Sole Source Columns 2020 (002).pdf

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

(FAR Section 6.302-1)

1. Identification of the agency and the contracting activity.

Contracting Activity:

Thomas Nasvytis, Contract Specialist

USDA, FSIS, Office of Administrative Services

Procurement Management Branch

5601 Sunnyside Avenue, Mail drop 5230

Beltsville, MD 20705-5230

Requesting Activity:

Dianna Abrahamson, Technical Contact

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

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

This is sole source procurement to enter into a one year contract with four option years to procure

UPLC™ Acquity™ high resolution columns and guards manufactured by Waters Corporation.

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

The required products are UPLC™ Acquity™ high resolution columns and guards. They are used by USDA-FSIS laboratories in the process of performing regulatory testing and confirmation for antibiotics and drug residue in meat animal tissue. This analytical work is performed using Ion

Trap and Triple Stage Mass Spectrometers coupled with Liquid Chromatographs used for separation and detection of the chemical contaminates. Liquid Chromatographs, which separate the chemicals prior to mass spectral analysis, use the required analytical and guard columns -

UPLC™ Acquity™ high resolution columns and guards.

The required part numbers are as follow:

Waters part number: 176000863

Description: Acquity UPLC BEH C18 Column 2.1 X 50mm, 1.7µm particle size

Quantity: 3 columns / package

Waters part number: 176001093

Description: Acquity UPLC BEH Hilic Column 2.1 X 100mm, 1.7µm particle size

Quantity: 3 columns / package

Document Title

Justification of Limited Source or Other Than Full and

Waters part number: 186003975

Description: Acquity BEH C18 VanGuard pre-column, 1.7µm, 2.1mm x 5mm

Quantity: 3 pre columns / package

Waters part number: 186000404

Description: XTerra MS C18 Column, 125Å, 3.5 µm, 2.1 mm X 100 mm, 1/pkg

Quantity: 1 column / package

Waters part number: 186002352

Description: Acquity BEH C18, 130Å, 1.7 μm, 2.1mm x 100 mm

Quantity: 1 column / package

The initial purchase will be an approximate 3-month supply. The columns do not have an expiration date. Product usage may vary according to instrumentation suitability and methods made by the Agency. Current estimated ordering frequency will be approximately every 3 months.

The estimated value of this contract over five years is $375,000.

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

In accordance with FAR Part 6.302-1, there is 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.

Waters is the only source for the columns. The columns are specified in USDA-FSIS analytical methods and cannot be substituted.

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

Because USDA-FSIS Liquid Chromatographs must use UPLC™ Acquity™ high resolution columns and guards provided by Waters Corporation, other sources were not considered.

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

The prices proposed by Waters Corporation are in line with the prices paid previously by FSIS, and are considered fair and reasonable.

Document Title

Justification of Limited Source or Other Than Full and Open Competition

8. Description of the market survey conducted.

See #6.

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

No other facts are stated here.

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

No other sources have expressed an interest in writing in this acquisition.

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.

Because UPLC™ Acquity™ high resolution columns and guards are integral to the separation of chemicals prior to mass spectral analysis, no other sources will be sought for the foreseeable future.

12. CERTIFICATION

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

Dianna Lankford Date

Program Office and COR

4/24/2020

Thomas Nasvytis Date

Contract Specialist

4-27-2020

Document Title

Justification of Limited Source or Other Than Full and

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

Document Title

Justification of Limited Source or Other Than Full and

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 develop0ment 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.