JOFOC_AG-6395-B-17-0014.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

In accordance with the authority granted under FAR Part SAP, this request for a noncompetitive acquisition is hereby submitted for consideration for acquisition approval.

IDENTIFICATION OF THE AGENCY AND THE CONTRACTING

ACTIVITY:

Requesting Agency:

USDA APHIS VS

105 Corporate Drive Suite H Frankfort KY 40601

Contracting Activity:

USDA, APHIS, MRPBS, ASD

Minneapolis Procurement Branch Butler Square, Fifth Floor 100 North 6th Street Minneapolis, MN 55403

NATURE AND/OR DESCRIPTION OF THE ACTION BEING

APPROVED:

The proposed action will consist of the purchase of Ellie Brucella Abortus FPA Test Kits (1,000 tests per kit). 10ea kits containing 1,000 tests per kit to be used in conjunction with the BioTek Synergy 2 Fluorescence Polarization Assay (FPA) instruments in our approved State-Federal brucellosis laboratories. Period is not to exceed five years. All cost to include but not limit to: overhead, general and administrative, profit, and insurance, transportation cost is not to exceed $200.00 per maximum order of 10 kits.

Approval is requested to use other than full and open competition to establish a 5 year Blanket Purchase agreement for Brucella Abortus Fluorescence Polarization Assay (FPA) Test Kits from Ellie LLC to support the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services' (VS) continued efforts to control and eliminate brucellosis from domestic livestock and wildlife populations in the United States.

The proposed contract type is a Firm-Fixed Price contract.

A DESCRIPTION OF THE SUPPLIES, EQUIPMENT, OR SERVICES

REQUIRED TO MEET AGENCY NEEDS (INCLUDING THE ESTIMATED

VALUE OF THE ACQUISITION INCLUSIVE OF OPTIONS):

10ea kits containing 1,000 tests per kit

IDENTIFICATION OF THE STATUATORY AUTHORITY PERMITTING

NONCOMPETITIVE ACQUISITIONS:

Authority 41 U.S.C. 253(c)(1) FAR Part 6.302-1 The property or services needed by the executive agency are available from only one responsible source and no other type of property or services will satisfy the needs of the executive agency

Ellie LLC is the sole source for the Brucella Abortus FPA Test Kit manufactured for use with the BioTek Synergy 2 FPA instruments. APHIS Veterinary Services. VS' wide-ranging responsibilities include coordinating national animal health emergency preparedness and disease response, diagnosing foreign and domestic animal diseases, monitoring the health and disease status of U.S. livestock and poultry, directing national programs to eradicate selected animal diseases, and managing key activities in a national network of laboratories to perform day-to-day testing and provide emergency response capability.

A key component of assuring VS accomplishes these responsibilities is the use of the most efficient, effective, and accurate disease diagnostic technology and testing.

Use of accurate disease diagnostic testing technology is paramount to identifying and eradicating brucellosis in a timely manner. The Surveillance Program currently uses a number of tests in the serological diagnosis of brucellosis. Some of these tests are prone to subjectivity and lack specificity for accurately identifying truly diseased animals. The FPA test, a test used in human medicine for years, has been adapted for use in the field and the laboratory for the detection of brucellosis in cattle, bison, swine and cervids.

A DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES

USE OF THE AUTHORITY CITED:

APHIS has evaluated the FPA and found it to be a highly sensitive and specific test for detecting brucellosis infected animals. FPA technology has a Transparent trail of published research that documents its accuracy and repeatability when used for cattle, bison, swine and cervids. The data from various studies clearly show that the FP A performs as well as or better than the conventional serological tests for brucellosis. In addition, it is faster to perform and produces quantitative test results using an automated instrument which removes much of the subjectivity inherent in other serological tests.

