SOLICITATION 36C26124Q0338.pdf

PDF 1 MB Posted Mar 19, 2024

Attached to: RENO HAZARDOUS PHARMACEUTICAL COMPOUNDING Federal contract opportunity
Solicitation number: 36C26124Q0338
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 21

About this file

Written by GovTribe AI · Mar 20, 2024

This document is a solicitation (Solicitation Number: 36C26124Q0338) for a firm fixed price contingency contract to provide compounded antineoplastic hazardous drugs (HDs) and compounded non-HDs to the VA Sierra Nevada Health Care System (VASNHCS). The contractor shall provide all personnel, equipment, supplies, facilities, transportation, and other items necessary to compound sterile preparations for patient-specific treatment regimens. The contract will be an Indefinite-Delivery-Indefinite-Quantity (IDIQ) contract with a 5-year period of performance from 5/1/2024 - 9/30/2028. Responses are due by 4/2/2024 at 11:00am PDT. This is an unrestricted solicitation, but may be set aside for small businesses depending on responses received. Pricing will be on a per-unit basis for various compounded drug products, with additional fees for special handling and delivery. The government has not provided a guaranteed minimum, but the maximum aggregate value of the contract is $4,000,000.

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PRICING SHEET.xlsx	XLSX spreadsheet	Mar 19, 2024
VHA PBM Assessment Guide for CSPs.pdf	PDF	Mar 19, 2024

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PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

654-24-1-118-0003

36C261-24-AP-0949

36C26124Q0338 03-19-2024

LEAH SMITH 702-791-9000 04-02-2024

11:00AM PDT

00261 Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

325412

1300 Employees

N/A

See Delivery Schedule

00261

Department of Veterans Affairs Network Contracting Office 21 Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

Financial Services Center P.O. Box 149971

Austin TX 78714-9971

See CONTINUATION Page

RENO CONTINGENCY HAZARDOUS PHARMACEUTICAL COMPOUNDING

SEE PRICE/COST SCHEDULE

This is a FAR Part 13 solicitation. Please see provisions 52.212-1 Instructions to Quoters and 52.212-2 Evaluation for important information regarding submitting your offer and how your offer will be evaluated.

Responses are due to Leah Smith at leah.smith@va.gov no later than the due date/time in box 8. No questions, including follow-up questions, will be accepted after Monday, March 25th.

See CONTINUATION Page

X 1

DAVID ALVAREZ

Contracting Officer

36C26124Q0338

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

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

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.8 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.10 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..90

C.11 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.12 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.13 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION)

C.14 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.15 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.16 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (FEB 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 ADDENDUM TO FAR 52.212-1 – INSTRUCTIONS TO QUOTERS

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.6 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.7 52.211-6 BRAND NAME OR EQUAL (AUG 1999)

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.9 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.10 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.11 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

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 36C261 David Alvarez

Network Contracting Office 21

VA Southern Nevada Healthcare System

6900 N. Pecos Road, Building 6

North Las Vegas NV 89086

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] After completion, inspection, and acceptance of all items.

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.

All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. VA's Electronic Invoice

Presentment and Payment System - The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten-network.com/US/en/veterans-affairs/ to register and begin submitting electronic invoices, free of charge. The Department of Veterans Affairs Tungsten Number is:

AAA544240062 (this allows you to file invoices online for free.)

More information on the VA Financial Services Center is available at:

http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

• FSC e-Invoice Contact Information: 1-877-353-9791

• FSC e-invoice email: vafsccshd@va.gov

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

AMENDMENT NO DATE

http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.fsc.va.gov/einvoice.asp mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov

B.2 STATEMENT OF WORK

Requirement For Compounding Hazardous Drug Agents Part 1

General Information

1. GENERAL: This is a firm fixed price contingency contract to provide compounded antineoplastic hazardous drugs (HDs) and compounded non-HDs to provide patient specific, buy-and-bill IV compounded sterile preparations (CSPs) for patient specific treatment regimens. The Government shall 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. DESCRIPTION OF REQUIREMENTS/INTRODUCTION: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to provide compounding of antineoplastic HD and compounding of non- HDs as defined in this Statement of Work. The contractor shall perform to the standards in this contract.

3. BACKGROUND: These compounded products are necessary to provide specific treatments, available only as compounded sterile preparations, to Veterans diagnosed with specific medical conditions. VASNHCS has approximately 10‐12 patients on any given day Monday‐Friday for specific disease state infusion treatment. Compounding must be done at an FDA 503A compliant facility and meet all state and federal laws.

4. OBJECTIVES:

• Specializes in fully customizable hazardous drug preparations including intrathecals, Fluorouracil (5FU), and the soaking/infusing of Drug Eluting Beads.

• Able to accommodate both complete outsourcing as well as interim services.

• Must comply with CGMP requirements.

• Must comply with USP 797 and USP 800 requirements.

• Are inspected by FDA according to a risk-based schedule; and must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.

Contract will be a firm-fixed price, Indefinite-Delivery-Indefinite-Quantity, contract.

Period of performance will be 5/1/2024 – 9/30/2028.

5. SCOPE:

Contractor shall provide all compounded antineoplastic hazardous drugs (commonly referred to as chemotherapy agents), compounded non-hazardous drugs (which may include monoclonal antibodies – MABs), IV tubing, closed system drug transfer devices, and any other items deemed necessary to ensure patient safety from contaminated CSPs and employee safety from exposure to HDs. All CSPs will be aseptically compounded based on patient specific orders.

Orders will be submitted via a secure network or fax. Once submitted, VA staff will confirm receipt of order with the Contractor via phone or email.

• Orders from VA Sierra Nevada Health Care System (VASNHCS) will be submitted by 11:00am PST.

Compounded orders shall be transported via Courier, overnight mail service, or any other means necessary as defined by the Contractor to ensure receipt prior to infusion date/time to the following locations:

VA Sierra Nevada Health Care System Inpatient Pharmacy (119) RM G2630 975 Kirman Ave.

Reno, NV 89502

Items shall be delivered to the VA by 9:00am, the first business day after orders are submitted.

Compounding, labeling, and beyond use dating/expiration dating will be based on USP 797, USP 800 and Federal Law.

A list of the common antineoplastic hazardous drugs and compounded non-hazardous drugs will be provided directly to the Contractor.

See attachment “Required Compounds” for common antineoplastic HD and compounded non- HDs used. This list is not inclusive, and drugs may be added or deleted as the mission needs change.

Contractor shall invoice for billable units for the amount of medication utilized for each individual patient. No advance payments will be authorized.

The Government shall pay the Contractor, upon the submission of a properly prepared invoice for prices stipulated in this contract for services and supplies delivered and accepted.

The invoice shall be itemized to include the following minimum information:

Invoice Number and Date.

Contract Number.

Purchase Order/Obligation Number (to be assigned upon task order award).

Date of service.

Itemized list of costs including drugs used, materials, and patient fees.

Contractor shall provide current and future certification reports for the sterile compounding areas and compounding hoods. In the case of any failures, contractor shall provide action plans for corrections of deficiencies and testing results showing the failures have been corrected.

Contractor shall update and provide the attached “VHA PBM Assessment Guide for Compounded Sterile Preparations within VAMCs and Outsourced Compounding Pharmacies” at time of solicitation response and annually.

Shipping is included with stated compound costs.

Specifications below for compatibility needs:

Bag Spike Rule: All HD and MABs

Primary IV Set: BD Secondary Set (REF 11426965) or interchangeable set

Secondary IV Set: BD Secondary Set (REF 2204-0007) or interchangeable set

In‐line Filter: All necessary compounded materials per manufacture recommendation Filter Rules: Filter is required for Abatacept, Avelumab, Cabazitaxel, Cetuximab, Daratumumab, Durvalumab, Pembrolizumab, Ramucirumab, Siltuximab, and others as recommended by manufacturing guidelines.

Special Priming: Prime tubing with base fluid prior to adding medications.

Total Volume Calculations – Overfills in IV Bags: Total volume only calculated when specified in order. No adjustments made for overfill.

Close System Device: Phaseal Optima

Pre‐meds: none

Other: Occasionally need 5‐FU Elastomeric pumps

6. WORK HOURS:

VASNHCS pharmacy is open to receive medications 24/7.

7. CONTINGENCY PLANNING:

The Contractor shall have a contingency backup plan in the event that compounding facility is affected by any certification discrepancies, equipment malfunctions, natural disasters, or other matters affecting performance of the contract. Contingency locations must meet the same criteria as stated herein.

8. COMPLIANCE WITH APPLICABLE LAWS AND REGULATIONS:

The Contractor shall ensure that services provided to the Government under this contract comply with all applicable laws, statutes, regulations, and guidelines. The Contractor shall also ensure that all supplies or services provided to the Government under this contract comply with all Government mandated procedures, standards, and requirements.

Information Systems Officer, Information Protection:

The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services.

9. PRIVACY OFFICER:

The contractor will have access to protected Patient Health Information (PHI), any memory storage devices, such as hard drives, solid state drives and non‐volatile memory units are prohibited. All research data available for Contractor analyses is de‐identified.

10. RECORDS MANAGER:

1. Records Manager:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

11. VA INFORMATION CUSTODIAL LANGUAGE

1) Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

2) VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

3) Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

4) The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies.

If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

5) The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

6) If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

7) If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate

Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

8) The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

9) The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

10) Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

11) Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus.

If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

12) For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the Contracting Officer Representative (COR).

12. SECURITY INCIDENT INVESTIGATION

1) The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

2) To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

3) With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

4) In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

13. NATIONAL HOLIDAYS

The Contractor is not required to provide delivery or pick up services on the following National Holidays.

New Year’s Day January 1 Martin Luther King’s Birthday Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday by U.S. Government agencies. Also included would be any other day specifically declared by the President of the United States as a National Holiday.

14. OVERTIME AND HOLIDAYS:

Any overtime or holiday pay that may be entitled to Contractor personnel performing under this contract shall be the sole responsibility of the Contractor and shall not be billed to nor reimbursed by the Government.

15. CHANGES TO CONTRACT:

Only those items specified herein are authorized. Before providing any items or support of a non-contractual nature, Contractor shall advise the CO of the reason(s) for the additional work and/or service. Only the Contracting Officer is capable of making modifications to the contract.

B.3 PRICE/COST SCHEDULE

The Contractor shall provide Contingency Hazardous Pharmaceutical Compounding for the Department of Veterans Affairs in accordance with the specifications listed herein.

The guaranteed minimum award amount for this contract is $1,000.00. The maximum aggregate value of orders that can be placed under this contract is $4,000,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

84.00 EA __________________ __________________

Azacitidine 100mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

4.00 EA __________________ __________________

Bendamustine 100mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

120.00 EA __________________ __________________

Bortezomib 3.5mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

1.00 EA __________________ __________________

Cabazitaxel 60mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

48.00 EA __________________ __________________

Carboplatin 150mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Carboplatin 50mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

30.00 EA __________________ __________________

Carboplatin 600mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

36.00 EA __________________ __________________

Carfilzomib 60mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Cisplatin 100mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

60.00 EA __________________ __________________

Cisplatin 50mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

2.00 EA __________________ __________________

Cyclophosphamide 1g Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

10.00 EA __________________ __________________

Cyclophosphamide 2g Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Cyclophosphamide 500mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Decitabine 50mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

Dextrose 5% 1000ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Dextrose 5% 100ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Dextrose 5% 250ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Dextrose 5% 500ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Dextrose 5% 50ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

Docetaxel 160mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Docetaxel 20mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Docetaxel 80mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

24.00 EA __________________ __________________

Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Doxorubicin 20mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

Doxorubicin 50mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Enfortumab 20mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

72.00 EA __________________ __________________

Enfortumab 30mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

12.00 EA __________________ __________________

Etoposide 100mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Fluorouracil 1g Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

Fluorouracil 500mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Fluorouracil 5g Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

70.00 EA __________________ __________________

Gemcitabine 1g Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Gemcitabine 200mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Irinotecan 100mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

Irinotecan 40mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

8.00 EA __________________ __________________

Liposomal Doxorubicin 20mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Liposomal Doxorubicin 50mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

18.00 EA __________________ __________________

Liposomal Irinotecan 4.3mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Magnesium Sulfate 1g Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

Mitomycin 20mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Mitomycin 40mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Mitomycin 5mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Oxaliplatin 100mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Oxaliplatin 50mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

Paclitaxel 300mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Paclitaxel 100mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Paclitaxel Protein-Bound 100mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Pemetrexed 100mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

14.00 EA __________________ __________________

Pemetrexed 500mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

Pertuzumab 420mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Potassium Chloride 20meq Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Sodium Chloride 0.9% 1000ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Sodium Chloride 0.9% 100ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Sodium Chloride 0.9% 250ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

Sodium Chloride 0.9% 500ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Sterile Water 1000ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Sterile Water 250ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Sterile Water 500ml Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Vincristine 2mg Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024

20.00 EA __________________ __________________

Facility Patient Fee,USP 797 Fee, USP 800 Fee, Delivery Fee Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Chemoembolic Mixing Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Exact Volume Requirement Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

Intrathecal Mixing Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation

STAT Order Contract Period: Ordering Period 1 POP Begin: 05-01-2024 POP End: 09-30-2024