6259-0 Saladax Sole Source Final.pdf
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- Attached to
- Sole Source Procurement for MyCare Psychiatry Clozapine Assay Kit and Controls from Saladax Biomedic
- Solicitation number
- S-44300-00016822
- Issued by
- Oregon
About this file
This is a Sole Source Procurement Final Justification document for the State of Oregon, specifically for the purchase of MyCare Psychiatry Clozapine Assay Kit and Controls from Saladax Biomedical. The procurement is intended to support Oregon's healthcare operations through the acquisition of specialized laboratory testing equipment and materials. The document outlines the justification for selecting Saladax Biomedical as the sole source vendor, establishing the technical and operational requirements for the clozapine assay kit and associated controls necessary for psychiatric patient monitoring and drug level testing.
The sole source justification identifies Saladax Biomedical as the only vendor capable of meeting the specific technical requirements for the MyCare Psychiatry Clozapine Assay Kit, citing unique product specifications and compatibility requirements that preclude competition. The procurement reflects Oregon's determination that competitive bidding is impracticable due to the proprietary nature of the testing system and its integration with existing laboratory infrastructure. This sole source procurement approach allows Oregon to proceed directly with Saladax Biomedical for the supply of the assay kits and controls needed to maintain uninterrupted psychiatric patient testing capabilities without the delays associated with competitive procurement processes.
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Text version
SOLE-SOURCE DETERMINATION MEMO
FOR SUPPLIES AND SERVICES
Date: May 4, 2026 Sole source number: 6259 | S-44300-00016822
To: Kirk N. Rhoades, Designated Procurement Officer ODHS Office of Contracts & Procurement
Requestor: Sharon Laddusaw Agency/division: Oregon State Hospital, herein after referred to as “Agency” Program/office: Laboratory Contract specialist: Andria Otjen
Agency Sole source rule: Sole source authority:
OHA OAR 137-047-0275 ORS 413.033
Estimated total contract value: $25,000.00 per year
Description of goods or services: MyCare Psychiatry Clozapine Assay Kit and Controls
1. Background: This sole source justification applies to the purchase of:
a) The MyCare Psychiatry Clozapine Assay Kit is an FDA-cleared, homogeneous immunoassay used for the rapid, quantitative measurement of clozapine in human serum and plasma to monitor patient adherence and optimize therapy, with results available in under 30 minutes on automated analyzers.
b) Saladax Biomedical is the sole supplier of MyCare Psychiatry Clozapine Assay Kits including reagent kits, controls, and linearity materials required for Clozapine testing.
c) Agency owns a Siemens Atellica CI 1900 Analyzer which can be used with MyCare Psychiatry Clozapine Assay Kits.
d) Saladax Biomedical is the only manufacturer and supplier of MyCare Psychiatry Clozapine Assay Kit designed to be used with the Siemens Atellica CI 1900 analyzer.
e) Saladax Biomedical does not sell MyCare Psychiatry Clozapine Assay Kit through distributors.
2. Prospective contractor/vendor:
Legal entity name: Saladax Biomedical
DBA:
Address: 116 Research Dr., Bethlehem, PA 18015 Contact person: Bryce Etter Phone: 610-419-6731 Email: better@saladax.com
Protests are due by 3:00 PM within seven calendar days after the first date the notice is posted on OregonBuys. Protests must be sent via mail, fax, email, or hand carried to the following address: Protests via telephone will not be accepted.
Oregon Department of Human Services Office of Contracts and Procurement ATTN: Andria Otjen Address: 500 Summer St E03 Phone: (971) 208-4125 Fax: 503-378-4324 Email: ANDRIA.OTJEN@odhsoha.oregon.gov
Agency reserves the right to purchase additional goods, include assay support, quality control material, linearity material (unless available on DAS price agreement), services and training for 10 years from date of Sole Source Notice.
3. Written findings of fact (market research):
The findings below must include factual information supporting the determination that meet the sole source requirement in statute.
Pursuant to ORS 279B.075, Agency must conduct market research that supports the assertion that there is only one source that can provide the goods or services. Market research includes utilization of the internet, trade journals, agency vendor lists, professional organizations, studies, catalogs/industrial periodicals, vendor sources, yellow pages, etc.
Agency must select at least one of the findings and prepare the determination as it specifically relates to the good or service being procured. More than one finding can be addressed. The findings are as follows:
Pursuant to ORS 279B.075 (2)(a): Provide findings supporting the determination that the efficient utilization of existing goods requires the acquisition of compatible goods or services from only one source. Saladax Biomedical is the sole supplier of MyCare Psychiatry Clozapine Assay Kit. See Attachment 1 for letter from Saladax Biomedical confirming they are the sole suppliers of MyCare Psychiatry Clozapine Assay Kit.
or Pursuant to ORS 279B.075 (2)(b): Provide findings supporting the determination that the goods or services required for the exchange of software or data with other public or private agencies are available from only one source.
or Pursuant to ORS 279B.075 (2)(c): Provide findings supporting the determination that the goods or services are for use in a pilot or an experimental project.
or
Pursuant to ORS 279B.075 (2)(d): Any other findings that support the conclusion that the goods or services are available from only one source.
APPROVED:
By:
Signed by DPO electronically via OregonBuys Kirk N. Rhoades or acting DPO
Attachment A
| 6259-0 Saladax Sole Source |
| 6259-0 Sole Source confirmation |
File details come from the government source that posted it. Updated .