36C10G25R0018.docx

Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

SET-ASIDE

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contract Specialist Courtney Chattman Courtney.Chattman@va.gov

PLACE OF PERFORMANCE

POSTAL CODE

ADDITIONAL INFORMATION

DESCRIPTION

Combined Synopsis/Solicitation Notice

Solicitation Number:

36C10G25R0018 Notice Type:

Combined Synopsis/Solicitation Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

Solicitation number 36C10G25R0018 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Proposal (RFP). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-03, dated 17 January 2025.

Requirement Description:

The Veterans Health Administration (VHA) Non-Expendable (NX) National Program has identified the Disinfectors: Liquid Germicide: Flexible Scope AERs product line as a candidate for an Enterprise-wide (otherwise referred to as “national”) single Requirements contract award. Disinfectors: Liquid Germicide: Flexible Scope AERs are designed to standardize and automate the preparation of a manually precleaned endoscope so that it is safe for immediate reuse. These units typically use a liquid chemical germicidal agent for reprocessing. AERs can reduce the likelihood that a crucial reprocessing step will be skipped, help ensure that reprocessing is performed consistently using a recommended protocol and reduce personnel exposure to the irritating effects of liquid disinfectants/sterilant. Most AERs provide documentation of the disinfection/sterilization cycle, either in the system's memory or as a hard-copy printout.

A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name or Equal, all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Proposals shall contain the terms for cost/price and technical capabilities of the brand name or equal equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339113 – Surgical Appliance and Supplies Manufacturing, Product Service Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 800 employees. This procurement action is issued as full and open competition.

This acquisition is for a single award Requirements contract with firm-fixed priced (FFP) delivery orders IAW FAR Part 16.5 for Steris brand name or equal Disinfectors and accessories as identified in ATTACHMENT A - PRICE COST SCHEDULE - NX DISINFECTORS. Offerors shall provide a proposal for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A - PRICE COST SCHEDULE - NX DISINFECTORS.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is Free on Board (FOB) destination. FFP Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors – Commercial, applies to this acquisition including attached addenda to the provision (see ATTACHMENT D - SOLICITATION PROVISIONS - NX DISINFECTORS).

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition (see ATTACHMENT D - SOLICITATION PROVISIONS - NX DISINFECTORS).

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with Volume V: Offer, Amendments, and Certifications & Representations of its proposal (see ATTACHMENT D – SOLICITATION PROVISIONS – NX DISINFECTORS).

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached (see ATTACHMENT C - CONTRACT CLAUSES – NX DISINFECTORS).

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition (see ATTACHMENT C - CONTRACT CLAUSES – NX DISINFECTORS).

All interested offerors must be registered in the System for Award Management (SAM) prior to submitting a proposal. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 16:30 CST on April 18, 2025, to Contract Specialist, Courtney Chattman at Courtney.Chattman@va.gov and Contracting Officer, Jessica Edwards at Jessica.Edwards6@va.gov. No questions will be accepted after the due date. No calls will be accepted.

Proposals are due via email by 16:30 PM CST on May 5, 2025, to Contract Specialist, Courtney Chattman at Courtney.Chattman@va.gov and Contracting Officer, Jessica Edwards at Jessica.Edwards6@va.gov.

System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

PRODUCT DESCRIPTION

1. SCOPE OF WORK

The VHA NX National Program has identified the Disinfector: Liquid Germicide: Flexible Scope AER product line as a candidate for inclusion in the National Equipment Catalog (NEC).

Disinfectors: Liquid Germicide: Flexible Scope AERs are designed to standardize and automate the preparation of a manually precleaned endoscope so that it is safe for immediate reuse. These units typically use a liquid chemical germicidal agent for reprocessing. AERs can reduce the likelihood that a crucial reprocessing step will be skipped, help ensure that reprocessing is performed consistently using a recommended protocol and reduce personnel exposure to the irritating effects of liquid disinfectants/sterilant. Most AERs provide documentation of the disinfection/sterilization cycle, either in the system's memory or as a hard-copy printout.

The Offeror must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Disinfectors and accessories to be used by clinicians throughout the VA medical centers and facilities CONUS and OCONUS. The period of performance is for a 12-month base period and four 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal which requires the offeror to indicate that each product being offered as an “equal” product to the Steris® Disinfectors and accessories. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The offeror must also clearly identify the item by brand name (if any) and make/model number. In addition, the offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the contracting officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements. Descriptive literature will be evaluated to determine whether proposed items meet the SCs. Descriptive literature will also be evaluated to assess the strengths, weaknesses, deficiencies, and risks for each technical sub-factor.

