36C25526Q0012.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

POINT OF CONTACT*

Contract Specialist Maria Espinosa maria.espinosa@va.gov

(913) 946-1967

PLACE OF PERFORMANCE

4801 Linwood Boulevard

Kansas City MO

COUNTRY

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

STATEMENT OF WORK

PET/CT Radiopharmaceuticals Kansas City, MO

Description/Specifications

1. Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to Kansas City VA Medical Center, Kansas City, MO located at 4801 E. Linwood Blvd, Kansas City, MO 64128 on a daily and/or as needed basis per this Statement of Work. Because of the critical need for these supplies in a timely manner, only vendors within a 50-mile radius of the VA Kansas City, MO need to respond to this RFQ.

2. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include DOT, DOE, UNNRC, and ICC regulations and standards.

3. Supplier shall hold a current unrevoked USNRC and/or FDA license to produce and distribute radiopharmaceuticals for human administration, and a license to receive, and dispose of radioactive waste. Supplier shall provide a copy of their radioactive material license to the Nuclear Medicine Service at Kansas City VA Medical Center (KCVA) upon commencement of this contract. Supplier shall immediately notify KCVA, upon any action be the USNRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts.

4. FDG-18 and CU-64 product radiopharmaceuticals not used will be returned for credit the next workday, using the DOT regulations.

5. Upon notification of contract award, Contractor will provide, in writing, within ten (10) days, the following information to the VA Medical Center:

a. Contractor’s regular work hours

b. Contractor’s telephone number for call-in orders during regular work hours.

c. Contractor’s telephone number and instructions for placing “Emergency” orders after contractor’s regular work hours, including weekends.

d. Contractor’s telephone number for expert advice concerning awarded products.

e. Contractor will furnish a statement that any radiopharmaceuticals delivered as “ready-to-use” (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of The Joint Commission (TJC) and/or with the United States Pharmacopeia.

f. Should any changes occur in above information during contract performance period, contractor will provide updates in writing.

6. Current package inserts of all radiopharmaceuticals supplied under this contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new and/or updated additions to the package inserts are made available, these will be sent to the Nuclear Medicine Service at Kansas City VA Medical Center.

7. Contractor shall make quality control records available to the VA Medical Center upon written request from the Contracting Officer.

8. Calibration time for each requested radiopharmaceutical is given in the Schedule of item, or if not so indicated, then it will be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery.

9. If dosage is given to Contractor, then the quantity of radioactivity must be within the dose provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%.

10. The expiration date and time shall be indicated and affixed to each product as noted below; in general:

a. Ready-to-use doses: not shorter than two (2) hours.

b. FDG-18 and CU-64: Not shorter than two (2) hours.

c. Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery.

d. Unused kits having expiration time not less than two (2) weeks will be exchanged by the Contractor at no additional charge for a comparable kit having the three (3) months life span.

11. In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COTR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

a. Provide technical expertise in calibration.

b. Provide professional examination of product; submit results and recommendations to the Contacting Officer.

c. Make expedient replacement of any product suspected of being deficient.

12. Contractor shall produce radiopharmaceuticals as described in the Bid/Price Schedule.

Deliverables and Acceptance Criteria

1. Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below:

a. Provide up to four deliveries per day during regular operating hours to KCVA.

b. Deliver directly to the Nuclear Medicine Service at KCVA daily quantity of radiopharmaceuticals by 7:15 am, as requested from the previous day.

c. Deliver directly to the Nuclear Medicine Service at KCVA quantity of radiopharmaceutical requested on an as needed/emergent basis to arrive within two (2) hours of notification.

d. Deliveries occurring outside of working hours are directed to KCVA Police. Contractor will not have access Nuclear Medicine outside of working hours.

e. Other delivery times may be outlined by the KCVA under this contract.

2. If shipments are contracted to be delivered specifically on Mondays, but Monday is a holiday, then the shipment will take place the next regular workday. Holidays are listed herein.

3. Shipments “called when needed” may be requested during regular work hours.

4. Requested shipments will be delivered as follows:

a. Requests placed after regular work hours (weekend, holiday, and night) will be delivered as specified.

b. All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent regulations.

c. All Radiopharmaceuticals, Radioassay Kits and/or Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable Local, State and Federal Laws.

d. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by KCVA under this contract, will be strictly adhered to.

