36C24923Q0270_1.docx

36C24923Q0270

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

596-23-4-029-0089 36C24923Q0270 05-04-2023 Martha Warren 615-225-6404 05-24-2023 16:00

CDT

90C Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400 Murfreesboro

TN

37129 X X 339113 800 Employees Net 30 days N/A X Department of Veterans Affairs Lexington VA Health Care System 1101 Veterans Dr.

Lexington

KY

40502 90C Network Contracting Office 9 Department of Veterans Affairs Network Contracting Office (90C) 1639 Medical Center Parkway Suite 400 Murfreesboro

TN

37129

90C FSC e-Invoicing Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

Setup 1-877-489-6135 See CONTINUATION Page This solicitation is for Automated Immunoflourescent Antibody Testing to include three (3) types of tests, for a Base period of 12 months plus four (4) 12-month options.

Quotes are due no later than 4:00 pm CDT on 05-24-2023.

Quotes must be mailed to martha.warren1@va.gov.

Questions are due no later than 4:00 pm CDT on 05-18-2023.

Award will be made to best value to the Federal Government.

Contracting POC: Martha Warren, martha.warren1@va.gov Contracting Officer: Phon Phasavath, phon.phasavath@va.gov See CONTINUATION Page X X Phon Phasavath Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C249 Phon Phasavath Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400 Murfreesboro TN 37129

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

Statement of Work (SOW) Immunofluorescent Antibody Testing The Contractor is to provide the Lexington VA Health Care System, Special Reference Lab (SRL), with a monthly rental agreement of an automated autoimmune testing system, which shall have the capability of processing and reading autoimmune Immunoflourescent Antibody (IFA) slides, in accordance with the terms and conditions stated herein. The instrument shall be able to perform the complete autoimmune testing menu, as described below, and meet the performance characteristics for accuracy and precision, as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSU). The instrument system used must be approved by the Food and Drug Administration (FDA). The Contractor shall propose the suggested/recommended equipment/reagents that meet the requirements of the facility.

Contractors are required to provide a price per reportable patient result. The per patient reportable shall include costs covering:

(a) equipment use;

(b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation of an FDA approved autoimmune patient reportable result by Immunofluorescent Assay (IFA). Additionally, instrumentation shall include a surge protector and battery backup and a printer to print both patient results and quality controls. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI).

(c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and

(d) training for Government personnel.

Contractors are required to provide delivery, installation, and removal of equipment at no additional charge. The instrumentation will have the capability of performing tests on approximately 500-550 patient samples per week, with those patient samples being tested over a 4-day, eight hour per day work week.

1. PRICES AND TERMS: Lexington VA Health Care System, estimates the autoimmune testing as below. For the purposes of this contract, number of test wells was used to calculate test volume (includes all controls, patients and titers), as there are considerable differences between vendors as to slide configuration. Pricing shall be based on the average yearly test volume per instrument/analyzer. The Government estimates the volumes listed, but does not guarantee volumes as listed; they are ESTIMATES ONLY. This is an IDIQ (Indefinite Delivery, Indefinite Quantity) agreement. Three slide types will be needed: ANA (Antinuclear Antibody) Hep2000, Tissue (Rat Liver Kidney Stomach, or equivalent) and dsDNA (double stranded deoxynucleic acid).

1. ANA (Antinuclear Antibody) Hep2000: 29,250 wells per year

1. Tissue (Rat Liver Kidney Stomach, or equivalent): 22,152 wells per year

1. dsDNA (double stranded deoxynucleic acid): 9,568 wells per year

1. TERM OF AGREEMENT: The agreement shall be effective for one year with four renewable option years.

1. IDENTIFICATION: Purchase Orders issued will be identified by Contract Number.

1. ORDERING METHOD: The Lexington VA Health Care System will order autoimmune slides, as needed, via telephone, facsimile, email, or other written communication, identifying the products by number, quantity, address for delivery, and any special instructions. All products must have a minimum of 90 days shelf-life (before expiration date) upon receipt. All shipping costs shall be included in the quoted price of each line item.

1. DELIVERY TICKETS: Unless otherwise agreed to, all deliveries under this agreement shall be accompanied by delivery tickets or sales slips that shall contain the following information, as a minimum:

4. Name of contractor

4. Contract number

4. Model number or National Stock Number (NSN)

4. Purchase order number

4. Date of purchase

4. Quantity, unit price and extension of each item

4. Date of shipment.

1. INVOICES AND PAYMENTS: The Contractor shall invoice each purchase order, as directed by the ordering activity. Payments will be made by the VA Finance Center, Austin, Texas.

1. INVENTORY AND SUPPLIES: Shall be in accordance with Statement of Work.

6. Delivery of supplies: Shall be in accordance with Statement of Work. Any unexpected changes in methodology/technology shall be at the expense of the Contractor.

6. Alert/Notification of delays in shipments as well as all technical advisory/recalls/alerts, prior to or simultaneously with field alerts shall be forwarded to the Special Reference Laboratory supervisor, Laboratory manager, and the assigned VISN 9 contracting officer.

6. Special handling for emergency orders of supplies: In the event that the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routing supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. If either circumstance has occurred, the contractor will deliver to the government site in the most expeditious manner possible without additional cost to the government.

1. GENERAL REQUIREMENTS {APPLICABLE TO ALL EQUIPMENT): Each model of autoimmune analyzer offered shall comply with all general requirements stated herein. Each Contractor shall submit as part of their offer, technical data or descriptive literature to ascertain that the equipment offered meets the requirements outlined below.

7. The Contractor shall provide instrumentation that is 510k exempt, in sufficient quantity to handle the forementioned workload, as determined by the Special Reference Laboratory supervisor, automated autoimmune slide processor and slide reader. Re-manufactured or discontinued models are unacceptable for this agreement.

7. The Contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Emergency replacement or repair of equipment shall be provided by the Contractor. Contractor shall return calls within 1 hour and repairs shall be completed within 24 hours.

1. AUTOIMMUNE TESTING SPECIAL REQUIREMENTS: The Contractor shall assess equipment, work flow, volumes and space to meet the Lexington VA Health Care System site's requirements.

8. GENERAL REQUIREMENTS:

0. IFA System: The system shall provide slide processor(s) and slide reader(s) capable of processing all the autoimmune slides listed above, with a throughput capable of processing and reading all slides within the constraints of a forty-hour work week. The system must interface with the Lexington VA Health Care System, Laboratory Information System (LIS), to meet the minimum requirements of reading a ten-digit barcode, downloading tests ordered, and uploading test results to the LIS.

0. Processing: The system must process the slides with minimal intervention of the Medical Laboratory Scientists who will operate the system, to the point that the slides are ready to have coverslips added (if needed). The slides may then be moved to the slide reader by the technologist, or may be read on the processing system, as appropriate.

0. Upgrades: The contractor shall provide hardware/software upgrades necessary to maintain the integrity of the system, at no additional charge to the government. These upgrades must be provided as they become available and as they are being offered to commercial customers.

0. Ancillary Equipment and Supplies: The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment, consumables/supplies, parts and accessories necessary to fully operate the processor and reader as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), Uninterruptible Power Supply (UPS) capable of supporting the full scope of equipment operation with a built-in line conditioner, for each proposed analyzer. The contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

0. Interface: All LIS interface programming, hardware, licenses, etc. will be VA Lexington’s responsibility. The Image Navigator will already be exporting data for LIS when installed. IT/LIS will be present during installation to work on connectivity to mapped drive where LIS files are located.

0. Maintenance and Repair: The Contractor shall be able to provide emergency equipment repair and preventative maintenance, and any incremental support equipment, offered according to the following terms:

5. A technical assistance or support center shall be available by telephone hot-line Monday through Friday (except Federal Holidays) with a maximum call back response time of 1 hour and with on-site service provided, not to exceed 24 hours following determination that site service is required. The technical assistance center shall be staffed with personnel who are fluent in English, without the use of an interpreter.

5. Every notification for a repair service call shall be treated as a separate and new service call.

5. During the term of this contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of more than 48 hours per quarter, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment, at no additional cost to the government. The responsibility for maintaining the equipment furnished in good condition, in accordance with manufacturer's instructions, shall be solely that of the contractor. The Government agrees to maintain the equipment according to manufacturer's specifications. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

1. date and time notified

1. date and time of arrival

1. serial number, type and model number of equipment

1. time spent for repair, and

1. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

5. Scheduled preventative maintenance calls shall occur at a frequency to meet the minimum manufacturer's requirements to keep the equipment in optimal operating condition. The contractor will be responsible for tracking and scheduling all preventive maintenance. This must conform to instrument specifications and all regulatory requirements. Documentation of the maintenance will be provided to the Laboratory at the time of completion. This maintenance must be provided within two weeks of the recommended schedule.

5. The system must require minimal daily and periodic maintenance.

0. Training: The Contractor shall provide training at the time of installation to include training on the operation of the system, data manipulation, preventative maintenance and basic trouble shooting and repair for 2 key operators. Any training program that involves off-site travel shall include the cost of airfare, room and board for each participant. A training or competency checklist shall be provided by the Contractor.

0. Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications. The Contractor shall be responsible for assessing the space available in the facility in order to ensure the right size equipment is provided; thereby not creating a safety hazard.

0. Implementation and Transition: The Contractor shall provide with its quotation a transitioning plan for the complete transition of all services under the awarded agreement including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., and performance of all correlations and validations. This transition shall be completed no later than 30 days after the award of the agreement. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe.

0. Comparison and Validation of Analyzer: The Contractor shall assist, to the satisfaction of the Government, at no cost to the Government, all comparison and validation studies to include any materials and reagents needed for such correlation. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer and shall be consistent with current CLSI (formerly NCCLS) and related documents, CAP Standards, Joint Commission Standards and Federal Regulations.

0. Procedure Manual: The vendor shall provide a copy of operating procedures in Clinical and Laboratory Standards Institute (CLSI) digital format at time of installation using software compatible with VA (Microsoft Office WORD).

8. TECHNICAL REQUIREMENTS:

(1) Bar-code System. The system shall support bar-code recognition for tracking of samples at entry into the system and throughout processing and incubation until such time as the slide is ready to be placed on the reader. The sample tracking system must interface with the reader such that identification does not have to be re-entered into the reader. The system will include a bi directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

The accuracy of the barcode reading must have less than a 1% failure rate. The equipment must accept, at a minimum, characters in specimen identifier that is alphanumeric.

1. Data Management System.

0. The data management system shall be able to support varied programmed slide titers as deemed appropriate by the user. All slides are initially processed at two titers, and the slide processor must be able to be programmed to process those two titers.

0. Positive samples are tittered to endpoint. The system must allow flexible programming for endpoint titers.

0. The reader must be capable of identifying the staining pattern (including mixed patterns) and approximate titer on the ANA slides, and providing a "screen shot" of any other slides so that the technologist can identify the staining pattern and can determine the endpoint titer on any positive samples. This information must transmit to the LIS.

0. The system shall be capable of maintaining all data for up to 30 minutes, in the event of normal electrical power interruptions via battery backup.

0. The system shall have a built-in quality control program to regularly monitor performance of vital components.

0. The system must have the capability to record, store and print the following information:

1. sample location on processor

1. sample location on test slide

1. presumptive negative results

1. presumptive positive results

1. presumptive pattern (for ANA slides)

1. specimen unique identifier and specimen results

1. daily qc results

1. monthly qc results with Levy Jennings Charts

1. Autoimmune Slides.

1. Shall be easily distinguished (e.g. color coded or clearly labeled) for utility or intended purpose.

1. Shall be bar-coded or otherwise labeled with unique identifiers for processing and specimen tracking.

1. Safety: The system must have sufficient safety features to avoid unnecessary exposure to bio hazardous and chemical materials. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. All liquid waste must be approved for disposal in the medical center's waste water stream. The reagents should not be listed as carcinogenic or at risk for reproductive toxicity.

1. Characterization of hazardous waste: The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 "Protection of the Environment" Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a by-product of the instrument operations Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

The determination and description shall address the following:

0. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR § 261.24)

0. Waste ignitability (Reference 40 CFR §261.21)

0. Waste corrosivity (Reference 40 CFR § 261.22)

0. Waste reactivity (Reference 40 CFR § 261.23)

0. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR § 261.31)

0. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR § 261.33)

0. Solid Waste (Reference 40 CFR § 261.2)

1. Progress and Compliance: The system must perform IFA testing, as advertised, and meet the performance characteristics for accuracy and precision, as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

1. Business Associate Agreement {BAA): A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provide certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. Any subcontractor used by the primary contractor is required to abide by government and agency guidance for protecting sensitive and proprietary information.

1. Government's Responsibility: The user will perform routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

1. Ownership of Equipment: Title to the equipment shall remain with the contractor. All accessories (unused consumables, etc.) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The contractor shall disconnect the analyzer and shall be responsible for all packing and shipping required to remove the analyzer. All patient names and/or patient identifiers must be removed from the hardware and/or software before removal of equipment from the Government Agency.

1. Record Management: Citations to pertinent laws, codes and regulations such as 44 U.S.C. chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

The contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

The contractor shall not create or maintain any records that are not specifically tied to, or authorized by, the contract using Government IT equipment and/or Government records.

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 by the Freedom of Information Act.

The contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

The Government Agency owns the rights to all data/records produced as part of this contract.

The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. The contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

The contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format (paper, electronic, etc.) or mode of transmission (e-mail, fax, etc.) or state of completion (draft, final, etc.).

No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 270 I. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

(End of Clause)

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Contract Period: Base POP Begin: 07-14-2023 POP End: 07-13-2024

LOCAL STOCK NUMBER: IN110

Fluorescent Hep-2000 ANA Bulk Pack - 2100 Wells Contract Period: Base POP Begin: 07-14-2023

LOCAL STOCK NUMBER: 2000CS-21-Ro

Fluorescen6t nDNA Bulk Pack w/IgG - 1400 wells

POP Begin: 07-14-2023

LOCAL STOCK NUMBER: 3002G

Rat LKS Tissue FA Test Kit -800 Tests

POP Begin: 07-14-2023

LOCAL STOCK NUMBER: 12800-03

Contract Period: Option 1 POP Begin: 07-14-2024 POP End: 07-13-2025

Fluorescent Hep-2000 ANA Bulk Pack - 2100 Wells Contract Period: Option 1 POP Begin: 07-14-2024

Fluorescen6t nDNA Bulk Pack w/IgG - 1400 wells

POP Begin: 07-14-2024

Rat LKS Tissue FA Test Kit -800 Tests

POP Begin: 07-14-2024

Contract Period: Option 2 POP Begin: 07-14-2025 POP End: 07-13-2026

Fluorescent Hep-2000 ANA Bulk Pack - 2100 Wells Contract Period: Option 2 POP Begin: 07-14-2025

Fluorescen6t nDNA Bulk Pack w/IgG - 1400 wells

POP Begin: 07-14-2025

Rat LKS Tissue FA Test Kit -800 Tests

POP Begin: 07-14-2025

Contract Period: Option 3 POP Begin: 07-14-2026 POP End: 07-13-2027

Fluorescent Hep-2000 ANA Bulk Pack - 2100 Wells Contract Period: Option 3 POP Begin: 07-14-2026

Fluorescen6t nDNA Bulk Pack w/IgG - 1400 wells

POP Begin: 07-14-2026

Rat LKS Tissue FA Test Kit -800 Tests

POP Begin: 07-14-2026

Contract Period: Option 4 POP Begin: 07-14-2027 POP End: 07-13-2028

Fluorescent Hep-2000 ANA Bulk Pack - 2100 Wells Contract Period: Option 4 POP Begin: 07-14-2027

Fluorescen6t nDNA Bulk Pack w/IgG - 1400 wells

POP Begin: 07-14-2027

Rat LKS Tissue FA Test Kit -800 Tests

POP Begin: 07-14-2027

B.3 DELIVERY SCHEDULE

1101 Veterans Drive Lexington, KY 40502

USA

859-233-4511 thomas.parr@va.gov

14.00

7.00

28.00

12.00

14.00

7.00

28.00

12.00

14.00

7.00

28.00

12.00

14.00

7.00

28.00

12.00

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Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(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; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 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…