JA_Sole-Source_Redacted_.pdf

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: Regional Health Contracting Office – Central (RHCO-C)

2. Description of Action: Cardiology Catheterization and Electrophysiology Labs at San Antonio Military Medical Center (SAMMC) requests a firm-fixed-price contract with Biosense Webster Inc. The Government projects award for 1 October 2019, Defense Health Program (DHP) funds will be used.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

This action is a follow-on to contract W81K00-17-D-0009. That contract was competed under authority 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 items. Paragraph 7, “Actions to Increase Competition” of the previous justification, stated: As long as SAMMC owns this equipment and Biosense Webster Inc. does not have any authorized distributors, it is expected this requirement will continue to be solicited on a sole-source basis. However, the government will continue to monitor the marketplace for any new entrants.” Those actions were accomplished by a Sources Sought Notice posted on FedBizOpps, Market Research and Acquisition History, furthermore Biosense Webster Inc. provided RHCO-C with a letter confirming they have no authorized distributors.

3. Description of Supplies/Services: Biosense Webster catheters are the only catheters compatible with the Government owned Carto XP EP Navigation, Smart Ablate Radiofrequency Therapy System and Cool Flow Pump. This requirement is for a base period plus two (2) twelve-month option periods.

Base Period: 1 October 2019 to 30 September 2020 Option Period 1: 1 October 2020 to 30 September 2021 Option Period 2: 1 October 2021 to 30 September 2022

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited:

(a) Biosense Webster Inc. is the sole manufacturer and seller of these catheters which are regular expendable proprietary items that are fundamentally designed to interface via direct connection with the Biosense Webster CARTO 3 System Patient Interface Unit (PIU), Smart Ablate Radiofrequency Therapy System and Cool

Flow Pump System government owned equipment.

(b) Failure to award a contract to Biosense Webster Inc. to provide the required cardiac catheters compatible with the CartoXP-EP Navigation and Ablation System used in the Cardiovascular Procedures Services Department could jeopardize the SAMMC Cardiovascular’s mission of providing accurate and timely care to its beneficiary population. If the contract is not awarded in time and a failure of any other catheter used in this equipment occurs, it would potentially be more expensive for a one-time repair than compared to the expected cost of this contract. Alternately, SAMMC could purchase new Carte XP EP Navigation and Ablation System, rendering the current equipment unusable. This new equipment would be higher in cost than the expected cost of this contract.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought notice was posted to the Government Point of Entry (GPE) FedBizOpps on 28 Feb 2019. No responses were received, however Biosense Webster Inc. provided a letter confirming that there are no authorized distributors. Based on market research and the results of the Sources Sought Notice, competition is not anticipated for this requirement. The Government will continue to assess the market for new entrants.

7. Actions to Increase Competition: After award, this justification will be available at the GPE, www.fedbizopps.gov. If in the future other compatible products become available, market research will be performed to consider other sources that meet or exceed the current requirement. Additionally, an evaluation of the market will be conducted prior to any renewal related to this requirement. Pricing, availability, and any alternative solutions will be the focus of that research. The contract file will be properly documented with any findings. In accordance with FAR Subpart 19.705-2, the Contracting Officer has taken actions to determine whether the proposed contractual obligation requires a sub-contacting plan. According to System for Award Management (SAM) the incumbent contractor is not a small business and a sub-contracting plan does apply.

8. Market Research: Market research was conducted via; internet, brochures, literature review, a comprehensive analysis of different neurological implants, rods, cages, and other ancillary products found on (https:/www.va.gov/nac/MedSurg/List and Federal Supply Schedules), surgeon experiences and actual historical data usage. However, this research did not reveal any other sources.

9. Interested Sources: A Notice of lntent to Sole Source this action to Biosense Webster Inc., was posted to the GPE on 19 April 2019. No response were received.

Future requirements of this type will be researched within the market to ascertain if additional vendors have entered the market offering the required products. To date, no other sources have written to express interest in this acquisition.

10. Other Facts:

a. Procurement History:

(1) Contract numbers of the last several contracts for these same requirements.

W81K00-17-D-0009, Sole Source, awarded 28 Aug 2017 http://www.fedbizopps.gov/ http://www.va.gov/nac/MedSurg/List

W81K00-13-D-0011, Brand Name or equal, awarded 1 Oct 2013 W81K00-11-P-0594, Unrestricted

(2) The competitive status of these actions.

W81K00-17-D-0009, Sole Source W81K00-13-D-0011, Brand name or equal

(3) Authority previously cited if less than full and open competition was used.

W81K00-17-D-0009, FAR 13.501(a)(1)(ii), sole source (Including brand name) under the authority of the simplified procedures for certain commercial items.

(4) As with this requirement, the contractor, Biosense Webster Inc. did not have any distributors or other authorized vendors that could provide the required cardiac catheters compatible with the CartoXP-EP Navigation and Ablation System used in the Cardiovascular Procedures Services Department.

(5) Biosense Webster Inc. equipment is installed in many Department of Defense medical treatment facilities, to include the hospitals at Fort Bliss, Texas; Fort Sill, Oklahoma; Fort Leonard Wood, Missouri; Goodfellow AFB, Texas; Keesler AFB, Mississippi, Beale AFB, California, and F.E. Warren AFB, Wyoming. Some of these contracts for these type of catheters were issued on a sole-source basis;

those that were competed resulted in the receipt of only one offer.