Statement of Work.pdf

STATEMENT OF WORK:

NUCLEAR MEDICINE SERVICE – PET/CT RADIOPHARMACEUTICALS

This requirement is for the radiopharmaceuticals F18 FDG, F18 NaF, Piflufolastat F-18 (Pylarify- PSMA)), Florbetaben F-18 (Neuraceq), and Ga-68 Dotatate, Ga-68 PSMA-11 as well as QC sources needed for the GE Discovery 690 PET/CT scanner.

Contractor will deliver radioisotope in amount greater than or equal to the activity ordered with calibration for the specified appointment time.

Contractor shall have available an adequate supply of contract products to meet the requirements of the Oklahoma City Department of Veterans Affairs Medical Center with proof of contingency supply chain (where such contingency supply chain exists) to prevent disruption of clinical care.

Price/quote expectations are for a competitive value per product when compared to national trends.

At least one (1) scheduled delivery of radiopharmaceutical per day with no associated fee and additional isotope availability, as per clinical schedule including emergency deliveries, as needed. Bulk pricing with associated cost advantage will be considered.

Contractor shall be able to supply delivered PET radiopharmaceuticals as unit doses or in container compatible with MEDRAD Intego Pet Delivery System. Contractor is responsible for supplying container(s) compatible with MEDRAD Intego system.

All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173.

Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

Contractor shall meet all Nuclear Regulatory Commission, National Health Physics Program (NHPP), Department of Transportation, FDA, OSHA, and all other agency rules and regulations (Federal and State), as well as any applicable Joint Commission Requirements.

PET Radiopharmaceutical Returns for Credit:

The Contractor shall be responsible to accept returns for full credit toward future orders. Particularly under the following conditions:

a. Product(s) ordered or shipped in error.

b. Product(s) damaged in shipment

c. Concealed shipping damages

d. Recalled product(s)

e. Outdated products in unopened, original container.

Note: OKC-VAMC can return at least 5% of radioisotope due to patient cancellation or no show at no cost to the facility.

Contractor shall invoice at least once per month showing period covered, billing date, name of preparation, quantity and amount.

All invoices are to be sent to Austin via electronic invoicing. The company is Tungsten Corporation – www.tungsten-network.com .

QC results will be furnished upon request.

Normal/ Routine PET Radiopharmaceutical Ordering and Deliveries:

Orders shall be placed by authorized VA personnel during the normal workday, and first delivery shall be received no earlier than 06:30 am the following workday to the Oklahoma City VAMC Nuclear Medicine Service – PET Department (1G-114)

After award, the Contractor will be furnished the name(s) of VA personnel that are authorized to place orders against the Contract. Orders shall only be placed by authorized VA OKC Nuclear Medicine personnel via telephone, fax, or e-mail.

Depending upon Medical Center patient care requirements, the contractor shall provide routine delivery and pick-up, as many times as required by the OKC VAMC.

Delivery orders shall include the following information:

• Contract item (s) and quantity,

• Time (s) of delivery,

• Applicable VA order number.

Contractor agrees to accept unused radiopharmaceutical and provide reimbursement per unit dose applicable towards future orders.

Contractor is responsible for on time delivery of radiopharmaceutical and will have back-up facilities/production options available (where such contingency supply chain exists) ( to maintain greater than 95% on time delivery) or risk penalty that includes no charge doses that, at a minimum, equal the amount of missed doses. All cancelled PET/CT scans due to contractor delayed delivery will be the responsibility of the contractor and the returned dose will not count towards the allotted 5% of available returns due to patient no show or cancellation.

The Contractor will be furnished with a copy of the user’s license information as per Nuclear Regulatory Commission guidelines.

Same-Day Delivery http://www.tungsten-network.com/

Contractor will be available for Emergency orders in accordance with the schedule of supplies with no associated delivery fees.

Same-Day Delivery is required to be delivered and received at the OKC VAMC Nuclear Medicine PET/CT Service no later than 4 hours after order is placed during normal business hours. Nuclear Medicine PET/CT normal business hours are considered Monday through Friday: 7:00 am – 4:30 pm, except Federal Holidays.

VHA RECORDS POLICY

All Veterans Health Administration (VHA) records (administrative and/or health specific) created during the period of the contract belong to Oklahoma City VA Healthcare System (OKC VAHCS). VHA records must always be handled by contractors and subcontractors in accordance with National Archives and Records Administration (NARA) requirements and as outlined in VHA Directive 6300 Records and Information Management and its Handbook 6300.1 Records Management Procedures, VHA Records Control Schedule 10-1, and VHA Handbook 6500.1 regarding Electronic Media Sanitization. Said records must also be returned to the OKC VAHCS at the end of the contract and/or destroyed in accordance with the VHA Record Control Schedule (RCS)10-1. For questions or clarification, please contact the Contracting Officer and/or the Oklahoma City VA Records Officer.

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 Oklahoma City VA Healthcare System records.

2. does not include personal materials.

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

Oklahoma City VA Healthcare System contract.

4. may include deliverables and documentation associated with deliverables.

VHA RECORDS MANAGEMENT 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 while 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. OKC VAHCS 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 the OKC VAHCS 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. Contractor must report all incidences of unlawful or accidental removal, defacing, alteration, or destruction of VHA records to the OKC VAHCS. The OKC VAHCS must report all said incidences 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 VA Handbook 6500.6 Appendix A. 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 the OKC VAHCS 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 Statement of Work and/or the VA Handbook 6500.6 Appendix A. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the Contractor/Subcontractor or any person acting on behalf of the Contractor/Subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/Subcontractors that contain VA information must be returned to VA for sanitization or destruction or the Contractor/Subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

7. 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 subcontractor) is required to abide by Government and the OKC VAHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

8. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with OKC VAHCS policy.

9. The Contractor shall not create or maintain any records containing any nonpublic OKC VAHCS information that are not specifically tied to or authorized by the contract.

10. 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.

11. The OKC VAHCS 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 the OKC VAHCS 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.

12. 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.

SUBCONTRACTOR GUIDANCE

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this VA Handbook 6500.6 Appendix A 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.

The following are Federal Holidays:

New Year’s Day Birthday of Martin Luther King, Jr.(day of observance) Washington’s Birthday Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day (Any other day designated as a National Holiday by the President of the United States.)

Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the “Schedule of Supplies and Services” Section.

POC Name:

Address:

City/State/Zip Code:

Ordering Phone Number:

Ordering Fax Number:

Ordering E-Mail Address:

DELIVERY COMMITMENT: Time of delivery specified or mutually agreed to at the time of receipt of telephone /on-line orders shall become mandatory upon the Contractor's acceptance to commitment.

Delivery of supplies by the scheduled time will be complete except as otherwise authorized by the Ordering Personnel.

Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default.

The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule. The contractor shall not be charged with damages when the delay in delivery arises out of causes beyond the control and without the fault or negligence of the contractor.

DELIVERY LOCATION:

Deliveries will be made to:

OKC VA Medical Center Attn: PET Center -1G-114 921 NE 13th St

OKC, OK 73104

Contract/Delivery personnel shall be escorted within the Radiation Oncology center to the PET/CT Hot lab by Nuclear Medicine personnel.

The C&A requirements do not apply, and that a Security Accreditation Package is not required

Upon request by the COR, the Contractor shall provide miscellaneous supplies and/or services including, but not limited to the following:

A copy of reports of contractor’s RSO Safety Audits of Federal compliance.