Attachment 1 - Statement of Requiements and Consignment Agreement.pdf

REQUIREMENTS SUMMARY

The Defense Health Agency (DHA) has a requirement for supplies via a Firm-Fixed Price (FFP) contract in accordance with FAR Part 12, Commercial Items and FAR 13, Simplified Acquisition Procedures for breast implants and associated supplies (i.e. sizers and tissue expanders) at Naval Medical Center San Diego (NMCSD).

Quotes must meet the following technical requirements:

A. STATEMENT OF REQUIREMENTS

1. The supplies shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver 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. Quoters must notify the Contract Specialist identified in this requirement in the event there are any non-compliance issues with the products being supplied.

2. The Contractor shall provide gel breast implants/sizers that are comprised of a non-toxic silicone gel that cannot be added or removed from the implant.

3. Gel implants must be pre-filled and held together uniformly while retaining a natural shape and texture that will resemble natural breast tissue.

4. Breast implants and sizers must be malleable and must be highly resistant to stress and rupture.

5. Quoters shall provide breast implants and sizers in a full complement of volume amounts ranging from 100cc to 800cc, diameter size from 7.8 cm to 18.0 cm, and projection size from 2.4 cm to 6.7 cm.

6. Quoters shall provide tissue expanders in a full complement of volume amounts ranging from 225cc to 900cc, diameter size from 7.8 cm to 18.0 cm, and projection size from 2.4 cm to 6.7 cm.

7. The quoter shall provide a variety of round and smooth breast implants to prevent late seroma.

8. Quoters shall provide a variety of textured tissue expanders to diminish the risk of a tight scar capsule inside breast. The tissue expander must include suture tabs and an integral metallic port to allow gradual inflation of the expander over time.

9. The quoter must also provide a wide variety of gel sizers, from 100cc to 800cc, to match implant sizes provided for temporary intraoperative placement to assist with determining the desired breast implant volume to best accommodate the patient.

10. Vendor 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.

Quoters shall package the products so they are not damaged during delivery. Any damaged products need to be replaced immediately by the manufacturer.

11. Quoter shall be able to provide a one-for-one exchange of consignment implants to meet the specific size of the request.

12. Quoters shall present their product listing for verification of the models and styles along with their quote.

13. WARRANTY - At a minimum, the following warranties should be covered:

Rupture:

o Implant replacement: 10 years for both affected and contralateral implants o Out-of pocket financial assistance

Capsular contracture Baker /Grade III/IV o Implant replacement for both affected and contralateral implants o Out-of-pocket financial assistance (augmentation patients only)

Late Seroma o Implant replacement: 20 years for both affected and contralateral textured implants o Late seroma diagnostic testing coverage

14. The Contractor shall provide product support to NMCSD at no additional cost to the Government. The Contractor shall appoint a representative for routine interactions with the NMCSD and provide representation during inventory. The Contractor shall provide a name, email address, and phone number for this individual. If the Contractor changes its appointed representative, it must notify NMCSD in writing and provide the new representative’s 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.

B. CONSIGNMENT AGREEMENT:

1. Inventory shall be provided on a consignment basis, remaining the property of the contractor until removed from inventory and utilized by the Government.

2. Quantity, make, model and size to be provided and stocked on-hand at NMCSD will be included as an attachment to the contract. The attachment will list the amount of each product model and size that shall be maintained on the shelf as the operative stock available for utilization.

3. Inventory will be maintained in a specified area located in the Plastic Surgery Department at the NMCSD. This space will be used for the storage and issuing of items furnished under this contract. The Government will maintain segregation between Government-owned items and Contractor-owned items.

4. The Contractor shall conduct an inspection with a Government representative at the beginning of the contract to verify the initial stocking of the consignment inventory. A product list will be provided to the Government within five (5) business days of inspection and shall be formally acknowledged, via signature, by both the Government and Contractor representatives. The Government will be responsible for all expenses incidental to the safekeeping and use of the consigned items and shall furnish proper storage for all items supplied.

5. The Government will utilize product in a first-in, first-out basis. The Government will notify the contactor when a product is removed or utilized from consignment inventory, via email. The Government shall provide to the contractor, at a minimum, the serial number of the items removed or utilized from the inventory. Restocks to be provided will be a direct one-for-one match for the style and size for the product(s) which were removed or utilized by the Government.

6. The Contractor shall be responsible for restocking the product(s) removed or utilized from consignment inventory within 48 hours of notification when a 48-hour restock is specifically requested by NMCSD Plastic Surgery Department. If no restocking period is specified by NMCSD, the Contractor shall be responsible for restocking the product(s) within five (5) calendar days. Restock shall be delivered FOB Destination. No additional charges or shipping may be levied to the Government in order to meet this requirement and the cost of shipping/delivery will be included in the contract. If the Contractor cannot provide product in the specified timeframe, the Contractor must contact the Technical Liaison (TL) and the designated point of contact for the Plastic Surgery Department at NMCSD as soon as reasonably possible, but not exceeding 48 hours from the receipt of the initial email request.

7. The Contractor shall provide a full range of products with valid expiration dates. The Contractor shall remove and replace any stock one (1) month prior to its expiration date with current/unexpired, matching stock at no additional cost to the government. If removal of product could potentially interrupt operations at NMCSD (e.g. removal of product will leave no stock available for surgery), the Contractor shall provide the replacement product prior to removal of the product due-to-expire.

8. The Contractor shall not provide substitutions or alterations to the product to be stocked without the express written consent from the Contracting Officer and the approval of the NMCSD Plastic Surgery Department. The Contractor shall make no adjustments, changes, deletions or additions to the base stock/inventory or to the list of products to be provided without a written contract modification from the Contracting Officer.

9. The Contractor shall make no adjustments, changes, deletions or additions to the base stock/inventory or 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 Contracting Officer.

10. The Contractor shall evaluate the usage/utilization and report and review these with the COR on a mutually agreed-to schedule, but not less than every six months. Requests for adjustments to product inventory may be made in writing to the Contracting Officer from the COR and the Contractor. Any adjustment must be finalized by the Contracting Officer, via contract modification.

11. The Government will be responsible for any consigned stock that is missing or has been opened after confirmation of receipt of product. The Contractor is responsible for replacement of defective products or any product subject to recall. The Contractor shall replace defective products at no charge to the Government, unless Government has misused or damaged the product.

12. At the end of each fiscal year (Sep 30, 2022 and every year thereafter until 2027), a joint inventory of remaining supplies will be conducted. The value of the remaining supplies will be de-obligated through a purchase order modification, and a new fiscal year line of accounting will be provided for the following fiscal year (except at the conclusion of the final option ordering period). This event will be coordinated between the Contractor, NMCSD Contracting Officer’s Representative, the NMCSD Logistics Department and the Contracting Officer to preclude violation of the “bona-fide needs rule.”

13. At the conclusion of the specified contract period, all unused consignment products shall be returned to the Contractor without any liabilities or expenses charged to the Government. The Contractor shall conduct a joint inventory with a Government representative at the conclusion of the contract. The Contractor will perform this inventory with a Government representative in order to ensure inventory accuracy and for reconciliation of any discrepancies. Restocking fees of any kind shall not be levied against the Government, except in cases where it can be clearly demonstrated that the Government has either willfully damaged or defaced a product, or damaged a product through gross negligence. The Contractor shall remove all remaining stock and completely vacate the facility no later than 48 hours after the last working day of the contract period.