Sole_Source_Steris_2019PM.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:

TBD, Contracting Officer USDA, FSIS, Office of Administrative Services Procurement Management Branch 5601 Sunnyside Avenue, Mail drop 5230 Beltsville, MD 20705-5230 Requesting Activity: Leslie Manis 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 Steris Corporation to perform preventive maintenance on 25 autoclave units located in the three USDA-FSIS Field Service Labs (FSL) in St. Louis MO, Athens GA, and Albany CA. Autoclaves are used to sterilize microbiological test items and decontaminate microbial waste generated from the Agency’s regulatory testing programs. Preventive maintenance will occur twice yearly as outlined in the Statement of Work (SOW).

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

The vendor shall provide semi-annual preventive maintenance checks and calibration requirements at each of the three location provided in the SOW. The three TSL’s are accredited to ISO 17025, and a requirement to maintain the ISO accreditation is semi-annual maintenance and calibration of sterilization equipment by an ISO certified company. The sterilizers require the replacement of hardware and software that is proprietary to the company. It will require calibration and re-programming that can only be provided by company representatives.

Document No.

Document Title Justification of Limited Source or Other Than Full and

The estimated value is $104,640.68.

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.

Authority: 41 U.S.C. 253 (c) (1).

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

The vendor is the only source for the maintenance and calibration of equipment that contains hardware and software that is proprietary to the company.

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

Other sources were not considered. Use of other sources would require replacement of 25 units at a much greater cost.

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

CO to complete

8. Description of the market survey conducted.

See #6.

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

No.

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

CO to complete

Document No.

Document Title Justification of Limited Source or Other Than Full and

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.

Is there anything the program office can do in the future?

12. CERTIFICATION

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

_________________TBD Date Program Office and COR

TBD Date Contracting Officer

Document No.

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:

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).

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 No.

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.

Document No.

Document Title Justification of Limited Source or Other Than Full and

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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