Surgical Sterilizer

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial products or services, issued as a Request for Quotation (RFQ) for Surgical Sterilizer Test Articles. The acquisition is for the Army Program Executive Office (PEO) Soldier, Soldier Medical Devices (SMD) Project Management Office (PMO). The government intends to procure four (4) surgical sterilizers initially, with options for three (3) additional units. These units will undergo operational and environmental testing. Following testing, the government intends to procure no less than one and up to 711 surgical sterilizers over a period of up to five years via a separate sole source procurement.

• Four (4) Surgical Sterilizer Test Articles.

• Units must undergo operational testing per Military Standard (MIL-STD) 810-H(1).

• Quoters must provide information on technical capabilities and specifications, including conformance to Critical Operational Device Specifications (CODS), Critical Logistical Specifications (CLS), and Additional Performance Parameters (APPs).

• Quoters must complete a Medical Device and Equipment Risk Assessment (MDERA).

• Quoters must submit at least one and no more than three past performance references for similar projects completed within the last three years.

• The acquisition is not set-aside for small business concerns.

• The government intends to execute one Firm-Fixed-Price purchase order.

• Quotes are due no later than 2:00 PM Local Time, 1 June 2026.

• Quotes can be submitted as Microsoft Word, Microsoft Excel, or Adobe PDF attachments to jamie.l.diggs.civ@health.mil and shannon.p.lertora.civ@health.mil.

• Questions concerning the RFQ are due no later than 4:00 PM Local Time, 30 April 2026, and should be submitted via email to jamie.l.diggs.civ@health.mil and shannon.p.lertora.civ@health.mil.

• The proposed price will be evaluated and must be determined to be fair and reasonable.

• Evaluation will consider technical capabilities/specifications, risk management, and past performance.

• This acquisition is not set-aside for small business concerns.

• Contractors must be registered in the System for Award Management (SAM) database at time of award.

• This solicitation incorporates provisions and clauses by reference. The full text may be accessed electronically at www.acquisition.gov.

• Amendment 0001 extends the due date to 2:00 PM Local Time, 1 June 2026. No other changes were made.

• Quoters shall provide pricing for all line items and a total contract price, and acknowledge any amendments.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial products or services, prepared in accordance with FAR Part 12. It constitutes the sole solicitation, and no separate written solicitation will be issued. The solicitation number is HT942726QE005 and it is issued as a Request for Quotation (RFQ) for Surgical Sterilizer Test Articles for the Army Program Executive Office (PEO) Soldier, Soldier Medical Devices (SMD) Project Management Office (PMO).

• The primary requirement is for Surgical Sterilizer Test Articles. Specific details are referenced in the "Critical Operational Device Specifications (CODS)", "Critical Logistical Specifications (CLS)", and "Additional Performance Parameter (APPs)" attachment.

• The acquisition also includes "Onsite In-Person Training".

• The solicitation incorporates provisions and clauses by reference, accessible at www.acquisition.gov.

• The government intends to execute one Firm-Fixed-Price purchase order for four (4) surgical sterilizers, with options for three (3) additional units.

• There is a potential for a separate sole source procurement of up to 711 Surgical Sterilizers over five (5) years following initial testing.

• The contract will be for Surgical Sterilizer Test Articles and Onsite In-Person Training.

• Quotes are due no later than 2:00 PM Local Time on May 18, 2026.

• Quotes should be submitted via email to jamie.l.diggs.civ@health.mil and shannon.p.lertora.civ@health.mil as Microsoft Word, Microsoft Excel, or Adobe PDF attachments.

• Questions concerning the RFQ are due no later than 4:00 PM Local Time on April 30, 2026.

• Award will be made on a competitive best value basis, considering price and non-price factors.

• Evaluation Factors (in descending order of importance): Technical Capabilities/Specifications, Risk Management Framework, Past Performance, and Price.

• Technical Capabilities/Specifications will be evaluated based on CODS, CLS, and APPs.

• Risk Management Framework will be evaluated based on the Medical Device and Equipment Risk Assessment (MDERA).

• Past Performance will be evaluated based on recent, relevant contracts (within the last three years).

• Price will be evaluated for reasonableness and completeness.

• This acquisition is not set-aside for small business concerns.

• Offerors must be registered in the System for Award Management (SAM) database at the time of award.

• The solicitation includes numerous FAR and DFARS clauses incorporated by reference and in full text, covering areas such as payment instructions, unique item identification, and representations and certifications.

• Attachments include: Critical Operational Device Specifications (CODS) / Critical Logistical Specifications (CLS) / Additional Performance Parameter (APPs); Medical Device and Equipment Risk Assessment (MDERA); Hardware/Software Import Template; Sample Topology Diagram; and Rating Standards & Standard Definitions.

Form / Attachment / Pricing Sheet

This document, "Critical Operational Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameter (APPS)", details the essential characteristics and requirements for a new surgical sterilizer the Army intends to procure. It outlines both minimum required and desired specifications for operational, logistical, and additional performance parameters.

Operational Device Specifications:

• FDA regulatory oversight (510(k) approval or registration).
• Core function to sterilize all necessary surgical instruments.
• Specific chamber dimensions (minimum 12.0" dia. x 23.5" long; desired 13.5" dia. x 24" long).
• Operating temperature range (35°F to 130°F) and sterilization temperature range (250°F/121°C to 275°F/135°C).
• Tray dimensions and material (stainless steel).
• Indicator lights (power, heat, dry).
• Power supply requirements (balanced power, auto-detection, dual voltage support).
• Operational cube and weight (minimum 4 cu ft, 35 lbs; desired 9 cu ft, 95 lbs).
• Water quality (requires distilled water).
• Maximum relative humidity (80% non-condensing).

Logistical Specifications:

• Trade Agreements Act (TAA) compliance.
• Repair parts support (comprehensive list required).
• Maintenance requirement (no proprietary-scheduled maintenance more than once per year).
• Special tools (not required for maintenance/repairs).
• Manuals (physical and digital copies of User/Operator and Maintenance/Service manuals).
• Training (one-time onsite training for 5-10 people).
• Risk Management Framework (RMF) / Authority to Operate (ATO) documentation.
• Copyright/distribution release for technical manuals.
• Reusable hardened transport case (meeting MIL-STD-810H).
• Warranty (one year manufacturer warranty).
• Packaging (self-contained hardcases with IUID, case contents list, protective inserts).
• Delivery (120-150 days after award).

Additional Performance Parameters (Desired):

• Support of Device for a minimum of five years post-procurement, with parts support for an additional five years.
• Collaboration with Defense Logistics Agency (DLA) to add the device to the Electronic Catalog (ECAT).

This document is critical for potential bidders as it defines the precise technical, logistical, and performance requirements for the surgical sterilizer. Vendors must ensure their proposed product meets all "Minimum Required" specifications to be considered acceptable. The "Desired Characteristics" and "Additional Performance Parameters" highlight areas where exceeding minimum requirements may provide a competitive advantage. Understanding these specifications is essential for developing accurate proposals and ensuring product compliance.

Form / Attachment / Pricing Sheet

This document is the Medical Device and Equipment Risk Assessment (MDERA) Questionnaire, Version 1. It is a mandatory requirement for vendors to complete as part of the Request for Offer (RFO)/Risk Management Framework (RMF) Change Control Board (CCB) review process. The questionnaire is used to ascertain security compliance with Federal Government, Department of Defense (DoD), and Project Manager Soldier Medical Devices (PM-SMD) policies and directives. It serves as a pre-procurement selection tool to support RMF Authorization and ensures all medical systems/devices meet DoD cybersecurity and NIST standards.

• Vendor POC Information: Primary and Technical POC details, including contact information and signature for accuracy confirmation.
• System Identification: Details about the medical device/equipment, including title, version, description, model, alternate names, category, software EOL dates, regulatory certifications (e.g., FDA 510K), contract/PO information, DoD/SMD RMF Authorization status, physical testing location, intended mode of operation (e.g., Standalone, Client/Server, Cloud-based), cloud offering details (FEDRAMP approval), and intended method of implementation (hardware/software configuration).
• Interfaces: Description of network connectivity (LAN, wireless, serial) and connected systems (e.g., EHR, PACS).
• Technical Information: Detailed breakdown of system hardware/firmware, operating systems (including EOL dates), installed applications (including EOL dates), migration paths for unsupported software, user account types and authentication methods, system architecture diagrams, endpoint protection (antivirus, HBSS), vulnerability scanning capabilities and limitations, patching/vulnerability management policies, remote access capabilities, wireless capabilities (Wi-Fi, Bluetooth), and mass storage usage (USB drives).
• Data Processing Capabilities: Information on data processing functions (receive, process, store, transmit, display), handling of ePHI/PII, specific ePHI/PII elements processed, data persistence and removal methods, data input methods, data workflow, and encryption capabilities for data at rest and in transit.

Completion of this questionnaire is critical for vendors proposing medical devices or equipment. Failure to disclose required information or misrepresentation can result in the system being ineligible for purchase or lead to contract breach. The detailed information required ensures that vendors understand and can meet the stringent cybersecurity and risk management requirements mandated by the DoD for medical devices. Vendors must address all information fields and cannot rely on external documents or product literature. The signed questionnaire signifies acceptance of the accuracy of the provided information.

Form / Attachment / Pricing Sheet

This Excel file serves as a template for bidders to provide detailed hardware and software inventory information. It is intended for import into the eMASS system.

• Hardware Sheet: Requires details on component type, machine name, manufacturer, model, OS version, memory, location, and criticality.
• Software Sheet: Requires details on software type, vendor, name, version, license information, and criticality.
• Instructions Sheet: Provides specific guidance on data entry, column/sheet integrity, required fields (e.g., Machine Name for hardware, Software Vendor/Name/Version for software), and character limits.
• Lists Sheet: Contains predefined lists for hardware types, software types, and approval statuses to ensure consistency.

Bidders must accurately complete this template as instructed to ensure successful import into eMASS. Failure to adhere to formatting or data requirements may negatively impact the eMASS ingestion process. Specific fields are mandatory, and certain entries (like Manufacturer/Model) become required if one is specified. The "Virtual Asset" and "Critical Information System Asset" fields require specific input. The Signature tab requires a double-click to fill out and apply a CAC signature, after which the document cannot be edited.

Form / Attachment / Pricing Sheet

This document provides a sample topology diagram for NIPRNET/SIPRNET, illustrating network components and their expected configurations. It serves as a reference for bidders to understand the expected network architecture.

• Topology Date: Specifies the date of the topology information.
• CCSD: Indicates the location of the CCSD, preferably near the premise router.
• IP Addresses: Requires IP addresses for all devices within the enclave.
• Specific Device Information: For Firewalls, IDS, Servers, and Workstations, the following details are required:
  • Firewalls: Manufacturer, model, and software/firmware version.
  • IDS: Manufacturer, model, and software/firmware version.
  • Servers: Server function (e.g., OWA, Web Server) and operating system (including the most updated Service Pack).
  • Workstations: Operating system (including the most updated Service Pack).
• Diagram: A visual representation of a sample NIPRNET/SIPRNET topology, including components like routers, firewalls, IDS, servers, workstations, and printers, with placeholder IP addresses.
• Notes: Highlights that private IP network addresses are not permitted in SIPRNet Enclaves and that the Enclave and Network Infrastructure should comply with DoD-level policies. It also directs users to the NIAP-CCEVS website for a listing of compliant devices.

This sample topology diagram is crucial for bidders to understand the expected network environment and the level of detail required for device information. It informs the technical approach and ensures compliance with security and configuration standards outlined by the government.

Form / Attachment / Pricing Sheet

This document, "Attachment 5 - Rating Standards & Standard Definitions," outlines the criteria and definitions used for evaluating proposals under the solicitation. It details the rating scales for three key evaluation factors: Technical Capabilities/Specifications, Risk Management Framework, and Past Performance.

Evaluation Factor I – Technical Capabilities/Specifications: Defines ratings from Outstanding to Unacceptable based on the quote's approach, understanding of requirements, and risk of unsuccessful performance.

Evaluation Factor II – Risk Management Framework: Defines ratings as Acceptable (meets solicitation requirements) or Unacceptable (does not meet requirements).

Evaluation Factor III – Past Performance: Defines ratings as Acceptable (reasonable expectation of successful performance or unknown) or Unacceptable (no reasonable expectation of successful performance). It clarifies that a "neutral" rating for unknown past performance is considered acceptable.

This document is crucial for bidders as it directly informs how their proposals will be evaluated. Understanding these rating standards allows vendors to tailor their proposals to meet or exceed the government's expectations for technical approach, risk mitigation, and demonstrated past performance, thereby increasing their chances of a favorable evaluation.