Sole_Source_-_Miseq_-_2018-_New_MWL_and_WL.docx

Document No.

PCMB 015b Document Title Justification of Limited Source or Other Than Full and Open Competition

JUSTIFICATION OF LIMITED SOURCE

OR OTHER THAN FULL & OPEN COMPETITION

(Add FAR Section Reference)

1. Identification of the agency and the contracting activity.

Contracting Activity:

Brenda Barber, Contracting Officer USDA, FSIS, Office of Administrative Services Procurement Management Branch 5601 Sunnyside Avenue, Maildrop 5230 Beltsville, MD 20705-5230

Requesting Activity:

USDA, FSIS, OPHS Midwestern Laboratory 4300 Goodfellow Blvd., Bldg. 105D St. Louis, MO 63120

And

USDA, FSIS, OPHS Western Laboratory 800 Buchanan Street Albany, CA 94710

2. Nature and/or description of the action being approved.

This is a sole source procurement to Illumina Inc. for the purchase and installation of two (2) MiSeq Systems. This is a purchase, installation, and maintenance contract.

3. A description of the supplies or services required to meet the agency’s needs (including estimated value).

Two (2) additional MiSeq systems to perform whole genome sequencing for Listeria, Salmonella, Escherichia coli and Campylobacter following the CDC sequencing methodology.

4. Identification of the statutory authority permitting other than full and open competition.

FAR 6.302-1 – Only One Responsible Source and no Other Supplies or Services will Satisfy Agency Requirements

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

FSIS is performing whole genome sequencing for Listeria, Salmonella, Escherichia coli and Campylobacter following the CDC sequencing methodology. In order maintain method and data equivalency and facilitate data sharing across multiple laboratories, CDC has standardized the system used to perform this assay. The Illumina MiSeq system is the CDC recommended and approved sequencing system.

6. .Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable.

The MiSeq system is the approved sequencing system by the CDC. Therefore, no other sources were considered due to CDC has standardized the system used to perform the required assays in order to maintain method and data equivalency and facilitate data sharing across multiple laboratories.

7. Determination by the contracting officer that the anticipated cost to the government will be fair and reasonable.

The anticipated cost to the government will be fair and reasonable in accordance with FAR part 13.106-3 (a) (2) (ii) (iii) the anticipated cost to the government will be fair and reasonable.

8. Description of the market survey conducted.

The MiSeq system is the approved sequencing system by the CDC. Therefore, no other sources were considered.

9. Any other facts supporting the use of other than full and open competition.

FSIS already has MiSeq systems in use and, therefore, the supplies and data that are produced would be compatible with the existing standards of the Agency. Comment by John Jarosh: Is this accurate?

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

There are no additional sources that expressed in writing an interest in the acquisition. CDC has standardized the system used to perform the required assays in order to maintain method and data equivalency and facilitate data sharing across multiple laboratories.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

At this time, there is nothing that the agency may do to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

12. CERTIFICATION

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

Program Office and COR

Contracting Officer

Document No.

PCMB 015b Document Title Justification of Limited Source or Other Than Full and Open Competition

STATUTORY AUTHORITIES

FOR OTHER THAN FULL AND OPEN COMPETITION

March 25, 2005

FAR 6.302-1 – Only One Responsible Source and no Other Supplies or Services will Satisfy Agency Requirements Citation: 41 U.S.C. 253(c)(1).

When the supplies or services required by the agency are available from only one responsible source and no other type of supplies or services will satisfy agency requirements, full and open competition need not be sought.

Examples:

· Laboratory equipment to meet a specific objective that is produced by only one manufacturer may be procured without competition.

· The existence of patent rights, copyrights, or secret processes.

· 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. Such circumstances must be justified and approved (This does not apply to “brand-name or equal” descriptions).

· Contracts for supplies or services that result from acceptance of an unsolicited research proposal.

· Follow-on contracts may be deemed available from only one source when it is likely that award to any other source would result in substantial duplication of cost or unacceptable delays.

6.302-2 – Unusual and Compelling Urgency Citation: 41 U.S.C. 253(c)(2).

When the agency’s need for the supplies or services is of such an unusual and compelling urgency that the government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits proposals, full and open competition need not be sought. When using this authority, quotations or offers must be requested from as many potential sources as is practicable under the circumstances.

Example: Laboratory supplies necessary for an E. coli breakout may be procured from a known source with limited, or in some cases, no competition.

6.302-3 – Industrial Mobilization; Engineering, Developmental, or Research Capability; or Expert Services Citation: 41 U.S.C. 253(c)(3).

Full and open competition need not be provided for when it is necessary to award the contract to a particular source in order to: 1) maintain a facility, producer, manufacturer, or other supplier available for furnishing supplies or services in case of a national emergency; 2) to establish or maintain essential engineering, research, or development capability to be provided by an educational or other nonprofit institution or a federally funded research and development center; or 3) to acquire the services of an expert or neutral person for any current or anticipated litigation or dispute.

Example: Special inspection services for imported products after the Chernobyl nuclear disaster were contracted on a sole source basis.

6.302-4 - International Agreement Citation: 41 U.S.C. 253(c)(4).

Full and open competition need not be provided for when precluded by the terms of an international agreement or a treaty between the United States and a foreign government or international organization.

Example: Equipment in support of an inspection agreement at a foreign processing plant may be purchased from the plants usual supplier without further competition.

6.302-5 - Authorized or Required by Statute Citation: 41 U.S.C. 253(c)(5).

Full and open competition need not be provided for when a statute expressly authorizes or requires that the acquisition be made through another agency or from a specified source. This includes the use of the 8(a) program, Federal Prisons, NIB/NISH, or GPO. Generally, a sole source justification is not required in these instances.

Example: Mailing services for the agency is provided by DC Association of Retarded Citizens, under a sole source award.

6.302-6 - National Security Citation: 41 U.S.C. 253(c)(6).

Full and open competition need not be provided for when the disclosure of the agency’s needs would compromise the national security unless the agency is permitted to limit the number of sources from which it solicits proposals. This authority should not be used merely because the acquisition is classified, or merely because access to classified matter will be necessary to submit a proposal or to perform the contract.

6.302-7 – Public Interest Citation: 41 U.S.C. 253(c)(7)

Full and open competition need not be provided for when the agency head determines that it is not in the public interest in the particular acquisition concerned. This authority should not be used without consulting the Contracting Officer first as it does require Congressional notification.

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