36C25524Q0296.docx

36C25524Q0296

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

589-24-2-1614-0151 36C25524Q0296 04-2 -2024 Flores, Betty | v eronica.

f lores@va.gov 913-946-1167 05-0 -2024 11:00 am

CDT

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 X X 325413 1250 Employees Net 30 N/A X Department of Veterans Affairs Kansas City VA Medical Center 4801 East Linwood Boulevard Kansas City MO 64128-2226 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

36C255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX 877-353-9791 512-460-5429 See CONTINUATION Page Automated Gel Protein Electrophoresis - Kansas City VAMC In Accordance with the Statement of Work ******** See Section B for details ******** This will result in a Firm Fixed Price, FOB Destination ID/IQ contract with a Five (5) Year Ordering Period.

This is intended as 100% Small Business Set Aside.

See Addendum to

FAR

clause 52.212-1 Instruction to Offerors- Commercial Items Vendor must be an authorized distributor, submit your A uthorized Distributor Letter from the OEM with your quote See CONTINUATION Page X X X One( 1) Teresa Cabanting Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(Continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR: NAME: __________________________________

UEI #: ___________________________________

b. GOVERNMENT: CONTRACTING OFFICER 36C255

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE (NCO) 15

3450 S 4th STREET

LEAVENWORTH, KS 66048

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

3. INVOICES: Invoices shall be submitted:

[ ] Upon Acceptance of Product [X] Other

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.

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp

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

Page 1 of Page 1 of

B.2 STATEMENT OF WORK

SCOPE OF PROCUREMENT:

· INTENT: It is the intent of the Department of Veterans Affairs, to establish a Reagent Rental Contract for Automated Gel Protein Electrophoresis testing. It is the intent of the Government to award this to a single contractor for the Fully Automated Gel Protein Electrophoresis testing. Contractor agrees to the following terms of the contract exclusively with the Kansas City VA Medical Center. Additional tests, reagents and instrumentation may be added to the award up to the contract ceiling.

· PRICES AND TERMS: Kansas City VA Medical Center will provide an estimated volume by reagent/supplies as reflected in Section D, Attachment A. The Government estimates the volumes for Kansas City VA Medical Center as listed in Section D, Attachment A but does not guarantee volumes as listed; they are estimates ONLY. If Contractor offers a family of analyzers, the technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

· DELIVERY TERMS: The delivery terms for all items ordered under the contract will be FOB destination. Contractor will make shipping arrangements and prepay all shipping and handling costs. Contractor will promptly replace all Products lost or damaged in shipment. Contractor will be responsible for all disputes with the shipper and all insurance claims related to the shipment. The Kansas City VAMC will call to schedule delivery dates of items.

· DELIVERY LOCATION:

Department of Veterans Affairs Kansas City VA Medical Center 4801 E. Linwood Blvd Kansas City, MO 64128

GENERAL REQUIREMENTS:

· The desired instrumentation and associated reagents shall have the capability of performing as defined in the statement of requirement.

· The desired instrumentation and associated reagent shall be acquired for Kansas City VA Medical Center as listed in Section D, Attachment A.

· The Contractor is required to provide a continuously stocked inventory of reagents, controls, and supplies required to ensure that patient care operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards, and control containers. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

· Special handling for emergency orders of supplies: In the event that the supplies 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 routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If the amount exceeds the ceiling of contract, the CO will need to be notified before any delivery can be approved. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

DEFINITIONS:

· Cost per Test (CPT)- Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) equipment use; (2) all reagents, standards, quality 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 and reporting of a test result; (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

· Reagent Rental Agreement- means an agreement between Borrower and a customer pursuant to which the customer rents a Diagnostic System and commits to buy estimated annual volumes of diagnostic test kits to be stipulated in Section D, Attachment A.

· TEST MENU: Refer to Section D, Attachment A for desired test menu and estimated annual volumes.

Gel Electrophoresis

· Protein Electrophoresis, Serum

· Protein Electrophoresis, Urine

· Immunofixation

SPECIFICATIONS/SALIENT CHARACTERISTICS:

· The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of requirement. The instrument shall have random access capability and be able to simultaneously perform the complete profile 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 (CLSI).

· Equipment must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. Preference will be given to vendors that can provide a self-contained complete system which carries out all the phases of electrophoresis testing from sample application to reading of the gels.

· Operational Features- The instrumentation offered shall have the following:

· The capability of performing analysis on 100% of the tests listed in Section D, Attachment A.

· Sufficient capacity and throughput to meet the volume and service demands as defined in Section D, Attachment A.

· A bi-directional, bar-coded computer 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 1% failure rate.

· Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

· Vendor will supply support to assist sites with set up of bi-directional interface.

· Minimal daily, monthly, and periodic maintenance.

· Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

· On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least three (3) to six (6) months for reagents.

· Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following:

· On-board QC data management system with a minimum storage capacity of QC, QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.

· Have minimal reagent and control preparation, preferably no reconstitution required.

· Capability to run proteins up to 100 tests/hour, and Immunofixations up to 15 tests/hour with the IF program.

· Capability of performing from one (1) to 55 samples per gel.

· Capability to test serum, urine, plasma and CSF samples.

· Ability to monitor instrument performance.

· Minimal carryover.

· Perform sequential migration and staining (fully automated system).

· Supply a computer driven built in densitometer to image visible electrophoresis analytes on agarose gels.

· Provide all necessary pipettors and pipet tips for analysis of samples.

· Any special items required maintaining the equipment/analyzer in optimal condition such as but not limited to tables, printers, water supply, drainage systems, UPS, surge suppressors etc. will be the responsibility of the vendor. Any maintenance, time and materials needed to keep the special items in working order will be the responsibility of the vendor.

· Provide necessary reagents to mitigate Daratumumab drug interference on Immunofixation tests.

· Hardware Features- The instrumentation shall have the following:

· A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Small footprint equipment that could fit on a counter with the following measurements:

Length: No larger than nine (9) feet 10 inches

· An on-board, adjustable monitor/screen that is easily readable.

· Color printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

· An uninterruptible power supply with line conditioner for each instrument provided under this contract.

· All necessary procedure manuals, troubleshooting manuals and operator manuals (available on computer or CD format). Procedures should be editable CLSI format on diskette or another electronic format. Updates provided when required.

METHOD PERFORMANCE/VALIDATION REQUIREMENTS

· Shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSII guidelines and related documents, College of American Pathologists (CAP) Standards and federal regulations, for the following:

· Correlation studies for each analyte. A minimum of 20 samples, spanning the reportable range, shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.

· Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The program(s) shall be provided to each laboratory at no charge.

IMPLEMENTATION/TRANSITION TIMEFRAME

· The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 60-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government.

· Upon award of a contract, the transition period for the awarded contract to have all equipment and peripherals installed and operational shall be from date of award through 60 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

· Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 60 days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents, and supplies, etc., performance of all correlations and validations.

· At the end of 60 days from award of the contract, the awarded contractor shall have full and sole responsibility for services under the awarded contract.

OTHER REQUIREMENTS

· Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

· Support Features-The equipment models being offered shall be in current production as of the date this offer is submitted. “Current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

· Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

· Commercial offerings. The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g., Computer disc containing their procedure manual in CLSI format or an online procedure manual in the instrument software.

· Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories, and any other item required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.

· Training.

· Upon Installation: The Contractor shall provide advanced (key operator) instrument training program for at least two operators per facility at no charge to the Government that is coordinated with and timely with the equipment installation, sufficient to the size and scope of the facility’s services. This shall include training on the operation of the system, data manipulation, and basic troubleshooting and repair.

· Thereafter: The Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor.

· Unlimited on-site training should be available for training of new staff member, when instrumentation upgrades occur or when deemed necessary as a follow-up to troubleshooting of an instrument or staining issue.

SERVICE REQUIREMENTS

· Equipment Preventative Maintenance/Repair Service:

· The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g., water system, offered according to the following terms:

· Phone support will be available Monday – Friday 8:00 AM to 5:00 PM.

· All services for this contract must meet manufacturer’s performance and technical specifications, Federal Regulations, FDA device certification and other specifications that may apply such as National Electric Code (NEC), Life Safety Code (LSC), the Joint Commission (JC), and VA Regulations.

· 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: date and time notified, date and time of arrival serial number, type and model number of equipment, time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

· Contractor must provide the appropriate service documentation to no additional expenses. Contractor shall provide hardcopy proof, upon request by COR, that contracting entity is a certified manufacturer service provider and that technicians are current in device certification training.

· Equipment repair service shall be provided during core business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

· Equipment repair response time shall be no more than 24 hours, from business day to business day excluding weekends.

· Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

· Each notification for an emergency repair service call shall be treated as a separate and new service call.

· The contractor shall provide maintenance both remotely (via off site service location) and on site, to include all replacement parts, software updates, labor, travel expenses, tools, test equipment, shipping costs, insurance costs for shipment and other incidentals necessary to maintain or restore the listed equipment to maintain or restore the listed equipment to operating specifications which meet or exceed the manufacturer’s specifications.

· All parts used must be new or factory rebuilt for that model and type of device. In-house Biomedical engineering will provide first look response to all trouble calls.

· Vendor will repair or replace the instrument within 10 working days after receipt of the malfunctioning instrument.

· COR/ POC will notify contractor when services are needed. Contractor will resolve the issue by one or more of the following:

· shipment of new or factory rebuilt parts to Customer with appropriate instructions for installation of the parts on an exchange basis,

· shipment of new or reconditioned replacement instrument that is at least functionally equivalent to the original instrument on an exchange basis,

· shipment of a new, in-service, or reconditioned instrument that is at least functionally equivalent to the original instrument on a temporary ‘loan’ basis,

· assistance of authorized distributors or service technicians or

· issuance of a return material authorization for Customer to return the instrument or defective component for repair or replacement.

· Upon receipt by Customer of the replacement part or replacement instrument, the original part or instrument becomes property of the vendor and shall be returned by customer to vendor.

UPGRADES

· The Contractor shall provide upgrades to the equipment hardware, bidirectional interface, and software to maintain the integrity of the system and the state-of–the art technology, at no additional charge to the Government if sites are interested. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e., new version of the software, correction of a hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace the model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability.

ANCILLARY SUPPORT EQUIPMENT:

· The Contractor shall provide, install, and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. universal interface equipment. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, etc.

STANDARD AND QUALITY OF PERFORMANCE:

This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order is accepted by the government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance.

· The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the contractor’s technical specification or as quoted in any contract at an effectiveness level of 90% or more.

· If equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue a day-by-day basis until the standard of performance is met for a total of 30 consecutive days.

· If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement.

· Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fide attempt to contact the contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

· The government will maintain daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

· During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR/POC to replace the malfunctioning equipment with new equipment.

· The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 90% in each month of the term of the contract for equipment.

· 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.

· 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 (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

· The vendor/contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any vendor/contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

· Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor while performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the contract.

· All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier.

· Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

· Vendor must accept the system without the drive;

· VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

· VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

· Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

· Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools.

· A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Automated Gel Protein - Electrophoresis in accordance with Statement of Work See Section D, Attachment A for estimated usage of Reagents

Automated Gel Protein - Electrophoresis in accordance with Statement of Work See Section D, Attachment A for estimated usage of Reagents

Automated Gel Protein - Electrophoresis in accordance with Statement of Work See Section D, Attachment A for estimated usage of Reagents

Automated Gel Protein - Electrophoresis in accordance with Statement of Work See Section D, Attachment A for estimated usage of Reagents

Automated Gel Protein - Electrophoresis in accordance with Statement of Work See Section D, Attachment A for estimated usage of Reagents

B.4 DELIVERY SCHEDULE

Kansas City VA Medical Center 4801 E. Linwood Blvd Kansas City, MO 64812 2226

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.