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Radiopharmaceutical (Ga68 Dotatate),


Texas, United States
Government : Federal
RFP
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ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
0001

70.00
EA
$00.00
$00.00

gallium Ga68 dotate










GRAND TOTAL
$00.00

The Department of Veterans Affairs is seeking both manufacturers and/or distributors of the exact match or functionally equivalent equipment/ services to the following listed above.

STATEMENT OF WORK

Background
The South Texas VA Health Care System (STVHS) requires the manufacturing and delivery of Gallium (Ga68) DOTATATE for the diagnosis and treatment of patients with gatroenteropancreatic neuroendocrine tumors that are positive for the hormone receptor somatostatin. The VA awards a firm-fixed-price purchase order, in accordance with FAR Parts 12 & 13. Delivery shall be made upon request of the STVHS
Place(s) of Performance: Imaging Services at ALM: NUCLEAR MEDICINE: 2nd Floor

Scope:
1. Contractor must be licensed by the US Nuclear Regulatory Commission (USNRC), or a State with a
formal Agreement with the USNRC that allows the State to regulate radioactive materials (Licensee), and
be regularly established in the business of providing radiopharmaceuticals at the scale and frequency
necessary to meet this requirement. Non-manufacturing waiver is not applicable to this solicitation.
Please note that the contractor shall provide copies of all relevant licenses and certifications, along with
their proposal, to the Contracting Officer upon request.

2. Contractor/licensee shall meet all applicable Nuclear Regulatory Commission, VA/National Health
Physics Program (NHPP), Department of Transportation, FDA, Joint Commission, OSHA, State, and
Federal requirements, rules, and/or regulations related to the supply of Radiopharmaceuticals.

3. Contractor/licensee must be able to provide Ga68 DOTATATE radiopharmaceuticals to the STVHS
Nuclear Medicine Service Treatment and PET Imaging Facility at the South Texas VA Hospital.

4. Contractor/licensee shall have available an adequate supply of contracted products to meet the
requirements of the STVHS. Doses will be ordered/scheduled with at least 48 hours advance notice to
the vendor. Should the vendor s ability to supply product from the applicable pharmacy be limited for any
reason the vendor shall notify the Customer of any limitations on the delivery times and dates that may
affect its ability to supply Product when requested.

5. Contractor/licensee shall label all unit doses of delivered radiopharmaceutical with the amount,
preparation time, expiration time, date, etc. It is preferred that the Contractor ensure bar code
compatibility with the STVHS Nuclear Medicine Information System (NMIS). Contractor will support
any necessary steps to ensure approval for use of new infrastructure (Example: Information Security) if
required - upon award, and prior to start of contract.
6. All packages containing radioactive material must be labeled and shipped in accordance with Title 49,
Code of Federal Regulations Part 172 and 173. An additional label shall be affixed to each syringe, vial,
or other container used to hold a radioactive drug to be transferred for commercial distribution. The label
must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or
"DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other
container can be correlated with the information on the transport radiation shield label.
7. Contractor/licensee shall perform all quality control procedures as required by Federal, and when
applicable, State regulatory agencies. Quality Control results will be furnished to STVHS upon request.
8. Contractor/supplier shall abide by Title 10, Code of Federal Regulation, which states: A Licensee may
use for medical purposes only:
(a) By-product material or cyclotron produced materials manufactured, labeled, packaged and distributed
in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations,
Part 35 and/or the equivalent regulations of an Agreement State.
(b) Reagent kit that has been manufactured, labeled, packed and distributed in accordance with approval
by the Commission pursuant to Title 10 CFR 32.72 or an Agreement State under equivalent regulations
for the preparation of radiopharmaceuticals for medical use.
9. Contractor will utilize only FDA approved products and sources for those products, unless otherwise
mutually agreed upon in the context of compassionate care or IRB approved research.
10. Contractor/licensee will deliver radioisotope in an amount greater than or equal to the activity
ordered with calibration for the specified appointment time so that patient administered quantity is within
regulatory limits of the prescribed dose. All routine diagnostic radiopharmaceutical dose deliveries must
occur >10 minutes prior to the calibration time. In the event that Nuclear Medicine Service is unable to
perform a patient procedure due to the dose/injection arriving in an unusable form (e.g. too low activity),
the vendor will not invoice for the dose.
11. Pricing and Radiopharmaceutical Returns for Credit:
Pricing will be based upon a unit dose price per quantity of doses ordered with no other fees or
surcharges. The Contractor shall accept returns for full credit toward future orders 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.
12. Invoicing: Contractor shall invoice at least once per month that product is utilized showing the period
covered, billing date, name of preparation, quantity and amount, as well as the correct purchase order
number. Unit dose (UD) based invoicing is preferred. A mutually agreed upon method to track unused
reimbursable doses must be established prior to contract initiation.


13. Normal/ Routine Ordering: Routine orders will be placed at least 48 hours in advance by authorized
VA personnel during normal business hours (8:00am 6:00pm).
Deliveries should be made directly to the NTVHCS Nuclear Medicine Service PET/MI&T
Radiopharmacy. After award, for Contractors without established business with STVHS Nuclear
Medicine Service, the Contractor/licensee will be furnished the name(s) of VA personnel that are
authorized to place orders against the Contract, and will provide appropriate personnel and contact
information for staff receiving orders, able to offer technical or administrative support, as well as staff
involved in radiopharmaceutical delivery in accordance with VA Radiation Safety Office requirements.
If not previously performed, completed background clearance checks must be submitted for review to
STVHS Nuclear Medicine Service/Radiation Safety Office for all delivery personnel following award
and prior to start of contract. Notification is required for any changes to these records, which should be
made available for audit when requested.
Orders shall only be placed by authorized STVHS NMS personnel via telephone, fax, e-mail, or via an
approved, secure, online ordering system. For electronic ordering systems, a closed-loop communication
process such as confirmation e-mails is preferred.
14. Normal/ Routine Deliveries: Delivery orders, or the electronic ordering system, shall include the
following information:
Contract item(s) and quantity
Time(s) of delivery
Applicable VA purchase order number
Offeror with secure online ordering portal, or that utilizes a VA approved Information Security system
that allows ordering which includes Protected Health Information (PHI) to better protect patient safety is
preferred. Upon award, contractor will take necessary steps to ensure any needed infrastructure is in place
prior to start of the contract.
It is incumbent upon the contractor to ensure delivery personnel are adequately familiar with each specific
delivery location. Delivery personnel will park at the nearest secure location and proceed directly to the
Nuclear Medicine Service site where they will be escorted to the radiopharmacy (Hot Lab) by STVHS
staff.
Nuclear Medicine Service normal business hours are considered Monday through Friday: 7:00 am 4:30
pm, except Federal Holidays, and Saturdays from 7:00 am 11:00 am.
The following are Federal Holidays:
New Year s Day
Birthday of Martin Luther King, Jr. (day of observance)
Washington s Birthday
Memorial Day
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.)




15. Contractor will provide STVHS NMS personnel access to relevant online and/or live Initial, as well
as Continuing, Education at no cost to STVHS when applicable, to ensure staff are trained and remain
current in this product as well as safe receipt and handling of radioactive materials/radiopharmaceuticals,
correct use of infrastructure applications such as an online ordering portal/NMIS, as well as any related
regulatory requirements (Example: DOT).
16. Ordering Contact Information: Contractor/licensee 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:
17. DELIVERY COMMITMENT: Time of delivery specified or mutually agreed to at the time of
receipt of telephone/electronic order(s) shall become mandatory upon the Contractor's/licensee 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 result in financial penalty or Contracting Officer review in certain instances this 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/licensee shall not be charged with damages when the delay in delivery arises
out of causes beyond their control and without the fault or negligence of the contractor/licensee.
18. DELIVERY LOCATION:
Deliveries will be made to:
VA SOUTH TEXAS STVHS (San Antonio)
Attn: Nuclear Medicine Service ()
2nd Floor
7400 Merton Minter
San Antonio, TX 78229
Security Requirements

Information System Officer, Information Protection: The contractor will not have physical access to access to online resources belonging to the government.

Privacy Officer: The contractor will not have physical access to protected Patient Health Information (PHI) and will not have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.




Records Manager:
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.

Contract Specialist: Dr. Vinicky Ann Ervin Ph.D.
All interested parties shall only contact
Dr. Ervin via email only by 26 Sep 2019
no later than 8 AM CST.

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