36C24220Q0809_1.docx

Contract Opportunity Combined Synopsis/Solicitation Notice

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* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice Albany Radiopharmaceuticals - Nuclear Medicine 14424 36C24220Q0809 08-12-2020

4 PM

EASTERN TIME, NEW YORK, USA

N 325412 Department of Veterans Affairs 400 Fort Hill Ave.

Canandaigua NY 14424

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 solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2020-07

This solicitation is for Full and Open Competition

The associated North American Industrial Classification System (NAICS) code for this procurement is 325412, with a small business size standard of 1000 employees.

The FSC/PSC is 3650.

The Albany VA Medical Center, 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.

All interested companies shall provide quotations for the following:

Supplies/Services Statement of Work Radiopharmaceuticals

1.0 SCOPE

The Department of Veterans Affairs Stratton 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 two 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 October 1, 2020 through September 30, 2023. 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 of the items listed in the Schedule of Radiopharmaceuticals with deliveries when required. Multiple awards will not be made.

1.1 BACKGROUND

The Stratton 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.

3.0 Deliverables and Acceptance Criteria

4.0 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 with the exception of 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.

5.0 CONTRACT AWARD

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

6.0 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.

7.0 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.

8.0 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.

9.0 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.

10.0 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.

11.0 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.

12.0 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 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.

13.0 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).

14.0 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.

15.0 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.

16.0 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 Veterans 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.

17.0 CONTRACT TERM

The respective awarded IDIQ contract shall be for one (1) base year and two (2) option years. The base year period of performance is from October 1, 2020 through September 30, 2021. Option year one (1) period of performance is from October 1, 2021 through September 30, 2022. Option year two (2) period of performance is from October 1, 2022 through September 30, 2023.

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.

Option Year Two (October 1, 2022 through September 30, 2023)

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:

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.

The contract period of performance is October 1, 2020 through September 30, 2023.

Place of Performance/Place of Delivery Address: Albany VA Medical Center 113 Holland Ave.

Albany, New York

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:

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 2008]

• FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” [June 2020]

All quotes shall be sent to the Contracting Officer: Sam DeMuzio, sam.demuzio@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 following are the decision factors:

Technical, Past Performance and Price

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 August 12, 2020, 4:00 pm at sam.demuzio@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 Sam DeMuzio Contracting Officer Sam.demuzio@va.gov See attached document: RFQ - 36C24220Q0809 - Radiopharmaceuticals for Albany VAMC.