6515--SMART Control Stent System Consignment Agreement

Active

Contract Opportunity

Sources Sought Notice
This notice is for planning purposes only and shall not be considered an invitation for bid, request for quotation, request for proposal, or as an obligation of the government to acquire any products or services. Responses to this notice will be used for informational purposes only and only for Network Contracting Office 5. No entitlement to payment of direct or indirect costs from the government will arise as a result from a response to this announcement. No contract will be awarded from this notice.
The information requested in this notice will be used to determine available sources for the supply/ service below.
The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office (NCO) 5 is seeking sources for the following procurement:
SMART Control stents through a Consignment Agreement

North American Industry Classification System (NAICS) number is 339112. The NAICS size is 1000.
Contractors that deem themselves capable of meeting the requirement shall provide the below information to Ryan Singletary, Contract Specialist, at ryan.singletary@va.gov no-later-than April 4, 2025 at 12PM, Eastern Time.
Needed Items:
Description / Model #
IMF
PAR
SMART CONTROL STENT C09040ML
32932
2
SMART CONTROL STENT C09020ML
32938
2
SMART CONTROL STENT C08060SL
32939
2
SMART CONTROL STENT C07100ML
32940
2
SMART CONTROL STENT C06040ML
32941
3
SMART CONTROL STENT C06060ML
32996
2
SMART CONTROL STENT C10040SL
32998
2
SMART CONTROL STENT C09060SL
32999
2
SMART CONTROL STENT C08040SL
33000
2
SMART CONTROL STENT C06150ML
33001
2
SMART CONTROL STENT C07030ML
33002
2
SMART CONTROL STENT C06080ML
33003
2
SMART CONTROL STENT C07020ML
33005
2
SMART CONTROL STENT C06030ML
33006
2
SMART CONTROL STENT C08020ML
33087
2
SMART CONTROL STENT sECC06100ML
33088
2

STATEMENT OF WORK
General

Contractor shall furnish all supplies listed in Part 7, Schedule of Supplies & Costs on a
Consignment Basis to the Hershel Woody Williams VA Medical Center (HWW VAMC), 1540 Spring Valley Drive, Huntington, WV 25704, in accordance with the terms and conditions
of this consignment agreement. This Consignment Agreement will be for a period of five (5)
years and shall be from May 1, 2025 through April 30, 2030.

Items listed in Part 7, Schedule of Supplies shall be placed at the VA Medical Center;
stocked in a secured area agreed upon by the Contractor, the Contracting Officer, and the
Contracting Officer s Representative (COR); stored as described by the product
labeling; and, provided at no expense to the Government until usage occurs.

Definitions

Consignment Agreement An agreement for a specified period of time during which the
Contractor provides an item to the Government, reimbursement for which is made only if and
when the Government makes use of the item. Unused items are returned to the Contractor at the
end of the effective period of the agreement without reimbursement or other expense to the
Government.

Period of Performance
Base: May 1, 2025 April 30, 2026
Option Period 1 May 1, 2026 April 30, 2027
Option Period 2 May 1, 2027 April 30, 2028
Option Period 3 May 1, 2028 April 30, 2029
Option Period 4 May 1, 2029 April 30, 2030

Place of Performance
Hershel Woody Williams VA Medical Center (HWW VAMC), 1540 Spring Valley Drive, Huntington, WV 25704

Modifications/changes

The Contracting Officer is the only person authorized to approve changes or modify any of the
requirements under this Consignment Agreement. The Contractor shall communicate with the
Contracting Officer on all matters pertaining to the administration of this Consignment Agreement.
Only the Contracting Officer is authorized to make commitments or issue changes which shall
affect price, quantity, quality, or performance of this Consignment Agreement.
In the event the Contractor effects any such change at the direction of any person other than the
Contracting Officer, the change shall be considered to have been made without authority and no
adjustment shall be made in the agreement price to cover any increase in cost incurred as a
result thereof.

