B01-HT942726QE005.pdf

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with FAR Part 12. This announcement constitutes the only solicitation.

Offers are being requested and a separate written solicitation will not be issued.

Solicitation number HT942726QE005 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).

This acquisition is not set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov.

http://www.acquisition.gov/

Solicitation/Contract Form Surgical Sterilizer Test Articles

Product Service Code: 6530

HT942726QE005

Supplies or Services & Prices or Costs Additional Information/Notes

Item Supplies / Services Quantity Unit Unit Price Amount

Surgical Sterilizer Test Articles

Generic Name Description: Surgical Sterilizer Test Articles Product Service Code: 6530 Pricing Arrangement: Firm Fixed Price

4 Each

Onsite In-Person Training

Generic Name Description: Onsite In-Person Training Product Service Code: 6530 Pricing Arrangement: Firm Fixed Price

1 Each

Option Line Item

Surgical Sterilizer Test Articles

Generic Name Description: Surgical Sterilizer Test Articles Product Service Code: 6530 Pricing Arrangement: Firm Fixed Price

3 Each

Description/Specifications/Statement of Work

Requirements Surgical Sterilizer Test Articles. See Critical Operational Device Specifications (CODS)/Critical Logistical Specifications (CLS)/Additional Performance Parameter (APPS) attachment.

Packaging and Marking

Inspection and Acceptance Overall Contract Inspection/Acceptance Locations

Inspection and Acceptance Location

Both Destination Instructions: See Contract Terms and Conditions for Inspection and Acceptance criteria.

DoDAAC: W51KAR CountryCode: USA

W6DS PEO SOLDIER FT DETRICK

PM SOLDIER MEDICAL DEVICES SMD, 1240 ROCKY SPRINGS ROAD

FORT DETRICK, MD 21702-0000

UNITED STATES

Inspection and Acceptance Location

Both Destination Instructions: See Contract Terms and Conditions for Inspection and Acceptance criteria.

DoDAAC: W51KAR CountryCode: USA

W6DS PEO SOLDIER FT DETRICK

PM SOLDIER MEDICAL DEVICES SMD, 1240 ROCKY SPRINGS ROAD

FORT DETRICK, MD 21702-0000

UNITED STATES

Option Line Item

Inspection and Acceptance Location

Both Destination Instructions: See Contract Terms and Conditions for Inspection and Acceptance criteria.

DoDAAC: W51KAR CountryCode: USA

W6DS PEO SOLDIER FT DETRICK

PM SOLDIER MEDICAL DEVICES SMD, 1240 ROCKY SPRINGS ROAD

FORT DETRICK, MD 21702-0000

UNITED STATES

Deliveries or Performance

Line Item Delivery Schedule Quantity Address and POC Special Handling/Notes

Delivery Schedule From date of lead time event to delivery 150 Calendar Days Date of Award

4 Each Ship To DoDAAC: W51KAR CountryCode: USA

W6DS PEO SOLDIER FT DETRICK

PM SOLDIER MEDICAL DEVICES SMD, 1240 ROCKY

SPRINGS ROAD

FORT DETRICK, MD 21702-0000

UNITED STATES

FoB Details Contractor Destination

Delivery Schedule From date of lead time event to delivery 150 Calendar Days Date of Award

1 Each Ship To DoDAAC: W51KAR CountryCode: USA

W6DS PEO SOLDIER FT DETRICK

PM SOLDIER MEDICAL DEVICES SMD, 1240 ROCKY

SPRINGS ROAD

FORT DETRICK, MD 21702-0000

UNITED STATES

FoB Details Contractor Destination

Option Line Item

Delivery Schedule From date of lead time event to delivery 150 Calendar Days Date of Award

3 Each Ship To DoDAAC: W51KAR CountryCode: USA

W6DS PEO SOLDIER FT DETRICK

PM SOLDIER MEDICAL DEVICES SMD, 1240 ROCKY

SPRINGS ROAD

FORT DETRICK, MD 21702-0000

UNITED STATES

FoB Details Contractor Destination

Contract Administration Data

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports. Dec 2018

DFARS Clauses Incorporated by Full Text

252.232-7006 Wide Area WorkFlow Payment Instructions. (Jan 2023)

WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (JAN 2023)

(a) As used in this clause- Definitions.

"Department of Defense Activity Address Code (DoDAAC)" is a six position code that uniquely identifies a unit, activity, or organization.

"Document type" means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

"Local processing office (LPO)" is the office responsible for payment certification when payment certification is done external to the entitlement system.

"Payment request" and "receiving report" are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Electronic invoicing.

Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) To access WAWF, the Contractor shall- WAWF access.

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site WAWF training.

before submitting payment requests through WAWF. Both can be accessed by selecting the "Web Based Training" link on the WAWF home page at https:// wawf.eb.mil/

(e) Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol. WAWF methods of document submission.

(f) The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for WAWF payment instructions.

this contract or task or delivery order:

(1) The Contractor shall submit payment requests using the following document type(s): Document type.

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items-

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

Invoice and Receiving Report Combo

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

Not Applicable

(Contracting Officer: Insert either "Invoice 2in1" or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial financing, submit a commercial financing request.

(2) ) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF "combo" document type to create some combinations of invoice and receiving report in one step.]

(3) The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating Document routing.

payment requests and receiving reports in the system.

Routing Data Table*

Field Name in WAWF Data to be entered in WAWF

Pay Official DoDAAC HQ0490

Issue By DoDAAC HT9427

Admin DoDAAC HT9427

Inspect By DoDAAC Not Applicable

Ship To Code W51KAR

Ship From Code Not Applicable

Mark For Code Not Applicable

Service Approver (DoDAAC) Not Applicable

Service Acceptor (DoDAAC) Not Applicable

Accept at Other DoDAAC Not Applicable

LPO DoDAAC Not Applicable

DCAA Auditor DoDAAC Not Applicable

Other DoDAAC(s) Not Applicable

(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert "See Schedule" or "Not applicable.")

(**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)

(4) The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in Payment request.

accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F. Receiving report.

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

To be Provided at Award

(Contracting Officer: Insert applicable information or "Not applicable.")

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

(End of clause)

Special Contract Requirements

Contract Clauses

FAR Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements. Jan 2017 52.204-13 System for Award Management-Maintenance. (Deviation 2026-O0038) Feb 2026 52.209-10 Prohibition on Contracting With Inverted Domestic Corporations. (Deviation 2026-O0038) Feb 2026 52.212-4 Terms and Conditions-Commercial Products and Commercial Services. (Deviation 2026-O0038) Feb 2026 52.222-50 Combating Trafficking in Persons. (Deviation 2026-O0038) Feb 2026 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving. May 2024 52.229-12 Tax on Certain Foreign Procurements. Feb 2021 52.232-33 Payment by Electronic Funds Transfer-System for Award Management. Oct 2018 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. Mar 2023 52.233-3 Protest after Award. (Deviation 2026-O0038) Feb 2026 52.233-4 Applicable Law for Breach of Contract Claim. (Deviation 2026-O0038) Feb 2026 52.240-91 Security Prohibitions and Exclusions. (Deviation 2026-O0038) Feb 2026 52.244-6 Subcontracts for Commercial Products and Commercial Services. (Deviation 2026-O0038) Feb 2026

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.203-7000 Requirements Relating to Compensation of Former DoD Officials. Sep 2011 252.203-7002 Requirement to Inform Employees of Whistleblower Rights. Dec 2022 252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting. May 2024 252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services. Jan 2023 252.223-7008 Prohibition of Hexavalent Chromium. Jan 2023 252.225-7001 Buy American and Balance of Payments Program. Feb 2024 252.225-7002 Qualifying Country Sources as Subcontractors. Mar 2022 252.225-7021 Trade Agreements. Feb 2024 252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime. Jan 2023 252.232-7010 Levies on Contract Payments. Dec 2006 252.233-7001 Choice of Law (Overseas). Jun 1997 252.247-7023 Transportation of Supplies by Sea. Oct 2024

FAR Clauses Incorporated by Full Text

52.217-7 Option for Increased Quantity-Separately Priced Line Item. (Mar 1989)

OPTION FOR INCREASED QUANTITY-SEPARATELY PRICED LINE ITEM (MAR 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within [insert in the clause the period of time in which the 365 Contracting Officer has to exercise the option]. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of clause)

DFARS Clauses Incorporated by Full Text

252.211-7003 Item Unique Identification and Valuation. (Jan 2023)

ITEM UNIQUE IDENTIFICATION AND VALUATION (JAN 2023)

(a) . As used in this clause- Definitions

"Automatic identification device" means a device, such as a reader or interrogator, used to retrieve data encoded on machine-readable media.

"Concatenated unique item identifier" means-

(1) For items that are serialized within the enterprise identifier, the linking together of the unique identifier data elements in order of the issuing agency code, enterprise identifier, and unique serial number within the enterprise identifier; or

(2) For items that are serialized within the original part, lot, or batch number, the linking together of the unique identifier data elements in order of the issuing agency code; enterprise identifier; original part, lot, or batch number; and serial number within the original part, lot, or batch number.

"Data matrix" means a two-dimensional matrix symbology, which is made up of square or, in some cases, round modules arranged within a perimeter finder pattern and uses the Error Checking and Correction 200 (ECC200) specification found within International Standards Organization (ISO)/International Electrotechnical Commission (IEC) 16022.

"Data qualifier" means a specified character (or string of characters) that immediately precedes a data field that defines the general category or intended use of the data that follows.

"DoD recognized unique identification equivalent" means a unique identification method that is in commercial use and has been recognized by DoD. All DoD recognized unique identification equivalents are listed at .https://www.acq.osd.mil/asda/dpc/ce/ds/unique-id.html

"DoD item unique identification" means a system of marking items delivered to DoD with unique item identifiers that have machine-readable data elements to distinguish an item from all other like and unlike items. For items that are serialized within the enterprise identifier, the unique item identifier shall include the data elements of the enterprise identifier and a unique serial number. For items that are serialized within the part, lot, or batch number within the enterprise identifier, the unique item identifier shall include the data elements of the enterprise identifier; the original part, lot, or batch number; and the serial number.

" Enterprise " means the entity (e.g., a manufacturer or vendor) responsible for assigning unique item identifiers to items.

" Enterprise identifier" means a code that is uniquely assigned to an enterprise by an issuing agency.

"Government's unit acquisition cost" means-

(1) For fixed-price type line, subline, or exhibit line items, the unit price identified in the contract at the time of delivery;

(2) For cost-type or undefinitized line, subline, or exhibit line items, the Contractor's estimated fully burdened unit cost to the Government at the time of delivery; and

(3) For items produced under a time-and-materials contract, the Contractor's estimated fully burdened unit cost to the Government at the time of delivery.

"Issuing agency" means an organization responsible for assigning a globally unique identifier to an enterprise, as indicated in the Register of Issuing Agency Codes for ISO/IEC 15459, located at http://www.aimglobal.org/?Reg_Authority15459.

"Issuing agency code" means a code that designates the registration (or controlling) authority for the enterprise identifier.

"Item" means a single hardware article or a single unit formed by a grouping of subassemblies, components, or constituent parts.

" Lot or batch number" means an identifying number assigned by the enterprise to a designated group of items, usually referred to as either a lot or a batch, all of which were manufactured under identical conditions.

"Machine-readable" means an automatic identification technology media, such as bar codes, contact memory buttons, radio frequency identification, or optical memory cards.

"Original part number" means a combination of numbers or letters assigned by the enterprise at item creation to a class of items with the same form, fit, function, and interface.

"Parent item" means the item assembly, intermediate component, or subassembly that has an embedded item with a unique item identifier or DoD recognized unique identification equivalent.

"Serial number within the enterprise identifier" means a combination of numbers, letters, or symbols assigned by the enterprise to an item that provides for the differentiation of that item from any other like and unlike item and is never used again within the enterprise.

"Serial number within the part, lot, or batch number" means a combination of numbers or letters assigned by the enterprise to an item that provides for the differentiation of that item from any other like item within a part, lot, or batch number assignment.

"Serialization within the enterprise identifier" means each item produced is assigned a serial number that is unique among all the tangible items produced by the enterprise and is never used again. The enterprise is responsible for ensuring unique serialization within the enterprise identifier.

"Serialization within the part, lot, or batch number" means each item of a particular part, lot, or batch number is assigned a unique serial number within that part, lot, or batch number assignment. The enterprise is responsible for ensuring unique serialization within the part, lot, or batch number within the enterprise identifier.

"Type designation" means a combination of letters and numerals assigned by the Government to a major end item, assembly or subassembly, as appropriate, to provide a convenient means of differentiating between items having the same basic name and to indicate modifications and changes thereto.

"Unique item identifier" means a set of data elements marked on items that is globally unique and unambiguous. The term includes a concatenated unique item identifier or a DoD recognized unique identification equivalent.

"Unique item identifier type" means a designator to indicate which method of uniquely identifying a part has been used. The current list of accepted unique item identifier types is maintained at .https://www.acq.osd.mil/asda/dpc/ce/ds/unique-id.html

(b) The Contractor shall deliver all items under a contract line, subline, or exhibit line item.

(c) Unique item identifier.

(1) The Contractor shall provide a unique item identifier for the following:

(i) Delivered items for which the Government's unit acquisition cost is $5,000 or more, except for the following line items:

Contract Line, Subline, or

Exhibit Line Item Number Item Description

(ii) Items for which the Government's unit acquisition cost is less than $5,000 that are identified in the Schedule or the following table:

Contract Line, Subline, or

Exhibit Line Item Number Item Description

(If items are identified in the Schedule, insert "See Schedule in this table.)

(iii) Subassemblies, components, and parts embedded within delivered items, items with warranty requirements, DoD serially managed reparables and DoD serially managed nonreparables as specified in Attachment Number .____

(iv) Any item of special tooling or special test equipment as defined in FAR 2.101 that have been designated for preservation and storage for a Major Defense Acquisition Program as specified in Attachment Number .____

(v) Any item not included in (i), (ii), (iii), or (iv) for which the contractor creates and marks a unique item identifier for traceability.

(2) The unique item identifier assignment and its component data element combination shall not be duplicated on any other item marked or registered in the DoD Item Unique Identification Registry by the contractor.

(3) The unique item identifier component data elements shall be marked on an item using two dimensional data matrix symbology that complies with ISO/IEC International Standard 16022, Information technology - International symbology specification - Data matrix; ECC200 data matrix specification.

(4) The Contractor shall ensure that- Data syntax and semantics of unique item identifiers.

(i) The data elements (except issuing agency code) of the unique item identifier are encoded within the data matrix symbol that is marked on the item using one of the following three types of data qualifiers, as determined by the Contractor:

(A) Application Identifiers (AIs) (Format Indicator 05 of ISO/IEC International Standard 15434), in accordance with ISO/IEC International Standard 15418, Information Technology - EAN/UCC Application Identifiers and Fact Data Identifiers and Maintenance and ANSI MH 10.8.2 Data Identifier and Application Identifier Standard.

(B) Data Identifiers (DIs) (Format Indicator 06 of ISO/IEC International Standard 15434), in accordance with ISO/IEC International Standard 15418, Information Technology - EAN/UCC Application Identifiers and Fact Data Identifiers and Maintenance and ANSI MH 10.8.2 Data Identifier and Application Identifier Standard.

(C) Text Element Identifiers (TEIs) (Format Indicator 12 of ISO/IEC International Standard 15434), in accordance with the Air Transport Association Common Support Data Dictionary; and

(ii) The encoded data elements of the unique item identifier conform to the transfer structure, syntax, and coding of messages and data formats specified for Format Indicators 05, 06, and 12 in ISO/IEC International Standard 15434, Information Technology - Transfer Syntax for High Capacity Automatic Data Capture Media.

(5) . Unique item identifier

(i) The Contractor shall-

(A) Determine whether to-

Serialize within the enterprise identifier; (1)

Serialize within the part, lot, or batch number; or (2)

Use a DoD recognized unique identification equivalent (e.g. Vehicle Identification Number); and (3)

(B) Place the data elements of the unique item identifier (enterprise identifier; serial number; DoD recognized unique identification equivalent;

and for serialization within the part, lot, or batch number only: original part, lot, or batch number) on items requiring marking by paragraph (c)(1) of this clause, based on the criteria provided in MIL-STD-130, Identification Marking of U.S. Military Property, latest version;

(C) Label shipments, storage containers and packages that contain uniquely identified items in accordance with the requirements of MIL- STD-129, Military Marking for Shipment and Storage, latest version; and

(D) Verify that the marks on items and labels on shipments, storage containers, and packages are machine readable and conform to the applicable standards. The contractor shall use an automatic identification technology device for this verification that has been programmed to the requirements of Appendix A, MIL-STD-130, latest version.

(ii) The issuing agency code-

(A) Shall not be placed on the item; and

(B) Shall be derived from the data qualifier for the enterprise identifier.

(d) For each item that requires item unique identification under paragraph (c)(1)(i), (ii), or (iv) of this clause or when item unique identification is provided under paragraph (c)(1)(v), in addition to the information provided as part of the Material Inspection and Receiving Report specified elsewhere in this contract, the Contractor shall report at the time of delivery, as part of the Material Inspection and Receiving Report, the following information:

(1) Unique item identifier.

(2) Unique item identifier type.

(3) Issuing agency code (if concatenated unique item identifier is used).

(4) Enterprise identifier (if concatenated unique item identifier is used).

(5) Original part number (if there is serialization within the original part number).

(6) Lot or batch number (if there is serialization within the lot or batch number).

(7) Current part number (optional and only if not the same as the original part number).

(8) Current part number effective date (optional and only if current part number is used).

(9) Serial number (if concatenated unique item identifier is used).

(10) Government's unit acquisition cost.

(11) Unit of measure.

(12) Type designation of the item as specified in the contract schedule, if any.

(13) Whether the item is an item of Special Tooling or Special Test Equipment.

(14) Whether the item is covered by a warranty.

(e) For embedded subassemblies, components, and parts that require DoD item unique identification under paragraph (c)(1)(iii) of this clause or when item unique identification is provided under paragraph (c)(1)(v), the Contractor shall report as part of the Material Inspection and Receiving Report specified elsewhere in this contract, the following information:

(1) Unique item identifier of the parent item under paragraph (c)(1) of this clause that contains the embedded subassembly, component, or part.

(2) Unique item identifier of the embedded subassembly, component, or part.

(3) Unique item identifier type.**

(4) Issuing agency code (if concatenated unique item identifier is used).**

(5) Enterprise identifier (if concatenated unique item identifier is used).**

(6) Original part number (if there is serialization within the original part number).**

(7) Lot or batch number (if there is serialization within the lot or batch number).**

(8) Current part number (optional and only if not the same as the original part number).**

(9) Current part number effective date (optional and only if current part number is used).**

(10) Serial number (if concatenated unique item identifier is used).**

(11) Description.

** Once per item.

(f) The Contractor shall submit the information required by paragraphs (d) and (e) of this clause as follows:

(1) End items shall be reported using the receiving report capability in Wide Area WorkFlow (WAWF) in accordance with the clause at 252.232-7003. If WAWF is not required by this contract, and the contractor is not using WAWF, follow the procedures at http://dodprocurementtoolbox.com/site/uidregistry/.

(2) Embedded items shall be reported by one of the following methods-

(i) Use of the embedded items capability in WAWF;

(ii) Direct data submission to the IUID Registry following the procedures and formats at http://dodprocurementtoolbox.com/site/uidregistry/; or

(iii) Via WAWF as a deliverable attachment for exhibit line item number (fill in) , Unique Item Identifier Report for Embedded Items, Contract ____ Data Requirements List, DD Form 1423.

(g) . If the Contractor acquires by subcontract, any item(s) for which item unique identification is required in accordance with paragraph (c)(1) of Subcontracts this clause, the Contractor shall include this clause, including this paragraph (g), in the applicable subcontract(s), including subcontracts for commercial products or commercial services.

(End of clause)

List of Attachments

Number Attachment Name Attachment Description Reference Identifier Date Line Item

B01-

HT942726QE005-

Attach1-CODs-

CLS-

APPs-20250922- Final

Critical Operational Device Specifications (CODS) / Critical Logistical Specifications/Additional Performance Parameter (APPs)

01 Dec

B01-

HT942726QE005-

Attach2-MDERA

Medical Device and Equipment Risk Assessment

(MDERA)

01 Dec

B01-

HT942726QE005-

Attach3-Hardware- Software-Import- Template

Hardware/Software Import Template 01 Dec

B01-

HT942726QE005-

Attach4-Sample- Topology-Diagram

Sample Topology Diagram 01 Dec

B01-

HT942726QE005-

Attach5-Ratings

Rating Standards & Standard Definitions 01 Dec

Representations, Certification, & Other Statements

FAR Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.240-90 Security Prohibitions and Exclusions Representations and Certifications. (Deviation 2026-O0038) Feb 2026

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.203-7005 Representation Relating to Compensation of Former DoD Officials. Sep 2022 252.225-7055 Representation Regarding Business Operations with the Maduro Regime. May 2022

DFARS Clauses Incorporated by Full Text

252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services- Representation.

(May 2021)

PROHIBITION ON THE ACQUISITION OF COVERED DEFENSE TELECOMMUNICATIONS EQUIPMENT OR SERVICES-REPRESENTATION (MAY 2021)

The Offeror is not required to complete the representation in this provision if the Offeror has represented in the provision at 252.204-7016, Covered Defense Telecommunications Equipment or Services-Representation, that it "does not provide covered defense telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument."

(a) . "Covered defense telecommunications equipment or services," "covered mission," "critical technology," and "substantial or essential Definitions component," as used in this provision, have the meanings given in the 252.204-7018 clause, Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services, of this solicitation.

(b) . Section 1656 of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91) prohibits agencies from procuring or obtaining, Prohibition or extending or renewing a contract to procure or obtain, any equipment, system, or service to carry out covered missions that uses covered defense telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system.

(c) . The Offeror shall review the list of excluded parties in the System for Award Management (SAM) at for entities that are Procedures https://www.sam.gov excluded when providing any equipment, system, or service to carry out covered missions that uses covered defense telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, unless a waiver is granted.

(d) . If in its annual representations and certifications in SAM the Offeror has represented in paragraph (c) of the provision at 252.204-7016, Representation Covered Defense Telecommunications Equipment or Services-Representation, that it "does" provide covered defense telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument, then the Offeror shall complete the following additional representation:

The Offeror represents that it will will not provide covered defense telecommunications equipment or services as a part of its offered products or services to DoD in the performance of any award resulting from this solicitation.

(e) . If the Offeror has represented in paragraph (d) of this provision that it "will provide covered defense telecommunications equipment or Disclosures services," the Offeror shall provide the following information as part of the offer:

(1) A description of all covered defense telecommunications equipment and services offered (include brand or manufacturer; product, such as model number, original equipment manufacturer (OEM) number, manufacturer part number, or wholesaler number; and item description, as applicable).

(2) An explanation of the proposed use of covered defense telecommunications equipment and services and any factors relevant to determining if such use would be permissible under the prohibition referenced in paragraph (b) of this provision.

(3) For services, the entity providing the covered defense telecommunications services (include entity name, unique entity identifier, and Commercial and Government Entity (CAGE) code, if known).

(4) For equipment, the entity that produced or provided the covered defense telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known).

(End of provision)

252.225-7000 Buy American--Balance of Payments Program Certificate. (Feb 2024)

BUY AMERICAN-BALANCE OF PAYMENTS PROGRAM CERTIFICATE-BASIC (FEB 2024)

(a) Definitions. "Commercially available off-the-shelf (COTS) item," "component," "critical component," "critical item," "domestic end product," "foreign end product," "qualifying country," "qualifying country end product," and "United States," as used in this provision, have the meanings given in the 252.225-7001, Buy American and Balance of Payments Program-Basic clause of this solicitation.

(b) The Government- Evaluation.

(1) Will evaluate offers in accordance with the policies and procedures of Part 225 of the Defense Federal Acquisition Regulation Supplement; and

(2) Will evaluate offers of qualifying country end products without regard to the restrictions of the Buy American statute or the Balance of Payments Program.

(c) Certifications and identification of country of origin.

(1) For all line items subject to the Buy American and Balance of Payments Program-Basic clause of this solicitation, the Offeror certifies that-

(i) Each end product, except those listed in paragraphs (c)(2) or (3) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c)(4) of this provision contains a critical component or a critical item; and

(ii) For end products other than COTS items, components of unknown origin are considered to have been mined, produced, or manufactured outside the United States or a qualifying country. For those end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select "no".

(2) The Offeror certifies that the following end products are qualifying country end products:

Line Item Number Country of Origin

(3) The following end products are other foreign end products , including end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select "no".

Line Item Number Country of Origin (If known) Exceeds 55% Domestic Content (yes/no)

(4) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component or a critical item (see Federal Acquisition Regulation 25.105).

Domestic end products containing a critical component or a critical item:

Line Item Number ____

[List as necessary]

(End of provision)

252.225-7020 Trade Agreements Certificate. (Nov 2014)

TRADE AGREEMENTS CERTIFICATE-BASIC (NOV 2014)

(a) "Designated country end product," "nondesignated country end product," "qualifying country end product," and "U.S.-made end product" as Definitions.

used in this provision have the meanings given in the Trade Agreements-Basic clause of this solicitation.

(b) The Government- Evaluation.

(1) Will evaluate offers in accordance with the policies and procedures of Part 225 of the Defense Federal Acquisition Regulation Supplement; and

(2) Will consider only offers of end products that are U.S.-made, qualifying country, or designated country end products unless-

(i) There are no offers of such end products;

(ii) The offers of such end products are insufficient to fulfill the Government's requirements; or

(iii) A national interest waiver has been granted.

(c) Certification and identification of country of origin.

(1) For all line items subject to the Trade Agreements-Basic clause of this solicitation, the offeror certifies that each end product to be delivered under this contract, except those listed in paragraph (c)(2) of this provision, is a U.S.-made, qualifying country, or designated country end product.

(2) The following supplies are other nondesignated country end products:

( ) Line Item Number ( ) Country of Origin

(End of provision)

Instructions, Conditions, & Notices to Offerors or Quoters

The Defense Health Agency Contracting Activity (DHACA) is issuing this Request for Quote (RFQ) on behalf of the Army Program Executive Office (PEO) Soldier, Soldier Medical Devices(SMD) Project Management Office (PMO).

This requirement is for a Surgical Sterilizer.

This requirement is being solicited full and open in accordance with FAR 12, Acquisition of Commercial Products and Commercial Services. The Government intends to execute one Firm-Fixed-Price purchase order to procure four (4) surgical sterilizers to include options for three (3) additional surgical sterilizers.

These units will undergo operational testing conducted by the Medical Test Evaluation Activity and environmental testing in accordance with Military Standard (MIL- STD) 810-H(1), Department of Defense, Test Method Standard, Environmental Engineering Considerations and Laboratory Tests. Once the operational and environmental testing have concluded, the Government intends to procure no less than one Surgical Sterilizer and up to 711 Surgical Sterilizers over a period of up to five (5) years via a separate sole source procurement.

Quote Submission Instructions. Quotes are due no later than 2:00 PM Local Time, 18 May 2026. Quotes shall be submitted in accordance with the Instructions to Quoters. Quotes maybe submitted as Microsoft Word, Microsoft Excel, or Adobe PDF attachments to jamie.l.diggs.civ@health.mil and shannon.p.lertora.civ@health.mil.

Instructions to Quoters. This section specifies the format and content that Quoters shall use in this RFQ. Quoters shall submit a quote that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Any quote which does not provide, as a minimum, that which is required in the RFQ may be determined to be substantially incomplete and not warrant any further consideration.

Questions concerning the RFQ are due no later than 4:00 PM Local Time, 30 April 2026. Questions will not be addressed after this cut off date. Questions shall be submitted via email to jamie.l.diggs.civ@health.mil and shannon.p.lertora.civ@health.mil (Subject: HT9427-26-Q-E005). Quoters shall submit one set of questions only; multiple submissions will not be accepted. An amendment to the RFQ will be issued providing responses to the questions.

The Quoter shall provide:

Company Details.

- Complete company name and address

- Company Point of Contact (POC)

- Email

- Phone Number

- Unique Entity ID

- CAGE Code

- Place of Manufacture

Technical Capabilities/Specifications.

- The Quoter shall include information to enable the evaluation of the proposed product and its conformance to the specified Critical Operational Device Specifications(CODS)/Critical Logistical Specifications (CLS)/Additional Performance Parameter (APPs) by part number, manufacturer and description.

Risk Management Framework.

- Quoters shall complete Medical Device and Equipment Risk Assessment (MDERA).

Past Performance.

- Quoters shall submit at least one and no more than three past performance references for projects of similar scope, magnitude, and complexity to the requirement in this solicitation. For each project, the Quoter shall provide the following details:

1. Contract/Task Order Number: The contract/task order number for the project.

2. Customer name: The name of the government agency or commercial client.

3. Point of contact: Name, title, email, and current phone number of a person who can provide information on the project.

4. Project description: A concise summary of the equipment delivered, including contract number and dollar value.

5. Relevance: A brief statement on how the referenced project is relevant to the current solicitation's requirements.

6. Delivery dates: The delivery dates of the project, to include the Quoters' ability to adhere to schedules and meet deadlines. If delivery issues occurred, explain how they were resolved to the client's satisfaction.

References must be for projects completed within the last three years. If a Quoter has no recent, relevant past performance, a statement to that effect shall be submitted. These Quoters will not be evaluated favorably or unfavorably on this factor. The Quoter's lack of past performance will be evaluated as an unknown/ neutral having no favorable or unfavorable impact on the evaluation and the Quoter will be found Acceptable for Past Performance.

In accordance with FAR 12.203(a)(2), the Government will also consider information from other sources, including references and other available government databases (e.g., Contractor Performance Assessment Reporting System (CPARS), System for Award Management (SAM)Responsibility/Qualification (formally the Federal Awardee Performance and Integrity Information System (FAPIIS), Supplier Performance Risk System (SPRS), Electronic Data Access (EDA), etc.) as part of the past performance evaluation.

Price.

- The Quoter shall provide pricing for all line items (to include optional CLINs) and a total contract price (all line items).

- The Quoter shall provide acknowledgement of any amendments.

- The proposed price will be evaluated by the Government and must be determined to be fair and reasonable for award.

Other Administrative Instructions.

- The Quoter shall complete and submit DFAR Provision 252.204-7017 [Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services-Representation].

- Contractors must be registered in the System for Award Management (SAM) database at time of award. Registration is free and can be completed on-line at

.https://sam.gov/

FAR Clauses Incorporated by Reference

HT942726QE005

https://sam.gov/

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation.

Jan 2017

52.204-7 System for Award Management-Registration. (Deviation 2026-O0038) Feb 2026 52.212-1 Instructions to Offerors-Commercial Products and Commercial Services. (Deviation 2026-O0038) Feb 2026

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.204-7024 Notice on the Use of the Supplier Performance Risk System. Mar 2023

Evaluation Factors for Award

Award of this purchase order will be made on a competitive best value basis, using "best value tradeoff" among price and non-price factors. The Government may elect to award to other than the lowest priced Quoter, or other than the Quoter with the highest rated non-price quote. Past Performance will be evaluated independently from the other non-price evaluation factors using different standards identified herein.

The evaluation factors are:

- Evaluation Factor I - Technical Capabilities/Specifications

- Evaluation Factor II - Risk Management Framework

- Evaluation Factor III - Past Performance

- Evaluation Factor IV - Price

The evaluation factors are in descending order of importance and when combined are more important than Past Performance. Past Performance is more important than Price. The non-price factors are collectively more important than price. As the collective non-price factors begin to reach equality in the evaluation, price becomes a more important factor in the tradeoff analysis.

Each individual factor shall be rated individually. If any of the factors receive an individual rating of "Unacceptable," the collective overall Factor rating will also be "Unacceptable." Only quotes receiving an overall Factor rating of "Acceptable" or higher will be considered for award. In addition, pricing that is not found fair and/ or reasonable will not be considered for award.

Government evaluators will not assume that the Quoter possesses any capability or knowledge unless it is specified in the quote.

Evaluation Criteria.

Evaluation Factor I - Technical Capabilities/Specifications The Technical Capabilities/Specifications are a combination of Critical Operational Device Specifications (CODS) and the Critical Logistical Specifications (CLS) characteristics. The quote shall be evaluated to determine if the proposed Surgical Sterilizer meets the minimum required Critical Operational Device Specifications and Critical Logistical Specifications. If evaluated as "acceptable," the quote will then be evaluated to determine if the proposed Surgical Sterilizer meets any of the Desired Operational and Logistical Characteristics, and Additional Performance Parameters. The Desired Operational and Logistical Characteristics are more important than Additional Performance Parameters.

Evaluation Factor II - Risk Management Framework The Medical Device and Equipment Risk Assessment (MDERA) shall be evaluated for completeness.

Evaluation Factor III - Past Performance Past Performance shall be evaluated in accordance with FAR 12.203(a)(2) and will assess the Quoter's record of successful and timely performance on recent, relevant contracts.

NOTE: In accordance with DFARS 252.204-7024, the Government will consider Supplier Performance Risk System (SPRS) risk assessments, if available, in the evaluation of a supplier's quotation or offer and to consider SPRS supplier risk assessments when determining contractor responsibility.

Evaluation Factor IV - Price Price will not be scored or rated. Evaluation of price will be performed in accordance with FAR 12.204(a). Through these techniques the Government will determine whether prices are reasonable. In as much as the best value offer will be determined through tradeoff analysis, the Government is not bound to award to the lowest evaluated price. On the other hand, if the Government determines that a higher rated proposal offers value-added features butat an unreasonable/unjustifiable incremental amount, it is not bound to award to a higher technically rated quote.

- Reasonableness: The degree to which the Quoter's total proposed price represents a fair and reasonable price.

- Completeness: Quoter has included pricing for all line items (to include options) and a total contract price (all line items), registered in SAM at time of award, and acknowledgement of all amendments.

- Options: The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful Quoter within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.