A.02. Justification and Approval (JA) for Other Than Full and Open Competition_Redacted.pdf

Control Number: 20-RHCO-A-541

For Official Use Only (See FAR 2.101 and 3.104-4)

(10 June 2016)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office- Atlantic (RHCO-A), Belvoir Health Contracting Cell, Fort Belvoir, Virginia.

2. Description of Action: The Womack Army Medical Center (WAMC), Department of the Operating Room is requesting approval for a new Sole Source Blanket Purchase Agreement (BPA) with Boston Scientific for three years, period of performance to begin 21 September 2020 through 20 September 2023. OMA funds will be used for purchases against the BPA Calls and prices will be firm fixed pricing on an annual basis.

3. Description of Supplies/Services: Boston Scientific was chosen for the products as they have recently trialed the Spinal Cord Stimulator, and this is the permanent implant.

The Spinal Cord Stimulator System that is implanted is essential to meet the treatment required to reduce persistent pain. Failure to provide these supplies will result in the diminished healthcare of the patient. A three-year ordering period is anticipated for the total amount of WAMC will be the only medical treatment facility covered under this BPA. Based on historical data provided by the Pain Department and the Operating Room, the annual estimate for the products and services is

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial services.

5. Reason for Authority Cited: The acquisition action is processed under 10 U.S.C.

2304(c)(1), FAR 6.302-1, Only One Responsible Source and no Other Supplies or Services Will Satisfy Agency Requirements. Boston Scientific provide related supplies for scheduled procedures in accordance with Womack Protocols, Joint Commission, American Association of Blood Banks, Department of Health and Environmental Control and College of American Patholigsts. Boston Scientific’s Spinal Cord Stimulator systems are FDA-approved to deliver both paresthesia and paresthesia-free therapy at the simultaneously. Clinical research shows that patients who have this flexibility achieve better overall pain relief.

6. Efforts to Obtain Competition: A sources sought notice was posted to BetaSam on 20 August 2020 for three days. There were no responses to the notice.

a. Effective competition. A sources sought notice was posted to BetaSam on 20 August 2020 for three days. There were no responses to the notice..

b. Subcontracting competition. Subcontracting clauses are not required for this requirement as the threshold is under the Simplified Acquisition threshold.

Control Number:

(Spinal Cord Stimulator System, Womack Army Medical Center, Fort Bragg, North Carolina)

(See FAR 2.101 and 3.104-4)

(28 Jan 2020)

7. Actions to Increase Competition: A sources sought notice was posted to BetaSam.gov on 20 August 2020 for three days. There were no responses to the notice.

If sources are discovered at a later date, future requirements will be competed against approved sources through BetaSam.

8. Market Research: Market research was performed using the internet and previous BPAs/Contracts to find qualified sources. Boston Scientific is the only source based on availability of products and services required by the Operating Room based on initial diagnosis of the patient’s anatomy.

9. Interested Sources: To date, no other sources have written to express an interest.

The requirement will be synopsized to indicate the intent sole-source. Any bids or proposals received in response to the notice shall be considered. A Request for Quote (RFQ) will not be posted, in accordance with FAR 5.202(a)2.

10. Other Facts:

a. Procurement history. This is a recurring requirement that has historically been sole sourced to Boston Scientific Corporation.

(1) Previous contracts with this vendor are W91YTZ-19-P-0086, W91YTZ-19-P-0133, W91YTZ-19-P-0207, W91YTZ-20-P-0034 and current “Price List” provided by the company.

(2) Sole source.

(3) FAR 6.302-1 – “Only One Responsible Source and no Other Supplies or Services Will Satisfy Agency Requirements”: 110 U.S.C. 2304(c)

(4) This sole source contract is to assist in the treatment of chronic spinal nerve pain.

Quoted special pricing for products and services is provided by company.

(5) Prior contracts for this requirement were sole source.

(6) Unusual and Compelling Urgency: Each purchase through Boston Scientific has been processed as a non-emergent requirement. These products and services are often required during duty hours and require standard handling and shipping.

(7) A sole source justification was prepared similar to this document. There are no significant changes from the previous justification.

b. Other facts. NA

9. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: ________________________________Date: ________________

Typed Name: Title:

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: ________________________________Date: ________________

Typed Name: Title:

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

Boston Scientific offers their products and services to the government from their published price commercial price list. Discounts are offered from the price list if annual or multi-year agreements are in place. Price will be evaluated on an annual basis compared to previous price lists and purchases. I hereby determine that the anticipated cost to Government for this contract action will be fair and reasonable based on published price lists and previous history.

Signature: _______________________________Date: ________________

Typed Name: Title:

14. Contracting Officer Certification: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval. Include the following statement:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: ________________________________Date: ________________

Typed Name: Title: