CASE-BASED SURVEILLANCE TOOLKIT Tools, Tips and Strategies for Strong Surveillance
May 2015
National Alliance of State & Territorial AIDS Directors Acknowledgements
For more than 23 years, the National Alliance of State & Territorial AIDS Directors (NASTAD) has worked to strengthen the role and promote the success of health departments as they develop health systems that reduce HIV/AIDS and viral hepatitis incidence, ensure quality care and treatment, and improve health outcomes.
NASTAD’s lead authors, Genevive Meredith, Robin Flanagan, and Anna Carroll developed this toolkit drawing on the experience developed through NASTAD’s support for case-based surveillance system development and quality utilization in PEPFAR-funded countries over the last 10 years.
Technical and experiential input, as well as practical tools and materials, have been compiled from NASTAD’s work in Haiti, Trinidad and Tobago, Guyana, Ethiopia, Zambia and Botswana, as well as from a series of Regional Integrated HIV/AIDS Surveillance Workshops implemented with CDC/DGHA/Epidemiology and Strategic Information Branch (ESIB) in Asia, East Africa, West Africa, the Caribbean, and Central America.
Specific thanks and recognition go to:
NASTAD Global staff: Girma Assefa, Annie Coriolan, Sheena De Freitas, Michelle Batchelor, Mark Griswold, Luisa Pessoa-Brandão, Barbara Roussel, Anne Sites, and Lucy Slater
NASTAD Technical Assistance providers: Chris Delcher, Jamie Cotnoir, Bethsabet de Leon- Justiniano, Mari Gasiorowicz, Jennifer Gunderman, Eve Mokotoff, Amy Robbins, and Jami Stockdale.
Acknowledgements June 2014
National Alliance of State & Territorial AIDS Directors 444 North Capitol Street, NW, Suite 339 Washington, D.C. 20001-1512
(202)434-8090 (phone) www.NASTAD.org
Development of this publication was supported by the Department of Health and Human Services (DHHS)/ Centers for Disease Control and Prevention (CDC) Division of Global HIV/AIDS (DGHA) Cooperative Agreement 5U2GPS001617. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC. Table of Contents
Acronyms ...... 6
Introduction: Case-based Surveillance of HIV...... 7
Surveillance Overview ...... 8 A. HIV Surveillance ...... 9
B. Case-based Surveillance of HIV ...... 10
C. Case-based Surveillance and Second Generation Surveillance ...... 13
D. Structure of This Toolkit ...... 14
Setting the Stage Case-based Surveillance System Development ...... 15
Module 1: Building Blocks of a Case-based Surveillance System ...... 17 1. Overview ...... 18 1.1: System Governance and Partner Engagement ...... 19 A. Leadership and Governance ...... 20 B. Regulatory Framework ...... 21 Table Contents of C. Stakeholder Engagement ...... 28 1.2: Human Resources to Support Case-based Surveillance ...... 30 A. Basic Human Resource Needs ...... 31 B. Advanced Human Resource Needs ...... 36 C. Training and Skills Building ...... 37 D. Human Resource Support and Supervision ...... 38 E. Human Resources Policies ...... 39 1.3: Case Reporting Process ...... 41 A. Reportable Events ...... 42 B. Data Sources ...... 46 C. Data Collection ...... 48 D. Case Reporting Policies and Procedures ...... 51
1 1.4: Data Systems to Manage Case Surveillance Data ...... 52 A. Data Transfer ...... 53 B. Electronic Information System ...... 57 C. Data Cleaning and Quality Assurance ...... 59 D. Case Matching ...... 60 E. Related Policies and Procedures ...... 62 1.5: Using Case-Based Surveillance Data ...... 65 A. Surveillance System and Process Monitoring ...... 66 B. Epidemiological Profiling ...... 69 C. Quality Improvement ...... 85 D. Data Use Related Policies and Procedures ...... 87
Module 2: Building and Improving a Case-based Surveillance System ...... 89
2.0: Overview ...... 90 2.1: Envisioning Your Case-based Surveillance System ...... 92 A. Define What You Want To Know ...... 93 B. Determine What Data You Will Need To Answer Your Questions ...... 94 C. Consider If The Desired Data Exist, and Where ...... 95
D. Consider How Cases May Be Reported ...... 97 Table Contents of E. Consider The Human Resources Required ...... 98 F. Summarize Your [draft] Vision ...... 99 2.2: Establishing Buy-in and Support ...... 100 A. Identify Key Stakeholders and Decision Makers ...... 100 B. Meet with Key Stakeholders and Decision Makers ...... 101 C. Establish a Technical Working Group ...... 102 2.3: Implementing an Environmental Scan ...... 104 A. Plan the Environmental Scan ...... 105 B. Conduct the Environmental Scan ...... 107 C. Summarize your Findings...... 109
2 2.4: Define and Plan Your Case-based Surveillance System ...... 112 A. Design the System ...... 113 B. Develop Required Policy ...... 114 C. Develop the Case Report Form ...... 116 D. Design Data Transfer Systems ...... 117 E. Design Data Management System ...... 118 F. Develop a Monitoring and Evaluation Process ...... 122 G. Develop the Standard Operating Procedures ...... 128 H. Plan for Sufficient and Skilled Human Resources ...... 130 I. Summarize Plan and Submit for Ethics Review and Approval ...... 133 2.5: Implement and Improve Your System ...... 138 A. Train Human Resources and Orient Reporting Facilities ...... 138 B. Implement Your Plan ...... 143 C. Support the Process ...... 145 D. Monitor and Evaluate the Process ...... 147 E. Improve the Process ...... 149 F. Expand the Process ...... 151
References...... 154
Appendices ...... 164 Table Contents of Index of Appendices, by Chapter ...... 164 Index of Appendices, by Source ...... 171 Index of Appendices, by Type...... 178
3 List of Tables and Figures
0. HIV Surveillance Overview ...... 8 Figure I: Monitoring the Spectrum of HIV Disease ...... 11 Figure II: UNAIDS Depiction of Second Generation Surveillance ...... 13
1.0. Building Blocks ...... 17 Figure 1.1: Building Blocks of a Case-based Surveillance System ...... 18
1.1. System Governance and Partner Engagement...... 19 Figure 1.2: Four Dimensions of Strong Leadership ...... 20 Figure 1.3: Mosaic of Case-based Surveillance of HIV Stakeholders ...... 28
1.2. Human Resources to Support Case-based Surveillance ...... 30 Table 1.1: National Level Human Resources Roles and Responsibilities ...... 32 Table 1.2: Sub-national Level Human Resources Roles and Responsibilities ...... 34 Table 1.3: Reporting Site Staff Roles and Responsibilities...... 35 Table 1.4: Advanced Human Resource Roles and Responsibilities ...... 36
1.3. Case Reporting Process ...... 41 s and Figures Figure 1.4: Minimum Reportable Events for Case-based Surveillance ...... 42 Table 1.5: Definition of Reportable Events for HIV Case Surveillance...... 42 Figure 1.5: Comprehensive Reportable Events for Case-based Surveillance ...... 43 Table 1.6: Definition of Reportable Events for Comprehensive HIV Case Reporting ...... 43 Figure 1.6: Additional Reportable Events for Pediatric Case-based Surveillance ...... 44
Table 1.7: Definition of Additional Reportable Events for Pediatric HIV Case Surveillance .... 45 List Table of Figure 1.7: Sources and Types of Data to Consider for HIV Case Reporting ...... 46
1.4. Data Systems to Mange Case Surveillance Data ...... 52 Figure 1.8: Sample Case-based Surveillance Data System Design ...... 53 Figure 1.9: Flat Model ...... 55 Figure 1.10: Hierarchical Model ...... 55 Table 1.8: Step One: Automated Case Matching and Data Cleaning Using Patient ID ...... 60 Table 1.9: Step Two: Automated Case Matching and Data Cleaning Using Patient ID ...... 61 Table 1.10: Example of a Basic Data Dictionary ...... 62
4 1.5. Data Use ...... 65 Figure 1.11: HIV Clinical Cascade ...... 77 Figure 1.12: Number and Percentage of HIV-Infected Persons Engaged in Selected Stages of The Continuum of HIV Care, United States, 2010 ...... 79 Figure 1.13: Percentage of Persons Diagnosed with HIV Engaged In Selected Stages of the Continuum of Care, By Sex at Birth, Minnesota ...... 80 Figure 1.14: Plan, Do, Study, Act Model for Continuous Quality Improvement ...... 85
2.0. Building and Improving a Case-based Surveillance System ...... 89 Figure 2.1: Steps for HIV Case-based Surveillance System Design and Reinforcement ...... 91
2.1. Envisioning Your Case-based Surveillance System ...... 87 Figure 2.2: Sources of Data to Consider for HIV Case Reporting ...... 96
Figure 2.3: Sample Case-based Surveillance Data System Design ...... 97
2.2. Establishing Buy-in and Support ...... 100 Figure 2.4: Mosaic of Case-based Surveillance of HIV Stakeholders ...... 100
2.3. Implementing an Environmental Scan ...... 104 Table 2.1: Four Components of a SWOT Assessment ...... 106 Figure 2.5: How to Implement a SWOT Assessment ...... 107
2.4. Define and Plan Your Case-based Surveillance System ...... 112 Table 2.2: Sample Process and Outcome Standards for Case-based HIV Surveillance ...... 123 Table 2.3: Suggested Monitoring Process ...... 126 Table 2.4: Sample Monitoring Plan Outline ...... 127 Figure 2.6: Characteristics of a Successful SOP ...... 128 List and Tables Figures of Table 2.5: Staff-specific Management Data Related Activities for Case-based Surveillance ... 131
2.5. Implement and Improve Your System ...... 138 Table 2.6: Level of Knowledge Needed among Personnel and Stakeholders to Support an Effective Case-based Surveillance System ...... 141 Table 2.7: Four Supportive Processes for Ensuring Maximum Human Resource Performance...... 146 Table 2.8: Routine Processes for Maximizing System Use and Data Quality ...... 148 Figure 2.7: Plan, Do, Study, Act Cycle ...... 149 Table 2.9: Steps of the PDS Method ...... 150
5 Acronyms
WHO World Health Organization UNAIDS Joint United Nations Programme on HIV/AIDS CDC Centers for Disease Control and Prevention ART Antiretroviral Therapy VCT Voluntary Counseling and Testing (for HIV) PICT Provider Initiated (HIV) Counseling and Testing TB Tuberculosis PMTCT Prevention of Mother to Child Transmission VMMC Voluntary Medical Male Circumcision ANC Antenatal Clinic EID Emerging Infant Diagnosis
MOH Ministry of Health PLHIV Person Living with HIV SOP Standard Operating Procedures EMR Electronic Medical Records
PCR Polymerase Chain Reaction Acronyms HCT HIV Counseling and Testing VL Viral Load CBO Community-Based Organization CQI Continuous Quality Improvement ToR Terms of Reference TWG Technical Working Group IRB Institutional Review Board SWOT Strengths, Weaknesses, Opportunities and Threats
6 INTRODUCTION CASE-BASED SURVEILLANCE OF HIV Case-based Surveillance of HIVCase-based Surveillance of
7 Surveillance Overview
Public health surveillance is the practice of measuring and monitoring rates of disease in a population, typically via the ongoing, systematic collection, analysis, interpretation, and dissemination of data regarding a health-related event. This process is critical in:
Identifying disease outbreaks
Highlighting areas where disease is concentrated
Providing key information for designing effective public heath interventions
Informing disease prevention or treatment interventions
Evaluating public health programs
Public health surveillance can help you answer the following key questions:
Who: Is infected? Overview Most needs prevention, treatment or care interventions?
How: Are individuals becoming infected?
Where: Are infections concentrated? Should interventions/services be targeted?
When: Was there a change in epidemiology of the disease? Was there a change in clinical outcomes? Are individuals with the disease entering into care? Surveillance
What: Are factors that influence disease transmission? Interventions might support a decline in infections?
Answers to these questions can help you to effectively plan programs, allocate resources, and evaluate impacts.
8 A. HIV Surveillance
Since the HIV virus (which causes AIDS) was first identified, public health surveillance has been used to measure and monitor rates of HIV in populations across the globe. A variety of methods have been used, and as a result, public health leaders such as the World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS), and the United States Centers for Disease Control and Prevention (CDC) have been able to effectively track and model the impact of HIV on the global community, and document trends over time.
Four key methods have been used for HIV surveillance over the thirty years of the epidemic. Three HIV surveillance methods are based on survey methodology: sentinel surveillance surveys, general population surveys, and bio-behavioral surveys. A fourth method, case-based surveillance, in which individual level information on all known cases of HIV are reported to a central database, will be the focus of this Toolkit.
Surveillance Overview
9 B. Case-based Surveillance of HIV
Case-based surveillance is a system in which longitudinal information on every individual identified with HIV is reported from the point of service delivery to a central database for epidemiological analysis. Case-based surveillance is a powerful tool for public health programs because it provides information on individuals with HIV throughout the course of their disease and engagement with HIV care.
Some key benefits of case-based surveillance are that it:
Can leverage the high volume of person-level data already collected at health care facilities
Can supplement or replace data historically provided by point-in-time surveillance surveys, which are often costly and complex
Takes advantage of the availability of both existing and emerging technology and telecommunications such as electronic medical records, electronic patient monitoring systems, and data reporting using smart phone/computer/3G interfaces
Can be implemented in a limited form using existing resources and processes and expanded and improved over time as resources allow
Given these characteristics, case-based surveillance is a viable consideration for countries that: Have existing sources of person-level data for people with HIV, such as electronic medical records or patient management systems Are interested in a strong focus on the clinical management of people with HIV, such as
the prevention and elimination of mother-to-child transmission and/or support for Surveillance Overview ART initiation and adherence to reduce transmission Are interested in developing a system that will generate routine surveillance data rather than depending on point-in-time surveys
As shown in Figure I, case-based surveillance of HIV collects information on key sentinel events for each person with HIV. These are also called reportable events and are related to HIV exposure, diagnosis, and disease progression. When these events are recorded and monitored, it allows for a detailed understanding of person-level factors related to infection, access to services, disease progression, and outcomes, as well as national or sub-national trends.
10 Figure I. Monitoring the Spectrum of HIV Disease
The sentinel events described in Figure I provide key information on HIV epidemiology, the continuum of HIV care and disease progression:
First Positive HIV Test can describe who is infected, where new diagnoses are occurring, what prevention services could be indicated, and where services should be focused.
Entry to Care provides information on linkage to indicated care and treatment services.
CD4 Testing and Results provide information on linkage to care and treatment services, coverage of HIV testing (by examining whether individuals are diagnosed early or late in disease progression), immunological staging information and ART eligibility. Surveillance Overview
Advanced HIV provides information on disease progression, as well as ART eligibility. Advanced HIV might be reported based on CD4 values or based on WHO clinical staging.
Viral Load Testing and Results, though not yet universal, provide information on viral suppression, the effectiveness of ART programs and of specific ART regimens.
Initiation of ART provides information on coverage of treatment and notable treatment gaps.
Date of Last Medical Visit provides an indication of retention in care, even in the absence of routine CD4 or Viral Load testing; this can also be used to indicate a patient is still alive.
Death ends the sentinel tracking of a person with HIV, and provides information on HIV associated mortality and outcomes.
11
Each of these sentinel events trigger an HIV case report in which a standard set of data is collected from each person diagnosed with HIV, and the data are reported to a central repository that monitors the trends in, and characteristics of, infection.
Adult and Pediatric Case-based Surveillance
Case-based HIV surveillance is a comprehensive approach to monitor an HIV epidemic in the general population and relevant subpopulations, including adults and children. However, case- based surveillance among adults and pediatrics implies slightly different considerations, and may be implemented together or separately.
A case-based surveillance system for the adult population will collect data on adults with HIV, focusing on individuals diagnosed with HIV aged 18 years and older. This system will draw the vast majority of new case reports from HIV testing facilities that serve adults (including
VCT, PICT, TB, PMTCT and VMMC service sites) and additional case report information is obtained on engagement in care and disease progression from care and treatment facilities, laboratories, and vital registries. This system may also collect data on adolescents aged less than 18 years where the age of consent is younger than 18 years.
A case-based surveillance system for the pediatric population will collect data on individuals aged 17 years and younger. This population includes children across a range of developmental stages, who may or may not be identified and reported by the same HIV service facilities where adult case report information is reported. Therefore, pediatric case-based surveillance systems should include facilities that specifically serve children, such as pediatric inpatient and pediatric care and treatment facilities. In addition, pediatric case-based surveillance systems collect data to monitor perinatal transmission of HIV, including information on HIV-positive pregnant Surveillance Overview women and their HIV-exposed infants, what services they receive to prevent perinatal transmission, the eventual sero-status of the infant, and engagement in care for HIV-positive children. For this reason, pediatric surveillance will draw a significant proportion of new case reports from pediatric testing facilities, which may include ANC, PMTCT, and/or early infant diagnosis (EID) facilities, as well as laboratories performing EID testing. As pediatric HIV cases age they would become part of the adult case-based surveillance system.
12 C. Case-based Surveillance and Second Generation Surveillance
UNAIDS encourages countries to consider second generation surveillance as they develop their approach to national HIV surveillance. The UNAIDS strategy, Guidelines for Second Generation HIV Surveillance: an Update: Know your Epidemic (1), is designed to help countries concentrate their strategic information resources where they will yield the greatest impact and make the best use of existing data to increase understanding of the HIV epidemic and the behaviors that spread it. As shown in Figure II, the guidelines suggest that public health surveillance units consider using HIV and AIDS case and mortality reporting (referred to as case reporting in this Toolkit), as a core component of second generation surveillance of HIV.
Figure II. UNAIDS Depiction of Second Generation Surveillance
Surveillance Overview Case-based surveillance directly supports the goals of second generation surveillance, in that it leverages existing public health data to provide timely data to:
Better understand trends in the epidemic over time
Identify where new cases are coming from, known as “epidemic hotspots”
Better understand the behaviors driving the epidemic
Identify and describe sub-populations at highest risk of infection
Better understand HIV service needs inform program planning
Adapt to the changing needs and state of the epidemic
13 D. Structure of This Toolkit
In the next two modules, this Toolkit will provide you with information and ideas to help you further consider, plan for, and implement a case-based surveillance system, or improvements to your existing case-based surveillance system .
Module 1 describes the “building blocks” that will help to ensure a strong case-based surveillance system. These components have been defined based on the authors’ experiences, and draw on public health literature and public health expertise. You should consider each of these elements, and seek to reinforce these components as much as possible.
Module 2 walks you through the six steps that we propose for HIV surveillance system reinforcement or implementation. These steps, and the related resources and tools, have been developed and/or used by the authors to support the development of case-based surveillance systems in six African and Caribbean countries. These steps and tools should be considered but modified and adapted to your local situation to ensure success.
Summary of Noted Resources # Source Title Description Appendix (1) UNAIDS Guidelines for Second An update to guidance released in 2000 that 1 Generation HIV helps countries to prioritize and plan Surveillance surveillance initiatives, maximizing resources for greatest public health impact
Other Relevant Reading and Resources Source Title Description Appendix CDC/UCSF HIV Clinical Staging A training that describes the basics of case 2
reporting Surveillance Overview CDC/UCSF Overview of the Epidemic A training that provides background 3 information about HIV, the global epidemic, and methods for disease surveillance NASTAD Introduction to Case-based An overview of what case-based 4 Surveillance surveillance is, and how you might conceive of a system in your country WHO/ Surveillance of HIV using Guidance to help countries improve their 5 PAHO Case Notification HIV surveillance system based on intern CDC Clinical Cascade MMWR A sample of how case-based HIV 6 surveillance data can be used for effective public health planning
14 Setting the Stage Case-based Surveillance System Development
This toolkit is designed to walk through all of the “building blocks” that we believe to be required for a strong and functional case-based surveillance system (Module 1), and to provide usable tools for application and improvement (Module 2). We believe that the content in its entirety is of value; however, this checklist may help you decide where to place your focus.
If you believe that you have all of these building blocks of a case-based surveillance system in place, skip to Module 2 to walk through stages of implementation and quality improvement: setting the vision for the system; ensuring buy-in and support for the system; scanning the environment to assess opportunities and readiness; defining the
system as a whole; and the system.
Introduction Module 1 Preparation 1. Governance
Review this section if you: Use this section to help reinforce:
Have an interest in case-based Strong leadership and a vision surveillance Surveillance Overview Policies and procedures to support case-based surveillance
Mandated reporting Have a commitment of time and resources to develop/improve the Data Security surveillance system Patient Privacy Standard Operating Procedures
Want to improve your knowledge Use of a committee of stakeholders on the topic to better lead the who can effectively contribute to effort this initiative
15 Module 1 Module 1 2. Human Resources 3. Case Reporting
Use this section to help: Use this section in order to:
Define roles & responsibilities for Clearly define reportable all levels of the health system so events, and a description of people know what is expected of all expected data variables them Develop an outline and map Develop processes to ensure of all expected data routine training and skills building sources,and the data for all human resources involved variables expected in surveillance Clearly define data collection Develop a system to provide process, and tools that make strong management and sense to the users supportive supervision to those reporting cases
Module 1 Module 1 4. Data Management 5. Data Use
Use this section in order to: Use this section to help:
Define a process to ensure that Develop a framework and plan to case report data are effectively ensure routine monitoring and and efficiently transferred from evaluation of the case reporting the facility to the master database process and data Surveillance Overview
Develop or refine a master Ensure a plan is in place to use database that can receive case the surveillance data, with other report data from all expected data sources, to profile the HIV sources, and can be managed by epidemic and support evidence- local staff based planning
Ensure you have dedicated human Formalize a commitment to using resources who have the the monitoring and evaluation knowledge and skills for routine data to define and implement data cleaning and quality quality improvement activities assurance, and case matching
16 MODULE 1 BUILDING BLOCKS OF A CASE-BASED SURVEILLANCE SYSTEM Building Blocks of a Case-based Buildingof System Blocks Surveillance
17 1 Overview
In this module we will review: Critical components that make up a functional case-based surveillance system in the areas of Governance, Human Resources, Case Reporting Process, Data Management, and Data Use
Introduction In order to build, implement and use a case-based surveillance system effectively, certain components or “building blocks” are needed. In this chapter, we will describe 15 building blocks which are necessary for effective system development and use (Figure 1.1). The importance of each building block will depend on your country’s situation; however they should all be addressed and accounted for. These building blocks will also be referenced in
Module 2, where we will discuss how to operationalize them.
Figure 1.1. Building Blocks of a Case-based Surveillance System
Regulatory Stakeholder 1.1 Governance Leadership Framework Engagement Overview
1.4 Data 1.2 Human 1.3 Case 1.5 Data Systems & Resources Reporting Use Management
System & Roles & Reportable Data Transfer Process Responsibilities Events Monitoring
Training & Epidemiologic Data Sources Database Skills Building al Profiling
Data Data Quality Management & Quality Collection Assurance and Supervision Process Case Matching Improvement
18 System Governance and 1.1 Partner Engagement
In this chapter, we will review:
The importance of strong leadership and governance in the effective development and use of a case-based HIV surveillance system
The role that robust policies and procedures play in supporting comprehensive case
reporting and HIV surveillance system use, including the protection of patient
privacy
The value that stakeholders bring to the case-based HIV surveillance system planning, implementation, and utilization phases
Introduction The development and use of an effective case-based HIV surveillance system should be a collaborative and interdisciplinary process as the utility of a system depends on the participation and involvement of many stakeholders. As such, strong leadership and governance, on the part of the Ministry of Health or the agency responsible for HIV surveillance, is critical to engage and involve stakeholders, to secure buy-in and support of system users, to receive (and respond to) feedback, and to support use of the surveillance data for evidence-based decision making.
For the purpose of this Toolkit, we use the term ‘stakeholder’ to describe all those who contribute to, use and are affected by the system, including decision makers, funders, civil society (such as organizations of PLHIV) and those who report case data. Although roles differ, we believe all stakeholders have an invested stake in the system, and should contribute to planning and monitoring, ensuring greater utility to all. Engagement System Governance and Partner A robust regulatory framework (including laws, regulations, and policies) is also integral to a successful surveillance system. Such a framework can help garner buy-in, standardize system use, strengthen data security and confidentiality practices, and define disease reporting requirements.
This chapter will describe three key elements of this building block: Leadership and Governance, a Regulatory Framework, and Stakeholder Engagement.
19 A. Leadership and Governance
In order for a case-based surveillance system to succeed and be impactful, a strong leader is needed, and the leader must have a team that can help to govern system design and use. As with any change, when updating an existing process or asking people to adopt a new system, resistance and setbacks should be expected, but should be able to be addressed. A strong leader will anticipate these issues, prepare to address them well, and engage those with the greatest resistance in the planning and implementation process.
Strong leadership and governance in the context of case-based surveillance of HIV is exemplified by actions. Some impactful actions include the establishment and application of a strategic policy framework, stakeholder engagement and coalition building, close attention to system design and use, supportive supervision to staff and users, and feedback of data to the system users. A single leader, or better yet a strong management team, can lead a national initiative for case-based HIV surveillance. Leadership characteristics that can help drive success include passion, persistence, and persuasiveness; the ability to build and maintain momentum and relationships during the planning and implementation processes; and the ability to listen and respond to emerging needs and concerns. There are many ways to define strong leadership; one model is shared in Figure 1.2, below.
Figure 1.2. Four Dimensions of Strong Leadership1
Cultivating enables you to share your passion and purpose, and recognize and utilize the strengths and contributions of others. Visioning supports strategic thinking, innovative ideas, and impactful problem solving by the team. Directing provides structure, organization, and management to the project and team; this includes defining roles, responsibility and accountability.
Including ensures broad and effective representation to support buy-in and success.
Engagement System Governance and Partner Your country’s leading voice for this initiative might come from the Ministry of Health, the HIV/AIDS Unit, the Surveillance and Statistics Unit, or another agency. Every country is different. What is important is that there is a clear and consistent leader who listens and responds, demonstrates commitment to the work, and is willing to get involved in the work. Leadership and governance roles and responsibilities are described in greater detail in Module 1, Chapter 2.
1 Kernox Learning Systems. (n.d.). Leadership development: An integrated approach with 4-D system. Retrieved from http://kernox.com/insight/
20 B. Regulatory Framework
A regulatory infrastructure is invaluable to support an effective and comprehensive case-based surveillance system. Policies, laws and regulations are key to building confidence in a system and ensuring compliance with reporting and confidentiality practices.
For the purpose of this Toolkit, we consider ‘laws’ to be legislation that is passed by government, ‘regulations’ as the ministry or division-specific interpretation, definition, and application of the law, and ‘policy’ as the program-specific definition of how activities are to be implemented in line with the regulations. That being said, policies and regulations can exist without a law in place, as can the regulatory framework noted below.
The regulatory framework related to case-based surveillance should include: 1. A mandate to report all known cases of HIV 2. Policies to support a patient’s right to privacy, including: i. Person-level data security and confidentiality practices ii. System-level data security and confidentiality practices iii. Data sharing, ownership and dissemination practices 3. Policies to guide system use, such as Standard Operating Procedures
Case Reporting Mandate
A case reporting mandate defines who should report a case, what information must be reported to whom, and within what timeframe. A strong and clear mandate will help motivate service providers to report cases, in the challenging environment of heavy workloads, HIV-related stigma and patient privacy concerns.
A reporting mandate should specify: System Governance and Partner Engagement System Governance and Partner a) What events are reportable: This would include the sentinel events that trigger a case report. This could include, for example: HIV diagnosis, CD4 values, ART initiation, and death.
b) Who is required to report a case: This would include which facilities must report (e.g. public health facilities, private facilities, private and public laboratories, etc.) and who must report at these facilities (e.g. nurses, physicians, counselors, laboratory technicians, etc.)
21 c) The specific information to include in the case report: This would include the data elements that are required in the case report. Your case reporting system may have two tiers of mandated data, with some variables mandatory from only a sub set of facilities (i.e., behavioral data are required from all testing sites but not laboratories); this must be clearly defined.
d) The use of specific forms, tools or reporting mechanisms: Reporting rules should reference national forms, tools, and reporting mechanisms so that there is a clear definition of what process is used to report each case.
e) The timeframe in which the report must be submitted: Timely case reporting will allow for a more current understanding of your epidemic. Rules should clearly state that cases and sentinel events must be reported within a specified timeframe.
The mandate to report cases should be developed by the highest level governmental public health authority that is feasible, and if possible, be adopted as legal statute or binding public health policy. If neither of these options is possible, the public health authority should adopt the reporting rules (1). The mandate should be widely disseminated among all relevant health facilities.
If your country does not have policies specific to HIV case reporting in place, there may be other disease notification mandates in place which would be amended to include HIV, or which could serve as a model for an HIV-specific policy. Reaching out to those who manage surveillance for reportable diseases may provide insight into the process for required reporting.
Three examples of a Case Reporting Mandate (2) (3) are included in the appendix.
Policies to Support a Patient’s Right to Privacy
Effective case-based HIV surveillance systems rely on the collection of patient-level data. However, malicious access to the data has the potential to harm the individual if used inappropriately. Given the stigma associated with HIV in many countries, in the context of case- based surveillance it is especially important to have a policy context that support a patient’s System Governance and Partner Engagement System Governance and Partner right to privacy. This policy should accomplish two things: First, the policy should protect a patient’s right to the privacy of their health information. Protected data should be described and include all information that could explicitly, by inference or in combination be used to identify or describe an individual.
22 This includes, but is not limited to, the following variables:
Patient Name (first, middle, last) Telephone number Date of birth Employer information Government-issued unique ID E-mail address Street address or GPS coordinates of Medical record numbers residence Biometric identifiers (such as fingerprint or retina scan)
Second, the policy should make limited, specific allowances for access to identifiable person- level data by public health professionals for public health surveillance purposes, including:
Identify which patient-level data are needed Provide a justification for why those data elements are needed Describe how the data will be protected within the system Provide guidance to staff on how to collect and report the data while ensuring patient privacy
If well described, patient privacy policies can help build confidence in the HIV case-based surveillance system among providers, patients, and PLHIV. Strong patient privacy policies will help to improve patients’ and providers’ buy-in to the case-reporting process, and use of the case-based surveillance data, as they will understand all that is being done to protect their privacy.
Data Security and Confidentiality Policies
It is essential to have in place policies that define the data security and confidentiality elements of a case-based surveillance system. These policies describe the rules, structures and procedures to which the system and persons participating in the system will adhere in order to safeguard data. These polices should describe how a patient’s data will be protected during collection, transfer, storage, and use in order to prevent unauthorized disclosure of personal information. These policies will outline the protocols in place to ensure physical, electronic, and procedural protection of data collected through the case-based surveillance system, and will guide practice of personnel involved in case reporting and data management at the site, sub-national and Engagement System Governance and Partner national levels. All persons involve in the case surveillance system at all levels should be trained on these policies, and thus will have the skills and knowledge needed to protect a patient’s privacy. These policies should be based on national policy, regulation, or law.
23 Comprehensive data security and confidentiality policies would include:
How surveillance data should be collected: Data collection procedures should be conducted in private and secure locations. If data are abstracted from existing records, paper-based or electronic data collection forms or databases should be handled and maintained in secure locations with role-appropriate access.
How data should be stored: Once data are collected, they should be protected as they move from one location to the next along the case reporting pathway and are stored in paper or electronic format. Data in paper format should be stored in secure locations
where access is limited to authorized staff. If data are stored electronically, only appropriate devices should be used (i.e. not a personal computer) and all storage hardware and files should be password-protected and encrypted with role-appropriate access.
How surveillance data will be transferred: Data transfer procedures should include measures to uphold data confidentiality, such as implementing chain of custody documentation processes and safety protocols for paper and electronic data transfers. All networks and files should be password-protected and encrypted with role- appropriate access.
Which surveillance staff will have access to the data: Only designated staff should have access to protected surveillance data. Staff should be trained in patient privacy and data security and confidentiality policies and asked to sign and adhere to confidentiality agreements.
How to practically avoid a breach in confidentiality: This might include a discussion of who should have access to surveillance information, and with whom this information can (e.g. regional surveillance coordinator) and cannot (e.g. persons not involved in the surveillance system, such as family) be shared or discussed.
The laws and regulations for reviewing and acting on breaches of surveillance data: Any breaches of protected data should be reported and investigated in a timely manner, and procedures should be put in place to ensure such breaches do not occur again. There must be clearly defined consequences for violations of these policies. These might
include retraining, suspension of duties, suspension of employment, and/or Engagement System Governance and Partner termination, depending on the severity or frequency of the breach(es).
How regulations and procedures will be reviewed and revised to ensure they are current: Methods to regularly review data security laws, regulations, and procedures should be in place to ensure that they are up-to-date and relevant. For example, data security procedures may need to be updated as new technologies become available.
Inclusion of a “Whistleblower” clause: This will allow personnel to report observed breaches in security without facing negative consequences for reporting.
24
With the laws and regulations in place, it is important to monitor adherence and compliance. If a breach is found, the laws and regulations must be followed to demonstrate your commitment to the privacy of the patients in the system.
In many cases, personnel are asked to sign off (4) on their understanding of this policy on an annual basis. Guidelines (5) (6) (7) to help with the development of a Data Security and Confidentiality Policy (8) are included in the appendix, as well as two examples (9) (10).
Data Sharing, Ownership and Dissemination Policies
Lastly, it is important for the agency managing surveillance data to have a policy or regulation that clearly states who has jurisdiction over (or who “owns”) the surveillance data; how the data will be shared within, across, and outside of national programs; and under what circumstances data may be shared. These policies or regulations will help you to build confidence in the system management of HIV surveillance data. Creating this type of policy is also an opportunity to outline procedures for matching HIV case-based surveillance data with other disease surveillance data such as tuberculosis and sexually transmitted infections. Data sharing, ownership, and dissemination policies may include guidance on:
How surveillance information will be used and disseminated: Data security and confidentiality regulations should ensure that no identifiable information is inadvertently presented when surveillance data are used and disseminated. Some restrictions may involve the reporting of small cell values or the dissemination of mapping or geographical data.
Policies and procedures for releasing data to third parties: Policies and procedures should defined data sharing procedures outside of national programs, including how third parties can formally request surveillance data, who will be responsible for reviewing and approving data requests, what oversight will be required for data dissemination, and how the data will be modified before sharing to protect patient privacy. Typically, third parties submit applications stating their proposed use of the data and a technical working group reviews and approves or denies each application. A data sharing
agreement should be established to set conditions for the use of the data. Data sharing Engagement System Governance and Partner policies should also ensure that no protected information (such as personal identifiers) is released to third parties.
Two examples of a Data Sharing Policy (7) (8) are included in the appendix.
System Governance and Partner Engagement System Governance and Partner
25 Standard Operating Procedures
In addition to the policies discussed above, it is critically important to have defined procedures in place to support the implementation of the surveillance system. The Standard Operating Procedures (SOP) manual is the most comprehensive and widely used resource in a case surveillance system.
SOPs should be detailed, practical and user-friendly guides that direct everyday activities involved in the HIV case-based surveillance system. SOPs often include tools with detailed instructions—such as job aids, checklists, and algorithms—to ensure the procedures are followed accurately by reporting and surveillance staff. The procedures and instructions detailed in the SOP ensure that all entities and staff involved in HIV surveillance in your country are following the same guidelines with the same expectations. This approach promotes consistency and sustainability of your HIV case-based surveillance system.
SOPs should be distributed to and used by all organizations, agencies, programs and staff involved in case-based HIV surveillance, whether at the national, sub-national or site level. The agency responsible for HIV surveillance in the country typically leads the development of the SOP, soliciting feedback from stakeholders during the process.
Your SOP should be tailored to match your system and your intended audience. It should describe the key components of your surveillance system and provide detailed, step-by-step directions for implementing the system. At the very least it should include:
Glossary of Terms Purpose of the Standard Operating Procedures Detailed description of the case-based HIV surveillance system o Purpose o Definitions Case Reporting Procedures o Reportable events o Data elements to be reported o List of reporting sources System Governance and Partner Engagement System Governance and Partner o Method for submitting case reports o Roles and responsibilities Surveillance Data Management o Cleaning, matching and deduplication o Preparation of data quality reports and feedback to providers o Roles and responsibilities Security and Confidentiality o Policies and procedures in place o Roles and responsibilities
26 Monitoring the HIV Case Surveillance System o Overview of the standards and procedures that will be used o Roles and responsibilities Data Analysis and Dissemination o Description of procedures for data analysis and dissemination.
Two examples of an SOP (9) (10) are included in the appendix.
Note: SOPs may not be used if they are too long, overly theoretical, or if they cover topics that don’t apply to their intended audience. SOPs that detail practical, commonly used procedures will be more useful and can improve adherence to system protocols. Use illustrations, diagrams, algorithms and figures to clearly outline instructions for SOP users.
System Governance and Partner Engagement System Governance and Partner
27 C. Stakeholder Engagement
Involving stakeholders in the planning, implementation, and use of a case-based surveillance system is vital to ensuring the success of the project. Because a case-based surveillance system requires that surveillance data be reported by many different sources and programs, collaboration is essential to system success. Involving stakeholders from the beginning of the initiative will allow you to strengthen your implementation approach and to identify potential barriers before they arise.
Stakeholders are individuals, groups, or institutions likely to be impacted by the surveillance system, or those who can impact the system. Stakeholders have knowledge and experience that is relevant to the project. To help think about stakeholders involved in case-based surveillance, consider the diagram in Figure 1.3, which highlights common sources of data for national surveillance systems, common users of the generated data, and those who would be impacted by the surveillance system and the HIV response. Open dialogue, including hearing and acknowledging dissenting opinions, will establish rapport and build trust between you and the stakeholders.
It is important to involve two levels of stakeholders. First, system and program administrators (e.g. National Treatment Program Manager, National Laboratory Network Supervisor, etc.) should be engaged as they can provide institutional collaboration and direct their program staff to follow case-based surveillance procedures. Second, facility staff (e.g. HIV testing counselor, site data managers, etc.) should be engaged as these personnel will be ones involved in generating and filing case reports and can provide valuable feedback about operational methods.
Figure 1.3. Mosaic of Case-based Surveillance of HIV Stakeholders
National Key Health PLHIV MoH Decision Public Health Systems Organizations Makers Agency Funders
Other Disease Engagement System Governance and Partner PMTCT Reporting VCT Program Surveillance Program Facilities Systems
HIV Care and Multilateral Treatment Laboratory Vital Registry Organizations Program
Sub-national HIV Clinical Health MoH Policy Public Health Implementing Information Makers Offices Partners Systems Office
28 Summary of Noted Resources # Source Title Description Appendix (1) U.S. State Mandatory Disease A disease reporting law from one U.S. state 7 Reporting Law that describes what diseases are reportable, to (Maine) whom, and by what process. Laws can be complex to pass, and likely need to be guided by the legislature. (2) U.S. State Disease Reporting These disease reporting rules describe the step- 8 Rules (Maine) by-step reporting expectations that are mandated by the disease reporting law. Rules can typically be drafted or modified by the
respective government division. (3) NASTAD Sample Case A simple policy tool used in Haiti to mandate 9 Field Reporting Mandate HIV case reporting, in the absence of a law (4) CDC/ Sample Employee This is extracted from a CDC/UCSF training 10 UCSF Confidentiality module and is a good sample for an employee Agreement data confidentiality agreement. related to data security and confidentiality (5) CDC/ Tips for Extracted from a training module; highlights 11 UCSF Confidentiality and key guidance that you might consider related Data Security to data security and confidentiality (6) UNAIDS Guidelines on Guidelines to help protect the confidentiality 12 Protecting and security of HIV information Confidentiality and Security of HIV Data (7) WHO/ Regional Policy document that guides epidemiological 13 PAHO Surveillance Policy surveillance in the Pan-American region (8) U.S. State Data Privacy, This policy is guided by and relates to the 14 Security and disease reporting law and rules, and guides Confidentiality day-to-day practice of data management, data Policy (Maine) security and patient privacy, and data use (9) NASTAD Sample Case-based An SOP that is used for the case-based 15 Field Surveillance SOP surveillance system in Haiti
(10) NASTAD Sample Case-based An SOP that is used for the case-based 16 Field Surveillance SOP surveillance system in Guyana
Other Relevant Reading and Resources Source Title Description Appendix
CDC Data Security and Guidelines to assist in the planning and 17 Engagement System Governance and Partner Confidentiality Guidelines monitoring of data collection and storage systems and policies NASTAD Ensuring Privacy and An overview of how you can create 18 Confidentiality structure and guide staff for data security and patient confidentiality ICF National Confidential and This tool may be used to identify where you 19 MACRO Security Policy Assessment might reinforce your security and Tool confidentiality policy
29 Human Resources to Support 1.2 Case-based Surveillance
In this chapter, we will review:
Key human resources needed to support a case-based surveillance system Considerations for human resources training and supervision
Introduction The public health professionals that develop, implement, and maintain the case-based surveillance system are critical to its success. In this context, supporting “human resources” involves planning for needed roles, deciding where human resources should be focused, and based Surveillance based
ensuring that the team can grow professionally for on-going support, use and improvement of - the surveillance system. In order for the system to fully function, appropriate human resources are needed at all levels of the surveillance system.
The human resource requirements of your case-based surveillance will depend in large part on the design and scope of your system. For example, a system in which data are received electronically will have different human resource skills and needs than based on paper case reports. Similarly, smaller countries or those with small epidemics may only require human resources at the central level, while larger countries or those with larger epidemics will likely Support Case Support require some human resources at the sub-national level.
In addition to having the appropriate human resources, certain policies and procedures are important to help personnel fulfill their roles. These roles and responsibilities, and related supervision and support mechanisms, should be clearly defined in documents such as Standard Operating Procedures (chapter 1.1).
This section outlines general case-based surveillance human resource needs, as well as suggested supplemental personnel needs related to certain types of systems. Sample Staff Position Descriptions (1) (2) (3) (4) are included in the appendix.
Human to Resources
30 A. Basic Human Resource Needs
A robust case-based surveillance system requires that certain roles and responsibilities—as described in this section—be defined and supported within the public health structure, including the site, sub-national, and national levels. It is important to note that in many cases, roles do not require a dedicated full time staff person; many of the defined responsibilities can be integrated into existing staff workflow (i.e., VCT counselors complete the case report form; site level data managers perform routine quality assurance) and building on existing staff’s strengths (i.e., a data manager with programming skills takes on the programming role). Dedicated staff should only be hired where necessary.
National Level Human Resources
National-level leadership and oversight are needed in order to support a functional and usable national system. Human resources at this level will:
Define, create, and disseminated policy, procedures, and guidelines Surveillance based - Train, mentor and support lower-level surveillance personnel Engage, sensitize and maintain productive relationships with service providers and other key stakeholders Manage the national case-based HIV surveillance database Monitor the system’s process and data Analyze, and disseminate data for public health planning.
Although the actual human resources structure will vary between countries—depending on the public health structure, available personnel, and epidemic size—there are several roles that are required of all case-based surveillance systems to assure the proper performance of surveillance activities. Later on, we will consider additional human resource needs that may be required of larger or more complex surveillance systems.
Table 1.1, below, outlines the minimum human resources required to support an effective case surveillance system, and the corresponding responsibilities. Depending on your country’s situation, a single person may handle more than one of these roles, but all roles should be filled.
Case Human to Support Resources
31 Table 1.1. National Level Human Resources Roles and Responsibilities
Role Responsibilities
Surveillance The Surveillance Director is ultimately responsible for the case-based Director surveillance system, and ensures that policies and procedures for case reporting, data management, patient privacy and data confidentiality are well defined and documented. The Surveillance Director is the primary spokesperson for information related to the surveillance system. S/he engages stakeholders, ensures national-level buy-in and support, and plays a role in assuring compliance with policies including reporting mandates, and security and confidentiality guidelines.
[Case-based] The Surveillance Coordinator provides day-to-day management of the Surveillance case surveillance system, including: process monitoring, review and Coordinator analysis of surveillance data, and the provision of recommendations on (1) improving the system.
The Surveillance Coordinator often supervises other public health system Surveillance based personnel, provides training and support to the surveillance team, and - service providers. Depending on the size of the surveillance system, the Surveillance Coordinator may be the primary contact for reporting sites to ensure complete and timely case reporting, and provide the feedback on performance; otherwise s/he will be the primary contact for sub-national personnel that will fill the same role.
With support from the Surveillance Director, the Surveillance Coordinator ensures adequate resources are in place at all levels of the surveillance system, ensures adherence to the security and confidentiality policy, sensitizes providers to reporting requirements, and secures buy-in and support from providers and stakeholders.
Data The Data Manager is the primary user of the case-based surveillance Manager (2) database. The Data Manager receives case reports from reporting sites and sub-national levels, applies quality checks, integrates the case data into the surveillance system, and ensures a clean data set. The Data Manager also performs routine monitoring of surveillance processes, and (with the Surveillance Coordinator) provides feedback to the reporting sites for improved data quality.
The Data Manager, in collaboration with the Surveillance Coordinator, Case Human to Support Resources will analyze the case report data and produce tables and reports for interpretation and dissemination.
32 Sub-national Level Human Resources
There are some cases where sub-national level human resources may be indicated as a link between the site-level and national-level staff. This may be the case in countries that: are geographically large, have a large population and a high HIV prevalence, have a substantially decentralized public health system, and/or have data transfer limitations.
If this level of human resources is indicated, sub-national personnel will supplement the national level roles, acting as the primary support to the reporting sites, and ensuring quality, complete, and timely reporting to the national level. In this case, national level personnel will provide support and oversight to the sub-national personnel, which will in turn provide support and oversight to the reporting sites.
Table 1.2, below, outlines the sub-national level human resource roles and their corresponding responsibilities. Depending on your country’s situation, a single person may handle more than one of these roles.
based Surveillance based
Site-level Human Resources -
A case-based surveillance system depends on the routine submission of complete case reports from service providers. Therefore, site-level capacity to submit case reports is a critical component of a case-based surveillance system. In most cases, site-level personnel will not be exclusively dedicated to the case-based surveillance system, but will incorporate case reporting responsibilities into their existing works flow with the support and guidance of national or sub- national surveillance personnel.
There are a small number of basic roles that should be ensured at each reporting site, as described in Table 1.3. These roles may be fulfilled by one or multiple staff members, depending on site human resource structure.
Human Resources to Support Case Human to Support Resources
33 Table 1.2. Sub-national Level Human Resources Roles and Responsibilities
Role Responsibilities
Regional The Regional Surveillance Coordinator is the primary spokesperson for [Case-based] information related to the surveillance system at the sub-national level. Surveillance S/he provides day-to-day oversight of the case-based surveillance
Coordinator (3) system. The Regional Surveillance Coordinator provides training and support to reporting sites to ensure quality, complete and timely reporting, as well as adherence to national policy and procedures. The Regional Surveillance Coordinator also assures adequate resources are in place to operate the surveillance system at the site level, coordinates resource delivery between national and site-levels, sensitizes providers to reporting requirements, and secures buy-in and support from providers and stakeholders.
The Regional Surveillance Coordinator also oversees regional system and process monitoring, and reviews and summarizes regional surveillance data to make recommendations on improving the system. based Surveillance based The Regional Surveillance Coordinator also plays a role in ensuring - compliance with security and confidentiality guidelines.
Regional Data The Regional Data Manager is the primary manager of case report data Manager (2) at the sub-national level. The Regional Data Manager receives case reports from reporting sites, conducts data quality checks and cleaning, integrates the case data into the surveillance system, and submits case data to the national level. The Data Manager also performs routine monitoring of surveillance processes, and (with the Regional Surveillance Coordinator) provides feedback to the reporting sites for improved data quality.
Human Resources to Support Case Human to Support Resources
34 Table 1.3. Reporting Site Staff Roles and Responsibilities
Role Responsibilities
Site The Site Supervisor is the primary link between the sub-/national level and Supervisor site-level personnel. The Site Supervisor ensures that consistent and quality processes are used to carry out case-reporting activities, in line with
national policy and procedures. The Site Supervisor is responsible for implementing routine site-level monitoring processes, ensuring all HIV cases and the related data are reported, and requesting the provision of support and technical assistance where needed.
This role is typically filled by the HIV testing site manager, the laboratory manager, or the clinical site manager. They will need to attend periodic meetings; review, understand and disseminate policy; and ensures compliance with national policy.
Site Case This role is responsible for the completion of the HIV report form, and based Surveillance based
Reporting potentially also compiling HIV case report forms, conducting data quality - Personnel checks, and submitting the case report forms to the national surveillance system.
This role is typically filled by existing personnel that interact with patients or patient level data, including HIV counselors, nurses, laboratory technicians, surveillance personnel, monitoring staff, data managers, or other related staff.
Human Resources to Support Case Human to Support Resources
35 B. Advanced Human Resource Needs
Some surveillance systems will have further human resource needs to ensure the system’s success. Advanced human resource needs may arise in several situations, including: Managing data through electronic transfer
Receiving data electronically from one or more partners Managing surveillance information for a large geographic area Processing a high volume of surveillance data
Advanced human resource roles, such as those in Table 1.4, may be helpful to support the core personnel listed in the tables presented above.
Table 1.4. Advanced Human Resource Roles and Responsibilities based Surveillance based
- Role Responsibilities
Provider EMR If the surveillance system receives data transfers from Electronic Manager Medical Records (EMRs), case-surveillance system staff will need to liaise with the Provider EMR Manager to ensure that all provider data are accurately reported. The EMR manager is often responsible for the maintenance of the EMR, and can automatically or manually extract data from the system to share case information.
Health The Health Information Officer coordinates with provider EMR Information managers to maintain electronic transfer of provider data between Officer (4) reporting sites and the case-based surveillance system. The Health Information Officer assists the Data Manager and the Surveillance Coordinator at the national level to abstract information from the surveillance system and to prepare reports.
Epidemiologist The Epidemiologist manages the analysis of case surveillance data. The Epidemiologist prepares dissemination products for internal and external stakeholders and represents surveillance team when presenting the data. The epidemiologist may also be involved in
surveillance system monitoring. Case Human to Support Resources
36 C. Training and Skills Building
National or sub-national level human resources need to know their expected roles and responsibilities and to be competent in all of their job functions. It is good practice to clearly define the expected roles and responsibilities (5) (6) of human resources at all levels of the surveillance system; examples are included in the appendix.
With roles clearly defined, training on surveillance procedures is needed in order for the human resources listed above to best fulfill their roles within the surveillance system. This training can occur through initial orientation when hiring new staff, or through ongoing staff development. Surveillance system personnel should be screened on their understanding of basic surveillance system elements and trainings should be tailored to their level of understanding. A sample tool to screen for surveillance-related competencies (7) is included in the appendix.
Reporting sites and other partners involved in the case surveillance system should also be oriented to their roles and trained on any procedures required of them prior to the start of the surveillance system. Module 2 discusses training needs of surveillance staff and providers in based Surveillance based
greater detail. -
Human Resources to Support Case Human to Support Resources
37 D. Human Resource Support and Supervision
To ensure that all surveillance and provider staff are aware of what is required or expected of them, and that they are performing at the appropriate level, support and supervision is imperative. Effective support and supervision will allow you to identify and address human resource challenges and concerns, and needs for additional sensitization, training or resources.
Supervision does not need to be formal: meeting with staff, observing staff, and providing feedback to staff are all strong and valuable mechanisms. Human resources supervision is further described in Module 2. However, remember that supervision should occur on a routine basis, feedback should be given promptly, and questions, concerns, and requests for assistance should be responded to ASAP.
based Surveillance based - Human Resources to Support Case Human to Support Resources
38 E. Human Resources Policies
Human resources policies that govern the rights and responsibilities of public sector/heath workers are provide regulatory structure and guidance to staff as they operationalize case surveillance processes, including:
Maintenance of patient privacy Data security and confidentiality Supervisory structures to support a high-quality system Human resource policies likely already exist for the overarching bodies that will employ staff involved in the case-based surveillance system. This could be the Government (Ministry of Health, Surveillance Unit, HIV/AIDS Bureau, National Laboratory, etc.) and/or a local or international implementing partner. Review the policies that already exist, and where needed, consider adding a supplemental component to address issues specific to case-based surveillance. Further information on policies related to case-based surveillance is provided in Chapter 1.1.
Surveillance based - As policies are created, it is important to ensure that personnel receive training to orient them to the policies. A good practice is to have the target staff sign off on the policy on a routine (i.e., yearly) basis.
Human Resources to Support Case Human to Support Resources
39 Summary of Noted Resources # Source Title Description Appendix (1) NASTAD Sample National A position description that may be helpful 20 Surveillance as you plan to hire a National Surveillance Coordinator Position Coordinator, or divide roles and Description responsibilities among existing staff. (2) NASTAD Sample Data A position description that may be helpful 21
Manager Position as you plan to hire a Data Manager, or Description divide roles and responsibilities among existing staff. (3) NASTAD Sample Sub-national A position description that may be helpful 22 Surveillance as you plan to hire a Sub-national Coordinator Position Surveillance Coordinator, or divide roles Description and responsibilities among existing staff. (4) NASTAD Sample Data System A position description that may be helpful 23 Programmer Position as you plan to hire a Data System Description Programmer, or divide roles and responsibilities among existing staff. (5) NASTAD Sample Surveillance A summary of roles and responsibilities of 24 Roles and staff and stakeholders. based Surveillance based
Responsibilities - (6) NASTAD Sample Surveillance 25 A summary of roles and responsibilities of Field Roles and staff and stakeholders in different tiers of Responsibility the case-reporting system. Checklist (Haiti) (7) NASTAD Public Health Provides an example of an assessment form 26 Surveillance used to determine staff’s strengthens and Competency Audit areas needing improvement.
Human Resources to Support Case Human to Support Resources
40 1.3 Case Reporting Process
In this chapter, we will review:
The four key components that are needed to support case reporting process, including:
Defined Reportable Events, also known as “sentinel events”, that trigger a case to be reported to the public health authority
Key Data Sources that feed a comprehensive national HIV case reporting system
Processes for case Data Collection
The applicable Policies and Procedures that support comprehensive national Introductionreporting of HIV cases. To identify and report all cases and sentinel events, the reporting process must be defined and articulated.
To ensure that all public health professionals are aware of the process and can comply with case reporting expectations, three steps must happen:
Reportable events and case definitions must be articulated so that public health professionals know when they need to submit a report and what information to submit
Applicable data sources must be identified so that the managers of each can be
sensitized to case reporting expectations Case Process Reporting
A method to capture the relevant data from each reporting source must be created
As noted at the beginning of this chapter, strong leadership, stakeholder buy-in and support, and a policy framework that supports the case reporting process must also be in place.
41 A. Reportable Events
In case-based surveillance, a reportable event for an individual patient will trigger a case report to the surveillance system. As case-based surveillance seeks to monitor and describe the longitudinal progression of HIV in each person, key milestones in HIV disease progression and engagement in care should be identified as reportable (sentinel) events. There are a suggested five minimum reportable events; these are depicted in Figure 1.4 and defined in Table 1.5.
Figure 1.4. Minimum Reportable Events for Case-based Surveillance
Table 1.5. Definition of Reportable Events for HIV Case Surveillance
Reportable Event Definition Data Collection Justification Case Process Reporting First Positive HIV Any HIV diagnosis as determined Describes all known cases of HIV. Diagnosis according to the national HIV testing algorithm. Entry to Care Any case of HIV that is registered in Demonstrates linkage to care and clinical care; could be inferred by record treatment services. of a CD4 test, Viral Load test, or ART initiation. Progression to Any case of HIV that is classified as Describes disease progression; Advanced HIV Advanced HIV via CD4 or WHO clinical provides information on coverage of staging. testing and treatment. Initiation of ART Prescription of ART to a person with Provides information on treatment HIV. coverage and gaps. Death Death of any person with HIV, regardless Provides information on HIV related of cause of death. mortality and outcomes; provides information on the total number of people living with HIV.
42 In countries where greater resources are available, comprehensive HIV case reporting should be considered, including the collection of more complete data on disease progression and engagement in care. In this approach, as depicted in Figure 1.5, eight reportable events should be defined via a case definition; these are described in Table 1.6.
Figure 1.5. Comprehensive Reportable Events for Case-based Surveillance
Table 1.6. Definition of Reportable Events for Comprehensive HIV Case Surveillance
Reportable Event Definition Data Collection Justification First Positive HIV Any HIV diagnosis as determined Describes all known cases of HIV. Diagnosis according to the national HIV testing algorithm. First and All CD4 All CD4 test values documented for a Demonstrates successful entry to the
Values person with HIV. care and treatment system; provides Case Process Reporting information on clinical staging and disease progression, late testing trends, trends; and eligibility for ART. First and All Viral All viral load values documented for Demonstrates successful entry to the Load Values a person with HIV. care and treatment system; provides an indication of treatment success and/or ART resistance. Date of initiation of Prescription of ART to a person with Provides information on treatment ART confirmed HIV. coverage and gaps. ART Regime can also be reported. Most Recent Medical Date of medical visit to a clinical care Provides information on retention in Visit facility by any person with confirmed clinical care. HIV. Death Death of any person with HIV, Provides information on HIV related regardless of cause of death. mortality and outcomes; provides information on the total number of people living with HIV.
43 Additional Reportable Events for Pediatric Surveillance
In addition to the sentinel events described above, pediatric case-based surveillance seeks to generate epidemiological and service data on perinatal transmission of HIV. For this reason, a pediatric surveillance also collects data to identify, monitoring and describe HIV-infection and engagement in PMTCT services among mother-child pairs. Additional sentinel events to monitor perinatal transmission depicted in Figure 1.6 and defined in Table 1.7.
Figure 1.6. Additional Reportable Events for Pediatric Case-based Surveillance1
Case Process Reporting
1 National norms for algorithms and timeframe for HIV testing of HIV-exposed infants vary by country.
44 Table 1.7. Definition of Additional Reportable Events for Pediatric HIV Case Surveillance
Reportable Event Definition Data Collection Justification Pregnancy in HIV- Any HIV diagnosis in pregnant Describes all known cases of HIV positive woman women as determined according among pregnant women and to the national HIV testing provides an indication of potential algorithm, or confirmed pediatric cases that need to be pregnancy in a previously tracked and confirmed. confirmed HIV-positive woman. ARV Prophylaxis Prescription of PMTCT ARV Provides information on PMTCT prophylaxis to a pregnant woman coverage and gaps. with confirmed HIV. Can occur at multiple time points: pre-partum, peri- partum (at delivery) or post- partum (during breastfeeding) PMTCT regime can also be reported. Date of Initiation Prescription of ART to a person Provides information on treatment of ART (mother) with confirmed HIV. coverage and gaps. ART Regime can also be reported. Birth of HIV- Any infant that is born to a Describes all potential pediatric exposed infant woman with confirmed HIV. cases that need to be tracked and confirmed. PCR Results in All PCR results among HIV Provides the ability to confirm HIV Exposed Infants exposed infants—whether diagnosis among exposed infants positive or negative. and to evaluate the effectiveness of PMTCT programs. Describes known cases of pediatric HIV. Case Process Reporting Infant HIV Screen All PCR results among HIV Provides the ability to confirm HIV and PCR in exposed infants—whether diagnosis among exposed infants Exposed Infants (9, positive or negative. and to evaluate the effectiveness of 18 months) PMTCT programs. Describes known cases of pediatric HIV. Date of Initiation Prescription of ART to a child Provides information on pediatric of ART (child) with confirmed HIV. treatment coverage and gaps. ART Regime can also be reported.
45 B. Data Sources
One of the strengths of a case-based surveillance system is the ability to capture and record defined sentinel events from multiple data sources, and to match case reports related to one single person, regardless of reporting source, using a consistent unique identification coding method. For this reason, the system benefits from redundancy in reporting because it provides a ‘safety net’ in case of reporting failure from any single reporting source. As shown in Figure 1.7, there are several key data sources should be considered for a case-based surveillance system.
Figure 1.7. Sources and Types of Data to Consider for HIV Case Reporting
VCT Facility - Demographics - Behavioral Risk Factors - Date of Diagnosis - Facility of Diagnosis PMTCT Facility Hospital - Demographics - Demographics - Date of Diagnosis (mother) - Behavioral Risk Factors - Data of Exposure (baby) - Date of Sentinel Event - PCR Value (baby) - Value of Sentinel Event (i.e., - ART (mother, baby) ART, CD4 value) - Facility Reporting - Facility Reporting HIV Case Database Laboratory
ART Facility Case Process Reporting - Case Identifier - Demographics - (demographics, if available) - Date of Sentinel Event - Lab Value (CD4, Viral Load, - Value of Sentinel Event (i.e., PRC) ART prescribed, CD4 value) - Data of Confirmation - Facility Reporting - Facility Reporting
Vital Statistics - Case Identifier - (demographics, if available) - Date of Death
46 HIV Testing Facilities. Health facilities that provide HIV testing services are the most critical reporting source in a case-based surveillance system as they are likely to identify the greatest number of cases of HIV. These facilities should report on all HIV cases that are diagnosed within their facility. Testing facilities include those providing: o Voluntary Counseling and Testing (VCT) o HIV Counseling and Testing (HCT) o Provider Initiated Counseling and Testing (PICT) o Prevention of Mother-to-Child-Transmission (PMTCT) o Voluntary Medical Male Circumcision (VMMC) o Tuberculosis (TB) diagnosis and treatment. HIV Care and Treatment Facilities. Health facilities that provide HIV care and treatment services, including PMTCT, are a critical reporting source as they are able to both identify large numbers of cases of HIV, and provide data on access to care, disease progression, and clinical outcomes. These facilities should report on all cases that are diagnosed with HIV or access HIV clinical services.
Laboratories. Laboratories that provide HIV diagnostic tests (HIV testing, PCR testing) or clinical monitoring tests (CD4 testing, viral load testing) are a critical source of case-based surveillance data, whether they are attached to a medical facility or stand-alone.
Vital Registry. The national vital registry provides information on HIV related mortality.
Case Process Reporting Both public and private facilities should be considered when identifying each of these data sources. A reporting mandate (see Chapter 1.1) can help facilitate adherence to reporting requirements.
47 C. Data Collection
For each sentinel event, defined data variables need to be collected and reported to a data repository. The surveillance system should define (and the SOP should document) which variables need to be included in each case report, both initial HIV case reports and follow-up reports on disease progression or engagement in care. These are documented in a data dictionary (1) that clearly defines each variable. The system should also define the minimum set of variables for a case to be considered valid, which typically include: 1. Unique Patient Identifier. In order for case-based surveillance to be effective, it is important to establish a reliable method for uniquely identifying individual cases. A unique identifier is necessary to link an initial diagnosis to subsequent disease progression reports (e.g., laboratory results, progression to AIDS, multiple clinic visits), and to identify duplicate cases (e.g., a person who is screened for and diagnosed with HIV, at multiple facilities). In general, a comprehensive unique identifier that includes both patient name and other essential patient information (i.e., date of birth, location of birth, sex, etc.) offers the most effective way to uniquely identify individuals.
According to the UNAIDS (2), the most effective unique identifiers have the following characteristics: o Unique to an individual o Ubiquitous (valid everywhere) o Available for every person o Unchanging (i.e., names, sex, date of birth, country of birth, eye color, biometrics) o Uncomplicated and easy to recall or record o Non-controversial.
Case Process Reporting Two types of unique identifiers might be considered for a case-based surveillance system: o Unique Personal Identifiers: Unique personal identifiers are a series of digits or alphanumeric codes (codes combining letters and numbers) that allow for the identification of an individual. An example of this is a type of national identification such as a passport number, a social security or tax ID number, or a driver’s license number. o Unique Patient Codes: Unique patient codes are typically alphanumeric codes or a series of digits that allow for the identification of a patient within a health care system. To be useful for case-based surveillance, a unique patient code must be national in scope, such as a national health identification number. That is, the unique patient code must cover the entire health system. Service-specific codes (e.g. ANC, TB, ART) are not useful for identifying the same individual across services and programs.
48
If a country does not have a unique personal identifier or a unique patient code, a pseudo-unique identifier can be considered. o Pseudo-Unique Identifiers: Pseudo-unique identifiers are typically alphanumeric codes that are generated from unchanging patient-specific details in order to allow for the identification of an individual. An example is a code generated from extractions of a patient’s name, date of birth, location of birth, and/or other unchanging variables such as mother’s or father’s names. Pseudo-unique identifiers are useful for surveillance in the absence of unique personal identifiers or unique patient codes, but have substantial limitations. Because pseudo-unique identifiers are composed of multiple demographic variables, they are vulnerable to errors in the accuracy or transcription of those component variables. Further, because pseudo-unique identifiers are not pre-
existing, they place the burden of identifier generation on the surveillance programme, and are vulnerable to errors in this process (i.e. incorrect combination of demographic variables into an identifier). If possible, the use of unique personal identifiers or unique patient codes is preferable.
2. Personal Demographics. This includes sex, date of birth, place of birth, place of residence, etc. that can help characterize the case in terms of person and place. These variables can also help to generate a pseudo-unique patient identifier.
3. Behavioral Characteristics. This includes high-risk behaviors (such as sex between males, injecting drugs, sex work), that could assist in identifying the behaviors that are associated with HIV transmission.
4. Reportable Event and the Date It Was Observed. The applicable reportable event(s) Case Process Reporting should be documented, along with the date the event was observed.
5. Who Reported the Case. This includes the clinician’s name and the health facility name so that follow-up may be initiated where more details or data corrections are needed.
49 Collection of Behavioral Information
Gathering information about behavioral characteristics is critical in HIV case surveillance because it can provide data about relationships between behaviors and disease transmission and/or engagement in care. In some contexts, this can also include non-standard demographic characteristics—such as occupational, national origin or migration information—where such characteristics are potentially associated with HIV exposure. However, collection of these data may be challenging as certain behaviors, or other characteristics, may be highly stigmatized or even illegal. In addition, behavioral characteristics may be subject to interpretation (for example: could someone engaged in transactional sex be classified as engaged in sex work?). For these reasons, health systems should take steps to ensure the collection of high quality behavioral and other demographic data. First, behavioral variables should be carefully and clearly defined and these definitions should be standardized throughout the system, taking into consideration:
Variables should be clear and leave as little room for interpretation as possible. Variables should regard behaviors, not group identities. o Example: Ask all persons whether they have sex with men and whether they have sex with women. Don’t ask if someone is homosexual. Variables should not imply any value or judgment. Avoid all terms that may have a negative or abnormal connotation. o Example: Ask persons whether they have exchanged sex for money. Don’t ask whether the person is a “prostitute.” The collection of behavioral and other demographic data should be routinized and normalized as much as possible so that the client perceives that these questions are part of routine care, not an interrogation of, or intrusion into, personal information.
Second, staff routinely collecting behavioral data should be appropriately trained on variable Case Process Reporting definitions and best practices for the collection of this data. For more information on how to implement the routine collection of behavioral and sexual histories, please refer to the Taking Routine Histories of Sexual Health ToolKit (3).
50
D. Case Reporting Policies and Procedures
To support definition of and adherence to the case reporting process, the following policies and defined procedures (described in Chapter 1.1) are recommended.
A Case Reporting Mandate defines who should report a case and what information must be reported to whom, using what format and in what timeframe. Patient Privacy, Data Security and Confidentiality Policies cover important areas to protect patients and staff from risk related to the disclosure of sensitive information. o Patient Privacy Policies provide a legal framework to ensure that a patient’s
data are protected. Case Process Reporting o Data Security and Confidentiality Policies ensure that patient data are protected
during storage, transfer, and use in order to prevent unauthorized disclosure of personal information to a third party. o Data Sharing, Ownership and Dissemination Policies define who has jurisdiction over the surveillance data; how the data will be shared within, across, and outside of national programs; and under what circumstances data may be shared. Standard Operating Procedures (SOPs) are manuals that include all policies, procedures, and protocols for implementing case-based HIV surveillance. The SOP should provide a clear, comprehensive step-by-step description of all reportable events, who should report, and what data should be collected and how.
Summary of Noted Resources Case Process Reporting # Source Title Description Appendix (1) CDC Data Dictionary This is a description of what a data 27 Definition dictionary can contain, and describes the example provided in the Data Dictionary Template (2) UNAIDS Guidance for Unique This guidance emerged from a UNAIDS 28 Identifiers Planning and consultation meeting and may be helpful as you define your method to uniquely identify case of HIV (3) National Taking Routine This toolkit will help you design a system 29 LGBT Histories of Sexual to collect routine histories of sexual health Health Health ToolKit with all adult patients, one important Education component of case-based surveillance data Center collection
51 Data Systems to Manage Case 1.4 Surveillance Data
In this chapter, we will review:
The importance of defined data systems to support data reporting, management, security, and use
Sample models for disease reporting and database design
The need for routine data cleaning and basic quality assurance in order to create and
maintain a strong surveillance data set
The basics of case matching whereby multiple case reports related to one person can be linked for analysis
Introduction In this chapter, a data system is defined as the process through which data moves from one location to another, the tools used to transfer and store data, as well as the defined policies and procedures to support data transfer, cleaning, and use. A strong case-based surveillance data system will ensure that case report data can be transferred to a secure database with high user functionality. Such a data system can be simple or complex—aligned with local needs and capacity—and should be able to grow in capacity and complexity over time, as needed.
In order to effectively manage all of the case report data that will be generated from reporting facilities, five key components must be considered: Technical: 1. Existence of data transfer mechanisms to facilitate the case reporting process 2. Existence of a database that can collect and store data in a way that allows for data cleaning, analysis and use Data Systems to Manage Case Surveillance Data Surveillance Manage Case Data to Systems Procedural: 3. Ability to implement routine data cleaning and quality assurance of case reports that are entered into the database 4. Ability to link multiple case reports pertaining to one person in order to monitor clinical progression and outcomes 5. Ability to apply defined data standards and security and confidentiality policies
52 A. Data Transfer
Data transfer is the process of moving HIV case report data from the reporting source to the central database. A sample data system is depicted in Figure 1.8. Note that there are multiple possible data entry and data transfer methods that merge data into a central data repository, and that data cleaning and case matching occurs before the case is logged in the master
database.
Figure 1.8: Sample Case-based Surveillance Data System Design
HIV Testing Data (Paper Case Reports)
HIV Clinical Data (EMR Transfer) Quality Assurance Case Data Cleaning HIV Surveillance Laboratory Data Report Database (Electronic Transfer) Data Entry Case Matching Vital Registry (Manual Data Match)
There are two considerations for data transfer: the case reporting mechanism and the case reporting pathway. The mechanism is the format used to move information, and the pathway reflects the flow of the information. Determining the most appropriate for both should first consider the existing public health and facility infrastructure.
Case Reporting Mechanism
The case reporting mechanism should fully leverage the technology available to you to efficiently submit the information without compromising its integrity. Mechanisms currently being used can be grouped into three broad categories: systems that rely only on paper-based Data Surveillance Manage Case Data to Systems reports, systems that rely on electronic reporting only, and systems that rely on a combination of the two (hybrid). The most commonly used is the hybrid.
A paper-based system relies solely on the use of paper forms for reporting cases. To use this system, providers complete paper-based case report forms and submit them to case surveillance staff at the sub-national or national level, where the case report is entered into a database. This option works well for low resource or low volume settings.
53 A paper-based system is simple, inexpensive and requires less technology and IT- trained staff at the site or sub-national level, however: o Case data entry at sub-national and national levels could be labor intensive. o A secure reporting pathway for the paper forms will be required to ensure that cases reports arrive at a central location to be entered without disclosure of patient-level data o Additional delay might be expected between the date of the sentinel event (case report completion) and the availability of the data for analysis due to the time
delay inherent in paper-based reporting.
An electronic system uses information and communication technology to capture and transmit case reports; this could include computers, web-based data collection portals, smart phones, and/or dedicated data flow pathways. To use this system, providers enter case report data into an electronic case reporting system, or data are extracted from the facility’s existing data management system, such as an electronic medical record (EMR). Data are then electronically transferred to the sub-national or national case-based surveillance database. An electronic system has multiple advantages: o Data may be entered electronically at the point of service so fewer centrally based data entry personnel will be needed o Case reporting may be more timely if data are available in electronic format at the point of service delivery o Quality assurance elements can be integrated into the electronic system to permit real-time quality checks and flags o Transcription errors could be minimized as data is entered once and data entry close to the point of service o Required human resources and may be significantly decreased as data entry is replaced by automated data transfer o Threats to data security associated with the management of a large number of paper forms may be reduced. However, an electronic system will require high coverage of electronic data systems among providers, and more technology and IT-trained expertise among case-based surveillance staff.
A hybrid system uses a combination of paper-based and electronic reporting. Paper-
based reports, using a standard case report form, are entered into the national database Data Surveillance Manage Case Data to Systems either at a sub-national or at the national level. Reporting sources that have an electronic data management system report using a standard electronic file format. In most cases, as long as the reporting source’s data system has the required variables, and it can be exported to a simple computer language, such as Excel, it is usable. A hybrid system is often appropriate to accommodate a variety of provider types and data capacities. A hybrid system is also a natural phase in the gradual adoption of electronic information systems.
54 Data Reporting Pathway
The pathway that the case reports take to the national HIV surveillance database will depend on the country context. The principal pathway options are:
Flat: cases are reported directly from the site to the national level, where data management (quality checks, cleaning, matching) occurs.
Hierarchical: cases are reported from the site to a sub-national level, where initial data management is performed before forwarding to the national level. Two sample models are depicted below in Figures 1.9 and 1.10.
Figure 1.9. Flat Model Figure 1.10. Hierarchical Model Flat Model Hierarchical Model
Central Database Laboratory
Facility 4 Facility 1 Laboratory
Central Region A Region B Database
Region B Region A
Facility 1 Facility 3
Facility 3 Facility 2
Facility 2 Facility 4
In this model, all reporting sites report directly In this model, reporting sites report to a sub- to the central database, using a paper or national level, such as a regional office. This electronic method. One office has the sub-national office has the responsibility to responsibility to enter, clean, and match the quality check, clean and enter the data. The data, and ensure a strong master data set. Data clean data are then submitted to the central are then fed back to the sub-national units database for a second round of cleaning and (regions) so that they can provide support and matching. The sub-national office is also Data Systems to Manage Case Surveillance Data Surveillance Manage Case Data to Systems supervision to the facilities. responsible for providing support, supervision, and quality improvement activities to reporting sites.
55 If a paper-based system will be used in whole or in part, there are some additional factors to consider depending on the case reporting model you will use:
In a flat system, paper case reports can be entered directly into the database or repository upon receipt, meaning that only one data access point is required. One or more staff at the single location can use the single data entry system to report cases; data cleaning and management will happen at one central location.
In a hierarchical, paper-based system, a networked data entry interface is indicated so that data can be entered into a consistent interface from multiple sub-national locations. The stored data will then be transmitted and merged at the final, central location. In this case, multiple staff will need to be able to enter data at multiple locations concurrently.
Whether the system is hierarchical or flat, a secure process is required to transport paper-based reports. As case reports contain personal and information that could potentially identify someone with HIV, the case reports must be kept in a locked and secure location in order to protect the privacy of those diagnosed with HIV. Case data should be moved from one location to the next only via a mechanism of transport that meets the data security and confidentiality standards articulated in the national policy (Chapter 1.1). If an electronic system will be used in whole or in part:
A secure process to transmit the case report data is imperative. As the case data contain personal and potentially identifiable information, case data should be encrypted and transmitted via a secure interface.
Data Systems to Manage Case Surveillance Data Surveillance Manage Case Data to Systems
56 B. Electronic Information System
The case-based surveillance electronic information system includes both the case surveillance database and any related electronic applications used to report or transfer data (if applicable). The electronic information system should be designed so that it is accessible to and/or manageable by the case-based surveillance team, and able to be modified and expanded as needed. Where possible, existing resources and data systems should be used and/or expanded upon. This could include alignment with other strategic information data management initiatives to build from local capacity and available systems and resources. (1)
In order for an electronic information system to be fully operational there are certain functionalities an agency needs to consider during its development. Electronic information systems should: 1. Allow one to compose, securely send and receive electronic messages using standard protocols, formats, and terminologies 2. Allow one to electronically enter, edit, and retrieve identifying and other information about persons, organizations, and other entities from an electronic database that adheres to standard database protocols, formats, and terminologies 3. Be secure and have mechanisms to ensure the appropriate level of access such that the information contained is only accessed or used by authorized users for authorized purposes. Further information on functional requirements can be found in the appendix items to consider for a Functional Electronic Information System (2). When evaluating the appropriateness of available HIV case reporting applications or developing one’s own electronic information system, several criteria exist that can be followed as a guide. These evaluation criteria can be grouped into four general criteria: 1) Basic, 2) Architectural, 3) Management, and 4) Functional. Further information can be found in the appendix HIV Case Reporting Application Evaluation Criteria (3). In addition, programs choosing or developing an electronic information system should consider the following tips. The system should:
Be fully accessible by the managing government agency, such as the Ministry of Health; Data Surveillance Manage Case Data to Systems third party proprietary systems that limit front- and back-end access and modifications are not recommended
Be built using software that is well known and accessible to the assigned government staff
Be simple but expandable to allow for more cases, additional data elements, and/or use for additional disease
57 Allow for redundancy, multiple inputs, and backups as redundancy in case surveillance permits for stronger and more comprehensive quality data; redundancy refers to the ability to receive case reports on one patient from multiple systems—such as testing sites, laboratories, medical centers—even if reporting on the same event
Support and adhere to data security and confidentiality guidelines such that all patient data will be protected
Include built in functionality that supports “one click” generation of data quality and epidemiological reports. Because case data that are submitted and entered into the data system may require data quality checks and correction, it is advisable to develop a two-part database whereby source data can be held in a repository of sorts until it can be cleaned and/or validated. Once data are clean, matched and de-duplicated, they can be submitted to the master database for storage and epidemiologic analysis.
Data Systems to Manage Case Surveillance Data Surveillance Manage Case Data to Systems
58 C. Data Cleaning and Quality Assurance
Data cleaning and quality assurance is the multi-part process through which data submitted via the case reporting system are reviewed, assessed, and, if necessary, verified and corrected, before they are entered into the master database.
We define data cleaning as the process of examining the data to identify invalid, anomalous or
inconstant values, and quality assurance as the process of correcting the errors before epidemiological analyses. These processes go hand-in-hand, and should be done at the central level with the master dataset, and at sub-national levels if possible. Importantly, quality assurance also includes providing feedback and support to the reporting facilities to reduce errors in the future.
The following data cleaning and quality assurance, steps should be taken to ensure quality data (4):
Define the data quality checks you will use to track and monitor quality, and orient staff to these checks and associated tools and processes. Data quality checks that you should consider include: o Are the variables you expect and need present? o Are the data in a usable and readable format? o Are the data within a normal and expected range? o Are there significant data gaps from a particular data source?
Ensure that all essential variables are reported, particularly the minimum set of variables required to meet the definition of a case.
Check data for errors such as blanks, possible data transmission errors, illegible values, or values that are outside of the normal range.
Follow up on the errors to ensure a quality and complete data. If all of the case-defining variables are not reported, or if data errors are noted, it is important to follow-up with the reporting source to complete the report, correct the errors and avoid future errors.
Provide training and technical assistance to improve data quality. Facilities that are high volume and/or that demonstrate repeat errors may benefit from in person technical assistance and additional training to standardize or improve the reporting Data Surveillance Manage Case Data to Systems process.
Data cleaning and quality assurance should be a routine part of the case-based surveillance process, and stakeholders should be involved with data quality assurance and supported to act on the findings. The involvement and support of stakeholders may be particularly important in the case that systematic or procedural changes need to be made in order to improve data quality.
59 D. Case Matching
The purpose of case matching is to distinguish between new and existing or already reported cases of HIV, and to link reports of disease progression, engagement in care or death to already reported cases. To do this, case reports must have some data element(s) that uniquely identify a case regardless of its source. A unique person ID (Chapter 1.3) is vitally important so that case matching can be implemented prior to data analysis and use.
The process for matching case data should follow a pre-determined algorithm so that matching happens consistently and methodically. Matching can be done manually, meaning a person physically reviews case reports to assess if there is a match to an existing case, or automatically via the use of computers and programmed data analysis code. The automated process facilitates review of a large data set, and can highlight difficult cases for further manual review.
A simple example of a two-step semi-automated case matching process is shown in Tables 1.8 and 1.9. In this example, case reports are submitted with a set of identifying information (name, date of birth, sex, district of birth, date of case report, facility of case report). The case report data are entered into a data base, and the data base “flags” possible matched cases via the reported Patient ID, a code the reporting facility generates from the patient name, date of birth, sex, and district of birth.
Table 1.8. Step One: Automated Case Matching and Data Cleaning Using Patient ID
Auto Submitted Auto Data Cleaning Auto Assigned Case Report Flagged Review of Source Data Generated Result
Record Possible Patient Patient Birth District [updated] Likely Patient ID Sex Number Match Name Month/Year of Birth Patient ID Match 1 JADO0367F23 Original Jane Doe 03/1967 F 23 JADO0367F23 source 2 JADO0367F23 Yes Janine Dobb 03/1967 F 23 JADO0367F23 Yes 3 JADO0367F23 Yes James Donn 03/1967 M 23 JADO0367M23 No 4 JADO0367F23 Yes Jane Doe 03/1967 F 23 JADO0367F23 Yes 5 JADO0367F23 Yes Jane Doe 03/1967 F 32 JADO0367F32 No 6 Yes
JADO0367F23 Yes Jayne Doe 03/1967 F 23 JADO0367F23 Data Surveillance Manage Case Data to Systems 7 JADO0367F23 Yes Jane Doe 03/1967 F 23 JADO0367F23 Yes Notes: During this matching process, six records were automatically flagged as a possible match to one existing record (#1) using the Patient ID that was reported by the facility. Via an automated process, other data from the case report form were reviewed by the computer, and an updated, auto generated Patient ID was created to verify this code. This data cleaning process identified two errors in the Patient IDs that were reported by the facility, and thus removed record #3 and #5 from the case matching process.
Result of Step One: The seven records with matched Patient IDs represent a minimum of three unique patients: Records #1/2/3/6/7, #3 and #5.
60 Following the automated data cleaning and case matching process, five records must still be considered to determine if they are in fact five records for one person. At this point, the initial case matching algorithm should be expanded to consider more nuanced variables, and should use source data from the case report form, and/or from the reporting facility.
Table 1.9. Step Two: Automated Case Matching and Data Cleaning Using Patient ID
Auto Auto Flagged Review of Source Data Findings
Assigned Generated Record [updated] Possible Patient Mother’s Reported Data Clean; Likely Facility Number Patient ID Match Name Name Event Quality Assurance Match 1 JADO0367F23 Original Jane Doe Anne Diagnosis R-1 source 2 JADO0367F23 Yes Janine Dobb Grace Diagnosis R-21 Different names No Follow-up report: 4 JADO0367F23 Yes Jane Doe Anne CD4 R-1 Yes CD4 value Different name 6 JADO0367F23 Yes Jayne Doe Ann Diagnosis R-14 spelling; similar Unsure sound Follow-up report: 7 JADO0367F23 Yes Jane Doe Anne ART R-1 Yes ART prescribed Notes: During this matching process, the five remaining records with a matched Patient ID are evaluated based on additional data variables not used to generate the Patient ID. Additional variables considered include: Patient’s full name, Patient’s mother’s name, the reported sentinel event, and the facility that reported the case. Record #4 and record #7 appear to be follow-up disease progression reports for record #1. All variables used to match are consistent, and there is logic to the reports. Record #2 appears to be a different, new, and unique case. All variables used to match are different from the source record, #1. Record #6 may or may not be related to record #1. There is consistency in the variables used to match, including district of birth; errors in the spelling of a patient name might not support a definitive decision. Furthermore, it may not be uncommon for a person to have more than one case report for HIV diagnosis; repeat testing is not uncommon. Result of Step Two: The five records with matched Patient IDs represent a minimum of two unique patients (Records #1/4/7, #2). One case will require further manual follow-up (Record #6). Overall Results: Of the seven cases flagged, we identified that these represent four or five unique patients: One case with three reported events (Record #1, #4, #7) One new male case (Record #3) Two new female cases (Record #2, #5) One case is pending further investigation (Record #6).
It is important to keep in mind that case matching is not an exact science, and there will always Data Surveillance Manage Case Data to Systems be a degree of error in the system. What you want to achieve is the best that you can with your available resources. The success of your matching process will be dependent on having quality data and a logical matching algorithm. In defining the algorithm, consider the balance between accidently matching individuals who are different people (‘false positive’) and accidently missing matches (‘false negatives’).
A more complex example of a case matching process (5) is described in the appendix.
61 E. Related Policies and Procedures
Through the data management process, defined policies and procedures on data standards, data interoperability, and security and confidentiality will help ensure quality, complete, and usable data while protecting the privacy of patients.
Data Standards
Data Standards (6) (7) are a set of criteria that define the content and format of the case report data, and how you expect to receive the data.
The goal of data standards is to ensure that all data elements are usable within your database, in a consistent form and format, regardless of the source. Data standards can have many levels of complexity, but at their most basic, they should clearly define the variables to be collected, and format you will use. These standards should be defined in a data dictionary (8) (9) (10). A simple example of a data dictionary is provided in Table 1.10.
Table 1.10. Example of a Basic Data Dictionary
[Variable] will be recorded as [Format] Unique Patient ID XXXX######XX# Female: 1 Sex Male: 2 Date of Birth DD/MM/YYYY Age ## Yes: 1 No: 2 Choice Questions N/A: 3 Unk: 88 No Resp: 99 Facility ### (National Facility #)
Data standards should also address data transmission: computer-mediated communication among electronic system users, and between electronic systems. In order to ensure and Data Systems to Manage Case Surveillance Data Surveillance Manage Case Data to Systems optimize information transmission from one computer to another, data must be encoded into certain formats using Data Transmission Standards (7) that define how information is packaged and communicated from one party to another.
62 As you consider the data-related elements of your case-based surveillance system, be sure to work with key stakeholders that already manage and use IT systems, as well as local programmers and those who are advising public health informatics development. Understanding the data interoperability efforts that are already underway, and aligning the case-based surveillance data collection with such efforts will improve data quality and completeness of the system. International standards are becoming more widely available and adopted, and may be applicable locally.
Data Standards and Data Transmission Standards (6) (7) are further described in the appendix.
Security and Confidentiality Policies
Security and Confidentiality Policies (Chapter 1.1) should cover the key areas that protect patients from risk related to the disclosure of sensitive information, and describe how data will be transferred, stored and managed.
Patient Privacy Policies provide a legal framework to ensure that a patient’s data are protected.
Data Security and Confidentiality Policies ensure that patient data are protected during storage, transfer, and use in order to prevent unauthorized disclosure of personal information to a third party.
Data Sharing, Ownership and Dissemination Policies define who has jurisdiction over the surveillance data; how the data will be shared within, across, and outside of national programs; and under what circumstances data may be shared.
Standard Operating Procedures
Standard Operating Procedures (SOPs) (Chapter 1.1) should clearly describe:
The format and pathway for transferring case reports. Measures to protect the security and confidentiality of data during transfer and storage. The criteria and processes that will be used for data cleaning and quality assurance, which may include measures, quality assurance tools, and checklists.
Roles and responsibilities in data transfer, cleaning and quality assurance. Data Surveillance Manage Case Data to Systems
63 Summary of Noted Resources # Source Title Description Appendix (1) NASTAD Hints for Developing Peer-based guidance that may help you 30 IT Systems for Case conceive of your data system Surveillance development (2) CDC Items to Consider for a This document describes items to 31 Functional Electronic consider to increase data interoperability Information System and electronic information system utility. (3) CDC HIV Case Reporting A summary document to describe the 32 Application criteria to consider when evaluating an
Evaluation Criteria electronic information system to support HIV case reporting (4) Van den Data Cleaning - A journal article to help guide data 33 Broeck Detecting, Diagnosing, cleaning and quality improvement and Editing Data processes Abnormalities (5) NASTAD Sample Case An example of the case matching process 34 Field Deduplication used in Haiti, guided by an automated Algorithm (Haiti) and manual deduplication algorithm (6) U.S. State Information Systems, Describes the planning process that the 35 Data Interoperability, Minnesota Department of Health and the Requirements implemented to address the question of for Exchange integrating data from local health (Minnesota) departments via electronic health records. Contains a number of resources including data flow diagrams and checklists that are helpful. (7) CDC Data Transmission A description of what data transmission 36 Standards standards are, and the role they play in quality data transmission. Health Level Seven International (HL7) is provided as an example. (8) CDC Data Dictionary This is a description of what a data 27 Definition dictionary can contain, and describes the example provided in the Data Dictionary Template (9) CDC Data Dictionary This data dictionary was developed using 37 Template different available HIV case reporting forms as sources. The following data dictionary combines similar data elements found on all forms and adds additional
relevant data elements not currently Data Surveillance Manage Case Data to Systems collected on available forms. This data dictionary should be viewed as a way to organize the various data elements relevant to HIV case reporting to increase data collection standardization, adaptability, and data interoperability. (10) CDC Data Dictionary Mind A graphic representation of a data 38 Map dictionary and the required elements of a sample case report form
64 Using Case-based Surveillance 1.5 Data
In this chapter, we will review:
The basis for monitoring of surveillance systems and processes
The value of case-based surveillance for understanding the epidemic and identifying
system and service needs and gaps
How data can be used to drive surveillance system quality improvement initiatives
Introduction Using data generated by a case-based HIV surveillance system is invaluable to reinforce and improve the quality of routine case reporting, as well as for evidence-based public health planning. Case-based surveillance can help program staff make important decisions about program planning and resource allocation, maximizing resources and efforts by identifying those most impacted by a disease and allowing a targeted response to that group.
This chapter will present three key uses of the system data: based Surveillance Surveillance Data based - Surveillance system and process monitoring to understand system performance and limitations;
Epidemiologic profiling to understand HIV-related trends, engagement in care, disease progression and HIV-related service needs; and
Quality improvement processes to support system strengthening. Using Case
65 A. Surveillance System and Process Monitoring
Monitoring is the routine collection, analysis, and use of information to understand surveillance system performance, limitations and areas for system improvement. (1) (2) In the context of case-based surveillance of HIV it is important to monitor:
The efficacy of the case reporting process through which case data are incorporated into the surveillance system, and
The quality of the surveillance data.
Effective monitoring is not a one-time event, but rather should be an ongoing, cyclical process. Routinely monitoring your surveillance system will allow you to leverage the feedback you obtain from all levels of the surveillance system to improve the performance of your case surveillance system and the data it produces.
Please note that this section describes the practical components of surveillance system and process monitoring. Module 2 describes the operationalization of these components and provides concrete examples of monitoring frameworks and plans, as well as sample tools.
