P03_ SSJ_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2 Revision: 00 Acquisition ID#: 36C241 25 AP 0311

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: 36C241 25 AP 0311

1. Contracting Activity: Network Contracting Office 1, Regional Procurement East on behalf of the Department of Veterans Affairs, VISN 1, West Roxbury VA Medical Center 1400 VFW Parkway West Roxbury, MA 02132 4927. Funding 523 25 1 7077 0002.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This is a new, brand name, sole source requirement. The Contracting Activity is looking to acquire (4) Hemostasis Management Systems manufactured by OEM LB Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN, 55432 5604 USA. Cardiac Section, located in West Roxbury Campus, is requesting the Medtronic HMS (Hemostasis Management System) Plus is a critical device used in cardiac surgery to monitor and manage heparin anticoagulation levels during procedures like cardiopulmonary bypass. This system benefits patients by ensuring accurate, real time measurement of heparin and protamine levels, which is essential for maintaining proper coagulation and reducing the risk of bleeding or clotting during surgery. It’s precise control of anticoagulation helps prevent complications such as thrombosis or excessive bleeding, which can be life threatening in cardiac patients. Estimated Total Amount

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The HMS Plus technology was created with the recognition that the activated clotting time (ACT) is a global or functional test that measures the effect of many variables including:

• Medications

• Heparin anticoagulation

• Temperature

• Dilution Measuring the ACT, or the degree of anticoagulation, is not always an indication of adequate heparinization or whether an appropriate antithrombotic state has been achieved. Medtronic has developed specific algorithms and sensors that are unique to their system, which enhances patient safety and outcomes in high risk surgical environments like cardiac surgery. This device has no comparable competitor because of the unique information it provides. The device has no direct comparable competitor, necessitating the need to purchase it exclusively from Medtronic. West Roxbury VAMC has used Medtronic products for several years at VA Boston. The perfusionist of the team has participated and attended tradeshows and industry conferences as well regarding this kit and it’s functionality. The Medtronic HMS Plus has technology that integrates advanced heparin management, real time monitoring, and individualized patient data to optimize anticoagulation therapy. No other competitor offers a system that matches the accuracy and integrated features of the HMS Plus.

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2 Revision: 00 Acquisition ID#: 36C241 25 AP 0311

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

Government wide database of contracts and other Government and commercial databases that provide information relevant to agency acquisitions such as VetCert, GSA e Library, SBA DSBS, and FPDS were queried. The Contracting Activity conducted its first search on VetCert under NAICS 339112, produced 670 broad results, however none of which are authorized by OEMMedtronic.

SBA DSBS search using keyword “Medtronic” along with NAICS 339112 returned 2 profiles, 1 SDVOSB Marathon Medical Corp. and 1 SB PA Lifeservers Inc., however neither are authorized to provide this HMS equipment. Two searches were conducted on FPDS, the first using keyword “HEMOSTASIS MANAGEMENT SYSTEM” which generated 1 contract action for the same equipment being purchased, which was purchased through the OEMMedtronic. The second FPDS search was using keyword “HMS Plus” which yielded 11 contract actions, 6 of which were direct purchases from the OEMMedtronic for the exact equipment being purchased “HMS Plus”. The 5 other contract actions found in the FPDS search were purchases for “HMS Controls” from other various vendors, all of which were purchases over 5 years ago. GSA e Library search under manufacture Medtronic yielded 1 schedule contractor SB Affirmative Solutions, LLC, who is authorized by Medtronic, however not for this particular line of equipment. All market research leads to SB InvoSurg, Inc being the only authorized distributor for this equipment. OEM LB Medtronic’s Northeast Distributor Giovanni Cecere informed Contracting that small business InvoSurg, Inc is the sole authorized distributor for this HMS Plus Instrument Set which warrants a small business sole source acquisition.

An intent to sole source notice will be published to Contract Opportunities under solicitation ID 36C24125Q0056. The rule of two was not met.

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.

Phillip Crockett Date Contracting Officer

NCO 1/ RPO EAST

PHILLIP

CROCKETT

Digitally signed by

PHILLIP CROCKETT

Date: 2024.10.30 11:42:23 -04'00'