Illumina MiniSeq SoleSourceJustification.docx

Sole Source CONTRACT Filing Justification Template

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 at the location required 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 the evaluation.

Specific Problem or Need

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

Washington State Public Health Laboratories (WA PHL) has been exploring methods for next generation sequencing (NGS) since 2012. The recent expansion for sequencing from environmental samples has created a need for an additional instrument to help alleviate workflow issues from clinical samples and make a more flexible capacity for the NGS program. Illumina holds all patent rights to their instrumentation and reagents. Illumina is the sole manufacturer and source of the Illumina gene sequencing products currently used by the public health laboratory.

Sole Source Criteria

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

Illumina is a leading developer, manufacturer, and marketer of life science tools and integrated systems for large-scale analysis of genetic variation and function. Illumina places a high value on collaborative interactions, rapid delivery of solutions, and meeting the needs of their customers. Illumina was founded in 1998 and is now serving institutions in over 140 countries. Illumina’s innovative sequencing and array technologies are fueling groundbreaking advancements in life science research, translational and consumer genomics, and molecular diagnostics. Public Health Laboratories across the united states rely on the Illumina platform. Maintaining this instrument at the PHL is essential to ensure our lab is able to participate in national disease surveillance efforts.

· 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 such as researching trade publications, industry newsletters and the internet; contacting similar service providers; and reviewing statewide pricing trends and/or agreements. Include a list of businesses contacted (if you state that no other businesses were contacted, explain why not), 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.

Currently there are five manufacturers of gene sequencing instruments. Oxford Nanopore, Ion Torrent, Illumina, and PacBio. Illumina has the most cost-effective platform and most importantly has best or lowest error rate in the industry. Illumina has led the market for decades, surpassed only by Ion Torrent for time in market. Ion Torrent has a significant limitation of variable coverage across the entire genome as do the other vendors listed.

· What considerations were given to providing opportunities in this contract for small business, including but not limited to unbundling the goods and/or services acquired.

Illumina holds all patent rights to their instrumentation and reagents. Illumina is the sole manufacturer and source of the Illumina products currently used by the public health laboratory. No small or diverse businesses are able to sell Illumiina products.

· 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).

The NGS program at WA PHL supports whole genome sequencing allowing for numerous genomic qualities, including genotyping of disease-causing organisms, identification of potential antibiotic resistance genes, toxin-producing genes, and analysis of variants and variant evolution. The NGS workflow is rapidly expanding, supporting public health in the areas of viral, fungal, and bacterial disease investigations. Currently the laboratory has three MiSeq, one MiniSeq and two NextSeq instruments. These Illumina instruments have functioned as the backbone of the next generation sequencing (NGS) program here at WA PHL and function in tandem, allowing multiple runs alternating across instruments, creating an adaptive and flexible testing workflow using Illumina technology. This workflow has been disrupted from the recent expansion of sequencing in wastewater samples, which has created delays in turn-around times and increased down time for maintenance and preventative care.

DOH is requesting additional delegation of $63,159.80, which includes: tax, shipping, and handling; $47,025 for the new MiniSeq Instrument, $7,180.20 for 1 year service agreement, $3,056.63 for shipping and $5,897.97 for tax. This request is in addition to the current delegation authority WA-PHL has for Illumina Consumables for $500,000 a year, to be renewed in 2024.

We expect workflows to increase over the next 5 years to include testing for additional wastewater targets (Influenza, respiratory syncytial virus, Mpox, norovirus and antibiotic resistance). We plan to re-evaluate the current Illumina Consumables DA to meet this growth.

While many of the reagents required on these new platforms are Illumina products, they won’t all be, and various vendors can be utilized for sequencing consumables.

As the DOH Public Health Laboratory has over 10 years of experience working with Illumina technology and serves as a regional training center for the western U.S. The risks associated with entering into this agreement with Illumina are exceedingly low. This agreement is to procure and standardize equipment that we already have and are already familiar with which helps to standardized lab protocols and reduce costs from training and developing methods using different instrumentation. This standardization lowers overall cost to the citizen’s of the state.

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

No special circumstances drive this contractual proposal.

· 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.

Acquisition of instruments via a public bid would require a lengthy procurement process as well as validation of new instruments and reagents, both requiring significant financial investments by DOH. Continuing with Illumina platforms will save significant amounts of time, money, and human resource attention.

We are proposing this sole source contract because we need to add an additional piece of equipment from the same manufacturer. This will ensure that the PHL can continue to use tried and true chemistries on equipment that has already been standardized. Which allows PHL to fulfil our mission without delay. Transitioning to a new manufacturer for this work would be cost prohibitive.

· Is the agency proposing this sole source contract because of a geographic limitation? If the proposed contractor is the only source available in the geographical area, state the basis for this conclusion and the rationale for limiting the size of the geographical area selected.

No geographical location constrains this contract proposal.

· 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.

Response to public health threats will be delayed with decreased NGS capacity. During the past decade, many of the federal ELC grant activities were made possible through groundwork achieved using Illumina instruments. Moreover, DOH Public Health Laboratory has become a leader in NGS, recognized by CDC, and awarded the Pathogen Genomics Center of Excellence. If DOH Public Health Laboratory cannot deliver for the ELC and PGCoE grants due to decreased NGS capacity, there will be millions of federal dollars at stake for this and future funding cycles for the WA PHL.

Sole Source Posting

· 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.

· If exempt from posting in WEBS, please provide which exemption.

· If failed to post, please explain why.

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

· If one or more responses are received, list name of entities responding and explain how the agency concluded the contract is appropriate for sole source award.

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.

The list price of the MiniSeq instrument is $49,500. In addition, Illumina is giving 5% discounts for the instrument and 10% discount on a 1-year maintenance support plan. This purchase is in line with previous instrument purchases made in 2023 where the MiniSeq instrument also had a list cost of $49,500.

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