36C25624Q1348 Solicitation.pdf
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- Solicitation number
- 36C25624Q1348
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This document is a combined synopsis/solicitation for a firm-fixed price contract to provide Fluorodeoxyglucose F-18 (FDG) radiopharmaceutical doses to support the nuclear medicine program at the Overton Brooks VA Medical Center in Shreveport, Louisiana.
The solicitation is unrestricted and has a NAICS code of 325412 with a size standard of 1300 employees. The period of performance is a one-year base period with four one-year option periods. The agency requires 1,000 doses per year of 15 mCi F-18 FDG, which will be delivered directly to the medical center. Quotes are due by October 25, 2024. The contractor must be licensed by the Nuclear Regulatory Commission or an Agreement State and able to remove all radioactive waste generated. The contractor will also provide consultation services and software/license for dose management if available. Award will be made without discussions if possible, but the government reserves the right to conduct discussions.
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A.1 COMBINED SYNOPSIS/SOLICITATION
1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, in conjunction with FAR Part 13, Simplified Acquisition Procedures for Certain 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 will not be issued.
2. The combined synopsis/solicitation number is 36C25624Q1348.
3. Solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2024-05 (eff. 05/22/2024).
4. This requirement is Unrestricted. The North American Industry Classification System number is 325412 with a size standard of 1300 Employees.
5. Place of Performance:
Overton Brooks VA Medical Center 510 East Stoner Ave.
Shreveport LA 71101-4295
6. Period of Performance: The period of performance shall be a base period of one year plus four
(4) one-year optional periods.
7. All questions regarding this solicitation shall be submitted via email to the Contract Specialist, Alan Scanio at alan.scanio@va.gov no later than 10:00A.M. Central Time on 10/18/2024.
8. Quotes are due no later than 10/25/2024 at 10:00A.M. Central Time and shall be submitted electronically via e-mail to the Contract Specialist, Alan Scanio at alan.scanio@va.gov
APPLICABLE Provisions and Clauses:
The provision at 52.212-1 Introduction to Offerors – Commercial, applies to this acquisition.
The provision at 52.212-2 EVALUATION – COMMERCIAL ITEMS (JAN 1999) applies to this acquisition.
All offers shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications –Commercial Items.
mailto:alan.scanio@va.gov
The clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition and a statement. The addendum to FAR 52.212-4 also applies to this acquisition.
The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition and all additional FAR clauses cited in the clause are applicable to the acquisition.
Addendum to FAR 52.212-4 Show FAR clauses followed by VAAR clauses in numeric order.
Solicitation contains a list of all clauses incorporated by reference in numeric order under 52.252-2 (see below), starting first with FAR and followed by VAAR.
36C25624Q1348
Table of Contents
A.1 COMBINED SYNOPSIS/SOLICITATION
SECTION B – CONTINUATION OF COMBINED SYNOPSIS-SOLICITATION
B.1 CONTRACT ADMINISTRATION DATA
B.2 PRICE/COST SCHEDULE
B.3 DELIVERY SCHEDULE
B.4 STATEMENT OF WORK
SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS
AND COMMERCIAL SERVICES (NOV 2023)
C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)
C.3 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE
ITEM (MAR 1989)
C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 22
C.5 52.225-1 BUY AMERICAN—SUPPLIES (OCT 2022)
C.6 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)
C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)
C.8 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)
C.9 VAAR 852.223-71 SAFETY AND HEALTH (SEP 2019)
C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS
(NOV 2018)
C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 28
C.12 VAAR 852.246-71 REJECTED GOODS (OCT 2018)
C.13 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)
C.14 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)
C.15 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
C.16 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT
STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND
COMMERCIAL SERVICES (MAY 2024)
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS
SECTION E - SOLICITATION PROVISIONS
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND
COMMERCIAL SERVICES (SEP 2023)
E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS
AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)
E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT
ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)
E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)
E.5 52.225-2 BUY AMERICAN CERTIFICATE (OCT 2022)
E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)
E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)
E.8 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY
ACCESSIBILITY NOTICE (FEB 2023)
E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB
1998)
E.10 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL
SERVICES (NOV 2021)
E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—
COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)
SECTION B – CONTINUATION OF COMBINED SYNOPSIS-
SOLICITATION
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 36C256 Le Kisha A. Douglas, MPA
Department of Veterans Affairs
Network Contracting Office 16
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:
[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.
FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
AMENDMENT NO DATE
B.2 PRICE/COST SCHEDULE
ITEM INFORMATION
ITEM
NUMBER
DESCRIPTION OF
SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
1,000.00 EA _____________ _____________
Fluorodeoxyglucose F-18 (FDG) 15 mCi Doses
Contract Period: Base POP Begin: 01-01-2025 POP End: 12-31-2025 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals
MANUFACTURER PART NUMBER (MPN): F-18 FDG
Contract Period: Option 1 POP Begin: 01-01-2026 POP End: 12-31-2026 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing
Contract Period: Option 2 POP Begin: 01-01-2027 POP End: 12-31-2027 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing
Contract Period: Option 3 POP Begin: 01-01-2028 POP End: 12-31-2028 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing
Contract Period: Option 4 POP Begin: 01-01-2029 POP End: 12-31-2029 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing
GRAND TOTAL _____________
B.3 DELIVERY SCHEDULE
ITEM
NUMBER SHIPPING INFORMATION QUANTITY
DELIVERY
DATE
0001 SHIP TO: Overton Brooks VA Medical Center Nuclear Medicine Service 510 East Stoner Ave Shreveport, LA 71101 4295
1,000.00 01/01/2025 - 12/31/2025
MARK FOR: Alan Fraser
(318) 990-5080 alan.fraser@va.gov
FOB: DESTINATION
0002 SHIP TO: Overton Brooks VA Medical Center Nuclear Medicine Service 510 East Stoner Ave Shreveport, LA 71101 4295
1,000.00 01/01/2026 - 12/31/2026
MARK FOR: Alan Fraser
0003 SHIP TO: Overton Brooks VA Medical
Nuclear Medicine Service 510 East Stoner Ave Shreveport, LA 71101 4295
1,000.00 01/01/2027 - 12/31/2027
MARK FOR: Alan Fraser
0004 SHIP TO: Overton Brooks VA Medical Center Nuclear Medicine Service 510 East Stoner Ave Shreveport, LA 71101 4295
1,000.00 01/01/2028 - 12/31/2028
MARK FOR: Alan Fraser
0005 SHIP TO: Overton Brooks VA Medical
Nuclear Medicine Service 510 East Stoner Ave Shreveport, LA 71101 4295
1,000.00 01/01/2029 - 12/31/2029
MARK FOR: Alan Fraser
B.4 STATEMENT OF WORK
Performance Work Statement
Radiopharmaceutical Supplies Supporting the Veteran’s Healthcare System of the Ozarks’ Nuclear
Medicine Radiation Safety Program
1.0. Introduction. This is a supply contract to provide the required radiopharmaceutical supplies listed below in support of the Overton Brooks VA Medical Center (OBVAMC), Nuclear Medicine Program. The contractor shall provide all transportation, handling and delivery of the radiopharmaceuticals needed to complete the requirements of this contract. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform the required service at OBVAMC as defined in this Performance Work Statement (PWS), section three (3.0) except for those items specified as Government-furnished property and services. The contractor shall perform to the standards of this PWS.
Description Unit Quantity Fluorodeoxyglucose F-18 (FDG) Base Period 15 mCi 1,000 Fluorodeoxyglucose F-18 (FDG) Option Period 1 15 mCi 1,000 Fluorodeoxyglucose F-18 (FDG) Option Period 2 15 mCi 1,000 Fluorodeoxyglucose F-18 (FDG) Option Period 3 15 mCi 1,000 Fluorodeoxyglucose F-18 (FDG) Option Period 4 15 mCi 1,000
1.1 Background. OBVAMC provides Nuclear Medicine services to a main hospital in Shreveport, LA.
1.2 Scope of Work. Authorized employees of the OBVAMC Nuclear Medicine service will place orders for radiopharmaceuticals on an as needed basis. The Contractor shall supply delivered Fluorodeoxyglucose F-18 (FDG) doses either as unit doses or in container compatible with the OBVAMC’s existing MEDRAD Intego FDG Delivery System. If the Contractor supplies PET Radiopharmaceuticals in a MEDRAD Intego compatible container, the Contractor shall use containers compatible with MEDRAD Intego system. The determination will by the Contractor.
The FDG will be delivered to OBVAMC Nuclear Medicine service at Overton Brooks VA Medical Center at 510 East Stoner Ave, 7 North Room 9, Shreveport, LA 71101-4295 within the timeframes outlined in section three (3.0).
Contractor will remove all radioactive waste generated by the Contractor, including syringes and vials that are no longer used, within the timeframes outlined in section three (3.0). Shipments “called when needed” may be requested during regular work hours, or after regular work hours, as “emergency”, including weekends, holidays and nights. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable.
2.0 General Requirements. This section describes the general requirements for this effort. The following sub-sections provide details of various considerations on this effort.
2.1 Personnel. These radiopharmaceuticals are United States Food and Drug Administration (FDA) approved drugs for use in patients. Contractor must be licensed by the Nuclear Regulatory Commission (NRC) or an Agreement State under equivalent regulations and be regularly established in the business of providing radiopharmaceuticals. The Contractor shall also hold a current state license for their state of residence to produce and distribute radiopharmaceuticals for human administration, which permits Contractor to receive and dispose of radioactive waste.
2.1.1. Contractor shall provide a copy of its radioactive material license to the Nuclear Medicine Service at OBVAMC upon commencement of the contract.
2.1.2. Contractor shall immediately notify OBVAMC of any action by the USNRC agreement state and/or FDA to suspend or modify suppliers.
2.1.3. The government will not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.
2.2. Type of Contract. The Government will award a Firm-Fixed price contract.
2.3. Period of Performance. The period of performance for this effort will be a base period of twelve (12) months, followed by four separate twelve (12) month option periods subject to exercise by the Government.
The items being request will be delivered continuously as ordered during this period of performance;
delivery shall be completed within the time frames specified in this performance work statement in Section 3.0.
Working hours are between 8:00 am to 4:30 pm, Monday through Friday excluding weekends and federal holidays. All federal holidays excluded.
VA follows all Federal holidays that are sent by law (USC Title 5 Section 6103). The Government hereby provided notice and Contractor hereby acknowledge s receipt that Government personnel observe the listed days as holidays.
New Year’s Day January 1st Martin Luther King’s Birthday 3rd Monday in January President’s Day 3rd Monday in February Memorial Day Last Monday in May Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day Last Thursday in November Christmas Day December 25th Juneteenth June 19 Independence Day July 4
Labor Day First Monday in September
When a holiday falls on a Sunday, the following Monday will be observed as a legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed by the US government agencies.
In addition to the days designated as holidays, the Government observes the following days:
- Any other day designated by Executive Order
- Any other day designated by the President’s Proclamation; and
- Any other day designated by Federal Statute
2.4. Scheduling of Work. The Contractor shall provide the requested radiopharmaceuticals at the requested time, in accordance with the timeframes specified in section three (3.0).
2.4.1. Radiopharmaceuticals will be delivered strictly in accordance with the requirements of the OBVAMC Nuclear Medicine Service. Deliveries will be made directly to Nuclear Medicine Service, commencing at 07:00 A.M. Monday through Friday.
2.4.2. Emergency deliveries may be made evenings, weekends and on Federal Holidays on an as needed basis.
2.5. Travel/Transportation. The Contractor shall provide all Travel/Transportation necessary to perform the requirements of this contract. All travel related costs, including lodging or any other miscellaneous costs, shall be the sole responsibility of the Contractor and shall be included in the firm fixed unit prices in the Price Schedule.
2.6. Medical Emergency Services. Shipments requested as emergency will be delivered per the specifications in section three (3.0).
2.6.1. The contractor shall provide unit dose radiopharmaceuticals after hours, on weekends and holidays, as needed for emergency procedures. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable.
2.7 Business Relations. The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timeliness, completeness, and quality of problem identification. The contractor shall provide corrective action plans, proposal submittals, and timely identification of issues. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.
2.7.1. Contractor shall supply OBVAMC Nuclear Medicine service with the contractor’s telephone number for call-in-orders during normal work hours.
2.7.2. The Contractor shall supply OBVAMC Nuclear Medicine service with two telephone numbers and instructions for placing “Emergency” orders after contractor’s regular working hours, including weekends and holidays.
3.0. Performance Requirements. The following section specifies the Performance Elements for the contract.
3.1. Deliver Radiopharmaceuticals directly to the Nuclear Medicine service at OBVAMC, Shreveport, LA when requested by the service.
3.1.1. Authorized employees of the OBVAMC Nuclear Medicine service will place orders on an as needed basis.
3.1.2. Individual radiopharmaceuticals will be provided in unit dose form or in a MEDRAD Intego compatible and will be delivered at the request of OBVAMC.
3.1.3. If the ordered radiopharmaceuticals are not available and cannot be delivered to the VA when needed, the contractor shall notify the VA Nuclear Medicine Department with sufficient time to allow for the rescheduling of patient appoints.
3.1.5. The contractor shall supply two (2) phone numbers for ordering after normal working hours.
3.1.6. Routine orders will be placed the afternoon before, or prior if known, the required delivery date for the exact quantities of each unit dose or quantity for bulk (vial) orders. The VA will set a calibration time for all routine orders at the time the order is made. The Contract shall delivery doses prior to this calibration time.
3.1.7. All radionuclide scanning material shall be packaged in accordance with applicable Nuclear Regulatory Commission (NRC) Regulations.
3.1.8. All shipments will have a Packing Slip enclosed, giving information about the product and its identification.
3.1.9. All radiopharmaceuticals shall be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable Local, State and Federal Laws.
3.1.10. All shipments shall be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent regulations.
3.1.11. Deliveries shall incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive materials.
Shipping containers must comply with all federal and state regulations.
3.2. The Contractor shall remove all radioactive waste generated by the contractor, including all syringes and vials that are no longer required.
3.2.1. All waste shall be picked-up the next working day. Safe transport of the waste is the responsibility of the contractor. The Contractor must adhere to OSHA guidelines regarding blood borne pathogens, DOT regulations, Board of Pharmacy regulations regarding radiopharmaceuticals, and NRC/Agreement State requirements regarding radioactive materials.
3.3. Consultation service regarding radiopharmaceutical applications, problems, controls, etc, shall be provided upon request at no additional charge.
3.4. Current package inserts of all Radiopharmaceuticals supplied will be provided to OBVAMC Nuclear Medicine service.
3.5. The Contractor shall guarantee the quality of the radiopharmaceuticals.
3.5.1. Contractor will furnish a statement that any radiopharmaceutical delivered as “ready-to-use” (individual doses in syringes or bulk vial) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of Joint Commission and/or with the United States Pharmacopeia.
3.5.2. All radiopharmaceuticals shall be calibrated and labeled with concentration, calibration time, total volume and total activity.
3.5.3. Contractor shall make quality control records available to VA upon written request.
3.5.4. The quantity of radioactivity for supplied radiopharmaceutical will not deviate more than +10% or -5%, at the time of calibration, from the quantities specified.
3.6.5. The expiration date and time shall be indicated and affixed to each product as noted below:
3.5.5. Ready-to-use doses: Not shorter than six (6) hours.
3.6. Contractor shall supply the software and license needed by OBVAMC for the user side of radiopharmaceutical dose management if available and accepted by the Government.
3.6.1. The contractor grants the VA a nonexclusive, nontransferable license to possess and use the software package within the OBVAMC Nuclear Medicine service.
3.6.2. OBVAMC will provide a computer for the use of the software. The computer and all data stored remain the property of OBVAMC at all times. The Contractor shall not have access to this computer or the information stored on the computer.
4.0 Performance Requirements Summary (PRS) Matrix
The Contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success. The government expects the contractor to perform at a minimum, the identified acceptable levels throughout the life of the contract, and the contractor’s performance shall be given significant consideration when evaluating recommendations for future government contracts and or awards.
Method of Surveillance: The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level
(AQL).
PRS
Performance Objective
Performance Standard
Acceptable Quality Level
Surveillance Method
Remedies
1 Quantity of radioactivity for supplied radiopharmaceutical
Will not deviate more than +10% or -5%, at time of calibration, from quantities specified.
100% compliance.
Monitored by Nuclear Medicine (NM) lead technologist or
COR
Doses will be refused/returned
2 Expiration of Ready-to-use doses will be affixed to each product and be within acceptable range.
Not shorter than six (6) hours.
100% compliance.
Monitored by Nuclear Medicine (NM) lead technologist or
COR
doses will be refused/returned
3 Timeframe for receiving emergency orders.
Contractor will deliver emergency orders to OBVAMC within one hour of the order.
100% compliance
Monitored by Nuclear Medicine (NM) lead technologist or
COR
doses will be refused/returned
4 Calibration and labeling of radiopharmaceuticals
All radiopharmaceuticals will be calibrated and labeled with the concentration, time, total volume and total activity.
100% compliance.
Monitored by Nuclear Medicine (NM) lead technologist or
COR
Unlabeled doses will be refused/returned and contractor will replace within 1 hour to not delay patient care.
4.1 Quality Assurance. The Government will evaluate the Contractor’s performance under the contract, in accordance with the PRS Matrix. If any of the services performed do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount and at no additional charge.
4.1.1. Whenever the COR notifies the contractor of any deficiencies detected in the work performed, the contractor shall correct cited deficiencies within three (3) working days, or as otherwise authorized by the COR, after the notification in writing by the COR without affecting the regularly scheduled work.
4.1.2. Upon satisfactory completion by the Contractor and acceptance by the COR of the work completed by the contractor in accordance with this Performance Work Statement, payment will be approved. Failure to complete the work stated in this PWS may result in unfavorable Contractor Performance Assessment Reporting System (CPARS) ratings and/or deduction to be determined by the Contracting Officer.
4.1.3. The contractor shall maintain an effective Quality Control Program to ensure services are performed IAW this PWS. The purpose of this program is to identify, prevent, and ensure non-recurrence of defective services.
4.1.4. Complete documentation of the QC results shall be provided upon request to the
OBVAMC.
5.0. Deliverables
Deliverable Frequency # of Copies Medium/Format Distribution Copy of Contractor’s state license and Radioactive Materials (RAM) Permit to produce and distribute radiopharmaceuticals for human administration
Upon contract award and as new licenses and permits take effect.
1 PDF COR
Contractor’s telephone numbers and processes for ordering routine and emergency radiopharmaceuticals.
Upon contract award and when changes occur. 1 PDF COR
Radiopharmaceutical management software and license, if applicable.
Upon contract award and as updates or renewals occur.
1 PDF COR
Current package inserts of all Radiopharmaceuticals supplied.
Upon contract award and as changes to supply list occur.
1 PDF COR
Contractor’s quality control records.
Upon request from OBVAMC, provided within 1 hour.
1 PDF COR
6.0 Definitions
CONTRACTING OFFICER (CO): A Contracting Officer is a government employee who has authority to enter into, administer, and or terminate contracts, as well as make related determinations and findings on behalf of the Government. (Note: The only individual who can legally bind the Government.)
CONTRACTING OFFICER’S REPRESENTATIVE (COR) - A representative from the requiring activity appointed by the Contracting Officer to perform surveillance and to act as liaison to the contractor
CONTRACTOR: A supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.
