rule under 13 CFR 121.406(b)(1)(iv) requires that under a set aside, a firm will provide the product of a small business. This sole source award is over the Simplified Acquisition Threshold and to a “manufacturer”. Therefore, a SDVOSB or VOSB set-aside is not feasible since a SDVOSB or VOSB would not be able to provide the product of a small business.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

VHAPM Part 808.405-6 Limiting Sources Page 4 of 5

Revision 02 Eff Date: 02/21/2020

The emergent nature of this requirement to support the National Emergency created by the COVID19 pandemic, does not lend itself to further action to remove future barriers, as there will most likely not be future such requirements.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

FACILITY

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

Heidi J. Gallaher, Contracting Officer Program Contracting Activity – Central

NAME AND TITLE FACILITY/NCO/PCO

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

Richard Dahmen Director, Program Contract Activity Center

Heidi J. Gallaher 120966

Digitally signed by Heidi J.

Gallaher 120966 Date: 2020.04.29 09:33:35 -04'00'

Jason C. Newman 221082 Digitally signed by Jason C. Newman 221082 Date: 2020.04.29 08:51:27 -05'00'

Richard C. Dahmen 199197 Digitally signed by Richard C. Dahmen 199197 Date: 2020.04.29 14:46:13 -04'00'

VHAPM Part 808.405-6 Limiting Sources Page 5 of 5

Revision 02 Eff Date: 02/21/2020

HIGHER LEVEL APPROVAL (Required for orders over $700,000):

c. VHA RPO HCA Review and Approval (over $700,000 to $68 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Terry L. Spitzmiller Executive Director DATE Regional Procurement Office Central Veterans Health Administration

04/30/2020

TERRY L.

SPITZMILLER 394683

Digitally signed by TERRY L.

SPITZMILLER 394683

Date: 2020.04.30 11:03:10 -05'00'