SAP Sole Source Biomerieux Biofire Special Notice r1.pdf

SIMPLIFIED ACQUISITION SOLE SOURCE JUSTIFICATION

FOR ACQUISITIONS USING SIMPLIFIED ACQUISITIONS

Activity: The Department of Health and Human Services, Indian Health Service (IHS) proposes to enter into a purchase order on a basis of other than full and open competition for the following acquisition as implemented by FAR Subpart 13.5.

1. Requisition#: IHS1486461

2. Description of Supplies or Services:

The Phoenix Area BioMedical Engineer Department is procuring for BioFire Filmarray Torch molecular diagnostic system for the laboratory department at the Hopi Health Care Center (HHCC) located in Polacca, AZ. Molecular diagnostics is a technique used to analyze biological markers in the patient’s genetic code by applying molecular biology to medical testing. This technique is used to diagnose, monitor, and decide which treatment will work best for the patient.

1. 1-Each, BioFire FilmArray Torch Molecular Diagnostic System, Part No. HTFA-ASY-0001

2. 5-Year, BioFire FilmArray Torch Extended Warranty Services

3. Shipping and Installation Services

3. Estimated Value of Procurement:

Base and Four Option Years: $78,538.00

4. Recommended Sources:

Biomerieux Inc 515 South Colorow Drive Salt Lake City, UT 84108

UEI SAM: HCNVCMEG9NL6, TIN: 43-1109770

5. Reason for Sole Source/Limited Sources/Expedited Processing:

[X] Only one source (unique capabilities) [ ] Proprietary drawings, specifications, and/or engineering data, patents, copyrights.

[ ] Brand Name essential to the Government’s needs.

[ ] Standardization Program supported by Agency Head Determination and Findings (D&F).

[ ] Unusual and Compelling Urgency (limited sources) [ ] Authorized or required by statute

6. Justification Narrative:

The BioFire FilmArray Torch analyzer are unique in performing molecular diagnostic testing using the BioFire FilmArray Panel Reagents. There is no compatible commercial BioFire FilmArray Torch analyzer that will work with the Biofire Panel Reagents manufactured to be used with the Biofire FilmArray Torch analyzer. Biomerieux has provided us a Sole Source Justification letter stating the Biofire FilmArray Torch analyzers and Panels Reagents are only available through Biomerieux Inc.

Phoenix Area Division of Acquisition Management has awarded a Area Wide BPA No 75H71224A00007 with Biomerieux Inc for BioFire FilmArray Panel Reagents.

7. Impact to the Government if not awarded in accordance with the above:

An open competition to complete the work would cause intolerable delay to the HHCC Laboratory Department and would cause undiagnosed patient health risk to the Indian Health Service patients. The requirement cannot be modified in any manner to increase competition due to patient health risk.

8. Program Office Certification

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs or requirements, or other rationale for limited sources, are accurate and complete.

Official Name & Title Signature Date

Project Officer

Project Officer’s Immediate Supervisor

9. Contracting Officer Certification

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name Signature Date

Contracting Officer

10. OPDIV Competition Advocate Approval

This is to certify that the justification and find that it adequately supports other than full and open competition.

Official Name Signature Date

*See Attached Applicable FAR References 11.104, 11.105, 6.302-1, 6.303-1 & 6.303-2

*6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

(a) Authority.

(1) Citations: 10 U.S.C. 2304(c) (1) or 41 U.S.C. 253(c) (1).

(2) When the supplies or services required by the agency are available from only one responsible source, or, for DOD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other

Signed

Signed

Signed type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

(i) Supplies or services may be considered to be available from only one source if the source has submitted an unsolicited research proposal that-

(A) Demonstrates a unique and innovative concept (see definition at 2.101), or, demonstrates a unique capability of the source to provide the particular research services proposed;

(B) Offers a concept or services not otherwise available to the Government; and

(C) Does not resemble the substance of a pending competitive acquisition. (See 10 U.S.C. 2304(d)(1)(A) and 41 U.S.C. 253(d)(1)(A).)

(ii) Supplies may be deemed to be available only from the original source in the case of a follow-on contract for the continued development or production of a major system or highly specialized equipment, including major components thereof, when it is likely that award to any other source would result in-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition;

or

(B) Unacceptable delays in fulfilling the agency's requirements. (See 10 U.S.C. 2304(d)(1)(B) or 41 U.S.C. 253 (d)(1)(B).)

(iii) For DOD, NASA, and the Coast Guard, services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition;

or

(B) Unacceptable delays in fulfilling the agency's requirements. (See 10 U.S.C. 2304(d)(1)(B).)

