36C25718Q9869-002.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 08 Page 1 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Brand-name Justification IAW FAR 13.501 For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: VA257-18 AP-7300

1. Contracting Activity: Department of Veterans Affairs, VISN 17, Network Contracting Officer in San Antonio is purchasing on behalf of Dallas VA Medical Center, under request (2237) number 549-18- 3-205-0537.

2. Nature and/or Description of the Action Being Processed: The Cardiology Department at the Dallas VA Medical Center would like to order an additional two (2) Cardiohelp equipment. The Cardiohelp Equipment is Needed for life saving procedures. It allows the patient to be transported for additional procedures and care as needed. Our physicians currently have to use alternative methods that are not always optimal for the patient.

3. FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Cardiohelp equipment in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

4. Description of Supplies/Services Required to Meet the Agency’s Needs: The equipment is needed for emergency procedures in the Cath Lab and OR. Patients with serious cardiac compromise require immediate stabilization and transfer. The system allows vital extracorporeal gas exchange and circulatory support for a period of use up to 30 days. CARDIOHELP is specifically needed so these patients can be transferred to UT Southwestern since their surgeons and our perfusionists are trained with this device.

OFOC SOP Revision 08 Page 2 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

Statutory Authority Permitting Other than Full and Open Competition: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

CARDIOHELP is a highly specialized portable heart-lung support system deployed during cardiac catheterization if the need arises. While there are other brands, this is the brand our surgical team from UT Southwestern (UTSW) and perfusion team are trained in and utlize at UTSW. Using another system would mean we would have no one to care for the patient after it was implanted which is unacceptable.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The initial RFQ, 36C25718Q9740, was posted on FedB O , and there were three ctionable quotes submitted in response to RFQ. The solicitation was posted brand name or equal; however, the e

Therefore, a “No Award” notice was posted to inform vendors that this requirement and will be re solicited at a later date.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be considered fair and reasonable based on competitive pricing for brand-name specific equipment, in accordance with FAR 13.106-3(a)(1). Solicitation was be posted on FBO.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted IAW FAR 10.002. Pursuant to FAR 8.002 and FAR 8.003, it was found that this requirement could not be fulfilled using mandatory Government sources or other mandatory sources. There were 0 SDVOSBS/VOSBs found on VIP. A search of GSA Advantage, utilizing the key word search for “cardiohelp”, was conducted and these items were not available on GSA Advantage from SDVOSBs or VOSBs. A search of SBA Dynamic Small Business Search utilizing the key word search for “cardiohelp” was conducted on DSBS, the search resulted in 0 matches from SDVOSB and 0 matches for VOSB, under NAICS

OFOC SOP Revision 08 Page 3 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018 code 339113. The key word search for “cardiohelp” was conducted on DSBS, the search resulted in 0 matches from SDVOSB and 0 matches for VOSB, under NAICS code 339113.

Based on the above, it is the recommendation of the Contracting Officer that the requirement be solicited as a competitive set-aside for SDVOSB concerns via firm fixed price, for an estimated amount of $319K to meet the needs of this requirement. This will allow for support of the Kingdom-ware Rule.

10. Any Other Facts Supporting the Use of Other than Full and Open Competition:

UT Southwestern (UTSW) provides coverage for emergency procedures performed at the Dallas VA.

They utilize CARDIOHELP. Our facility is not equipped to care for the patients after the device is implanted, therefore we must use the system that is compatible with UTSW so we are able to transfer patients to that facility. Our perfusion team is also trained on CARDIOHELP.

11. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Cardiology Administrative Officer, NTX

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date

Contracting Officer

NCO 17

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Jeff Morris Date Division Chief

NCO 17

08/08/2018