RFQ 1449 36C26326Q1098 Blood and Blood Products Omaha VA.pdf

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

PR is N/A

36C263-26-AP-4223

36C26326Q1098 09-10-2026

Joseph Bennett 319-688-3633 09-20-2026

05:00 PM CDT

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

1303 5TH STREET, SUITE 300

CORALVILLE IA 52241

X

621991

$40 Million

N/A

X

36C368

Department of Veterans Affairs

Omaha VA Medical Center

VA Nebraska-Western Iowa HCS

4101 Woolworth Avenue

Omaha NE 68105

36C263

NETWORK CONTRACTING OFFICE 23

1303 5TH STREET, SUITE 300

CORALVILLE IA 52241

FMS-VA-2(101)

FINANCIAL SERVICES CENTER

See CONTRACT ADMINISTRATION DATA below

See CONTINUATION Page

Request for Quote for Blood and Blood Products and Services

Firm Fixed Price, IDIQ, Base Year and 4 Ordering Periods.

See Instructions to Offerors, Page 3.

See STATMENT OF WORK below.

See PRICE/COST SCHEDULE below.

See Clause 52.212-2 for Evaluation Factors.

Questions shall be submitted by 12:00 PM CDT Thurs, 9/17/26

Offers shall be received NLT 05:00pm CDT, Sun, 9/20/26

All offers shall be emailed to Joseph.Bennett@va.gov

All emails shall this number in subject line: 36C26326Q1098

Note: Clause 52.212-5 does not apply even though it is reference in boxes 27a & 27b below.

See CONTINUATION Page

Funding will be provided with each Delivery Order placed against this IDIQ contract.

X X

Joseph Bennett

VA-VHA-RPOC-2024-0088

36C26326Q1098

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 INSTRUCTIONS TO OFFERORS

B.2 CONTRACT ADMINISTRATION DATA

B.3 STATEMENT OF WORK

B.4 VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY

LANGUAGE

B.5 RECORDS MANAGEMENT OBLIGATIONS

B.6 PRICE/COST SCHEDULE

ITEM INFORMATION

B.7 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

C.2 52.216-18 ORDERING (AUG 2020) Tailored

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995) Tailored

C.4 52.216-22 INDEFINITE QUANTITY (NOV 2025) (DEVIATION) Tailored

C.5 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

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

C.7 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.8 52.222-40 NOTIFICATION OF EMPLOYEE RIGHTS UNDER THE NATIONAL

LABOR RELATIONS ACT (NOV 2025) (DEVIATION)

C.9 52.222-42 STATEMENT OF EQUIVALENT RATES FOR FEDERAL HIRES (MAY

2014)

C.10 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS

(DEVIATION APR 2026)

C.11 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.12 52.240-91 SECURITY PROHIBITIONS AND EXCLUSIONS (NOV 2025)

(DEVIATION)

C.13 VAAR 852.211-76 LIQUIDATED DAMAGES - REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023)

C.14 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN

1997) Tailored

C.15 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.3 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

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

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (OCT 2025) (DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 INSTRUCTIONS TO OFFERORS

All Instructions to Offerors added by the CO in addition to the standard 52.212-1 INSTRUCTIONS TO OFFERORS are here on this page. Read this entire page.

This solicitation is issued under Revolutionary FAR Overhaul, FAR 12 Simplified Acquisitions.

This RFQ is Unrestricted.

The Government intends to award without Discussions.

The Contract will be Single Award, Firm Fixed Price, IDIQ base year with four ordering periods.

Ordering Periods of 1-Yr each are used instead of Option Years. All references to Option Years or Option Periods in the contract shall be taken to mean Ordering Periods.

Period of Performance:

Base Year: 10/01/2026 – 09/30/2027 Ordering Period 1: 10/01/2027 – 09/30/2028 Ordering Period 2: 10/01/2028 – 09/30/2029 Ordering Period 3: 10/01/2029 - 09/30/2030 Ordering Period 4: 10/01/2030 – 09/30/2031

Offerors are required to be registered in SAM when submitting a quote and at time of award.

Late offers will NOT be accepted regardless of how late offers are treated anywhere else in this document.

The Buy American Statute applies.

The Government intends to evaluate all line items on a group basis and make a single award for

BAA/TAA applicability.

The Service Contract Labor Standards Act applies, and a wage determination is attached.

Wage Determination applies to the services portion of this contract.

Offeror shall have an active registration in the FDA Blood Establishment Registration Database. This registration must stay active during the life of the contract.

All deliveries are FOB Destination.

All products and services must be compliant with, and meet the standards of the American Association of Blood Banks (AABB) and regulations of Title 21, Code of Federal Regulations as administered by the U.S. Food and Drug Administration (FDA).

SUBMITTAL - PAST PERFORMANCE & REFERENCES:

Provide three examples of current or past contracts of similar size and scope performed in the last 5 years. Include this information for each:

-Name of Organization, Hospital, Medical Center, Agency the contract was/is with.

-Address of organization contract was/is with.

-Contact Person’s name.

-Contact person’s phone number -Contact person’s email address.

-Contract Id number.

-Total contract dollar value at award.

-Period of performance.

-Brief description of the work performed (products and services provided)

SUBMITTAL - BUY AMERICAN CERTIFICATE.

This RFQ includes RFO Clause 52.225-1 Buy American-Supplies (Nov 2025)(Deviation) The Buy American Certificate, 52.225-2 is attached. It must be completed and signed at the very bottom and included with offer.

Instructions:

a) List all products that are not domestic (produced in the United States) in column A of the table in paragraph (b);

b) A company representative with the proper authority shall fill in their name, sign and date at the bottom. See yellow highlights.

SECURITY AND PRIVACY TRAINING COURSES

Training Courses are required. See page Yellow Highlights on page 15.

SUBMISSION OF OFFERS:

All Questions shall be submitted by 12:00 PM CDT Thursday, September 17, 2026.

All offers shall be received by the CO no later than 05:00 PM CDT Sunday, September 20, 2026.

All offers shall be emailed to Joseph.Bennett@va.gov All Emails/correspondence shall include this RFQ number in the Subject Line: 36C26326Q1098.

B.2 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: NCO 23 Contracting Officer Department of Veterans Affairs Network 23 Contracting Office 1303 5th St. Suite 300 Coralville, IA 52241

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[ ] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

[ ] a. Quarterly [ ] b. Semi-Annually [ X ] c. Other: Within 30 days of Receipt and 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.

mailto:Joseph.Bennett@va.gov

In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (FSC).

The VA Financial Service Center(FSC) has partnered with third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

Vendor e-Invoice Set-Up Information:

Please contact the phone numbers or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

Tungsten e-Invoice set-up information: 877-489-6135 Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com FSC e-Invoice Contact Information: 877-353-9791 FSC e-Invoice email: vafsccshd@va.gov More information on the FSC electronic invoicing process can be found at http://www.fsc.va.gov/einvoice.asp.

FAR and VAAR Causes may be accessed at these links:

https://www.acquisition.gov/browsefar https://www.va.gov/oal/library/vaar/

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

AMENDMENT NO DATE

B.3 STATEMENT OF WORK

Blood Products, Reference Laboratory Testing, Apheresis Services

A. GENERAL INFORMATION

B. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables, reference laboratory testing, apheresis services as described in this statement of work (SOW) and attached itemized list, except as otherwise specified.

C. Background:

The Omaha VA Medical Center (VAMC) has a requirement for a reliable FDA registered source of blood products and services for the treatment of patients. All products will be used for human administration, blood and blood products are considered domestic end times as they are drawn and processed in the United States of America. All referred patient testing results will be included in treatment of the patient based on clinical presentation.

http://www.fsc.va.gov/einvoice.asp https://www.acquisition.gov/browsefar https://www.va.gov/oal/library/vaar/

Apheresis services will be provided in accordance with written orders issued by the patient’s ordering physician.

D. Performance Period: 10/01/2026 – 09/30/2031.

E. Type of Contract: Firm-Fixed Price, five-year Indefinite Delivery Indefinite Quantity (IDIQ)

Ordering Periods of 1-Yr each are used instead of Option Years. All references to Option Years or Option Periods in the contract shall be taken to mean Ordering Periods.

F. GENERAL REQUIREMENTS

G. Blood Products: Contractor shall furnish all personnel, supplies, and facilities necessary to collect, process, store, and deliver human blood components and derivatives. The contractor shall supply the following blood products which are listed on the attached Price/Cost Schedule, Attachment A.

H. Services: Contractor shall provide all the following services to the Omaha VAMC.

I. Vendor shall stock and maintain homologous leukoreduced red blood cell units, blood components, plasma derivatives and/or services. Said units shall be procured from volunteer donors only and shall be tested and processed in a manner commensurate with standards consistent with those promulgated by the American Association of Blood Banks (AABB) and regulations of Title 21, Code of Federal Regulations as administered by the U.S.

Food and Drug Administration (FDA). Inventory levels will be mutually agreed upon and may be changed from time to time, subject to review by the Director of the Omaha VAMC Hospital Transfusion Service and the Contractor. Changes or modifications to the contract require the authorization of the Contract Officer.

J. Normal hours of operations are Monday through Friday, between the hours of 8:00am and

4:00pm, excluding holidays. Federal holidays observed are as follows:

New Year’s Day (January 1st) Birthday of Martin Luther King, Jr. (third Monday in January) Washington’s Birthday (third Monday in February) Memorial Day (last Monday in May) Juneteenth (June 19th) Independence Day (July 4th) Labor Day (first Monday in September) Columbus Day (second Monday in October) Veterans Day (November 11th) Thanksgiving Day (fourth Thursday in November) Christmas Day (December 25th)

*Note: If the federal holiday falls on a Saturday it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.

K. Contractor shall provide blood (leukoreduced red blood cell units) and blood products as needed during off-hours, weekends, and holidays. Deliveries shall be billed according to the after-hour courier fee as per the Price/Cost Schedule.

L. Contractor shall supply trained staff, supplies, and equipment for conducting donor mobile operations at/or within the Omaha VAMC.

M. Contractor shall provide reference testing and apheresis services in a manner commensurate with standards consistent with those promulgated by the American Association of Blood Banks (AABB) and regulations of Title 21, Code of Federal Regulations as administered by the U.S. Food and Drug Administration (FDA) and must maintain Clinical Laboratory Improvement Amendments (CLIA) certification.

N. THERAPEUTIC APHERESIS:

a. Responsibilities of the contractor:

i. The contractor will use reasonable efforts to provide apheresis services at the

Customer’s location. Such apheresis services will include the separation and removal of a blood component, reinfusion of the unused portion and the infusion of a suitable replacement fluid, if required, as well as other duties associated with therapeutic apheresis. Apheresis and Associated Duties are collectively referred to as Apheresis Services. For the avoidance of a doubt, Apheresis Services are included within the definition of Services as set forth in the Agreement. The contractor will perform the Apheresis Services in accordance with the written orders issued by the patient’s ordering physician as documented in the patient’s chart. Such written orders may include, without limitation, the treatment schedule, the patient’s weight, the amount of blood to be processed, the amount and type of replacement fluid, if required, and instructions for the care of the lines after the procedure, including without limitation, heparinization. No contractor personnel, regardless of status or title, will write the orders for the Apheresis. The orders for Apheresis will be written by a VA provider only.

ii. Before the performance of the Apheresis Services, when necessary, consult with the ordering physician to determine the medical necessity, type, and frequency of the required procedure and to schedule a time of times, and a place to perform the Apheresis Services. Obtain a written informed consent for the performance of the Apheresis Services from the patient (or responsible guardian of parent).

iii. Monitor the patient during the provision of the Apheresis Services and report any progress and/or complications to the ordering physician or the physician responsible for the patient during the procedure.

iv. Perform the Apheresis Services at the customer’s location between the hours of 0700 and 1700 on non-holiday weekdays. The contractor will endeavor without guarantee to perform unscheduled emergency apheresis services (less than twenty-four (24) hours’ notice time) on a twenty-four (24) hour-a-day basis, subject to staffing availability.

v. Provide qualified personnel, equipment, supplies and disposables for the performance of the apheresis services. The contractor is responsible for proper equipment maintenance and documentation of contractor equipment, supplies and disposables. If the contractor is required to use the customer’s equipment or disposables for the performance of the apheresis services.

vi. Upon completion of the Apheresis Services, a detailed report will be provided to the Omaha Veterans Administration Hospital for inclusion in the patient’s medical record. The report will document the Apheresis Services performed, including any replacement solutions administered, fluid balance, medications administered, and any adverse reactions or other complications that occur during the Apheresis Services.

b. Responsibilities of the Customer:

i. Ordering physician will contact the contractor by telephone in order to request

Apheresis Services for patient. The ordering physician will be knowledgeable of the patient’s condition, as well as the appropriate application of and risks and benefits associated with therapeutic apheresis.

ii. During consultation, ensure that the ordering physician provides the contractor with the patient’s name, diagnosis, physical size and location, pertinent laboratory values, and the ordering physician’s name and contact information.

iii. Maintain responsibility for making the final decision for the contractor to perform the apheresis service following the consultation and the patient’s care at all times, including the period of time the apheresis services are provided by the contractor.

iv. Provide the orders for the apheresis services with which the contractor must comply. In addition, the customer is responsible for obtaining the informed consent for the apheresis services as a treatment

v. Supply and prepare replacement fluids prior to the performance of the apheresis services.

vi. Make available at no additional cost a suitable site adequate for the performance of the apheresis services, support personnel, laboratory service accessibility, and emergency care, equipment and medical personnel. Customer will also provide security badges, parking and twenty-four (24) hour per day access to the building(s), the apheresis room(s), and record storage room(s) at no additional cost to the contractor.

vii. Ensure that the ordering physician, or at least one designated physician from the primary care team familiar with the patient, is readily available throughout the apheresis services.

viii. Arrange for the insertion of a central line or other venous access if venous access other than peripheral veins is required for the apheresis service.

ix. Dispose of any waste or biohazardous materials resulting from the apheresis service.

x. Provide the contractor with emergency evacuation procedures and the customer’s code system.

O. REFERENCE LABORATORY TESTING SERVICES:

a. The reference laboratory services are made available twenty-four (24) hours a day, seven

(7) days each week. Customers understand and agree that depending on the complexity of the patient’s blood sample, the time involved for testing resolution may range from several hours to several days.

b. The reference laboratory(s) must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare and Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments (CLIA) or must demonstrate accreditation by regulatory agency(s) with deemed status from the Centers for Medicare and Medicaid Services, e.g., The College of American Pathologists, and/or other statute regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory must maintain valid certifications during the performance period of this contract.

P. Orders will be categorized into three types: routine, as soon as possible and STAT. These categories are defined as follows:

a. Routine-Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request.

b. As Soon As Possible (ASAP) – Shipments of blood products to fill a request for a waiting outpatient, or a non-life-threatening need, or to replenish a depleted inventory of a blood product which has been used since the previous routine delivery. ASAP orders will be processed and ready to ship within 4 hours.

c. STAT – A need for blood products so acute that a patient’s life could be jeopardized if the request for blood products is unfulfilled. STAT orders will be processed and ready to ship within one (1) hour of the order being placed. In the event there is an issue with antibodies and/ or compatibility of the blood available, the delivery time may be longer than 2 hours at the Government’s discretion. The Contractor shall notify the VA immediately in the event of a delivery time delay, or if it be delayed due to antibodies present or compatibility issues or not on hand.

Q. Quality of Products: All blood products and specimens must be transported/shipped in such a way to ensure integrity and compliance with standards and requirements. The government has the right to inspect quality, quantity, and to verify adherence to the technical and delivery requirements of the contract and regulatory agencies.

R. Donor Requirements: Donor selection must be in accordance with criteria established by the FDA and AABB. All ABO group, Rh type, infectious disease testing and final labeling must be completed prior to distribution of blood and blood components.

S. Orders/Deliveries/Invoices:

a. The Contractor shall notify the Omaha VAMC Blood Bank and advise them of the estimated delivery time. Based on the estimate delivery time, Omaha VAMC will determine the effect on patient care and advise the Contractor accordingly. Delivery shall occur within two (2) hours after preparation for ASAP and within one (1) hour for STAT orders. Omaha VAMC reserves the right to contact another vendor if the estimated delivery time is not acceptable to patient care. It is the responsibility of the Contractor to arrange for pickup of specimens and delivery of blood products in an emergency.

b. Blood products shall be delivered to the Laboratory main hospital building Room 2291.

All blood and blood products shall be properly packaged and insulated in such a way as to ensure that a proper temperature appropriate for the product is maintained during transport between contractor’s place of business and the Omaha VA Medical Center.

The contractor will meet all federal and state DOT requirements for the transportation of human blood and blood products.

c. Contractor shall make delivery services for blood products available 24 hours a day, 7 days a week, 365 days a year.

d. All blood products should be leuko-reduced unless otherwise unavailable. If leuko-reduced products are not available, the contractor shall contact the blood bank to verify acceptance of blood or blood product.

e. The specific volumes distributed in a routine order will be mutually agreed upon by Omaha VA Medical Center and the vendor based on current inventory levels. Platelet, Cryoprecipitate orders and other special requests will be placed as needed.

T. CREDIT FOR RETURNED BLOOD OR BLOOD PRODUCTS

a. Full Credit will be given for blood products that are returned to the contractor under the following conditions:

b. When blood is delivered to the VAMC with a shelf life of less than 7 days or fewer. The contractor can contact the VA if the only product available has a short shelf life, and it is the only blood available to meet the patients’ needs. The VA can determine whether to accept or reject the short, dated blood product. The ARC shall provide credit for products that are put into quarantine at their direction, which expire while in quarantine, of the VAMC is unable to use due to the extended time the products were out of circulation.

c. When blood products do not meet the “acceptance criteria” of the VAMC Blood Bank.

Acceptance criteria may be based on abnormalities in physical appearance, indications of contamination, product temperature on receipt, and other criteria regarding the quality or acceptability of blood products.

U. RECALLED AND DEFECTIVE PRODUCTS

a. The contractor will immediately notify the Contracting Officer of any recalls of product of other important safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled/defective products.

B.4 VA INFORMATION AND INFORMATION SYSTEM SECURITY AND

PRIVACY LANGUAGE

NOTE: For Contracts that do not have an assigned COR, the term COR shall be replaced with

VA POC (VA Person of Contact).

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is

FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define

Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and

VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and V VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability

Office (GAO) staff during periodic control assessments, audits, or investigations.

The contractor may only use VA information within the terms of the contract and applicable

Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive

6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate

Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using

VA-approved encryption tools which are, at a minimum, Federal Information Processing

Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements.

The contractor shall transmit VA sensitive information using VA approved Transport Layer

Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and

Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer to all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor shall not release VA records protected by

Title 38 U.S.C. § 5705, Confidentiality of medical quality-assurance records and/or Title 38

U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer to such court order or other requests to the

VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and

Access Management (IAM) Security processes specified in the VA Information Security

Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with

National Archives and Records Administration (NARA) requirements as outlined in VA Directive

6300, Records and Information Management, VA Handbook 6300.1, Records Management

Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal

Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the

Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the

COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS.

This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rules of Behavior

(ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and

Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security

Clearance shall be processed through the Special Security Officer located in HRA/OSP.

Contractors shall conform to all requirements stated in the National Industrial Security Program

Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-

71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR /CO in writing prior to access being granted.

e. The contractor shall notify the COR /CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company- owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United

States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing

Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA access will return VA- issued property to VA. This property includes, but is not limited to: documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

4. TRAINING. This entire section applies to all acquisitions which include section 3.

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course

(Talent Management System (TMS) #10176) initially and annually thereafter.

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

Also complete: TMS #10203 HIPPA

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role- based information security training]

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.

5. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The contractor, subcontractor, their employees, or business associates shall immediately

(within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise

Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to

VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA was believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA

Information Systems VA Information Security Program, and VA Information Security Knowledge

Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

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

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving

Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract;

the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs.

6. INFORMATION SYSTEM DESIGN AND DEVELOPMENT. Intentionally deleted.

7. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE OR USE. Intentionally deleted.

8. SECURITY AND PRIVACY CONTROLS COMPLIANCE TESTING, ASSESSMENT AND

AUDITING. Intentionally deleted.

9. PRODUCT INTEGRITY, AUTHENTICITY, PROVENANCE, ANTI-COUNTERFEIT AND

ANTI-TAMPERING. Intentionally deleted.

10. VIRUSES, FIRMWARE AND MALWARE. – Intentionally deleted.

11. CRYPTOGRAPHIC REQUIREMENT. Intentionally deleted.

12. PATCHING GOVERNANCE. Intentionally deleted.

13. SPECIALIZED DEVICES/SYSTEMS (MEDICAL DEVICES, SPECIAL PURPOSE

SYSTEMS, RESEARCH SCIENTIFIC COMPUTING). This entire section applies when the acquisition includes one or more Medical Device, Special Purpose System or Research

Scientific Computing Device. If appropriate, ensure selected clauses from section 6 or 7 and 8 through 12 are included.

a. Contractor supplies/delivered Medical Devices, Special Purpose Systems-Operational

Technology (SPS-OT) and Research Scientific Computing Devices shall comply with all applicable Federal law, regulations, and VA policies. New developments require creation, testing, evaluation, and authorization in compliance with processes specified on the Specialized

Device Cybersecurity Department Enterprise Risk Management (SDCD-ERM) Portal, VA

Directive 6550, Pre-Procurement Assessment and Implementation of Medical Devices/Systems, VA Handbook 6500, and the VA Information Security Knowledge Service. Deviations from

Federal law, regulations, and VA Policy are identified and documented as part of VA Directive

6550 and/or the VA Enterprise Risk Analysis (ERA) processes for Specialized Devices/Systems processes.

b. All contractors and third-party service providers shall address and/or integrate applicable VA

Handbook 6500 and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO for governance or resolution.

c. The contractor shall certify to the COR/CO that devices/systems that have completed the VA

Enterprise Risk Analysis (ERA) process for Specialized Devices/Systems are fully functional and operate correctly as intended. Devices/systems must follow the VA ERA authorized configuration prior to acquisition and connection to the VA computing environment. If VA determines a new VA ERA needs to be created, the contractor shall provide required technical support to develop the configuration settings. Major changes to a previously approved device/system will require a new ERA.

d. The contractor shall comply with all practices documented by the Food Drug and

Administration (FDA) Premarket Submission for Management of Cybersecurity in Medical

Devices and Postmarket Management of Cybersecurity in Medical Devices.

e. The contractor shall design devices capable of accepting all applicable security patches with or without the support of the contractor personnel. If patching can only be completed by the contractor, the contractor shall commit the resources needed to patch all applicable devices at all VA locations. If unique patching instructions or packaging is needed, the contractor shall provide the necessary information in conjunction with the validation/testing of the patch. The contractor shall apply security patches within 30 business days of the patch release and have a formal tracking process for any security patches not implemented to include explanation when a device cannot be patched.

f. The contractor shall provide devices able to install and maintain VA-approved antivirus capabilities with the capability to quarantine files and be updated as needed in response to incidents. Alternatively, a VA-approved whitelisting application may be used when the contractor cannot install an anti-virus / anti-malware application.

g. The contractor shall verify and document all software embedded within the device which does not contain any known viruses or malware before delivery to or installation at a VA location.

h. Devices and other equipment or systems containing media (hard drives, optical disks, solid state, and storage via chips/firmware) with VA sensitive information will be returned to the contractor with media removed. When the contract requires return of equipment, the options available to the contractor are the following:

(1) The contractor shall accept the system without the drive, firmware, and solid state.

(2) VA’s initial device purchase includes a spare drive or other replacement media which must be installed in place of the original drive at time of turn-in; or

(3) Due to the highly specialized and sometimes proprietary hardware and software associated with the device, if it is not possible for VA to retain the hard drive, firmware, and solid state, then:

(a) The equipment contractor shall have an…