Combined Synopsis Solicitation 36C25624Q0295 Embolic Coils _Consignment.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* Implanted Detachable Embolic Coils (Consignment)

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25624Q0295

RESPONSE DATE/TIME/ZONE 12-20-2023 15:00 EASTERN TIME, NEW YORK,

USA

ARCHIVE 9 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* 6515

NAICS CODE* 339112

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

POINT OF CONTACT*

Contract Specialist Jeneice Matthews jeneice.matthews@va.gov

PLACE OF PERFORMANCE

ADDRESS Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard Houston Texas

POSTAL CODE 77030

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov

URL DESCRIPTION Department of Veterans Affairs

AGENCY CONTACT’S EMAIL ADDRESS jeneice.matthews@va.gov

EMAIL DESCRIPTION 36C25624Q0295 Consignment Embolic Coils mailto:jeneice.matthews@va.gov

DESCRIPTION

36C25624Q0295 – Implanted Detachable Embolic Coils (Consignment) at Michael E.

DeBakey VA Medical Center (MEDVAMC) located in Houston, Texas.

1. This is a combined synopsis/solicitation (CSS) for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6 Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with FAR Part 13, Simplified Acquisition Procedures as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a written solicitation document will not be issued.

2. The CSS number is 36C25624Q0295. It is issued as a Request for Quote (RFQ).

This solicitation is in support of a requirement for the MEDVAMC that is sole source to the manufacturer. The government anticipates awarding a consignment agreement resulting from this solicitation to the sole source offeror. The sole source offeror shall comply with the following conditions below when responding to this solicitation.

3. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-06 (effective: 11/06/2023).

4. Please review the attached document(s) for more details on this requirement.

See attached 36C25624Q0295.

Contracting Office:

Department of Veteran Affairs Network Contracting Office (NCO)-16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston, TX 77056

Contract Specialist:

Jeneice Matthews POC: jeneice.matthews@va.gov

Quote in response to this RFQ is due at 2:00 PM Central Standard Time, December 20, 2023. Quote shall be submitted in writing and sent via email to jeneice.matthews@va.gov .

Please insert “36C25624Q0295 Quote” in the subject line of your email. The Sole Source Offeror shall submit the following for 36C25624Q0295:

1. Inventory Price/Cost Schedule

36C25624Q0295

SECTION B -

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: ___________________________________

CONTRACTOR TELEPHONE NUMBER: _________________________

CONTRACTOR ADDRESS: ___________________________________

EMAIL ADDRESS: ___________________________________________

SAM UEI Number ____________________________________________

CAGE Code: ________________________________________________

TAX ID ____________________________________________________

b. GOVERNMENT: Contracting Officer 36C256 Oney Kelly

Department of Veterans Affairs

Network Contracting Office 16

Galleria Financial Center

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 INVENTORY PRICE/COST SCHEDULE

ITEM INFORMATION

Item No.

Part No. Description Product

PAR

Level

Unit Price

Total Pricing of Line Item

1 4004C0610 Embolic Coil Coil 400 Complex Soft 6mm x 10cm 2 2 4004C0720 Embolic Coil Coil 400 Complex Soft 7mm x 20cm 2 3 4004C0820 Embolic Coil Coil 400 Complex Soft 8mm x 20cm 2 4 4004C0509 Embolic Coil Coil 400 Complex Soft 5mm x 9cm 2 5 4004C1235 Embolic Coil Coil 400 Complex Soft 12mm x 35cm 2 6 4004C0412 Embolic Coil Coil 400 Complex Soft 4 mm x 12 cm 2 7 4004C0925 Embolic Coil Coil 400 Complex Soft 9mm x 25cm 2 8 4004C1135 Embolic Coil Coil 400 Complex Soft 11mm x 35cm 2 9 4004C0513 Embolic Coil Coil 400 Complex Soft 5mm x 13cm 2

