36C26025Q0346.docx

36C26025Q0346

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

36C26025Q0346 03-18-2025 Eric Lingenfelter 360-852-9891 03-24-2025 16:00

PDT

36C260 Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver

WA

98661 X 621991 $41.5 Million Net 30 Days N/A X 36C531 Department of Veterans Affairs Boise, ID VA Medical Center 500 W Fort St.

Boise

ID

83702 36C260 Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver

WA

98661

Dept of Veterans Affairs

FMS-VA-2(101)

Financial Services Center

PO BOX 149971

Austin

TX

78714-9971 See CONTINUATION Page Contractor shall provide blood & blood products to VA Boise, Idaho Medical Center in accordance with Terms and Conditions of the Performance Work Statement (PWS).

The Government intends to fund a single award Indefinite Delivery Indefinite Quantity (IDIQ) five-year contract.

Individual bulk funded Task Orders will be issued as needed by the NCO 20 Contracting Office.

Period of Performance (POP): 04/01/2025 - 03/31/2030 All vendor questions regarding solicitation 36C26025Q0346 shall be submitted in writing to Andrew O'Neal at Andrew.O'Neal@va.gov no later than 16:00 PST on 03/24/2025.

Questions and offers are to be submitted by electronic mail only. Telephone calls will not be accepted.

See CONTINUATION Page X Table of Contents

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 36C260 Network Contracting Office 20

ATTN: V4CONT

1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661

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

3. INVOICES: Invoices shall be submitted in arrears:

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.

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Transfusion Medicine Services-Blood and Blood Products

Contract Period: Base POP Begin: 04-01-2025 POP End: 03-31-2026

Transfusion Medicine Services-Blood and Blood Products

Contract Period: Option 1 POP Begin: 04-01-2026 POP End: 03-31-2027

Transfusion Medicine Services-Blood and Blood Products

Contract Period: Option 2 POP Begin: 04-01-2027 POP End: 03-31-2028

Transfusion Medicine Services-Blood and Blood Products

Contract Period: Option 3 POP Begin: 04-01-2028 POP End: 03-31-2029

Transfusion Medicine Services-Blood and Blood Products

Contract Period: Option 4 POP Begin: 04-01-2029 POP End: 03-31-2030

B.3 DELIVERY SCHEDULE

1.00

1.00

1.00

1.00

1.00

Page 1 of Page 1 of B.4 Statement of Work Blood and Blood products boise vamc Contracting officer’s technical representative (COTr)

contract Objective

1.1 This acquisition seeks to continue a secure a blood supplier that can procure, transfer, and make available blood/blood components and related services. These products and services are an integral part of the care of patients and directly impacts the patient care at Boise Veterans Affairs Medical Center (VAMC).

scope

1.2 General Requirements. The contractor shall provide, upon request and as reasonably available, Boise VAMC requirements for blood/blood components set forth on the Fee Schedule attached hereto and incorporated herein as Attachment A. Blood Center will serve as Boise VAMC’s exclusive provider of the Blood Products. In the event Blood Products are not available through Blood Center’s local distribution center, Blood Center will use reasonable efforts to coordinate with one or more of its affiliated or other blood centers to secure necessary Blood Products. If Blood Center is unable to furnish Blood Products as requested, Boise VAMC shall be free to procure such Blood Products from other sources, but only to the extent and for the duration of such inability.

1.3 Ordering Practices. Boise VAMC will submit requests for Blood Products in accordance with Blood Center policies, as may be amended by Blood Center from time-to-time. Blood Center will provide Boise VAMC with prior written notice of any change to ordering policies. STAT orders will be filled with the shortest shelf-life product available. Material changes in scope and volume must be mutually agreed upon between the parties.

1.4 Product Service Availability. Contractor must be located within the Treasure Valley and Blood product ordering available 24 hours per day, seven days a week, and 365 days a year.

· Stock. Boise VAMC has a designated number of blood product units and types required to maintain operations. At defined intervals or “rotation”, contractor will supply stock levels of blood products with expirations dates that extend beyond the next rotation. Boise VAMC will rotate previous stock levels to contractor for reissue.

