3650--Radiopharmaceuticals for Albany VA Nuclear Medicine

The Department of Veterans Affairs, Albany VA Medical Center located at 113 Holland Avenue, Albany, New York 12208 has a requirement for Radiopharmaceuticals. The period of performance will be starting on April 1, 2024. This is a Combined Synopsis Solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and 13.5, as supplemented with additional information included in this solicitation. This announcement constitutes the only solicitation. Quotes are being requested and a written solicitation will not be issued. Interested Contractors that respond to this Combined Synopsis Solicitation must provide evidence that they are able to meet all the requirements identified herein. This requirement is being solicitated as unrestricted. The proposed contract action is for supplies for which the Government intends to solicit competitive offers to award a firm fixed price contract. Interested Contractors may submit offers, and all eligible offers received prior to the date listed in SAM.gov shall be considered by the Government. The NAICS code for this requirement is 325412 and the size standard is 1,300 Employees.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-02. Only emailed proposals received directly from the offeror shall be considered.

Statement of Work

Radiopharmaceuticals

1.0 SCOPE

The Department of Veterans Affairs Straton VA Medical Center (VAMC) located at 113 Holland Avenue, Albany, NY 12208 has a requirement for a United States Nuclear Regulatory Commission (US NRC) and Food and Drug Administration (FDA) Licensed Contractor to provide radiopharmaceuticals for the Nuclear Medicine Department for patient care. The Albany VAMC intends to award a base year plus four option years, firm fixed price, Requirements Contract to a licensed Radiopharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in New York State with a period of performance of April 1, 2024 through March 31, 2029. The Contractor agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with Federal, State, and Local Regulations. The Contractor shall be able to provide all the items listed in the Schedule of Radiopharmaceuticals with deliveries when required. Multiple awards will not be made.

BACKGROUND

The Straton VAMC is responsible for providing high quality and timely commodities and services for our Veterans. One area to serve our Veterans is to ensure that the best possible medical supplies are both timely and in accordance with proper regulations with Contractors that are licensed and monitored according to Federal, State, and Local Regulations. Under the Atomic Energy Act, the US NRC is responsible for regulating uses of radioactive material, including radio pharmaceuticals. The US NRC requires all nuclear medicine facilities to be licensed. The license assures that the facility has a radiation protection program to protect both the patients and the staff. In addition, the staff must meet certain standards of training and experience before they are allowed to administer radioactive material to patients. Each state has one or more radiation programs that ensure the safe use of radioactive materials. The US NRC has transferred regulatory authority over the use of this material to 35 NRC Agreement States. In these states, the regulatory authority inspects the facility to ensure the staff is trained properly and the equipment is operating safely. FDA s Center for Drug Evaluation and Research regulates the radio pharmaceuticals, ensuring effectiveness and patient safety. The mission of The National Institute of Standards and Technology (NIST) is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life.

STATEMENT OF WORK

The Contractor agrees to provide all listed radiopharmaceuticals as identified in the Schedule of Radiopharmaceuticals to the Stratton VAMC on a daily or as needed basis in accordance with this Statement of Work. Because of the critical need for these supplies in a timely manner, only Contractors that can deliver within two hours to the Stratton VAMC need to respond to this solicitation. Time is of the essence for all deliveries. These delivery timeframes are critical to ensure proper patient care and safety. The two-hour timeframe shall include the following: order processing, compounding order, travel, locating parking at the Medical Center, and delivery of radiopharmaceuticals to Radiology. The Contractor shall be licensed by the State of New York, or another agreement state approved by the Nuclear Regulatory Commission and shall be regularly established in the business of providing radionuclides in accordance with New York State regulations. The Contractor shall provide evidence of delivery in less than 2 hours with their proposal. The Contractor shall identify the location of the point of shipment to the address listed in the first paragraph of this solicitation. Verification will be completed via www.mapquest.com.

Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable Federal, State, and Local standards relating to shipment of radioactive materials. Shipping containers must comply with all Federal and State regulations. This will include the FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT package integrity testing shall also be provided with each delivery.

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

The Contractor shall label all products delivered to the Stratton VAMC with the radiopharmaceutical, activity, time of preparation, and expiration time and date.

The Contractor shall hold a current unrevoked NRC or an agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material, as well as an FDA license to produce and distribute radiopharmaceuticals for human administration. The Contractor shall provide a copy of their radioactive material license with their proposal. The Contractor shall immediately notify the Contracting Officer (CO) and the Contracting Officer Representative (COR), upon any action by the NRC or an agreement state or the FDA to suspend or modify their radioactive materials license. The Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts and applicable FDA requirements. The Contractor shall perform all quality control procedures as required by Federal and State Regulatory Agencies.

The Contractor will provide with their proposal all the following information for paragraphs a through d:

The Contractor s regular work hours.

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

The Contractor s telephone number and instructions for placing Emergency orders after the Contractor s regular work hours to include weekends.

The Contractor s telephone number for expert advice concerning awarded products.

The 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 (JC) and with the United States Pharmacopeia.

Should any changes occur in the above information during the contract period of performance the Contractor will immediately provide all applicable updates in writing to the CO and COR.

Current package inserts of all radiopharmaceuticals supplied under the awarded contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new or updated additions to the package inserts are made available, these will be sent to the COR at the Stratton VAMC Nuclear Medicine Department.

The Contractor shall make quality control records available upon written request from the CO or COR.

The Contractor shall test all products for Quality Control periodically. This testing shall be performed at no cost to the Government. The Contractor shall provide a detailed description of the test results when requested.

The calibration time for each requested radiopharmaceutical shall be provided in the Schedule of Radiopharmaceuticals as part of the Contractor s proposal pricing.

If an ordered dosage of radioactive material is given to the Contractor such that it is to fall within a specified range, then the quantity of radioactivity must be within the dose range provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%.

Technetium product radiopharmaceuticals not used will be returned for credit the next work day (including the bulk doses), using the DOT regulations. Credit will be reflected in the current month s invoice.

The Contractor shall replace any items delivered damaged or in error at no cost to the Government. The COR shall define the replacement date and time. Replacements may be required immediately or within a specified time in accordance with patient needs.

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

Ready-to-use doses: not shorter than six (6) hours.

Tc-99m pertechnetate: Not shorter than twelve (12) hours.

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

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.

In the event that a quality control or material defect is suspected or detected by the COR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion or defect by the following:

Provide technical expertise in calibration.

Provide professional examination of product. Submit results and recommendations to the COR.

Make expedient replacement of any product suspected of being deficient.

Approximately five (5) times per year, the below procedures are to be followed for labeling of patient's white blood cells (WBC) with Indium-111 Oxine or Tc-Ceretec, for re-injecting to the same patient:

Telephone requests to the Contractor to arrange for the procedure will take place no later than 3:30 PM for the next workday procedure.

The Contractor shall be at the Nuclear Medicine Department no later than 8:30 AM to pick up the patient's blood specimen for labeling.

The return by the Contractor, of the patient's Indium or Tc-Ceretec labeled white blood cells will take place no more than 5 (five) hours from the time of specimen pick up time.

Pertinent documentation confirming that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for labeling procedure.

The Contractor shall pick up radiopharmaceuticals (used and unused) for proper disposal at no cost to the Government.

The Contractor shall produce radiopharmaceuticals as described in the Schedule of Radiopharmaceuticals.

Deliverables and Acceptance Criteria

The Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the Statement of Work, as set forth below:

Provide up to two deliveries per day during regular operating hours to the Stratton Nuclear Medicine Service at no additional charge. The delivery charge for emergency orders to be included on the Schedule of Radiopharmaceuticals. The Delivery charge for STAT orders is to be included on the Schedule of Radiopharmaceuticals. STAT deliveries will average, three (3) times a week.

Deliver directly to the Stratton Nuclear Medicine Service daily quantity of radiopharmaceuticals by 7:00 AM, as requested from the previous workday by 4:00 PM, unless otherwise noted as an emergency, requiring a two hour turnaround time.

Second daily delivery, if necessary, must be delivered no later than 11:00 AM.

Orders can be placed orally by telephone by Ordering Officers provided by the COR.

Deliver directly to the Nuclear Medicine Service at the Straton VAMC, the quantity of radiopharmaceutical requested on an emergency basis to arrive in less than two (2) hours after notification.

Radioactive dose boxes that are delivered outside of working hours will be delivered to Nuclear Medicine. The Contractor shall not leave a radioactive materials package at the Stratton VAMC unless they have verbally communicated with a Nuclear Medicine staff member.

Other delivery times may be outlined by the Stratton VA Medical Center in this Statement of Work.

On Federal Holidays, no normal deliveries will be expected. If Monday is a Federal Holiday, no deliveries will be expected. Holidays are listed under 4.0 VA Operating Hours.

Emergency deliveries may be requested at any time outside normal delivery times, including weekends, holidays, and nights.

Shipments requested as an Emergency will be delivered as follows:

Requests placed after regular work hours (weekends, holidays, and nights) will be delivered within two (2) hours, or as specified.

Emergency, weekend, and holiday deliveries are to be delivered to location(s) specified by the Stratton VA Nuclear Medical Department, unless otherwise specified when called for.

Emergency deliveries will be required within two (2) hours after the order is placed.

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

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

Delivery dates, times, frequency of deliveries, specific dosages, and all other specific requirements by the Stratton VAMC in this Statement of Work will be strictly adhered to.

All shipments must have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes) the Stratton VAMC Purchase Order Number issued for the current fiscal year, and the Contractor s invoice number. Providing incorrect Purchase Order numbers on invoices will cause a substantial delay in payments to the Contractor.

VA OPERATING HOURS

The delivery of products provided by the respective awarded contract shall be furnished by the Contractor in accordance with section 3.0 Deliverables and Acceptance Criteria. 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 except for normal next day delivery.

The following terms have the following meanings:

Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:00 AM to 4:00 PM Eastern Standard Time

Normal deliveries shall be accomplished at 7:00 AM and 11:00 AM. The Contractor to include up to two (2) deliveries per normal working day during normal working hours as needed at no additional charge.

National Holidays: The ten (10) holidays observed by the Federal Government are as follows:

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.

CONTRACT AWARD

Upon Contract Award (within five (5) business days) the awarded Contractor shall provide:

A copy of their Laboratory s current quality control manual to the COR.

A dedicated inside sales representative to aide in facilitation in the smooth coordination between the Stratton VA Medical Center and the Contractor s Laboratory Pharmacy.

Material safety data sheets and updates on all delivered products as per contract award to include any additions throughout the period of performance of the awarded contract.

Patient orientation education video presentations and other appropriate material at no additonal cost to the Government.

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

QUALITY REQUIREMENTS

The Contractor shall guarantee the quality of their radiopharmaceuticals. Quality Control (QC) shall include pH testing, percent tag, alumina, and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, shall be provided upon request at no charge. On an annual basis, the Contractor shall provide documentation demonstrating compliance with applicable agreement state or NRC license requirements to the Radiation Safety Officer or COR.

PERSONNEL POLICY

The Contractor is responsible for all costs, including personnel costs, associated with the awarded contract, unless otherwise specified.

Qualifications - Personnel assigned by the Contractor to prepare and provide the products covered within this Statement of Work shall be Nuclear Pharmacists or a Licensed Technologist working under the supervision of a Nuclear Pharmacist licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia.

SPECIAL CONTRACT REQUIREMENTS: HHS/OIG

To ensure that the individuals providing services under the respective awarded contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding Federal Health Care Programs, the Contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website for each person providing services under the respective awarded contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud or abuse of the Medicare and Medicaid programs. During the period of performance of the respective awarded contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty imposed against them. By signing their proposal, the Contractor certifies that all persons or entities listed in the Contractor s proposal have been compared against the OIG list and are not listed as of the date their proposal was signed.Â

CONTRACTOR STAFF ROLES AND RESPONSIBILITIES

The Contractor must be in compliance with all Nuclear Regulatory Commission, United States Pharmacopeia, United States Food and Drug Administration, State, Local and Joint Commission guidelines, as well as United States Pharmacopeia 797 guidelines.

CONTRACTOR PERFORMANCE ASSESSMENTS (CPARS)

Assessments: The Government will complete assessments of the Contractor s performance. The Contractor shall have an opportunity to respond to said assessments.

Record: The Government will keep completed assessments that will serve as past performance data. Past performance data will be available to assist agencies in the selection of radio-pharmacy Contractors for future contracts.

DESIGNATION OF CONTRACT OFFICER REPRESENTATIVE (COR)

The COR will be designated in writing. The COR will be furnishing technical guidance and advice regarding the work being performed under the respective awarded contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the respective awarded contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer.

CONTRACTOR RECALL AND SAFETY PLAN AND PROCESS NOTIFICATION TO FACILITY

The Contractor shall take immediate action to notify the COR whenever a product, piece of equipment or item is recalled or considered dangerous, hazardous or unsafe in order to remove such products, equipment or items from use. This notification process also applies to safety alerts. The Contractor recall and safety notification plan and process are necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment or items can be made in an expedient and efficient manner as possible. The Contractor shall provide to the COR their plan for this safety notification process and also maintain a record system in order to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the COR.

HIPAA COMPLIANCE

The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA).

AVAILABILITY OF FUNDS DURING A CONTINUING RESOLUTION

At the beginning of each new fiscal year (1 October) the Federal Government or parts thereof may be operating under a Continuing Resolution (CR) and only be funded for a limited period of time rather than for the entire fiscal year. If at any time funds for this contract are provided under a CR, funds will only be available for performance under the respective awarded contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of the respective awarded contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under the respective awarded contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability.

REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS)

As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government Contracting Specialists and procurement officials through the Past Performance Information Retrieval System (PPIRS). The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement VA uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. Each Contractor whose contract award is estimated to exceed the thresholds outlined in FAR Part 42.15 is required to provide to the Contracting Officer contact information for the Contractor s representative with their response to the solicitation. The Contractor is responsible to notify the Contracting Officer of any change to the Contractor s representative during the contract period of performance. The Contractor s representative contact information consists of their name, telephone number, and email address.

The Government will register the respective awarded contract within thirty (30) days after contract award. For contracts exceeding one (1) year, the Contracting Officer will evaluate the Contractor s performance annually. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the Contractor s designated representative for comment. The Contractor s representative will have thirty (30) days to submit any comments and return the report to the VA Contracting Officer. Failure by the contractor to respond within those thirty (30) days will result in the Government s evaluation being placed on file in PPIRS without contractor s comments.Â

PROHIBITION (WORKING OUTSIDE OF US)

The entire performance of the respective awarded contract shall be within the borders of the United States of America. The Contractor shall not access any Department of Veteranas Affairs data information (for example, by remote computer access) from locations that are outside the above-stated borders. Furthermore, the Contractor shall not send, transfer, mail, or otherwise transmit any Department of Veterans Affairs data or information to locations outside the above-stated borders.

CONTRACT TERM

The respective awarded IDIQ contract shall be for one (1) base year and four option years. The base year period of performance is from April 1, 2024 through March 31, 2025. Option year one (1) period of performance is from April 1, 2025 through March 31, 2026. Option year two (2) period of performance is from April 1, 2026 through March 31, 2027.

Option year three (3) period of performance is from April 1, 2027 through March 31, 2028. Option year four (4) period of performance is from April 1, 2028 through March 31, 2029.

18.0 Schedule of Radiopharmaceuticals

Please Note: Your proposal must provide pricing on ALL items in the Schedule of Radiopharmaceuticals Required and all four columns must be filled in with your proposal.

Prices quoted are all inclusive including all associated costs including shipping, handling, packaging, storage, licenses etc. excluding emergency delivery, Pharmacist After-Hour Emergency Call-Back and Weekend White Blood Cell labeling charge.

Base Year (April 1, 2024 March 31, 2025)

CLIN

Radiopharmaceutical

Unit of Measure

Qty

Size

Price For Each mCi or Bulk

Total Price

Number of Minutes Needed to Prepare Product at Radiopharmacy

NDC Of Offered Product

0001

Tc99m (Bulk) Pertechnetate

Bulk dose

4

250 mCi

0002

Cardiolite

Unit dose

400

30mCi

0003

Cardiolite

Unit dose

400

10mCi

0004

MAA

Unit dose

30

6mCi

0005

DTPA

Unit dose

40

75mCi

0006

MDP

Unit dose

90

25mCi

0007

Sulfur Colloid (Liver/ Spleen or gastric emptying)

Unit dose

20

6mCi

0008

Tc99m Pertechnetate (MUGA/Hemangioma )

Unit dose

30

25mCi

0009

Choletec

Unit dose

25

6mCi

0010

PYP (MUGA/Hemangioma)

Unit dose

30

1 Vial

0011

Mag-3

Unit dose

20

10mCi

0012

Certec WBC

Study

10

10-30mCi

0013

Octreotide

Unit dose

10

6mCi

0014

I-123 200 s

Caps

40

200mCi

0015

I-131 Therapy/Whole Body 1 6 mCi)

Caps

5

Up to 6mCi

0016

I-131 Therapy (per mCi)

Caps

5

Up to 6mCi

0017

Thallium 201

Unit dose

1

5mCi

0018

Gallium 67

Unit dose

1

10mCi

0019

Sulfur Colloid (filtered)

Unit dose

15

250uCi

0020

Thallium 201 Brain

Unit dose

4

5mCi

0021

Tc99m Pertechnetate Meckel s Thyroid Imaging

Unit dose

1

10mCi

0022

Cardiolite (Parathyroid)

Unit dose

15

25mCi

0023

Ceretec Brain (Brain Imaging)

Unit dose

3

30mCi

0024

Sulfur Colloid (gastric emptying)

Unit dose

20

1mCi

0025

Tc99 Pertechnetate (hemangioma)

Unit dose

10

25mCi

0026

PYP (hemangioma)

Unit dose

10

1 Vial

0027

Tc99m Pertechnetate (Thyroid Imaging)

Unit dose

5

10mCi

0028

Thallium 201 (stress cardiac)

Unit dose

5

4mCi

0029

DATSCAN I-123 Ioflupane

1 Vial

5

3 -5mCi

0030

Quadramet Therapy

Unit

1

0031

Emergency order fee to include Pharmacist preparation and delivery

Delivery

Approx. 3 per week. Estimate156 Annually

Order

0032

Ga 68 NETSPOT

Unit dose

50

6mCi

0033

Ga 68 illuccix

Unit dose

150

7mCi

Option Year One (April 1, 2025-March 31, 2026)

CLIN

Radiopharmaceutical

Unit of Measure

Qty

Size

Price For Each mCi or Bulk

Total Price

Number of Minutes Needed to Prepare Product at Radiopharmacy

NDC Of Offered Product

1001

Tc99m (Bulk) Pertechnetate

Bulk dose

4

250mCi

1002

Cardiolite

Unit dose

400

30mCi

1003

Cardiolite

Unit dose

400

10mCi

1004

MAA

Unit dose

30

6mCi

1005

DTPA

Unit dose

40

75mCi

1006

MDP

Unit dose

90

25mCi

1007

Sulfur Colloid (Liver/ Spleen or gastric emptying)

Unit dose

20

6mCi

1008

Tc99m Pertechnetate (MUGA/Hemangioma)

Unit dose

30

25mCi

1009

Choletec

Unit dose

25

6mCi

1010

PYP (MUGA/Hemangioma)

Unit dose

30

1 Vial

1011

Mag-3

Unit dose

20

10mCi

1012

Certec WBC

Study

10

10-30mCi

1013

Octreotide

Unit dose

10

6mCi

1014

I-123 200 s

Caps

40

200mCi

1015

I-131 Therapy/Whole Body 1 6mCi)

Caps

5

Up to 6mCi

1016

I-131 Therapy (per mCi)

Caps

5

Up to 6mCi

1017

Thallium 201

Unit dose

1

5mCi

1018

Gallium 67

Unit dose

1

10mCi

1019

Sulfur Colloid (filtered)

Unit dose

15

250uCi

1020

Thallium 201 Brain

Unit dose

4

5mCi

1021

Tc99m Pertechnetate Meckel s Thyroid Imaging

Unit dose

1

10mCi

1022

Cardiolite (Parathyroid)

Unit dose

15

25mCi

1023

Ceretec Brain (Brain Imaging)

Unit dose

3

30mCi

1024

Sulfur Colloid (gastric emptying)

Unit dose

20

1mCi

1025

Tc99 Pertechnetate (hemangioma)

Unit dose

10

25mCi

1026

PYP (hemangioma)

Unit dose

10

1 Vial

1027

Tc99m Pertechnetate (Thyroid Imaging)

Unit dose

5

10mCi

1028

Thallium 201 (stress cardiac)

Unit dose

5

4mCi

1029

DATSCAN I-123 Ioflupane

1 Vial

5

3-5mCi

1030

Quadramet Therapy

Unit

1

1031

Emergency order fee to include Pharmacist preparation and delivery

Delivery

Approx. 3 per week. Estimate156 Annually

Order

1032

Ga 68 NETSPOT

Unit dose

50

6mCi

1033

Ga 68 Illuccix

Unit dose

150

7mCi

Option Year Two (April 1, 2026-March 31, 2027)

CLIN

Radiopharmaceutical

Unit of Measure

Qty

Size

Price For Each mCi or Bulk

Total Price

Number of Minutes Needed to Prepare Product at Radiopharmacy

NDC Of Offered Product

2001

Tc99m (Bulk) Pertechnetate

Bulk dose

4

250mCi

2002

Cardiolite

Unit dose

400

30mCi

2003

Cardiolite

Unit dose

400

10mCi

2004

MAA

Unit dose

30

6mCi

2005

DTPA

Unit dose

40

75mCi

2006

MDP

Unit dose

90

25mCi

2007

Sulfur Colloid (Liver/ Spleen or gastric emptying)

Unit dose

20

6mCi

2008

Tc99m Pertechnetate (MUGA/Hemangioma)

Unit dose

30

25mCi

2009

Choletec

Unit dose

25

6mCi

2010

PYP (MUGA/Hemangioma)

Unit dose

30

1 Vial

2011

Mag-3

Unit dose

20

10mCi

2012

Certec WBC

Study

10

10-30mCi

2013

Octreotide

Unit dose

10

6mCi

2014

I-123 200 s

Caps

40

200mCi

2015

I-131 Therapy/Whole Body 1 6mCi)

Caps

5

Up to 6mCi

2016

I-131 Therapy (per mCi)

Caps

5

Up to 6mCi

2017

Thallium 201

Unit dose

1

5mCi

2018

Gallium 67

Unit dose

1

10mCi

2019

Sulfur Colloid (filtered)

Unit dose

15

250uCi

2020

Thallium 201 Brain

Unit dose

4

5mCi

2021

Tc99m Pertechnetate

Unit dose

1

10mCi

2022

Cardiolite (Parathyroid)

Unit dose

15

25mCi

2023

Ceretec Brain (Brain Imaging)

Unit dose

3

30mCi

2024

Sulfur Colloid (gastric emptying)

Unit dose

20

1mCi

2025

Tc99 Pertechnetate (hemangioma)

Unit dose

10

25mCi

2026

PYP (hemangioma)

Unit dose

10

1 Vial

2027

Tc99m Pertechnetate (Thyroid Imaging)

Unit dose

5

10mCi

2028

Thallium 201 (stress cardiac)

Unit dose

5

4mCi

2029

DATSCAN I-123 Ioflupane

1 Vial

5

3- 5mCi

2030

Quadramet Therapy

Unit

1

2031

Emergency order fee to include Pharmacist preparation and delivery

Delivery

Approx. 3 per week. Estimate156 Annually

Order

2032

Ga 68 NETSPOT

Unit dose

50

6mCi

2033

Ga 68 Illuccix

Unit dose

150

7mCi

Option Year three (April 1, 2027-March 31, 2028)

CLIN

Radiopharmaceutical

Unit of Measure

Qty

Size

Price For Each mCi or Bulk

Total Price

Number of Minutes Needed to Prepare Product at Radiopharmacy

NDC Of Offered Product

3001

Tc99m (Bulk) Pertechnetate

Bulk dose

4

250mCi

3002

Cardiolite

Unit dose

400

30mCi

3003

Cardiolite

Unit dose

400

10mCi

3004

MAA

Unit dose

30

6mCi

3005

DTPA

Unit dose

40

75mCi

3006

MDP

Unit dose

90

25mCi

2007

Sulfur Colloid (Liver/ Spleen or gastric emptying)

Unit dose

20

6mCi

3008

Tc99m Pertechnetate (MUGA/Hemangioma)

Unit dose

30

25mCi

3009

Choletec

Unit dose

25

6mCi

3010

PYP (MUGA/Hemangioma)

Unit dose

30

1 Vial

3011

Mag-3

Unit dose

20

10mCi

3012

Certec WBC

Study

10

10-30mCi

3013

Octreotide

Unit dose

10

6mCi

3014

I-123 200 s

Caps

40

200mCi

3015

I-131 Therapy/Whole Body 1 6mCi)

Caps

5

Up to 6mCi

3016

I-131 Therapy (per mCi)

Caps

5

Up to 6mCi

3017

Thallium 201

Unit dose

1

5mCi

3018

Gallium 67

Unit dose

1

10mCi

3019

Sulfur Colloid (filtered)

Unit dose

15

250uCi

3020

Thallium 201 Brain

Unit dose

4

5mCi

3021

Tc99m Pertechnetate

Unit dose

1

10mCi

3022

Cardiolite (Parathyroid)

Unit dose

15

25mCi

3023

Ceretec Brain (Brain Imaging)

Unit dose

3

30mCi

3024

Sulfur Colloid (gastric emptying)

Unit dose

20

1mCi

3025

Tc99 Pertechnetate (hemangioma)

Unit dose

10

25mCi

3026

PYP (hemangioma)

Unit dose

10

1 Vial

3027

Tc99m Pertechnetate (Thyroid Imaging)

Unit dose

5

10mCi

3028

Thallium 201 (stress cardiac)

Unit dose

5

4mCi

3029

DATSCAN I-123 Ioflupane

1 Vial

5

3- 5mCi

3030

Quadramet Therapy

Unit

1

3031

Emergency order fee to include Pharmacist preparation and delivery

Delivery

Approx. 3 per week. Estimate156 Annually

Order

3032

Ga 68 NETSPOT

Unit dose

50

6mCi

3033

Ga 68 Illuccix

Unit dose

150

7mCi

Option Year four (April 1, 2028-March 31, 2029)

CLIN

Radiopharmaceutical

Unit of Measure

Qty

Size

Price For Each mCi or Bulk

Total Price

Number of Minutes Needed to Prepare Product at Radiopharmacy

NDC Of Offered Product

4001

Tc99m (Bulk) Pertechnetate

Bulk dose

4

250mCi

4002

Cardiolite

Unit dose

400

30mCi

4003

Cardiolite

Unit dose

400

10mCi

4004

MAA

Unit dose

30

6mCi

4005

DTPA

Unit dose

40

75mCi

4006

MDP

Unit dose

90

25mCi

4007

Sulfur Colloid (Liver/ Spleen or gastric emptying)

Unit dose

20

6mCi

4008

Tc99m Pertechnetate (MUGA/Hemangioma)

Unit dose

30

25mCi

4009

Choletec

Unit dose

25

6mCi

4010

PYP (MUGA/Hemangioma)

Unit dose

30

1 Vial

4011

Mag-3

Unit dose

20

10mCi

4012

Certec WBC

Study

10

10-30mCi

4013

Octreotide

Unit dose

10

6mCi

4014

I-123 200 s

Caps

40

200mCi

4015

I-131 Therapy/Whole Body 1 6mCi)

Caps

5

Up to 6mCi

4016

I-131 Therapy (per mCi)

Caps

5

Up to 6mCi

4017

Thallium 201

Unit dose

1

5mCi

4018

Gallium 67

Unit dose

1

10mCi

4019

Sulfur Colloid (filtered)

Unit dose

15

250uCi

4020

Thallium 201 Brain

Unit dose

4

5mCi

4021

Tc99m Pertechnetate

Unit dose

1

10mCi

4022

Cardiolite (Parathyroid)

Unit dose

15

25mCi

4023

Ceretec Brain (Brain Imaging)

Unit dose

3

30mCi

4024

Sulfur Colloid (gastric emptying)

Unit dose

20

1mCi

4025

Tc99 Pertechnetate (hemangioma)

Unit dose

10

25mCi

4026

PYP (hemangioma)

Unit dose

10

1 Vial

4027

Tc99m Pertechnetate (Thyroid Imaging)

Unit dose

5

10mCi

4028

Thallium 201 (stress cardiac)

Unit dose

5

4mCi

4029

DATSCAN I-123 Ioflupane

1 Vial

5

3- 5mCi

4030

Quadramet Therapy

Unit

1

4031

Emergency order fee to include Pharmacist preparation and delivery

Delivery

Approx. 3 per week. Estimate156 Annually

Order

4032

Ga 68 NETSPOT

Unit dose

50

6mCi

4033

Ga 68 Illuccix

Unit dose

150

7mCi

After hour/Emergency charges Stratton VA Medical Center

Deliveries during normal work hours (Monday - Friday) at no charge. Offeror (s) may list any additional charges below:

Deliveries during normal business hours Day: No Charge

Emergency Delivery1 Each:

Pharmacist After-Hour Emergency Call-Back2 Each:

Weekend White Blood Cell labeling charge3 Each:

Emergency Delivery: Charge for delivering unscheduled Emergency orders during normal business hours within two (2) hours of receiving the order by phone from the Stratton VA Medical Center Nuclear Medicine Department.

Pharmacist (Emergency after hours): The charge for having a pharmacist called back to the Pharmacy after hours, prepare the ordered dose and have it delivered to the VA within two hours. (Emergency orders only).

Weekend WBC labeling charge: The charge for the pharmacy to attach a radionuclide to the patient s white blood cells on a weekend.

This announcement constitutes the only solicitation. Quotes are being requested and the Government shall award a contract for Radiopharmaceuticals. This combined synopsis solicitation shall result in the award of a firm fixed price contract. The provisions and clauses incorporated into this solicitation document are those in effect at the time of publication. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) may be accessed on the Internet at https://www.acquisition.gov/content/regulations. The North American Industry Classification System (NAICS) code is 325412 with a size standard of 1,300 employees applies to this solicitation. This requirement consists of Delivery and installation of all acuity charts and chair with a period of performance of April 1, 2024, through March 31, 2029. Delivery of said equipment shall be to the Albany VA Medical Center, 113 Holland Avenue, Albany, NY 12208. The following solicitation provisions and contract clauses apply:

52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS (OCT 2018)

52.216-18 ORDERING (OCT 1995)

52.216-19 ORDER LIMITATIONS (OCT 1995)

52.216-22 INDEFINITE QUANTITY (OCT 1995)

52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)

VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (JUN 2020)

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER (MAY 2011)

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013)

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS COMMERCIAL ITEMS (JUN 2020)

52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS (OCT 2018)

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

52.216-1 TYPE OF CONTRACT (APR 1984)

52.233-2 SERVICE OF PROTEST (SEP 2006)

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018)

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016)

52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS NOTICE AND REPRESENTATION (JUN 2020)

852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (JUN 2020)

52.212-2 EVALUATION COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price, and other factors considered. The following factors shall be used to evaluate quotations: Technical or Quality, Past Performance, and Price. Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. The evaluation will consider the following:

Technical or Quality: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation.

Past Performance: The past performance evaluation will assess the relative risks associated with a quoter s likelihood of success in fulfilling the solicitation requirements as indicated by the quoter s record of past performance. The past performance evaluation may be based on the contracting officer s knowledge of and previous experience with the supply or service being acquired; Customer surveys, and past performance questionnaire replies, Contractor Performance Assessment Reporting System (CPARS) at http://www.cpars.gov/; or any other reasonable basis.

Price: The Government will evaluate the price by adding the total of all line-item prices. The Total Evaluated Price will be that sum. If your proposal does not provide pricing for all of the line items, it shall be evaluated as unacceptable and will receive no further consideration for award. This is a combined synopsis solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice.

Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). This includes options under FAR 52.217-8, Option to Extend Services, which applies to this solicitation. Evaluation of options under FAR 52.217-8 will be accomplished by adding six months of the quoter's price for the last potential period of performance under this contract to the quoter's total price. For example, if the contract includes option periods that are exercisable under FAR 52.217-9, the quoter's total price for the purpose of evaluation will include the base period, all option periods, and an additional six months of the last option period. Quoters must price only the base and option periods specified in the contract line-item numbers (CLINs) and shall not submit a price for the potential six-month extension of services under FAR 52.217-8. The Government reserves the right to exercise the option under FAR 52.217-8 before the end of any of the contractor's performance periods and will be exercised at the price and/or rates in effect at the time the clause is exercised. Evaluation of options shall not obligate the Government to exercise the option(s).

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)