Active

Contract Opportunity

The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 17, is issuing this Notice of Intent (NOI) to inform industry contractors of the Government s intent to execute a Sole Source Award under FAR Part 13 Simplified Acquisition Procedures, specifically FAR 13.106-1(b)

The intended Contractor is Cardinal Healthcare., a Large business, headquartered at 7000 Cardinal Pl. Dublin, OH 43017.

The Nuclear Medicine Service at the North Texas Veterans Health Care System (NTVHS), Dallas VA Medical Center 4500 S. Lancaster Rd., Dallas, Texas 75216 is in need of the uninterrupted provision of Radium Ra-223 dichloride injection for the treatment of patients with prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has spread to the bones with symptoms, but not to other parts of the body (metastatic castration-resistant prostate cancer) in accordance with the SOW. We require this continuity for a period of June 01, 2024 to September 30, 2024.
(See Attachment A - Statement of Work (SOW)).

Cardinal Healthcare is the only contractor that is capable to provide these services, due to the highly specialized services required under this contract, discontinued use would result in substantial duplication of cost to the government that is not expected to be recovered through competition and will result in unacceptable delays in fulfilling the agency s requirements.

This procurement is being conducted using commercial items procedures pursuant to FAR Part 13, specifically FAR 13.106-1(b) allowing the Contracting Officer (CO) to solicit from one source in the interest of brand name.

The North American Industry Classification System (NAICS) for this requirement is, 325412 Pharmaceutical Preparation Manufacturing. Product/Service Code for this requirement is 6505 Drugs and Biologicals. The Small Business Administration (SBA) size standard for this sector is 1,300 Employees.

This notice of intent is neither a formal solicitation nor a request for competitive proposals. No solicitation document is available and telephone requests will not be honored. No award will be made on the basis of unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling, and convincing evidence that competition will be advantageous to the Government. The intent of this synopsis is for informational purposes only. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this action based on this notice is solely within the discretion of the Government.

All inquiries and concerns must be addressed in writing via e-mail to Oneka Robertson
at Oneka.Robertson@va.gov with the following information referenced in the subject line, 36C25724Q0548 RA223 (Xofigo) Therapy. A determination by the Government not to compete this proposed procurement based on the responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All interested parties who are responsible, certified, and capable may identify their interest and may submit capability statement which shall be considered by the agency no later than 12:00 PM, Central Time on April 19, 2024 to Oneka Robertson at Oneka.Robertson@va.gov. The interested parties bear full responsibility to ensure complete transmission and timely receipt.

Attachment A - Statement of Work (SOW)

STATEMENT OF WORK:
NUCLEAR MEDICINE SERVICE
Radium Ra223 Dichloride (Xofigo)
Introduction: VANTHCS Nuclear Medicine Service (NMS) requires Radium Ra-223 dichloride injection for the treatment of patients with prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has spread to the bones with symptoms, but not to other parts of the body (metastatic castration-resistant prostate cancer).

Qualifications of Bidders: Bids will only be considered from those who are regularly involved in the business called for, and who in the judgment of the Contracting Officer are financially responsible and able to show evidence of the reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service.

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 Offeror must provide copies of all relevant licenses and certifications, along with their proposal, to the Contracting Officer.

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.

Contractor/licensee must be able to provide Radium-223 (Xofigo) radiopharmaceuticals to the Nuclear Medicine Service at the Dallas VA Medical Center.

Contractor/licensee shall have available an adequate supply of contracted products to meet the requirements of the VA North Texas Healthcare System. Ra223 (Xofigo) doses will be ordered/scheduled with at least 72 hours advance notice to the vendor to ensure dose availability. 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.

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 VANTHCS 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.

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.

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 VANTHCS upon request.

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.

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.

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 radiopharmaceutical dose deliveries must occur >30 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.

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.

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.

Normal/ Routine Ordering: Routine orders for diagnostic imaging doses will be placed at least 72 hours in advance by authorized VA personnel during normal business hours (8:00am 4:30 pm).
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 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:

VA North Texas HCS (Dallas)
Attn: Nuclear Medicine Service (115)
3rd Floor, Room 3B-623
4500 S. Lancaster Road
Dallas, TX 75216

Access to the radiopharmacy during non-business hours shall be obtained by contacting VA Police Service. Delivery personnel shall be escorted at all times within the Nuclear Medicine Service.

Contractor will sign in/sign out with Nuclear Medicine Service personnel upon each delivery of radiotracer and follow all policies and procedures in place at VANTHCS facility Nuclear Medicine Service. Compliance with all applicable regulatory bodies, including FDA and TX/US DOT is requisite.

Upon request by VANTHCS Radiation Safety Officer, the Contractor shall provide a copy of reports of contractor s RSO Safety Audits of Federal Compliance.

