About this file

This document is a solicitation for sterile hazardous drug compounding services for the Kansas City Veterans Affairs Medical Center pharmacy. The solicitation seeks to establish multiple blanket purchase agreements to provide all chemotherapy agents, supplies, and compounding of hazardous drugs from September 2023 through December 2023. Pricing will be firm fixed price for each order placed against the BPAs, which are not binding contracts but provide an avenue for future orders that are not guaranteed. The solicitation lists over 100 chemotherapy agents and supplies that may be ordered and includes requirements for compounding, delivery, labeling, certification, and pricing of individual medications utilized for each patient. Responses are due by September 11, 2023, with orders to be delivered the following day. The Department of Veterans Affairs Veterans Health Administration VISN 15 is the contracting agency, with the Kansas City VA Medical Center as the primary location for delivered products and services.

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File Type Posted
Chemotherapy Infusion SOW.docx DOCX document
VHA PBM.pdf PDF
Service Contract Act WD No 2015-5105 Rev 20.pdf PDF
KCVA Common Supplies and Chemotherapy Agents List.xlsx XLSX spreadsheet

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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

36C25523Q0553 08-21-2023 Chattman, Courtney 913-946-1975 09-11-2023 10:00

CDT

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

Leavenworth KS 66048

X

424210 250 Employees

N/A

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 3450 S 4th Street Trafficway

Leavenworth KS 66048

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 - Kansas City VAMC

The purpose of this solicitation is to establish a MULTIPLE-AWARD Blanket Purchase Agreement (BPA) for the Kansas City VA Medical Center. The Period of Performance is September 18, 2023 - December 31, 2023.

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.1 Performance Work Statement for full details.

Service Contract Act WD # 2015-5105, Rev 20 does apply.

CO POC: Courtney Chattman; Courtney Chattman@va.gov

No questions will be accepted after September 4, 2023.

See CONTINUATION Page

TBD

Courtney Chattman

Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES1
SECTION B - CONTINUATION OF SF 1449 BLOCKS4
B.1 PERFORMANCE WORK STATEMENT4
B.2 PRICE/COST SCHEDULE8
ITEM INFORMATION8
B.3 DELIVERY SCHEDULE18
B.4 TERMS AND CONDITIONS18
B.5 ADMINISTRATIVE DATA19
B.6 PRICING DATA19
B.7 OPTION TO EXTEND THE TERM OF THE BPA20
B.8 SEGREGATION OF COSTS20
B.9 GENERAL SERVICES ORDERS20
B.10 AUTHORIZED LIMITS21
B.11 OBLIGATION OF FUNDS21
B.12 INVOICES21
B.13 PERIOD OF PERFORMANCE21
B.14 AUTHORIZED INDIVIDUALS21
B.15 ORDER FORMAT22
B.16 AUTHORIZED REPRESENTATIVES22
B.17 FEDERAL HOLIDAYS23
B.18 ORDERING MANAGEMENT23
B.19 PERFORMANCE24
B.20 MANAGEMENT CONTROL25
B.21 PRECEDENCE25
SECTION C - CONTRACT CLAUSES26
ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES26
C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)26
C.2 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)26
C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)27
C.4 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY (FEB 2023)27
C.5 VAAR 852.208-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS – ORDERS or BPAs (JAN 2023) (DEVIATION)36
C.6 VAAR 852.208-71 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTOR COMMITMENTS-ORDERS AND BPAS (JAN 2023) (DEVIATION)37
C.7 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)38
C.8 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)38
C.9 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION)39
C.10 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)40
C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)40
C.12 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)42
C.14 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)42
C.15 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JUN 2023)42
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS51
SECTION E - SOLICITATION PROVISIONS52
ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES52
E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)52
E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)52
E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)55
E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)56
E.5 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)57
E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)57
E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)58
E.8 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE (FEB 2023)58
E.9 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY REFERENCE (JAN 2008)59
E.10 ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES59
E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)60
LIST OF ATTACHMENTS80

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 PERFORMANCE WORK STATEMENT

1. BACKGROUND:

The Department of Veterans Affairs has a requirement for compounding hazardous chemotherapy agents for the Kansas City VA Medical Center (KCVAMC) located at 4801 E Linwood Blvd, Kansas City, MO 64128. These compounding services are necessary to provide chemotherapy treatments to Veterans diagnosed with specific medical conditions. KCVAMC has approximately 10‐24 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. Contract is an emergent request for a period of performance as follows:

The Government anticipates awarding Firm-Fixed Price Multiple-Award Blanket Purchase Agreements (BPA) for this requirement. There is no minimum price required and this is for contingency purposes.

Estimated Period of Performance: September 18, 2023 – December 31, 2023

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 encrypted email or fax. Once submitted, VA staff will confirm receipt of order with the Contractor via phone or encrypted email.

· Orders from KCVAMC will be submitted by noon CST to receive next day by 9am CST.

· Each prescription will include the following:

· Patient name

· Patient address (with first order for each patient)

· Patient phone number (with first order for each patient)

· Gender

· Date of Birth

· Height

· Weight

· Allergies

· Drug dosage

· Diluent and volume

· Rate

· Administration/procedure date

· 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 Kansas City, MO:

Kansas City VA Medical Center Inpatient Pharmacy Room V2-710 4801 Linwood Boulevard Kansas City, MO 64128

Items shall be delivered to the KCVAMC by 9:00am CST, 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 and supplies will be provided directly to the Contractor.

All drugs are to be supplied by the Contractor. See attachment “KCVAMC Common Supplies and Chemotherapy Agents List”. 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.

Shipping fees shall be included with the order. 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 chemo 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: Equashield

· Pre‐meds: none

· Other: Occasionally need 5‐FU in WalkMed bags

Refer to attachment “KCVAMC Common Supplies and Chemotherapy Agents List” for more details for each individual chemotherapy agent. The Contractor will refer to this list to understand what tubing, filters, and other supplies are used for each compounded chemotherapy agent.

3. WORK HOURS:

KCVAMC Inpatient Pharmacy (Room V2-710) 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 USP 797, USP 800, and other applicable guidelines for sterile compounding chemotherapy agents. 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
1
Orders processed accurately
Contractor shall ensure all orders are processed per prescription order
100%
Labeling
Positive Past Performance &Exercise of Option Period
2
Orders received prior to infusion date/time
Contractor shall comply with all safety requirements
100%
Validated receipt of order
Positive Past Performance &Exercise of Option Period
3
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 Option Period

(End of Performance Work Statement)

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
19.00
EA
______________
______________

Arsenic trioxide 12mg

LOCAL STOCK NUMBER: 63459-0601-06

18.00
EA
______________
______________

Atezolizumab 1200mg

LOCAL STOCK NUMBER: 50242-0917-01

20.00
EA
______________
______________

Azacitadine 100mg

LOCAL STOCK NUMBER: 00781-3253-94

24.00
EA
______________
______________

Bendamustine 100mg

LOCAL STOCK NUMBER: 63459-0348-04

20.00
EA
______________
______________

Bevacizumab-bvzr 100mg

LOCAL STOCK NUMBER: 00069-0315-01

20.00
EA
______________
______________

Bortezomib 3.5mg

LOCAL STOCK NUMBER: 63323-0821-10

18.00
EA
______________
______________

Brentuximab vedotin 50mg

LOCAL STOCK NUMBER: 51144-0050-01

18.00
EA
______________
______________

Cabazitaxel 60mg

LOCAL STOCK NUMBER: 00024-5824-11

19.00
EA
______________
______________

Carboplatin 150mg

LOCAL STOCK NUMBER: 00703-4248-01

20.00
EA
______________
______________

Carfilzomib 60mg

LOCAL STOCK NUMBER: 76075-0101-01

20.00
EA
______________
______________

Cetuximab 100mg

LOCAL STOCK NUMBER: 66733-0948-23

21.00
EA
______________
______________

Cisplatin 100mg

LOCAL STOCK NUMBER: 63323-0103-51

20.00
EA
______________
______________

Cladribine 10mg

LOCAL STOCK NUMBER: 63323-0140-10

20.00
EA
______________
______________

Cyclophosphamide 1g

LOCAL STOCK NUMBER: 10019-0956-01

21.00
EA
______________
______________

Cytarabine 100mg

LOCAL STOCK NUMBER: 61703-0319-22

20.00
EA
______________
______________

Cytarabine 2g

LOCAL STOCK NUMBER: 63323-0120-20

20.00
EA
______________
______________

Dacarbazine 200mg

LOCAL STOCK NUMBER: 63323-0128-20

24.00
EA
______________
______________

Daratumumab 400mg

LOCAL STOCK NUMBER: 57894-0502-05

20.00
EA
______________
______________

Decitabine 50mg

LOCAL STOCK NUMBER: 67457-0316-25

20.00
EA
______________
______________

Docetaxel 80mg

LOCAL STOCK NUMBER: 16729-0267-64

20.00
EA
______________
______________

Doxorubicin 50mg

LOCAL STOCK NUMBER: 00069-3032-20

18.00
EA
______________
______________

Durvalumab 500mg

LOCAL STOCK NUMBER: 00310-4611-50

18.00
EA
______________
______________

Eculizumab 300mg

LOCAL STOCK NUMBER: 25682-0001-01

24.00
EA
______________
______________

Elotuzumab 300mg

LOCAL STOCK NUMBER: 00003-2291-11

22.00
EA
______________
______________

Etoposide 100mg

LOCAL STOCK NUMBER: 63323-0104-05

24.00
EA
______________
______________

Fam-trastuzumab deruxtecan-nxki 100mg

LOCAL STOCK NUMBER: 65597-0406-01

18.00
EA
______________
______________

Ferric carboxymaltose 750mg

LOCAL STOCK NUMBER: 00517-0650-01

20.00
EA
______________
______________

Fludarabine 50mg

LOCAL STOCK NUMBER: 63323-0192-02

22.00
EA
______________
______________

Fluorouracil 1g

LOCAL STOCK NUMBER: 63323-0117-20

19.00
EA
______________
______________

Fluorouracil 500mg

LOCAL STOCK NUMBER: 63323-0117-10

20.00
EA
______________
______________

Fluorouracil 5g

LOCAL STOCK NUMBER: 63323-0117-61

20.00
EA
______________
______________

Fosaprepitant 150mg

LOCAL STOCK NUMBER: 00591-4385-79

20.00
EA
_________________
_______________

Fulvestrant 250mg

LOCAL STOCK NUMBER: 63323-0715-05

20.00
EA
______________
_______________

Furosemide 100mg

LOCAL STOCK NUMBER: 63323-0280-10

19.00
EA
______________
__________________

Furosemide 20mg

LOCAL STOCK NUMBER: 63323-0280-02

19.00
EA
______________
______________

Ganciclovir 500mg

LOCAL STOCK NUMBER: 63323-0315-10

20.00
EA
______________
______________

Gemcitabine 1g

LOCAL STOCK NUMBER: 00409-0181-01

20.00
EA
______________
______________

Gemcitabine 2g

LOCAL STOCK NUMBER: 00409-0182-01

19.00
EA
______________
______________

Gemcitabine 200mg

LOCAL STOCK NUMBER: 00409-0183-01

18.00
EA
______________
______________

Gentamicin Sulfate 80mg

LOCAL STOCK NUMBER: 63323-0010-02

18.00
EA
______________
______________

Idarubicin 10mg

LOCAL STOCK NUMBER: 00013-2586-91

20.00
EA
______________
______________

Idarubicin 20mg

LOCAL STOCK NUMBER: 00013-2596-91

21.00
EA
______________
______________

Idarubicin 5mg

LOCAL STOCK NUMBER: 00013-2576-91

19.00
EA
______________
______________

Ifosfamide 1g

LOCAL STOCK NUMBER: 10019-0925-01

20.00
EA
______________
______________

Ifosfamide 3g

LOCAL STOCK NUMBER: 10019-0926-02

18.00
EA
______________
______________

Infliximab 100mg

LOCAL STOCK NUMBER: 57894-0030-01

20.00
EA
______________
______________

Infliximab-abda 100mg

LOCAL STOCK NUMBER: 78206-0162-01

20.00
EA
______________
______________

Irinotecan 100mg

LOCAL STOCK NUMBER: 00009-7529-03

20.00
EA
______________
______________

Liposomal Doxorubicin 20mg

LOCAL STOCK NUMBER: 00338-0063-01

24.00
EA
______________
______________

Liposomal Doxorubicin 50mg

LOCAL STOCK NUMBER: 43598-0541-25

18.00
EA
______________
______________

Lurbinectedin 4mg

LOCAL STOCK NUMBER: 68727-0712-01

20.00
EA
______________
______________

Mepolizumab 100mg

LOCAL STOCK NUMBER: 00173-0881-01

18.00
EA
______________
______________

Mesna 1g

LOCAL STOCK NUMBER: 10019-0953-01

20.00
EA
______________
______________

Methotrexate 1g

LOCAL STOCK NUMBER: 61703-0408-41

19.00
EA
______________
______________

Mitomycin 5mg

LOCAL STOCK NUMBER: 16729-0115-05

20.00
EA
______________
______________

Mitoxantrone 25mg

LOCAL STOCK NUMBER: 63323-0132-12

18.00
EA
______________
______________

Mycophenolate mofetil 500mg

LOCAL STOCK NUMBER: 60429-0070-01

20.00
EA
______________
______________

Nivolumab 100mg

LOCAL STOCK NUMBER: 00003-3774-12

18.00
EA
______________
______________

Nivolumab 240mg

LOCAL STOCK NUMBER: 00003-3734-13

19.00
EA
______________
______________

Nivolumab 40mg

LOCAL STOCK NUMBER: 00003-3772-11

12.00
EA
______________
______________

Ocrelizumab 300mg

LOCAL STOCK NUMBER: 50242-0150-01

22.00
EA
______________
______________

Ondansetron 40mg

LOCAL STOCK NUMBER: 72266-0124-01

22.00
EA
______________
______________

Ondansetron 4mg

LOCAL STOCK NUMBER: 72266-0123-25

20.00
EA
______________
______________

Oxaliplatin 100mg

LOCAL STOCK NUMBER: 43066-0018-01

19.00
EA
______________
______________

Oxaliplatin 50mg

LOCAL STOCK NUMBER: 00703-3985-01

19.00
EA
______________
______________

Paclitaxel 300mg

LOCAL STOCK NUMBER: 61703-0342-50

20.00
EA
______________
______________

Paclitaxel 100mg

LOCAL STOCK NUMBER: 61703-0342-22

19.00
EA
______________
______________

Paclitaxel 30mg

LOCAL STOCK NUMBER: 61703-0342-09

18.00
EA
______________
______________

Paclitaxel Protein-Bound 100mg

LOCAL STOCK NUMBER: 68817-0134-50

18.00
EA
______________
______________

Paclitaxel Protein-Bound 200mg

LOCAL STOCK NUMBER: 60505-6230-04

21.00
EA
______________
______________

Palonosetron 0.25mg

LOCAL STOCK NUMBER: 63323-0673-05

21.00
EA
______________
______________

Pamidronate 30mg

LOCAL STOCK NUMBER: 67457-0430-10

21.00
EA
______________
______________

Pamidronate 90mg

LOCAL STOCK NUMBER: 61703-0326-18

19.00
EA
______________
______________

Panitumumab 100mg

LOCAL STOCK NUMBER: 55513-0954-01

18.00
EA
______________
______________

Panitumumab 400mg

LOCAL STOCK NUMBER: 55513-0956-01

20.00
EA
______________
______________

Pemetrexed 500mg

LOCAL STOCK NUMBER: 00338-0722-01

18.00
EA
______________
______________

Pertuzumab 420mg

LOCAL STOCK NUMBER: 50242-0145-01

20.00
EA
______________
______________

Polatuzumab Vedotin-piiq 30mg

LOCAL STOCK NUMBER: 50242-0103-01

18.00
EA
______________
______________

Ramucirumab 100mg

LOCAL STOCK NUMBER: 00002-7669-01

18.00
EA
______________
______________

Ramucirumab 500mg

LOCAL STOCK NUMBER: 00002-7678-01

12.00
EA
______________
______________

Risankizumab-rzaa 150mg

LOCAL STOCK NUMBER: 00074-2100-01

20.00
EA
______________
______________

Rituximab-pvvr 500mg

LOCAL STOCK NUMBER: 00069-0249-01

20.00
EA
______________
______________

Trastuzumab -dttb 150mg

LOCAL STOCK NUMBER: 78206-0147-01

18.00
EA
______________
______________

Vedolizumab 300mg

LOCAL STOCK NUMBER: 64764-0300-20

21.00
EA
______________
______________

Vinblastine 10mg

LOCAL STOCK NUMBER: 63323-0278-10

21.00
EA
______________
______________

Vincristine 1mg

LOCAL STOCK NUMBER: 00703-4402-11

20.00
EA
______________
______________

Vincristine 2mg

LOCAL STOCK NUMBER: 00703-4412-11

20.00
EA
______________
______________

Vinorelbine 50mg

LOCAL STOCK NUMBER: 45963-0607-56

1,677.00
EA
______________
______________

Facility Patient Fees, USP 797 Fees, USP 800 Fees, Delivery Fees, Chemoembolic Mixing Fees, Exact Volume Requirement Fees, & Intrathecal Mixing Fees

LOCAL STOCK NUMBER: FEES1

50.00
EA
______________
______________

STAT Order Fees

LOCAL STOCK NUMBER: FEES2

GRAND TOTAL
______________

B.3 DELIVERY SCHEDULE

ITEM NUMBER
QUANTITY
DELIVERY DATE
ALL
SHIP TO:
Department of Veterans Affairs

Kansas City VA Medical Center 4801 East Linwood Boulevard Kansas City, MO 64128 2226

USA

ALL

B.4 TERMS AND CONDITIONS

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

B.5 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:

SAM UEI NUMBER:

Cognizant Office (Include complete address):

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

B.6 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.7 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.8 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.9 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.10 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.11 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.12 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.13 PERIOD OF PERFORMANCE

This BPA expires on 12-31-2023 or such later ending date as determined by the exercise of any option.

B.14 AUTHORIZED INDIVIDUALS

Individuals Authorized to Place Orders:

DVA authorizes the following entities to place orders:

Kansas City VA Medical Center Pharmacy Services
NCO 15 Contracting Office

B.15 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.16 AUTHORIZED REPRESENTATIVES

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

Courtney Chattman
Contracting Officer
Department of Veterans Affairs
Network Contracting Office (NCO) 15
3450 S 4th Street Trafficway
Leavenworth, KS 66048
Courtney.Chattman@va.gov

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

TBD

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

TBD

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.17 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
Memorial Day
Thanksgiving Day
Juneteenth
Christmas Day

Independence Day

B.18 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.19 PERFORMANCE

The following terms and conditions are applicable:

a. All services will be initiated within 5 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 12-31-2023, 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.20 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.21 PRECEDENCE

36C25523Q0553 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.

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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):

(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
52.224-1
PRIVACY ACT NOTIFICATION
APR 1984
52.224-2
PRIVACY ACT
APR 1984
52.227-17
RIGHTS IN DATA—SPECIAL WORKS
DEC 2007
52.212-4
CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES
DEC 2022
52.232-40
PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS
MAR 2023

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).

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