The Brucella Abortus FP A Test Kit made by Ellie is a rapid, easy, accurate and cost effective diagnostic method that can be used to detect antibodies against Brucella abortus. The Ellie Brucella Abortus FP A Test is the only validated FPA diagnostic test officially approved for use in the USDA APHIS VS State-Federal Brucellosis Eradication Program to detect brucellosis in cattle, bison, and swine. The FP A is approved as both a presumptive and confirmatory test, and has the highest degree of sensitivity and specificity in accurately identifying truly diseased animals. The acquisition of the Ellie LLC Brucella Abortus Test Kits will enhance the efficiency and effectiveness of the National Brucellosis Surveillance Program which currently includes the diagnostic testing of approximately six million samples annually. The FPA has been incorporated into the standardized bovine brucellosis slaughter surveillance sample testing protocol currently being implemented in our laboratories.

A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS IS

PRACTICABLE, INCLUDING WHETHER A NOTICE WAS, OR WILL BE,

PUBLICIZED AS REQUIRED BY FEDERAL ACQUISITION REGULATION

(FAR) SUBPART 5.2, AND IF NOT, WHICH EXCEPTION UNDER FAR 5.202

APPLIES:

Fedbizopps Special Notice PR-17-824504 Cls 11/02/2016 No capability statements were received.

A DETERMINATION BY THE CONTRACTING OFFICER THAT THE

ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND

REASONABLE, AND THE BASIS FORTHAT DETERMINATION:

Price is considered fair and reasonable based on historical pricing of $1,100.00 per 1,000kts.

Previous orders –

AG-6395-P-16-0094 10KTS @ – 1,100.00 = $11,000.00

AG-6395-P-14-0166 4KTS @ $1,100.00 = $4,400.00

AG-6395-P-15-0027 8KTS @ $1,100.00 = $8,800.00

A DESCRIPTION OF THE MARKET RESEARCH CONDUCTED (FAR

PART 10) AND THE RESULTS, OR AN EXPLANATION OF THE REASON

MARKET RESEARCH WAS NOT PERFORMED:

Market research was performed by APHIS VS.

Consultations were held with brucellosis laboratory personnel regarding FP A testing currently being conducted and test kits in use. All patties consulted are currently using the Ellie Brucella Abortus FPA Test Kit. No other FPA test kit is currently validated and licensed and no other licensed distributor for the Brucella Abortus FPA Test Kit has been identified at this time.

The competitive market for this test kit is nonexistent at this time due to the fact that there is only one manufacturer and distributor of the Brucella Abortus FPA Test Kit.

ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL

AND OPEN COMPETITION - FAR 6.303-2(a)(9):

a. Procurement History: Diachemix Brucella Abortus FP A Test Kits have been purchased in the past by USDA APHIS VS for use in the Brucellosis Program.

This manufacturer went out of business.

b. Product Availability: Readily available at this time.

c. Efforts to Retrieve Information: Information retrieved regarding product technical data, usage, application results and other info1mation obtained during this market research are available to potential future sources to encourage and assist them in competing for future requirements.

d. Development of Acquisition Data Suitable for Competition: The Ellie Brucella

Abortus FPA Test Kit is the only validated and licensed FPA that has been approved by USDA for official use in the Brucellosis program for testing of cattle, bison and swine sera. USDA APHIS VS has previously requested and received a validation rep01t which demonstrates the accuracy and reliability of the Ellie Brucella Abortus FP A Test Kit used with the BioTek Synergy 2 FPA instrument.

Data indicated that the Ellie Brucella Abortus FPA Test Kit used in conjunction with the Synergy 2 FP A instrument provide rapid, accurate, and cost-effective detection of Brucella abortus.

e. Harm to the Government in Unusual and Compelling Urgency: APHIS developed and implemented a Cooperative State-Federal Brucellosis Eradication and Surveillance Program that is vital to the livestock industry for the protection of animal health, public health, food safety, and the economic viability of the U.S.

livestock industry. Disease testing to identify brucellosis infected animal populations is vital to the eradication and surveillance mission of the program.

f. This program has a positive impact on public and animal health and national and international marketability of U.S. livestock.

A LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN

INTEREST IN THE ACQUISITON:

No capability surveys were received.

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,

EQUIPMENT, OR SERVICES REQUIRED:

Will continue to synopsize new requirements on Fedbizopps to monitor possible changes in the market.