10 4004C0615 Embolic Coil Coil 400 Complex Soft 6mm x 15cm 2 11 4004C1030 Embolic Coil Coil 400 Complex Soft 10mm x 30cm 2 12 4004C0408 Embolic Coil Coil 400 Complex Soft 4 mm x 8 cm 2 13 4004C1440 Embolic Coil Coil 400 Complex Soft 14mm x 40cm 2 14 4004C0306 Embolic Coil Coil 400 Complex Soft 3 mm x 6 cm 2 15 4004C0715 Embolic Coil Coil 400 Complex Soft 7mm x 15cm 2 16 4004C0310 Embolic Coil Coil 400 Complex Soft 3 mm x 10 cm 2 17 4004C1335 Embolic Coil Coil 400 Complex Soft 13mm x 35cm 2 18 4002C2457 Embolic Coil Coil 400 Complex Standard 24mm x 57cm 2 19 4002C1135 Embolic Coil Coil 400 Complex Standard 11mm x 35cm 2 20 4002C0935 Embolic Coil Coil 400 Complex Standard 9mm x 35cm 2 21 4002C1145 Embolic Coil Coil 400 Complex Standard 11mm x 45cm 2 22 4002C1660 Embolic Coil Coil 400 Complex Standard 16mm x 60cm 2 23 4002C0830 Embolic Coil Coil 400 Complex Standard 8mm x 30cm 2 24 4002C1235 Embolic Coil Coil 400 Complex Standard 12mm x 35cm 2 25 4002C0925 Embolic Coil Coil 400 Complex Standard 9mm x 25cm 2 26 4002C1040 Embolic Coil Coil 400 Complex Standard 10mm x 40cm 2 27 4002C1245 Embolic Coil Coil 400 Complex Standard 12mm x 45cm 2 28 4002C1450 Embolic Coil Coil 400 Complex Standard 14mm x 50cm 2 29 4002C2260 Embolic Coil Coil 400 Complex Standard 22mm x 60cm 2 30 4002C1030 Embolic Coil Coil 400 Complex Standard 10mm x 30cm 2 31 4002C1348 Embolic Coil Coil 400 Complex Standard 13mm x 48cm 2 32 4002C1857 Embolic Coil Coil 400 Complex Standard 18mm x 57cm 2 33 4002C2060 Embolic Coil Coil 400 Complex Standard 20mm x 60cm 2 34 4002C0820 Embolic Coil Coil 400 Complex Standard 8mm x 20cm 2 35 DH1 Embolic Coil Coil Detachment Handle 2 36 4006C0308 Embolic Coil Coil 400 Complex Extra Soft 3mm x 8cm 2 37 4006C0203 Embolic Coil Coil 400 Complex Extra Soft 2mm x 3cm 2 38 4006C0305 Embolic Coil Coil 400 Complex Extra Soft 3mm x 5cm 2 39 4006C0204 Embolic Coil Coil 400 Complex Extra Soft 2mm x 4cm 2 40 4006C0202 Embolic Coil Coil 400 Complex Extra Soft 2mm x 2cm 2 41 4006C0406 Embolic Coil Coil 400 Complex Extra Soft 4mm x 6cm 2 42 4006C0408 Embolic Coil Coil 400 Complex Extra Soft 4mm x 8cm 2 43 4006C0306 Embolic Coil Coil 400 Complex Extra Soft 3mm x 6cm 2 44 400PAC25 Embolic Coil PAC400 Embolization Coil 25cm 2 45 400PAC35 Embolic Coil PAC400 Embolization Coil 35cm 2 46 400PAC10 Embolic Coil PAC400 Embolization Coil 10cm 2 47 400PAC60 Embolic Coil PAC400 Embolization Coil 60cm 2

48 400PAC40 Embolic Coil PAC400 Embolization Coil 40cm 2 49 400PAC50 Embolic Coil PAC400 Embolization Coil 50cm 2 50 400PAC7 Embolic Coil PAC400 Embolization Coil 7cm 2 51 400PAC15 Embolic Coil PAC400 Embolization Coil 15cm 2 52 400POD3 Embolic Coil POD400 Embolization Coil 3mm x 20mm 2 53 400POD6 Embolic Coil POD400 Embolization Coil 6mm x 50mm 2 54 400POD5 Embolic Coil POD400 Embolization Coil 5mm x 30mm 2 55 400POD4 Embolic Coil POD400 Embolization Coil 4mm x 30mm 2

GRAND

TOTAL

1. PERIOD OF PERFORMANCE (Ordering Period): The ordering period for this consignment agreement will be for a firm term of five (5) years.

2. The rates specified in the schedule above shall be the maximum paid the Contractor as orders are placed during the term of the agreement. In no event can the rates listed in the schedule be exceeded.

(End of B.2 Inventory/Price Schedule)

B.3 DELIVERY SCHEDULE

*** FOB Destination. All shipping charges must be included in price of items. ***

ITEM

NUMBER SHIPPING INFORMATION

0001-

SHIP TO: Michael E. DeBakey VA Medical Center ATTN: Warehouse, Building 100 2002 Holcombe Blvd.

Houston, TX 77030 USA

MARK FOR: VA POC: TBD

FOB: DESTINATION

(End of B.3 Delivery Schedule)

B.4 STATEMENT OF WORK (SOW)

CONSIGNMENT AGREEMENT

1. SCOPE:

The Department of Veterans Affairs (VA), Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Boulevard, Houston, Texas 77030 intends to procure various Implanted Detachable Embolic Coils under a consignment agreement.

Consignment agreements must only be established under a contract and by a Contracting Officer (CO). A consignment agreement is a delivery method for a specified period of time in which the Contractor provides items for Government use and the Contractor receives reimbursement only if and when the item is used by the Government. Unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expenses to the Government.

2. REQUIREMENTS:

MEDVAMC Interventional Radiology department requires Implanted Detachable Embolic Coils for use in Veteran patients for the treatment of cerebral aneurysms and fistulas. These embolic coils are permanent proximal embolization devices used in interventional procedures to block blood flow in medium to large-sized target vessels and pathological pathways.

3. PRODUCT CHANGES/MODIFICATIONS:

It is understood that there are continual changes in the field of interventional radiology, and new and improved products are released to the marketplace every year. Therefore, the awarded agreement may be modified, through mutual agreement of the parties, to include new embolic coils.

Pursuant to Federal Acquisition Regulation (FAR) 43.102, no government personnel other than the CO can execute contract modifications on behalf of the Government. The Contractor shall communicate with the designated Contracting Officer Representative (COR)/ VA Point of Contact (POC) on all matters pertaining to contract administration and technical direction. Only the CO is authorized to make commitments or issue changes that shall affect price, quantity, or quality of performance of this contract. All unauthorized inventory, regardless of amount, will be handled through the ratification process.

4. CONTRACT PERIOD:

The ordering period for this consignment agreement will be for a firm term of five (5) years. The Government reserves the right to cancel the consignment agreement at any time.

5. CONSIGNMENT TERMS AND CONDITIONS: The Contractor agrees to the following terms and conditions of the consignment agreement exclusively with MEDVAMC.

a. GENERAL:

1. The Contractor shall furnish and maintain an inventory of embolic coils as required. The

Contractor shall coordinate with the designated VA POC to have the requested items stocked at the medical facility. The products shall be placed in the MEDVAMC Radiology Department on a consignment basis in accordance with the terms and conditions of this agreement. The Government will be responsible for security and proper storage as described by the product labeling for all items supplied. Delivery of products shall be made to MEDVAMC, at no cost to the Government.

2. The Government is obligated only to the extent if and when use of the item is made by the Government; except as provided otherwise. Unused (unopened and undamaged) items shall be returned to the Contractor at the end of the effective period of the agreement, without reimbursement or other expense to the Government.

3. The term “Products” as used herein shall mean all medical devices which are owned by the Contractor but located on Customer’s premises (or within customer’s control).

MEDVAMC is responsible for storing the product to use as indicated by the product’s labeling. Once a product is used, MEDVAMC orders a replacement and is invoiced at the agreed upon price within this agreement.

NOTE: The designated VA POC at MEDVAMC will have the responsibility for determining the product(s) that will be utilized from the entire product line. If MEDVAMC determines that a Veteran patient’s circumstance warrants use of a product that is unavailable from the Contractor product line, MEDVAMC will be free to use another contract or if needed, a non-contract source to meet the particular need.

4. The Contractor shall be required to provide a quarterly report of sales by line item, no later than fifteen (15) calendar days after the end of each calendar quarter ending March, June, September and December. The report shall include, but not be limited to, date of implantation, description of item sold, model and serial number of the implanted items, price of each item. Reports shall be sent electronically to the designated VA POC responsible for the consignment agreement.

5. The Contractor shall provide an efficient delivery system for the use of a “Consignment

Agreement”. After award, the MEDVAMC will inform the Contractor of the chosen method of delivery. Normal delivery will be within forty-eight (48) hours. In emergency situations, the Contractor must be capable of delivering within a few hours on the same day as per the MEDVAMC needs and instructions. The Government will pay the difference between Normal and Urgent/Emergency freight charges.

The Contractor shall replace, at no additional charge, any item(s) that is damaged in shipment. The Contractor shall replace any items that are handled but not implanted.

Contractors shall pick-up or have handled items shipped back to the Contractor at no expense to the Government.

b. INVENTORY LEVEL:

1. Initial consignment inventory shall be delivered to MEDVAMC within ten (10) calendar days after receipt of the fully executed agreement at no expense to the Government.

Products listed below in section 4.c Stock Level Agreement represent the embolic coils that shall be available for the initial inventory. There is no expressed or implied guarantee that the estimated quantities will be purchased under this agreement.

MEDVAMC will provide adequate space/shelving for the consignment items.

2. Delivery tickets. All shipments made under this agreement shall be accompanied by a delivery ticket. At minimum, delivery tickets will include the following:

i. Name and Address of Contractor

ii. Name and Address of Receiver

iii. Consignment Agreement Number

iv. Product Number, Product Description, and Quantity Shipped

v. Serial numbers and or expiration date (if applicable)

vi. Customer PO number and Sales Order number

vii. Date of Delivery

3. At no time shall the number of products MEDVAMC holds on consignment fall below the minimum quantity specified without the concurrence of the VA POC. If it is discovered that the stock quantities fall below the agreed minimum stock level, the Contractor must replenish the stock level with like quantities of items within forty-eight (48) hours at no additional expense to the Government.

4. The inventory level may be increased based upon need and usage during the agreement term with mutual agreement of the parties. The VA POC will verify and approve the Contractor’s proposed consignment level as acceptable. A copy of the approved inventory stocking level will be forwarded to the CO for the contract modification. The Contractor shall not commence any changes until notified in writing by the CO.

c. STOCK LEVEL AGREEMENT:

Part#

Item Description

Periodic Automatic Replacement (PAR) Level

4004C0610 Embolic Coil Coil 400 Complex Soft 6mm x 10cm 2 4004C0720 Embolic Coil Coil 400 Complex Soft 7mm x 20cm 2 4004C0820 Embolic Coil Coil 400 Complex Soft 8mm x 20cm 2 4004C0509 Embolic Coil Coil 400 Complex Soft 5mm x 9cm 2 4004C1235 Embolic Coil Coil 400 Complex Soft 12mm x 35cm 2 4004C0412 Embolic Coil Coil 400 Complex Soft 4 mm x 12 cm 2 4004C0925 Embolic Coil Coil 400 Complex Soft 9mm x 25cm 2 4004C1135 Embolic Coil Coil 400 Complex Soft 11mm x 35cm 2 4004C0513 Embolic Coil Coil 400 Complex Soft 5mm x 13cm 2 4004C0615 Embolic Coil Coil 400 Complex Soft 6mm x 15cm 2 4004C1030 Embolic Coil Coil 400 Complex Soft 10mm x 30cm 2 4004C0408 Embolic Coil Coil 400 Complex Soft 4 mm x 8 cm 2 4004C1440 Embolic Coil Coil 400 Complex Soft 14mm x 40cm 2 4004C0306 Embolic Coil Coil 400 Complex Soft 3 mm x 6 cm 2 4004C0715 Embolic Coil Coil 400 Complex Soft 7mm x 15cm 2 4004C0310 Embolic Coil Coil 400 Complex Soft 3 mm x 10 cm 2 4004C1335 Embolic Coil Coil 400 Complex Soft 13mm x 35cm 2 4002C2457 Embolic Coil Coil 400 Complex Standard 24mm x 57cm 2

4002C1135 Embolic Coil Coil 400 Complex Standard 11mm x 35cm 2 4002C0935 Embolic Coil Coil 400 Complex Standard 9mm x 35cm 2 4002C1145 Embolic Coil Coil 400 Complex Standard 11mm x 45cm 2 4002C1660 Embolic Coil Coil 400 Complex Standard 16mm x 60cm 2 4002C0830 Embolic Coil Coil 400 Complex Standard 8mm x 30cm 2 4002C1235 Embolic Coil Coil 400 Complex Standard 12mm x 35cm 2 4002C0925 Embolic Coil Coil 400 Complex Standard 9mm x 25cm 2 4002C1040 Embolic Coil Coil 400 Complex Standard 10mm x 40cm 2 4002C1245 Embolic Coil Coil 400 Complex Standard 12mm x 45cm 2 4002C1450 Embolic Coil Coil 400 Complex Standard 14mm x 50cm 2 4002C2260 Embolic Coil Coil 400 Complex Standard 22mm x 60cm 2 4002C1030 Embolic Coil Coil 400 Complex Standard 10mm x 30cm 2 4002C1348 Embolic Coil Coil 400 Complex Standard 13mm x 48cm 2 4002C1857 Embolic Coil Coil 400 Complex Standard 18mm x 57cm 2 4002C2060 Embolic Coil Coil 400 Complex Standard 20mm x 60cm 2 4002C0820 Embolic Coil Coil 400 Complex Standard 8mm x 20cm 2 DH1 Embolic Coil Coil Detachment Handle 2 4006C0308 Embolic Coil Coil 400 Complex Extra Soft 3mm x 8cm 2 4006C0203 Embolic Coil Coil 400 Complex Extra Soft 2mm x 3cm 2 4006C0305 Embolic Coil Coil 400 Complex Extra Soft 3mm x 5cm 2 4006C0204 Embolic Coil Coil 400 Complex Extra Soft 2mm x 4cm 2 4006C0202 Embolic Coil Coil 400 Complex Extra Soft 2mm x 2cm 2 4006C0406 Embolic Coil Coil 400 Complex Extra Soft 4mm x 6cm 2 4006C0408 Embolic Coil Coil 400 Complex Extra Soft 4mm x 8cm 2 4006C0306 Embolic Coil Coil 400 Complex Extra Soft 3mm x 6cm 2 400PAC25 Embolic Coil PAC400 Embolization Coil 25cm 2 400PAC35 Embolic Coil PAC400 Embolization Coil 35cm 2 400PAC10 Embolic Coil PAC400 Embolization Coil 10cm 2 400PAC60 Embolic Coil PAC400 Embolization Coil 60cm 2 400PAC40 Embolic Coil PAC400 Embolization Coil 40cm 2 400PAC50 Embolic Coil PAC400 Embolization Coil 50cm 2 400PAC7 Embolic Coil PAC400 Embolization Coil 7cm 2 400PAC15 Embolic Coil PAC400 Embolization Coil 15cm 2 400POD3 Embolic Coil POD400 Embolization Coil 3mm x 20mm 2 400POD6 Embolic Coil POD400 Embolization Coil 6mm x 50mm 2 400POD5 Embolic Coil POD400 Embolization Coil 5mm x 30mm 2 400POD4 Embolic Coil POD400 Embolization Coil 4mm x 30mm 2

d. MAINTENANCE OF INVENTORY:

1. All consignment inventories will be coordinated with the VA POC. The designated VA POC periodically (no less than once per quarter) will conduct a physical inventory of the consignment inventory with the Contractor representative and the results shall be detailed in a report to the VA POC.

