6515--Quest MPS3ND Cardioplegia Devices/Kits, Ann Arbor **J&A posted instead of Notice of Award due to no RFQ**

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT Last Updated: 02/01/22 Page 1 of 1 DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: Contracting Activity: Department of Veterans Affairs, NCO 10, Ann Arbor VA Medical Center, Ann Arbor, MI. 2237: Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Surgery Services is requesting the purchase of two MPS3 ND devices, along with needed accessories, for the purpose of maintaining appropriate life-sustaining monitoring and care during cardiac surgeries and other related procedures. Typically, during these procedures, medication is used to manually stop the patient s heart (cardioplegia), while maintaining proper blood flow and lung function. Due to supply chain and regulatory issues, the most common medications used in this process have had a national shortage. The requested device is a workaround, allowing for a proper infusion of a hospital-made solution that reaches the same desired outcome. The service has requested the MPS3ND Console & MPS Controller Kit, which is manufactured by Quest Medical, Inc., a small business. The estimated value of the proposed action is: $173,108.12 Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Perfusionist technology has been slow to develop due to the long-used supply of readily available cardioplegia compounds. The national shortage of these compounds is not typical, but this is the second time a national shortage has occurred in the past few years. As such, advances in perfusionist technology are uncommon. The MPS3 ND is the only known device capable of performing the desired outcome with current, readily available service supplies. The manufacturer only partners with one SDVOSB, limiting the availability of these devices to one source. As the LTC Charles S Kettles VA Medical Center is the only VA hospital in the state of Michigan that performs these procedures, the need to fulfill this request is emergent. Most other local VHA facilities in MI send their cardiothoracic surgery cases to the Ann Arbor VAMC for these specialty procedures. Recently, when this facility was unable to perform one of these cardiothoracic surgery procedures, other local community care facilities, such as UM and St. Joseph s Hospitals, were also unable to take on an additional case. The LTC Charles S Kettles VA Medical Center was then forced to send a patient to the Cleveland VA facility for treatment at a community cost exceeding $130k for one surgery that is typically done in-house. With the national drug shortage, the inconsistent ability of other local facilities to take on additional cardiothoracic surgery cases, the life-threatening degree to which these cases arise, and prohibitive distance and cost for sending these cases outside the Michigan VHA system, VA Ann Arbor Healthcare System Chief of Staff, Dr. Richard Shildhouse, has authorized this procurement to be sought as an emergency purchase, stating: In case you are required to submit justification to logistics for the emergency request, as Dr. Lake mentioned, we feel wholeheartedly that this meets the criteria for loss of life or limb if not moved forward emergently. Description of market research conducted and results or statement why it was not conducted: Queried SBA VetCert database using NAICS 339113 and 856 concerns were found. Queried DSBS database with same NAICS code and keyword Cardioplegia , and zero concerns were found. Required items are not listed on GSA Advantage, nor do any FSS contracts exist for this procurement. The OEM, Quest Medical, Inc. (SB), does not sell direct to the U.S. Government, but they do utilize a single SDVOSB authorized distributor, Sustainment Technologies, LLC. The VA and SBA Rules of Two cannot be attained because there is not a reasonable expectation that two or more small businesses can meet the requirement. CS recommends sole source award to Sustainment Technologies, LLC. 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. ____________________________ ________________________ Date Contracting Officer