Pre-consignment and Initial Inventory Levels

The Contractor shall remove all existing stock items in inventory and issue credit usable
against future order(s) placed (Upon written request, the COR will provide a listing of
existing inventory). Contractor shall be responsible for all shipping costs associated with
their return to Contractor.

A complete listing of model and/or part numbers shall be provided to the Contracting Officer
upon delivery of the initial consignment inventory. The HWW VAMC will maintain an inventory
showing all transactions.

An initial consignment inventory is indicated in the schedule; however, this level may be
changed by written notification of the Contracting Officer. Initial consignment inventory shall
be placed in the Medical Center within ten (10) calendar days after receipt of Notice of
Award.

Schedule of Supplies

Contractor to provide the following equipment for the Cath Lab in the Cardiology Section of the Medical Service Department located at the Hershel Woody Williams VA Medical Center:

Need Items:

Description / Model #
IMF
PAR
SMART CONTROL STENT C09040ML
32932
2
SMART CONTROL STENT C09020ML
32938
2
SMART CONTROL STENT C08060SL
32939
2
SMART CONTROL STENT C07100ML
32940
2
SMART CONTROL STENT C06040ML
32941
3
SMART CONTROL STENT C06060ML
32996
2
SMART CONTROL STENT C10040SL
32998
2
SMART CONTROL STENT C09060SL
32999
2
SMART CONTROL STENT C08040SL
33000
2
SMART CONTROL STENT C06150ML
33001
2
SMART CONTROL STENT C07030ML
33002
2
SMART CONTROL STENT C06080ML
33003
2
SMART CONTROL STENT C07020ML
33005
2
SMART CONTROL STENT C06030ML
33006
2
SMART CONTROL STENT C08020ML
33087
2
SMART CONTROL STENT sECC06100ML
33088
2

Consignment Item Ownership/Title

The Contractor shall maintain ownership of all consigned items and related supplies furnished
under this Agreement, until such time that the Government uses the consigned item (implants).

Government Safeguarding of items on Government premises

The Government is responsible for storing the consignment items and for using the items as
indicated by product labeling. Once used, the Government orders a replacement and is invoiced
at the contract price for the replacement product. The Government will provide proper storage
and security for all items supplied hereunder and is responsible for all expenses incidental to the
safekeeping and security of items on Government premises.

The Smart Control Stents for this Consignment will be stocked in a secured
area agreed upon by the Contractor and the COR and approved by the Contracting Officer.

Liabilities

Contractor Liability

The Contractor shall not be held liable for any consignment item that has been without question damaged, misused, or lost by Government. If the Contractor
damages the item, or the item is defective, it shall be replaced by the Contractor, with
no re-stocking fees of any kind assessed upon the VA Medical Center. The
determination as to whether or not the Government was negligent shall be decided
by mutual agreement between the Contractor and the Contracting Officer, based on
evidence presented; however, the decision of the Contracting Officer will be final.
Disagreements thereafter shall be settled in accordance with the Disputes Clause.

b. Government Liability

The Government assumes no liability for any items assigned to the HWW VAMC on a
consignment basis until such time as a requirement for the item exists, a
consignment item is used, and a purchase (delivery) order is placed against this
consignment agreement. If an item has been opened by the Government and/or
damaged or cannot be re-sterilized, the item will be purchased by HWW VAMC .

11. Consignment Expiration/Termination

a. All unused, unopened, and undamaged items will be returned to the Contractor at the end of
the term of this agreement, or cancellation of this agreement, without reimbursement or any
additional expense to HWW VAMC. Contractor shall be responsible for all shipping costs
associated with their return.

b. This agreement may be cancelled by either party upon written 30 day notice to the other party.

12. Payment

The HWW VAMC shall use a Government Purchase Card as the preferred method of payment.
However, Purchase Orders issued by the Government shall also be an available payment option.
Contractor shall accept net 30-day payment terms. Contractor shall submit all invoices directly
to the contracting officer. The requirements of a proper invoice are specified below.
Invoice Requirements: Invoices shall be submitted in original copy to the Government office
designated below. To constitute a proper invoice, the document must contain the following
information:
a. Name of Contractor and Invoice Date
b. Contract/agreement Number, Purchase Order Number
c. Description, Price, and Quantity
d. Other charges
(i) Government Invoice Address: Invoices shall be submitted to:

Department of Veterans Affairs
FMS-VA-FSC
PO Box 149971
Austin, TX 78714-9971

13. Replacement

As consignment items listed under Supplies/Services are used, a purchase order will be placed by the Contracting Officer/Purchasing Agent with the Contractor within 24 hours of its use, at the price listed in Supplies/Services and Prices/Costs. All requests and invoices will reference contract number and purchase order number at a minimum. This purchase order will authorize payment for the used item(s) and will also authorize delivery of the replacement item(s). The purchase order shall be referenced on the invoice and delivery ticket for the replaced items. All replacement items shall be delivered within forty-eight (48) hours from receipt of purchase order. Replacement of consignment items is through the contractor s Customer Service department by providing a purchase/delivery order number including model, size and serial number, for the consignment items and quantities needed. Contractor will be paid only after consigned item(s) is/are used (implanted) by the Government, at the replacement cost indicated in this agreement. Purchase orders and/or Government credit card may be issued/used for ordering and payment.

The Contractor shall be provided with a copy of the Delegation of Authority indicating those
individual personnel authorized to place and receive orders.

14. Consignment Items Rotation

Contractor shall remove and/or replace items from consignment inventory as necessary. Such
items may have 90 days or less remaining before the sterility expiration date or have been in
inventory for 90 days or more. All consignment inventories shall be coordinated with the COR, HWW VAMC Cath Lab and Inventory Management Specialists. HWW VAMC shall consume Contractor s product at the catalog # level on a first-in, first out basis. The COR shall be advised prior to any inventory item(s) being removed or replaced; upon removal or replacement of that item, the COR will sign receipt for that item. These services will be completed at no cost to the Government.

15. Inventory Sign In/Out Process

The HWW VAMC shall utilize TracCore to track all consigned inventory items. The
Diagnostic Radiologic Technologist will log the item s disposition each time an item is removed from inventory.
Contractor shall log each item that they place or remove from the consignment inventory; the
item s disposition shall be logged, dated, and double signed (Contractor s signature and the
COR s signature).

These actions will produce an TracCore report log sheet which shall consist of (at a
minimum) the following information:
a. Date
b. Item Description
c. Item serial number (or identification number)
d. Description of item disposition (Narrative stating what happened to the item)
e. Printed Name and Title of person who placed or removed the item
f. Log in code of item e above
g. User ID (including Printed Name and Title) if required

The COR shall provide a copy of this report to the Contractor within 24 hours of a written
notification.

16. Quarterly Reports
Contractor shall furnish the Contracting Officer a Quarterly Usage/Saving Report, within 30 days
of the close of the preceding quarter.
At a minimum, this report shall contain:
a. Contractor s name and contact information
b. Consignment title and number
c. Report date
d. Reporting timeframe
e. Current Reporting period:
1.All implanted models/types including serial numbers
2.Quantities used since last report
3.List price (before Agreement)
4.Contract price and any additional discounted prices
f. Consignment History
1.Total to date quantity of implanted items, broken down by model types
2.Running total of amount expended at contracted price
3.Running total of amount saved from contracted price verses list price

17. Contractor Inventory Checks

Contractor shall periodically conduct four (4) quarterly physical inventory reports and one (1) bi-annual physical inventory report of all consignment items. Contractor shall submit the inventory results to the COR and shall use ATTACHMENT A - QUALITY ASSURANCE SURVEILLANCE PLAN.

On a monthly basis, the Contractor shall be permitted, during normal business hours, to enter where
the Stents associated with this Consignment Agreement are stored for the purpose of inspecting and inventorying such item(s) and shall be escorted by the COR assigned. Such visits shall be at the convenience of the Government. A jacket accountability file shall be established and maintained showing all transactions and the total value of property on consignment at all times. This jacket accountability file shall be kept and maintained with the HWW VAMC Cardiology Supervisory MIT/COR. The record of orders placed, if done by other than Cath Lab employees, must be sent to Cardiology Supervisory MIT/COR and cleared by the Contracting Officer. As a minimum, the accountability file shall reflect:

a. Date of receipt of property.
b. Ownership of property.
c. Description of property.
d. Quantity.
e. Value of Property.
f. Agreement number.
g. Record of orders placed for property used during agreement period; and,
h. Acknowledgement of receipt of unused property returned to owner.

18. Special Implant Needs

Occasionally specific patients may require a special implant not available from the consignment
inventory. HWW VAMC will make every effort to ensure full and open competition for all potential
vendors, and is not limited to one vendor, in order to enable pricing that is deemed to be fair and
reasonable following all Government rules and regulation as they pertain to the acquisition of
supplies. Special use items that become routinely used may be added to this agreement by a
modification issued by the Contracting Officer.

19. Defective Consignment Items/Guarantee
Contractor shall replace defective consignment items or related supplies at no charge to the
Government. The consignment items shall be subject to the terms and conditions specified in
the warranty information for each individual item. All items will be in proper working condition as
required by applicable quality standards.

20. Technical Support

Technical support shall be available twenty-four (24) hours a day for patient follow up, in-service
training and/or consultation on technical issues. Contractor shall return telephone calls for
assistance within 30 minutes of HWW VAMC telephone call to Contractor.

21. Information Security

The contractor and their personnel shall be subject to the same Federal laws, regulations,
standards and VA policies as VA personnel, regarding information and information system
security. These include, but are not limited to Federal Information Security Management Act
(FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the
Department of Commerce s National Institute of Standards and Technology (NIST). This also
includes the use of common security configurations available from NIST s Web site at:
http://checklists.nist.gov/.
To ensure that appropriate security controls are in place, Contractors must follow the procedures
set forth in VA Information and Information System Security/Privacy Requirements for IT
Contracts located at the following Web site: http://www.iprm.oit.va.gov/.
22. ID Badges/Parking/Smoking Policy

a. CONTRACTOR SIGN-IN Contractor personnel shall report to Acquisition and Material
Management Service, before visiting the facilities, to sign-in and receive a contractor s
security badge.
b. BADGES All Contractor personnel are required to wear identification (ID) badges
during the entire period during which they are on VA grounds. ID badges must show an
identification picture, name of the individual, and the represented company.
c. PARKING It is the responsibility of Contractor personnel to park only in designated
parking areas.
Parking information is available from the VA Security Service. The VA will not
validate or make reimbursement for parking violations of the Contractor s
personnel under any circumstances.
d. SMOKING Smoking is not permitted within or around the VA Healthcare System
facilities, except in designated areas.

Responses (Any item not addressed in vendor s response may be considered a negative inference by the Contracting Officer):
If interested, please provide the following information in a response:
1. Name of Company
2. Point of Contact; name, phone number and email address
3. SAMS UEI
4. Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.
5. Is your company considered small under the NAICS code identified under this Sources Sought?
6. Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? What is the manufacturing country of origin of these items?
7. If not manufacturer, provide a letter, memo, or certification that firm is authorized distributor.
8. If you re a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified?
9. Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number.
10. If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract?
11. Please provide general pricing for your products/solutions for market research purposes.
12. Please submit your capabilities in regard to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes?
*** Submissions addressing Section (8) should show clear, compelling, and convincing*** evidence that all equal to items" meet all required salient characteristics.
Responses to this notice shall be submitted via email to Ryan.Singletary@va.gov. Telephone responses shall not be accepted. Responses must be received no later than April 4, 2025, at 12:00 PM EST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.

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