Autoclave-LegalNoticeUpdate1-13-25.docx

STATE OF WASHINGTON

Department of Agriculture

SOLE SOURCE POSTING

January 10, 2025

The Washington State Department of Agriculture (WSDA) contemplates awarding a sole source contract to STERIS Corporation to provide three AMSCO 250 LS small steam sterilizers as well as include the installation, maintenance, and accreditation of the machines. STERIS Corporation will also include removal of current non-functional autoclave machines.

WSDA’s microbiology lab requires the AMSCO 250 LS small steam sterilizer to meet the stringent standards outlined in our federal cooperative agreements with the FDA and USDA. The STERIS Corporation is the sole factory-authorized supplier of parts, service, and maintenance for the equipment they manufacture, including the AMSCO 250 LS model.

STERIS uniquely qualified to fulfill our lab’s requirements due to several critical factors:

1. Manufacturing Expertise: As the manufacturer of the AMSCO 250 LS small steam sterilizer, STERIS ensures the highest level of compatibility and reliability with their equipment.

2. Comprehensive Services: STERIS is capable of installing the equipment, performing routine maintenance, and addressing any required repairs. This all-inclusive service capability is essential to maintaining the functionality and compliance of the sterilizer.

3. Accreditation Support: To comply with our federal cooperative agreements, the autoclaves must undergo three separate accreditation processes. STERIS has the qualifications and expertise to meet these accreditation standards, ensuring the equipment’s performance aligns with federal expectations. The three accreditation processes are:

Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) All three processes are required to produce consistent high quality lab analyses that meet the standards set by our partners at the FDA and USDA. For additional details please see A Basic Guide to IQ, OQ, PQ in FDA-Regulated Industries.

4. Rapid Response Times: Our federal cooperative agreements mandate a 24-hour turnaround for equipment repairs to minimize disruptions in lab operations. STERIS Corporation is uniquely positioned to meet this requirement, providing prompt and reliable service in the event of equipment breakdowns.

In summary, STERIS Corporation is the only supplier capable of manufacturing, installing, maintaining, and accrediting the AMSCO 250 LS small steam sterilizer to meet the lab’s operational needs and federal cooperative agreement requirements. For these reasons, we feel confident STERIS Corporation meets the requirements for a sole source.

WSDA will enter into a TWO (2) YEAR contract with Steris Corporation. The contract will be issued on or after February 3, 2025 and will continue for a TWO year initial term. The cost of this TWO year contract is $379,062.75. WSDA may opt to extend the contract for an additional THREE (3) times in ONE (1) YEAR INCREMENTS if required. WSDA determines that each optional additional ONE YEAR EXTENSION would result in equal (and/or slightly higher) service and maintenance costs being added to the contract value.

Offerors contemplating the above requirements are required to submit capability statements detailing their ability to meet the state’s requirements within ten (10) working days of this announcement.

Vendor capability statements should address how they are qualified and capable of performing the following requirements:

· Contractor must demonstrate that they are able to provide the service requirements for the AMSCO 250 LS steam sterilizers as required within the WSDA’s federal cooperative agreements;

· Contractor must demonstrate that they are able to fulfill all three accreditation requirements (IQ, OQ and PQ);

· Contractor must demonstrate that they are able to be on-site at the microbiology lab in Tumwater, WA and make a reasonable effort to have the autoclave’s repaired all within a 24-hour time period.

In the absence of other capable sources, it is the state’s intent to make a sole source award of the contract. To submit capability statements or for questions, contact:

Name: Laura Holmes Phone: 360.801.7895 Email: laura.holmes@agr.wa.gov image1.png