A.03.02_KO_Signed_J_ _A_LT_150k_-_LDR_Spine.pdf

Control Number: 16-RHCO-C-732

Limited Sources Justification or

Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold (Simplified Acquisition Threshold is $150K)

1. Contracting Activity: Regional Health Contracting Office-Central, Fort Carson Health Contracting Cell, 4886 Barkeley, Bldg 1161, Fort Carson, CO 80913.

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: DHP O & M funds

Total Dollar Value: $ 149,000.00

Name of Intended Contractor: LDR Spine Usa, Inc.

Street Address: 13785 N Highway 183 #200 City, State, Zip: Austin, TX 78750-1873

Phone: (915)471-2225

3. Description of Supplies/Services: William Beaumont Army Medical Center, (WBAMC), Fort Bliss, TX. is requesting approval of a sole source purchase order to LDR Spine USA, Inc. (CAGE: 51EW3, DUNS: 615789729) for Spinal Surgical Implants.These include Mobi-C, Cervical Disc Prosthesis.

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.

(10 February 2016)

5. Reason for Authority Cited: Based on a comparison with similar products in the marketplace, the surgeon in consultation with the attending surgical team has determined the Spinal Surgical Implants Implant offered by LDR Spine USA, Inc. best meets the specific patient needs for implant surgery. The supplies offered by LDR USA are unique for Spinal procedures. Mobi-C is the first and only cervical disc in the U.S. approved to treat more than one level of the cervical spine. It is Mobi-C is different from other cervical discs because of a unique mobile bearing core, that eliminates the need for invasive bone keels and optimizes it for two-level applications. The surgeon is trained on the surgical procedures for using this implant. The surgeries are scheduled and the implants can be delivered in time for surgery preparation.

Reduced liability risk, administrative and training time represent a cost savings to the Government.

Increased likelihood of successful surgery, recovery, and quality of life derived from the most appropriate implant based on the surgeon’s diagnosis is a significant intangible benefit to the Government consistent with the mission of the Army Medical Command.

6. Actions to Increase Competition: A general competitive effort is made by the surgeon and attending team throughout the requirement review process which considers the applicability of products from various sources to determine the product that best meets the needs of the patient. This effort at the requirement definition level is not publicized on Federal Business Opportunities in accordance with FAR 5.201, but is standard industry practice. Efforts to obtain competition are not practical because this requirement is needed for surgeries scheduled on 19 Oct 2016 through 9 Nov 2016. In addition, the intended contractor is the only source capable of meeting the surgeon’s requirements prescribed for the patient.

This will be posted on ASFI to increase competition.

7. Market Survey: This requirement is for surgical supplies

a. FAR 8.002(a)(1)(i) through FAR 8.002(a)(1)(v), which addresses supplies (including Federal Prison Industries and Ability One), is not applicable.

b. FAR 8.002((a)(2) is for Services and does not apply.

c. FAR 8.003, Use of Other Mandatory Sources, does apply. However, a search of the Federal Supply System through GSA eBuy using the search keywords of “Mobi-C” and Cervical Disc Prosthesis” did not provide any vendors.

d. FAR 8.004, Use of Other Sources, and FAR 12.1, Acquisition of Commercial Items, does apply. A Google search using the keywords “Cervical Disc Prosthesis” shows vendors are available on the open market. However, the supplies offered by LDR USA are unique for Spinal procedures. Mobi-C is the first and only cervical disc in the U.S. approved to treat more than one level of the cervical spine. The Mobi-C is different from other cervical discs, because of a unique mobile bearing core that eliminates the need for invasive bone keels and optimizes it for two-level applications.

e. A Dynamic Small Business Search was conducted with keywords using the search keywords of “Mobi-C” and “Cervical Disc Prosthesis” did not provide any vendors that can provide the same or equal services outlined by the requiring activity.

8. Procurement History:

Previous Contract or Purchase Order Number: W81K00-15-A-0008 CALL 0001 or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition:

The original requirement was competed with two BPAs awarded. The Call was not competed.

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:

Typed Name: Terry L. Parks

Position Title : Supervisor Medical Supply Technician Email address: terry.l.parks6.civ@mail.mil

Date: October 14, 2016

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: Barbara C. Nelson Position Title: Contracting Officer

Email address: Barbara.c.nelson.civ@mail.mil Date: October 14, 2016

(10 February 2016)