Medical Equipment - CardioQuip Heart-Lung Controllers

Chapter VI: Other Than Full and Open Competition (OFOC) SOP

Attachment 4: Single Source Justification for SAP under $150K





OFOC SOP Revision 05 Page 1 of 2

Original Date: 03/22/11

Revision 05 Date: 05/02/2016





JUSTIFICATION FOR SINGLE SOURCE AWARDS IAW FAR 13.106-1

(OVER MICRO-PURCHASE THRESHOLD($3.5K) BUT NOT EXCEEDING THE SAT ($150K))

IAW FAR13.104, COs must promote competition to the maximum extent practicable to obtain supplies and services from the source whose offer is the most advantageous to the Government, considering the administrative cost of the purchase. When competition is not practicable, IAW FAR13.106-1(b), COs solicit from a single source for purchases not exceeding the simplified acquisition threshold. COs may solicit from one source if the CO determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). IAW FAR13.106-3(b)(3),COs are required to include additional statements explaining the absence of competition (see 13.106-1 for brand name purchases) if only one source is solicited and the acquisition does not exceed the simplified acquisition threshold (does not apply to an acquisition of utility services available from only one source) or supporting the award decision if other than price-related factors were considered in selecting the supplier. This template when completed can be used to document single source awards IAW FAR13.106-3(b)(3). Note: Statements such as "only known source" or "only source which can meet the required delivery date" are inadequate to support a sole source purchase.

1. ACQUISITION PLAN ACTION ID:

618-17-1-4008-0151

1A. PROJECT/TASK No.

1B. ESTIMATED AMOUNT:

$121,260.00

2. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED AND THE INTENDED USE:

Fixed price emergency sole source purchase order for the following items: 3 each CardioQuip, Modular Cooler-Heater, Model 1000(i) (Ice based unit with single wheel-set, Standard tubing set with connectors, Operator's manual), 3 each Refrigeration Module, and 3 each Cardioplegia Shared Channel (CSC) Module.

3. UNIQUE CHARACTERISTICS THAT LIMIT AVAILABILITY TO ONLY ONE SOURCE, WITH THE REASON NO OTHER SUPPLIES OR SERVICES CAN BE USED:

The Minneapolis VA has an immediate need to repair the heart lung bypass system. The system controllers need to be repaired as soon as possible so that patient care is not affected. On October 13, 2016 the CDC and FDA updated previous safety communications related to the strong correlations of Mycobacterium Chimaera infections with current 3T Heater-Cooler System components. The Minneapolis VA 3T Heater-Cooler System components are from 2011 and per the FDA and CDC recommendations should, Strongly consider transitioning away from the use of these devices for open-chest cardiac surgery until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection. The manufacturer has not been able to implement strategies with the current equipment so the facility is transitioning away from the 3T devices. Currently, heart lung bypass procedures cannot be completed due to the increased risk of Mycobacterium Chimaera infections to patients. The only exception is emergency surgeries. To completely remove the risk to the patients, and to continue with safe heart lung bypass procedures, these new components must be procured. The cost to outsource a single procedure is over $100,000.00 and the cost to replace the equipment on all three machines is $121,260.00, so the sooner the equipment is procured the greater the overall cost savings for the facility. Lead time for the equipment is currently 8 weeks due to the demand to replace these components nationally. The facility has tested the CardioQuip equipment and it is compatible with existing systems. Shamrock Surgical is the authorized dealer for CardioQuip equipment for the state of Minnesota. This equipment has been found compatible with existing equipment and capable of meeting the requirement. Additionally, since this is a national health issue, demand for replacement equipment is high and earlier requests are honored first. This necessitates immediate need to order the equipment to assure the earliest possible delivery for patient care and maximization of savings to the government.

4. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND RESULTS OR STATEMENT WHY IT WAS NOT CONDUCTED:

Internet, GSA, VETBIZ searches all conducted and Sources Sought posted to FBO. GSA Advantage searches for CardioQuip and for Heart Bypass were conducted and no other sources found. VETBIZ search for CardioQuip resulted in zero matches. VETBIZ search for CardioQuip resulted in zero matches. VETBIZ search for Cardiovascular resulted in 3 matches. VETBIZ search for Heart resulted in 23 vendor matches of which 4 have medical equipment. Sent specifications to the 7 vendors and received one reply but none can meet the requirement. Received zero replies from FBO sources sought. CardioQuip has authorized dealers for their equipment throughout the U.S., and Shamrock Surgical is the dealer for the state of Minnesota. They are a small business and are registered and current in SAM.



5. 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. Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the Commercial Supply and Service SOP for Price Reasonableness templates.







Signature: ________________________ Date:___________

Name:____________________________

Title:____________________________ NCO:_________________________________