36C24826Q0989.docx

36C24826Q0989

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

516-27-1-033-0001 36C24826Q0989 08-05-2026 Moneque Rodriguez 813-550-9486 08-19-2026 15:00

EDT

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 10,000 Bay Pines Blvd Bay Pines FL 33744 X 334516 1000 Employees NET 30 Days N/A X

MCC: 90D

Department Of Veteran Affairs C.W. Bill Young VA Medical Center Department of Pathology and Laboratory 10,000 Bay Pines Blvd.

Bay Pines FL 33744 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) C.W. Bill Young VA Medical Center 10000 Bay Pines Blvd.

Bay Pines FL 33744

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page The Government anticipates awarding a single award Indefinite Delivery Indefinite Quantity contract for Identification and Antimicrobial Susceptibility Testing Cost- Per-Test for Bay Pines VA Healthcare System.

Period of Performance: October 01, 2026 – September 30, 2031 See CONTINUATION Page 516-3670160-033-822300-2625 010022300 X Moneque Rodriguez 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 36C248 Moneque Rodriguez Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

10,000 Bay Pines Blvd Bay Pines FL 33744

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:

36C24826Q0989

Page 1 of Page 1 of

B.2 STATEMENT OF WORK

Dated: August 03, 2026

TITLE: Microbial Incubation, Identification (ID) and Susceptibility Cost-per-Test (CPT)

1. SCOPE:

The contractor shall provide a complete Microbiology Identification and Antimicrobial Susceptibility (ID/AST) testing system cost-per-test (CPT) with automated instrumentation and software for an integrated, automated platform for flexibility, simplicity and improved productivity for the Bay Pines Veterans Affairs Healthcare System (BPVAHCS), 10000 Bay Pines Blvd., Bay Pines, Florida 33744, Department of Pathology and Laboratory Medicine Service (P&LMS).

All work is to be performed in accordance with the guidelines established by Federal, State and local ordinances, with the FDA and manufacturer's guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein.

2. REQUIRED TEST MENU:

a) Bacterial identification – 1,000 annually

b) Yeast identification – 200 annually

c) Bacterial Gram-positive and Gram-negative antimicrobial susceptibility – 10,000 annually

3. GENERAL REQUIREMENTS:

a) Under the CPT contract, the contractor is required to furnish all of the following:

1) New instrumentation hardware and software (analyzers, operating system, UPS, etc.).

2) Quality Control materials / validation materials are not provided by bioMérieux. These must be purchased by the Government. However, Start-up kits are provided and 2 boxes of each card type utilized will be provided at no charge for validation.

3) All consumables and user-defined replacement parts necessary to operate the contractor's equipment. Vendor must provide an all-inclusive list including part number, price per item, and quantities based on estimated test volume.

4) Updates to and maintenance of hardware and software necessary to fulfill the test requirements. bioMérieux will provide equipment hardware and software updates for bioMérieux proprietary products to maintain the products integrity and performance. Equipment, hardware and software upgrades will be made available in the same way they are made available to commercial customers which may include additional fees. Any changes will be made with a bilateral agreement and modification.

5) On- and/or Off-site training for end users and key operators. One training slot per new instrument. Virtual training is available to all team members at no charge. Upon installation, onsite training by a Field Application Specialist (FAS) will occur using a train-the-trainer model.

6) Delivery and installation of equipment at no additional charge as well as return shipping costs at end of contract (removal).

7) Equipment / assay installation. All validation testing is the responsibility of the lab personnel, according to their medical director’s guidance. bioMérieux FAS team can assist the customer with coordinating the validation, but cannot perform, evaluate, nor make recommendations based on the data.

8) Assist with system software verification and provide tools with supporting documents, including initial rule build and validation, including but not limited to system operating rules and auto-verification for the entire defined test menu. This applies to the initial test menu and any new assays added via modification of the contract throughout the life of the contract.

9) Standard Operating Procedures (SOP) for all assays, maintenance tasks, and equipment operation shall be provided by the vendor. CLSI Formatted procedures are available at www.biomerieuxuniversity.com

b) CPT pricing shall be based on the ESTIMATED annual test volume, with no expected minimum volume.

1) A tiered pricing structure should be utilized with additional savings as testing volume increases. Testing volume can be reviewed annually to determine if additional tiered discounts are applicable.

2) Annual test volumes provided are based upon historical reported result data and are not a guaranteed minimum.

3) New tests will be added as requested as reduced pricing cost per test (CPT) without instrumentation hardware and software or service costs added, unless replacing tests with instrumentation, hardware, software and service costs already burdened onto the test.

4) All validation testing is the responsibility of the lab personnel, according to their medical director’s guidance. bioMérieux FAS team can assist the customer with coordinating the validation, but cannot perform, evaluate, nor make recommendations based on the data. However, Start-up kits are provided and 2 boxes of each card type utilized will be provided at no charge for validation.

5) bioMérieux sends notices of allocation states as long as bioMérieux is provided with a designated individual’s Name, Title, Email and Phone Number to ensure that the correct person is getting notices. bioMerieux shall work with VA Pines to secure enough supply, even during a state of allocation. If the allocated quantity is not enough, bioMerieux shall work with VA Pines on alternate testing solutions. bioMerieux shall provide or reimburse additional costs associated with the procurement of another source, however, the solution and/or costs must be mutually agreed upon prior to bioMerieux assuming financial responsibility.

6) Failure to adequately charge for estimated cost on volume as disclosed will not incur additional charges.

4. EQUIPMENT – SYSTEM TECHNICAL SPECIFICATIONS AND FEATURES:

1) Analyzer General Specifications:

· Vendor must provide primary analyzer(s) – base equipment – that shall fully support the scope of operation (minimal workload requirements) for the isolation of bacteria for automated identification and susceptibility.

· Instrument(s) must integrate with existing laboratory’s operating system or middleware. MAESTRIA allows for enhanced cybersecurity and it is suggested to implement MAESTRIA as soon as possible. Instrument can integrate with existing middleware, however, a migration to MAESTRIA middleware will be required prior to January 2029 due to end of support of Windows OS.

· Instrument(s) must have bi-directional interfaces.

· Instrument(s) must be table-top models (CART included).

· Must have full traceability with pre-applied barcodes.

· Must allow multiple users simultaneously from individual workstations.

· Must link patient demographics to patient results.

· Vendor shall provide all hardware and software for up to 10 workstations, including workstation barcode scanners.

· Must include a quality control module to manage, report, and store quality control results.

· Must have search function on software for results to be searched by patient demographics, bench, date tested, organism, technologist, and/or accession number.

2) System must have the following, but not limited to, identification capabilities:

· Rapid microorganism identification (ID)

· Gram negative bacilli identification – >150 organisms

· Neisseria, Haemophilus and other fastidious Gram-negative bacteria identification – >30 organisms

· Gram positive cocci and bacilli identification – >100 organisms

· Anaerobic bacteria and coryneform bacteria identification – >75 organisms

· Yeast identification – >50 organisms

3) System must have Antibiotic Susceptibility Testing (AST) and resistance mechanism detection.

· Gram negative antibiotic susceptibility testing (AST) cards – >35 antimicrobials and Extended-spectrum-beta-lactamase (ESBL) tests

· Gram positive antimicrobial susceptibility testing (AST) cards

· Streptococci – >10 antimicrobials and Inducible Clindamycin Resistance (ICR) test

· Streptococcus pneumoniae – >10 antimicrobials

· Staphylococci &/or Enterococci – >20 antimicrobials, 2 high level aminoglycoside screens and (ICR) tests

· Fungal – Fluconazole antimicrobial susceptibility testing (AST) card for yeast susceptibility testing – At least 2 antimicrobials.

4) System must have epidemiologic trending and reporting.

5) System must have resistance detection by phenotype identification.

6) System must have rapid, same-day antimicrobial susceptibility testing.

7) The system must analyze minimum inhibitory concentration (MIC) patterns and detects phenotypes for most organisms tested.

8) The system must have at least:

· 2,000 described phenotypes

· 20,000 MIC distributions

· 100 resistance mechanisms detected.

· 75 organisms

9) The systems must have an extended MIC range to detect low-level resistance.

10) The systems must have resistance-oriented results for rare phenotypes.

11) The systems must understand the antibiotic results to meet formulary requirements.

12) Required electrical connection type.

· Frequency: 50/60 Hz

· Current: 12.5 A

· Power: 1 800 W

· 20A@100-120 VAC / 50-60 Hz

· 1800 Watts B Unit: 1320 Watts (@120 VAC)

· 20A @ 100 – 120 VAC / 50-60 Hz

· 1800 Watts

(Total of 2 receptacles required) Each additional module will require a separate receptacle circuit.

Recommended Power / Operational AC Voltage Range : 85-264 VAC, 50-60 HZ Instrument : 135 – 230 W Sealer: 320 – 540 W

13) Water consumption per analyzer.

14) Heat production per analyzer.

B Unit: 1129 BTU/hr

Vitek 2 XL: 682 BTU/hr

Sealer: 1090 – 1844 BTU/hr

a) Upgrades / Replacement of Equipment: Request for upgrades or replacement hardware/software, due to workload increase, excessive instrumentation failures will be evaluated as needed or at least annually with communication to the Contractor for modification of the contract. A high incidence of such problems with any equipment/analyzer or assay within the test menu supplied may indicate probable non-compliance with the terms of this contract and will entitle the government to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily.

1) “Downtime” is defined as any time the equipment is not available for patient testing due to malfunction, unacceptable quality control, software system errors, or hardware failures. This includes time used for end-user troubleshooting, conversations with technical support or on-site engineer repair/support.

During the term, bioMerieux guarantees that the Equipment will maintain a level of downtime of equal to or less than 10%. Equipment is considered to be “down “when it can no longer generate reportable results. “Downtime” for each piece of Equipment covered by this Agreement means the period of time during the equipment’s normally scheduled hours of operation that any of the Customer’s authorized users determine in good faith that the Equipment is not performing due to any malfunction of the Equipment. Downtime shall commence upon Customer’s timely notice via telephone to bioMerieux that the Equipment is malfunctioning and will end when the Customer and Supplier in good faith mutually agree in writing that the malfunction has been corrected and that the Equipment is up. The measurement criteria for calculating Uptime is the Customer’s elected coverage hours pursuant to the agreement between Customer and bioMerieux of: (a) hours per day, (b) days per week for 52 weeks, less (c) hours spent on planned maintenance during that interval.

Therefore, for example , the number of hours of Uptime required to meet Seller’s Uptime guarantee is equal to: [(a x b x 52) – c] x .90.

The following exceptions apply: The Uptime guarantee does not apply if the Customer does not adhere to bioMerieux’s service agreement terms and conditions, user manual and/or maintenance guidelines. The Uptime guarantee does not apply if the Equipment is eligible for ViLink remote connectivity, but Customer does not allow bioMerieux to access their system remotely to perform remote diagnostics and troubleshooting. The Uptime guarantee does not apply if the Customer causes the downtime of an instrument for any reason including, but not limited to, relocation of instrument, operator negligence, contaminated or disrupted power or deliberate sabotage. Should any Equipment covered under this Agreement fail to meet the Uptime guarantee of 90% in any twelve-month period, Customer and bioMerieux may mutually agree to replace the instrument.

2) Standard acceptable performance for the life of the contract, following acceptance as defined in section 8 below, is defined as a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification without prolonged downtime (>4 hours) per instance more than 3 times within 30 days or more than 10 instances of downtime (of any length of time) within 30 days. In the event the equipment or an assay does not meet the standard acceptable performance for 30 consecutive days, the government will notify the contractor of the ongoing unacceptable performance and the performance will be monitored for an addition 90 consecutive days. If after 120 calendar days from the initial date of unacceptability, the vendor does not resolve the performance concerns to meet the governments expectations, the government, through the contracting officer, may request a replacement of the equipment / assay or terminate the order upon mutual agreement.

3) Removal of the existing instrument by the Contractor shall be performed within 30 days following the acceptance of replacement equipment without additional charge to the government.

4) Updates available to the contractor's equipment shall occur within 60 days of their issuance or date of first commercial availability. bioMérieux will provide equipment hardware and software updates for bioMérieux proprietary products to maintain the products integrity and performance. Enhancements and Upgrades will be made available in the same way they are made available to commercial customers which may include additional fees. Any changes will be made with a bilateral agreement and modification.

5) The Contractor shall provide all updates to the equipment hardware and operating system software without additional charge to the government. bioMérieux will provide equipment hardware and software updates for bioMérieux proprietary products to maintain the products integrity and performance. Enhancements and Upgrades will be made available in the same way they are made available to commercial customers which may include additional fees. Any changes will be made with a bilateral agreement and modification.

b) Adding New Assays to the Existing Analyzers: A contract modification may be used to add additional assays to the existing test menu at any time during the contract period. All validation testing is the responsibility of the lab personnel, per their medical director’s guidance.

5. SYSTEM DATA MANAGEMENT HARDWARE / SOFTWARE

a) The Data Management System must include production account. The contractor is responsible for assisting the government with the initial virtual server build and on-going maintenance of both servers.

1) The system must have sufficient data storage for 2 years of workload data and provide immediate access to patient records, including instrument identification (houses PHI and PII). Analyzers or software systems shall be able to access a network storage drive for backup or be able to work with VA to provide suitable backup solution. If needed, the VA agrees to provide the contractor with a local account. The device is not required to be on VA domain.

2) The Contractor’s equipment shall be compatible, or have the ability to, act as a pass-through to the government’s Data Innovations (DI) Instrument Manager for instances when the government’s DI is the primary rule management software. DI connection is not required for vendor’s who connect directly to the government’s LIS and when the vendor’s middleware is the primary rule management software.

b) The contractor can assist with the complete system software verification, including initial rule build and validation, including but not limited to test rules and auto-verification rules for the entire defined test menu. This applies to the initial test menu and any new assays added via modification of the contract throughout the life of the contract.

c) bioMérieux does not provide printers, a network printer can be utilized.

d) All equipment / analyzers must have 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 CPRS/VistA.

e) Must have an HL7 (Health Level 7) interface in order to send comments to host. If MAESTRIA is also in the scope it uses the MYLA HL7 driver by DI.

f) Equipment shall be able to support barcode format code 128. Success rate is dependent upon the quality of the label used and its position.

g) Equipment shall accept, at a minimum, 10 characters in specimen identifier that is alphanumeric.

h) The contractor and lab information manager must have remote access connectivity for troubleshooting systems, interface connections, and analyzers. Contractors require network access to the instruments and to the interface manager. Contractor agrees to complete the VA required training as applicable and be knowledge of Information Security requirements specific to VA installations and work with government BioMed and OI&T personnel to meet these requirements.

i) The contractor shall provide a minimum of 5 thin client middleware licenses, if applicable, for system access throughout the healthcare network.

j) All software and software licenses, interfaces, and hardware shall be included with cost of hardware required disclosed for removal if needed.

k) Procurement of systems with unsupported operating systems is prohibited. Unsupported operating systems are software systems that are not supported by the manufacturer and have reached the end of the OS lifecycle as published by the OS manufacturer (i.e., no further security patches will be released for the OS by the manufacturer after the OS end of life nor will be available by other methods such as extended warranty purchases from the OS manufacturer). If the proposed medical device runs an unsupported OS, the medical device vendor must provide a support plan for the device (i.e., purchase of extended warranty from the OS manufacturer, an upgrade path to a supported OS, etc.) prior to deployment of the system. Contractor is responsible for maintaining operating system software in compliance with VA TRM (Technical Reference Model) and agrees to upgrade or replace the OS for ongoing approval with OI&T and BioMed network guidelines.

For avoidance of confusion, the VA is responsible for maintaining the security configuration (monthly security patching) provided by Microsoft for the OS as well as any and all signature and definition updates to the anti-virus/anti-malware software for all hosted medical devices/systems. Contractor is responsible for the security and patching of the application/software it provides.

6. PREVENTATIVE MAINTENANCE:

a) The contractor shall provide maintenance, at their expense (travel, labor and parts), to keep the equipment in good operating condition and subject to security regulations. The government shall provide the contractor access to the equipment to perform maintenance services.

b) The preventive maintenance shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment. All scheduled maintenance must be completed within 2 weeks of the scheduled due date (based on previously completed task).

Enhanced Warranty and Full Service Agreement (FSA) covers all telephone support, labor, travel, expenses, and parts for an unlimited number of telephone support calls and on-demand service visits, to the extent defined in the General Service Terms and Conditions. bioMérieux shall use commercially reasonable efforts to provide Customer on-site remedial maintenance during the stated coverage hours within twenty four (24) hours of determination by bioMérieux that an on-site visit is necessary.

This Agreement also includes the recommended preventive maintenance visits per year and bioMérieux’s remote diagnostics feature for troubleshooting instrumentation (NOTE: remote access denial may result in additional service charges for unnecessary dispatches).

The extent of the level of the technical call center support is at the discretion of bioMérieux and does not include support such as, but not limited to, intensive data mining, training, LIS Support, or situations where dispatch is required.

COVERAGE: On Site Available between 7:00AM – 7:00PM local time in the Continental U.S., 7 Days a week. Zone charges may apply for Instruments located outside the Continental U.S.

Technical Support Center Support 24 hours a day / 7 days a week.

c) Contractor shall have remote access to system for troubleshooting purposes.

7. SERVICE AND SUPPORT:

a) Telephone technical support shall be available 24 hours/day, 7 days/week with follow up on all calls within one hour of initial call. Following determination that service is required, technical on-site support must be provided within 24 hours.

b) Contractor shall provide full service on-site technical support, 5-days per week, Monday – Friday 8:00am-4:30pm for all vendor-owned equipment to keep the equipment in good operating condition to prevent patient care delays.

c) The government shall provide the contractor access to the equipment to perform the repair.

d) The contractor will provide all parts and labor needed to repair the malfunction.

e) Travel, per diem and other expenses associated with the repair will be borne by the contractor.

f) The contractor shall furnish a malfunction incident report to the institution upon completion of each maintenance call. The report shall include, as a minimum, the following: (a date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.

At the conclusion of each maintenance call (whether the completion of PM, update, or system repair) the FSE will provide a copy of the service report and obtain signatures from the customer representative.

8. DELIVERY, PERFORMANCE, INSPECTION AND ACCEPTANCE:

a) General:

1) The Contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services furnished under the contract conform to contract requirements. The VA has the right to test all services ordered under the contract at all times and places throughout the term of the contract Government testing and inspection will not unduly delay any Contractor work being performed nor will it create a defect in services covered by this contract. At install, all equipment is tested to ensure systems are performing as expected.

2) The VA reserves the right to thoroughly inspect and investigate the contractor and manufacturer business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance.

3) bioMérieux does not accept returns.

4) Standard and Acceptance of performance shall begin on the installation date. It shall end on the earlier date of when a certificate of acceptance has been signed or the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification or as quoted in any contract at an effectiveness level of 90% or more. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue on 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 or terminate the order upon mutual agreement.

5) Operational use time for performance testing for a system is defined as the accumulated time during which the analyzer is in actual use. System failure downtime is that period of time when any analyzer 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 analyzer(s) is returned to the government in proper operating condition.

During the term, bioMerieux guarantees that the Equipment will maintain a level of downtime of equal to or less than 10%. Equipment is considered to be “down” when it can no longer generate reportable results. “Downtime” for each piece of Equipment covered by this Agreement means the period of time during the equipment’s normally scheduled hours of operation that any of the Customer’s authorized users determine in good faith that the Equipment is not performing due to any malfunction of the Equipment. Downtime shall commence upon Customer’s timely notice via telephone to bioMerieux that the Equipment is malfunctioning and will end when the Customer and Supplier in good faith mutually agree in writing that the malfunction has been corrected and that the Equipment is up. The measurement criteria for calculating Uptime is the Customer’s elected coverage hours pursuant to the agreement between Customer and bioMerieux of: (a) hours per day, (b) days per week for 52 weeks, less (c) hours spent on planned maintenance during that interval. Therefore, for example , the number of hours of Uptime required to meet Seller’s Uptime guarantee is equal to:

[(a x b x 52) – c] x .90.

The following exceptions apply: The Uptime guarantee does not apply if the Customer does not adhere to bioMerieux’s service agreement terms and conditions, user manual and/or maintenance guidelines. The Uptime guarantee does not apply if the Equipment is eligible for ViLink remote connectivity but Customer does not allow bioMerieux to access their system remotely to perform remote diagnostics and troubleshooting. The Uptime guarantee does not apply if the Customer causes the downtime of an instrument for any reason including, but not limited to, relocation of instrument, operator negligence, contaminated or disrupted power or deliberate sabotage.

Should any Equipment covered under this Agreement fail to meet the Uptime guarantee of 90% in any twelve month period, Customer and bioMerieux may mutually agree to replace the instrument.

6) During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The government shall maintain appropriate 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 performance period. Operations use time and downtime shall be measured in hours and whole minutes.

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

b) Equipment:

1) The contractor is required to provide new state-of the art equipment. Previously used or discontinued models are not acceptable.

2) Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training.

3) The VA reserves the right to request a ninety (90) day test and evaluation of all pieces of equipment prior to placing a delivery order under the contract. If the test and evaluation is not successful as determined by the CO and COR, the VA will not be required to continue with placing a delivery order under this contract, and no default or penalty will accrue.

4) The contractor shall be responsible for installation, which consists of in-house delivery, positioning and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

5) Upon completion of installation the equipment will be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government shall accept installation with guaranteed date commencing ten calendar days after installation. Upon installation of the equipment will be turned over to hospital once the POI is completed and signed off by bioMérieux Service representative.

6) The contractor will provide all operational updates to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. These updates to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

7) Ownership of Equipment shall remain with the contractor, except for previously defined equipment (by model and serial number) at the time of contract award. All equipment accessories (hardware and software) 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, will remove the equipment. The contractor will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within ten business days. The hard drive will remain within the VA.

c) Reagents/Supplies/Consumables:

1) The VA shall require the delivery of reagents for all services required under this contract. The contractor shall deliver reagents, shipping cost included, as needed (including emergency over-night delivery orders) from CALL orders within 24 hours.

2) The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality result. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and The Joint Commission.

3) In the event that the supplies, to include 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 herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order for priority delivery from the government activity. This will be done at no cost to the government and in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume).

4) The Contractor is required to provide a continuously, unless notified of allocation state, stocked inventory of reagents, calibrators, troubleshooting controls, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment. Unexpected changes in methodology or technology will be at the expense of the Contractor. Alert and Notification of all technical advisory recalls and, or alerts, prior to or simultaneously with field alerts should be forwarded to Laboratory Supervisor and the Laboratory Manager. On or about the first day of each month, the contractor will ensure that each site is furnished with sufficient consumable supplies to produce a volume of tests for that month. Separate deliveries of products will be shipped to each testing site, as applicable. Failure to reserve adequate inventory will result in default, unless notified of allocation state.

bioMérieux will be provided with a designated individual’s Name, Title, Email and Phone Number to ensure that the correct person is getting notices.

5) If additional requests for emergency supply delivery are required by the government, the contractor shall honor them until the arrival of the monthly standing order and routine supplies are delivered.

6) All deliveries (routine and emergent) of reagents, supplies, consumables must be delivered directly to the laboratory at the expense of the contractor.

9. TRAINING:

a) The contractor, without additional charge to the government, shall provide off-site training for minimally one (1) key operating personnel per instrument module installed per facility. In addition, the contractor shall provide supplemental operating training to (2) two government personnel, without additional charge to the government, upon installation of an update in equipment hardware or operating system software connected with the operation of an instrument already furnished.

Off-site training provided in the first year only. Additional off-site training can be purchased as needed.

Virtual training is available to all team members at no charge. Classroom training for one key operator including airfare, room and board is included. Entitlement expires 6 months after installation. Upon installation, onsite training by a Field Application Specialist will occur using a train-the-trainer model. Support documentation and material is regularly updated and made available to customers through www.mybiomerieux.com operators manual can be found on the desktop of our systems operating computer and updated with every software update. E-Learning is also available through www.biomerieuxuniversity.com

b) Training of Operating Personnel: The contractor shall provide the services of a qualified technical person, at the time of equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Representative (COR) to on-site orientation and training to designated personnel in: operation and care of equipment; techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under contract guarantee clause. This training shall include at least (2) two-day on-site training sessions, all day, upon installation and acceptance of equipment and later, for refresher training.

10. REGULATORY REQUIREMENTS: If the product(s) included in this solicitation are considered medical devices by the US Food and Drug Administration, the manufacturer shall be in compliance with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated there under.

11. TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all applicable equipment offered under this contract shall conform to all common industry standards.

12. MANUFACTURED PRODUCTS: Materials furnished shall be of the current productions of manufacturers regularly engaged in manufacture of such items. Approval by Contracting Officer is required of deviation from products and manufacturers as shown in the schedule of items. Shelf-life of all consumables shall be at least 8 months from shipping date unless FDA requires different expiration date.

13. REFERENCE SPECIFICATIONS AND PUBLICATIONS: Where an item is required to conform to certain requirements, conformance shall be evidenced by seal, label, stamp, or approval listing from such agency, or by a certified test report from an independent testing laboratory acceptable to the Government, that the item has been tested and conforms to requirements of referenced agency.

14. RECALLS: If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement.

15. CONTRACT ADMINISTRATION DATA: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the contracting officer, the change shall be considered to have been made without authority and no adjustment will be made in contract price to cover any increase in costs incurred as a result thereof.

16. RECORDS MANAGEMENT OBLIGATIONS

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

b) Definitions:

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

2) The term Federal record:

· includes Bay Pines VA’s Hospital Network records.

· does not include personal materials.

· applies to records created, received, or maintained by Contractors pursuant to their Bay Pines VA’s Hospital Network contract.

· may include deliverables and documentation associated with deliverables.

c) Requirements:

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

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

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

4) Bay Pines VA’s Hospital Network and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Bay Pines VA’s Hospital Network or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Bay Pines VA’s Hospital Network. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5) The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Bay Pines VA’s Hospital Network control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6) The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts.