JA_Memo.pdf

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

1. Contracting Activity: Control Number: 15-297; The Department of Anesthesia and Operative Service (DOAOS) William Beaumont Army Medical Center is requesting approval of a sole source contract to Intergra Inc for a patient specific surgery products. Period of Performance 1 October 2015 thru 30 September 2016.

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $100,000.00

Name of Intended Contractor: Integra LifeScience Corporation Street Address: 311 Enterprise Drive City, State, Zip: Plainsboro, NJ 08536-3344 Phone: 609-936-2262

3. Description of Supplies/Services The doctor/surgeon under the Department of Anesthesia and Operative Service (DOAOS) William Beaumont Army Medical Center (WBAMC) is requesting a sole source purchase to Integra LifeScience Corporation for various invasive surgical implants products for a specific patient that will be going through surgery. The required allograft and bone tissue prescribed by the patients’ physician/surgeon and determined by the physicians to be best suited to meet the medical, health and life-style needs of the specific patient.

4. Authority Cited:

xx (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 doctor/surgeon has evaluated several vendors on implant surgical products to determine the ones that will best meet the patient's needs during surgery under FAR 13.106-1 (b)(1)(i) , Based on a comparison with similar invasive surgical implants products in the market place the surgeon in consultation with the attending surgical team has determined that the invasive surgical implants products offered by Integra Lifescience best meets the specific patients’ needs for surgery during the period of performance 1 Oct 2015 thru 30 Sep 2016 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 the surgery scheduled on various dates for the patients care. Due to the increase in patient care at WBAMC the invasive surgical implants considered mission critical and imperative to the surgeon for patients care In addition, the intended contractor is the only source capable of meeting the surgeon’s requirements prescribed to the patient.

7. Actions to Increase Competition: This is a one time purchase.

Will this be posted on ASFI to increase competition: YES

8. Market Research: This requirement is for surgical supplies (Class VIII). Details, including key word searches, are described in the Market Research Report that supports this J&A, found at PCF 01.01_Market_ Research and submitted with the J&A for review purposes. A Dynamic Small Business Search was conducted and did not identify two or more small business that can provide the same or equal product prescribed by the surgeon for the patient.

9. Procurement History:

Previous Contract or Purchase Order Number W91YU0-15-P-0038 and W91YU0-15-P-0208 Previously competed? N/A No Yes

Previous authority for less than Full & Open Competition: FAR Subpart 13.106-1 (b) (1)

10. 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.

Submitted By: Terry Parks (DOAOS) Position Title : Supervisor Operating Room Supply Purchasing Cell

William Beaumont Army Medical Center

Email address: terry.l.parks6.civ@mail.mil Date: 10 Sep 2015

PARKS.TERRY.LAMAR.1119135237 Digitally signed by PARKS.TERRY.LAMAR.1119135237 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=PARKS.TERRY.LAMAR.1119135237 Date: 2015.09.11 09:01:50 -06'00'

11. 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: Larry A. Bradbury Position Title: Contracting Officer Email address: Larry.a.bradbury2.civ@mail.mil

Date:

BRADBURY.LARRY.A.116

4241951

Digitally signed by BRADBURY.LARRY.A.1164241951 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=BRADBURY.LARRY.A.1164241951 Date: 2015.09.11 09:32:46 -07'00'