DELIVERABLE: A tangible or intangible object produced as a result of the project that is intended to be delivered to a customer (either internal or external). Examples of a deliverable are a report, a document, a server upgrade or any other building block of an overall project.
FISCAL YEAR: A period beginning in October 1 and ending September 30 of the consecutive calendar year. The fiscal year is designated by the calendar year in which it ends.
QUALITY ASSURANCE SURVEILLANCE PLAN (QASP): A plan specifying the surveillance methodology used by the COR for surveillance of the contractor’s performance.
7.0 Billing:
7.1 Invoice requirements and supporting documentation: Payment for services rendered by the
Contractor under the terms of this contract will be made monthly upon receipt of a properly executed invoice. Invoice to be submitted within ten (10) workdays following the end of a month in which the Contractor rendered services. VA will verify services performed and certify invoice for payment within thirty (30) days following date of receipt. Any identified discrepancy(s) in billings shall be cause for extending provisions of this paragraph until such time as the discrepancy or other identified problem with the billing invoice has been resolved. The Contractor must perform all services specified in the contract or the contract cost will be decreased accordingly during each billing cycle. Contractor may send invoice for review prior to electronic submittal. Subsequent changes or corrections shall be submitted by separate invoice.
In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:
7.1.1 Name and Address of Contractor
7.1.2 Invoice Date and Invoice Number
7.1.3 Contract Number/Task Order/Purchase Order Number
7.1.4 Date of Service
7.1.5 Each Billable CLIN and Rate
7.1.6 Total Price
7.2 Vendor Electronic Invoice Submission Methods:
Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:
7.2.1 Electronic Invoice Submission: Invoices will be electronically submitted to the Tungsten website at https://www.fsc.va.gov/einvoice.asp. Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax- Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. To successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror the current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed https://www.fsc.va.gov/einvoice.asp with your Certifying Official (your CO or buyer). Payments will only be made for actual services rendered. Payments shall be made monthly, in arrears. The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements.
The Contractor shall be reimbursed upon receipt of a proper invoice.
7.2.2 For additional information, please contact:
Tungsten Support Phone: 1-877-489-6135 Website:
Department of Veterans Affairs Financial Service Center
SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL
PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)
(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—
(1) Within a reasonable time after the defect was discovered or should have been discovered;
and
(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.
(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.
(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.
(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.
(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.
(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.
(g) Invoice.
(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—
(i) Name and address of the Contractor;
(ii) Invoice date and number;
(iii) Contract number, line item number and, if applicable, the order number;
(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;
(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;
(vi) Terms of any discount for prompt payment offered;
(vii) Name and address of official to whom payment is to be sent;
(viii) Name, title, and phone number of person to notify in event of defective invoice; and
(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.
(x) Electronic funds transfer (EFT) banking information.
(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.
(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.
(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.
(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.
(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.
(i) Payment.—
(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.
(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.
(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.
(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.
(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—
(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—
(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);
(B) Affected contract number and delivery order number, if applicable;
(C) Affected line item or subline item, if applicable; and
(D) Contractor point of contact.
(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
(6) Interest.
(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.
(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.
(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—
(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;
(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or
(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).
(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.
(v) Amounts shall be due at the earliest of the following dates:
(A) The date fixed under this contract.
(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.
(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—
(A) The date on which the designated office receives payment from the Contractor;
(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or
(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.
(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.
(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:
(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or
(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.
(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.
(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.
(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.
(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.
(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.
(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.
(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.
(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.
(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:
(1) The schedule of supplies/services.
(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;
(3) The clause at 52.212-5.
(4) Addenda to this solicitation or contract, including any license agreements for computer software.
(5) Solicitation provisions if this is a solicitation.
(6) Other paragraphs of this clause.
(7) The Standard Form 1449.
(8) Other documents, exhibits, and attachments
(9) The specification.
(t) [Reserved]
(u) Unauthorized Obligations.
(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:
(i) Any such clause is unenforceable against the Government.
(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.
(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.
(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.
(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.
(End of Clause)
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.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)
The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the
Contractor within 15 days. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.
(End of Clause)
C.3 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED
LINE ITEM (MAR 1989)
The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 15 days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.
(End of Clause)
C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR
2000)
(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days days before the contract expires. The preliminary notice does not commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.
(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.
(End of Clause)
C.5 52.225-1 BUY AMERICAN—SUPPLIES (OCT 2022)
(a) Definitions. As used in this clause—
Commercially available off-the-shelf (COTS) item—(1) Means any item of supply (including construction material) that is—
(i) A commercial product (as defined in paragraph (1) of the definition of ‘‘commercial product’’ at Federal Acquisition Regulation (FAR) 2.101;
(ii) Sold in substantial quantities in the commercial marketplace; and
(iii) Offered to the Government, under a contract or subcontract at any tier, without modification, in the same form in which it is sold in the commercial marketplace; and
(2) Does not include bulk cargo, as defined in 46 U.S.C. 40102(4), such as agricultural products and petroleum products.
Component means an article, material, or supply incorporated directly into an end product.
Cost of components means—
(1) For components purchased by the Contractor, the acquisition cost, including transportation costs to the place of incorporation into the end product (whether or not such costs are paid to a domestic firm), and any applicable duty (whether or not a duty-free entry certificate is issued); or
(2) For components manufactured by the Contractor, all costs associated with the manufacture of the component, including transportation costs as described in paragraph (1) of this definition, plus allocable overhead costs, but excluding profit. Cost of components does not include any costs associated with the manufacture of the end product.
Critical component means a component that is mined, produced, or manufactured in the United States and deemed critical to the U.S. supply chain. The list of critical components is at
FAR 25.105.
Domestic end product means—
(1) For an end product that does not consist wholly or predominantly of iron or steel or a combination of both—
(i) An unmanufactured end product mined or produced in the United States;
(ii) An end product manufactured in the United States, if—
(A) The cost of its components mined, produced, or manufactured in the United States exceeds 60 percent of the cost of all its components, except that the percentage will be 65 percent for items delivered in calendar years 2024 through 2028 and 75 percent for items delivered starting in calendar year 2029. Components of foreign origin of the same class or kind as those that the agency determines are not mined, produced, or manufactured in sufficient and reasonably available commercial quantities of a satisfactory quality are treated as domestic.
Components of unknown origin are treated as foreign. Scrap generated, collected, and prepared for processing in the United States is considered domestic; or
(B) The end product is a COTS item; or
(2) For an end product that consists wholly or predominantly of iron or steel or a combination of both, an end product manufactured in the United States, if the cost of foreign iron and steel constitutes less than 5 percent of the cost of all the components used in the end product. The cost of foreign iron and steel includes but is not limited to the cost of foreign iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the end product and a good faith estimate of the cost of all foreign iron or steel components excluding COTS fasteners. Iron or steel components of unknown origin are treated as foreign. If the end product contains multiple components, the cost of all the materials used in such end product is calculated in accordance with the definition of ‘‘cost of components’’.
End product means those articles, materials, and supplies to be acquired under the contract for public use.
Fastener means a hardware device that mechanically joins or affixes two or more objects together. Examples of fasteners are nuts, bolts, pins, rivets, nails, clips, and screws.
Foreign end product means an end product other than a domestic end product.
Foreign iron and steel means iron or steel products not produced in the United States.
Produced in the United States means that all manufacturing processes of the iron or steel must take place in the United States, from the initial melting stage through the application of coatings, except metallurgical processes involving refinement of steel additives. The origin of the elements of the iron or steel is not relevant to the determination of whether it is domestic or foreign.
Predominantly of iron or steel or a combination of both means that the cost of the iron and steel content exceeds 50 percent of the total cost of all its components. The cost of iron and steel is the cost of the iron or steel mill products (such as bar, billet, slab, wire, plate, or sheet), castings, or forgings utilized in the manufacture of the…
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