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MEMORANDUM OF UNDERSTANDING DATA SHARING AGREEMENT BETWEEN MARICOPA COUNTY DEPARTMENT OF PUBLIC HEALTH (MCDPH) AND NATIVE HEALTH 1. TERM OF THE AGREEMENT: The term of this Agreement shall become effective upon signature by all parties and shall remain in effect until terminated, canceled or extended as otherwise provided herein. 2. TERMINATION OR AMENDMENT: Each party shall have the right to terminate this Agreement by mailing the other party written notice of termination by certified mail, return receipt requested, at least thirty (30) days prior to the termination date. This Agreement may be modified at any time by mutual, written Amendment in order to accommodate unforeseen circumstances by the authorized representative of the respective parties. 3. CONFIDENTIALITY: A. Any information that may be exchanged through this Agreement shall not be used for purposes other than those covered in the scope of work without prior approval of all parties to this Agreement. B. No personally identifying information that may be exchanged through this Agreement shall be made available for any political or commercial purpose, nor shall such information be used as basis for determining eligibility for care or source of payment for care to any individual. C. All data provided by NATIVE HEALTH to the MCDPH shall be used by the MCDPH only for the official purposes of the MCDPH and will be accessible only to duly authorized persons. All authorized persons shall understand and abide by the confidentiality requirements. D. The MCDPH shall provide the names and addresses of any individuals or entities outside the MCDPH who receive the data. The MCDPH shall assure NATIVE HEALTH that the individuals or entities outside the MCDPH will protect the confidentiality and security of the data and the MCDPH shall monitor the individuals or entities outside the MCDPH regarding the confidentiality and security of the data. E. All data provided by NATIVE HEALTH to the MCDPH that is transmitted in emails shall be encrypted F. All data provided by NATIVE HEALTH to the MCDPH shall be stored on a secure server 4. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) COMPLIANCE: Both parties warrant that it is familiar with the requirements of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009, and accompanying regulations and will comply with all applicable HIPAA requirements in the course of this Contract. Both parties warrant that it will cooperate with the other party in the course of performance of the Contract so that both parties will be in compliance with HIPAA, including, if necessary, cooperation and coordination with the Government Information Technology Agency (GITA), Statewide Information Security and Privacy Office (SISPO) Chief Privacy Officer and HIPAA Coordinator and other compliance officials required by HIPAA and its regulations. If requested by either patty, the other party agrees to sign a "Pledge to Protect Confidential Information" and to abide by the statements addressing the creation, use and disclosure of confidential information, including information designated as protected health information and all other confidential or sensitive MEMORANDUM OF UNDERSTANDING information as defined in policy. In addition, if requested, both parties agree to attend or participate in HIPAA training or provide written verification that the party has attended or participated in job related HIPAA training that is: (1) intended to make the Contractor proficient in HIPAA for purposes of performing the services required and (2) presented by a HIPAA Privacy Officer or other person or program knowledgeable and experienced in HIPAA. 5. APPLICABLE LAW: Ar[zona Law Applicable law of Arizona applies to this Agreement including, where applicable, the Uniform Commercial Code as adopted by the State of Arizona. 6. CONFLICT OF INTEREST: Pursuant to A.R.S. §38-511, the State, its political subdivisions or any department or agency of either may, within three (3) years after its execution, cancel any Agreement, without penalty or further obligation, made by the State, its political subdivisions, or any of the departments or agencies of either if any person significantly involved in initiating, negotiating, securing, drafting or creating the Agreement on behalf of the State, its political subdivisions or any of the departments or agencies of either is, at any time while the Agreement or any extension of the Agreement is in effect, an employee or agent of any other party to the Agreement in any capacity or a consultant to any other party of the Agreement with respect to the subject matter of the Agreement. A cancellation made pursuant to this provision shall be effective when both parties to this Agreement receive written notice of the cancellation unless the notice specifies a later time. 7. ARBITRATION: Pursuant to A.R.S. § 12-1518, disputes under this Agreement shall be resolved through the use of arbitration as follows: A. Cases under the Jurisdictional Limit. In all cases filed in superior court in which the court finds or the parties agree that the amount in controversy does not exceed the jurisdictional limit, arbitration shall be used, unless all parties file a written stipulation waiving the arbitration requirement, and the court waives the arbitration requirement on a showing of good cause. 