6515--NX EQ Disinfectors: Liquid Germicide: Flexible Scope (AERs) (VA-25-00025497)

Combined Synopsis/Solicitation Notice

Page 1 of

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.Â

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:

CLIN#

Brand

Part Number

Description

0001

Steris

ADV1007

ADV SU RAP PA 110V W/AIR - AER Plymouth - Advantage Plus

0002

Steris

ADV1008

ADV SU RAP PA 110V NO AIR - AER Plymouth - Advantage Plus

0003

Steris

ADVPT3007

ADV+ PT 120V 30C W/AIR - AER Plymouth - Advantage Pass Thru

0004

Steris

ADVPT3008

ADV+ PT 120V 30C NO AIR - AER Plymouth - Advantage Pass Thru

0005

Steris

67199157

BARCODE, ADV 100-199

0006

Steris

67199158

BARCODE, ADV 200-299

0007

Steris

67199541

BARCODE, ADV 300-399

0008

Steris

67199660

BARCODE, ADV 400-499

0009

Steris

ADV1063

ADV, PRINTER SYSTEM

0010

Steris

40100104

PAPER, ADV PRINTER, 6PK

0011

Steris

72233310

WALL MOUNT BRACKET

0012

Steris

78400915

ASSY, HOOKUP STORAGE RACK

0013

Steris

78400931

ASSY, HOOKUP RACK, SHORT

0014

Steris

78400924

KIT, INTERCEPT UPTAKE 1G

0015

Steris

78400974

SPILL KIT RAP PA

0016

Steris

ADV1062

ADV, ACTIVE VAPOR MGT

0017

Steris

CAS1000

MODEL CAS-1000 ASSY, CASSETTE, TRANSPORT

0018

Steris

CB120002

BAG, SMALL ACCESSORY 2/PK

0019

Steris

100555

MODEL 100555 UCR ADAPTER [1 EA]

0020

Steris

CLM110HU0108

MODEL CLM-110-HU0108 HOOKUP, ADPTR AIR/WTR

0021

Steris

28001

MODEL 2-8-001 HU ZERO CHANNEL NO LT

0022

Steris

28010

MODEL 2-8-010 ASSY, HOOK-UP, OLYMPUS

0023

Steris

28030

MODEL 2-8-030 ASSY, HOOKUP, PENTAX-0K

0024

Steris

28030HAN

MODEL 2-8-030HAN ASSY, HOOKUP, PENTAX-OK

0025

Steris

28040

MODEL 2-8-040 ASSY, HKUP STORZ 0K

0026

Steris

28040HAN

MODEL 2-8-040HAN ASSY, HKUP STORZ 0K

0027

Steris

28112

MODEL 2-8-112 ASSY, HOOKUP OLMPUS 1K

0028

Steris

28112HAN

MODEL 2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K

0029

Steris

28210

MODEL 2-8-210 ASSY, HOOK-UP OLYMPUS 2K

0030

Steris

28218

MODEL 2-8-218 ASSY HOOKUP OLY 2K

0031

Steris

28245HAN

MODEL 2-8-245HAN ASSY, HOOKUP, STORZ-2K

0032

Steris

28335HAN

MODEL 2-8-335HAN ASSY, HOOKUP, OLYMPUS

0033

Steris

28437HAN

MODEL 2-8-437HAN ASSY, HOOK-UP, PENTAX

0034

Steris

28511

MODEL 2-8-511 ASSY, HOOK-UP, OLY

0035

Steris

28511HAN

MODEL 2-8-511HAN ASSY, HOOK-UP, OLY

0036

Steris

28537HAN

MODEL 2-8-537HAN ASSY HKUP, PTX90 4K+JET

0037

Steris

28611

MODEL 2-8-611 ASSY, HOOK-UP, OLY

0038

Steris

28611HAN

MODEL 2-8-611HAN ASSY, HOOK-UP, OLY

0039

Steris

28617HAN

MODEL 2-8-617HAN ASSY, HKUP, OLY 2 BIOPSY

0040

Steris

28619

MODEL 2-8-619 ASSY HU 140 W/MH-974

0041

Steris

28711

MODEL 2-8-711 ASSY, HOOKUP, OLYMPUS 5K

0042

Steris

28711HAN

MODEL 2-8-711HAN ASSY, HOOKUP, OLYMPUS-5K

0043

Steris

28718HAN

MODEL 2-8-718HAN ASSY, HOOK-UP, OLY 160/180

0044

Steris

28753

MODEL 2-8-753 ASSEMBLY, HOOKUP, OLY-4K

0045

Steris

28811

MODEL 2-8-811 ASSY HKUP OLY-ECHO+LIFT

0046

Steris

28901

MODEL 2-8-901 KIT TEE/TOE/RUS HU ADV+

0047

Steris

58010

MODEL 5-8-010 ASSY, HOOKUP DBL LT

0048

Steris

58030HAN

MODEL 5-8-030HAN ASSY, HOOKUP

0049

Steris

58040HAN

MODEL 5-8-040HAN ASSY HOOKUP STORZ OK DBL

0050

Steris

58050HAN

MODEL 5-8-050HAN ASSY, HOOKUP, DILATOR

0051

Steris

58112

MODEL 5-8-112 ASSY, HOOKUP 2-SCOPE 1-K

0052

Steris

INS1004

INSTALL, ADVANTAGE PLUS BUSINESS DAY

0053

Steris

INS1005

INSTALL, ADVANTAGE PLUS NON-BUSINESS DAY

0054

Steris

INS1015

INSTALL, ADV-PASS THRU BUSINESS DAY

0055

Steris

INS1016

INSTALL, ADV-PASS THRU NON-BUSINESS DAY

0056

Steris

SE2000121

DEINSTALL ADVANTAGE PLUS

0057

Steris

SE2000221

DEINSTALL ADVANTAGE PASS THRU

0058

Steris

SE2000900071

DISPOSAL OF AER

0059

Steris

SE20001696

ADVANTAGE TRAINING - 1 PRODUCT (PER STUDENT)

0060

Steris

SE20002696

ADV PASS-THRU - 1 PRODUCT (PER STUDENT)

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:

SC #

Salient Characteristics

Method of Evaluation

SC Literature Map

SC 1

The unit should be a floor configuration that must be capable of efficiently cleaning and high-level disinfection (HLD) of all major brand endoscopes.

Literature Review

Brand Name:

Page #:Â

SC 2

The unit must have visual and/or audible alarms to alert the user if there is a problem with the cycle or when the reprocessor requires maintenance (i.e. filter changes, etc.)

Literature Review

Brand Name:

Page #:Â

SC 3

The unit must have automated leak detection capabilities.

Literature Review

Brand Name:

Page #:Â

SC 4

The unit must have the ability to electronically document, at a minimum: cycle parameters, times, and dates.

Literature Review

Brand Name:

Page #:Â

SC 5

The unit must be FDA approved for sale in the U.S.

Literature Review

Brand Name:

Page #:

3. PRODUCT REFRESHÂ Â

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.Â