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CONTRACT NO: C-86-13-089-3-05 AMENDMENT NO: 4 AMENDMENT TO THE INTERGOVERNMENTAL AGREEMENT between MARICOPA COUNTY by and through its DEPARTMENT OF PUBLIC HEALTH and ARIZONA BOARD OF REGENTS FOR AND ON BEHALF OF THE UNIVERSITY OF ARIZONA This fourth amendment, effective July 1, 2017, amends the above Agreement entered into on May 22, 2013, and modified via Amendment Nos. 1, 2, and 3 between Maricopa County by and through its Department of Health (MCDPH), and the Arizona Board of Regents for and on behalf of the University of Arizona (Contractor). The Parties wish to amend the Agreement as follows: I. Section Ill, Work Statement, as modified by Amendment No. 3, is deleted and replaced in its entirety with the attached Work Statement. The revised Work Statement includes changes to incorporate the following, as agreed upon by the parties: a. Include throughout additional responsibility for Contractor to report on Shigella, in addition to Campylobacter and Salmonella. b. Update submission timelines in Part 5, RIGHTS IN DATA, to require Contractor abstracts be sent to MCDPH at least 3 weeks prior to submission, and publications and presentations external to Contractor sent to MCDPH at least 5 weeks prior to submission. II. Section IV, Compensation, as modified by Amendment No. 3, is deleted and replaced in its entirety with the attached Compensation. The revised Compensation is changed to indicate the authorized budget for July 1, 2017 through June 30, 2018 in the not-to- exceed amount of $134,000. III. Attachment D, as modified by Amendment No. 3, is deleted and replaced in its entirety with the attached Attachment D. The revised Attachment D adds Shigella to list of diseases, updates the MEDSIS liaison contact and removes the requirement regarding an abbreviated form. IV. Attachment E as modified by Amendment No. 3, is deleted and replaced in its entirety with the attached Attachment E. The revised Attachment E adds Shigella to list of diseases and adds a new table of key fields to be completed by Contractor. V. Add Attachment F, Abstract and Manuscript Submission Protocol to the contract documents, to add abstract and publication and presentation submission requirements as referenced in the modified in the Amended and Restated Work Statement. Except as amended herein, all of the terms and conditions of the Agreement and previous amendments shall remain unchanged and in full force and effect. IN WITNESS WHEREOF, the parties agree to the changes indicated herein: FOR AND ON BEHALF OF FOR AND ON BEHALF OF MARICOPA COUNTY THE ARIZONA BOARD OF REGENTS ON BEHALF OF THE UNIVERSITY OF ARIZONA By: By: Denny Barney, Chairman, Board of Supervisors Date Date ATTEST Clerk of the Board Date APPROVED AS TO FORM APPROVED AS TO FORM Attorney for Maricopa County Associate General Counsel Date Date Attachments: Work Statement (5 pages) Compensation (1 page) Attachment D (2 pages) Attachment E (2 pages) Attachment F (1 page) WORK STATEMENT SECTION III WORK STATEMENT 1. PURPOSE The University of Arizona's Mel and Enid Zuckerman College of Public Health (MEZCOPH) 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) during large community events such as the Super Bowl, infectious disease outbreaks, and public health emergencies. SAFER will provide public health and epidemiology students with experiential learning opportunities and will enhance MCDPH preparedness for public health emergencies and contribute to the safety of Maricopa County citizens. The SAFER students function under the Maricopa County Office of Epidemiology (OE) and will be coordinated by the Incident Command Center (ICC) as needed in coordination with the Maricopa County Office of Preparedness and Response (OPR). 2. BACKGROUND The University of Arizona's Mel and Enid Zuckerman College of Public Health (MEZCOPH) 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 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. 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. Document on a quarterly basis (inclusive of Campylobacter, Salmonella, and Shigella): • Number (N) of cases received • Number (N) of cases Interviewed • Number (N) of attempts to contact • Number (N) interviewed afterhours and weekends • A final year end "cleaned" dataset will be appended to the annual report E. SAFER performance of case and outbreak investigations must comply with completeness and timeliness metrics which MCDPH is subject to. Please see Attachment E for further clarification. F. The Pl will return a cleaned data set of all case investigation data to MCDPH OE once the annual report is completed and reviewed by MCDPH. 