36C26026Q0851 This is a combined synopsis/solicitation for commercial products prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.2, “Streamlined Procedures for Solicitation, Evaluation, and Award for Acquisition of Commercial Products and Commercial Services. “Commercial Services,” as supplemented with additional information included in this notice. This announcement constitutes only the solicitation; quotes are being requested, and a written solicitation document will not be issued.

This is a Request for Quote (RFQ), and the solicitation number is 36C26026Q0851. The Government anticipates awarding five-year firm-fixed price purchase order.

This is a solicitation for Reference Laboratory Services for the Portland VA Medical Center. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-06 Effective March 17th, 2026.

This solicitation is set as Unrestricted Open Market and is being Competed as such. The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, with a business size of $41.5 Million, and the Product Service Code (PSC) is Q301.

The Department of Veterans Affairs, Veterans Healthcare Administration, Regional Procurement Office West, Network Contracting Office 20, on behalf of the VA Portland VA Healthcare System, is seeking the following Service and Support in compliance with the included Statement of Work.

The VA Portland Healthcare System (VHAPORHCS) Pathology & Laboratory Medicine Service Department requires continued access to specialized testing for Measurable Residual Disease (MRD) detection in hematologic malignancies. MRD is a powerful diagnostic and prognostic tool that quantifies the presence of residual cancer cells during and after treatment in patients with multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), and chronic lymphocytic leukemia (CLL).

The contractor shall provide MRD testing of an FDA-cleared, next generation sequencing (NGS)-based assay — for blood and bone marrow samples from patients diagnosed with multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and B-cell acute lymphoblastic leukemia (B-ALL).

Combined Synopsis/Solicitation Notice

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

07-27-2026 Hector Baltazar 360-553-7632 08-10-2026 10:00

PDT

36C260 Network Contracting Office 20

ATTN: V4CONT

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

X

621511 $41.5 Million

Net 30 Days

N/A

36C648 Department of Veterans Affairs Portland VA Medical Center

3710 NW US Veterans Hospital Road Portland OR 97239 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

1. Location: Portland VA Medical Center.

2. Services being solicitated: Reference Laboratory Services for MRD detection of hematologic malignancies.

3. Award will be a Base Year Plus Four Option Year Purchase Order.

Base Year: 09/01/2026 - 08/31/2027 Option Year 1: 09/01/2027 - 08/31/2028 Option Year 2: 09/01/2028 - 08/31/2029 Option Year 3: 09/01/2029 - 08/31/2030 Option Year 4: 09/01/2030 - 08/31/2031

4. Please see the Continuation Pages below for details regarding the submission of quotes.

5. For further information, please contact Hector Baltazar at hector.baltazar@va.gov.

See CONTINUATION Page

One

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.

https://www.fsc.va.gov/einvoice.asp

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

B.2 STATEMENT OF WORK

1. BACKGROUND

The VA Portland Healthcare System (VHAPORHCS) Pathology & Laboratory Medicine Service Department requires continued access to specialized testing for Measurable Residual Disease (MRD) detection in hematologic malignancies. MRD is a powerful diagnostic and prognostic tool that quantifies the presence of residual cancer cells during and after treatment in patients with multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), and chronic lymphocytic leukemia (CLL).

The contractor shall provide MRD testing of an FDA-cleared, next generation sequencing (NGS)-based assay — for blood and bone marrow samples from patients diagnosed with multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and B-cell acute lymphoblastic leukemia (B-ALL).

Testing shall be performed at the contractor’s CLIA-certified (requirement) and CAP-accredited (or equivalent; requirement) reference laboratory and include full interpretation and reporting of results to VHAPORHCS clinicians.

This full-service Reference Laboratory contract will provide services required for specimen testing, interpretation, testing supplies, and customer service. This requirement will ensure accurate and timely test results are made available to healthcare providers which will ensure high quality healthcare is provided to the Veterans at the VA Portland Health Care System.

2. SCOPE

a. The objective of this agreement is to provide VHAPORHCS with access to FDA-cleared and clinically validated MRD testing to support direct patient care within the Hematology/Oncology and Pathology and Laboratory Medicine Services (PALMS), ensuring accurate disease monitoring and outcome assessment for veterans undergoing cancer therapy.

b. The contractor shall:

1. Provide MRD testing for the following specimen and disease types:

1. Bone marrow aspirate or peripheral blood for:

a. Multiple Myeloma (MM)

b. Chronic Lymphocytic Leukemia (CLL)

c. B-cell Acute Lymphoblastic Leukemia (B-ALL)

2. FFPE Bone Marrow tissue (as applicable)

3. Please see Attachment A to this Statement of Work (SOW) for the test and quantities required by VAPORHCS.

4. Perform testing within the contractor’s CLIA-certified, CAP-accredited (or equivalent) laboratory using FDA-cleared protocols.

5. Provide average turnaround time shall be (6) business days from receipt of specimen.

6. Provide secure electronic results via a vendor-managed portal and fax reports directly to designated VA clinicians.

7. Maintain a customer-accessible results portal for tracking orders and retrieving historical patient data.

8. Provide technical support for order management and result interpretation.

9. Ensure all testing is performed using validated instruments, reagents, and methodologies per FDA clearance and CLIA/CAP (or equivalent) standards.

10. The Reference Laboratory shall also provide the following support services: supplies, customer service, reporting services, and verification of certification.

11. Provide all necessary supplies as defined in the laboratory user manual, to include, but not limited to the following:

12. Requisition forms or agreed computer ordering system

13. Specimen containers & collection kits

14. Specimen requirements for specimen collection & specimen processing

15. Methodologies and reference ranges

16. Expected turn-around times

17. All forms, including authorization of consent for genetic testing, informed consent, and chain of custody.

2. The VAPORHCS requires that the Reference laboratory provide technical and consultative support as it relates to any results provided by the vendor.

3. The vendor shall identify on Attachment A, whether the testing is performed in-house or sent out/referred to an alternate lab, not owned by the vendor.

c. Clinical Application and Importance:

1. The MRD assay is clinically essential for identifying and quantifying MRD in patients treated for hematologic malignancies. MRD detection is a powerful biomarker for determining remission depth and relapse risk, directly impacting:

1. Treatment continuation or modification (chemotherapy, transplant, immunotherapy decisions)

2. Clinical trial eligibility and disease response categorization

3. Prognostic evaluation for relapse-free and overall survival outcomes

2. For VHAPORHCS patients, MRD testing allows Hematologists/Oncologists to make data-driven treatment decisions, prevent unnecessary toxicity from ineffective therapies, and improve long-term survival rates.

3. These testing services are an integral component of direct patient care activities within the VHAPORHCS Hematology and Oncology Service and are performed in coordination with laboratory and clinical teams.

d. Deliverables:

1. The Reference Laboratory shall perform testing available at their site as requested by VA Portland Health Care System (VAPHCS).

2. Testing results for each submitted sample.

3. The specimen will be logged into the system within 24 hours of receipt.

4. VAPHCS will be notified if specimens are sub-optimal for testing within 24 hours of receipt at their facility.

5. Timely reporting of results in a format compatible with PALMS and clinical workflows.

6. A final report will be issued on the same day the test is complete and no later than 24 hours after testing is completed.

7. Documentation of quality control and laboratory compliance records as requested by the VA.

8. Services shall include the performance of analytical testing as defined by the Laboratory's reference test manual, the reporting of analytical test results and consultative services as required assimilating the full scope of its laboratory operations to Portland VA Laboratory Services.

e. Acceptance Criteria:

1. All test results must meet established clinical laboratory standards.

2. Test results must be delivered in a timely manner compatible with patient care needs and PALMS integration.

3. Reports must be accurate, complete, and actionable for the ordering clinician

4. Please see Attachment A to this Statement of Work (SOW) for the test and quantities required by VAPORHCS.

f. The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the specific range of referral testing within their capability.

3. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS

a. Identification of Possible Follow-on Work: None

b. Identification of Potential Conflicts of Interest (COI): None

c. Identification of Non-Disclosure Requirements: This medical center provides specific privacy to patients as part of its normal protocols.

d. Packaging, Packing and Shipping Instructions: Specimens will be packaged and shipped in accordance with Department of Transportation regulations for the shipment of biologic substances.

e. Inspection and Acceptance Criteria: Reference Laboratory shall notify the VAPHCS Department of Pathology and Laboratory Medicine of any specimens that do not meet the requirements for acceptance.

4. RISK CONTROL: None.

5. PLACE OF PERFORMANCE:

Reference Laboratory defined at award

6. TESTING METHODOLOGY, REFERENCE AND TURN AROUND TIME

a. Routine test results shall be reported within the specified turnaround time (TAT) which is defined from time of specimen pickup to when results are available. TAT is established by the VA facility. If testing is not within TAT, notify the VA Facilities of the new estimated TAT within 24 hours.

b. Testing methodology and reference ranges for a test must be defined in the Reference Laboratory user manual and/or website. Reference Laboratory shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced 30 days in advance.

c. Reference Laboratory agrees to maintain the minimum acceptable service, reporting systems and quality control. Exception handling: Reference Laboratory will notify VA Facilities Laboratory Service within 24 hours of any problems with specimens received.

d. The VA Facilities will provide laboratory specimens prepared according to the Reference Laboratory's user’s manual, identified, and labeled for testing.

e. Critical Value test results are not applicable.

f. The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the test listed in Attachment A. All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. perform reference testing on behalf of the Reference Laboratory.

g. The above is an estimated list of testing services needed, but not limited to. Based on the nature of patient care, there may be times in which a test is needed that is not found within the corresponding test list. From changing methodology, thus creating a new or different test, discovery of new antigens or antibodies or gene and/or urgent patient care needs. The included test list is an estimated and projection of use and is not all-inclusive.

h. Specimen type. Vendor must be able to process blood, bone marrow and formalin fixed paraffin embedded (FFPE) tissue blocks.

i. In the event new products or testing services are required, Contracting Office will determine if the new products or testing services are within scope, and if they are within scope, a modification to the contract will be required to add the new products or testing services prior to beginning any of the new testing services or processes.

7. CUSTOMER SERVICE

a. The Reference Laboratory will provide VA Laboratory with a means of communication to permit immediate inquiry regarding the status of pending tests or specimen problem, 24 hours per day, 7 days per week.

b. The Reference Laboratory shall provide names and telephone numbers of technical Directors and Pathologists available to provide information.

8. DELIVERY AND REPORTING

a. Billing summaries shall begin the first day of the month and include the last day of the month.

b. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government.

c. Deliveries must be accompanied by a delivery ticker or sales slip that contains the following information as a minimum:

1. Vendor Name

2. Applicable FSS contract number

3. Contract Number, Task order number, and Purchase Order number

4. Date of Purchase

5. Date of Shipment

6. Description of item

7. Quantity of each item

8. Unit price and extended (quantity x unit price) price for each item

d. The Reference Laboratory shall provide an end of year report showing sample issues, facility usage, and cost savings generated during the reporting period. The report will be due 45 days after the close of the calendar year.

e. Invoicing: An itemized invoice shall accompany each service order from the Contractor. This invoice must show item number, description, quantity, unit, unit price, and totals for each design (advanced and basic) used. All invoices shall include contract number, purchase/delivery order number and detail of services provided.

f. Invoicing: Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements:

1.) Your firm’s Tax Payer ID number (TIN) 2.) Your firm’s “Remit Address” information 3.) The VA Purchase Order (PO) number 4.) Your firm’s contact information: (Personal Name, Email, and Phone) 5.) Your VA point of contact information: (Personal Name, Email, and Phone) 6.) The Period of Performance dates (Beginning and Ending) 7.) All discount information if applicable (Percent and Date Terms) For additional information, please contact:

Tungsten Support Phone: 1-877-489-6135 Website: http://www.tungsten-network.com/uk/en/ Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafscched@va.gov

h. Invoices shall be submitted monthly with the following information:

1.) Contract number and purchase order number 2.) Station ID (648) 3.) Date services were requested 4.) Patient name and test 5.) Invoice will be billed as individual line items as they are listed in the price schedule.

i. Monthly invoice(s) will contain only those item numbers used for that month. Invoices not received in proper format will be returned

9. PERFORMANCE MONITORING

a. It is the intention of both parties to conduct joint reviews prior to the expiration date of the contract to determine and evaluate if services being provided are in accordance with the contract terms, payments and billings are being properly handled and to jointly determine if this agreement is satisfactory to both parties in terms of services provided and consideration being received. This review may include. but not be limited to: analyzing all billings, payments, costs, administrative issues, patient satisfaction, quality of care and other related documentation that identities that services have been received.

b. Upon conclusion of the initial contract period, and in coordination with the Contracting Officer, the service using it shall provide a statement to the Contracting Officer providing a summary of contractor actions and a statement that all requirements of the contract were fulfilled as agreed.

10. LICENSING AND ACCREDITATION

0. Reference Laboratory Contractor shall provide copies of all licenses, permits, accreditation and certificates required by law (please see b. and c. below).

0. The Laboratory Director shall be a licensed American Board of Pathology certified pathologist.

0. All medical facilities providing laboratory services under the contract must possess a valid state license, and meet CLIA and CMS requirements including CLIA certificate of compliance, and accredited by the College of American Pathologists (CAP) or equivalent accreditation agency.

11. PERSONNEL

a. The Reference Laboratory shall make sure employees have current and valid professional certifications before starting work under this contract.

b. The Reference Laboratory staff shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines.

c. The Government’s reserves the right to request information or certification from the contractor verifying they comply with this contract requirement. If discovered the contractor is not in compliance with this requirement the contract shall be terminated for cause in accordance with clause 52.212-4.

12. HOURS OF OPERATION

a. The Portland VA is open 24 hours a day, 7 days a week, 12 months of the year and may require services during those times.

13. PATIENT INFORMATION SAFETY

a. VAPORHCS will provide Protected Health Information (PHI) with each submitted specimen to the Reference Laboratory which includes full name, medical record number, social security number, date of birth, ordering provider’s name, laboratory accession number, specimen type, and specimen collection date and time.

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.

14. SECURITY REQUIREMENTS

The Reference Laboratory shall be responsible for adhering to the following statements as they relate to the contract. VA Portland Health Care System in coordination with the COR 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.

15. Quality Assurance Surveillance Program

Level

BACKGROUND INVESTIGATIONS AND SPECIAL AGREEMENT CHECKS

All Reference Laboratory employees are subject to the same level of investigation as VA employees who have access to VA sensitive information. The level of background investigation commensurate with the level of access needed to perform the work is: Low Risk. This requirement is applicable to all subcontractor personnel requiring the same access.

The Reference Laboratory shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the Reference Laboratory shall reimburse the VA within 30 days.

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

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 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. In accordance with VHA DIR 1605.05, A Business Associate Agreement is not required for this contract as it falls under the treatment exemption of the HIPAA Privacy Rule.

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.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Reference Laboratory Services for specialized Testing for Measurable Residual Disease (MRD) detection in hematologic malignancies.

Contract Period: Base POP Begin: 09-01-2026 POP End: 08-31-2027

Reference Laboratory Services for specialized Testing for Measurable Residual Disease (MRD) detection in hematologic malignancies.

Contract Period: Option 1 POP Begin: 09-01-2027 POP End: 08-31-2028

Reference Laboratory Services for specialized Testing for Measurable Residual Disease (MRD) detection in hematologic malignancies.

Contract Period: Option 2 POP Begin: 09-01-2028 POP End: 08-31-2029

Reference Laboratory Services for specialized Testing for Measurable Residual Disease (MRD) detection in hematologic malignancies.

Contract Period: Option 3 POP Begin: 09-01-2029 POP End: 08-31-2030

Reference Laboratory Services for specialized Testing for Measurable Residual Disease (MRD) detection in hematologic malignancies.

Contract Period: Option 4 POP Begin: 09-01-2030 POP End: 08-31-2031

GRAND TOTAL

B.4 DELIVERY SCHEDULE

3710 NW US VETERANS HOSPITAL ROAD

PORTLAND, OR 97239 2999

USA

Page 1 of Page 1 of

SECTION C – CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025) (DEVIATION)

(a) Definitions. The clause at Federal Acquisition Regulation (FAR) 52.202-1, Definitions, is incorporated by reference.

(b) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

© Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(d) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

© Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause FAR 52.233-1, Disputes, which is incorporated in this contract by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence. Examples of occurrences include acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. When an excusable delay occurs, the Contractor shall—

(1) Notify the Contracting Officer in writing as soon as possible;

(2) Remedy the delay as quickly as possible; and

(3) Notify the Contracting Officer when the occurrence is over.

(g) Invoice. The Government will handle invoices according to the Prompt Payment Act (31 U.S.C. 3903) and 5 CFR part 1315. The Contractor shall submit invoices to the address designated in the contract to receive invoices. An invoice must include the information required by 5 CFR part 1315.9(b).

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees, and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark, or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date that appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(4) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

© Affected line item or subline item, if applicable;

(D) Contractor point of contact; and

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(5) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by FAR part 33 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or © The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see FAR part 32).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a termination for cause.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on-

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or © The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures for interest credits prescribed in FAR part 32 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon—

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for…