P03 LSJ - AED.pdf

VHAPG Part 808.405-6 Limiting Sources Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C24623AP0181

1. Contracting Activity: Department of Veterans Affairs, NCO 06, located at 100 Emancipation Dr. Hampton, VA 23667, in support of VISN 06 VA Health Care System at the Charles George Asheville VA Medical Center, located at 1100 Tunnel Rd, Asheville NC 28805.

Purchase Request Number: 637-23-1-996-0010

2. Description of Action: The Charles George Asheville VA Medica Center has a Sole Source

Only request for the ZOLL Medical Corp. for (3) three new ZOLL, X-Series Defibrillators.

Order against: FSS Contract Number: V797D-40135

Name of Proposed Contractor: ZOLL Medical Corporation (LB) Street Address: 269 Mill Road City, State, Zip: Chelmsford, MA 01824 Phone: (978)303-4127

3. Description of Supplies or Services:

The estimated value of the proposed action is $72,155.86

ZOLL, X Series Defibrillators use electric shock (often called counter-shocks) to start a stopped heart — or momentarily stop a chaotic rhythm — and get the heart beating normally again.

While CPR keeps oxygenated blood flowing to vital organs, only defibrillation can correct certain types of cardiac rhythms, including pulseless ventricular tachycardia (VT), ventricular fibrillation (VF) and SCA associated with VF and SCA caused by dysrhythmia. Common signs of heart rhythm problems include the following symptoms:

• shortness of breath,

• chest pain

• rapid heartbeat

• loss of consciousness

The X Series® Advanced monitor/defibrillator goes beyond cardiac arrest, providing real-time clinical feedback for patients in respiratory distress and patients with traumatic brain injury.

Effective Date: 02/01/2022 Page 2 of 3

X Series features:

• Real CPR Help® technology nearly triples the odds of your patients surviving cardiac arrest

• Open 12-lead capabilities reduces time-to-balloon by interfacing with all leading ECG management and STEMI systems

• Cutting-edge open communication, including integrated WiFi, simplifies transmission and charting

• Remote view functionality allows clinicians to see real-time data from the X Series screen via a cellular or WiFi connection

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

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

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

(FAR 8.405-6(a)(1)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rationale/explanation to support cited authority:

The ZOLL defibrillator’s proprietary features and operating system must be compatible with other ZOLL monitor/defibrillators currently in use at CGVAMC. ZOLL defibrillators are almost exclusively used in the Emergency Medical Service (EMS), both in Federal and State government and public and private medical facilities. The CGVAMC works with a number of agencies, both governmental and private which requires compatibility between https://www.zoll.com/medical-technology/cpr/real-cpr-help https://www.zoll.com/products/data/ems/remote-view-capabilities https://www.zoll.com/products/data/ems/remote-view-capabilities https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6

Effective Date: 02/01/2022 Page 3 of 3 defibrillators when more than one agency becomes involved in transporting patients during an emergency medical event. The ZOLL defibrillator’s proprietary features and operating system make it the most widely used in the EMS community. Due to its proprietary features only the ZOLL defibrillator can meet the requirement to interface with other agencies, particularly when patients are transferred from one EMS service to another.

The EOM (ZOLL Medical Corp) was contacted directly to see if they could provide a listing of their authorized distributors of the X-Series Monitor/Defibrillators. On January 4, 2023, ZOLL provided a Sole Source letter stating that they were the sole manufacturer and distributor of X Series and X Series Advanced Defibrillators for the EMS Market and that they would not sell an X Series and X Series Advanced Defibrillator to Asheville VA Medical Center, through any other distributor and that they were the only vendor authorized to provide warranty or service for the ZOLL, X-Series Defibrillators. With not being able to meet the Rule of Two and the OEM providing documentation that they were the sole manufacture and distributor of the requested X- Series Defibrillators it has been determined by the Contracting Officer to solicit this requirement as a Sole Source Acquisition directly to the OEM, ZOLL Medical Corp under their GSA contract: V797D-

40135. IAW FAR 8.405-6.

6. BRAND NAME ONLY : This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

JAMES RISBON

CONTRACTING OFFICER

NCO 06

Date: 01/10/2022 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-6#FAR_6_303