36C26226Q1445 0001.docx

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation

GENERAL INFORMATION

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

POINT OF CONTACT*

Hestia Sim Hestia.Sim@va.gov

PLACE OF PERFORMANCE

VA Long Beach Healthcare System

5901 East 7th Street

Long Beach CA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

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DESCRIPTION

Amendment 0001 under Solicitation/RFQ 36C26226Q1445 is hereby issued

i. To answer the contractors’ questions and post the Government’s responses.

ii. To amend section B.2 Statement of Work. Changes are highlighted.

iii. To extend the quote due date to 9/16/2026 10am Pacific Time.

All contractors must acknowledge this amendment.

No further questions will be accepted or answered at this time. Additional inquiries will only be considered if the Contracting Officer determines the responding is in the best interest of the Government.

All other terms and conditions remain unchanged.

Quotes are due on September 16, 2026, at 10am Pacific Time.

Contractors’ Questions

1. Basis for the stated VA QXJ requirement: The Statement of Work states that “VA facilities are required” to use FDA Class II Whole Room Microbial Reduction Devices under 21 CFR 880.6510/Product Code QXJ. Please identify the VA/VHA Directive, Handbook, memorandum, national policy, regulation, patient-safety requirement, or other authority establishing this requirement for VA facilities.

If no VA-wide authority is being cited, please confirm whether this statement instead reflects a VA Long Beach-specific minimum requirement for this procurement.

If the QXJ requirement is based in whole or in part upon a VA Long Beach-specific determination of minimum need, please identify the safety, performance, clinical, or operational objective that the mandatory QXJ-status requirement is intended to satisfy.

VA Long Beach Healthcare System is acquiring a whole-room microbial-reduction device, which falls directly within FDA’s definition and regulatory framework for product code QXJ under 21 CFR 880.6510. FDA classifies whole-room microbial-reduction devices as medical devices intended to reduce microbial loads on environmental or medical-equipment surfaces following cleaning and disinfection. As a result, devices meeting this intended use require FDA clearance through either the 510(k) pathway or De Novo authorization, both of which constitute FDA-cleared status for purpose of this specific procurement. The Veterans Health Administration (VHA) Healthcare Environmental Sanitation Program (HESP) has issued national guidance for UV whole-room microbial reduction devices. Under that guidance, these devices must have an active FDA 510(k) clearance or a granted De Novo authorization because FDA requires any whole-room ultraviolet (UV) device making microbial reduction claims to obtain 510(k) clearance or De Novo Authorization. The requirement for FDA 510(k) clearance or De Novo authorization is not specific to VA Long Beach. VHA HESP guidance and their Training and Ops Manual define “Whole Room Microbial Reduction Device” as “a U.S. Food and Drug Administration (FDA) 510(k)-cleared, or De Novo medical authorized device used to reduce microbial load on medical device surfaces following cleaning and disinfection.”

2. FDA authorization terminology and referenced Xenex model: The solicitation uses the terms “FDA-approved,” “FDA-cleared,” and “501(k).” Please confirm whether the Government’s intended requirement is that an offered device be legally marketed by FDA as a Class II Whole Room Microbial Reduction Device under 21 CFR 880.6510/Product Code QXJ.

The current solicitation contains clerical errors, specifically the use of “FDA-approved” or “501(k)”, which should be removed by this amendment. The offered device must be either FDA 510(k)-cleared or De Novo-authorized as a Class II Whole Room Microbial Reduction Device, product code QXJ, under 21 CFR 880.6510.

The solicitation identifies Xenex LightStrike+ MXSUV1-FTXCT as the brand-name reference product. FDA’s public De Novo record for DEN230007 identifies LightStrike+ models MXSUV1-SL and MXSUV1-FT. Please clarify whether MXSUV1-FTXCT is a commercial configuration or SKU of an FDA-authorized model and identify the applicable FDA authorization documentation for the reference product.

The correct LightStrike+ model should be MXSUV1-SL.

Please also confirm whether an offered QXJ device may qualify regardless of whether its applicable FDA authorization originated through the De Novo or 510(k) pathway.

Any FDA-cleared Class II Whole Room Microbial Reduction Device under Product Code QXJ qualifies, regardless of whether its FDA authorization originated through the De Novo pathway or the 510(k) pathway, provided the device meets all required salient characteristics.

3. Intended use and surface scope: FDA defines the QXJ generic device type as a whole-room microbial reduction device used to reduce microbial load on medical-device surfaces following cleaning and disinfection. The FDA-authorized indication for the Xenex LightStrike+ reference device specifically describes microbial reduction on non-porous, non-critical medical-device surfaces following manual cleaning and disinfection practices. Please clarify whether the Government’s minimum need under this solicitation is limited to microbial reduction within that FDA-authorized intended-use framework, or whether VA also requires the procured system to demonstrate microbial reduction or disinfection of broader environmental room surfaces. If broader environmental-surface performance is required, please identify the applicable minimum performance criterion and the evidence an offered product must provide to demonstrate compliance.

The Government’s minimum need under this solicitation is for a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection.

4. Minimum microbial-reduction performance: The Statement of Work requires a validated disinfection cycle capable of “high-level microorganism reduction” and requires microbial-reduction data addressing MRSA, VRE, Acinetobacter, Clostridioides difficile, and representative virus surrogates. Please identify the minimum quantitative microbial-reduction criterion required for an offered device to satisfy this salient characteristic, including the required log reduction, if applicable, for each organism or organism category. Please also clarify whether each required organism-specific performance criterion must appear in the offered device’s FDA-authorized labeling or Instructions for Use, or whether other validated performance data may be submitted to demonstrate compliance.

To meet the “high-level microorganism reduction”, the minimum quantitative microbial-reduction performance should demonstrate validated reductions in the range of 4-log (99.99%) up to 6-log (99.9999%). Regarding acceptable documentation, it is sufficient for the organism-specific performance criteria to appear in the device’s FDA labeling or Instruction for Use. Alternatively, vendors may submit validated performance data demonstrating compliance, provided that the device is FDA 510(k)-cleared or De Novo authorized.

5. Electrical and fire-safety requirements: The Statement of Work specifies several UV-exposure and operational safety safeguards, and VAAR 852.211-72 identifies FDA as the applicable technical-industry standards organization. The solicitation does not appear to identify a separate electrical or fire-safety certification requirement.

Does the Government require the complete offered system to be certified or listed by an OSHA-recognized Nationally Recognized Testing Laboratory (NRTL)? If yes, please identify the applicable product-safety standard and required evidence of certification or listing. If not, please identify what electrical and fire-safety testing, certification, listing, or other evidence the Government requires an offered system to provide. Please also identify by title, number, citation, or publication the specific FDA standard(s), special controls, guidance, or other technical requirements incorporated through VAAR 852.211-72 for determining conformance.

The Government does not have any specific electrical or fire-safety testing, certification, or listing requirement for this procurement and contractors are not required to submit any listing or fire-safety test documentation. As long as FDA reviewed and validated the manufacturer’s submitted safety and performance data, the minimum safeguard requirements are met.

6. Functional equivalents for operational and reporting requirements: For the remote-user controls, automated reporting, data synchronization, telemetry, performance-management portal, predictive-maintenance functions, monthly reporting, and other operational capabilities identified in the Statement of Work, please confirm whether functionally equivalent methods of accomplishing the stated objective are acceptable under the solicitation’s “brand name or equal” provision. If any listed feature requires a particular implementation, architecture, platform, or manufacturer-specific method rather than functional equivalence, please identify that requirement.

Functionally equivalent methods of accomplishing the stated objective are acceptable. There is no implementation, architecture, platform, or manufacture-specific method required rather than functional equivalence.

7. Availability of an “equal” product: For purposes of the solicitation’s “brand name or equal” structure, did the Government’s market research identify at least one currently available product from a manufacturer other than Xenex that is capable of satisfying all mandatory salient characteristics, including the QXJ, operational, reporting, remote-access, service, maintenance, and support requirements? No identification of the manufacturer or disclosure of proprietary information is requested.

Yes.

8. Replacement emitter and refurbished-component requirements: The Statement of Work states that the purchase includes a “refurbished to new replacement emitter exchange,” while VAAR 852.212-71 states that no used, refurbished, or remanufactured supplies, equipment, or parts may be provided. Please clarify whether refurbished or remanufactured replacement emitters or other components are permitted during the warranty/support period, or whether all replacement components must be new OEM components. Please also clarify whether an “emitter exchange” program is itself a mandatory salient characteristic or whether an equivalent OEM maintenance or replacement program satisfying the same operational objective is acceptable.

All replacement components must be new OEM components. An equivalent OEM maintenance or replacement program satisfying the same operational objective is acceptable.

9. FAR 52.211-6 – Brand Name or Equal: The solicitation states that this acquisition is for “brand name or equal” items. We did not identify FAR 52.211-6, Brand Name or Equal, among the solicitation provisions. Please confirm whether FAR 52.211-6 applies to this procurement and will govern the evaluation of offered “equal” products. If FAR 52.211-6 does not apply, please identify the solicitation provision or evaluation standard governing the determination that an offered product is “equal” to the referenced brand-name product.

FAR 52.211-6 does not apply to this procurement because the Government is operating under the Revolutionary FAR Overhaul (RFO) framework. However, the solicitation specifies that brand name equivalents are acceptable. The Government will evaluate “equal” products against the solicitation’s stated salient characteristics.

10. The Statement of Work uses the terms “FDA-approved” and “501(k).” Please confirm that a Class II Whole Room Microbial Reduction Device under 21 CFR 880.6510, Product Code QXJ, that is FDA-cleared through a 510(k) or authorized through De Novo satisfies the regulatory requirement.

Any FDA cleared/authorized Class II Whole Room Microbial Reduction Device under Product Code QXJ qualifies, regardless of whether its FDA-cleared originated through the De Novo pathway or the 510(k) pathway satisfies the requirement, provided the device meets all remaining salient characteristics.

11. Does any wage determination or prevailing-wage requirement apply to the on-site training, warranty service, repairs, or other support associated with the equipment? If yes, please provide the applicable determination.

No. The main purpose of this procurement is for whole room microbial reduction devices and the cost these devices represent the predominant portion of the requirement. Therefore, the Service Contract Act (SCA) does not apply.

12. The instructions state to complete “section E.5 52.225-2 Buy American Certificate,” while FAR 52.225-2 appears in Section E.3 and E.5 contains the security representations. Please confirm that E.3 is the Buy American Certificate section to be completed.

Please complete E.3 Buy American certificate if applicable.

13. B.2 references a “refurbished to new replacement emitter exchange,” while VAAR 852.212-71 states that used, refurbished, and remanufactured equipment or parts may not be furnished. Please clarify whether warranty emitter exchanges may be manufacturer-refurbished, or whether all replacement emitters and components must be new.

Warranty emitter exchange must be brand new.

14. If a quoter elects not to provide trade-in credit under CLIN 0002, should the price schedule show $0.00 unit price and $0.00 extended amount for that CLIN?

Yes.

Updated Statement of Work

Supplies/Services

If ‘equal to’, please provide Brane name: Model number:

**Please ensure to reflect a negative value (-) clearly to reflect the discounted rate. The unit price or extended amount should display the minus sign to indicate if it reduces the total cost**

Grand Total

STATEMENT OF WORK

Introduction: VA Long Beach Healthcare System Environment Management Service (EMS), located at 5901 E. 7th St, Long Beach, CA 90822, is seeking to purchase seven (7) each of a whole-room microbial-reduction Mobile UV Disinfection Devices equivalent to Xenex’s LightStrike+ UV Robot MXSUV1-SL. This purchase includes software licensing, upgraded safety assurance, reporting and archiving, factory replacement accessories, on-site service and training, new replacement emitter exchange, portal usage and cloud-based storage and general repairs covered by 1-year warranty.

Place of Performance:

VA Long Beach Healthcare System Environmental Management Service (EMS) 5901 E. 7th Street, Long Beach, CA 90822

Salient Characteristics:

· Must be FDA-cleared as a Class II Whole Room Microbial Reduction Device under 21 CFR 880.6510 (intended specifically for healthcare environment), meaning it must comply with FDA performance, safety, and labeling requirements applicable to devices reviewed under Product Code QXJ to align with VA’s patient safety and goals to reduce harm using validated medical devices. VA facilities are required to use FDA 510(k)-cleared or De Novo Authorized as a Class II Whole Room Microbial Reduction Device under 21 CFR 880.6510, intended specifically for healthcare environment, to ensure the device has undergone regulatory review for safety and effectiveness related to its intended use.

· Must emit germicidal UV within a spectrum and intensity validated by the manufacturer and published in the device’s FDA 510(k)-cleared or De Novo Authorized Instructions for Use (IFU) sufficient to achieve whole-room microbial reduction.

· Must emit germicidal ultraviolet energy using either continuous or pulsed UV technology, with output spectrum and intensify sufficiently to achieve FDA 510(k) cleared or De Novo Authorized whole-room microbial reduction as documented in the device’s IFU.

· Must provide validated bacteria disinfection cycle capable of high-level microorganism reduction; acceptable range validated and published in the FDA 510(k) cleared or De Novo Authorized IFU. The Government shall only accept FDA 510(k) cleared or De Novo Authorized devices and the FDA clearance shall define the operational specification ranges.

· Must support wireless or equivalent automated data synchronization to enable real-time reporting and software updates.

· Must provide automated cycle logging with secure, cloud-based or equivalent secure reporting, enabling audit traits and performance dashboard accessible to authorized personnels for documentation, surveillance, and auditability within infection prevention and control standards.

· Must have validated safeguards to prevent or terminate UV operation when unauthorized entry or an unsafe condition occurs to prevent unintended UV exposure.

· Must be constructed with durable, damage-resistant materials suitable for frequent transport in healthcare environments.

· Must be designed for mobility.

· Must include protective features that prevent UV emission, internal damage, or unintentional activation during transport and must incorporate mechanisms that protect all light-emitting and sensing components during transport.

· Must automatically shut down if sensors detect unsafe conditions, tampering, tipping, or system fault.

· Must allow operators to stop any active cycle immediately via a remote or external control.

· Must display real-time operational status including active cycle, fault, completion, or ready status.

· Must provide microbial reduction data demonstrating performance against the following organism categories:

· Vegetative bacteria: MRSA, VRE, Acinetobacter

· Spore-formers: Clostridioides difficile

· Virus surrogates: Representative non‑enveloped and/or enveloped surrogate viruses appropriate for environmental disinfection testing To meet the “high-level microorganism reduction”, the minimum quantitative microbial-reduction performance should demonstrate validated reductions in the range of 4-log (99.99%) up to 6-log (99.9999%). Regarding acceptable documentation, it is sufficient for the organism-specific performance criteria to appear in the device’s FDA-authorized labeling or Instruction for Use. Alternatively, contractors may submit validated performance data demonstrating compliance, provided that the device is FDA 510(k)-cleared or De Novo authorized.

· Must include a remote user device with onboard charging, countdown cycle timer, and cycle-completion indicators allowing a means for trained personnel outside the treatment area to determine the cycle status and terminate a cycle without entering the exposure area for safety purposes.

· Must have a secure, centralized management of remote user access, including capabilities to:

· Control and audit user account actions

· Update and modify individual user remote-access settings

· Add, change, or update approving officials responsible for access authorization

· Validate and document the continued need for remote access

· Allow administrators to regularly check who has access and make sure each person only has the minimum amount of access they need

· Must operate without warm-up or cool-down delays that impact workflow efficiency.

· Must provide support for secure cellular or Wi-Fi data transmission without requiring connection to VA internal networks

· Must come with a validated Standard Operating Plan (SOP) to ensure proper deployment and consistent microbial reduction cycles.

· Must include a base year warranty and support package that provides minimum of:

· Replacement of consumable components as necessary for routine device operation and maintenance

· Replacement parts required for maintenance and repairs performed by the original equipment manufacturer (OEM) trained and certified technician.

· Manufacturer-provided repair or replacement of the device if it fails to operate due to a manufacturing defect.

· Remote diagnostic capabilities and telemetry monitoring to support troubleshooting, performance verification, and maintenance planning.

· Software and firmware updates for all device components during the warranty period.

· 24/7 customer support availability for technical assistance.

· Predictive maintenance monitoring and proactive alerts regarding potential service needs or component wear.

· Access to manufacturer’s performance-management platform or portal for device data, reporting, and usage analytics.

· Monthly performance and compliance reports summarizing device utilization and operational outcomes.

· Online or virtual training resources to support user competency.

· If the support package, including training, is not included in the initial equipment purchase cost, the contractor must show additional cost for training and support package as added line items per unit, or apply the additional charges to each unit cost.

For Trade-in Credit for Old Xenex MXSUV1-SL

· The Government has seven (7) units approximately ten (10) years old. Five (5) of the units are non‑operational and require repair; the remaining two (2) units are still functional.

· The Government considers the old equipment eligible for trade‑in credit; no money is owed on these units, and no service agreements remain in effect.

· Honoring trade-in credits is not mandatory; however, contractors are encouraged to provide trade-in options or equivalent competitive pricing.

· The contractor is responsible for picking up the trade-in equipment and applying trade-in credits. Pickup shall occur at the VA Long Beach Healthcare System and must be coordinated with VA Long Beach EMS personnel. The point of contact shall be provided upon award.

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Amendment to a Previous Combined Solicitation