36C24224Q0763 6.26.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* RFQ: Brand Name NETSPOT GA68

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 14227

SOLICITATION NUMBER* 36C24224Q0763

RESPONSE DATE/TIME/ZONE 07-15-2024 16:00 EASTERN TIME, NEW YORK, USA

ARCHIVE 20 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SBA

PRODUCT SERVICE CODE* 6505

NAICS CODE* 325412

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga NY 14227

POINT OF CONTACT*

Contracting Officer Janelle Bonafede Janelle.Bonafede@va.gov 716-862-7461 ext. 24570

PLACE OF PERFORMANCE

ADDRESS New York Harbor Health Care System (Brooklyn) New Jersey Healthcare System (East Orange) James J. Peters VA Medical Center (Bronx)

POSTAL CODE

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://va.gov URL DESCRIPTION https://va.gov AGENCY CONTACT’S EMAIL ADDRESS Janelle.Bonafede@va.gov EMAIL DESCRIPTION Network Contracting Office

DESCRIPTION

New York Harbor Health Care System (Brooklyn), New Jersey Healthcare System (East Orange), and the James J. Peters VA Medical Center are requiring the brand name purchase of Radiopharmaceutical drug Netspot (Ga68 dotatate) for patients on an as needed basis.

Statement of Work NetSpot (Ga68 Dotatate Intravenous) 2024

Vision Integrated Supported Network 2 South

Statement of Need

NetSpot (Ga68 dotatate Intravenous) is a diagnostic PET radiopharmaceutical that is used to assess the extent of disease in patients with neuroendocrine tumors. The Veterans Integrated Service Network (VISN) 2 South requires delivery of 5.4 mCi doses of intravenous NetSpot (Ga68 dotatate Intravenous) to the Veterans Administration Medical Centers (VAMC) located below:

1. New York Harbor Health Care System (NYHHCS) at Brooklyn

800 Poly Place, Brooklyn, NY 11209

2. New Jersey Health Care System (NJHCS) at East Orange

385 Tremont Avenue, East Orange, NJ 07018

3. Bronx VAMC

130 W Kingsbridge Road, Bronx, NY 10468

The contractor shall provide all labor, supervision, and transportation necessary to meets the needs of the daily deliveries for the different Radiology Service/Nuclear Medicine Section at the specific VA medical centers listed above. The contactor shall have an adequate supply of contract products to meet the requirements of the needs of the participating VAMCs. The contractor shall provide product on an as needed basis.

PERIOD OF PERFORMANCE: Single order period of (5) five years with (6) six pricing periods as noted:

Pricing Period 1: 7/30/2024-12/31/2024 Pricing Period 2: 01/01/2025 - 12/31/2025 Pricing Period 3: 01/01/2026 - 12/31/2026 Pricing Period 4: 01/01/2027 - 12/31/2027 Pricing Period 5: 01/01/2028 - 12/31/2028 Pricing Period 6: 01/01/2029 - 07/29/2029

Orders should be established within the pricing periods so as to minimize the impact of potential price changes authorized by Public Law 102-585.

CONTRACTOR REQUIREMENTS

The Contractor Shall:

1. Deliver all items on the Product List.

2. Deliver to each site daily Monday through Friday prior to 12:00 pm (noon).

3. Provide a bar code for each product delivered that is compatible with the local Nuclear Medicine Information System (NMIS).

4. Provide a plan for deliveries of products during inclement weather.

5. Provide adequate level of products during periods of shortages.

6. Deliver radiopharmaceutical doses in sanitized lead containers.

7. Provide full credit for all radiopharmaceuticals not used for scheduled patients who do not show up for their appointment (“no shows”).

8. Accept returns of unused products prior to expiration date for full credit.

9. Demonstrate an established record of reliability for on time daily deliveries (95 %) or products on the Products List.

10. Validate that they are in compliance with USP 797.

11. Provide evidence of satisfactory air quality in the clean rooms.

Price Change: Contractor shall provide the Contracting Officer notification of proposed price change within a week the FSS Contractor, Advanced Accelerator Applications USA, Inc., submits a Request for Modification on FSS contract 36F79719D0169 (or subsequent FSS contract after expiration) seeking a price change. The Contractor shall identify the Product Name, NDC number and the proposed price change. The Contractor shall immediately notify the Contracting Officer when the price change is approved on FSS contract 36F79719D0169 (or subsequent FSS contract after expiration) and provide evidence of the approval and the approved price. The Contracting Officer shall complete a modification to reflect the new price change.

Nuclear Regulatory Commission License: The contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Additionally, the contractor shall meet the US Department of Transportation (DOT), NRC/NHPP, FDA, OSHA, USP 797 and all other agency rules and regulations (Federal and State). Contractors shall provide copies of licenses and certifications along with proposals.

USP 797: The contractor must validate compliance with USP 797. Each vendor must provide clean room reports and evidence of satisfactory air quality in the clean rooms.

Radiation Safety Audits: The contractor will supply a copy of their Radiation Safety Officer’s safety audits for federal compliance.

Quality Control Manual: The contractor shall provide a copy of their laboratory’s current quality control manual and shall be willing to discuss discrepancies in lab results which do not fit the clinical picture. The contractor shall test all products for quality control periodically and only those products that pass quality control may be sent to each participating medical center. The testing and the detailed report shall be furnished to each participating medical center at no additional cost. All contractor quality control testing/procedures shall be performed as required by Federal and State regulatory agencies.

Available Products: The contractor must be able to supply all diagnostic radiopharmaceuticals, therapeutic radiopharmaceuticals, radioactive material used for QA purposes, non-radioactive pharmaceuticals and related supplies listed on the Product List.

MSDS Sheets: When the contract is awarded, the contractor must provide MSDS sheets (Material Safety Data Sheets) for each radiopharmaceutical, radioactive product and non-radioactive product on the Product List to the each participating medical center. Any new or updated additions to the MSDS sheets will be sent by the contractor to the each participating medical center promptly.

Package Inserts: The contractor will ship current package inserts of all radiopharmaceuticals, radioactive product and non-radioactive product supplied under the awarded contract to each participating medical center at the inception of the contract. Any new or updated additions to the package inserts will be sent by the contractor to each participating medical center promptly.

Sales Representative: The contractor shall assign to each participating medical center an individual sales representative to (1) aid in the facilitation of a smooth coordination between each medical center and the contractor and to (2) aid in the prompt resolution of discrepancies.

The contractor will notify each VAMC of the name and contact information for the sales representative.

Contractor Contact Information: The contractor will provide the following information with their proposal:

1. The contractor’s regular daily work hours.

2. Instructions for placing over the phone, by fax and through a web-based ordering system.

No veteran specific information will be transmitted through any web-based ordering system.

Orders that are placed through any web-based system will not include veteran specific information. Veteran specific information will only be transmitted over the phone.

3. The contractor’s telephone number for call-in orders during regular work hours.

4. The contractor’s telephone number for placing emergency orders after the contractor’s regular working hours including weekends and holidays, 24 hours a day, 7 days a week, 365 days a year.

5. The contractor’s telephone number for expert advice about awarded products.

6. The contractor’s fax number for radiopharmaceutical orders.

7. If there are any changes to the above, the contractor will immediately provide updates to each participating medical center in writing.

Delivery of Product:

1. Deliveries must be available Monday through Friday before 12:00 pm (noon).

2. Delivery drivers follow all relevant pandemic VHA infection and control policies.

3. Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the contractor’s acceptance to the commitment.

4. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by ordering personnel.

5. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default.

6. Invoice shall include period covered, billing date, name of product, quantity, and amount.

7. The contractor is responsible for on time delivery of radiopharmaceuticals and must have back-up facilities/production options to maintain greater than 95% on time delivery or risk penalties that include no charge doses that, at a minimum, equal the number of missed doses.

8. The contractor must provide an emergency plan for deliveries during inclement weather.

9. The contractor must be located close enough to each participating VISN 2 South Medical Center to meet time constraints.

10. Deliveries of radioactive products must incorporate sufficient lead or other high-density material shielding to comply with applicable Federal and or State standards relating to shipment of radioactive material.

11. Deliveries are to be made to Nuclear Medicine Hot Labs in each of the participating medical centers. If the medical center has 2 Hot Labs, deliveries are to be made to the specified Hot Lab.

12. Access to the Nuclear Medicine Hot Labs during non-business hours is obtained by contacting the VA Police Service.

13. Drivers who make deliveries must present acceptable photographic identification to the VA Police Service.

14. Drivers must have documentation of radiation safety training that is available to the receiving facility upon request.

15. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default.

Labeling Doses: The contractor shall label all unit doses of delivered radiopharmaceuticals with the amounts, preparation time, expiration time and date, etc., and provide a bar code labeled insert to allow scanning data into the VAMC’s nuclear medicine information management system (NMIS). If the contractor’s system varies from the current NMIS information system in use at the participating medical centers, the contractor shall provide their system as well as data migration, technical support, and training to staff on its use at no additional cost to the government.

A label must be affixed to each syringe, vial, or other container that is used to hold a radioactive radiopharmaceutical to be transferred for commercial distribution. The label must include a radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

Shipping and Radioactive Labels: All packaging of radioactive materials must be clearly labeled “Caution, Radioactive Material” and contain a radioactive symbol with the proper US Department of Transportation (DOT) Class and exposure levels, preparation time, expiration time and date and order number on the outside of the shipping container in order to comply with specific regulatory requirements. All shipping containers must be free of radioactive contamination both inside and outside and adequately packaged to prevent damage during handling, shipment and storage. The contractor must supply with each shipment/order/delivery a system for spent (used) syringes, which meets OSHA’s Biohazard Policy/Regulations and is needleless.

CFR10: The contactor shall abide by the Title Code of Federal Regulations (CFR 10).

Transmission of VA Sensitive Information: All technology that transmits VA sensitive information must be FIPS 140-2 compliant.

Canceling orders and Returned Products: Each participating medical center may cancel ordered doses within a ten-hour (10) notice to contractor.

1. The contractor shall accept returns for credit under the following conditions:

a. Product(s) ordered or shipped in error.

b. Product(s) damaged in shipment.

c. Recalled product(s).

d. Unused and unopened doses of all radiopharmaceuticals for patients who fail to keep their appointments (“no shows”).

e. Unused and unopened nonradioactive products prior to expiration.

2. Credit for the returned product will be reflected in the current month’s invoice.

3. Any cost to replace damaged or incorrect products will be at cost of the contractor.

Replacements shall be received within 48 hours of notification.

Invoicing and Payments:

1. The contractor must submit an invoice at least once per month that shows the period covered, the billing date, the name of each product delivered, the quantity delivered, the amount delivered, the date each product was delivered and the correct Veterans Administration Medical Center purchase order number.

2. All invoices are to be sent to (a) Austin vial electronic invoicing and (b) to each participating medical center via secure e-mail.

3. Payments shall be made in the arrears via government purchase credit card.

4. The contractor shall not add to the invoice the cost of overages.

5. All charges for delivery shall be included in the fee schedule. Additional delivery/fuel surcharges will not apply.

6. The contractor will pick up radioactive and non-radioactive products to be returned for proper disposal at no cost to the government.

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.

1. Employees of the vendor who accept orders must complete two on-line courses on the VHA TMS System:

a. VA Privacy and Information Security Awareness and Rules of Behavior

b. Privacy and HIPAA Requirement

2. The vendor must send copies of training certificates for each involved employee to the COR for this contract.

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only

Combined Synopsis-Solicitation for Commercial Products and Commercial Services solicitation; quotations are being requested, and a written solicitation document will not be issued.

This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC_2024-05 5-22-2024.

This solicitation is set-aside for: Small Business

The associated North American Industrial Classification System (NAICS) code for this procurement is 325412, with a small business size standard of 1,250 employees.

The FSC/PSC is 6505.

New York Harbor Health Care System (Brooklyn), New Jersey Healthcare System (East Orange), and the James J. Peters VA Medical Center are requiring the brand name purchase of Radiopharmaceutical drug Netspot (Ga68 dotatate) for patients on an as needed basis.

All interested companies shall provide quotations and a letter of authorization to distribute (if applicable) for the following: This is a brand name requirement with the following specifications:

This Requirements Contract will be set up as a single order period of (5) five years with

(6) six pricing periods as noted below:

Item # Description / NDC (National Drug Code) Qty

GALLIUM DOTATATE (GA-68) 40MCG/VIL INJ / NDC 69488-0001-40

7/30/2024-12/31/2024

GALLIUM DOTATATE (GA-68) 40MCG/VIL INJ / NDC 69488-0001-40

01/01/2025 - 12/31/2025

GALLIUM DOTATATE (GA-68) 40MCG/VIL INJ / NDC 69488-0001-40

01/01/2026 - 12/31/2026

GALLIUM DOTATATE (GA-68) 40MCG/VIL INJ / NDC 69488-0001-40

01/01/2027 - 12/31/2027

GALLIUM DOTATATE (GA-68) 40MCG/VIL INJ / NDC 69488-0001-40

01/01/2028 - 12/31/2028

5001 GALLIUM DOTATATE (GA-68) 40MCG/VIL INJ / NDC 69488-0001-40 23

01/01/2029 - 07/29/2029

Place of Performance/Place of Delivery

Period of Performance:

Single order period of (5) five years with (6) six pricing periods as noted:

Pricing Period 1: 7/30/2024-12/31/2024 Pricing Period 2: 01/01/2025 - 12/31/2025 Pricing Period 3: 01/01/2026 - 12/31/2026 Pricing Period 4: 01/01/2027 - 12/31/2027 Pricing Period 5: 01/01/2028 - 12/31/2028 Pricing Period 6: 01/01/2029 - 07/29/2029

Delivery to:

New York Harbor Health Care System (NYHHCS) at Brooklyn 800 Poly Place Brooklyn, NY 11209

New Jersey Healthcare System (NJHCS) at East Orange 385 Tremont Ave.

East Orange, NJ 07018

James J. Peters VA Medical Center 130 W. Kingsbridge Rd.

Bronx, NY 10468

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Products and Commercial Services” (Sep 2023)

1. The contractor must provide its Nuclear Regulatory Commission License with its offer.

2. The contractor must provide the latest clean room reports and evidence of satisfactory air quality in the clean rooms with its offer.

3. The contractor must provide a copy of their Radiation Safety Officer's safety audits for federal compliance with its offer.

4. The contractor must provide a copy of their laboratory's current quality control manual with its offer.

5. The contractor must provide with its offer Contractor Contact Information as detailed in the Statement of Work.

2. FAR 52.212-3, “Offerors Representations and Certifications– Commercial Products and Commercial Services” (Feb 2024)

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 Products and Commercial Services” (Nov 2023)

FAR 52.212-5, “Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services” (Feb 2024)

The following subparagraphs of FAR 52.212-5 are applicable:

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021)

52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021)

52.216-5 Price Redetermination-Prospective. (Jan. 2022) 12/31/2024 12 Months 60 Days, 30 Days First month

52.216-18 Ordering (Aug. 2020)

7/30/2024 through 7/29/2029

52.216-19 Order Limitations $10,000.00 $2,406.00 $125,112.00 180 days 3 days

52.216-21 Requirements 7/29/2029

52.219-6, Notice of Total Small Business Set-Aside (NOV 2020)

52.219–33, Nonmanufacturer Rule (SEP 2021)

52.222-3, Convict Labor (June 2003)

52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2024)

52.222-21, Prohibition of Segregated Facilities (Apr 2015)

52.222-26, Equal Opportunity (Sept 2016) (E.O.11246)

52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212)

52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793)

52.222-50, Combating Trafficking in Persons (Nov 2021)

52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513)

52.224-3 ALT 1 Privacy Training

52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83)

52.225-2, Buy American Certificate (Oct. 2022)

52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Oct 2018)

852.212-71 Gray Market and Counterfeit Items (Feb 2023)

52.225-2 Buy American Certificate.

Buy American Certificate (Oct 2022)

(a)(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component.

(2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select ‘‘no’’.

(3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(4) The terms ‘‘commercially available off-the-shelf (COTS) item,’’ ‘‘critical component,’’ ‘‘domestic end product,’’ ‘‘end product,’’ and ‘‘foreign end product’’ are defined in the clause of this solicitation entitled ‘‘Buy American—Supplies.”

(b) Foreign End Products:

Line item No. Country of origin Exceeds 55% domestic content (yes/no)

[List as necessary]

(c) Domestic end products containing a critical component:

Line item No.

[List as necessary]

(d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation.

All quoters, shall submit the following: 1 (one) copy.

All quotations shall be sent to Janelle.Bonafede@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.

52.212-2 EVALUATION

Comparative Evaluation

Per FAR 13.106-2 Evaluation of quotations or offers, a comparative evaluation based on price and other factors will be conducted. Please provide such factors as warranty information, availability of expedited delivery, or any other factor differentiating your proposal from others that you believe should be considered and taken into account in comparing with other offers.

Past Performance

Prospective offerors are hereby notified that past performance will be evaluated from any or all of the following:

Federal Data Check (FedDataCheck)

SAM.gov

Past Performance Information Retrieval System (PPIRS), Dun and Bradstreet (D&B)

Any other sources deemed appropriate to determine the Offeror’s ability to fulfill the requirements in this solicitation.

The following are the decision factors:

Award shall be made to the quoter, whose quotation, offers the best value to the government, considering technical capability, past performance, and price. The government will evaluate information based on the following evaluation criteria: (1) technical capability factor meeting or exceeding the requirement, (2) past performance, and (3) price.

The award will be made to the offer 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 shall be received not later than 1600 hours EST 07/15/2024 to Janelle.Bonafede@va.gov.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). e-mailed quotes will be accepted.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Janelle Bonafede at Janelle.Bonafede@va.gov.

Point of Contact

Janelle Bonafede Contracting Officer Network Contracting Office (NC02), Supply Team 1 Appletree Business Park 2875 Union Road Suite 3500 Cheektowaga, NY 14227 Office: 716-862-7461 ext. 24570 E-mail: Janelle.Bonafede@va.gov