5. All shipments will have a Packing Slip enclosed, giving information about the product and it’s identification, plus (for billing purposes) the VA Medical Center’s Purchase Order Number issued for the current fiscal quarter or month, and the Contractor’s invoice number. (Incorrect P.O. numbers may cause a substantial delay in payments.)

6. Billing:

6.1. Invoice requirements and supporting documentation: Supporting documentation and invoices must be submitted on a monthly cycle and no later than the 20th workday of the month for the previous months billing. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

6.1.1. Name and Address of contractor to whom the payment is to be sent.

6.1.1.2 Name, title, and phone number of person to notify in event of defective invoice

6.1.2. Invoice Date and Invoice Number

6.1.3. Contract Number and Purchase/Task Order Number

6.1.4. Line-Item Number associated to each Dose (IAW price Schedule for that current POP).

6.1.5. Description, quantity, unit of measure, unit price and extended price of the items delivered.

6.1.6. Shipping number and date of shipment.

6.1.6. Date of Service / Order

6.1.7. Number of Doses

6.1.8. LOT/RX number associated with the order.

6.2. Vendor Electronic Invoice Submission Methods

6.2.1. Invoices will be electronically submitted to the Tungsten website at http://www.tungsten-network.com/customer-campaigns/veteransaffairs/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Taxpayer ID Number with the VA-FSC.

In order to successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer).

The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact:

Tungsten Support Phone: 1-877-489-6135 Website: http://www.tungsten-network.com/customer-campaigns/veteransaffairs/ Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafscched@va.gov

6.3. Payment Adjustments:

6.3.1. In the event that payment adjustments are required, the COR will work along with the Contractor to review invoices to determine if an adjustment is required. The COR shall present the findings to the Contracting Officer in order for a final decision to be determined. At that time an adjusted may be granted.

6.4. Payments in full/no billing VA beneficiaries: The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.

Work Hours

The delivery of products provided by this contract shall be furnished by the contractor. The contractor shall not be required, except in case of an emergency, to furnish such products on a national holiday or during non-working hours as described below with the exception of normal next day delivery as described in (1) above and (2) below.

The following terms have the following meanings:

(1) Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:30a.m. to 4:30 p.m.

(2) Normal Next Day Delivery: 7:15a.m.

(3) National Holidays: The ten holidays observed by the Federal Government are:

New Year's Day, Martin Luther King's Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving, and Christmas, and any other day specifically declared by the President of the United States to be a national holiday

Personnel Policy The contractor is responsible for all costs, including personnel costs, associated with this contract.

Qualifications Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be nuclear pharmacists, or licensed technologist working under the supervision of nuclear pharmacist licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director.

Contractor Staff, Roles and Responsibilities Must be in compliance with all NRC, USP, state, local and TJC guidelines.

Contractor Performance Assessments

Assessments. The Government may do assessments of the Contractor’s performance. The Contractor shall have an opportunity to respond to assessments.

Record. The Government will keep completed assessments and may serve as past performance data. Past performance data will be available to assist agencies in the selection radio-pharmacy providers for future projects. Past performance data may also be utilized in future procurement efforts.

Radiopharmaceutical list for the Kansas City Nuclear Medicine Section.

*These are estimated requirements only, amounts may differ*

VA RECORDS POLICY: All records (administrative and specific) creating, maintaining, safeguarding, and disposing during the period of the contract belong to Kansas City VAMC and must be returned to Kansas City VAMC at the end of the contract or destroyed in accordance with the VHA Record Control Schedule (RCS)10-1.

RECORDS MANAGEMENT STATEMENT:

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. Kansas City VAMC 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 [Agency] 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 Kansas City VAMC. 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 Kansas City VAMC 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 Kansas City VAMC 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 Kansas City VAMC policy.

8. The Contractor shall not create or maintain any records containing any non-public Kansas City VAMC 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 Kansas City VAMC 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 Kansas City VAMC 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 Kansas City VAMC-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.]

Flowdown of requirements to subcontractors

12. 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.

Important information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to an acquisition approach. The Government will in no way be bound to this information if any solicitation is issued.

Any response to this source selection from Interested parties must be received NLT 10/07/2025, 1000 AM CST.

Attention: Maria Espinosa, Contracting Specialist Email: maria.espinosa@va.gov

Please reference 36C25526Q0012 Radiopharmaceuticals PET Doses KCVAMC in the subject line.

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Sources Sought Notice