Statement of Work.pdf

Solicitation Number: FSIS-12-B-12

Statement of Work August 9, 2012 Attachment 1

Background

The Food Safety and Inspection Service (FSIS), a public health regulatory agency of the U.S. Department of Agricultural (USDA), protects consumers by ensuring that meat, poultry, and egg products are safe, wholesome, and accurately labeled. The FSIS Midwestern Lab (ML) is located at 4300 Goodfellow Blvd., Bldg 105D, Saint Louis MO 63120. The ML, a FSIS regulatory laboratory, analyzes meat, poultry and egg products to ensure that they are free of adulteration.

Objective/Scope

The FSIS Midwestern Laboratory performs regulatory testing of meat, poultry and egg products for the presence Salmonella spp., Listeria monocytogenes, Campylobacter and shiga toxin producing E.coli, which are food borne pathogens. The test method for the detection of Listeria monocytogenes requires the use of a recovery isolation media containing 4% Sterile Defibrinated Horse Blood. Other test media require the use of 5% Sterile Defibrinated Sheep Blood.

Requirements

The contractor shall supply the Midwestern Lab with the following two types of vials:

- Vial containing 100 milliliters (ml) of Sterile Defibrinated Horse Blood (unit quantity shall be 1 vial) Vials containing 100 ml of Sterile Defibrinated Sheep Blood (unit quantity shall be a set of 2 vials)

The contractor must supply vials that meet the following requirements:

These products shall be aseptically collected in the United States from healthy adult donor animals.

Nutrition and health records shall be maintained by the contractor to ensure the eligibility of each donor animal.

The products shall be mechanically defibrinated without the addition of anticoagulants.

The Hematocrit level shall be 34% or above.

- The products shall be supplied in a pre-sterilized vessel with a minimum 38 millimeter (mm) cap closure to allow easy access for pipetting.

The products shall have a shelf-life of at least two weeks from the date of delivery.

Solicitation Number: FSIS-12-B-12

- A minimum 48 hour sterility test shall be completed prior to release.

The bottle shall be labeled with product name, lot or batch number, collection date and storage requirements.

Certificates of analysis shall accompany each shipment. Certificates shall list the product name and description, lot or batch number, collection date, appearance, bioburden, country of origin, shelf life, hematocrit level, signature and dates of responsible person(s). Donor animal records must be available on request.

Deliverables

The contractor shall provide the following:

1 unit quantity contains: 1 (one) - 100 ml bottle or vial Sterile Defibrinated Horse Blood; and 2 (two) - 100 ml bottles or vials Sterile Defibrinated Sheep Blood.

Products shall be shipped in refrigerated shipper for overnight deliveries.

If required, contractor shall ship bi-weekly in a refrigerated shipper for overnight delivery on Tuesdays. If the shipping or delivery date falls on a Federal Holiday other arrangements shall be agreed upon by both parties. Extra cooling packs shall be used as necessary for warmer periods of the year.

The contractor shall be required to provide a minimim of 1 unit containing 1 (one)

- 100 ml bottle or vial Sterile Defibrinated Horse Blood and 2 (two) - 100 ml bottles or vials Sterile Defibrinated Sheep Blood, and a maximum of 5 (five) units, each unit containing 1 (one) - 100 ml bottle or vial of Sterile Defibrinated Horse Blood and 2 (two) bottles or vials containing 100 ml of Sterile Defibrinated Sheep Blood, for a total of 5 (five) - 100 ml bottles or vials of Sterile Defibrinated Horse Blood and 10 (ten) - 100 ml bottles or vials Sterile Defibrinated Sheep Blood on a bi-weekly basis if required.

Product are to be delivered to this address:

USDA, FSIS, OPHS, Midwestern Laboratory Federal Center Building 105D 4300 Goodfellow Blvd Saint Louis, MO 63120