36C26223Q1821_1.docx

DOCX document 168 KB Posted Sep 19, 2023

Attached to: 6505--VISN 22 IDIQ for TheraSphere Y-90
Solicitation number: 36C26223Q1821
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 22

About this file

Written by GovTribe AI · Dec 21, 2023

This is a combined synopsis/solicitation for a base plus four year indefinite delivery indefinite quantity contract for Y-90 TheraSphere, which is used in radioembolization procedures to treat liver cancer. The Department of Veterans Affairs VISN 22 network requires this product for use at its medical centers in New Mexico, Arizona, California, and Southern Nevada. Responses are due by September 28, 2023. The solicitation identifies 35 line items for TheraSphere doses ranging from 3 to 20 Gigabecquerels. The period of performance is from October 1, 2023 through September 30, 2028. Delivery must be made within three business days of order and pricing shall remain firm-fixed for the potential five year ordering period. Training and safety compliance with FDA, NRC, and DOT regulations are also required.

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36C26223Q1821

SUBJECT*

VISN 22 IDIQ for TheraSphere Y-90

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*

90815

SOLICITATION NUMBER*

36C26223Q1821

RESPONSE DATE/TIME/ZONE

09-28-2023 09:00 PACIFIC TIME, LOS ANGELES, USA

ARCHIVE

15 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

PRODUCT SERVICE CODE*

6505

NAICS CODE*

325412

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

POINT OF CONTACT*

Contracting Specialist Adrienne Brown adrienne.brown4@va.gov

PLACE OF PERFORMANCE

ADDRESS

Department of Veteran Affairs

VISN 22 Medical Centers

4811 Airport Plaza Drive

Suite 600

Long Beach CA

POSTAL CODE

90815

COUNTRY

USA

ADDITIONAL INFORMATION

AGENCY’S URL

https://www.va.gov

URL DESCRIPTION

Department of Veteran Affairs

AGENCY CONTACT’S EMAIL ADDRESS

adrienne.brown4@va.gov

EMAIL DESCRIPTION

Contracting Specialist

DESCRIPTION

This is a combined synopsis/solicitation and is unrestricted for commercial supplies prepared in accordance with the format in Subpart 12.6, as supplemented with the additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This is a request for quotes under solicitation number: 36C26223Q1821

The Department of Veterans Affairs VISN 22 has a requirement for a base plus four year indefinite delivery indefinite quantity (IDIQ) contract for TheraSphere Y-90. The Contractor shall furnish all supplies/services at the ordering medical center.

Shipping included in cost.

NOTE: Potential offers must be aware that the items being acquired are procured as Brand Name or Equal. For those items that are “or equal”, a description of the salient characteristics are outlined below. The FAR Clause 52.211-6 Brand Name or Equal applies to this acquisition. Any items quoted as equal not confirming to the requirements of clause 52.211-6 will be considered non- responsive and not considered for award.

No remanufactures or gray market items will be acceptable. Vendor shall be an Original Equipment Manufacturer (OEM), authorized dealer, authorized distributor or authorized reseller verified by an authorization letter or other documents from the OEM.

