Limited_Source_Justification.docx-.docx-_KIS_test_kits.docx

JUSTIFICATION OF LIMITED SOURCE

OR OTHER THAN FULL & OPEN COMPETITION

(FAR Sections 6.303)

1. Identification of the agency and the contracting activity.

Contracting Activity:

Contracting Officer USDA, FSIS, Administrative Services Division Procurement Management Branch 5601 Sunnyside Avenue, Maildrop 5230 Beltsville, MD 20705-5230

Requesting Activity:

Terry Dutko, Technical Contact USDA, FSIS, OPHS, Midwestern Laboratory 4300 Goodfellow Blvd., Bldg. 105-D P.O. Box 200005 St. Louis, MO 63120-0005

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

This is sole source procurement to Charm Sciences Incorporated for KIS™ test (Kidney Inhibition Swab), negative controls, and heating blocks (incubators). The test is an inhibition screening test for broad spectrum antimicrobial drugs such as beta lactams (both penicillins and cephalosporins), aminoglycosides, macrolides, tetracyclines, fluoroquinolones, sulfonamides, etc. in fresh or thawed kidney tissue.

The estimated minimum value is $15,000 with a maximum value of $6M for a 5-year (1-year base with four 1-year options) Indefinite Delivery Indefinite Quantity (IDIQ) contract.

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

The KIS™ test is the only commercially available screen test which has been validated and implemented agency wide in all livestock establishments. This is sole source procurement to Charm Sciences Incorporated for the required products necessary to perform FSIS field screening activities for antimicrobials in livestock:

1) KIS™ Test kits, #KIS-100

2) Negative Controls (sold in packages with 4 tablets), #NGKIS-4

3) Digital Incubator, 20 Place, #INC-110-20

4) Contractor shall specify any maintenance/replacement contingencies associated with purchase. (This would include warranty information on the model(s) proposed).

5) Contractor shall provide and continue to provide all information and any updates as to the test’s testing capability and must include at a minimum – compounds detected, applicable detection levels in comparison to established tolerances, selectivity data, all quality assurance acceptability information, certificates of analysis if applicable, shelf life of test, and storage requirements (refrigeration or freezing).

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 Citation: 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.

With the implementation of FSIS NOTICE 43-12 “USING THE KIDNEY INHIBITION SWAB (KIS™) TEST TO DETECT ANTIMICROBIAL DRUG RESIDUES IN ALL LIVESTOCK IN SLAUGHTER ESTABLISHMENTS – PHASE IV” (see website: http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/43-12.pdf) , in August 2012, all federal livestock establishments (cattle, swine, sheep, lamb, and goat slaughter establishments) are expected to use the KIS™ test for screening activities. The KIS™ test is the only commercially available screen test which has been validated and implemented agency wide in all livestock establishments. The required and necessary equipment for performing the test has been provided and implemented in over 500 livestock establishments. FSIS proposed a similar implementation scenario for all State programs that have an "at-least equal to" status. This requires all State Establishments to use the KIS™ test instead of the former FAST (Fast Antimicrobial Screening Test) as well.

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

No other sources were considered.

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

A price analysis will be conducted to determine the fairness and reasonableness of proposed prices.

8. Description of the market survey conducted.

No other sources were considered.

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.

This requirement will be synopsized in FedBizOpps.

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.

None

12. CERTIFICATION

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

Program Office /Project Manager

Dianna Abrahamson Date Program Office /COR

Contracting Officer

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 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.

Sole Source Justification Page 1 of 5 Solicitation No. FSIS-*-B-0*

Sole Source Justification Page 1 Reference No. 123A9418Q0023