[TIER T1 AND T2 ART MONITORING AND EVALUATION IMPLEMENTATION PLAN]

Transcription

1 April 2011 National Department of Health Version 4 [TIER T1 AND T2 ART MONITORING AND EVALUATION IMPLEMENTATION PLAN] The implementation of standardised ART monitoring systems and simplification of the ART data elements will provide facilities with the tools to support their programme and generate quality data with a goal to strengthen programme management, data generation and use.

2 TABLE OF CONTENTS Acknowledgements... 4 Acronyms and Definitions... 5 Introduction... 7 Establishing the Implementation Teams... 8 National Department of Health... 8 Provincial Implementation Team (PIT)... 8 District Implementation Team (DIT)... 8 Support for Implementation Contained within the Global Fund Grant... 9 District Implementation Planning...10 Facility Information Session and Information Gathering...10 Discussions with facilities should include:...11 Facility Assessment...11 Registry management...12 Facility staff...12 Sub-district and district staff...13 Tools used in the ART monitoring programme...14 Clinical Stationery...14 Criteria to Guide monitoring system Selection...15 Tier 1: Paper Register...16 Tier 2: Electronic Register...17 Phasing to the Electronic Register...18 Tier 3: Networked electronic system...18 Staff to Support the Monitoring Systems...19 Timeline for implementation...20 Data Generated...21 Overview...21 Monthly data...21 Quarterly data...21 Data Management Overview...23 Background...23 Reporting...23 Data Flow...24 Implementation process...26 Training Schedule...27 Support needs...28 Page 2 of 61

3 Annexure A: National ART M&E strategy...29 Annexure B: Frequently Asked Questions...36 Annexure C: Instructions to manage the paper Register (printed in register)...39 Annexure D: Paper Based ART Register (sample)...41 Annexure E: Patient summary (page 1)...42 Patient Summary (Page 2)...43 Patient Sumamry (Page 3)...44 Patient Sumamry (Page 4)...45 Annexure F: Visit Summary...46 Annexure G: ART Monthly reporting form...48 Generating the monthly report from the paper-based register...48 How to generate your monthly data:...49 When to report...50 Annexure H: Monthly Validation Form...51 Annexure I: Generating the Quarterly report from the Paper Register...52 Annexure J: Generating a report for the electronic register...55 Generating the monthly report:...55 Generating the ART quarterly report:...55 Annexure K: Quarterly ART Reporting Form...56 Annexure L: Quarterly ART Indicators Explained...57 Annexure M: National Department of Health data user agreement...58 Annexure N: Example of roll-out planning schedule...61 TABLE OF FIGURES Table 1: Criteria summary...15 Table 2: Staffing support...19 Table 3: Monthly data elements...21 Table 4: Quarterly data elements...22 Table 5: Current Data Flow...23 Table 6: Expected data flow...24 Table 7: Preliminary schedule...27 Table 8: Monthly reporting form...51 Table 9: Quarterly reporting form...56 Table 10: Quarterly indicators...57 Page 3 of 61

4 ACKNOWLEDGEMENTS This document provides guidance on the implementation of the Tier 1 and Tier 2 ART monitoring systems in South Africa and on managing the tools to be implemented throughout all the public health ART facilities. The 3-Tiered approach provides the tools to support the ART monitoring with the system that best suits the context and resources available to the ART service point. The three tiers complement one another and all generate the minimum data required to manage the ART programme and produce the monthly and quarterly data elements as approved by the NHC and NHIS/SA on 10 March The paper register is based on the WHO paper registers and aligned to the 2010 Clinical Guidelines for the Management of HIV and AIDS in Adults, Adolescents and Children. The Electronic Register was developed by the Centre for Infectious Disease and Epidemiology Research (CIDER) at the University of Cape Town to electronically capture the minimum data elements required to monitor the ART services. The tools and forms in this document are the result of collaborative work by a number of people throughout the country and through experiences of and feedback from CIDER, clinicians and managers from existing ART sites nationwide and from clinical staff from the National Department of Health. Their input and support is greatly appreciated. All forms and data elements included, while up to date at the point of inclusion in this document, are subject to change. Page 4 of 61

5 ACRONYMS AND DEFINITIONS AIDS Acquired Immunodeficiency Syndrome ART Antiretroviral therapy ART Naive Has not had prior antiretroviral therapy ARV Antiretroviral (drug) ASSA Actuarial Science Society of South Africa BMI Body mass index CCMT Comprehensive Care, Management and Treatment of HIV/AIDS in South Africa CD4 CD4 cell or T4 helper lymphocyte CDA CD4 above 200 CDC United States Centres for Disease Control and Prevention CDD CD4 done CG Conditional Grant Cohort A group of people who are followed up over time. Events are reviewed at specific time points to understand the impact of the intervention. CPT Cotrimoxazole preventive therapy CrCl Creatinine DHIS District Health Information System (South Africa's HMIS) DIT District Implementation Teams DOH Department of Health DORA Division of Revenue Act DQA Data Quality Assessment EMR Electronic Medical Record (the Tier 3 system) EPTB Extra pulmonary tuberculosis FBC Full blood count FLR First line regimen GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria HAART Highly Active Antiretroviral Therapy (triple therapy) HCT HIV Counselling and Testing HIV Human Immunodeficiency Virus HMIS Health Management Information System INH Isoniazid IPT Isoniazid preventive therapy LTF Lost to follow-up M&E Monitoring and Evaluation MDR-TB Multidrug resistant TB MHz Megahertz MTEF Medium Term Expenditure Framework N/A Not Applicable NDoH National Department of Health NGO Non-Governmental Organization NHA National Health Act NHC National Health Council NHIS/SA National Health Information System Committee (South Africa) NHLS National Health Laboratory Services NSP National Strategic Plan for HIV & AIDS and STI Page 5 of 61

6 OGAC OI P24 Patient Summary PEP PEPFAR PHC PIT PMTCT PTB RIP SAG SANAC SI SLR STI STO TB TFI TFO Three Tiered ART Monitoring Tier 1 (T1) Tier 2 (T2) Tier 3 (T3) TRIC UN UNAIDS UNGASS UNICEF USAID USG VCT Visit Summary VL VLD VLS WHO XDR Office of the Global AIDS Coordinator (United States) Opportunistic infection HIV antigen test A structured clinical record to manage the occasional information for HIV and ART management Post-exposure Prophylaxis President s Emergency Plan for AIDS Relief Primary health care Provincial Implementation Teams Prevention of Mother-to-Child Transmission Pulmonary tuberculosis Rest in Peace (died) South African Government South African National AIDS Council Strategic Information Second line regimen Sexually Transmitted Infection Stopped treatment Tuberculosis Transferred in Transferred out A set of standardised ART M&E systems: paper-based (Tier 1), nonnetworked (Tier 2) and networked system (Tier 3) The paper based register. The most basic of monitoring tools of the three Tiered approach to ART monitoring The electronic register. A non-networked tool to electronically manage the ART monitoring A networked electronic medical record to manage ART monitoring Total remaining in care (clients still remaining in care, RIP, LTF and TFO excluded) United Nations Joint United Nations Program on HIV and AIDS United Nations General Assembly Special Session on HIV/AIDS United Nations Children s Fund United States Agency for International Development United States Government Voluntary HIV Counselling and Testing Structured clinical record to manage routine HIV and ART clinical visit. It summarises each clinical visit into a column for longitudinal HIV and ART management. Each sheet allows for 6 visits to be captured. Viral load (HIV) Viral Loads done Viral Loads suppressed World Health Organisation Extensively drug resistant tuberculosis Page 6 of 61

7 INTRODUCTION South Africa has the largest ART programme globally with over 1.2 million people on ART. The Presidential mandate to expand access to treatment initiated in April 2010 has seen a rapid increase in numbers of clients on ART. Until recently standardised tools have not been available to manage the facility level ART data. In December 2010 South Africa s NDoH introduced the Tiered ART Monitoring Strategy comprising of a paper-based (Tier 1), non-networked (Tier 2) and networked system (Tier 3) for patient monitoring in line with the WHOs 3 Tiered ART M&E strategy. This approach provides the tools to standardise ART monitoring nationally with a system that best suits the varied needs of facilities, sub-districts, districts and provinces and the resources available to manage the systems. The goal of the 3 Tiered approach is to provide the tools that best suit the context of the facility to facilitate standardised reporting and supporting information management as well as patient management nation-wide. The purpose of this document is to guide Provinces in implementing Tier 1 and Tier 2 ART monitoring tools throughout their ART service points. Each of the three tools generate the same monthly and quarterly reports required for the long-term routine monitoring of patients on ART and these data meet the reporting requirements of the NDoH. This project aims to guide the implementation of Tier 1 and Tier 2 ART monitoring systems throughout the country Standardisation of ART monitoring will enable facilities, sub-districts, districts, provinces and the NDoH to track and respond to the expansion of ART services Success of the implementation will be assessed where complete, robust and verifiable data is available in the DHIS Implementation of the Tiered monitoring strategy requires support from a team of staff and buy-in of all individuals involved in ART monitoring. The NDoH recommends the establishment of Provincial Implementation Teams (PIT) and District Implementation Teams (DIT). The Provincial Implementation Team (PIT) will play the coordination role and manage procurement while the DIT will operationalise the implementation. The District Implementation Team will plan the implementation by first engaging with the district, sub-districts and ultimately, the facility. During implementation meetings, the DIT will provide information on the ART monitoring systems and what the implementation processes will entail. They will also conduct a Facility Review which will ascertain the needs of the ART service point to successfully implement the ART monitoring system i.e. computers, additional data capturers, registers, etc. The results of these meetings will better inform the implementation and procurement strategies run by the DIT and PIT respectfully. Page 7 of 61

8 ESTABLISHING THE IMPLEMENTATION TEAMS The successful implementation of the Tiered ART Monitoring Strategy relies on collaboration and support of Government and Development Partners. The following sections outline the establishment of the implementation teams, the recommended composition of each team and their roles and functions. NATIONAL DEPARTMENT OF HEALTH The Global Fund Grant provides for the NDoH to employ National coordinators and Provincial coordinators to support this strategy. Procurement of equipment using Global Fund funds will be managed at the NDoH upon requests from Provinces. The printing and circulation of the standardised clinical stationery and registers will be done by the NDoH. PROVINCIAL IMPLEMENTATION TEAM (PIT) The Provincial Implementation Team is responsible for the overall project management of the ART monitoring implementation processes. Teams need to be aware of the procurement needs of the districts and to coordinate these needs through feedback from the District Implementation Teams. These teams will need to familiarise themselves with the contents of their Conditional Grant and the contents of the Global Fund Grant to meet their procurement and staffing requirements. While the implementation is being planned the PIT should hold regular meetings (2 weekly initially and then monthly once roll-out has stabilised) with the project leader of the DIT to identify challenges, support needs and equipment procurement status. RECOMMENDED COMPOSITION OF THE PIT Provincial HAST staff (project leader) or Global Fund ART M&E project manager when appointed Provincial Information Management o NHIS/SA representative (if not one of the above) Lead development partners PEPFAR Provincial Liaison Officer (PPL) Development partner(s) supporting HIV/ART services Provincial IT staff DISTRICT IMPLEMENTATION TEAM (DIT) District Implementation Teams are the operational centres responsible for assessing the current situation and the requirements of the facilities. They will coordinate with the sub-district to identify the appropriate ART monitoring system: paper register or the electronic register. Each DIT must nominate an individual who takes the lead in coordinating and managing the roll out process. The decision to roll out T2 must be informed by a facility s capacity to manage the additional IT management responsibilities. Page 8 of 61

9 RECOMMENDED COMPOSITION OF THE DIT District Information Officer (possible project leader) District HAST Staff District partner(s) supporting the HIV/ART services IT officer (or equivalent) SUPPORT FOR IMPLEMENTATION CONTAINED WITHIN THE GLOBAL FUND GRANT South Africa has been awarded Global Fund (GF) money to support health system strengthening activities; an aspect of the grant is to support the implementation of the electronic register. Listed below is a summary of key support offered by the GF Grant. Following the establishment of the Provincial Implementation Teams and the District Implementation Teams and a thorough needs assessment/facility assessment, the PITs are responsible for identifying and quantifying its provincial needs and communicating them to the NDoH implementation team. The NDoH will review the needs and the requirements and manage the procurement accordingly. OUTLINE OF SUPPORT FOR PROVINCES CONTAINED WITHIN THE GF GRANT: Provincial coordinator 2 data capturers per province to assist with implementation Infrastructure roll out, procuring and installing electronic register system nationwide o Computers (450 computers to be procured and distributed over 5 years) o Network manager support (50% FTE) o Equipment for network manager and provincial coordinator Operational costs to support the infrastructure roll out Training of the trainers User training Page 9 of 61

10 DISTRICT IMPLEMENTATION PLANNING District Implementation Teams will be the operational team to evaluate the district/sub-district/facility needs for implementation. DIT PROCESSES TO FOLLOW TO IMPLEMENT TIER 1 OR TIER 2 Organise engagements with the sub-districts Identify ART service points within the sub-district. Review the existing HAST planning documents which outline existing ART sites and the planned expansion sites Organise engagements with facilities and provide information about paper register and electronic register and clinical stationery Plan strategy for implementation of Tier 1 and Tier 2 i. Prioritise sites that do not have any monitoring system Communicate procurement needs to PIT Identify facility staff, i.e. data clerk to manage the ART data (if not already present) Identify an appropriate individual within the District to conduct clinical governance training on the clinical stationery Create a roll-out plan based on the findings from facility visits and DIT planning sessions o See sample implementation schedule in annexure FACILITY INFORMATION SESSION AND INFORMATION GATHERING The Facility Meeting provides an opportunity to engage with facility staff, to inform them of the National process and to help them to understand how it applies to them. This meeting also enables the District Implementation Team to work with the ART service point to do the needs assessment and to identify what is required to roll out the ART monitoring tools. During the early implementation of the monitoring systems the Facility Implementation Meetings should consist of the following staff (this is not an exhaustive list): Facility staff: including data clerks, nurses, doctors, pharmacists, facility manager and counsellors Sub-district staff: stakeholders including information management, partner staff, sub-district information officers, HAST coordinators, sub-district manager District staff: stakeholders including information management, programme staff and partner staff Page 10 of 61

11 DISCUSSIONS WITH FACILITIES SHOULD INCLUDE: Availability of facility level staff to support the ART monitoring system The data generated from the system and how it can assist facility management What kind of clinical stationery is currently in use Folder management: Is the current folder management and storage system working? How are folders organised (by folder number)? Facility mapping process: identify the appropriate folder flow to ensure the data capturer will receive the folder before it is filed. The flow should not require a client to stay at the facility and to await his folder before the folder can be captured i.e. the client has to personally oversee folder delivery and capture. Who is the main contact at sub-district/district to send the data to or to report on issues to? Which system (paper or electronic register) is best for the facility? What does the facility need to do to get started? FACILITY ASSESSMENT Before implementing the monitoring system, the following should be considered: Has the data capturer been trained on the ART monitoring system (Tier 1 or Tier 2) Has the clinical stationery been implemented and is it being used correctly? o If not: the facility has until March 2012 to implement the ART clinical stationery. Review current registry organisation: are the folders easily retrievable? o If not: using the Patient / folder flow: are the folders reaching the data capturer before they are filed? Is the patient s baseline data easily retrievable for the data capturer? Is the treatment start date easily retrievable? Are the blood results available in the patient folder for clinical management? Is the clinician writing this information in the visit summary and on the front of the patient summary to assist the data capturer? Identification of the appropriate monitoring system (paper or electronic register) will be done based on the clinic size (patient numbers) and the available infrastructure. If the electronic register is determined to be the appropriate M&E system, the following need to be considered: Procurement of computer Procurement of memory stick to back up register and transfer data to sub-district Working printer (if printer not already available in facility) Available space for a computer Power supply: power plug or extension cord Security for a computer Ability to replace a computer if it is broken or stolen Page 11 of 61

12 REGISTRY MANAGEMENT The clinical records are being printed by the NDoH and will be circulated centrally via the NDoH. Clinical records will need to be introduced to the clinical staff and they will have to understand their role in supporting the patient monitoring. The clinical staff are required to capture the relevant clinical information in the patient summary and visit summary. The data capturing staff will capture the information into the appropriate monitoring system from this record. The registry staff must to ensure the standardised clinical records are available in each patient folder. The registry staff will capture the basic demographic information in the front section of the clinical stationery. The folder management is important in supporting effective patient management and supporting monitoring the ART programme: Orderly registry and retrievable patient folders o o o Folders must have a unique number to differentiate one patient folder from another patient folder. This number is captured in either the paper register or the electronic register to uniquely identify the patient within the monitoring tool. Where there is no standardised folder number generation use the NHLS prefix and patients birth date (yyyy/mm/dd) and first three letters of the last name to organise the patient folder in the registry. Folders would be organised by year of birth, then month, then day. Where there are patients with exactly the same birth date the folder would then be organised alphabetically by the first three letters of the last name This is to be implemented where there is no file management system Use a coloured tape over the spine of the folder where all patient folders are filed in an integrated registry. This will subtly identify the ART folders from the general services folder and assist in pulling patient folders. Folder flow ensures the patient folder is managed by the data capturer before it is filed. (DIT to work with facility to map the facility and develop a flow chart that can be posted in the clinic to communicate this to all facility staff). The clinical folder must stay on site. There are some sites where clients retain their clinical information. This will be a change management process that has to be managed both from the client perspective and the facility. Retaining the information on site through an orderly and safe system is important for the chronic management of ART and will ultimately better serve patient needs. FACILITY STAFF Are there adequate data capturing staff to manage the ART data? Staff to manage patient data: Facilities with: o patients: 1 data capturer is required to assist with folder management and data capturing o patients: 1 data capturer is required plus management and filing of bloods additional staff to assist with folder o > 1500 or 2000 patients: 2 data clerks will be required and assistance with folder management and filing of bloods o > 2000 clients will need 3 or more data capturers Page 12 of 61

