J_and_A.pdf

Sole Source Justification for Acquisitions of surgical implants and supplies under the Simplified Acquisition Threshold ($100K)

1. Contracting Activity: Health Care Acquisition Activity, Western Regional Contracting Office (W91YU0). Justification Control Number: 16-038.

2. Description of Action: This will be a firm fixed price purchase completed in accordance with FAR Part 12, Acquisition of Commercial items.

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

Total Dollar Value: $ 100,000.00

Name of Intended Contractor: Cochlear Americas Corporation (CAGE: 06QL6: , DUNS:

130866817)

Street Address: 13059 Parkview Ave City, State, Zip: Centennial, Co 80111-6511

Phone: 1-919-619-6899

3. Description of Supplies/Services: William Beaumont Army Medical Center, El Paso, Texas, is requesting approval of a sole source purchase order for Various Surgical / Audiological Implants products used in Otolaryngology (ENT) cases, to include but not limited to, Dermalock Abutments, Disposables, Drill rental, Baha 5, Cochlear microphone, etc.

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: Based on a comparison with similar products in the marketplace, the attending surgeon has determined the Cochlear Baha 5 connect System best meets the specific patient needs for audiological defects, facilitating minimally invasive procedure. The surgeon is trained on the surgical procedures for using these Cochlear implants. The products are available and can be delivered in time for surgery preparation. The required Cochlear implant materials prescribed by the patients’ physician and determined by the surgeons to be suited to meet the repair of Otolaryngology (ENT) damage by trauma or disease needs of our Otolaryngology specific patients.

6. Efforts to Obtain 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 10 December 2015. In addition, the intended contractor is the only source capable of meeting the surgeon’s requirements prescribed for the patient.

7. Actions to Increase Competition: A BPA is not practical for this recurring requirement because there is not sufficient demand to justify one at this time.

This will be posted on ASFI to increase competition.

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. FAR 8.002(a)(1)(i) through FAR 8.002(a)(1)(v), which address supply sourcing priorities are not applicable. This product is not available through these programs/sources.

b. FAR 8.002((a)(2) is for Services and does not apply. Services that are on the Procurement List maintained by the Committee for Purchase from People Who Are Blind or Severely Disabled does not apply.

c. FAR 8.003, Use of Other Mandatory Sources, does not apply. A search of the Federal Supply System through GSA e-buy was conducted and did not identify any vendors providing this product.

d. FAR 8.004, Use of Other Sources, and FAR 12.1, Acquisition of Commercial Items, shows Brigade ALIF cages x2, Osteocel Plus 10 CC and Precept Posterior fixation are available on the open market.

e. A Dynamic Small Business Search was conducted and did not identify a company that can provide the same or equal product prescribed by the surgeon for the patient.

9. 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: N/A

10. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this justification are accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name: Noel Rosales

Position Title : Medical Supply Tech Email address: Noel.rosales.civ@mail.mil

Date: 2 December 2015

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: Contracting Officer

Email address: .civ@mail.mil Date:

Noel Rosales