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STATEMENT OF WORK
MANCHESTER VA MEDICAL CENTER
G.E DaTscan
Machester VA Medical Center is requesting a contract with GE Healthcare for the purchase and delivery of the radiopharmaceutical DaTscan (Iodine-123 Ioflupane) used for striatal dopamine transporter visualization using Nuclear Medicine SPECT brain imaging. DaTscan imaging assists the clinician in the evaluation of adult patients with suspected Parkinsonian syndromes.

Doses will be ordered directly from the GE Pharmacy in Woburn, MA by nuclear medicine personnel or a qualified radiologist. Orders may be placed two days prior to the administration of the dose.

Approximately six (6) doses per month will be needed (Total 72). DaTscan is supplied as a 2.5 ml single-use vial of sterile solution for intravenous injection. GE Healthcare will produce, package, and deliver the individual unit dose for each patient.

Any cancellations of DaTscan medication may be made 48 hours before the scan date at no charge. If a dose was delivered but was unable to be administered to the patient due to an eligible issue , the product will be destroyed and GE will offer a credit for the value of the purchase price toward the existing account, up to five credits per year. Eligible issues include: 1) The patient could not make their appointment due to a situation outside the patient s control; 2) The dose was delivered too late and cannot be injected due to imaging protocol; 3) The patient did not stop a contraindicated medication per the product s package insert on the day of the study; and 4) The patient cannot be injected due to a medical condition on the day of the study.

Direct delivery of each vial will be made to the Nuclear Medicine modality of the Radiology Department of the Manchester VA Medical Center, 718 Smyth Road, Manchester, NH 03104.
RECORDS AND CONFIDENTIALITY
Records created by the Contractor in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable federal laws and regulations. Whenever possible, records and reports will be made available in digital form.

The contractor shall provide VACTHS with the hard-drive system at the conclusion of the contract period. This shall be signed off by a VA Connecticut s Information Security Officer (ISO) and Clinical Engineering (CE) services.

The treatment and administrative records created by, or provided to the Contractor under this award, shall be covered by the VA system of records entitled Patient Medical Records- VA (24VA136). In responding to VA Patient requests that copies of their patient records be released to a third party, the Contractor shall refer the VA patient/family to the Release of Information Act (ROI), located within the VA Business office for response.
Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

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 by the Freedom of Information Act.

Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

The Government Agency owns the rights to all data/records produced as part of this contract.

The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

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