13 Has there been a delegation of responsibility from the facility manager to existing data staff or are additional staff required to support the data capturing? Does the facility manager understand the process that is underway, the importance of folder flow, clinical stationery and its management, and the data that is generated from the monitoring tool? SUB-DISTRICT AND DISTRICT STAFF It is important that the sub-district information staff understand each monitoring system that is implemented in their sub-district and how to support it. Their ability to support each system within their sub-district (it could be that one sub-district will have three systems T1, T2 and T3) is key to ensuring the success and future sustainability of the ART system implementation. During the introduction of the new system, there must be staff available from the sub-district office to provide daily onsite visits, later phasing to weekly visits, to support implementation of the monitoring system and to support the facility organisation that might be required. Once the processes and systems are understood the DIT team leader should be and available ad-hoc to provide assistance when challenges arise or additional assistance is required. The sub-district and district staff responsible for supporting the Tier 2 ART M&E must have an understanding of the monitoring systems and be able to problem solve basic computer challenges. They should be available to support data requirements, engage with the data and identify problems i.e. lack of training or technical expertise among facility staff, and be able to resolve or refer the problems. Sub-districts need to have easy access to the aggregated data as it is generated by the monitoring tools, understand its use and generate feedback. Are there adequate sub-district staff to manage the ART data in addition to other routine data being submitted to sub-district information office? Questions to consider: Will they have the time to receive and validate the monthly reports and enter into the DHIS? Will they have time to receive the quarterly reports? Will they have time to validate and manually enter the paper based data on a quarterly basis? Will they have time to receive and import the electronic register data and export it to the DHIS on a quarterly basis? Page 13 of 61

14 TOOLS USED IN THE ART MONITORING PROGRAMME CLINICAL STATIONERY Standardised clinical records are the most basic of clinical tools and they are the international standard of care in chronic disease management. Standardised records support the clinical management of clients and provide the source data to data capturers for the routine monitoring of patient enrolment and clinical outcomes. These records are aligned to the 2010 South African national treatment guidelines. Clinical records provide the summary of care and the chronological account of treatment. This assists with continuity of care and communication between all levels of clinical staff and data capturing staff. They also structure important care information in the case of allergies or adverse events. Additionally, a data clerk can easily and efficiently view and capture the important monitoring information. The following comprise the minimum set of standard stationery: Patient summary - Serves as outer folder and summarises work up and occasional clinical information. Visit summary A3 form summarises 6 clinical visits per form. Patient card Lab results forms No other stationery should be used. A sample of the NDoH clinical records are in the annexure E and F. Page 14 of 61

15 CRITERIA TO GUIDE MONITORING SYSTEM SELECTION The following criteria should be considered when selecting the appropriate monitoring system and should inform the district implementation strategy: Registry management Infrastructure Clinical stationery Security Space Networks Staffing All systems require facility acceptance as well as sub-district and district engagement and support to manage the system and the data generated. TABLE 1: CRITERIA SUMMARY Tier 1 Paper Register patients Standardised clinical records implemented Folders managed on site and folders are easily retrievable Staff to manage patient data (1 data capturer for up to 500 patients) Workspace to manage the patient register (a desk) Sub-district staff to support tool,; provide facility-based data validation Tier 2 Electronic Register patients Criteria of T1 met (i.e. folders managed on site, standardised clinical records implemented and used, staff available to manage the system) Available hardware: Computer with >700 MHz processor speed (this is a basic computer), access to printer to print reports Reliable electricity and a power point near the workstation. Mechanism to secure the computer System for transmitting data and data back-up (CD, memory stick or if available network) Facility has the capacity to support the computer system. Sub-district capacity to support computer system Tier 3 Electronic Medical Record patients Conditions for Tier 1 and Tier 2 must be met Existing data must already be digitised (by electronic register) Space and staff to accommodate the T3 system and multiple computers (likely 3 or more data capturers will be required) Sub-district capacity to support electronic systems and network administration Ability to swap out machines in the case of a computer breaking or being stolen (e.g. Availability of a back up computer) The electronic medical record should only be considered where robust network infrastructure is available, there is staff available to manage the network and the data, and the IT and information management structures can support it. The implementation of the Tier 3 strategy is not part of this implementation plan. Page 15 of 61

16 TIER 1: PAPER REGISTER Recommended in sites with fewer than 500 patients. The paper register is a simplified monitoring system that records basic demographic and treatment information as a minimum requirement for patient management and reporting. This is the first step to understanding the patient population within facilities with 0 to 500 ART patients. It can be quickly implemented as soon as an ART service point is started or it can be implemented where currently no system exists. It does not require any infrastructure and is ideally suited for sites with unreliable or no electricity. The data elements collected in both the paper and the electronic system are the data elements required for National CCMT and DORA reporting. Work space is a consideration for any implemented monitoring system. The data capturer managing the paper register requires both the time and the physical space to manage the patient registers and to generate reports. The following must be met to successfully implement the paper register: Standardised clinical stationery has been implemented Folder Flow ensures the data capturer is the last to receive the patient folder before filing There is space for the data capturer to work A Staff member (data capturer) is available to transcribe the patient information from the standardised clinical record into the patient register A separate register is implemented for: o Adult patients o Paediatric patients o Transfer-in and prior-art patients The paper registers will be implemented in new sites where computers are not available. Tier 1 does not require any infrastructure apart from a desk for the data capturer to work from. The clinic s registry must be able to store the patient folders onsite. The paper register is also a tool to assist transition to Tier 2 when a site is determined to have met the requirements. Both Tiers 1 and 2 collect the same information, in the same format, with the Tier 2 system assisting rapid report generation, rather than manual report generation. PAPER REGISTER: TRANSFER IN REGISTER This register will be reserved for clients who transfer into the facility and clients who are already on ART (these are your historical clients). The register was introduced in May 2010 but the paper register has not been consistently implemented. DITs will support facilities to manage their historical clients on ART as well as their transfer in clients. It is important to record on the front of the patient folder the treatment start date and, if the client is a transfer in, the month they transferred in. Transfer in clients will be recorded in the transfer in register under the month that they transferred in. The treatment start date should also be filled-in in this section. This means that the date started under the baseline section will include the patient s treatment start date and the month they are being written in the register. Historical data will not be captured but prospective data will be captured to provide the total patients remaining in care data. On the front of the patient folder the ART start date and the month the patient Page 16 of 61

17 transferred in is written in the register will be recorded. This will help data capturers to find the patient in the register. Clients started on ART from the point the register is implemented in your facility will be recorded in the new patient register and their prospective data will be captured. This will provide the cohort data for the current patients while being cognizant that the backlog of patient data and their historical data will not be captured in the paper register. TIER 2: ELECTRONIC REGISTER Priority implementation in sites with > patients. The electronic HIV register is a simple non-networked electronic monitoring software that works on a standalone computer and that does not require a network. It is a tool to manage patients initiated and patients in care more efficiently. It helps to monitor a larger patient population and to quickly generate reports. Before implementing the electronic register the conditions for Tier 1 must be met, specifically the implementation of the clinical stationery, file management and the folder flow to the data capturer. Where a site has the infrastructure to implement Tier 2 the paper based register does not need to be implemented before the electronic register is implemented. Sites with > 500 patients will be prioritised to receive equipment during the roll-out phase. Planned or existing sites with the infrastructure and resources to manage an electronic register should implement the electronic register immediately. If it is determined that a facility meets the requirements to implement the electronic register, the following need to be considered: Is a computer available or must a computer be procured? 700 MHz processor or better At least 80 mb hard disk space Microsoft Windows operating system 98 or higher Adobe reader CD ROM drive 1 A memory stick will need to be procured to back up the electronic register and also to transmit data to the sub-district (or a writable CD). Is a printer available on site to print reports or must one be procured? Has space been identified for the data clerk to work? Is a desk available for the computer? Is a power source available near this space or does it require an extension lead? Is the electricity supply reliable? Will the space for the computer be secure? If the computer breaks or is stolen is there capacity to swap out the machine? 1 TIER.NET user guide gives further computer requirement specifications Page 17 of 61

18 District implementation teams must consider the IT management of the computers, who the staff will be to support the desktop management and what the process will be to quickly replace broken or stolen computer. Consideration must also be given to computer maintenance and virus management. The District Information officer should have a 3G dongle to update antivirus software during routine visits in sites where there is no network connectivity. The Tier 2 approach introduces additional responsibility to the provincial IT infrastructure and IT departments as there are security needs (from viruses and also from theft), power supply issues; back-up procedures; maintenance; replacement and work space as well as additional computers to manage and maintain. PHASING TO THE ELECTRONIC REGISTER Once facilities have been assessed for roll out DITs should also work with sites with an existing non-standard electronic database to transfer data to the electronic register and implement the electronic register. Sites will have to the end of March 2012 to transition their database to the electronic register. CAPTURING EXISTING PATIENTS The electronic register is able to manage historical patients more efficiently. The baseline treatment data must be captured completely. The system has the option to import existing electronic data via the data exchange standards to capture data in back capture mode and to capture data in prospective mode. IMPORTING EXISTING ELECTRONIC DATA The electronic register is able to import data from databases providing they align their data to the standard structures of the data exchange standards as outlined in the HICDEP: HIV Cohorts Data Exchange Protocol. A copy of this is available at or contact Magoro (tieredartmande@gmail.com) for assistance. BACK CAPTURE MODE The electronic register allows for the rapid capture of historical client data. If the longitudinal information of clients is available (either from a previous patient register or from the clinical notes) this should be captured. This data will provide historical outcome information for the ART programme. Where historical patient information is not available DNA (did not attend) will be captured in the treatment history section. Data will be recorded upon its availability. PROSPECTIVE MODE This is real time capture of clients. Each time a client receives ART care the client is captured into the electronic register. This is not an efficient means to capture historical data but once all the historical data is captured the register would be transferred to prospective mode for the future (prospective) management of patient data. TIER 3: NETWORKED ELECTRONIC SYSTEM The Tier 3 monitoring system is an electronic medical record. The Tier 3 system relies on the basic systems implemented for Tier 1 and Tier 2 to be met. It is a networked tool and relies on the infrastructure to be Page 18 of 61

