36C26226Q1445 0002.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 0002 under Solicitation/RFQ 36C26226Q1445 is hereby issued

i. To answer the contractor’s questions and post the Government’s response.

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

iii. To extend the quote due date to 9/17/2026 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.

Quotes are now due no later than 9/17/2026 10am Pacific Time.

All other terms and conditions remain unchanged.

Contractor’s Questions

1. HESP authority, scope, and treatment of legacy systems Amendment 0001 states that VHA HESP national guidance and its “Training and Ops Manual” require Whole Room Microbial Reduction Devices to have FDA 510(k) clearance or De Novo authorization.

We reviewed the publicly available VHA Directive 1850.01(1), Health Care Environmental Sanitation Program. The Directive establishes national HESP responsibilities and refers to additional EPS/HESP guidance maintained on internal VA resources, but we did not identify the quoted Whole Room Microbial Reduction Device/QXJ requirement in the publicly available Directive.

Please identify the specific HESP guidance or Training and Operations Manual provision relied upon, including its title, version or effective date, section/page, and operative language. If the source is internal, please provide or quote the applicable provision.

VA follows the controlling federal regulatory requirements. Under 21 CFR 880.6510, FDA classifies a whole-room microbial reduction device (Produce Code QXJ) as Class II medical devices, requiring 510(k) premarket notification prior to marketing.

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.”

A VA internal source, VHA Environmental Programs Service (19HEFC), referenced this FDA requirement in June 2026 Quarter 3 Volume 13 Issue 3 page 4, which addresses the UV Whole Room Microbial Reduction Devices requirement:

“Many VHA facilities use ultraviolet (UV) whole-room microbial reduction devices as an adjunct to routine cleaning and disinfection practices. As the use of these technologies has expanded, questions have risen regarding efficacy and safety of UV disinfecting technologies. As a result, the FDA has developed a 510(k)-clearance requirement for UV whole room microbial reduction devices. The following FAQs provide guidance on these requirements and considerations for implementing UV technologies in your facility:

· What type of UV devices are authorized for use in VHA facilities?

VHA facilities are required to use FDA cleared whole room microbial reduction devices with a 510(k) clearance.

· What does FDA 510(k) clearance mean?

FDA 510(k) clearance indicates that the manufacturer has demonstrated validation of microbial reduction claims and supporting performance data that has been reviewed by the FDA.

· Why is FDA 510(k) clearance important?

FDA 510(k) clearance helps ensure the device has undergone regulatory review for safety and effectiveness related to its intended use.”

It adds: “BLUF: There have been recent questions regarding the difference between De Novo and 510(k) clearance. The FDA De Novo Pathway is a regulatory route for novel medical devices without an existing predicate device. Any subsequent devices in this category are cleared through the 510(k) process. For purchasing purposes, any FDA-cleared devices within the same UV Whole Room Microbial Reduction Device category may be considered for purchase by VA facilities.”

Please also clarify:

(a) whether the cited guidance establishes QXJ authorization as a mandatory requirement for any whole-room UV/UVC equipment used by VHA EMS, or specifically for devices acquired for the FDA-regulated intended use of reducing microbial load on medical-device surfaces following cleaning and disinfection; and Internal VHA Environmental Program Services guidance relies on the existing FDA regulatory requirement applicable only to whole-room microbial reduction devices that are marketed for the FDA-regulated intended use of reducing microbial load on medical-device surfaces following cleaning and disinfection. Under 21 CFR 880.6510, devices in this category (product code QXJ) are Class II medical devices and therefore must obtain FDA 510(k) clearance or De Novo authorized prior to marketing for that intended use.

Since this solicitation is to procure whole-room microbial-reduction devices, the FDA QXJ requirements are applicable. FDA QXJ refers to the classification for Whole‑Room Microbial Reduction Devices, which are Class II medical devices regulated under 21 CFR 880.6510 and require FDA 510(k) clearance or De Novo authorized.

(b) whether the guidance distinguishes between new procurements and continued operation of legacy whole-room UV/UVC systems already deployed within VA facilities.

If non-QXJ legacy systems may continue to operate, please identify any applicable grandfathering, transition, continued-use, replacement, or retirement criteria and clarify whether the QXJ requirement is a prospective acquisition requirement, an operating requirement, or both.

Consideration of legacy whole-room UV/UVC systems is not appliable to this procurement. The current requirement is solely for the acquisition of new equipment, and therefore questions regarding continued operation, grandfathering, transition, or retirement criteria for non-QXJ legacy system fall outside of the scope of the current solicitation.

2. Meaning and application of the 4-log to 6-log requirement Amendment 0001 states that the “minimum quantitative microbial-reduction performance should demonstrate validated reductions in the range of 4-log (99.99%) up to 6-log (99.9999%).”

Please clarify:

(a) whether 4-log is a mandatory pass/fail minimum;

(b) whether that minimum must be demonstrated separately for each listed organism or organism category, including MRSA, VRE, Acinetobacter, Clostridioides difficile, and the required virus surrogate(s);

(c) under what circumstances, if any, performance greater than 4-log and up to 6-log is required; and

(d) the minimum-need or performance basis for selecting this range.

The FDA De Novo decision summary for the referenced LightStrike+ device, DEN230007, describes approximately 2-log microbial-reduction performance in simulated-use testing. Please clarify how the referenced product satisfies the amended 4-log to 6-log requirement and whether additional validated evidence outside FDA-authorized labeling may be used for this purpose.

The microbial-reduction performance language in Amendment 0001 contained errors and has been redefined. The solicitation now requires the following revised and correct criteria:

The offered device must meet a minimum of 2-log reduction of bacterial organism, and this validated performance of a minimum of 2-log microbial reduction must appear in the offered device’s FDA-authorized labeling or Instruction for Use (IFU).

In addition, the previous requirement to provide microbial-reduction performance data for specific organism categories – including Vegetative bacteria: MRSA, VRE, Acinetobacter, Spore-formers: Clostridioides difficile, Virus surrogates: Representative non‑enveloped and/or enveloped surrogate viruses appropriate for environmental disinfection testing – has been removed from the solicitation.

3. Standard for validated performance data Amendment 0001 permits vendors to submit validated performance data outside FDA-authorized labeling or Instructions for Use.

Please identify the standard the Government will use to determine whether such evidence is sufficiently validated, including any required test methodology, test conditions, independent laboratory qualification, peer review, simulated-use or in-use testing, or other validation criteria.

If performance evidence generated using a predecessor or earlier-generation system may be considered, please identify the technical-equivalence or bridging documentation required to establish applicability to the currently offered system.

The microbial-reduction performance language in Amendment 0001 contained errors and has been redefined. The solicitation now requires the following revised and correct criteria:

The offered device must meet a minimum of 2-log reduction of bacterial organism, and this validated performance of a minimum of 2-log microbial reduction must appear in the offered device’s FDA-authorized labeling or Instruction for Use (IFU).

In addition, the previous requirement to provide microbial-reduction performance data for specific organism categories – including Vegetative bacteria: MRSA, VRE, Acinetobacter, Spore-formers: Clostridioides difficile, Virus surrogates: Representative non‑enveloped and/or enveloped surrogate viruses appropriate for environmental disinfection testing – has been removed from the solicitation.

4. Common evaluation standard Please confirm that the referenced Xenex LightStrike+ MXSUV1-SL and every offered “equal” product will be evaluated under the same microbial-reduction thresholds, organism-specific requirements, and validation standards.

No proprietary manufacturer information is requested. We are seeking only the common technical and evidentiary standard that will govern evaluation of all offered products.

Yes.

Updated Statement of Work

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 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 meet a minimum of 2-log reduction of bacterial organism, and this validated performance of a minimum of 2-log microbial reduction must appear in the offered device’s FDA-authorized labeling or Instruction for Use (IFU).

· 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