Monitoring and Evaluating the Case Reporting Process
Process monitoring focuses on the procedures used to capture, report, and manage case data. Criteria that are important to monitor include: based Surveillance Surveillance Data based
- 1. Timeliness. This describes the amount of time between steps in the case reporting and data management process, such as the time between diagnosis and availability of the case report for analysis. This provides information on whether the data within the surveillance system are current, and implies whether system processes are functioning appropriately. Using Case a. Sample metrics for timeliness include: b. Median time between diagnosis and receipt of case report at the national level c. Proportion of cases reported to the national level within a time period
2. Representativeness. This measures the degree to which the case-based surveillance system is capturing all cases and sentinel events—the degree to which cases in the surveillance system are “representative” of all cases in the population. This metric examines whether all expected cases are being reported to the system, and whether all expected facilities are reporting to the system.
66 Sample metrics for representativeness include: o Proportion of HIV cases diagnosed in a quarter that were reported o Proportion of eligible reporting facilities that submitted case reports in a quarter
Formulas for these criteria, and examples of how to monitor processes, are in Module 2.
Monitoring and Evaluating Surveillance System Data
This type of monitoring focuses on data that are in the system and allows you to discern if the data are of sufficient quality to accurately describe the epidemic. Criteria that are important to monitor include:
1. Completeness. This describes the proportion of case reports that contain an expected Data variable or variables. a. Sample metrics for completeness include: b. Proportion of case reports have a select variable complete c. Proportion of case reports have all case defining variables complete
2. Validity. This describes the degree to which the case-based surveillance data ‘makes sense,’ or whether the data fall within the range of possible or expected values. Examples of data that are not valid are: based Surveillance Surveillance based
a. Males reported as pregnant - b. Cases with HIV are 120 years old c. Cases diagnosed with HIV in 1958 d. Cases with negative CD4 values e. Sample metrics for validity include: f. Proportion of case reports in which a selected variable is valid (e.g., for “year of Using Case birth”: four digits between the range of 1940 and 2014; for “CD4 value”: a number between 0 and 1,200)
3. Accuracy. This describes the degree to which the data are ‘true,’ or whether the reported data match the corresponding data in the source record (e.g. patient registry). This measure helps to establish a degree of confidence in the surveillance data. Sample metrics for accuracy include:
67 o Proportion of case reports in which a selected variable value matches the value in the source record (e.g., PCR result on the case report from matches that in the laboratory register).
Formulas for these criteria, and examples of how to monitor quality, are in Module 2.
Closing the Monitoring Loop
Results obtained from monitoring activities should be shared at all levels in order to accelerate and reinforce improvement and motivate stakeholders to support the system. Sharing findings
can help empower clinical facilities and reporting sites to:
Improve data timeliness, quality and representativeness
Identify needs for further support or training
Appreciate that the data they report are being reviewed and used
The process you use to share the monitoring findings with stakeholders can take many forms. Simple, routine (i.e., monthly) data reports that show a facility their progress as compared to targets can be helpful.(3) In-person conversations and follow-up training or support to fill knowledge gaps can also be useful. In some instances, having many stakeholders together in one venue to discuss system wide successes and gaps can help highlight those facilities or programs that are doing well and motivate those that are underperforming. The most important thing is that you share data, in some form, with the people who work in the system you are based Surveillance Surveillance Data based monitoring and evaluating. Module 2 provides some ideas for sharing data. -
Using Case
68 B. Epidemiological Profiling
Routine analysis of case-based surveillance data provides up to date information on trends in the HIV epidemic, the characteristics and needs of individuals living with HIV and their access to care. Because the purpose of surveillance is to inform public health action, case surveillance data must be analyzed in a way that is most useful and consumable for program planners and decision makers. As you plan for data analysis and dissemination, it is a good idea to coordinate with the ultimate users of the data to ensure that analyses and dissemination products provide the data needed, in the format needed.
Describe the HIV Epidemic
Analysis of case surveillance data should address key second generation surveillance questions pertaining to the “who, what, where, when and how” of the HIV epidemic.
Who
Among whom is the burden of HIV disease high?
Case surveillance data analysis should describe the number of HIV cases nationally, and among different demographic Surveillance Data based - groups.
Example: Adults and adolescents living with a
diagnosis of HIV infection in Using Case 2009, United States. Epidemiology of HIV Infection through 2011, Centers for Disease Control. based Surveillance Surveillance Data based - Using Case
69 Who is contributing to new HIV diagnoses? Case surveillance data analysis should describe the number of new HIV cases nationally, and among different demographic groups.
Example 1: Diagnoses of HIV infection among adults and
adolescents, by sex and race/ethnicity, United States, 2011. Epidemiology of HIV Infection through 2011, Centers for Disease Control.
based Surveillance Surveillance Data based
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Using Case Example 2: Perinatally acquired HIV infections in children born during 2011, United States. Pediatric HIV surveillance through 2011, Centers for Disease Control.
70 What
What is the progression of disease among HIV cases?
Case surveillance data analysis should describe the number of HIV cases progressing to advanced HIV disease or AIDS, nationally, and among demographic groups, key populations and geographic areas. Analysis should also
describe trends in disease progression. Example 1: Stage 3 (AIDS) classifications among adults and adolescents with HIV infection, by race/ethnicity and year of diagnosis 1985-2011, United States. HIV Surveillance AIDS trends through 2011, Centers for Disease Control.
Surveillance Data based -
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Example 2: AIDS diagnoses, 2010, United States. 2010 HIV Surveillance Report, US Centers for Disease Control.
71
What is the level of mortality among HIV cases? Case surveillance data analysis should describe the number and rate of deaths among HIV cases nationally, and among demographic groups, key populations and geographic areas. Analysis should also describe trends in mortality.
Example 1: Trends in annual age-adjusted rate of death due to HIV infection, 1987-2010, United States. HIV Mortality through 2010, Centers for Disease Control.
Surveillance Data based -
Using Case
Example 2: Age-adjusted rate of death among persons with HIV infection, by state, 2010, United States. 2010 HIV Surveillance Report, US Centers for Disease Control.
72
Where
Where is the burden of HIV high? Case surveillance data analysis should describe the number and rate of HIV cases nationally, by geographic areas, and by groups within geographic areas. Analysis should also describe trends in the geographic distribution of HIV cases. Example 1: Adults and adolescents living with a diagnosis of HIV infection in 2009, United States. 2010 HIV Surveillance Report, US Centers for Disease Control.
based Surveillance Surveillance Data based -
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Example 2: Adult and adolescent backs/African Americans living with a diagnosis of HIV infection, year-end 2009, United States. 2010 HIV Surveillance Report, US Centers for Disease Control.
73 Where are new HIV cases coming from? What are the hotspots? Case surveillance data analysis should describe the number and rate of new HIV cases nationally, by geographic areas, and by demographic groups, key populations within geographic areas.
Example 1: Diagnoses of HIV infection, 2010, United States. 2010 HIV Surveillance Report, US Centers for Disease Control.
Surveillance Data based -
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Example 2: Rates of diagnoses of HIV infection among adult and adolescent blacks/African Americans, 2001, United States. 2010 HIV Surveillance Report, US Centers for Disease Control
74 When
When is there a change in the direction of the epidemic? Case surveillance data analysis should describe trends in the national epidemic, and trends in the epidemic among demographic groups, key populations and geographic areas. Example: Diagnoses of HIV infection among adults and adolescents by race/ethnicity, 2008-2011, United States. Epidemiology of HIV Infection through 2011, Centers for Disease Control.
Surveillance Data
based - How
What behaviors are associated with HIV infection? Case surveillance data analysis should describe the number of
HIV cases with reported risk Using Case behaviors. Analysis should also describe trends in behavioral associations.
Example: Diagnoses of HIV infection among adults and adolescents by transmission category, 2008-2011, United States. Epidemiology of HIV Infection through 2011, Centers for Disease Control.
75 What behaviors are associated with new HIV infections? Case surveillance data analysis should describe the number of new HIV cases with reported risk behaviors.
Example: Diagnoses of HIV infection among adults and
adolescents by transmission category, 2011, United States. Epidemiology of HIV Infection through 2011, Centers for Disease Control.
based Surveillance Surveillance Data based - Using Case
76
Describe Engagement in Care
In order to impact HIV incidence, HIV control programs must provide multiple highly effective interventions that are delivered in the same geographic area achieve high levels of coverage, achieve strong linkages between services, and achieve high adherence and retention in care.
The last three elements of this paradigm are known as the “HIV clinical cascade1,” which describes the series of linked services that HIV-positive persons should enter and progress Surveillance Data based - through (Figure 1.11).
Figure 1.11. The HIV Clinical Cascade
HIV Enter clinical Retained Eligible Initiate Retained Suppresed
diagnosed care in care for ART ART on ART viral load Using Case
A comprehensive case-based surveillance system that tracks HIV cases longitudinally can provide valuable information on the progression of HIV cases though the clinical cascade, and identify gaps and hemorrhage points in the chain of HIV services. Analysis of case-based surveillance data should address such questions as: Testing Coverage: Low initial CD4 values at diagnosis or entry into to care suggest low coverage of HIV testing that is not reaching HIV-positive persons before they progress to an advanced, symptomatic stage of HIV disease. High CD4 values suggest a high based Surveillance Surveillance Data based
coverage of HIV testing which reaches HIV-positive persons before they progress to an - advanced, symptomatic stage of HIV disease. Specific questions you can pose include: o Do persons newly diagnosed with HIV have high or low initial CD4 values? o Are there differences in testing coverage among different demographic groups, key populations, or geographic areas? o Is testing coverage improving? Using Case Linkage to Care: What proportion of persons newly diagnosed with HIV is successfully linked to care? o Are they linked to care in a timely manner? o Are there differences in linkage to care among different demographic groups, key populations, or geographic areas? o Are linkage to care rates improving?
1 Centers for Disease Control and Prevention. (2011). Vital signs: HIV prevention through care and treatment — United States. Morbidity and Mortality Weekly Report, 60(47), 618-1623.
77 Immunologic Monitoring: What proportion of persons in care receives CD4 testing to determine treatment eligibility? o Do they receive CD4 testing in a timely and routine manner? o Are there differences in CD4 testing coverage among different demographic groups, key populations, or geographic areas? o Is CD4 testing coverage improving?
Retention in Care: What proportion of persons linked to care is retained in care? o Are they linked to care in a timely manner? o Are there differences in retention in care among different demographic
groups, key populations, or geographic areas? o Are rates of patient retention improving?
ART Eligibility and ART Coverage: What proportion of HIV cases is eligible for ART (per CD4 value or clinical criteria) and what proportion of these have initiated ART? o Are there differences in ART coverage among different demographic groups, key populations, or geographic areas? o Is ART coverage improving?
Initiation of ART: What proportion of persons newly diagnosed with HIV successfully
initiates ART? Surveillance Data o Do they initiate ART in a timely manner based on eligibility criteria? o Are there differences in ART coverage and timeliness of ART initiation
among different demographic groups, key populations, or geographic areas? based - o Is ART coverage improving?
Retention on ART: What proportion of persons initiating ART is retained on ART? o Are there differences in ART retention among different demographic groups, key populations, or geographic areas? o Are rates if ART retention improving? Using Case Viral Load (VL) Monitoring: What proportion of persons in care receives VL testing to monitor the effectiveness of treatment? o Do they receive VL testing in a timely and routine manner? o Are there differences in VL testing coverage among different demographic groups, key populations, or geographic areas? o Is VL testing coverage improving?
78 VL Suppression: Virologic suppression is a sensitive measure of the effectiveness of a treatment program, including: initiation of appropriate ART regimens in a timely fashion; retention in ART and on-time ARV pick up; regular clinical, immunologic and virologic monitoring; ART regimen change where appropriate. o What proportion of persons on ART has achieved VL suppression? o Are there differences in VL suppression among different demographic groups, key populations, or geographic areas? o Are rates of VL suppression improving?
An example of an analysis focused on the clinical cascade is provided in Figure 1.12.
Figure 1.12. Number and Percentage of HIV-Infected Persons Engaged in Selected Stages of The Continuum of HIV Care2, United States, 2010. based Surveillance Surveillance Data based -
Using Case
2 Centers for Disease Control and Prevention. (2011). Vital signs: HIV prevention through care and treatment — United States. Morbidity and Mortality Weekly Report, 60(47), 618-1623.
79 Analysis of access to care and the clinical cascade should also describe differences in care access by demographic groups, geographic regions and risk behavior, as exampled in Figure 1.13.
Figure 1.13. Percentage of Persons Diagnosed with HIV Engaged In Selected Stages of the Continuum of Care, By Sex at Birth, Minnesota3
In addition, in the context of PMTCT and pediatric services, analysis of case surveillance data should address such questions as: based Surveillance Surveillance Data based What proportion of HIV positive pregnant women receives ARV prophylaxis? What - regimen did they receive? What proportion of HIV-exposed infants receives HIV testing? What proportion of HIV-exposed infants receiving HIV testing is positive? (the rate of mother-to-child transmission)
What proportion of HIV-positive infants enroll in care or treatment? Using Case
Interpreting Case-based Surveillance Data
Increases and decreases in case reports of HIV and/or advanced HIV infection may be due to factors other than a true decrease or increase in the number of infections and deaths occurring. The following factors that may influence the interpretation of case reporting data:
3 Minnesota Department of Health. (2013). Minnesota treatment cascade for people living with HIV/AIDS [PDF document]. Retrieved from http://www.health.state.mn.us/divs/idepc/diseases/hiv/hivtreatmentcascade.pdf
80 Increases or decreases in the size of the population will affect both the number of infections and the incidence and prevalence levels.
Increases in coverage of HIV testing may lead to more new diagnoses of HIV cases, but do not necessarily reflect changes in the epidemic.
Changes in the case definition could result in an increase or decrease in new cases.
Changes to the case surveillance system would be expected to affect the number of new HIV case reports. While a case surveillance system is still maturing, one would expect the numbers of new HIV cases to continually rise as the system: o Captures a large number of existing HIV cases (non-recent diagnoses)
o Progressively rolls out to new geographic areas and types of reporting sites o Progressively increases in the quality and representativeness of reporting, as reporting sites make strides towards submitting complete reports for 100% of identified cases. In this context, it may be difficult to distinguish between increases in HIV cases due to an expanding system and increases in HIV cases due to real changes in the epidemic. However, once the system achieves a sufficient level of maturity and coverage, new HIV case reports would be expected to decline as the significant volume of case reports produced by system expansion and the “backlog” of existing HIV cases is reduced.
Duplicate case reports (more than one report provided for an individual) may lead to counting one person twice. If a case surveillance system does not have a robust method
for matching and deduplication cases, the number of cases in the system could be Surveillance Data based - artificially inflated.
ART delays the progression of HIV infection thereby, thereby reducing the incidence of advanced HIV infection.
Estimates of HIV prevalence based on case surveillance data can be affected by two additional considerations: Using Case o Incomplete data on mortality among HIV-positive persons can lead to an overestimation of prevalence based on case surveillance data, as those persons who have died are not removed from the count of living HIV-positive persons. o Changes in HIV-related mortality due to increasing coverage of ART can result in increased prevalence as HIV-positive persons exit the HIV-positive population at a lower rate.
81 Disseminating Case-based Surveillance Data
Just as it is vitally important to analyze data that are collected, analyzed data must be reported and shared. Dissemination should be viewed as a vehicle to promote public health practice or set priorities for public health action. Following best practices in the dissemination of surveillance results can optimize the impact of surveillance results, and ensure official and civic society support for surveillance systems. Surveillance results should be disseminated to all persons and organizations implicated in the response to the HIV epidemic, especially those responsible for decision making. Potential target audiences for dissemination products include:
Public health officials at the district, provincial, national and levels Government officials, policy-makers and planners Civil society organizations and advocacy groups National and international partners Journalists and the media The PLHIV community The general public. It is important that results are also disseminated to persons who contribute to the production and collection of the data to maintain their engagement in, and commitment to, the production of high quality data for surveillance. Dissemination products and channels (how the dissemination products are delivered) that are tailored to the target audience will be more successful in meeting dissemination objectives. based Surveillance Surveillance Data based
There are a variety of products that can be used to disseminate surveillance results, including: -
Annual HIV case surveillance reports should focus on the analysis and interpretation of the data. This type of report is usually limited to descriptive statistics, though more sophisticated analyses may be included. The report should include observed trends of the HIV epidemic, observed risk patterns, transmission categories, age, sex and geographic distributions. Guidance on how to develop epidemiological data reports are Using Case presented in the appendix. (4) (5)
Fact sheets or press releases are brief descriptions written in simple language and formatted to convey basic information on a single topic or subject area. In areas where multiple languages are spoken, some fact sheets may need to be translated into other languages. Fact sheets or press releases often will include contact information for follow- up when more in-depth information is desired. They also can be tailored to address specific populations, including division by special interest, sex, risk category, age, etc.
82 Visual presentations of surveillance data are useful for conveying information to the Ministry of Health (MOH) staff, the National AIDS Program staff, community-based organizations (CBO), community-planning groups, the general public, international donors and policy-makers. Graphic presentations can add interest and impact to numeric data, such as comparisons and trends. Slides prepared in Microsoft PowerPoint (or similar programs) can be used for electronic presentations, embedded with text in printed reports or printed as posters/displays. Slide sets can address topics similar to the fact sheets and should be updated annually. Examples of information included in these slides are: o Summary data o Geographic distribution o Trends (five or 10 years) o Proportions by demographic factors (race/ethnicity, sex, risk). Likewise, there are multiple options for dissemination channels, including: dissemination workshops, conferences, press conferences, and formal meetings. When presenting the data, always consider your audience. Be sure to understand what they want to know, what their level of data comprehension is, and what they hope to discern from the data. The channel, product and target audience should align in a successful a dissemination strategy. For example:
Public health officials will have considerable technical expertise; require significant breadth and depth of data for use in program planning and evaluation; and have substantial expectations with regards to engagement. A full surveillance report delivered in a workshop or conference may be appropriate for this audience.
Government officials, policy-makers and planners may have limited technical expertise, Surveillance Data based - limited data needs and many demands on their time. However, government officials are important decision makers and may require significant engagement. Briefings or slide sets focusing on major results, involving audience-friendly displays and delivered in formal meetings may be appropriate for this audience.
Journalists, media and the public have limited technical expertise and data needs. Press
releases or fact sheets focusing on major results, involving audience-friendly displays Using Case and provided in press conferences may be appropriate for this audience.
Civil society organizations and the PLHIV community may have moderate technical expertise and data needs, but significant expectations with regards to engagement. Surveillance reports, fact sheets, slide sets provided in conferences may be appropriate for this audience. In order for surveillance results to be utilized for public health action they must provide a current picture of the HIV epidemic. This can only be achieved if surveillance results are disseminated in a timely fashion.
83 Ethical Issues in Disseminating Case-based Surveillance Data
To reduce the risk of inadvertent identification of individuals, it is essential that data be presented in a way that preserves the confidentiality of persons in the HIV database. Only aggregate data and summary statistics should be disseminated and presented. Because it may be possible to identify individuals when small numbers of cases are presented (which may occur more frequently when cases are broken down by age, gender or other demographic factors), all case surveillance systems should define and adhere to data restriction policy on small cell sizes. A common standard is that cells with a value of five or less should be suppressed (data value not provided). Surveillance staff should also exercise tremendous care and consideration in presenting data about groups or behaviors that may be heavily stigmatized or illegal. Data that could allow for identification of where individuals and groups live (i.e. use of small geographic units), work, socialize, or access services should not be presented.
based Surveillance Surveillance Data based - Using Case
84 C. Quality Improvement
Continuous Quality Improvement (CQI) is a routine and cyclical process that uses monitoring data to identify and drive systematic improvements in surveillance implementation and outcomes. Quality improvement processes support stronger surveillance systems and broader system ownership.
Case-based surveillance is an extremely process-rich activity with many moving parts. As such, case-based surveillance can be plagued by inefficient processes and missed opportunities. A commitment to CQI can foster collaboration, communication and joint decision-making to help ensure that case surveillance is efficient, effective and well-integrated into other activities.
Plan, Do, Study, Act Model for Continuous Quality Improvement
One method used for CQI is the Plan, Do, Study, Act4 (PDSA) cycle. As shown in Figure 1.14, this iterative, four-stage problem-solving model provides a framework for assessing quality and testing changes to improve surveillance processes, quality, and outcomes. (6)
Figure 1.14. Plan, Do, Study, Act Model for Continuous Quality based Surveillance Surveillance Data based
Improvement -
Surveillance Data based -
Using Case
Using Case
4 Langley, G. L., Nolan, K. M., Nolan, T. W., Norman, C. L., Provost, L. P. (2009). The improvement guide: A practical approach to enhancing organizational performance (2nd edition). San Francisco: Jossey-Bass Publishers.
85 The strength of the PDSA model is that it supports small and incremental changes, and the changes are planned and measured to understand impact. If the change is impactful on a small scale, the change can be tested on a larger scale. Because the changes are evidence-based and incremental, risk and resource-needs tend to be low. The steps proceed as follows:
First, a system or performance issue or area for improvement is identified.
Second, a measure of performance is taken at baseline.
Third, staff brainstorm the cause of the issue, and possible strategies to address the issue are considered. Because PDSA focused on starting small, the strategies typically involve
simple, manageable steps.
Fourth, the Plan, Do, Study, Act cycle is initiated: o Plan: Once ideas for change or improvement are identified, an implementation plan is developed. The plan typically describes who will do what, when, where, how, and with what tools. The tools are then developed, the process defined, staff are orientated and trained, and a method to measure change or improvement is defined.
o Do: Per the implementation plan, the “test of change” is then implemented.
o Study: Through implementation—which may last for as little as one hour, or one day—observations and results are noted and summarized. This process is also iterative and relatively informal; you just want to see if the change made a based Surveillance Surveillance Data based difference, and if it should be expanded. The summarized results should be shared - with the participating staff so that they can help verify if the process changes are having the desired effect.
o Act: Based on the findings of the “test of change”, the team then decides how to act. If the results were positive, the process change can be expanded. If the change was
not impactful, or if the results were not as good as expected, the team can return to Using Case the plan stage and try something new, again on a small scale until a positive change is identified. Frequently, a number of small PDSA cycles are needed to find the right solution.
86 D. Data Use Related Policies and Procedures
As with the other areas already describe in this module, defined policies and procedures will support strong monitoring and evaluation and quality improvement initiatives, and will support ethical data utilization.
The Case Reporting Mandate is a useful tool during this process as it serves as reinforcement during the surveillance monitoring. If a facility is not reporting, the mandate can be referenced to motivate them to report.
The Standard Operating Procedures (SOPs) should clearly describe the criteria, process and frequency that will be used to monitor the surveillance system and the case reporting process. This could include measures, targets, and tools.
The Security and Confidentiality Policies should cover key areas related to data dissemination that will reinforce the protection of patient privacy. This could include what level of data can be described and to whom, as well as what level of detail (i.e., cell size), can be presented.
These are further described in Chapter 1.1.
Summary of Noted Resources # Source Title Description Appendix based Surveillance Surveillance Data based
(1) Hall and Case Surveillance Guidance document walks you through 39 - Mokotoff Evaluation the suggested step to use to evaluate your case surveillance system (2) CDC Guidelines for Evaluating Guidelines for public health surveillance 40 Public Health system evaluation Surveillance Systems (3) NASTAD Sample Monitoring Data A sample of a standard monitoring report 41 Field Report that could be used in case-based Using Case surveillance system (4) CDC Guidelines for Guidelines to assist in the compilation 42 Developing and interpretation of data, and Epidemiologic Profiles development of epidemiologic profiles (5) CDC/ Producing a National A training that can guide you in 43 UCSF HIV Report developing a basic national HIV data report (6) HRSA Quality Management A training focused on public health 44 Technical Assistance quality assessment and improvement Manual processes and activities
87 Other Relevant Reading and Resources Source Title Description Appendix SMDP Process Improvement A training focused on public health quality 45 Facilitator Guide assessment and improvement processes and activities. SMDP Process Improvement A training focused on public health quality 46 Participant Guide assessment and improvement processes and activities. SMDP Process Improvement A training focused on public health quality 47 PowerPoint assessment and improvement processes and activities. NASTAD Epidemiology for Data A training manual to guide you in the use of 82 et al. Users Training (Zambia) epidemiological data UNAIDS Guidelines for Effective Guidelines to help you consider how you might 83
Use of Data from HIV analyze and use your HIV surveillance data Surveillance Systems CDC HIV Case Surveillance A document to help guide planning of a case- 84 Informatics Business based surveillance informatics system Process Modeling CDC HIV Case Surveillance A summary of reference and guiding 85 Informatics Resource documents related to surveillance system Guide informatics Kotz et al. Effective Writing and A ten-part training document to guide the 86 Publishing of Scientific development of scientific publications Papers
based Surveillance Surveillance Data based - Using Case
88 MODULE 2 BUILDING AND IMPROVING A CASE-BASED SURVEILLANCE SYSTEM Building and Improving a Case-based BuildingImproving System and Surveillance
89 2 Overview
Introduction Planning to implement or expand a case-based HIV surveillance system allows you, as a public health leader, to consider what it is that you want to know about the HIV epidemic in your country, to take action—via surveillance system design or revision—to find the answers, and to then use those answers to impact the HIV epidemic and response. The system you devise can be simple or complex, low- or high-cost, and a quick-fix or a long-term investment. You will need to select the elements, processes, and design with close consideration of the time and resources that you have available.
We believe that many countries have data, systems and structures in place such that implementation or improvement of case-based surveillance is readily achievable. In this
chapter, we present six steps, as well as tools and ideas, which may help you to devise realistic solutions to help answer your public health questions.
The six steps that we will suggest you consider are described in Figure 2.1, below. Each of these steps is predicated on the existence of the Building Blocks of a Case-based Surveillance System, presented in Module 1. Where relevant, references to these components are listed. Overview
It is important to note that each of these steps can be used by countries that want to design and implement a case-based surveillance system where none currently exists, and can also be of value to countries that want to evaluate and improve their existing case-based HIV surveillance system. It is also important to note that while all steps are valuable, they are not dependent on each other. In other words, we suggest you consider each step, and use the ones that make most sense in your local context.
As a guide to this section, we’ve also included a sample implementation outline (Figure 2.1) that includes key activities that you might consider, as well as proposed outputs. These are described in greater detail throughout this chapter.
90 Figure 2.1 Steps for HIV Case-based Surveillance System Implementation or Strengthening
1. Devise a vision for your system This "gold standard vision" will help guide your progress. Dream •Identify the public health questions you want to answer big, but also remember that it is •Identify existing resources - particularly data and data systems OK to start small; a successful - that can be used to provide case-based surveillance data system can grow. •Explore how you can use these resources to build your system
2. Establish buy-in and support
•Meet with stakeholders to inform, advise, and build Identify key stakeholders that can consensus help you plan for and achieve your vision. Engage them early and often. •Establish a Technical Working Group and meet to support planning, implementation, and progress review
3. Implement an environmental scan
Based on the "gold standard vision," assess the Gather data to help refine your vision environment: based on available resources: human resources; data; systems; and •Use a SWOT to assess strengths, weaknesses, procedures. opportunities, and threats to system development •Use the SWOT findings to plan for implementation Overview
4. Define and plan your system
Refine your "gold standard" into a •Design the case-based surveillance system phased implementation plan. Focus •Develop policies and the standard operating procedures initial efforts on areas that are: (SOP) useful (generate usable data); •Design the data flow process and pathway, and the data simple (leverage existing data); and management system will be successful. •Develop monitoring process; plan for human resource needs
5. Implement and/or improve your system Define what the facilities should do. ● Pilot the system and refine it Train them and support them. Observe •Train staff and facilities what barriers emerge, and refine the •Supervise roll-out; Provide ongoing monitoring and CQI steps and process until you see the •Manage, clean, and use data outputs you want.
91 Envisioning Your Case-based 2.1 Surveillance System
In this chapter, we will review how to:
Begin to plan for your case-based surveillance system development, including:
o Defining what you want to know about the HIV epidemic o Envisioning how you might collect data to achieve these goals
Introduction Before you start the development or improvement of a case-based surveillance system plan to do something new and innovative, it is valuable to envision and document what it is that you want to achieve, and why. Because planning and implementation will likely involve many stakeholders, it is important that you know what you want, and why, so that you can clearly articulate this, and engage others to share and implement the vision. Working with your team to establish interest and buy-in and to define a common vision and purpose will assist in all further planning and implementation.
There are five pre-planning steps we suggest you take before engaging a large group of System based Surveillance - stakeholders: Define what you want to know Determine what data you will need to answer these questions Consider if desired data exist, and where Consider how the data might be reported Summarize your “Gold Standard” vision for a case-based surveillance system
This pre-planning phase will allow you to have an evidence base from which to present a realistic project plan; this will help you guide critical planning conversations, and gain wide- spread buy-in and support.
Envisioning Case Your
92 A. Define What You Want To Know
As you define your “Gold Standard” system, consider what questions you want to answer: What do we want to describe about HIV? What do we want to describe about trends over time? What do we want to describe about the population infected with HIV?
As described in the Toolkit Introduction, case-based surveillance can help you to answer many HIV-related questions and inform an effective public health response. Examples of such questions include:
Who is infected with HIV? Where are new infections coming from? What are the hotspots in the epidemic? What behaviors are associated with HIV infection? o Being able to describe infections by gender, age range, behaviors, and geography will allow you to target prevention interventions and support access to care.
What is the direction of the epidemic? o Understanding the trajectory of the epidemic within different populations will allow you to design targeted HIV prevention and outreach interventions.
What behaviors are associated with HIV infection? o Understanding behavioral risk factors for HIV transmission will allow you to based Surveillance System based Surveillance
design targeted HIV prevention and outreach interventions. -
Do people test for HIV early or late in their infection? o If people first test for HIV late in their infection (i.e., when their CD4 count is lower and viral load is higher), there are greater risks for HIV transmission and decreased years of productive life. Late testing also suggests suboptimal coverage of HIV testing.
What proportion of people who test positive for HIV enter into, and are retained in, the care and treatment system? Do linkage and retention vary by population characteristics? o Understanding limitations in linkage and retention can empower you to design or improve measures to support patient care.
What proportion of people in the care and treatment system access regular CD4 and/or Envisioning Case Your viral load tests? What proportion of those eligible for ART is on treatment? o These data can help you understand gaps in coverage of clinical monitoring and treatment.
93 B. Determine What Data You Will Need To Answer Your Questions
Once you have defined your public health questions, you can consider which data elements you will need to collect from each diagnosed case of HIV to answer your questions. As described in Chapter 1.3, collecting the following information at diagnosis and at follow-up contact will allow you to track the progression of the disease from the time a patient is diagnosed with HIV until they die:
Who the Person Is. This includes a way to uniquely identify each patient (1) so as to them to subsequent disease progression and engagement in care reports.
Personal Demographics. This includes sex, age, place of birth, place of residence, etc. that can help characterize the case in terms of person and place. These variables can also help to generate a pseudo-unique patient identifier.
Behavioral Characteristics. This includes high-risk behaviors (such as sex between males, injecting drugs, sex work), that could assist in identifying the behaviors that are associated with HIV transmission.
Reportable Event and the Date It Was Observed. The applicable reportable event(s) should be documented, along with the date the event was observed.
Who Reported the Case. This includes the clinician’s name and the health facility name
so that follow-up may be initiated where more details or data corrections are needed. System based Surveillance -
Other beneficial data elements that you might consider collecting include those listed below. These may be available at the time of first HIV diagnosis, but are more likely to come from subsequent disease progression or engagement in care reports.
Date and Value of First CD4 Test. This demonstrates successful entry to the care and treatment system and provides information on clinical staging and disease progression, late testing trends, and eligibility for ART.
Date and Value of All Subsequent CD4 Tests (and/or viral loads), First CD4 test <350, or Change in Clinical Staging. These data elements will allow you to understand a patient’s disease progression, eligibility for ART and other prophylaxis.
Date of ART Initiation (and regime) and/or Other Key Prophylaxis. This provides Envisioning Case Your information on treatment coverage and gaps.
Most Recent Medical Visit. This provides information on who is connected with and retained in clinical care.
Death. (All deaths of people with HIV, not just HIV-related) This provides information on HIV related mortality and outcomes; provides information on the total number of people living with HIV.
94 C. Consider If The Desired Data Exist, and Where
After defining the data elements that you want to capture in your surveillance system, you will want to consider who collects these data and how. This will include:
HIV Testing Facilities. Health facilities that provide HIV testing services are the
most critical reporting source in a case-based surveillance system as they are likely to identify the greatest number of cases of HIV. These facilities should report on all HIV cases that are diagnosed within their facility. Testing facilities include those providing: Voluntary Counseling and Testing (VCT), HIV Counseling and Testing (HCT), Provider Initiated Counseling and Testing (PICT), Prevention of Mother-to- Child-Transmission (PMTCT), Voluntary Medical Male Circumcision (VMMC), and Tuberculosis (TB) diagnosis and treatment.
HIV Care and Treatment Facilities. Health facilities that provide HIV care and treatment services, including PMTCT, are a critical reporting source as they are able to both identify large numbers of cases of HIV, and provide data on access to care, disease progression, and clinical outcomes. These facilities should report on all cases that are diagnosed with HIV or access HIV clinical services.
Laboratories. Laboratories that provide HIV diagnostic tests (HIV testing, PCR
testing) or clinical monitoring tests (CD4 testing, viral load testing) are a critical System based Surveillance - source of case-based surveillance data, whether they are attached to a medical facility or stand-alone. Case Vital Registry. The national vital registry provides information on HIV related mortality.
Figure 2.2, below, depicts possible data sources and what data each source may provide.
Envisioning Your
95
Figure 2.2. Sources of Data to Consider for HIV Case Reporting
VCT Facility - Demographics
- Behavioral Risk Factors - Date of Diagnosis - Facility of Diagnosis
PMTCT Facility - Demographics Hospital - Date of Diagnosis (mother) - Demographics - Data of Exposure (baby) - Behavioral Risk Factors - PCR Value (baby) - Date of Sentinel Event - ART (mother, baby) - Value of Sentinel Event (i.e., - Facility Reporting ART, CD4 value) HIV Case - Facility Reporting Database Laboratory - Case Identifier - (demographics, if available) ART Facility
- Lab Value (CD4, Viral Load, - Demographics System based Surveillance PRC) - Date of Sentinel Event - - Data of Confirmation - Value of Sentinel Event (i.e., - Facility Reporting ART prescribed, CD4 value) - Facility Reporting
Vital Statistics - Case Identifier - (demographics, if available) - Date of Death
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96 D. Consider How Cases May Be Reported
The next aspect you will want to consider is how cases might be reported. This includes initial HIV diagnosis, as well as important disease progression data. As described in Chapter 1.4, three different types of mechanisms may be considered.
A paper-based system is based on the use and submission of paper case report or paper
data logs to a central system for data entry.
An electronic system is based primarily on generation and transmission of electronic case reports either through entry of case reports into an electronic reporting system, or direct data transfer of existing electronic data (such as from electronic medical records) into an electronic case reporting system.
A hybrid system is a mix of a paper-based and electronic system, and is often appropriate to accommodate a variety of provider types and data capacities.
You will also want to consider the pathway that case reports will take. How will a case report move from a site to the national database? Depending on the size of your country, the public health infrastructure available, the human resources buy-in, and the number of cases you anticipate receiving, you may want to consider the value of all cases being reported to the national level immediately, versus reporting to a sub-national tier as an intermediary. Drawing based Surveillance System based Surveillance a figure like that presented below (Figure 2.3) can be of assistance. -
Figure 2.3. Sample Case-based Surveillance Data System Design
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Consider data collection and reporting methods that already exist and whether these paper tools, electronic systems, and strategic information pathways be used or improved to allow you access to the data you want.
97 E. Consider The Human Resources Required
Finally, as you define the pathway that each case report will take, consider human resources and access to data entry, secure computers and consistent electricity. As described in Chapter 1.2, you will need some level of human resource commitment at the reporting facility level, as well as human resources at the national, and potentially sub-national level, to enter and manage data. Those staff (and the public health system office) that you designate to receive case reports will likely be asked to:
Generate and submit case reports, paper or electronic
Quality check, clean and match case reports and follow-up with reporting sites if needed
Monitor case surveillance data and processes
Maintain a surveillance database, conduct analysis and develop dissemination materials
Follow security and confidentiality policies throughout the process
Considering who you might ask to do what, at which level of the public health system will help you present more realistic resource needs in the planning phase. It will also help to identify valuable policies and procedures (as described in Chapter 1.1) that you will want to apply in order to maintain data security and protect patient privacy.
System based Surveillance - Envisioning Case Your
98 F. Summarize Your [draft] Vision
Once you have reviewed each of the building blocks that are required for an effective case- based surveillance system, and have developed some ideas as to what you would like to see implemented, it is time to draft your vision. This “Gold Standard” vision for case-based surveillance will just be a starting point, a “zero draft”, but will give you a starting point for collaboration, advocacy and planning. In a very simple way, try to describe:
Why you think this initiative is important, and the value it will bring to your country
Why this is an achievable initiative, and what existing resources can be leveraged
What the system MIGHT look like, including what data MIGHT be reported from where, and to whom, using which tools and with what frequency. An example of this type of “Gold Standard” vision summary (2) is included in the appendix, as well as a success story (3) of system implementation.
Summary of Noted Resources
# Source Title Description Appendix System based Surveillance - (1) UNAIDS Guidance for Unique This guidance emerged from a UNAIDS 28 Identifiers Planning and consultation meeting and may be helpful as you define your method to uniquely identify case of HIV (2) NASTAD Leveraging Data to A summary document that describes 48 Monitor and Respond to case-based surveillance in its simplest the Epidemic form that was used to justify case-based surveillance initiatives in some countries (3) NASTAD Uniting and Unifying A poster that was presented summarizing 49 Field Existing HIV Case Data Haiti’s system vision and some of the (Haiti) outcomes to date
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99 2.2 Establishing Buy-in and Support
In this chapter, we will review how to: Identify key stakeholders and engage them in designing and implementing your system
Now that you and your team have a surveillance vision in mind, you will want to establish buy-
in and secure support for your vision. As has been discussed, a successful and useful case-based surveillance system is dependent on quality data being reported from multiple inputs on a timely basis; these multiple inputs are your stakeholders and key allies. In this chapter, we will review how to identify and engage stakeholders so that they can help your surveillance system succeed.
A. Identify Key Stakeholders and Decision Makers in and Support in and Support
In Module 1 we presented a mosaic of key stakeholders that are integral to the case reporting - process. As you begin to identify and map out stakeholders, think about the flow of a case report through your proposed case surveillance system—from data capture to data cleaning to data use—and create your own mosaic of all of the key stakeholders at every level of the proposed case surveillance system. Be sure to include both private and public institutions, managing and implementing bodies, civil society organizations, as well as policymakers and government leaders. A template (1) to help in your stakeholder identification process is included in the appendix.
Figure 2.4: Mosaic of Case-based Surveillance of HIV Stakeholders
Buy Establishing
100 B. Meet with Key Stakeholders and Decision Makers
After you have identified key stakeholders and decision makers, you will next want to plan how to best engage them. Certainly, this will be guided by the way you typically engage colleagues, partners, and funders, as well as your local protocol. Getting strong buy-in early on is invaluable.
In our experience, using three different types of meetings in tandem is most effective.
Individual Meetings are likely most useful when meeting with peers or administrators as they allow for engaged discussion where you can effectively present your ideas, listen
to their comments or concerns, and have a dynamic discussion to come to agreement on the way forward. These meetings are an opportunity to both gather feedback and garner buy-in and support.
Small-group Meetings can be very effective when engaging a like-minded group and/or when you, as a governing body, are in a position to advise or direct the group, such as implementing partners or service (VCT, PMTCT, ART, etc.) leads. If you are in a position to advise or direct, still consider using these fora to present your vision, and seek and listen to concerns or questions. in and Support in and Support - Site Visits are another great option to consider when to engage and understand the perspective of staff that will be directly involved in the creation and submission of case reports. Site visits and open conversations with site-level personnel will allow you to identify appropriate and acceptable data methods and potential barriers.
Regardless of the type of meeting, it is advisable to:
Provide an overview of the system and process that you envision, and the purpose/value to you and them. Try to help the stakeholder(s) understand why the
system is important for the public health system, and also how the data will help them. Buy Establishing
Discuss the role that each stakeholder that is present will play in the proposed system, and the likely time commitment this will entail. Try to walk the participants through the activities you will ask of them, and ask for input or ideas that you may have overlooked.
Solicit feedback, and show that you are listening. Even if you ultimately choose not to
heed all of their advice, it is important to show that you seek and consider it.
101 C. Establish a Technical Working Group
A Technical Working Group (TWG) (1) can be a useful way to engage stakeholders in your planning, implementation, and quality assurance process, as it is a natural venue to provide information to and receive input from a representative group of experts and key stakeholders.
To effectively establish and manage a Technical Working Group, consider these three steps:
Establish a Technical Working Group
Ideally, you should look to create a TWG that is representative of the wide range of organizations, ministries, and entities that will be involved in your surveillance system or be impacted by the system, including funders, governing entities, regional surveillance advisors, service providers, data managers, data users and organizations representing people living with HIV.
Your list of stakeholders formed using the stakeholder mapping exercise (2) is a great place to start to identify possible TWG members.
A TWG should have about 10-15 members. More than that, meeting management n and Support i
becomes complicated; fewer than that, it may be hard to have enough members present - at each meeting to provide sufficient input.
Once you have identified potential TWG members, reach out to them individually to share your vision and to invite them to participate.
Arrange an Initial Mobilization Workshop
After developing your TWG, it is important to host a mobilization workshop to help transform
the experts into an effective group. This initial workshop should be used to: Buy Establishing
Share your system vision, and present how, when, and for what you would like input; and
Define Terms of Reference (ToR) for the TWG, which should define the purpose, the membership, TWG structure and leadership, and the members’ roles and responsibilities, including activities, outputs, and the timeline. A sample TWG ToR (3) is included in the appendix.
102 Meet Routinely
Following the initial mobilization workshop, the TWG should meet regularly (at least quarterly) in order to effectively contribute to all aspects of the case-based surveillance system development and improvement. Here are some ways that you might use your TWG:
Foster buy-in and collaboration. Establishing a high-quality surveillance system is a complex process involving many moving parts. A strong TWG composed of members active in many sectors of the health care system will allow you to expand and strengthen your advocacy ability. A diverse TWG will allow you to communicate your vision and proposed system with multiple partners, stakeholders, decision makers and communities throughout the system development process.
Troubleshoot. Because some members of the TWG will likely be working actively with certain aspects of the system, they can help to brainstorm solutions and ways forward when obstacles arise or gaps are identified.
Defray costs and/or leverage resources. As already noted, an effective case-based surveillance system will use existing resources. One of the most effective ways to do this is to have partners who can help you identify resources and systems to build from.
Apply best-practices. The TWG can be an excellent resource for learning about in and Support in and Support
strategies, methods and resources that have been effective in other contexts and could be - useful in the surveillance system.
Peer consultation. Your TWG will provide invaluable direction and peer consultation as you develop and implement your surveillance system. For example, the TWG may provide guidance on system expansion, devising solutions to identified challenges, and interpreting and disseminating epidemiological and monitoring data
It is important to document what is discussed in each TWG meeting, and to ensure follow-up
on action items or outstanding questions. Buy Establishing
Summary of Noted Resources # Source Title Description Appendix (1) NASTAD Surveillance Technical This is a summary document that describes Working Group the goals, objectives, and ideal structure of a 50 Summary case-based surveillance technical working group (2) NASTAD Key Stakeholder Tool to help you identify key stakeholders to 51 Mapping Tool engage in surveillance system development and use (3) NASTAD Sample Technical This is a sample “Terms of Reference” (ToR) 52 Working Group Terms to help guide a case-based surveillance of Reference technical working group
103 Implementing an Environmental 2.3 Scan
In this chapter, we will review how to:
Design and implement a rapid assessment of the public health environment to help
effectively plan for your case-based surveillance system development
Introduction Before you take steps to implement your vision of a new or improved case-based HIV surveillance system, it is important to consider existing environmental factors that may support or hinder your success. These factors may include existing policies and laws (or lack thereof), existing supervisory or IT structures and systems (or lack thereof), available resources (human and fiscal), known health system gaps, and existing data collection and reporting processes (or lack thereof). By identifying these factors, you can better plan ways to leverage strengths and mitigate risk as you move forward. An environmental scan, also known as a Rapid Situational Assessment, can be used to help identify these factors.
A rapid situational assessment can be used whether you are looking to build from and improve an existing surveillance system, or start from scratch. This type of assessment will help to gather information about what resources, processes and systems currently exist, what can be used or improved, and what may need to change in the environment in order to support success. This information will allow you to strategically plan for the implementation of a case-based surveillance system that is tailored to the specific context of your country.
Implementing an Implementing Environmental Scan
104 A. Plan the Environmental Scan
While an environmental scan may take many forms, one commonly used method is the SWOT Assessment which allows you to evaluate the Strengths, Weaknesses, Opportunities, and Threats that are both internal and external to your system vision. The implementation of a SWOT assessment will allow you to mitigate threats and weaknesses and focus on the strengths of your current health information system or the aspects of your environment that will facilitate the development of a new case surveillance system. A SWOT poses questions such as:
What data gaps currently exist, and what is the significance of the gaps?
What existing systems, processes, resources, materials can be leveraged for case-based surveillance, or improved quality and availability of data? What limitations of the environment or existing systems, processes, resources, and materials that can be addressed and improved to support high-quality data collection? What emerging situations, opportunities, partners, can support this system growth? What structures, situations, policies might warrant special attention is order to support system growth?
The four components of a SWOT assessment are described in greater detail in Table 2.1 below, along with examples of factors you might consider during a SWOT assessment.
an Implementing Environmental Scan
105
Table 2.1: Four Components of a SWOT Assessment
Helpful Harmful to achieving the objective to achieving the objective Strengths Weaknesses Commitment of the public health Weak oversight of/collaboration with leadership sub-national public health units
Existing tools that collect the indicated Tradition of limited use of national HIV case reporting variables data collection tools
Existence of person-level data at the Poor quality of existing data facility level Lack of any electronic data or IT Internal Existing data collection or reporting infrastructure systems that work well Limited internal resources Availability of internal resources (fiscal, human resources, IT, etc.) Opportunities Threats Strong collaborations with Weak leadership implementing partners who would Lack of interest in strong data to report case data drive public health programs
Strong policy framework Major concerns about the ability of Existing or emerging interest in the the government to securely manage
availability and routine use of patient-level data
External surveillance data for health action Poor relationships with Existing or emerging IT infrastructure implementing partners or community and/or electronic health records advocates Availability of external resources (fiscal, Limited external resources human resources, IT, etc.)
When completing a SWOT assessment, keep in mind that Strengths and Weaknesses are generally internal to your current or proposed system, and relate to areas such as human resources, financial resources, systems, and past experiences. Opportunities and Threats, on the other hand, are generally external to your system, and include areas such as policies and laws, funding sources, and the physical environment.
an Implementing Environmental Scan Planning a SWOT Assessment
To plan your SWOT assessment, start by identifying questions or areas you want the SWOT to address. A good place to start is the set of Building Blocks described in Module 1. A comprehensive SWOT should identify strengths, weaknesses, opportunities, and threats related to each of these building blocks. Depending on the country context, some building blocks may require more attention than others in the SWOT.
A detailed list of sample SWOT questions (1) is included in the appendix.
106
B. Conduct the Environmental Scan
The implementation of a SWOT assessment should be “quick and easy”; it can often be completed over the course of one-to-three months. A simple overview of a SWOT assessment is shown in Figure 2.5, below.
Figure 2.5: How to Implement a SWOT Assessment
•Desk review Use These •Interviews Tools... •Site visits •Observations
•Existing policies •Existing data sources and data systems •Existing technology capacity and ...to Assess: infrastructure •Existing data reporting mechanisms and pathways •Existing human resources
Consider following the steps outlined below as you plan and implement your SWOT assessment.
Implementing an Implementing Environmental Scan Conduct a Document and Literature Review
A good place to start is by implementing a desk review where you can review all applicable documents such as written policies, procedures, forms and tools. Make notes of any questions that you have about these existing documents that you may need to follow up on during site visits or meetings with stakeholders.
107 Conduct Informational Interviews with Stakeholders
Stakeholders, such as members of your TWG, can provide valuable perspectives on the existing and/or proposed case-based surveillance system; this includes diverse bodies such as the Ministry of Health administrators, IT staff, policy makers, program administrators, civil society, staff that will be directly involved in completing and submitting case reports, etc. Prepare by compiling a list of SWOT questions (1) to be asked at each site visit. These questions should address each of the four components of a SWOT assessment, and should be designed to capture the most information in the shortest time.
Conduct Site Visits
Consider visiting facilities, administrative offices, and other sites where information may be gathered about the existing strategic information system. Remember, this can be information about existing infectious disease reporting practices (HIV or other), HIV-surveillance related data collection (such as patient registers, EMRs, service logs), data collection and reporting practices for other surveillance or monitoring activities, or how existing supervision structures function from the national to the facility level.
You might consider selecting just five-to-ten high-volume sites or sites of strategic importance for site visits; data collection does not need to be exhaustive. Try to select a representative variety of sites that cover the range of possible data sources.
During site visits it is also helpful to conduct observations to better understand how the site may operationalize the case reporting process. Keep in mind that patients’ privacy and confidentiality must be prioritized during such observational visits.
Implementing an Implementing Environmental Scan
108 C. Summarize your Findings
Although the SWOT should look comprehensively at all case surveillance building blocks, there are five areas that we suggest you pay special attention to when summarizing the strengths, weaknesses, opportunities, threats, and related recommendations of your SWOT.
Summarize Existing Policies
As described in Module 1, public health laws and policies can address crucial logistical components of case surveillance, thereby supporting implementation and strong functioning. Knowing which policies are in place will allow you to develop a surveillance system that can function optimally within the existing legal environment, and will help to identify areas where additional policy development would support the surveillance system. When reviewing relevant policies, be sure to review:
Disease Reporting Mandates: Reporting rules and laws that define who should report what disease events, and what information must be reported to whom. Patient Privacy, Data Security and Confidentiality Policies: Patient Privacy Policies provide a legal framework to ensure that a patient’s data are protected. Security and confidentiality policies help to ensure that the people who have access to patient-level data protect their patients’ right to privacy. These policies identify protected information and state why it is needed for surveillance purposes and how it will be protected within the system.
Other Policy-related Barriers to Data Collection: You will also want to consider non- surveillance-specific policies or laws that might pertain to people living with HIV. This may include regulations on human subjects research and laws related to behaviors that impact the transmission of HIV (e.g. laws relating to same sex behavior).
Summarize Key Data Sources and Data Collection Processes Implementing an Implementing Environmental Scan From the process of envisioning your surveillance system, you will already have a sense of which data variables you seek to collect. The SWOT should reveal what variables are in fact being collected from the respective data sources, how they are collected, and how data quality is assured. If a variable that you know to be of significance for case-based surveillance is not currently available in a data source (i.e., behavioral data or patient name) it does not mean that you should not ultimately try to collect it. Instead, noting what data elements are currently unavailable will help you to develop an approach to collect those data in the future.
109 In addition, as described in Chapter 1.3, the SWOT should describe what unique identifiers, as well as what personally identifying information that could be used to generate a unique identifier (name, sex, date of birth, etc.) is collected.
Summarize Existing Data Reporting Mechanisms and Pathways
As you come to understand the existing data sources, it is a great idea to map existing data reporting mechanisms (the format used to move information) and data reporting pathways (the flow of the information) (2) that are in use. This will help you think through and plan every step a case report should take as it moves from the site level to the national HIV surveillance database.
As described in Chapter 1.4, the data reporting mechanism that you ultimately decide to use may be paper-based, electronic, or a hybrid. Where possible, consider building from existing data reporting mechanisms and pathways that are used to submit reports and/or forms to a sub-national or national administrative body; this can be a great use of fiscal, IT and human resources.
For example, if all VCT sites submit monthly reports to a national VCT administration, it might make the most sense to have them submit paper case report forms through this same pathway. However, if laboratories are already submitting electronic data feeds to a national database, creating and automated data extraction of case report variables would save significant resources and likely improve the quality of reported data.
Highlight Roles Responsibilities and Human Resources within Public Health System Tiers
As you implement the SWOT assessment, document and observe the organizational roles and responsibilities of each tier of the public health system—national, sub-national, and local—and try to understand their role as it relates to public health data collection, reporting, monitoring and use. Furthermore, try to understand the level and organizational structure of the human
resources at each of the tiers, and the staff’s competency in areas such as: an Implementing Environmental Scan
Data collection and data entry Data cleaning, validation, and quality assurance Data compilation and submission Process and data monitoring Data analysis and presentation.
110 Understanding skills, ability, and availability of different cadres of existing staff will help you plan your data collection and reporting process. For example, if your SWOT assessment highlights weak sub-national oversight, you might then suggest that cases be reported from the facility directly to the national level. Alternatively, in a country with strong, decentralized public health structures, the sub-national level might be empowered to collect, compile, and clean the case data before submission to the national level.
Summarize Recommendations for Next Steps
As a final step, summarize the finding, recommendations or “next steps” that will allow you to use the information gained from the SWOT to move from your “gold standard” vision towards an implementation plan. This summary document can be a strong planning and advocacy tool, as well as a legacy document that can be revisited and revised in future years to document progress and highlight emerging priorities.
Summary of Noted Resources # Source Title Description Appendix (1) NASTAD Sample Case An outline of a SWOT/Environmental Scan 53 Surveillance SWOT along with sample goals, objectives, and Outline questions (2) NASTAD Sample Data Flow A sample data flow mapping template that can 54 Mapping Template be used to map existing or potential data flow
Implementing an Implementing Environmental Scan
111 Define and Plan Your 2.4 Case-based Surveillance System
In this chapter, we will review how to: Design a case-based surveillance system Develop case-based surveillance policies and procedures Design a case-based surveillance data management system Create a monitoring structure for the surveillance system Plan for human resource and training needs Summarize the plan into a document that can be submitted to an ethics committee for approval
Introduction After gathering input from stakeholders (Chapter 2.2) and via implementation of an environmental scan (Chapter 2.3), you will likely be ready to modify and adapt your original based Surveillance System based Surveillance case-based surveillance system vision (Chapter 2.1) to prepare for implementation. This could - include changes and improvements to your existing system, or the development of a new system to pilot and roll-out.
As we will discuss in this chapter, piloting these large or small ideas before large-scale implementation will help to highlight strengths, weaknesses and feasibility in a low-risk environment, and will allow you to implement system improvements before full roll-out.
This chapter discusses the seven steps we suggest you take to help to plan for a strong case- based surveillance system implementation or expansion process, including the development of documents, tools, procedures, and human resources. It is important to understand that these preparatory steps will require a good amount of resources (time, human), as system and process development is required. However, all of the time that is invested in preparing for a pilot and making modifications prior to full system implementation will result in a significantly stronger and more effective case-based surveillance system in the long term. Define and Plan Case Your
112 A. Design the System
Stating goals and objectives will help to define your workplan, and will thus keep the surveillance staff organized during its implementation. This process follows naturally from reviewing and interpreting your SWOT assessment (Chapter 2.3); the following activities can help guide you:
Review your case-based surveillance system vision. (Chapter 2.1) This should be the starting point to help lay out what you are going to pilot. This will include what data you are going to collect, from whom, and via what mechanism(s).
Review the SWOT Assessment. (Chapter 2.3) These findings should provide guidance on areas of strength and weakness that you’ll want to consider as you plan for the roll- out of the case reporting process. Taking time to plan for and meet those needs will help to ensure a smooth transition to your new system.
Define your implementation plan. (1) (2) (3) At this point, you should be able to modify your surveillance system vision into an implementation plan. Be sure to address the key elements: o Who (staff role and facility type) must report case data, and when based Surveillance System based Surveillance - o What data elements must be reported for each case o How (tool, pathway, to whom) should the data be reported o Who will manage the data, and with what system o How this phase will be monitored
Prepare data collection tools (4) (5) (6) (7) (8) and data management systems (9) (10) (11) (12). Remember that “Less is More”, meaning simple tools and those that build on existing processes are more likely to succeed. Comments on documents, tools and procedures should be encouraged from users of the system, at all levels, during the pilot period in order to create robust procedures for the national surveillance roll-out. nd Plan Case Your
Document the proposed system and processes in an SOP.(13) (14)0 The SOP is an invaluable training and supervision tool, to get all who will participate in the pilot on board, and it will be a critical tool (once updated!) to guide national implementation. Define a
Engage with stakeholders: (Chapter 2.2) The success of the surveillance system depends on how well it is accepted and used by the agencies and individuals that report data. As a result, it is essential to involve them in the pilot phase. Arranging in-person meetings with staff at each site is often the best approach for sharing your vision and addressing concerns and questions.
113 B. Develop Required Policy
As noted in Chapter 1.1, a policy framework is an important step when developing a strong case-based surveillance system. Knowing that policies are in place can also help garner buy-in from stakeholders. Five types of policies were suggested in Chapter 1.1 :
A mandate to report all known cases of HIV Policies to support a patient’s right to privacy Data security and confidentiality policies Data sharing, ownership and dissemination practices Policies to guide system use, such as Standard Operating Procedures.
The following five-stage conceptual framework may assist with the development of any case- based surveillance related policy as it proceeds through the policy to practice life cycle: 1. Identify baseline policy issue or problem: During this stage, the initial concept of case-based surveillance of HIV is recognized as an issue needing further government attention. The proposal to conduct HIV case–based surveillance is presented and discussed comprehensively so that the policy can be properly defined to address policy needs. based Surveillance System based Surveillance - 2. Develop policy intervention/document: Once policy needs are defined, the case- based surveillance policy itself must be developed and drafted, taking into account the potential impact of the policy and the opinions of those stakeholders participating in the policy-making process. A variety of options may be explored at this stage to arrive at a feasible and effective HIV case-based surveillance policy. 3. Official government approval or endorsement of policy: Once the HIV case-based surveillance policy has been developed, it must undergo an approval process, during which the appropriate government body decides whether to adopt the policy. Depending on government procedures, this process may entail additional evaluation and revision of the policy. 4. Implementation of policy (e.g., training, dissemination, compliance, enforcement): The policy is put into effect and enforced. This stage includes critical decisions such as the passing of laws that support the HIV case-based surveillance policy, allocating
and spending funding for implementation, and the development of regulations and Define and Plan Case Your regulatory bodies to oversee implementation. 5. Evaluation of policy implementation: Once the HIV case-based surveillance policy has been implemented, routine evaluations of the policy should be conducted to assess whether the policy is effective or if the policy requires amendment.
114 You will need to work with your public health infrastructure to determine how best to draft these policies (see Chapter 1.1 for examples), or integrate the critical elements into other existing policies.
Resource documents are available to help guide your development of policies to ensure HIV cases are reported, and to protect the security and confidentiality of patient-level data (Chapter
1.1). But, again, as these may be considered legal documents, it is important to work within your own systems and processes.
Strategies for Policy Development:
It may be difficult to develop, implement, and enforce case-based surveillance, particularly if there is not a strong culture of disease reporting in your country. Work with administrators, legislators and other policymakers to create an enabling framework for disease reporting. Developing a culture of data security and confidentiality can be challenging in any context, but is an essential step for ensuring confidence in the surveillance system. Data quality may suffer if it is perceived that gaps in security could compromise personal information. Be prepared to review and revise policy and legislation over time to ensure that it based Surveillance System based Surveillance remains maximally effective. An iterative process is often needed for development of a - policy and legal framework whereby language or requirements are strengthened and/or clarified over time.
Define and Plan Case Your
115 C. Develop the Case Report Form
The case report form should be as simple as possible while still collecting the essential data elements described in Chapter 1.3: Unique identifier, or variables that will help to create one;
Personal demographics; Behavioral characteristics that influence HIV transmission; The reportable event and the date it was observed; and The person and facility that reported the case.
Your case report form ultimately needs to be developed to meet your needs and context. As you begin to imagine your HIV case report form, you may want to consider other models, and build from there (some examples are included in the appendix (4) (5) (6) (7) (8)). Remember to: Only include essential data needed to answer your public health questions; each additional data element is extra work for the person collecting the data Ensure the form is simple and user friendly based Surveillance System based Surveillance
Clearly indicate the minimum data required to classify a case report as valid. This might - include: the sentinel event, the date of identification, patient name (or unique ID), patient sex, patient date of birth and patient’s current residence (street address or town). Align the case report form with standard data collection forms that are already in use, such as service registers and logs, to facilitate data transcription Include clear instructions to make the form easy to use.
Once the case report form is developed, it should be piloted. Based on feedback, the case report form can be modified and then disseminated more broadly.
Define and Plan Case Your
116 D. Design Data Transfer Systems
As described in Chapter 1.4, data transfer is the process of moving HIV case report data from the reporting source to the central database, and consists of both a mechanism and a pathway. The mechanism is the format used to move information, and the pathway reflects the flow of the information. The data transfer system should be designed to meet the unique resources and limitations of your country context.
The case reporting mechanism can be paper-based, electronic or a hybrid system (both paper- based and electronic). Designing a mechanism should account for the following considerations:
Reliable power and information technology infrastructure at each level of the health system
Data security and confidentiality advantages and challenges inherent to the different systems
Availability and capacity of human resources for data entry at each level of the health system, and to use information technology
Existing process and/or systems for date reporting (i.e., existing processes for reporting
aggregate M&E data or other notifiable diseases (e.g. Ebola)) that can be leveraged or System based Surveillance adapted. -
The case reporting pathway can be flat (cases are reported directly from the site to the national level where data management [quality checks, cleaning, etc.] occurs) or hierarchical (cases are reported from the site to a sub-national level, where initial data management is performed before forwarding to the national level). Designing a pathway should account for the following considerations:
The size of your country and the volume of case reports
Availability of human resources for data entry and/or management at each level of the health system
Data security and confidentiality advantages and challenges inherent to the different systems
Reliable power and information technology infrastructure at each level of the health Define and Plan Case Your system
Existing supervisory structures in the public health system
Existing process and/or systems for date reporting that can be leveraged or adapted.
117 E. Design Data Management System
The next step is to develop the data system that will manage the case report data. The data system should have functionality to provide secure storage, allow for data entry and cleaning, and facilitate data analysis and case matching. Furthermore, the system should be fully accessible to you and your team—both the front and back end—and be adaptable and expandable to meet your evolving surveillance information and reporting needs.
The design of the surveillance data management system can be an iterative and lengthy process. It is important to consider your goals for the data management system from the beginning of the planning process. Consider both the necessary system outputs and the various constraints you may face early on, and seek input to troubleshoot in advance of development. Common challenges for planning data management include limited time, money, human resources or expertise. Identifying these at the start of the process will focus planning efforts and give you a better sense of the type of system that will work best for you.
System Design Basics
Chapter 1.4 noted essential criteria for designing a surveillance data management system. At a minimum, it should: System based Surveillance - Be fully accessible to you Be built with accessible software Be simple and expandable Allow for redundancy, multiple inputs, and backups Be built with data security and confidentiality protections in mind
In addition to these points, other design criteria to consider are noted here:
At its most basic, a surveillance data management system should allow for data to be entered, cleaned, and extracted for analysis and reporting purposes.
Front (user interface) and back end (data table) access, data transfers and easy modifications should be easily accessible to the managing public health entity, such as the Ministry of Health.
Be aware of any applicable laws and regulations your country has—related to public Define and Plan Case Your health data transfer, storage, sharing, etc.—when designing the system. Ensure the data is stored on a secured server.
If there are existing data systems that collect case-based HIV surveillance-related information that you want to extract data from—whether electronic or paper-based— design your case surveillance data system to match existing data fields where possible.
118 When planning your data management system, remember that the success of the system comes from how well it meets your surveillance data needs, not by fancy features and gadgets. For example, although web-based systems can be efficient and might be the correct choice in some countries, if the infrastructure does not already exist, such an investment may not be indicated. A simple system that works for you and builds from existing resources is a great starting point. Improvements and expansions to a well-working system are easier to implement than troubleshooting a system that is overly complex. Guidance (9) is included in the appendix.
Design Features
The design elements listed above describe the basic functionality that your surveillance data system should provide. Beyond these, there are several specific design elements that will strengthen your surveillance data management system. Consider working with your system programmer to develop methods to do the following:
Create Unique IDs In general, the most effective way to uniquely identify individuals for case-based surveillance is with a combination of patient name and other identifying information (such as date of birth, sex, location of birth, and/or national ID number). Receiving surveillance data reports from multiple sources will likely result in more than one case
report per patient in the surveillance database; you need a method to distinguishing one System based Surveillance - unique person from another, and to link case reports. In the absence of a reliable truly national unique ID code, work with your programmer to see if the database create a “pseudo unique identifier” (Chapter 1.3) for each case report received. This will strengthen the data cleaning and analysis process, and allow you to link patient care and outcomes over time.
Automate Data Quality Checks Even the most basic surveillance database should be able to be programmed to provide automated data quality checks as information is entered or imported. These checks can save time and prevent analytical errors later on. Examples of automated data quality features include: o Generate flags when key variables are missing, or when the case report does not include the minimum set of variables to be considered a valid case report. Define and Plan Case Your o Flag or disallow invalid values (e.g., persons born in 1910) or contradictory values (e.g., pregnant males). o Include skip patterns to assist data entry. For example, pregnancy related questions can be skipped if the patient is male.
119 o Make data entry as uniform as possible. Using drop down menus or radio buttons in fields that have fixed responses (i.e., “male”/”female” or county of residence) will ensure consistent spelling and/or coding for that variable in the database, vastly simplifying your data cleaning and analysis process.
Automate Case Matching (Deduplication)
The process for matching case data—in order to link case reports related to one person from multiple data sources, or to confirm receipt of a new case—should follow a pre- determined process or algorithm so that matching happens consistently. This matching can be done automatically or manually with the surveillance database. (Chapter 1.4) Automated case matching can be accomplished by creating programs to query the surveillance database to look for matching cases, often using the case defining elements. These queries will identify cases that are considered automatic matches, as well as potential duplicates within the database requiring further follow-up by a surveillance staff person. Examples of this process are included in Chapter 1.4 and the appendix. (15)
Generate Reports A key feature of an effective surveillance system is the capacity to easily create standardized epidemiology and monitoring reports. A variety of report generation options are possible, and any system can be designed to create reports of some kind. based Surveillance System based Surveillance
Even simple systems, such as Excel, can summarize data using automated formulas and - pivot tables. Surveillance systems built on Access and SQL can be programmed to produce customized reports. (16) (17) In addition to creating reports, your surveillance data system should be able to export data for review and analysis in other programs. Some data management systems do not perform data analysis in the database itself; in these cases, an analysis program such as SAS, SPSS, or STATA may be used.
Data Standards
If your surveillance system will collect electronic data from more than one source, it will be important for you to define data standards such that all the data you import will be compatible and of a uniform format. The most critical step for you to take is to develop data standards, (18) and describe these standards in a data dictionary. (19) These standards define each variable you expect via a case report, and the format you want it in. As an example: Define and Plan Case Your
Do you want Date of Birth as MM/DD/YYYY or DD/MM/YYYY? Do you want Sex to be listed as F/M, Female/Male, or 1/2? Do you want blank fields to be listed as “blank”, “0”, “N/A”, or other? In addition, it is important to define data transmission standards (18) that define how information is packaged and communicated from one electronic system to another.
120 Setting data standards will allow your partners to know what is expected of them with regards to the format of reported data, and can work to program the data exports to meet your needs. Technical documents related to data standards and data transmission standards (18) (19) (20) are included in the appendix.
Steps to Take
Based on our experience, there are several steps that can help you plan for and design a strong data management system. 1. Clearly define what you want the data to say, and ensure you have a system that will be able to collect the correct variables. Work from your “gold standard vision” and your case report form to define this. 2. Understand what software and technical expertise are available. Look at data that are currently collected and stored electronically and understand the format(s) used. Will this format work for you and your system? 3. Understand current limitations to high-quality data. If key stakeholders note that there are limitations to their data, try to understand what the influencing factors are; can your system be designed to avoid these barriers? 4. Tap into an existing pipeline of data. It is likely that a lot of data are currently being based Surveillance System based Surveillance collected in your country. If these data are available—in whole or in part—electronically, - prioritize working with the managing organization to gain access to the HIV surveillance-related variables. 5. Find a skilled data manager early on. If you have strong data staff from the start, they can help you to effectively manage the development of a system and interoperability standards, likely increasing your success. 6. Place the burden of data cleaning and formatting as close to the original source as possible. Trying to clean and troubleshoot clinic-specific data from the national level can be challenging, as the source data are not readily available. Seek to decentralize this process as much as possible, so that you are receiving high-quality data at the national level. 7. Strip the data down. Try to get the data as “naked” as possible. This will help guard against unexpected software features that limit data interoperability. For example, getting a clean text (.txt) file will be smaller and easier to work with than the same Define and Plan Case Your information in an Excel spreadsheet.
Once you have taken these elements into consideration, you can begin to design the data system. Remember that starting small is alright, especially for a pilot. Leverage resources and expertise that are available to you, and start with something simple.
121 F. Develop a Monitoring and Evaluation Process
Monitoring the surveillance system is essential to understanding if the information produced by the system is reliable. To do this, you should consider the development of a monitoring framework (metrics and standards) and plan (how monitoring will be implemented) to tell you if your system is working, if the data are of high quality, and what you can do to improve the system.
Monitoring Framework
A Monitoring Framework (21) describes the criteria you will monitor, and the performance System e targets you aim to achieve. A framework will help you and your team to effectively and consistently monitor your system and process. The monitoring framework should detail the quality measures you are interested in, as well as the objectives to be reached for each of these measures. As presented in Chapter 1.5, key criteria to monitor include:
Timeliness. The amount of time between steps in the case reporting and data management process, such as the time between diagnosis and availability of the case
report for analysis. based Surveillanc - Representativeness. The degree to which all expected cases are being reported to the system, and whether all expected facilities are reporting to the system.
Completeness. The proportion of case reports that contain an expected variable or variables.
Validity. The degree to which the case-based surveillance data ’makes sense,’ or whether the data fall within the range of possible or expected values.
Accuracy. The degree to which the data are ‘true,’ or whether the reported data match the corresponding data in the source record (e.g. patient register). This measure helps to establish a degree of confidence in the surveillance data.
Indicators related to each of these criteria—as defined in your Monitoring Framework—will provide specific performance targets that you can measure and monitor. When performance
targets are met, one can be reasonably certain that surveillance methods are working and the Define and Plan Case Your data obtained are of high quality. Each of these criteria is described below, in Table 2.2, in greater detail, along with sample performance targets.
To develop your Monitoring Framework, consider what performance elements you are most interested in and define corresponding indicators and performance targets; an example of how to present this framework as a Logic Model (21) is include in the appendix.
122 Table 2.2. Sample Process and Outcome Standards for Case-based HIV Surveillance Criteria What it Describes How it is Calculated Sample performance targets Completeness The proportion of an expected count Define the variable(s) you will assess (a) 85% of reported cases have that is “complete” all case defining variables Record the number of records you will assess complete Form: What proportion of fields (b) on the case report form is 85% of all reported cases Record (count) the number of records with a complete? have “Date of HIV value © System: What proportion of cases Diagnosis” complete is submitted with a selected
variables complete?
Timeliness The measure of time between steps Can be measured two ways Median time between date case reporting and data usage of case report and date of Median time between two events: process availability of case report o Month of second event – month of first data in central database Facility: Are the cases submitted event = time delay within the expected time? 85% of cases are reported o Add the time delay for each case, and within three months of System: Are the data cleaned and calculate the median (order numbers diagnosis processed within the expected smallest to largest and find the middle) time? Proportion of cases that achieve the time benchmark o Month of second event – month of first event = time delay
Accuracy The degree to which the data are a Identify a subset of case reports for validation 85% of case defining “true” reflection of patient Visit the reporting facility and compare variables are accurate, characteristics information in the case report to source data when compared to source Facility: Do reported data match (e.g. facility register). data source data? Calculate the proportion of variables for which the case report matches the source data.
Define and Plan Your Case-based Surveillance System 123 Validity The degree to which the data are Define the variable(s) you will assess (a) 95% of cases have valid within the expected range of values, data for a select variables Record the number of records you will assess including: (b) Facility: Were the data correctly Record (count) the number of records with a documented? And correctly valid value © transcribed?
System: Were the data correctly
transmitted and recorded? Representativeness The degree to which the system is Can be measured two ways 85% of cases from the last capturing all cases quarter were reported Cases in System: Facility: Have all expected HIV This can be measured by visiting a site and using 90% of expected facilities cases been reported to the site records to identify all cases (or sentinel events) reported in the last quarter system? If 100 HIV+ tests were during a defined period of time, then comparing
performed, 100 HIV cases should these with the number of cases (or sentinel events) be reported. that were reported into the system.
System: Are all expected
facilities, types of service, regions reporting? If there are 100 facilities, all 100 should be reporting cases. Facilities Reporting to the System:
Define and Plan Your Case-based Surveillance System 124 Monitoring Plan
Your Monitoring Plan (22) should build from your Monitoring Framework, and describe the process of how monitoring of the surveillance system will occur and monitoring results will be acted upon. Some examples of monitoring processes are described in Table 2.3.
Your monitoring plan should describe who will do what (related to monitoring), with what tools, with what frequency, and what will be done in response to the findings. Having all steps, roles and responsibilities, simple tools and templates,(23) (24) (25) and timelines written into a plan will ensure that monitoring activities are standardized and routinized, and that suboptimal monitoring results motivate additional training, support and supervision . A sample Monitoring Plan Outline is presented in Table 2.4; a sample Monitoring Plan (22) is included in the appendix.
Implementing the monitoring process can be a hurdle to get over, as it will seem like extra work. However, the investment can pay dividends. Some hints are to:
Develop tools that facilities themselves can use to pre-screen and monitor the quality of their data pre-submission. If you support facility-level staff to submit high-quality and complete data, national level monitoring will be much simpler.
Give feedback—either positive or negative—information to the facilities as soon as based Surveillance System based Surveillance
possible to support their work or highlight the need for quality improvement. -
Program the surveillance database to produce regular monitoring reports (monthly or quarterly) that highlight performance on your selected measures. Some surveillance systems may also incorporate a ‘dashboard’ that updates monitoring figures in real time. The results of these summaries can then be used to follow-up with reporting sites or make other adjustments to the surveillance system.
Provide follow-up supervision, mentoring, and technical assistance as indicated. Define and Plan Case Your
125 Table 2.3. Suggested Monitoring Process Criteria Process Level and Frequency Result Completeness This requires: Facility level staff may review their own case report In order to allow for strong process and quality review of case forms for completeness prior to submission improvement, results should be presented by report forms (weekly/monthly) facility, and by system as a whole, describing the proportion of case reports with: review of data in [sub]National level staff should review all case report all key variables complete the database forms prior to data entry (daily/weekly) and the a specific variable complete database periodically (quarterly) Timeliness This requires: Facility level staff may review their timeliness by In order to allow for strong process and quality comparison of looking at the date of the reportable event vs. the date improvement, results should be presented by two “time- of submission of the case report (monthly) facility, describing how their case reporting stamps” [sub]National level staff should review the time timeliness compares to the national between key process events (quarterly) such as: standard o Reportable event and receipt of the case report system as a whole, describing the timeliness o Receipt of case report and data entry of other key elements that relate to the o Reportable event and availability of data for availability of high-quality and usable data analysis Accuracy This requires: Facility level staff may assess their own accuracy In order to allow for strong process and quality validation of (monthly/quarterly) by comparing data in case reports improvement, results should be presented by data in the against source data (register, log book, etc.) facility, provider type (PMTCT, lab, EMR),, surveillance [sub]National level staff should implement facility-level system as a whole, describing common system against data validation (sample of case reports) periodically errors and places for improvement source data (e.g. (quarterly/annually) with supervision visits site registers) Validity This requires: Facility level staff may review their own case report In order to allow for strong process and quality review of case forms for validity prior to submission improvement, results should be presented by report forms (weekly/monthly) facility, provider type (PMTCT, lab, EMR),, review of data in [sub]National level staff should review all case report system as a whole, describing common the database forms prior to data entry (daily/weekly) and the errors and places for improvement database periodically (quarterly) for invalid values Representative- This requires: Facility level staff may assess their own In order to allow for strong process and quality ness comparison of representativeness (weekly/monthly) by comparing the improvement, results should be presented by cases in # of cases reported vs. number of recorded events (per facility, provider type (PMTCT, lab, EMR), surveillance the register, log book, etc.) and system as a whole, describing reporting system against [sub]National level staff should calculate case report gaps and focal points for improvement cases in source representativeness and facility representativeness data (e.g. site routinely (quarterly); registers)
Define and Plan Your Case-based Surveillance System 126
Table 2.4. Sample Monitoring Plan Outline System Level Monitoring Activities Who When National and/or sub- Cross-match and deduplicate reported cases to ensure that unique cases are only Data manager Weekly National Level: counted once Using: Produce frequency tables to check for: Data manager Weekly The master data set Standardized spelling of sites, towns, and geographic units created from data Missing or miscoded variables submitted via sites, Invalid values electronic interfaces, Provide feedback to sites and EMR data: Analyses by site, region and/or network to measure Data manager and Quarterly/ Summary monitoring timeliness, Surveillance yearly data generated at the completeness Coordinator national level (or sub- Prioritize follow-up activities for reporting sites national, depending Disseminate monitoring reports to sub-national surveillance staff and sites Data manager and Quarterly/ on data access) (quarterly) and stakeholders (yearly). Surveillance yearly Coordinator Site Level Site monitoring visit to collect data on: National or sub- Quarterly/ accuracy national Surveillance yearly representativeness Coordinator or Data Manager Direct observation of reporting processes: National or sub- Quarterly/ Adherence to data collection and reporting procedures national Surveillance yearly/ Adherence to privacy, security and confidentiality policies Coordinator or Data as needed Clearly defined reporting responsibilities and timelines Manager Supervision of case surveillance activities Site-level process for data review and validation Barriers to optimal system functioning Follow up observation, training or support to investigate or remediate data National or sub- As needed quality or monitoring issues. national Surveillance Coordinator or Data Manager Routine monitoring of: Site Supervisor / EMR Monthly Case reporting processes Manager Case reporting data quality (completeness, validity, representativeness, accuracy). Adherence to privacy, security and confidentiality policies
Define and Plan Your Case-based Surveillance System 127
G. Develop the Standard Operating Procedures (SOP)
Writing and implementing the Standard Operating Procedures (13) (14) manual goes hand in hand with the process of planning your case-based surveillance system and serves to document all of the planned processes and procedures. The procedures and instructions detailed in the
SOP ensure that all entities and staff involved in HIV case-based surveillance in your country are aware of their expected roles and are following the same guidelines.
A SOP should be a user friendly “living document” that all people who use the case-based surveillance system have, refer to, and use to guide the case reporting process as needed. Figure 2.6 lists some characteristics of a successful SOP that you might consider. A good measure of success is if you see copies of the SOP on peoples’ desk, with dog-eared and marked-up pages; it’s no use if it just sits on a bookshelf!
Figure 2.6. Characteristics of a Successful SOP
Is Practical and User based Surveillance System based Surveillance
Friendy -
Is Offers Step- Continuously by-Step, Tested, role-based Modified and Instructions Improved A Successful SOP
Includes All Solicits and Forms and Incorporates Tools Feedback Required Define and Plan Case Your
128 The suggested SOP structure is detailed in Chapter 1.1, and should include a detailed description of:
The case-based HIV surveillance system All sentinel events and required variables for them The process to report a case or a sentinel event The surveillance data management process Security and confidentiality guidelines The monitoring process and benchmarks Plans for data analysis and dissemination Roles and responsibilities for human resources at all levels
Here are some steps that you may follow as you develop and implement your SOP:
Determine the agency and staff that will lead the development of the SOP and will be accountable for its implementation. The SOP must be used to be impactful, and so ownership from the lead agency is important.
Draft the SOP using your team and other experts as co-authors; samples (13) (14) are included in the appendix. based Surveillance System based Surveillance Present the SOP and materials to a small group of stakeholders for review. Ask them to - identify areas that are not clear, are confusing, or inaccurate.
Modify the SOP, as needed.
Test the SOP, including the case report form and other data collection tools, during your pilot or initial roll-out.
Gather input and feedback for improvement through interactions and observations.
Continue to modify the SOP, as needed. The SOP should be a living document.
Use the SOP as a training tool. Consider using the SOP as the only resource during staff training so that users are forced to become well oriented to the SOP, and learn to use it as a true reference manual.
Define and Plan Case Your
129 H. Plan for Sufficient and Skilled Human Resources
Chapter 1.2 outlined the suggested human resource needs for a basic and advanced case-based surveillance system. Now that you are in the surveillance planning phase, it is time to consider how well the necessary roles are filled, given your current context, and what further support might be needed via training, task-shifting, or even hiring. As already noted, we suggest that you try to leverage existing human resources to support the system if at all possible. Integrating case-based surveillance roles into existing staffing structures will do much more to support a sustainable system over the long term.
Table 2.5, below, elaborates the duties of each of these positions regarding the various types of surveillance activities. Use this table to assess whether your staff composition is sufficient to meet the needed outputs of the surveillance system, and make adjustments where needed, either in staff duties, or in anticipated surveillance activities.
Human resource development requires that qualified staff are available to cover the necessary roles, and that there is training and appropriate supervision and support to ensure that staff can perform well; these are described in Chapter 2.5. based Surveillance System based Surveillance - Define and Plan Case Your
130 Table 2.5. Staff-specific Management and Data Related Activities for Case-based Surveillance
Role Leadership & Human Resources Case Reporting Process Data Management Data Use Governance National Develop national Supervise the National Provide leadership on Final approval of SOP and Provide guidance on monitoring Surveillance policy and Case-based establishing reportable data policies, as well as and analyses Director procedure; Surveillance events and reporting surveillance database and Guide data dissemination approach Coordinator process case matching process Principal contact for Ensure monitoring and quality stakeholders and Gain buy-in from Serves as the Overall improvement is implemented media reporting sites Responsible Party for the national HIV case-based Facilitates liaison with other data Ensure buy-in sources to support triangulation among stakeholders surveillance data set National Case- Ensure Supervise the national Ensure all staff are well Oversee development and Oversee monitoring and resultant based implementation of and sub-national staff trained on, and comply use of database quality improvement activities Surveillance national policy and Provide training and with, policies and Lead development of a Develop quarterly/annual analysis Coordinator procedure technical assistance to procedures data security policy plan for surveillance data (Epidemiologist Develop and sub-national and site- Coordinate supervision Conduct surveillance Interpret epidemiological data and may further implement SOP level staff and support to sites monitoring activities summarize findings in reports support this role Liaise with Assure proper function of Ensure data security and Generate dissemination products
stakeholders data collection process confidentiality National Data Provide technical Provide training and Receive and process case Develop and use Conduct monitoring activities Manager expertise to TWG technical assistance to reports surveillance database Support quality improvement (Health sub-national and site- Coordinate supervision Perform quality checks activities Information level staff and follow-up support to and follow up with sites Assist with generation of Officer may reporting site Ensure data security and dissemination products support this role) confidentiality
Regional Case- Support Supervise Regional Provide training and Ensure routine submission Conduct monitoring activities based implementation of staff and reporting support to facility staff of case data Assist with data quality and Surveillance national policy and facilities Represent Surveillance Perform quality checks epidemiological analyses Coordinator procedure Provide training and team to other stakeholders and follow up with sites TA to facility staff Ensure data security and confidentiality
Define and Plan Your Case-based Surveillance System 131
Leadership & Role Human Resources Case Reporting Process Data Management Data Use Governance Provide technical Provide training and Receive, process, and enter Conduct monitoring Conduct monitoring activities expertise as technical assistance to cases activities Support quality improvement requested facility-level data staff Regional Data Assure proper function of Perform quality checks activities Manager data collection process and follow up with sites Assist with generation of Compile data to send to dissemination products the National level
Ensure facility-level Supervise facility-level Ensure all staff are well Ensure all staff are well Assist with data quality assurance compliance with staff trained in and comply trained in, and comply and improvement national policy and with reporting policies with, policies and Facility Coordinate routine TA Work with Surveillance procedure and procedures procedures, including Supervisor and re-training Coordinator to implement quality security and improvement activities based on confidentiality monitoring reports Fulfill normal duties Complete the specified Assist with data quality assurance Facility-level to meet case reporting case report form for each Case Ensure data security and Work with supervisor to implement None requirements case and sentinel event Reporting confidentiality quality improvement activities Staff Submit each case report based on monitoring feedback per the national policy Fulfill normal duties Ensure collection of all Collate case report forms Assist with data quality assurance to meet data entry completed case report per national policy and Facility-level Work with supervisor to implement requirements forms submit to the Regional or Data Manager, quality improvement activities None National Data Manager M&E officer, based on monitoring process etc. Ensure data security and reports confidentiality Fulfill normal duties Ensure collection of all Collate case report data Assist with data quality assurance to support EMR applicable case reporting per National policy and Implement quality improvement EMR Manager None requirements data in the EMR submit to the Regional or activities based on monitoring National Data Manager process reports
Define and Plan Your Case-based Surveillance System 132 I. Summarize Plan and Submit for Ethics Review and Approval
In most countries, surveillance activities require bioethical review and approval of a formal surveillance protocol by an institutional review board (IRBs). This process is implemented to ensure that surveillance activities are designed and implemented in line with national and international ethical principles of biomedical research. Two Sample Protocols (26) (27) are included in the appendix.
Local IRBs often have their own processes for reviewing and approving protocols that relate to the collection and analysis of person-level data, so be sure to get input early on in the process.
Surveillance as a Non-research Activity Many IRBs classify epidemiological studies as either “research” or “non-research”, with each category carrying different criteria and considerations for obtaining IRB approval. Case-based surveillance is often viewed as “non-research” because it (a) is a part of routine public health practice, and (b) uses already collected data. Even though it is not, or may not be, considered a research activity, a protocol must be drafted and submitted to validate this determination. System based Surveillance - Two samples of such protocols are included in the appendix: - One Sample Protocol (26) that proposes a pilot to initiate a new case-base surveillance process - One Sample Protocol (27) that proposes activities to assess, monitor, expand, and improve an existing case-based surveillance process.
For an IRB review, your protocol should include all of the following components, as well as key appendices such as the case report form.
a) Project Summary Provide a high-level overview of what the surveillance initiative is, what the epidemiological data gaps are, and what the value of the project is.
b) Background and Justification Describe what is known about the epidemic, what epidemiological gaps this system Define and Plan Case Your will fill, and what environmental factors support implementation.
c) Objectives State the goal(s) and specific objectives of the project. Summarize what you seek to achieve via this project.
133 d) Project Design and Methodologies Describe the case reporting process, including who will report what and to whom, using which tool, on what timeframe. Don’t be afraid to start small with a pilot or a phased roll-out. o For a pilot, establish a set amount of time for which the pilot will run, after which an evaluation will be performed.
o For a phased roll-out, start where you will be able to show success: high volume facilities, facilities that can be most easily incorporated into the system, or those that will showcase early progress. o Collect core data that are most important for analysis and dissemination. o Build on existing data sources and structures to facilitate early startup. Provide reference to your monitoring process and indicators. e) Data Collection Process Describe the data mechanisms and pathways. f) Data Management and Analysis Plan Document how and where data will be managed, stored, and analyzed. g) Ethical Considerations Describe how the privacy of people with HIV will be protected throughout the data based Surveillance System based Surveillance collection, management, and analysis process. - h) Timeframe Include a timeline to describe the process of implementation. Remember that starting small or planning a staggered roll-out to allow for process monitoring and improvement. i) Appendices The protocol should contain a number of appendices, including all forms that will be used for data collection and informed consent. Be sure to include: o Data collection tools o Monitoring tools o Defined policies and procedures
Define and Plan Case Your
134 Summary of Noted Resources # Source Title Description Appendix (1) NASTAD Sample Case Reporting A sample of a case report form algorithm 55 Field Algorithm to guide data submission (Guyana) (2) NASTAD Sample Adult Sentinel This template may be of use in your 56 Event Diagram planning process
(3) NASTAD Sample Pediatric Sentinel This template may be of use in your 57 Event Diagram planning process (4) NASTAD Sample HIV Case Report A case report form used to report 58 Field Form diagnosed cases of HIV (Guyana) (5) NASTAD Sample Adult HIV Case A case report form used to report 59 Field Report Form diagnosed cases of HIV in adults (Haiti) (6) NASTAD Sample Pediatric HIV A case report form used to report 60 Field Case Report Form diagnosed cases of HIV in children (Haiti) (7) NASTAD Sample PMTCT Case A case report form used by case managers 61 Field Tracking and Report to track HIV-exposed mother and baby Form pairs, and to report cases of HIV to the MoH (Haiti) (8) NASTAD Sample Adult TB Case A case report form used to report cases of 62 Field Report Form TB to the MoH (Haiti) (9) NASTAD Hints for Developing IT Peer-based guidance that may help you 30
Systems for Case conceive of your data system System based Surveillance Surveillance development - (10) NASTAD Sample Case Surveillance Template can be used to help plan for 63 Implementation Timeline your implementation Template (11) NASTAD Sample Surveillance Data A sample data flow algorithm used by a 64 Field Flow Diagram country to help describe data follow to case-based surveillance system users (Haiti) (12) NASTAD Sample Data Flow A sample data flow mapping template 57 Mapping Template that can be used to map existing or potential data flow (13) NASTAD Sample Case-based An SOP that is used for the case-based 15 Field Surveillance SOP surveillance system in Haiti (14) NASTAD Sample HIV Case-based An SOP that is used for the case-based 16 Field Surveillance SOP surveillance system in Guyana (15) NASTAD Sample Case An example of the case matching process 34 Field Deduplication Algorithm used in Haiti, guided by an automated Define and Plan Case Your (Haiti) and manual deduplication algorithm (16) NASTAD Epidemiological Data A sample of a standard report that is 65 Field Report programmed into Haiti’s case-based surveillance data management system
135 # Source Title Description Appendix (17) NASTAD Sample Monitoring Data A sample of a standard monitoring report 41 Report that could be used in case-based surveillance system (18) CDC Data Transmission A description of what data transmission 36 Standards standards are, and the role they play in quality data transmission. Health Level
Seven International (HL7) is provided as an example (19) CDC Data Dictionary This is a description of what a data 27 Definition dictionary can contain, and describes the example provided in the Data Dictionary Template (20) U.S. State Information Systems, Describes the planning process that the 35 Data Interoperability, Minnesota Department of Health and the Requirements for implemented to address the question of Exchange (Minnesota) integrating data from local health departments via electronic health records. Contains a number of resources including data flow diagrams and checklists that are helpful. (21) NASTAD Sample Monitoring A sample monitoring framework that 66 Framework includes system performance objectives and a logic model (22) NASTAD Sample Monitoring Plan A sample monitoring plan that describes 67
how the surveillance system will be System based Surveillance - monitored in Haiti (23) NASTAD Sample Monitoring Tool A tool that is used to assess basic data 68 quality and completeness at the facility level (24) NASTAD Sample Monitoring Tool A tool that is used to assess basic data 69 quality and completeness at the facility level (25) NASTAD Sample Database This tool may be used to review the 70 Monitoring Tool quality of key variables in your case- based surveillance database, and help to plan for corrective action related to data collection, data entry, and/or data transfer (26) NASTAD Sample Case Reporting A sample of a case-based surveillance 71 NRD Protocol for System system monitoring and quality Assessment and improvement protocol that was submitted improvement to CDC for "non-research determination" approval. Define and Plan Case Your (27) NASTAD Sample Case Reporting A sample of a protocol that was submitted 72 Field NRD Protocol for to CDC for "non-research determination" Development approval to describe implementation of a new case-based surveillance system
136 Other Relevant Reading and Resources Source Title Description Appendix NASTAD Planning for Case-based An introduction to the components of case- 73 Training Surveillance based surveillance NASTAD Case reporting and Case A summary of considerations for designing or 74 Training Management Process improving your case reporting process NASTAD Developing a Case A summary of how to develop a case report 75
Training Report Form form
based Surveillance System based Surveillance - Your Case Your Define and Plan
137 Implement and Improve Your 2.5 System
In this chapter, we will review how to: Train persons to effectively use the surveillance system Roll out the surveillance system
Support, monitor and evaluate the surveillance system
Introduction After much planning, it is time to establish or improve a case-based surveillance system. The main focus at this time is to prepare your team and personnel at reporting sites for roll-out, and to put practices in place to monitor system performance. Throughout the process, it is essential to set up a culture of review and adjustment, and remember that your case-based surveillance system is a work in progress.
A. Train Human Resources and Orient Reporting Facilities
Before implementing your case-based surveillance plans, you must ensure that the human resources that will be the core of your system are oriented and trained. They must understand your goal and vision, the case reporting process, and the case-based surveillance system. A short training and orientation is usually sufficient for ensuring understanding and buy-in, and for the development of skills among clinical, laboratory and administrative staff responsible for case reporting.
Personnel involved in the surveillance system should be able to understand and address Your System and Implement Improve emerging needs and priorities with little guidance from you; decentralized and facility-based personnel should understand their roles and responsibilities in the surveillance system.
Determine Training Needs
Before organizing trainings, it is important to clearly define the expected roles and responsibilities of human resources at all levels of the system (Chapter 1.2). If possible, try to understand baseline knowledge, skills, and overall competency, as it relates to the critical skill areas such as surveillance, epidemiology, data quality assurance, and data management.
138 To assess knowledge and skill gaps of existing personnel, consider conducting a competency assessment with a self-assessment tool (1) or surveying a sample of key personnel. The results, when compared to the needs of the surveillance system, will help you to tailor your training sessions to ensure impact.
Core Elements of Training
After you have assessed the training needs and determined the areas you want to address in your training, you can develop a training plan. A training plan can serve as a road map for
building on baseline knowledge and skills in order to meet the goals and/or standards for the surveillance program. Two templates (2) (3) to help organize your training are included in the appendix.
While the content of each training session should be tailored to the needs of the personnel and stakeholders, the following elements should be assured in any training:
Expectations are clear: Participants know what they will gain from the training.
There is value to the topic: The topic is important for the implementation and/or improvement of the case-based surveillance system. The topic originates from the results of a competency assessment, and participants understand why the topic is applicable to their work.
The message is being delivered appropriately and effectively: The message is delivered most effectively, either through presentation, facilitated conversation and/or interactive exercises. The message is delivered in a way that meets all participants’ learning styles, abilities, and cultures.
Trainers are knowledgeable and engaging: The presenters and/or facilitators are comfortable with the topic and can provide real life examples to clarify concepts. Implement and Improve Your System and Implement Improve Materials provided are relevant: Materials provided are relevant and provide role-based instruction. SOPs and other guiding and supporting tools are used wherever possible.
An evaluation is conducted: Conduct pre- and post-evaluations to measure change in knowledge, attitude, and/or skill. Collect anonymous feedback on the quality and content of the training.
139 Key Training Topics
As defined in your implementation plan, human resources at different levels of the public health system will play different roles in the case-based surveillance system, and the trainings should reflect these differences. For the purposes of establishing and maintaining a case-based surveillance system, human resources can be divided into three main groups:
A. Personnel who work for the agency responsible for the case-based surveillance system (e.g., the Ministry of Health.) This may include national or sub-national surveillance coordinators, data entry clerks, surveillance data managers, health information officers, etc.
B. Personnel who complete and submit case reports or other data. This may include counselors, nurses, physicians, phlebotomists, lab technicians, site data managers, data clerks, EMR managers, etc. that are employed by the government or other implementing partners.
C. Management level personnel at organizations who submit case reports or other data. This includes, especially, management within the implementing partner organizations (umbrella organizations). Their support to engage and allow (or better yet, expect) their staff to report to the system is imperative to a comprehensive system.
Table 2.6, below, presents common training topics and the depth of knowledge you should aim to provide to groups A and B. The latter group, C, can often be informed of the developments in the case surveillance system through meetings rather than formalized trainings. We suggest that you organize trainings according to people’s involvement in the case reporting and surveillance system process. By separating the groups, you can be strategic and specific about what each group needs to know in order to assure the smooth operation of the surveillance system.
Following the training, it is good to plan for follow-up in the form of observation, mentoring, or refresher trainings as a means of reiterating important points or actions. Your System and Implement Improve
140 Table 2.6. Level of Knowledge Needed among Personnel and Stakeholders to Support an Effective Case-based Surveillance System
Knowledge Needed Training Topic A. Surveillance B. Personnel Who System Personnel Report Cases
1. General Epidemiology and Surveillance: Trainings should cover general epidemiology Moderate to Basic to moderate, and surveillance to varying degrees depending on the audience. The Surveillance advanced, depending depending on case load: Coordinator needs to have a strong understanding of epidemiology and surveillance. on personnel role personnel with few Other positions such as the data manager and the data clerks need just a basic cases need only basic understanding of these subjects. knowledge 2. HIV Surveillance: Trainings in this area should cover the aspects of surveillance Advanced Basic to moderate, specific to HIV disease. In particular, an overview of the disease progression of HIV as depending on case load: well as clinical treatments that are recommended and available in your country will personnel with few provide an important background on why specific information should be reported to cases need only basic the surveillance system (i.e. CD4 counts, viral loads, start of ART, etc.). knowledge 3. Standard Operating Procedures (SOP): SOPs contain all protocols and procedures Advanced knowledge Advanced knowledge of needed for the operation of the surveillance system. Trainings related to SOPs should of internal & external procedures relevant to therefore review the components of the SOP that are most relevant to the target processes their work audience. 4. Roles and Responsibilities: If not covered during the SOP training, this should cover Advanced Advanced the roles required for the operation of the surveillance system, and the specific understanding of their responsibilities associated with each role. Roles and responsibilities will differ for own role(s) and surveillance system personnel and external stakeholders, and each group should be responsibilities acquainted with their expected contributions to the system. 5. Data Security and Confidentiality: Training should briefly cover the applicable laws Advanced Advanced and regulations protecting personal information in your country. Furthermore, the understanding of their specific procedures that the surveillance system will have in place and the particular own role(s) and role of training participants in those procedures should be clearly communicated. responsibilities 6. Data Collection Processes: Review Data collection methods and sources of HIV case Advanced Advanced surveillance data. Examples of these are: cases from testing sites and hospitals, understanding of their laboratory results, clinical staging, and the death registry. Specify how information own role(s) and will be captured at each data source. responsibilities
Implement and Improve Your System 141 7. Using forms and other data collection tools: Clarify how and when forms should be Advanced Advanced completed and submitted in order to maintain high data quality in the surveillance system. 8. Behavioral Information Ascertainment: It is important to train personnel on how to Advanced Advanced properly obtain behavioral information potentially related to HIV transmission (e.g. sex work) so that data is gathered in a consistent way at all HIV testing and counseling encounters. 9. HIV Surveillance Data Management: Personnel and stakeholders should know how Moderate to Basic data will be managed once it is entered into the surveillance system, although advanced, depending personnel will require a much more detailed knowledge of these procedures. on personnel role 10. Analysis and Interpretation: Surveillance system personnel, and the surveillance Basic to advanced, Basic coordinator and epidemiologist in particular, should be trained on what analyses to depending on conduct and how to interpret their results. Although stakeholders may want to personnel role provide input into what analyses are done, those more familiar with the database should decide whether the existing data can/should be analyzed in the ways requested. Stakeholders should be made aware of routine analyses that the surveillance system personnel will produce, and with what frequency. Analysis personnel should be able to work with stakeholders and others who make data requests to assist them in producing reports that answer their questions and are appropriate with the available data. 11. Monitoring: Training on monitoring of the surveillance system is a key to ensuring Moderate to Basic, including what that personnel understand their role in maintaining the system and overall data advanced, depending may be asked of them quality. Further information on this area is included in the resources table at the end of on personnel role this section. 12. Preparing and Disseminating Epidemiologic Reports: Personnel and stakeholders Moderate to Basic but should be should be aware of how reports on surveillance system data will be prepared and advanced, depending asked to provide input disseminated for use by stakeholders. Specifically, information about where reports on personnel role into content are available (online, hard copy only, etc.) and the timing and location of presentations on surveillance data will help to garner buy-in for and use of surveillance information. Samples of trainings on these topics and training agendas for personnel and stakeholders that can be adapted to your context are included in the appendix. (2-4)
Implement and Improve Your System 142 B. Implement Your Plan
Once training is complete, you can start to roll-out your proposed case-based surveillance activities per your Implementation Plan (Chapter 2.4). The goal of the surveillance system roll- out, is to bring together the five building blocks you have established in the planning stages that were discussed in Module 1: Governance ; Human Resources; Case Reporting Process; Data Management; and Data Use. Remember to be strategic about your timeline, the stakeholders that you involve, and the data that you collect, so that you can demonstrate success early on in the process. You will not implement the perfect system right away, so aim to achieve early successes that will enable you to garner support.
Piloting Your System
Piloting the system is an important opportunity to field-test your system to identify gaps and challenges before full roll-out, and document positive outcomes that can further support stakeholder buy-in. A good pilot should:
Be small and manageable If possible, include a diverse set of reporting sites, both in terms of geography and type of site (e.g. VCT, ART, PMTCT, and laboratory) to understand system implementation in different contexts Include all elements of the case reporting system: human resource training, case reporting form, case reporting mechanism and pathway, data management, data and process monitoring, and supervision and support. These elements should be implemented with the same rigor and attention as if this were the actual system roll-out. A pilot will not be able to provide information to improve the system if the pilot itself is limited, incomplete or not fully supported. Gather feedback from participants in the pilot of all levels and roles to identify strengths and challenges Document, analyze and use information from the pilot to refine or revise the building Implement and Improve Your System and Implement Improve blocks of the system or the system implementation plan. Although the scale of implementation is different for a pilot as compared to the full system, the process and goals are the same, and are covered together in this chapter. Remember that many countries scale up to full national implementation (all inputs) over the course of several years.
143 System Implementation
To begin implementation, we suggest holding a formal “launch” of the case reporting process with all key players who will be involved. Even if you have done a series of formal trainings, hosting a one-day meeting or issuing an official notice will be very helpful. Be sure to note:
Who is supposed to do what. Reiterate who should report what, to whom, using which method/tool, and in what timeframe. Be as clear as possible so each individual can identify their own role.
Starting from what date. Be sure to note an “official start date”.
Where to find the “instructions”. Provide a reference to the SOP, or other sources of documented instructions related to the case-based surveillance process.
Where to find assistance. List one or more people—including name, phone number, email address—who will be available to provide assistance.
What the expectations (benchmarks) are. Note what you will be monitoring: timeliness, completeness of key variables, and representativeness (submission of a report for each case or event).
How and when monitoring, evaluation, and support will occur. Set a timeline as to when monitoring and quality assurance will begin, and how it will occur.
Implement and Improve Your System and Implement Improve
144 C. Support the Process
All data collection systems experience challenges during implementation. System and process change can be challenging for many. To help ensure success, you will need to prioritize support, supervision and positive reinforcement of the people working to support the system.
Supervision and Support
All personnel involved in the case reporting system, regardless of where they work (both surveillance staff and personnel that work at reporting facilities), must receive support and supervision to do their work successfully. Supervision should focus on:
Role Definition: What are the expectations of the role? On a daily, weekly, monthly or annual basis, what tasks need to be completed? Consider what actions the staff must take that impact other members of the team. Supervisors should be familiar with the expectations of each team member; these expectations should be communicated clearly and revisited often to assure a clear understanding.
Team Interaction: It is often helpful for personnel to understand one another’s roles and expectations. You can increase efficiency by improving each person’s understanding of how their own work impacts that of others.
Communication: Supervisors should clearly outline expectations regarding communication. Routine one-on-one communication provides time for both the supervisor and the staff person to share information, express concerns, and generate ideas. Outcomes of these meetings should be documented so follow-up actions are understood.
Professional Development: Professional development goals should target skills or qualifications to improve performance in a current position, or targeting a future position. Skill development in the surveillance context is varied, and may include interviewing techniques, laboratory procedures, data analysis, and technical Implement and Improve Your System and Implement Improve applications for data integration. Professional development may be accomplished through traditional training courses, or through mentoring between professionals.
Because high-quality human resource performance is the most critical element of a successful case-based surveillance system, we suggest that you consider at least the four supportive processes outlined in Table 2.7.
145
Table 2.7. Four Supportive Processes for Ensuring Maximum Human Resource Performance
What Who How Clear SOPs The lead public health agency Documentation of processes in in charge of the case-based the SOP Documenting all case HIV surveillance system reporting steps in an Use SOP as a training manual should take the lead in writing SOP will set the for all users and training people on the foundation for system SOP Reference the SOP during support quality improvement and
supervision visits Update SOP as needed Integrated Training The lead public health agency Identify who provides pre- and in charge of the case-based in-service training to HIV Training should be HIV surveillance system counselors, HIV clinicians, data integrated with other should take the lead in managers involved in national pre- and in-service developing and implementing monitoring processes and EMR trainings for site staff to trainings, and should identify management generate efficiencies and existing training mechanisms ensure that almost any Seek to integrate your core to integrate HIV case health worker in the curricula into their trainings via surveillance training into HIV-related health training and mentoring their system will be equipped trainers to report a case
Supportive Supervision and The agency in charge of the Supportive supervision should Technical Assistance surveillance system should be structured, routinized, and lead this effort engage personnel to identify One of the best ways to gaps and solutions ensure strong Provision of supportive performance is through supervision and technical Develop user friendly tools that observation and assistance by sub-national people can use to monitor their proactive feedback and monitoring personnel can own performance assistance increase the coverage and Create a system where frequency of these activities innovation and performance is Implement and Improve Your System and Implement Improve acknowledged Feedback The agency in charge of the Consider disseminating surveillance system should surveillance process and data System users will be lead this effort monitoring reports to sub- motivated by seeing national and site level acknowledgement of Involvement of sub-national personnel to demonstrate that their effort personnel can increase the their data are monitored and coverage and frequency of used feedback
146 D. Monitor and Evaluate the Process
Now that your surveillance system has been implemented, you should evaluate how it is working, and where to implement change or support improvement. To do so, you will want to implement your Monitoring Framework and Plan (Chapter 2.4). This can be an exciting process as baseline values can be established, and system performance can be mapped.
The goal of monitoring is to identify challenges as they arise. To do this, you should, in accordance with the monitoring plan:
Conduct routine visits to reporting sites (e.g., monthly or quarterly)
Review monitoring metrics on a regular basis (e.g., weekly or monthly)
Follow-up with sites quickly when case reporting challenges are recognized
Share results obtained from monitoring activities at all levels to help motivate staff and validate their efforts
Establish a culture of communication with reporting sites by asking for their feedback
Conduct follow-up trainings to refresh knowledge or address gaps as needed Taken together, these activities will help your surveillance team to build relationships and gather information needed to keep the surveillance system healthy and dynamic.
At some point you might consider a more substantial surveillance system evaluation (5) (6) in order to identify gaps and prepare for substantial system change or realignment. An evaluation would be appropriate approximately every five years. Two guiding resources are included in the appendix.
Human Resource Considerations for Monitoring
Given the importance of monitoring activities, appropriate human resources at national, sub- Implement and Improve Your System and Implement Improve national, and site-levels should be identified to support the monitoring process. Here are some suggestions for roles and duties:
At the National Level, establish a role to review monitoring data, implement routine site visits, and coordinate or provide training and technical assistance as needed.
Establish a monitoring role to at the Sub-national or Regional Level, if at all possible, in order to review monitoring data, implement routine site visits, and coordinate or provide training and technical assistance as needed. Remember, more frequent supervision will ensure stronger data.
147 At the Facility Level, establish a role to implement monitoring activities, including regular review of case reports for submission and monitoring indicators, and to request training and TA as needed. These duties may certainly be incorporated into existing staff positions.
Routine Process and System Monitoring
The way you go about implementing routine monitoring will depend largely on the plan that you’ve developed. However, here are some hints to consider in order to maximize system use and data quality (see Table 2.8).
Table 2.8. Routine Processes for Maximizing System Use and Data Quality
At The… Consider… In Order To… Reporting Developing and implementing Monitor and improve Facility monthly monitoring tools to help completeness and timeliness of Level facility managers monitor their own reporting performance Assess and improve accuracy of data Identify and address process gaps Engaging facility-level leads in Support engagement of facility- periodic (annual or biennial) level personnel in the case planning meetings to receive reporting process feedback and identify challenges Sub-national Training monitoring leads so that Ensure frequent supervision and Level they can provide routine supportive face-to-face support and supervision visits to sites (monthly assistance for system use for high-volume; quarterly for low- Improve the ability of your volume) system to respond to emerging quality concerns Disseminating monthly data reports Help prioritize focus areas for to help personnel identify priority improvement: certain facilities, areas of need processes, or variables National (at a minimum) Identify data quality and process Your System and Implement Improve Level Committing to weekly data entry issues and be in a position to Cleaning and assessing data quality respond on a timely basis on a bi-weekly basis Providing feedback to facilities Engage with facilities to provide regarding data quality issues on a feedback and support to reinforce monthly basis or improve their performance Following up with facilities to correct/address data quality issues in the two weeks following
148 E. Improve the Process
Data generated from the monitoring process will provide you with information on performance gaps and areas for improved efficiency. Personnel involved in monitoring will be critical players in guiding or driving change and improvement. Continuous Quality Improvement (CQI) (7) (8) is a process through which you can affect change. As noted in Chapter 1.5, CQI is an ongoing, routine process to ensure systematic improvements in how a project or program is implemented. The Plan, Do, Study, Act1 cycle (Figure 2.7) is model that allows you to strengthen your systems and processes by breaking down the quality improvement process into discrete steps.
Figure 2.7: Plan, Do, Study, Act Cycle
Implement and Improve Your System and Implement Improve The steps outlined in Table 2.9, below, can be used to respond to gaps identified through your monitoring process.
CQI results should be regularly shared with participating personnel so that they can be used to verify if the Plan/Do/Study/Act process changes have had the desired effect. Frequently, tweaks are needed to ensure success.
1 Langley, G.L., Nolan, K.M., Nolan, T. W., Norman, C.L., Provost, L.P. (2009). The improvement guide: A practical approach to enhancing organizational performance (2nd edition). San Francisco: Jossey-Bass Publishers.
149 Table 2.9. Steps of the PDSA Method.
Steps of the PDSA Method: Step 1: What is the issue that concerns you? Identify an o Break the issue down into small components issue/area for o Which components are within your power to modify? improvement o Select one component to focus on Step 2: Define and measure who is doing what, when, where, and how, and Understand current what the outcome is performance Take a baseline measure
Set an objective for what you would like to see for improved performance Step 3: Gather information on what is causing the issue Brainstorm cause of o Meeting with local personnel to understand the issue issue Step 4: Identify: Generate and Plan o What is one thing we can do in one day to see improvement? Improvement Ideas o Who do we need to train/support to make this one change? o How will we measure if this creates an improvement? Select ONE area and ONE element to improve o Start small, start local, start quickly! Step 5: Implement Consider the ONE area and ONE element you’ve chosen. change Support Implementation: o Train/orient the key personnel o Implement the change for a short period of time Step 6: Consider the ONE area and ONE element you have chosen. Study Results of Evaluate the result
Change o What happened from baseline to post-evaluation? Your System and Implement Improve o Did you see a change in the direction that you wanted? o What are some possible influencing factors? Step 7: If you saw the expected improvement outcome Act accordingly o Communicate the change and expand the initiative o If results continue to support the change, codify it and incorporate it into SOP If the change did not generate the expected outcome o Refine idea o Run through the PDSA again o Keep trying to drive improvement.
150 F. Expand the System
When you are satisfied with the progress your system is showing, you can consider expanding it further. Expansion could take several forms. For example, a country may:
Add additional reporting sites (either new types of sites or a new geographic area)
Expand or add data reporting methods. For example: expand capacity to receive electronic case reports from electronic medical record systems or electronic laboratory information systems.
Expand data collection to include other types of data such as: o co-morbidities (e.g. tuberculosis or STIs) o clinical data (ART initiation, pregnancy and PMTCT interventions, etc.) o clinical monitoring data such as CD4, viral load o pediatric data
When looking to add new data elements, consider data quality, the ease of access, and how the format will be integrated into the surveillance database.
Implement and Improve Your System and Implement Improve
151 Summary of Noted Resources # Source Title Description Appendix (1) NASTAD Public Health Surveillance Provides an example of an assessment 26 Competency Audit form used to determine staff’s strengthens and areas needing improvement (2) NASTAD Sample Stakeholder A sample agenda used to help orient 76 Training Agenda stakeholders to the case-based surveillance process (3) NASTAD Sample Surveillance Staff A sample agenda used to train key staff 77
Training Agenda and system users to the case-based surveillance process (4) NASTAD Regional Case-based A set of PowerPoint presentations used 78 Training Surveillance Workshop in regional workshops to orient Trainings countries to strong case-based surveillance systems. It includes 9 sessions: 1. HIV Case Surveillance 2. Overview and Review of Case Surveillance 3. Unique Case Identification 4. Ensuring Privacy and Confidentiality 5. Using Case Surveillance Data 6. Eliciting Quality Data 7. QM of Case Surveillance Systems + M&E Case Study (Haiti) and Improve Your System and Improve
8. Evaluation of Case Surveillance Systems 9. Innovative Uses of Case Reporting Data (5) Hall and Case Surveillance Guidance document walks you through 39 Mokotoff Evaluation the suggested step evaluate a case surveillance system Implement (6) CDC Guidelines for Evaluating Guidelines for public health 40 Public Health Surveillance surveillance system evaluation Systems (7) SMDP Process Improvement A training focused on quality 47 PowerPoint assessment and improvement processes and activities (8) SMDP Process Improvement A training focused on quality 45 Facilitator Guide assessment and improvement processes and activities
152 Other Relevant Reading and Resources Source Title Description Appendix HRSA Quality Management A training focused on public health quality 44 Technical Assistance assessment and improvement processes and Manual activities SMDP Process Improvement A training focused on public health quality 46 Participant Guide assessment and improvement processes and activities NASTAD Quality Management Contains practical detail on Monitoring and 79 Training of Case Surveillance Evaluation and other aspects of evaluating and Systems maintaining high quality case surveillance systems U.S. State Sample Case Report Sample training/job aid used by one U.S. state to 80 Completion Job Aid improve quality data collection and reporting (Indiana) NASTAD Sample Job Aid for A sample job aid that was created to help improve 81 Field Completion of the quality data collection Case Report Form
Implement and Improve Your System and Implement Improve
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163 Appendices by Chapter
Introduction Title Description Guidelines for Second An update to guidance released in 2000 that helps countries to Generation HIV Surveillance prioritize and plan surveillance initiatives, maximizing resources for greatest public health impact HIV Clinical Staging A training that describes the basics of case reporting Overview of the Epidemic A training that provides background information about HIV, the global epidemic, and methods for disease surveillance Introduction to Case-based An overview of what case-based surveillance is, and how you Surveillance might conceive of a system in your country Surveillance of HIV using Case Guidance to help countries improve their HIV surveillance system Notification based on intern Clinical Cascade MMWR A sample of how case-based HIV surveillance data can be used for effective public health planning
Chapter 1 – Section 1 Title Description Mandatory Disease Reporting A disease reporting law from one U.S. state that describes what Law (Maine) diseases are reportable, to whom, and by what process. Laws can be complex to pass, and likely need to be guided by the legislature. Disease Reporting Rules (Maine) These disease reporting rules describe the step-by-step reporting expectations that are mandated by the disease reporting law. Appendices Rules can typically be drafted or modified by the respective government division. Sample Case Reporting Mandate A simple policy tool used in Haiti to mandate HIV case reporting, in the absence of a law Sample Employee Confidentiality This is extracted from a CDC/UCSF training module and is a Agreement good sample for an employee data confidentiality agreement. related to data security and confidentiality Tips for Confidentiality and Data Extracted from a training module; highlights key guidance that Security you might consider related to data security and confidentiality Guidelines on Protecting Guidelines to help protect the confidentiality and security of HIV Confidentiality and Security of information HIV Data Regional Surveillance Policy Policy document that guides epidemiological surveillance in the Pan-American region Data Privacy, Security and This policy is guided by and relates to the disease reporting law Confidentiality Policy (Maine) and rules, and guides day-to-day practice of data management, data security and patient privacy, and data use
164
Appendices Sample Case-based Surveillance An SOP that is used for the case-based surveillance system in SOP Haiti Sample Case-based Surveillance An SOP that is used for the case-based surveillance system in SOP Guyana Data Security and Confidentiality Guidelines to assist in the planning and monitoring of data Guidelines collection and storage systems and policies Ensuring Privacy and An overview of how you can create structure and guide staff for Confidentiality data security and patient confidentiality National Confidential and This tool may be used to identify where you might reinforce your Security Policy Assessment Tool security and confidentiality policy
Chapter 1 – Section 2 Title Description Sample National Surveillance A position description that may be helpful as you plan to hire a Coordinator Position Description National Surveillance Coordinator, or divide roles and responsibilities among existing staff. Sample Data Manager Position A position description that may be helpful as you plan to hire a Description Data Manager, or divide roles and responsibilities among existing staff. Sample Sub-national Surveillance A position description that may be helpful as you plan to hire a Coordinator Position Description Sub-national Surveillance Coordinator, or divide roles and responsibilities among existing staff. Sample Data System Programmer A position description that may be helpful as you plan to hire a Position Description Data System Programmer, or divide roles and responsibilities among existing staff. Sample Surveillance Roles and A summary of roles and responsibilities of staff and stakeholders. Appendices Responsibilities Sample Surveillance Roles and A summary of roles and responsibilities of staff and stakeholders Responsibility Checklist (Haiti) in different tiers of the case-reporting system. Public Health Surveillance Provides an example of an assessment form used to determine Competency Audit staff’s strengthens and areas needing improvement.
Chapter 1 – Section 3 Title Description Data Dictionary Definition This is a description of what a data dictionary can contain, and describes the example provided in the Data Dictionary Template Guidance for Unique Identifiers This guidance emerged from a UNAIDS Planning and consultation meeting and may be helpful as you define your method to uniquely identify case of HIV Taking Routine Histories of This toolkit will help you design a system to collect routine Sexual Health ToolKit histories of sexual health with all adult patients, one important component of case-based surveillance data collection
165 Chapter 1 – Section 4 Title Description Hints for Developing IT Systems Peer-based guidance that may help you conceive of your data for Case Surveillance system development Items to Consider for a Functional This document describes items to consider to increase data Electronic Information System interoperability and electronic information system utility. HIV Case Reporting Application A summary document to describe the criteria to consider when Evaluation Criteria evaluating an electronic information system to support HIV case reporting Data Cleaning - Detecting, A journal article to help guide data cleaning and quality Diagnosing, and Editing Data improvement processes Abnormalities Sample Case Deduplication An example of the case matching process used in Haiti, guided by Algorithm (Haiti) an automated and manual deduplication algorithm Information Systems, Data Describes the planning process that the Minnesota Department of Interoperability, and the Health implemented to address the question of integrating data Requirements for Exchange from local health departments via electronic health records. (Minnesota) Contains a number of resources including data flow diagrams and checklists that are helpful.
Data Transmission Standards A description of what data transmission standards are, and the role they play in quality data transmission. Health Level Seven International (HL7) is provided as an example. Data Dictionary Definition This is a description of what a data dictionary can contain, and describes the example provided in the Data Dictionary Template Data Dictionary Template This data dictionary was developed using different available HIV case reporting forms as sources. The following data dictionary Appendices combines similar data elements found on all forms and adds additional relevant data elements not currently collected on available forms. This data dictionary should be viewed as a way to organize the various data elements relevant to HIV case reporting to increase data collection standardization, adaptability, and data interoperability. Data Dictionary Mind Map A graphic representation of a data dictionary and the required elements of a sample case report form
Chapter 1 – Section 5 Title Description Case Surveillance Evaluation Guidance document walks you through the suggested step to use to evaluate your case surveillance system Guidelines for Evaluating Public Guidelines for public health surveillance system evaluation Health Surveillance Systems Sample Monitoring Data Report A sample of a standard monitoring report that could be used in case-based surveillance system Guidelines for Developing Guidelines to assist in the compilation and interpretation of data, Epidemiologic Profiles and development of epidemiologic profiles
166 Producing a National HIV Report A training that can guide you in developing a basic national HIV data report Quality Management Technical A training focused on public health quality assessment and Assistance Manual improvement processes and activities Process Improvement Facilitator A training focused on public health quality assessment and Guide improvement processes and activities. Process Improvement Participant A training focused on public health quality assessment and Guide improvement processes and activities. Process Improvement PowerPoint A training focused on public health quality assessment and improvement processes and activities. Epidemiology for Data Users A training manual to guide you in the use of epidemiological data Training (Zambia) Guidelines for Effective Use of Guidelines to help you consider how you might analyze and use Data from HIV Surveillance your HIV surveillance data Systems HIV Case Surveillance A document to help guide planning of a case-based surveillance Informatics Business Process informatics system Modeling HIV Case Surveillance A summary of reference and guiding documents related to Informatics Resource Guide surveillance system informatics Effective Writing and Publishing A ten-part training document to guide the development of of Scientific Papers scientific publications
Chapter 2 – Section 1 Title Description Guidance for Unique Identifiers This guidance emerged from a UNAIDS Planning and consultation meeting and may be helpful as you define your Appendices method to uniquely identify case of HIV Leveraging Data to Monitor and A summary document that describes case-based surveillance in its Respond to the Epidemic simplest form that was used to justify case-based surveillance initiatives in some countries Uniting and Unifying Existing A poster that was presented summarizing Haiti’s system vision HIV Case Data (Haiti) and some of the outcomes to date
Chapter 2 – Section 2 Title Description Surveillance Technical Working This is a summary document that describes the goals, objectives, Group Summary and ideal structure of a case-based surveillance technical working group Key Stakeholder Mapping Tool Tool to help you identify key stakeholders to engage in surveillance system development and use Sample Technical Working This is a sample “Terms of Reference” (ToR) to help guide a case- Group Terms of Reference based surveillance technical working group
167
Chapter 2 – Section 3 Title Description Sample Case Surveillance SWOT An outline of a SWOT/Environmental Scan along with sample Outline goals, objectives, and questions Sample Data Flow Mapping A sample data flow mapping template that can be used to map Template existing or potential data flow
Chapter 2 – Section 4 Title Description Sample Case Reporting A sample of a case report form algorithm to guide data Algorithm submission (Guyana) Sample Adult Sentinel Event This template may be of use in your planning process Diagram Sample Pediatric Sentinel Event This template may be of use in your planning process Diagram Sample HIV Case Report Form A case report form used to report diagnosed cases of HIV (Guyana) Sample Adult HIV Case Report A case report form used to report diagnosed cases of HIV in
Form adults (Haiti) Sample Pediatric HIV Case A case report form used to report diagnosed cases of HIV in Report Form children (Haiti) Sample PMTCT Case Tracking A case report form used by case managers to track HIV-exposed and Report Form mother and baby pairs, and to report cases of HIV to the MoH (Haiti) Sample Adult TB Case Report A case report form used to report cases of TB to the MoH (Haiti)
Form Appendices Hints for Developing IT Systems Peer-based guidance that may help you conceive of your data for Case Surveillance system development Sample Case Surveillance Template can be used to help plan for your implementation Implementation Timeline Template Sample Surveillance Data Flow A sample data flow algorithm used by a country to help describe Diagram data follow to case-based surveillance system users (Haiti) Sample Data Flow Mapping A sample data flow mapping template that can be used to map Template existing or potential data flow Sample Case-based Surveillance An SOP that is used for the case-based surveillance system in SOP Haiti Sample HIV Case-based An SOP that is used for the case-based surveillance system in Surveillance System SOP Guyana Sample Case Deduplication An example of the case matching process used in Haiti, guided by Algorithm (Haiti) an automated and manual deduplication algorithm Epidemiological Data Report A sample of a standard report that is programmed into Haiti’s case-based surveillance data management system
168 Sample Monitoring Data Report A sample of a standard monitoring report that could be used in case-based surveillance system Data Transmission Standards A description of what data transmission standards are, and the role they play in quality data transmission. Health Level Seven International (HL7) is provided as an example Data Dictionary Definition This is a description of what a data dictionary can contain, and describes the example provided in the Data Dictionary Template Information Systems, Data Describes the planning process that the Minnesota Department of Interoperability, and the Health implemented to address the question of integrating data Requirements for Exchange from local health departments via electronic health records. (Minnesota) Contains a number of resources including data flow diagrams and checklists that are helpful. Sample Monitoring Framework A sample monitoring framework that includes system performance objectives and a logic model Sample Monitoring Plan A sample monitoring plan that describes how the surveillance system will be monitored in Haiti Sample Monitoring Tool A tool that is used to assess basic data quality and completeness at the facility level Sample Monitoring Tool A tool that is used to assess basic data quality and completeness at
the facility level Sample Database Monitoring This tool may be used to review the quality of key variables in Tool your case-based surveillance database, and help to plan for corrective action related to data collection, data entry, and/or data transfer Sample Case Reporting NRD A sample of a case-based surveillance system monitoring and Protocol for System Assessment quality improvement protocol that was submitted to CDC for Appendices and improvement "non-research determination" approval. Sample Case Reporting NRD A sample of a protocol that was submitted to CDC for "non- Protocol for Development research determination" approval to describe implementation of a new case-based surveillance system Planning for Case-based An introduction to the components of case-based surveillance Surveillance Case Reporting and Case A summary of considerations for designing or improving your Management Process case reporting process Developing a Case Report Form A summary of how to develop a case report form
Chapter 2 – Section 5 Title Description Public Health Surveillance Provides an example of an assessment form used to determine Competency Audit staff’s strengthens and areas needing improvement Sample Stakeholder Training A sample agenda used to help orient stakeholders to the case- Agenda based surveillance process
Sample Surveillance Staff A sample agenda used to train key staff and system users to the Training Agenda case-based surveillance process
169 Regional Case-based Surveillance A set of PowerPoint presentations used in regional workshops to Workshop Trainings orient countries to strong case-based surveillance systems. It includes 9 sessions:
1. HIV Case Surveillance 2. Overview and Review of Case Surveillance 3. Unique Case Identification 4. Ensuring Privacy and Confidentiality 5. Using Case Surveillance Data 6. Eliciting Quality Data 7. QM of Case Surveillance Systems + M&E Case Study (Haiti) 8. Evaluation of Case Surveillance Systems 9. Innovative Uses of Case Reporting Data Case Surveillance Evaluation Guidance document walks you through the suggested step evaluate a case surveillance system Guidelines for Evaluating Public Guidelines for public health surveillance system evaluation Health Surveillance Systems Process Improvement PowerPoint A training focused on quality assessment and improvement processes and activities Process Improvement Facilitator A training focused on quality assessment and improvement Guide processes and activities Quality Management Technical A training focused on public health quality assessment and Assistance Manual improvement processes and activities Process Improvement Participant A training focused on public health quality assessment and Guide improvement processes and activities Quality Management of Case Contains practical detail on Monitoring and Evaluation and other Surveillance Systems aspects of evaluating and maintaining high quality case Appendices surveillance systems Sample Case Report Completion Sample training/job aid used by one U.S. state to improve quality Job Aid (Indiana) data collection and reporting Sample Job Aid for Completion A sample job aid that was created to help improve quality data of the Case Report Form collection
170 Appendices by Source
Source Title Description CDC Clinical Cascade MMWR A sample of how case-based HIV surveillance data can be used for effective public health planning CDC Data Dictionary Definition This is a description of what a data dictionary can contain, and describes the example provided in the Data Dictionary Template CDC Data Dictionary Mind Map A graphic representation of a data dictionary and the required elements of a sample case report form
CDC Data Dictionary Template This data dictionary was developed using different available HIV case reporting forms as sources. The following data dictionary combines similar data elements found on all
forms and adds additional relevant data elements not currently collected on available forms. This data dictionary should be viewed as a way to organize the various data elements relevant to HIV case reporting to increase data collection standardization, adaptability, and data interoperability. CDC Data Security and Confidentiality Guidelines to assist in the planning and Appendices Guidelines monitoring of data collection and storage systems and policies CDC Data Transmission Standards A description of what data transmission standards are, and the role they play in quality data transmission. Health Level Seven International (HL7) is provided as an example. CDC Guidelines for Developing Guidelines to assist in the compilation and Epidemiologic Profiles interpretation of data, and development of epidemiologic profiles CDC Guidelines for Evaluating Public Guidelines for public health surveillance Health Surveillance Systems system evaluation CDC HIV Case Reporting Application A summary document to describe the criteria Evaluation Criteria to consider when evaluating an electronic information system to support HIV case reporting CDC HIV Case Surveillance Informatics A document to help guide planning of a case- Business Process Modeling based surveillance informatics system
171 CDC HIV Case Surveillance Informatics A summary of reference and guiding Resource Guide documents related to surveillance system informatics CDC Items to Consider for a Functional This document describes items to consider to Electronic Information System increase data interoperability and electronic information system utility. CDC/UCSF HIV Clinical Staging A training that describes the basics of case reporting CDC/UCSF Overview of the Epidemic A training that provides background information about HIV, the global epidemic, and methods for disease surveillance CDC/UCSF Producing a National HIV Report A training that can guide you in developing a basic national HIV data report CDC/UCSF Sample Employee Confidentiality This is extracted from a CDC/UCSF training Agreement module and is a good sample for an employee data confidentiality agreement. related to data security and confidentiality CDC/UCSF Tips for Confidentiality and Data Extracted from a training module; highlights Security key guidance that you might consider related to data security and confidentiality Hall and Case Surveillance Evaluation Guidance document walks you through the Mokotoff suggested step evaluate a case surveillance system HRSA Quality Management Technical A training focused on public health quality Assistance Manual assessment and improvement processes and Appendices activities ICF MACRO National Confidential and Security This tool may be used to identify where you Policy Assessment Tool might reinforce your security and confidentiality policy
Kotz et al. Effective Writing and Publishing A ten-part training document to guide the of Scientific Papers development of scientific publications
NASTAD Ensuring Privacy and An overview of how you can create structure Confidentiality and guide staff for data security and patient confidentiality NASTAD Hints for Developing IT Systems Peer-based guidance that may help you for Case Surveillance conceive of your data system development
NASTAD Introduction to Case-based An overview of what case-based surveillance Surveillance is, and how you might conceive of a system in your country
172 NASTAD Key Stakeholder Mapping Tool Tool to help you identify key stakeholders to engage in surveillance system development and use NASTAD Leveraging Data to Monitor and A summary document that describes case- Respond to the Epidemic based surveillance in its simplest form that was used to justify case-based surveillance initiatives in some countries NASTAD Public Health Surveillance Provides an example of an assessment form Competency Audit used to determine staff’s strengthens and areas needing improvement.
NASTAD Sample Adult Sentinel Event This template may be of use in your planning Diagram process NASTAD Sample Case Reporting Algorithm A sample of a case report form algorithm to guide data submission (Guyana) NASTAD Sample Case Reporting NRD A sample of a case-based surveillance system Protocol for System Assessment monitoring and quality improvement protocol and improvement that was submitted to CDC for "non-research determination" approval.
NASTAD Sample Case Surveillance Template can be used to help plan for your Implementation Timeline implementation Template NASTAD Sample Case Surveillance SWOT An outline of a SWOT/Environmental Scan Outline along with sample goals, objectives, and questions NASTAD Sample Data Flow Mapping A sample data flow mapping template that can Appendices Template be used to map existing or potential data flow
NASTAD Sample Data Manager Position A position description that may be helpful as Description you plan to hire a Data Manager, or divide roles and responsibilities among existing staff. NASTAD Sample Data System Programmer A position description that may be helpful as Position Description you plan to hire a Data System Programmer, or divide roles and responsibilities among existing staff. NASTAD Sample Database Monitoring Tool This tool may be used to review the quality of key variables in your case-based surveillance database, and help to plan for corrective action related to data collection, data entry, and/or data transfer NASTAD Sample Monitoring Data Report A sample of a standard monitoring report that could be used in case-based surveillance system
173 NASTAD Sample Monitoring Framework A sample monitoring framework that includes system performance objectives and a logic model NASTAD Sample Monitoring Plan A sample monitoring plan that describes how the surveillance system will be monitored in Haiti NASTAD Sample Monitoring Tool A tool that is used to assess basic data quality and completeness at the facility level NASTAD Sample Monitoring Tool A tool that is used to assess basic data quality and completeness at the facility level NASTAD Sample National Surveillance A position description that may be helpful as Coordinator Position Description you plan to hire a National Surveillance Coordinator, or divide roles and responsibilities among existing staff. NASTAD Sample Pediatric Sentinel Event This template may be of use in your planning Diagram process NASTAD Sample Stakeholder Training A sample agenda used to help orient Agenda stakeholders to the case-based surveillance process
NASTAD Sample Sub-national Surveillance A position description that may be helpful as Coordinator Position Description you plan to hire a Sub-national Surveillance Coordinator, or divide roles and responsibilities among existing staff. NASTAD Sample Surveillance Roles and A summary of roles and responsibilities of staff Responsibilities and stakeholders. Appendices NASTAD Sample Surveillance Staff Training A sample agenda used to train key staff and Agenda system users to the case-based surveillance process NASTAD Sample Technical Working Group This is a sample “Terms of Reference” (ToR) to Terms of Reference help guide a case-based surveillance technical working group
NASTAD Surveillance Technical Working This is a summary document that describes the Group Summary goals, objectives, and ideal structure of a case- based surveillance technical working group NASTAD et al. Epidemiology for Data Users A training manual to guide you in the use of Training (Zambia) epidemiological data NASTAD Field Epidemiological Data Report A sample of a standard report that is programmed into Haiti’s case-based surveillance data management system
NASTAD Field Sample Adult HIV Case Report A case report form used to report diagnosed Form cases of HIV in adults (Haiti)
174 NASTAD Field Sample Adult TB Case Report A case report form used to report cases of TB to Form the MoH (Haiti) NASTAD Field Sample Case Deduplication An example of the case matching process used Algorithm (Haiti) in Haiti, guided by an automated and manual deduplication algorithm NASTAD Field Sample Case Reporting Mandate A simple policy tool used in Haiti to mandate HIV case reporting, in the absence of a law NASTAD Field Sample Case Reporting NRD A sample of a protocol that was submitted to Protocol for Development CDC for "non-research determination" approval to describe implementation of a new case-based surveillance system NASTAD Field Sample Case-based Surveillance An SOP that is used for the case-based SOP surveillance system in Haiti NASTAD Field Sample Case-based Surveillance An SOP that is used for the case-based SOP surveillance system in Guyana NASTAD Field Sample HIV Case Report Form A case report form used to report diagnosed cases of HIV (Guyana) NASTAD Field Sample Job Aid for Completion of A sample job aid that was created to help the Case Report Form improve quality data collection NASTAD Field Sample Monitoring Data Report A sample of a standard monitoring report that could be used in case-based surveillance system NASTAD Field Sample Pediatric HIV Case Report A case report form used to report diagnosed Form cases of HIV in children (Haiti) NASTAD Field Sample PMTCT Case Tracking and A case report form used by case managers to Appendices Report Form track HIV-exposed mother and baby pairs, and to report cases of HIV to the MoH (Haiti) NASTAD Field Sample Surveillance Data Flow A sample data flow algorithm used by a Diagram country to help describe data follow to case- based surveillance system users (Haiti) NASTAD Field Sample Surveillance Roles and A summary of roles and responsibilities of staff Responsibility Checklist (Haiti) and stakeholders in different tiers of the case- reporting system. NASTAD Field Uniting and Unifying Existing HIV A poster that was presented summarizing Case Data (Haiti) Haiti’s system vision and some of the outcomes to date
NASTAD Case Reporting and Case A summary of considerations for designing or Training Management Process improving your case reporting process NASTAD Developing a Case Report Form A summary of how to develop a case report Training form
NASTAD Planning for Case-based An introduction to the components of case- Training Surveillance based surveillance
175 NASTAD Quality Management of Case Contains practical detail on Monitoring and Training Surveillance Systems Evaluation and other aspects of evaluating and maintaining high quality case surveillance systems NASTAD Regional Case-based Surveillance A set of PowerPoint presentations used in Training Workshop Trainings regional workshops to orient countries to strong case-based surveillance systems. It includes 9 sessions:
1. HIV Case Surveillance 2. Overview and Review of Case Surveillance 3. Unique Case Identification 4. Ensuring Privacy and Confidentiality 5. Using Case Surveillance Data 6. Eliciting Quality Data 7. QM of Case Surveillance Systems + M&E Case Study (Haiti) 8. Evaluation of Case Surveillance Systems 9. Innovative Uses of Case Reporting Data National LGBT Taking Routine Histories of Sexual This toolkit will help you design a system to
Health Education Health ToolKit collect routine histories of sexual health with Center all adult patients, one important component of case-based surveillance data collection SMDP Process Improvement Facilitator A training focused on quality assessment and Guide improvement processes and activities SMDP Process Improvement Participant A training focused on public health quality Guide assessment and improvement processes and activities Appendices SMDP Process Improvement PowerPoint A training focused on quality assessment and improvement processes and activities U. S. State Data Privacy, Security and This policy is guided by and relates to the Confidentiality Policy (Maine) disease reporting law and rules, and guides day-to-day practice of data management, data security and patient privacy, and data use U. S. State Disease Reporting Rules (Maine) These disease reporting rules describe the step- by-step reporting expectations that are mandated by the disease reporting law. Rules can typically be drafted or modified by the respective government division U. S. State Information Systems, Data Describes the planning process that the Interoperability, and the Minnesota Department of Health implemented Requirements for Exchange to address the question of integrating data (Minnesota) from local health departments via electronic health records. Contains a number of resources including data flow diagrams and checklists that are helpful.
176 U. S. State Mandatory Disease Reporting Law A disease reporting law from one U.S. state (Maine) that describes what diseases are reportable, to whom, and by what process. Laws can be complex to pass, and likely need to be guided by the legislature. U.S. State Sample Case Report Completion Sample training/job aid used by one U.S. state Job Aid (Indiana) to improve quality data collection and reporting UNAIDS Guidance for Unique Identifiers This guidance emerged from a UNAIDS Planning and consultation meeting and may be helpful as you define your method to uniquely identify case of HIV UNAIDS Guidelines for Effective Use of Guidelines to help you consider how you Data from HIV Surveillance might analyze and use your HIV surveillance Systems data UNAIDS Guidelines for Second Generation An update to guidance released in 2000 that HIV Surveillance helps countries to prioritize and plan surveillance initiatives, maximizing resources for greatest public health impact
UNAIDS Guidelines on Protecting Guidelines to help protect the confidentiality Confidentiality and Security of and security of HIV information HIV Data Van den Broeck Data Cleaning - Detecting, A journal article to help guide data cleaning Diagnosing, and Editing Data and quality improvement processes Abnormalities WHO/PAHO Regional Surveillance Policy Policy document that guides epidemiological Appendices surveillance in the Pan-American region WHO/PAHO Surveillance of HIV using Case Guidance to help countries improve their HIV Notification surveillance system based on intern
177 Appendices by Type
Type Title Description Guidance Case Surveillance Evaluation Guidance document walks you through the suggested step to use to evaluate your case surveillance system Guidance Data Cleaning - Detecting, A journal article to help guide data Diagnosing, and Editing Data cleaning and quality improvement Abnormalities processes Guidance Data Dictionary Mind Map A graphic representation of a data dictionary and the required elements of a sample case report form
Guidance Data Security and Confidentiality Guidelines to assist in the planning and Guidelines monitoring of data collection and storage systems and policies Guidance Data Transmission Standards A description of what data transmission standards are, and the role they play in quality data transmission. Health Level Seven International (HL7) is provided as an example. Guidance Guidance for Unique Identifiers This guidance emerged from a UNAIDS Planning and consultation meeting and may be helpful as you define your Appendices method to uniquely identify case of HIV Guidance Guidelines for Developing Guidelines to assist in the compilation Epidemiologic Profiles and interpretation of data, and development of epidemiologic profiles Guidance Guidelines for Effective Use of Data Guidelines to help you consider how you from HIV Surveillance Systems might analyze and use your HIV surveillance data Guidance Guidelines for Evaluating Public Guidelines for public health surveillance Health Surveillance Systems system evaluation
Guidance Guidelines for Second Generation An update to guidance released in 2000 HIV Surveillance that helps countries to prioritize and plan surveillance initiatives, maximizing resources for greatest public health impact Guidance Guidelines on Protecting Guidelines to help protect the Confidentiality and Security of HIV confidentiality and security of HIV Data information
178 Guidance Hints for Developing IT Systems for Peer-based guidance that may help you Case Surveillance conceive of your data system development Guidance HIV Case Reporting Application A summary document to describe the Evaluation Criteria criteria to consider when evaluating an electronic information system to support HIV case reporting Guidance HIV Case Surveillance Informatics A document to help guide planning of a Business Process Modeling case-based surveillance informatics system Guidance HIV Case Surveillance Informatics A summary of reference and guiding Resource Guide documents related to surveillance system informatics Guidance Information Systems, Data Describes the planning process that the Interoperability, and the Minnesota Department of Health Requirements for Exchange implemented to address the question of (Minnesota) integrating data from local health departments via electronic health records. Contains a number of resources including
data flow diagrams and checklists that are helpful. Guidance Information Systems, Data Describes the planning process that the Interoperability, and the Minnesota Department of Health Requirements for Exchange implemented to address the question of (Minnesota) integrating data from local health departments via electronic health records. Appendices Contains a number of resources including data flow diagrams and checklists that are helpful. Guidance Items to Consider for a Functional This document describes items to consider Electronic Information System to increase data interoperability and electronic information system utility. Guidance Quality Management of Case Contains practical detail on Monitoring Surveillance Systems and Evaluation and other aspects of evaluating and maintaining high quality case surveillance systems Guidance Quality Management Technical A training focused on public health Assistance Manual quality assessment and improvement processes and activities
Guidance Regional Surveillance Policy Policy document that guides epidemiological surveillance in the Pan- American region
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s Appendice Guidance Sample Case Deduplication An example of the case matching process Algorithm (Haiti) used in Haiti, guided by an automated and manual deduplication algorithm
Guidance Sample Case Deduplication An example of the case matching process Algorithm (Haiti) used in Haiti, guided by an automated and manual deduplication algorithm
Guidance Surveillance of HIV using Case Guidance to help countries improve their Notification HIV surveillance system based on intern
Guidance Taking Routine Histories of Sexual This toolkit will help you design a system Health ToolKit to collect routine histories of sexual health with all adult patients, one important component of case-based surveillance data collection
Guidance Tips for Confidentiality and Data Extracted from a training module; Security highlights key guidance that you might
consider related to data security and confidentiality
PowerPoint Case Reporting and Case A summary of considerations for Presentation Management Process designing or improving your case reporting process
PowerPoint Developing a Case Report Form A summary of how to develop a case Appendices Appendices Presentation report form
PowerPoint Ensuring Privacy and An overview of how you can create Presentation Confidentiality structure and guide staff for data security and patient confidentiality
PowerPoint Introduction to Case-based An overview of what case-based Presentation Surveillance surveillance is, and how you might conceive of a system in your country
PowerPoint Planning for Case-based Surveillance An introduction to the components of Presentation case-based surveillance
PowerPoint Process Improvement PowerPoint A training focused on quality assessment Presentation and improvement processes and activities
180 PowerPoint Regional Case-based Surveillance A set of PowerPoint presentations used in Presentations Workshop Trainings regional workshops to orient countries to strong case-based surveillance systems. It includes 9 sessions:
1. HIV Case Surveillance 2. Overview and Review of Case Surveillance 3. Unique Case Identification 4. Ensuring Privacy and Confidentiality 5. Using Case Surveillance Data 6. Eliciting Quality Data 7. QM of Case Surveillance Systems + M&E Case Study (Haiti) 8. Evaluation of Case Surveillance Systems 9. Innovative Uses of Case Reporting Data Sample Clinical Cascade MMWR A sample of how case-based HIV surveillance data can be used for effective
public health planning
Sample Data Dictionary Definition This is a description of what a data dictionary can contain, and describes the example provided in the Data Dictionary Template Sample Data Privacy, Security and This policy is guided by and relates to the
Confidentiality Policy (Maine) disease reporting law and rules, and Appendices guides day-to-day practice of data management, data security and patient privacy, and data use
Sample Disease Reporting Rules (Maine) These disease reporting rules describe the step-by-step reporting expectations that are mandated by the disease reporting law. Rules can typically be drafted or modified by the respective government division. Sample Epidemiological Data Report A sample of a standard report that is programmed into Haiti’s case-based surveillance data management system
Sample Leveraging Data to Monitor and A summary document that describes case- Respond to the Epidemic based surveillance in its simplest form that was used to justify case-based surveillance initiatives in some countries
181 Sample Mandatory Disease Reporting Law A disease reporting law from one U.S. (Maine) state that describes what diseases are reportable, to whom, and by what process. Laws can be complex to pass, and likely need to be guided by the legislature. Sample Sample Adult HIV Case Report A case report form used to report Form diagnosed cases of HIV in adults (Haiti) Sample Sample Adult TB Case Report Form A case report form used to report cases of TB to the MoH (Haiti) Sample Sample Case Report Completion Job Sample training/job aid used by one U.S. Aid (Indiana) state to improve quality data collection and reporting Sample Sample Case Reporting Mandate A simple policy tool used in Haiti to mandate HIV case reporting, in the absence of a law Sample Sample Case Reporting NRD A sample of a protocol that was submitted Protocol for Development to CDC for "non-research determination" approval to describe implementation of a new case-based surveillance system
Sample Sample Case Reporting NRD A sample of a case-based surveillance Protocol for System Assessment and system monitoring and quality improvement improvement protocol that was submitted to CDC for "non-research determination" approval. Sample Sample Case-based Surveillance SOP An SOP that is used for the case-based surveillance system in Haiti Appendices Sample Sample Case-based Surveillance SOP An SOP that is used for the case-based surveillance system in Guyana Sample Sample Data Flow Mapping A sample data flow mapping template Template that can be used to map existing or potential data flow Sample Sample Data Manager Position A position description that may be helpful Description as you plan to hire a Data Manager, or divide roles and responsibilities among existing staff. Sample Sample Data System Programmer A position description that may be helpful Position Description as you plan to hire a Data System Programmer, or divide roles and responsibilities among existing staff. Sample Sample Employee Confidentiality This is extracted from a CDC/UCSF Agreement training module and is a good sample for an employee data confidentiality agreement. related to data security and confidentiality
182 Sample Sample Monitoring Data Report A sample of a standard monitoring report that could be used in case-based surveillance system Sample Sample Monitoring Framework A sample monitoring framework that includes system performance objectives and a logic model Sample Sample Monitoring Plan A sample monitoring plan that describes how the surveillance system will be monitored in Haiti Sample Sample National Surveillance A position description that may be helpful Coordinator Position Description as you plan to hire a National Surveillance Coordinator, or divide roles and responsibilities among existing staff. Sample Sample Pediatric HIV Case Report A case report form used to report Form diagnosed cases of HIV in children (Haiti) Sample Sample PMTCT Case Tracking and A case report form used by case managers Report Form to track HIV-exposed mother and baby pairs, and to report cases of HIV to the MoH (Haiti)
Sample Sample Stakeholder Training A sample agenda used to help orient Agenda stakeholders to the case-based surveillance process
Sample Sample Sub-national Surveillance A position description that may be helpful Coordinator Position Description as you plan to hire a Sub-national Surveillance Coordinator, or divide roles and responsibilities among existing staff. Appendices Sample Sample Surveillance Data Flow A sample data flow algorithm used by a Diagram country to help describe data follow to case-based surveillance system users (Haiti) Sample Sample Surveillance Roles and A summary of roles and responsibilities of Responsibilities staff and stakeholders.
Sample Sample Surveillance Roles and A summary of roles and responsibilities of Responsibility Checklist (Haiti) staff and stakeholders in different tiers of the case-reporting system.
Sample Sample Surveillance Staff Training A sample agenda used to train key staff Agenda and system users to the case-based surveillance process
Sample Sample Technical Working Group This is a sample “Terms of Reference” Terms of Reference (ToR) to help guide a case-based surveillance technical working group
183 Sample Surveillance Technical Working This is a summary document that Group Summary describes the goals, objectives, and ideal structure of a case-based surveillance technical working group
Sample Uniting and Unifying Existing HIV A poster that was presented summarizing Case Data (Haiti) Haiti’s system vision and some of the outcomes to date
Template Data Dictionary Template This data dictionary was developed using different available HIV case reporting forms as sources. The following data dictionary combines similar data elements found on all forms and adds additional relevant data elements not currently collected on available forms. This data dictionary should be viewed as a way to organize the various data elements relevant to HIV case reporting to increase
data collection standardization, adaptability, and data interoperability.
Template Sample Adult Sentinel Event This template may be of use in your Diagram planning process
Template Sample Pediatric Sentinel Event This template may be of use in your Diagram planning process Appendices
Tool Key Stakeholder Mapping Tool Tool to help you identify key stakeholders to engage in surveillance system development and use Tool National Confidential and Security This tool may be used to identify where Policy Assessment Tool you might reinforce your security and confidentiality policy
Tool Public Health Surveillance Provides an example of an assessment Competency Audit form used to determine staff’s strengthens and areas needing improvement.
Tool Sample Case Reporting Algorithm A sample of a case report form algorithm to guide data submission (Guyana) Tool Sample Case Surveillance Template can be used to help plan for Implementation Timeline Template your implementation Tool Sample Case Surveillance SWOT An outline of a SWOT/Environmental Outline Scan along with sample goals, objectives, and questions
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Tool Sample Database Monitoring Tool This tool may be used to review the Appendices quality of key variables in your case- based surveillance database, and help to plan for corrective action related to data collection, data entry, and/or data transfer Tool Sample HIV Case Report Form A case report form used to report diagnosed cases of HIV (Guyana) Tool Sample Job Aid for Completion of A sample job aid that was created to help the Case Report Form improve quality data collection Tool Sample Monitoring Tool A tool that is used to assess basic data quality and completeness at the facility level
Tool Sample Monitoring Tool A tool that is used to assess basic data quality and completeness at the facility level Training Effective Writing and Publishing of A ten-part training document to guide the Scientific Papers development of scientific publications
Training Epidemiology for Data Users A training manual to guide you in the use Training (Zambia) of epidemiological data Training HIV Clinical Staging A training that describes the basics of case reporting Training Overview of the Epidemic A training that provides background information about HIV, the global
epidemic, and methods for disease Appendices surveillance Training Process Improvement Facilitator A training focused on quality assessment Guide and improvement processes and activities Training Process Improvement Participant A training focused on public health Guide quality assessment and improvement processes and activities Training Producing a National HIV Report A training that can guide you in developing a basic national HIV data report Training Quality Management Technical A training focused on public health Assistance Manual quality assessment and improvement processes and activities
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