Information Technology Security requirements section

As prescribed in 839.201, the contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.
1. GENERAL
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be
subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks
as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA
information and VA information systems for their employees, subcontractors, and affiliates only
to the extent necessary to perform the services specified in the contract, agreement, or task
order.
b. All contractors, subcontractors, and third-party servicers and associates working with
VA information are subject to the same investigative requirements as those of VA appointees
or employees who have access to the same types of information. The level and process of
background security investigations for contractors must be in accordance with VA Directive
and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations,
Security, and Preparedness is responsible for these policies and procedures.
c. Contract personnel who require access to national security programs must have a valid
security clearance. National Industrial Security Program (NISP) was established by Executive
Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the
classified information in their possession while performing work on contracts, programs, bids,
or research and development efforts. The Department of Veterans Affairs does not have a
Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security
Clearance must be processed through the Special Security Officer located in the Planning and
National Security Service within the Office of Operations, Security, and Preparedness.
d. Custom software development and outsourced operations must be located in the U.S.
to the maximum extent practical. If such services are proposed to be performed abroad and
are not disallowed by other VA policy or mandates, the contractor/subcontractor must state
where all non-U.S. services are provided and detail a security plan, deemed to be acceptable
by VA, specifically to address mitigation of the resulting problems of communication, control,
data protection, and so forth. Location within the U.S. may be an evaluation factor.
e. The contractor or subcontractor must notify the Contracting Officer immediately when
an employee working on a VA system or with access to VA information is reassigned or leaves
the contractor or subcontractor s employ. The Contracting Officer must also be notified
immediately by the contractor or subcontractor prior to an unfriendly termination.
3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in
performance or administration of the contract shall be used only for those purposes and shall
not be used in any other way without the prior written agreement of the VA. This clause
expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data
- General, FAR 52.227-14(d) (1).
b. VA information should not be co-mingled, if possible, with any other data on the
contractors/subcontractor s information systems or media storage systems in order to ensure
VA requirements related to data protection and media sanitization can be met. If co-mingling
must be allowed to meet the requirements of the business need, the contractor must ensure
that VA s information is returned to the VA or destroyed in accordance with VA s sanitization
requirements. VA reserves the right to conduct on site inspections of contractor and
subcontractor IT resources to ensure data security controls, separation of data and job duties,
and destruction/media sanitization procedures are in compliance with VA directive
requirements.
c. Prior to termination or completion of this contract, contractor/subcontractor must not
destroy information received from VA, or gathered/created by the contractor in the course of
performing this contract without prior written approval by the VA. Any data destruction done on
behalf of VA by a contractor/subcontractor must be done in accordance with National Archives
and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records
and Information Management and its Handbook 6300.1 Records Management Procedures,
applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media
Sanitization. Self-certification by the contractor that the data destruction requirements above
have been met must be sent to the VA Contracting Officer within 30 days of termination of the
contract.
d. The contractor/subcontractor must receive, gather, store, back up, maintain, use,
disclose and dispose of VA information only in compliance with the terms of the contract and
applicable Federal and VA information confidentiality and security laws, regulations and
policies. If Federal or VA information confidentiality and security laws, regulations and policies
become applicable to the VA information or information systems after execution of the
contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after
execution of this contract, the parties agree to negotiate in good faith to implement the
information confidentiality and security laws, regulations and policies in this contract.
e. The contractor/subcontractor shall not make copies of VA information except as
authorized and necessary to perform the terms of the agreement or to preserve electronic
information stored on contractor/subcontractor electronic storage media for restoration in case
any electronic equipment or data used by the contractor/subcontractor needs to be restored to
an operating state. If copies are made for restoration purposes, after the restoration is
complete, the copies must be appropriately destroyed.
f. If VA determines that the contractor has violated any of the information confidentiality,
privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the
contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.
g. If a VHA contract is terminated for cause, the associated BAA must also be terminated
and appropriate actions taken in accordance with VHA Handbook 1600.01, Business
Associate Agreements. Absent an agreement to use or disclose protected health information,
there is no business associate relationship.
h. The contractor/subcontractor must store, transport, or transmit VA sensitive information
in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2
validated.
i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request.
j. Except for uses and disclosures of VA information authorized by this contract for
performance of the contract, the contractor/subcontractor may use and disclose VA information
only in two other situations: (i) in response to a qualifying order of a court of competent
jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all
requests for, demands for production of, or inquiries about, VA information and information
systems to the VA contracting officer for response.
k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA
records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records
and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug
addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human
immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other
requests for the above mentioned information, that contractor/subcontractor shall immediately
refer such court orders or other requests to the VA contracting officer for response.
l. For service that involves the storage, generating, transmitting, or exchanging of VA
sensitive information but does not require C&A or an MOU-ISA for system interconnection, the
contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on
a yearly basis and provide it to the COTR.