The following line-items comprise the Steris Disinfectors and accessories product line:

The VA is seeking offerors who can provide Steris Disinfectors and accessories or equal as listed above which meet all SCs listed below. Offerors may offer any product solution or configuration so long as they meet the SCs.

Offerors may propose an alternative CLIN structure IAW FAR 4.1003 and 4.1004. Offerors may also propose any product solution or configuration so long as they meet the salient characteristics. Products proposed in the technical volume must be appear on and correspond with the Offeror’s pricing volume (Attachment A - Price Cost Schedule - NX Disinfectors).

Offerors may propose any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these ancillary items must be quantified in the Offeror’s pricing volume with an estimated quantity of zero (0).

Only new equipment is acceptable; no remanufactured or "gray market" items. No product in development shall be considered. All items must be covered by the manufacturer's warranty.

Distributors must be authorized distributors/resellers as certified by the Original Equipment Manufacturer (OEM) (i.e., OEM letter dated within 12 months of the solicitation close date and duly signed by OEM’s authorized representative) to be eligible for award. The OEM letter must be valid for the life of the contract. Failure to include the OEM letter with the Offer will render the Offer non-compliant and will not be considered for award.

The following SCs apply to CLINs 0001-0004:

Page #:

Page #:

Page #:

Page #:

Page #:

3. PRODUCT REFRESH

Product refresh is when a current CLIN is no longer being manufactured due to obsolescence and the product item is being replaced with a newer, and more often, a superior version of the same item. The current CLIN product will be revised to reflect the refreshed product information, manufacturer’s part number, IDIQ price (inclusive of Service Level Agreement (SLA) fee), etc.

The Government reserves the right to not accept the products offered under product refresh. The contractor will be notified in writing if a product refresh is not accepted. All products offered shall be provided with the warranty that is agreed upon for this contract.

The contractor agrees to ensure that all upgraded improved/replaced products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements.

The contractor shall provide the Contracting Officer’s Representative (COR) and Contracting Officer the following information for product refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA fee));

(2) Product literature for the item(s) refreshed.

(3) A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added.

(4) Proper identification of any product requirements and/or procedures related to those product(s) proposed to be refreshed or upgraded.

(5) FDA approval, if applicable

(6) Provide historical sales to VA by item(s), if applicable

(7) Copy of Commercial Warranty.

The request shall be submitted to the COR, copy to the Contract Specialist and Contract Officer, for review and recommendation of approval to be submitted to the Contracting Officer. The Contracting Officer shall prepare a bilateral modification for execution.

4. PRODUCT REMOVAL OR RECALL

For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer agrees to take following steps immediately:

Notify the Contracting Officer at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to Contracting Officer, Contracting Specialist, COR, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from customers and the contract number assigned as a result of an issuance on the solicitation;

(2) Reasons for modifications, removal or recall; and

(3) Necessary instructions for return for credit, replacement or corrective action.

A copy of the notification will be provided to:

Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106

5. DELIVERY

The Period of Performance will be from date of award for a base of 12-months with four 12-month option periods. Contractors will be required to deliver Disinfectors and accessories to VHA facilities, CONUS AND OCONUS, IAW the terms and conditions of the contract. Delivery requirements shall be specified under each individual order. All shipments shall be FOB Destination. The contractor must coordinate delivery with the ordering facility point of contact.

6. INSTALLATION

The ordering facility and the Contractor will schedule any required installation, deinstallation, and disposal. When installation is not required, the Contractor shall note if there are instructions for use.

7. TRAINING

The ordering facility and the Contractor will schedule any required training. When training is not required, the Contractor shall note if there are instructions for use.

8. MAINTENANCE, REPAIRS AND REPLACEMENT

The ordering facility and the vendor/manufacturer will schedule any offered installation, deinstallation, and disposal. When there is a need to procure these CLINs, the ordering facility will communicate with the vendor on the schedule and delivery times upon receipt of goods based on facility needs. In some instances when installation is not required, the contractor should note if there are instructions for use.

9. DATA RIGHTS

Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.212. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrink-wrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ) IAW 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.

See attached document: ATTACHMENT A - PRICE COST SCHEDULE - NX DISINFECTORS.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX DISINFECTORS.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX DISINFECTORS.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX DISINFECTORS.

See attached document: ATTACHMENT E - QUARTERLY SALES REPORT - NX DISINFECTORS.

See attached document: ATTACHMENT F - PAST PERFORMANCE REFERENCES - NX DISINFECTORS.

See attached document: ATTACHMENT G - PAST PERFORMANCE QUESTIONAIRE - NX DISINFECTORS.

Page 1 of Page 1 of