4. EXPECTATIONS AND METHODOLOGY A. During Events and Exercises The University of Arizona's Mel and Enid Zuckerman College of Public Health (MEZCOPH) Student Aid for Field Epidemiology Response (SAFER) Team will provide response aid to Maricopa County Department of Public Health (MCDPH) during events, outbreaks, and emergencies. The SAFER Students will function under the direction of OE in coordination with the Office of Preparedness and Response (OPR). SAFER students serve on the field epidemiology team during various large events in Maricopa County including sporting events, Annual Fiesta College Bowls, Phoenix International Raceway (PIR) events, and other situations when the decision is made by OE to activate the team. B. Assist with Outbreaks and Enteric Disease Investigations, Data Collection and Analysis During routine enteric disease investigations, pandemics, and other large outbreaks, the students will function under the direction 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 based interview distribution and collection. Analysis of data is limited to that required for routine quality assurance analysis to ensure the IGA requirements are being met and the annual SAFER report being produced. Additional descriptive and/or complex data analysis may also be completed in collaboration with OE following a written request and permission granted. In order to increase timeliness and efficiency on reports, it is understood by MCDPH that the SAFER Students will enter data into an online database and the faculty Pl/Director, GRAs, or other student workers will be responsible for transfer of the data into Medical Electronic Disease Surveillance Intelligence System (MEDSIS) on behalf of MCDPH. Priority of data collection and data entry will be determined by MCDPH. See Attachments D and E for clarification. For outbreaks and single case investigations, the data should be collected from the clients/cases using MCDPH supplied forms. Any additional data collected which is not included on the original MCDPH form shall be included in the online database only with the express permission of MCDPH. 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. I. For cases with contact phone numbers and address: A. A maximum of up to three (3) attempted phone calls with varied time of day contact (i.e.: morning, evenings and weekends). B. A MCDPH standardized contact letter sent to address if phone contact is unsuccessful after three (3) attempts. II. MCDPH will provide updated contact information for cases. If for any reason the contact information is incorrect or missing the follow steps should be taken: A. For cases with contact phone numbers, but no contact address: A maximum of up to three (3) attempted phone calls. B. For cases with contact address, but no contact phone number (after MCDPH search): A MCDPH standardized contact letter sent to address. C. For cases with no contact information: Contact provider to retrieve contact address and/or phone number MCDPH will provide updated contact information when possible. 5. RIGHTS IN DATA A. Uses of Data: A.1. Carefully restrict use and access of information to those designated by MCDPH. A.1.A. No data, aggregate or line list, may be released by SAFER. A.1.B. 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 (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 compliance with OE policies and procedures A.1.C. If SAFER receives a request for data or information related to activities covered under this IGA, they should direct the party to http://www.mari copa.gov/epi and MCDPH OE will work with that party in accordance with OE policies and procedures. A.2. The data shall only be accessed at locations which are considered physically secure for data access and use including, specified SAFER call center or MCDPH offices. The data shall not be accessed at any public venue. A.3. For submission of abstracts, the abstract must be sent to MCDPH OE at least 3 weeks prior to submission to review and comment on. Please see Attachment F for details. A.4. For publications and presentations external to the University of Arizona which present MCDPH data or reference work done for or with MCDPH under this or past IGAs, notification must be made and all materials submitted for review to MCDPH OE at least 5 weeks prior to submission. Please see Attachment F for details. A.5. For studies, investigations, or field experiences which lead to draft manuscripts, the SAFER student(s) most involved and/or Pl as well as OE staff will be invited to contribute and have an author position relative to the amount of work contributed to the manuscript. 6. SECURITY OF CONFIDENTIAL INFORMATION A. The Contractor shall monitor the use of all Public Health Data disclosed by MCDPH under this IGA, including but not limited to Personal Identifying Information, and to carefully restrict the use and disclosure of such information as provided for herein. B. Survival of Duty to Protect Confidential Information It is understood and agreed by the Parties that the obligations set forth in this Section 6 shall survive the expiration or termination of this IGA, except as expressly provided for herein. C. Minimum Safeguards for Protected Health Information The Contractor shall carefully restrict use and access of MCDPH Personally Identifying Information solely to Authorized Persons and shall ensure that the Contractor implements the following minimum safeguards to prevent a Security Breach in a manner consistent with the requirements of this IGA or applicable law. Contractor safeguards shall, at the minimum, require that the Contractor and its Authorized Persons: C.1. Prohibit Personally Identifying Information supplied under the terms of this IGA from being released or disclosed to anyone not working on MCDPH data collection and analysis as an Authorized