19 available including a robust network, a central server to securely store and back up the data and an IT support team to monitor the system. The ART Tier 3 system is part of the country s electronic health record (EHR) strategy. The ART Tier 3 implementation can set the foundation (training, registry management, network, infrastructure etc) to a larger EHR system. Guidance to implement the Tier 3 system is not part of this document. If facilities in your province meet the requirements for the Tier 3 system please contact the NDoH for further guidance. STAFF TO SUPPORT THE MONITORING SYSTEMS TABLE 2: STAFFING SUPPORT Patients in care Tier < 500 pts 1 data clerk 1 data clerk 1 data clerk > 500 < data clerks (Recommend transition to Tier 2 system) 1 data clerk Include assistance from registry staff with filing bloods and folders management. Clinical records should be completed and data easily retrievable (possibility 2 might be needed if registry support not sufficient) 2 data clerks as additional data will be collected > data clerk Ideally this facility has already transitioned to T2 or T3. 2 data clerks (computers linked via crossover cable discussed in training) 3+ data clerks Page 19 of 61

20 TIMELINE FOR IMPLEMENTATION March 31, 2011: April 1 14: April 18 May 6: NDoH, Provinces and Partners meet to discuss the ART M&E Implementation Strategy Provinces receive Implementation Planning document. Review the document and establish PIT. Provinces convene PIT and commence planning. Colleagues from NDoH and Catherine White available. May 9, 2011 May 9 May 31: June 1, 2011 June 2 17, 2011: NDoH train the trainer sessions to commence District implementation teams to be established. Districts to commence facility assessments Use schedule in annex to identify facility resources and requirements to inform implementation DITs to compile facility assessments and establish district implementation plans. These are to be forwarded to PITs PITs to collate district implementation plans and identify staffing, infrastructure and additional needs required. Review contents of CG and GF and assess what is required from GF. June 20 24, 2011 End June 2011 Milestones: End September 2011 Milestones End December 2011 Milestones End March 2012 Milestones PITs to communicate GF procurement requirements to NDoH. DHIS should serve as the single repository to report monthly ART data Each district identify sites that will be easy to implement the Tier 1 or Tier 2 monitoring system Each district identify sites in which it will be challenging to implement the monitoring system (identify what would assist to resolve these challenges) (will be informed by PIT and DIT plans) (will be informed by PIT and DIT plans) All sites with non-standard electronic registers transitioned to electronic register All PHC ART service points have adopted clinical stationery Training of the trainers and district training to commence after all PITs have been met with (after May 6). Provinces and districts to request training dates to NDoH ART M&E [tieredartmande@gmail.com]. Page 20 of 61

21 DATA GENERATED The data generated through the ART registers, both paper and electronic, will be captured into the DHIS routine data file. All other existing data elements collected for ART will be removed, and provinces will need to motivate for keeping additional elements. OVERVIEW The 3-tiered monitoring programme is in line with the WHO approach for monitoring, it provides facilities and subdistricts with the tools to monitor their ART services with the system that best suits their context. All ART monitoring tools generate the same aggregate data elements providing which then provides a single aggregate data set at the subdistrict for ART programme management. The data generated provides two data sets: Monthly Data and Quarterly Data. Combined, this data meet NDoH reporting requirements including DORA and CCMT reporting as required by Treasury. The two data sets provide different information. The Monthly Data is programme management data. Six data elements are reported consisting of enrolment and retention in care data broken down by adults and children. The Quarterly Data consists of 27 data elements which are clinical care data and which report the baseline data and patient outcomes over time and immunologic responses to treatment. Training will be provided on how to use the information for both programme management and reporting. MONTHLY DATA The paper-based register and the electronic register capture the minimum data elements for monitoring the ART programme. New patients started and total patients remaining in care comprise the six data elements and assist with managing the programme and understanding programme enrolment and expansion. The reporting form is provided in the annexure G. TABLE 3: MONTHLY DATA ELEMENTS New adults started New children started (<15 years) Total new patients started Calculated by DHIS Total adults in care Total children in care Total patients remaining in care (TRIC) Calculated by DHIS QUARTERLY DATA Quarterly data describes the clinical outcomes of clients on ART and programme quality indicators at different time points. With this data, clinical outcomes can be compared between sites, sub-districts, districts and, with the standardisation of monitoring tools, between provinces. Page 21 of 61

22 This data is aggregated quarterly (not monthly) and, like the TB programme, is reported one quarter in arrears. The three month delay enables sites to confirm the outcomes reported and to ensure the capturing of blood results into the register is included in the reporting. Quarterly data is reported three months after the end of the quarter as outlined below: January (reports data captured in July, August, September) April (reports data captured in October, November, December) July (reports data captured in January, February, March) October (reports data captured in April, May, June) TABLE 4: QUARTERLY DATA ELEMENTS AT BASELINE THE BELOW DATA ELEMENTS CAN BE GENERATED: Number of ART-naïve patients commenced (TOT) o Adults and children reported separately o Proportion of adult TOT that are male and female Number of ART-naïve children commenced (TOT) o Number of ART-naïve children <1 o Number of ART-naïve children 1 to <5m o Number of ART-naïve children 5 to <15 Number screened for TB Number on TB treatment at ART Start Number on IPT at start of ART Number on CPT at start of ART Number pregnant at start of ART Total number of CD4 counts taken at baseline (CDD) o Number with CD4 below 100 (adults) or 15% TLC (paeds) o Number with CD4 100 to 199 (adults) or 20% TLC (paeds) o Number with CD4 199 to 350 (adults) or 25% TLC (paeds) Number of treatment experienced (Exp) DURATIONS IN CARE: 3, 6, 12, 24, 36...AD INFINITUM (DURATIONS DIVISIBLE BY 12) The clinical outcomes of naïve clients are then evaluated over time: o In care (defined by on first line or second line regimen) o Stopped treatment (STO) o Clients who have died between certain time points (RIP) o Become lost to follow-up between durations (LTF) o Or transferred out between different durations (TFO) Additionally o The immunologic response is evaluated by calculating the number of CD4 counts done (CDD) and The proportion above 200 cells/µl or 20% TLC (CDA) o The viralogic suppression is evaluated by calculating the viral loads done (VLD) and the proportion viral loads < 400 copies/ml (VLS) Transferred in between x and x months (TFI) Page 22 of 61

23 DATA MANAGEMENT OVERVIEW BACKGROUND The Monitoring and Evaluation unit (M&E unit) at the NDoH is responsible for reporting programme and performance data of all health programmes, including from the ART programme. The District Health Information System (DHIS) is the primary repository for reporting routine health services data. The current data flow policy for the DHIS states the turnaround time for reporting from sub-district to NDoH is 60 days. The CCMT programme is a priority intervention and data is therefore required at the NDoH before this timeline. Standardised reporting tools were developed for facilities to report their data but data collection tools such as a register or standardized clinical records were not available to manage data at facility level. This led to the organic growth of various ART data management systems throughout the country. As a result, parallel mechanisms for reporting have evolved resulting in a lack of standardized reporting and data quality problems. REPORTING The ART programme is a priority intervention and data is required at the NDoH by the 28 th of each month. This is not aligned to the current reporting timelines or capacity of the DHIS, where data is often three months delayed and incomplete. Data is currently generated at facility level off non-standard data collection and data aggregation tools. In response to CCMT needs for data the M&E unit developed an Excel tool to collate data separate from the DHIS; provinces adapted this tool to expand the data elements for their own needs. Data generated is cross sectional and unable to generate longitudinal (cohort) type data, which are essential to effectively manage the programme. TABLE 5: CURRENT DATA FLOW System and Data Flow DHIS Facility Sub-District District Province National Spreadsheets Facility Province National # Data elements required Variable (~ 66 monthly) Variable (~24 monthly) Responsibility Information Management Reporting schedule 60 (though often received > 60 days) Programme 15 (though often received > 30 days) In December 2010 the NDoH introduced the Tiered ART Monitoring Strategy consisting of a paper-based (Tier 1), non-networked (Tier 2) and networked system (Tier 3) for patient monitoring in line with the World Health Organization s (WHO) 3-tiered ART M&E strategy. This approach provides the tools to standardise ART monitoring nationally based on the resources available to manage the systems. The of goal the 3-tiered approach is to provide the tools that best suit the context of the facility and enable standardized reporting while supporting information management and patient management nationwide. Page 23 of 61

24 TABLE 6: EXPECTED DATA FLOW System and Data Flow DHIS Facility Sub-District District Province National # Data elements required 6 data elements to be reported monthly Responsibility Information Management with data validation support from the programme Reporting schedule 6 data elements to be reported monthly: Data required at NDoH by 28 th of each month Phasing Monthly: Reporting to DHIS to commence immediately with complete implementation by end June data elements to be reported quarterly 27 Quarterly data elements: 28 th after the end of every quarter (in line with TB reporting) Quarterly: The first paper register cohort reports due March Spreadsheets Facility Province National Electronic register cohort reports due once the data clean up has been signed off by the DIT. Data will be extracted from the electronic register and imported into the DHIS at the sub-district. Nil Nil Nil This mechanism of reporting is no longer required and should be phased out by end June 2011 DATA FLOW On 10 March 2011 the National Health Council (NHC) and the National Health Systems of South Africa (NHIS/SA) approved a revision to the frequency of reporting the ART data elements to be aligned with the reporting abilities of the ART paper register and electronic register. MONTHLY DATA The DHIS has the facility to receive the required 4 monthly data elements and output the 6 data elements. The monthly report, generated by either the paper register or the electronic register, is to be generated at facility and reviewed by the facility manager by the 5 th of each month. The report is then submitted to the sub-district information office by the 7 th of each month. Page 24 of 61

25 The sub-district information office then collates and enters the facility-level aggregate data into the DHIS by the 14 th of each month. The sub-district will forward the data to the district information office by the 21 st of each month. The district information office will collate the sub-district ART file and forward an extract of the combined district ART data to the PDoH and NDoH by the 28 th of each month. The PDoH to submit their full DHIS data file to the NDoH as per the DHIS data policy document. ART QUARTERLY REPORTS The reporting of the ART quarterly reports will be postponed while the facilities implement the paper register or the electronic register. Where sites have fully implemented either the paper register or the electronic register the ART quarterly data is reported three months after the end of the quarter as outlined below: ART QUARTERLY REPORTING SCHEDULE January 5 th (reports data captured in July, August, September) April 5 th (reports data captured in October, November, December) July 5 th (reports data captured in January, February, March) October 5 th (reports data captured in April, May, June) The first ART quarterly report from paper sites will be required at the sub-district information office by the March PAPER REGISTER DATA FLOW: Reports are generated at facility and signed off by the facility manger as per the quarterly reporting schedule above Reports are to flow to the sub-district information office by the 7 th of the same month The sub-district information officer will receive the cohort reports and capture the paper reports into the DHIS Data will flow to the district, province and NDoH as per the DHIS data policy data flow Following full implementation sites using the electronic register will generate the interpreted cohort report for review and sign off by the facility manager as per the quarterly reporting schedule above. ELECTRONIC REGISTER DATA FLOW: Facility generates a dispatch of data and saves it onto a memory stick Data will be transmitted to the sub-district information officer by the 7 th of the month in line with the quarterly reporting schedule above Sub-district information officer will collate all electronic sub-district data into the sub-district electronic register The sub-district information officer will export all sub-district data into the DHIS Data will flow to the district, province and NDoH as per the data flow policy Page 25 of 61

26 IMPLEMENTATION PROCESS The transition to the Tier 1 or Tier 2 monitoring system will take time. The data contained within the spreadsheets is no longer required for reporting to the NDoH. Reporting using these tools should be phased out by end June 2011 and the DHIS should serve as the single repository for all ART data. The sub-district information office and the DIT will actively monitor the implementation of the paper or electronic register at each facility. When the DIT, with input from the sub-district, deems the implementation complete with either the paper register or the electronic register the DIT will then request validated monthly reports from the facility. At this point quarterly reports can also be submitted. MONTHLY DATA While facilities transition to the paper or electronic register the PDoH and NDoH require only the new patients started, disaggregated by adults and children, to be reported. The reporting of total remaining in care (TRIC) requires all clients in care to be entered into the monitoring tool (TFI/Prior ART register and a separate new patients started register). As such, the provincial information office and consequently the NDoH will only require TRIC once the facility has completed their implementation process. Three months following implementation DIT will expect all data to have been captured and validated. Historical corrections of the enrolment and TRIC, disaggregated by adults and children, must be submitted to the sub-district information office using the monthly validation form (form and guidance document in Annexure G) and the historical corrections will be captured into the DHIS. Those facilities able to report complete and valid data before the 3 month deadline should report immediately. This will be overseen by the DIT. ART QUARTERLY REPORTS Facilities with paper registers will be expected to report their first quarterly report in March This delay enables them to establish their cohort of patients and learn to generate the quarterly report. ART quarterly reports will be required from electronic register sites once all historic patients have been captured and the clean up document has been signed off by a member of the DIT. At this point the quarterly report export will be done from the facility to the sub-district as per the electronic register data flow. The DHIS will then follow the routine data flow from sub-district to district, district to province and province to NDoH as per the DHIS data policy document. Page 26 of 61

27 TRAINING SCHEDULE Provincial engagements to commence April 25 May 13, 2011 These meetings will assist provinces in formulating their district implementation plans, identifying what the needs of the different districts/sub-districts and facilities are, planning procurement strategies (equipment and staff), and planning the implementation in the districts. TABLE 7: PRELIMINARY SCHEDULE Provincial engagements and provisional training schedule April 25 May 13 PITs to convene meeting. NDoH to attend first engagement May 16 + Train the trainers June 8 + District implementation trainings Dates will be booked by the provincial implementation teams based on their out plans and the district implementation team requests. District implementation trainings will conclude in early June. This will provide the provinces time to establish their DITs and identify priority training requirements. District Implementation trainings will include 2 days of didactic learning and a third day to visit a site to make the implementation planning and site assessment a practical exercise. Trainings must assist the implementation of the standardised clinical stationery. Once primary health care facilities receive the clinical stationery, it must be implemented as soon as possible, no later than March All ART service points with existing non-standard electronic databases must transition to the electronic register by March Page 27 of 61

28 SUPPORT NEEDS For additional queries or comments please contact Mmbangiseni Terrance Magoro and on or Catherine White on Page 28 of 61

29 ANNEXURE A: NATIONAL ART M&E STRATEGY ART IMPLEMENTATION STRATEGY Page 29 of 61

30 VISION To have a standard and system in place that effectively captures, reports and tracks patients on the ART programme. BACKGROUND Primary Health Care facilities in South Africa currently do not have a standardised methodology for the capturing and processing of patient information on the ART programme. This causes confusion and problems when reporting is required at district, provincial and national levels. In order to address this challenge a standardised register and clinical stationery needs to be adopted for the capturing and tracking of patient information at health facilities. The Western Cape has already started to implement such a register 2, which the National Department of Health (NDoH) has adopted as well. This approach supports information integration at national levels for effective reporting. Information quality would increase substantially even if patients move from one primary health care facility to another. The other advantage of this approach is that all health care professionals would be able to seamlessly work from the same system which would support effective data capturing and interpretation at all levels. INTERVENTIONS To give effect to the vision a 3 phased intervention strategy needs to be followed. This would enable the National Department of Health to address current challenges with regards to non-standardised methodologies and systems being used and over time phase them out in order to create a more manageable and integrated system nationally. The 3 phased intervention strategy will consist of: a standardised paper based system as a first phase (Tier 1) at health care facilities an electronic stand-alone system as a second phase (Tier 2) for health care facilities a fully networked patient management system in place as a third phase (Tier 3) for health care facilities TIER 1 PAPER BASED SOLUTION STRATEGIC APPROACH To implement the first phase the NDoH would need to develop standardised stationary to be used at all health care facilities nationally. This would ensure all other paper-based systems are replaced with a standardised paper-based system that all health professionals can use. Support and training is critical for the first phase because it lays the foundation for the other two phases into the future. 2 Adapted from the WHO register

31 OPPORTUNITIES AND CHALLENGES ADVANTAGES Current systems are replaced with one standardised system that all health professionals can use irrespective of their location. Reporting format is standardised, which supports provincial integration of data for national statistical analysis. NDoH has control over the system from a national perspective and can develop policy according to more reliable data being received. Health professionals become accustomed to a standard system, which enables them to progress to an electronic system much easier. All support that is provided to health professionals will be based on the same standard. DISADVANTAGES AND RISKS Manual systems are error prone, especially when data capturing is being processed for monthly and quarterly reporting. A paper-based system does pose a challenge when patient numbers exceed levels of patients. Monthly and quarterly reporting can be time consuming especially when patient numbers are high. This system is entirely premised on human input and calculation which is inherently error prone and depends on the appreciation of data by health professionals. TIER 2 PAPER TO ELECTRONIC BASED SOLUTION STRATEGIC APPROACH The next phase is to progress from a paper-based register to an electronic register. The system will need to be a standalone configuration. It will not be networked in any manner but will need to have the capability for data capturing and reporting for ART programs on a monthly basis. Software required will need to fit criteria as determined by the NDoH. The scope of the electronic register will be expanded over time to collect data for PMTCT and TB/HIV as part of an integrated approach to patient monitoring, care and management. Requirements for an electronic stand-alone system include: A computer A printer, (dot matrix more cost-effective than laser printers) CDs, memory sticks etc. which allows data to be saved for backup, archiving and reporting purposes Electricity to enable computer equipment to function Secure room and cabinets, to prevent theft of equipment Page 31 of 61

32 OPPORTUNITIES AND CHALLENGES ADVANTAGES Health care professionals are already familiar with paper-based registers, thus change management should be minimal. Data capturing is done electronically, which supports data collection and storage. Monthly and quarterly reporting of data would be faster National integration of data will be easier, due to a standardised format being followed. Health care professionals can be moved between provinces and still function effectively on the system. Patient tracking and follow-up becomes easier. Stand-alone configuration is not dependant on networked infrastructure. Offsite storage and archiving of data becomes a possibility at lower cost DISADVANTAGES AND RISKS Electronic system could malfunction, which could place pressure on a health facility. Facility would then need to revert back to the paper based system. Health personnel might not be IT literate, which would impact change management processes. Data backup processes not followed, which could result in data loss. Back capturing could be required, but a process could be put in place that when a patient visits the health facility, that the patient file is then only captured electronically this would save on costs. Theft of equipment needs to be taken into account. Not enough resources for support to ensure continual hardware support and swop out units could present challenges. Dependent on electricity being available in the facility Reporting of data to the upper levels would have to be done manually in the absence of network that automatically consolidates the data TIER 3 FULLY ELECTRONIC PATIENT MANAGEMENT SYSTEM SOLUTION STRATEGIC APPROACH The last phase requires all stand alone configurations of Tier 2 to be networked, in order to send and receive patient data. The establishment of a central patient repository with subsets of patient data at clinic level is critical for the implementation of the last phase. This system will also enable monthly reporting to be submitted electronically and replace current submission methods. Requirements for an interconnected online capable system include: National call centre for support Local support centres Page 32 of 61

