Statement of Work for Covera Consignment Draft.pdf

STATEMENT OF WORK

COVERA CONSIGNMENT FOR MICHAEL E. DEBAKEY VA MEDICAL CENTER

1. SCOPE:

The Michael E. DeBakey VA Medical Center, 2002 Holcombe Blvd, Houston, Texas 77030 intends to procure Bard Peripheral Vascular, Inc. for vascular covered stents under consignment for a base period of date of award and four (4) one-year optional renewal years expiring.

2. REQUIREMENTS: MEDVAMC Interventional Radiology requires these Covera stents for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an arterio-venous (AV) fistula and at the venous anastomosis of an expanded polytetrafluoroethylene (ePTFE) or other synthetic AV graft. These stents keep grafts and fistulas open, allowing patients to continue dialysis treatments.

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 contract may be modified, through mutual agreement of the parties, to include new vascular covered stents.

4. CONSIGNMENT TERMS

a. GENERAL:

The Contractor shall furnish and maintain an inventory of stents as required.

Products shall be placed in the MEDVAMC Radiology Department on a consignment basis in accordance with the terms and conditions of this contract. The Government will be responsible for proper storage and security for all items supplied.

b. INVENTORY LEVEL:

The initial level of consignment inventory to be placed in the Interventional Radiology Suite shall be maintained at the Stock Level Agreement (section 4.c.)

quantities. This inventory level may be increased based upon need and usage during the contract term with mutual agreement of the parties. The Interventional staff 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 Contracting Officer for the contract modification. The Contractor shall not commence any changes until notified in writing by the Contracting Officer.

DRAFT

To determine appropriate stock levels, the COR and the Contractor representative will periodically (no less than once per month) conduct a physical inventory of the consignment inventory. The Contractor shall evaluate the actual usage and purchase volume versus the estimated usage and review the results with designated Contract Officer Representative. Inventory levels may be adjusted accordingly. A copy of inventory list shall be provided to the VA Contracting Office Representative by the Contractor after each monthly review. 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 COR 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.

f. OWNERSHIP AND LIABILITY:

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 item(s) has/have been used.

g. PURCHASE ORDERS/ORDERING REPLACEMENT INVENTORY:

The use of any item is entirely dependent on patient diagnosis and need as determined by the attending physician. The Contractor will be paid only after items are implanted or used by the Government. MEDVAMC Prosthetics or Logistics will issue purchase order to the contractor which shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures.

Products used will be paid for at prices awarded in the contract.

h. DELIVERY:

The Contractor shall deliver replacement products within 48 hours after receipt of the purchase order. The Contractor shall ship products directly to the Michael E.

DeBakey Medical Center at no additional charge.

i. ACCEPTANCE OF PRODUCTS:

MEDVAMC physicians will have the responsibility to determine which item to use and Logistics’ staff will have final approval for acceptance of products.

j. DEFECTIVE PRODUCTS:

The Contractor shall submit all recall notices within the last 24 months to the Contracting Officer. VA will review and determine potential impact on clinical need. The Contractor shall replace defective products at no cost to the Government.

5. TECHNICAL SUPPORT:

The Contractor shall provide on-site, in-service training to VA Radiology Suite personnel as needed, as well as when approval has been given to add new products to the contract.

The Contractor shall adhere to Vendor Sale Representative Guidelines while on-site (see attached guidelines).

a. REPORTS:

The Contractor shall furnish the Contracting Officer Representative monthly reports. At minimum, these reports shall list all products purchased from the consignment inventory during that contract period.

6. CONTRACT PERIOD:

The VA anticipates consignment for a base period of date of award through June 1, 2023, and four (4) one-year optional renewal years expiring May 31, 2027.

Base Year:

Date of award – 10/01/2025-09/30/2026

Option Year One (1): 10/01/2026-09/30/2027

Option Year Two (2): 10/01/2027-09/30/2028

Option Year Three (3): 10/01/2028-09/30/2029

Option Year Four (4): 10/01/2029-09/30/2030

7. TECHNOLOGY REFRESH:

All stents 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.

7.a.1.1. If upgrades of stents become available after award of this contract, the contractor will substitute them for the awarded items according to the following:

7.a.1.2. A list of specific awarded items which shall be updated.

7.a.1.3. 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.

7.a.1.4. The Contracting Officer Representative will provide the information to the Clinical Product Review Committee for approval. Upon approval, the contract will be modified to acknowledge the updated items.

7.a.1.5. All new products that replace awarded items and released to the market during the term of the contract 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 current products on contract and the Contractor shall be required to continue to supply the contracted item.

7.a.1.6.

8. RECALLED AND DEFECTIVE PRODUCTS:

The Contractor shall notify the Government within three (3) workdays of any notification by the Manufacturer of any removal, recall or modification of supplies required under the contract. In the event of any notice of removal, recall, or modification of supplies, the Contractor shall make available to the Government supplies with specifications and features equal to or in excess of those supplies no longer available.

9. RECONCILIATION AT CONTRACT EXPIRATION:

The Contractor shall reconcile all consigned items and inventory and pickup within 10 days of expiration/termination. MEDVAMC agrees to return all consignment products in saleable condition (unopened and undamaged) in the original packaging. The VA will issue a purchase order paying for all unsalable products.

10. NARA RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS (MAY 2017):

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and shall be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created while performing the contract and/or delivered to, or under the legal control of the Government and shall manage in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. Michael E. DeBakey VA Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of MEDVAMC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor shall report to Michael E. DeBakey VA Medical Center. The agency shall report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to MEDVAMC control, or the Contractor shall hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Michael E. DeBakey VA Medical Center guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Michael E. DeBakey VA Medical Center policy.

8. The Contractor shall not create or maintain any records containing any non-public Michael E. DeBakey VA Medical Center information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The Michael E. DeBakey VA Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Michael E. DeBakey VA Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables shall be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flow down of requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.