Statement of Work_Penumbra 02.docx

Statement of Work Penumbra Lightning Flash Intelligent Aspiration Catheters

Introduction: The VA Healthcare System (VAHCS) at Bay Pines, Florida, intends to award on a Sole Source basis. Seeks to procure Penumbra Lightning Flash intelligent aspiration catheters to support mechanical thrombectomy (clot removal) procedures performed by Bay Pines VAHCS providers. These single-use, FDA-cleared endovascular aspiration catheters are used to remove thrombus (blood clots) from vessels during emergent and scheduled vascular procedures, including the treatment of acute vascular occlusion. The catheters operate in conjunction with the facility's existing Penumbra System, including the ENGINE aspiration pump and associated aspiration tubing. This procurement will aid in the prompt, safe, and effective treatment of Veterans requiring thrombectomy. This is a one-time supply purchase.

Requirements:

· Contractor shall furnish all items new, unused, and in the manufacturer's original sealed sterile packaging.

· Items furnished shall be Penumbra Lightning Flash intelligent aspiration catheters, manufacturer part/catalog number [insert part number], compatible with the facility's existing Penumbra System (ENGINE aspiration pump and aspiration tubing).

· Each item furnished shall be cleared by the U.S. Food and Drug Administration (FDA) for its labeled indication.

· Each item shall be delivered in sterile, undamaged, original manufacturer packaging with a legible lot number.

· Contractor shall provide quantities as specified in the Delivery section of this Statement of Work.

· Contractor shall provide the standard manufacturer warranty for all items furnished.

References:

· U.S. Food and Drug Administration (FDA) clearance and labeling applicable to the item furnished.

· Federal Acquisition Regulation (FAR) 11.002, Policy (market acceptance and requirements description).

Delivery:

· Contractor shall deliver the following items within [X] calendar days after receipt of order (ARO):

· Delivery shall be F.O.B. Destination. Contractor shall bear all shippin

· g, handling, and transportation costs to the delivery location.

· Items shall be delivered to: Bay Pines VAHCS, 10,000 Bay Pines Boulevard, 100 / Floor 2 / Surgery, Bay Pines, Florida 33744.

· Contractor shall deliver items during normal receiving hours, Monday through Friday 0800-1600, and shall coordinate delivery with the Government point of contact prior to shipment.

Progress and Compliance:

· The Government will inspect all delivered items at destination for correct quantity, correct part number, and undamaged sterile packaging.

· The Government will reject any item that is damaged, incorrectly supplied, or nonconforming to the requirements of this Statement of Work. Contractor shall replace rejected items at no additional cost to the Government.

· Invoices will be compared to departmental records of items ordered and received to assure accuracy.

Notes and Other Information:

· Bay Pines VAHCS reserves the right to inspect and accept or reject all items in accordance with the requirements of this Statement of Work.

· RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions "Federal record" as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes Bay Pines VA Healthcare System records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their Bay Pines VA Healthcare System contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

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 must 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 in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed 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.

1. Bay Pines VA Healthcare System 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 Bay Pines VA Healthcare System 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 must report to Bay Pines VA Healthcare System. The agency must report promptly to NARA in accordance with 36 CFR 1230.

2. 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. 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 Bay Pines VA Healthcare System control or the Contractor must 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. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

3. 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 Bay Pines VA Healthcare System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

4. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Bay Pines VA Healthcare System policy.

5. The Contractor shall not create or maintain any records containing any non-public Bay Pines VA Healthcare System information that are not specifically tied to or authorized by the contract.

6. 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.

7. The Bay Pines VA Healthcare System 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 Bay Pines VA Healthcare System 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 must be identified as required by FAR 52.227-11 through FAR 52.227-20.

8. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flowdown 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.