J_and_A_under_SAT_Redacted.pdf

Control Number: 19-RHCO-C-105

(17 March 2017)

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 W81K00-19-P-0027 Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $ _249,000.00

Name of Intended Contractor: OrthoPediatrics Corp Street Address: 2850 Frontier Drive City, State, Zip: Warsaw, IN 46582

Phone:

3. Description of Supplies/Services: BAMC Operating Room Pediatrics Orthopedics Services is requesting approval of a sole source award for the Response Bandloc Spinal Deformity System spinal fixation hardware. This product is needed for pediatric patients with scoliosis requiring surgical intervention to halt the progression of spinal deformity. The Orthopediatric Response System includes the proprietary Jiminy Reduction Instruments which assist the placement of anatomically correct spinal position for fixation.

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.

Control Number: 19-RHCO-C-105

(17 March 2017)

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 OrthoPediatrics Response Bandloc System offered by OrthoPediatrics Corp best meets the specific patient needs for implant surgery. The surgeon is trained on the surgical procedures for using this implant. 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 BAMC mission. This urgent requirement is for patients with progressive spinal deformity condition which threatens impairment of vital organ systems.

6. Actions to Increase Competition: Due to the urgency of the requirement, time for ordering and shipping are less than allotted time needed. The J&A will be posted to FedBizOps no later than 14 days after the date of award. If future patients or treatments are required market research will be conducted to determine the availability of other manufacturers/distributors or other treatments.

7. Market Survey: Market research was conducted on the internet and has shown that OrthoPediatrics Corp is the sole manufacturer of OrthoPediatrics Response Bandloc System. The OrthoPediatrics is commercial in nature and no other known company manufacturers this product.

The OrthoPediatrics Response BandLoc System and Jiminy Reduction instruments are the only system proven to show a significant reduction in the rate of revision surgery due to infection.

8. Procurement History:

Previous Contract or Purchase Order Number: W81K00-18-P-0359 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:

Submitted By:

Position Title :

Email address:

Date:

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: