36C25524Q0002 - Solicitation for Hazardous Compounding Services - Wichita.pdf

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Q517--Sterile Hazardous Drug Compounding Services Robert J. Dole Robert J. Dole VACM, Wichita (Pharmacy Compounding Services)
Solicitation number
36C25524Q0002
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This document is a solicitation for hazardous drug compounding services to support the Robert J. Dole VA Medical Center in Wichita, Kansas. The solicitation seeks to establish multiple blanket purchase agreements for sterile compounding of chemotherapy agents and other hazardous drugs. The period of performance is from November 2023 through October 2025. Pricing will be firm fixed price for individual orders placed against the agreements.

The scope of work requires contractors to aseptically compound patient-specific prescriptions of chemotherapy agents and deliver them for next-day infusion. Contractors must maintain FDA-compliant compounding facilities and meet all state and federal laws. The solicitation identifies common chemotherapy agents and provides requirements for labeling, beyond use dating, filtration, and delivery. Contractors will invoice based on billable units utilized per patient. The maximum value of the blanket purchase agreements is $4 million. Responses are due by August 2023.

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36C25524Q0002_2.docx DOCX document
Attachment 2 - List of Common Chemotherapy Drugs and Supplies -RJD.pdf PDF
Attachment 1 - VHA PBM.pdf PDF
36C25524Q0002_1.docx DOCX document

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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

TBD

36C25524Q0002

Robert Bleichner 913-758-9920 10-23-2023

08:00 CDT

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

X

456110

$37.5 Million

N/A

X

Department of Veterans Affairs Kansas City VA Medical Center 4801 Linwood Blvd Kansas City MO 64128

36C255

Department of Veterans Affairs Network Contracting Office (NCO) 15

36C255

Financial Services Center http://www.fsc.va.gov/einvoice.asp

Austin TX

877-353-9791 512-460-5429

See CONTINUATION Page

Pharmacy Compounding Services - Wichita VAMC

The purpose of this solicitation is to establish a multiple-award Blanket Purchase Agreement (BPA) for the Wichita VA Medical Center. The Period of Performance is 1 November 2023 - 31 October 2025.

Pricing will be Firm Fixed Price (FFP) for each order.

IAW FAR 13.004, this BPA is not a binding contract. A contract only arises when the Government places an order that is properly accepted by the BPA holder. Placement of orders are not guaranteed.

See Section B.2 Performance Work Statement for full details.

The government may resolicit this requirement if the initial solicitation period results in less than three BPA's.

See CONTINUATION Page

X X

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 PERFORMANCE WORK STATEMENT

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

B.5 TERMS AND CONDITIONS

B.6 ADMINISTRATIVE DATA

B.7 PRICING DATA

B.8 OPTION TO EXTEND THE TERM OF THE BPA

B.9 SEGREGATION OF COSTS

B.10 GENERAL SERVICES ORDERS

B.11 AUTHORIZED LIMITS

B.12 OBLIGATION OF FUNDS

B.13 INVOICES

B.14 PERIOD OF PERFORMANCE

B.15 AUTHORIZED INDIVIDUALS

B.16 ORDER FORMAT

B.17 AUTHORIZED REPRESENTATIVES

B.18 FEDERAL HOLIDAYS

B.19 ORDERING MANAGEMENT

B.20 PERFORMANCE

B.21 MANAGEMENT CONTROL

B.22 PRECEDENCE

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

C.2 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.4 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY

(FEB 2023)

C.5 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.6 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

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

C.7 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.9 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JUN 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 LIST OF ATTACHMENTS

D.2 WAGE DETERMINATIONS INCORPORATED BY REFERENCE

SECTION E - SOLICITATION PROVISIONS

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

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

1998)

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

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 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED

BY REFERENCE (JAN 2008)

E.10 ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

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 36C255

Network Contracting Office (NCO) 15

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

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly, in arrears, upon acceptance

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.

Financial Services Center http://www.fsc.va.gov/einvoice.asp

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

AMENDMENT NO DATE

B.2 PERFORMANCE WORK STATEMENT

1. BACKGROUND:

The Robert J Dole VA Medical Center (RJDVAMC) has a requirement for compounding hazardous chemotherapy agents for its Wichita campus. These compounding services are necessary to provide chemotherapy treatments to Veterans diagnosed with specific medical conditions. RJDVAMC has approximately 10‐12 patients on any given day Monday‐Friday for Chemotherapy Infusion.

Compounding must be done at an FDA 503A compliant facility and meet all state and federal laws.

2. SCOPE OF WORK:

Services Non‐Personal; Contractor shall provide all chemotherapy agents, IV Tubing, closed system drug transfer devices, and any other items deemed necessary. All Hazardous Chemotherapy Agents will be aseptically compounded based on patient specific orders.

Prescription 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 RJDVAMC will be submitted by noon CST to receive next‐day by 9am CST

• Each prescription will include the following:

o Patient Name o Patient address (with first order for each patient) o Patient phone number (with first order for each patient) o Gender o Date of Birth o Height o Weight o Allergies o Drug dosage o Diluent and volume o Rate o Administration/procedure date o Prescribing physician/signature

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

Orders for Wichita, KS:

Robert J Dole VA Medical Center Inpatient Pharmacy Room 101‐3 5500 E Kellogg.

Wichita, KS 67218

Items shall be delivered to the VA by 9:00am, the 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 chemotherapy agents will be provided directly to the Contractor.

All drugs are to be supplied by the Contractor. See Attachment 1 for common chemotherapy agents used. This list is not inclusive, and agents 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.

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 “VHA PBM Assessment Guide for Compounded Sterile Preparations within VAMCs and Outsourced Compounding Pharmacies” at time of solicitation response and annually (See Attachment 2)

Shipping is included with the order and there is no additional cost for any items delivered for the weekend. All shipments for weekend delivery will be arranged as needed to ensure delivery can be successfully completed.

Specifications below for compatibility needs:

Bag Spike Rule: All chemos

Primary IV Set: BD Low Sorbing Secondary Set (REF 10014881) 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, and others as recommended by manufacturing guidelines.

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

Total Volume Calculations – Overfills in IV Bags: Total volume calculated for all orders. HD Chemos and MABs will have volume adjusted to stated diluent volume (removing calculated overfill and volume of medication).

Close System Device: Equashield

Pre‐meds: none

Other: Occasionally need 5‐FU in CADD Medication Cassette (REF 21‐7002‐24) or interchangeable cassette

3. WORK HOURS:

RJDVAMC pharmacy (Room 101‐3) is open to receive medications 24/7.

4. 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.

5. 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 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. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non‐volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer:

The contractor will have access to protected Patient Health Information (PHI), but it will not have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non‐volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de‐identified.

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.

6. QUALITY ASSURANCE SURVEILLANCE PROGRAM:

The Government will monitor the Contractor’s performance under this contract with the below performance objectives:

Task ID Indicator Standard Acceptable

Quality Level

Method of Surveillance Incentive Rating

General

Orders processed accurately

Contractor shall ensure all orders are processed per prescription order

100% Labeling

Positive Past

Performance &Exercise of

Option Period

Orders received prior to infusion date/time

Contractor shall comply with all safety requirements

100% Validated receipt of order

Positive Past

Performance &Exercise of

Contractor maintains certifications required for compounding

Contractor shall furnish copies of certificates and complete

VHA PBM

Assessment Annually

100%

Validated receipt of certificates and/or assessment

Positive Past

Performance &Exercise of

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVI

CES

QUANTI

TY

UNI

T UNIT PRICE AMOUNT

1.00 YR _______________

Compounded Pharmaceuticals will be patient specific upon order placement and prices will be based on contractors price list that will be attached to this BPA and/or individual BPA Calls. Estimated daily volume is 10 -12 patients if an order is placed.

The maximum value of this BPA is $4,000,000.

The expiration date of this BPA is 31 Oct 2025 unless otherwise extended according to the terms and conditions contained herein.

GRAND TOTAL _______________

B.4 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001 SHIP TO: Robert J. Dole VA Medical Center 5500 East Kellogg Wichita, KS 67218

USA

1.00

MARK

FOR:

Victoria (Tory) Arnce 316-925-1610 victoria.arnce@va.gov

B.5 TERMS AND CONDITIONS

The Contractor agrees to the following terms of a Blanket Purchase Agreement (BPA) EXCLUSIVELY WITH the Department of Veterans Affairs:

B.6 ADMINISTRATIVE DATA

A Blanket Purchase Agreement (BPA) is hereby established between and the Department of Veterans Affairs under the following terms and conditions incorporated in this BPA:

Primary Point of Contact:

Alternate Point of Contact:

DUNS NUMBER:

Cognizant Office (Include complete address):

Network Contracting Office (NCO) 15

B.7 PRICING DATA

1. The prices included on the BPA list (or applicable "discounted" rates submitted in a proposal response to an RFQ resulting in award) that are in effect on the effective date of an order shall govern that order's basic performance period. With regard to any option years, which are later exercised, the proposed option year rates as incorporated into the order award are in effect until such time, if applicable, that the contractor has been authorized a rate increase culminating from a negotiation with the Contracting Officer.

2. The BPA holder can voluntarily reduce offered prices at any time by giving 24-hour advance notice (by facsimile or electronic-mail) to the Department of Veterans Affairs/Contracting Officer.

This BPA also allows for additional discounts if a "large order" is placed at one time. An advanced notice is not required for discounts offered for only an individual order. Whether an order is large enough to warrant such a discount is subject to the discretion of the BPA holder.

3. The BPA holder may also increase BPA prices at any time. Any BPA price increase shall not take effect until the Department of Veterans Affairs Contracting Officer receives written notification (U.S. mail, facsimile, or electronic-mail). Any order already issued shall not be affected by any change to BPA pricing. The prices offered under this BPA will undergo annual review by the Department of Veterans Affairs Contracting Officer.

B.8 OPTION TO EXTEND THE TERM OF THE BPA

a. The Government may extend the term of this BPA by written notice to the Contractor at any time prior to the expiration of the BPA, provided that the Government shall give the Contractor a preliminary written notice of its intent to extend at least 30 days before the BPA expires. The preliminary notice does not commit the Government to an extension.

b. If the Government exercises this option, the extended BPA shall be considered to include this option provision.

B.9 SEGREGATION OF COSTS

a. The "Payments under Time-and-Materials and Labor-Hour Contracts" clause provides for reimbursement to the contractor of costs incurred for certain items and services purchased directly for the contract, subject to certain limitations set forth in the clause. Such items may include the lease/purchase of equipment, travel expenses for Government- directed travel, consumable materials, tuition and registration fees for specialized training, and other services or items acquired for the Government's account under the Government Property clause. The items and services which the BPA holder is authorized to purchase on a cost- reimbursement basis shall be limited to only those specific items and services described in the order(s) issued to the BPA holder as authorized for purchase.

b. The BPA holder shall segregate costs associated with materials and other items authorized to be purchased on a cost-reimbursement basis (to be specified in each order) from other costs associated with the performance of this contract in such a manner that at any time the costs subject to reimbursement under each order shall be readily ascertainable.

c. The "Ceiling Price" referred to in the "Payments under Time and Materials and Labor-Hour Contracts" clause shall be the ceiling price as stated in each order.

B.10 GENERAL SERVICES ORDERS

a. The BPA holder shall furnish all the necessary qualified personnel, materials, facilities and management resources to furnish the services set forth in the Statement of Objectives (SOO) or the Performance Work Statement (PWS) within the terms specified and at the price(s) stated.

b. It is understood and agreed that the BPA holder shall provide Fixed-Price proposals when requested by the Contracting Officer (CO). The contractor's proposal shall be priced using labor rates and labor categories here in provided. The CO will issue Fixed Priced Orders upon completion of negotiations of contractor proposals.

B.11 AUTHORIZED LIMITS

The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach $50,000.00/per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at $4,000,000.00 over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process.

B.12 OBLIGATION OF FUNDS

This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by the Contracting Officer.

B.13 INVOICES

a. Inspection and acceptance shall be accomplished as follows: The Government, for all services furnished under any resulting order, hereby designates the COR in the program office as the point of final inspection and acceptance. The BPA holder will submit each invoice, including all back-up data, to the Contracting Officer (CO) for review and signature. When the CO receives an accurate and complete invoice, he/she will return a signed copy to the BPA holder within five (5) working days. If the invoice is incomplete or inaccurate, the CO will return the unsigned invoice to the BPA holder for correction. The Contracting Officer will then forward the signed invoice to the Chief Financial Officer (CFO) for payment. Final payment for each order will be accomplished by final invoice accompanied by a receiving report.

b. An itemized invoice shall be submitted to the CO at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received. Copies of delivery tickets shall support these invoices.

"Approved-for-payment" invoices will be submitted to the payment address specified on each individual order issued under this BPA.

B.14 PERIOD OF PERFORMANCE

This BPA expires on 10-31-2025 or such later ending date as determined by the exercise of any option.

B.15 AUTHORIZED INDIVIDUALS

Individuals Authorized to Place Orders:

DVA authorizes the following entities to place orders:

Wichita VA Medical Center Pharmacy Services NCO 15 Contracting Office

B.16 ORDER FORMAT

Orders will be placed against this BPA via e-mail, Electronic Data Interchange (EDI), FAX, or in hardcopy format. Each individual BPA Order will describe the tasks, services and deliverables required.

B.17 AUTHORIZED REPRESENTATIVES

The primary Contracting Officer (CO) for this Agreement is:

Contracting Officer Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth, KS 66048

The Primary Contracting Officer's Representative (COR) for projects under this Agreement is:

Victoria Arnce 316-925-1610 victoria.arnce@va.gov

The Secondary Contracting Officer's Representative (COR) for projects under this Agreement is:

The Primary and/or Secondary COR will be responsible for technical monitoring of the contractor's performance and deliveries. The COR and the Contractor's Representative shall work together to ensure that all contractual requirements are being met. The COR will interpret specifications or technical portions of the work. The COR is not authorized to perform, formally or informally, any of the following actions:

(1) Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract;

(2) Waive or agree to modification of the delivery schedule;

(3) Make any final decision on any contract matter subject to the Disputes Clause;

(4) Terminate, for any reason, the contractor's right to proceed;

(5) Obligate in any way, the payment of money by the Government. Only a warranted Contracting Officer is authorized to obligate funds on this or any other contract action.

The contractor shall immediately notify the Contracting Officer in writing if the COR has taken an action (or fails to take action) or issues directions (written or oral) that the contractor considers to exceed the above limitations.

The contractor shall provide the Contracting Officer information copies of all correspondence to the COR.

B.18 FEDERAL HOLIDAYS

Unless specifically authorized in writing by the Contracting Officer, no services will be provided and no charges will be incurred and/or billed to any order on this contract on any of the Federal Holidays listed below.

New Year’s Day Labor Day Birthday of Martin Luther King, Jr. Columbus Day Washington’s Birthday Veterans' Day mailto:victoria.arnce@va.gov

Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

B.19 ORDERING MANAGEMENT

a. Order Management Requirements: Delivery of services shall be implemented only if directed by an order. The BPA holder shall respond in no more than 1 working days from the issuance of the order to identify the Contractor's Task Leader. The Contractor's Task Leader shall arrange for a meeting between the BPA holder Task Leader and the COR to obtain the necessary detailed information to proceed with the task.

b. Order Procedures: Each Request for Proposal for an order will contain a Statement of Objectives (SOO), or other performance based work statement, describing the program to be supported, a description of the task, evaluation criteria, the deliverables, an order start and completion date, and the COR. The BPA holder(s) solicited will respond to the SOO with a Performance Work Statement (PWS), a proposed technical solution including labor mix and hours, and a proposed ceiling or fixed price for the order. Note: The Government will accept order proposals only from BPA holders that it has solicited. The PWS and labor mix will be incorporated into any resulting order. The proposed technical solution may also be incorporated in the order. The BPA holder on a per site basis will assign the Task Leader.

c. Order Accounting: The BPA holder's order accounting system shall provide traceability of all labor hour and cost reimbursable elements (e.g. travel, material, other authorized direct costs) ordered by each program's funding citation's Accounting Classification Reference Number (i.e.

"acrn" assigned at the "SubCLIN" level in Section B), if required by the program office.

Otherwise, traceability shall be at the CLIN level, to include segregation by Government appropriation (i.e. "color of money"), set forth in the order. Under no circumstances will any invoice exceed the period of performance, hours or dollar amount (ceiling price) for any funded order. The BPA holder will separately track and invoice US Government and FMS charges. All invoices submitted for payment shall clearly identify:

1. Government order number.

2. Period of performance

3. Amount due by CLIN

4. Labor hours provided per labor category

d. The BPA holder shall prepare and maintain a Funds and Man-hour Expenditure Report for each order. The BPA holder will submit reports, in contractor format, to the COR and Contracting Officer on a regular basis as defined by each order. Reporting shall include schedule by task, labor hour expenditures by labor category by task, cost reimbursable elements, calendar of supported travel, reviews, meetings and briefings, deliverables status and an estimated completion date. The report shall also identify the most significant cost driver(s) for each task (i.e. Schedule, Type of Program, and Complexity), the value of the driver, and a brief explanation. The Government shall identify a standard set of activities and definitions. For each task, the BPA holder shall identify the approximate percentage of hours allocated to those activities. Until such a time as the Government provides this standard set of activities, the BPA holder will not be required to provide this information. The Funds and Man-hour Expenditure Report will be prepared and submitted by those individuals covered by company overhead and will not be directly charged to any specific labor category on a specific order. These reports will be submitted electronically.

e. Closeout Procedures: To facilitate closeout of individual orders placed under this BPA, within thirty (30) days of completion of any individual order, the BPA holder shall present a final invoice to the Contracting Officer that contains a complete accounting of hours expended by category, the prices associated with those hours, any cost reimbursable expenses, and a proposed final price. If the Government concurs with the invoice and the proposed final price is within the ceiling price of the order, the Government will issue an order modification converting the order to a firm fixed price order at the proposed final price.

B.20 PERFORMANCE

The following terms and conditions are applicable:

a. All services will be initiated within 1 calendar days following receipt of a valid order, unless otherwise specified in the order.

b. The BPA holder shall be familiar with Federal Government and Department of Veterans Affairs acquisition regulations, directives and instructions. If a particular document is required in a specific order, it will be cited within the order's PWS.

c. The BPA holder shall not provide technical direction to any other acquisition BPA holder(s) or government personnel at any time. Neither shall the Government directly supervise BPA holder employees. The BPA holder Task Leader should conduct day to day supervision of BPA holder personnel wherever the BPA holder personnel are located. All direction of the BPA holder shall be through the Contracting Officer (CO) of the ordering organization specified in each individual order. Technical "tasking" assignments for the BPA holder will be transmitted by the program office's COR (or program manager) to the BPA holder's Task Leader.

d. The "ordering period" will run from BPA award to 10-31-2025, or until such ending date of any option year, which may be exercised under the Agreement. The "performance period" will terminate with the end of the BPA, unless the ordering CO elects to extend performance as provided under the BPA. If the ordering CO elects to extend performance beyond the end of the BPA, he/she may extend performance up to six (6) months beyond the end of the order period.

