Statement of Work

Contingency Chemotherapy Compounding Services

Clarksburg VA Medical Center

STATEMENT OF WORK AND GENERAL SPECIFICATIONS FOR Chemotherapy Compounding

1. Background

VA Clarksburg Inpatient Pharmacy is need of a contingency contractor to handle hazardous compounding in the event of IV room shutdown. Currently, Pharmacy only has one IV room for compounding and would be unable to handle hazardous compounding if it were shut down for any reason.

2. Specifications

Please see below for salient characteristics.

Chemotherapy Compounding Base +4 years of chemotherapy compounding services

Services Contractor shall provide all chemotherapy agents, IV Tubing, closed system drug transfer devices, and any other items deemed necessary.

All Hazardous Chemotherapy Agents will be aseptically compounded based on patient specific orders.

Drugs All drugs are to be supplied by the Contractor.

Order Procedure Orders will be submitted via a VA secure network or fax. Once submitted, VA staff will confirm receipt of order with the Contractor via phone or email.

Shipping/Delivery Procedure • Compounded orders shall be transported via Courier, overnight mail service, or any other means necessary to ensure receipt prior to infusion date/time to VA Clarksburg.

• Shipping is included with the order and there is no additional cost for any items delivered for the weekend. All shipments for weekend delivery will be arranged as needed to ensure delivery can be successfully completed.

Billing Contractor shall invoice for billable units for the amount of medication utilized for each individual patient.

Regulation • Compounding must be done at an FDA 503A compliant facility and meet all state and federal laws.

• Compounding, labeling, and beyond use dating/expiration dating will be based on USP 797, USP 800 and Federal Law.

• Contractor shall provide current and future certification reports for the sterile compounding areas and compounding hoods.

In the case of any failures, contractor shall provide action plans for corrections of deficiencies and testing results showing the failures have been corrected.

Contingency Plan The Contractor shall have a contingency backup plan in the event that the compounding facility is affected by any certification discrepancies, equipment malfunctions, natural disasters, or other matters affecting performance of the contract. Contingency locations must meet the same criteria as stated herein.

3. Delivery Location

Attn: (Pharmacy) Louis A. Johnson Medical Center 1 Medical Center Drive Clarksburg, WV 26301

Prior to delivery, Contracting Officer Representative and/or Service Line Representative shall receive shipping information from Contractor and forward to Logistics using the email(s) listed above.

The Contractor must comply and provide all necessary information to VA Clarksburg. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government.

4. Requested Delivery Date

Delivery of supplies is TBD based on need.

5. Period of Performance

Base Year: August 27, 2026 – August 26, 2027 Option Year 1: August 27, 2027 – August 26, 2028 Option Year 2: August 27, 2028 – August 26, 2029 Option Year 3: August 27, 2029 – August 26, 2030 Option Year 4: August 27, 2030 – August 26, 2031

6. Safety Data Sheet (SDS)

If applicable, contractor shall provide three (3) copies of each Safety Data Sheet for every product, chemical, etc. SDS sheets shall be provided for any material on the same day those materials arrive on VA property.

7. Records Management

When Federal agencies acquire goods or services, they need to determine what Federal records management requirements should be included in the contract. Federal contractors often create, send, or receive Federal records.

Federal contracts should provide clear legal obligations describing how the contract employees must handle Federal records.

Agency records officers, procurement counsel, and acquisitions officers must discuss how to integrate records management obligations into their existing procurement processes. NARA has developed the following language to be included as an agency-specific term and condition in Federal contracts for a variety of services and products. The majority of contracts should include language on records management obligations, but each contract should be evaluated individually. For example, the data-rights paragraph (Paragraph 10 below) may not be appropriate for all contracts. Instead, agencies may be better served by one of the established data-rights clauses in the Federal Acquisition Regulations.

This language should not replace specific records management requirements included within Federal information system contracts.

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 LAJVAMC records.

2. Does not include personal materials.

3. Applies to records created, received, or maintained by Contractors pursuant to their LAJVAMC 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.

4. LAJVAMC 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 LAJVAMC 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 LAJVAMC .The agency must 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 LAJVAMC 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 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 LAJVAMC 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 LAJVAMC policy.

8. The Contractor shall not create or maintain any records containing any non-public LAJVAMC 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 LAJVAMC 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 LAJVAMC 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.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take LAJVAMC-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.

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