A.02.04_Limited_Sources_Justification_Abbott_MitraClip_(KO_Signed).pdf

Control Number: 19-RHCO-C-96

Limited Sources Justification or

Sole Source Determination for Actions under the Simplified Acquisition Threshold (Currently $150K)

1. Contracting Activity: Regional Health Contracting Office-Central, US Army Health Care Acquisition Activity, San Antonio Military Medical Center, Fort Sam Houston, Texas 78234

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $120,000.00

Name of Intended Contractor: Abbott Street Address: 6300 Bee Cave Road, Bldg Two, Ste. 100 City, State, Zip: Austin, TX 78746

Phone: 800- 777-2237

3. Description of Supplies/Services:

MBR0303 MitraClip Bundle Includes: 1-SGC0301, 1-CDS0601-NTR & 2 CDS0601-XTR. Items requested/required for Mitral Valve Repair procedure anticipated for 16 Nov 2018 (Priority 06).

4. Authority Cited:

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

(d) FAR 8.405-6(a)(1)(i)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: The Abbott Structural Heart MitraClip Delivery System is the world’s first transcatheter mitral valve repair that delivers a therapeutic option when no other option exists. The MitraClip repairs the mitral valve without the need for an invasive surgical procedure and is delivered to the heart through the femoral vein (a blood vessel in the leg.) The device works by clipping together a portion of the leaflets of the mitral valve to reduce the backflow of blood, which allows the heart to pump blood more efficiently, thereby relieving symptoms and improving patient quality of life. The MitraClip treats the primary or degenerative form of mitral regurgitation (MR), which is caused by an anatomic defect of one or more of the structures of the mitral valve, which prevents the valve from closing properly and subsequently causes leakage. Approximately one in 10 adults age 75 and older in the U.S. suffer from M.R. Patients with MR are often not eligible for standard-of-care surgery because of advanced age, frailty, multiple comorbidities or other complicating factors and the MitraClip therapy offers a; minimally invasive alternative. MitraClip treatment resulted in a reduction in the composite of death or first heart failure hospitalization by 43%. This therapeutic mitral valve intervention is the first and only to demonstrate positive outcomes in a clinical trial for ailing heart failure patients with clinically significant with clinically significant secondary mitral regurgitation. The MitraClip Delivery System is required/requested as it is a less –invasive treatment option allowing a beating heart procedure with no cardiopulmonary bypass required, preserves surgical options for patients, and results in limited hospital length of patient stay resulting in reduced overall medical cost to the Government.

6. Actions to Increase Competition: Abbott is the sole manufacture of the MitraClip Delivery System.

The MitraClip Delivery System is required by the Cardiac Catheterization and Electrophysiology doctors to for use in Mitral Regurgitation procedures. Other products are available for Mitral Valve repair, however these require invasive surgery. The MitraClip is a minimally invasive procedure which is implanted through the femoral vein.

This will be posted on FBO to increase competition.

7. Market Survey: There is no other product like this in the medical field.

Searched online.

8. Procurement History:

Previous Contract or Purchase Order Number: or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition:

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

Signature: Elena Ochoa Submitted By: Elena Ochoa Position Title : Supply Technician

Email address: Elena.ochoa.civ@mail.mil Date: 10/25/2018

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name:

Position Title:

Email address:

Date:

(17 March 2017)