LUCAS 3 Limiting Competition at or Below the SAT (Stryker Medical) REDACTED.docx

For All Actions At or Below the Simplified Acquisition Threshold Use for FAR Part 8, FAR Subpart 13.1, or FAR Part 16, Including Brand Name Remove or Replace Text Control No: 20-RHCO-326

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: Regional Health Contracting Office-Central

2. Description of Action:

Nature: X New Requirement Xx

Order #_______ against a single award IDC Contract Modification # _______ to existing PO/TO/DO/Call Order #________________

Pricing/Contract Type: X Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) Other Funds: DHP

FY: 20

Name of Proposed Contractor(s) and Address:

_Stryker Medical_________________________________________ __PO Box 93308__________________________________ __Chicago, IL 60673-3308________________________

Brand Name Buy: x Yes No

3. Description of Services or Supplies: Lucas 3 is a chest compression system that performs automated compressions during CPR on a patient in cardiac arrest. Minimizes care provider contact during CPR. Can decrease transmission of disease during CPR. ITEM RECOMMENDED in the DoD COVID-19 PRACTICE MANAGEMENT GUIDE. Purchase request is for three LUCAS systems. They will be pre-positioned in the hospital, with one in the Emergency Department, one in cath lab, and the third possibly with the Code Blue Team or ECMO team. The quote from Stryker includes one PCI back plate, which is a specialty carbon fiber back plate to be used in the cath lab… it allows for imaging using fluoroscopy. The quote also includes power supplies, rechargeable batteries, and an initial supply of disposable suction cups (the part that touches the patient during compressions). Total cost is $50,436.96 For Actions without Options:

Period of Performance: 3 weeks ARO Total Value: $ 50,904.96

For Actions with Options*:

FAR Clause 52.217-8 option: _______ to _______ or (insert completion date) Value: $________ Total: $________

4. Authority:

X FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

Or

FAR 8.405-6(a)(1)(i)(B) and 8.405-6(b)(1)Brand Name FAR 8.405-6(a)(1)(i)(A) Urgency FAR 8.405-6(a)(1)(i)(B) Only One Source is Capable FAR 8.405-6(a)(1)(i)(C) Logical Follow-on

Or

FAR 16.505(b)(2)(i)(B) Only One Awardee is Capable FAR 16.505(a)(4) Brand Name FAR 16.505(b)(2)(i)(A) Urgency FAR 16.505(b)(2)(i)(C) Logical Follow-on FAR 16.505(b)(2)(i)(D) Minimum Guarantee

5. Reasons for Authority Cited:

a. Stryker is the preferred vendor because BAMC IMD was only willing to approve the request for the LUCAS devices if the Bluetooth/wifi capabilities were disabled. Stryker is the only vendor who is able to provide the service of disabling the Bluetooth. Physio-Control is the original manufacturer of the device, but was bought out by Stryker.

b. LUCAS 3 is the only brand that will meet the Government’s needs because Stryker is the only company that can disable the Bluetooth/wifi feature. LUCAS 3 devices are already in use at multiple DoD facilities around the world. The LUCAS 3 has been flight tested already by the U.S. Army Aeromedical Research Laboratory in Fort Rucker, AL. It received a Certification for Airworthiness Eligibility on U.S. Army Rotary-Wing Aircraft on 16 April 2019.

c. During this time of COVID-19 patients, entry into a patient’s room is limited to vital staff, which may mean a reduction in the Code Blue Team respondents. CPR is an aerosol generating procedure. Not having an automated compressor device means that more staff will potentially be exposed to diseases during times of CPR.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, X apply and will be followed, or do not apply due to an exception at 5.202 ______________________.

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A) Action is NOT a brand name restriction and is under $150K, no posting required Action is a brand name restriction, under $25K, no posting required X Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

FAR 8.405-6(b)(3)(iii)(B)

7. Market Research: Market research was completed in February and March 2020. I was able to get quotes from at least six different vendors, including GSA (Grainger, Wrigglesworth), small businesses (Panakeia, Janz, 1 Source Solutions) and large business (Stryker). I researched and received quotes for two different products (LUCAS 3 and Defibtech). BAMC IMD was only willing to approve the request if the Bluetooth/wifi feature was disabled. The only company that was able to complete the service of disabling the Bluetooth was Stryker. The LUCAS 3 is the only device that is certified for airworthiness by the US Army.

8. Other Facts: None.

9. Technical/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.

Typed Name:

Date:

Title:

Signature:

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name: Marc Flores Date:

Title: Contracting Officer Signature:

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