36C10G24R0032 COMBINED SYNOPSIS SOLICITATION - NX EQ WASHER DECONTAMINATION UNITS.docx

Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contract Specialist Trevor Mason Trevor.Mason@va.gov

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

DESCRIPTION

Combined Synopsis/Solicitation Notice

Solicitation Number:

36C10G24R0032 Notice Type:

Combined Synopsis/Solicitation Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with 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; offers are being requested and a written solicitation will not be issued.

Solicitation number 36C10G24R0032 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) 2024-05, dated 22 May 2024.

Requirement Description:

VA has a requirement to purchase Washer/Decontamination Units to deliver patient care at its VA Medical Centers around the country. Washer/Decontamination Units are designed for automatic or semiautomatic washing (i.e., eliminating dirt and/or stains) and physical removal (i.e., physical decontamination) of organic debris such as blood, fat, bone from surgical instruments, reusable respiratory devices (e.g., anesthesia sets), and other critical devices. These units typically consist of a corrosion-resistant chamber containing baskets or trays for the soiled instruments; some can accommodate instrument trays and/or dedicated racks. The equipment performs a cycle of operations typically including water prewash, enzyme treatment, detergent wash, heated rinse, and drying; the process includes mechanical removal of contaminants by water jets and/or ultrasound energy and may include thermal disinfection (usually using water from 60 to 95 degrees Celsius [140 to 203 degrees Fahrenheit]). Surgical instrument washer/decontamination units are frequently used as an adjunct to manual cleaning of surgical instruments before sterilization; they provide some level of disinfection by killing or inactivating several types of microorganisms. They are available in stand-alone and wall-recessed configurations, typically for use in central supplies departments of healthcare facilities.

A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name or Equal in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Offers 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: 6515 – Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1000 employees. This procurement action is issued as full and open.

This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Steris brand name or equal Washer/Decontamination Units and related equipment and accessories as identified in ATTACHMENT A – PRICE COST SCHEDULE - NX EQ WASHER DECONTAMINATION UNITS. All interested companies shall provide a quote for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A – PRICE COST SCHEDULE - NX EQ WASHER DECONTAMINATION UNITS.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price 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 Products and Commercial Services, applies to this acquisition including attached addenda (Attachment D) to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, and the specific evaluation criteria as attached addenda (Attachment D) also applies to this acquisition.

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Products and Commercial Services, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached (Attachment C).

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Products and Commercial Services, 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. Addendum is attached (Attachment C).

An Offeror is required to be registered in SAM when submitting an offer and shall continue to be registered until time of award, during performance, and through final payment of any contract. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 0900 AM EST on September 12, 2024, to Contract Specialist, Trevor Mason at Trevor.Mason@va.gov and Contracting Officer, Sara Vickroy at Sara.Vickroy@va.gov. No calls will be accepted.

Offers are due via email by 0900 AM EST on September 18, 2024, to Contract Specialist, Trevor Mason at Trevor.Mason@va.gov and Contracting Officer, Sara Vickroy at Sara.Vickroy@va.gov.

1. SCOPE OF WORK

The Veterans Health Administration (VHA) Non-Expendable Equipment (NX) National Program has identified the Washer/Decontamination Units product line as a candidate for inclusion in the National Equipment Catalog (NEC). This will be accomplished via the awarding of a VA-wide (otherwise referred to as “national”) single award Requirements contract (BNOEs).

Washer/Decontamination Units are designed for automatic or semiautomatic washing (i.e., eliminating dirt and/or stains) and physical removal (i.e., physical decontamination) of organic debris such as blood, fat, bone from surgical instruments, reusable respiratory devices (e.g., anesthesia sets), and other critical devices. These units typically consist of a corrosion-resistant chamber containing baskets or trays for the soiled instruments; some can accommodate instrument trays and/or dedicated racks. The equipment performs a cycle of operations typically including water prewash, enzyme treatment, detergent wash, heated rinse, and drying; the process includes mechanical removal of contaminants by water jets and/or ultrasound energy and may include thermal disinfection (usually using water from 60 to 95 degrees Celsius [140 to 203 degrees Fahrenheit]). Surgical instrument washer/decontamination units are frequently used as an adjunct to manual cleaning of surgical instruments before sterilization; they provide some level of disinfection by killing or inactivating several types of microorganisms. They are available in stand-alone and wall-recessed configurations, typically for use in central supplies departments of healthcare facilities.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Washer/Decontamination Units to be used by clinicians throughout the VA medical centers and facilities.

