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Contract Opportunity

The Veterans Health Administration Minneapolis Health Care System requires Brand Name or equal radiopharmaceutical agents and supplies in accordance with the draft Statement of Work below.
This is a sources sought looking for businesses to provide the supplies listed below for market research purposes. No awards of a contract will be made from this announcement.
Identify if your organization is the manufacturer of the required supplies.A If you are not the manufacturer, identify the manufacturer of the supplies that you will provide.A
A Identify any foreign end products per FAR 52.225-4, that would be provided to meet this requirement (https://www.acquisition.gov/far/52.225-4).
A Identify your organization's socio-economic category.
A Address whether your organization meets the requirements of 13 CFR 121.406 (b)(1)(i), (b)(1)(ii) and (b)(1)(iii) (https://www.ecfr.gov/current/title-13/chapter-I/part-121/subpart-A/subject-group-ECFR0fca5207262de47/section-121.406#p-121.406(b)).
A If you are a vendor that can provide the requested information and required supplies described below with competitive pricing, send your information (to include your organization's Unique Entity Identifier number) with a description of proof of capability to: Jeffrey.Brown8@va.gov on or before January 12th, 2024.
*If applicable, VAAR 852.219-76A VA Notice of Limitations on Subcontracting Certificate of Compliance for Supplies and Products, will apply to the potential solicitation if set-aside for Veteran Owned Small-Businesses.*
A *If applicable, VAAR 852.212-71 Gray Market Items, will apply to the potential solicitation. *
A *If applicable, FAR Provision 52.219-14 Limitations on Subcontracting, will apply to the potential solicitation if set-aside for Small-Businesses. *

STATEMENT OF WORK
GENERAL:
The purpose of this contract is to provide Minneapolis Veteran Affairs Health Care System with Brand name or equal radiopharmaceutical agents and provide the delivery of those agents to the Nuclear Medicine Department, Minneapolis Veterans Affairs Health Care System, One Veterans Drive, Minneapolis, MN 55472, here in referred to as MVACHS.

Estimated Quantities:

The quantities as listed in the Schedule of Items are estimated requirements based on historical usage. The MVAHCS attempts to be as accurate as possible when providing estimated quantities, however, actual quantities required may vary from quantities as listed. MVAHCS does not guarantee to order the quantities listed. The unit prices supplied quoted to NCO 23 contracting officer shall apply to the quantities actually ordered by Authorized Ordering Individuals.

All products will be requested on an on demand, as needed basis order via phone or email by MVACHS authorized personnel only. Authorized ordering Individuals are MVAHCS Nuclear Medicine Technologists and the COR (Contracting Officer Representative).
The quantities listed in the schedule of items are estimates.

2A. Schedule of Items
Base ordering Period
CLIN
Product #
Description
Estimated Annual Qtys
0001
A
Axumin (fluciclovine F 18)
4
0002
A
Posluma (flotufolastat F 18)
1
0003
A
Amyvid (florbetapir F 18)
25
0004
A
Tauvid (flortaucipir F18)
1
0005

Cerianna (fluoroestradiolA F18)
25

Ordering Period 1
CLIN
Product #
Description
Estimated Annual Qtys
1001
A
Axumin (fluciclovine F 18)
6
1002
A
Posluma (flotufolastat F 18)
1
1003
A
Amyvid (florbetapir F 18)
35
1004
A
Tauvid (flortaucipir F18)
1
1005
A
Cerianna (fluoroestradiolA F18)
30

Ordering Period 2
CLIN
Product #
Description
Estimated Annual Qtys
2001
A
Axumin (fluciclovine F 18)
8
2002
A
Posluma (flotufolastat F 18)
1
2003
A
Amyvid (florbetapir F 18)
45
2004
A
Tauvid (flortaucipir F18)
1
2005
A
Cerianna (fluoroestradiolA F18)
35

Ordering Period 3

CLIN
Product #
Description
Estimated Annual Qtys
3001
A
Axumin (fluciclovine F 18)
10
3002
A
Posluma (flotufolastat F 18)
1
3003
A
Amyvid (florbetapir F 18)
55
3004
A
Tauvid (flortaucipir F18)
1
3005
A
Cerianna (fluoroestradiolA F18)
40

Ordering Period 4
CLIN
Product #
Description
Estimated Annual Qtys
4001
A
Axumin (fluciclovine F 18)
12
4002
A
Posluma (flotufolastat F 18)
1
4003
A
Amyvid (florbetapir F 18)
65
4004
A
Tauvid (flortaucipir F18)
1
4005
A
Cerianna (fluoroestradiolA F18)
45
Deliveries:

Deliveries shall be made to one of MVAHCS hot rooms, to be specified at time of ordering by MVACHS:

Location 1:
VA Medical Center, Bldg 70, Room BW101D
Warehouse (90D), PO#________
One Veterans Drive
Minneapolis, MN 55417
Location 2:

VA Medical Center, Bldg 70, Room BV113
Warehouse (90D), PO#________
One Veterans Drive
Minneapolis, MN 55417

Between 8:00 am and 3:30pm, Monday-Friday except Federal Holidays.

The Federal Holidays (actual days observed by the Federal Government) are:

New Year s Day
Martin Luther King s Birthday
Washington s Birthday
Memorial Day
Juneteenth National Independence Day
Independence Day
Labor Day
Columbus Day
Veterans Day
Thanksgiving Day
Christmas Day
And any day specifically declared by the President of the United States to be a national holiday.

Note: If the federal holiday falls on a Saturday it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.

All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain Vendor s name, Purchase order number, Date of order, Date of delivery, Itemized list of products furnished including product description, and quantity shipped.

