P03 - Single Source Justification MPT to SAT - FAR 13 - 36C261-23-AP-2182 - ds.pdf

Last Updated: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name Only IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C261-23-AP-3550 JOFOC Log Number: 2023-06-02T12:46:42

Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional Procurement Office West, Network Contracting Office (NCO) 21, for the Sacramento VAMC located at 10535 Hospital Way Mather, CA 95655.

2237: 612-23-3-145-0151

1. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Estimated Total Value: $88,289.00

The Sacramento Veteran’s Affairs Medical Center located at 10535 Hospital Way Mather, CA 95655 is requesting the procurement of one Brand Name Only, AC3 Intra-Aortic Balloon Pump for the Cath Lab. An Intra-Aortic Balloon Pump (IABP) is a therapeutic device used during Cath Lab procedures to help the patient’s heart pump more blood throughout the body. This equipment is necessary for the department to be able to perform Percutaneous Coronary Interventions (PCI) procedures.

2. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The Sacramento VAMC is requesting a AC3 Intra-Aortic Balloon Pump unit and is proprietary to

Teleflex INC.. An email confirming the propriety is uploaded in the eCMS Briefcase. VANCHCS currently has one AC3 Intra-Aortic Balloon Pump unit. This request is to procure an additional unit because the site now has two Cath Lab procedure rooms. Per the VACO National Cardiology office, the Cath Lab needs at least two Intra-Aortic Balloon Pumps (IABP) in order to add percutaneous cardiac intervention (PCI) services. The unit purchased must be able to be used Interchangeably between the two labs and all staff must be familiar with the operations of the unit. For consistency throughout the department, the service would like to maintain the same make/model with the additional IABP unit.

Cardiology office, the Cath Lab needs at least two intra-aortic balloon pumps (IABP) in order to add percutaneous cardiac intervention (PCI) services. The unit purchased must be able to be used interchangeably between the two labs, and all staff must be familiar with the https://www.acquisition.gov/?q=/browse/far/13

Last Updated: 02/01/22 Page 2 of 3 operations of the unit. For consistency throughout the department, the service would like to maintain the same make/model with the additional IABP unit.

Essential/significant physical, functional, or performance characteristics.

Brand Name Item: AC3 OPTIMUS INTRA-AORTIC BALLON PUMP

• Device must be able to rescue patients in the event of cardiogenic shock

• Device must include a color, high-definition touch screen

• Device must offer a 360 ° viewable indicator denoting the pump is alarming and the priority level

• Device must show heart rate with assisted hemodynamic, unassisted hemodynamic and balloon pressure values and waveforms

• Device must offer a horizontal FOS port

• Device must include no scheduled replacement parts

• Device must offer balloon volume adjustments by at least 0.5 cc increments

• Device must offer a pumping volume range of at least 0.5cc to 50cc

• Device must make end-users confirm routine checks have been completed

• Device must offer therapy status reports

• Device must be able to store alarm history and offer reports

• Device must be able to support patients with severe arrhythmias and heart rates as high as 200 bpm

• Device must offer a Counterpulsation rate range of at least 40 to 200 pulsations/min

• Device must be able to continuously analyze up to 6 ECG sources

• Device must offer feature that allows the unit to auto and manually update inflation and deflation timing, and triggering parameters

• Device Inflation Timing Methods must include Aortic flow, Predictive, and Weissler

• Device Deflation Timing Methods must include R-Wave, Predictive, and Weissler

• Device must offer operations statuses including, but not limited to Operational mode, trigger mode, AP zero status, AP alarm/battery charge status, balloon volume, battery charge icon and status, zeros status icon

• Device must include diagnostic alarm/help messages

• Device must include handle and wheels for easy mobility

• Device must offer a lockable the touch screen

• Device screen must have a visual indicator of battery power level

• Device screen must include a visual indicator of Helium tank level

• Device must operate using a standard 120V outlet

• Device must offer patient hemodynamics including, but not limited to: Heart rate, AP-systolic, augmented, diastolic, and mean arterial

• Device must be able to freeze at least 5 seconds of patient data on the screen

• Device must include time display

• Device must include a cursor to measure waveforms

• Device must include condensation removal

Last Updated: 02/01/22 Page 3 of 3

• Device Operator mode must allow user control of most pump functions

• Device recorder must include Selectable recording length and adjustable automatic print times, ECG, AP, or balloon pressure waveforms, and Alphanumeric data

3. Description of market research conducted and results or statement why it was not conducted:

VANCHCS currently has one AC3 intra-aortic balloon pump unit. This request is to procure an additional unit because the site now has two Cath Lab procedure rooms. Per the VACO National

CS searched Vet Cert using keywords “Balloon Pump” and “339112” and found that there were thirteen (13) SDVOSB that populated. None of the vendors that were detected produces or distributes the (AC3 Optimus Intra-Aortic Balloon Pump) brand name item.

Teleflex is the only company that manufactures this proprietary requested item, and they are certified in SAM.gov as a large business under NAICS code 339112. Teleflex has one authorized vendor to distribute this product and is a Service-Disabled Veteran-Owned Small Business (SDVOSB). An email of this conversation is uploaded in the Briefcase.

4. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Signature: ____________________________

Dennis Salmonsen

Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466