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This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation. Â
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This is a request for quote (RFQ), and the solicitation number is 36C25022Q0182. The Government anticipates awarding a firm-fixed price Purchase Order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circulars 2022-08, effective 10/28/2022. The associated NAICS Code is 325412, Pharmaceutical Preparation Manufacturing
 The Department of Veterans Affairs, Network Contracting Office 10, is soliciting quotes from all sources to supply the Cleveland VA Medical Center Axumin & Amyvid Doses for patient care. Respondents to this solicitation must fully demonstrate their capability by supplying detailed quote information, along with any other documents necessary to support the requirements below. However, we believe PETNET Solutions Inc. is the only source for Florbetapir F18 (Amyvid) and Fluciclovine F18 (Axumin). Blue Earth Diagnostics, Ltd. licensed the product from GE Healthcare, Inc. who has patented the preparation methods for Amyvid through Patent #8,506,929 and for Axumin through Patent #9,387,266. In addition, PETNET Solutions Inc. has verified that TrillaMed LLC is their exclusive SDVOSB authorized distributor.
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Quotes are to be provided to Gina P. Crank, Contracting Officer, via email at gina.crank@va.gov, no later than December 13,  2022, by 5:00 PM EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted.Â
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STATEMENT OF WORK (SOW)
1. Contracting Officer s Representative (COR).

Name:
Jaymie Claytor
Section:
Nuclear Medicine
Address:
10701 East Boulevard, Cleveland, Ohio 44106
Phone Number:
216-791-3800 x65212
Fax Number:
216-421-3015
E-Mail Address:
Jaymie.Claytor@VA.gov

2. Contract Title.
Axumin and Amyvid Doses January 2023 to December 2023
3. Background.
The Nuclear Medicine Service at the Louis Stokes Cleveland VA Medical Center is interested in using state-of-the-art radiopharmaceuticals for diagnostic patient care. Axumin is used in the diagnosis of recurrent prostate cancer and Amyvid is helpful in the diagnosis of Alzheimer s disease. These radiopharmaceuticals are proprietary. The base dose is manufactured by Blue Earth Diagnostics Inc. and then it is made radioactive and distributed by PETNET Solutions. Due to the radioactive nature of the doses and their relatively short half-life (each has a 10-hour shelf life), a local radiopharmacy must be utilized.
4. Scope.

This request is for an annual contract for purchase of the following radiopharmaceuticals, Axumin and Amyvid. These radiopharmaceutical doses would be used in the Nuclear Medicine Service at the Louis Stokes Cleveland VA Medical Center.

5. Specific Tasks.
The Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio, is soliciting for a vendor to supply radioactive doses of Axumin and Amyvid for patient studies performed onsite.

Tasks include:

The government requires delivery to be made according to the schedule for quantities as ordered daily or as needed. Axumin will be available for delivery on Tuesday through Friday between 10:00a.m. and 4:00 p.m. Amyvid is available any day of the week after 10:00 am calibration time.
Doses will be ordered two days prior to actual need of the dose. Next day doses will be available with prior approval of the radiopharmacy, depending on capacity.
Contractor shall provide daily routine deliveries and pick-ups as well as emergent deliveries when the products are available.
Contractor shall replace any items delivered in error at no cost to the medical center.
Contractor shall label all products as to the amount of radiopharmaceutical, preparation time, expiration time and date; and to comply with the specific facility requirements.
Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, and all other agency rules and regulations (Federal and State). Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.
Items shall be adequately packaged to prevent damage during handling and storage.
All packaging of radioactive material shall be clearly labeled RADIOACTIVE on the outside of the carton it is shipped in.
Contractor shall invoice at least once a month, showing the period covered, billing date, name of preparation, quantity, and amount. Invoices will be submitted electronically.
Contractor shall provide a copy of their laboratory s current quality control manual as requested. Contractor shall be willing to discuss discrepancies in lab results, which do not fit the clinical picture.
Contractor shall test all products for Quality Control and only those products that pass quality control may be sent to the VA. The testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.
All doses shall be free of contaminants and pyrogens and safe for human injection.
Contractor shall notify the Louis Stokes Cleveland VA Medical Center of any recalls on the products supplied.
Contractor shall assign to this medical center an individual sales representative to aid in facilitation in the smooth coordination between the medical center and nuclear pharmacy.
Contractor shall pick up scheduled items, used and unused, for proper disposal.
Contractor shall provide current safety data sheets in a binder and updates as necessary on all delivered products for the medical center.
Contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor.
Contractor shall be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radionuclides. Offeror shall provide copies of licenses and certifications along with proposal to the Contracting Officer.

5.1 Task 1 - Enterprise Management Controls.

5.1.1 Subtask 1 - Integration Management Control Planning.
N/A

5.1.2 Subtask 2 - Contract Management. P
Contractor shall test all products for Quality Control and only those products that pass quality control may be sent to the VA. The testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.
Each radiopharmaceutical dose will be inspected and measured in a dose calibrator to ensure that the correct dosage is in a properly labeled syringe/vial. Doses that have any visual contaminants will be replaced by the vendor at no additional cost. Any unlabeled or mislabeled syringes/vials will be subject to immediate action by nuclear medicine. Replacement doses will be sent stat from the Radiopharmacy at no cost to the VAMC.

The parties representatives will meet periodically as agreed to review the radiopharmaceutical doses and to address any requests or issues as may have arisen in the period prior to review. Meetings can be held over the telephone or face to face.

Either party may call a meeting not less than three (3) days notices if that party
reasonably considers that there are issues which need to be discussed and/or resolved relating
to the radiopharmaceutical doses. Both parties will make reasonable efforts to attend meetings called on shorter notice when required. Any meeting may be carried out by teleconference or videoconference.

Deliverables: Axumin and Amyvid radiopharmaceutical doses

Contract Management Plan: See subtask 5.1.2

Monthly Status Report N/A

6. Performance Monitoring: Please see subtask 5.1.2 listed above.
7. Security Requirements
There are no security requirements since the contractor will not have, or need, access to sensitive/personal information, patient records, data or VA computer systems.
8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

None

9. Other Pertinent Information or Special Considerations.
a. Identification of Possible Follow-on Work.

None.
b. Identification of Potential Conflicts of Interest (COI).

There are no conflicts of interest.

c. Identification of Non-Disclosure Requirements.

N/A

d. Packaging, Packing and Shipping Instructions.
All radiopharmaceutical doses shall be delivered to Nuclear Medicine Service Hot Lab, Room BC518. All doses shall be labeled correctly by DOT standards for radioactive shipments. All shipments will be sealed from tampering, intact and free from removable contamination

e. Inspection and Acceptance Criteria.
Each shipment received daily will be visually inspected for any possible damage and to ensure package is free from tampering. Each shipment will be tested for radioactive levels and for removable radioactive material. Any deviations from the instructions in d. above will be brought to the attention of the Radiopharmacy immediately for action.
10. Risk Control
There are minimal risks involved.
11. Place of Performance.
Nuclear Medicine Service at the Louis Stokes Cleveland VA Medical Center. Room B-C518 in the basement of the main hospital.
12. Period of Performance.
This request is for an annual contract to cover the period of January 1, 2023 to December 31, 2023.
13. Delivery Schedule.

Doses of Axumin and Amyvid will be ordered and delivered on an as needed basis depending on the demand for the studies. It is understood that at this time, Axumin is only available on Tuesday and Wednesday of each week. It is also understood that Amyvid is available for calibration times after 10:00 am Monday through Friday. Should availability of doses increase, the COR will be notified immediately.
Doses of Axumin and Amyvid will be ordered several days in advance of actual need and that orders will be confirmed the day prior to delivery. Doses ordered less than two days prior to the procedure will be filled if there is adequate capacity from the vendor.

SOW Task#
Deliverable Title
Format
Number
Calendar Days After CO Start
Tasks 1-20
Delivery of Axumin/Amyvid
As needed- to be ordered by the government based on patient care needs.
* Standard Distribution: 1 copy of the transmittal letter without the deliverable to the Contracting Officer shall be
Emailed.

The 11 Federal Holidays observed by the Federal Government are:

New Year s Day January 1
Martin Luther King s Birthday 3rd Monday in January
Presidents Day 3rd Monday in February
Memorial Day Last Monday in May
Juneteenth Day June 19
Independence Day July 4
Labor Day 1st Monday in September
Columbus Day 2nd Monday in October
Veterans Day November 11
Thanksgiving Day 4th Thursday in November
Christmas Day December 25th

The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

ITEM INFORMATION
ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
0001

25.00
EA

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
LOCAL STOCK NUMBER: Axumin F18

Funding/Req. Number: 1

541-23-2-778-0027
0002

65.00
EA

Amyvid is a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations. Amyvid for intravenous use is supplied in multidose vials containing 500-1900 MBq/mL Florbetapir F 18.
LOCAL STOCK NUMBER: 00002120001

Funding/Req. Number: 1

541-23-2-778-0027


GRAND TOTAL

The following solicitation provisions apply to this acquisition:
FAR 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS (JUNE 2020)
FAR 52.212-3, OFFERORS REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (FEB 2021)
Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required.
The following contract clauses apply to this acquisition:
FAR 52.212-4, CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS (OCT 2018)
ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS
Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
The following clauses are incorporated into 52.212-4 as an addendum to this contract:
FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
FAR 52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (DEC 2011)
FAR 52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR 2014)
FAR 52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER (MAY 2011)
FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)
FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013)

VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) 852.203-70, 852.232-72, 852,233-70, 852.233-71 852.246-71, 852.247-71, 852.270-1
VAAR 852.212-71 GRAY MARKET LANGUAGE (MAY 2016)

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Jan 2021
The following subparagraphs of FAR 52.212-5 are applicable:
[52.203-6, 52.204-10, 52.209-6, 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, 52.232-18, 52.232-19, and 52.232-33.]
FAR 52.232-2 SERVICE OF PROTEST (SEPT 2006) - - Hand-Carried Address: Department of Veterans Affairs, Network Contracting Office 10, 2780 Airport Drive, Suite 340, Columbus, OH 43219

All quoters shall submit the following: A completed schedule with pricing, adequate documentation detailing the capabilities of the product.
All quotes shall be sent to the electronically via email to Gina P. Crank @ gina.crank@va.gov.
Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.
The award will be made to the response most advantageous to the Government.
Responses should contain your best terms, conditions.
To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:
"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."
OR
"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"
Quoters shall list exception(s) and rationale for the exception(s), if any.
Submission of your response shall be received not later than December 13, 2022 by 5:00 PM Eastern Time to gina.crank@va.gov
Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).
Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.
Point of Contact
Gina P. Crank
Contracting Officer
Network Contract Office (NCO) 10
Office: 614-625-1236
Email: gina.crank@va.gov

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5
Acquisition Plan Action ID: 36C25022AP6081

Contracting Activity: Department of Veterans Affairs, VISN 10, Louis Stokes Cleveland VA Medical Center, 10701 East Blvd., Cleveland, OH 44106. NCO 10 Columbus, 2780 Airport Drive, Suite 340, Columbus, OH 43219 using 2237# 541-23-2-778-0027.

Nature and/or Description of the Action Being Processed: : The requirement being reviewed and approved is for the purchase of Florbetapir F18 (Amyvid) doses and Fluciclovine F18 (Axumin) doses. This action will be awarded as a Firm Fixed Price, New Contract.

Description of Supplies/Services Required to Meet the Agency s Needs: In April 2012, the United States Food and Drug Administration approved Florbetapir F18, branded as Amyvid. This injectable drug is a molecular imaging agent used in position emission tomography imaging to identify beta-amyloid neurotic plaque in patients being evaluated for Alzheimer s disease. It is estimated that the Louis Stokes Cleveland VA Medical Center would purchase sixty-five (65) Amyvid per year.

In late May 2016, the United States Food and Drug Administration approved Fluciclovine F18, branded as Axumin. This injectable drug is a molecular imaging agent used in position emission tomography imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen following prior treatment. It is estimated that the Louis Stokes Cleveland VA Medical Center would purchase twenty-five (25) Axumin doses per year.

The estimated Period of Performance is January 1, 2023 December 31, 2023.

Statutory Authority Permitting Restricted Competition:Â
FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement.  Competition is restricted on this procurement for the reason below:
       ( x ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements
       ( ) Unusual and Compelling Urgency
       ( )  Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services
       ( ) International Agreement
       ( ) Authorized or Required by Statute
       ( ) National Security
       ( ) Public Interest

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): PETNET Solutions Inc. is the only source of Florbetapir F18 (Amyvid) as they are the United States sole distributors and manufacturer for Blue Earth Diagnostics, Ltd., an England-based pharmaceutical company. Blue Earth Diagnostics, Ltd. licensed the product from GE Healthcare, Inc. who has patented the preparation methods for Amyvid through Patent #8,506,929. This also holds true for Fluciclovine F18 (Axumin) who has patented the preparation methods for Axumin through Patent #9,387,266.
Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The manufacturer of the requested Radiopharmaceuticals was contacted; PETNET Solutions Inc. verified that TrillaMed LLC is their exclusive SDVOSB authorized distributor. VetBiz was queried using NAICS code 325412, Pharmaceutical Preparation Manufacturing and keyword radiopharmaceutical that returned one SDVOSB. This non-competitive procurement is in the best interest of the government due to there being no other sources that can meet this requirement.
Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: : Pricing from PETNET Solutions is considered to be fair and reasonable and in the best interest to the government. The determination of fair and reasonableness has been made based on what the government is currently spending on similar treatments outside the Louis Stokes Cleveland VAMC. In addition, the final contract price for these radiopharmaceuticals is identical to the prices on a previously awarded contract for this exact same requirement. Also, the contract prices are in line with the IGCE.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market Research was conducted using the internet search engines using the terms Florbetapir F18 and Fluciclovine F18. Each search result provided additional evidence that the tracing agent is only available through PETNET Solutions Inc. by way of the permission of Blue Earth Diagnostics, Ltd. The Contracting Officer queried VetBiz, the search returned zero results. AbilityOne, Unicor, GSA, and VA NAC were reviewed which also netted zero results. In addition, as mentioned above, the manufacturer of the requested Radiopharmaceuticals was contacted; PETNET Solutions Inc. PETNET s Authorized SDVOSB Distributor is TrillaMed.

Any Other Facts Supporting the Use of Other than Full and Open Competition: NA

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:
PETNET Solutions Inc.
810 Innovation Drive
Knoxville, TN 37932
DUNS# 015223951

TrillaMed
30100 Telegraph Road, Suite 366
Bingham Farms, MI 48025
DUNS# 828126321

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: No actions are being taken to remove or overcome any barriers to competition. Patent laws and licensing agreements limit the influence of the VA on removing barriers to competition at this time. Proceeding with this sole source to PETNET Solutions Inc, authorized SDVOSB. This allows the Government to reduce costs by utilizing innovation and novel treatments as compared to traditional methods.

Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

_____________________________ ________________________
Jaymie Claytor Date
Supervisory Nuclear Medicine
Louis Stokes Cleveland VAMC

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

_____________________________ ________________________
Gina P. Crank Date
Contracting Officer
NCO 10 Columbus
One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

_____________________________ ________________________
Adam P. Weber Date
Branch Chief, Supply Team 1
NCO 10 Dayton

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