6505--RUBIDIUM GENERATOR

THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED  SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION.

SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MARKET, AND CAPABILITIES IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI FOR PLANNING PURPOSES IN ACCORDANCE WITH (IAW) FAR 15.201(e).

DISCLAIMER

This RFI is issued solely for information and planning purposes and does not constitute a solicitation.  All information received in response to this RFI that is marked as proprietary will be handled accordingly.  IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract.  Responders are solely responsible for all expenses associated with responding to this RFI.

SOURCES SOUGHT/RFI DESCRIPTION

This is NOT a solicitation announcement.  This is a Sources Sought Notice / RFI only.  The purpose of this Sources Sought Notice / RFI is to gain information about potential qualified sources and their size classification relative to NAICS 325412 (size standard of 1,300 Employees). Responses to this Sources Sought Notice / RFI will be used by the Government to make appropriate acquisition decisions.  After review of the responses to this Sources Sought Notice / RFI, further RFIs and/or a solicitation or other announcements may be published. 

The Department of Veterans Affairs (VA) is seeking sources capable of providing RUBIDIUM (RB-82) GENERATOR.

STATEMENT OF WORK

SCOPE

The intent of this Request for Quote (RFQ) is to enter a Firm Fixed-Price Contract to provide Rubidium generator supplies to the VA Greater Los Angeles Healthcare System (VAGLAHS). The Contractor shall provide all labor, supervision, and transportation necessary to meet the needs of the monthly deliveries for the VA Greater Los Angeles Healthcare System (VAGLAHS).

Rubidium RB 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.  Using this tracer gives better images and better diagnostic accuracy and gives smaller radiation doses to patients and occupational workers than previously used methods.

Rubidium RB 82 Chloride injection is used in adults to help diagnose heart disease. It is used in a positron emission tomography (PET/CT) scan to help the doctor see an image of a patient’s heart. This medicine shows how much blood is getting to the heart muscle when patients are resting or exercising (stressed). Rubidium RB 82 belongs to the group of medications called radiopharmaceuticals (radioactive agents). The FDA approved RB-82 in 1995. Since that time, the application of PET/CT for cardiac imaging has become a robust tool to image patients’ hearts. In contrast to the use of the Tc-99m Sestamibi procedure of SPECT/CT in the past, the new PET/CT method can obtain calcium scores is an added benefit to assess a patient's long-term prognosis.

The radiopharmaceutical Rubidium-82 generator is a closed system used to produce rubidium RB 82 chloride injection for intravenous administration. The radiation of the generator is shielded in a generator cart. The generator and the generator cart are connected.  The technologist would activate the production of the Rubidium-82 by pushing a button whenever the radiopharmaceutical is needed.

TASKS

                       

The clinic is serving eight (8) patients a day and approximately 2,080 patients a year.

Period of Performance (PoP):

Base: 7/15/2025 – 7/14/2026

Option Year 1: 7/15/2026 – 7/14/2027

Option Year 2: 7/15/2027 – 7/14/2028

DELIVERABLES

PoP

CLIN

Description

Quantity

UOM

Base

0001

Rubudium RB-82 Generator

1

YR

Base

0002

Cart/System Lease/Rental

1

YR

Base

0003

All associated accessories

1

YR

OY1

1001

Rubudium RB-82 Generator

1

YR

OY1

1002

Cart/System Lease/Rental

1

YR

OY1

1003

All associated accessories

1

YR

OY2

2001

Rubudium RB-82 Generator

1

YR

OY2

2002

Cart/System Lease/Rental

1

YR

OY3

2003

All associated accessories

1

YR

Contractor shall provide a quote for complete accessory sets to go with the machine. The contractor shall quote enough accessory sets to provide eight (8) patients plus one QC run per day, five (5) days a week, 52 weeks a year.  Each contractor should specify what items their accessory sets contain.

SALIENT CHARACTERISTICS

The generator must have and provide the following salient characteristics:

• Contractor must provide supplies that covers the entire year (12 months).
• RB Generator must have a built-in dose calibrator to increase productivity and reduce the technologist’ radiation exposure.
• RB Generator must automatically administer a minimum of 45cc saline flush after the rubidium injection to ensure it adequately clears from unintended area of organs other than the heart to increase productivity and reduce technologists’ workload.
• RB Generator must have an alert system to notify using personnel when air is detected in line for safety purposes.
• RB Generator must not require syringe refilling for each patient infusion in order to minimize any disruption during the infusion process.
• The new generator shipment must arrive two days before the current expiration date.
• RB Generator must have automatic tracking for radiation volume to eliminate the need for manual data entry.
• RB Generator's computer must be capable of reprinting labels in case they are lost.
• RB Generator must have automated Daily Quality Control.
• RB Generator must have built-in weight-based dosing system (mCi/kg).
• RB Generator must have functions to report of Dose Data Report.
• It is contractor’s responsibility to provide an annual preventative maintenance care service.

TRAINING

The contractor shall provide on-site education training.  The purpose is to certify all Nuclear Medicine Technologists such that they are competent to operate the Rubidium Generator. 

ROUTINE ORDERS

Delivery as scheduled; delivery must be arrived two days before the expiration date to avoid interruption in patient care.

DELIVERY LOCATION AND NORMAL WORK HOURS

All items must be delivered as specific below except for the Federal Holidays.

• Delivery Location - Nuclear Medicine Service, Room 0072 and Building 500 at 11301 Wilshire Blvd, Los Angeles, CA  90073.
• Normal Work Hours – 7:30am to 4:30pm, Monday thru Friday

PACKAGING AND MARKING

The Contractor shall package, mark, and transfer all radioactive material in accordance with all applicable local, state, and federal regulations.

• Items must be adequately packaged to prevent damage during shipping, handling, and storage.
• All outer packages must contain the complete purchase order number, obligation number and contract number in addition to the shipping address.  The purchase order number and obligation number will be provided by the individual at the time of ordering.  The contract number will be provided upon notice of contract award.
• Packaging List:  A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quality ordered, and items/quality shipped.

The Contractor shall meet all requirements of regulatory agencies for deliveries of radioactive generator between facilities and shall strictly adhere to these requirements.

QUALITY ASSURANCE

The Contractor shall immediately notify the Using Service Point of Contact (POC) of any recalls of product or other important product safety issues.  If a quality control or material defect is suspected and/or detected by any VA POC, the Contractor will be requested to provide any consultation necessary to alleviate any suspicion and/or defect by the following:

• Provide technical expertise.
• Provide professional examination of product; submit results and recommendations to the Contracting Officer.
• Make expedient replacement of any product suspected of being deficient.
• The Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education.
• The vendor shall credit the government for the number of days that a generator is not available for use including shipping problems, recalls and quality control issues.

SAFETY GUIDELINES AND REQUIREMENTS

The Contractor shall perform all functions of this contract in compliance with Occupational Safety and Health Administration (OSHA), FDA, NRC, Joint Commission safety guidelines and Department of Transportation (DOT) requirements.  The Contractor shall self-report any violations to the COR within twenty-four (24) hours.  The contractor shall provide MSDS sheets (Material Safety Data Sheets) and updates as necessary on all delivered products to the medical center.

BADGES

All Contractor personnel are required to wear identification (LD.) badges during the entire time they are on the VA Healthcare System grounds. I.D. badges must have picture identification, name of the individual and the represented company depicted on it.

PARKING POLICY

It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police. The VA shall not validate or make reimbursement for parking violations of the Contractor's personnel under any circumstances.

INVOICE AND PAYMENT

No advanced payments will be authorized. The invoice must include the contract number, assigned purchase order, assigned obligation number, date the order was placed, date the order was shipped, name of preparation, quantity, and amount. Payments may be delayed if the invoice(s) are not completed correctly. The payment invoice must be submitted promptly.

SECURITY CONSIDERATION

The Contractor may require access to secured areas during the performance of their duties for any individual delivery orders only as regulated by the current rules and regulations involving all Contractors when entering a VISN facility.  The Contractor will not have access to any Federally Controlled Information   Systems.

VA POLICY

Smoking is permitted only in designated areas. Possession of weapons is prohibited.  Enclosed containers, including tool kits, are subject to search.  Violations of VA regulations may result in citations answerable in United States (Federal) District Court.

The list of DRAFT characteristics is intended to be descriptive, not restrictive, of the supplies/services that are required.

If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: 

(1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of SOW requirements.  For instances where your company cannot meet the SOW requirement(s), please explain.  For instances where your company can meet the SOW requirement(s), please show how your company meets/exceeds each requirement. 

(2) Please review the list of SOW requirements and provide any additional feedback or suggestions.  If none, please reply as N/A.

(3) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran-Owned Small Business (SDVOSB), Veteran-Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc.

(4) Is your company considered small under the NAICS code identified in this RFI?

(5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of SOW?

(6) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available).

(7) If you’re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified.

(8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6?

(9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items?

(10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice?

(11) Please indicate whether your product conforms to the requirements of the Buy American Act?

(12) What is your lead time to deliver a single unit with all components?  Is there scale in lead time with greater quantities? Please elaborate.

(13) What is estimated life span of your solution?  What support/services does that entail?

(14) Does your proposed equipment have FDA clearance?  Please specify what FDA clearance(s) have been obtained.

(15) Does your organization offer a leasing solution?  Please elaborate.

(16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s).

(17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract.

(18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.

(19) Please provide your SAM.gov Unique Entity ID/Cage Code number.

Responses to this notice shall be submitted via email to Hestia.Sim@va.gov. Telephone responses will not be accepted.  Responses must be received no later than Wednesday, June 4, 2025, by 10AM Pacific Local Time. 

All responses to this Sources Sought/RFI will be used for planning purposes only.  Responses to this Sources Sought Notice / RFI are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation.  If further RFIs and/or a solicitation or other announcement is issued as a result of the information provided from this RFI, all interested parties must respond to the specific posting separately IAW the specifications of that announcement.