All products are purchased subject to acceptance by the MVAHCS, Nuclear Medicine Service. Products will be rejected and may be discarded if found unsatisfactory when they are received, or later if deterioration of the product occurs before the outdate. The MVACHS shall not be financially liable for unacceptable radiopharmaceutical agents.
At no time shall delivery driver leave radioactive material unattended in facility. All deliveries shall be delivered directly to the nuclear medicine department in one of their hot rooms .

REQUIREMENTS:

Contractor must be licensed by the State of Minnesota. Additionally, contractor must the licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Offeror must provide copies of these licenses and certifications upon request of the Contracting Officer.

All products provided under this contract shall meet all requirements of the Nuclear Regulatory Commission. All products provided under this contract shall be packaged and shipped in accordance with the requirements of the Nuclear Regulatory Commission (NRC) and Department of Transportation (DOT). All products returned will also be packaged in accordance with the requirements of the NRC and the DOT.

All products provided under this contract shall be in compliance with all OSHA manufacturing, packaging and shipping regulations.

All labeled products shall be LEU-derived radiopharmaceuticals where applicable and available.

The contractor shall guarantee the quality of all radiopharmaceuticals. The contractor shall provide quality control on each agent dispensed.

The contractor shall provide complete documentation on quality Control results upon request.

The contractor shall provide documentation of inventory, disposal and patient dose records, which documents compliance with Nuclear Regulatory Commission (NRC) requirements and Minneapolis VAHCS Radioactive Material License (RAM).

The contractor shall be capable of providing the radiopharmaceuticals and estimated quantities necessary to provide operation levels. Types and quantities of product may change throughout the course of the contract.

Contractor/supplier shall abide by (CFR 10) Title 10 Code of Federal Regulations, which states: Title 10 Code of Federal Regulations is available at: http://www.nrc.gov/reading-rm/doc-collections/cfr/. A licensee may use for medical use only:

Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issue pursuant to the regulations in Title 10, Code of Federal Regulations, part 30 and SS32.72, or 32.74 of this chapter or the equivalent regulations of an Agreement State:

Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Commission pursuant to S32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.

Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all federal and state regulations. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped.

Contractor must provide a copy of their laboratory s current quality control manual and must be willing to discuss any discrepancies in lab results, which do not fit the clinical picture.

Contractor must test all products for Quality Control periodically and only those products that pass quality control may be sent to the VA. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.

Contractor must assign to this medical center an individual sales representative to aide in facilitation in the smooth coordination between the medical center and laboratory pharmacy.

Contractor must provide current material safety data sheets in a in a binder and updates as necessary on all delivered products for each medical center or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed.

Contractor may provide patient orientation education video presentations and other appropriate material as deemed necessary by the medical center.

Contractor may provide appropriate signs and posters alerting patients, employees, and the public of safety precautions in handling of radioactive materials.

Contractor must replace any items delivered in error at no cost to the government.

Contractor must label all products as to the amount of radiopharmaceutical, preparation time, expiration time and date, etc.

Contractor must follow all USP 797 guidelines and provide verification of compliance upon Contracting Officer request.

No Employee status: The contractor shall be responsible for protecting the contractor s staff furnishing services. To carry out this responsibility, the contractor shall provide or certify that the following are provided for all their staff providing services under the resultant contract:

Workers compensation
Professional liability insurance
Health examinations
Income tax withholding, and
FICA and Medicare tax withholding

TRANSPORTATION: Contractor personnel, drivers and alternates, shall be able to read, write, speak and understand English language. Personnel shall present a neat appearance and be easily recognized as a contract employee by wearing an identification badge that includes the company s name/logo and employee name and photograph. Vehicles used during this service shall prominently display the company s name/logo.

Contractor must ensure that courier service/drivers maintain their Motor Carrier Permit, hazardous material license number, certificate of training of couriers (employees), valid state-issued drivers licenses, vehicle insurance and registration.

The contractor shall be required to maintain a record log of courier deliveries, indicating time and date, number and description of items for each location, along with signatures.

The contractor will be responsible for all reimbursement of the original and/or repeat items because of mishandling or loss.

All vehicles are to be insured in accordance with the regulations of the State of Minnesota at the expense of the contractor.
BILLING/INVOICES:

Contractor must submit a weekly invoice to the COR, in arrears, showing period covered, billing date, name of preparation, quantity, and amount. The invoices shall contain the following information at a minimum:
Purchase Order Number
Name of Radiopharmaceutical agent and the number provided
The unit/unit cost
Total price

Contractor shall add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements must be received within 48 hours of notification by the VA.

Contractor shall provide upon request a detailed description of the test to be performed, as provided by the manufacturer.

Billings rendered by the contractor to the Minneapolis VA Health Care System for services furnished under the terms of this contract shall be billed in full. Neither beneficiary, his/her insurer, nor any other third party shall be billed.

Payments for services will be at the rates specified in the Schedule of Supplies/Services.

Payment shall only be made for actual services rendered and items that are received and found acceptable.

Vendor Electronic Invoice Submission Methods: Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below. Reference VAAR Clause 852.232-72: The contractor shall submit electronic payment requests through:

VA s Electronic Invoice Presentment and Payment System (See Web site at http://www.fsc.va.gov/einvoice.asp.); or,

A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org) includes additional information on EDI 810 and 811 formats.

The Contract may contact FSC at the phone number or email address listed below with any questions about the e-invoicing program:
TungstenA e-Invoice Setup Information: 1-877-489-6135
TungstenA e-Invoice email: VA.Registration@Tungsten-Network.com
FSC e-Invoice Contact Information: 1-877-353-9791
FSC e-invoice email: vafsccshd@va.gov

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