RFQ 36C25726Q0805.docx

36C25726Q0805

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

07-30-2026 Kathryn Prose (kathryn.prose@va.gov)

(254) 217-2835 08-13-2026

1:00 PM

EDT

36C257 Department Of Veterans Affairs Network Contracting Office (NCO) 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

X

334516 1000 Employees

N/A

36C504 Department of Veterans Affairs Amarillo Veterans Healthcare System

6010 Amarillo Blvd W Amarillo TX 79106 36C257 Department Of Veterans Affairs Network Contracting Office (NCO) 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

(877) 353-9791

(512) 460-5540

See CONTINUATION Page The Amarillo Veterans Healthcare System (AVAHCS) has a requirement for Integrated Microbiology Cost Per Test (CPT) supporting Thomas E. Creek VA Medical Center and Lubbock VA Community Based Outpatient Clinic (CBOC). CPT includes the instruments, consumables, training, and instrument services.

The Government will award an Indefinite Delivery / Indefinite Quantity (ID/IQ) Contract with five (5) ordering periods.

The ordering periods are anticipated to be as follows:

Ordering Period 1: 09/01/2026 to 08/31/2027 Ordering Period 2: 09/01/2027 to 08/31/2028 Ordering Period 3: 09/01/2028 to 08/31/2029 Ordering Period 4: 09/01/2029 to 08/31/2030 Ordering Period 5: 09/01/2030 to 08/31/2031

Technical questions regarding this solicitation are to be submitted in writing to kathryn.prose@va.gov NLT 08/06/2026.

See B.2 for the Statement of Work (SOW) See E.2 Addendum to FAR 52.212-1 for Instructions to Offeror See E.3 for FAR 52.212-2 for Evaluation Criteria

See CONTINUATION Page

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: POC Name: _____________________________ Address: _______________________________ City/State/Zip: ___________________________ POC Phone: ____________________________ POC Email: _____________________________

b. GOVERNMENT: Contracting Officer 36C257 Department Of Veterans Affairs Network Contracting Office (NCO) 17 5441 Babcock Road Ste. 302 San Antonio TX 78240

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. This is accomplished through the Tungsten Network, located at: http://www.fsc.va.gov/einvoice.asp. This is mandatory and the sole method for submitting invoices.

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

B.2 STATEMENT OF WORK

1. Scope of the Procurement.

a. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrumentation shall include an integrated solution for automated blood culture detection at the Amarillo VA Medical Center and automated organism identification and antimicrobial susceptibility testing (ID/AST) systems supporting both Amarillo and Lubbock laboratory operations. The instrument shall be able to simultaneously perform the testing 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).

b. Equipment must maintain, or preferably reduce, the number of workstations or overall labor required to accomplish the required testing by each laboratory. The proposed solution should support an integrated microbiology workflow between blood culture detection and ID/AST systems to minimize manual intervention and improve operational efficiency.

c. Equipment shall be acquired for each of the clinical laboratories located at the AVAHCS facilities listed below. Blood culture instrumentation shall be required at the Amarillo VA Medical Center, which serves as the primary microbiology laboratory for AVAHCS.

3510 4th St, Lubbock, TX 79415

(1) Automated Blood Culture Testing (Amarillo)

- Estimated quantity is 2,400 blood culture sets across both sites annually.

(2) Automated Organism Identification / Susceptibility Testing Central Laboratory (Amarillo)

- Gram-negative isolates: ~366

- Gram-positive isolates: ~514

- AST: ~880

- Other organisms (e.g., Haemophilus/Neisseria): minimal

- Yeast identification: currently not performed; future capability of interest (including Candida auris) Satellite Site (Lubbock)

- Gram-negative isolates: ~155

- Gram-positive isolates: ~105

- AST: ~260

(3) Antibiotic Information

(a) Gram-Negative Organisms (including Enterobacterales): Amikacin, Ampicillin, Ampicillin/Sulbactam, Cefazolin, Cefoxitin, Ceftazidime, Ceftriaxone, Ciprofloxacin, Gentamicin, Levofloxacin, Meropenem, Piperacillin/Tazobactam, Tetracycline, Trimethoprim/Sulfamethoxazole

(b) Urinary Pathogens (as applicable): Ampicillin, Ampicillin/Sulbactam, Cefazolin, Ceftriaxone, Ciprofloxacin, Gentamicin, Levofloxacin, Meropenem, Nitrofurantoin, Piperacillin/Tazobactam, Trimethoprim/Sulfamethoxazole

(c) Pseudomonas aeruginosa: Amikacin, Aztreonam, Ceftazidime, Ciprofloxacin, Gentamicin, Levofloxacin, Meropenem, Piperacillin/Tazobactam

(d) Gram-Positive Organisms (including Staphylococcus species): Ceftaroline, Clindamycin, Erythromycin, Levofloxacin, Linezolid, Oxacillin, Penicillin, Tetracycline, Trimethoprim/Sulfamethoxazole, Vancomycin

(e) Enterococcus species: Ampicillin, Ciprofloxacin, Linezolid, Penicillin, Tetracycline, Vancomycin

(f) Streptococcus species (including fastidious organisms): Ampicillin, Ceftriaxone, Clindamycin, Erythromycin, Levofloxacin, Penicillin, Tetracycline, Trimethoprim/Sulfamethoxazole, Vancomycin

(g) Streptococcus pneumoniae: Ceftriaxone, Clindamycin, Erythromycin, Levofloxacin, Penicillin, Tetracycline, Trimethoprim/Sulfamethoxazole, Vancomycin

d. The Contractor is required to provide a continuously, unless notified of an allocation state, stocked inventory of reagents, standards, controls, supplies, disposables, blood culture bottles, and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity, and tested to assure precision and accuracy. Expiration dates must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology or technology shall be at the expense of the Contractor. Alert/notification of any delays in shipment, as well as any technical advisories, recalls, or alerts, shall be provided to designated Government personnel prior to or simultaneously with field notification.

e. Special handling for emergency orders of supplies: In the event that supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor shall deliver replacement supplies within 24 hours of receipt of a verbal order for emergency delivery. The Contractor shall deliver, at no additional cost to the Government, sufficient consumables to allow operation of the Contractor’s equipment for a minimum of one week under normal Government test load volume. Additional emergency supply requests shall be honored until routine delivery schedules are restored.

f. The automated blood culture detection system shall provide sufficient incubation capacity to support projected testing volumes while maintaining additional capacity to accommodate workload variability, STAT prioritization, and continuous specimen loading without delay. The system shall support uninterrupted incubation and monitoring of blood culture specimens to ensure timely detection of bloodstream infections.

g. An instrument cart is required for the Amarillo installation to provide better stability, cable management, and workflow support. The Lubbock site installation will be a benchtop placement.

2. Definitions.

a. Cost-Per-Test (CPT). Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) five year equipment use; (2) all reagents, standards, supplies, consumable/disposable items, parts, accessories, blood culture bottles, and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result; (3) all necessary maintenance to keep the equipment in good operating condition (including preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors shall provide delivery, installation, and removal of equipment at no additional charge.

b. Business Associate Agreement (BAA)– A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of protected health information (PHI), or that provides certain services involving the disclosure of PHI. VHA is a covered entity under the HIPAA Privacy Rule. HIPAA regulations require VHA to execute HIPAA-compliant BAAs with entities that receive, use, or disclose VHA PHI in order to perform activities on behalf of VHA. These BAAs obligate business associates to provide the same protections and safeguards to PHI that are required of VHA under the Privacy Rule.

3. Test Menu. See paragraph 1 for the Government’s desired test menu, estimated annual volumes and antibiotic information. The Contractor shall provide microbiology instrumentation and associated methodologies capable of supporting organism identification and antimicrobial susceptibility testing (ID/AST) for clinically significant organisms encountered in routine and acute care settings. The system must support identification and susceptibility testing of aerobic organisms, as well as clinically significant yeast and fungal organisms. The proposed solution shall support testing capabilities aligned with current Clinical and Laboratory Standards Institute (CLSI) guidelines and must be capable of addressing emerging and antimicrobial-resistant organisms as applicable to clinical care. Contractors may utilize proprietary panels, cards, or methodologies; however, the proposed system must demonstrate the flexibility to support evolving clinical requirements and updates to testing capability over the life of the contract.

4. General Requirements.

a. The instrumentation provided shall fully support the scope of microbiology operations as defined in this statement of work, including automated blood culture detection systems and automated organism identification and antimicrobial susceptibility testing (ID/AST) systems. Depending upon the technical functionality and capabilities of the Contractor’s proposed solution, one or more systems may be required to meet the productivity and performance requirements defined herein. All proposed instrumentation shall meet the technical specifications of this solicitation and collectively provide continuous and reliable microbiology diagnostic capability.

b. The Contractor shall provide a solution that ensures continuity of operations in the event of equipment malfunction or downtime. The proposed system shall support uninterrupted microbiology testing capability, including continuous incubation and monitoring of blood culture specimens, through system reliability, service support, and operational design, rather than reliance on idle or standby instrumentation.

c. The system shall provide automated organism identification and antimicrobial susceptibility testing (ID/AST) for aerobic, facultative, fastidious, and anaerobic microorganisms, as applicable to clinical laboratory operations, and shall integrate with the blood culture detection system to support efficient progression from positive blood culture detection to organism identification and susceptibility testing.

5. Operational Features. The instrumentation offered shall have the following:

a. The capability of performing analysis on the tests listed above, as well as supporting additional clinically relevant microbiology testing as required.

b. Sufficient capacity and throughput to meet the volume and service demands defined in paragraph 1, including both blood culture incubation capacity and ID/AST testing capacity, while maintaining additional capacity to accommodate workload variability, STAT prioritization, and continuous specimen processing without delay.

c. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

d. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system, Veterans Health Information Systems and Technology Architecture (VISTA), and the coming system Cerner Millennium. The fully operational interface (both hardware and software) shall be immediately available for implementation.

(1) The accuracy of the barcode reading must have less than a 1% failure rate.

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

e. Equipment must accept specimen identifiers consistent with VA system requirements.

f. Minimal daily, monthly, and periodic maintenance.

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

h. The proposed solution shall support an integrated microbiology workflow between blood culture detection and ID/AST systems, minimizing manual intervention and supporting efficient progression from specimen collection through organism identification and susceptibility reporting.

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

a. The capability of accurately and reliably identifying both Gram-negative and Gram-positive bacteria, as well as clinically significant yeast and other emerging organisms as applicable.

b. The capability of reporting antimicrobial susceptibility tests in accordance with FDA and Clinical and Laboratory Standards Institute (CLSI) guidelines. At a minimum, the equipment must provide Minimum Inhibitory Concentrations (MIC) values where applicable.

c. Blood Culture System Technical Features.

(1) The fully automated blood culture detection system shall provide continuous, automated monitoring of inoculated blood culture bottles for microbial growth, utilizing detection methodologies capable of identifying positive cultures in a timely and clinically relevant manner.

(2) The system shall support continuous loading of specimens without batching or delay, allowing blood culture bottles to be loaded at any time without interrupting system operation.

(3) The system shall provide sufficient incubation capacity to support projected volumes as defined in paragraph 1, while maintaining additional capacity to accommodate workload variability, STAT prioritization, and uninterrupted specimen loading.

(4) The system shall support efficient workflow for bottle loading, unloading, and processing, minimizing manual handling and reducing the risk of specimen handling errors.

(5) The system shall support detection of a broad range of clinically significant microorganisms, including aerobic and anaerobic organisms, in accordance with current clinical laboratory standards.

(6) The system shall provide alerts or notifications for positive cultures in a manner that supports timely clinical response.

(7) The system shall support data capture and traceability of specimens and blood culture bottles, including information that may assist in quality management and investigation of contamination events.

(8) The system shall support integration with organism identification and antimicrobial susceptibility testing (ID/AST) workflows to facilitate efficient progression from positive blood culture detection to organism identification.

(9) The system shall be capable of continuous operation with minimal downtime and shall support maintenance and service activities without significant disruption to ongoing specimen incubation.

7. ID/AST System Technical Features.

a. The system shall provide automated organism identification and antimicrobial susceptibility testing (ID/AST) for aerobic, facultative, fastidious, and anaerobic microorganisms as applicable to clinical laboratory operations.

b. The system shall support testing capabilities aligned with current CLSI guidelines and shall be updated as standards evolve.

c. The system shall provide a comprehensive and extensive database of bacterial and yeast species consistent with FDA and CLSI guidelines.

d. The system shall provide a comprehensive array of antimicrobial susceptibility panels or equivalent methodologies which each facility may select to meet clinical needs. Contractor shall supply a list of available panels and methodology limitations at time of proposal.

e. The system shall support detection of emerging antimicrobial resistance and clinically significant resistant organisms, including organisms producing carbapenemase and other resistance mechanisms.

f. Software or equipment modifications required to comply with updated CLSI, CDC, or other authoritative guidance shall be provided as they become available. The system shall allow for manual modification of susceptibility breakpoints as needed.

g. The system shall support generation of cumulative microbiology data, including antibiograms and organism-specific susceptibility profiles.

h. The system shall include a built-in quality control program to monitor system performance.

i. Antimicrobial Susceptibility Standards. The Government’s current antimicrobial susceptibility testing profile is reflected through representative antibiotic groupings described above and is intended to communicate clinical expectations for organism specifc susceptibility testing.

j. The Contractor shall provide antimicrobial susceptibility testing panels or equivalent methodologies sufficient to support clinically appropriate testing across organism types in accordance with current Clinical and Laboratory Standards Institute (CLSI) guidelines.

k. The Contractor’s proposed system shall demonstrate the ability to support antimicrobial agents, or clinically equivalent alternatives, within available susceptibility testing panels or methodologies. The Contractor shall provide documentation of available panels and clearly identify any limitations or exceptions associated with their testing methodology at the time of proposal.

8. Data Management. The System shall have the following:

a. Capability to provide varied options for analysis and reporting/review of cumulative patient data on isolated organisms, blood culture results, and antimicrobial profiles.

b. Capability to record, store, and print the following information:

(1) Required quality control and instrument maintenance information.

(2) Patient demographic information and specimen results.

(3) Capability of manipulating/sorting patient demographic information and microbiology test results, including blood culture data, to generate epidemiological reports (e.g., antibiograms, contamination monitoring, and quality management reports).

(4) Sufficient memory to store patient information and test results for at least one (1) year with downloading capability to an external medium for long term storage of patient records and other information.

(5) Capability to capture and retain specimen and blood culture bottle traceability data, including information that may assist in quality management and investigation of contamination events.

9. Hardware Features. The instrumentation shall have the following:

a. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

b. An on-board monitor/screen that is easily readable.

c. An uninterruptible power supply with line conditioner for each instrument provided.

10. Specific Equipment Requirements. The Contractor shall provide a microbiology solution configured to support operations at both the Amarillo VA Medical Center and the Lubbock Community-Based Outpatient Clinic (CBOC), consistent with the scope of this statement of work. The proposed solution shall reflect the operational roles of each site, with blood culture detection systems deployed at Amarillo and organism identification and antimicrobial susceptibility testing (ID/AST) systems supporting both locations. The instrumentation provided shall function as a cohesive microbiology solution across sites, supporting standardized workflows, training, and operational consistency. Solutions that result in fragmented or non-standardized microbiology operations across AVAHCS are not acceptable.

11. Validation. All validation testing is the responsibility of the Government. The Contractor shall assist the Government with coordinating validation.

12. Support Features.

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

b. Training. The Contractor shall provide an instrument training program coordinated with equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training. Training shall include system operation, data management, troubleshooting, and basic maintenance. The Contractor shall provide training for at least one operator per facility. Off-site training shall include airfare, lodging, and per diem. One classroom training entitlement per instrument. Onsite training shall be offered for each instrument for one (1) key operator per instrument immediately following installation. The Contractor shall also offer annual off-site classroom training supporting at least one key operator per instrument.

c. Equipment Preventative Maintenance and Repair Service. The Contractor shall provide comprehensive preventative maintenance and repair services for all instrumentation provided under this Indefinite Delivery / Indefinite Quantity (ID/IQ) contract. Preventative maintenance shall be performed in accordance with the manufacturers’ recommended frequency.

d. The Contractor shall ensure that service activities are performed in a manner that minimizes disruption to ongoing microbiology operations, including continuous incubation of blood culture specimens where applicable.

e. Service shall ensure continuous operational capability of microbiology systems, including blood culture and ID/AST instrumentation. Service support shall include:

(1) On-site service availability seven (7) days per week for systems that do not have functional redundancy and where downtime would result in interruption of clinical testing capability.

(2) Remote diagnostic capability where available to facilitate rapid troubleshooting.

(3) Response time and resolution consistent with maintaining uninterrupted laboratory operations.

(4) Provision of all parts, labor, travel, and materials necessary to maintain full system functionality at no additional cost

g. Updates. The Contractor shall provide updates to both equipment hardware and software to maintain system integrity and current technology at no additional cost. Updates shall be provided as they become commercially available and at the same time they are provided to commercial customers. This includes software updates, hardware corrections, and enhancements necessary to maintain performance and regulatory compliance.

h. Ancillary support equipment. The Contractor shall provide, install, and maintain all ancillary support equipment required to fully operate the system, including cabinetry, water systems, interface components, and any other required infrastructure. All standard components customarily provided with the equipment shall be included.

13. Commercial Offerings. The Contractor shall provide all support materials routinely provided to commercial customers that support regulatory compliance and system operation, including procedure manuals in CLSI format or equivalent electronic documentation integrated within system software.

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

a. The determination and description shall address the following:

(1) Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

(2) Waste ignitability (Reference 40 CFR §261.21)

(3) Waste corrosivity (Reference 40 CFR §261.22)

(4) Waste reactivity (Reference 40 CFR §261.23)

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

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

(7) Solid Waste (Reference 40 CFR §261.2)

(8) Exclusions (Reference 40 CFR §261.4)

b. The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

c. The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

15. Shipping and Delivery.

Amarillo, TX 79106

16. Implementation/transition timeframe.

a. The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award. This timeline is based on a reasonable attempt of the Contractor to complete all necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government. Implementation shall be planned and executed in a manner that ensures continuity of microbiology operations, including uninterrupted blood culture incubation and testing capability during system transition.

b. Upon award, the transition period to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

c. Contractor shall provide with its quotation and implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded ID/IQ including installation and training of personnel. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate for cause under the Termination for Cause clause of the ID/IQ.

d. At the end of 90 days from award of the ID/IQ, the awarded Contractor shall have full and sole responsibility for services under the awarded ID/IQ.

17. Standard and Quality of Performance. This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or ID/IQ] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any ID/IQ at an effective level of 90% or more.

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

b. 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 in accordance with the provisions of FAR 52.212-4 entitled “Termination for Cause.”

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

d. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall 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.

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

f. During the term of the ID/IQ, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

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

19. Ownership of Equipment. Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.

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

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

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

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

(1) The Contractor must accept the system without the drive.

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

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

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

(1) The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

(2) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or ID/IQ.

(3) A statement would need to be signed by the Director (System Owner) stating that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.

20. Information Security and Privacy Requirements. The Contractor, their personnel, and their subcontractors shall be subject to all applicable Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. The Contractor shall also comply with all Information Technology Security Requirements outlined in this SOW.

21. Information Technology Security Requirements.

a. General. This applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

b. Access to VA Information and VA Information Systems. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

c. Security Incident Investigation. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

(1) The contractor, subcontractor, their employees, or business associates shall report within 72 hours suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues, following confirmation of a reportable breach. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within 72 hours, provide the COR/CO the incident number received from the ESD.

(2) To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(a) The date and time (or approximation of) the Security Incident occurred.

(b) The names of individuals involved (when applicable).

(c) The physical and logical (if applicable) location of the incident.

(d) Why the Security Incident took place (i.e., catalyst for the failure).

(e) The amount of data belonging to VA believed to have been compromised.

(f) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

(3) After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

(4) VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

(5) 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 the VA Office of 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 violations associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other 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.

(6) With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

(7) If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages—Reimbursement for Data Breach Costs.

(End of Statement of Work)

B.3 PRICE/COST SCHEDULE

This is a Single Award, Firm-Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) Contract.

The guaranteed minimum award amount for this contract is $10,000.00. The maximum aggregate value of orders that can be placed under this contract is $950,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount. Contractor shall notify the Contracting Officer and Contracting Officer’s Representative when 85% of the IDIQ ceiling is reached.

Ordering Periods.

Ordering Period 1: 09/01/2026 to 08/31/2027 Ordering Period 2: 09/01/2027 to 08/31/2028 Ordering Period 3: 09/01/2028 to 08/31/2029 Ordering Period 4: 09/01/2029 to 08/31/2030 Ordering Period 5: 09/01/2030 to 08/31/2031

Delivery.

Amarillo Veterans Affairs Medical Center Thomas E. Creek VA Medical Center ATTN: Laboratory 6010 Amarillo Blvd W Amarillo, TX 79106

Lubbock VA Community Based Outpatient Clinic ATTN: Laboratory 3510 4th Street Lubbock, TX 79415

ITEM INFORMATION

Organism Identification / Susceptibility Testing Cost-Per-Test (CPT) Amarillo Veterans Medical Center (VAMC) - 880 Tests Ordering Period 1 POP Begin: 09-01-2026 POP End: 08-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Medical Laboratory Use Cost-Per-Test (CPT) Estimated Annual Quantities

0001AA

Automated Identification & Antimicrobial Susceptibility (ID/AST) Analyzer - Amarillo Ordering Period 1 POP Begin: 09-01-2026 POP End: 08-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Medical Laboratory Use

ANALYZER AND MODEL # NAME: ______________

MANUFACTURER PART NUMBER (MPN): __________________

Estimated Annual Quantity

0001AB

Gram-negative isolates: ~366

POP Begin: 09-01-2026 POP End: 08-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Medical Laboratory Use

0001AC

Gram-positive isolates: ~514

POP Begin: 09-01-2026 POP End: 08-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Medical Laboratory Use

0001AD

Antimicrobial Susceptibility Test (AST): ~880

POP Begin: 09-01-2026 POP End: 08-31-2027 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6632 - Analysis Instruments, Medical Laboratory Use

Organism Identification / Susceptibility Testing Cost-Per-Test (CPT) Lubbock VA Community Based Outpatient Clinic (CBOC) - 260 Tests Ordering Period…