Autoclave-SoleSourceContractJustification.docx

Sole Source CONTRACT Filing Steris Autoclaves

Use the following justification template for preparing to file sole source contracts in the Sole Source Contracts Database (SSCD). Once completed, copy and paste the answers into the corresponding SSCD question and answer fields. You will also need to include a copy of this completed form in the documents you post to your agency website and in WEBS.

What is a sole source contract?

"Sole source" means a contractor providing goods or services of such a unique nature or sole availability that the contractor is clearly and justifiably the only practicable source to provide the goods or services. (RCW 39.26.010)

Unique qualifications or services are those which are highly specialized or one-of-a-kind.

Other factors which may be considered include past performance, cost-effectiveness (learning curve), and/or follow-up nature of the required goods and/or services. Past performance alone does not provide adequate justification for a sole source contract. Time constraints may be considered as a contributing factor in a sole source justification, however will not be on its own a sufficient justification.

Why is a sole source justification required?

The State of Washington, by policy and law, believes competition is the best strategy to obtain the best value for the goods and services it purchases, and to ensure that all interested vendors have a fair and transparent opportunity to sell goods and services to the state.

A sole source contract does not benefit from competition. Thus the state, through RCW 39.26.010, has determined it is important to evaluate whether the conditions, costs and risks related to the proposal of a sole source contract truly outweigh forgoing the benefits of a competitive contract.

Providing compelling answers to the following questions will facilitate DES’ evaluation.

Specific Problem or Need

· What is the business need or problem that requires this contract?

· The Washington State Department of Agriculture’s Microbiology Laboratory (lab) plays a vital role in providing analytical support and data to state regulatory agencies, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the broader agricultural community. The lab is currently in need of replacement autoclaves. The original autoclaves that were installed at the lab did not meet specifications are were insufficient to meet standards. These new autoclaves are essential for the lab’s decontamination and sterilization processes, which are critical for accurately identifying potential foodborne pathogens. Additionally, the lab maintains federal cooperative agreements with the FDA and USDA that require adherence to specific standards to secure crucial federal funding. Along with replacement of the equipment, the lab is required by cooperative agreement to obtain three (3) separate accreditations on the equipment as well as a 24-hour service turnaround should the machine break down or stop working.

Sole Source Criteria

· Describe the unique features, qualifications, abilities or expertise of the contractor proposed for this sole source contract.

a. WSDA’s microbiology lab requires the AMSCO 250 LS small steam autoclave 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 is 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 service or repairs within 24 hours. This all-inclusive service capability is essential to maintaining the functionality and compliance of the autoclaves.

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

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.

· What kind of market research did the agency conduct to conclude that alternative sources were inappropriate or unavailable? Provide a narrative description of the agency’s due diligence in determining the basis for the sole source contract, including methods used by the agency to conduct a review of available sources. Use DES’ Market Research Template if assistance is needed.

· WSDA conducted thorough market research to identify potential alternative sources for the required autoclaves to meet the needs of the microbiology lab. This research included an evaluation of manufacturers, service providers, and equipment options capable of complying with the lab’s federal cooperative agreement requirements. However, the analysis determined that no alternative suppliers could meet the combined needs for manufacturing, installation, maintenance, accreditation, and 24-hour repair turnaround required by the lab. As a result, it was concluded that alternative sources are unavailable to fulfill these critical operational and compliance requirements.

· As part of the market research requirements, include a list of statewide contracts reviewed and/or businesses contacted, date of contact, method of contact (telephone, mail, e-mail, other), and documentation demonstrating an explanation of why those businesses could not or would not, under any circumstances, perform the contract; or an explanation of why the agency has determined that no businesses other than the prospective contractor can perform the contract.

· WSDA reviewed contract #20722. Through review of the businesses included on the contract it was determined that Fisher Scientific Company was the only company that offered the specific AMSCO 250 LS small steam sterilizer model. WSDA staff reached out to Fisher Scientific Company via telephone in November, 2024 to determine whether they would be able to meet the specific, unique requirements of our lab. Fisher determined they are a certified seller of the AMSCO model and that is the only service they are able to provide. They do not offer installation, maintenance, repair or accreditation services, all of which are critical to this contract.

· Per the Supplier Diversity Policy, DES-090-06: was this purchase included in the agency’s forecasted needs report?

· Yes, in compliance with DES policy we did include this purchase on our forecasted needs report.

· Describe what targeted industry outreach was completed to locate small and/or veteran-owned businesses to meet the agency’s need?

a. Due to the specificity of this purchase, we determined through website searches as well as experience from purchasing other laboratory equipment in the past, that there are no small and/or veteran owned businesses who are able to meet the needs.

· What considerations were given to unbundling the goods and/or services in this contract, which would provide opportunities for Washington small, diverse, and/or veteran-owned businesses. Provide a summary of your agency’s unbundling analysis for this contract.

a. WSDA conducted an internal analysis to evaluate whether separating the procurement of goods and services for the AMSCO 250 LS small steam autoclave would provide a cost-effective solution for the lab. The analysis considered sourcing the autoclave equipment, installation, maintenance, accreditation services, and repair separately.

The findings revealed that unbundling these components would significantly increase the total cost by over $70,000. This increase is attributed to higher costs associated with coordinating multiple vendors, potential delays in service, additional administrative expenses, and the inability of alternative vendors to meet federal cooperative agreement requirements for accreditation and 24-hour repair turnaround.

Based on this analysis, WSDA determined that by including the goods and services under a single contract with STERIS Corporation is the most cost-effective and efficient solution to meet the lab’s operational and compliance needs.

· Provide a detailed and compelling description that includes quantification of the costs and risks mitigated by contracting with this contractor (i.e. learning curve, follow-up nature).

a. Contracting with STERIS Corporation for the AMSCO 250 LS small steam sterilizer and associated services mitigates significant costs and operational risks for the WSDA microbiology lab. Below is a detailed assessment of the benefits, including quantifiable cost savings and reduced risks:

i. Cost Savings

1. Avoided Unbundling Costs: The unbundling analysis conducted by WSDA determined that separating the procurement of goods and services would increase costs by over $70,000. This is due to higher administrative overhead, increased vendor coordination costs, and inefficiencies in managing multiple service providers.

2. In addition to the efficiencies above, Steris was able to provide one year’s service free of charge.

3. Integrated Service Efficiencies: By contracting with STERIS, WSDA avoids duplicative costs associated with hiring separate vendors for installation, maintenance, and accreditation, saving an estimated $25,000 in labor and coordination costs.

ii. Operation Risk Mitigation

1. Compliance with Federal Cooperative Agreements: STERIS is uniquely qualified to meet federal accreditation requirements for the AMSCO 250 LS, a mandatory condition for securing federal funding. Failure to meet these requirements could jeopardize cooperative agreements valued at approximately $500,000 to $1M annually.

2. 24-Hour Repair Turnaround: The lab’s operations rely on STERIS’s capability to provide a 24-hour repair response, minimizing downtime and reducing potential productivity losses, which would put the lab in non-compliance with the federal cooperative agreements.

3. Proprietary Expertise: As the sole manufacturer of the AMSCO 250 LS, STERIS ensures the highest standard of service and reliability. Using unauthorized or third-party providers increases the risk of equipment malfunctions, potentially leading to additional repair costs of up to $30,000 annually and further delays.

iii. Long-term Value

1. Equipment Longevity: STERIS’s expertise in maintaining and servicing their proprietary equipment extends the life of the autoclave, reducing the need for premature replacement and saving an estimated $50,000 over a 10-year period.

2. Accreditation Assurance: STERIS’s ability to support the lab through three mandatory accreditation processes avoids the risk of non-compliance, which could result in significant operational interruptions and loss of funding.

By contracting with STERIS Corporation, WSDA ensures cost efficiency, operations continuity, and compliance with federal cooperative agreements. The integrated services and rapid response capabilities provided by STERIS reduce risks, enhance productivity, and safeguard critical federal funding streams, making this contract essential to the success of the Microbiology Lab’s mission.

· Is the agency proposing this sole source contract because of special circumstances such as confidential investigations, copyright restrictions, etc.? If so, please describe.

a. No. This sole source contract is being proposed in order to ensure that WSDA’s microbiology lab has the equipment and resources available to continue their important mission and work ensuring our state’s food supply is safe.

· Is the agency proposing this sole source contract because of unavoidable, critical time delays or issues that prevented the agency from completing this acquisition using a competitive process? If so, please describe. For example, if time constraints are applicable, identify when the agency was on notice of the need for the goods and/or service, the entity that imposed the constraints, explain the authority of that entity to impose them, and provide the timelines within which work must be accomplished.

a. N/A

· What are the consequences of not having this sole source filing approved? Describe in detail the impact to the agency and to services it provides if this sole source filing is not approved.

a. Failure to approve this sole source filing for the AMSCO 250 LS small steam sterilizer would have significant far-reaching consequences for WSDA and the critical services provided by its microbiology lab. Without access to the necessary equipment and the comprehensive services provided by STERIS Corporation, the lab would face increased operational downtime due to delays in repairs, maintenance, and accreditation processes. This disruption would impede the lab’s ability to conduct timely and accurate testing for foodborne pathogens, directly impacting the state’s regulatory oversight of food safety. Furthermore, non-compliance with federal cooperative agreement requirements, such as the mandatory 24-hour repair turnaround and triple accreditation processes, could jeopardize critical federal funding, valued at approximately $500,000 to $1M annually. The resulting loss of funding would undermine the lab’s ability to maintain essential operations, leading to diminished support for state regulatory agencies, the agricultural community, and public health initiatives. Ultimately, the inability to provide these services would pose a significant risk to public health and safety, as the lab’s role in identifying and mitigating foodborne illness outbreaks would be severely compromised.

Sole Source Posting

· Sole Source Posting on Agency Website - Provide the date in which the sole source posting, the draft contract, and a copy of the Sole Source Contract Justification Template were published on your agency’s website.

· Posted on WSDA internet January 10, 2025

· Provide the date in which the sole source posting, the draft contract, and a copy of the Sole Source Contract Justification Template were published in WEBS.

Posted on WEBS January 10, 2025

· Were responses received to the sole source posting in WEBS?

WSDA will advise DES if we receive any response to the ads.

Reasonableness of Cost

· Since competition was not used as the means for procurement, how did the agency conclude that the costs, fees, or rates negotiated are fair and reasonable? Please make a comparison with comparable contracts, use the results of a market survey, or employ some other appropriate means calculated to make such a determination.

WSDA determined through market analysis and review of other autoclave manufacturers that the prices quoted by Steris for removal of the old autoclaves, installation, calibration and accreditation of the three new autoclaves, as well as a warranty and two years of service and maintenance, are reasonable and within market range.

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