Limiting-Competition_JA_Redacted.pdf

Control No: 20-RHCO-469

Version – February 2017

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

1. Contracting Activity: Regional Health Contracting Office-Central, 3160 McIndoe, Bldg 1103, JBSA Fort Sam Houston TX

2. Description of Action:

Nature: XX New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number 001151687 Blanket Purchase Agreement (BPA) Number _______________ Order/BPA# _______ against FSS Contract #_____ _________ Order #___________ against Multiple Award IDIQ Contract Name or #______________

Order #_______ against a single award IDC Contract

Modification # _______ to existing PO/TO/DO/Call Order

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

Funds: XX Operations & Maintenance, Army (OMA) Other Funds: ________

FY: 20

Name of Proposed Contractor(s) and Address:

Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454-9141 800-458-5813

Brand Name Buy: XX Yes No

3. Description of Services or Supplies: William Beaumont Army MedicalCenter Ft.

Bliss, TX request a firm-fixed price contract for Nova Statstrip. The Nova Statstrip glucose meters are the only FDA approved glucometers for use on critically ill patients receiving intensive medical intervention. These meters ensure compliance with accrediting agencies and provide superior patient care.

Sole Source contract for Glucose Meters for William Beaumont Army Medical Center, Fort Bliss, Texas

Delivery Date: 30 September 2020 Total Value: $67,375.00

4. Authority:

XX 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. Nova Biomedical Corporation is the only manufacturer of Nova Statstrip, whole blood glucose meters that has obtained FDA 510(k) clearance for use with capillary blood from critically ill patients. The use of glucometers not FDA cleared for use on the critically ill results in the organization falling out of compliance. WBAMC is accredited by the Joint Commission and the College of American Pathologists, in addition to following FDA guidelines. Compliance with these accrediting organizations is paramount, particularly when it pertains to treating critically ill patients. As these are the only FDA cleared meters, to provide superior care while maintaining compliance the Nova StatStrip glucometers are the only option available.

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, XX 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 XX 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 6.305(f) FAR 8.405-6(b)(3)(iii)(A)

FAR 8.405-6(b)(3)(iii)(B) FAR 8.405-6(b)(3)(iii)(C) FAR 16.505(a)(4)(iii(C)

7. Market Research: The Nova Statstrip glucose meters are the only FDA approved glucometers for use on critically ill patients receiving intensive medical intervention.

These meters ensure compliance with accrediting agencies and provide superior patient care. Nova Biomedical Corporation is the only manufacturer of whole blood glucose meters that has obtained FDA 510(k) clearance for use with capillary blood from critically ill patients and is the sole distributor of the FDA approved Nova StatStrip glucometers in the United States.

8. Other Facts: The Centers for Disease and Control Clinical Laboratory Improvement Amendments (CLIA) is the ultimate governing body for laboratory practices and procedures. The CLIA documents, laws and regulations were searched for manufacturers who meet the criteria required for whole blood testing on the critically ill.

Other whole blood glucose meter manufacturers were also researched to include Abbott and Roche, neither of which met the criteria required

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: 21 July 2020 Title:

Signature:

7/21/2020

X Right-Click "Signature Setup"

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 the IGCE.

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: Emerita Torres Date:

Title: Contracting Officer

Signature:

X Right-Click "Signature Setup"

, , Simiilar equipment and historical data.

TORRES.EMERIT

A.1017361771

Digitally signed by

TORRES.EMERITA.101736177

Date: 2020.07.22 07:17:17 -05'00'