2. The Contractor shall evaluate the actual usage and purchase volume versus the estimated usage and review the results with designated VA POC. Inventory levels may be adjusted accordingly. A copy of inventory list shall be provided to the VA POC by the Contractor after each physical inventory. In the event any such audit reveals that the actual inventory of consigned products is less than the levels set out in the current stock inventory, the VA POC will determine and communicate with the Contractor the best solution to get the inventory levels adjusted by either replacing stock, returning item(s) to the stock, or determining if stock has been used.

3. The Contractor will maintain, remove, or replace inventory as necessary. The VA POC may request that inventory having less than 60 days sterility/expiration date be removed and replaced within forty-eight (48) hours of notification. A list of all products will be provided to the designated VA POC overseeing the agreement. These services will be completed at no cost to the Government. The VA is not liable for devices that are allowed to expire.

e. OWNERSHIP AND LIABILITY:

1. The ownership and title of all consigned items shall remain with the Contractor until item(s) are used by the Government. The Government assumes no ownership for any item(s) stored at the VA on a consignment basis until the product(s) have been used.

2. The Government assumes no liability for assigned consignment product(s), but that the Government will be obligated only to the extent of authorized orders against the agreement. An exception to Contractor liability is loss or damage of any consignment product(s) due to Government negligence.

3. Until such a time a requirement exists and an authorized order is placed against the agreement, the Government will safeguard all products consigned to it. The Government agrees that it shall be responsible for the following. To cover all incidental operating expenses for the safekeeping of the products. To furnish proper storage and security for all item(s) supplied hereunder at no cost to the Contractor.

6. CONSIGNMENT ORDERING PROCEDURES/REPLACEMENT PRODUCTS:

a. This consignment agreement does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the agreement. Orders are considered placed at the time the consigned item is used.

b. The use of any item is entirely dependent on Veteran patient diagnosis and need as determined by the MEDVAMC. The Contractor will be paid only after items are implanted or used by the Government at the price agreed to in this agreement. The Government will notify the Contractor that a consigned item has been used and provide accounting and appropriation data.

c. MEDVAMC will withdraw products from the consignment stock on a first-in first-out basis.

MEDVAMC shall order replenishment product(s) through the Contractor’s Customer Service Department or designated Contractor Representative by providing a Purchase Order (PO) number after each procedure. This PO will authorize payment for the used product(s) and will also authorize delivery of the replacement product(s). The PO will include model, size, and serial number, for the item and quantities needed. All replacement product(s) shall be delivered within forty-eight (48) hours after receipt of PO. Contractor agrees to accept either a PO or VA Purchase Card as methods of payment.

d. MEDVAMC determines the prosthetic needs of Veteran patients as a part of their clinical care and follow-up with the Veteran patient to ensure the necessary device(s) are purchased to achieve the optimal clinical outcomes. Clinicians, in consultation with the Veteran patient, will decide what device is medically necessary to best meet the need(s) of the Veteran patient.

When requesting the device, clinicians are required to provide information to the Prosthetic and Sensory Aids Services (PSAS) staff in the form of a Veteran patient consult via the Computerized Patient Record System (CPRS). PSAS is responsible for:

i. Ensuring all request for purchase of prosthetic appliances and sensory aids, above the micro-purchase threshold, are entered into the eCMS Planning Module in accordance with the established timelines/standards to include an invoice and other appropriate documentation.

ii. Ensuring all request for the purchase of prosthetic appliances and sensory aids, below the micro-purchase threshold, are directed to the appropriate purchasing unit.

iii. Working with the prescribing clinician to ensure consults contains all pertinent information, for example, quantity, delivery date and location, and any other special requirements.

e. Replacements shall be shipped/delivered FOB Destination at no additional charge to the

Government. The Contractor shall replace, at no charge, any item(s) that are handled but not implanted. The Contractor shall reference the PO number on the invoice and delivery ticket for the replaced products. Payment for items furnished under the agreement is applicable only when such items are used (implanted) or the package is opened by MEDVAMC. Contractor agrees to accept the VA Purchase Card as the preferred method of payment for opened and damaged products.

7. TECHNICAL SUPPORT:

a. The Contractor shall assign a representative to the MEDVAMC to initiate and oversee the consignment inventory. At the time of the award, technical support shall be available twenty four (24) hours a day for Veteran patient follow up, in-service training, and consultation on technical issues. Contractor must return telephone calls for assistance from MEDVAMC within fifteen (15) minutes of telephone call to the Contractor. At the beginning of the award period the Contractor must provide: names of the representatives covering MEDVAMC and their direct contact information. If the vendor fails to provide the above information or the needed support the agreement may be terminated.

b. Contractor shall provide on-site, in-service training to VA personnel as needed, as well as when approval has been given to add new products to the agreement. The Contractor shall be responsible to ensure that Contractor personnel providing work on this agreement are fully trained and completely competent to perform the required work.

c. Non-Personal Services: The Government shall neither supervise Contractor personnel nor control the method by which the Contractor performs the required tasks. Under no circumstances shall the Government assign work to, or prepare work schedules for, individual Contractor personnel. It shall be the responsibility of the Contractor to manage its personnel and to guard against any actions that are the nature of personal services or give the perception of personal services. If the Contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the Contractor’s responsibility to notify the CO immediately.

8. TECHNOLOGY REFRESH:

a. All embolic coils offered shall be state-of-the-art technology. "State-of-the-art" is defined as the most recently designed components which are announced for marketing purposes, available, maintained and supported by the Contractor. Components and products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable.

b. If upgrades of embolic coils become available after award of this agreement, the Contractor will substitute them for the awarded items according to the following:

iv. A list of specific awarded items which shall be updated.

v. Product literature for the new items and a detailed description of the differences between the awarded items and the new items, and a specific analysis of the comparative advantages/disadvantages of the items involved.

vi. The VA POC will provide the information to the Clinical Product Review Committee for approval. Upon approval, the contract will be modified by the CO to acknowledge the updated items.

vii. All new products that replace awarded items and released to the market during the term of the agreement shall be made available to the Government at a discount price agreed to base on commercial sales practices disclosure. If pricing for new products is unacceptable, the VA will continue to use the current products and the Contractor shall be required to continue to supply the contracted item.

9. RECALLED AND DEFECTIVE PRODUCTS:

a. The Contractor shall submit all recall notices within the last 24 months to the VA POC. The

VA POC will review and determine potential impact on clinical need.

b. The Contractor shall notify the VA POC within three (3) days in the event of a product recall, removal, required adjustment, or required modification that is suggested or mandated by the Contractor, distributor, manufacturer, or any regulatory or official agency.

The information that shall be included in this notification is as follows:

i. A complete item description, identification (to include serial number and/or lot number).

ii. Administrative identification data including contract number, order numbers, and order date.

iii. Reasons for recall, removal, adjustment, or modification. Instructions for appropriate corrective action.

c. Defective or expired products will be replaced by Contractor at no charge to the

Government, unless the Government has misused, mishandled or caused damage or lost the product. There will be no re-stocking fees of any kind assessed upon the MEDVAMC. If an item is opened and is damaged or defective by the Contractor, then it shall be replaced by the Contractor at no charge to the Government.

10. RECONCILIATION AT CONTRACT EXPIRATION:

Upon expiration/termination of the agreement, MEDVAMC will reconcile all consignment stock units. The Contractor shall remove all unused items within ten (10) days at the end of the effective period of the agreement without reimbursement or other expense to the Government. MEDVAMC agrees to return all consignment products in saleable condition (unopened and undamaged) in the original packaging. The VA will be responsible to pay for all unsaleable products.

11. REQUIRED DELIVERABLE:

At the time of the award, the Contractor will not have any outstanding actions from the Food and Drug Administration (FDA) or other regulatory agencies or unresolved FDA warning letters on the manufacturing processes or quality control issues involving the products covered by this agreement. The VA will require proof from the Contractor that the FDA issues have been resolved.

A letter to the Contractor from the regulatory agency will meet this requirement. The Contractor shall include the letters to the CO prior to award of this agreement. If the Contractor has no outstanding issues the Contractor must provide a negative response to this requirement.

12. AUTHORIZED INDIVIDUALS:

The Government authorizes the MEDVAMC Interventional Radiologist physicians to place orders.

The Government authorizes the MEDVAMC Implant Coordinator(s) to place orders.

13. CONSIGNMENT ADMINISTRATION REQUIREMENTS:

The VA POC shall establish and maintain an accountability file showing all transactions and the total value of property on consignment at all times. As a minimum, the accountability file must reflect the following:

i. Date of receipt of property

ii. Ownership of property

iii. Description of property

iv. Quantity

v. Value of property

vi. Agreement number

vii. Record of orders placed for property used during agreement period and receiving official.

viii. Acknowledgment of receipt of unused property returned to owner.

14. ANNUAL REVIEW:

This agreement is subject to an annual review.

(End of Statement of Work)

SECTION C - CONTRACT CLAUSES

C.1 ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2023

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

NOV 2023

52.217-6 OPTION FOR INCREASED QUANTITY MAR 1989

52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY

PRICED LINE ITEM

MAR 1989

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

MAR 2023

C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

C.4 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

(b) No counterfeit supplies or equipment/ parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause.

Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United

States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

C.6 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

(a) Supplies and equipment. Rejected goods will be held subject to Contractor’s order for not more than 15 days, after which the rejected merchandise will be returned to the Contractor’s address at the Contractor’s risk and expense. Expenses incident to the examination and testing of materials or supplies that have been rejected will be charged to the Contractor.

(b) Perishable supplies. The Contractor shall remove rejected perishable supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. The Department of Veterans Affairs will not be responsible for, nor pay for, products rejected. The Contractor will be liable for costs incident to examination of rejected products.

C.7 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

Shipment of deliverable items, other than reports, shall be to:

Michael E. DeBakey VA Medical Center ATTN: Warehouse, Building 100 2002 Holcombe Boulevard Houston, TX 77030-4298

C.8 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause)

(End of Addendum to 52.212-4)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

NOTHING IN THIS SECTION

SECTION E - SOLICITATION PROVISIONS

E.1 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

Submission of Quote: Quotation shall be received no later than 2:00 PM Central Standard Time (CST), December 20, 2023. Quote shall be submitted electronically through email addressed to Jeneice Matthews, Contract Specialist at jeneice.matthews@va.gov .

Offeror shall complete and submit the following:

1. Blocks 17 a-b and 30 a-c of the SF 1449 (page 1).

2. B.1 Contractor Contract Administration Data (page 3). Provide POC name, complete address, phone number, email, SAM UEI Number, and Tax ID.

3. B.2 Inventory/Price Schedule (page 4). Insert legible proposed unit and total all-inclusive price in

Section B.2 Inventory/Price Schedule table for each line item. The price quote shall be legible, specific, and complete in every detail. No other format for the submission of the B.2 Inventory/Price Schedule shall be accepted.

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer.

Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

FAR

Number

Title Date

52.204-7 SYSTEM FOR AWARD MANAGEMENT OCT 2018

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE

REPORTING

AUG 2020

52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

SEP 2023

52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS—NOTICE

AND REPRESENTATION

JUN 2020

mailto:jeneice.matthews@va.gov

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it ‘‘does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument’’ in paragraph (c)(1) in the provision at 52.204–26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212–3, Offeror Representations and Certifications–Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it ‘‘does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services’’ in paragraph (c)(2) of the provision at 52.204–26, or in paragraph (v)(2)(ii) of the provision at 52.212–3.

(a) Definitions. As used in this provision—

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. (1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for “covered telecommunications equipment or services.”

(d) Representations. The Offeror represents that— https://www.sam.gov/

(1) It [ ] will, [ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds “will’’ in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It [ ] does, [ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds “does’’ in paragraph (d)(2) of this section.

(e) Disclosures. (1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded “will’’ in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable);

and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided;

and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded “does’’ in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable);

and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

(a) Definitions. As used in this provision—

"Administrative proceeding" means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative Proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings).

This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

"Federal contracts and grants with total value greater than $10,000,000" means—

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

"Principal" means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror [ ] has [ ] does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked "has" in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity…