NOTICE OF INTENT to Sole Source.pdf

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: NIMH25004881

2. TITLE: One Year Tecniplast/IWT Cagewash Equipment

3. CLASSIFICATION CODE:J066 – Maintenance, Repair and Rebuilding of Equipment: Instruments and Laboratory Equipment

NAICS CODE: 811210 – Electronic and Precision Equipment Repair and Maintenance

4. RESPONSE DATE: August 19, 2025, at 12:00 PM EST

5. PRIMARY POINT OF CONTACT:

Joe Kennedy Joseph.kennedy@nih.gov Phone: 262-391-7630

6. DESCRIPTION:

INTRODUCTION

This is a notice of intent, not a request for a quotation.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR

OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Mental Health (NIMH) intends to negotiate on a sole source basis with Tecniplast USA Inc., for one year.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

and SET ASIDE STATUS

The intended procurement is classified under NAICS code 811210 – Electronic and Precision Equipment Repair and Maintenance with a Size Standard of $34M.

This intended procurement will be a small business set-aside requirement.

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization).

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) Number 2025-04, dated May 12, 2025.

DESCRIPTION OF REQUIREMENT

Purchase Description

The Animal Health Care Section (AHCS) has a need for a comprehensive multi-year service agreement to provide parts and technical services on six (6) cage and bottle processing machines located in the Building 35 Shared Animal Facility (SAF). Regular service and preventive maintenance is essential in order to keep these machines operational so that daily and weekly cage processing requirements are achieved. These six (6) cage and bottle processing machines were manufactured and installed by Tecniplast/IWT. The mechanical design and software control of these machines is proprietary, and can only be serviced by factory-trained service personnel. The AHCS is therefore requesting a sole source award to Tecniplast USA.

Specific Requirements

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life and reduce illness and disability.

The National Institutes of Health is comprised of 27 Institutes and Centers. The

National Institute of Neurological Disorders and Stroke (NINDS), is one of those member institutes. The NINDS mission is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

The Porter Neuroscience Research Center (PNRC) is located in Building 35/35A, on the Bethesda, Maryland campus. In this unique research setting, principal investigators from ten (10) NIH institutes and centers collaborate on neuroscience research.

A key component to the important and ongoing neuroscience research conducted in the PNRC/Building 35/35A, is the basement-level vivarium. This vivarium is utilized to house rodents approved for use in many of the neuroscience research protocols. Since this vivarium is shared and available for use by the collaborating institutes and centers, the vivarium is commonly referred to as a Shared Animal

Facility (SAF). NINDS is considered the “lead institute” in the PNRC/Building

35/35A SAF. The Animal Health and Care Section (AHCS) is a component of

NINDS, which is tasked with providing veterinary care, management, and oversight responsibilities for SAF.

The PNRC SAF, located in Building 35/35A, contains approximately 62,885 gross square feet, of which there is approximately 26,367 square feet of animal holding space, and approximately 20,615 square feet of dedicated cage and water bottle processing space. The SAF has an overall capacity of ~25,000 rodent cages.

The building 35/35A SAF is accredited by the Association for Assessment and

Accreditation of Laboratory Animal Care International (AAALAC). Every three years AAALAC reviews the animal program in the building 35/35A SAF. The triennial review consists of a site visit whereby multiple experts in laboratory animal care selected by AAALAC walk through the facilities and examine animal welfare, animal husbandry practices, experimental protocols and standard operating procedures. The AAALAC site visitors utilize the Guide for the Care and Use of

Laboratory Animals, 8th Edition as a reference for their site visit evaluation. 2024 was the most recent AAALAC site visit. As a result of the 2024 site visit, AAALAC recommended that the building 35 Shared Animal Facility retain its accreditation.

One of the criteria for maintaining accreditation, and to reduce experimental variables in study protocols, is the ability for the building 35/35A SAF to effectively and efficiently clean and process large volumes of soiled animal caging and water bottles on a daily and weekly basis. The building 35/35A SAF is, therefore, dependent upon the washing and processing equipment located in the central cage wash facility. This equipment must work each and every day with minimal downtime in order to meet the facility’s daily cage changing schedule, sanitation requirements, and compliance with regulatory authorities. When the equipment is not functional, due to breakdown or lack of factory-authorized preventive maintenance, there is the potential for placing animal welfare and experimental protocols at risk. The health and safety of contract employees working in the cage and water bottle processing area can also be placed at risk when the equipment is not functional since soiled caging and water bottles will need to be processed manually. Manual processing of soiled caging and water bottles has the potential to expose contract employees to allergens, scalding water, slip hazards, and a variety of twisting, turning, and repetitive motion hazards.

Salient Characteristics:

Equipment Description Equipment Model/Type

Equipment Serial #

Installation Year

Manufact urer’s

Warranty Status

IWT Tunnel Washer #1 9LATUN 011135 2010 Expir ed

IWT Tunnel Washer #2 9LATUN 011136 2010 Expir ed

IWT Tunnel Washer #3 9LATUN 011165 2013 Expir ed

IWT Rack Washer #1 Atlantis EVO 931333 2021 Expir ed

IWT Rack Washer #2 9LAV9 901469 2013 Expir ed

IWT P-Line Automated Bottle Processing System

9P000 581178 2024 Unde r

Warr anty

The equipment listed in the schedule above is located in the Building 35/35A

Shared Animal Facility (SAF) Central Cage Wash Facility, Rooms 35/BB-103A, 35/BBC-104, 35A/BE-731A, and 35A/BE-731B. This equipment is non-decaled, and is considered fixed equipment to the building. Each piece of equipment is hard-connected to building utilities, including medium pressure steam, softened hot water, 480 VAC 3 phase and 120 VAC single phase power, sanitary drain lines, and laboratory-grade compressed air. This equipment has been under warranty or under continuous service agreement by the equipment manufacturer

(Tecniplast/IWT) since the equipment was installed. The contractor may, therefore, assume that each piece of equipment has been properly serviced and maintained and will not need significant repair, adjustment, or replacement parts prior to the commencement of this multi-year service agreement.

Period of Performance

The proposed period of performance shall be one base year.

Base: 9/1/2025 – 8/31/2026

Level of Effort n/a

Government Responsibilities

Work will be performed at NIH Main Campus, a government owned facility at 9000

Rockville Pike, 35 Convent Drive, Bldg. 35/35A, Central Cage Wash Facility, Bethesda, MD. The government designates the work to be performed on-site.

The government will evaluate the performance under this contract in accordance with performance metrics collected, maintained, and analyzed by the government.

If the government deems that the contractor has met the service expectations under the agreement for the current year, the government may exercise its option to renew the service agreement for the following year. The government will provide

60 days’ notice to the contractor of the government’s intent to exercise its option for the next year.

REPORTING REQUIREMENTS

Service Documentation

Equipment service documentation detailing equipment operation shall be collected by the contractor and made readily available on an as required basis by the government. Reports regarding service or PM visits shall be sent to the government within 24 hours of the completion of a Level 1 or Level 2 Support visit or within 24 hours of the completion of a

PM service. Hard copies of all service and PM service reports will be accepted by the government at the completion of the service. Only the project officer representing the government or the project officer’s designee will sign the service report acknowledging receipt.

Deliverables/Performance Reports

Quality Performance Reports go to the COR/PO. Content influences invoice payments per the “ATTACHMENT 1 to SOW Tecniplast Deliverables Chart for Performance

Reports”. A Quality Performance Report to the COR/PO stating performances have risen to or above Acceptable levels prompts a positive payment response.

Contractor shall submit, as part of the Proposal, a Quality Assurance Plan (QAP) that becomes the basis of the government’s Quality Assurance Surveillance Plan (QASP). The

QASP details the Quality Assurance Monitoring standards. Contractor shall manage the contract in accordance with the standards found in “ATTACHMENT 1 to SOW Tecniplast

Deliverables Chart for Performance Reports”. Standards are found below:

Item # Service

Element Standard of Work to be Observed Venue/Format

Due to

Gove rnme nt

1a Parts

Consumable Parts: Equipment maintenance, repair and replacement parts delivered same day.

To Government’s facility

Same day as event

1b Parts

Non-Stock Parts: Equipment maintenance, repair and replacement parts delivered within 24 hours.

To Government’s facility

Hours from date of event

2 PM service Preventive Maintenance service visits for all covered machines

To Government’s facility

Accor ding to sched ule descri bed in

SOW

Level 1 repair service

Telephone consult for government-reported problems

To Government’s facility

Withi n 1 hour of reque st for servic e

Level 2 repair service

Qualified service provider on site to fix problems not resolved by

Level 1 service

To Government’s facility

Withi n 4 hours of escal ation to

Level

OTHER CONSIDERATIONS

Travel:

The contractor shall be responsible for making all travel arrangements for its representatives. The contractor shall be responsible for all travel-related costs incurred under this contract.

Key Personnel:

Experience. The contractor must have documented 3 years of experience performing a service contract for cage and bottle processing equipment similar to the equipment listed in the Equipment Description chart above (tunnel washers, rack washers, and automated bottle processing equipment). Additionally, the contractor must be able to document that their field service personnel, telephone service personnel and sub-contractors have the required proficiency in the following relevant technologies and protocols:

a) Gantry/indexing robotics

b) Process control software and hardware utilizing HMI (Human Machine Interface) controllers and PLC (Programmable Logic Controllers)

c) Wi-Fi and Ethernet networking

d) Hot and cold water plumbing systems utilizing domestic cold water and domestic hot water

e) Medium pressure steam (MPS)

f) Heat exchangers utilizing MPS to heat domestic hot water to temperatures approximating 180 degrees Fahrenheit

g) Field welding and field passivation of stainless steel

h) Pneumatic and solenoid controls

i) Electrical and electric motor systems, including 480 VAC 3 phase and 120 VAC single phase applications

j) Variable Frequency Drive (VFD) electric motors

k) Laboratory grade compressed air systems

l) Control sensors

m) Chemical dosing systems which control and monitor dosing of detergents, acid de-scaling, and acid neutralization

The government may permit the contractor to utilize sub-contractor providers on a limited, case-by-case basis for such repairs as welding. The government may also permit the contractor to utilize qualified sub-contractor providers to perform work under this contract if the contractor cannot meet the expected arrival times described under Level 2 Support

(above). The government expects that any sub-contractor providers utilized to repair, adjust, calibrate, or troubleshoot the equipment listed in this agreement must either work under the direct supervision of a qualified service technician that is an employee of the contractor, or have technical proficiency in the 13 items (a thru m) listed above that are pertinent to the repair. The contractor will be held responsible for all work performed under this service agreement whether the work is performed by employees of the contractor or assigned to sub-contractor providers. The contractor will also be held responsible for any damage to government equipment that results from the work performed by sub-contractor providers.

References. To do their part in retaining NIH/NINDS’s accreditation, contractor shall perform in accordance with the AAALAC accreditation requirements, and regulations and guidelines as found in the Guide for the Care and Use of Laboratory Animals; 8th Edition.

Information System Security Plan:

Contractor employees shall have no access to government data or networks. Contractor employees shall display NIH/NINDS Security Clearance badges, obtained by the contractor from the NIH security office and worn, face out, above the waist by the contractor employees.

Data Rights:

N/A

Section 508—Electronic and Information Technology Standards:

Publications and Publicity:

Confidentiality of Information:

(INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted.

Specifically, Tecniplast USA Inc. is the only vendor in the marketplace that can provide the services required by the National Institute of Health.

The intended source is:

Tecniplast USA Inc.

1345 Enterprise Drive

West Chester PA 19380

Tecniplast USA is the only qualified vendor to provide preventive and ongoing maintenance and training for the equipment currently installed in the building 35 SAF Tecniplast USA is the manufacturer of all of the equipment listed in the SOW. This equipment was installed in several phases into the building 35/35A Shared Animal Facility between 2010 and 2024. The equipment and the software that controls this equipment is proprietary and Tecniplast USA does not authorize or train third parties to maintain their machines. Additionally, as the manufacturer and sole provider of its equipment, Tecniplast USA has sole access to repair parts and highly trained service engineers with specialized knowledge on their machines’ maintenance and operational needs.

CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID UEI), the Taxpayer Identification Number (TIN), and the certification of business size.

Responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH25004881.

Responses must be submitted electronically to Joe Kennedy, Contract Specialist, at joseph.kennedy@nih.gov

U.S. Mail and fax responses will not be accepted.

mailto:joseph.kennedy@nih.gov