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 is being offered as an “equal” product to the Steris Washer/Decontamination Units. 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. Finally, 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.

The Department of Veterans Affairs (VA) is seeking vendors who can provide Steris Brand Name or Equal (BNOE) Washer/Decontamination Units as listed above or equal commodities which meet all the following salient characteristics.

CLIN’s 0001-0012 apply to the following SC’s.

DOCUMENT

TITLE

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Literature Review

Literature Review

In addition to meeting the Salient Characteristics the following sub factors will be evaluated:

· Safety Features and functions of the offered device will be evaluated for the ability to safely wash and decontaminate surgical instruments. Areas may include but are not limited to the following:

· Safety stop push button

· Audible alarms

· Visual alarms

· Safety interlock/lockout features

· Reduce user biohazard risk

· Cycle status indicators

· Design Design features and functions of the offered device will be evaluated. Areas may include but are not limited to the following:

· Automatically add and monitor chemical levels

· Steam or electric heating

· Monitoring and maintaining water temperature

· Visual indicators/control system to assess the status of certain conditions before cycle completion

· Doors

· Size and number of chambers

· Number of baskets/trays

· Touch Screen control system

· Chamber illumination

· Performance Device will be evaluated for its ability to perform its intended function. Areas may include but are not limited to:

· Ease of use

· Ease of Maintenance

· Manual or automatic loading

· At least six cycles (i.e., cold prewash, detergent wash, rinse, distilled-water rinse, rinse/lubricate, and dry).

· Selectable water temperature

· Automatic detergent dispensing

· Number of standard-size (DIN) trays processed per hour

· Quality/Construction Aspect of the construction and quality of material of the device will be evaluated and may include but are not limited to:

· Corrosion-resistant chambers

· Energy efficiency

· Reduce water consumption

· Warranty, installation, training

· Glass window on doors

· Doors

Vendors may offer any product solution or configuration so long as they meet the salient characteristics. Products offered in the technical volume must be captured on the Vendor’s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may offer any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero.

3. INSTALLATION

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.

4. TRAINING

The ordering facility and the vendor/manufacturer will schedule any offered training as established by CLIN. Training mode of delivery and training schedule will be purchased based on facility needs.

5. MAINTENANCE, REPAIRS AND REPLACEMENTS

Instructions and procedures will be provided by the vendor specific to the warranty, maintenance, repairs, and replacement of product and services. At minimum, vendor will propose manufacturer warranty period that may include response time, parts, associated maintenance services and consumables.

6. 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, see attachment XXXXX.

The contractor shall provide the COR and CO 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 IDC 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 Contracting Officer, for review and recommendation of approval to be submitted to the CO. The CO shall prepare a bilateral modification for execution.

7. 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 (CO) at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to CO, Contracting Specialist, Contracting Officer Representative, 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

8. 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) in accordance with 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.

The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this combined synopsis/solicitation.

See attached document: ATTACHMENT A - PRICE COST SCHEDULE - NX EQ WASHER DECONTAMINATION UNITS.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ WASHER DECONTAMINATION UNITS.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ WASHER DECONTAMINATION UNITS.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ WASHER DECONTAMINATION UNITS.

See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ WASHER DECONTAMINATION UNITS.

See attached document: ATTACHMENT F – PAST PERFORMANCE QUESTIONNAIRE - NX EQ WASHER DECONTAMINATION UNITS.

See attached document: ATTACHMENT G – PAST PERFORMANCE QUESTIONNAIRE - NX EQ WASHER DECONTAMINATION UNITS.

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