e. Capitalization Requirements: The BPA holder shall provide their employees sufficient computer equipment to support orders. The BPA holder shall be able to support the automatic transmission of unclassified data only to the requiring Program Office by modem if so requested. Any computers connected to, or transmits to (connected or via magnetic media) the government shall be properly protected from computer viruses. The BPA holder shall be capable of supporting the software packages utilized by Department of Veterans Affairs for the indicated processors. Specific software packages utilized within a program office shall be stated in the order PWS if it is other than Microsoft Office Professional or Microsoft Project.

f. Cancellation: This BPA may be canceled if the BPA holder fails to perform in accordance with the terms and conditions of this BPA, any order established under this BPA, or if deemed as in the best interests of the Government. The BPA holder must strictly comply with all terms and conditions or the Department of Veterans Affairs/ Contracting Officer may determine that performance by the BPA holder has been unsatisfactory and cancel this BPA.

B.21 MANAGEMENT CONTROL

The BPA holder shall provide to the Contracting Officer (CO) a list of all teaming partners or subcontractors within 15 calendar days after order award. As subcontractors and/or teaming partners are added, and/or deleted, an updated listing will be provided to the CO within 15 calendar days of such change. All BPA holder personnel shall display identification badges at all times while charging hours to the order or at a government or government contractor location. Authorized Government personnel shall accompany all visits to Department of Veterans Affairs Program Offices, unless other specific arrangements have been made.

B.22 PRECEDENCE

The Terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the Contractor's invoice, the provisions of this BPA will take precedence.

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/

(End of Clause)

FAR

Number

Title Date

52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST JUN 2020

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

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS

NOV 2021

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

DEC 2022

52.224-1 PRIVACY ACT NOTIFICATION APR 1984

52.224-2 PRIVACY ACT APR 1984

52.227-17 RIGHTS IN DATA—SPECIAL WORKS DEC 2007

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

MAR 2023

852.219-70 VA SMALL BUSINESS SUBCONTRACTING PLAN

MINIMUM REQUIREMENTS (DEVIATION)

JAN 2023

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

C.2 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC

2022) The Contracting Officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee’s authority. A copy of the designation letter shall be furnished to the Contractor.

(End of Clause)

C.3 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.4 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS

SECURITY (FEB 2023)

(a) Definitions. As used in this clause—Business Associate means an entity, including an individual (other than a member of the workforce of a covered entity), company, organization or another covered entity, as defined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, that performs or assists in the performance of a function or activity on behalf of the Veterans Health Administration (VHA) that involves the creating, receiving, maintaining, transmitting of, or having access to, protected health information (PHI). The term also includes a subcontractor of a business associate that creates, receives, maintains, or transmits PHI on behalf of the business associate.

Business Associate Agreement (BAA) means the agreement, as dictated by the Privacy Rule, between VHA and a business associate, which must be entered into in addition to the underlying contract for services and before any release of PHI can be made to the business associate, in order for the business associate to perform certain functions or activities on behalf of VHA.

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information whether automated or manual.

Information technology (see FAR 2.101) also means Information and Communication Technology (ICT).

Information technology-related contracts means those contracts which include services (including support services), and related resources for information technology as defined in 802.101.

Privacy officer means the VA official with responsibility for implementing and oversight of privacy related policies and practices that impact a given VA acquisition.

Sensitive personal information means, with respect to an individual, any information about the individual maintained by VA, including but not limited to the following:

(1) Education, financial transactions, medical history, and criminal or employment history.

(2) Information that can be used to distinguish or trace the individual’s identity, including but not limited to name, social security number, date and place of birth, mother’s maiden name, or biometric records.

Security plan means a formal document that provides an overview of the security requirements for an information system or an information security program and describes the security controls in place or planned for meeting those requirements.

VA Information Security Rules of Behavior for Organizational Users (VA National Rules of Behavior) means a set of VA rules that describes the responsibilities and expected behavior of users of VA information or information systems.

VA sensitive information means all VA data, on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information and includes sensitive personal information. The term includes information where improper use or disclosure could adversely affect the ability of VA to accomplish its mission, proprietary information, records about individuals requiring protection under various confidentiality provisions such as the Privacy Act and the HIPAA Privacy Rule, and information that can be withheld under the Freedom of Information Act. Examples of VA sensitive information include the following:

individually-identifiable medical, benefits, and personnel information; financial, budgetary, research, quality assurance, confidential commercial, critical infrastructure, investigatory, and law enforcement information; information that is confidential and privileged in litigation such as information protected by the deliberative process privilege, attorney work-product privilege, and the attorney-client privilege; and other information which, if released, could result in violation of law or harm or unfairness to any individual or group, or could adversely affect the national interest or the conduct of Federal programs.

(b) General. Contractors, subcontractors, their employees, third-parties, and business associates with access to VA information, information systems, or information technology (IT) or providing and accessing IT-related goods and services, shall adhere to VA Directive 6500, VA Cybersecurity Program, and the directives and handbooks in the VA 6500 series related to VA information (including VA sensitive information and sensitive personal information and information systems security and privacy), as well as those set forth in the contract specifications, statement of work, or performance work statement. These include, but are not limited to, VA Handbook 6500.6, Contract Security; and VA Directive and Handbook 0710, Personnel Security and Suitability Program, which establishes VA’s procedures, responsibilities, and processes for complying with current Federal law, Executive Orders, policies, regulations, standards and guidance for protecting VA information, information systems (see 802.101, Definitions) security and privacy, and adhering to personnel security requirements when accessing VA information or information systems.

(c) Access to VA information and VA information systems.

(1) Contractors are limited in their request for logical or physical access to VA information or VA information systems for their employees, subcontractors, third parties and business associates to the extent necessary to perform the services or provide the goods as specified in the contracts, agreements, task, delivery or purchase orders.

(2) All Contractors, subcontractors, third parties, and business associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors to access VA information and VA information systems shall be in accordance with VA Directive and Handbook 0710, Personnel Security and Suitability Program.

(3) Contractors, subcontractors, third parties, and business associates who require access to national security programs must have a valid security clearance.

(4) HIPAA Business Associate Agreement requirement. Contractors shall enter into a Business Associate Agreement (BAA) with VHA, VA’s Covered Entity, when contract requirements and access to protected health information is required and when requested by the Contracting Officer, or the Contracting Officer’s Representative (COR) (see VAAR 824.103–70).

Under the HIPAA Privacy and Security Rules, a Covered Entity (VHA) must have a satisfactory assurance that its PHI will be safeguarded from misuse. To do so, a Covered Entity enters into a BAA with a contractor (now the business associate), which obligates the business associate to only use the Covered Entity’s PHI for the purposes for which it was engaged, provide the same protections and safeguards as is required from the Covered Entity, and agree to the same disclosure restrictions to PHI that is required of the Covered Entity in situations where a contractor—

(i) Creates, receives, maintains, or transmits VHA PHI or that will store, generate, access, exchange, process, or utilize such PHI in order to perform certain health care operations activities or functions on behalf of the Covered Entity; or

(ii) Provides one or more of the services specified in the Privacy Rule to or for the Covered Entity.

(A) Contractors or entities required to execute BAAs for contracts and other agreements become VHA business associates. BAAs are issued by VHA or may be issued by other VA programs in support of VHA. The HIPAA Privacy Rule requires VHA to execute compliant BAAs with persons or entities that create, receive, maintain, or transmit VHA PHI or that will store, generate, access, exchange, process, or utilize such PHI in order to perform certain activities, functions or services to, for, or on behalf of VHA. There may be other VA components or staff offices which also provide certain services and support to VHA and must receive PHI in order to do so. If these components award contracts or enter into other agreements, purchase/delivery orders, modifications and issue governmentwide purchase card transactions to help in the delivery of these services to VHA, they will also fall within the requirement to obtain a satisfactory assurance from these contractors by executing a BAA.

(B) BAA requirement flow down to subcontractors. A prime Contractor required to execute a BAA shall also obtain a satisfactory assurance, in the form of a BAA, that any of its subcontractors who will also create, receive, maintain, or transmit VHA PHI or that will store, generate, access, exchange, process, or utilize such PHI will comply with HIPAA requirements to the same degree as the Contractor. Contractors employing a subcontractor who creates, receives, maintains, or transmits VHA PHI or that will store, generate, access, exchange, process, or utilize such VHA PHI under a contract or agreement is required to execute a BAA with each of its subcontractors which also obligates the subcontractor (i.e., also a business associate) to provide the same protections and safeguards and agree to the same disclosure restrictions to VHA’s PHI that is required of the Covered Entity and the prime Contractor.

(d) Contractor operations required to be in United States. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practicable. If such services are proposed to be performed outside the continental United States, and are not otherwise disallowed by other Federal law, regulations or policy, or other VA policy or other mandates as stated in the contract, specifications, statement of work or performance work statement (including applicable Business Associate Agreements), the Contractor/subcontractor must state in its proposal where all non-U.S. services are provided. At a minimum, the Contractor/ subcontractor must include a detailed Information Technology Security Plan, for review and approval by the Contracting Officer, specifically to address mitigation of the resulting problems of communication, control, and data protection.

(e) Contractor/subcontractor employee reassignment and termination notification. Contractors and subcontractors shall provide written notification to the Contracting Officer and Contracting Officer’s Representative (COR) immediately, and not later than four (4) hours, when an employee working on a VA information system or with access to VA information is reassigned or leaves the Contractor or subcontractor’s employment on the cognizant VA contract. The Contracting Officer and COR must also be notified immediately by the Contractor or subcontractor prior to an unfriendly termination.

(f) VA information custodial requirements.

(1) Release, publication, and use of data. Information made available to a Contractor or subcontractor by VA for the performance or administration of a contract or information developed by the Contractor/subcontractor in performance or administration of a contract shall be used only for the stated contract purpose and shall not be used in any other way without VA’s prior written approval. This clause expressly limits the Contractor’s/ subcontractor’s rights to use data as described in Rights in Data—General, FAR 52.227–14(d).

(2) Media sanitization. VA information shall not be co-mingled with any other data on the Contractors/subcontractor’s information systems or media storage systems in order to ensure federal and VA requirements related to data protection, information segregation, classification requirements, and media sanitization can be met (see VA Directive 6500, VA Cybersecurity Program). VA reserves the right to conduct scheduled or unscheduled on-site inspections, assessments, or audits of Contractor and subcontractor IT resources, information systems and assets to ensure data security and privacy controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with Federal and VA requirements.

The Contractor and subcontractor will provide all necessary access and support to VA and/or GAO staff during periodic control assessments or audits.

(3) Data retention, destruction, and contractor self-certification. The Contactor and its subcontractors are responsible for collecting and destroying any VA data provided, created, or stored under the terms of this contract, to a point where VA data or materials are no longer readable or reconstructable to any degree, in accordance with VA Directive 6371, Destruction of Temporary Paper Records, or subsequent issue. Prior to termination or completion of this contract, the Contractor/subcontractor must provide its plan for destruction of all VA data in its possession according to VA Handbook 6500, and VA Cybersecurity Program, including compliance with National Institute of Standards and Technology (NIST) 800–88, Guidelines for Media Sanitization, for the purposes of media sanitization on all IT equipment. The Contractor must certify in writing to the Contracting Officer within 30 days of termination of the contract that the data destruction requirements in this paragraph have been met.

(4) Return of VA data and information. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to the VA (as stipulated by the Contracting Officer or the COR) or the Contractor/subcontractor must hold it until otherwise directed. Items returned will be hand carried, securely mailed, emailed, or securely electronically transmitted to the Contracting Officer or to the address as provided in the contract or by the assigned COR, and/or accompanying BAA.

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