Agenda Item   

AGENDA STAFF REPORT

 

                                                                                                                        ASR Control  21-000528

 

MEETING DATE:

12/07/21

legal entity taking action:

Board of Supervisors

board of supervisors district(s):

All Districts

SUBMITTING Agency/Department:

Health Care Agency   (Approved)

Department contact person(s):

Margaret Bredehoft (714) 834-3882 

 

 

Clayton Chau (714) 834-2830

 

 

Subject:  Contract for Test Kits, Equipment, Maintenance for Detection of Infectious Agent

 

      ceo CONCUR

County Counsel Review

Clerk of the Board

Concur

Approved Agreement to Form

Discussion

 

 

3 Votes Board Majority

 

 

 

    Budgeted: Yes

Current Year Cost: $1,250,000

Annual Cost: FY 2022-23 $2,500,000
FY 2023-24 $2,500,000
FY 2024-25 $1,250,000

 

 

 

    Staffing Impact:

No

# of Positions:

Sole Source: Yes

    Current Fiscal Year Revenue: N/A

  Funding Source: GF: 4%, FED: 63% (Ryan White, Epidemiology and Laboratory Capacity), State: 33% (Realignment)

County Audit in last 3 years: No

 

 

    Prior Board Action: 11/19/2019 #16, 11/20/2018 #28, 10/31/2017 #16

 

RECOMMENDED ACTION(S):

 

 

1.

Approve Contract with Gen-Probe Sales & Service, Inc., for Reagent Test Kits, Equipment, and Maintenance for Detection of Infectious Agents, effective January 1, 2022, through December 31, 2024, in an amount not to exceed $7,500,000.

 

2.

Authorize the County Procurement Officer, or authorized Deputy, to execute the Contract with Gen-Probe Sales & Service, Inc., as referenced in the Recommended Action above.

 

 

 

 

 

SUMMARY:

 

Approving the Contract with Gen-Probe Sales & Service, Inc., for reagent test kits, equipment and maintenance for detection of infectious agents will allow the Health Care Agency Orange County Public Health Laboratory to continue testing for detection of infectious agents for public health and safety.

 

 

 

BACKGROUND INFORMATION:

 

On November 22, 2016, the Health Care Agency (HCA) executed a sole source commodity Contract with Gen-Probe Sales & Services, Inc. (Gen-Probe) for Reagent Test Kits, Equipment and Maintenance for Detection of Infectious Agents, effective January 1, 2017, through December 31, 2017, in the amount not to exceed $250,000 per year, renewable for four additional one-year terms. Subsequently, on October 31, 2017, your Honorable Board of Supervisors (Board) approved the renewal of that Contract. The below additional actions were executed on the Contract pursuant to appropriate authorities.

 

Board Date

Contract/Amendment

Action

Term

October 31, 2017

Amendment No. 1

Contract renewed for $500,000

January 1, 2018 - December 31, 2018

November 20, 2018

Amendment No. 2

Contract renewed for $500,000

January 1, 2019 - December 31, 2019

November 19, 2019

Amendment No. 3

Contract renewed for $500,000

January 1, 2020 - December 31, 2020

N/A

Amendment No. 4

DPA Authority - Federal Emergency Management Agency provisions added to Contract

January 1, 2020 - December 31, 2020

N/A

Amendment No. 5

Emergency Board Resolution - Contract increased by $1,503,788

January 1, 2020 - December 31, 2020

N/A

Amendment No. 6

Emergency Board Resolutino - Contract renewed for $1,000,000

January 1, 2021 - December 31, 2021

N/A

Amendment No. 7

Emergency Board Resolution - Contract increased by $3,124,939

January 1, 2021 - December 31, 2021

 

Through the Contract, Gen-Probe provides and maintains two instruments and HCA purchases Food and Drug Administration (FDA) cleared or authorized test kits, all necessary ancillary products and instrumentation for processing and detection of the bacterial and viral agents. The Orange County Public Health Laboratory (OCPHL) tests approximately 22,000 patient specimens per year for chlamydia and gonorrhea using the Gen-Probe Panther instruments under a Reagent Rental Contract in place since 2012. In 2017, Gen-Probe upgraded the existing Panther instrument in order to run the HIV-1 and Hepatitis C Viral Load Quantitative assays and added a second Panther instrument to handle the increased workload for the additional tests the OCPHL added to the Panther platforms.

 

The Panther instruments provide high-volume, rapid testing for a variety of pathogens of public health concern. In June 2020, the Aptima SARS-CoV-2 Panther) assay for COVID-19 was implemented in order to meet the demands for automated COVID-19 testing and is an integral part of OCPHL’s response to the COVID-19 pandemic. Since June 2020, OCPHL has tested approximately 35,000 patient specimens on the Panther instruments. In December 2020, OCPHL acquired the Panther Fusion module using Coronavirus Aid, Recovery, and Economic Security Act funding and an emergency memo to accommodate additional tests for COVID-19, as well as Influenza testing. This response to COVID-19 and subsequenct increase is testing necessitated Amendments 4 through 7 shown in the table above.

 

This Contract is a sole source commodity Contract and the approved sole source request form is attached as Attachment C. Since 2012, as stated above, OCPHL has used the proprietary Panther instrument and test kits to complete Chlamydia/Gonorrhea Nucleic Acid Amplification Testing (CT/GC NAAT) for physician-collected specimens. In 2017, OCPHL with 17th Street Testing and Treatment clinic, completed a study to validate the use of patient collected specimens for CT/GC NAAT. As a result of this study, OCPHL receives an increased number of specimens for CT/GC NAAT. The validation was specific to the Panther instrument, and OCPHL would not be able to test the patient collected specimens on a different instrument without first performing another validation study. In addition, the Centers for Disease Control and Prevention recommends the use of amplified molecular tests for the detection of Trichomonas infections. At the request of the physicians at Orange County Juvenile Hall, OCPHL has implemented amplified molecular testing for Trichomonas using the FDA cleared assay from Gen-Probe, and the Aptima Trichomonas assay can only be run on the Panther instrument. Gen-Probe also received FDA clearance for an HIV-1 Viral Load assay to run on the Panther instrument, the Aptima HIV-1 Quant. OCPHL implemented HIV-1 Viral Load testing using the Gen-Probe assay in January 2017. There is substantially less hands on time for staff performing this assay as well as other advantages, such as an increase in the number of specimens per run and the ability to load additional specimen after the run has begun. The Panther system is more efficient than the previous method.

 

Gen-Probe is the sole manufacturer and only authorized service provider for the Panther instruments and the Fusion module, and is the only authorized vendor that can perform maintenance and repairs to their proprietary instruments. In June 2020, the Aptima SARS-CoV-2 assay was validated and implemented in order to meet the demands for automated COVID-19 testing and is an integral part of the laboratory's response to the COVID-19 pandemic. In November 2020, Gen-Probe received FDA approval for HIV-1 NAT. The Panther instrument has a robust interface with the OCPHL Pathnet Laboratory Information System (LIS), which is an improvement over the previous system used for HIV-1 Viral Load. Due to the robust interface between the Panther instruments and the OCPHL PathNet LIS, the laboratory is able to report results via auto verification through the instrument for multiple assays, including COVID-19. This has significantly decreased result turnaround times, as well as reducing  data entry errors and saving staff time.

 

The item is coming to the Board less than 30 days prior to the Contract's start date due to delays in the contract review and negotiation process.

 

This Contract does not currently include subcontractors or pass through to other providers. See Attachment B for Contract Summary Form.

 

The Contractor's performance has been confirmed as at least satisfactory. HCA has verified there are no concerns that must be addressed with respect to Contractor's ownership/name, litigation status or conflicts with County interests. The Orange County Preference Policy is not applicable to this contract award.

 

HCA requests that the Board authorize the County Procurement Officer or authorized Deputy to execute the Contract with Gen-Probe Sales & Service, Inc. as referenced in the Recommended Action.

 

 

 

FINANCIAL IMPACT:

 

Appropriations for this Contract is included in Budget Control 042 FY 2021-22 Budget and will be included in the budgeting process for future years.

 

The Contract contains language that will allow HCA to terminate the Contract in the event of non-appropriation of funds and in the event of Contractor's material breach and failure to substantially cure the breach within 30 days of receipt of notice of the breach.

 

 

 

STAFFING IMPACT:

 

N/A

 

ATTACHMENT(S):

 

Attachment A – Contract MA-042-22010349 with Gen-Probe Sales & Service, Inc.
Attachment B – Contract Summary Form
Attachment C – Sole Source Request Form