· Routine. Contractor will fill routine orders for blood products to maintain stock levels at Boise VAMC. Routine orders shall be delivered within 24 hours.

· STAT. Emergency orders of blood products are to be delivered within 2 hours of ordering during business hours and as soon as possible during off service hours. STAT orders will be always filled, 24 hours a day no matter the day of the week including holidays.

· Blood products include, but are not limited to, the following products.

Leukoreduced Red Blood Cells

Apheresis Platelets – LVDS

Apheresis Platelets – PAS Pathogen Reduced

Plasma

Cryoprecipitate

Cryoprecipitate Pools

· The Contractor shall modify products as requested and as necessary for the protection of the patient, to include, but not limited to leukocyte reduction and irradiation.

1.5 Reference Laboratory. The Reference Laboratory testing shall be available 24 hours per day, seven (7) days per week, including all holidays. The Emergent shall be completed as urgent as possible. The STAT shall be completed within 1 business day (M-F). The ROUTINE shall be completed within 3 business days or Date/Time needed.

1.6 Account Manager. The contractor shall designate a contract service manager to address any satisfactory or unsatisfactory performance of required services. All situations shall be followed up with documentation when applicable. The manager shall meet, as necessary, to discuss immediate administrative or technical issues as they arise.

1.7 Medical Director. The contractor shall maintain a Medical Director available for consultation purposed and resolving blood product availability concerns.

1.8 Licensure, Certification and Accreditation. Contractor shall be currently registered and licensed with the Food and Drug Administration (FDA), Health and Human Services pursuant to Section 510 of the Federal Food, Drug, and Cosmetic Act, as amended, 21 USC Section 260 and certified by the Association of Blood and Biotherapies (AABB). All products, if interstate shipment of blood products is involved, contractor must submit statement that such approval has been authorized under section 251 of the Public Service Act, as amended, 2 USC Section 262, as a source of supply for blood products. Contract shall submit proof of AABB accreditation and CLIA certification upon request.

1.9 Service Standards. In addition to the service standards described above, Blood Center shall, throughout the term of this Agreement: maintain a written quality assurance program which includes quality assurance, quality control and proficiency testing programs. Upon Hospital's reasonable request, Blood Center will provide Hospital with written documentation reflecting Blood Center’s compliance with its quality assurance program.

Technical staff performing tasks under this contract shall be certified by a national professional certification body appropriate for the specialty and complexity of the task being performed. The Supervisory personnel, including the Medical Director(s) shall maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the College of American Pathologist (CAP), and AABB accreditation standards. The Medical Director shall be a licensed physician with suitable qualifications and experience to direct a laboratory and blood bank facility. Copies of the professional certification and licensure of the Laboratory Director and Medical Director shall be provided upon request.

1.10 Delivery of Blood Products. Blood Center and Hospital will establish a mutually agreeable schedule for routine stock deliveries. Additional fees for deliveries in excess of routine deliveries are set forth on Attachment A delivery fees. Blood Center shall provide and retain ownership of transportation containers and equipment for use in providing the routine delivery service for Products. Deliveries may be made seven (7) days each week, twenty-four (24) hours per day.

Contractor provide and maintain ownership of transportation containers verifying and meeting transportation and storage standards established by AABB.

1.11 Blood Product Testing and Donor Selection. If and to the extent required by applicable Standards and Laws, Blood Center will (i) perform donor and Blood Product testing; and (ii) utilize aseptic methods to minimize the risk of Blood Products contamination. Blood Center will employ methods to detect, limit or inactivate potential contaminates that are either FDA-approved or validated to provide sensitivity equivalent to FDA-approved methods. Information regarding specific testing methods is available upon request. To ensure compliance with applicable Laws and Standards or for operational reasons, Blood Center may from time-to-time update or initiate new donor testing procedures. Blood Center shall use commercially reasonable efforts to provide Hospital with thirty (30) days prior written notice of any such updated or new testing procedures and will determine whether it is necessary for Hospital to return or exchange Blood Products not subject to the updated testing procedures.

Blood shall be typed for ABO & Rh antigens and labeled in accordance with the methods recommended in the current editions of “Standard for Blood Banks and Transfusion Services and Technical methods and Procedures,” published by the AABB.

All blood shall be collected by closed system under aseptic conditions and shall be processed in appropriate solutions and the container meet International Society of Blood Transfusion (ISBT) label standards. All blood supplied shall be grossly free of hemolysis, clots, and excessive lipemia. Blood products will be considered only from blood banks that are able to provide the VA with 100% “volunteer donors” blood in accordance with the latest FDA rules and regulations. Definition of a “volunteer donor”. A volunteer donor is a person who does not receive monetary payment for blood donation.

1.12 Notifications, Recalls, and Lookback. The contractor will promptly notify Boise VAMC when information indicates that Blood may deleteriously affect a transfusion recipient.

· Contractor will provide the following notifications to the Customer: (a) within three calendar days if Blood collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; (b) within forty-five (45) days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by the FDA; and (c) as set forth in 21 C.F.R 610.47(a)(3).

· Conversely, Boise VAMC will report possible transfusion-transmitted infections or other serious complications associated with transfusion which may have resulted from Blood ("Adverse Event"). Boise VAMC will cooperate with investigation of any Adverse Event and supply information concerning the recipient of the blood product.

1.13 Credit and Return of Blood Components.

· Damaged Blood: If the Blood arrives to the Customer: (1) in a damaged condition, or (2) in a condition rendering the Blood unsuitable for transfusion, then Customer should notify ARC immediately in Connect for further instructions. If ARC requests the return of Blood, ARC will pay the shipping costs associated with such returns. Credit may not be issued if notification is not made within 24 hours of product receipt.

· Regulatory Recall: If the FDA or another regulatory agency requires ARC to recall Blood, or if ARC voluntarily chooses to recall Blood for quality reasons, Customer will discard the Blood unless ARC instructs otherwise. If ARC requests the return of recalled Blood, ARC will pay the shipping costs associated with such returns.

· Boise VAMC may return blood units for reissue with a credit for the products per an agreed upon schedule of “Stock Rotation”. A credit will be given per eligible return units and may include a restocking fee.

Confidentiality

1.14 Confidentiality. Neither Party will disclose to any third party any provision in this Agreement unless: (a) required by law, in which case, the disclosing Party will provide prompt advance notice of disclosure so the other Party may seek a protective order or other remedy; (b) required by an accreditation or regulatory agency during an inspection, in which case, the disclosing Party will protect the disclosures through the use of a comprehensive nondisclosure agreement, or (c) such disclosure is to the disclosing Party's legal advisor(s), in which case, the disclosing Party will protect the disclosures through the use of a comprehensive nondisclosure agreement.

1.15 Pursuant to this Agreement, either Party (the "Disclosing Party") may provide Confidential Information to the other Party (the "Recipient"). For purposes of this Agreement, "Confidential Information" includes. all documents, materials and information regarding or relating to the Disclosing Party's business, assets, personnel (including but not limited to volunteers), financial condition, results of operations, inventions, discoveries, methods, operations, ideas, concepts, plans, designs, products, processes, know-how, trade secrets, intended uses, technology, and/or prospects. Without limiting the scope of the foregoing, "Confidential Information" shall also include all documents, materials and other information that constitute, relate to, and/or identify (i) protected health information about an individual; (ii) any vendor or other third party that provides any goods or services to, or receives any goods or services from, either Party. Any such documents, materials or other information disclosed to Recipient shall constitute Confidential Information regardless of whether it is marked or designated as "confidential" by the Disclosing Party. The term "Confidential Information" shall also include any changes, modifications, derivations, or improvements (collectively, "Changes") made by Recipient to any of the Confidential Information (whether at the request of the Disclosing Party or otherwise). The Disclosing Party shall retain all rights of ownership in the Confidential Information and in any and all Changes that Recipient may affect.

1.16 Notwithstanding the foregoing, "Confidential Information" shall not include information that (i) was already part of the public domain at the time of the disclosure by the Disclosing Party; (ii) became part of the public domain after the disclosure by the Disclosing Party; or (iii) was lawfully in Recipient's possession prior to the disclosure by Disclosing Party and was not acquired from Disclosing Party or from a third party who was under a contractual, legal, fiduciary or other obligation restricting or prohibiting transmittal of such information to Recipient.

1.17 Recipient shall safeguard and maintain all Confidential Information as strictly confidential and shall use it solely for the purpose of fulfilling its obligations under this Agreement. Recipient will limit access to Confidential Information to its employees with a need to know the Confidential Information and will instruct its employees to keep the information confidential. Without the Disclosing Party's prior written consent, Recipient shall not disclose any Confidential Information to any third party.

1.18 In the event that Recipient is required by law or is requested, in the course of any judicial, administrative, or governmental proceeding, to disclose any Confidential Information, Recipient shall promptly notify the Disclosing Party and reasonably cooperate with the Disclosing Party's efforts (at Disclosing Party's expense) to seek an appropriate protective order, confidential treatment, or other remedy.

VA INFORMATION SECURITY LANGUAGE

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.

Access to VA Information and VA Information Systems

5.1 When patient samples are sent to the reference laboratory for additional testing the following patient information is submitted along with the sample: Patient Name, Patient Social Security Number, Patient Date of Birth, Patient Diagnosis and the Patient Provider.

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.

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 US 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 Veteran Affairs does not have a Memorandum of Agreement with Defense Security Services (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 US 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-US services are provided and detail a security plan, deemed to be acceptable to VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the US 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.

Custody of VA Information

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

b. VA information should not be co-mingled, if possible, with any other data on the contractor/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 onsite 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 the 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 VA Directive 6300, Records and Information Management and its Handbook 6300.1, Electronic Media Sanitization. Self0-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 to 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 date used by the contractor/subcontractor needs to be restored in 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 FAR Part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated an 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 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, the 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 COTR.

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 Contracting Officer and the COTR 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 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 date 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, 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.

Liquidated Damages for Data Breach

a. Consistent with the requirements of 38U.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 the 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 of the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the date 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 event (loss, theft, unauthorized access);

3. Number of individuals affected or potentially affected;

4. Names of individuals or groups affected or potentially affected;

5. Ease of logical date 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 date 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 of $37.50 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 report 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 coverage at $0 deductible; and

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

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. Within 10 working day 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.

PATIENT INFORMATION SAFETY

a. The Reference Laboratory shall not use or disclose Protected Health Information (PHI) other than as permitted or required by the agreement or as required by law.

b. The Reference Laboratory shall use appropriate safeguards to prevent use or disclosure of the PHI other than is provided for by this agreement.

c. The Reference Laboratory shall report immediately any breach of safeguards and mitigate any harmful effects related to the use or disclosure of PHI by the Reference Laboratory or any of its agents, including sub-contractors.

SECURITY REQUIREMENTS

The Reference Laboratory shall be responsible for adhering to the following statements as they relate to the contract. Boise VA in coordination with their site Information Security Officer (ISO) shall monitor the work performed by contractor personnel, including sub-contractors, on a periodic basis to make sure contractor personnel are following the stated security requirements.

Fees and Payment

1.19 Properly completed invoices shall be submitted for certification to:

Boise Veterans Affairs Medical Center 500 W Fort Street, Boise Idaho 83702

1.20 Invoice shall be itemized to include the following information:

1. Invoice number and date.

1. Customer Number

1. Payment terms – 1.5/15 net 30

1. American Red Cross Tax ID

1. Accounts receivable phone number

1. Selling Unit

1. Purchase Order Number

1. Invoice Date

1. Description of services performed, or products supplied.

1. Quantity delivered and/or returned.

1. Unit cost billed.

1. Credit Total Amount

ATTACHMENT A

QUANTITIES, FEES AND DELIVERY TERMS