Person. C.2. Secure all printouts containing individual identifiers or confidential data in a locked vault, file cabinet or other method reasonably necessary to protect the confidential information. C.3. Store all Public Health Data shared pursuant to this IGA only on secured servers or encrypted devices within MCDPH, which, at the termination of this IGA, shall be securely deleted upon the conclusion of this IGA consistent with the requirements of this IGA and applicable law. C.4. Provide MCDPH with a description of the security measures that are in place to maintain the confidentiality of the data being received under this IGA. C.5. Provide MCDPH, upon request, with a current list of Authorized Persons, and evidence that all Authorized Persons who have access to the Public Health Data shared under this IGA have participated in any required training and signed any documents that are necessary to keep both MCDPH and the Contractor in compliance with HIPAA, including but not limited to, user confidentiality affirmation statement, HIPAA training certification or other HIPAA related compliance documents, if applicable. C.6. Provide or continue to provide MCDPH with a copy of the contractor's procedure for the notification of MCDPH of any Security Breach, which shall include a requirement that any user of the Public Health Data shared under this IGA shall immediately notify a designated individual at MCDPH of any known or reasonably suspected Security Breach. C.7. Maintain a log of all encrypted devices and identification numbers of those devices that are authorized to transmit, receive, or store the Public Health Data shared under this IGA, until the data is destroyed. MCDPH may request a copy of the log at any time during the term of the IGA or until the data is destroyed. C.8. Make clear to all Authorized Persons and other employees with a need to know that the Contractor is prohibited from storing Public Health Data on non- encrypted flash drives, CDs, external drives, smart phones or other non- networked hard drives. C.9. Provide MCDPH prompt proof of the complete destruction of the original data and any copies or subsidiary data sets containing Personally Identifying Information that are developed from the original data upon the conclusion of this IGA or at such time that such destruction is required by applicable law and in compliance with County record retention policies. Proof of destruction may include a certificate of destruction. D. Security Breach In the event of a Security Breach, pursuant to A.R.S. § 44-7501, MCDPH and the Contractor agree to collaborate with each other on the investigation, mitigation, remediation and, if necessary, breach notification of citizens. Pursuant to A.R.S. § 41- 3507, MCDPH shall notify ADHS and the Arizona Strategic Enterprise Technology (ASET) Statewide Information Security and Privacy Office (SISPO) immediately upon becoming aware or receiving notice of a Security Breach. 7. AMENDMENTS AND EXTENSION All amendment to this Agreement must be in writing and signed by both parties. COMPENSATION SECTION IV COMPENSATION 1. COMPENSATION REIMBURSEMENT RATE is $134,000 per year. 1.1. Subject to availability of funds and as amended to the Contract by the parties each year, the County shall pay the University of Arizona for the services described herein in the not-to-exceed amount of $134,000 per year. The annual allocations authorized and appropriated by MCDPH are as follows: July 1, 2013 to June 30, 2014: $134,000 July 1, 2014 to June 30, 2015: $134,000 July 1, 2015 to June 30, 2016: $134,000 July 1, 2016 to June 30, 2017: $134,000 July 1, 2017 to June 30, 2018: $134,000 1.2. Compensation will be reimbursed on a monthly fixed rate. Any changes to funds allocated for this Agreement shall be adjusted via Amendment in writing and signed by both parties. ATTACHMENT D SAFER Salmonella and Shigella Investigation Protocol MCDPH will facilitate getting access to MEDSIS for Kristen Pogreba-Brown and SAFER Teaching Assistants (TAs) and will provide MEDSIS training and user manuals. If students are to have access to MEDSIS, 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. Jennifer Collins is the MEDSIS liaison who will be responsible for deactivating student MEDSIS accounts at the end of their rotation. 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. MCDPH will provide Salmonella and Shigella specific investigation training for SAFER students every semester. This can be incorporated into the training session normally given at the start of the semester. New Salmonella and Shigella cases will be assigned by MCDPH triage to Kristen Pogreba-Brown or a current TA which will then be distributed to SAFER students for investigation. Salmonella and Shigella cases indicating the case is a food handler, childcare worker or attendee, or healthcare worker will not be assigned to SAFER but rather handled by MCDPH staff. The Pl will have the responsibility for managing the investigation queues in MEDSIS to ensure timely investigation of cases. MCDPH will provide SAFER the Salmonella and Shigella investigation form to be used during case interviews, students will attempt to interview the case in accordance with protocol in Attachment E below. If during the case investigation, the student determines the case is a food handler, childcare worker or attendee, or is a healthcare worker. Also, 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, water park, 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). SAFER will send an email to the designated and pre-determined list at MCDPH OE. This will be done at the end of the shift, outlining all the following information (in the table format below): MEDSIS ID Binational Others Ill New Contact Needed Upon completion of the investigation, Kristen Pogreba-Brown or a TA will enter information contained in the form into corresponding MEDSIS fields within one (1) day. "Key" critical MEDSIS fields will be addressed during training; these fields should be filled if at all 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 notes 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 and Shigella 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. ADHS will enter information gained from the returned seven (7) day food history into MEDSIS. ATTACHMENT E 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, Campylobacter, and Shigella cases. Initial case entry • Salmonella, Campylobacter, and Shigella cases associated with a food-handler, day care worker or attendee, or healthcare worker must be entered within one working day. • Salmonella, Campylobacter, and Shigella cases not associated with a special population must be entered within three working days. 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 MEDSIS Field All closed All investigated Fields cases cases County X X Date of Birth X Pregnant X School Name X Patient Details Race X Ethnic Group X Primary Language X Died X Local Classification X X Detection Method X X Investigation Status X X Reporting Source X X Case Details Date Report to County X X Onset Date X Diagnosis Date X Disease Imported X Patient Outcome X Date Investigation Started X (date/time field) Case Standing X Case Control Action: were any specific Management control action taken? X Type of Control Measure X Date Control Measure Initiated X Lab Observations Date Collected X Test Result Date X Lab Notes X DSO Key Fields How field appears in MEDSIS Campy Salmonella Shigella Diarrhea “>3 loose stools” X X Hospitalized “Were you hospitalized?” X X Food handler “Food handler (work or volunteer)” X X Childcare “Work at or attend childcare” X X Contact with “Contact with someone with similar X similar symptoms symptoms?” Contact with “Any contact with animals or animal X animals products?” Poultry “Poultry (chicken, turkey, etc.)?” X Travel “In the week prior to your illness onset, did you travel outside the X country?” 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- casedefinitions ATTACHMENT F Abstract and Manuscript Submission Process and Approval Conference Abstract and Journal Publication Submission Process: Prior to receiving an approval for any abstract/ journal publication submission. Abstract submission topic shall be discussed with the assigned supervisor prior to write up. The abstract/ publication draft shall be approved by all co-authors, assigned supervisor, Nursing Supervisor and/or Program Manager and the MCDPH Division Director prior to conference/ journal submission. 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 Nursing Supervisor or Program Manager. If a submission is rejected, the lead 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 Director) but re-approval of the manuscript is not needed. If the Division Director is unable to approve due to tight submission deadlines, authors shall agree to withdraw the submission if the Division Director subsequently disapproves of the abstract/manuscript or has significant edits. Presentation/ Manuscript Process and Approval: Once selected for a presentation or publication, the lead presenter/ author shall determine the submission/print date 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). If the subject is a publication, please include the journal name, deadline submission date, length of manuscript if applicable. Abstract Submission Review Timelines: • 3 weeks prior to submission deadline - The assigned supervisor shall receive an email with the title. • 2 weeks prior to submission deadline - A calendar appointment shall be sent to the assigned supervisor and one of the office supervisors. • 1 weeks prior to submission deadline - A calendar appointment shall be sent to the assigned supervisor, one of the office supervisors, Dr. Rebecca Sunenshine and administrative assistant. Manuscript Submission Review Timelines: • 5 weeks prior to submission deadline - The assigned supervisor shall receive an email with the title. • 4 weeks prior to submission deadline - A calendar appointment shall be sent to the assigned supervisor and one of the office supervisors. • 3 weeks prior to submission deadline - A calendar appointment shall be sent to the assigned supervisor, one of the office supervisors, Dr. Rebecca Sunenshine and Administrative Assistant. * If the abstract or publication includes data obtained from Arizona Department of Health Services (ADHS), after approval by MCDPH Division Director, it must be submitted to ADHS for review and this process shall be facilitated by Kate Goodin.