JA15-265CChangeSurgical.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: 15-265; The Department of Nursing, William Beaumont Army Medical Center, (WBAMC) is requesting approval of a sole source contract to C Change Surgical for a Surgical Slush Kit. Required Delivery Date: 24 September 2015

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $52,950.00

Name of Intended Contractor: C Change Surgical (POC): Patrick Kammer pkammer@cchangesurgical.com

Street Address: 101 N Chestnut Street STE 301 City, State, Zip: Winston Salem, NC, 27101-4046

Mobile: 336.210.5525 Office: 336.723.0200

3. Description of Supplies/Services: The total estimated value of the proposed action is $52,950.00, (1) each Slush Freezer Unit.

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:

mailto:pkammer@cchangesurgical.com

a. Approved by the FDA last January, C Change Surgical developed the SurgiSlushTM fully automated slush unit. This cost-effective technology has eliminated the need for sterile slush drapes and requires no re-sterilization of basins and other reusable components, providing significant cost savings over competitive slush systems.

b. Sterile surgical slush has applications in more than 400,000 cardiac, vascular, urologic, general and transplant surgical procedures annually in the U.S. It is used therapeutically to reduce the organ’s need for oxygen, slows cellular damage to exposed organs or tissues and can give doctors more time for treatment.

c. The expensive, disposable sterile drapes required by legacy slush units can tear in the process of mixing and maintaining the slush and can cause contamination of the sterile field. Clinicians have reported that leaking sterile drapes can not only be a cause for potential patient injury but when detected intraoperatively, these leaks can add significant time and costs to the procedure.

d. The SurgiSlushTM requires no set-up. Users create sterile slush inside sealed, secure Hospira sterile fluid bottles with no exposure to slush drapes, open basins or non-sterile environment prior to use. There is no need for basin scraping, breaking up of solidified slush or any sterile field maintenance.

e. Flexibility is another plus for the SurgiSlushTM since the slush can be produced when convenient and maintained for hours within the SurgiSlushTM or any refrigerator until needed. The mobile unit is non-sterile and can be positioned conveniently for use without taking up limited space in the sterile field.

f. The Surgical Slush Kit offered by C Change Surgical would greatly improve patient care in the Department of Nursing, William Beaumont Army Medical Center (WBAMC), El Paso, TX. 79920.

6. Actions to Increase Competition: If contract personnel can identify a similar or brand name piece of equipment or system that meets the stringent demands of required by this system please open the requirement to competition. If in the future, other manufactures are identified that can supply this highly specialized equipment full and open competition will be acceptable.

Will this be posted on ASFI to increase competition: YES

7. Market Survey: Internet searches and existing manufactures product supply catalogues were thoroughly examined.

Market research has been conducted by searching the System for Award Management (SAMS) at www.sam.gov under NAICS Code 339112 (Surgical and Medical Instrument Manufacturing).

A. Internet was extensively researched.

B. GSA E-Library, GSA Advantage and the VA website was researched for the same or similar product.

C. Other available Vendor catalogs and price lists.

8. Procurement History:

Previous Contract or Purchase Order Number: See Below Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: N/A http://www.sam.gov/

Was action competed? ID Yes X No

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. William Beaumont Army Medical Center has an exceptional research program and identified need to train highly qualified residents in the most modern research techniques. The Institute simply can’t or shouldn’t continue to operate using outdated methodology/equipment if it wants to maintain its position in the field of research and training for its residents.

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