S-44300-00011814 sole-source-determination.pdf

SOLE-SOURCE DETERMINATION MEMO

FOR SUPPLIES AND SERVICES

Date: October 9, 2024 Sole source number:

S-44300-00011814

To: Kirk N. Rhoades, Designated Procurement Officer ODHS Office of Contracts & Procurement

Requestor: Eric Gebbie Agency/division: Oregon Health Authority/ Public Health Division, herein after referred to as “Agency” Program/office: Health Security, Preparedness and Response Program Contract specialist: Paul Yakis

Agency Sole source rule: Sole source authority:

OHA OAR 137-047-0275 ORS 413.033

Estimated total contract value: $1,300,000

Description of goods or services: A medical countermeasures redistribution contractor is necessary to secure medical countermeasures access for individuals that reside in Oregon, prevent medical countermeasures losses due to expiration, and redistribute medical countermeasures to providers needed to reach all populations in Oregon.

Medical countermeasures are medicines and medical supplies that can be used to diagnose, prevent, or treat diseases. The purpose of this Contract will establish the necessary services required to receive, store, maintain, redistribute, recover, and otherwise manage time and temperature sensitive medical materials including but not limited to vaccines and therapeutics, collectively the “Services”, critical to both the readiness and active response by the OHA and its partners across the State of Oregon.

Contractor will provide a physical location in Oregon with the ability to manage a broad inventory of medical countermeasures, such as vaccine and other temperature controlled medical materials, as designated by the OHA to meet current threat assessments, event response missions, and maintain or rotate existing medical countermeasure caches as needed for key partners identified by OHA.

1. Background:

Agency proposes a sole source contract with Coldchain Technology Services, LLC (Contractor) to re-instate contract #172124 and execute amendment -4 in order to compensate vendor for services provided since the contract expired in May 11, 2023.

Work continued past the contract termination date. The agency already pursued executing a new price agreement in a timely fashion, through a similar sole source determination. However, since that sole source determination process was completed, the agency has determined that outstanding invoices should not be paid under a newly established contract but, rather, through an amendment to the previous contract #172124. Therefore, the agency is pursuing this new sole source determination to re-instate and amend that prior contract.

Need for services: To meet immediate public health needs, the agency required COVID-19 and Mpox pharmaceuticals beyond the expiration of contract #172124.

Further, the agency recognized the need and value of this service in response to emergency public health threats, including the performance and savings that outsourcing the service to a private contractor can provide rather than the agency attempting to do so in house.

OHA Public Health Division (PHD) completed market research during April 2023 through October 2023 which resulted in determination that only one Contractor operating in Oregon is able to meet the complex needs and timelines for this medical countermeasure redistribution contract. The agency requires a Contractor to be engaged and ready to perform these services on an emergency basis in response to outbreaks and public health emergencies.

This Contractor’s capabilities have already been demonstrated under Contract #172124 issued under ORS 179B.080 Emergency on 4/1/2022 in response to ongoing COVID-19 response for Vaccine Redistribution. The Contractor has provided the services to distribute sensitive and urgently needed COVID-19 vaccine and therapeutics. The Contractor additionally took on receipt and distribution of vaccine for the Mpox outbreak, for which the agency could find no other immediate distribution options, as reflected in the “written Findings of Fact” section below.

Tasks and Specifications.

a) Contractor shall provide a secure storage facility location in the State of Oregon that has the ability to manage a broad inventory of medical countermeasures, as designated by the OHA, to meet current threat assessments, event response missions, and maintain or rotate existing medical countermeasure caches, as needed, for OHA key partners. Contractor’s secure storage facility must be accessible to OHA staff on an as needed basis.

b) Contractor shall store, repackage, and redistribute medical countermeasures to providers throughout the State of Oregon. Contractor shall have the immediately operational capacity to provide up to 500 shipments to providers per week. If needed, contractor shall return any manufacturers medical countermeasures shipping containers to the manufacture after the medical countermeasures are repackaged in Contractor’s own purpose-built shipping containers.

c) Contractor shall manage the secure storage facility supplies and medical countermeasures ordering process from US Health and Human Services (US HHS), manufacturer, or other entity to meet the volume of provider orders.

d) Contractor shall ensure medical countermeasures and associated ancillary supplies delivered from manufacturers, US HHS or other entity are stored appropriately in the secure storage facility.

e) Contractor shall pick and pack medical countermeasures for shipment to providers. Contractor must divide large shipments of medical countermeasures into smaller shipments. Contractor must pack medical countermeasures orders in purpose-built shipping containers that are validated to maintain the required temperature of the medical countermeasures throughout the shipping process.

f) Contractor shall pick and pack ancillary supplies. Contractor must ensure the appropriate amount of received ancillary supplies are shipped alongside each medical countermeasure’s shipment.

g) Contractor shall track and document medical countermeasure temperatures in the secure storage facility and during the shipment process pursuant to manufacturer, CDC, and Food and Drug Administration (FDA) specifications.