8. FUNDING: This Agreement is not an obligation of or a commitment of funds, or a basis for a transfer of funds, but rather a statement of understanding between the Parties concerning the sharing and use of confidential information related to the purposes of this Agreement. Expenditures by each party are subject to that party's budgetary processes and to the availability of funds and resources pursuant to applicable laws, regulations, and policies of the respective parties. 9. INSURANCE Maricopa County Department of Public Health and its representatives are self-insured under Maricopa County's Declaration of Trust for Maricopa County, Arizona, Self-Insured Risk Trust Fund. 10. NON-DISCRIMINATION Both parties shall comply with Executive Order 2009-09, which mandates that all persons regardless of race, color, religion, sex, age, national origin or political affiliation, shall have equal access to employment opportunities, and all other applicable State and Federal employment laws, rules and regulations, including the Americans with Disabilities Act. All parties shall take affirmative action to ensure that applicants for employment and employees are not discriminated against due to race, creed, color, religion, sex, national origin or disability. MEMORANDUM OF UNDERSTANDING 11. AMENDMENTS Any Amendments to this Agreement must be in writing and signed by both parties. 12. BACKGROUND: The MCDPH is seeking data from the NATIVE HEALTH related to indicators of the latent tuberculosis infection cascade of care related to testing, diagnosis, and treatment practices. The MCDPH is currently working on measures to identify Latent Tuberculosis Infection (LTBI) among populations at high risk in order to accelerate progress towards TB elimination. The data will be solely used for the official purposes of the MCDPH. 13. PURPOSE: This Agreement establishes the basis for the sharing of public health statistics information on Tuberculosis and Latent Tuberculosis Infection testing and treatment practices between NATIVE HEALTH and the MCDPH. The information will be used for the official purposes of the MCDPH. (See Exhibits A and B). The sharing of this data will be in accordance with the Terms and Conditions stated in this Agreement and predicated on the mutual assurance that all unique identifiers in this data will be protected and kept strictly confidential. 14. SCOPE OF WORK: A. NATIVE HEALTH agrees to provide the MCDPH with the data described in Exhibits A and B. 1.1 The above noted data will be made available to the MCDPH within 60 days from the date of execution of the Agreement and forward. 1.2 The above noted data will be made available to the MCDPH by supplying the information requested in the questionnaire (Exhibit B). The information will be entered in a Microsoft Word document and can be sent by an encrypted email or provided to Maricopa County in a protected CD. The information can also be provided in hard copy form. If the information is provided in hard copy form, Maricopa County will enter the information in the Word document (Exhibit B) within 7 business days of receipt. The information shall be stored in a secured server. MCDPH will destroy the hard copy form within 7 business days of receipt. 1.3 The above noted data will be provided as requested for the data sets and time periods specified. 1.4 Following signature of this Agreement by both parties, the above noted data, if available for release, will be provided within sixty (60) days of receipt by NATIVE HEALTH of the specific request. B. Confidential Information: 1. The MCDPH agrees that the name of the institution providing the aggregate information shall not be released outside MCDPH. However, the aggregate information collected in Exhibit B, excluding the name of the provider of the information, will be shared with the Centers for Disease Control and Prevention Tuberculosis Epidemiologic Studies Consortium. 2. The MCDPH shall not use, or disclose to any third party, any data of NATIVE HEALTH in any manner whatsoever except for the various aspects of MCDPH work, and will require that its employees and agents who have access to such information maintain the same strict confidence after the termination of this Agreement; provided that the MCDPH's obligations hereunder shall not apply to information that: MEMORANDUM OF UNDERSTANDING a. Was already known to the receiving party prior to the time of first disclosure, as demonstrated by contemporaneous, written documentation; b. At the time of disclosure is in the public domain, or after the date of the disclosure, lawfully becomes a part of the public domain other than through breach of this Agreement by the receiving party; c. Is received without any obligation of confidentiality from a third party having a legal right to disclose the same; d. Is independently developed by the receiving party by individuals without access to such information, as demonstrated by contemporaneous, written documentation; or e. Is required to be disclosed by the receiving party pursuant to a legally enforceable order, subpoena, or other regulation (ORDER), provided, however, that the receiving party promptly notifies the disclosing party in advance of such disclosure and discloses only that INFORMATION necessary to comply with said ORDER. C. The Parties agree to: 1. Carefully restrict use and access of information to those designated by the MCDPH. Any vital records provided by NATIVE HEALTH are for the use of the MCDPH only and no copies may be made of such records to provide to other individuals or entities for other purposes. 2. Prohibit identifying information about a person that was supplied under the terms of this Agreement, from being released to anyone not working on MCDPH data collection and analysis. 3. Require all officers, agents and employees to keep all such shared information strictly confidential. 4. Communicate the requirements for this section to all officers, agents, and employees; discipline all persons who may violate the requirements of this section; and notify the originating party in writing within forty-eight (48) hours of any violation and corrective actions to be taken. 5. The MCDPH shall provide a copy of their written procedure for notification of the actual or reasonable belief of a data breach to NATIVE HEALTH upon signature by both parties to the Agreement. The procedure shall require users of the data to immediately notify a designated individual at the MCDPH and NATIVE HEALTH. Breach is defined as unauthorized access, use, secondary disclosure, loss, theft, alteration or destruction of the data. Pursuant to A.R.S. § 44- 7501, The MCDPH and NATIVE HEALTH shall collaborate with each other on the investigation, mitigation, remediation and, if necessary, breach notification of citizens. Pursuant to A.R.S. § 41-3507, the MCDPH and NATIVE HEALTH shall notify the Arizona Government Information Technology Agency (GITA) Statewide Information Security and Privacy Office (SISPO) immediately of any breach. 6. Pursuant to Paragraph Four (4), all parties that have access to the data will participate in any training that may be required or shall sign any documents that are reasonably necessary to keep both parties in compliance with HIPAA, including but not limited to, business associate agreement, user confidentiality affirmation statement, HIPAA training certification or other HIPAA related compliance documents. 7. The data shall only be accessed at locations which are considered physically secure for data access and use including but not limited to, specified MCDPH offices or other authorized locations. The data shall not be accessed at any public venue. 8. The MCDPH shall maintain a log of all encrypted devices and identification numbers of those devices that are authorized to transmit, receive or store the information until the data is destroyed. NATIVE HEALTH may request a copy of the log at any time during the term of the Agreement or MEMORANDUM OF UNDERSTANDING until the data is destroyed or returned to NATIVE HEALTH. The MCDPH is prohibited from storing the data on non-encrypted flash drives, CDs, external drives, smart phones or other non- networked hard drives. 15. NOTICES, CORRESPONDENCE AND REPORTS: A. Notices, correspondence and reports from the MCDPH to NATIVE HEALTH shall be sent to: Patricia Patron Chief Operating Officer 4041 N. Central Avenue, Bldg. C Phoenix, AZ 85012 602-279-5262x3134 ppatron@nachi.com vvww.nativehealthphoenix.org B. Notices, correspondence and reports from NATIVE HEALTH to the MCDPH shall be sent to: Maricopa County Department of Public Health Division of Clinical Services - TBESC Senior Research Epidemiologist 1645 E. Roosevelt Street Phoenix, AZ 85006 602-372-7413 MEMORANDUM OF UNDERSTANDING SIGNATURES/APPROVALS: FOR NATIVE HEALTH: By PC.3 — Date: SI 1 —i I 200? By Date: FOR AND ON BEHALF OF MARICOPA COUNTY BY AND THROUGH ITS DEPARTMENT OF PUBLIC HEALTH By Steve Chucri Chairman, Board of Supervisors Date ATTEST: By Clerk of the Board Date APPROVED AS TO FORM: Attorney for Maricopa County Date MEMORANDUM OF UNDERSTANDING EXHIBIT A The Maricopa County Department of Public Health (MCDPH) Division of Clinical Services is currently working on measures to identify Latent Tuberculosis Infection (LTBI) among populations at high risk in order to accelerate progress towards TB elimination. MCDPH is gathering LTBI data from healthcare providers regarding screening practices, diagnosis, and treatment. The information will be used to develop estimates for the TB prevention and treatment cascade in Maricopa County. All prevention cascade estimates will be calculated based on aggregate information. MCDPH plans to share and release aggregate estimates in scientific publications, public health reports, and during collaboration with other public health partner agencies. MCDPH will not release the name of the partner facility and will not use facility identifiers in any reports or publications. MCDPH understands that each facility may have different information available and that they may be willing to share certain variables but perhaps not others. Although not ideal, it is still very useful for MCDPH to access this data, even if such data cannot be shared in its entirety. Ideally, MCDPH would like to receive information for at least a six-month consecutive period of time. MCDPH would prefer to receive information from the period of July 1, 2016 to December 31, 2016 but other consecutive six month periods are acceptable. If this period is unavailable, MCDPH can accept any consecutive six month retrospective period that is available in 2017 or 2018. Exhibit B shows the questionnaire that will be used to gather information. MEMORANDUM OF UNDERSTANDING EXHIBIT B: Data Collection Tool See Next 4 Pages EXHIBIT B TBESC, TUBERCULOSIS EPIDEMIOLOGIC STUDIES CONSORTIUM-fl Data Collection Tool for TBESC clinical partners: An aggregate summation of important indicators for LTBI cascade to cure This document is a tool to collect aggregate level data from your clinical partners outside your TB program. TBESC recognizes that not every provider will collect all of these variables; what follows is a list of the variables we would like if they are available. Knowing what variables are not available is also important information. We recommend that site study staff fill out this form in collaboration/conversation with the partner(s), rather than sending them the document to fill out without your assistance. NOTE that we are interested in data that your partners already collect and can easily access. Estimates, including percentages, are welcome where specific numbers are not available. CDC will not have access to facilities' names and will not use facility identifiers in any reports or publications. We would like to collect six months of aggregate level data, preferably for the same 6-month timeframe that the TBESC site used for entry of cascade data into STEMS. If that is not possible, pick a 6-month cohort period that is convenient for the site and its partner. If a patient's treatment extends beyond this 6-month period, include completion (or non-completion) data in the aggregate totals if possible. TBESC Site: Partner outside the TB program (the name should not be transmitted to CDC): Cohort Dates for Aggregate Data Collection: 1. What kind of medical record system does your partner provider/clinic use (select one): CI Electronic El Paper El Both 2. If yes to electronic, what system (e.g. Epic, Cerner, eClinicalWorks, etc...): 4 CDC EXHIBIT B TBESCAA, TUBERCULOSIS EPIDEMIOLOGIC STUDIES CONSORTIUM n FACILITY DESCRIPTIVE INFORMATION 3. Total number of patients seen during cohort period: 4. Age: Number OR Percent <18 years old: 5 5 years old: . % 5. Total number of patients with HIV: OR 6. Patients' top 5 countries of birth outside the U.S. Number OR Percent 1.) 2.) 3.) 4.) 5.) 7. Patients' top 5 languages spoken, including English (NOTE: we are interested in the patient's primary spoken language): Number OR Percent 1.) 2.) 3.) 4.) 5.) FACILITY'S APPROACH TO LTBI TESTING AND TREATMENT 8. Does your partner facility provide on-site testing for LTBI? Yes No 8a. If NO: Please indicate how your partner facility handles patients who need LTBI testing. 8b. IF YES: Which LTBI test(s) does your partner facility use (select all that apply): El 1ST 1:1 OFT CI TSPOT TBEs0,4-„, TUBERCULOSIS EPIDEMIOLOGIC STUDIES CONSORTIUM II 9. Does your partner facility provide on-site treatment for LTBI? Yes No 9a. If NO: Please indicate how your partner facility handles patients who need treatment for LTBI. 9b. IF YES: Which LTBI treatments does your partner facility use (select all that apply): 0 Isoniazid, 9 months 0 Isoniazid, 6 months CI Rifampin, 4 months CI Isoniazid and rifapentine, 12 weeks—directly observed therapy Li Isoniazid and rifapentine, 12 weeks—self-administered therapy 10. Please list the main reasons your partner facility tested patients for LTBI during the six-month cohort period (e.g., medical reasons [chronic dialysis treatment, treatment with TNF inhibitors], administrative screening [students, employees, residents of congregate facilities, etc.], refugee/immigrant screening) NOTE: This includes patients tested in-house and those referred out for testing. Number OR Percent 1.) 2.) 3.) 4.) 5.) AGGREGATE NUMBERS FOR LTBI TESTING AND TREATMENT 11. Tested for LTBI/TB: 12. Of those tested for LTBI, how many were positive? OR 13. Of those who tested positive, how many received a clinician diagnosis of LTBI? OR 14. Of those diagnosed with LTBI, how many started treatment? OR 15. Of those who started treatment, how many completed treatment? OR 16. Does your partner facility document why patients were not offered treatment? Yes 1=1 No TBESC(45, TUBERCULOSIS EPIDEMIOLOGIC STUDIES CONSORTIUM-II If yes, please indicate the most common reason(s) treatment was not offered. Number OR Percent 1.) 2.) 3.) 4.) 5.) 17. Does your partner facility document why patients did not complete treatment? 1:1 Yes No 18. If yes, please indicate the main reason(s) patients did not complete treatment. Number OR Percent 1.) 2.) 3.) 4.) 5.) K. CDC