(b) Application. This authority shall be used, if appropriate, in preference to the authority in 6.302-7; it shall not be used when any of the other circumstances is applicable. Use of this authority may be appropriate in situations such as the following (these examples are not intended to be all inclusive and do not constitute authority in and of themselves):

(1) When there is a reasonable basis to conclude that the agency's minimum needs can only be satisfied by-

(i) Unique supplies or services available from only one source or only one supplier with unique capabilities; or

(ii) For DOD, NASA, and the Coast Guard, unique supplies or services available from only one or a limited number of sources or from only one or a limited number of suppliers with unique capabilities.

(2) The existence of limited rights in data, patent rights, copyrights, or secret processes; the control of basic raw material; or similar circumstances, make the supplies and services available from only one source (however, the mere existence of such rights or circumstances does not in and of itself justify the use of these authorities) (see Part 27).

(3) When acquiring utility services (see 41.101), circumstances may dictate that only one supplier can furnish the service (see 41.202); or when the contemplated contract is for construction of a part of a utility system and the utility company itself is the only source available to work on the system.

(4) When the agency head has determined in accordance with the agency's standardization program that only specified makes and models of technical equipment and parts will satisfy the agency's needs for additional units or replacement items, and only one source is available.

(c) Application for brand name descriptions. An acquisition that uses a brand name description or other purchase description to specify a particular brand name, product, or feature of a product, peculiar to one manufacturer does not provide for full and open competition regardless of the number of sources solicited. It shall be justified and approved in accordance with FAR 6.303 and 6.304. The justification should indicate that the use of such descriptions in the acquisition is essential to the Government's requirements, thereby precluding consideration of a product manufactured by another company. (Brand-name or equal descriptions, and other purchase descriptions that permit prospective contractors to offer products other than those specifically referenced by brand name, provide for full and open competition and do not require justifications and approvals to support their use.)

(d) Limitations.

(1) Contracts awarded using this authority shall be supported by the written justifications and approvals described in 6.303 and 6.304.

(2) For contracts awarded using this authority, the notices required by 5.201 shall have been published and any bids and proposals must have been considered.

To Whom It May Concern:

The BIOFIRE® FILMARRAY® TORCH System and the BIOFIRE® FILMARRAY® 2.0 System are the latest in user-friendly automated multiplex PCR. The BIOFIRE Systems integrate sample preparation, amplification, detection, and analysis into one easy-to-use system capable of massively multiplexed PCR. Each platform is a fully automated, multiplex PCR system capable of detecting multiple targets in one sample in about one hour.

BIOFIRE Systems are the only products on the market with all of the following capabilities and attributes:

1. DNA/RNA extraction, purification, and highly multiplexed PCR

2. Generation, detection, and analysis of PCR melting curves; the analysis includes a meta-analysis of all applicable controls and gene targets required for determination of a single result for each organism included in the multiplex reaction

3. Fluorescence acquisition via LED excitation

4. Sensitivity and specificity that is comparable to common commercially available real-time PCR instruments

5. Two minutes of hands-on time and a run-time of about one hour

6. Simultaneous analysis of up to 43 targets per sample (depending on the panel)

7. Scalable up to 12 modules (BIOFIRE TORCH)

8. A Windows® 10-based computer installed with analysis software

9. Full automation following initial run set-up

10. All necessary reagents for sample prep, PCR, and detection

11. The BIOFIRE TORCH and BIOFIRE 2.0 Systems are capable of running 6 FDA-cleared panels:

• BIOFIRE® Respiratory 2.1 Panel

• BIOFIRE® FILMARRAY® Gastrointestinal Panel

• BIOFIRE® Blood Culture Identification 2 Panel

• BIOFIRE® FILMARRAY® Meningitis/Encephalitis Panel

• BIOFIRE® FILMARRAY® Pneumonia Panel

• BIOFIRE® Joint Infection Panel

12. The BIOFIRE® FILMARRAY® 2.0 EZ Configuration runs the BIOFIRE® Respiratory 2.1-EZ Panel (EUA).*

The BIOFIRE® FILMARRAY®

System Sole Source Justification

*This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;

*This product has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and, *The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/ or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

FLM

1-M

KT-0017-03

For all United States Department of Veterans Affairs and State Public Health Laboratory customers as well as all other customers which are not part of the United States Government including, without limitation, the Department of Defense and its agencies; the Departments of State, Commerce, Treasury, Transportation, Interior, Agriculture, Labor, Justice, Education, Health and Human Services, and Homeland Security; the National Aeronautics and Space Administration; the General Services Administration; the Small Business Administration; the National Science Foundation; the Environmental Protection Agency; the United States Agency for International Development; the Federal Reserve System; the Nuclear Regulatory Commission; the United States International Trade Commission; the United States Trade Representative; the Federal Communications Commission; and the Government Accountability Office U.S., the BIOFIRE® Systems are only available through bioMérieux, Inc. in the USA.

If I can be of further assistance please feel free to contact me (801-736-6354 x438).

Sincerely, Dawn Rossin Vice President of Clinical Marketing, North America