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DATE: |
December 10, 2024 |
15 |
SUBJECT
Title
AUTHORIZE SINGLE SOURCE PROCUREMENT OF DIASORIN MOLECULAR LLC FOR THEIR INSTRUMENTATION, MAINTENANCE, CONSUMABLES, REAGENTS, AND SUPPLIES FOR THE PUBLIC HEALTH LABORATORY (DISTRICTS: ALL)
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OVERVIEW
The County of San Diego (County) Health and Human Services Agency, Public Health Laboratory (PHL) provides high-quality laboratory services to protect the health of the community and prevent the spread of disease. The PHL has been a leader in infectious disease control locally, in California, and across the nation by analyzing clinical and environmental samples through surveillance, assessment, and assurance activities. In addition, the PHL supports regional preparedness and response to communicable disease events, outbreaks, and emerging infectious disease threats.
On October 25, 2022 (11), the San Diego County Board of Supervisors (Board) approved the establishment of appropriations for design and pre-construction services for a new PHL. The new facility, in addition to being larger than the previous PHL, will also be a Biosafety Level 2 and 3 reference laboratory as the County serves as an approved Centers for Disease Control and Prevention Select Agent Laboratory for San Diego and Imperial Counties. The PHL is also the designated location for the federal BioWatch program for the detection of bioterrorism agents in San Diego County. This new expanded PHL will allow our team to enhance and expand testing services and capabilities. To ensure this expansion of testing while maintaining and increasing testing proficiency and accuracy, the use of specialized laboratory equipment is essential.
Today’s actions request the Board authorize a single source contract with Diasorin Molecular LLC for their manufacturer-specific specialized instrumentation, maintenance, consumables, reagents, and supplies to sustain critical services and enhance PHL activities.
Today's actions support the County vision of a just, sustainable, and resilient future for all, specifically those communities and populations in San Diego County that have been historically left behind, as well as our ongoing commitment to the regional Live Well San Diego vision of healthy, safe, and thriving communities. This will be accomplished by re-enforcing the PHL’s ability to safeguard and improve the health and well-being of San Diego County residents through enhanced and increased testing, prevention, and intervention to interrupt transmission of disease while maintaining good fiscal management.
RECOMMENDATION(S)
CHIEF ADMINISTRATIVE OFFICER
1. In accordance with Board Policy A-87, Competitive Procurement, approve and authorize the Director, Department of Purchasing and Contracting to enter into negotiations with Diasorin Molecular LLC, and subject to successful negotiations and determination of a fair and reasonable price, award a contract for public health laboratory products and/or services, including the manufacturer-specific Liaison series instrumentation, consumables and ongoing maintenance and repairs for the life of the equipment, for an Initial Term of up to one year, with four one-year Options, and up to an additional six months, if needed, and to amend the contract as needed to reflect changes to services or funding allocations, subject to the availability of funds and the approval of the Deputy Chief Administrative Officer, Health and Human Services Agency.
2. Authorize the Deputy Chief Administrative Officer, Health and Human Services Agency, or designee, to apply for additional funding opportunity announcements, if available, that would support the Public Health Laboratory
EQUITY IMPACT STATEMENT
San Diego County has one of the busiest border crossings in the United States and is home to a diverse population including military and tribal communities. Reports from the Centers for Disease Control and Prevention have highlighted disparities among populations impacted by diseases such as HIV, viral Hepatitis, Sexually Transmitted Infection, Tuberculosis, and COVID-19. Disparities in ethnicity have shown to be linked to behavioral risk factors, environmental exposures, social determinants of health, and access to accurate and timely testing. To protect the health and well-being of all residents, the County of San Diego (County) Health and Human Services Agency, Public Health Laboratory (PHL) provides diagnostic testing that helps to diagnose diseases among the general public, including but not limited to tuberculosis, measles, mumps, norovirus, and malaria. Additionally, insights from testing results and patient demographics, available through the laboratory information management system, enables the PHL to record and monitor health disparities and inequities across a wide range of diseases. The PHL works in conjunction with public health clinics, local hospitals and healthcare providers, and the County Department of Environmental Health and Quality to analyze clinical and environmental samples to detect and identify bacteria, viruses, and other pathogens, perform rapid diagnostic testing, and characterize pathogens.
A fully functioning PHL that implements the core activities of surveillance, assessment, and assurance, is essential to provide the best health outcomes for our communities. Thus, the PHL is continuously tracking advancements in specialized laboratory and testing equipment to ensure the most efficient and effective instrumentation is a priority. The procurement of advanced instrumentation will lead to improved testing capabilities, reduced response times, and more efficient and effective services to interrupt the transmission of disease and protect all San Diego County residents, especially the most vulnerable.
SUSTAINABILITY IMPACT STATEMENT
Today’s actions support the County of San Diego (County) Sustainability Goal #3 to transition to a green, carbon-free economy, and reduce greenhouse gas emissions; and Sustainability Goal #4 to protect the health and well-being of everyone in the region, with a focus on collaborating with community partners and advocating for environmental justice for communities that have been disproportionately impacted. The County Public Health Laboratory continuously increases capacity and testing services aimed at detecting and preventing illnesses by using the most effective and efficient equipment available. Testing and identification will improve the overall health of communities, reduce the demand for associated care services, while increasing the effectiveness of care providers and lowering operating costs of facilities, thus reducing greenhouse gas emissions and waste generated within the care sector. Since climate change and air pollution are direct threats to human health, the reduction of pollution is also considered a preventative healthcare measure.
FISCAL IMPACT
Funds for this request are included in the Fiscal Year (FY) 2024-26 Operational Plan of the Health and Human Services Agency. If approved, this request will result in estimated costs and revenue of $140,000 in FY 2024-25 for purchase of one-time equipment and lab supplies and estimated costs and revenue of $100,000 in FY 2025-26 for ongoing laboratory supplies and maintenance of the equipment. Funds for subsequent years will be incorporated into future operational plans. The funding source is existing Health Realignment appropriations. There will be no change in net General Fund cost and no additional staff years.
BUSINESS IMPACT STATEMENT
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Details
ADVISORY BOARD STATEMENT
The Health Services Advisory Board reviewed this item on October 8, 2024, and recommended approval of the recommendations.
BACKGROUND
The County of San Diego (County) Health and Human Services Agency, Public Health Laboratory (PHL) provides high-quality laboratory services to protect the health of the community and prevent the spread of disease. The PHL has been a leader in infectious disease control locally, in California, and in the nation by analyzing clinical and environmental samples through the core activities of surveillance, assessment, and assurance. These services include clinical testing, beach water testing, rabies testing, and sequencing, as well as bioterrorism preparedness.
Previously, the County PHL was housed at the Health Services Complex building, and in February 2022, an inspection of the building determined that significant structural work was required, and it was decided that the building was no longer suitable for use. Due to this, an immediate plan for a new laboratory was initiated, and on October 25, 2022 (11), the San Diego County Board of Supervisors (Board) approved the design and pre-construction services for a new public health laboratory. The new facility will be a Biosafety Level 2 and 3 reference laboratory as the County serves as an approved Centers for Disease Control and Prevention (CDC) Select Agent Laboratory for San Diego and Imperial Counties. The new PHL is estimated to be approximately 52,000 square feet to accommodate laboratory needs. The space allocation at the new facility will almost double the previous laboratory workspace to allow expansion of testing capabilities and methods within the PHL. Thus, in addition to maintaining the established testing processes, the County aims to expand and improve the PHL’s capabilities through updated instrumentation, consumables, reagents, and preventative and needed maintenance.
On March 26, 2019 (10) the Board authorized amendments to extend contracts for the PHL, including a contract with Diasorin Molecular LLC. Due to the PHL closure in 2022, this contract ended and limitations to the temporary laboratory space did not allow for the instrumentation to be moved and used during this time. However, with the upcoming opening of the newly constructed PHL, there will be ample space to once again use this instrumentation in the laboratory.
The Diasorin Liaison instruments are fully automated systems that offer the benefits of high throughput testing processing of up to 171 tests per hour (depending on the test performed). It is able to run multiple tests at the same time and deliver the first test result in as little as 17 minutes. This instrument significantly reduces the turnaround time of each test and allows the laboratory to maintain multiple patients and assays, or tests, simultaneously, with minimal human involvement, leading to quick interventions that curb the spread of infections. If acquired, this instrument will revolutionize the PHL operations, enabling staff to quickly screen for latent tuberculosis (TB) and offering more efficient and accurate alternatives to the traditional tuberculin test. The Diasorin Liaison instruments are also able to assess the vaccine status of patients for vaccine preventable diseases such as measles, mumps, and rubella. Having an in-house platform to perform these tests will bolster the Immunization and Epidemiology unit’s ability to assess the immunity status of individuals exposed, following an outbreak.
This QuantiFERON-TB Gold Plus assay, used to test for TB, must be performed using the Diasorin Liaison series instrumentation and allows the laboratory to process TB samples promptly with a turnaround time of less than one hour. In addition to the continued need to perform these tests and reduced turnaround time, an added benefit of this specific instrumentation and single source contract is workflow optimization and reduced hands-on time for laboratory staff. This is possible as the Diasorin Liaison instrumentation was previously used within the PHL and therefore laboratory staff are already trained in properly using the instrumentation and verifying test results. In addition to this, the Diasorin Liaison instrumentation cannot be sold by anyone other than the manufacturer, Diasorin Molecular LLC and qualifies for a single source contract pursuant to Board Policy A-87 sections:
• 1.D.1 - Competition is precluded because of the existence of patent rights, copyrights, secret processes, control of the basic raw material(s) or similar circumstances, and no equivalent good or service is available.
• 1.D.6 - Continuity: The procurement is for goods and/or services where continuity of providers will provide efficiency or critical knowledge, and other providers of the goods and/or services cannot provide similar efficiencies or critical knowledge.
Today’s actions request the Board authorize a new single source contract with Diasorin Molecular LLC for an Initial Term of up to one year with four one-year options, and up to an additional six months, if needed for their Liaison series instrumentation, consumables and then ongoing maintenance and repairs for the life of the equipment, to sustain critical services with the goal of building a more improved PHL. Pricing is determined to be fair and reasonable based on comparable pricing for other governmental entities for the Diasorin equipment and consumables. In addition, today’s actions request the Board authorize procurement of new instrumentation, testing materials, maintenance, and services to allow PHL to continue providing extensive analytical testing and monitoring to support the health and well-being for all San Diego residents.
LINKAGE TO THE COUNTY OF SAN DIEGO STRATEGIC PLAN
Today’s proposed action supports the County of San Diego 2024-2029 Strategic Plan Initiatives of Equity (Health) and Community (Quality of Life) as well as the regional Live Well San Diego vision of healthy, safe, and thriving communities. This is accomplished by reducing disparities and the disproportionality of individuals by protecting the health of residents through enhanced and increased testing, prevention, and intervention to interrupt transmission of disease.
Respectfully submitted,
ebony n. shelton
Chief Administrative Officer
ATTACHMENT(S)
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