36C25926Q0375.docx

36C25926Q0375 RFQ Solicitation-36C25926Q0375 Respiratory Panel, Strep ID, and Blood Culture ID

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

36C259-26-AP-0725

36C25926Q0375 05-19-2026 Ernest Appiah

(303) 712-5734 06-19-2026

10:00AM

MDT

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village

CO

80111 X 532490 $40 Million

NET 30

N/A X Department of Veterans Affairs Fort Harrison VA Medical Center Multiple Locations per Statement of Work (SOW)

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village

CO

80111

Submitted Electronically

Financial Service Center PO Box 149971 Austin

TX

78714-9971 See CONTINUATION Page The Contractor shall provide all equipment, reagents, standards, supplies, consumable/disposable items, parts, accessories, furnish all labor, parts, supplies and equipment necessary on a cost per test pricing structure to provide scheduled and unscheduled maintenance, tech support, periodic preventative maintenance inspections for a molecular system and any other items required for the proper operation of its contractor owned analyzer and peripherals necessary for the generation of but not limited to Molecular Diagnostic Testing system per the price schedule.

All interested contractors should review all content of this solicitation to include all clauses, provisions, Statement of Work, Price Schedule, Instructions to Offerors, and Evaluation Factors before submitting a quote.

This is an unrestricted solicitation in accordance with Revolutionary Far Overhaul Part 12.

See CONTINUATION Page X X X X 36C259

VA-VHA-RPOW-2025-0014

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

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

B.1.1. Contract Administration: All contract administration matters will be handled by the following individuals:

B.1.1.1. CONTRACTOR: Name: ___________________

B.1.1.2. GOVERNMENT: Contracting Officer (CO)

Rocky Mountain Network NCO 19 Contracting 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 Telephone: (303) 712-5734

FAX: 303-712-5800

E-mail: NCO19lab@va.gov

B.1.2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

B.1.3. GOVERNMENT INVOICE ADDRESS: Invoices shall be submitted in arrears:

c. Other [X] MONTHLY IN ARREARS B.1.4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted electronically to the VA Financial Services Center for payment processing, free of charge. For any questions about the e-invoicing program, please contact the FSC at the phone number or email address listed below:

1. TUNGSTEN e-Invoice Setup Information: (877) 752-0900

1. TUNGSTEN e-Invoice email: USClientServices@ob10.com

1. FSC e-Invoice Contact Information: (877) 353-9791

1. FSC e-invoice email: vafsccshd@va.gov

1. The following two codes will be required when creating a vendor profile in TUNGSTEN:

· TUNGSTEN Buyer Number AAA544240062

· Promo Code: VAPC7Y18

B.1.5. Unique Entity Identification (UEI): _________________________

B.1.6. TAX IDENTIFICATION NUMBER: ___________________________

B.1.7. PERIOD OF PERFORMANCE: 06/30/2026 through 06/29/2031 36C25926Q0375

B.2 STATEMENT OF WORK

Page 1 of Page 1 of Molecular Diagnostic Testing Services VA Montana Healthcare, Ft. Harrison, MT Benjamin Steele VA Clinic, Billings MT

I. SCOPE

The Contractor shall provide all equipment, reagents, standards, supplies, consumable/disposable items, parts, accessories, furnish all labor, parts, supplies and equipment necessary to provide scheduled and unscheduled maintenance, tech support, periodic preventive maintenance inspections for a molecular system and any other items required for the proper operation of its contractor owned analyzer and peripherals necessary for the generation of but not limited to Molecular Diagnostic Testing system for the following test panels: Respiratory Pathogen Panel , Blood Culture Identification panel to include Gram negative bacteria, Gram positive bacteria and Fungus Identification, and Streptococcus panel to include Strep group C/G strep and Strep group A strep cost per test services. The instrument shall 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). Services shall be required for VISN 19; VA Medical Center Ft. Harrison Montana (3687 Veterans Drive, Fort Harrison, Mt 59636 and Benjamin Steele VA Clinic (1766 Majestic Lane Billings MT 59102) Facility points of contact information:

II. DEFINITIONS

1) Cost Per Test (CPT): The cost per test result price shall include all costs covering:

a) equipment use;

b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories, maintenance and any other item required for the proper operation of the contractor’s equipment and necessary for the generation of a patient reportable result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result price shall also encompass all costs associated with repeat and confirmatory testing required to produce a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control (provide control material or credit to purchase controls from other vendors), calibration and correlation study testing that is prescribed by Clinical and Laboratory Standards Institute (CLSI);

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

d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. Instrument and testing methods need to be FDA approved. These instruments are a critical function to the service as its purpose is to perform real-time PCR from patient’s specimen which could lead to sepsis or an infection if not identified accurately and timely. This is not a process or a system that can be referred to another VA facility nor sent to a reference laboratory. It is required for patient safety, management, and help provider to avoid morbidity and mortality.

III. GENERAL REQUIREMENTS

1) Offered models of the Molecular Diagnostic Testing System shall be capable of producing accurate and reproducible assays on biological specimens by established vitro diagnostic methods. The system shall provide accurate test assay results for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

a) Offered testing equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted.

b) The contractor shall provide all upgrades to the equipment, hardware and operating system software, at no additional cost to the Government during the lifetime of the instrument. These enhancements shall be delivered and installed at the VA Medical Center Ft. Harrison Montana and Benjamin Steele VA Clinic within 30 days of issuance to the commercial market.

c) The system being offered is 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 manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

d) Contractor offered equipment shall perform satisfactorily at any laboratory temperature between 50- and 90-degrees Fahrenheit (10 and 32 degrees Celsius) and relative humidity between 10 and 85 percent.

e) An operator’s manual for the instrument shall be supplied to the VA Medical Center Ft. Harrison Montana and Benjamin Steele VA Clinic Billings, MT

f) Analyzer shall conform to the VA Medical Center Ft. Harrison Montana and Billing Montana laboratory space.

g) Estimated yearly quantities provided under this agreement are estimates based upon prior history of actual volumes and are not a guaranteed minimum. See Schedule for a list of tests and volumes.

IV. MAINTENANCE AND REPAIRS

1) With the exception of the specific maintenance and repair requirements stated herein, which shall have precedence; preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment shall be performed and provided in accordance with the terms, conditions, and provisions of contractor's existing Federal Supply Service Contract for performance of CPT services as stated in Subsection III of the VA National Acquisition Center contract requirements. Contractors should maintain an adequate parts bank to handle common break down occurrences; refurbished replacement parts will not be acceptable.

2) Emergency repairs shall be performed after initial telephone notification that the equipment is inoperative. The contractor shall provide the Government with a designated point of contact and telephone number and shall decide to enable his maintenance representative to receive such notification. Should contractor instrumentation be unable to result patient testing for a period greater than 24 hours, testing should be sent out to a reference laboratory at contractor’s expense.

3) The contractor shall be on-site at VA Medical Center Ft. Harrison Montana and Billings MT to perform emergency repair service to the testing instrument within twenty-four hours after receipt of initial telephone notification of a malfunction. Contractor shall provide medical center service coverage Monday through Sunday 0800 to 1700 MST including all Federal holidays. Multiple service personnel shall be available in the local area to back up primary service person to meet the demands for guaranteed on-site time. Contractor should provide a service hotline with technical support to assist in troubleshooting 48 hours per day, seven days per week including Federal holidays. ALL repairs must be completed within 24 hours from the time the field engineer arrives.

4) In addition to above, the contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following:

a) Date and time notified

b) Date and time of arrival

c) Serial number, type, and model number of equipment

d) Time spent for repair

e) Description of malfunction and repair

f) Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance

5) Should the repair record of any piece of contractor laboratory equipment reflect a downtime of 5% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial contractor laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in operating condition in accordance with manufacturer’s instruction, shall be solely that of the contractor. The instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement. 95% uptime guarantee is based on the contractor laboratory equipment operating 24 hours/day, 7 days/week. Down time is considered from time of notification that the instrument is down (patient results are unable to be reported out) to when the instrument is back up running QC within the laboratory’s acceptable limits and reporting patient results.

6) The contractor shall not leave a service call open pending verification that repairs are completed by the contractor’s maintenance personnel. The contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call.

V. TRAINING

1) The contractor shall provide training in accordance with the terms, conditions, and provision of the contractor’s existing federal supply service contract.

2) The contractor shall provide the following on-site support and training prior to going live.

a) Training key user: Maximum of four (4)

b) Days on site to train: Maximum of three (3)

c) Verification supports onsite: maximum of three (3)

3) Contractor shall provide one annual retraining of one key user, at no additional cost

VI. SYSTEM REQUIREMENTS

1) Contractor must provide a FDA approved, CLIA waived Moderately Complex, fully-integrated, random access, and automated platform analysis instrument.

2) Fully automated “walk-away” Extraction/Amplification/Detection

3) Moderately Complex PCR tests availability allows for any technologist to operate the system.

4) Real-time PCR system integrated complete random access platform, and on-board nucleic acid purification and system with amplification and detection in one self-contained system with reliable methodologies for the detection of:

a) Streptococcus panel: Must identify Streptococcus dysgalactiae group C/G strep, Streptococcus pyogenes group A Strep.

b) Respiratory Panel: Must identify Adenovirus, Coronavirus SARS-COV-2, Coronavirus, Human Metapneumovirus, Human Rhinovirus, Human Enterovirus, Influenza A Virus (subtypes) Influenza B virus, Parainfluenza virus, Respiratory syncytial Virus(RSV), chlamydia pneumoniae and mycoplasma pneumoniae

c) For Fort Harrison location only: Blood Culture Identification panel: Must identify Gram positive bacteria, Gram Negative bacteria and Yeast. Analyzer must be fully automated; capable of incorporating sample lysis, extraction, amplification, and detection all in one system.

5) Sequential Testing Capability: system shall be able to run individual samples without the need for batching and a new run can be “interleaved” into the middle of a currently processing run without stopping current run.

6) Provides and performs bar-code operations for sampling, reagents, controls and calibrators.

7) Walkaway automation, ease in handling and resolving errors, sample ID tracking, on board test reagent inventory tracking and volumes, and auto lot recognition/calibration and expiration.

8) Allows multiple assays to run separately on the same instruments at the same time

9) Closed system eliminates contamination and does not require special operating environments normally required for PCR activity.

10) Minimal “hands-on” time – rapid, easy to perform sample loading. Saves lab personnel considerable time in loading and offloading tests cartridges.

11) Utilizes proprietary dried reagent technology for ambient temp stability, precision of microfluidics-based reconstitution, and simplification of automated filling.

12) Integrated software has LIS connectivity for bi-directional interface.

13) System must include an on-board QC program capable of printing/displaying all internal QC/calibrations (e.g. when QC is out-of-limits).

14) System must include software to calculate and track positivity rate of assays.

15) System must have capability to perform user defined assays.

16) System must use unprepared samples with little or no preparation time (measured in minutes).

17) System should be able to conduct the test and give results rapidly (measured in hours including preparatory time).

18) User Friendliness:

a) should not require a molecular trained technologist to operate the analyzer or to perform the test

b) must provide software and/or supporting instrumentation required to maintain, or improve levels of data retrieval, which may use for epidemiology, or cost-decreasing measures;

c) ease in handling and resolving errors;

VII. SOFTWARE

1) Provide bi-directional interface for Data Innovations LIS connectivity: Contractor shall provide, as part of its offer, a list of VA sites currently using interfaces for the instrument offered.

2) Contractor shall make procedures available on electronic media or website for each analyte in CLSI format that must be editable by the user.

3) Contractor shall make Individualized Quality Control Plan (IQCP) information available for each assay in electronic form or on the website.

4) Instrument software shall be versatile and easy to use with following capabilities:

a) Look up capabilities for results on samples being processed with 24-48-hour on-board patient history list and ability to retransmit results.

b) Ability to store QC lot files, work list edit capability.

c) Ability to alert user of empty/expired reagents and on-board inventory.

d) Ability to print, archives, and retransmit data results for patients and/or QC.

e) Closed system eliminating contamination, ambient temperature stability for storage/shipping, and extended shelf life for reagents and extraction reagents

f) Minimal "hands-on" time — rapid, easy to perform sample processing.

g) Allow multiple assays to run separately at the same time.

h) Software upgrades are automatic and include training if needed.

VIII. INSTALLATION / VALIDATION / TRAINING

1) With the exception of the specific training requirements stated herein, which shall have precedence; contractor shall provide training in accordance with the terms, conditions, and provisions of contractor's existing Federal Supply Service Contract for performance of CPT services.

2) The Contractor shall provide training as per the National FSS Statement of Work. This shall include training on the operation of the system, data manipulation, preventative maintenance and basic trouble shooting and repair for 2 key operators training requirement). Any training program that involves off-site travel shall include the cost of airfare, room and board for each participant. A training or competency checklist shall be provided by the Contractor.

3) Provide on-site vendor operator training for all personnel who will run instrument with training provided for all applicable staff.

4) D. Any training program that involves off-site travel shall include the cost of airfare, room and board for each participant. A training or competency checklist shall be provided by the Contractor.

5) E. Upon completion of installation at the VA Medical Center Ft. Harrison Montana the contractor shall provide a technical support specialist to perform all validation procedures including analytical sensitivity, analytical specificity, reproducibility, limit of detection (LOD), correlations, and reference range studies at contractors’ expense using validation parameters provided by pathologist in charge of laboratory (evaluation/comparison data sufficient to satisfy CAP standards). Basic operating and maintenance training during installations or update to the equipment.

6) F. Provide on-site operator training for all personnel on all applicable shifts.

7) G. Contractor shall provide all necessary procedure manuals, troubleshooting manuals and operator manuals (also available on computer disk format).

8) H. Vendor must provide education/training on site — basic operating and maintenance training during installations or update to the equipment.

IX. QUALITY CONTROL

1) System must include an on-board QC program capable of printing/displaying all internal QC/calibrations (e.g. when QC is out of limits).

2) System must include software for calculating and tracking positivity rates for all assays.

3) The QC and standards to include calibrator material shall be included in the contract for all tests in use (or credit toward purchase). A minimum suggested outdate for control lots should be more than one year).

4) Reagent, controls and all other supplies shall be provided to VA Medical Center Ft. Harrison Montana and Billings MT F.O.B. Destination.

X. REAGENTS / STANDARDS / SUPPLIES

1) All reagents, controls, calibrators and consumables/disposables required for operating the analyzer and producing quality results should be listed as an addendum in the pricing schedule.

2) Standards to include calibrators with extended calibration life – little or no daily/weekly calibrations, automatic calibration

3) Reagents have prolonged shelf life and stability once opened/on-board and on-board reagent inventory.

4) Reagents should not contain guanidine thiocyanate or other chemicals which require special handling for disposal or could create toxic fumes when mixed with bleach.

5) Instrument alerts operator to any operational errors, regents/consumables needed to complete testing

6) Contractor will characterize each method and provide exact vendor guaranteed minimum linearity/AMR, CRR limits, etc.

7) As new methods are released for instrument, the updates are automatically enabled promptly and at no cost to the government.

8) Provide values for calibrators and AMR calibrator values, if needed to perform testing and/or preventive maintenance.

9) Provide complete list of reagents, calibrators, controls, and consumables to include Safety data sheet (SDS) and Waste Stream information for the proper disposal of chemicals used for daily running and analysis of patient specimens.

10) Provide UPS, uninterruptible power supply

11) Provide Printer and probes

12) Frequency of supply shipments. Contractor shall provide initial inventory based on prior use, when available, then establish a standing monthly/quarterly shipment based on current use, with the capacity to fill emergency requests on-demand.

13) Contractor shall provide geographical location of like instruments to assist in reagent/supply crisis situations.

14) Contractor shall provide SDS and waste stream information for all reagents, controls, calibrators and disposables required for operating the analyzer.

15) Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees must be clearly indicated in the price quote.

XI. MANDATORY VALUE-ADDED CHARACTERISTICS

These characteristics are mandatory. Value added characteristics include, but are not limited to:

1) Preventative Maintenance is required. Contractor shall define maintenance requirements and indicate scheduled PM’s and which items are performed by the user and which are not.

2) Software should be compatible with all barcode styles and bidirectional interface to LIS. All necessary software/hardware (drivers) for bi-directional interface with Data Innovations shall be provided by contractor.

3) Equipment should include 120-220 volt UPS system provided and serviced by the contractor.

4) System must include an on-board QC program capable of printing/displaying all internal QC/calibrations (e.g. when QC is out-of-limits).

5) Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees must be clearly indicated in the price quote.

XII. UPGRADES / TEST VOLUME ADJUSTMENT

1) Contractor shall work with the laboratory to adjust reagent supply to match workload changes.

2) Automatic software upgrades as available and within two months of release, and will at all times maintain compatibility of systems with the host LIS in place, especially when vendor software is upgraded. Upgrades to equipment, hardware or software are at no additional charge to the Government.

XIII. INVENTORY CONTROL OF REAGENTS, SUPPLIES AND DISPOSABLES

1) DELIVERY OF SUPPLIES. Any unexpected changes in methodology/technology shall be at the expense of the Contractor.

2) ALERT/NOTIFICATION OF DELAYS. In shipments as well as all technical advisory/recalls/alerts, prior to or simultaneously with field alerts shall be forwarded to the department supervisor, lab chiefs, and the VA Medical Center Ft. Harrison Montana program office manager.

3) SPECIAL HANDLING FOR EMERGENCY ORDERS OF SUPPLIES: In the event that the consumables are found to be defective and unsuitable for use with the contractor’s equipment, or the contractor has failed to comply with the requirements for routing supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. If either circumstance has occurred, the contractor will deliver to the government site in the most expeditious manner possible without additional cost to the Government.

4) QUALITY OF SUPPLIES: The contractor shall maintain on Government provided space a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other material or commonly stocked parts required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision/reproducibility and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP), Clinical Laboratory Standards Institute (CLSI) and the Joint Commission on Accreditation (JC).In the event that the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the VA Medical Center Ft. Harrison Montana and Billings Montana 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) without additional cost to the Government. If additional requests for emergency supply delivery are required by the Government, they will be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery.

XIV. IMPLEMENTATION AND TRANSITION

1) The Contractor shall provide with its quotation a delivery schedule for the complete transition of all services including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all comparisons and validations. This transition shall be completed no later than 30 days after award. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe.

2) Comparison and Validation of Analyzer: The Contractor shall assist or perform all comparison and validation/verification studies to include any material and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within four weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

3) Instrument and method validations by Contractor not to exceed 90 days delivery after receipt of order (ARO). During this time, Contractor provides fully editable electronic copies of all methods, instruments, operations, and maintenance procedures to be used for the preparation of standard operating procedures (SOPs).

4) Billing by Contractor starts on the first day of patient testing after all installation, training, and method validations have been completed and accepted in writing by Pathologist or Medical Director. At this time, the awarded contractor shall have completed full transition of all services under this agreement and shall have full and sole responsibility for services under the awarded contract.

XV. INFORMATION SECURITY AND PRIVACY

GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

XVI. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1) A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

2) All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

3) Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

a) Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

b) The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

XVII. VA INFORMATION CUSTODIAL LANGUAGE

1) Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

2) VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

3) Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing 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 of the contract.

4) The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

5) The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold

XVIII. SECURITY INCIDENT INVESTIGATION

1) The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

2) To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

3) With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

4) In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other.

5) compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident

XIX. LIQUIDATED DAMAGES FOR DATA BREACH

1) Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

2) The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

3) Each risk analysis shall address all relevant information concerning the data breach, including the following:

a) Nature of the event (loss, theft, unauthorized access);

b) Description of the event, including: date of occurrence; and data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

c) Number of individuals affected or potentially affected;

d) Names of individuals or groups affected or potentially affected;

e) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

f) Amount of time the data has been out of VA control;

g) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

h) (h)Known misuses of data containing sensitive personal information, if any;

i) (i)Assessment of the potential harm to the affected individuals;

4) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

5) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

6) Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $42.00 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

a) Notification;

b) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

c) Data breach analysis;

d) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

e) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

f) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

XX. TRAINING

1) All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

a) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

b) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

c) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

d) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

2) The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

3) Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

(END OF STATEMENT OF WORK)

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Streptococcus Panel CPT Code:

Contract Period: Base POP Begin: 06-30-2026 POP End: 06-29-2031 PRINCIPAL NAICS CODE: 532490 - Other Commercial and Industrial Machinery and Equipment Rental and Leasing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies Open Market CPT

Respiratory Pathogen Panel

Contract Period: Base POP Begin: 06-30-2026 POP End: 06-29-2031 PRINCIPAL NAICS CODE: 532490 - Other Commercial and Industrial Machinery and Equipment Rental and Leasing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

Blood Culture ID Panel

Contract Period: Base POP Begin: 06-30-2026 POP End: 06-29-2031

B.4 DELIVERY SCHEDULE

Fort Harrison VA Medical Center 3687 Veterans Drive Fort Harrison, CO 59636 9700

USA

425.00

Fort Harrison VA Medical Center 3687 Veterans Drive Fort Harrison, CO 59636 9700

4,665.00

Fort Harrison VA Medical Center 3687 Veterans Drive Fort Harrison, CO 59636 9700

200.00

B.5 INTRODUCTION

In the spirit of the Federal Acquisition Streamlining Act, the Department of Veterans Affairs (DVA) and hereby enter into a cooperative agreement, otherwise referred to as a Blanket Purchase Agreement (BPA), to further reduce the administrative costs of acquiring supplies/services.

The agreement details all with accompanying prices and descriptions, which may be ordered under this BPA.

All orders placed against this BPA are subject to the terms and conditions of all the clauses and provisions in full text or incorporated by reference in this document.

B.6 TERMS AND CONDITIONS

The Contractor agrees to the following terms of a Blanket Purchase Agreement (BPA) EXCLUSIVELY WITH the Department of Veterans Affairs:

B.7 ADMINISTRATIVE DATA

A Blanket Purchase Agreement (BPA) is hereby established between and the Department of Veterans Affairs under the following terms and conditions incorporated in this BPA:

Primary Point of Contact:

Alternate Point of Contact:

DUNS NUMBER:

Cognizant Office (Include complete address):

Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

B.8 PRICING DATA

1. The prices included on the BPA list (or applicable "discounted" rates submitted in a proposal response to an RFQ resulting in award) that are in effect on the effective date of an order shall govern that order's basic performance period. With regard to any option years, which are later exercised, the proposed option year rates as incorporated into the order award are in effect until such time, if applicable, that the contractor has been authorized a rate increase culminating from a negotiation with the Contracting Officer.

2. The BPA holder can voluntarily reduce offered prices at any time by giving 24-hour advance notice (by facsimile or electronic-mail) to the Department of Veterans Affairs/Contracting Officer. This BPA also allows for additional discounts if a "large order" is placed at one time. An advanced notice is not required for discounts offered for only an individual order. Whether an order is large enough to warrant such a discount is subject to the discretion of the BPA holder.

3. The BPA holder may also increase BPA prices at any time. Any BPA price increase shall not take effect until the Department of Veterans Affairs Contracting Officer receives written notification (U.S. mail, facsimile, or electronic-mail). Any order already issued shall not be affected by any change to BPA pricing. The prices offered under this BPA will undergo annual review by the Department of Veterans Affairs Contracting Officer.

B.9 OPTION TO EXTEND THE TERM OF THE BPA

a. The Government may extend the term of this BPA by written notice to the Contractor at any time prior to the expiration of the BPA, provided that the Government shall give the Contractor a preliminary written notice of its intent to extend at least 30 days before the BPA expires.