C03 36C26024P0508.pdf

PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

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

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

648-24-3-066-0059

36C26024P0508

EFFECTIVE: 05-01-2024

Eric Lingenfelter 360-852-9891

36C260 60 Network Contracting Office 20

ATTN: V4CONT

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

X

621511

$41.5 Million

N/A

Department of Veterans Affairs Portland VA Medical Center 3710 NW US Veterans Hospital Road Portland, OR 97239-2999

0YUJ3

OREGON HEALTH & SCIENCE UNIVERSITY

OREGON HEALTH & SCIENCE UNIVERSITY

3181 SW SAM JACKSON PARK RD

PORTLAND OR 97239

NPSNT86JKN51

Dept of Veterans Affairs

FMS-VA-2(101)

Financial Services Center

PO BOX 149971

Austin TX 78714-9971

See CONTINUATION Page

a. Location: Portland VA Medical Center

b. Referral Laboratory Services For Histocompatibility and Immunogenetics Testing and Interpretation to Support VAPORHCS Transplant Program.

c. Period of Performance: 5/1/2024 - 10/31/2024.

d. Please reference IFCAP Order 648-C45225 on all invoices for this Period of Performance.

e. VA POC for this order is Eric Lingenfelter, 360-852-9891, eric.lingenfelter@va.gov.

$749,944.45 See CONTINUATION Page

648-3640160-066-822300-2560 010022365

X X

Jose Ronstadt Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ACCOUNTING AND APPROPRIATION DATA

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

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

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

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

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEC 2023) (DEVIATION) (JAN 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

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: Oregon Health & Science University

Kelli Rigsbee

503-494-4147 riggsbek@ohsu.edu

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:

[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 IN ARREARS.

d. The following hyperlink contains information for invoicing e-Invoice Program - VA-FSC Internet. https://www.fsc.va.gov/einvoice.asp

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

B.2 STATEMENT OF WORK

A. DEFINITIONS

1. UNOS – United Network for Organ Sharing

2. OPTN – the Organ Procurement and Transplantation Network

3. ASHI – American Society for Histocompatibility

4. CLIA – Clinical Laboratory Information Act

5. P&LMS – Portland VA Pathology and Laboratory Service

6. VAPORHCS – VA Portland Health Care System

7. OPO – Organ Procurement Organization

B. BACKGROUND:

The VA Portland Health Care System Pathology & Laboratory Medicine Service requires Referral Laboratory services to provide histocompatibility and immunogenetics testing & interpretation to support VAPORHCS transplant program.

This contract is required because patients that are considered for transplant must have specific laboratory tests performed by a lab that is accredited by the UNOS and OPTN.

Pathology and Laboratory Medicine Service at the VA Portland Health Care System is not accredited by UNOS/OPTN, or ASHI and does not have the capability to perform these tests in-house.

C. PERIOD OF PERFORMNCE:

This is a request is for a sole-sourced bridge for a period of six-months with an option to extend for six months.

D. SCOPE

1. 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.

2. Services shall include the performance of analytical testing as defined by the Laboratory's reference test manual, the reporting of analytical test results and subsequent interpretation, as required.

3. All requirements and provisions defined in the specifications of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory.

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

E. SPECIFIC TASKS

1. The Reference Laboratory shall provide laboratory services to include:

preanalytical processing as defined in Reference Laboratory published user’s manual; analysis, reporting of analytic results and interpretation of analytic clinical results. The number of tests requested under this contract will change throughout the life of the contract. The volumes or amounts shown in the solicitation are estimates only and impose no obligation on the VA.

2. The Reference Laboratory shall also provide the following support services:

supplies, customer service, reporting services, and verification of certification.

3. The Reference Laboratory Shall provide all necessary supplies as defined in the laboratory user manual, to include, but not limited to the following:

a. Requisition forms or agreed computer ordering system.

b. Specimen containers & specimen collection kits

i. Reference laboratory shall be responsible for shipping specimen containers and specimen collection kits to patients and other VA medical facilities for patients who are unable to present to the Portland VA for specimen collection. Return shipping capability is also required.

c. Specimen requirements for specimen collection & specimen processing

d. Methodologies and reference ranges

e. Expected turn-around times.

f. All forms, including authorization of consent for genetic testing, informed consent, and chain of custody, if applicable.

4. The Reference Laboratory shall provide test results and or interpretation for all line items contained within price list.

5. The Reference Laboratory shall hold accreditation through the following organizations: UNOS, and/or OPTN.

6. The Reference Laboratory shall meet all compliance regulations from the following organizations: ASHI, CLIA.

7. The Reference Laboratory shall have an existing relationship with the federally designated OPO of Oregon.

8. The Reference Laboratory shall perform the following non-testing tasks in relation to maintaining VAPORHCS transplant patients.

a. The Reference Laboratory shall perform registration of Portland VA patients to

UNOS kidney waitlist: adding HLA type and ABO, ABO verification with two sources including the internal source, listing of appropriate unacceptable HLA antigens based on the risk assessment, and listing protocols for donor status (e.g. DCD, A2 into B protocol, HepC acceptance).

b. The Reference Laboratory shall perform a detailed management and quarterly review of hard-to-transplant candidates such as 100% cPRA candidate.

c. The Reference Laboratory shall review VA patients on the waitlist and assign either a virtual crossmatch or flow crossmatch protocol based on risk assessment and acceptable single antigen bead results. In some cases, surrogate crossmatches or additional antibody screening by phenotype beads is performed.

d. The Reference Laboratory shall initiate the monthly antibody screening testing of all patients on the waitlist (single antigen beads every 3 months, FlowPRA on the other 2 months), following our testing agreement. Orders don’t need to be placed by the transplant program.

e. The Reference Laboratory shall provide a personalized report to the VA lab services program per request for the VA to verify the billing of all tests performed by testing laboratory.

f. The Reference Laboratory shall have a Laboratory Director review all single antigen bead assay results and changes to unacceptable HLA antigens. Both DPB1 discrete antigens and DPB1 epitopes are listed as unacceptable antigens to cover DPB1 types not present on the single antigen bead panel.

g. The Reference Laboratory shall perform quality reviews to correlate flow crossmatch values and donor-specific antibody values. Review of test discrepancies. Discussion of appropriate testing methods and frequency and the test limitations.

h. The Reference Laboratory shall send sample tubes and mailers to patients and/or dialysis centers. Direct coordination with patients and/or dialysis centers when tubes don’t arrive or have shipping issues.

i. The Reference Laboratory shall create Biannual letters to dialysis centers with the list of the patients on the Portland VA UNOS waitlist.

j. The Reference Laboratory shall perform timely UNOS kidney waitlist management while the patient is on the waitlist, including maintaining the updated list of unacceptable antigens, updating the waitlist status (Active, inactive), and cPRA approval for 99-100% cpra candidates. Initiation of the approval documentation and waitlist updates for the 99-100% cpra approval cases.

k. The Reference Laboratory shall perform weekly QC of the UNOS waitlist and email of QC reports to the center.

l. The Reference Laboratory shall review weekly reports stating the most recent serum stored for waitlist candidates. If candidate samples are >35 days out, these are at the top of the list.

m. The Reference Laboratory shall facilitate storage of monthly serum samples while patients are on the waitlist, disposal of samples after 4-5 months.

n. The Reference Laboratory shall initiate quarterly anti-A1 titer testing and subsequent updating of the documentation in UNOS Waitlist for patients accepted in the ABO A2 into B protocol. Weekly QC of the A2 into B testing documentation.

o. The Reference Laboratory shall perform training of new VA clinical staff on topics of histocompatibility testing, the UNOS waitlist and matchrun system.

p. The Reference Laboratory shall perform the STAT virtual crossmatch assessment for all candidates at the top of the organ waitlist, provides assessment in a report to the program. 24/7 coverage of this service.

q. The Reference Laboratory shall provide access to a medical director and technical director provide for 24/7 consultation services to the VA providers, staff, and surgeons.

r. The Reference Laboratory shall maintain a close relationship with the local OPO. The Reference Laboratory shall and the OPO shall have direct communication lines for real-time updates on the status of donor typing and matchrun virtual crossmatch reporting. This supports the timely organ offers to the Portland VA transplant program.

9. Vendor must have a robust on-call system to provide critical testing services for donor testing 24 hours a day, 7 days a week.

