6515--Consignment - Prosthetic Valves - Ann Arbor

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items

Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 9

REVISION: 01

Acquisition ID#: 36C250-25-AP-3827

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-25-AP-3827

Contracting Activity: Department of Veterans Affairs, NCO 10, 24 Frank Lloyd Wright Drive, Suite M2200, Ann Arbor, MI 48105 in support of LTC Charles S. Kettles VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105. 2237: 506-25-3-1022-0044.

Nature and/or Description of the Action Being Processed: This is an individual justification to support a new firm-fixed price, 5-year ordering period IDIQ requirements contract with Edwards Lifesciences LLC for an assortment of different sized Inspiris Resilia Aortic Valves, Physio Mitral Annuloplasty Ring, Tricuspid Annuloplasty System, MC3 Tricuspid Annuloplasty System, Perimount Plus Pericardial Mitral Bioprosthesis with Tricentrix Holder with Thermafix, and Magna Mitral Ease Pericardial Valve with Thermafix for various scheduled and emergent procedures at the LTC Charles S. Kettles VA Medical Center. These items must be stocked in the Operating Room/Surgery Service Department or available just-in-time at all times; therefore, a consignment agreement will be established against the IDIQ as the method of delivery. The contractor, Edward Lifesciences LLC, will be responsible for maintaining the agreed to inventory levels and will retain ownership of the material until the VA uses an item, at which time, the VA will make payment for the used item. The procurement will be completed 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.

Description of Supplies/Services Required to Meet the Agency s Needs: The proposed IDIQ contract is for different sized Inspiris Resilia Aortic Valves, Physio Mitral Annuloplasty Ring, Tricuspid Annuloplasty System, MC3 Tricuspid Annuloplasty System, Perimount Plus Pericardial Mitral Bioprosthesis with Tricentrix Holder with Thermafix, and Magna Mitral Ease Pericardial Valve with Thermafix for various scheduled and emergent procedures. Therefore, these items must be stocked in the Operating Room/Surgery Service Department or available just-in-time at all times and will utilize a consignment agreement as the delivery method. The exact sizes and/or models are not always known prior to the surgical procedure. Availability of an array of non-biological implant inventory at any given moment increases timely access to quality patient care. Proposed period of performance will include a 5-year ordering period.

Period of Performance: 9/30/2025 9/29/2030.

Â

Description

Part Number

Estimated Yearly Usage

Unit

1

Inspiris Resilia Aortic Valve, 19mm

11500A19

2

EA

2

Inspiris Resilia Aortic Valve, 21mm

11500A21

2

EA

3

Inspiris Resilia Aortic Valve, 23mm

11500A23

2

EA

4

Inspiris Resilia Aortic Valve, 25mm

11500A25

2

EA

5

Inspiris Resilia Aortic Valve, 27mm

11500A27

2

EA

6

Inspiris Resilia Aortic Valve, 29mm

11500A29

2

EA

7

Physio Mitral Annuloplasty Ring 24M

4450M24

2

EA

8

Physio Mitral Annuloplasty Ring 26M

4450M26

2

EA

9

Physio Mitral Annuloplasty Ring 28M

4450M28

2

EA

10

Physio Mitral Annuloplasty Ring 30M

4450M30

2

EA

11

Physio Mitral Annuloplasty Ring 32M

4450M32

1

EA

12

Physio Mitral Annuloplasty Ring 34M

4450M34

1

EA

13

Physio Mitral Annuloplasty Ring 36M

4450M36

1

EA

14

Physio Mitral Annuloplasty Ring 38M

4450M38

1

EA

15

Physio Mitral Annuloplasty Ring 40M

4450M40

1

EA

16

Cosgrove Annuloplasty System 26MM

460026MM

2

EA

17

Cosgrove Annuloplasty System 28MM

460028MM

2

EA

18

Cosgrove Annuloplasty System 30MM

460030MM

2

EA

19

Cosgrove Annuloplasty System 32MM

460032MM

2

EA

20

Cosgrove Annuloplasty System 34MM

460034MM

1

EA

21

Cosgrove Annuloplasty System 36MM

460036MM

1

EA

22

Cosgrove Annuloplasty System 38MM

460038MM

1

EA

23

MC3 Tricuspid Annuloplasty System 26T

4900T26

1

EA

24

MC3 Tricuspid Annuloplasty System 28T

4900T28

1

EA

25

MC3 Tricuspid Annuloplasty System 30T

4900T30

1

EA

26

MC3 Tricuspid Annuloplasty System 32T

4900T32

1

EA

27

MC3 Tricuspid Annuloplasty System 34T

4900T34

1

EA

28

MC3 Tricuspid Annuloplasty System 36T

4900T36

1

EA

29

Magna Mitral Ease Pericardial Valve with ThermaFix 25MM

7300TFX25

2

EA

30

Magna Mitral Ease Pericardial Valve with ThermaFix 27MM

7300TFX27

2

EA

31

Magna Mitral Ease Pericardial Valve with ThermaFix 29MM

7300TFX29

2

EA

32

Magna Mitral Ease Pericardial Valve with ThermaFix 31MM

7300TFX31

1

EA

33

Magna Mitral Ease Pericardial Valve with ThermaFix 33MM

7300TFX33

1

EA

34

MITRIS RESILIA Mitral Valve, 25MM

11400M25

1

EA

35

MITRIS RESILIA Mitral Valve, 27MM

11400M27

1

EA

36

MITRIS RESILIA Mitral Valve, 29MM

11400M29

1

EA

37

MITRIS RESILIA Mitral Valve, 31MM

11400M31

1

EA

38

MITRIS RESILIA Mitral Valve, 33MM

11400M33

1

EA

Statutory Authority Permitting Restricted Competition:Â

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement.  Competition is restricted on this procurement for the reason below:

        ( X )  Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

        (  )  Unusual and Compelling Urgency

        (  )  Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

        (  )  International Agreement

        (  )  Authorized or Required by Statute

        (  )  National Security

        (  )  Public Interest

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Only one responsible source. In the marketplace for implantable heart valves there are two main types: mechanical and bioprosthetic. For the majority of patients, age is the critical factor, with bioprosthetic being recommended for patients over the age of 65. While each patient is given individual attention and care when choosing which valve replacement option is best for them, Edwards Lifesciences has typically been the most requested bioprosthetic valve by both patients and surgeons. Edwards Lifesciences also has a more robust product line to include mitral valves, tricuspid annuloplasty systems, annuloplasty rings, etc., which have also been requested by our physicians. The Edwards Lifesciences product storage is also recommended vs other competitors, where their ability for dry storage tends to be optimal compared to the cold storage of most other bioprosthetic heart valves.

Edwards Lifesciences LLC heart valves are specific because the INSPIRIS Magna Ease uses the INSPIRIS design, it is an internally mounted pericardial tissue using 3 leaflets that are each individually cut. They have a 2 stage anti-calcification process addressing both phospholipids and residual glutaraldehyde. The 7300TFX uses a dual stage anti-calcificationepic. The 4900 features a specific 3d semi-rigid design that has been specifically designed for the Tricuspid position. The 4600 Cosgrove comes pre sized and does not need to be cut and it can be used in Mitral and Tricuspid position. The Physio uses 4 individual elgiloy bands to preserve natural annular movement and shape of the annulus. Consignment contracts allow the VA to keep several of these short shelf-life items in the facility without having to buy them until they are used. The items requested meet the strict requirements of quality and functionality for the procedures for which they are chosen. The supplies are selected based on their specific use during procedures. Edwards Lifesciences, LLC is the only firm capable of providing the supplies and services described in Section III above. The VA Ann Arbor Healthcare System has several different consignment instruments put in place for flexibility and added variety of sizes and models that allow the VA physicians the ability to make the best match possible of implantable device to the veteran s health need.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An Intent to Sole Source will be posted to Contract Opportunities prior to award to confirm there are no other sources.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will use the price analysis technique in FAR 13.106-3(a)(2)(ii), comparison of the proposed price with prices found reasonable on previous purchases, and any other techniques necessary to determine the prices to be fair and reasonable.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: In accordance with FAR Part 10 and VAAR 810, market research has been conducted for this acquisition. VetCert was searched under NAICS 339113 and 932 concerns were found. DSBS was searched under NAICS 339113 and keyword heart valve consignment and no results were found. Searched SAM under heart valve consignment agreement . There were 21 results. Edwards Lifesciences, Abbott Laboratories, Medtronic, St. Jude, and ATS Medical. All are Large Businesses. Searched NAC under Heart Valve and no results were found. Searched SCMC under consignment and refined with heart valve and one result was found from Abbott Laboratories. Searched GSA advantage under consignment and refined with heart valve and no results were found. Searched FPDS under heart valve consignment and several results were found: Edwards Lifesciences, Medtronic Inc., Carbiomedics, Inc., St. Jude medical Inc., and Cryolife, Inc. Seared MSPV and Edwards Lifesciences is not a Prime Vendor. The Interagency Contract Directory was searched under consignment, Edwards Lifesciences, and heart valves and 3 results were found for consignment contracts in other NCO s. Category Management Quick Decisions Dashboard was searched under heart valve consignment with no results. Searched Defense Logistics Agency Electronic Catalog (ECAT) using keyword heart valve consignment with no results. FDA was searched under Edwards Heart Valves and several items were found. The market for prosthetic heart valves is regulated mainly by which devices are FDA approved. As such, several name brands, such as Perimount, Mosaic/Hancock, Biocor/Epic, MitroFlow/Crown, Soprano, and Trifecta, are available on the market. As these devices are typically placed during a complex and life-altering surgery, the specific valve is usually chosen by the patient with input from the surgeon. Therefore, the expert opinion of the surgeons is of utmost importance when choosing which specific brand a hospital should choose. Their recommendation has been to stay with Edwards Lifesciences LLC. A consignment contract allows the facility to have a full variety of devices on hand for immediate use, while cost is deferred until the device is surgically placed. Edwards Lifesciences LLC is a large business and they have no distributors for consignment contracts. Therefore, the VA Rule of Two and the SBA Rule of Two cannot be met.

The products are manufactured in US, Singapore and Costa Rica. A non-availability determination and a Buy American Act waiver are not required as the procurement will be completed under the authority of 38 U.S.C. §8123.

Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other supporting facts.

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Edwards Lifesciences LLC, 1 Edwards Way, Irvine, CA 92614.

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: Should a requirement of this nature recur, the market will again be surveyed.