36C26025P0022 For SAM.pdf

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Reference Laboratory Testing for VA Portland Health Care System Federal contract opportunity
Solicitation number
36C26025P0022
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 20

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This document is a federal contract award notice for a five-month order for reference laboratory testing services at the VA Portland Health Care System. The contract was awarded to Oregon Health & Science University for $741,387.92, with a period of performance from 10/1/2024 to 2/28/2025. The reference laboratory is required to provide a wide range of specialized testing services, including immunology, hematology/oncology, pathology, microbiology, and core laboratory services. Key requirements include rapid turnaround times, 24/7 availability, consultation services, and electronic interface capabilities with the VA's EHR system. The contract will be administered by the VA's Network Contracting Office 20.

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PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

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

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

648-25-1-066-0002

36C26025P0022

EFFECTIVE: 10-01-2024

Eric Lingenfelter 360-852-9891

36C260 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

36C648

Department of Veterans Affairs Portland VA Medical Center 3710 NW US Veterans Hospital Road

Portland OR 97239-2999

36C260

Network Contracting Office 20

ATTN: V4CONT

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

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. This is a Five (5) Month Order for Reference Laboratory testing.

c. Period of Performance: 10/1/2024 - 2/28/2025.

d. Please reference IFCAP Order 648C55063 on all invoices for this Period of Performance.

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

f. NOTICE: 52.232-18 AVAILABILITY OF FUNDS (APR 1984) applies hi d To this award.

$741,387.92 See CONTINUATION Page

648-3650160-066-822300-2560 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.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ACCOUNTING AND APPROPRIATION DATA

B.3 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 (MAY 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

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.

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

B.2 STATEMENT OF WORK

1. BACKGROUND

The VA Portland Health Care System (VHAPORHCS) Pathology & Laboratory Medicine Service (PLMS) requires Referral Laboratory services to provide testing and interpretation to assist in the diagnosis and treatment monitoring of Veterans with cancers, bleeding disorders, and specialized diseases, including organ transplants. Referral (reference) laboratory that specializes with these types of complex tests and provide a quick turn-around-time (TAT) of the test results is required for care. VAPORHCS is a VHA Level 1A facility which are the largest levels of volume and patient risks along with the largest number and breadth of physician specialists. VAPORHCS is also unique with active kidney and liver transplants partnering with its academic affiliate. VAPORHCS requires a full-service of Referral laboratory that provides specimen testing, interpretation, testing supplies, customer service, and verification of certification for test results. It is imperative that the Reference laboratory shall perform the following type of testing: Immunology, Hemostasis & Thrombosis, Hematology/Oncology, Anatomic Pathology, including Transplant and Renal Pathology, Neuropathology, Dermatopathology, Cytopathology and Anatomic Pathology, Microbiology/Virology, Molecular, Electron Microscopy, Ophthalmic Pathology and Diseases related testing, and Core Laboratory (Clinical). This requirement will ensure accurate and timely test results are available to healthcare providers that ensure high quality healthcare is provided to the Veteran at the VA Portland Health Care System.

2. PERIOD OF PERFORMANCE:

This is a request is for a five (5) month term, sole sourced award, bulk funded agreement with an option for an extension for up to a six-months. It is proposed to be a sole source award to Oregon Health and Science University. In accordance with FAR 8.405-3(d), the Government shall conduct an annual review of the established BPA. Upon completion of the annual review, a determination will be made whether or not it is in the best interest of the Government to continue with performance of this BPA.

3. SCOPE

a. 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.

b. 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.

c. 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.

d. 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.

4. SPECIFIC TASKS:

a. 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.

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

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

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

1) Requisition forms or agreed computer ordering system

2) Kidney Biopsy collection materials.

3) Specimen requirements for specimen collection & specimen processing

4) Methodologies and reference ranges

5) Expected turn-around times.

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

d. The Reference laboratory shall provide testing and interpretation services for all tests found within Attachment A.

e. The Reference laboratory shall serve as primary for consultation services for the following, when required: Neuropathology, including both muscle and nerve biopsies, Renal Pathology, including transplanted organs, Dermatopathology, Cytopathology, and Hematopathology

1) Neuropathology - The Reference Laboratory shall provide physicians who are fellowship trained and board certified by the American Board of Pathology.

