BIOFIRE_JUSTIFICATION_AND_APPROVAL_FY20_Redacted.pdf

Control # 19-RHCO-C-635

For Official Use Only

(See FAR 2.101 and 3.104-4)

Page 1 of 5 (25 February 2016)

Justification and Approval

For Other than Full and Open Competition

1. Contracting Activity: Regional Health Contracting Office – Central (RHCO-C), at Carl R.

Darnall Army Medical Center (CRDAMC), Fort Hood, TX 76544

2. Description of Action: Carl R. Darnall Army Community Medical Center (CRDAMC) requests a base, plus one (4) option year firm-fixed-price, contract for Assay Test Kits for the

Government-owned BioFire Diagnostics, Inc., Film Array System used in the Microbiology

Laboratory. This action will be accomplished through the use of a firm-fixed-priced. Funds used will be OMA.

3. Description of Supplies/Services: This requirement is for Assay Test Kits for Carl R.

Darnall Army Medical Center (CRDAMC), Fort Hood, Texas 76544. The total estimated value of this proposed action is approximately . The requirement Period of Performance is 01 October 2019 – 30 September 2020, including four (4) twelve-month option periods through 30 September 2024.

Base Period: 01 October 2019 to 30 September 2020 Value:

Option Period 1: 01 October 2020 to 30 September 2021 Value:

Option Period 2: 01 October 2021 to 30 September 2022 Value:

Option Period 3: 01 October 2022 to 30 September 2023 Value:

Option Period 4: 01 October 2023 to 30 September 2024 Value:

Total:

The base year and the options are Subject to Availability of Funds.

4. Authority Cited: In accordance with FAR § 8.405-6(a)(i)(b), Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

5. Reason for Authority Cited:

(a). Technical data packages, specifications, engineering descriptions, statements of work or purchase descriptions for molecular gastroenterology, respiratory and blood culture assay test kits suitable for full and open competition have not been developed and are not available. This item is proprietary. BioFire is the only FDA-cleared sample-to answer test capable of simultaneously testing for 20 respiratory pathogens in one sample if approximately one hour.

The Government owns the BioFire Film Array System on which the test kits will be used.

BioFire Diagnostics, Inc. is the manufacturer and sole authorized distributor of the molecular gastroenterology, respiratory and blood culture assay test kits for the BioFire Film Array

Systems required for this procurement. BioFire owns patented rights, number 8,394,608, covering the Film Array system. BioFire is currently available on GSA contract number V797D-

30085.

Page 2 of 5 (25 February 2016)

BioFire Diagnostics

6. Efforts to Obtain Competition: For future actions, the Government will reassess the market for available contractors, will include issuing a source sought, and posting competitive solicitation for the requirement, on the Government Point of Entry, i.e. Federal Business

Opportunities.

7. Actions to Increase Competition: Any future requirements shall, also, try to be procured through full and open competition on the Government Point of Entry. The life cycle replacement of the Bio Fire Film Array System is five years. When the current system equipment becomes obsolete or when equivalent equipment becomes available every effort shall be made to increase competition. CRDAMC will continue to evaluate the capabilities of other vendor's products and re-procure the system equipment that provides the best value to the Government. The government will continue to seek new resources that will satisfy these requirements through continued market research, requests for Statements of Capability, and telephonic inquiries. The government will monitor industry for diversified test kits to fit the current Government owned

BioFire Film Array System in order to overcome barriers to competition.

8. Market Research: Market research was conducting using the previous contract W81K00-15-

F-0124, which indicates that same/similar components were purchased on contract. A Sources

Sought was posted to the Federal Business Opportunity and GSA Ebuy on 16 August 2019. No potential vendors responded to the sources sought. Research conducted within the past 90 days indicates Category List 65 VII, In-vitro Diagnostics, Reagents, Test Kits and Test Sets, SIN 555-

6 Microbiology has ten small business concerns, however, due to the proprietary nature of the assay kits being procured, there are no small businesses able to provide them. BioFire

Diagnostics, Inc. is the sole authorized distributor of the assay test kits for the BioFire Film

Array System required for this procurement. Based on the findings, only one vendor will be able to satisfy the government's requirement.

9. Interested Sources: Due to the negative impact on the MTF, meeting the requirement of a

Assay Testing Kit on 01 October 2019, and in the best interest of the Government; the only acceptable vendor is the current vendor BioFire Dianostics,

10. Other Facts:

a. Procurement history

W81K00-15-F-0124:

(1) Total dollar value was $ (15 July 2015 to 30 September 2019).

(2). Competitive Status of these actions: N/A.

Page 3 of 5 (25 February 2016)

(3). Authority previously cite if less than full and open competition was used: Sole

Source Acquisition IAW FAR 13.106-1-(b)(1)(i)

(4). If 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: Researched was conducted using three (3) potential vendors under Category List 65 VII, Invitro Diagnostics, Reagents, Test Kits and Test Sets, SIN

555-6 Microbiology deeper including checking the price list to ensure these items were not available. Vendors researched included:

a. Abbott Laboratories, Inc. does not offer molecular gastroenterology, respiratory and blood culture assays which are compatible with the patented BioFire Film Array System.

b. Bio-Rad Laboratories does not offer molecular gastroenterology, respiratory and blood culture assays which are compatible with the patented BioFire Film Array System.

c. Cepheid does not offer molecular gastroenterology, respiratory and blood culture assays which are compatible with the patented BioFire Fill Array System.

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

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

(7). If a 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. N/A.

b. Other facts. N/A.

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.

Signature: Date: 1_3 S_e_p_te_m__be_r 2_01_9

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.

Page 4 of 5 (25 February 2016)

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. Fair and reasonable pricing will be determined by using price analysis and the

Independent Government Estimate. As part of the basis certified cost or pricing date is not required per FAR 15.403-1(b)(3).

Signature: Date: _

Typed Name: Title:

14. Contracting Officer Certification:

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

Signature: Date:

Page 5 of 5 (25 February 2016)

Approval

Based on the foregoing justification, I hereby approve the contract for the procurement of the

Biofire Diagnostics, Assay Test Kits for CRDAMC, on an other than full and open competition basis, pursuant to the authority of FAR§ 8.405-6( a )(1 )(i)(b ), only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized for a total with a total dollar value of $ , subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: Date: