Costing guidelines for tuberculosis interventions

Costing guidelines for Tuberculosis interventions Lucy Cunnama Inés Garcia Baena Gabriela Gomez Yoko Laurence Carol Levin Mariana Siapka Sedona Sweeney Anna Vassall Edina Sinanovic Costing guidelines for tuberculosis interventions/ Lucy Cunnama, Inés Garcia Baena, Yoko Laurence, Sedona Sweeney, Anna Vassall, Edina Sinanovic et al. ISBN 978-92-4-000009-4 © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution- NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/ licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. 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Cover designed by Irwin Law Copy editing by Galbraith-Emami Associates Designed by minimum graphics iii CONTENTS Acknowledgements v Abbreviations vii SECTION A. Introduction 1 Background 1 Aim of the guidelines 2 SECTION B. Defining TB interventions 4 Standardized unit costs for TB interventions 4 SECTION C. Study objectives and set-up 8 Initial conceptualization and defining the study team 10 Study protocol formation and submission of protocol for ethical approval 13 SECTION D. Designing data collection 18 Understanding the production process 18 Costing approaches 21 The Standardized Value TB Costing Tool Suite 28 SECTION E. Data analysis, presenting results and dissemination of cost data 31 SECTION F. Appendices 33 Appendix 1. Basic concepts and terms in costing 33 Appendix 2. Specific TB interventions 37 Appendix 3. Standardized unit costs for TB interventions 43 Appendix 4. Principles and methods reporting checklist 49 Appendix 5. Amortization table 53 Appendix 6. Protocol outline 54 Appendix 7. Examples of queries and comments from ethics committees 55 Appendix 8. Value TB Costing Tool Suite 57 Appendix 9. Non-exhaustive list of unit costs per patient per output, top-down and bottom-up generated by the Data Entry Tool 105 Appendix 10. Terms of reference for the study team 106 Appendix 11. Three case studies 114 Appendix 12. Informed consent templates 117 References 123 CONTENTS Costing guidelines for Tuberculosis interventionsiv List of figures and tables Figure 1. Standard unit costs 5 Figure 2. Example of activities for national costing study (example of Value TB) 8 Figure 3. Example of timeline for national costing study (example of Value TB) 16 Figure 4. Example of a process flow diagram for smear microscopy in a laboratory 19 Figure 5. Capital and recurrent inputs 20 Figure 6. Estimating efficiency 22 Figure 7. Top-down allocation of costs within a laboratory 24 Figure 8. Post data collection activities 31 Figure 9. Intervention flow chart 37 Figure 10a. The Value TB Costing Tool Suite 57 Figure 10b. The Value TB Costing Tool Suite 82 Figure 11. Shared above service level costs 97 Table 1. Sample of annex 3 from Reference Case [5] for TB treatment 7 Table 2. Costing approaches 25 Table 3. Defining standard costs for each intervention 41 vAcknowledgements These guidelines were jointly produced by a core writing team comprising the following people: Lucy Cunnama, Health Economics Unit, University of Cape Town (UCT), Cape Town, South Africa; Inés Garcia Baena, Global TB Programme, World Health Organization (WHO), Geneva, Switzerland; Gabriela Gomez, London School of Hygiene and Tropical Medicine (LSHTM), London, England; Yoko Laurence, LSHTM, London, England; Carol Levin, University of Washington, Seattle, United States of America; Mariana Siapka, LSHTM, London, England; Sedona Sweeney, LSHTM, London, England; Anna Vassall, LSHTM, London, England; and Edina Sinanovic, UCT, Cape Town, South Africa. The writing team forms part of the Global Health Cost Consortium (GHCC), which will disseminate the guidelines alongside WHO. The core writing team would like to thank the Value TB project research groups in Ethiopia, Georgia, India, Kenya  and the Philippines, who were the first users of the guidelines. Their feedback shaped the Value TB Costing Tool Suite, which is the set of costing instruments that accompanies the guidelines. Special thanks are due to Katherine Floyd for providing inspiration to produce new guidelines on TB costing and for her support to both the GHCC and the Value TB project. Thanks are also due to the TB Modelling and Analysis Consortium (TB MAC) and the WHO Global Taskforce on TB Impact Measurement, for feedback on the reporting formats during two of their joint annual meetings, in September 2017 and September 2019. Funding for this work was provided by the Bill and Melinda Gates Foundation (grant no. OPP1109722), through the GHCC. Acknowledgements Costing guidelines for Tuberculosis interventionsvi ABBREVIATIONS 3HP three months of once-weekly isoniazid and rifapentine 6H isoniazid for six months ACF active case finding ALT alanine aminotransferase ART antiretroviral therapy AST aspartate aminotransferase (also known as SGOT) BCG Bacille Calmette-Guérin BMI body mass index COPD chronic obstructive pulmonary disease CPI consumer price index CT computed tomography CXR chest x-ray DOTS directly observed therapy, short-course DR drug-resistant DS drug-susceptible DS-TB drug sensitive tuberculosis DST drug susceptibility testing ECG electrocardiography EPTB extra-pulmonary tuberculosis FLD first-line drugs FTE full-time equivalent GFATM Global Fund to Fight AIDS, Tuberculosis and Malaria GHCC Global Health Cost Consortium H isoniazid HCW health care worker HEU UCT Health Economics Unit, University of Cape Town HMIS health management information system HR human resources ICF intensified case finding IEC information, education and communication IGRA interferon-gamma release assay INH isoniazid IPD inpatient department IPT isoniazid preventive therapy KEMRI Kenya Medical Research Institute KEMRI-WT Kenya Medical Research Institute Wellcome Trust LAMP loop-mediated isothermal amplification LED light-emitting diode LF-LAM lateral flow urine lipoarabinomannan assay vii ABBREVIATIONS LJ Lowenstein-Jensen LPA line probe assay LSHTM London School of Hygiene and Tropical Medicine LTBI latent tuberculosis infection M-health mobile-health MCH maternal and child health MDR multidrug-resistant (resistant to both rifampicin and isoniazid) MDR-TB multidrug resistant tuberculosis MGIT mycobacteria Growth Indicator Tube NCDs noncommunicable diseases NGOs non-governmental organizations NTLP-P National Tuberculosis, Leprosy and Lung Disease Program NTP National Tuberculosis Programme OPD outpatient department PCF passive case finding PCR-DNA polymerase chain reaction – deoxyribonucleic acid PI principal investigator PMT payment function PPD purified protein derivative PTB pulmonary tuberculosis R rifampicin RBC red blood cell RBS random blood sugar (also known as random blood glucose) S streptomycin SGOT serum glutamic-oxaloacetic transaminase (also known as AST) SGPT serum glutamic-pyruvic transaminase (also known as ALT) SLD second-line drugs TB tuberculosis TST tuberculin skin test (also known as PPD Mantoux test) UHC Universal Health Coverage UNICEF United Nations Children’s Fund USD United States dollars UV ultraviolet WBC white blood cell WHO World Health Organization XDR-TB extensively drug resistant tuberculosis Xpert® MTB/RIF Xpert mycobacterium tuberculosis/rifampicin resistance Z Pyrazinamide ZN Ziehl-Neelsen

1Section A. Introduction Background Substantial progress has been made in the past decade to improve tuberculosis (TB) outcomes and control, particularly with the development and implementation of new diagnostic tests and treatment regimens [1–3]. Addressing the global TB epidemic is in line with the goals of Universal Health Coverage (UHC) to provide health care for all, without financial adversity. However, funding for TB still needs to be increased in order to reach global targets. Estimating the costs of TB interventions is an essential component to planning, prioritizing and managing the funding of TB services [4]. The ‘Reference Case for Estimating the Costs of Global Health Services and Interventions’ [5] (referred to hereafter as the ‘Reference Case’) encourages consistent adherence to core principles when collecting data to estimate the costs of health services. As a guiding document, it also presents the different costing methodologies that can be utilized, indicating the strengths and weaknesses of each, and provides a set of principles to improve global health costing. In this set of guidelines, we draw on the Reference Case principles to outline the main steps for costing TB services. Researchers can develop specific protocols which draw from these steps depending on the purpose of their costing study. For example, cost methods may vary depending on the time available, size or scope of a study. Throughout this document, we use the Value TB Study as an illustration of how a TB costing study can be undertaken. Value TB was funded by The Bill and Melinda Gates Foundation (https://datacompass.lshtm.ac.uk/817/). The purpose of the Value TB Study was to assess the service delivery costs of all TB interventions in five countries (Kenya, Ethiopia, India, Philippines and Georgia) in order to update current data and inform users of the cost data, such as modellers and policy makers. The primary aim of Value TB was to enable National Tuberculosis Programmes (NTPs) and their funders to allocate their resources, both to and within TB, in an efficient and fair way. We also include a set of costing instruments called the Value TB Costing Tool Suite (including Data Collection and Data Entry components) which can be adapted depending on the costing protocol developed. The complementary Value TB Costing Tool Suite can be found on the Global Health Cost Consortium (GHCC) and World Health Organization (WHO) websites (https://ghcosting.org/ and https://www.who.int/tb/publications/ en/), and a detailed explanation of these tools can be found in Appendix 8 of these guidelines. Section A. Introduction Costing guidelines for Tuberculosis interventions2 Aim of the guidelines The aim of these guidelines is to provide a step-by-step guide for those who need to conduct primary data collection to estimate the cost of delivering TB interventions and produce a standard set of unit costs. These guidelines take the reader from protocol design to cost data analysis. They provide practical advice on how to collect cost data for specific chosen purposes, perform analysis and disseminate data. These guidelines do not cover how to assess cost savings for TB interventions over time, as the focus of the guidelines is the production of unit costs through a cost analysis rather than undertaking economic modelling. They also do not touch on assessing cost-effectiveness of programmes or interventions, or the analytics required to produce cost functions. Rather, they assist with the collection and estimation of a standard set of unit costs as this relates to making estimates of economics costs, setting budgets, financial planning, understanding TB programmes and responding to the introduction of new technologies as they emerge. Several guidelines have previously been developed for TB costing. This set of guidelines specifically updated and built on existing work by Floyd [6–9]. Who should use these guidelines? These guidelines are intended for experienced producers of cost data who may know less about how to cost TB services. This manual is TB-specific and allows costing work to be adapted to context and purpose. While this guidance can be used for those who have not costed health services previously, where this is the case we would advise using the Reference Case as a complementary resource [5]. The primary user may be the costing coordinator based in the NTP, a primary investigator or a manager at a facility. For the co-ordinator of studies, particular reference should be made to Section C – Study Design and Set Up. Section C covers the necessary steps in establishing the study, including defining the purpose of the study, setting up a study team to perform the data collection and analysis, gaining ethical approval and establishing the study aims and objectives. This guidance is also designed to support those collecting data in the field. In this case, the focus should be on Section D, which highlights the important aspects in TB cost data collection, including understanding the production process, adapting the Data Collection Tool, mapping data sources and measuring resource use. Structure of the guidelines The guidelines are structured into the following stages in a costing study: pre-data collection activities (initial conceptualization, defining the interventions, setting up country links/selection of study partners, establishing country teams, study protocol formation and submission of protocol for ethical approval, training and piloting); data collection at the facility level (and the community level if required), data collection at above-facility level; and post-data collection activities (data analysis, preparation of reports, papers and a publicly accessible database, dissemination of data). Accordingly, the guidelines have the following four sections: Section B: Defining the TB Interventions to be costed This encompasses a brief overview of TB interventions, with additional detail in Appendix 2. 3Section C: Study Design and Set Up Section C focuses on study design aspects and how to set up a TB costing study, highlighting key steps in the process. Section D: Data Collection: Resource and Service Use Measurement; Pricing and Valuation Section D outlines the features of data collection and the production process, details costing approaches and provides an introduction to the Value TB Costing Tool Suite. These features include: the scope, methods, sampling, data sources, timing of data collection and adjustments to data. Section E: Data Analysis, Presenting Results and Dissemination of Cost Data Section E speaks to the data analysis stage where one assesses the unit costs that have been generated. It also addresses the need to look at the drivers of cost, variation in costs, sensitivity analyses one may want to undertake to assess uncertainty and how to disseminate this information effectively in a transparent manner to the users of TB unit costs. Additionally, appendices can be found in the final section: Section F: Appendices Appendix 8 describes the corresponding Value TB Costing Tool Suite, how to make best use of these tools and how to adapt them to specific contexts. Appendix 11 provides case studies to illustrate steps for learning how things are practically and pragmatically done when costing TB services. Section A. Introduction Costing guidelines for Tuberculosis interventions4 Section B. Defining TB interventions Standardized unit costs for TB interventions In order to enable cross-country comparisons of TB costs and extrapolate costs across settings, it is important to develop a set of standardized unit costs for TB services. This was done as part of the GHCC, contained here in Appendix 3 [5]. Appendix 3 outlines the main TB intervention categories (under the heading Intervention), intervention details and standardized cost units that should be reported. The main classes of intervention for TB are: A. Vaccination (which includes Bacille Calmette-Guérin (BCG) Vaccination) B. TB case detection and diagnosis, which includes the intervention types of passive, active and intensified case finding (PCF, ACF and ICF) C. TB treatment D. TB prevention E. TB infection control F. TB programme above site services (which comprises policy, planning, coordination and management for TB services) Over time there may be further adoption of future technologies and thus interventions to be included, for instance if new vaccine candidates are developed. To ensure comparability of costs, Appendix 3 also provides details of different options for intervention implementation, including: an open field for any specific intervention modality (e.g. centralized, decentralized etc.), the technologies utilized for that particular intervention (such as first line treatment, or type of diagnostic), the delivery platform ownership and type (such as private facilities, public clinics and hospitals), and the population that is covered, for instance adults with pulmonary TB, HIV comorbidity or children (which can be further separated into demographic and clinical details). For TB treatment, the particular phase should be indicated (start-up, implementation, intensive or continuation). If a new intervention for TB care emerges and requires costing, it should be described in a similar manner (platform, population covered etc). For each intervention, a standardized unit cost is presented (unit cost per recipient/ person reached) in order to standardize the outputs of TB costing studies to provide comparability and generalizability. Further breakdowns of unit costs are indicated: an optional quality adjusted unit cost per recipient, and unit costs for the list of outputs required to deliver the intervention or services. The activity and other total cost breakdowns, input category breakdown and mandatory reported inputs are listed by intervention. 5 Section B. Defining TB interventions Fig. 1. Standard unit costs Passive case finding Intervention ‘unit’ cost Direct and ancillary service ‘unit’ costs Activity costs Cost per person diagnosed (with either drug sensitive or drug resistant TB) Quantity (visits) * Cost per outpatient visit Quantity (visits) * Cost per inpatient visit (e.g. for children needing fine- needle biopsy) Quantity * Cost of patient support visit Only included if within the health sector Quantity (number of tests) * Cost per test (defined per technology: Symptom Screen; Xpert® MTB/RIF; Microscopy LED; X-ray (chest x-ray); Digital X-ray (chest x-ray); rapid HIV Test etc.) Quantity (minutes) * Cost per minute (personnel time includes time of clinical and non-clinical staff) Quantity (square metre per minute) * Cost per square metre per minute (infrastructure including building, equipment, furniture, overhead inputs including administration, cleaning, kitchen, utilities, security, laundry, monitoring and evaluation/pharmacovigilance, maintenance, training) Quantity (minutes) * Cost per minute (personnel time see above) Quantity (square metre per minute) * Cost per square metre per minute (infrastructure and overhead cost see above) Quantity (minutes) * Cost per minute (personnel time includes time of health care or social care worker) Quantity (square metre per minute) * Cost per square metre per minute for counseling visit (infrastructure and overheads see above) Quantity * Cost of cash transfer (includes the actual cash transfer itself) Quantity * infrastructure cost surrounding administration of the transfer (personnel time, infrastructure, overhead inputs, information technology and banking fees, etc.) Quantity (minutes) * Cost per minute (personnel time of laboratory staff) Quantity (number of tests) * cost of ‘technology’ (infrastructure, consumables, chemicals and reagents, overhead inputs, biosafety, quality assurance (national, regional, supranational), monitoring and evaluation, transportation of samples, transport for reporting results back to the patient, training of laboratory workers to operate that technology (both capital and recurrent) Costing guidelines for Tuberculosis interventions6 Figure 1 shows one diagrammatic example of a unit cost per recipient for PCF (from Table 3, Appendix 2). It explores the possible activities that make up the direct and ancillary unit costs in term the intervention unit cost. When starting a costing study, it is important to describe the intervention and all the outputs and inputs required to produce the intervention (the production process). For example, in the instance of TB Treatment (Table 1), one would first define the intervention unit costs e.g. the Cost per person completing treatment for children with pulmonary TB having taken first line treatment in the context of a hospital delivering TB care). This intervention ‘unit’ cost can be broken down into the direct (mean cost per output) and ancillary (mean cost per additional output that supports the delivery of health services). The direct and ancillary service ‘unit’ costs can be further broken down into activity costs, which are the costs for each action required to provide services. The activity costs are in turn determined by the quantity of input multiplied by price (see Table 3 in Appendix 2). To cost an intervention, it is necessary to understand and describe this production process and build up the cost from the different components to ensure the cost is not biased. Much of the work of costing involves describing this detail, often together with TB service planners. For instance, for drug sensitive TB (DS-TB) treatment, one needs to include the cost of all the capital items/assets or providing outpatient visits (building, training, vehicle, equipment and furniture unit costs) to the recurrent cost per visit (overhead utility costs and staff costs). The cost per DS-TB treatment visit is then added to the diagnostic test cost per DS-TB treatment case and then the drug cost per DS-TB treatment case. To determine the total cost of treating a DS-TB case, the cost per visit would be multiplied by the average number of visits made added to the diagnostic test cost and drug costs multiplied by the number of tests performed and drugs received respectively. Generic descriptions of the TB interventions are given in Appendix 2 which can be adapted as needed to define the interventions in the setting selected. 7 Section B. Defining TB interventions Ta bl e 1. S am pl e of A nn ex 3 fr om R ef er en ce C as e [5 ] f or T B tr ea tm en t In te rv en ti on cl as s In te rv en ti on In te rv en ti on D et ai ls P ha se Te ch no lo gy P la tf or m (c ho os e m or e th an o ne o nl y w he n ne ce ss ar y) P op ul at io n (c ho os e m or e th an o ne o nl y w he n ne ce ss ar y) S TA N D A R D U N IT C O S T IN TE R V E N TI O N (q ua li ty -a dj us te d un it co st ) S TA N D A R D U N IT C O S T S E R V IC E D IR EC T S TA N D A R D U N IT C O S T S E R V IC E A N C IL L A R Y TB tr ea tm en t TB T re at m en t Tr ea tm en t o f ac ti ve T B w it h ob se rv at io n an d po ss ib ly pa ti en t su pp or t In te ns iv e C on ti nu at io n F ir st -l in e tr ea tm en t R et re at m en t S ec on d- lin e tr ea tm en t Th ir d- lin e tr ea tm en t P al lia ti ve c ar e M on it or in g te st s (f or st at us , a dv er se ev en ts a nd nu tr it io na l as se ss m en t) Fo ll ow u p of de fa ul te rs M -h ea lt h A R T re gi m en if H IV + H ou se ho ld C om m un it y P ub lic f ac ili ty P ri va te f ac ili ty H os pi ta l ge ne ra l H os pi ta l T B C hi ld re n A du lt s (H IV +, H IV -) A du lt s (p ul m on ar y TB , E P TB ) A du lt s (D S -T B , M D R -T B , pr e- X D R -T B , X D R -T B ) C os t p er tr ea tm en t m on th D S -T B C os t p er tr ea tm en t m on th D R -T B C os t p er tr ea tm en t m on th M D R -T B C os t p er tr ea tm en t m on th p re -X D R -T B C os t p er tr ea tm en t m on th X D R -T B C os t p er p er so n tr ea te d C os t p er tr ea tm en t m on it or in g C os t p er p er so n co m pl et in g tr ea tm en t C os t p er ou tp at ie nt v is it C os t p er in pa ti en t b ed - da y C os t p er D O T vi si t c om m un it y C os t p er D O T ou tp at ie nt v is it C os t p er d ru g pi ck u p vi si t C os t p er co m m un it y tr ea tm en t v is it C os t p er m ic ro sc op y C os t p er o th er te st C os t p er D S -T B re gi m en C os t p er s ho rt D R -T B r eg im en C os t p er lo ng D R -T B r eg im en C os t p er pe rs on m on th pa ti en t s up po rt C os t p er pe rs on p at ie nt su pp or t C os t p er p at ie nt su pp or t v is it C os t p er co m m un it y ev en t Costing guidelines for Tuberculosis interventions8 Section C. Study objectives and set-up Overview This section addresses how to determine the broad objectives and scope of the costing study, as well as the study set up. It briefly describes the various steps with examples from recent costing studies with a focus on the study methodology and design. Depending on the aim of the study, the steps may take a different order than laid out here (in Figures 2 and 3). In practice a TB costing study involves the following pre- data collection activities. Fig. 2. Example of activities for national costing study (example of Value TB) Pre-data collection activities n The initial conceptualization of the study – deciding the research purpose n Setting up the core research team n Planning meetings to define TB costing needs, ascertain study objectives, agree on activities and responsibilities n Identification of funding sources for the study n Where relevant, sampling of countries n Where relevant establishing links with sampled potential countries and investigating their interest n Where relevant, initial country visits to set up country teams with the NTP n Develop country budgets and initial study timeframe planning n Any relevant contracts to partners issued n Writing specific country protocols n Ethical approval processes n Establish technical advisory group (national and international) n Training of research staff, primarily research assistants n Adaptation and piloting the data collection tools 2. Setting up country links/ selection of study partners and establishing country teams 4. Study protocol formation and submission of protocol for ethical approval 5. Training and piloting 1. Initial conceptualization 9 Section C. Study objectives and set-up Pre-data collection activities Initial conceptualization and defining the study team (three to six months) 1. The first step will be the initial conceptualization of the research purpose and scope as well as setting up the core research team who will oversee the study. Applications for funding may need to be made at this stage. If an external international study team is involved, this is the time to establish links in potential countries and investigate their interest. 2. The core research team should hold planning meetings to define TB costing needs, develop a study question, ascertain study aim and specific objectives, and agree on activities, roles and responsibilities of each of the members. 3. If a multi-country study is selected, at this stage researchers will need to collate global data so that sampling of countries can be undertaken (e.g. sampling of high TB burden countries by region). 4. Inclusion of study partners (NTP, local research group, other researchers, technical assistance support) should be considered. When funding is awarded, sub-contracts from the study lead to other partners may also be required, which may take additional time. Study protocol formation and submission of protocol for ethical approval (three to six months) 5. A protocol development workshop can be an effective platform to develop a common vision, establish the purpose of the costing and decide what is within (and out of) the study scope at the start of the costing study. Specific roles and responsibilities of the team members can be considered. Protocol development should be initiated, as well as proposed budget and timeline. 6. At this point, all relevant information that is available at the country level for TB services for the sampling frame for site selection should be collated. 7. Country adaptation of existing tools and inclusion of specific country protocols (standard operating procedures) is required. 8. Protocols need to be submitted in a timely manner for appropriate ethical approval. While an expedited review can be requested if no patient records will be used, with patient observation the process of review may take longer. 9. A technical advisory group (national and/or international) should be established to assist with decision-making and strategic direction. Training and piloting (two months) 10. Once ethical approval is given, a study pilot can be undertaken. Together with initial training, this process can take around two months. The analysis of the study pilot can help fine-tuning of generic tools (such as the Value TB Costing Tool Suite) and direct the data collection. 11. Throughout the process, training is necessary to familiarize data collectors with the tool, the purpose, scope and aim of the study. 1. Initial conceptualization 2. Setting up country links/ selection of study partners and establishing country teams 4. Study protocol formation and submission of protocol for ethical approval 5. Training and piloting Costing guidelines for Tuberculosis interventions10 Initial conceptualization and defining the study team Overview A costing study is initiated where a need for primary costing has been identified based on what the cost estimates are going to be used for, and the level of availability of existing cost data. There may be some cases where a country would not need a primary costing to be undertaken for instance if cost data already available is detailed, recent and of good enough quality for the required purpose (see Reference Case [5] for further details). 1. Understanding the purpose of the costing study The first step in any costing study is to identify what the costs are needed for and defining the purpose of the TB costing study [5]. Costing can be done with a specific purpose in mind. For instance, costing could be applied if a new technology (e.g. loop-mediated isothermal amplification (LAMP)) is being rolled out and one wants to assess cost and cost-effectiveness in a particular setting (e.g. an urban district in the Republic of Congo). Alternately, the purpose for the study can be more general, for instance costing all TB interventions in a particular country (e.g. treatment costs in Yemen) to inform resource allocation between different TB interventions. Methods used to estimate the cost of health interventions or ‘costing’ will depend on the purpose of the study. To reduce expenditures, any primary data-derived cost estimate ideally should be able to be used for multiple purposes. However, in practice, costing studies are often commissioned with a specific purpose in mind, and the methodological choices will be driven by that purpose. Each purpose may require different approaches to definition and measurement (i.e. the unit of the costs reported). There are several groupings of potential purposes that are outlined below. A. Economic evaluation and/or priority setting Certain cost estimates assess allocative efficiency of either single or multiple TB interventions. Allocative efficiency is achieved by maximizing health impact among different (competing) health care interventions within a given (restricted) health budget. There are various approaches and processes that help decision-makers assess allocative efficiency of investment in TB interventions. These include cost-effectiveness analysis and benefit cost analysis. Assessing the cost-effectiveness of alternative uses of resources is now recognized as a core piece of information for decisions around whether to invest in new technologies or set priorities across different strategies and interventions, and as part of the WHO TB guideline development. For example, cost-effectiveness can inform the design of health care benefit packages provided by governments or insurers. As many low-income countries move towards national insurance schemes, these assessments can estimate reimbursement levels. B. Medium- and long-term financial planning, budget impact and resource requirements estimation Cost estimates are also used to predict expenditures in the medium (three to five years) and longer term. Examples include using costs to inform budget impact 11 analyses and budgets for national strategic plans; support medium-term expenditure frameworks; develop financial plans for investment cases; and produce ‘global price tags’. These analyses support national planning but can be used in both national and global fundraising efforts for increased investment in a specific global health area. For example, since 2009, the South African government has collected cost data to predict the medium- and long-term costs to the South African national public sector antiretroviral treatment (ART) programme, which was then used to advocate for increasing funding for ART. C. Budgeting and price-setting Cost data may also be useful to those planning both the incomes and expenditures of health providers (or funders). Costs can predict expenditures by specific budget holders and help to set prices for specific services. Budget settings would include annual programme budgeting by managers for routine health services, or a specific provider, or could refer to an investment case for a specific study or a funding application. For some organizations, such as insurance companies or private providers, budgets involve planning incomes, and prices for specific goods and services for the coming year and costs are core elements in this process. D. Technical efficiency analyses Costs can also be used to explore differences and drivers of technical efficiency between providers and/or modes of delivery (integrated services, platforms, level of decentralization, etc.) for health interventions or services. Technical efficiency analyses are usually conducted through the comparison or analysis of costs over multiple sites, or by comparing actual costs to benchmarks. Technical efficiency can be defined as assessing the best way of spending a given (limited) budget to produce a set of TB services. Cost data from studies that help to estimate technical efficiency can also help identify the minimum efficient scale of operation or providing insights into areas of efficient or inefficient practices. For example, WHO, the United Nations Children’s Fund (UNICEF), and Gavi, the Vaccine Alliance, use unit cost data to identify and design efficient supply chain logistic systems in immunization activities. For each of these purposes, there may be different theoretical and practical reasons that a certain type of cost or methodological approach is preferred. For example, where countries are moving towards UHC, the need to generate reimbursement rates and to understand the comparative value of new technologies (i.e., applying economic evaluation/and or priority setting) creates a demand for unit cost data that are comparable across diseases and health services, follow a standardized methodology, and reflect economic cost. In contrast, cost data for technical efficiency studies may need larger sample sizes, have a different perspective, and need additional information about cost determinants collected to enable analysis. For the purposes of financial planning and resource requirement estimates, financial costs are generally needed rather than economic costs (see Principle 3 [5]), and disaggregation of prices and quantities in unit cost reporting is helpful. The Reference Case [5] explains which type of cost can be used for which purpose. Section C. Study objectives and set-up Costing guidelines for Tuberculosis interventions12 2. Establishing the research team The core research team may be set up before, during, or after deciding the costing purpose. This is the group that will oversee the study, define the scope, and bear primary responsibility for applying for or sourcing funding for the study. The core research team will also develop a study question, plan study aims and objectives, decide what the study activities will entail and identify the roles and responsibilities of each team member. The core research team may be comprised of individuals in the country of interest or outside of the country or countries included in the study (as was the case with Value TB). Careful consideration should be given to appropriate study team composition and roles and responsibilities. A range of skills sets may be required. For instance, the primary investigator will need experience in protocol writing, ethical applications, managing teams, TB and costing generally; those in the field doing the data collection should be organized, keep well-documented notes and records, be able to understand and disentangle different clinical TB procedures and processes, enquire and interview, and report back to the study co-ordinator. The study co-ordinator should have good oversight of the data collection process, and be able to provide additional guidance and training if needed and to identify any errors in data collection as they arise. Appendix 10 contains a sample terms of reference for the costing team. Box 1. Selecting a study team for Value TB Core Research Team For Value TB, it was important to select individuals with extensive previous TB costing experience and a current interest in the field, to oversee the study to its completion. Three institutions were selected to be involved: the London School of Hygiene and Tropical Medicine (LSHTM); the Global TB Programme at WHO; and the Health Economics Unit, University of Cape Town (HEU UCT). Setting up country links/selection of study partners and establishing country teams At a country level, the NTP took responsibility for the TB costing, supported by the core team of seven researchers from the three institutions listed above. The NTP was responsible for selecting the principal investigator (PI) within the country (this role was given either to someone within the NTP with prior costing knowledge or to an external principal investigator (PI) from a consultancy or academic institution in the country with experience in TB costing such as a health economist). In Kenya, this PI role was shared between a senior member of the NTP (National Tuberculosis, Leprosy and Lung Disease Program (NTLP-P)) and a senior health economist and researcher at Kenya Medical Research Institute Wellcome Trust (KEMRI-WT). The country PI formulated the country specific protocol (with input from the broader team) and ensured its timely submission to ethical committees. The PI supported by the NTP focal point for the study also communicated with public and private facilities to ensure that permission had been obtained, and that data collection would be welcome. Piloting and training were organized by both the country PI as well as the core research team. The PI and NTP were responsible for assigning the remainder of the within-country research team, generally comprised of research assistants and data managers hired by the PI. Research assistants’ main roles were data collection at the facilities and centrally (when data such as salary grades were not available at the facility) as well as data cleaning and some primary analysis. If a data manager was employed, his/her role was to manage incoming data and to ensure the quality of this data. In addition to the core country team, a national advisory committee or task force was established to provide inputs in the initial stages as well as later stages of data analysis and dissemination. This task force met initially to discuss results, and were contacted regarding specific issues as needed. An international advisory panel was also established, hosted by the WHO Task Force on Impact Measurement. The rest of the panel was made up of members (advisors and stakeholders) linked to the GHCC, as well as others who are involved in the economics of TB. The members comprise a mix of global agencies, TB economic modelers, NTP representatives and ‘costing experts’. A 36-month duration of funding was applied for through the Bill and Melinda Gates Foundation. 13 When deciding an appropriate timeframe and timeline, planners should consider the trade-off between the number of staff hired and the amount of time needed for data collection. Generally, it takes a trained data collector one week to collect good quality TB cost data at a facility (this of course will vary based on the facility size, the way records are stored at the facility and the number of interventions to be costed at a given facility). However, as more staff are involved the role of a coordinator becomes even more crucial as facilities will be seen in parallel, and multiple data points will need to be checked for consistency and errors. With larger groups of data collectors, there may be a need for greater investment in ongoing training. Study protocol formation and submission of protocol for ethical approval Overview This section summarizes the main elements of a draft study protocol; a draft protocol outline is provided in Appendix 6. The protocol has been developed as part of the Value TB study which closely follows the Reference Case [5] as a guiding document. The Value TB study design and methodology can be applied in small (<10 sites) or large (>10 sites) costing studies. Study protocols outline objectives, present the detailed study design, develop a timeline and budget. Objectives and scope are described below, with more detail on the methods used presented in Section C. The process should closely involve cost data users from the start, and ideally the initial draft of the protocol should be developed through a workshop to facilitate a participatory process. These initial stages can be time-consuming if starting from scratch. However, adapting the protocol in Appendix 6 and associated Value TB Costing Tool Suite can accelerate the study design phase considerably. 1. Specifying the study objectives The primary output from a costing study is a dataset of unit costs; this dataset should be constructed along the lines outlined in Annex 3 of the Reference Case and Appendix 3. For the Value TB study, the output was a nationally representative set unit costs (when feasible) for the delivery of TB interventions and services in five countries. The dataset should be eventually made available in a disaggregated form, as this facilitates future analysis and decision-making at the country level and by researchers. Breakdowns of data presented in Value TB include: n prices and quantities of inputs by site; n costs broken down by activity and level (service-level versus above-service level); n economic and financial costs by provider/payer (i.e. The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) versus NTP-funded interventions/resources); and n ‘real world’ and ‘per protocol’ costs where possible (see Principle 3). Section C. Study objectives and set-up Costing guidelines for Tuberculosis interventions14 2. Perspective of the evaluation These guidelines have been developed to guide costing of TB interventions from the perspective of the providers of health services. The provider perspective takes the point of view of the provision of services; the costs are those incurred by a hospital, clinic or TB facility providing the services. WHO has developed a ‘Tuberculosis patient cost surveys’ handbook which will guide the user in collecting patient costs relating to TB [10]. A patient perspective assesses the costs from the patients’ perspective, and considers direct patient costs such as medical out-of-pocket payments or non- medical expenses (transport, relocation costs), as well as indirect costs which relate to productivity losses such as time off work. Some data can be easily collected at the same time or may include the same information, such as time with a healthcare provider, and so it can be worthwhile to include both the provider and patient perspective in a study (i.e. a societal perspective). 3. Site selection/sampling There are several different approaches to sampling. Random sampling ensures that the sample is representative of the population it characterizes, i.e. that each individual in a population has an equal chance of being drawn. In order to obtain a random sample a sampling frame is necessary. A method for stratified random sampling using a sampling frame is described below. The strata are the subgroups that should be represented which should also be mutually exclusive. There are other non-random methods for sampling such as convenience and purposive. The advantage of convenience sampling is that selection is based on easy inclusion or willingness to participate, although this can introduce bias. Purposive sampling can be suitable if it is necessary to include something that is rare in the broader population (such as patients with extensively drug-resistant TB (XDR-TB)) but may not be desirable if more broad costing is being done (i.e. DS-TB pulmonary TB). In principle the sample size of a costing can be determine with a set precision in mind [11]. Depending on the purpose of the cost estimation, the sampling frame may involve the selection of countries, geographical regions within countries, sites within regions, patients within sites, and different client groups. The purpose will also determine the most appropriate sampling method and size. For example, some financial planning processes will require the collection of data from different site types. For economic evaluation, the aim is usually to compare the ‘intervention’ with the ‘comparator’ and this will determine the method used. For the sampling process, the first step is to Box 2. Study objectives The XTEND study had the overall goal of understanding how Xpert® MTB/RIF should best be used under conditions of national roll-out by determining its effectiveness and cost-effectiveness and modelling these data to project the impact at a population level in South Africa.a This goal required empirical costing in a ‘real world’ setting. The objective for the costing component of the XTEND project was therefore: To estimate the unit cost per test and total costs per laboratory for Xpert® MTB/RIF and microscopy tests during Xpert® MTB/RIF roll-out. a Vassall A, Siapka M, Foster N, Cunnama L, Ramma L, Fielding K, et al. Cost-effectiveness of Xpert MTB/RIF for tuberculosis diagnosis in South Africa: a real-world cost analysis and economic evaluation. The Lancet Global Health. 2017;5(7): e710-e719. 15 synthesize information that is available at the country level for relevant TB services to outline the sampling frame (from which the eventual site selection is made). Due to logistical challenges and budget constraints, most cost estimates in low- and middle-income countries have been typically conducted on a small number of sites or locations (<10), though in recent years, larger studies have emerged, particularly in HIV. Where large studies have occurred, they have demonstrated a high variation of costs, suggesting that the common practice of estimating costs on a small sample may produce highly unrepresentative results [15]. However, even if a few sites are selected, explicit consideration (and transparency) of the sampling frame and selection method can at least assist others apply cost estimates to other settings. Depending on the structure of the health system in one’s setting, developing the sampling frame will require determining where the interventions of interest take place. For instance, a screening for TB symptoms might take place in a clinic as an Box 3. Sampling in large (>10 facilities) costing study: example from Value TB site selection/sampling Given the objective of the Value TB study (to assess the costs of all TB interventions in five countries in order to update current data and inform users of the cost data, such as modellers and policy makers), sampling was done on two levels. The first level was to select countries based on five criteria: budget, study team capacity, data availability, representativeness and feasibility. In terms of budget, the sample size for participating countries was agreed upon with the funder based on budgetary considerations. Data collection was budgeted to take place in five countries. Countries with the highest burden of TB, TB and HIV coinfection and multidrug-resistant TB (MDR-TB) were prioritized. Only one country with extensive hospitalization due to MDR-TB was selected and hospital costing was simplified due to the limited study team capacity and limited time. To assess data availability among the countries of interest, published literature was mapped from the GHCC database (https://ghcosting.org/pages/data/ucsr/app/) by type of intervention. Countries were excluded where data were considered recent and sufficient. Selecting a wide range of countries is helpful when only a few can be studied. In this case, rather than comparing randomly chosen countries, countries were selected to represent a range of income levels and geographical regions. Finally, feasibility was considered when selecting the order in which countries were approached. Feasibility included both local NTP interest in the study and capacity to collaborate (on-going research platforms/ partnerships); both aspects are critical to ensure cost data produced is relevant and useful to countries so that it ultimately contributes to decision making processes. The second level of sampling/selection took place within the five countries. Preliminary data was collected regarding the TB interventions offered at different facilities levels, population density of regions, and TB notifications etc. The focus of the facility selection was to obtain a sample of facilities to estimate unit costs for a comprehensive set of TB interventions and, where feasible, to calculate a nationally representative unit cost. Again, budget played a role in the selection of 24–30 facilities per country. The selected facilities followed a standardized sampling strategy shared across the five countries. Three regions were purposively sampled to reflect a high, medium and low burden of TB respectively based on population size and cases of TB as well as urbanicity as a proxy for spread of facilities/accessibility of services. A stratified random sampling approach was used to obtain a sample of facilities within the following strata: level of care, ownership (public, private), and diagnostic interventions available (availability of Xpert® MTB/RIF, microscopy and none) to ensure a representation of facilities in each stratum (facilities with very low volume of TB services were excluded). These strata were selected as they represent important determinants of cost variation. If a facility refused to take part in the study, a substitute facility from the same strata was selected from a ‘substitution’ list. Section C. Study objectives and set-up Costing guidelines for Tuberculosis interventions16 outpatient whereas a microscopy test would take place in a laboratory either at the clinic or peripherally. Consideration should also be given to how to access data for the target population and the epidemiological context in one’s setting. For the intervention(s) being costed, coverage level or phase should be noted: the cost may differ if an intervention has just been piloted or is well-established. 4. Timeframe and budgeting The costing study timeline is usually around six months or longer (Figure 3). Costing selected TB services in a smaller sample (less than 10 sites) should take less than a year. However, costing all TB services in a nationally representative sample (such as in the example of Value TB) using the current TB guidelines and Value TB Costing Tool Suite (described in Appendix 8) will take approximately one year. The average budget for one Value TB country, for approximately 20 sites (taking around 12 months) was in the region of US$100 000 (excluding external technical support from core research team). This includes around a third for travel funds, training and meeting funds; and the rest for staff (two co-principal investigators spending 5% and 10% of their time respectively; a study co-ordinator working 10%; a data manager working 10%; and four research assistance/data collectors working 25% each for the year). Fig. 3. Example of timeline for national costing study (example of Value TB) n Conceptualization n Country links n Country teams n Protocol formation and ethical approval n Training and piloting n Data collection, preparation and analysis n Dissemination YEAR 2 YEAR 1 5. Ethical consideration/approval As costing work requires review of medical records and interviews with staff, costing studies require ethical approval. If a costing study is done alongside a larger existing study which already has such approval (such as a study collecting widespread epidemiological data on TB with a costing component), expedited ethical approval may be sought or, if the TB costing work is included in the existing study, this may be combined with the proposal sent for ethical approval. If a study is a stand-alone TB costing study, then ethical approval will need to be sought from all relevant parties. Ethical approval can take time to obtain depending on the setting and whether patient records or observation of patients during TB care are included (the ethical approval can take anywhere from one to six months). This needs to be considered when planning the overall study and timeline. 17 Box 4. Ethical approval for Value TB In the case of Value TB, ethical approval was obtained from the three institutions involved (LSHTM; Global TB Programme, WHO; Health Economics Unit UCT). In addition, ethical approval was granted by the medical ethical committees within the five relevant countries for instance in Kenya through the Kenya Medical Research Institute (KEMRI) and WHO African Regional Office. Permission to gain access to the selected facilities was requested in each of the five countries. In Kenya this was done by approaching the Ministry of Health at a County Level with a letter applying for entry (with letters of ethical approval attached), and then at a facility level through telephone communications with the facility managers stating that the relevant ethical approval and County Level permissions had been obtained. The NTPs were central to the facilitation of this process as well as to data collection teams accessing facilities. Section C. Study objectives and set-up Costing guidelines for Tuberculosis interventions18 Section D. Designing data collection Understanding the production process In the costing approach, describing the outputs of interest (see Tables 2 and 3) allows planners to consider what needs to be estimated in terms of the cost per activity broken down into cost per output. Activities can occur at different platforms, for instance at health facilities, or as outreach, mobile or household visits. The first step consists of establishing and defining the interventions that require costing. While the protocol will describe TB service delivery process as per country guidelines and the “generic” Data Collection Tool (from the Value TB Costing Tool Suite) will be adapted accordingly, data collectors will need to reassess the production process of each TB service at a given facility. Where interventions are placed will depend on the delivery mechanism and will vary by setting. For example, an intervention may be housed within the health system level, at different facility types, in the community, or in facilities such as non-governmental organizations (NGOs), or faith-based organizations. At the facility level, possible TB interventions include: vaccination; TB case detection and diagnosis; PCF, ACF and ICF; TB treatment; TB prevention; TB infection control. Above the facility level, TB interventions include: development of strategic plans, programme reviews, national and regional meetings, surveys, management and information systems, supervision, procurement and supply chain management, transportation of specimens, advocacy, technical assistance, training, accreditation and quality assurance of laboratories, community media, information, education and communication (IEC) campaigns or any partnership activities (see Appendix 2). For each intervention, data collectors will then need to understand the workflow of the ‘facility’ (health facility, laboratory, pharmacy, community outreach etc.) (see Figure 4 and Appendix 11; Case Study 1 as examples). This entails asking questions and observing practices (how services are provided and by whom) and the structure of how the services are delivered. A good starting point is a discussion with the clinic manager or TB nurse or laboratory manager about the facility. For instance, within a health facility at an introductory meeting questions could include: n Where are patients seen? n Is space shared between TB and other services? n If TB and HIV care are integrated, how (ie. physically, temporally, clinically)? n Are TB patients kept separate from other patients? n Where do patients wait? n Which staff attend to the patients? 19 n Is staff time shared between TB and other services (such as outpatient care, curative medicine, noncommunicable diseases (NCDs)/chronic care, maternal and child health, family planning, ART)? n Which days are TB services offered (every day or only selected days)? n Do patients make appointments or come on an ad hoc basis? n How often do patients come for treatment? n Do patients come with a treatment support partner, or can send one to collect medicine? n Where are tests sent? n What is the process for referring tests (do they send a letter with a patient, phone the laboratory/private facility)? n How are results returned? n Is transport or vehicles provided to staff or patients? n How often has training occurred in the previous year? n How many TB patients are seen on average in a day? A process flow diagram can be helpful at this stage (often drawn immediately after the site visit) and this can then be used to validate the process by asking the staff to look at the diagram and confirm that it is accurate representation of what happens within the facility (see Figure 4). This is then used to ensure that all aspects are being costed and to better understand cost estimates within the context of the facility. Section D. Designing data collection Fig. 4. Example of a process flow diagram for smear microscopy in a laboratory Smear microscopy process in laboratory Room 1 (reception) Personnel: Data clerk Room 2 (laboratory) Personnel: Laboratory technician Room 3 (dark room with microscope) Personnel: Senior laboratory technician n Specimens delivered to laboratory n Patient information entered into database and processing sheet printed n Printed barcodes attached to sputum containers n Batch of 15 decontamination of sputum in a biosafety cabinet n Preparation of slides n Adding of chemicals and reagents n Multitasking when slides are drying n Batch of 15 decontamination of sputum in a biosafety cabinet n Preparation of slides n Adding of chemicals and reagents n Multitasking when slides are drying n Reading of all slides for the day (5 sets of batches of 15) n No multitasking during this reading Costing guidelines for Tuberculosis interventions20 Within a laboratory, it is useful to speak to the laboratory manager and to observe the tests being processed (which is slightly more straightforward as there are no patients present). Some laboratories keep standard operating procedures that record the diagnosis delivery process, which can then be verified through an interview with the laboratory manager who has an overview of TB diagnostic services. This process of workflow mapping can help data collectors to identify inputs, or resources, which need to be measured. Figure 5 shows the capital and recurrent inputs to consider at each level of the health system. The platform refers to the type Fig. 5. Capital and recurrent inputs Platform Capital costs (input) Recurrent costs (input) Public health facilities (including TB Care, HIV care, Hospital general, Hospital TB) and laboratories Private health facilities (including TB Care, HIV care, Hospital general, Hospital TB) and laboratories National TB Programme Ministry of Health Non-governmental organizations Households Community Mobile Prisons Schools (through health facility outreach) Building space Quantities: Size of department/ clinic/room/area/building Prices: Value if sold today Vehicles (transportation) Quantities: Number of vehicles Prices: Current market value of all vehicles Equipment and furniture Quantities: Inventory of equipment and furniture Prices: Current price/ replacement cost for the listed equipment and furniture Training (the effects of which will last more than one year) Quantities: Duration of training, number of participants trained, number of trainers Prices: Training fee per participant (venue, catering, training materials, training staff salaries, per diem) Above service level cost Quantities: Number of facilities served Prices: Expenditure on above service level activities such as NTP support, TB drug delivery Recurrent expenditure/ Overhead inputs Quantities: Per facility Price: Annual expenditure Personnel (Staff costs) Quantities: Staff time on task(s) measured using timesheets/ observation/interview Prices: Salaries/wages of staff Supplies Quantities: Quantity of consumables used Price: Annual expenditure/price of consumables etc Drugs Quantities: Number and type of drugs/regimen used Price: Current price of medication Diagnostic tests Quantities: Number and type of diagnostic tests/supplies used Price: Current price of diagnostic test/supplies Other This could include calibration of instruments, chemicals and reagents, administration of cash transfer, quality assurance, 21 Section D. Designing data collection of facility or structure (such as community outreach, visits at the household level, or schools) used to administer TB. The prices and quantities for both capital and recurrent inputs are outlined in Figure 5 to illustrate which prices and quantities of items should be collected in the different platforms. Mapping of interventions After fully defining the interventions and classifying them according to the GHCC intervention definitions [5], the available interventions and technologies in each facility level should be mapped. This will establish where the relevant interventions will be captured when conducting the costing at the facility. A new blank Data Collection Tool should be used for each facility (see Appendix 8). The facility costing tool has been organized to capture the description of the health facility, followed by service utilization and overhead items. It also includes default lists of staff type, equipment, consumables, chemicals and reagents and drugs used in the TB interventions provided at the facility. The quantities and costs of each item can be inputted into these lists. Additional items can also be added to the lists. Defining inputs Another consideration involves which inputs need to be included in order to work out the unit cost from the provider perspective. The broad groupings are capital and recurrent categories with specific inputs in these categories (Figure 5). Depending on the platform costed, these can include capital (building space; vehicles (transporta- tion); equipment and furniture; training (the effects of which will last more than one year) and recurrent inputs (recurrent expenditure/overhead inputs, personnel (staff costs) and supplies) that make up a visit cost. Input costs of diagnostic testing and medication (drugs) are added subsequently, as these are the most likely to change or need updating. Costing approaches There are a number of core principles laid out in the Reference Case on how to measure and value inputs. The two main (but complementary) approaches to estimating costs are bottom-up and top-down (see Principle 7 in the Reference Case [5]). Perfect efficiency as represented by guideline or normative costing in a system is rare in real health systems, and it is much more likely that the costs in the real world reflect some inefficiency both in capacity and production. In order to capture real world costs, we can use bottom-up costing of real world services to capture process inefficiency and top-down costing to also capture capacity inefficiency (see Figure 6). If both time and resources are available to the study team, both top-down and bottom-up should be undertaken in order to have a range of costs for most efficient practice (bottom-up) to a cost that includes inefficiency (top-down). Bottom-up costing Bottom-up is a detailed approach to costing which involves detailed measurement of all resources used in the provision of a specific health service or intervention. This involves the “ingredients” approach where all resources (i.e. inputs) utilized or consumed in the production of a service are costed separately. Bottom-up costing can Costing guidelines for Tuberculosis interventions22 use interviews (as a minimum), time-in-motion style data collection, observation, or work sampling techniques of health providers. Methods of estimating building space, staff, equipment and furniture are detailed here, with further detail on all inputs provided in Appendix 8. Estimating resource use Estimating resources used requires assessing the quantities of inputs. This may be from routine data, patient file abstraction or alongside a study. The methods used to estimate the levels of inputs used in an intervention can bias estimates, and therefore should be reported. For instance, observation can be biased in that it may suffer from the Hawthorne effect of observation bias, where more efficient practice is presented due to an awareness of being studied. The methodological specification is to report the source of data, report the approach used to sample or fill missing data and justify why the approach was selected given the potential for bias caused by misreporting or incomplete data [5]. Measurement and valuation of space The size of all the buildings at the facility should be reported in square metres (m2). The best-case scenario is if the facility has a record of the size in square metres or better still a map with the dimensions and floor plan. If this is unavailable, one of the following options for estimating the facility size can be used: n value of the building, obtained by sourcing the current replacement value; n original facility records inflated to the current value; n insurance valuation of the building; n tax forms for the building or government rate for stamp duty; n cost of recent renovations; n rental value from lease agreement; n where total land space is known but building size is not, estimation of the proportion of land that the building occupies; or n physical measurement of the space with a laser distance measurer or a tape measure or street mapping software (e.g. Google Earth). Fig. 6. Estimating efficiency Capacity efficiency Production process efficiency Perfect efficiency 23 Measurement of equipment and furniture This is generally done through an itemized count or reliance on an existing detailed list per department. Measurement of staff time Calculation of quantities of staff time using a bottom-up approach can be assessed through either an observation or interview. This is calculated by multiplying the price of staff time per minute (derived from their cost of employment and the number of minutes they work for in a year) by the number of minutes for a TB service collected through either observation (ideal) or interview (as a minimum). Valuing resources Once all resources have been identified for each facility/place, these need to be quantified and valued. Figure 4 illustrates how this could be done for both capital and recurrent costs. Examples of prices for different inputs have been given. If research costs are part of the intervention there may be a need to include these, however that is up to the judgement of the researcher. Data sources should be listed, for instance NTP under the Ministry of Health or TB clinical records etc. Valuation, especially for economic costs, is important as it is a way of making unit costs comparable. Current prices for consumables, medical equipment may be obtained from the records kept by a facility or from a medical supplier. Pricing for furniture and equipment may be kept at a facility level or more likely will need to be requested from a furniture or medical equipment supplier. See the Reference Case [5] for further detail on exchange rates, discount rates, etc. Estimation of total costs Total costs are estimated through the multiplication of unit costs with the total utilization for the period of interest. Top-down costing The top-down approach is a more aggregative method which involves estimating the cost of delivering a TB service (e.g. a hospitalization for a TB patient) by using a national average figure or expenditure accounts from a facility. The top-down approach involves preferably the step-wise allocation of the facility expenditure by various departments (usually of a complex organization) to specific cost centres of interest. Criteria used to allocate shared resources should be explicit and reflect usage of each input. Where allocations have been made ‘top-down’, either to sites or within sites to services, or above-service delivery or overhead costs have been allocated, the criteria used and the relevant data sources of the allocation factors should be explained. As indicated in previous work, one can cost resources within a laboratory through top-down methods [13]. The top-down approach utilizing expenditure for different cost centres, departments or inputs considers inefficiency. The example of staff time is given here, while more detail for other inputs is provided in Appendix 8. Section D. Designing data collection Costing guidelines for Tuberculosis interventions24 Measurement of staff time top-down Top-down costing methods use the proportion of time for each TB output calculated from timesheets and the expenditure of facilities on TB services for staff (as derived from their cost of employment). Timesheets and interview may have an overestimation or underestimation of time being spent on tasks depending on staff ability to recall work practices and workload. Valuing resources top-down For salary information, facility expenditure and overhead costs (such as administra- tion, cleaning, kitchen, utilities, security, laundry, monitoring and evaluation, phar- macovigilance, maintenance), information is often obtained from a central level, for instance the finance department of a Minstry of Health. Fig. 7. Top-down allocation of costs within a laboratory Total cost of LED microscopy tests for TB (area of innermost circle only) 500 LED microscopy tests processed for TB; 1000 TB tests (all types) processed Allocation factor 500/1000=0.5 Total cost of TB diagnostics (area of two innermost circles) e.g. 1000 TB tests (all types) processed; 5000 all tests processed (TB and other) Allocation factor 1000/5000=0.2 Total cost of TB diagnostics $100000*0.2=$20000 Total cost of all tests performed in laboratory (TB and other) (entire surface area of circle) e.g. $100000 In a top-down costing of light emitting diode (LED) microscopy for TB diagnosis in a laboratory, the cost of the microscopy department would be separated from the total TB diagnostic costs for the laboratory using an allocation factor (such as the number of microscopy tests using LED divided by the total number of all TB tests processed in that laboratory multiplied by the total TB diagnostic cost for the laboratory). A separate allocation procedure may be needed to separate out the cost of processing TB diagnostic tests, if the cost of all diagnostic tests in the laboratory, TB-related and all others, are aggregated (see Figure 7). The allocation factor could be the total number of TB tests processed divided by the total number of all tests processed in the laboratory. 25 Ta bl e 2. C os tin g ap pr oa ch es A ct iv it y an d ot he r to ta l co st b re ak do w ns O ut pu ts B ot to m -u p co st in g (C os t c at eg or y in pu t b re ak do w ns ) To p -d ow n co st in g S it e- le ve l d ir ec t se rv ic e pr ov is io n O ut pa ti en t v is it Q ua nt it y (Q ) ( m in ut es ) * C os t p er m in ut e (p er so nn el ti m e of cl in ic al a nd n on -c lin ic al s ta ff ) Q (s qu ar e m et re s pe r m in ut e) * C os t p er s qu ar e m et re p er m in ut e (in fr as tr uc tu re in cl ud in g bu ild in g, eq ui pm en t, fu rn it ur e, v eh ic le s; o ve rh ea d in pu ts in cl ud in g ad m in is tr at io n, c le an in g, k it ch en , u ti lit ie s, s ec ur it y, la un dr y, m on it or in g an d ev al ua ti on /p ha rm ac ov ig ila nc e, m ai nt en an ce an d tr ai ni ng ) To ta l e xp en di tu re f or T B o ut pa ti en t d ep ar tm en t/ N um be r of TB o ut pa ti en t v is it s In pa ti en t b ed -d ay Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e of c lin ic al a nd no n- cl in ic al s ta ff ) Q (s qu ar e m et re p er m in ut e) * C os t p er s qu ar e m et re p er m in ut e (in fr as tr uc tu re a s ab ov e; o ve rh ea d in pu ts a s ab ov e) To ta l e xp en di tu re f or h os pi ta liz ed T B /N um be r of T B in pa ti en t v is it s H ou se ho ld v is it Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e, tr av el ti m e co st ) Q (m in ut es ) * C os t p er m in ut e (o ve rh ea d in pu ts in cl ud in g ad m in is tr at io n, s ec ur it y, m on it or in g an d ev al ua ti on / ph ar m ac ov ig ila nc e, tr an sp or t a nd tr ai ni ng ) To ta l e xp en di tu re f or T B h ou se ho ld v is it te am /N um be r of TB h ou se ho ld v is it s M ob ile c lin ic v is it Q (m in ut es ) * C os t p er v is it p er m in ut e (p er so nn el ti m e; ov er he ad in pu ts (e .g . c le an in g, la un dr y, m ai nt en an ce ); ve hi cl es , f ue l a nd e qu ip m en t) To ta l e xp en di tu re f or T B o ut re ac h ca re /N um be r of T B m ob ile c lin ic v is it s Tr ia ge (p eo pl e liv in g w it h hu m an im m un od efi ci en cy vi ru s (H IV ), di ab et es m el lit us , c hr on ic ob st ru ct iv e pu lm on ar y di se as e (C O P D ), ca nc er o r at te nd in g m at er na l a nd ch ild h ea lt h cl in ic s) Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e fo r cl in ic al an d no n- cl in ic al s ta ff ) Q (s qu ar e m et re p er m in ut e) * C os t p er s qu ar e m et re p er m in ut e (in fr as tr uc tu re a s ab ov e; o ve rh ea d in pu ts a s ab ov e) To ta l e xp en di tu re f or T B c ar e (in H IV c lin ic +d ia be te s cl in ic +C O P D +o nc ol og y cl in ic + m at er na l a nd c hi ld h ea lt h (M C H ) c lin ic )/ N um be r of c lin ic v is it s fo r TB c ar e in H IV cl in ic +d ia be te s cl in ic +C O P D +o nc ol og y cl in ic + M C H c lin ic D ia gn os ti c te st (s am pl e/ sl id e) a Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e of la bo ra to ry st aff ) Q (t es ts ) * C os t o f ‘ te ch no lo gy ’ ( in fr as tr uc tu re a s ab ov e; co ns um ab le s, c he m ic al s an d re ag en ts ; o ve rh ea d in pu ts , an d bi os af et y, q ua lit y as su ra nc e (n at io na l, re gi on al , su pr an at io na l) , m on it or in g an d ev al ua ti on , t ra ns po rt at io n of sa m pl es a nd r es ul ts to p at ie nt s, tr ai ni ng o f l ab or at or y st aff to o pe ra te th at te ch no lo gy (b ot h ca pi ta l a nd r ec ur re nt )) To ta l e xp en di tu re f or T B d ia gn os ti cs /N um be r of T B te st s pe rf or m ed D ru gs b … Q * C os t o f d ru gs To ta l e xp en di tu re f or T B d ru gs /N um be r of T B d ru gs di sp en se d Section D. Designing data collection Costing guidelines for Tuberculosis interventions26 A ct iv it y an d ot he r to ta l co st b re ak do w ns O ut pu ts B ot to m -u p co st in g (C os t c at eg or y in pu t b re ak do w ns ) To p -d ow n co st in g O th er te ch no lo gy c … Q * C os t o f o th er te ch no lo gy To ta l e xp en di tu re o f o th er te ch no lo gy (s uc h as s pu tu m sc re en in g) /N um be r of p at ie nt s tr ea te d us in g ot he r TB te ch no lo gy (s uc h as s pu tu m s cr ee ns p er fo rm ed ) S it e le ve l a nc ill ar y se rv ic e pr ov is io n P at ie nt s up po rt p ro vi si on pe r pa ti en t Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e fo r he al th ca re o r so ci al c ar e w or ke r) Q (s qu ar e m et re p er m in ut e) * C os t p er s qu ar e m et re p er m in ut e fo r co un se ll in g vi si t i f w it hi n th e he al th s ec to r (in fr as tr uc tu re a nd o ve rh ea d in pu ts a s ab ov e) A nd /o r Q * C os t o f c as h tr an sf er (i nc lu de s th e ac tu al c as h tr an sf er ; in fr as tr uc tu re s ur ro un di ng a dm in is tr at io n of th e tr an sf er (p er so nn el ti m e; in fr as tr uc tu re a nd o ve rh ea d in pu ts a s ab ov e; a nd in fo rm at io n te ch no lo gy , b an ki ng f ee s, e tc .) To ta l e xp en di tu re o f T B p at ie nt s up po rt /N um be r of T B pa ti en ts s up po rt ed S it e le ve l a nd a bo ve - si te le ve l o pe ra ti on al ac ti vi ti es : P ro gr am m e m an ag em en t (n at io na l a nd r eg io na l m ee ti ng s, p ar tn er sh ip ac ti vi ti es a nd te ch ni ca l as si st an ce ) Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e of c lin ic al a nd no n- cl in ic al s ta ff p ar ti ci pa ti ng a nd f ac ili ta to rs ’ t im e) Q (p ar ti ci pa nt s) * C os t p er p ar ti ci pa nt (v en ue , m at er ia ls , ca te ri ng , t ra ns po rt , a cc om m od at io n) To ta l e xp en di tu re o f T B p ro gr am m e m an ag em en t/ N um be r of T B n at io na l a nd r eg io na l m ee ti ng s, p ar tn er sh ip a ct iv it ie s an d te ch ni ca l a ss is ta nc e pr ov id ed S up er vi si on Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e of c lin ic al a nd no n- cl in ic al s ta ff ) Q (s qu ar e m et re p er m in ut e) * C os t p er s qu ar e m et re p er m in ut e fo r su pe rv is or y vi si t ( in fr as tr uc tu re in cl ud in g bu ild in g, e qu ip m en t, fu rn it ur e; o ve rh ea d in pu ts in cl ud in g ad m in is tr at io n, c le an in g, k it ch en , u ti lit ie s, s ec ur it y, la un dr y, m on it or in g an d ev al ua ti on /p ha rm ac ov ig ila nc e, m ai nt en an ce an d tr ai ni ng ) To ta l e xp en di tu re o f T B s up er vi si on /N um be r of T B s ta ff su pe rv is ed M an ag em en t a nd in fo rm at io n sy st em s Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e of c lin ic al a nd no n- cl in ic al s ta ff ) Q (s qu ar e m et re p er m in ut e) * C os t p er s qu ar e m et re pe r m in ut e (s up pl ie s, in fr as tr uc tu re in cl ud in g bu ild in g, eq ui pm en t, fu rn it ur e; o ve rh ea d in pu ts in cl ud in g ad m in is tr at io n, c le an in g, k it ch en , u ti lit ie s, s ec ur it y, la un dr y, m on it or in g an d ev al ua ti on /p ha rm ac ov ig ila nc e, m ai nt en an ce an d tr ai ni ng ) To ta l e xp en di tu re o f m an ag em en t a nd in fo rm at io n sy st em s/ N um be r pa ti en ts w it h TB R es ea rc h, s ur ve ill an ce an d su rv ey s Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e of c lin ic al an d no n- cl in ic al s ta ff , p at ie nt s, h ou se ho ld o r co m m un it y m em be rs a nd s ur ve y ad m in is tr at or s’ ti m e) Q (s ur ve ys p er m in ut e) * C os t p er s ur ve y pe r m in ut e (e qu ip m en t, so ft w ar e, m at er ia ls , t ra ns po rt at io n, s ec ur it y, tr ai ni ng , b ui ld in g, u ti lit ie s, a dm in is tr at io n, f ur ni tu re , cl ea ni ng ) To ta l e xp en di tu re o f T B r es ea rc h, s ur ve ill an ce a nd s ur ve ys / N um be r pa ti en ts w it h TB 27 A ct iv it y an d ot he r to ta l co st b re ak do w ns O ut pu ts B ot to m -u p co st in g (C os t c at eg or y in pu t b re ak do w ns ) To p -d ow n co st in g P ro cu re m en t a nd s up pl y ch ai n m an ag em en t To ta l e xp en di tu re o f T B p ro cu re m en t a nd s up pl y ch ai n m an ag em en t/ N um be r pa ti en ts w it h TB C om m un it y m ed ia /I EC / m ob ili sa ti on /a dv oc ac y Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e of c lin ic al an d no n- cl in ic al s ta ff ; a ux ili ar y st aff , c on su lt an ts a nd vo lu nt ee rs ) Q (s qu ar e m et re p er m in ut e) * C os t p er s qu ar e m et re pe r m in ut e (v en ue , m at er ia ls , c at er in g, tr an sp or t, ac co m m od at io n; in fr as tr uc tu re a nd o ve rh ea d in pu ts a s ab ov e) To ta l e xp en di tu re o f T B c om m un it y m ed ia , I EC , m ob ili sa ti on , ad vo ca cy /N um be r pa ti en ts w it h TB Tr ai ni ng Q (m in ut es ) * C os t p er m in ut e (p er so nn el ti m e of c lin ic al an d no n- cl in ic al s ta ff ; a ux ili ar y st aff , c on su lt an ts a nd vo lu nt ee rs ) Q (s qu ar e m et re p er m in ut e) * C os t p er s qu ar e m et re pe r m in ut e (v en ue , m at er ia ls , c at er in g, tr an sp or t, ac co m m od at io n; in fr as tr uc tu re a nd o ve rh ea d in pu ts a s ab ov e) To ta l e xp en di tu re o f T B tr ai ni ng /N um be r of s ta ff tr ai ne d La bo ra to ry s up po rt (a cc re di ta ti on a nd q ua lit y as su ra nc e in la bo ra to ri es )   To ta l e xp en di tu re f or la bo ra to ry s up po rt /N um be r of te st s pe rf or m ed A da pt ed A nn ex 3 o f t he R ef er en ce C as e [5 ]. In th is t ab le th e sy m bo l “ /” r ep re se nt s di vi de d by . Section D. Designing data collection Costing guidelines for Tuberculosis interventions28 The Standardized Value TB Costing Tool Suite In conjunction with this set of guidelines, a generic Value TB Costing Tool Suite has been developed in Microsoft Excel spreadsheets with aligning instructions in Microsoft Word (see Appendix 8). The Value TB Costing Tool Suite encompasses all the aspects one needs to consider for costing a variety of TB interventions in any country setting, which should be adapted to specific country contexts. The Value TB Costing Tool Suite consists of a list of all data required for costing (for submission to ethics), a Data Collection Tool (a unit cost generation tool), a separate Data Entry Tool, and draft informed consent forms. The rationale for having two instruments, one for data collection and one for unit cost generation stems from the need to simplify the data collection itself, leaving the data analyst to use the Data Entry Tool to clean data reported by research assistants/data collectors (through the Data Collection Tool) and to generate unit costs for the facility. The Data Collection Tool can be used by research assistants to collect data for one facility. The tool will essentially allow recording of quantity and price data collected from the facility for each of the TB interventions that are present in a given facility. The Data Collection Tool collects the necessary bottom-up and top-down ingredients. In terms of bottom-up costing this relates to the prices and quantities. The quantities include time spent on tasks by health care workers, training, building space utilized for tasks, the equipment, drugs and supplies used etc. Prices include the prices for these items, the price of staff time per minute (derived from their cost of employment and the number of minutes they work for in a year), time spent on training, the price of space, equipment, drugs and supplies, etc. For top-down costing this relates to the expenditure of facilities on TB services on staff, training, buildings, equipment, drugs supplies, and the service statistics or utilization by patients (to work out the allocation to TB services). The Data Entry Tool will be used by data analysts to clean and copy data from the Data Collection Tool, and generates unit costs and other intermediary results for a facility. The Data Entry Tool takes all these ingredients and produces unit costs of delivering each TB service using both bottom-up and top-down methodologies. For bottom-up this means taking the prices and quantities for all inputs (staff time, training, building space, equipment, drugs and supplies) and calculating the bottom-up unit costs. For top-down costing, this entails calculating the unit cost for all inputs (recurrent expenditure (overhead costs), staff time, training, building space, equipment, drugs and supplies) based on step-down accounting using allocations based on space or service statistics (as described in Appendix 8). The Value TB Costing Tool Suite and accompanying instructions can easily be adapted to any costing of TB service delivery exercise. When submitting the protocol to the ethics review board, one can include a draft interview questionnaire and a list of the other types of data that are planned to be collected. Consent form sheets also need to be submitted to ethics – these will be required from all staff interviewed and providing data to the data collector. Samples of facility information and consent form sheets have been provided (see Appendix 12). Format and content that is appropriate or required for the setting as per local ethical guidelines should be used, but these samples can also be adapted for use in the setting. 29 What the Value TB Costing Tool Suite can do The Value TB Costing Tool Suite has been organized to allow the collection of data and calculation of unit costs of TB service delivery at the facility level. It supports obtaining unit costs for both top-down and bottom-up costing, economic and financial cost approaches, different methodologies for measuring staff time (interviews, observations and timesheets) and disaggregated by key input categories. The Value TB Costing Tool Suite allows costing in different platforms (such as outpatient and inpatient care and facility outreach services), but is currently limited to facility level (i.e. it does not allow for community-based costing). Above-facility cost data collection will need to be done using an additional data collection instrument which is currently under development. What the Value TB Costing Tool Suite cannot do Due to the comprehensive nature of the tools, certain components within TB interventions have been omitted so that the costing process remains feasible within a reasonable time frame. No unit costs have been derived for individual adverse events related to TB treatment or prevention nor are the list of monitoring tests required to identify these events entirely comprehensive. However, the current tool allows for the cost of inpatient care to capture some time spent treating the adverse drug reactions associated with anti-TB drugs. The most frequent adverse event monitoring tests have been included in the Tool Suite and can therefore be costed. Adapting the Value TB Costing Tool Suite and mapping data sources In drafting these guidelines and associated data collection instruments, efforts were made to ensure the specific costing’s country context, scope and objectives can be Box 5. The accompanying data collection instructions include the following documents n An observation guide assists the data collector in observation of a TB service. n This guide will be used to estimate the bottom-up costing of an intervention and to populate the data collection and data entry bottom-up sheets for staff time, equipment utilization and supply consumption. n Observation is considered as the gold-standard method to measure staff time. n An interview guide will be used by data collectors to carry out interviews to staff providing TB, MDR or TB/HIV services in the health facility and staff working in the laboratory or radiology departments. n The interviews, like observation, will provide the data collector with information on staff time, equipment utilization and supply consumption. n Timesheets are another instrument to collect staff time. n Timesheets are distributed to facility staff providing TB services at the beginning of the week of data collection at the facility and collected on the last day of data collection. n The timesheets will capture the time spent on the 25 predefined TB related service outputs, non-TB services, administration and down time (lunch, break) over a few typical work days by various cadres of health professionals. n The facility contact list collects participant names and contact information but is stored separately and securely at all times, ensuring no identifiable information can be linked to any data in the tools. n Facility information sheets summarize the key features of the study and will be made available to staff interviewed. Section D. Designing data collection Costing guidelines for Tuberculosis interventions30 incorporated. The generic tool provided alongside this guide can be modified to the country context and there are four main steps in this adaptation process. 1. Defining the TB interventions that will be costed: this is done by the study team at the protocol development phase. 2. Defining the production process and potential data sources: this is done by the study team at the protocol development phase, but data collectors re-evaluate for each of the facilities during site visits. 3. Piloting: if a comprehensive range of TB interventions have been selected, then the piloting at a couple of facilities can take up to two weeks to complete. Once piloting has been undertaken, one must then adapt the tool to the country context. 4. Adaptation of the tools Adapting the tools during the study pilot During the piloting process, the research assistant(s) and team should endeavour to add as many of the context-specific and country appropriate service outputs, drug names, test procedures, service utilization labels, consumables supplies, staff titles, department or clinic names and other important labelling as possible. 31 Section E. Data analysis, presenting results and dissemination of cost data Section E. Data analysis, presenting results and dissemination of cost data Data analysis The data analysis stage is an important stage in the costing process and resources (research staff and money) should be allocated for this. The main purpose is to take the prices and quantities collected at each of the facilities and at the level above facilities and produce both total costs and unit costs that meet the objectives of the study (see Section C). However, total and unit costs on their own have little value: it is important to think about the unique setting from which these costs are produced and situate them, providing information on the elements that appear to drive cost. In addition, differences can be compared by subgroup, such as DS-TB, MDR-TB and XDR-TB. If the sample size is large enough, statistical differences between population/ facility groups can be examined. Descriptive analyses can include assessing the average number of visits per patient for different patient groups/subgroup (such as pulmonary, EPTB, new and retreatment) and the breakdown for the different types of visit (diagnostic visit, treatment visit, treatment support, community treatment visits, inpatient bed-days etc). The cost per input (as well as mean, standard deviation, median and interquartile range) for different interventions can also be assessed and looked at by patient group/subgroup. For instance, assessing the cost for first- line treatment for different facilities broken up by input (diagnostic tests – Xpert® MTB/RIF, microscopy; treatment visits; inpatient bed-days etc). One can look at the variation within a country for the number of visits per patient for different visit type by health facility (the levels of care). The proportion for the inputs in a visit cost can also be evaluated through, for example, looking at the proportion spent on personnel; building space; furniture and equipment; or consumables/supplies. This can help in assessing the variability in efficiency. For instance, looking at the cost of smear micro scopy in different levels of care broken down into inputs can illustrate where the highest amounts are being spent from both top-down and bottom-up points of view. Again, the unit cost per intervention can be assessed by platform and from both top- down and bottom-up approaches. Econometric analysis can also be conducted on larger data sets to explore technical efficiency, extrapolate costs to other settings and understand the determinants of costs. These analyses are not outlined here, but please see Arinaminpathy et al., Silva et al. and Denysiuk et al. [14–16] for further reading on cost functions and other aspects. Fig. 8. Post data collection activities 7. Post-data collection activities n Commencement of data analysis and data analysis workshop (cross-country meeting) n Preparation of reports, papers and a publicly accessible database n Cross-country data analysis and write up n Dissemination of findings at a country and international level n Publicly share datasets n Wrapping up the study and discussion about updating cost estimates managed by the NTPs going forward Costing guidelines for Tuberculosis interventions32 Sensitivity analyses Whenever doing a cost analysis, it is important to assess possible areas of bias. Sensitivity analyses are also crucial for looking at factors that may contribute to uncertainty in the unit cost estimates. Examples are altering the cost of medication (one can often use this information to inform at what threshold the cost could become affordable); the utilization rate (especially if the cost analysis was done during a start- up phase only); one could also alter the salary costs if task shifting could be likely in the future. This can be in the form of a one-way sensitivity analysis (univariate sensitivity analysis), where one alters one variable at a time, or a multi-way sensitivity analysis (multivariate sensitivity analysis) where one alters several factors at one time to see their combined effect on the cost estimates. Scenario analyses are helpful in looking at different approaches or options for the future. Techniques such probabilistic sensitivity analysis (PSA) can be used to look at uncertainty ranges in a cost analysis, where one initially assigns a probability range to the input data [17–20]. Presenting results and dissemination of cost data While it is important to tailor presentations to a specific audience, in general simple graphical presentation of data is best. Bar graphs can effectively compare costs across sites, with percentage breakdowns to visually indicate which components are the highest/lowest contributors. For policymakers, data should be presented in transparent and easy to digest format, so that they can make decisions about resource allocation to better combat TB. Audiences of health care workers will need the knowledge to be translated so that it can be practically applied in a work setting, for instance the expense of certain tests may mean that rationing is appropriate. The limitations of the study should be identified and described. This includes inter alia interventions that have not been costed, where sample size was not sufficient, when above-facility costs were not assessed and adaptation of methods. The ability to generalize and its application should be explained. For example, is it only appropriate to generalize to other low- and middle-income settings, or, if the sample is not representative of the country, only to similarly sized facilities within other districts or within the country. Any conflicts of interest (i.e. involvement with developers or pharmaceutical companies) should be declared. This allows the reader and consumers of costs to be able to judge whether the research is independently undertaken or may suffer from bias. If a conflict of interest is not declared but exposed later, the reader may feel misled and the credibility of the work may be reduced. An important part of the dissemination process is to translate the information into easily digestible knowledge which is appropriate for the audience. One example might be presentation applicable for National Strategic Plan costing. In addition, it is important to share feedback with those that were involved in the cost analysis, such as stakeholders, clinic and laboratory managers, members of the NTP and Ministry of Health/Departments of Health, funders, and other interested parties. Wherever possible data should be openly accessible to the public such as on the GHCC. If work is published in journal articles, open access should be granted so that the information becomes a public good. 33 Section F. Appendices Appendix 1. Basic concepts and terms in costing Cost is a general term that refers to the value of resources or inputs used to produce a good or service. This can refer to financial, economic, unit (or average) or other types of costs depending on the ingredients included. TB costing is the process of estimating the value of resources used for a TB service/intervention through identification, measurement and valuing of resources consumed by an intervention. Costs generally relate to four areas where costs are incurred: the health sector (health care providers), other sectors (e.g. education or housing sector), patients and households costs of seeking care, and productivity losses [21]. This manual focuses on costing the resources used in the health sector. In this methodology, common costs to different interventions (shared costs) are identified so that double counting (where the costs are accounted for more than once making the cost seem higher than it actually is) does not take place. This highlights the importance of understanding what one is costing, how the health system (or part of the health system) works and the processes that are involved. Costs are comprised of quantities of resource used and the unit costs or prices (referred to as the prices and quantities – P’s and Q’s). To estimate quantities, several techniques might have to be employed: this could include interviewing staff about the time that tasks take them, using timesheets, observing consultation time, or following patients through a facility. For prices, market price can be used. This could be estimated through the current replacement value for a piece of equipment, or the price paid for an item (adjusted to the relevant year). Where price data is unavailable (for example to value the cost of volunteer time), a shadow price can be estimated to reflect the value of these resources. Economic costs reflect the full value of all resources utilized in producing a good or service, for example the value of all resources used in a TB intervention. Economic costs include all resources, whether paid for or not; volunteers or donated goods should be included. An opportunity cost is the value of the benefits that are sacrificed due to making an alternate choice to provide a service (hence the resources are not available) [21]. Resources refer to monetary resources as well as staff time, building space and equipment etc. Another way of looking at this opportunity cost is the value or benefit that one could have had if one had made a different choice. Economic costs are sometimes referred to as opportunity costs since they represent resources actually consumed, preventing the opportunity to devote those resources to another purpose. For example, if resources are used for expanding an MDR-TB programme, those same resources cannot be used for additional infection control measures. The opportunity cost is the benefits of the additional infection control measures. Section F. Appendices Costing guidelines for Tuberculosis interventions34 When it comes to donated goods and services (such as volunteered time or donated clinic space), assessing economic costs should include and value these costs so that if a programme was reproduced elsewhere, all the costs would be accounted for. This is one area where economic and financial costs differ. Financial costs are the actual expenditures, or monetary amount paid (the price tag), which are distinctly different from economic costs which include opportunity cost [22]. These costs are not generalizable across settings, unless there is a similar payment structure. Cost of health service provision is the cost of providing health care, for instance through TB interventions, but this cost does not cover the payments made by patients nor economic costs borne by households. A costing can be done from the point of view of the provider (health services) or a societal perspective. In addition, a patient perspective assesses the costs from the point of view of the patients themselves and considers both the direct patient costs such as medical out-of-pocket payments or non-medical expenses (transport, relocation costs) as well as indirect costs which relate to productivity losses such as time off work. The provider perspective takes the point of view of the provision of services, so here the costs are those incurred by a hospital, clinic or TB facility providing the services. With a societal perspective, provider and patient costs (and any broader societal costs) are combined in a meaningful way to assess the overall cost of an intervention to both the patient and provider. Health care costs from the provider perspective can be divided into capital and recurrent costs. Capital costs are one-time costs for items that have a useful life of over one year – such as buildings, vehicles, laboratory or medical equipment. Usually capital costs are outlaid at the beginning of a programme (see Table 2 for a comprehensive list of TB capital and recurrent items), and do not vary per patient treated. These costs are defined according to useful life of potential use rather than purchase price alone. Capital costs should be amortized (annuitized) or depreciated to reflect the expected life years of capital inputs (for example a building could be expected to have a useful lifetime of 30 years). This means that the initial capital item investment (the amount paid for the capital item, or the current replacement value), which is usually fairly substantial once off cost, is shared over the expected lifetime of the item so that it can be realistically reflected in an annual cost [22]. Economic and financial costs also differ in the valuation of capital items. When performing an economic costing, one would amortize capital costs (as described in Appendix 8) so that both capital and recurrent costs are presented in the same year and can be meaningfully combined. In a sense, one is taking the large capital outlay and representing how much it would cost to have that item for a single year, by spreading the cost over the useful lifetime of that item. An amortization table is included in Appendix 5 and an explanation of how to calculate the amortized cost in Box A below and in Appendix 8 using Microsoft Excel (under subheading Amortizing capital costs). Recurrent or operating costs are the value of resources or inputs with useful lives of less than one year. These inputs can be purchased irregularly and include chemicals and reagents within a laboratory. Their costs can be recovered at any time for instance by buying fewer supplies the next month to lower costs or by task shifting between lay workers and professional nurses for TB screening. 35 Overhead costs are costs that are necessary to support services but are not directly part of providing patient care (further examples are given in Appendix 8). Integral overhead costs for a facility could consist of items such as administration, cleaning, kitchen, utilities, security, laundry, monitoring and evaluation, pharmacovigilance, maintenance and training (if the effects last for less than a year). Above site level costs are items that are necessary for the functioning the health system as whole, such as the management of human resources, financial services, information technology, procurement and others. Steps should be taken to disentangle whether an above service item is better placed under overhead costs (at the site level) or above site level costs and ensure that the cost has only been costed under one of the two. Above site level structures are essential to the smooth functioning of TB (and other) services but may be challenging to allocate to the facility or service level as they generally aid many different facilities of various sizes and types of service provision. Total cost is the entire cost of producing the service, which is made up of fixed and variable costs. Fixed costs do not vary with the level of output [22], whereas variable costs vary directly with the level of output. Total costs can also be calculated through the addition of recurrent and capital costs, i.e. the sum of all the costs of an intervention. Box A. Amortizing capital costs To combine capital and recurrent costs in a substantial way, capital cost should be amortized (annuitized) or depreciated to reflect the expected useful life years of capital inputs (for example, 30 years for buildings). The amortization process to estimate the annual value of the capital assets, including buildings, equipment, furniture, vehicles and training, is described below: Step 1: Estimate the life expectancy (estimated life years) of the capital item; this may be 30 years for a building, 10 years for laboratory equipment, two years for training, etc. Step 2: Establish the current replacement value or ‘price’ of the capital item (see source of costs above). Step 3: Use the amortization table in Appendix 5 to identify the amortization factor based on the number of expected life years (or ‘number of remaining years or useful life’ in the first column) and the desired discount rate (1–19%), or use the payment (PMT) function (as is done in the tool). Step 4: Divide the current replacement value by the amortization factor to arrive at the amortized cost. If a discount rate of 0% is selected, the current replacement value can be divided by the expected life years to provide the amortized cost (also called the annualized financial cost). Worked example 1: amortizing a building price Step 1 Building, estimated life expectancy of 30 years Step 2 Current replacement value $300 000 Step 3 30 years at 3% discount rate = 19.60 Step 4 $300 000/19.60 = $15 306 Step 4 if discount rate of 0% is used, then divide by the number of years – i.e. 30 years in this case $300 000/30 = $10 000 This annual equivalent cost of $15306 can then be used when calculating the cost of space. For instance, if 30% of the building is used exclusively for TB outpatient visits, then the estimated annual cost of space allocated for TB outpatient visits is $4592. If 100 outpatient TB visits are made in the year, then the cost per TB outpatient visit for space only is $45.92. The economic (using standard and local discount rates) and financial costs then need to be allocated to the departments providing direct (outpatient, inpatient and community), support (laboratory and radiology) and indirect services (pharmacy, administration & management, and other overhead services). The proportion allocated to each department has already been completed based on the building space being costed. Section F. Appendices Costing guidelines for Tuberculosis interventions36 Marginal cost is the additional cost to produce one extra unit (change in total cost when one extra unit is produced) [22]. Unit costs or average costs (mean costs) are the total costs divided by the quantity (service/output), with output being measured in different ways (i.e. the cost per patient treated, the cost per test or the cost per patient retained). Full costing assesses all the resources used in the intervention, including basic infrastructure, overhead inputs, etc., as opposed to incremental costing. Incremental costing estimates the costs of adding or implementing an additional study or programme to existing services. It is useful when sound data of existing service cost is available, but difficult to generalize to other settings. It does not include the cost of existing services and is appropriate when the intervention being costed is not a major component of an organization’s activities. Incremental costing will underestimate costs that are of a general administrative nature (such as overhead inputs). It is more difficult to generalize from incremental cost analyses, unless the prior level of existing services and infrastructure is clearly specified and understood. Defining incremental costs may be challenging unless the analyst has sound data on current health service delivery capacity. A cost function reflects the underlying production function of a service and how inputs/factors of production are combined to produce a health service – in this case, TB service. It describes how cost varies with input prices, volume of service provision (scale), quality or other factors. Real world costing is done as per actual implementation, as seen in health facilities. This contrasts with guideline costing/normative best practice costing which is done per national (or WHO) guidelines. In an ideal world, guideline costing and real- world costing would produce similar results, however in most cases it is likely that there will be deviations in the real-world costing (for instance practical changes to the guidelines). Two methods that are used in costing are bottom-up and top-down costing, although generally mixed methodology is used (a combination of both bottom-up and top-down costing). In essence, this refers to whether there are the time and resources needed to enter a facility and cost all the processes that are being undertaken within a facility or laboratory providing TB services (bottom-up costing), or whether if one has the appropriate information available that allows one to cost the services using a top-down approach (also known as gross costing or step-down accounting/costing). Both approaches have their limitations; however, Cunnama et al. 2016 recommend doing both as a gold standard, so that a range of costs can be produced, the lower limit representing the most efficient practice without regard for breaks, leave or suboptimal processing (bottom-up cost value). The upper limit represents a more inefficient and, in some ways, more realistic cost in terms of inclusion of leave, breaks, sub optimal processing speed and down time (top-down cost value). If the researcher has the resources (time and money) to perform both methodologies, then this is the recommended practice. Examples of these methodologies are given in Appendix 8. 37 Section F. Appendices Appendix 2. Specific TB interventions Understanding the process of the intervention will help to establish which inputs are needed and what units will be costed. For example, inputs for costing an intervention in a clinic would differ from those used for costing in a laboratory setting. For this, it is necessary to describe the interventions (through national guideline review and consultation with experts) and how they are undertaken in the facility, laboratory, community or other setting (through time-motion studies, observation, work sampling or interviews). To describe the TB intervention, one needs to have a clear understanding of the coverage in terms of what the intervention aims to achieve, whether that is defined by intervention specific targets or recent epidemiological data pertaining to the intervention (see Figure 9). Fig. 9. Intervention flow chart With input from clinical and program- matic experts Determine the intervention platform Target population that should be receiving the intervention Duration that is needed to capture any variation in activities for the intervention Activities required to produce the service or intervention Include all the technolo- gies required to perform the most common iter- ations of the intervention Establish whether the interven- tion is new, existing or if modifications are being applied to the existing service Where the intervention takes place such as public or private facilities, a general hos- pital or health centre, within a community or household setting Such as adults or children, PTB or EPTB, HIV+ or HIV-, latent TB Such as an episode or for a patient, treatment phase, during implemen- tation or scale-up E.g. for passive case finding this would include diagnostic visits, diagnostic tests and any patient support This can include tests, treatment protocols or drug regi- men, contact tracing or follow-up, M-health or infection control equip- ment and supplies Vaccination Vaccination for TB is used to prevent TB and currently includes the BCG vaccine for infants, children and young adults (between eight and eighteen years old). Treatment for adverse reactions has been included as part of the vaccination intervention. TB case detection and diagnosis: Passive case finding PCF is defined as detection of TB cases (screening and diagnosing of active and latent TB) reporting to public or private TB services in health facilities. The standard method of identifying people with TB is PCF, where individuals with TB symptoms present themselves at a health facility. A health worker assesses the person and orders a diagnostic test. Several technologies are available for PCF depending on the setting and patient attributes, including a verbal symptom screen, cough triage, sputum Costing guidelines for Tuberculosis interventions38 induction, Xpert® MTB/RIF, (LED or Ziehl-Neelsen (ZN)) microscopy, culture (solid or liquid), film and digital x-ray, rapid HIV test, line probe assay for first (LPA-FLD) and second-line drugs (LPA-SLD), drug sensitivity testing (DST), LAMP, lateral flow urine lipoarabinomannan assay (LF-LAM), interferon-gamma release assay (IGRA) (where used for detection of latent TB infection (LTBI)), tuberculin skin test (TST, also known as Mantoux test or purified protein derivative (PPD) skin test), fine needle biopsy, bronchial and gastric lavage, and tests for extra-pulmonary TB (EPTB) (aspirates, computed tomography (CT) scan and ultrasound). Other tests include: HIV confirmatory test, cluster of differentiation 4 (CD4) count, erythrocyte sedimentation rate, total white blood cell count, full heamogram, aspartate aminotransferase (AST also known as serum glutamic-oxaloacetic transaminase (SGOT)), creatinine, creatinine clearance, glucose random blood sugar (RBS), lactic acid, lipase, thyroid stimulating hormone, body fluid analysis polymerase chain reaction – deoxyribonucleic acid (PCR-DNA) and electrocardiography (ECG). The population of concern includes both children and adults, irrespective of HIV status or TB strain. Costing should be conducted for the entire duration of the diagnostic visit, diagnostic test and patient support activity. PCF occurs in both public and private health facilities, but rarely occurs outside of the health facility or laboratory. TB case detection and diagnosis: Intensified case finding ICF detects potential active and latent TB cases among people living with HIV or diabetes or attending maternal and child health clinics or in other high-risk populations, receiving non-TB health care. Symptom screening, film or digital x-ray and Xpert® MTB/RIF are the main ICF technologies, but technologies used in PCF may also become part of the diagnostic algorithm for HIV positive adults, persons within high-risk groups (including people exposed to drug-resistant TB) attending health facilities, and children. Screening and diagnostic visits, diagnostic tests and patient support activities should be costed to obtain the unit cost of ICF. TB case detection and diagnosis: Active case finding ACF is defined as screening and diagnosing active and latent TB in those who are not in public health care (i.e. who are not detected passively). Generally, fewer technologies are used to detect cases actively, which include a verbal symptom screen, Xpert® MTB/ RIF, microscopy (LED), film or digital X-ray, rapid HIV test, contract tracing, fine needle biopsy aspirates, CT scan or ultrasound. Other tests can include culture (solid or liquid), LPA, DST, IGRA, TST, and bronchial or gastric lavage. It can be conducted in private or public facilities, in mobile clinics, through outreach programmes such as to schools, prisons, or within the household. Target populations are household contacts (adults and children less than five and between five and eighteen years old), poor urban populations, prisoners, mobile populations, migrant populations, healthcare and other workers with an occupational risk of contracting TB. Any new ACF technologies should be costed during the start-up as well as the continued implementation for a patient or an episode. The activities included in ACF are the screening visits, diagnostic visits, diagnostic tests and all patient support services. 39 Section F. Appendices TB treatment TB treatment includes all activities involved in treating patients with active TB, observation of treatment, patient support, restoring quality of life and productivity, preventing relapse or death, reducing transmission and preventing development and transmission of drug resistance. During the intensive and continuation phases of treatment, persons of all ages being treated for either DS-TB or DR-TB (mono- resistant, poly-drug resistant, Rifampicin resistant, MDR-TB, pre-XDR-TB or XDR-TB) can be treated within the household, the community, through outreach programmes, in public or private facilities, or at general or specialized TB hospitals. HIV-positive or negative patients with either pulmonary TB (PTB) or EPTB are included. In addition to the drugs for first-, second- and third-line treatment; retreatment, palliative care, monitoring tests for treatment response, adverse events, nutritional assessment, lost to follow-up tracing, ART regiment if HIV-positive and M-health are included in TB treatment. TB prevention TB prevention refers to screening and treatment to prevent latent and active TB (PTB and EPTB) amongst children and HIV-positive adults. Screening visits, treatment monitoring (including for breakthrough disease, adverse events, acquired drug resistance), visits occur in public or private facilities. The technologies for prevention of TB include symptom screening to rule out active TB, IGRA test or TST, as well as treatment protocols of isoniazid for six months (6H), lifelong isoniazid (H), three months of once-weekly isoniazid and rifapentine (3HP), or rifapentine only, ART regimen for HIV positive patients and cotrimoxazole prophylaxis. TB infection control Infection control for TB in environments such as health facilities, laboratories, congregate settings and households involves a combination of activities to minimise the risk of transmitting TB within these settings. Successful TB infection control includes early and fast diagnosis of TB, coupled with appropriate management of people with TB. Within health facilities, in addition to the administrative controls to reduce diagnostic delays and prompt treatment initiation, infection control for patients, laboratory staff and health care workers includes the use of ventilation systems, laboratory biosafety systems, UV fixtures and personal protective equipment. Congregate settings include hospital premises, prisons, refugee camps and schools. TB infection control in these settings must be coordinated with other sectors. Within households, TB infection prevention includes campaigns educating on behaviour and social change to minimize exposure. The delivery platforms include private and public health facilities, as well as facilities managed by international and national NGOs. Infection control can also occur in community-based activities and during outreach activities. TB programme above site services: Above service costs At the national level activities and technologies that contribute to the successful deliv- ery of TB services include development of strategic plans, TB care guidance develop- ment or adaptation, programme reviews, national and regional meetings, surveys, Costing guidelines for Tuberculosis interventions40 management and information systems, supervision, procurement and supply chain management, transportation of specimens, advocacy, technical assistance, training, accreditation and quality assurance of labs, community media or information, educa- tion and communication (IEC) campaigns or any partnership activities. The delivery platforms for these activities and technologies are ministries of health, NTPs, reference laboratories, government and non-government research institutes, public health facilities, private health facilities and laboratories, regulatory bodies for food, drugs and health, NGOs, and bi- and multi-lateral partners, including WHO. Populations involved in these activities include health care workers, laboratory staff and management involved in TB or any support services. Defining standard costs for each intervention Table 3 was devised as part of the GHCC and Reference Case development. The table lists the interventions and a default and optional unit cost per recipient. The default unit cost per recipient is the one that makes the most sense in terms of standardising and using these costs for budgeting and modelling purposes. Table 3 also lists the possible outputs as well as the direct and ancillary (supportive) unit costs per output. 41 Ta bl e 3. D ef in in g st an da rd u ni t c os ts fo r ea ch in te rv en tio n In te rv en ti on U ni t c os t p er r ec ip ie nt Li st o f o ut pu ts U ni t c os t p er o ut pu t d ir ec t U ni t c os t p er o ut pu t a nc il la ry Va cc in at io n D ef au lt u ni t c os t ( re qu ir ed ) Co st p er p er so n va cc in at ed O ut pa ti en t v is it C om m un it y vi si t C os t p er o ut pa ti en t v is it C os t p er o ut pa ti en t v is it C os t p er p er so n su pp or te d P as si ve ca se fi nd in g D ef au lt u ni t c os t ( re qu ir ed ) Co st p er p er so n di ag no se d D S -T B Q ua lit y ad ju st ed u ni t c os t p er r ec ip ie nt (o pt io na l) Co st p er p er so n di ag no se d D R -T B Co st p er T B c as e di ag no se d O ut pa ti en t v is it In pa ti en t b ed -d ay D ia gn os ti c te st (s am pl e/ sl id e) P at ie nt s up po rt p ro vi si on p er pa ti en t A bo ve s er vi ce o ut pu ts C os t p er o ut pa ti en t v is it C os t p er in pa ti en t v is it C os t p er te st C os t p er s am pl e/ sl id e   C os t p er p er so n su pp or te d         In te ns ifi ed ca se fi nd in g C os t p er p er so n sc re en ed C os t p er p er so n di ag no se d C os t p er T B c as e di ag no se d P at ie nt s cr ee n O ut pa ti en t v is it In pa ti en t b ed -d ay Tr ia ge te st D ia gn os ti c te st (s am pl e/ sl id e) P at ie nt s up po rt p ro vi si on C os t p er s cr ee n C os t p er o ut pa ti en t v is it C os t p er in pa ti en t v is it C os t p er tr ia ge te st C os t p er d ia gn os ti c te st C os t p er s am pl e/ sl id e C os t p er p at ie nt s up po rt (p er v is it , sc re en o r di ag no si s) A ct iv e C as e F in di ng C os t p er p er so n sc re en ed C os t p er p er so n di ag no se d C os t p er T B c as e di ag no se d P at ie nt s cr ee n O ut pa ti en t v is it In pa ti en t b ed -d ay Tr ia ge te st D ia gn os ti c te st (s am pl e/ sl id e) P at ie nt s up po rt p ro vi si on C om m un it y ev en t C os t p er s cr ee n (d iff er en t p la tf or m s an d al go ri th m s) C os t p er o ut pa ti en t v is it C os t p er in pa ti en t v is it C os t p er m ob ile c lin ic v is it C os t p er h ou se ho ld v is it C os t p er o th er v is it C os t p er tr ia ge te st C os t p er d ia gn os ti c te st C os t p er s am pl e/ sl id e C os t p er p at ie nt s up po rt (p er v is it , sc re en o r di ag no si s) C os t p er c om m un it y ev en t TB tr ea tm en t C os t p er tr ea tm en t m on th D S -T B C os t p er tr ea tm en t m on th M R -T B / C os t p er tr ea tm en t m on th P D R -T B / C os t p er tr ea tm en t m on th M D R -T B / C os t p er tr ea tm en t m on th p re -X D R -T B / C os t p er tr ea tm en t m on th X D R -T B C os t p er p er so n tr ea te d C os t p er p er so n co m pl et in g tr ea tm en t C os t p er tr ea tm en t m on it or in g O ut pa ti en t v is it In pa ti en t b ed -d ay D O T vi si t c om m un it y pl at fo rm M on it or in g te st C os t p er o ut pa ti en t v is it C os t p er in pa ti en t b ed -d ay C os t p er D O T vi si t c om m un it y C os t p er m ic ro sc op y C os t p er o th er te st C os t p er D S -T B r eg im en C os t p er s ho rt D R -T B r eg im en C os t p er lo ng D R -T B r eg im en C os t p er p er so n pa ti en t s up po rt C os t p er p er so n m on th p at ie nt s up po rt C os t p er p at ie nt s up po rt v is it Section F. Appendices Costing guidelines for Tuberculosis interventions42 In te rv en ti on U ni t c os t p er r ec ip ie nt Li st o f o ut pu ts U ni t c os t p er o ut pu t d ir ec t U ni t c os t p er o ut pu t a nc il la ry TB pr ev en ti on C os t p er tr ea tm en t m on th L TB I C os t p er p er so n tr ea te d LT B I C os t p er p er so n co m pl et in g tr ea tm en t L TB I O ut pa ti en t v is it P er so n sc re en ed D ia gn os ti c te st C os t p er o ut pa ti en t v is it C os t p er s cr ee n C os t p er te st C os t p er r eg im en C os t p er p er so n m on th p at ie nt s up po rt C os t p er p er so n pa ti en t s up po rt C os t p er p at ie nt s up po rt v is it C os t p er c om m un it y ev en t TB in fe ct io n co nt ro l C os t p er f ac ili ty C os t p er la bo ra to ry TB pr og ra m m e ab ov e si te se rv ic es : A bo ve se rv ic e co st s If in cl ud ed in in te rv en ti on th en u ni t c os t pe r re ci pi en t e st im at ed b y 1) m ul ti pl yi ng ea ch u ni t c os t b y un it (f ac ili ty , d is tr ic t e tc .) 2) if to p -d ow n co st d iv id in g by a n al lo ca ti on fo rm ul a pe r in te rv en ti on , 3 ) d iv id ed b y nu m be r of r ec ip ie nt s A dv oc ac y ca m pa ig n Tr ai ni ng p ro gr am m e pe r fa ci lit y A cc re di ta ti on p er la bo ra to ry C om m un it y m ob ili sa ti on ca m pa ig n pe r di st ri ct P ro gr am m e m an ag em en t c os t p er re gi on P ro gr am m e m an ag em en t c os t p er di st ri ct C os t o f s up er vi si on p er f ac ili ty IT /s of tw ar e co st p er n at io na l s ys te m C os t p er s ur ve ill an ce s tu dy C os t o f a dv oc ac y pe r di st ri ct C os t o f c om m un it y ca m pa ig n pe r di st ri ct C os t o f t ra in in g pe r fa ci lit y C os t o f s up po rt p er la bo ra to ry C os t o f s up pl y ch ai n pe r re gi on A da pt ed a nn ex 3 o f t he R ef er en ce C as e[ 5] 43 Ap pe nd ix 3. St an da rd ize d un it co st s f or tb in te rv en tio ns Th is is t ak en fr om A nn ex 3 o f t he R ef er en ce C as e [5 ] In te rv en ti on cl as s In te rv en ti on In te rv en ti on D et ai ls Te ch no lo gy P la tf or m (c ho os e m or e th an on e on ly w he n ne ce ss ar y) P op ul at io n (c ho os e m or e th an on e on ly w he n ne ce ss ar y) S TA N D A R D U N IT C O S T IN TE R V E N TI O N (q ua li ty -a dj us te d un it c os t) S TA N D A R D U N IT C O S T S E R V IC E D IR EC T S TA N D A R D U N IT C O S T S E R V IC E A N C IL L A R Y Va cc in at io n Va cc in at io n Va cc in at io n to pr ev en t T B B C G v ac ci na ti on a lo ne B C G , p lu s tr ea tm en ts fo r ad ve rs e re ac ti on s: liv er f un ct io n, c re at in in e, se ru m p ot as si um , t hy ro id st im ul at in g ho rm on e, au di om et ry , s ym pt om sc re en in g fo r pe ri ph er al ne ur op at hy (s pe ci fy ) C om m un it y M ob ile P ri va te f ac ili ty fo r pr ofi t (d iff er en t fa ci lit ie s) P ri va te f ac ili ty no t f or p ro fi t (d iff er en t fa ci lit ie s) P ub lic f ac ili ty (d iff er en t de pa rt m en ts ) P ub lic /p ri va te m ix In fa nt s C hi ld re n an d yo un g ad ul t po pu la ti on (1 1– 18 ye ar s) C os t p er p er so n va cc in at ed C os t p er ou tp at ie nt v is it C os t p er co m m un it y vi si t C os t p er p er so n su pp or te d Section F. Appendices Costing guidelines for Tuberculosis interventions44 In te rv en ti on cl as s In te rv en ti on In te rv en ti on D et ai ls Te ch no lo gy P la tf or m (c ho os e m or e th an on e on ly w he n ne ce ss ar y) P op ul at io n (c ho os e m or e th an on e on ly w he n ne ce ss ar y) S TA N D A R D U N IT C O S T IN TE R V E N TI O N (q ua li ty -a dj us te d un it c os t) S TA N D A R D U N IT C O S T S E R V IC E D IR EC T S TA N D A R D U N IT C O S T S E R V IC E A N C IL L A R Y TB c as e de te ct io n an d di ag no si s P as si ve C as e F in di ng S cr ee ni ng an d di ag no si ng ac ti ve a nd la te nt T B in th os e w ho re po rt to T B se rv ic es w it h sy m pt om s A sp ir at es (E P TB ) A S T al so k no w n as S G O T B od y fl ui d an al ys is P C R -D N A B ro nc hi al la va ge C D 4 co un t C ou gh tr ia ge C re at in in e C re at in in e cl ea ra nc e C T sc an (E P TB ) C ul tu re (s ol id m ed ia ) C ul tu re (l iq ui d m ed ia ) D ig it al x -r ay D S T – F LD (s ol id m ed ia ) D S T- S LD (s ol id m ed ia ) D S T – F LD (l iq ui d m ed ia ) D S T – S LD (l iq ui d m ed ia ) EC G E ry th ro cy te s ed im en ta ti on ra te F in e ne ed le b io ps y Fu ll he am og ra m G as tr ic la va ge G lu co se (R B S ) H IV c on fi rm at or y te st IG R A a La ct ic A ci d L A M P LF -L A M Li pa se LP A – F LD LP A – S LD M ic ro sc op y (L E D ) M ic ro sc op y (Z N ) R ap id H IV T es t S pu tu m in du ct io n S ym pt om s cr ee n Th yr oi d st im ul at in g ho rm on e To ta l w hi te b lo od c el l c ou nt TS T or P P D o r M an to ux te st U lt ra so un d (E P TB ) X pe rt ® M TB /R IF X- ra y fi lm P ub lic f ac ili ty (T B ca re ) P ri va te f ac ili ty (T B c ar e) M ay in cl ud e cl in ic ty pe (e .g . H IV , di ab et es , M C H et c. ) C hi ld re n A du lt s (H IV +, H IV -) A du lt s (p ul m on ar y TB , E P TB ) A du lt s (D S -T B , M D R -T B , p re - X D R -T B , X D R -T B ) C os t p er p er so n sc re en ed f or T B C os t p er p er so n di ag no se d TB C os t p er T B c as e di ag no se d C os t p er sc re en in g vi si t ( di ff er en t pl at fo rm s an d ap pr oa ch es ) C os t p er di ag no st ic v is it C os t p er o th er ou tp at ie nt v is it (b y cl in ic w he re re le va nt ) C os t p er in pa ti en t be d- da y (e .g . f or ch ild re n ne ed in g fi ne n ee dl e bi op sy ) C os t p er di ag no st ic te st C os t p er x -r ay o r ra di ol og y te st C os t p er pe rs on o r vi si t pa ti en t s up po rt (v ou ch er s, c as h or o th er ) C os t p er P P M ac ti vi ty C os t p er p er so n lo st to f ol lo w -u p tr ac in g 45 Section F. Appendices In te rv en ti on cl as s In te rv en ti on In te rv en ti on D et ai ls Te ch no lo gy P la tf or m (c ho os e m or e th an on e on ly w he n ne ce ss ar y) P op ul at io n (c ho os e m or e th an on e on ly w he n ne ce ss ar y) S TA N D A R D U N IT C O S T IN TE R V E N TI O N (q ua li ty -a dj us te d un it c os t) S TA N D A R D U N IT C O S T S E R V IC E D IR EC T S TA N D A R D U N IT C O S T S E R V IC E A N C IL L A R Y TB c as e de te ct io n an d di ag no si s In te ns ifi ed ca se fi nd in g D et ec t po te nt ia l ac ti ve a nd la te nt T B am on g pe op le li vi ng w it h H IV or in o th er hi gh -r is k po pu la ti on s re ce iv in g no n- TB he al th c ar e (d ia be te s, M C H c lin ic s) A sp ir at es (E P TB ) B ro nc hi al la va ge C T sc an (E P TB ) C ul tu re (s ol id m ed ia ) C ul tu re (l iq ui d m ed ia ) D ig it al x -r ay D S T (s ol id m ed ia ) D S T – F LD (l iq ui d m ed ia ) D S T – S LD (l iq ui d m ed ia ) F in e ne ed le b io ps y G as tr ic la va ge IG R A a L A M P LF -L A M LP A – F LD LP A – S LD M ic ro sc op y (L E D ) M ic ro sc op y (Z N ) R ap id H IV T es t S ym pt om S cr ee n TS T or P P D o r M an to ux te st U lt ra so un d (E P TB ) X pe rt ® M TB /R IF X- ra y fi lm P ub lic f ac ili ty (d iff er en t de pa rt m en ts ) P ri va te f ac ili ty (d iff er en t fa ci lit ie s) A du lt s (H IV +) O th er h ig h- ri sk gr ou ps a tt en di ng he al th f ac ili ti es C os t p er p er so n sc re en ed C os t p er p er so n di ag no se d C os t p er T B c as e di ag no se d C os t p er s cr ee n (d iff er en t pl at fo rm s an d ap pr oa ch es ) C os t p er ou tp at ie nt v is it C os t p er in pa ti en t be d- da y C os t p er tr ia ge te st C os t p er di ag no st ic te st C os t p er pe rs on o r vi si t pa ti en t s up po rt (v ou ch er s, c as h or o th er ) C os t p er P P M ac ti vi ty C os t p er P A L ac ti vi ty C os t p er p er so n lo st to f ol lo w -u p tr ac in g TB c as e de te ct io n an d di ag no si s A ct iv e C as e F in di ng S cr ee ni ng an d di ag no si ng ac ti ve a nd la te nt T B in th os e w ho a re no t i n pu bl ic he al th c ar e A sp ir at es (E P TB ) B ro nc hi al la va ge C on ta ct tr ac in g C T sc an (E P TB ) C ul tu re (s ol id ) C ul tu re (l iq ui d) m ed ia D ig it al x -r ay D S T F in e ne ed le b io ps y G as tr ic la va ge IG R A a LP A M ic ro sc op y (L E D ) R ap id H IV T es t S ym pt om S cr ee n TS T or P P D o r M an to ux te st U lt ra so un d (E P TB ) X pe rt ® M TB /R IF X- ra y fi lm H ou se ho ld M ob ile P ri so ns S ch oo ls (t hr ou gh he al th f ac ili ty ou tr ea ch ) H ou se ho ld co nt ac ts : A du lt s C hi ld re n un de r 5 C hi ld re n 5 –1 8 P ri so ne rs P oo r ur ba n po pu la ti on s (s lu m s) M ob ile a nd m ig ra nt po pu la ti on s P ri va te p ro vi de rs O cc up at io na l gr ou ps (m in er s, he al th -c ar e w or ke rs , e tc .) C os t p er p er so n sc re en ed C os t p er p er so n di ag no se d C os t p er T B c as e di ag no se d C os t p er s cr ee n (d iff er en t pl at fo rm s an d al go ri th m s) C os t p er ou tp at ie nt v is it C os t p er in pa ti en t be d- da y C os t p er m ob ile cl in ic v is it C os t p er co m m un it y sc re en in g vi si t C os t p er co m m un it y di ag no st ic v is it C os t p er tr ia ge te st C os t p er di ag no st ic te st C os t p er pe rs on o r vi si t pa ti en t s up po rt (v ou ch er s, c as h or o th er ) C os t p er co m m un it y ev en t Costing guidelines for Tuberculosis interventions46 In te rv en ti on cl as s In te rv en ti on In te rv en ti on D et ai ls P ha se Te ch no lo gy P la tf or m (c ho os e m or e th an o ne o nl y w he n ne ce ss ar y) P op ul at io n (c ho os e m or e th an o ne o nl y w he n ne ce ss ar y) S TA N D A R D U N IT C O S T IN TE R V E N TI O N (q ua li ty -a dj us te d un it co st ) S TA N D A R D U N IT C O S T S E R V IC E D IR EC T S TA N D A R D U N IT C O S T S E R V IC E A N C IL L A R Y TB tr ea tm en t TB T re at m en t Tr ea tm en t o f ac ti ve T B w it h ob se rv at io n an d po ss ib ly pa ti en t su pp or t In te ns iv e C on ti nu at io n F ir st -l in e tr ea tm en t R et re at m en t S ec on d- lin e tr ea tm en t Th ir d- lin e tr ea tm en t P al lia ti ve c ar e M on it or in g te st s (f or st at us , a dv er se ev en ts a nd nu tr it io na l as se ss m en t) Fo ll ow u p of de fa ul te rs M -h ea lt h A R T re gi m en if H IV + H ou se ho ld C om m un it y P ub lic f ac ili ty P ri va te f ac ili ty H os pi ta l ge ne ra l H os pi ta l T B C hi ld re n A du lt s (H IV +, H IV -) A du lt s (p ul m on ar y TB , E P TB ) A du lt s (D S -T B , M D R -T B , pr e- X D R -T B , X D R -T B ) C os t p er tr ea tm en t m on th D S -T B C os t p er tr ea tm en t m on th D R -T B C os t p er tr ea tm en t m on th M D R -T B C os t p er tr ea tm en t m on th p re -X D R -T B C os t p er tr ea tm en t m on th X D R -T B C os t p er p er so n tr ea te d C os t p er tr ea tm en t m on it or in g C os t p er p er so n co m pl et in g tr ea tm en t C os t p er ou tp at ie nt v is it C os t p er in pa ti en t b ed - da y C os t p er D O T vi si t c om m un it y C os t p er D O T ou tp at ie nt v is it C os t p er d ru g pi ck u p vi si t C os t p er co m m un it y tr ea tm en t v is it C os t p er m ic ro sc op y C os t p er o th er te st C os t p er D S -T B re gi m en C os t p er s ho rt D R -T B r eg im en C os t p er lo ng D R -T B r eg im en C os t p er pe rs on m on th pa ti en t s up po rt C os t p er pe rs on p at ie nt su pp or t C os t p er p at ie nt su pp or t v is it C os t p er co m m un it y ev en t 47 Section F. Appendices In te rv en ti on cl as s In te rv en ti on In te rv en ti on D et ai ls Te ch no lo gy P la tf or m (c ho os e m or e th an on e on ly w he n ne c- es sa ry ) P op ul at io n (c ho os e m or e th an on e on ly w he n ne c- es sa ry ) S TA N D A R D U N IT C O S T IN TE R V E N TI O N (q ua li ty -a dj us te d un it c os t) S TA N D A R D U N IT C O S T S E R V IC E D IR EC T S TA N D A R D U N IT C O S T S E R V IC E A N C IL L A R Y TB pr ev en ti on TB P re ve nt io n Tr ea tm en t o f la te nt T B 3H P 6H A R T re gi m en if H IV + C ot ri m ox az ol e pr op hy la xi s IG R A a Li fe lo ng is on ia zi d M on it or in g te st s (b re ak th ro ug h di se as e, a dv er se ev en ts a nd ac qu ir ed d ru g re si st an ce ) R if ap en ti ne TB s cr ee n to r ul e ou t a ct iv e TS T or P P D o r M an to ux te st P ub lic f ac ili ty (H IV ca re ) P ub lic f ac ili ty P ri va te f ac ili ty H os pi ta l g en er al H os pi ta l T B C hi ld re n A du lt s (H IV +) C os t p er tr ea tm en t m on th la te nt T B in fe ct io n C os t p er p er so n tr ea te d la te nt T B in fe ct io n C os t p er p er so n co m pl et in g tr ea tm en t l at en t T B in fe ct io n C os t p er o ut pa ti en t vi si t C os t p er s cr ee n C os t p er te st C os t p er r eg im en C os t p er p er so n m on th p at ie nt su pp or t C os t p er p er so n pa ti en t s up po rt C os t p er p at ie nt su pp or t v is it C os t p er co m m un it y ev en t TB in fe ct io n co nt ro l TB in fe ct io n co nt ro l A dm in is tr at iv e, en vi ro nm en ta l an d pe rs on al pr ot ec ti on to pr ev en t i nf ec ti on in h ea lt h fa ci lit ie s an d la bo ra to ri es A dm in is tr at iv e co nt ro ls B io sa fe ty in la bo ra to ri es E nv ir on m en ta l (v en ti la ti on , U V lig ht s) In fe ct io n co nt ro l fo r pa ti en ts P ro te ct iv e eq ui pm en t a nd su pp lie s P ub lic f ac ili ty P ri va te f ac ili ty H os pi ta l g en er al H os pi ta l T B H ea lt h ca re w or ke rs P at ie nt s A cc om pa ny in g fa m ily o r fr ie nd o r su pp or te r or D O T ob se rv er La bo ra to ry s ta ff C os t p er f ac ili ty C os t p er la bo ra to ry   A ct iv it y un it c os ts C os ts p er la bo ra to ry sp ec ifi ca ti on C os t o f s af et y eq ui pm en t C os t o f p er so na l pr ot ec ti ve eq ui pm en t C os t o f w as te ha nd lin g C os t p er s af et y tr ai ni ng C os t o f c od es a nd st an da rd o pe ra ti ng pr oc ed ur es Costing guidelines for Tuberculosis interventions48 In te rv en ti on cl as s In te rv en ti on In te rv en ti on D et ai ls Te ch no lo gy P la tf or m (c ho os e m or e th an on e on ly w he n ne ce ss ar y) P op ul at io n (c ho os e m or e th an on e on ly w he n ne ce ss ar y) S TA N D A R D U N IT C O S T IN TE R V E N TI O N (q ua li ty -a dj us te d un it c os t) S TA N D A R D U N IT C O S T S E R V IC E D IR EC T S TA N D A R D U N IT C O S T S E R V IC E A N C IL L A R Y TB p ol ic y, pl an ni ng , co or di na ti on an d m an ag em en t TB p ol ic y, pl an ni ng , co or di na ti on an d m an ag em en t P ol ic y, pl an ni ng , co or di na ti on an d m an ag em en t fo r TB s er vi ce s D ev el op m en t o f s tr at eg ic pl an s P ro gr am m e re vi ew s N at io na l m ee ti ng s R eg io na l m ee ti ng s S up er vi si on M an ag em en t a nd in fo rm at io n sy st em s S ur ve ys P ro cu re m en t a nd s up pl y ch ai n m an ag em en t A dv oc ac y Te ch ni ca l a ss is ta nc e Tr ai ni ng A cc re di ta ti on a nd qu al it y as su ra nc e fo r la bo ra to ri es Tr an sp or t f or s pe ci m en s C om m un it y m ed ia In fo rm at io n, e du ca ti on an d co m m un ic at io n P ar tn er sh ip A ct iv it ie s N at io na l T B pr og ra m m e M in is tr y of H ea lt h P ub lic h ea lt h fa ci lit ie s an d la bo ra to ri es P ri va te h ea lt h fa ci lit ie s an d la bo ra to ri es N on - go ve rn m en ta l or ga ni za ti on s H ea lt h- ca re w or ke rs La bo ra to ry s ta ff M an ag em en t C os t p er pr og ra m m e   A ct iv it y un it c os ts C os ts p er tr ai ni ng C os ts p er so ft w ar e de ve lo pm en t C os t p er e ve nt C os t p er w or ks ho p C os t p er su pe rv is or y vi si t C os t p er it em tr an sp or te d TB : t ub er cu lo si s; M TB : m yc ob ac te ri um t ub er cu lo si s; R IF : r if am pi ci n; LE D : l ig ht -e m it ti ng d io de ; ZN : Z ie hl N ee ls en ; H IV : h um an im m un od efi ci en cy v ir us ; C D 4: c lu st er o f d iff er en ti at io n 4; LP A : l in e pr ob e as sa y; F LD : fi rs t- lin e dr ug ; S LD : s ec on d- lin e dr ug ; D S T: d ru g- su sc ep ti bi lit y te st in g; L A M P : l oo p -m ed ia te d is ot he rm al a m pl ifi ca ti on ; LF -L A M : l at er al fl ow u ri ne li po ar ab in om an na n as sa y; IG R A : i nt er fe ro n -g am m a re le as e as sa y; TS T: t ub er cu lin s ki n te st ; P P D : p ur ifi ed p ro te in d er iv at iv e; A S T: a sp ar ta te a m in ot ra ns fe ra se ; S G O T: s er um g lu ta m ic -o xa lo ac et ic tr an sa m in as e; R B S : r an do m b lo od s ug ar ; P C R -D N A : p ol ym er as e ch ai n re ac ti on -d eo xy ri bo nu cl ei c ac id ; E P TB : e xt ra -p ul m on ar y tu be rc ul os is ; C T: c om pu te d to m og ra ph y; E C G : e le ct ro ca rd io gr ap hy ; M C H : m at er na l c hi ld h ea lt h; D S -T B : d ru g se ns it iv e TB ; M D R -T B : m ul ti dr ug -r es is ta nt ; P re -X D R -T B : p re -e xt en si ve ly  d ru g- re si st an t T B ; X D R -T B : e xt en si ve ly  d ru g- re si st an t; P P M : p ub lic -p ri va te m ix ; P A L : p ra ct ic al a pp ro ac h to lu ng h ea lt h; M -h ea lt h: m ob ile h ea lt h; A R T: a nt ir et ro vi ra l t he ra py ; D R -T B : d ru g re si st an t T B ; D O T: d ir ec tl y ob se rv ed tr ea tm en t; 6H : 6 -m on th is on ia zi d; 3H P : o nc e- w ee kl y is on ia zi d- ri fa pe nt in e fo r 12 w ee ks U V : u lt ra vi ol et ; a IG R A is n ot r ec om m en de d fo r de te ct io n of la te nt T B in fe ct io n in W H O G ui de lin es b ut is b ei ng u se d in s om e se tt in gs . 49 Section F. Appendices Ap pe nd ix 4 . P ri nc ip le s a nd m et ho ds r ep or tin g c he ck lis t Th is t ab le is r ec om m en de d by G H CC fo r re po rt in g m et ho ds [5 ]. Fo r a sp ec ifi c co st in g st ud y, t he “O pt io ns ” c ol um n sh ou ld b e co m pl et ed a cc or di ng to h ow t he s tu dy w as c on du ct ed . R ef er en ce C as e C he ck li st It em s O pt io ns S TU D Y D E S IG N A N D S C O P E P ri nc ip le 1 – T he p ur po se o f t he s tu dy , t he p op ul at io n, a nd th e in te rv en ti on a nd /o r se rv ic e/ ou tp ut b ei ng c os te d sh ou ld b e cl ea rl y de fi ne d. P ur po se P ur po se t yp e: E co no m ic e va lu at io n, F in an ci al p la nn in g, B ud ge t i m pa ct a na ly si s, E ffi ci en cy a na ly si s, O th er R el ev an ce f or h ea lt h pr ac ti ce a nd /o r po lic y de ci si on s: Fr ee te xt A im o f t he c os t a na ly si s: Fr ee te xt In te nd ed u se r( s) o f t he c os t e st im at e: Fr ee te xt In te rv en ti on M ai n ac ti vi ti es /t ec hn ol og ie s in vo lv ed : Fr ee te xt Ta rg et p op ul at io n: A s re le va nt : a ge , g en de r, g eo gr ap hi ca l l oc at io n, c lin ic al in di ca ti on C ov er ag e le ve l: P er ce nt ag e of t ar ge t p op ul at io n or s it es D el iv er y m ec ha ni sm (e .g . h ea lt h sy st em le ve l, fa ci lit y ty pe , o w ne rs hi p, e tc .): A s re le va nt : l ev el o f h ea lt h se rv ic e, f ac ili ty t yp e E pi de m io lo gi ca l c on te xt (i .e . i nc id en ce /p re va le nc e of d is ea se ) A s re le va nt : i nc id en ce a nd /o r pr ev al en ce In te rv en ti on D es cr ib e pr od uc ti on p ro ce ss (e .g . l is t m ai n ac ti vi ti es a nd k ey te ch no lo gi es in vo lv ed in de liv er in g th e in te rv en ti on ) P ri nc ip le 2 – T he p er sp ec ti ve (e xt en t o f t he r es ou rc e us e ca pt ur ed ) o f t he c os t e st im at io n sh ou ld b e st at ed a nd ju st ifi ed r el ev an t t o pu rp os e S tu dy p er sp ec ti ve (e .g . p ro vi de r, h ea lt h sy st em , s oc ie ta l, ho us eh ol d) : (N am ed ) p ro vi de r or s oc ie ta l, an d lis t s pe ci fi c pa ye rs . S ta te a ny s to pp in g ru le s. P ri nc ip le 3 – T he t yp e of c os t b ei ng e st im at ed s ho ul d be c le ar ly d efi ne d, in te rm s of e co no m ic v s fi na nc ia l, r ea l w or ld v s gu id el in e, a nd in cr em en ta l v s fu ll c os t, a nd w he th er th e co st is ‘n et o f f ut ur e co st ’, sh ou ld b e ju st ifi ed r el ev an t t o pu rp os e. D efi ni ng th e co st E co no m ic v s. fi na nc ia l c os t E co no m ic v s. fi na nc ia l c os t R ea l w or ld ’ v s. g ui de lin e co st R ea l w or ld ’ v s. g ui de lin e co st Fu ll vs . i nc re m en ta l c os t Fu ll vs . i nc re m en ta l c os t N et o f f ut ur e co st Ye s or N o P ri nc ip le 4 – T he ‘u ni ts ’ i n th e un it c os ts f or s tr at eg ie s, s er vi ce s an d in te rv en ti on s sh ou ld b e de fi ne d, r el ev an t f or th e co st in g pu rp os e an d ge ne ra liz ab le Li st th e un it c os ts u se d: C ho os e fr om li st o f s ta nd ar di ze d un it c os ts D es cr ib e an y ad ju st m en ts m ad e to r efl ec t t he q ua lit y of s er vi ce o ut pu t: C ho os e fr om li st o f s ta nd ar di ze d ad ju st m en ts Costing guidelines for Tuberculosis interventions50 R ef er en ce C as e C he ck li st It em s O pt io ns P ri nc ip le 5 – T he ti m e ho ri zo n sh ou ld b e of s uffi ci en t l en gt h to c ap tu re a ll c os ts r el ev an t t o th e pu rp os e, a nd c on si de ra ti on s ho ul d be g iv en to d is ag gr eg at in g co st s in to se pa ra te ti m e pe ri od s w he re a pp ro pr ia te . Ti m e pe ri od P er io d ty pe (s ta rt -u p vs im pl em en ta ti on ): S ta rt -u p, im pl em en ta ti on o r bo th Ti m e pe ri od : Ye ar s an d m on th s S ER V IC E A N D R E S O U R C E U S E M E A S U R EM EN T P ri nc ip le 6 – T he s co pe o f t he in pu ts to in cl ud e in th e co st e st im at io n sh ou ld b e de fi ne d an d ju st ifi ed r el ev an t t o pu rp os e D efi ni ng th e sc op e A bo ve s er vi ce d el iv er y co st s in cl ud ed : Ye s or N o C os ts o f s up po rt in g ch an ge in cl ud ed : Ye s or N o R es ea rc h co st s in cl ud ed : Ye s or N o U nr el at ed c os ts in cl ud ed : Ye s or N o If in cr em en ta l c os ts , a ss um pt io ns m ad e fo r ex is ti ng c ap ac it y Fr ee te xt A ny e xc lu si on s ot he r to s co pe : Fr ee te xt P ri nc ip le 7 – T he m et ho ds f or e st im at in g th e qu an ti ty o f i np ut s sh ou ld b e de sc ri be d, in cl ud in g m et ho ds , d at a so ur ce s an d cr it er ia f or a ll oc at in g re so ur ce s D es cr ib e th e m ea su re m en t o f e ac h in pu t a s ei th er to p -d ow n or b ot to m -u p To p -d ow n or b ot to m -u p D es cr ib e m et ho d to a ll oc at e hu m an r es ou rc es in pu ts O bs er va ti on , t im es he et s, w or k- sa m pl in g, in te rv ie w s, o th er D es cr ib e m et ho ds to a ll oc at ed a bo ve s it e/ ov er he ad in pu ts M et ho d, c ri te ri a an d da ta s ou rc e fo r cr it er ia D es cr ib e th e m et ho ds f or e xc lu di ng r es ea rc h co st s: M et ho d, c ri te ri a an d da ta s ou rc e fo r cr it er ia D es cr ib e th e m et ho ds f or m ea su ri ng o th er r es ou rc es M et ho d an d da ta s ou rc e P ri nc ip le 8 – T he s am pl in g st ra te gy u se d sh ou ld b e de te rm in ed b y th e pr ec is io n de m an de d by th e co st in g pu rp os e an d de si gn ed to m in im is e bi as S it e/ cl ie nt s el ec ti on p ro ce ss /c ri te ri a D es cr ib e ge og ra ph ic s am pl in g (if a pp lic ab le ): Fr am e an d m et ho d D es cr ib e si te s am pl in g (if a pp lic ab le ): Fr am e an d m et ho d D es cr ib e pa ti en t s am pl in g (if a pp lic ab le ): Fr am e an d m et ho d D es cr ib e m et ho ds to c al cu la te s am pl e si ze : C al cu la ti on P ri nc ip le 9 – T he s el ec ti on o f t he d at a so ur ce (s ) a nd m et ho ds f or e st im at in g se rv ic e us e sh ou ld b e de sc ri be d, a nd p ot en ti al b ia se s re po rt ed in th e st ud y lim it at io ns . Id en ti fy th e da ta s ou rc e us ed to m ea su re th e un it s: C as e no te e xt ra ct io n, p at ie nt in te rv ie w s, p ro vi de r in te rv ie w s, r ou ti ne in fo rm at io n sy st em s, c la im s da ta , o th er W he re r el ev an t d es cr ib e th e sa m pl in g fr am e, m et ho d an d si ze : Fr ee te xt D es cr ib e an y m et ho d us ed to fi ll m is si ng d at a Fr ee te xt 51 Section F. Appendices R ef er en ce C as e C he ck li st It em s O pt io ns P ri nc ip le 1 0 – C on si de ra ti on s ho ul d be g iv en to th e ti m in g of d at a co ll ec ti on to m in im iz e re ca ll b ia s an d, w he re r el ev an t, th e im pa ct o f s ea so na lit y an d ot he r di ff er en ce s ov er ti m e Th e ti m in g of d at a co ll ec ti on s ho ul d be s pe ci fi ed in th e fo ll ow in g w ay s: Ti m in g of d at a co ll ec ti on (r es ou rc e an d se rv ic e us e) D at e of d at a co ll ec ti on P ro sp ec ti ve o r re tr os pe ct iv e P ro sp ec ti ve o r re tr os pe ct iv e Lo ng it ud in al v s. c ro ss -s ec ti on al d at a: Lo ng it ud in al v s. c ro ss -s ec ti on al d at a: W he re r el ev an t r ec al l p er io d: M on th s or w ee ks VA LU A TI O N A N D P R IC IN G P ri nc ip le 1 1 – Th e so ur ce s fo r pr ic e da ta s ho ul d be li st ed b y in pu t, a nd c le ar d el in ea ti on s ho ul d be m ad e be tw ee n lo ca l a nd in te rn at io na l p ri ce d at a so ur ce s, a nd tr ad ea bl e an d no n- tr ad ea bl e go od s. R ep or t t he s ou rc es o f p ri ce d at a by in pu t: M in is tr y of H ea lt h, lo ca l m ar ke t e tc . R ep or t i np ut s w he re lo ca l a nd in te rn at io na l p ri ce s w er e us ed : Lo ca l o r in te rn at io na l P ri nc ip le 1 2 – C ap it al c os ts s ho ul d be a pp ro pr ia te ly a nn ui ti ze d or d ep re ci at ed to r efl ec t t he e xp ec te d lif e of c ap it al in pu ts D es cr ib e th e de pr ec ia ti on a pp ro ac h: S tr ai gh t l in e de pr ec ia ti on , a m or tiz at io n D es cr ib e an y di sc ou nt r at e us ed f or c ap it al g oo ds : P er ce nt ag e R ep or t t he e xp ec te d lif e ye ar s of c ap it al g oo ds , a nd d at a so ur ce s: Ye ar s an d fr ee te xt P ri nc ip le 1 3 – W he re r el ev an t a n ap pr op ri at e di sc ou nt r at e, in fl at io n an d ex ch an ge r at es s ho ul d be u se d, a nd c le ar ly s ta te d. D es cr ib e an y di sc ou nt r at e us ed f or f ut ur e co st s: P er ce nt ag e D es cr ib e th e re po rt ed c ur re nc y ye ar : C ur re nc y an d ye ar D es cr ib e an y co nv er si on s m ad e: E xc ha ng e ra te , s ou rc e an d ye ar R ep or t t he in fl at io n ty pe a nd r at e us ed : P er ce nt ag e, G D P d efl at or /C P I, so ur ce P ri nc ip le 1 4 – Th e us e an d so ur ce o f s ha do w p ri ce s fo r go od s an d fo r th e op po rt un it y co st o f t im e sh ou ld b e re po rt ed M et ho ds f or v al ui ng th e fo ll ow in g sh ou ld b e re po rt ed : R ep or t m et ho ds f or v al ui ng v ol un te er ti m e: Fr ee te xt R ep or t a dj us tm en ts f or in pu t p ri ce s (d on at ed o r su bs id is ed g oo ds ): Fr ee te xt A N A LY S IN G A N D P R E S EN TI N G R E S U LT S P ri nc ip le 1 5 – Va ri at io n in th e co st o f t he in te rv en ti on b y si te s iz e/ or ga ni za ti on , s ub -p op ul at io ns , o r by o th er d ri ve rs o f h et er og en ei ty s ho ul d be e xp lo re d an d re po rt ed . D es cr ib e an y su b -g ro up s or p op ul at io ns a na ly se d Fr ee te xt D es cr ib e an y st at is ti ca l m et ho ds u se d to e st ab lis h di ff er en ce s in u ni t c os ts b y su b - gr ou p Fr ee te xt D es cr ib e an y de te rm in an ts o f c os t ( m od el s pe ci fi ca ti on ) Fr ee te xt D es cr ib e an y m ul ti va ri at e st at is ti ca l m et ho ds u se d to a na ly se c os t f un ct io ns Fr ee te xt Costing guidelines for Tuberculosis interventions52 R ef er en ce C as e C he ck li st It em s O pt io ns P ri nc ip le 1 6 – Th e un ce rt ai nt y as so ci at ed w it h co st e st im at es s ho ul d be a pp ro pr ia te ly c ha ra ct er iz ed . D es cr ib e se ns it iv it y an al ys es c on du ct ed Fr ee te xt Li st p os si bl e so ur ce s of b ia s Fr ee te xt P ri nc ip le 1 7 – C os t e st im at es s ho ul d be c om m un ic at ed c le ar ly a nd tr an sp ar en tl y to e na bl e de ci si on -m ak er (s ) t o in te rp re t a nd u se th e re su lt s. Li m it at io ns Li m it at io ns in th e de si gn , a na ly si s, a nd r es ul ts : Fr ee te xt A sp ec ts o f t he c os t e st im at es th at w ou ld li m it g en er al iz ab ili ty o f r es ul ts to o th er co ns ti tu en ci es : Fr ee te xt C on fl ic ts o f i nt er es t A ll pe cu ni ar y an d no n- pe cu ni ar y in te re st s of th e st ud y co nt ri bu to rs : Fr ee te xt A ll so ur ce s of f un di ng th at s up po rt ed c on du ct o f t he c os ti ng : Fr ee te xt N on -m on et ar y so ur ce s of s up po rt f or c on du ct o f t he c os ti ng : Fr ee te xt O pe n ac ce ss D at as et a va ila bl e Ye s or N o 53 Section F. Appendices AP PE ND IX 5. A MO RT IZ AT IO N TA BL E U se t he n um be r of e xp ec te d lif e ye ar s (o r ‘n um be r of r em ai ni ng y ea rs o r us ef ul li fe ’ i n th e fir st c ol um n) a nd t he d es ir ed d is co un t r at e (1 –1 9% ) t o fin d th e am or ti za ti on fa ct or . n 1% 2% 3% 4% 5% 6% 7% 8% 9% 10 % 11 % 12 % 13 % 14 % 15 % 16 % 17 % 18 % 19 % 20 % 1 0. 99 0 0. 98 0 0. 97 1 0. 96 2 0. 95 2 0. 94 3 0. 93 5 0. 92 6 0. 91 7 0. 90 9 0. 90 1 0. 89 3 0. 88 5 0. 87 7 0. 87 0 0. 86 2 0. 85 5 0. 84 7 0. 84 0 0. 83 3 2 1. 97 0 1. 94 2 1. 91 3 1. 88 6 1. 85 9 1. 83 3 1. 80 8 1. 78 3 1. 75 9 1. 73 6 1. 71 3 1. 69 0 1. 66 8 1. 64 7 1. 62 6 1. 60 5 1. 58 5 1. 56 6 1. 54 7 1. 52 8 3 2. 94 1 2. 88 4 2. 82 9 2. 77 5 2. 72 3 2. 67 3 2. 62 4 2. 57 7 2. 53 1 2. 4 87 2. 4 4 4 2. 40 2 2. 36 1 2. 32 2 2. 28 3 2. 24 6 2. 21 0 2. 17 4 2. 14 0 2. 10 6 4 3. 90 2 3. 80 8 3. 71 7 3. 63 0 2. 54 6 3. 4 65 3. 38 7 3. 31 2 3. 24 0 3. 17 0 3. 10 2 3. 03 7 2. 97 4 2. 91 4 2. 85 5 2. 79 8 2. 74 3 2. 69 0 2. 63 9 2. 58 9 5 4. 85 3 4. 71 3 4. 58 0 4. 45 2 4. 32 9 4. 21 2 4. 10 0 3. 99 3 3. 89 0 3. 79 1 3. 69 6 3. 60 5 3. 51 7 3. 43 3 3. 35 2 3. 27 4 3. 19 9 3. 12 7 3. 05 8 2. 99 1 6 5. 79 5 5. 60 1 5. 41 7 5. 24 2 5. 07 6 4. 91 7 4. 76 7 4. 62 3 4. 4 86 4. 35 5 4. 23 1 4. 11 1 3. 99 8 3. 88 9 3. 78 4 3. 68 5 3. 58 9 3. 49 8 3. 41 0 3. 32 6 7 6. 72 8 6. 47 2 6. 23 0 6. 00 2 5. 78 6 5. 58 2 5. 38 9 5. 20 6 5. 03 3 4. 86 8 4. 71 2 4. 56 4 4. 42 3 4. 28 8 4. 16 0 4. 03 9 3. 92 2 3. 81 2 3. 70 6 3. 60 5 8 7. 65 2 7. 32 5 7. 02 0 6. 73 3 6. 4 63 6. 21 0 5. 97 1 5. 74 7 5. 53 5 5. 33 5 5. 14 6 4. 96 8 4. 79 9 4. 63 9 4. 4 87 4. 34 4 4. 20 7 4. 07 8 3. 95 4 3. 83 7 9 8. 56 6 8. 16 2 7. 78 6 7. 43 5 7. 10 8 6. 80 2 6. 51 5 6. 24 7 5. 99 5 5. 75 9 5. 53 7 5. 32 8 5. 13 2 4. 94 6 4. 77 2 4. 60 7 4. 45 1 4. 30 3 4. 16 3 4. 03 1 10 9. 47 1 8. 98 3 8. 53 0 8. 11 1 7. 72 2 7. 36 0 7. 02 4 6. 71 0 6. 41 8 6. 14 5 5. 88 9 5. 65 0 5. 42 6 5. 21 6 5. 01 9 4. 83 3 4. 65 9 4. 49 4 4. 33 9 4. 19 2 11 10 .3 68 9. 78 7 9. 25 3 8. 76 0 8. 30 6 7. 88 7 7. 49 9 7. 13 9 6. 80 5 6. 49 5 6. 20 7 5. 93 8 5. 68 7 5. 45 3 5. 23 4 5. 02 9 4. 83 6 4. 65 6 4. 4 86 4. 32 7 12 11 .2 55 10 .5 75 9. 95 4 9. 38 5 8. 86 3 8. 38 4 7. 94 3 7. 53 6 7. 16 1 6. 81 4 6. 49 2 6. 19 4 5. 91 8 5. 66 0 5. 42 1 5. 19 7 4. 98 8 4. 79 3 4. 61 1 4. 43 9 13 12 .1 34 11 .3 4 8 10 .6 35 9. 98 6 9. 39 4 8. 85 3 8. 35 8 7. 90 4 7. 4 87 7. 10 3 6. 75 0 6. 42 4 6. 12 2 5. 84 2 5. 58 3 5. 34 2 5. 11 8 4. 91 0 4. 71 5 4. 53 3 14 13 .0 04 12 .1 06 11 .2 96 10 .5 63 9. 89 9 9. 29 5 8. 74 5 8. 24 4 7. 78 6 7. 36 7 6. 98 2 6. 62 8 6. 30 2 6. 00 2 5. 72 4 5. 4 68 5. 22 9 5. 00 8 4. 80 2 4. 61 1 15 13 .8 65 12 .8 49 11 .9 38 11 .1 18 10 .3 80 9. 71 2 9. 10 8 8. 55 9 8. 06 1 7. 60 6 7. 19 1 6. 81 1 6. 4 62 6. 14 2 5. 84 7 5. 57 5 5. 32 4 5. 09 2 4. 87 6 4. 67 5 16 14 .7 18 13 .5 78 12 .5 61 11 .6 52 10 .8 38 10 .1 06 9. 4 47 8. 85 1 8. 31 3 7. 82 4 7. 37 9 6. 97 4 6. 60 4 6. 26 5 5. 95 4 5. 66 8 5. 40 5 5. 16 2 4. 93 8 4. 73 0 17 15 .5 62 14 .2 92 13 .1 66 12 .1 66 11 .2 74 10 .4 77 9. 76 3 9. 12 2 8. 54 4 8. 02 2 7. 54 9 7. 12 0 6. 72 9 6. 37 3 6. 04 7 5. 74 9 5. 47 5 5. 22 2 4. 99 0 4. 77 5 18 16 .3 98 14 .9 92 13 .7 54 12 .6 59 11 .6 90 10 .8 28 10 .0 59 9. 37 2 8. 75 6 8. 20 1 7. 70 2 7. 25 0 6. 84 0 6. 4 67 6. 12 8 5. 81 8 5. 53 4 5. 27 3 5. 03 3 4. 81 2 19 17 .2 26 15 .6 78 14 .3 24 13 .1 34 12 .0 85 11 .1 58 10 .3 36 9. 60 4 8. 95 0 8. 36 5 7. 83 9 7. 36 6 6. 93 8 6. 55 0 6. 19 8 5. 87 7 5. 58 4 5. 31 6 5. 07 0 4. 84 3 20 18 .0 4 6 16 .3 51 14 .8 77 13 .5 90 12 .4 62 11 .4 70 10 .5 94 9. 81 8 9. 12 9 8. 51 4 7. 96 3 7. 4 69 7. 02 5 6. 62 3 6. 25 9 5. 92 9 5. 62 8 5. 35 3 5. 10 1 4. 87 0 21 18 .8 57 17 .0 11 15 .4 15 14 .0 29 12 .8 21 11 .7 64 10 .8 36 10 .0 17 9. 29 2 8. 64 9 8. 07 5 7. 56 2 7. 10 2 6. 68 7 6. 31 2 5. 97 3 5. 66 5 5. 38 4 5. 12 7 4. 89 1 22 19 .6 60 17 .6 58 15 .9 37 14 .4 51 13 .1 63 12 .0 42 11 .0 61 10 .2 01 9. 4 42 8. 77 2 8. 17 6 7. 64 5 7. 17 0 6. 74 3 6. 35 9 6. 01 1 5. 69 6 5. 41 0 5. 14 9 4. 90 9 23 20 .4 56 18 .2 92 16 .4 4 4 14 .9 57 13 .4 89 12 .3 03 11 .2 72 10 .3 71 9. 58 0 8. 88 3 8. 26 6 7. 71 8 7. 23 0 6. 79 2 6. 39 9 6. 04 4 5. 72 3 5. 43 2 5. 16 7 4. 92 5 24 21 .2 43 18 .9 14 16 .9 36 15 .2 47 13 .7 99 12 .5 50 11 .4 69 10 .5 29 9. 70 7 8. 98 5 8. 34 8 7. 78 4 7. 28 3 6. 83 5 6. 43 4 6. 07 3 5. 74 6 5. 45 1 5. 18 2 4. 93 7 25 22 .0 23 19 .5 23 17 .4 13 15 .6 22 14 .0 94 12 .7 83 11 .6 54 10 .6 75 9. 82 3 9. 07 7 8. 42 2 7. 84 3 7. 33 0 6. 87 3 6. 4 64 6. 09 7 5. 76 6 5. 4 67 5. 19 5 4. 94 8 26 22 .7 95 20 .1 21 17 .8 77 15 .9 83 14 .3 75 13 .0 03 11 .8 26 10 .8 10 9. 92 9 9. 16 1 8. 4 88 7. 89 6 7. 37 2 6. 90 6 6. 49 1 6. 11 8 5. 78 3 5. 4 80 5. 20 6 4. 95 6 27 23 .5 60 20 .7 07 18 .3 27 16 .3 30 14 .6 43 13 .2 11 11 .9 87 10 .9 35 10 .0 27 9. 23 7 8. 54 8 7. 94 3 7. 40 9 6. 93 5 6. 51 4 6. 13 6 5. 79 8 5. 49 2 5. 21 5 4. 96 4 28 24 .3 16 21 .2 81 18 .7 64 16 .6 63 14 .8 98 31 .4 06 12 .1 37 11 .0 51 10 .1 16 9. 30 7 8. 60 2 7. 98 4 7. 4 41 6. 96 1 6. 53 4 6. 15 2 5. 81 0 5. 50 2 5. 22 3 4. 97 0 29 25 .0 66 21 .8 4 4 19 .1 88 16 .9 84 15 .1 41 13 .5 91 12 .2 78 11 .1 58 10 .1 98 9. 37 0 8. 65 0 8. 02 2 7. 47 0 6. 98 3 6. 55 1 6. 16 6 5. 82 0 5. 51 0 5. 22 9 4. 97 5 30 25 .8 0 22 .3 96 19 .6 00 17 .2 92 15 .3 72 13 .7 65 12 .4 09 11 .2 58 10 .2 74 9. 42 7 8. 69 4 8. 05 5 7. 49 6 7. 00 3 6. 56 6 6. 17 7 5. 82 9 5. 51 7 5. 23 5 4. 97 9 N =N um be r of r em ai ni ng y ea rs o f u se fu l l if e Costing guidelines for Tuberculosis interventions54 Appendix 6. Protocol outline Title of the study Investigators and institutional affiliations Abstract Introduction/Background Justification for the study/Purpose and study question Null hypothesis Objectives: 1. General objectives 2. Specific objectives Study design and methodology: 1. Study site 2. Study populations 3. Sampling 4. Procedures a. Costing methods b. Interventions and unit costs c. Piloting and data collection Perspective of the evaluation Selecting a study team Data management: 1. Data storage 2. Data analysis Intellectual property Time frame/Duration of the study: Ethical consideration: 1. Human subjects 2. Informed consent 3. Confidentiality 4. Benefits and risks 5. Data sharing 6. Community engagement Expected application of the results References Appendices: Appendix 1: Summary budget Appendix 2: Justification of budget Appendix 3: Role of investigators Appendix 4: Description of interventions 1. Vaccination intensified case finding 2. Active case finding 3. Passive case finding 4. Treatment of TB 5. Prevention (latent TB infection treatment) 6. Infection prevention control 7. TB policy, planning, coordination and management Appendix 5: Facility information sheet Appendix 6: Informed consent Appendix 7: Curriculum vitae of each investigator 55 Section F. Appendices Appendix 7. Examples of queries and comments from ethics committees 1. What will happen if facilities do not agree to take part? Will you need to rerun your sample? 2. Could you add more information on the observations? 3. Special care needs to be given to ensure the anonymity of participants and to mitigate the risk that they are identifiable by their location/institution. Be careful about how you describe respondents to ensure that they cannot be identified by location/role. The sentence “Your questionnaire will not bear your names; this way your responses will be anonymous” is not always true if you reveal the respondents job title and hint at their location – colleagues/managers will know who has been interviewed and may be able to identify who said what. 4. In both the information sheet and consent form, it should be specified how the observation will be done, who and number of observers involved. Similarly, with the timesheet it should state in the consent form the actual period rather than saying ‘over the period specified’. 5. In the information sheet, it states that participation is voluntary and that choosing to withdraw can be at any time without consequence. The committee suggest adding the commonly used ‘without the need to give a reason’. 6. The committee thinks you should consider asking participants to initial the sentences indicating permission granted for different aspects of your research rather than ticking a box. 7. How will the data be aggregated? Since only 3–5 staff per facility will be inter- viewed, will there not be a risk of breach of confidentiality? 8. The approach and justification for the proposed sampling of health facilities is unclear. Please explain how the reference list of 25 was derived? 9. The information sheet/consent form states that they may be asked to complete a diary over the course of one week or allow researchers to observe them as they go about daily tasks. Is the observation for 1-day or 1-week? Please make that clear to the participant. 10. Kindly consider adding the study population in the title. 11. Please clarify whether both direct and indirect costs will be collected. 12. Indirect cost is an important cost driver for TB services, why was this not neces- sary in this study? 13. Three (3) regions Nairobi, Eastern and Western Kenya were selected due to high number of TB cases, but sampling table does not show the five other regions of Kenya to justify site selections. Please clarify. 14. Sampling of health facilities has been provided but the sample size determination has not been provided. Of the total 3690, you will randomly select 24 facilities, which translates to 20% margin of error which is quite low compared to traditional 5% margin of error which would need 350 health facilities with adequate power to generalize to the entire country: please provide a section for sample size determination and procedures and level of power needed for analysis. Costing guidelines for Tuberculosis interventions56 15. Please clarify the exclusion of prisoners as study subjects; the other facilities listed where the study may be conducted will also possibly have a mix of funding resource? Given also their close living conditions, the likelihood of TB infection is high. 16. Per protocol costs tend to over-estimate costs if the intervention is funded by donors and often deviate from real world costs, how will the study handle these variances? Please clarify. 17. Which econometric models/methods will be used in the analysis? 18. Given that you intend to observe health providers in the course of delivering service, please also [ensure] direct sensitization of the study activities to patients who will be present during that observation, through fliers, posters etc. 19. In the informed consent document, under “who has allowed…”, please indicate the institution names rather than several national and international committees for added confidence. 57 Section F. Appendices Appendix 8. Value TB Costing Tool Suite This appendix details all the aspects included in the Value TB Data Collection Tool and the Data Entry Tool, providing instruction and some methodology. For ease of use, an image of each of the sheets is displayed for the different sections. The layout follows a thought process of how one might collect and enter data, however given the nature of costing the sequence of quantities and prices collected may vary. data collection tool The Data Collection Tool, used by data collectors, is described here (see Figure 10a). First, general instructions are given for the tool sheets. This is followed by an overview of how to use the generic unadapted tool to collect facility data for bottom-up and top-down unit costs calculation. Types of sheets ■n In the Data Collection Tool, there are five types of color-coded sheets. ■n Black sheets are meant to help with the planning of the data collection and to acquire an understanding of the structure and processes within the facility. Fig. 10a. The Value TB Costing Tool Suite (Data Collection Tool highlighted in orange) Value TB generic facility provider cost Data Collection Tool Facility provider cost Data Collection Tool (Country-specific assumptions & parameters, facility-selection of relevant TB service delivery outputs) Costing Guidelines for Tuberculosis Interventions (for facility provider costing) Facility provider cost Data Entry Tool for one facility used for initial analysis tool (generic/no adaptation required) Number of facilities in sample Extraction of P’s and Q’s for analysis in a statistical package Value TB cost model – analysis Unit costs for all TB interventions/services for one country • Per visit/test BU and TD • Per patient BU and TD X Costing guidelines for Tuberculosis interventions58 ■n These sheets, in particular Data collection planning 1 and Data collection planning 2, can be used during an introductory visit while one becomes familiar with the facility. ■n Data should be entered into the yellow cells and nowhere else. ■n The blue sheets are for data related to the facility, including identifying facility- specific service outputs, inventory of capital assets, building dimensions, overhead (recurrent and capital) costs and availability of above service level data. ■n Green sheets are for prices for drugs, supplies, and equipment. ■n The grey sheets relate to TB service utilization for the 20 standardized service outputs and at least 39 diagnostic and monitoring tests being costed, as well as the drug regimens and supplies used. ■n The red sheets are for capturing quantities related to time for staff (assessed by observations, interviews and timesheets) and usage for equipment, supplies and vehicles (observation and interviews), which are inputs for both top-down and bottom-up costing. ■n In the red sheets one would collect and enter the information on utilization within the health facility, such as the annual number of outpatient and community visits for TB-related services and for the entire facility. ■n A breakdown is also provided for top-down and bottom-up relevant quantities. For example, for drugs, the top-down quantities refer to the total amount of each TB medication disbursed within the facility, while for the bottom-up quantities sampled usage by patients is collected. ■n The template for staff-time interviews is used as one method to capture the quantity and allocation of staff time. ■n The second method is that of weekly timesheet templates, also printable. ■n During the detailed costing, these would be printed out or provided on electronic tablets to staff members at the beginning of the data collection week and collected at the end of the week. ■n Total drug expenditure, which will enable top-down cost calculations later on, will be estimated based on the product of the total annual quantity of drugs disbursed at the facility by the unit price of the drugs. ■n Similarly, bottom-up calculations will be performed based on the product of the drug prices and the average quantity per average patient for each TB treatment and prevention regimen by phase. ■n The instructions for Data Collection Tool often apply to the Data Entry Tool too. This is because one collects the quantities (such as minutes observed, etc.) and prices in the Data Collection Tool and then transfers the pertinent information to the Data Entry Tool, where costs are allocated to departments and services and the unit costs are calculated. ■n Throughout the data collection and Data Entry Tools, if an input cell is not applicable, it can be left blank or the cell can be changed to green (MS Excel ‘Good’ style). ■n Do not enter NA or 0 in cells that are not applicable, as this may affect the calculations in the Data Entry Tool. 59 Section F. Appendices Adaptation of the tool to the context In addition to default listings, there ispace to add as many of the context-specific and country appropriate service outputs, drug names, test procedures, service utilization labels, consumables supplies, staff titles, department or clinic names and other important labelling as possible, is provided in blue font in the non-yellow (un-highlighted) cells, such as in the column labelled ‘Health care worker type’ in the Staff Salaries sheet (9) or by including yellow highlighted cells where information can be typed in, such as the ‘Name or description of supply’ column in the Price list- Supplies sheet (22) of the Data Collection Tool. Without adaptation, the generic Data Collection Tool allows the data collector to: A. Plan for data collection ■n As a guide for planning the data collection, it is estimated that a health centre would require two days, a large health centre or small hospital would require four days and a regional or tertiary hospital or reference laboratory would require two weeks. ■n Sheets Data collection planning 1 (4) and Data collection planning 2 (5) can be used during an introductory visit while one becomes familiar with the facility. Data collection planning 1 ■n This is an optional sheet that has been developed to help with planning for data collection by noting the location and title of the contact person who can provide further information about each TB intervention type. ■n Please be sure to only record the title of the contact person and not their name in this tool so that data protection and participant anonymity are ensured. ■n If one would like to capture the name of the contact, please use the separate facility contact workbook, which should always be saved separately from the data, in a locked cabinet or with password protection. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 4.Data  collection  planning  1 27/11/19 Page  1 Start  date  of  data  collection dd/mm/yyyy Start  time  of  data  collection HH:MM End  date  of  data  collection dd/mm/yyyy End  time  of  data  collection HH:MM Name  of  data  collector Sheet  complete  (dropdown) Class Type Intervention   provided  at  or   through  facility? [use  dropdown] Location  1  of   intervention  (facility   or  offsite) [use  dropdown] Title  of  person(s)   responsible  for   intervention Location  2  of   intervention  (facility   or  offsite) [use  dropdown] Title  of  person(s)   responsible  for   intervention Location  3  of   intervention  (facility   or  offsite) [use  dropdown] Title  of  person(s)   responsible  for   intervention Location  4  of   intervention  (facility   or  offsite) [use  dropdown] Title  of  person(s)   responsible  for   intervention VACCINATION BCG  vaccination Passive  case  finding Intensified  case   finding  -­‐  cough   triage Intensified  case   finding  -­‐  screening Active  case  finding If  no,  list  missing  data?  INSTRUCTIONS:  THIS  SHEET  IS  OPTIONAL.  It  is  intended  to  help  you  understand  and  plan  your  interviews  and  other  data  collection. There  is  space  to  identify  up  to  4  locations  (within  the  facility  or  community  spaces)  where  each  TB  intervention  type  occurs,  with  the  title  of  the  corresponding  contact  person.  The  information  in  this  sheet  can  be  obtained  from  the  head  TB  nurse  or  another  staff  member  with   knowledge  of  TB  service  delivery. Interview  Planning TB  CASE   DETECTION  AND   DIAGNOSIS Notes [include  any  additional  details  on  the  nature   and  extent  of  the  intervention,  where   appropriate] INTERVENTIONS Costing guidelines for Tuberculosis interventions60 ■n For each intervention, the user includes services/interventions that are happening both within the facility and in the community. ■n Community visits (BCG vaccination, ACF and TB Treatment) can occur in various platforms. ■n The user specifies the platforms where these TB services are offered through this health facility. ■n These platforms should be specified and could include health clinics, health posts, community buildings, households, mobile clinics, schools, places of work, prisons or camps. ■n The ‘TB Screening, Diagnostic & Monitoring Tests’ are for diagnosis of latent and active TB, and HIV, as well as monitoring of treatment for active TB. Data collection planning 2 ■n In addition, the user can also fill in a complementary sheet (Data collection planning 2) to organize the data collection by the data collection methodology (timesheets, interviews, observation, and extraction of service statistics, resource quantities, prices and overhead data). ■n Each staff member or input can then be selected from a dropdown or is listed under the methodology type. ■n The potential locations for the data and the corresponding data collection sheet are either listed or can be selected from a dropdown. ■n In order to track the data collection progress, the start and end date, person responsible for obtaining the data and the status of the data can be completed as one proceeds. ■n The dropdown options for the status column are: not started, in progress, completed and not applicable and each is colour-coded, so the status can be visually assessed at a glance. ■n This checklist sheet is optional and intended to assist with the organization of the costing process. ■n For various types of data needed for completing the tool, Appendix 8 provides potential sources (see page 31, Table 4.1 of WHO Guidelines for cost and cost- effectiveness analysis of tuberculosis control (2002)) Value  TB  -­‐  Estimating  unit  costs  of  TB  services 5.Data  collection  planning  2 27/11/19 Page  1 Data  collection  activity/category [use  dropdown] Location  in  facility [use  dropdown] Sheet  name Start  date  of  interview,   observation  or  extraction End  date  of  interview,   observation  or  extraction Status [use  dropdown] Data  collector   responsible Notes A. Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets 20.Staff  time  sheets INSTRUCTIONS:  This  checklist  can  be  used  to  keep  track  of  the  various  data  needed  and  obtained  from  the  different  cadres  of  health  staff  in  the  departments  of  the  health  facility.  The  'Status'  column  allows  you  to  indicate  whether  the  data  is  not   applicable  to  this  facility,  not  started,  in  progress  or  complete  and  is  colour  coded  to  reflect  the  status.   Please  note,  the  list  included  is  not  exhaustive  and  additional  rows  can  be  added  to  the  checklist  to  include  more  staff.  Potential  locations  for  data  collection  have  been  included  but  these  can  be  edited  based  on  the  structure  of  the  facility  and  the  TB   services  provided  there. Checklist 61 Section F. Appendices Title page ■n This provides an overview of the study, outlining the aims of the study and the tool, as well as how the data can be used. ■n The example of the Value TB study is used throughout this section. Glossary ■n Defines the acronyms and abbreviations used within the tool. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 27/11/19 Page  1 AE adverse  events ACF active  case  finding AFB acid-­‐fast  bacilli ALT alanine  aminotransferase  (also  known  as  SGPT) AST asparate  aminotransferase  (also  known  as  SGOT) BCG bacille  Calmette-­‐Guérin BSC biosafety  cabinet BU bottom-­‐up  cost  estimation/allocation BUN blood  urea  nitrogen CBC complete  blood  count CCC comprehensive  care  clinic CT computed  tomography CXR chest  x-­‐ray DOTS directly  observed  therapy,  shortcourse DR drug-­‐resistant DS drug-­‐susceptible DST drug  susceptibility  testing E Ethambutol ECG electrocargiogram Glossary VALUE-­‐TB Data  collection  tool  for  estimating  unit  costs  of  TB  services VALUE-­‐TB  is  a  three-­‐year  project,  funded  by  the  Bill  and  Melinda  Gates  Foundation,  established  to  work  with  National   Tuberculosis  Programmes  (NTPs)  from  high  TB  burden  countries  to  collect  unit  cost  data,  using  new  standardised  methods.   Project  overview: The  included  TB  interventions  are  those  that  are  most  relevant  for  future  local  planning  and  resource  requirement  projections  and  have  been  jointly  defined  by   the  NTP  and  the  VALUE-­‐TB  team. This  cost  data  collection  tool  has  been  developed  to  estimate  the  unit  costs  of  a  comprehensive  set  of  TB  services  from  the  providers'  perspective.  It  is  a  facility-­‐ based  tool  that  collects  data  needed  to  calculate  the  bottom-­‐up  and  top-­‐down,  economic  and  financial  costs  of  TB  services  offered  at  this  facility.   for  programme  management,  funding  and  planning to  inform  the  estimates  of  the  costs  of  TB  services  globally Using  this  instument,  financial  and  TB  service  records  will  be  examined;  all  rooms  and  equipment  used  for  TB  will  be  listed;  staff  will  be  interviewed  about  their   time  spent  on  different  activities;  some  activities  will  be  observed;  and  price  data  will  be  collected,  including  supplies,  equipment  and  salaries. The  estimated  time  for  data  collection  is  approximately  1  week  per  facility,  with  data  being  collected  from  20  to  30  public  and  private  providers  of  TB  services   and  interventions  nationally.   There  are  two  tools  required  to  estimate  the  unit  costs  of  TB  services  at  the  facility  level:  this  Data  Collection  Tool  and  an  accompanying  Data  Entry  Tool.  The   data  collection  tool  will  be  used  by  data  collectors  while  at  the  facility  to  gather  the  required  data.  The  data  entry  tool  will  be  compiled  by  the  study  principal   investigator  or  study  coordinator  to  produce  the  calculated  unit  costs. Outpatient  and  community  services  linked  to  this  facility  will  be  costed.  While  the  unit  costs  of  TB  related  inpatient  care  are  also  calculated,  this  has  not  been   done  at  the  patient  level.  The  estimated  values  may  include  time  spent  in  hospital  receiving  treatment  for  adverse  events  but  the  additional  costS  of  tests  and   drugs  for  TREATING  adverse  events  has  not  been  included  so  that  the  tool  remains  feasible  within  a  reasonable  amount  of  time. The  cost  data  collected  in  this  tool  can  further  be  used: March  8,  2019 Version 2.0 Costing guidelines for Tuberculosis interventions62 Instructions ■n Describes the colour-coding of the sheets and the cells in the tool and how they should be used. ■n Instructions throughout the tool are in blue font, including in cells where data type or name is stated, and the blue font tells one how to input the data needed (e.g. [see dropdown]) or provides an example of the options (e.g. Culture – liquid media [e.g.: MB/Bact Alert, Bactec Mycobacteria Indicator Tube (MGIT) 960]). ■n The data collection sheets have been formatted so they can be printed on A4 paper in either portrait or landscape orientation. ■n If one finds that the printed documents are too small, the size of paper can be changed in the Page Layout tab of Excel and the scaling increased to allow the content to fill up the entire space. B. Record data related to the facility including identifying facility-specific service outputs, inventory of capital assets, building dimensions, overhead (recurrent and capital) costs and availability of above service level data Facility characteristics Value  TB  -­‐  Estimating  unit  costs  of  TB  services 3.Instructions 27/11/19 Page  1 1. 2. 3. 4. 5. 6. Instructions Black  sheets  are  designed  to  help  plan  the  study  but  no  data  is  collected  here  so  the  degree  of  utilisation  of  these  sheets  is  up  to  you. Blue  sheets  capture  captial  and  recurrent  data  for  the  facility.   Grey  sheets  describe  where  and  how  TB  services  are  delivered  and  how  much.   Green  sheets  are  prices  and  expenditure. All  sheets  in  this  tool  have  been  formated  so  that  they  can  be  printed  and  data  collected  on  hard  copies  or   entered  electronically  into  the  sheets. This  data  collection  tool  is  comprised  of  black,  blue,  grey,  red  and  green  sheets.   Red  sheets  relate  to  staff  time.  Optional  sheets: Additional  instructions  for  data  collection  is  given  in  blue  text  throughout  the  tool. Please  use  the  "Notes"  column  to  explain  any  values  that  are  not  in  the  spreadsheet,  provide  more  detail  on  the  source  or  method  of    calculation  of  the  data,  or  anything  else  that  you  think  would  be  of  interest.   Do  not  enter  data  anywhere  else. The  yellow  cells  are  input  cells  where  you  need  to  enter  data.   Value  TB  -­‐  Estimating  unit  costs  of  TB  services 6.Facility  Characteristics 27/11/19 Page  1 Start  date  of  data  collection dd/mm/yyyy HH:MM End  date  of  data  collection dd/mm/yyyy HH:MM Name  of  data  collector Country District  name Town/city  name Sheet  completed  [use  dropdown] Source Year  of  data Facility  name Facility  location/address  1 Facility  location/address  2 Geography  1  -­‐  urbanicity  [use  dropdown] Geography  2 Geography  3 Facility  level  [use  dropdown] Ownership  [use  dropdown] Size  (approximate)  of  facility  buildings  (m2) Size  (approximate)  of  land  (m2) Operating  hours  of  facility (total  opening  hours  per  week) Operating  hours  of  TB  services (total  opening  hours  per  week) Total  hospital  beds  (inpatient) (all) (DS-­‐TB) (MDR-­‐TB) (TB-­‐HIV) Total  day  beds  (outpatient) (all) (DS-­‐TB) (MDR-­‐TB) (TB-­‐HIV) Total  outpatient  visits (all) (DS-­‐TB) (MDR-­‐TB) (TB-­‐HIV) Size  of  catchment  population Total  clinical,  allied,  and  auxiliary  staff  FTE Total  support  and  administrative  staff  FTE Total  staff  FTE INSTRUCTIONS:  on  day  1  of  data  collection,  meet  with  facility  manager,  briefly  outline  VALUE-­‐TB  background  and  objectives,  obtain  written  informed  consent.  Then  obtain  an  overview  of  the  facility   characteristics  and  the  population  it  serves.  This  sheet  will  be  used  to  provide  a  description  of  the  health  facility  and  provide  context  when  reporting  results. Ch ar ac te ri st ic s Start  time  of  data  collection End  time  of  data  collection (days  of  the  week) (days  of  the  week) 0 NotesValue Facility  Characteristics 63 Section F. Appendices ■n Information about the geography where the facility is located includes whether that area is urban, rural or a mixture of the two. ■n Local knowledge of potential drivers of costs is additional contextual information (e.g. socio-economic status of community) that can be included in the Geography 2 and Geography 3 cells. ■n The size of all the buildings at the facility should be reported in square metres (m2). ■n The best-case scenario is if the facility has a record of the size in square metres or, better still. a map with the dimensions and floor plan. ■n If this is unavailable see options for estimating the facility size in Building space. ■n Operating hours for the entire facility and of TB services (regular hours of TB clinic) should be recorded by first indicating the days of the week that the facility is open and the services are provided, and then by inserting the total hours of operation of the facility and TB services during a seven day week. ■n Please be sure to enter values for both the facility and TB services, even if they are the same. ■n Total hospital beds (inpatient) should be reported for the entire hospital (all) as well as for DS-TB, MDR-TB and TB-HIV patients. Values should be reported for the same categories for day beds (outpatient), which may also be referred to as cots, gurneys or other name in different settings. ■n Information about the TB services offered at that facility is being captured for treatment services, patient support during diagnosis or treatment, and community services provided through or to the facility. ■n Additional service outputs relevant to the facility can be selected from dropdowns in the categories of visit and bed-day types; additional laboratory tests; additional radiology tests; and other TB services. ■n Other TB services could include, but are not limited to, lost to follow-up tracing by a home visit, contact tracing, education or health talks, adherence or infection control. Adaptation If one requires an additional service output for any of these categories that is not already an option, please go to the Lists sheet at the end of the tool and enter the name of the service output in the yellow cells of the relevant category. Building space ■n The value of the building could be obtained by sourcing the current replacement value for a similar type of building and situation. This could be the value of rebuilding a clinic in an urban, peri-urban or rural area. ■n An architect, structural engineer, centre for scientific and industrial research or construction company could be contacted to give a valuation of the facility. ■n Alternatively, original facility records from when it was built, sourced from the facility administrative department or government records offices, could be used and inflated to arrive at the current value. Costing guidelines for Tuberculosis interventions64 ■n If these options are not available then one could look at the insurance valuation of the building, the cost per square metre (m2) in that area (from commercial realtors, construction companies or the internet), tax forms for the building or government rate for stamp duty. ■n If buildings have been recently renovated, then the cost can be inflated using the consumer price index (CPI) for the country. ■n The rental value, if the facility or certain buildings within the facility have been rented, can be found in the lease agreement, sourced from the finance department within the facility or from the leasing agency. ■n The size measurements should be in square metres (m2). ■n If perimeters are measured in feet, please convert to metres by multiplying by 0.305, then calculate the area, or convert square feet to m2 by multiplying by 0.093. ■n Data for the MDR-TB clinic in the Outpatient Department (OPD) should be included only if there is a separate space for MDR-TB services within the facility. ■n If the total land space is known but not the building size, then one option is to estimate the proportion land that the building resides on which can then be multiplied by the total size of the land (m2) and the number of floors (if a multi- storey building is being costed). ■n It is a good idea to ask if there is a map of the facility or draw a map. On this map note which rooms are dedicated to TB consultation, sputum collection, waiting, diagnostics, dispensing medication, other services, shared spaces (e.g. space that is used for both TB and HIV care). ■n If space is shared, note if specific days are assigned to the room or how the time is divided. ■n One can then physically measure the space with a laser distance measurer or a tape measure. ■n The dimensions of the various areas may also be obtained from building plans or by estimating based on length of steps (if a step is on average one metre). ■n Street mapping software (e.g. Google Earth) can also be used for land or external buildings; again, multiplying the measured size by the number of floors. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 7.Building  Space 27/11/19 Page  1 Start  date  of  data  collection dd/mm/yyyy Start  time  of  data  collection HH:MM End  date  of  data  collection dd/mm/yyyy End  time  of  data  collection HH:MM Name  of  data  collector Sheet  completed  [use  dropdown] Owned,  rented  or  donated [use  dropdown] Value  if  sold  today   (local  currency) OR  Annual  Rent   (local  currency) Building  -­‐  general  information Name  of  department  or  clinic  or  room  or  area  or   building Name  of  department/  clinic/  room/   area/  building  in  language  of  site Size  of  department/   clinic/  room/  area/   building   (m2) Percent  of  space  used   for  TB (%) Notes Outpatient  Department  (OPD) OPD:  General OPD:  Registration  office/reception  area OPD:  TB  clinic TB:  Common/waiting  area TB:  Sputum  collection  room  or  space TB:  Consultation  area  (with  doctor) TB:  Convalesing  area  (with  nurse) TB:  Dispensary  for  medication TB:  Laboratory TB:  Management  of  TB  services  (eg:  office(s)  of   nurse  in  charge  for  TB  clinics) TB:  Other  space INSTRUCTIONS:  Obtain  or  create  map  of  each  area  with  dimensions.  Please  ensure  that  there  is  no  overlap  of  the  dimensions  of  the  spaces  within  each  department  or  building;  that  is  if  the  values  for  clinics,  rooms  or   areas  are  not  available,  put  values  for  the  entire  department. If  there  are  additional  spaces  within  a  department  that  are  not  included  in  the  list,  use  the  rows  with  'other  space'  and  change  the  name  to  match  that  space  as  used  within  the  facility. If  a  space  is  used  for  more  than  one  output  (e.g.  LPA  preparation  and  culture)  then  please  list  all  outputs  relevant  to  that  space  in  the  'Notes'  section. Ph ys ic al  fa ci lit ie s If  no,  list  missing  data? Building  space 65 Section F. Appendices ■n One can then add these measurements to the map. This allows for repeatability in the future as the ‘quantities’ of the building will be known and mapped with measurements so one can then work out the space used if the room allocation changes i.e. the square meterage of the building. ■n The size of the space is then calculated by multiplying the length by the breadth of the room resulting in the number of square metres. ■n The total space of the facility can then be calculated by adding together all the rooms (or if it is a perfect square or rectangle one could calculate the total square meterage of the building by multiplying the length by the breadth). ■n If TB services are provided in a designated space then the total space for TB would be calculated by adding space that the TB services utilize in metres squared (for example using a bottom-up approach, 3 rooms which are each 5m2=a total of 15m2 for TB services in a 100m2 facility). ■n Do not include spaces that are no longer in use for instance if they are abandoned or derelict. However, ‘empty space’ should be included. ■n In order to not double count, either fill in the total m2 value for a department or the subsets, but not both. ■n If the TB services do not occupy a designated area one could calculate the space used in top-down manner (described under the data entry sheet). ■n If there are spaces at the facility where TB services are performed that have not been listed in the sheet, try to include the space (including m2 and proportion used for TB) in the most overarching department or room and make a note of the additional space that has been captured there (rather than adding a room). ■n For example, to incorporate the size and percentage of space allocated TB for a consulting room for the laboratory doctor, that space can be included under ‘Laboratory – main’. Recurrent expenditure ■n This usually relates to the running costs of the facility (i.e. clinic, hospital or lab- oratory) such as administration, kitchen, utilities (water, gas, heating, cooling, electricity), security, laundry, maintenance (of buildings, vehicles, furniture and equipment), cleaning, monitoring and evaluation/pharmacovigilance, mainte- Value  TB  -­‐  Estimating  unit  costs  of  TB  services 10.Recurrent  Expenditure 27/11/19 Page  1 Start  date  of  data  collection dd/mm/yyyy Start  time  of  data  collection End  date  of  data  collection dd/mm/yyyy End  time  of  data  collection Name  of  data  collector Sheet  completed  [use  dropdown] Recurrent  overhead  costs  (ENTIRE  FACILITY) Annual  expenditure (Local  currency) Water Sewerage  and  sanitation Electricity  (light  and  heat) Gas Bio-­‐safety  disposal Other TOTAL  UTILITIES Internet Telephone Post TV  and  radio Other TOTAL  COMMUNICATIONS Stationery  and  general  office  supplies Printing Subscriptions Packaging Photocopying Other  admin  costs TOTAL  ADMINISTRATIVE Notes [Include  HMIS  code  for  easy  verification,  if  relevant] Recurrent  expenditure INSTRUCTIONS:  Data  collected  in  this  sheet  should  be  for  the  ENTIRE  FACILITY  and  downloaded/extracted  from  the  facility  expenditure  records. If  disaggregated  expenditure  for  a  category  (e.g.  administrative,  food,  etc.)  is  not  available,  please  enter  the  total  value  for  that  category  in  the  row  provided.  