F. ELECTRONIC INTERFACE

Not applicable

G. TESTING METHODOLOGY AND TURN AROUND TIME

1. Routine test results shall be reported within the specified turnaround time (TAT) which is defined from time of specimen receipt by the contractor to when results are available. If testing is going to be delayed and the results will not be within published TAT, notify the VA Facilities of the new estimated TAT within 12 hours.

2. 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.

4. 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 12 hours of any problems with specimens received.

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

6. Critical Value test results shall be reported to transplant provider. Stat test results will be faxed or telephoned to Laboratory Service. Telephoned results will be confirmed with a follow-up by vendor via fax.

7. 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 tests 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. performing reference testing on behalf of the Reference Laboratory.

8. Results will be sent to the VA via a secure means and in compliance with Health Portability and Accountability Act (HIPPA) guidelines. Stat test results will be faxed or telephoned to Laboratory Service. Telephoned results will be confirmed with a follow-up by vendor via fax.

H. CUSTOMER SERVICE & PATIENT INFORMATION SAFETY

1. 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.

2. The reference laboratory shall provide names and telephone numbers of technical Medical Directors and Pathologists available for questions, discussions, and consultations.

3. The contractor will consult with PLMS on test result by telephone as needed.

4. The contractor will provide data on tests not performed due to issues such as sample type, quantity, or stability.

5. Reference lab agrees not to use or disclose Protected Health Information (PHI) other than as permitted or required by the agreement or as required by law.

6. Reference lab agrees to use appropriate safeguards to prevent use or disclosure of the PHI other than is provided for by this agreement.

7. Reference lab agrees to report immediately any breach of safeguards and to mitigate any harmful effect related to the use or disclosure of PHI by the Reference Laboratory or any of its agents, including subcontractors.

8. The contractor will provide test related information that is readily available and easy to access to help select the proper test, interpret results, and build tests in our computer system for interconnection for electronic data interchange (EDI).

9. The contractor will provide a 24-hour response time to all inquiries made by

PLMS.

10. 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.

I. COURIER SERVICES

1. The Reference Laboratory shall be responsible for transporting and storing specimens in such a manner as to ensure stability and integrity of the specimen where applicable.

2. Reference Laboratory shall supply any special preservatives required for specimen preservation.

3. Reference Laboratory shall notify VA Facilities of any specimen problems or discrepancies from the submitted manifest within 24 hours after shipping.

4. The Reference Laboratory shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA facilities but not less than once a day.

5. The VA Facilities laboratory manager or designee shall notify the Reference Laboratory during weekends and federal holidays, via telephone, when a pick-up courier is required.

6. When possible, specimens will be sent to the Reference laboratory via a pneumatic tube system if an interconnection exists between Portland VA Laboratory and the awarded Reference Lab.

J. DELIVERY AND REPORTING

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

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

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

i. Vendor Name

ii. Applicable FSS contract number

iii. BPA Number, Task order number, and Purchase Order number

iv. Date of Purchase

v. Date of Shipment

vi. Description of item

vii. Quantity of each item

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

4. 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.

5. 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:

i. Your firm’s Tax Payer ID number (TIN)

ii. Your firm’s “Remit Address” information

iii. The VA Purchase Order (PO) number

iv. Your firm’s contact information: (Personal Name, Email, and Phone)

v. Your VA point of contact information: (Personal Name, Email, and Phone)

vi. The Period of Performance dates (Beginning and Ending)

vii. 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

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

i. Contract number and purchase order number

ii. Station ID (648)

iii. Date services were requested.

iv. Patient name and test

v. Invoice will be billed as individual line items as they are listed in the price schedule.

8. Monthly invoice(s) will contain only those item numbers used for that month.

Invoices not received in proper format will be returned.

9. Marketing: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the VA without consent.

K. PERFORMANCE MONITORING

1. At the time of contract award the Contracting Officer will appoint a Contracting

Officer Representative (COR) to assist with the contract monitoring requirements.

The COR or designee will monitor such items as quality of service, contractor's ability to meet TAT's, correct billing, customer service, and review of the contractor's proficiency program.

2. Contractor shall provide to the COR or designee no later than Ninety (90) days prior to the end of each contract period a proficiency report. The COR or designee shall review the proficiency results. The contractor shall maintain a minimum of 95% success rate for proficiency testing to be considered successful. Failure to achieve 95% success rate two periods in a row could be grounds for Termination for Cause.

3. The COR or designee will ensure that services performed are in accordance with all terms and conditions of the contract.

4. The delegated COR or designee will notify the Contracting Officer of any non-compliance immediately upon his/her gaining knowledge of any such situation or incident. After such communication, the COR or designee will provide a written statement to the contracting officer along with any supporting documentation regarding the performance failure noted.

5. Upon receipt of a proper invoice, the COR or designee shall certify that the services identified have been performed. Once certification has been made, the invoice will be forward through the proper billing channels and payment shall be made to the Contractor.

6. 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, analyze all billings, payments, costs, administrative issues, patient satisfaction, quality of care and other related documentation that identities that services have been received.

7. Upon conclusion of the initial contract period, and in coordination with the Contracting Officer, the using service 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. This information shall be forwarded by the COR or designee to the Contracting Officer prior to exercising any extension of this agreement (at least 60 days prior to contract expiration).

8. Performance Standards – The Contract personnel shall be subject to the following standards and acceptable quality levels (AQL):

i. Standard 1 – Complies with quality of work requirements stated in the contract.

Standard 1– Acceptable Quality Level (AQL): 100%

ii. Standard 2 – Complies with all contract security requirements.

Standard 2 – AQL: 100%

iii. Standard 3 – Complies with timely invoicing Standard 3 – AQL: 95%

iv. Standard 4 – Completes all testing in a timely fashion in accordance with the contractors published test menu.

Standard 4 – AQL: 95%

v. Standard 5 – Contractor will submit all documentation to UNOS Standard 5 – AQL: 100%

L. LICENSING AND ACCREDITIATION

1. Reference Laboratory shall provide copies of all licenses, permits, accreditation and certificates required by law.

i. The Laboratory Director shall be a licensed American Board of Pathology certified pathologist or deemed equivalent by CLIA definition.

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

N. PERSONNEL

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

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

3. 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.

O. HOURS OF OPERATION

1. VA Portland Health Care System Medical Center is open 24 hours a day, 7 days a week, 12 months of the year and may require services during those times.

P. PLACE OF PERFORMANCE

Reference Laboratory Oregon Health and Science University – Laboratory of Immunogenetics and Histocompatibility Testing

Q. PERIOD OF PERFORMANCE

Contract is proposed to be a six-month bridge, with an option to extend for up to 6-months.

Base Period: 5/1/24 to 10/31/24 Option to extend: 11/1/24 to 4/30/25

R. SECURITY REQUIREMENTS

The Reference Laboratory shall be responsible for adhering to the following statements as they relate to the contract. The VA Portland HCS, PLMS, 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.

S. 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.

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. 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);

2. Description of the event, including:

a. Date of occurrence

b. Date 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 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.

VA RECORDS MANAGEMENT OBLIGATIONS LANGUAGE

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VA Portland Health Care System records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VA contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a).

These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. The Reference Laboratory and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation.

Records may not be removed from the legal custody of the Reference Laboratory or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA COR. The VA must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the SOW. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected.

The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the SOW.

Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA policy.

8. The Contractor shall not create or maintain any records containing any non-public VA information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 JB $749,944.450000 $749,944.45

REFERRAL LABORATORY SERVICES TO PROVIDE

HISTOCOMPATIBILITY, IMMUNOGENETICS, AND

INTERPRETATION TO SUPPORT VAPORHCS

TRANSPLANT PROGRAM.

POP: 5/1/2024 - 10/31/2024

SEE ATTACHMENT A FOR TEST LIST

GRAND TOTAL $749,944.45

ACCOUNTING AND APPROPRIATION DATA

ACRN APPROPRIATION

REQUISITION

NUMBER AMOUNT

1 648-3640160-066-822300 Laboratory-2560 Medical Care Contracts an-010022365

648-24-3-066-0059 (P)

$749,944.45

B.4 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

ALL SHIP TO: Department of Veterans Affairs VA Portland Healthcare System 3710 SW US Veterans Hospital Rd Portland, OR 97239 United States

ALL POP: 5/1/2024 -

10/31/2024

FOB: DESTINATION

SECTION C - CONTRACT CLAUSES

C.1 52.