2) Renal Pathology – The Reference Laboratory shall provide physicians who are board certified in Anatomic Pathology by the American Board of Pathology AND fellowship trained in Renal Pathology. The pathologist will be available for consultation with regard to transplant pathology and upon request by the Nephrologists.

3) Dermatopathology – The Reference Laboratory shall provide physicians who are fellowship trained and board certified by the American Board of Dermatology/American Board of Pathology. The pathologist will be available upon request for consultation for continuity of care.

4) Cytopathology – The Reference Laboratory shall provide physicians who are fellowship trained and board certified by the American Board of Pathology.

5) Hematopathology – The Reference Laboratory shall provide physicians who are fellowship trained and board certified by the American Board of Pathology.

6) Surgical Pathology – All pathologists who report anatomic pathology cases MUST be board certified by the American Board of Pathology. Subspecialty fellowship training is preferred.

7) For all Anatomic Pathology Services, consultation and discussion of the case shall be readily available upon request.

8) For all Anatomic Pathology services, slides of the cases shall be available upon request (i.e. actual slide or digital images of the case) as these slides/images will be required for tumor board and case discussion.

5. ELECTRONIC INTERFACE

a. If awarded, the Reference Laboratory agrees to a transition period for providing a fully functioning interconnection for exchanging data between the new proposed Electronic Health Record (EHR) for the Portland VA, Cerner, to the Reference Laboratory's electronic lab information system. During this time the Reference Laboratory will supply the VA Facility with available test menu and agrees to receive test orders as they are transitioned until full menu implementation. The Reference laboratory agrees to work with the new EHR system, Cerner, to ensure connectivity and aid in the transition by the VA. Test orders that were created for testing the interface system will be at no charge.

b. An existing or VA Planned integration to Cerner (with ATC, ATO approvals) must already exist.

c. System drivers must be compatible with Cerner. The server and interface software will be owned and maintained by the Reference Laboratory.

d. The Reference Laboratory must already possess a signed MOU-ISA (Memorandum of Understanding of Interconnection Security Agreement) with the VA Network and Security Operations Center (NSOC).

e. This interconnection shall be protected through the use of VA approved encryption algorithms and products as required and in compliance with HIPAA guidelines.

Connections at each end shall be located within a controlled access facility. All access shall be controlled by authentication methods to validate approved users.

f. Reference Laboratory shall notify VA Facilities of any specimen problems or discrepancies, within 24 hours of receipt of specimens.

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 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.

Required TAT is identified on Attachment A. Urgent (STAT) TAT is considered 1 HOUR and Routine testing is 8 Hours.

b. The Reference laboratory shall meet all TAT needs, and stat processing needs.

1) It is necessary for the contracted vendor to be able to provide immediate services for critical testing that must be able to start within 1 hour of specimen collection.

2) Coagulation & platelet status must be monitored before during and after liver transplant and other surgeries to provide immediate adjustment to blood thinners or blood products on a 24/7 basis. Coagulation and platelet function are critical life monitors for patients with liver diseases or other high-risk factors (cancer, cardiovascular disease and serious health conditions). Delays in test results beyond 4-12 hours may result in canceled/delayed surgeries/treatments or serious negative consequences for patients with high risk factors (cancer, cardiovascular disease and other serious health conditions). Test are required to establish an immediate update/adjustment to dosage and treatment plan for blood clotting disorders, blood products or transplant care.

3) Many specimens are fresh tissue requiring test processing to be initiated within 1 hour of collection to prevent specimen degradation, which leads to unsatisfactory cell recovery or responses giving inconclusive or inadequate diagnoses resulting in delayed treatment with serious consequences for cancer patients.

4) Certain specimens are unique and irretrievable and aid in the diagnosis and staging of malignancies. Requirements for quick initial diagnosis and treatment initiation for new leukemia and aggressive lymphoma patients.

5) Back-up testing to critical in-house testing, is needed in case of instrument downtime and essential for operations of a 1A facility. These tests are identified by the requirement for a STAT TAT of 1 Hour and or a Routine TAT of 8 hours.

6) Consultation may be required for continuity of care.

c. 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.

d. 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.

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

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

g. 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.

7. COURIER SERVICES

a. 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.

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

b. Transport samples in such a manner as to ensure the integrity of the specimen.

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

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

e. 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.

f. 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.

g. 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.

8. CUSTOMER SERVICE & PATIENT INFORMATION SAFETY

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 Medical Directors and Pathologists available for questions, discussions and consultations.

c. 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.

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

e. 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.

f. The reference lab will comply with reporting test results with the specified time frame in accordance with the nature of the testing, following all regulatory requirements for reporting of patient results. Test results shall be reported within specified times established by the reference laboratory. Critical value test results shall be reported immediately by telephone. Results will be sent to the VA via a secure means and in compliance with Health Portability and Accountability Act (HIPPA) guidelines.

g. 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).

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

i. 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.

9. 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) BPA 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 a quarterly and 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 each government fiscal quarter.

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

g. 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.

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

Invoices not received in proper format will be returned.

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

10. PERFORMANCE MONITORING

a. 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.

b. 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.

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

d. 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.

e. 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.

f. 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.

g. 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).

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

1.) Standard 1 – Complies with quality of work requirements stated in the contract Standard 1– Acceptable Quality Level (AQL): 100%

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

Standard 2 – AQL: 100%

3.) Standard 3 – Complies with all contract timely invoicing Standard 3 – AQL: 95%

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

Standard 4 – AQL: 95%

5.) Standard 5 – Complies with timely response time to all inquiries. Courier service follows specimen shipping guidelines, protects patient sensitive information, and dependable.

Standard 5 – AQL: 100%

11. LICENSING AND ACCREDITATION

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

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

b. As the subspeciality of dermatopathology consultation will be requested from the Reference Laboratory Contractor, fellowship training and Board Certification in Dermatopathology from the American Board of Pathology is required.

c. As the subspeciality of Renal Pathology consultation will be requested from the Reference Laboratory, Board Certification in Anatomic Pathology from the American Board of Pathology, and fellowship training in Renal Pathology is required.

d. As the subspeciality of Neuropathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required.

e. As the subspeciality of Cytopathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required.

f. As the subspeciality of Hematopathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required.

g. As per VHA Handbook 1106.01 Pathology and Laboratory Medicine (P&LMS) Procedures, only qualified, licensed, and privileged pathologists certified by the American Board of Pathology in Anatomic Pathology can provide the written report for all surgical pathology, autopsy, diagnostic EM, non-GYN cytopathology and abnormal GYN cytopathology examinations. All pathologists who report the referred/consultation cases must have board certification from the American Board of Pathology.

h. 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.

12. 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.

13. HOURS OF OPERATION

a. 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.

14. PLACE OF PERFORMANCE

Oregon Health and Science University

15. PERIOD OF PERFORMANCE

10/1/2024 – 2/28/2025

16. 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.

17. 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.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 JB $741,387.920000 $741,387.92

Reference Laboratory Testing for Portland Health Care System

See Attachment A for Test List Period of Performance Start: 10/1/2024 Period of Performance End: 2/28/2025

GRAND TOTAL $741,387.92

ACCOUNTING AND APPROPRIATION DATA

ACRN APPROPRIATION

REQUISITION

NUMBER AMOUNT

1 648-3650160-066-822300 Laboratory-2560 Medical Care Contracts an-010022365

648-25-1-066-0002 (P)

$741,387.92

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001 SHIP TO: Department of Veterans Affairs VA Portland Healthcare System 3710 SW US Veterans Hospital Rd Portland, OR 97239 United States

1.00 POP: 10/1/2024

- 2/28/2025

FOB: DESTINATION

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) 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.

(b) 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.

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

(d) 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 at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(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 such as, 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. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(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) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) 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 which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) 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;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

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

(6) 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 33.211 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

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(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 default termination.

(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

(C) 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 prescribed in FAR 32.608-2 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 its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

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

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

FAR

Number

Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.232-18 AVAILABILITY OF FUNDS APR 1984

852.203-70 COMMERCIAL ADVERTISING MAY 2018

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

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

(End of Clause)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT

REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic…

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