36C25623Q1880_1_RFQ.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* CSS RFQ: Radioactive Isotopes – Lymphoseek

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*

SOLICITATION NUMBER*

RESPONSE DATE/TIME/ZONE

ARCHIVE

RECOVERY ACT FUNDS

SET-ASIDE

PRODUCT SERVICE CODE*

NAICS CODE*

CONTRACTING OFFICE ADDRESS

POINT OF CONTACT*

77056-5643

36C25623Q1880

09-25-2023 4:00pm CENTRAL TIME, CHICAGO, USA 9 DAYS AFTER THE RESPONSE DATE

N

325412 Department of Veterans Affairs Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

Contracting Specialist Shasta Britt shasta.britt@va.gov

PLACE OF PERFORMANCE

ADDRESS Department of Veterans Affairs Michael E. DeBakey VA Medical Center

(MEDVAMC)

2002 Holcombe Blvd.

Houston Texas

POSTAL CODE 77030-4211

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov URL DESCRIPTION Department of Veterans Affairs AGENCY CONTACT’S EMAIL ADDRESS shasta.britt@va.gov EMAIL DESCRIPTION 36C25623Q1880 - RFQ Response mailto:shasta.britt@va.gov https://www.va.gov/ mailto:shasta.britt@va.gov

DESCRIPTION

This is a Sole Source Combined Synopsis/Solicitation (CSS) 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,” in conjunction with FAR Part

13.5 for Certain Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, a quote is being requested, and a written solicitation document will not be issued.

This solicitation is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular

(FAC) 2023-05 (eff. 09/07/2023), VAAR Update 2008-37 (eff. 07/28/2023), and Acquisition

Policy Flash 23-15 (eff. 07/28/2023).

Contractor is required to be actively registered in the System for Award Management (SAM).

Vendor quote may be considered non-compliant and rejected if the Contracting Officer is unable to verify registration and certification status.

The Michael E. DeBakey VA Medical Center (MEDVAMC) Diagnostic and Therapeutic Care, 2002 Holcombe Blvd, Houston, Texas 77030 is seeking nuclear medicine imaging isotopes, Lymphoseek (Sole Source). This solicitation is being solicited noncompetitively to a sole source offeror. The sole source offeror shall comply with the following conditions below when responding to this solicitation. Please review the attached document(s) for more details on this requirement.

See attached document: 36C25623Q1880_1_RFQ

36C25623Q1880

Table of Contents

SECTION B - CONTINUATION CONTRACT OPPORTUNITIES COMBINED SYNOPSIS

SOLICITATION

B.1CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION [Completed by Offeror]

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.3 VAAR 852.223-71 SAFETY AND HEALTH (SEP 2019)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.6 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.7 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.8 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 STATEMENT OF WORK

D.2 JUSTIFICATION AND APPROVAL (JA)

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021) [Completed by

Offeror]

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.5 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.6 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.7 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022) [Completed by Offeror]

SECTION B - CONTINUATION CONTRACT OPPORTUNITIES

COMBINED SYNOPSIS SOLICITATION

B.1CONTRACT ADMINISTRATION DATA

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

[Completed by Offeror]

a. CONTRACTOR: Company Name:

ATTN/POC Name:

Address:

Phone:

Email:

UEI:

Tax ID:

GSA/FSS, NAC, SEWP Contract# (if applicable):

b. GOVERNMENT: Contracting Officer 36C256

Department of Veterans Affairs Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

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

a. 52.232-33 Payment by Electronic Funds Transfer - System for Award Management through

TUNGSTEN

3. INVOICES: Invoices shall be submitted in arrears:

a. Other: Upon receipt and acceptance by the Government

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.

a. Include purchase order number (PO#) _TBD on all invoices.

5. Offeror shall complete the following located in Sections B thru E of this solicitation to be deemed eligible:

a. Section B- CONTRACT ADMINISTRATION DATA, CONTRACTOR contact information.

b. Section B- PRICE/COST SCHEDULE, unit price, amount, and grand total.

c. Section D- D.1 SOW unit price, total price, and yearly pricing at table M.1.

d. Section E- 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT.

e. Section E- 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS.

f. Submission of manufacturer’s authorized distributor letter, cut-sheets, and specifications.

6. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

N/A N/A

(End of Contract Administration Data)

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION [Completed by Offeror]

LINE

ITEM

DESCRIPTION

OF SUPPLIES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 YR __________________ __________________

Lymphoseek Isotopes Reagents and Consumables

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024

PRINCIPAL NAICS CODE: 325412

PRODUCT/SERVICE CODE: 3650

LOCAL STOCK NUMBER: Ordering Year One

Contract Period: Option 1 POP Begin: 10-01-2024 POP End: 09-30-2025

PRINCIPAL NAICS CODE: 325412

LOCAL STOCK NUMBER: Ordering Year Two

Contract Period: Option 2 POP Begin: 10-01-2025 POP End: 09-30-2026

PRINCIPAL NAICS CODE: 325412

LOCAL STOCK NUMBER: Ordering Year Three

Contract Period: Option 3 POP Begin: 10-01-2026 POP End: 09-30-2027

PRINCIPAL NAICS CODE: 325412

LOCAL STOCK NUMBER: Ordering Year Four

Contract Period: Option 4 POP Begin: 10-01-2027 POP End: 09-30-2028

PRINCIPAL NAICS CODE: 325412

LOCAL STOCK NUMBER: Ordering Year Five

GRAND TOTAL

B.3 DELIVERY SCHEDULE

ITEM NUMBER QTY/UNIT DELIVERY DATE

365ARO 1.00/YR POP Begin: 10-01-2023 thru 09-30-2024

365ARO 1.00/YR POP Begin: 10-01-2024 thru 09-30-2025

365ARO 1.00/YR POP Begin: 10-01-2025 thru 09-30-2026

365ARO 1.00/YR POP Begin: 10-01-2026 thru 09-30-2027

365ARO 1.00/YR POP Begin: 10-01-2027 thru 09-30-2028

[End of Section B]

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

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

AUG 2020

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

DEC 2022

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

JUN 2023

52.217-6 OPTION FOR INCREASED QUANTITY MAR 1989

52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY

PRICED LINE ITEM

MAR 1989

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT MAR 2000

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

MAR 2023

(End of Clause)

C.2 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of

Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.3 VAAR 852.223-71 SAFETY AND HEALTH (SEP 2019)

(a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) and other regulatory/enforcement agencies at the Federal, State, and local levels.

(1) Additionally, the Contractor shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects:

(i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories. These regulations are available at https://www.osha.gov/.

(ii) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy

Reorganization Act of 1974 (42 U.S.C. 5801 et seq.) Copies are available from the U.S. Nuclear

Regulatory Commission, Washington, DC 20555-0001.

(2) The following Government guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel and facilities:

(i) Biosafety in Microbiological and Biomedical Laboratories, Centers for Disease Control and Prevention (CDC), available at http://www.cdc.gov/biosafety/publications/index.htm.

(ii) Prudent Practices in the Laboratory, National Research Council, National Academy

Press, Washington, DC 20001, available at http://www.nap.edu.

(b)(1) The Contractor shall maintain an accurate record of, and promptly report to the

Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials; the injury or death of any person; or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency.

(2) The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

https://www.osha.gov/ http://www.cdc.gov/biosafety/publications/index.htm http://www.nap.edu/

(c) If the Contractor fails or refuses to comply with the Federal, State or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer.

No part of the time lost due to any such stop work order shall form the basis for a request for extension or costs or damages by the Contractor.

(d) The Contractor shall insert this clause in each subcontract involving toxic substances or hazardous materials. The Contractor is responsible for the compliance of its subcontractors with the provisions of this clause.

(End of Clause)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT

REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a

Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National

Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting

Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT

2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer

(ACO) for the purpose of performing certain tasks/duties in the administration of the contract.

Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.6 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

(a) Supplies and equipment. Rejected goods will be held subject to Contractor’s order for not more than 15 days, after which the rejected merchandise will be returned to the Contractor’s address at the Contractor’s risk and expense. Expenses incident to the examination and testing of materials or supplies that have been rejected will be charged to the Contractor.

(b) Perishable supplies. The Contractor shall remove rejected perishable supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. The Department of Veterans Affairs will not be responsible for, nor pay for, products rejected. The Contractor will be liable for costs incident to examination of rejected products.

(End of Clause)

C.7 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

Shipment of deliverable items, other than reports, shall be to:

Michael E. DeBakey VA Medical Center Nuclear Medicine Department, Rm 2C-254D 2002 Holcombe BLVD Houston TX 77030-4298

(End of Clause)

C.8 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause)

(End of Addendum to 52.212-4)

[End of Section C]

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR

ATTACHMENTS

D.1 STATEMENT OF WORK

Radioactive Isotopes – Lymphoseek

Part I: General Information

A. Introduction

The Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd, Houston, Tx 77030 has a requirement for Nuclear Medicine imaging isotopes, specifically to Lymphoseek, for use in the Nuclear Medicine Department’s with/without imaging for lymphatic mapping.

B. Background

Lymphoseek injection is a radioactive diagnostic agent indicated with or without scintigraphic imaging for lymphatic mapping using a handheld gamma counter or gamma camera to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management, and for guiding sentinel lymph node biopsy using a handheld gamma counter or gamma camera in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. The other isotopes are for diagnostic imaging and testing.

C. Scope

Contractor shall provide all single unit and bulk doses of isotopes for use in Nuclear Medicine diagnostic imaging at MEDVAMC in Houston, Texas. Further, the Contractor shall use non-HEU derived isotopes whenever possible to support the Department of Veterans Affairs procurement initiative.

D. Applicable Documents

10 Code of Federal Regulations Part 35: United States Nuclear Regulatory Commission- Medical Use of Byproduct Material 49 Code of Federal Regulations Part 173 Subpart I: Class 7 (Radioactive) Materials Department of Veteran Affairs Materials Permit: Reference # 03-01082- 01 Amendment # 76.

Part II: Requirements

E. Ordering Requirements

1. The Contractor shall provide personnel for orders to be placed by MEDVAMC employees for Lymphoseek and other isotopes during standard hours of care Monday through Friday from 0800 (8:00 AM CST) until 1600 hours (4:00 PM CST), not including Federal holidays outlined in paragraph K.

2. The Contractor shall receive orders for Lymphoseek and other isotopes from Staff Nuclear Medicine Technologists assigned to the Nuclear Medicine Department at MEDVAMC. The

Contractor shall ensure the Staff Nuc Med Technologist name and contact information that placed the order is included with the Contractor’s internal order processing system so that the Contractor can immediately verify who placed the order at the VA’s request.

3. The Contractor shall calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 20 percent of the specified ordered dose per specific requirements provided by the Nuclear Medicine department based on guidelines outlined in 10 CFR Part 35.

4. Orders may be placed orally, in writing, or by electronic means.

5. The Contractor shall notify MEDVAMC Nuclear Medicine department should the inability arise to provide Radiopharmaceutical doses by the required date and time. Notification shall be made within two (2) hours of the Contractor becoming aware of the inability to provide the required doses.

F. Delivery Requirements

1. The Contractor shall deliver ordered Radiopharmaceutical doses to:

Michael E. DeBakey VA Medical Center 2002 Holcombe Blvd.

Nuclear Medicine Department, Room 2C-254D Houston, Texas 77030

Access to MEDVAMC during non-business hours shall be obtained by locating the VA Police located in the Emergency Department. The VA Police must accompany the delivery Person to the Nuclear Medicine department and supervise the delivery.

2. The Contractor shall ensure all orders are delivered at least 60 minutes of the calibration time specified on the order.

(a) Normal business hours are 8:00 am to 4:00 pm, Monday through Friday. All other hours are considered after “normal business” hours. All charges incurred for delivery shall be included in the fee schedule to include fuel surcharges.

(b) Stat delivery shall be within one (1) hour after receipt of order during normal business hours and within two (2) hours after receipt of order after normal business hours.

(c) Non-stat delivery shall be within two (2) hours after receipt of order during normal business hours and within two (2) hours after receipt of order after normal business hours.

3. The Contractor shall provide a packing slip accompanying all Radiopharmaceutical shipments to the Nuclear Medicine department for all orders placed that is compatible to be scanned into the BioDose system.

4. The Contractor shall ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Pharmacist Contractor.

5. The Contractor shall provide courier service licensed to transport radioactive material in accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating authorities enabling the delivery of radioactive isotopes.

6. Time of delivery specified or mutually agreed to at the time of receipt of telephone order shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default.

G. Additional Requirements

1. The Contractor shall provide any training or education required to meet commercial standards related to use of the radiopharmaceutical Lymphoseek to qualified Staff Nuc Med Physicians/Technologist stationed at the MEDVAMC no later than 60 days after commercial standards changes.

2. The Contractor shall obtain, maintain, and provide evidence of at the request of the Government, U.S. Food & Drug Administration (FDA) approval of the isotopes prior to shipment.

3. The Contractor shall provide on-site support to ensure proper set up and delivery of this new procedure at MEDVAMC.

H. Government Responsibilities

The Government must ensure all orders placed by the MEDVAMC to the Contractor in accordance with currently accepted Contractor guidelines.

Part III: Supporting Information

I. Place of Performance:

All supplies shall be delivered to the:

Department of Veterans Affairs Michael E. DeBakey VA Medical Center 2002 Holcombe Blvd.

Nuclear Medicine Department, Room 2C-254D Houston, Texas 77030

J. Period of Performance:

Contract is awarded as a one-year base ordering period with four additional ordering years funding the contract one year (annually) at a time, for a total ordering period of five years.

K. Hours of Work:

Normal business hours for the Nuclear Medicine Department at the MEDVAMC are 8:00 a.m. to 4:00 p.m., Monday through Friday excluding the following federal holidays: New Year's Day, Martin Luther King Day, President's Day, Memorial Day, Juneteenth Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas, and any other day specifically declared by the President of the United States to be a national holiday.

L. Changes to Statement of Work:

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract and such changes must be executed bi-laterally in accordance with FAR 52.212-4(c). The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which must affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the Contracting Officer, the change must be considered to have been made without authority and no adjustment must be made in the contract price to cover any increase in costs incurred as a result thereof.

M. SCHEDULE OF SUPPLIES/SERVICES

Provide radioactive isotopes to the Department of Veterans Affairs Medical Center, 2002

Holcombe Blvd., Houston, Texas 77030, in unit dose, yearly in accordance with patient requirements from:

Table M.1. [Completed by Offeror]

# Product

Description Est. Yrly.

Qty.

Unit Unit Price Total Est.

Price

1 102337 I-123 USP Nal 100 uCi Cap 2 UD

2 102338 I-123 USP Nal 200 uCi Cap 10 UD

3 102983 Tc-99m NaTc04 MD 500 mCi

4 103039 TI-201 Thallous Chloride UD 30 mCi

5 103931 Lymphoseek Study Dose 70 UD

*Yearly Ordering/Pricing Subtotal Value:

*Yearly Ordering / Price shall match each Line Item for Section B table at B.2 Price/Cost Schedule.

(End of Statement of Work)

D.2 JUSTIFICATION AND APPROVAL (JA)

See below attached JA Redacted…

Effective Date: 02/01/2022 Page 1 of 6

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Radioactive Isotopes � Radiopharmaceuticals Lymphoseek

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 16, located at 5075 Westheimer Rd., Ste. 750, Houston, TX 77056. Program Office: Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd; Houston, Texas 77030.

Purchase Request Number:

2. Nature and/or Description of the Action Being Processed: MEDVAMC is seeking to procure radioactive isotopes Lymphoseek in the diagnosis and testing of disease as a FFP Sole Source procurement under the SAP for commercial items over the SAT but below $750k. This requirement with options will be a follow on to the Sole Sourced contract 36C25619P0258 that was awarded on 11/27/2018 and expires on 09/30/2023 in the amount of The estimated value of the proposed action is (base +4 ).

3. Description of Supplies/Services Required to Meet the Agency�s Needs: MEDVAMC is seeking to purchase radioactive isotopes in the diagnosis and testing of disease. Nuclear Medicine uses radioactive isotopes in the diagnosis and testing of disease. Nuclear medicine enables clinicians to noninvasively and precisely identify specific molecular activity within tissues and organs of the body, facilitating the early detection of disease and the immediate monitoring of therapeutic responses. Lymphoseek injection is a radioactive diagnostic agent indicated with or without scintigraphic imaging for lymphatic mapping using a handheld gamma counter or gamma camera to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management, and for guiding sentinel lymph node biopsy using a handheld gamma counter or gamma camera in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Item list described the supplies that are needed:

Description Est. Yrly. Qty. Unit

1 I-123 USP Nal 100 uCi Cap 2 UD

2 I-123 USP Nal 200 uCi Cap 10 UD

3 Tc-99m NaTc04 MD 500 mCi

4 TI-201 Thallous Chloride UD 30 mCi

5 Lymphoseek Study Dose 70 UD

4. Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106- 1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 2 of 6

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or

Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor�s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

LYMPHOSEEK® is the only agent designed and FDA approved for lymphatic mapping in pateints. LYMPHOSEEK® (technetium Tc 99m tilmanocept) injection is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: (1) Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. (2) Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. Navidea Biopharmaceuticals manufacturer of Lymphoseek® announced 03/07/2017 the completion of the sale to Cardinal Health of its Lymphoseek® product for lymphatic mapping, lymph node biopsy and the diagnosis of metastatic spread to lymph nodes for the staging of cancer in North America.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Contract Specialist (CS) consider the items that are prioritized for use by the VAAR. Below contains a list of websites researched in regard to the FAR & VAAR Priorities for Use of Mandatory Government Supply Sources (FAR 8.002 and VAAR 808.002). In addition, the below took in consideration the specific requirements of the Veterans First Contracting Program which requires to apply the Rule of Two to all contracting determinations. CS completing a search of: AbilityOne, General Services Administration (GSA) Federal Supply Schedule (FSS) eLibrary, GSA Advantage, VA NAC, Medical Electronic Catalog (ECAT), VA Supply Chain Master Catalog, System for Award Management (SAM), Federal Procurement Data System (FPDS), Interagency Contract Directory, and SBA Dynamic Small Business Search (DSBS) per the VHAPG Part 810.001 Market Research paragraph 5 with no concerns found that can provide Radiopharmaceuticals Lymphoseek Isotopes on existing contracts.

08/28/2023 SBA DSBS searched with key word �Isotopes� with six (6) SBs found, none of the six (6) listed responded to RFI 36C25623Q1782 nor did their description identify could provide Lymphoseek isotpoes. VetCerts Search on 09/07/2023 under NAICS �325412� with 132 concerns found.

CS posted on 08/25/2023, an RFI/ Sources Sought was posted to the SAM website with the responses requested by 08/30/2023. The posting remains available until 09/13/2023, prior to archiving. The intent of the RFI was to 1) Determine the availability of sources who could provide the exact brand name products being requested and 2) Determine the availability of sources who could provide the listed items. The posting was essentially an intent to

Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 6 of 6

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Branch Chief NCO16, DIV III, Supply B

[End of Section D]

SECTION E - SOLICITATION PROVISIONS

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

FAR

Number

Title Date

52.204-7 SYSTEM FOR AWARD MANAGEMENT OCT 2018

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE

REPORTING

AUG 2020

52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS—NOTICE

AND REPRESENTATION

JUN 2020

52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

MAR 2023

(End of Provision)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR

EQUIPMENT (NOV 2021) [Completed by Offeror]

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the

Offeror has represented that it ‘‘does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument’’ in paragraph (c)(1) in the provision at

52.204–26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212–3, Offeror Representations and Certifications–

Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it ‘‘does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services’’ in paragraph (c)(2) of the provision at 52.204–26, or in paragraph (v)(2)(ii) of the provision at 52.212–3.

(a) Definitions. As used in this provision—

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204–25, Prohibition on Contracting for

Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. (1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization

Act for Fiscal Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after

August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal

Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract.

Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award

Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for “covered telecommunications equipment or services.”

(d) Representations. The Offeror represents that— https://www.sam.gov/

(1) It [ ] will, [ ] will not provide covered telecommunications equipment or services to the

Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds “will’’ in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It [ ] does, [ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services.

The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds “does’’ in paragraph (d)(2) of this section.

(e) Disclosures. (1) Disclosure for the representation in paragraph (d)(1) of this provision. If the

Offeror has responded “will’’ in the representation in paragraph (d)(1) of this provision, the

Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand;

model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded “does’’ in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand;

model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph

(b)(2) of this provision.

(End of Provision)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government

Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Electronically Address:

Steven Berkeley, Contracting Officer Steven.Berkeley@va.gov

Hand-Carried Address:

Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center

Houston TX 77056-5643

Mailing Address:

Network Contracting Office 16 Michael E. DeBakey VA Medical Center mailto:Steven.Berkeley@va.gov

Houston TX 77056-5643

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

(End of Provision)

E.4 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

This solicitation provides offerors fewer than 30 days to submit proposals. In the event that only one offer is received in response to this solicitation, the Contracting Officer may cancel the solicitation and resolicit for an additional period of at least 30 days in accordance with 815.370–

2.

(End of Provision)

E.5 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

(a) Any protest filed by an interested party shall—

(1) Include the name, address, fax number, email and telephone number of the protester;

(2) Identify the solicitation and/or contract number;

(3) Include an original signed by the protester or the protester’s representative and at least one copy;

(4) Set forth a detailed statement of the legal and factual grounds of the protest, including a description of resulting prejudice to the protester, and provide copies of relevant documents;

(5) Specifically request a ruling of the individual upon whom the protest is served;

(6) State the form of relief requested; and

(7) Provide all information establishing the timeliness of the protest.

(b) Failure to comply with the above may result in dismissal of the protest without further consideration.

(c) Bidders/offerors and Contracting Officers are encouraged to use alternative dispute resolution (ADR) procedures to resolve protests at any stage in the protest process. If ADR is used, the Department of Veterans Affairs will not furnish any documentation in an ADR proceeding beyond what is allowed by the Federal Acquisition Regulation.

(End of Provision)

E.6 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

(a) As an alternative to filing a protest with the Contracting Officer, an interested party may file a protest by mail or electronically with: Executive Director, Office of Acquisition and Logistics, Risk Management and Compliance Service (003A2C), Department of Veterans Affairs, 810

Vermont Avenue NW, Washington, DC 20420 or Email: EDProtests@va.gov.

(b) The protest will not be considered if the interested party has a protest on the same or similar issue(s) pending with the Contracting Officer.

(End of Addendum to 52.212-1)

E.7 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

(a) 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 offers:

Lowest Priced Technically Acceptable (LPTA).

(i) The Government will award a contract resulting from this on the basis of the Lowest

Priced Technically Acceptable (LPTA) responsible vendor whose quote, conforming to the solicitation, meets or exceeds the acceptable standards for non-cost factors. All quoters must have a current registration in the System for Award Management (SAM.gov) and self-certified under Provision FAR 52.212-13, provide required authorized distributor letter (if not the original equipment manufacturer (OEM)), and meet all specifications outlined in the SOW to be considered responsive. Since this solicitation is Lowest Price Technically Acceptable (LPTA), the evaluation board will begin by reviewing the lowest priced quote. If the board determines that this quote is technically acceptable, no other quotes will be reviewed. This quote will have been deemed technically acceptable with the lowest price, so for this reason the award will be made based on FAR guidance.

(b) 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).

(c) 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.

mailto:EDProtests@va.gov

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

[Completed by Offeror]

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management

(SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision—

Covered telecommunications equipment or services has the meaning provided in the clause

52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance

Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR 127, and the concern is identified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-

9999, except—

(1) PSC 5510, Lumber and Related…