Item #

Description

Base

OY 1

OY 2

OY 3

OY 4

0001

Y-90 THERASPHERE (3 GBQ) US COMM

0002

Y-90 THERASPHERE (3.5 GBQ) US COMM

0003

Y-90 THERASPHERE (4 GBQ) US COMM

0004

Y-90 THERASPHERE (4.5 GBQ) US COMM

0005

Y-90 THERASPHERE (5 GBQ) US COMM

0006

Y-90 THERASPHERE (5.5 GBQ) US COMM

0007

Y-90 THERASPHERE (6 GBQ) US COMM

0008

Y-90 THERASPHERE (6.5 GBQ) US COMM

0009

Y-90 THERASPHERE (7 GBQ) US COMM

0010

Y-90 THERASPHERE (7.5 GBQ) US COMM

0011

Y-90 THERASPHERE (8 GBQ) US COMM

0012

Y-90 THERASPHERE (8.5 GBQ) US COMM

0013

Y-90 THERASPHERE (9 GBQ) US COMM

0014

Y-90 THERASPHERE (9.5 GBQ) US COMM

0015

Y-90 THERASPHERE (10 GBQ) US COMM

0016

Y-90 THERASPHERE (10.5 GBQ) US COMM

0017

Y-90 THERASPHERE (11 GBQ) US COMM

0018

Y-90 THERASPHERE (11.5 GBQ) US COMM

0019

Y-90 THERASPHERE (12 GBQ) US COMM

0020

Y-90 THERASPHERE (12.5 GBQ) US COMM

0021

Y-90 THERASPHERE (13 GBQ) US COMM

0022

Y-90 THERASPHERE (13.5 GBQ) US COMM

0023

Y-90 THERASPHERE (14 GBQ) US COMM

0024

Y-90 THERASPHERE (14.5 GBQ) US COMM

0025

Y-90 THERASPHERE (15 GBQ) US COMM

0026

Y-90 THERASPHERE (15.5 GBQ) US COMM

0027

Y-90 THERASPHERE (16 GBQ) US COMM

0028

Y-90 THERASPHERE (16.5 GBQ) US COMM

0029

Y-90 THERASPHERE (17 GBQ) US COMM

0030

Y-90 THERASPHERE (17.5 GBQ) US COMM

0031

Y-90 THERASPHERE (18 GBQ) US COMM

0032

Y-90 THERASPHERE (18.5 GBQ) US COMM

0033

Y-90 THERASPHERE (19 GBQ) US COMM

0034

Y-90 THERASPHERE (19.5 GBQ) US COMM

0035

Y-90 THERASPHERE (20 GBQ) US COMM

The solicitation will be in accordance with FAR Part 12, 13, and 16, Acquisition of Commercial Items, Simplified Acquisition Procedures, Types of Contracts, and Veteran Affairs Acquisition Regulations as supplemented with additional information in this notice. The North American Industrial Classification System (NAICS) code for this requirement is 325412, Size Standard 1,300 Employees. The Contractor shall adhere to all federal and state laws and regulations in effect during the term of this contract. The Government intends to award a firm-fixed-price contract. The Contract begins on the date of award. Due to time constraints, responses to the solicitation shall be due on Thursday, September 28, 2023 at 09:00 AM PT Local Time. Offerors are advised that it is your responsibility to review and monitor the website frequently to ensure you have the most up to date information, including amendments. Correspondence or questions may be directed to Adrienne Brown, Contracting Officer at ADRIENNE.BROWN4@va.gov with "36C26223Q1821, VISN 22 TheraSphere” in the subject line within 48 hours of release of this notice. Telephone inquiries will not be honored. Inquiries after the allotted period may not be responded to due to the time constraints of the procurement. All offerors must be registered in www.sam.gov to do business with the Government. Ensure your registration is correct, current and has not expired.

Combined Synopsis/Solicitation Notice

*= Required Field

Combined Synopsis/Solicitation Notice

Table of Contents

SECTION B - CONTINUATION OF COMBINED SYNOPSIS	7
B.1 CONTRACT ADMINISTRATION DATA	7
STATEMENT OF WORK	9
B.3 PRICE/COST SCHEDULE	16
ITEM INFORMATION	16
B.4 DELIVERY SCHEDULE	58
SECTION C - CONTRACT CLAUSES	66
C.1 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)	66
C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)	66
C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JUN 2023)	72
C.4 52.216-18 ORDERING (AUG 2020)	80
C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)	81
C.6 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)	81
C.7 52.216-22 INDEFINITE QUANTITY (OCT 1995)	82
C.8 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)	82
C.9 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE ITEM (MAR 1989)	82
C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)	82
C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)	84
C.12 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)	84
C.13 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)	84
C.14 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)	84
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS	85
SECTION E - SOLICITATION PROVISIONS	86
E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)	86
E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)	89
E.3 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAR 2023)	90
E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)	94
E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)	95
E.6 52.216-1 TYPE OF CONTRACT (APR 1984)	113
E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)	113
E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)	113
E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)	114

SECTION B - CONTINUATION OF COMBINED SYNOPSIS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X]

52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[]

52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly	[]
b. Semi-Annually	[]
c. Other	[X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

https://www.tungsten-network.com ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO

DATE

STATEMENT OF WORK

Statement of Work

Scope:

The Department of Veteran Affairs requires a VISN 22 base plus four indefinite delivery indefinite quantity (IDIQ) contract for Y-90 TheraSphere, which is a relatively new, safe, and highly successful treatment for cancer in the liver that targets tumors with a high dose of radiation without affecting other healthy parts of the body (radioembolization procedure). Y-90 refers to a powerful Beta emitter radioactive isotope Yttrium-90, inserted into tiny particles (TheraSpheres), and delivered radiation directly to tumors via long, thin catheters. Plexiglas administration Kit (system) reduces radiation exposure to staff and hosts the Y-90 TheraSpheres ready to be used by the interventional radiologist. The interventional radiologist performs this procedure on liver cancer patients or other cancers that have metastasized (spread) to the liver.

Participating VA Medical Centers:

New Mexico VA Healthcare System (Albuquerque, NM) Northern Arizona VA Healthcare System (Prescott, AZ) Phoenix VA Healthcare System (Phoenix, AZ) Southern Arizona VA Healthcare System (Tucson, AZ) VA Greater Los Angeles Healthcare System (GLA) (Los Angeles, CA) VA Loma Linda Healthcare System (Loma Linda, CA) VA Long Beach Healthcare System (Long Beach, CA) VA San Diego Healthcare System (San Diego, CA)

Training:

The contractor shall provide on-site training to all ordering medical centers. The purpose is to certify all Interventional Radiologists so that they are competent to operate the administration kit and deliver the Y-90 radiation to patients.

Ordering Procedures:

Orders shall be placed upon receipt of an approved purchase order (PO).

An approved purchase order will be signed by a warranted contracting officer.

Authorized to Issue Orders:

VA Medical Centers with an approved purchase order.

Schedule of Supplies

Est. Min Order Dollar Value

Est. Maximum Dollar Value

Base Year

$17,995.00

$700,000.00

Option Year 1

$17,995.00

$700,000.00

Option Year 2

$17,995.00

$700,000.00

Option Year 3

$17,995.00

$700,000.00

Option Year 4

$17,995.00

$700,000.00

Period of Performance

Base Year

10/1/2023 – 9/30/2024

Option Year 1

10/1/2024 – 9/30/2025

Option Year 2

10/1/2025 – 9/30/2026

Option Year 3

10/1/2026 – 9/30/2027

Option Year 4

10/1/2027 – 9/30/2028

Material

Material Description

Unit

M00139552US0300

Y-90 THERASPHERE (3 GBQ) US COMM

M00139552US0350

Y-90 THERASPHERE (3.5 GBQ) US COMM

M00139552US0400

Y-90 THERASPHERE (4 GBQ) US COMM

M00139552US0450

Y-90 THERASPHERE (4.5 GBQ) US COMM

M00139552US0500

Y-90 THERASPHERE (5 GBQ) US COMM

M00139552US0550

Y-90 THERASPHERE (5.5 GBQ) US COMM

M00139552US0600

Y-90 THERASPHERE (6 GBQ) US COMM

M00139552US0650

Y-90 THERASPHERE (6.5 GBQ) US COMM

M00139552US0700

Y-90 THERASPHERE (7 GBQ) US COMM

M00139552US0750

Y-90 THERASPHERE (7.5 GBQ) US COMM

M00139552US0800

Y-90 THERASPHERE (8 GBQ) US COMM

M00139552US0850

Y-90 THERASPHERE (8.5 GBQ) US COMM

M00139552US0900

Y-90 THERASPHERE (9 GBQ) US COMM

M00139552US0950

Y-90 THERASPHERE (9.5 GBQ) US COMM

M00139552US1000

Y-90 THERASPHERE (10 GBQ) US COMM

M00139552US1050

Y-90 THERASPHERE (10.5 GBQ) US COMM

M00139552US1100

Y-90 THERASPHERE (11 GBQ) US COMM

M00139552US1150

Y-90 THERASPHERE (11.5 GBQ) US COMM

M00139552US1200

Y-90 THERASPHERE (12 GBQ) US COMM

M00139552US1250

Y-90 THERASPHERE (12.5 GBQ) US COMM

M00139552US1300

Y-90 THERASPHERE (13 GBQ) US COMM

M00139552US1350

Y-90 THERASPHERE (13.5 GBQ) US COMM

M00139552US1400

Y-90 THERASPHERE (14 GBQ) US COMM

M00139552US1450

Y-90 THERASPHERE (14.5 GBQ) US COMM

M00139552US1500

Y-90 THERASPHERE (15 GBQ) US COMM

M00139552US1550

Y-90 THERASPHERE (15.5 GBQ) US COMM

M00139552US1600

Y-90 THERASPHERE (16 GBQ) US COMM

M00139552US1650

Y-90 THERASPHERE (16.5 GBQ) US COMM

M00139552US1700

Y-90 THERASPHERE (17 GBQ) US COMM

M00139552US1750

Y-90 THERASPHERE (17.5 GBQ) US COMM

M00139552US1800

Y-90 THERASPHERE (18 GBQ) US COMM

M00139552US1850

Y-90 THERASPHERE (18.5 GBQ) US COMM

M00139552US1900

Y-90 THERASPHERE (19 GBQ) US COMM

M00139552US1950

Y-90 THERASPHERE (19.5 GBQ) US COMM

M00139552US2000

Y-90 THERASPHERE (20 GBQ) US COMM

Contractor shall deliver supplies within (3) business days from date of order. Business days are defined as, Monday thru Friday excluding federally recognized holidays.

If the contractor is not able to meet the (3) day delivery timeframe from date the order is placed, the contractor shall provide a notification to the ordering medical center and contracting point of contact within 48 hours, which specifically states that the order request is declined.

Payments:

Payments will be made monthly by individual medical centers. Contractor shall use the purchase order (PO) number referenced on order form when submitting for payment through the Tungsten network website at https://www.tungsten-network.com.

Delivery Locations and Work Hours:

Deliver to Nuclear Medicine Department at ordering medical center.

Delivery Hours: 0700 – 1630 Local Time

New Mexico VA Healthcare System (Albuquerque, NM) 1501 San Pedro SE Albuquerque, NM 87108

Northern Arizona VA Healthcare System (Prescott, AZ)

500 HW 89N

Prescott, AZ 86313

Phoenix VA Healthcare System (Phoenix, AZ) 650 E Indian School Road Phoenix, AZ 86313

Southern Arizona VA Healthcare System (Tucson, AZ) 3601 S 6th Ave Tucson, AZ 85723

VA Greater Los Angeles Healthcare System (GLA) (Los Angeles, CA) 11301 Wilshire Blvd Los Angeles, CA 90073

VA Loma Linda Healthcare System (Loma Linda, CA) 11201 Benton Street Loma Linda, CA 92357

VA Long Beach Healthcare System (Long Beach, CA) 5901 East 7th Street Long Beach, CA 90822

VA San Diego Healthcare System (San Diego, CA) 3350 La Jolla Village Drive San Diego, CA 92161

Packaging and Marking The Contractor shall package, mark and transfer all radioactive material in accordance with the Food and Drug Administration (FDA), Occupational Health and Safety Administration (OSHA), Department of Transportation (DoT), all applicable local, state and federal regulations.

Items must be adequately packaged to prevent damage during shipping, handling, and storage.

All outer packages must contain the complete purchase order number, obligation number and contract number in addition to the shipping address. The purchase order number and obligation number will be provided by the medical center at the time of ordering. The contract number will be provided upon notice of contract award.

Packaging List: A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quality ordered and items/quality shipped.

The Contractor shall meet all requirements of regulatory agencies for deliveries of radioactive generator between facilities and shall strictly adhere to these requirements (see paragraph Safety Guidelines and Requirements).

Quality Assurance:

The Contractor shall immediately notify the Contracting Officer of any recalls of product or other important product safety issues. In the event that a quality control or material defect is suspected and/or detected by any VA medical center personnel, the contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

· Provide technical expertise.

· Provide professional examination of product; submit results and recommendations to the Contracting Officer.

· Make expedient replacement of any product suspected of being deficient.

· The Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education.

· The vendor shall credit the government for the number of days that a generator is not available for use including shipping problems, recalls and quality control issues.

Safety Guidelines and Requirements

The Contractor shall perform all functions of this contract in compliance with the following agencies:

· Occupational Safety and Health Administration (OSHA)

· Food and Drug Administration (FDA)

· Nuclear Regulatory Commission (NRC)

· Joint Commission safety guidelines

· Department of Transportation (DOT) The Contractor shall self-report any violations to the contracting officer within twenty-four (24) hours.

The contractor shall provide MSDS (Material Safety Data Sheets) and updates as necessary on all delivered products to the ordering medical center.

National Holidays Observed by Government https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/#url=Overview

The President of the United States of America may declare additional days as Federal holidays, and if so, such holidays 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.

Badges

All Contractor personnel are required to wear identification badges during the entire time they are on the VA Medical Center grounds. Identification (ID) badges must have:

· Employee picture

· Employee name

· Company name/Identifying Logo

Parking Policy

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

Invoices and Payments

No advanced payments will be authorized. The Contractor shall submit invoices on a monthly basis. The invoice must include, the contract number, assigned purchase order (PO), assigned obligation number, date order was placed, date order was shipped, name of preparation, quantity, and amount. Payments may be delayed if invoice(s) are not completed properly.

Security Considerations

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

VA Policy

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

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0.00

__________________

Y-90 THERASPHERE (3 GBQ) US COMM

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

LOCAL STOCK NUMBER: M00139552US0300

0.00

__________________

Y-90 THERASPHERE (3.5 GBQ) US COMM