36C26221Q0120.docx

Contract Opportunity Combined Synopsis/Solicitation Notice

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* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice TheraSphere Y-90 Cancer Treatment 90815 36C26221Q0120 11-20-2020 2:00pm

PACIFIC TIME, LOS ANGELES, USA

N 325412 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815 Cervantes, Luis Luis.Cervantes@va.gov Department of Veteran Affairs VA Greater Los Angeles Healthcare System 11301 Wilshire Blvd Los Angeles, Ca

90073

USA

https://www.va.gov/ https://www.va.gov/ Luis.Cervantes@va.gov Luis.Cervantes@va.gov

REQUEST FOR QUOTE (RFQ)

VHA Greater Los Angeles Healthcare System: TheraSphere Y-90 Cancer Treatment

COMBINED SYNOPSIS/SOLICITATION – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 - Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with FAR 13 Simplified Acquisition Procedures; and supplemented with additional information included in this notice. This solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular 2019-05, dated August 13, 2019.

The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking sources under NAICS 325412 or related that can provide the Veterans Health Administration Greater Los Angeles Healthcare System with TheraSphere Y-90 Cancer Treatment. The vendor shall provide all materials, transportation/ delivery, and supervision necessary to satisfy the needs of each ordering activity. Line item descriptions are listed below:

Statement of Work – TheraSphere Y-90

1. SCOPE

The Department of Veterans Affairs, Greater Los Angeles Healthcare system is in need of TheraSphere Y-90 to treat 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.

Salient Characteristics:

· The dimension of the Plexiglas of the dosing system is 10.5 "x 9" x10".

· Weight is approximately 10 lbs.

· Used to treat non-operable metastatic hepatic malignancies for salvage treatments and curative intent.

· FDA approved used device for radiation treatment for liver cancer patients - Glass Y90 (Theraspheres)

· The ability to downstage tumors, be an effective bridge to transplant and surgical resection, and improve patients' survival not suitable for curative measures. Y90 radioembolization

· The ability for patients to have radioembolization done in combination with traditional cancer treatments, including surgery, chemotherapy, and immunotherapy.

· Treated patients have the ability to be discharged after three to six hours of the procedure.

2. TRAINING

The contractor shall provide on-site training. 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.

3. PERIOD OF PERFORMANCE

One year from the date of award.

4. ORDERS

Doses are ordered as needed.

5. DELIVERY LOCATION AND NORMAL WORK HOURS

VAGLAHS

All items must be delivered as specific below except for the Federal Holidays.

a. Delivery Location - Nuclear Medicine Service, Room 0072 and Building 500

b. Normal Work Hours – 7:30am to 4:30pm, Monday through Friday

6. PACKAGING AND MARKING

a. The Contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, and federal regulations.

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

c. 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 individual at the time of ordering. The contract number will be provided upon notice of contract award.

d. 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.

e. The Contractor shall meet all requirements of regulatory agencies for deliveries of radioactive generator between facilities and shall strictly adhere to these requirements.

7. 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 Point of contact (POC), the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

a. Provide technical expertise.

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

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

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

e. 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.

8. SAFETY GUIDELINES AND REQUIREMENTS

Contractor shall perform all functions of this contract in compliance with Occupational Safety and Health Administration (OSHA), FDA, NRC, Joint Commission safety guidelines and Department of Transportation (DOT) requirements. The Contractor shall self-report any violations to the POC within twenty-four (24) hours.

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

9. BADGES

All Contractor personnel are required to wear identification (LD.) badges during the entire time they are on the VA Healthcare System grounds. I.D. badges must have picture identification, name of the individual and the represented company depicted on it.

10. 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 shall not validate or make reimbursement for parking violations of the Contractor's personnel under any circumstances.

11. INVOICE AND PAYMENT

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, 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.

12. 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 VISN facility. The Contractor will not have access to any Federally Controlled Information Systems.

13. VA POLICY

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

Submitting a Quote: Offeror(s) shall submit their quote on company letterhead and shall include the completed pricing forms, along with their name, address, the telephone number of the offeror, the firm’s DUNS#, and total price. Offerors shall have completed FAR Clause 52.212-3 Offerors Representations and Certifications - Commercial Items in Systems for Award Management SAM. Representations and Certifications -at www.sam.gov as required by FAR Clause 52.212-3 Offerors Representations and Certifications - Commercial Items. All offerors shall be an authorized distributor by the manufacturer and must be able to offer full manufacturer warranties for products delivered to the Government. All quotes will be evaluated on the basis of Lowest Price Technically Acceptable (LPTA). Vendor are required to demonstrate in written how their submission is technically acceptable to the requested requirement.

Responses to this RFQ are due by November 20, 2020 at 2:00 PM Pacific Standard Time (PST). Quotes shall be submitted electronically via email to the Contract Specialist Luis.Cervantes@va.gov. Offerors are advised to review and monitor their emails for any correspondence regarding amendments. Correspondence or questions may be directed to the Contract Specialist with “TheraSphere Y-90 Cancer Treatment” in the subject line, (48) hours of the posting of this solicitation. Telephone inquiries will not be honored. Inquiries after the allotted period may not receive a response due to the time constraints of the procurement.

NOTICE LISTING CLAUSES INCORPORATED BY REFERENCE

The following clauses are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR "52.252-2 CLAUSES INCORPORATED BY REFERENCE" contained in this document. See FAR 52.252-2 for an internet address (if specified) for electronic access to the full text of a clause.

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NOTICE LISTING CLAUSES INCORPORATED BY REFERENCE

The following clauses are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR "52.252-2 CLAUSES INCORPORATED BY REFERENCE" contained in this document. See FAR 52.252-2 for an internet address (if specified) for electronic access to the full text of a clause.

PROVISIONS

-COMMERCIAL ITEMS

NOV 2014

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