Redacted_--JA_Sole-Source.pdf

Control No: 19-RHCO-C 609 Contractor: Getinge USA Sales, LLC.

Equipment: Disposable Circuits

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: The Extracorporeal Membrane Oxygenation (ECMO) Program at San Antonio Military Medical Center (SAMMC), Joint Base San Antonio Fort Sam Houston, Texas requests a Firm-Fixed-Price contract with Getinge USA Sales, LLC.

(formerly Maquet LLC.) to purchase 96 each USA BEQ-HLS 7050 USA HLS Set Advanced 7.0 Oxygenator Disposable Circuits. The disposable circuit houses the patient’s blood and in the event of a patient suddenly requiring assistance in removing carbon dioxide and oxygenating red blood cells the circuit is the vital component of the Cardiohelp unit; hence as it is a life sustaining intervention and only used in the latter stages of heart/lung failure treatment. The funding type for this requirement is O&M DHP;

Subject to the Availability of FY20 funds.

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-P-0460. 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 the 6 Getinge USA Sales, LLC. equipment and 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 Getinge USA Sales, LLC. provided RHCO-C with a letter confirming they have no authorized distributors.

3. Description of Supplies/Services: The Extracorporeal Membrane Oxygenation (ECMO) Program at San Antonio Military Medical Center (SAMMC) requests to purchase USA BEQ-HLS 7050 USA HLS Set Advanced 7.0 Oxygenator Disposable Circuits. Gentinge USA Sales, LLC. are the only HLS Set Advanced 7.0 Oxygenator Disposable Circuits that are compatible with the Government owned Cardiohelp units/pump. The Cardiohelp unit/pump utilizes the disposable circuits in order to assist with patient mobility and wound management. The estimated value of this requirement is $2,928,000.00. This requirement is for a base period plus two (2) twelve-month option periods.

Base Period: 1 October 2019 to 30 September 2020 Value: $960,000.00 Option Period 1: 1 October 2020 to 30 September 2021 Value: $960,000.00 Option Period 2: 1 October 2021 to 30 September 2022 Value: $1,008,000.00

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) The ECMO Program at SAMMC exclusively uses the Cardiohelp pump made by Getinge USA Sales, LLC. Getinge USA Sales, LLC. is the sole manufacturer and seller of the disposable circuits needed that are fundamentally designed to interface via direct connection with the currently government owned Getige USA Sales, LLC. Cardiohelp Unit. While several companies offer heart-lung machines, Getinge is the only one who makes a transport ECMO unit that is light-weight, all-inclusive and reliable.

Approximately half of the SAMMC ECMO patients are transported in by the ECMO team.

Due to the critical nature of direct patient care and the complexity of ECMO itself, it is not feasible to change patients to a different pump after they are transported into SAMMC.

(b) Failure to award a contract to Getinge USA Sales, LLC. to provide the required disposable circuits compatible with the Cardiohelp unit/pump used in the ECMO for lung support to patients could potentially 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 disposable circuit used in this equipment occurs, it could possibly be more expensive for a one-time repair than compared to the expected cost of this contract; overall affecting direct patient care. Alternately, SAMMC could purchase new Cardiohelp cardiovascular equipment, however this new equipment could potentially result in higher 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 6 August 2019. No responses were received, however Maquet/Getinge USA Sales, LLC. 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. Due to the nature of this device, subcontracting opportunities are not available. The disposable circuit houses the patient’s blood and in the event of a patient suddenly requiring assistance in removing carbon dioxide and oxygenating red blood cells the circuit is the vital component of the Cardiohelp; hence as it is a life sustaining intervention used in the latter stages of heart/lung failure treatment. 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.

8. Market Research: Market research was conducted via; internet, brochures, literature review, a comprehensive analysis of different disposable circuits for a Cardiohelp Unit for lung assistance and the removal of carbon dioxide and oxygenating red blood cells as well as other ancillary products found on (https:/www.va.gov/nac/MedSurg/List and Federal Supply Schedules) and actual historical data. Although there are several companies that offer heart-lung machines, none of them meet the requirements of the ECMO program at SAMMC.

The ECMO program at SAMMC currently owns six (6) Getinge Cardiohelp units/pumps.

Ordering the disposable circuits from a different company would not fit the Cardiohelp machines and would require SAMMC to purchase several new heart-lung machines to fit those circuits.

9. Interested Sources: A Sources Sought for this requirement was posted to the GPE on 6 August 2019; no responses 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-P-0460 awarded-23 June 2017; Sole Source (Maquet)

W81K00-17-P-0258 awarded-6 Mar 2017; Full and Open (only one offer received—Maquet)

W81K00-17-P-0060 awarded-16 Nov 2016; Full and Open (only

W81K00-16-P-0193 awarded-22 Apr 2016; Full and Open (only

(2) The contractor did not have any distributors or other authorized vendors that could provide the required disposable circuits used with the Cardiohelp unit in the ECMO Program.

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

W81K00-17-P-0460, FAR 13.501(a)(1)(ii), sole source (Including brand name) under the authority of the simplified procedures for certain commercial items.

(4) A justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results is a follows:

As long as SAMMC owns the 6 Getinge USA Sales, LLC equipment and 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 Getinge USA Sales, LLC provided RHCO-C with a letter confirming they have no authorized distributors.

(5) Prior contract for this requirement was accomplished using full and open competition, a detailed explanation of the changed circumstances causing this action to now limit the sources. N/A

(6) An explanation of any unusual patterns were revealed by the history, e.g., several consecutive, urgent buys. N/A

(7) Justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. Getinge USA Sales, LLC. is the sole manufacturer and seller of the disposable circuits needed that are fundamentally designed to interface via direct connection with the currently government owned Getinge USA Sales, LLC. Cardiohelp Unit. There are no know authorized dealers nor that have expressed an interest in this acquisition.

11. 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.

Kathryn Negaard Date:

22 Aug 2019

Adult ECMO Program Coordinator Signature:

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.

Kathryn Negaard Date: 22 Adult ECMO Program Coordinator Signature:

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. A price analysis will be conducted to compare the proposed prices to competitive contracts within RHCO-C for the same or similar requirements.

This determination will be made using the following: IGCE.

As a part of this basis, in accordance with FAR 15.403(b) (3) certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Jamie M. Brunner Date:

4 September 2019

Contracting Officer Signature:

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

Jamie M. Brunner Date: 4 September 2019

Contracting Officer Signature:

Approval

Based on the foregoing justification, I hereby approve the procurement of Getinge USA Sales, LLC., for estimated amount of $2,982,000.00, of USA BEQ-HLS 7050 USA HLS Set Advanced 7.0 Oxygenator Disposable Circuits on a sole source basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the requirement herein described have otherwise been authorized for acquisition.

Liza J. Esmond Date:

Special Advocate for Competition Signature: