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CONTRACT NO: C-86-18-071-3-02
AMENDMENT NO: 2
AMENDMENT TO
INTERGOVERNMENTAL AGREEMENT (IGA)
Between MARICOPA COUNTY
By and Through its
DEPARTMENT OF PUBLIC HEALTH
and ARIZONA BOARD OF REGENTS (ABOR) ON BEHALF OF
THE UNIVERSITY OF ARIZONA (U of A)
I.
The above named IGA is hereby amended as specified below:
3.
Agreement Amount: $60,000 annually
5.
Start Date:
July 1, 2020
6.
Expiration Date:
June 30, 2021
II.
In accordance with a change to the Investigation Protocol, Paragraphs 1-5 of
Section III Work Statement are hereby deleted in their entirety and replaced with the
following paragraphs 1-5:
1. PURPOSE
The University of Arizona's Student Aid for Field Epidemiology Response (SAFER)
is a team of students who will provide response aid to Maricopa County Department
of Public Health (MCDPH). Support will include, but is not limited to, investigating
communicable
diseases,
providing
enhanced
surveillance
support
during
community mass gatherings, and responding to outbreaks or other public health
emergencies. SAFER will provide public health and epidemiology students with
experiential learning opportunities, enhance MCDPH preparedness for public health
emergencies, and contribute to the health and wellness of Maricopa County
citizens. The SAFER students will function under the Maricopa County Office of
Epidemiology and Data Services (OE) but will be coordinated by the Public Health
Incident Command Structure (ICS) in coordination with the Maricopa County Office
of Preparedness and Response (OPR), in the event of an emergency or as needed.
2. BACKGROUND
The University of Arizona's Student Aid for Field Epidemiology Response (SAFER)
Team's goals are to provide public health and epidemiology students with
experiential learning opportunities with Maricopa County Department of Public
Health (MCDPH). Benefits to SAFER team members include gaining public health
experience and conducting tasks relevant to the mission of MCDPH.
3. RESPONSIBILITIES OF THE CONTRACTOR
A. The Faculty Principal Investigator (Pl) / Director for the SAFER Team will be
responsible for the supervision, tracking, and maintenance of all activities to
the Intergovernmental Agreement (IGA).
B. Two to four staff persons and/or student positions, as needed by workload
and determined by the Pl for the SAFER Team, shall each work on activities
pertaining to this Agreement.
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C. The University of Arizona shall have students available to MCDPH when
requested during the academic calendar. Students should be available to
MCDPH within one business day from the date of the request. In the event
students are not available, the Faculty Director and/or Graduate Research
Assistant(s) will respond.
D. The SAFER annual report will be available to MCDPH for evaluation at the
end of each calendar year. At a minimum, the annual report will include:
1. Number (N) of cases received
2. Number (N) of cases interviewed
3. Number (N) of attempts to contact
4. Number (N) interviewed afterhours and weekends
The county may request additional data quality metrics.
E. The SAFER team will be responsible for investigating all Salmonella cases
and a sample of Campylobacter cases (i.e., ten percent of the monthly
average Campylobacter case counts for the previous five years; see
Attachment A-1). Attempts will be made to collect complete data (all
MEDSIS questions including DSO) from each case interviewed.
F. SAFER’s performance of case and outbreak investigations must comply with
completeness and timeliness metrics to which MCDPH is subject. Please
see Attachment B-1 for further clarification.
4. EXPECTATIONS AND METHODOLOGY
A. Support Public Health Initiatives during Events and Exercises
The University of Arizona's Student Aid for Field Epidemiology Response
(SAFER) Team will provide response aid to Maricopa County Department of
Public Health (MCDPH) during large-scale public health events and
emergencies. Maricopa County hosts major events at large indoor and
outdoor venues. Recent planned events have included NCAA Final Four,
Super Bowl, BCS National Championship, Fiesta Bowl, and the PGA Tour’s
Waste Management Open. When OE decides to activate the SAFER Team,
students may serve on field epidemiology teams to support enhanced
surveillance of all hazards during public health emergencies or scheduled
large-scale events. SAFER students may also participate in emergency
preparedness and response initiatives, such as tabletop exercises and point
of dispensing (POD) evaluations. The SAFER students will function under
the direction of OE in coordination with the Office of Preparedness and
Response (OPR).
B. Assist with Enteric Disease Investigations, Outbreak Investigations, Data
Collection, and Analysis
During routine enteric disease investigations and outbreaks, SAFER
students will function under the direction of MCDPH OE for any number of
supportive functions including, but not limited to, survey creation, phone
interviews, medical record requests and chart extraction, email and web-
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based interview distribution and collection. Analysis of data is limited to that
required for routine quality assurance analysis to ensure the IGA
requirements are met and the annual SAFER report is produced. Additional
descriptive and/or complex data analysis may be completed in collaboration
with OE following a written request and permission granted.
In order to increase timeliness and efficiency on case investigations, the
data will be entered directly into Medical Electronic Disease Surveillance
Intelligence System (MEDSIS) on behalf of MCDPH. Priorities for data
collection and data entry will be determined by MCDPH. See Attachments A-
1 and B-1 for clarification.
For outbreaks, single case investigations, and special events, data should
be collected from clients/cases using MCDPH supplied forms. SAFER will
attempt to collect complete data for each case interviewed including
disease-specific observations (DSO). SAFER will not collect any data
beyond what is included on the original MCDPH form unless the express
permission of MCDPH is granted. MCDPH shall have full access to and the
right to examine, copy, and make use of any and all such data.
To achieve an optimal response rate during routine disease case
investigations, the following contact methodology will be attempted.
1. For cases with contact phone numbers:
A. The student will attempt a maximum of three (3) documented phone
calls with varied time-of-day contact (i.e. morning, evenings and
weekends).
B. Following one (1) unsuccessful phone attempt, a text message will
be sent to the case to contact the health department if the number is
a verified mobile number.
C. After three (3) unsuccessful attempts at contact, case should be
returned to MCDPH.
2. MCDPH will provide updated contact information for cases, if available. If
for any reason the contact information is incorrect or missing, the cases
should be returned to MCDPH.
5. USE OF DATA
A. Carefully restrict use and access of information to those designated by
MCDPH.
1. No data, in line list or aggregate form, may be released by SAFER.
2. Analysis authorized under this IGA is limited to the minimum necessary
to ensure completion of contract requirements as outlined in Section 3.
Any analysis or use of the data beyond that, even by parties previously
considered covered by this IGA (e.g., Pl, GRAs, SAFER students), must
be submitted to MCDPH OE at http://www.maricopa.gov/epi and will be
considered similar to all other academic institution data requests in
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compliance with OE policies and procedures.
3. If SAFER receives a request for data or information related to activities
covered under this IGA, then they should direct the party to
http://www.maricopa.gov/epi, and MCDPH OE will work with that party in
accordance with OE policies and procedures.
B. The data shall only be accessed at locations which are considered
physically secure for data access and use including, the specified SAFER
call center or MCDPH offices. The data shall not be accessed at any public
venue.
C. Prior to write-up and submission, conference abstracts must undergo the
MCDPH OE abstract approval and submission process. Please see
Attachment C-1 for details. Abstract proposals must be sent to MCDPH OE
at least three (3) weeks prior to submission for review, comment, and
permission to submit.
D. Prior to presenting MCDPH data or referencing work done for or with
MCDPH under this or past IGAs to audiences external to the University of
Arizona and MCPDH, notification must be made, and all materials submitted
for review to MCDPH OE at least five (5) weeks prior to submission. Please
see Attachment C-1 for details.
E. Prior to writing a manuscript that includes MCDPH data or references work
done under this or past IGAs, the project must undergo the MCDPH OE
manuscript approval and submission process. After approval of the project
proposal, a manuscript draft may proceed. Once a draft is complete,
notification must be made, and all materials submitted for review to MCDPH
OE at least five (5) weeks prior to submission. Please see Attachment C-1
for details.
F. For studies, investigations, or field experiences which lead to draft
manuscripts, the SAFER student(s) most involved, Pl, and OE staff will be
invited to contribute and have an author position relative to the amount of
work contributed to the manuscript.”
III.
In accordance with a change in the Investigation Protocol, Paragraph I.A. of
SECTION IV COMPENSATION is hereby deleted in its entirety and replaced with
the following paragraph 1.A.
“1.A. Subject to availability of funds, the County shall pay University of Arizona for
the services described herein not to exceed $60,000.00 per year.”
IV.
SECTION IV COMPENSATION: DELETE the Maricopa County address in
Paragraph 2.F.4 in its entirety and replace with the following:
Maricopa County Department of Public Health Attn: Dr. Sarah Scott
4041 N. Central Avenue, Suite 600
Phoenix, AZ 85012
E-mail: Sarah.Scott@maricopa.gov
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V.
SECTION IV COMPENSATION: DELETE Paragraph 4.2 in its entirety and replace
with the following:
MARICOPA COUNTY:
Maricopa County Department of Public Health, Disease Control Division
Office of Epidemiology
Attn: John Keenan, PhD, MSPH
4041 N. Central Avenue, Suite 612
Phoenix, AZ 85012 Phone:602-372-2621
Email: John.Keenan@maricopa.gov “
VI.
DELETE ATTACHMENT A in its entirety and replace with ATTACHMENT A-1 (2
pages) which is attached hereto and fully incorporated herein.
VII.
DELETE ATTACHMENT B in its entirety and replace with ATTACHMENT B-1 (2
pages) which is attached hereto and fully incorporated herein.
VIII.
DELETE ATTACHMENT C in its entirety and replace with ATTACHMENT C-1 (2
pages) which is attached hereto and fully incorporated herein.
All other terms and conditions of the original IGA shall remain in full force and effect.
IN WITNESS WHEREOF, the parties agree to the changes indicated herein:
FOR
AND
ON
BEHALF
OF
MARICOPA COUNTY
FOR AND ON BEHALF OF
ARIZONA BOARD OF REGENTS on
behalf of University of Arizona
By:
By:
Clint Hickman
Chairman, Board of Supervisors
Elisha Johnson, JD
Director, Clinical Trials and Contracting
Date
Date
ATTEST
Clerk of the Board
Date
APPROVED AS TO FORM
READ AND ACKNOWLEDGED
Attorney for Maricopa County
Kristen Pogreba-Brown, PhD
Date
Date
6/17/2020
June 18, 2020
Elisha Johnson
Digitally signed by Elisha Johnson
Date: 2020.06.18 15:59:44 -07'00'
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ATTACHMENT A-1 (2 Pages)
SAFER Salmonella and Campylobacter Investigation Protocol
Kristen Pogreba-Brown or designee should submit student names and signed user agreements
at the beginning of each semester for each student needing access to MEDSIS. Kristen
Pogreba-Brown or designee will directly facilitate this process with ADHS, access to MEDSIS
will be given to all the students enrolled in Kristen Pogreba-Brown's class as well as SAFER
teaching assistants and program coordinator. MCDPH will provide MEDSIS training, data entry
and user manuals. At the end of their rotation, Kristen Pogreba-Brown or designee should
submit a deactivation request directly to ADHS, for deactivating students’ MEDSIS accounts.
Students who are staying on as members of SAFER for more than one semester should have
that noted as soon as possible to prevent account deactivation.
SAFER will investigate a sample of Campylobacter cases determined by taking ten percent of
the five year monthly average number of cases. The monthly Campylobacter case totals are:
January
6
February
5
March
6
April
10
May
15
June
13
July
9
August
7
September
6
October
6
November
6
December
6
MCDPH will provide enteric-specific investigation training for SAFER students every semester.
Campylobacter and Salmonella cases will be assigned by MCDPH triage team to Kristen
Pogreba-Brown, which will then be distributed to SAFER students for investigation. The Pl will
have the responsibility for managing the investigation queues in MEDSIS to ensure timely
investigation of cases.
SAFER will use the relevant MEDSIS forms for Campylobacter and Salmonella investigations
during case interviews. Students will attempt to interview the case in accordance with protocol
in Attachment B-1 below. SAFER will attempt to collect compete case information, including all
questions from MEDSIS including the DSO.
If during the case investigation, the student determines the case is a food handler, childcare
worker or attendee, or a healthcare worker, or if student(s) discover similarities between two (2)
unrelated cases (not members of the same household; examples included below).
• Consuming food or drink from the same establishment (excluding common venues such
as Taco Bell, McDonalds, Jack in the Box, etc. unless the unrelated cases mention the
same location).
• Visits to the same zoo, farm, pet shop, fair, waterpark, lake, river, social gathering,
sporting event, etc.
• Cases which have similar travel related exposures.
• Cases which reside in the same facility (assisted living, halfway house, etc. or attend
the same adult daycare facility).
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SAFER will send an email to the pre-determined list at MCDPH OE, to be completed at the end
of each shift.
Upon completion of the investigation, data entry into MEDSIS will be done within one (1) day.
"Key" critical MEDSIS fields will be addressed during training; these fields should be completed
if possible.
Any information/data collected during case interviews which does not have a corresponding
data entry field on the DSO shall be entered in the MEDSIS case Comments section. The case
should then be closed and submitted to Arizona Department of Health Services (ADHS) per
MEDSIS training and protocol.
MCDPH will provide SAFER with an informational packet on Salmonella which can be emailed
to the person interviewed after obtaining their email address. For those cases who do not have
an email, SAFER will mail packets via USPS.
The informational packet includes instruction and a seven (7) day food history to be completed
by the case and returned to ADHS via email or USPS. SAFER will request the person not to
reveal their diagnosis when sending via email, simply complete the history and send to ADHS
as indicated. SAFER will enter information gained from the returned seven (7) day food history
into MEDSIS, if returned by case.
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ATTACHMENT B-1 (2 Pages)
Completeness and Timeliness Metrics
In accordance with the MEDSIS data entry and investigation guidelines, the below standards
for the data entry and investigation of cases by SAFER shall apply to Salmonella and
Campylobacter cases.
Initial case entry
•
Salmonella and Campylobacter cases must be entered within one working day.
Control action within appropriate time frame
• For Salmonella only, control action should be initiated within three business days of the
initial case report to public health. This does not mean the date SAFER was notified,
but rather from when the initial case report was received, as indicated above.
Key fields for data entry include:
MEDSIS Key
Fields
MEDSIS Field
All closed cases All investigated cases
Patient Details
County
x
x
Date of Birth
x
Pregnant
x
School Name
x
Race
x
Ethnic Group
x
Primary Language
x
Died
x
Case Details
Local Classification*
x
x
Detection Method
x
x
lnvestiQation Status
x
x
Reportina Source
x
x
Date Report to County
x
x
Onset Date
x
DiaQnosis Date
x
Disease Imported
x
Patient Outcome
x
Case Management
Date
Investigation Started
(date/time field)
x
Case StandinQ
x
Control Action. Were any specific
control actions taken?
x
Type of Control Measure
x
Date Control Measure Initiated
x
Lab Observations
Date Collected
x
Test Result Date
x
Lab Notes
x
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DSO Key Fields
How field appears in
MEDSIS
Campylobacter
Salmonella
Diarrhea
“> 3 loose stools”
X
Hospitalized
“Were
you
hospitalized?”
X
Food handler
“Food handler (work
or volunteer)”
X
Childcare
“Work at or attend
childcare”
X
Contact with similar
symptoms
“Contact
with
someone with similar
symptoms”
Contact with animals
“Any
contact
with
animals
or
animal
products?”
X
Poultry
“Poultry
(chicken,
turkey, etc.)?”
X
Travel
“In the week prior to
your illness onset, did
you travel outside the
country?”
X
*Case Classification: Cases will be entered in MEDSIS for Salmonella, Campylobacter, and
Shigella in accordance with the current classification defined by Arizona Department of Health
Services Case Definitions For Public Health Surveillance found at the following web location:
http://www.azdhs.gov/preparedness/epidemiology-disease-control/index.php#investigations-
case-definitions
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ATTACHMENT C-1 (2 Pages)
Abstract, Presentation, and Manuscript Approval and Submission Process
Conference Abstract and Journal Publication Approval and Submission Process:
Prior to drafting any abstracts or manuscripts that will be submitted to a conference or journal
publication, the author must complete the MCDPH Project Proposal form and submit it to the
designees in OE. The proposal must be discussed prior to abstract/manuscript write-up.
The abstract/publication draft must be approved by all co-authors, the Epidemiology Supervisor
(Dr. Keenan), Program Manager (Dr. White), and MCDPH Division Medical Director (Dr.
Sunenshine) prior to conference/journal submission. Calendar appointments shall be set up for
review of material. In the email, if a conference, please attach appropriate materials and
include the conference name, date, location, the type of presentation accepted and the length
of time for your talk (if applicable). If the subject is a publication, please include the journal
name, deadline submission date, and length of manuscript if applicable.
If substantive comments are made which lead to changes in the conclusions, alteration of
analytic methods, or further analysis, then the updated draft highlighting these changes should
be submitted for review up to either the Epidemiology Supervisor or Program Manager.
If a submission is rejected, the lead author should discuss with the co-authors whether to
submit to another journal or not. If the same manuscript will be submitted to another journal,
notification should be made to all reviewers (except the Division Medical Director) but re-
approval of the manuscript is not needed.
The Epidemiology Supervisor or Program Manager may elect to withdraw the submission if one
of the following conditions are met: 1) the Division Medical Director is unable to approve due to
tight submission deadlines, 2) the Division Medical Director disapproves of the
abstract/manuscript, 3) the Division Medical Director has significant edits which will create a
significant delay or lead to fundamental changes in the body of work.
Presentation Approval Process:
Once selected for a presentation, the lead presenter/author shall determine the submission as
soon as possible. Calendar appointments shall be set up for review of material. In the email, if
a conference, please attach appropriate materials and include the conference name, date,
location, the type of presentation accepted and the length of time for your talk (if applicable).
Abstract Submission Review Timelines:
•
3 weeks prior to submission deadline - The Epidemiology Supervisor shall receive an
email with the title and proposed abstract for edits and review.
•
2 weeks prior to submission deadline - The Epidemiology Supervisor and Program
Manager will return any edits back to the corresponding author for review.
•
1 week prior to submission deadline - A calendar appointment and revised abstract
shall be sent to the Epidemiology Supervisor, Program Manager Division and
Medical Director for final approval
•
48 hours prior to submission deadline - If approved, the final abstract will be returned
to the corresponding author for submission.
Manuscript Submission Review Timelines:
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•
5 weeks prior to submission deadline - The Epidemiology Supervisor shall receive
an email with the full manuscript and all coordinating figures and tables for edits and
review.
•
4 weeks prior to submission deadline - The Epidemiology Supervisor and
Program Manager will return any edits back to the corresponding author for review.
•
3 weeks prior to submission deadline - A calendar appointment shall be sent to
the Epidemiology Supervisor and Program Manager and Division Medical Director for
final review.
•
2 weeks prior to submission deadline - MCDPH will return any edits back to the
corresponding author for review.
•
1 week prior to submission deadline - the corresponding author will submit the
final manuscript for approval.
•
48 hours prior to submission deadline - If approved, the final manuscript will be
returned to the corresponding author for submission.
If the abstract or publication includes data obtained from Arizona Department of Health
Services (ADHS), after approval by MCDPH Division Medical Director, it must be submitted to
ADHS for review and this process shall be facilitated by Epidemiology Supervisor.