GENERAL RULES OF BEHAVIOR
a. Rules of Behavior are part of a comprehensive program to provide complete
information security. These rules establish standards of behavior in recognition of the fact that
knowledgeable users are the foundation of a successful security program. Users must
understand that taking personal responsibility for the security of their computer and the
information it contains is an essential part of their job.
b. The following rules apply to all VA contractors. I agree to:
(1) Follow established procedures for requesting, accessing, and closing user accounts
and access. I will not request or obtain access beyond what is normally granted to users or
by what is outlined in the contract.
(2) Use only systems, software, databases, and data which I am authorized to use,
including any copyright restrictions.
(3) I will not use other equipment (OE) (non-contractor owned) for the storage, transfer,
or processing of VA sensitive information without a VA CIO approved waiver, unless it has
been reviewed and approved by local management and is included in the language of the
contract. If authorized to use OE IT equipment, I must ensure that the system meets all
applicable 6500 Handbook requirements for OE.
(4) Not use my position of trust and access rights to exploit system controls or access
information for any reason other than in the performance of the contract.
(5) Not attempt to override or disable security, technical, or management controls
unless expressly permitted to do so as an explicit requirement under the contract or at the
direction of the COTR or ISO. If I am allowed or required to have a local administrator
account on a government-owned computer, that local administrative account does not confer
me unrestricted access or use, nor the authority to bypass security or other controls
except as expressly permitted by the VA CIO or CIO's designee.
(6) Contractors use of systems, information, or sites is strictly limited to fulfill the terms
of the contract. I understand no personal use is authorized. I will only use other Federal
government information systems as expressly authorized by the terms of those systems. I
accept that the restrictions under ethics regulations and criminal law still apply.
(7) Grant access to systems and information only to those who have an official need to
know.
(8) Protect passwords from access by other individuals.
(9) Create and change passwords in accordance with VA Handbook 6500 on systems
and any devices protecting VA information as well as the rules of behavior and
security settings for the particular system in question.
(10) Protect information and systems from unauthorized disclosure, use, modification, or
destruction. I will only use encryption that is FIPS 140-2 validated to safeguard VA sensitive
information, both safeguarding VA sensitive information in storage and in transit regarding
my access to and use of any information assets or resources associated with my
performance of services under the contract terms with the VA.
(11) Follow VA Handbook 6500.1, Electronic Media Sanitization to protect VA
information. I will contact the COTR for policies and guidance on complying with this
requirement and will follow the COTR's orders.
(12) Ensure that the COTR has previously approved VA information for public
dissemination, including e-mail communications outside of the VA as appropriate. I will not
make any unauthorized disclosure of any VA sensitive information through the use of any
means of communication including but not limited to e-mail, instant messaging, online chat,
and web bulletin boards or logs.
(13) Not host, set up, administer, or run an Internet server related to my access to and
use of any information assets or resources associated with my performance of services
under the contract terms with the VA unless explicitly authorized under the contract or in
writing by the COTR.
(14) Protect government property from theft, destruction, or misuse. I will follow VA
directives and handbooks on handling Federal government IT equipment, information, and
systems. I will not take VA sensitive information from the workplace without authorization
from the COTR.
(15) Only use anti-virus software, antispyware, and firewall/intrusion detection software
authorized by VA. I will contact the COTR for policies and guidance on complying with this
requirement and will follow the COTR's orders regarding my access to and use of any
information assets or resources associated with my performance of services under the
contract terms with VA.
(16) Not disable or degrade the standard anti-virus software, antispyware, and/or
firewall/intrusion detection software on the computer I use to access and use information
assets or resources associated with my performance of services under the contract terms
with VA. I will report anti-virus, antispyware, firewall or intrusion detection software errors, or
significant alert messages to the COTR.
(17) Understand that restoration of service of any VA system is a concern of all users of
the system.
(18) Complete required information security and privacy training, and complete required
training for the particular systems to which I require access.

Records Management

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.Â

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.Â

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.Â

4. VA North Texas Health Care 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 VA North Texas Health Care 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 VA North Texas Health Care System. 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 VA North Texas Health Care 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 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 VA North Texas Health Care System 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 VA North Texas Health Care System policy.Â

8. The Contractor shall not create or maintain any records containing any non-public VA North Texas Health Care System information that are not specifically tied to or authorized by the contract.Â

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.Â

10. The VA North Texas Health Care 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 VA North Texas Health Care 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.

11. 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 #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.Â
SCHEDULE OF SUPPLIES AND SERVICES

The Department of Veterans Affairs North Texas Health Care System, Nuclear Medicine Service Center for PET Imaging requires the contractor/licensee to provide radiopharmaceuticals. Items will be unit dose or bulk delivery, daily, and on an as needed basis, in accordance with patient requirements for the period of one year plus option years, if applicable.
Note: All annual quantities are estimates, contractor will only be paid for items and quantities actually ordered and delivered.

Item #
Description/Part Number
Qty
1
Ra223 (Xofigo) dose injection
1500

Attachments/Links