36C26324Q0869.pdf

PDF 630 KB Posted Jun 13, 2024

Attached to: 6505--Blood Products & Testing IDIQ CIVAHCS
Solicitation number: 36C26324Q0869
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 23

About this file

Written by GovTribe AI · Jun 13, 2024

This document is a solicitation for an Indefinite Delivery Indefinite Quantity (IDIQ) contract for blood, blood products, and necessary testing services for the Department of Veterans Affairs (VA) Central Iowa Healthcare System.

The key details are:

The contract will provide blood, blood products, and necessary testing for the VISN 23 VA Central Iowa Pathology and Laboratory department to allow for an uninterrupted blood and blood products supply and testing not performed at the VA Central Iowa Laboratory.
The period of performance is 10/1/2024 to 9/30/2029, with a base year and four one-year option periods.
The contract is set aside for small business and has a maximum value of $1,000,000.
Offerors must submit offers by 7/12/2024 at 4pm CST.
Pricing is requested for various blood products and testing services, with estimated quantities provided.
The contracting office is the VA Network 23 Contracting Office in Coralville, IA.

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File	Type	Posted
36C26324Q0869_1.docx	DOCX document	Jun 13, 2024
D.1 Supply eCMS Line Item Template.xlsx	XLSX spreadsheet	Jun 13, 2024

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PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

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

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C26324Q0869 6/13/2024

Joshua Imdacha 3193397017 7/12/2024 4pm CST

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

621991

$40 Million

N/A

CENTRAL IOWA HCS

3600 30TH ST. BLDG 10

DES MOINES IA 50310

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

NCO 23 has a requirement for blood, blood products, and necessary testing IDIQ for the Central Iowa

VA Healthcare System See sections B.2-B.3 for details

FAR 13.5 procedures

Comparative Evaluation see provision 52.212-2

FOR CONSIDERATION ALL QUESTIONS MUST BE RECEIVED 72 HOURS

BEFORE DATE STIPULATED IN BLOCK 8 OF THE SF1449 FORM.

EMAIL ALL QUESTIONS AND RESPONSES TO JOSHUA.IMDACHA@VA.GOV

SIGN SF1449 AND RETURN ALL PAGES WITH OFFER SUBMISSION

See CONTINUATION Page

X X

X 1

Joshua Imdacha Contracting Officer

36C26324Q0869

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.216-18 ORDERING (AUG 2020)

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

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.7 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.9 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (MAY 2020)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) .. 39

C.12 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (FEB 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

See attached document: D.1 Supply eCMS Line Item Template

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

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

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.10 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

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

SERVICES (NOV 2021)

ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (FEB 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C263

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 []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

http://www.tungsten-network.com

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

STATEMENT OF WORK (SOW)

1. Contract Title

Blood, blood products, and necessary testing.

2. Objectives

• The contract will provide blood, blood products, and necessary testing for the VISN

23 VA Central Iowa Pathology and Laboratory department.

• To allow for an uninterrupted blood and blood products supply and testing not performed at the VA Central Iowa Laboratory.

3. Place of Performance

Supplies delivered to:

VA Central Iowa Health Care System

3600 30th Street, Des Moines, IA 50310

Necessary testing:

Contractor site

4. Period of Performance

Performance period is from 10-1-2024. The Contractor shall provide deliveries and testing under this contract as requested.

• Base Year from 10-1-2024 to 9-30-2025

• Option Year One 10-1-2025 to 9-30-2026

• Option Year Two 10-1-2026 to 9-30-2027

• Option Year Three 10-1-2027 to 9-30-2028

• Option Year Four 10-1-2028 to 9-30-2029

5. Scope.

A. Quality of the Product

1. All whole blood and blood components provided to patients in VA medical centers must meet the requirements of the American Association of Blood Banks (AABB), the Food and Drug Administration (FDA), and Department of Health and Human Services.

2. Allogeneic blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies and must be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB.

a. All blood must be collected by the closed system under aseptic conditions, processed in appropriate solutions and the container so labeled. The label must also bear the expiration date of the contents, which must not exceed the Food and Drug Administration (FDA) allowable limit for the type of anticoagulant in which the blood component is drawn.

b. All blood supplied must be free of hemolysis, clots, and excessive chyle.

3. Autologous blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies, and must be tested for all transfusion transmitted disease markers currently required by the FDA.

4. The Contractor shall supply 100% “volunteer donor” blood as defined in 21CFR606.121(c)(5)(ii) . All blood/blood components must be collected from donors in accordance with the requirements of the AABB and the FDA.

5. In the event of a recall, Contractor shall promptly send copies of the recall request to the Blood Bank Medical Director at the VA medical center where the blood product was issued.

6. Contractor shall make reference transfusion services available as outlined in the schedule of services. The offeror must be capable of providing the blood components and specialized testing detailed in the Schedule of Supplies/Services and Prices/Costs (the Schedule) on a 24-hour per day, seven days per week basis.

B. Changes in Testing Requirements for Transfusion Transmitted Diseases

In the event that additional testing for transfusion transmitted diseases is nationally mandated by the FDA during the contract period, specific price adjustments may be requested by the supplier to address the cost for the additional testing. In the event that this should occur, a letter detailing the rationale for the price increase must be submitted to the Contracting Officer at least 30 days before the intended implementation date.

C. Donor Requirements

1. The contractor shall maintain readily available blood donor lists, including names, addresses, and date of birth. Such lists must indicate whether, and on what date, blood of a particular donor was furnished to the VA under this contract.

Offeror’s donor identification numbers must be unique to the donor unit and must have an FDA-approved numbering schematic.

2. Donor selection must be in accordance with criteria established by the FDA and/or the AABB.

3. Each unit of blood collected through voluntary donation must minimally be tested for infectious diseases as outline by regulatory agencies.

4. Each platelet component must be tested for bacterial contamination in accordance with AABB standards.

D. Orders/Deliveries

1. 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 particular blood product which has been used since the previous routine delivery.

ASAP orders must be delivered within 2 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 must be delivered within 60 minutes.

2. Contractor shall make delivery services for blood and blood components available to all VA sites 24 hours per day, seven days a week, 365 days a year, subject to blood product availability and a lack of force majeure events as set forth in 48CFR52.212-4(f).

3. All blood products delivered under this contract 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 VA Medical Center. The contractor will meet all federal and state DOT requirements for transportation of human blood and blood products.

4. Routine orders shall be placed utilizing the contractor’s computer based on-line ordering/inventory system; and shall be delivered by the contractor within 24 hours.

STAT and ASAP orders shall be placed utilizing a direct line telephone system.

5. Once units are received by a VA medical center, those units become the property of the VA medical center, and payment will be made appropriately, based on contract terms and proper invoicing. They are not to be treated as though they are on consignment. However, for inventory control purposes, efforts will be made by the VA medical center to assist the contractor and other facilities in meeting patient transfusion needs.

6. The VA will comply with all requirements and regulations associated with the recall and withdrawal of blood or blood components from its inventory due to health and safety risks.

E. Shelf Life

1. All blood/blood components must be labeled, stored, and shipped in accordance with the current regulations of both the FDA and the AABB. In the event that these regulations change during the course of the contract, the contractor shall implement the necessary changes as directed/recommended by the regulatory and accrediting agencies.

2. For routine orders, allogeneic blood/blood components must be supplied with appropriate remaining shelf life, as detailed below.

Allogeneic blood/blood components Appropriate Remaining Shelf Life Red Blood Cells Shelf life more than 14 days, regardless of anti-coagulant Fresh Frozen Plasma Shelf life more than 60 days Plateletapheresis or Acrodose Platelets

Stored at Contractor’s facility until date of transfusion: remaining shelf life 1 day

Cryoprecipitate Shelf life more than 60 days

3. For ASAP and STAT orders, the contractor shall provide units with the appropriate remaining shelf life whenever possible, however, the VA understands that the urgency of the situation and the availability of the blood product may preclude this possibility.

4. When the VA returns units prior to expiration in accordance with the contractors return policy, the contractor shall credit the VA for units which are returned, as detailed in the Price Schedule.

F. Services

1. Contractor shall provide physician and medical technologist consultative services to the VA Central Iowa Health Care System that are consistent with the services offered to other non-VA contracted customers. These services shall include telephone consultative assistance to VA Central Iowa blood bank laboratory staff, for testing performed on site by the VA. A description of the services must be included with the offeror’s proposal.

This assistance must be available on a 24/7 basis.

2. Contractor shall provide educational programs to the Central Iowa Health Care System that are consistent with the programs offered to other non-VA contracted customers. A description of the educational programs must be included with the offeror’s proposal.

3. Contractor shall provide storage of platelets at their facility until needed for transfusion.

4. Contractor shall provide a computer on line ordering/inventory management system that VA staff can access to order blood products and check status of orders. Contractor shall provide a telephone number that is monitored 24/7 for ordering ASAP and STAT blood products and related testing.

G. Security

1. The C&A requirements do not apply. A Security Accreditation Package is not required.

H. Definitions

ALLOGENEIC: Blood or blood components drawn from a non-related donor for subsequent transfusion to a patient (synonymous with homologous).

ANTIBODY WORK-UP: Serological work-up performed on potential transfusion recipients, per patient per episode (set of examples); may be defined as simple or complex.

AUTOLOGOUS: Blood drawn from a donor-patient for subsequent transfusion; in this case, restricted to pre-deposit units of blood, i.e., not including intra-operative or post-operative blood salvage.

BLOOD GROUP: ABO Blood group plus the Rho(D) type of the unit, specifically O+, O-, A+, A-, B+, B-, AB+, AB-.

CMV NEGATIVE: Unit from a donor who has been screened for antibody to Cytomegalovirus and deemed to be negative. Use of CMV negative blood components are indicated in those patients who are undergoing transplantation or are otherwise severely immunocompromised.

COMPONENT (BLOOD COMPONENT): Portion of a unit of whole blood which has been physically separated by some mechanical means, e.g., centrifugation.

CRYOPRECIPITATE: Plasma component which has been prepared to contain high concentrations of Factor VIII and fibrinogen. It is stored in the frozen state and thawed immediately prior to transfusion. Product is used for the treatment of specific coagulation factor deficiencies, such as von-Willebrand’s Disease, hypofibrinogenemia and uremic thrombocytopenia which have been shown to be irresponsive to DDAVP treatment.

DERIVATIVE: Portion of a unit of whole blood or blood component which has been chemically separated by some type of fractionation process. Examples include albumin, plasma protein fraction, intravenous gamma globulin, and various coagulation products.

FRESH FROZEN PLASMA (FFP): Plasma component that is stored in the frozen state and is thawed immediately prior to transfusion. Used for the treatment of significant multiple coagulation factor deficiencies or congenital factor deficiencies not treatable by cryoprecipitate. These may be associated with massive transfusion, severe liver disease, disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenia purpura, but not as a volume expander. Fresh frozen plasma 24 (FP24) is plasma frozen within 24 hours of collection and contains reduced levels of Factor VII and normal levels of Factor V. FP24 may be used interchangeably with FFP unless used to treat Factor VII deficiency.

HOMOLOGOUS: Blood or blood component drawn from a non-related donor for subsequent transfusion to a patient (synonymous with allogeneic).

IRRADIATED COMPONENT: Blood component that has been subject to a minimum central dose of 2500 cGy of irradiation.

LEUKOCYTE-REDUCED BLOOD COMPONENTS: Cellular products prepared by an approved filtration method.

PLATELETAPHERESIS: Platelet component which is drawn from a donor using apheresis equipment, is stored in the liquid state, and is roughly equivalent to six to eight units of random platelets. Used for the treatment of significant thrombocytopenia as indicated for random platelets; however, it offers the advantage of minimizing donor exposures to prevent the patient from becoming refractory and/or contracting a transfusion transmitted disease.

PLATELETS (Acrodose): Platelet component that is prepared from a pool of platelet donations from approximately six units of whole blood and is stored in the liquid state.

Used for the treatment of significant thrombocytopenia associated with a variety of other clinical conditions, including active bleeding, massive transfusion, disseminated intravascular coagulation, and scheduled invasive procedures. Provides similar quantity of platelets as Plateletapheresis, but is not derived from a single donor and does not have the advantage of minimizing donor exposures to prevent the patient from becoming refractory and/or contracting a transfusion transmitted disease.

RECALL: A request from the supplier of blood component to return a specific unit(s) which was inadvertently issued to the VA medical center, regardless of the reason, or was issued to the VA medical center prior to the receipt of information about a donor which would have prevented such release.

RED BLOOD CELLS (RBC): Red cell components that remain in the liquid state, i.e., not frozen, regardless of anticoagulant. Used for the treatment of anemia which is not treated pharmacologically either due to etiology or time constraints.

ROUTINE ORDERS: Orders that are generally placed on a regular basis at a pre-established time to provide adequate inventory of specific blood components of specific blood groups.

SHELF LIFE: Number of days remaining prior to the expiration date from the date received in the facility.

SPECIAL TYPINGS: Typings for RBC antigens other than ABO and Rho(D); performed in order to find red blood cell units appropriate for patients who have developed unexpected antibodies.

STANDING ORDER: A type of routine order which allows for shipment of a specific volume of specific blood components according to an established delivery schedule; assists the supplier in projecting volumes of components required in order to improve recruitment and minimize waste.

VOLUNTEER DONOR: Person who does not receive monetary payment for blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs, and cancellations on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment.

6.0 Invoice / Payment: The Contractor shall submit the invoice at the completion of services to the POC/COR prior to submitting it to OB10 for verification. OB10 shall forward the Contractor’s invoice directly to DFAS Austin (also known as the Finance Service Center) for payment. All invoices shall include the Contract number, Purchase Order number, Order Date, Period of Performance, and Description of Services. The invoices shall provide significant detail to enable reconciliation.

IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and 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 must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

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

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

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT – Not required per 6500.6

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE - Not required per 6500.6

6. SECURITY INCIDENT INVESTIGATION

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

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

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

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

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis.

Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

8. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

9. TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document - e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, 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 training and documents are complete.

B.3 PRICE/COST SCHEDULE

Please complete attachment D.1 Supply eCMS Line Item Template The Department of Veterans Affairs has set the maximum cost limitation for this IDIQ at $1,000,000.00 for the lifetime of this contract.

The guaranteed minimum value of this contract is set at $40,000.00.

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES

ESTIMATED

QUANTITY UNIT UNIT PRICE

ESTIMATED

AMOUNT

500.00 ea __________________ __________________ Red Blood Cells Leukoreduced Units

Contract Period: Base POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

5.00 ea __________________ __________________ RBC Washed