33 Centralized distribution system Network connection, either wired or wireless Computer and security requirements as for a Tier 2 solution SUPPORT When a support call is received by a centralized call centre, the call needs to be dispatched to a local support centre within South Africa. This is required in order to ensure that calls can be transferred and allocated to these support teams, which are geographically located closest to the health facility that requires support. Such a model would also ensure that downtime of a health facility is minimized. CENTRALIZED DISTRIBUTED SYSTEM In order for health facilities to be fully electronically operational, each facility requires a standalone subset of a full centralized database. This effectively will ensure that systems are only requesting and sending data when required and will maintain an effective local data set of patients that visit the site on a regular basis. This model allows redundancy in the system, which enables health facilities to continue operations even if the national centralized system is offline. The only time that health facilities would experience a problem is when a patient has not visited the clinic before and requires treatment. In such a case it would not be possible to extract that patient s information from the national repository as would normally be the case when the centralized system is online. To address this problem the patient can still receive health services, but when the national database is back online, back capturing can take place. The health facility system should be in a position to capture and only verify patient information if required. NETWORK REQUIREMENTS Building of a Tier 3 solution will require network connectivity at a reasonable speed. GSM/GPRS network coverage in South Africa is estimated to be above 85% and provides the basis for a Tier 3 text-based solution, where health facilities would be in a position to send and receive patient information wirelessly at a reasonable speed. The country network is capable of supporting a GPRS text base solution and not a data intensive transfer solution. SECURITY Security is and remains a concern, especially when sensitive patient information is kept, and proper security protocols need to be in place to ensure patient data integrity and confidentiality. Access levels would need to be controlled at a national level. OPPORTUNITIES AND CHALLENGES ADVANTAGES Patient tracking becomes easier especially when patients move between provinces The system allows for a full patient management system, which enables NDoH to receive data more accurately and frequently and allows for centralized point of care Page 33 of 61

34 Monthly reporting becomes much faster and data submitted can be integrated quicker, due to standardised submission format as per requirements determined by NDoH More modules of the system can be developed for other treatment areas, thus not limiting it to on the ART programme National call centre can track and monitor support requirements All support calls can be resolved faster due to the local support centres where support calls are dispatched to Clinics can be managed more effectively and efficiency rates of clinics will improve Health professionals can be moved anywhere and use the system, no re-training requirement DISADVANTAGES AND RISKS Security levels and access to patient information needs to be controlled, else information leaks could occur Physical access to computer equipment needs to be controlled, else theft will be the result Centralized patient repository could experience off time, the risk is that a new patient could require treatment with no local data record. In this scenario treatment could be provided until such time the patient information can be retrieved from the central repository. National receive support calls and dispatch calls to local support centres, which could delay the process if response times are not quick enough Costs of operations and maintenance of a fully networked system could prove to be an expensive exercise. Money that could rather be used for patient care. OTHER CONSIDERATIONS RESOURCES Support personnel to ensure IT systems function effectively Training personnel, to train all health professionals on new standardised based systems be it paper based or electronically. Funding, this will need to be factored in from phase 1. Paper-based will be easier to implement but continuous operational costs will include stationary, training and support. When taken software systems into consideration, operational costs will include training, IT support and maintenance of the system when it is networked. ROLES NDoH establish standards and norms that needs to be implemented and followed at all health care facilities Provinces need to ensure that training and support is in place to support such an exercise IT support needs to be established by the NDoH as per requirements at national level and ensure provinces provide necessary support for the establishment of local support centres when phase 3 is being implemented. Page 34 of 61

35 TIMELINES Tier 1 with 5000 health facilities, would require training and printing of stationery. One would be able to have reached all health facilities within 1 year. Tier 2, IT support needs to be put in place and equipment needs to be procured. Taking 5000 health facilities into account, each facility needs to have IT support and installation as well as training done. The estimated time to reach national coverage is 3 years. Tier 3, IT support is already in place, but the establishment of a national call centre as well as local support centres could take some time. The estimated time to reach an acceptable level of coverage would be at least 5 years. Consideration to be given to cost, coverage and scalability, strength of network infrastructure and technical assistance before implementation. CONCLUSION The solution in the short term that would enable health care facilities to function in a standardised manner nationally is paper based. Following this first phase is a standalone computer configuration, which enables electronic patient data capturing and reporting. The last phase that would be required is a fully operational networked solution, which enables patient data sending and receiving to and from a centralized repository. Having such a system in place would enhance clinic effectiveness and faster monthly reporting. Page 35 of 61

36 ANNEXURE B: FREQUENTLY ASKED QUESTIONS WHAT IS TIER 1? Tier 1 is the first of the Tiers of the Tiered ART monitoring strategy. It is a paper based register. It is best suited for small ART service points or ART service points with limited or no electricity. Both registers and clinical stationery have been printed by the NDoH and will be distributed centrally. Patients must be uniquely identified in the patient register and the patient folder. This is to ensure patient data is traceable between the patient folder and the register. Without a networked electronic system an automatically generated PMI is not possible but facilities must ensure they have a robust way of storing and recalling folders that will ensure no folder duplication. WHAT IS TIER 2? Tier 2 is an electronic register that manages the patient monitoring for clients on ART. Data generated meets the National reporting requirements. This system does not require a network to function; however, access to the internet can assist with transmitting the reports, but this is not a requirement. WHAT IS TIER 3? Tier 3 is a networked electronic medical record that will assist with the patient management and patient monitoring of ART patients in South Africa. WHO IS RESPONSIBLE FOR PRINTING THE CLINICAL STATIONERY The National Department of Health will print the clinical stationery and manage its distribution. The tools will be distributed centrally from the NDoH to the Provinces. Provinces will distribute to the next level. The clinical stationery is important for both the clinical management and the patient monitoring of clients on ART. It is also a tool that can assist quality improvement strategies and clinical audits. Phasing to electronic register WHAT HAPPENS IF I ALREADY HAVE AN ELECTRONIC DATABASE IN MY FACILITY? Standardised clinical monitoring will assist with the management of the ART programme in South Africa. Primary Health Care facilities in South Africa currently do not have a standardised methodology for the capturing and processing of patient information on the ART programme. This has caused confusion and problems with reporting and not provided standardised reports. Through a standardised paper register and a standardised electronic register, standardised clinical stationery the information integration will provide the tools to support information management and effective reporting at all levels. Page 36 of 61

37 If your site already has an existing database this must be migrated to the electronic register by the end of the 2011/2012 financial year. Data can be exchanged using the data exchange standards or it can be quickly captured into the electronic register. The best process will have to be investigated by the IT units and the District Implementation Teams. I HAVE A MEDIUM SIZED ART SITE AND WOULD REALLY BENEFIT FROM THE ELECTRONIC REGISTER, HOW DO I GET IT? WHERE DO I GET A COMPUTER FROM? This is a very good question and the answers should be directed to the District Implementation Team. The District Implementation Team is the entity that will operationalise the implementation of the ART monitoring system and support you to transition from your current system to the electronic system. They will need to assess your facility and identify whether it meets the criteria to implement the electronic register. You can ask yourself a few questions first: Does my site have reliable electricity Do we have staff to manage the electronic register? Do we use the standardised clinical records? Would a computer be secure in our facility? If you can answer yes to these questions then you can contact your district implementation team for assistance. The Global Fund does make allowance to procure computers to support ART service points that meet the criteria to implement the electronic register. If a computer is not possible through that channel then look to your development partners in the District. They may be able to assist. HOW WILL THE TIERED MONITORING STRATEGY BE GOVERNED? Refer to standards committee WHAT WILL TRAINING CONSIST OF? Epidemiology of HIV / AIDS, the South African ART programme and why we monitor it The Tiered ART monitoring strategy and an introduction to the tools (paper and electronic) and how to manage them Data elements Roles and responsibilities: facility management, folder management, data flow Reporting Monthly reporting Cohort monitoring Reporting schedule UNGASS Data flow In facility Reporting Managing the backlog Page 37 of 61

38 WHEN WILL TRAINING START? Refer to the training schedule. Further trainings will be informed by the provincial implementation teams, their roll out plans and the district implementation teams. WHAT IS THE STANDARDS COMMITTEE? The standards committee is an advisory body to assist with the strategic planning for the Tiered ART monitoring systems for the National Department of Health in South Africa. Future adaptations to any of the systems will be discussed by this panel. WHAT IS THE DATA FLOW? On March 10, 2011 the NHC and NHIS/SA accepted the ART data elements and revised reporting timelines for managing the ART programme. The DHIS is aligned to receive the monthly data but not the quarterly data. Once the DHIS has been aligned to receive the quarterly data the DHIS will be the source for reporting all ART programme data. Page 38 of 61

39 ANNEXURE C: INSTRUCTIONS TO MANAGE THE PAPER REGISTER (PRINTED IN REGISTER)

40 Page 40 of 61

41 Adult Female Adult Male Child 0 < 1 Child 1 - < 5 Child 5-15 Screened for TB (Y/N) On TB Rx at start of ART (Y/N) On IPT at start of ART (Y/N) On CPT at start of ART (Y/N) Pregnant at start of ART (Y/N) Prior ART: Exp / PMTCT / PEP Regimen Outcome (R)IP/(L)TF/(T)FO Transfer In Regimen Viral load CD4 Outcome (R)IP/(L)TF/(T)FO Transfer In Regimen Viral load CD4 Outcome (R)IP/(L)TF/(T)FO Transfer In WHO stage CD4 Count Viral load (1-15 years) Starting regimen ANNEXURE D: PAPER BASED ART REGISTER (SAMPLE) Cohort Outcome Age & Gender At 3 months: At 6 months: At 12 months: (Events between (Report on events between 3 & (Report on events between 6 & starting ART & 3 Months) 12 months) months) Date started ART (Day) Patient's Name, Surname, folder number and ID number Died/ Lost/ TFO Date 1 2 Folder # Folder # Folder # Folder # Folder # 5 6 Folder # 6 7 Folder # 7 8 Folder # 8 9 Folder # 9 10 Folder # ID Y Y M M D D Folder # ID Y Y M M D D Folder # ID Y Y M M D D Folder # ID Y Y M M D D Folder # ID Y Y M M D D Folder # ID Y Y M M D D Folder # ID Y Y M M D D Folder # ID Y Y M M D D Folder # ID Y Y M M D D Folder # ID Y Y M M D D Folder # ID Y Y M M D D TOT TBART EXP FLR RIP TFI FLR VLD VLS CDDCDA RIP TFI FLR VLD VLS CDDCDA RIP TFI CD4<100 CD4 100 to 199 CD4 200 to 350 Total SLR LTF SLR LTF SLR LTF STO TFO STO TFO STO TFO Page 41 of 61

42 ANNEXURE E: PATIENT SUMMARY (PAGE 1) Referral clinic: 1. PATIENT DETAILS First name Surname Current Clinic: Date: Folder # Phone # DOB ID Number Next of kin: name, address and contact no. Sex: M / F Address 2. LONG-TERM RECORD Use this section to maintain an ongoing summary of your patient s health. If another clinician sees this patient for the first time five years from now, s/he should be able to ascertain the major features of the clinical course from this page. Year HIV Diagnosed HAART prior to above start date? Past medical history ART start date at this or transferring clinic NONE / PMTCT / HAART / PEP Details Record here significant medical events that occurred before this patient record was started Transfer-in Date (ART only) Note: Patient can only be considered transferred in if this record can be completed in full from the date of the original start. If there is prior treatment with incomplete treatment history, the patient should be considered a new patient with prior HAART exposure Longitudinal Record Date Patient Summary Complete each time there is a new stage defining illness, new CD4 or viral load, regimen change or a hospitalisation Record here the date and duration on ART in months " " (if applicable), CD4, viral load, stage, pap, regimen changes and hospitalisations Stage Weight Viral load CD4 Stage defining illness, regimen change, hospitalisation details, pap, etc.

43 PATIENT SUMMARY (PAGE 2) Page 43 of 61

44 PATIENT SUMAMRY (PAGE 3) 4. CLINICAL EVALUATIONS FOR HAART OR TO RE-START HAART If HAART is indicated for your patient, use this section to help decide whether there are any medical contra-indications to starting PRIOR HAART HISTORY If your patient has ever had previous HAART, detail the period when taken, treatment changes and the reasons they stopped treatment: BASELINE SAFETY BLOODS Test Date Result ALT Other tests Creatinine Clearance Date Result Notes Haemoglobin CD4 TB WORK-UP Symptoms suspicious of TB? Y N If YES: Perform TB work-up, record results in visit summary sheet NUTRITIONAL ASSESSMENT Symptoms Nausea / Vomiting / Diarrhoea / Severe loss of w eight / Difficulty sw allow ing CLINICAL NOTES Baseline BMI CLINICAL FACTORS INFLUENCING REGIMEN CHOICE 1. On TB treatment? 5. Has had more than 1 month PLAN: of HAART? (excluding PM TCT or PEP) Y / N Y / N ARV 1 2. Pregnant? 6. BMI > 27.5 ARV 2 Y / N Y / N ARV 3 3. Has severe peripheral 7. Other neuropathy? Y / N Y / N Cotrimoxazole 4. Has a history of psychiatric 8. Other Fluconazole illness? Y / N Y / N IPT COMMENCING HAART Psychosocial readiness (see section 7) Regimen factors (clinical factors influencing choice) Y / N Y / N Clinically ready Regimen ASSESSMENT OF OVERALL READINESS FOR HAART Signature: Date: Page 44 of 61

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46 Plan and treatment Medication, incl. ARVs and prophylaxis PH Assessment HIV conditions / OIs, TB & other conditions Investigations Barcode 1 Barcode 2 History and examination ANNEXURE F: VISIT SUMMARY # Temp / Height Months on HAART Notes STI screen FP / Condoms Adverse event / grade WHO stage Weight Months on regimen Months on TB Rx (or TB symptoms if not on treatment) TB M / C / S CD4 (CD4%) Viral Load ALT HB / WCC / PLT Creatinine clearance Other investigation results (incl. XR) Adverse event / grade Notes Adherence & Counselling ARV1 ARV2 ARV3 ARV4 or other ARV5 or other ARV6 or other Cotrimoxazole IPT Fluconazole Referred Date of next visit N / D : Nurse/Doctor Signed (Initialed) Date: IN Clinic OUT Data Capturer #: record the patient number on every sheet in the space provided N/D: Circle D for doctor and N for nurse (and print name alongside Weight: Record the weight at every visit. This is important to see if a patient is losing or putting on weight between visits Temp: note the temperature at each visit. Height: this should be taken 3 monthly for children, or monthly if on HAART. At least one height measurement should be done for adults. This will is used to calculate BMI Months on HAART: Months on HAART from the first time HAART was commenced. Months on Regimen: Number of months on current regimen, if the regimen has changed whilst on HAART. Any change in drug will set the regimen "clock" back to zero. Safety bloods are timed according to the current regimen, whilst viral loads and CD4 counts are preferably linked to the time on HAART. Notes: Enter presenting complaints, symptoms and signs STI Screen / FP / Condoms: At each visit ask details of STI symptoms and family planning. (STI Screen urethral discharge, dysuria, vaginal discharge, genital ulcers, genital warts, lower abdominal pain) Months on TB Rx: Fill in duration on TB treatment. Remember to check 2, 3, and 5, 7 month sputa. In the absence of TB treatment use the space to record symptoms (TB Screen: cough > 2 weeks, weight loss, fever, night sweats, haemoptysis, emaciated, fatigue) Barcode 1 and 2: affix the barcode from the lab forms in the allocated space. Tick in the row next to the test that was done. This alerts the next clinician to retrieve the results and enter them on the date the specimens were collected, and not the date they were received. TB M / C / S: Note the results of any specimens sent for microscopy, culture or sensitivity. CD4 (CD4%): Record the absolute CD4 count, and if relevant CD4%, alongside in brackets. Viral Load: Record the absolute viral load in copies/ml. If log values are recorded these should berecorded alongside in brackets. New CD4 and Viral Load results MUST be noted on the patient card and on the front ofthe patient summary. ALT, FBC, Creatinine and other investigations: Additional result lines are available for safety bloods and other investigations. When recording FBC the relevant parameters can be recorded on a single line prefixed as appropriate. E.g. HB 8.6 N: 1.6 P: 180 HIV Conditions / OI: List each diagnosis/dominant complaint on a separate line. When filling in these spaces not whether the condition is new (N), ongoing (O), or recurring (R). For TB, please note which type of TB. It is important to note these conditions at each visit e.g.: 1. PTB, O 2. Oral candidiasis, R 3. PPE, N Adverse event and grade: Note the type of adverse event, the grade (1, 2, 3 or 4) and if it is new (N), ongoing (O) or recurring (R). The adverse event should be presumed to be ongoing until proof of the contrary (e.g. normal blood result). Stage: record the WHO stage at each appointment. Where there is a WHO stage change, record this on the front of the patient summary. Notes: Record assessment and management plan, include complicated X- ray findings here if relevant. Adherence and counselling: Note assessment of adherence or referrals for counselling. Counsellors should initial and date this space after seeing patient. Adherence percentage may also be recorded here. ARV 1-6: This corresponds to the ARV drugs and dose in milligrams. Please use correct codes for drug substitutions: Begin (B) Continue (C) Restart (R) Stop for contraindication (SC) Stop for hospitalisation or illness (SH) Stop for intolerance (SI) Stop due to patient defaulted (SD) Stop for failure (SF) Stop due to a problem with other drugs (SO) Stop for non-adherence (SA) Stop due to protocol change or end of contraindication (SE) Stop for patient reason (SP) Regimen changes must be noted on the patient card and on the front of the patient summary IN/OUT/PH: note the number of tablets still held by the patient. The pharmacist will indicate the number dispensed and initial under "PH" ARV 4-6 or other: Note incidental medications here for the attention of subsequent clinicians. If Fluconazole is being given for Rx note it here, if it is been given asa prophylactic note it in the next section as prophylaxis. Cotrimoxazole, INH, Fluconazole: Note the prophylaxis and dose given in the case of INH, record TB treatment details here if on TB treatment to indicate not eligible for prophylaxis. Referred/hospitalised: Note name of hospital patient is referred to, or if it is home based care, note this. Also record the number of nights spent in the institution. Date next visit: The date should also be written on the patient card Signed: The clinician must sign that all the above is correct. The data capturer should initial once the record has been captured into the monitoring tool WHO All CD CD Refer to monthl - Give a - Initiat - Contr Eligible CD4 coun OR CD4 coun o patie o Pregn OR WHO sta OR MDR/XD Isoniaz Eligibil All TB sympt 1) In p with is side 2) A PP 3) Preg 4) Inte progre 5) Do n term T Dosag Adults Childre Vitami periph 6 mon Record summ At eac Patien Patien Patien should hepato Intensi If New Re - Make Prescri - if - and - age

47 Plan and treatment Medication, incl. ARVs and prophylaxis PH PH PH PH PH Assessment HIV conditions / OIs, TB & other conditions Investigations Barcode 1 Barcode 2 Barcode 1 Barcode 2 Barcode 1 Barcode 2 Barcode 1 Barcode 2 Barcode 1 Barcode 2 Barcode 1 Barcode 2 History and examination # Date: N / D : N / D : N / D : N / D : N / D : N / D : Weight Temp / Height Months on HAART Months on regimen Notes STI screen FP / Condoms Months on TB Rx (or TB symptoms if not on treatment) TB M / C / S CD4 (CD4%) Viral Load ALT HB / WCC / PLT Creatinine clearance Other investigation results (incl. XR) Adverse event / grade Adverse event / grade WHO stage Notes Adherence & Counselling IN OUT IN OUT IN OUT IN OUT IN OUT IN OUT ARV1 ARV2 ARV3 ARV4 or other ARV5 or other ARV6 or other Cotrimoxazole IPT Fluconazole Referred Date of next visit Signed (Initialed) Clinic Clinic Clinic Clinic Clinic Clinic Data Capturer Data Capturer Data Capturer Data Capturer Data Capturer Nurse/Doctor Nurse/Doctor Nurse/Doctor Nurse/Doctor Nurse/Doctor Nurse/Doctor Data Capturer

48 ANNEXURE G: ART MONTHLY REPORTING FORM This data reports the total number of patients started ART disaggregated by adults and children in a given month and the total patients in care, disaggregated by adults and children in that reporting month. It is a basic requirement for monitoring the ART programme. Understanding the number of New Patients Initiated on ART each month assists programme managers to understand the extent the programme is expanding over time. This data is generated by looking at the number of patients who are written in the register in the month being reported. Each register page has 20 lines and to report the patient numbers you look at the number of patients recorded in that month. The total patients on ART refers to the patients who are still receiving care from the facility and excludes patients who have died, been lost-to-follow up and who have transferred out of the facility. This is useful for programme management and estimating future patient targets. The total patients on ART is generated by going through the register and recording the number of patients with a regimen recorded in the column (month) that is being reported. GENERATING THE MONTHLY REPORT FROM THE PAPER-BASED REGISTER These instructions are printed in the back pages of the patient register and repeated here for your information. Instructions for the monthly validation tool: This tool has been developed to validate historical monthly totals in your clinic as well as future monthly totals. This tool is particularly useful for large clinics that are taking a long time to extract a monthly report. This form records all patients who enter your clinic in a given month: new patients including treatment experienced (EXP); PMTCT and PEP exposed patients; those who have transferred in and finally those who were previously tracked as lost to follow up or transferred out and have returned to the clinic. This report further records all patients that leave your clinic during each month (LTF, RIP and TFO). The columns categorise events that occur. The row captures the month in which the event happens.

49 HOW TO GENERATE YOUR MONTHLY DATA: FIGURE 1: SAMPLE MONTHLY VALIDATION FORM Preparation: Data for adults and children are aggregated and submitted on separate forms Please remember to fill in the facility name and circle whether it is adults or children being reported. 1. In each month enter the new patients that start on treatment in your facility. New patients include all naïve patients as well as those that have been on the PMTCT and PEP programmes. 2. Methodically go through each patient, on each line, on each page, in your register and mark down when/if an event happens (TFI, Returns, TFO, RIP, LTF) in the month in which it happens - a patient who transfers out in July should be ticked under TFO in July Please note that a patient is considered a RETURN if they transfer out (TFO) or are lost to followup (LTF) and return some months later. In order to keep things neat we do not change the TFO or LTF originally recorded as this would affect the following month s totals. Instead, they are added back into the total remaining in care (TRIC) by tracking them as a RETURN. 3. Once you have completed this exercise and recorded all information in your register fill in the TOTAL columns. In each row add up (1) New (2) TFI (3) Return to find TOTAL A In each row add up those who have left care : (4) RIP + (5) LTF + (6) TFO to find TOTAL B 4. In each row, add up the monthly total (Total A Total B = Total C). This may be a negative number if more people leave the clinic in comparison to new patients starting (e.g. March 2007) 5. Find the total patients remaining in care (TRIC) in your facility at the end of each month by adding the TRIC from the previous month to Total C from the current month In Figure 1, May had 13 new adults and 36 TRIC (adult) 6. Update this form at the end of each month. If you find events that were not previously reported you will need to update the reporting form. 7. If using the monthly validation tool this report can be submitted instead of the Monthly reporting form. Page 49 of 61

50 NB: NB: This form must always be submitted in its entirety. Filling out the form with the current reporting month does not enable you or the information managers to validate your historical data or your total remaining in care. An electronic version of this tool is available. Please request from your information officer. If you are using the electronic version, please only use numbers and no letters in the columns. The formulae can only calculate from numbers. WHEN TO REPORT Data is to be submitted to the facility manager for validation and signature by the 5 th of each month. Data should then be forwarded to the sub-district information officer by the 7 th of each month. Note: you will submit the report for January on February 5 th. If the 5 th falls on a weekend, submit earliest on the Monday morning. Preparation: Data for adults and children should be aggregated separately and submitted on one form. Please use the Monthly Validation Tool to help you aggregate the Monthly Report if you are a big clinic. Aggregation using the register: New patients Please use the register to total the number of new patients started ART (ART naïve) for the previous month plus: Please tally the following patients together to get sum total new patients for the given month: o ART naïve patients o Treatment experienced patients o Patients from the PEP programme o Patient from the PMTCT programme Submit the total on the monthly report in the appropriate cell (box) Total patients This is a total of all patients remaining at your clinic Please go through each register page looking only at the month that is being reported Please tally the following patients together o Any patient that has a current regimen in the column designating the month being reported o Any patient that has a star without a circle (someone who is not yet considered lost to care (LTF)) in the column designating the month you are reporting on o Please note: patients who have an outcome in the specified month (or months previous) should not be counted in this total Page 50 of 61

51 ANNEXURE H: MONTHLY VALIDATION FORM TABLE 8: MONTHLY REPORTING FORM MONTHLY REPORT FOR : (Clinic name) Please circle: Adults or Children person completing the form: Months year Total # of pt Left care New (1) TFIs (2) Return (3) Total A RIP (4) LTF (5) TFO (6) Total B Monthly Total: total A - total B T o tal remaining in care (T R IC ) = T R IC fro m previo us mo nth + Total C Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec year Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec year Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Page 51 of 61

52 ANNEXURE I: GENERATING THE QUARTERLY REPORT FROM THE PAPER REGISTER The ART quarterly report provides data on the clinical outcomes of patients started ART within your facility. These instructions are printed in each of the paper registers. When to submit report: Please submit the updated data one quarter after the end of the quarter, similar to TB reporting (e.g. baseline data for quarter 1 (January March) can be tallied at the end of June and submitted to your facility manager by July 5th). This ensures the blood results of patients who were seen towards of the quarter are entered in the register and allows for the confirmation of lost to follow up. Submission dates: January 5 th (report July September data) April 5 th (report October, November, December data) July 5 th (report January, February, March data) October 5 th (report April, May, June data) Preparing the register for reporting (Paper Register): Only prepare summary months in the register that ended over 3 months ago. Ensure to go through each patient (each row) to ensure all data is complete. The summary column is one which summarises events between two time periods and where blood results are captured. Please make sure that any outcome which occurred after the last summary month is recorded in the outcome column in the current summary month. If an outcome occurred prior to a previous summary month, it is not carried over to the new summary month as the outcome has already been reported. o If the outcome and regimen cells (boxes) in a summary column The summary column in the below section is the 12 month summary column. are both blank and one or two of the previous two months are not blank: o Pull the patient s folder confirming that they did not attend for the months that are blank. If confirmed, place a star in the top right hand side of the box showing that the patient did not attend. If it is a summary month regimen column, place the most recently prescribed regimen number in the top left hand side of the box (e.g. 1 for first line or 2 for second line). This will help in tallying the columns. o If the outcome and regimen cells (boxes) in a summary month are both blank and the previous two months are also blank o If they do not have an outcome in a previous summary month, then please pull that patients folder and confirm that they have not attended for at least three months. o Place a star in the first three consecutive blank boxes confirming that the patient did not attend. FIGURE 2: MANAGING A PATIENT WITH NO o Circle the third start to signify that a REGIMEN AND IS ALSO NOT LTF patient is a confirmed LTF. o Please also remember to mark this patient with a LTF in outcome column of the first