HomeMy WebLinkAboutThe Regents of the University of California San Francisco-On-Call COVID-19 Vaccine Monoclonal Antibody Therapy Flu Vaccine and Screening Vaccination Treatment of Communicable Diseases_A-22-378 D-21-130.pdf COU Y Count of Fresno Hall of Records,Room301
2281 Tulare Street
Al Fresno,California
o Board of Supervisors 93721-2198
O� 185 0 Telephone:(559)600-3529
FRE` Minute Order Toll Free: 1-800-742-1011
www.co.fresno.ca.us
August 23, 2022
Present: 5- Supervisor Steve Brandau, Supervisor Nathan Magsig, Supervisor Buddy Mendes,
Chairman Brian Pacheco, and Vice Chairman Sal Quintero
Agenda No. 34. Public Health File ID: 22-0742
Re: Approve and authorize the Chairman to execute Second Amendment to Agreement with The Regents
of the University of California,San Francisco, to add the provision of conducting screening,
vaccination, and treatment of communicable diseases,with no change in the term of April 15, 2021
through April 14, 2023 and increasing the maximum by$1,481,238 to a total of$8,887,042
APPROVED AS RECOMMENDED
Ayes: 5- Brandau, Magsig, Mendes, Pacheco,and Quintero
Agreement No.22-378
County of Fresno Page 34
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Board Agenda Item 34
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DATE: August 23, 2022
TO: Board of Supervisors
SUBMITTED BY: David Luchini, RN, PHN, Director, Department of Public Health
SUBJECT: Approve Second Amendment to Agreement with The Regents of the University of
California, San Francisco
RECOMMENDED ACTION(S):
Approve and authorize the Chairman to execute Second Amendment to Agreement with The
Regents of the University of California, San Francisco, to add the provision of conducting
screening,vaccination, and treatment of communicable diseases, with no change in the term of
April 15, 2021 through April 14, 2023 and increasing the maximum by$1,481,238 to a total of
$8,887,042.
There is no additional Net County Cost associated with the recommended action.Approval of the
recommended action will add the provision of conducting screening, vaccination, and treatment of
communicable diseases as well as add additional funding to The Regents of the University of California, San
Francisco (UCSF)to accommodate the provision of new and existing services through April 14, 2023. This
item is countywide.
ALTERNATIVE ACTION(S):
There are no viable alternative actions. Should your Board choose not to approve the recommended action,
UCSF will not be able to screen and treat for other communicable diseases and will not be able to receive
additional funding. The Department has projected that UCSF will exhaust all funds by November 2022. Not
approving the recommended action will also result in the early termination of all COVID-19 and flu related
services offered by UCSF to Fresno County residents, leaving a void during a potential upcoming surge.
FISCAL IMPACT:
There is no increase in Net County Cost associated with the recommended action. The agreement will
continue to be funded by the COVID-19 Epidemiology and Laboratory Capacity(ELC)funding, Immunization
Cooperative Agreement funding, and any other funding made available through legislative action for
COVID-19 response efforts. The recommended action will increase Agreement No. D-21-130 for a
maximum payable of$8,887,042 which represents a$1,481,238 increase. Sufficient appropriations and
estimated revenues are included in the Department's Org 5620 FY 2022-23 Recommended Budget.
DISCUSSION:
On March 15, 2020, pursuant to California Government Code, Section 8630 and Fresno County Ordinance
Code Chapter 2.44, due to the imminent and proximate threat of COVID-19, a Local Emergency was
proclaimed by the County Administrative Officer acting as the Emergency Services Director.Your Board
adopted a Resolution proclaiming and ratifying the Local Emergency on March 17, 2020. Your Board has
County of Fresno Page 1 File Number:22-0742
File Number:22-0742
terminated the proclamation of the local emergency and Fresno County continues to function under the
State proclaimed emergency. On December 14, 2021, your Board ratified the Agreement(no. D-21-130)
and First Amendment (no. D-21-130-1)with UCSF to serve as an on-call COVID-19 vaccine administration
team, added the provision of flu vaccine administration, MAB, and COVID-19 testing services, and increased
the maximum compensation to accommodate the provision of new and existing services through April 14,
2022. The Department and UCSF has executed the two (2)additional 6-month extensions, extending the
agreement through April 14, 2023.
The Department previously had contracts with ten vendors to provide COVID-19 vaccination and testing
services. The Department made the strategic decision to demobilize the COVID-19 response efforts which
reduced the number of providers. Along with UCSF, the other partner to remain in response efforts is
Pinnacle Training System, LLC. UCSF is the only contractor with Fresno County that provides on-call, as
needed services.
Of the two contractors remaining, UCSF has the most flexibility to provide mobile clinics to the County's
vulnerable population in the rural and metropolitan areas. As COVID-19 cases continue to impact our
community, it is critical to continue COVID-19 services and make them available to Fresno County residents
as potential surge months approach. UCSF continues to open their clinic 5-days a week and since April 14,
2021, has administered more than 75,000 doses of COVID-19 vaccines, including 3,058 doses to ages 5-11
years old. UCSF has also conducted over 86,000 PCR tests, administered 1,551 flu doses, and provided
over 500 courses of MAB.
Approval of the recommended action will add the provision to screen and treat for communicable diseases
and grant additional funding to UCSF to continue these much-needed services through April 14, 2023.The
County and UCSF will continue to work together to assure the maximization of resources and meeting
expected goals.
REFERENCE MATERIAL:
BAI #64, December 14, 2021
BAI #2, March 17, 2020
BAI #3, March 17, 2020
ATTACHMENTS INCLUDED AND/OR ON FILE:
On file with Clerk-Second Amendment to Agreement with UCSF
CAO ANALYST:
Ron Alexander
County of Fresno page 2 File Number:22-0742
Agreement No. 22-378
1 SECOND AMENDMENT TO AGREEMENT
2 THIS SECOND AMENDMENT TO AGREEMENT (hereinafter"Amendment") is made and
3 entered into this 23rd day of August 2022, by and between COUNTY OF FRESNO, a Political
4 Subdivision of the State of California, Fresno, California (hereinafter "COUNTY"), and The Regents of
5 the University of California, San Francisco, a public university, whose address is c/o Office of
6 Sponsored Research, 490 Illinois Street, 4th Floor, San Francisco, CA 94143 (hereinafter
7 "CONTRACTOR").
8 WITNESSETH:
9 WHEREAS, COUNTY and CONTRACTOR entered into Agreement number D-21-130, dated
10 April 21, 2021, pursuant to which CONTRACTOR agreed to provide on-call COVID-19 vaccination
11 administration teams, including all necessary staffing, to conduct on-call vaccination clinics that will
12 provide vaccinations and documentation (using the local immunization registry) to COUNTY residents;
13 and
14 WHEREAS, COUNTY and CONTRACTOR entered into a First Amendment number D-21-130-
15 1, dated October 8, 2021, to add the provision of monoclonal antibody therapy, flu vaccine
16 administration services, the addition of COVID-19 testing services, and increase the total
17 compensation to accommodate the provision of new and existing services through and including April
18 14, 2022 (Agreement number D-21-130 and First Amendment Number D-21-130-1, collectively, shall
19 be referred to herein as "Agreement'); and
20 WHEREAS, the Agreement was extended for one (1) additional six (6) month period upon
21 written approval of both parties through and including October 14, 2022; and
22 WHEREAS, COUNTY and CONTRACTOR have extended the Agreement with the second and
23 final one (1) additional six (6) month period upon written approval of both parties through and including
24 April 14, 2023; and
25 WHEREAS, COUNTY and CONTRACTOR now desire to amend the Agreement to add the
26 provisions to conduct screening, vaccination, and treatment of communicable disease, effective upon
27 execution, and increase the total compensation to accommodate the provision of new and existing
28 services through April 14, 2023.
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1 NOW, THEREFORE, for good and valuable consideration, the receipt and adequacy of which
2 is hereby acknowledged, COUNTY and CONTRACTOR agree as follows:
3 1. That all references to "Revised Exhibit A" in existing COUNTY Agreement number D-
4 21-130 shall be changed to read, "Second Revised Exhibit A", attached hereto and incorporated herein
5 by reference.
6 2. That all references to "Revised Exhibit B" in existing COUNTY Agreement number D-
7 21-130 shall be changed to read, "Second Revised Exhibit B", attached hereto and incorporated herein
8 by reference.
9 3. That Section 5 of the Agreement, located on page 3, lines 8 through 19, is deleted in its
10 entirety and replaced with the following:
11 "COMPENSATION/INVOICING: COUNTY agrees to pay CONTRACTOR and
12 CONTRACTOR agrees to receive compensation for actual costs as identified in Second Revised
13 Exhibit B, attached hereto and incorporated herein by reference. CONTRACTOR shall submit monthly
14 invoices to the County of Fresno, Department of Public Health, 611 Floor, P.O. Box 11867, Fresno, CA
15 93775, Attention: Business Office or dphboap(@fresnocountyca.gov. Invoices shall be accompanied by
16 supporting cost documentation such as payroll records, equipment/supply invoices, lease payment,
17 payment records for marketing/education/outreach costs, utility/janitorial payment, mileage records if
18 applicable.
19 In no event shall services performed under this Agreement be in excess of Eight Million
20 Eight Hundred Eighty-Seven Thousand Forty-One and 67/100 Dollars ($8,887,041.67) during the term
21 of this Agreement. It is understood that all expenses incidental to CONTRACTOR'S performance of
22 services under this Agreement shall be borne by CONTRACTOR. Invoice terms shall be a Net forty-
23 five (45) days from date of receipt of invoice by COUNTY."
24 COUNTY and CONTRACTOR agree that this Amendment is sufficient to amend the
25 Agreement and, that upon execution of this Amendment, the Agreement and this Amendment together
26 shall be considered the Agreement.
27 The parties agree that this Amendment may be executed by electronic signature as provided in
28 this section. An "electronic signature" means any symbol or process intended by an individual signing
- 2 -
1 this Amendment to represent their signature, including but not limited to (1) a digital signature; (2) a
2 faxed version of an original handwritten signature; or (3) an electronically scanned and transmitted (for
3 example by PDF document) of a handwritten signature. Each electronic signature affixed or attached
4 to this Amendment (1) is deemed equivalent to a valid original handwritten signature of the person
5 signing this Amendment for all purposes, including but not limited to evidentiary proof in any
6 administrative or judicial proceeding, and (2) has the same force and effect as the valid original
7 handwritten signature of that person. The provisions of this section satisfy the requirements of Civil
8 Code section 1633.5, subdivision (b), in the Uniform Electronic Transaction Act (Civil Code, Division 3,
9 Part 2, Title 2.5, beginning with section 1633.1). Each party using a digital signature represents that it
10 has undertaken and satisfied the requirements of Government Code section 16.5, subdivision (a),
11 paragraphs (1)through (5), and agrees that each other party may rely upon that representation. This
12 Amendment is not conditioned upon the parties conducting the transactions under it by electronic
13 means and either party may sign this Amendment with an original handwritten signature.
14 The Agreement, as hereby amended, is ratified and continued. All provisions, terms,
15 covenants, conditions and promises contained in the Agreement and not amended herein shall remain
16 in full force and effect.
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1 IN WITNESS WHEREOF, the parties hereto have executed this Second Amendment to
2 Agreement as of the day and year first hereinabove written.
3
4 CONTRACTOR COUNTY OFFRESNO
The Regents of the University of
5 California, San Francisco
6 �� >
7 (Authorized Sign _t,re) Brian Pacheco, Chairman of the Board of
Supervisors of the County of Fresno
8 Catherine Laciarde, ContractsOfficer
Print Name & Title
9
OSR
10 49b Illinois 4th Flow
San Francisco, CA 94143
11 Mailing Address ATTEST:
12 Bernice E. Seidel
Clerk of the Board of Supervisors
13 County of Fresno, State of California
14
15
16
17
By:
18 Deputy
FOR ACCOUNTING USE ONLY:
19
20 Fund: 0001
21 Subclass: 10000
22 ORG: 56201018, 56201019
23 Account: 7295
24
25
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j,;
Second Revised Exhibit A
SCOPE OF WORK
The County of Fresno (County) Department of Public Health (DPH) is in need of temporary vendors to
provide on-call COVID vaccine, COVID testing, flu vaccine, and Monoclonal Antibody Therapy
administration teams, while also conducting screening, vaccination, and treatment of communicable
diseases, available for vaccination events. Licensed and unlicensed medical staff(Registered Nurses,
Licensed Vocational Nurses and Medical Assistants or Certified Nursing Assistants with valid licensure
and/or certification in the State of California) and clerical staff will be needed to conduct on-call
vaccination clinics that will provide vaccination and documentation through the appropriate State system
(e.g. MY Turn or Interface from allowed electronic medical record) to County residents. Clinics will be
held through employers or through community medical clinic/vaccination events that may be open to the
general public.
The vendor will work with County staff to determine the size, date and time of the clinic request. Lead
time to clinic scheduling will be 5 days—4 weeks. The County anticipates 20 to 30 clinics per month,
providing services to up to 1,000 patients per clinic. Clinic times will vary as follows:
• Any day of the week, including weekends and evenings.
• Clinic hours will vary from 2 — 8 hours depending on size of event.
• Events may be held inside, outside or as a drive thru.
• Events may be located anywhere within Fresno County.
• Patients served will be dependent on which vaccine is being administered at the event. The Pfizer
vaccine is authorized for use in individuals 16 years of age and older. The Moderna and Janssen
vaccines are authorized for use in individuals 18 years of age and older. The Monoclonal
Antibody Therapy is authorized for use in individuals over 12 years of age and older with
mild-to-moderate COVID-19 who meet criteria under the FDA's Emergency Use
Authorization. EUAs issued for each vaccine:
o Pfizer EUA: https://www.fda.gov/media/144412/download
o Moderna EUA: https://www.fda.gov/media/144637/download.
o Janssen EUA: Janssen COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers
fda. ov
o Monoclonal Antibody Therapy EUA: https://www.fda.gov/media/143893/download
o Other vaccine requirements may vary. Vendor will be required to adhere to EUA for
specific vaccines as additional vaccines are approved by the Food and Drug
Administration(FDA).
• Vendor will be required to work with the venue host to determine if the vendor will need to
provide tables, chairs, popup tents, etc.
• At County's request, vendor may be required to conduct a similar event at the same venue in
order to administer required second doses of vaccine. Arrangements for both events shall be
made at the same time. Timing of the second event will depend on the recommended second
dose frequency: Pfizer is currently 21 days and Moderna is one month (see respective EUAs
Page 1 of 5
Second Revised Exhibit A
linked above and CDC clinical considerations linked here: https://www.cdc.gov/vaccines/covid-
19/info-by-product/clinical-considerations.html ). Janssen vaccine is one dose only. Vendor
should always check for CDC and/or vaccine manufacturer updates to these requirements prior
to each event.
• When applicable, the requirement to conduct a second, similar event, and its timing, are subject
to change depending on vaccine availability at the time of the second event and changes in
recommended second dose administration timing.
• Any extra ancillary supplies not included with vaccine shipment must be supplied by vendor.
• The County prefers that the vaccine and ancillary supplies be shipped directly to the vendor
rather than be held by the County prior to the clinic. This will be dependent on the vendor's
ability to maintain vaccine at the appropriate temperatures (see Cold Storage Capacity, below)
and the size of the event.
The County will provide the following:
• Venue and direct payment to venue for any rental costs.
• Clinic date, time, location and venue contact information.
• Vaccine and ancillary supplies as provided for by CDPH. Depending on vendor's cold chain
capabilities and registered Provider status, vaccine and ancillary supplies may be shipped
directly to vendor or picked up at the Department of Public Health.
• For Pfizer, Moderna, Janssen, flu and potentially other vaccines, as well as Monoclonal
Antibody Therapy, we expect the following ancillary supplies to be provided with each 100
vaccine doses.
0 105 needles
0 105 syringes
0 210 alcohol prep pads
o 1 needle information card
o 100 vaccination cards
0 2 disposable face shields
0 4 surgical masks
The vendor will be responsible for the following:
• County prefers vendors to enroll as a Provider in the federal COVID-19 Vaccination Program,
utilizing the California Department of Public Health's (CDPH) COVIDReadi portal and agree
and adhere to all requirements specified in the Provider agreement. If provider is not currently
an approved California COVID vaccine provider then provider must adhere to all COVID
vaccine handling and reporting requirements established by the State of California.
• Vendor shall administer the vaccine and enter all vaccinations into the appropriate State system
within 24 hours of administration.
• Vendor is to provide all office supplies, ancillary medical supplies not included with vaccine,
PPE, tables, chairs, tents, etc., when needed.
Page 2 of 5
Second Revised Exhibit A
• Vaccine will be transferred according to CDC or VFC recommendations, such as noted in the
CDC's Vaccine Storage and Handling Toolkit, linked here:
https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html
• Return unused/unopened vaccines to DPH the day of the event, or the day following, as directed
by DPH when scheduling each event(to be determined prior to each event.) However, with
County's permission, vendor may retain unused vaccine for use on the following clinic date
provided vendor has appropriate cold storage capacity and the vaccine will not have expired per
manufacturer guidelines.
• If vendor has vaccine that may expire before it can be used at an upcoming vendor event, vendor
will work with the County to ensure any surplus or short-dated doses are transferred to an
approved provider in a timely manner.
• Document and notify DPH of any wasted vaccine doses.
• Staff in charge of storage and handling, will complete the 7 EZIZ training modules at the
following website: https://eziz.org/eziz-training/
• Per federal regulations, vendor is required to provide the appropriate EUA document to all
vaccine recipients:
o Pfizer: https://www.fda.gov/media/144414/download
o Moderna: https://www.fda.gov/media/144638/download
o Janssen: Janssen COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers(fda.sov)
o Monoclonal Antibody Therapy: https://www.fda.gov/media/143893/download
• COVID-19 vaccination providers are required to report the following adverse events after
COVID-19 vaccination, and other adverse events if later revised by CDC, to VAERS:
https://vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.
• Vaccination administration errors, whether or not associated with an adverse event
• Severe COVID-19 illness (e.g., resulting in hospitalization)
• Serious adverse events (AE) regardless of causality. Serious AEs are defined as:
o Death
o A life-threatening AE
o Inpatient hospitalization or prolongation of existing hospitalization
o Persistent or significant incapacity or substantial disruption of the ability to
conduct normal life functions
o A congenital anomaly/birth defect
o Multisystem Inflammatory Syndrome
• Important medical events that may not result in death, be life-threatening, or require
hospitalization may be considered serious when, based upon appropriate medical judgment,
they may jeopardize the patient and may require medical or surgical intervention to prevent
one of the outcomes listed above
• Also report any additional select adverse events and/or any revised safety reporting requirements
per FDA's conditions of authorized use of vaccine(s) throughout the duration of any COVID-19
Vaccine being authorized under an Emergency Use Authorization (EUA).
• Vendor must make provision for patients with a history of anaphylaxis (due to any cause)to
remain for observation for 30 minutes. For all other persons, observation period is 15 minutes.
• In the event of anaphylactic reaction, vendor must maintain appropriate emergency equipment at
the event to manage anaphylaxis resulting from vaccination. See CDC recommended equipment
Page 3 of 5
Second Revised Exhibit A
linked here: https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/anaph laxis-
management.html. Equipment supply should be sufficient to manage multiple patients
experiencing anaphylaxis.
Cold Storage Survey (please check as appropriate):
We have an ultra-low temperature freezer(temperature capability is -80°C to -60°C/-112°F to -
76°F). Freezer make/model and cubic feet: SO-LOW MODEL U85-22 23.1 cubic ft- 3 units
purchased. American Biotech Supply—ABT 115V-2186 17cubit ft. —3 units purchased
We have freezer storage capability (-25°C to -15°C/-1YF to 5°F). Freezer make/model and cubic
feet: MCA Corporation MODEL HMCF7W4—7 Cubic Feet
We have refrigerator storage capability (2°C to 8°C/36°F-40°F). Refrigerator make/model and
cubic feet: American Biotech Supply PH-ABT-HC S16G 16 cubic ft.
*Current calibration certification will be required for freezers/refrigerators.
❑ We will pick up and return the vaccine the same day to the County and will make arrangements
with County staff on pick up and drop off times.
We have qualified container and packout for transport and digital data logger for continuous
temperature monitoring during transport. We have purchased 6 transport containers for the
purpose of transporting vaccines.
❑ We do not have qualified container and packout for transport and digital data logger for
continuous monitoring during transport and will need to borrow from the Department of Public
Health.
Per the CDC, a"qualified container and packout" are defined as "A type of container and
supplies specifically designed for use when packing vaccines for transport. They are passive
containers that do not require a power source and are `qualified' through laboratory testing under
controlled conditions to ensure they achieve and maintain desired temperatures for a set amount
of time." (https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-tgplkit.pdf)
An example a qualified container is linked here: https://www.vericonned.com/product/cooler-
cool-cube-08-vaccine-transport-cooler-at-refi i gerated-temperatures-fresh-vaccine-vt-08/
Vendor shall submit invoices to:
County of Fresno Department of Public Health
1221 Fresno Street, 6th fl. (Business Office)
Fresno, CA 93721
DPHBOAP(&,,fresnocoun ca.gov
Page 4 of 5
Second Revised Exhibit A
KEY RESOURCES
• CDC's Storage and Handling Toolkit
• CDC's COVID-19 Vaccination Information Page
• Phase Guidance:
o CDC's Phase 1A Powerpoint
o Interim ACIP Guidance
o Early NASEM Phase Guidance
Page 5 of 5
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