Contractor must use approved equipment as outlined in CDC (or other authority) storage and handling materials, including digital data loggers, purpose-built shipping containers, and PCM cold pack (PCM) cold pack materials as applicable.

h) Contractor shall transport medical countermeasures using established transport systems which may include, but is not limited to, FEDEX, UPS, USPS, courier services, commercial logistics companies, or contractor’s own systems.

i) Contractor shall coordinate with OHA to relocate unused, unneeded, or short-dated medical countermeasures from provider offices to the centralized redistribution warehouse for redistribution. Contractor shall manage all medical countermeasures to ensure optimum use of possible short-dated medical countermeasures and minimize medical countermeasure expiration.

j) Contractor shall store expired medical countermeasures vaccines under closely monitored temperature-controlled conditions pending possible FDA extension of expiration dates.

k) Contractor shall appropriately destroy medical countermeasures and related materials when requested by OHA.

Deliverables

a) Contractor shall provide all materials, supplies, and equipment required for the storage and transportation of medical countermeasures and other temperature controlled medical supplies.

b) Contractor shall access and use OHA’s ALERT IIS, or a substitute or replacement system, to coordinate and document medical countermeasures shipments and transfers.

c) Contractor shall provide tracking information or notice of delivery estimated time of arrival to all receiving providers.

2. Prospective contractor/vendor:

Legal entity name: Coldchain Technology Services, LLC

DBA:

Address: 244 Flightline Drive

Spring Branch, TX 78070 Contact person: Scott Bullard Phone: 888-687-2553 Email: sbullard@coldchain-tech.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: Paul Yakis

Address: 500 Summer St NE, Salem, OR 97301 Phone: 503-509-5493 Fax:

Email: Paul.yakis@odhsoha.oregon.gov

Agency reserves the right to purchase additional goods, services , or training (unless available on DAS price agreement).

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.

For information technology contracts, any ownership or proprietary issues should be fully addressed with written documentation to support facts.

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.

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.

Supporting documentation:

Market research has identified only one vendor qualified to meet the complex requirements needed to receive, store, and ship temperature sensitive vaccines and medical countermeasures currently operating within the state of Oregon. The agency became very familiar with the services and the marketplace of potential vendors throughout the pandemic and has performed targeted market research in search for any firm that offers related services. Since the COVID pandemic has subsided many vendors that had offered similar services have since closed or ceased offering similar services. For this new proposed contract, an additional thorough market review was conducted. This market review consisted of thorough internet research and additionally, interviewing of other state agency programs for determination of vendors who provide pharmaceutical distribution and cold chain support. This research resulted in four companies offering these services being identified. Follow up calls and email exchanges were made with possible vendors largely completed from April to October of 2023. Upon OHA PHD contacting these companies, they determined none of them could provide the complex requirements required by OHA, as detailed below. The companies are:

1. Trane Thermo King https://www.thermoking.com/na/en/newsroom/2020/09-sept/thermo-king-by-trane-technologies-launches-cold-storage-solution.html

Trane Thermo king offers medical logistics services and cold chain products to assist with vaccine relocation and shipping. After contacting them to request information it was determined that they do not offer end to end services including operation of warehouses in Oregon, receipt of products, and the ability to ship to a destination. They can meet only parts of the need for this contract and do not serve as a distributor themselves.

2. Nordic https://nordiccoldchain.com/solutions/life-sciences/vaccines/

Nordic offers planning, consultation, temperature management and cold chain storage solutions. After contacting them it was determined that they do not act as a vaccine redistributor but assist groups with implementing storage and handling for vaccines and other temperature sensitive medical products. They are not able to meet the redistribution needs of this contract.

3. LogiCare3PL https://logicare3pl.com/what-we-do/ https://www.thermoking.com/na/en/newsroom/2020/09-sept/thermo-king-by-trane-technologies-launches-cold-storage-solution.html https://www.thermoking.com/na/en/newsroom/2020/09-sept/thermo-king-by-trane-technologies-launches-cold-storage-solution.html https://nordiccoldchain.com/solutions/life-sciences/vaccines/ https://logicare3pl.com/what-we-do/

LogiCare3PL does offer end to end cold chain management and redistribution services. They would be able to meet the requirements for this contract however, do not currently operate in Oregon.

4. Carrier https://www.corporate.carrier.com/news/news-articles/carrier-offers-solutions-to-meet-increased-covid19-vaccine-distribution-demand.html

Carrier no longer offers comprehensive vaccine cold chains services. They distribute storage and handling equipment only and are not able to meet the redistribution need for this contract.

Further, the agency is not guaranteeing work of any volume that would bring a new company into the marketplace. The contract will guarantee no future work.

APPROVED:

By:

Signed by DPO electronically via OregonBuys Kirk N. Rhoades or acting DPO https://www.corporate.carrier.com/news/news-articles/carrier-offers-solutions-to-meet-increased-covid19-vaccine-distribution-demand.html https://www.corporate.carrier.com/news/news-articles/carrier-offers-solutions-to-meet-increased-covid19-vaccine-distribution-demand.html