36C24719Q1140-002.pdf

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Terumo Advanced Perfusion System **Brand Name Only** Federal contract opportunity
Solicitation number
36C24719Q1140
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 7

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36C24719Q1140 P03 - PM_Part806.3_Atch2_FAR6_JA_OVER_SAT - Terumo.pdf

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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 5 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:__VA247-19-AP-3582_________________

1. Contracting Activity: Department of Veterans Affairs, VISN 07, Birmingham VA Medical Center, 3701 Loop Road East, Birmingham, AL 35233-1927 2237 No. 521-19-3-237-0138

2. Nature and/or Description of the Action Being Processed:

This transaction is needed to purchase equipment for the Birmingham VA Medical Center (BVAMC) operating room. The purchase of this equipment is to allow more efficient treatment of cardiothoracic patients in the operating room

It is essential a new Advanced Perfusion System is purchased due to increased number of patients requiring open heart surgery at the Birmingham VA. If this equipment is not purchased there would be an increased wait time for surgical procedures.

This purchase is needed to replace equipment that needed repair twice this past year. During the non-functional period patients were provided timely care in the community. The replacement of existing equipment will be purchased as a firm-fixed price contract on the open market for brand name only competition.

The estimated value of this procurement is $452,766.14.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Contractor shall Terumo

Advanced Profusion system.

Description/Part Number*

Qty Price Extended

Amount

801763 100/120V AC APS PLATFORM 2 $70,963.81 $ 141,927.62

816300 CENTRAL CONTROL MONITOR 2 $0.00 $ -

802110 ASBY AIR BUBBLE DETECTOR POD 2 $0.00 $ -

OFOC SOP Revision 08 Page 2 of 5

802111 ASSEMBLY LEVEL POD, APS 2 $0.00 $ -

195240 LEVEL DETECT II MOUNT PAD 2 $0.00 $ -

16553401 4' POLE (1.2m) APS1/8K 2 $350.09 $ 700.18

145980 FITTING CROSSBAR APS1/8K 2 $258.40 $ 516.80

801188 EPGS SYSTEM 2 $14,706.60 $ 29,413.20

814475 US HOSE KIT 02 AIR CO2 25FT 2 $281.74 $ 563.48

144223 US-OHIO DIAMOND HOSE ADAP SET 2 $269.51 $ 539.02

816571 LARGE ROLLER PUMP 6" DIAMETER 10 $17,001.64 $ 170,016.40

801093 ASMBLY, AUX PUMP MOUNT,INLINE 4 $922.46 $ 3,689.84

816572 CENTRIFUGAL CONTROLLER UNIT 2 $9,160.71 $ 18,321.42

164267 CENTRIFUGAL DRIVE MOTOR 2 $4,453.94 $ 8,907.88

816620 FLEXIBLE MOUNTING ARM 2 $1,308.67 $ 2,617.34

164268 MANUAL DRIVE UNIT 2 $5,145.78 $ 10,291.56

802018 ASSEMBLY FLOW POD APS 2 $6,824.00 $ 13,648.00

6382 FLOW SENSOR 3/8X3/32 2 $1,322.57 $ 2,645.14

801550 ASSEMBLY FLOW POD BRACKET 2 $313.97 $ 627.94

803480 ASSEMBLY OCCLUDER POD APS 2 $3,534.25 $ 7,068.50

806455 OCCLUDER HEAD APS1/8K 2 $4,603.97 $ 9,207.94

816620 FLEXIBLE MOUNTING ARM 2 $1,308.67 $ 2,617.34

5773 ULTRASONIC AIR SENSOR 3/8x3/32 4 $2,467.31 $ 9,869.24

802110 ASBY AIR BUBBLE DETECTOR POD 2 $1,144.74 $ 2,289.48

802112 ASSEMBLY PRESSURE POD APS 4 $1,200.31 $ 4,801.24

802114 ASSEMBLY TEMPERATURE POD,

APS

4 $1,200.31 $ 4,801.24

801238 ASSEMBLY, LAMP, LONG NECK APS 2 $1,322.57 $ 2,645.14

OFOC SOP Revision 08 Page 3 of 5

803479 ASSEMBLY INTERFACE POD CDI 500 2 $1,144.74 $ 2,289.48

16434101 INSTRUMENT TRAY 2 $1,375.36 $ 2,750.72

Total: $ 452,766.14

4. Statutory Authority Permitting Other than Full and Open Competition:

( ) (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;

FAR13.5 Simplified Procedures for Certain Commercial Items: 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).

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

This is a procurement for Brand Name Only Competition.

The Birmingham VA Medical Center has the need for two Advanced Perfusion Systems. Terumo Cardiovascular Group is the only manufacturer of the Advanced Perfusion System. This system provides real-time organ assessment, metabolic support and the ability to add pharmacologic agents during surgery. These new Terumo Advanced Perfusion Systems will provide continuity of care, just like the ones that are currently used at the University of Alabama Birmingham. The purchase of the Advanced Perfusion Systems will ensure compatibility with current technology for reliable patient data transfer.

This new equipment will be located at the Birmingham VA Medical Center and used in the 4th floor operating room. However, because of the limited number of open heart cases performed at the BVAMC, the staff(nursed/tech) are unable to remain proficient with the use of the Terumo Advanced Perfusion System. Additionally, the BVAMC has an ongoing service contract with the UAB Perfusionist Team, which also utilizes identical Terumo CDI 550 Systems at UAB. These new advanced Perfusion Systems will ensure staff familiarity, patient safety, and workflow efficiency.

OFOC SOP Revision 08 Page 4 of 5

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

VET VIP indicates there are 339 SDVOSBs with NAICS 339112, Surgical Appliance and Supplies Manufacturing. Subsequently, this will be an SDVOSB set-aside.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

There will be adequate competition as an SDVOSB set-aside; this is a commercial item; and should be on established price lists maintained by the contractors.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

VET VIP indicates there are 339 SDVOSBs with NAICS 339112, Surgical Appliance and Supplies Manufacturing. Subsequently, this will be an SDVOSB set-aside.

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

This is a brand name only justification.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: N/A

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required: N/A

12. 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.

Name: Mardale Bracy Date Title: OR Business Manager Facility: 521

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

http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

OFOC SOP Revision 08 Page 5 of 5

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.

AMJ 11 Sep 19

Michael L. Tempero Date Contracting Officer VA Southeast Network NCO 7

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.

Name: Bonita Floyd-Ross Date Deputy Director of Contracting, NCO 07

2019-09-12T15:24:17-0500
Mardale L. Bracy 446603
2019-09-13T10:44:09-0400
MICHAEL L. TEMPERO 1074554
2019-09-13T11:14:22-0400
Bonita L Floyd-Ross 187732

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