C SOW Breast Implant Supplies 2-pages.docx

Statement of Work

STATEMENT OF WORK (SOW)

Project Title: Breast Implant Supplies

1. Requirements:

Phoenix Indian Medical Center has a requirement for reconstruction breast implants and expanders. The contractor shall provide Saline and Gel breast implants and that are filled with a silicone gel or saline that holds together uniformly and retains a natural shape and texture that will resemble breast tissue. The implants must have a set-fill volume for predictable results. The breast implants are pre-filled to an appropriate volume that is required by the surgeon. Offerors shall provide a full complement of volume amounts ranging from 80cc to 800cc. Saline or Gel shall not be added or removed from the implant. Tissue expanders, used in breast reconstruction shall be designed to allow for differential expansion of the breast pocket (greater expansion in the lower portion of the breast). The expander should have an integral “injection port” that allows for simplified and more convenient expansion. Offerors shall provide at a minimum a 30mm port. However, a larger port entry point is optimal due to the potential patient risk should an expander puncture occur.

The technical requirements shall include the styles described within the Price Schedule (See Section III, Price Schedule). Offerors shall provide their gel implant, saline implant and expander listing specifications for verification of the models, styles, profiles, catalog number, volume, width and projections along with their proposals.

The Contractor shall not provide substitutions or alterations to the product to be ordered without the express written consent from the Contracting Office and the approval from PIMC. The Contractor shall make no adjustments, changes, deletions or additions to the list of products to be provided without a written contract modification from the Contracting Officer. Request for modification must be submitted in writing to the Contract Specialist as specified in the Instructions to Offerors.

The Contractor shall provide product support to PIMC. The Contractor shall appoint a representative for the routine interactions with the PIMC. The Contractor shall provide a name, email address, and phone number for this individual. If the Contractor changes its appointed representative, it must notify PIMC in writing and provide the new representatives contact information. This individual shall be well-versed in the items provided by the Contractor under the contract and be able to address any technical issues/questions.

The supplies shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver of medical products for use in the United States of America. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America. Offerors must notify the Contract Specialist identified in this requirement in the event there are any non-compliance issues with the product being supplied.

Contractor shall be the original supply manufacturer, authorized dealer, authorized distributor or authorized reseller for the proposed supplies. Warranty and service are provided and maintained by the original supply manufacturer.

2. Ordering and Returns:

Ordering Frequency:

Orders will be issued on an “As Needed Basis” by the ordering activity. Contractor shall provide designated customer representative, email address, phone number or fax number

Returns:

● Upon receipt and inspection, a credit will be issued on the specified time from date of invoice:

● No credit will be issued on opened or damaged product boxes

● Freight charges will not be credited

● Returned Goods Policy may not apply to promotional Offers

The Government will utilize a provisional ordering program. The Contractor shall be responsible on providing a worksheet for Ordering Officials to place implants and expanders orders. The Ordering Officials will provide the Contractor an order no earlier than 14 days before surgery. Orders shall be delivered FOB Destination. All unused implants and expanders must be returned within 30 days after surgery and the Contractor will provide prepaid return labels and phone number with their designated transportation carrier. No additional charges or shipping may be levied against the Government in order to meet this requirement and the cost of shipping/delivery will be included in the contract. The Contractor shall provide email notices to the COR and Ordering Officials to return unused implants and expanders. The Contractor shall provide PIMC an invoice for the ordered implants and expanders.

The Government will issue BPA Call(s) as the need arises either in a lump sum for the year or for individual emergencies.