Proportion  of  total  expenditure  (column   D)  can  be  used  if  the  information  is  available. A dm in is tr at iv e If  no,  list  missing  data? U ti lit ie s Co m m un ic at io ns Costing guidelines for Tuberculosis interventions66 nance, training (such as in service training the effects of which potentially last less than one year) and quality assurance, etc. ■n Supplies in the facility, such as gloves, masks, etc., can also be costed under recurrent overhead costs (for laboratories this has been described under diagnostic tests below). Other recurrent costs could include calibration of instruments, administration of cash transfers or similar expenditures. ■n Infrastructure/resources jointly used or shared between different departments within a health system/programme or facility (such as administration, mainte- nance, transport, electricity, etc.) are known as overhead inputs. ■n In a cost analysis, overhead inputs are allocated accordingly to various departments or activities. For example, inputs could be allocated to ‘cost centres’ (depends on how cost data are organized, and cost centres are defined). ■n An allocation basis needs to be defined for allocating each input to various cost centres. For instance, some costs can be assigned directly to certain cost centres. ■n If ‘inpatient care’ is a cost centre, then the line item ‘laundry’ could be allocated to that centre, using ‘a patient day equivalent’ as an allocation method. ■n If ‘maintenance’ is a cost centre, then ‘floor space utilized by department’ could be a useful allocation method. Allocation of overhead inputs usually requires step down costing. ■n It is important to note which costs have been considered overhead costs at the facility level (service level) and which costs are included in above service level costs, so that double counting does not take place. ■n The easiest way to distinguish between overhead costs at the facility level and above service level costs, is to ascribe any operating costs to the facility level under overhead costs if they occur and are paid for by the facility. ■n Overhead costs are often obtained through the finance office at a larger facility, facility records or through interviews with staff. TransportationValue  TB  -­‐  Estimating  unit  costs  of  TB  services 11.Transportation 27/11/19 Page  1 A Health  Facility  or  Laboratory  Owned  Transport  Service Vehicles Number  of  vehicles Life  expectancy  (years) Own,  rent  or  donated If  own  or  donated,   current  market  value   of  all  vehicles (local  currency) If  rent,  total  annual   rental  value (local  currency) Total  annual  maintenance   costs  (insurance,  repairs   etc.) (local  currency) Total  annual  fuel  costs (local  currency) Ambulance Bicycle Motorcycle   Small  car Large  car SUV Mini-­van Van Mobile  clinic Bus Other Transportation INSTRUCTIONS:  Data  is  for  transportation  of  TB  specimens,  supplies,  drugs  or  results  or  transporting  TB  patients  for  diagnostics  or  treatment  or  TB  staff  for  provision  of  TB  services. The  sheet  contains  data  to  be  sourced  from  the  Finance  and  Human  Resources  Departments,  as  well  as  utilisation  data. Ensure  both  sections  A  (health  facility  or  laboratory  owned  services)  and  B  (courier  services)  are  completed  where  relevant. Ask  FINANCE  DEPARTMENT 67 Section F. Appendices ■n Vehicles used by a facility, for instance vans used for transporting TB patients or mobile clinics, should be included as capital items. ■n For vehicle current market (i.e. replacement) value, a vehicle with equivalent specifications can be used and derived by contacting local automotive dealers or visiting their websites ■n Allocation to TB for each vehicle should be derived by asking the transportation manager or driver to estimate based on the time and/or mileage for TB services divided by total time and/or mileage. ■n The percent of time spent on TB for Department 1 (column O) and Department 2 (column Q) should add up to 100%. ■n Note: if any services, such as transportation or training, are paid for by the NTP or NGOs but the benefit of the service is at the facility level, the costs still need to be included in this facility costing tool. For example, courier services paid for by the NTP are for samples for patients seen at the facility, so these costs need to be included in the facility tool. Training ■n Costs of training are usually established through facility records or by estimating the cost of replicating a similar training (for example by looking at a venue cost, catering costs, facilitator hourly rates etc.). ■n For training (which is considered a capital asset if the effects will last longer than a year), bottom-up costing requires obtaining the duration of training, number of staff trained, transportation and/or per diem costs, training materials used, number of facilitators/trainers and their qualifications. ■n The top-down approach to training is to look at the expenditure on training for TB services and divide this by the staff that received the training. V lue  TB  -­‐  Estimating  unit  costs  of  TB  services 12.Training 27/11/19 Page  1 Start  date  of  data  collection dd/mm/yyyy Start  time  of  data  collection HH:MM End  date  of  data  collection dd/mm/yyyy End  time  of  data  collection HH:MM Name  of  data  collector Sheet  completed  [use  dropdown] Name  of  training Facility,  or  if  offsite   provide  location Training  provider   (institution  or   programme  name) Date  of  training Duration (days) Number  of   partipants  from   this  facility Training  fees  per   participant (local  currency) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 If  no,  list  missing  data? Training INSTRUCTIONS:  Training  data  should  be  TB  related,  for  staff  of  this  facility. Costing guidelines for Tuberculosis interventions68 ■n Data needs to be for all TB-related training for staff attached to this facility. ■n Training fees are the amount paid for the training to occur, including costs for facilitators and any training material. ■n Allocation of training costs to TB can be obtained by asking the person receiving the training (or another member of staff with this knowledge, e.g. their manager or TB focal person) about the total time (hours or days) spent on TB compared to the time for any other training topic. ■n This information may also be obtained from training letters held in the Human Resources department or within the TB department. ■n If training covers more than one service output, the training can be entered on multiple rows and allocated to the respective outputs based on the proportion for each. ■n If the proportion is not known, these could be split. For example, a four-day training on TB outpatient and inpatient treatment can be entered as: 1. TB treatment training | 4 | 10 | 200 | 25 | 100 | 0 | 100% | Outpatient diagnostic visit | 50% 2. TB treatment training | 4 | 10 | 200 | 25 | 100 | 0 | 100% | Outpatient treatment visit | 50% Above service level ■n The above service level costs are for activities that support the facility but are paid for by external sources such as the NTP (for instance, management of human resources, financial services, information technology, procurement and others). ■n These above service level costs can be TB-specific (i.e. not shared such as training for health care workers on TB reporting standards) or shared between TB and other services (such as training for health care workers on general reporting standards). ■n This would mean that training provided by the NTP for employees nationally would fall into above service level costs, whereas in service training (facility level training) would be considered an overhead or service level cost. Valu  TB  -­‐  Estimating  unit  costs  of  TB  services 13.Above  Service  Level 27/11/19 Page  1 Start  date  of  data  collection dd/mm/yyyy Start  time  of  data  collection HH:MM End  date  of  data  collection dd/mm/yyyy End  time  of  data  collection HH:MM Name  of  data  collector Sheet  completed  [use  dropdown] TB  processes  -­‐  above  service  level  costs Type  of  support Whom? How  often? If  yes,  please  describe  the  type  of  TB  support  and  the  frequency. D ru gs How  often  are  TB  drugs  delivered  to  the  facility? Have  there  been  any  stock-­‐outs  of  TB  drugs  in  the  last  year? If  yes,  describe  frequency  and  circumstances  of  TB  drugs  stock-­‐out. Su pp or t Do  you  receive  TB  support  from  other  entities? Above  Service  Level  Costs INSTRUCTIONS:  This  sheet  assesses  the  ease  of  access  of  above  facility  level  cost  data  and  is  optional.  If  you  do  wish  to  collect  this  information,  speak  with  the  facility  manager  or  TB  focal  person  at  the  facility. Notes  (including  any  additional  support  activities) What  type  of  TB  supervisory  support  do  you  receive  from  the  district  health  bureau/authority ?   How  often? What  type  of  TB  support  do  you  receive  from  the  National  TB  Programme?  How  often? If  no,  list  missing  data? 69 Section F. Appendices ■n Allocations of above service level are implemented in the Data Entry Tool. ■n The data collection for above service level costs is done separately from the facility data collection. ■n It involves approximately an additional week of data collection at the national, district or regional level. ■n However, to guide the allocation of above service level costs to each facility, the data collector will complete the Above service level sheet which covers visits related to monitoring and supervision and drug procurement from national, regional or district levels. ■n There are different ways to allocate above service level costs. The recommended approach is weighting based on the number of staff at each facility (Figure 12); equal weighting is not recommended. ■n The shared above service level costs would need to be further allocated to TB services based on the utilization figures for the facility. In this tool, the above service level costs cover support from the NTP, other entities and delivery of medication C. Record prices for drugs, supplies, and equipment Equipment inventory ■n The Data Collection Tool includes a default list (alphabetically ordered) of equipment used for TB care. Default categories are to be used in preference to adding new elements to the list given that there are automatized links within the tool. ■n The equipment price list should be collected centrally and used for each facility. If the prices paid for the equipment are known, then (inflate using CPI if necessary and) convert to United States dollars (USD) using the exchange rate of that year. ■n The standard and most appropriate value for the unit price is the replacement cost. ■n Equipment and furniture that are used at the facility for TB services, for instance beds, tables, chairs, x-rays, biosafety cabinets etc., should be included as capital items. ■n As the interest lies in the TB services only, any equipment that is not used for TB services should not be captured. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 8.Equipment  Inventory 27/11/19 Page  1 Equipment  name Department Clinic  or  room Manufacturer [if  applicable] Model [if  applicable] %  use  for  TB [eg.  Based  on  TB  tests/all   tests  performed  by  total   numbers  of  machines] Analytical  balance Analytical  balance  (electronic)  for  DST Autoclave  -­‐  horizontal Autoclave  -­‐  vertical Autoclave  (basic  unit  for  media  kitchen)  -­‐  1 Autoclave  (basic  unit  for  media  kitchen)  -­‐  2 Autoclave  (basic  unit  for  media  kitchen)  -­‐  3 Autoclave  (basic  unit  for  media  kitchen)  -­‐  4 Automatic  filling  station AVR  (for  autoclave) BACTEC  -­‐  starter  kit BACTEC  MGIT  320  System BACTEC  MGIT  960  system BACTEC  printer Balance  (analytical) Balance  (precision) Balance  (precision)  -­‐  electronic Biosafety  cabinet  -­‐  2  filters Biosafety  cabinet  -­‐  3  filters Biosafety  cabinet  -­‐  BSC  Type  II  A Biosafety  cabinet,  with  horizontal  laminar  airfl w   hood  and  UV  light Biosafety  cabinet,  with  vertical  laminar  flow  hood   and  UV  light Blender  with  glass  jar Bottle  washer Inventory  -­‐  equipment  and  furniture INSTRUCTIONS:  This  should  be  a  complete  list  of  all  equipment  and  furniture  used  in  any  of  the  TB  service  outputs.  If  there  is  more  than  one  of  a  particular  type  of  equipment  but  with  different  manufacturers  and/or  models,  please  list  them  separately.  For  several  pieces  of  equipment  with  the  same  make  and  model,  indicated   the  quantity  in  use  at  the  facility  for  TB  services. Any  additional  equipment  or  furniture  that  is  not  already  included  in  this  sheet  should  be  added  to  the  bottom  of  the  appropriate  section. Po w er ed  e qu ip m en t Costing guidelines for Tuberculosis interventions70 ■n The bottom-up approach to costing these items is by auditing/counting how many there are within the facility. ■n The facility may keep a record of all the equipment and furniture; however, one will need to establish if these are used for TB services or not. ■n It is often useful to note which rooms these items can be found in, on the map of the facility. ■n A new line should be used for each piece of equipment or furniture, for instance if there are 10 chairs then 10 lines are used to enter information for these 10 chairs. The top-down approach would be to take lists of all the equipment and furniture (or expenditure of all the equipment and furniture) ■n When estimating usage of equipment, the bottom-up approach is either through observation or interview, while timesheets are used for the top-down approach. ■n Observation should be the default; if not possible, then collect equipment infor- mation via an interview. Keep good notes on things such as stockouts, broken equipment and overused equipment (i.e. estimated life years (ELY)=5 but used for 30 years) so that one can try to understand and explain cost variation. ■n If equipment is broken but was used in the last year and will be fixed or replaced, then this should be costed. The same is true for equipment that has been purchased and has not yet been used but is planned to be used (for instance if training is pending). ■n Derelict equipment that has broken down and will not be fixed should not be costed – if this has not been used in a year and is not expected to be used again, the item should not be costed. Price list-drugs ■n Drug prices per drug delivered at the health facility are collected. ‘Wastage of supplies’ is also documented; this is an estimate of the percent of drugs thrown out, i.e. drugs expired or damaged, within the year. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 21.Price  list-­‐Drugs 27/11/19 Page  1 Drug  wastage  factor Transportation  mark-­‐up  (within  country),  % (1st-­‐line  drugs) (2nd-­‐line  drugs) Drug  name Product  code  (e.g.  GDF) Strength Unit  of  measure Items  per   unit Order  size (#  units) Order  price (local  currency) Unit  price (local  currency) Unit  price (USD) Source/vendor TB  intervention Rifampicin/Isoniazid,  Dispersible  tablet(s),  Strip(s) 2-­‐FDC/RH-­‐75/50-­‐(B)-­‐84  (28x3) FDC-­‐child Per  pack/blister 84 FDC-­‐child Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐672 FDC-­‐adult Per  pack/blister 672 FDC-­‐adult Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐336 FDC-­‐adult Per  pack/blister 336 FDC-­‐adult Rifampicin/Isoniazid/Ethambutol,  Film  coated   tablet(s),  Blister(s) 3-­‐FDC/RHE-­‐150/75/275-­‐(B)-­‐672 FDC-­‐adult Per  pack/blister 672 FDC-­‐adult Rifampicin/Isoniazid/Pyrazinamide,  Dispersible   tablet(s),  Blister(s) 3-­‐FDC/RHZ-­‐75/50/150-­‐(B)-­‐84   (28x3) FDC-­‐child Per  pack/blister 84 FDC-­‐child Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film   coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐ (B)-­‐672 FDC-­‐adult Per  pack/blister 672 FDC-­‐adult Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film   coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐ (B)-­‐336 FDC-­‐adult Per  pack/blister 336 FDC-­‐adult Cat  I  &  III  Kit  A,  Film  coated  tablet(s),  Blister(s) PK-­‐Cat  I  &  III-­‐A Per  blister Price  List  for  Drugs INSTRUCTIONS:  Please  provide  data  for  the  yellow  cells.  The  unit  price  in  local  currency  is  for  drugs  that  are  procured  locally  and  the  unit  price  in  USD  is  for  drugs  and  supplies  that  are  sourced  outside  of  the  country.   Standard  drugs  for  TB  treatment,  prevention  and  palliative  care  have  already  been  listed.  Any  additional  drugs  that  are  not  already  included  should  be  added  at  the  bottom  of  the  appropriate  section. D RU G S:  fi rs t-­‐ lin e fix ed -­‐d os e   co m bi na ti on  (c om bi -­‐p ac ks ) This  sheet  can  be  used  to  get  prices  on  drugs  from  the  facility  or  from  a  central  source  such  as  the  Ministry  of  Health  or  Regional  Health  Authority.   71 Section F. Appendices ■n The unit price of many of the drugs on this list can be centrally sourced through the Ministry of Health, Central Stores, some government procurement agency or from the Stop TB Partnership’s Global Drug Facility. ■n If locally obtained prices are not available one can use international prices available through http://www.stoptb.org/assets/documents/gdf/drugsupply/ GDFMedicinesCatalog.pdf as recommended by the Reference Case [5]. ■n These values need only be obtained once and can be used for all facilities. ■n For drugs that are not sourced internationally or are unique to a particular facility, e.g. if XDR treatment is only offered in one specialized facility, invoices or procurement records may need to be sourced at the facility level. ■n The order size and price for the year should be collated and entered into columns G and H. The source of the quantity or price data or the vendor should be included in column K. Price list-supplies ■n The Data Collection Tool includes a default list (alphabetically ordered) of supplies used for TB care. Default categories are to be used in preference to adding new elements to the list. ■n A price list for the supplies used at the facility may be centrally sourced, but it is likely that some supplies would have been obtained from a vendor directly through the facility. ■n Multiple sources of data are acceptable. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 22.Price  list-­‐Supplies 27/11/19 Page  1 Name  or  description  of  supply Unit  of  measure Package  amount   or  volume Price  per  package (local  currency) Price  per  package (USD) Brand Source/vendor 0.5-­‐10  μl  tips   100-­‐1000  μl  pipette  tips   100-­‐1000  μl  pipette  tips   100-­‐1000  μl  pipette  tips  (Long  tip)   10-­‐100  μl  tips   1-­‐20  μl  tips   1-­‐200  μl  pipette  tips   1-­‐200  μl  tips   20-­‐200  μl  pipette  tips   20-­‐200  μl  pipette  tips   2ml  standard  reaction  tube   Applicator  stick  (disposable) box 20 BACTEC  MGIT  960  AST  transport  rack  –   445942.   BACTEC  MGIT  960  Supplement  Kit  (100  tests,   PANTA  and  OADC  combined)  Catalogue  No:   245124   BACTEC  MGIT  960  Supplement  Kit  (PANTA   and  OADC  combined) kit 100 BACTEC  MGIT  OADC  Kit  for  Manual  MGIT   Catalogue  No:  245116   BACTEC  MGIT  PANTATM  Kit  for  Manual  MGIT   Catalogue  No:  245114   BACTEC  MGIT  PZA  kit kit 50 BACTEC  MGIT  PZA  tubes pack 25 BACTEC  MGIT  S.I.R.E.  Kit  for  Manual  MGIT   Catalogue  No:  245119   Price  List  for  Supplies This  sheet  can  be  used  to  get  prices  on  supplies  from  the  facility  or  from  a  central  source  such  as  the  Ministry  of  Health  or  Regional  Health  Authority.   INSTRUCTIONS:  The  list  of  supplies  is  not  exhaustive  so  please  insert  any  additional  supplies  that  have  been  provided  to  health  facilities  to  provide  TB  services  at  the  end  of  the  relevant   supplies  section. M ed ic al  s up pl ie s Costing guidelines for Tuberculosis interventions72 Staff salaries ■n The list of staff should include any personnel involved in TB services, i.e. any staff who spend at least 10% of their time on TB or anyone with TB-specific tasks in their job description. ■n The list is organized by direct service personnel, support personnel and volunteers. To provide clarity on where staff salaries should be allocated, one can append the location of the health care worker to their title (e.g. ‘Nurse 2’ can become ‘Nurse 2 – ART clinic’). ■n The gross annual salary of each staff member should be provided. Staff salaries are often obtained through the finance office at a larger facility, facility records or through interviews with staff. It may necessary to approach a central finance office and human resources department separately to obtain the list of staff titles at a facility and the corresponding salaries. ■n If gross salaries are not available, obtain the net (post deductions) value. Using an estimate of the proportion of income tax and other deductions relevant to the type of employee in the country, calculate the gross salary. For instance, if net annual salary for a nurse is $61,237 and the average income tax is 20%, with additional deductions averaging 9%, the gross salary would be ($61,237/(100-(20+9)%)) = $86,249.30. ■n If it is not possible to collect the actual salary data for facilities based on the staff mix, an average salary can be used for a cadre of staff. ■n Gross annual benefits should include housing and travel allowances, or payments, hazard or other incentive pay, and any other payments made to staff for their service to the facility. ■n For staff working less than the full year of assessment (i.e. retiring, resigning or doing periodic work), the gross annual salary should be adjusted by the proportion of the year worked. ■n Similarly, the working hours per week on average over the year should account for any time when the staff member was not working at the facility, by using the total hours worked for the year of assessment and finding the average hours per week across the entire year. ■n The method used to measure staff time for each health care worker included in the study should be captured in column H. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 9.Staff  Salaries 27/11/19 Page  1 Start  date  of  data  collection dd/mm/yyyy Start  time  of  data  collection HH:MM End  date  of  data  collection dd/mm/yyyy End  time  of  data  collection HH:MM Name  of  data  collector Sheet  completed  [use  dropdown] Health  care  worker  category Gross  annual  salary  (local   currency) Gross  annual  benefits (local  currency) Total  working  hours  per   week Quantity  of  staff Clinical,  allied  and  auxiliary  staff Support  and  administrative  staff Total  Staff Fa ci lit y   St af f If  no,  list  missing  data? Staff  Salaries INSTRUCTIONS:  'TB  Personnel'  should  list  every  staff  member  (direct  and  support)  providing  TB  services  within  the  facility. For  staff  salaries,  if  gross  values  are  not  available,  use  net  values  and  gather  information  on  government  (central  and  local)  and  other  deduction  types  and  quantities/proportions  (e.g.  income  tax,  PAYE,  health  surcharge,  etc.). If  relevant,  the  type  of  health  care  worker  (column  C)  can  be  modified  to  include  the  clinic  or  specialty  of  the  health  care  worker. Data  for  columns  I  to  M  should  only  be  obtained  if  a  timesheet  is  NOT  obtained  for  that  staff  member  (e.g.  for  all  support  personnel,  phlebotomists,  pharmacists,  etc.) Notes 73 Section F. Appendices ■n Specialized personnel providing direct services (e.g. phlebotomists, pharmacists, social workers, etc.) should be interviewed to provide an estimate of the proportion of time spent on TB, and how that time is split between various departments (e.g. outpatient and inpatient departments for social workers). ■n Recommendation: For staff, bottom-up costing is performed either through observation or interview; for top-down costing, timesheets are used. Observations, interviews and timesheets should be administered to at least one staff member per cadre in a big facility, however for small facilities, where perhaps there are only two staff members working on TB, both should be interviewed and given timesheets. There should be at least one bottom-up and one top-down estimate of staff time per service. However, if an observation or interview is impossible, one can use an assumption based on interviews at another facility, standard operating procedures or a demonstration of a process. D. Record TB service utilization for the 20 standardized service outputs and at least 39 diagnostic and monitoring tests being costed, as well as the drug regimens and supplies used Service statistics ■n Estimation of unit costs requires information on utilization which covers data on services received by patients in a facility, or about diagnostic tests processed in a laboratory. ■n The figures needed vary depending on the unit cost to be calculated; however standard utilization data might be “Total number people initiating treatment for MDR-TB using the long regimen per year” or “Total number of inpatient bed-days for DS-TB treatment per year” or “Number of Xpert® MTB/RIF tests performed per year”. ■n These utilization data allow one to allocate costs if a top-down methodology is being utilized. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 14.Service  Statistics 27/11/19 Page  1 Start  date  of  data  collection dd/mm/yyyy Start  time  of  data  collection End  date  of  data  collection dd/mm/yyyy End  time  of  data  collection Name  of  data  collector Sheet  completed  [use  dropdown] Year  of  data  (latest  financial  or  calendar  year) Unit Annual  quantity  -­‐  entire   facility Annual  quantity  -­‐   TB  services  only Source  document  or  file  name Outpatient  visits TB  Clinic MCH  Clinic Paediatric  Clinic HIV  Clinic Chronic  Disease  (diabetes)  Clinic Comprehensive  Care  Clinic Inpatient  beddays Inpatient  admissions Laboratory  tests  (all  labs) Microbiology  Lab  -­‐  tests Bacteriology  Lab  -­‐  tests Laboratory:  main  (clinical  path,  incl  haematology)  -­‐  tests Area  for  blood,  serum,  plasma  collection  -­‐  samples Area  for  sputum  sample  collection  -­‐  samples Area  for  AFB  and  GeneXpert  -­‐  tests Area  for  biopsy  -­‐  tests Area  for  LPA  -­‐  tests Laboratory:  culture  -­‐  tests Radiology  tests INSTRUCTIONS:  This  sheets  asks  for  summary  facility  data  (C12-­‐C31)  as  well  as  summary  and  disaggregated  data  for  TB. Service  statistics  data  should  be  obtained  from  the  head  of  the  facility,  head  of  the  laboratory  or  radiology  departments,  head  of  respective  clinics  or  other  personnel  who  perform  surveillance  or  prepare  service  utilisation   reports  (HMIS). TB  treatment  data  can  be  extracted  from  the  TB  Register  or  annual  or  quarterly  reports  for  TB.   Data  should  be  collected  only  for  service  outputs  performed  at  the  facility  or  for  community  services  performed  by  staff  from  this  facility. Please  ensure  that  the  metrics  listed  and  period  for  the  data  collected  matches  that  of  the  Service  outputs  of  the  '15.Service  Description  '  sheet. Service  Statistics Se ct io n   I:   H ea lt h   fa ci lit y   st at is ti cs If  no,  list  missing  data? Costing guidelines for Tuberculosis interventions74 ■n Data will be collected for total facility and TB specific utilization data for the main departments (‘Section I: Health facility statistics’ – Outpatient, Inpatient, Laboratory and Radiology) within the facility, with some disaggregation by clinic or laboratory specialization. This service utilization data can be obtained from health management information system (HMIS or DHIS2), or other routinely reported TB data. ■n Data will also be collected for TB service outputs only which can be populated using the WHO Global TB recording and reporting forms (https://apps.who.int/ iris/bitstream/handle/10665/44840/9789241564465_eng.pdf?sequence=1) for the facility, except for the distinction between short and long MDR-TB treatment which is not always available from routine reporting. ‘Section II: TB service statistics’ is for TB service outputs only, within Section II, rows 29–37 can be populated using the WHO Global TB recording and reporting forms for the facility. Rows 39–55 should be obtained from disaggregated TB reports for the key facility departments, as well as community services provided through this facility ■n It is important that the utilization data collected in this sheet is for the year of assessment of the study and matches the cost data being collected for the facility. ■n If it is unavoidable that this criterion cannot be met at this facility and any of the data is not for the year of assessment, be sure to indicate this in the ‘Notes’ column of this sheet. ■n The ideal is to collect information on the number of visits that actually occur at a facility based on the reporting done by the facility. ■n However, if number of patients is known but not number of visits, it is then appropriate to calculate the number of visits using the average number of visits per patient = average #visits per patient * #patients. ■n For test volume, if there are no records for the annual values, the head of the laboratory or equivalent personnel should be requested to estimate the total TB and all tests per week and then multiply this number by 52 to get the annual value. Present this figure to the person being interviewed and ask if this is a reasonable estimation. ■n If there is missing data, the allocations (see Data Entry Tool) cannot be calculated, so this should be avoided as far as possible. Service description ■n The average number (quantity) of each service output required for each patient type (population, regimen and phase) is obtained by interviewing the TB head nurse or focal person or another member of staff with knowledge of TB service utilization. This is entered into the yellow cells (grey cells indicate where the service output is not applicable to that intervention). ■n The gold standard here is to obtain the average per patient type by extracting the service utilization from patient records and calculating the average. However, if one does not have ethical approval to extract data from patient records or are unable to access them, the quantities should be obtained by interviewing the TB focal person or head nurse at the facility or an individual who has knowledge of the service utilization for the TB services at the facility. 75 Section F. Appendices ■n For the community vaccination visits, the total number of visits per year and the number of infants vaccinated in that year are needed (in rows 16 and 17, respectively). This will be used to calculate the average number of people vaccinated during a community vaccination visit and subsequently the cost per person vaccinated during a visit. ■n Similarly, the total visits in the year of assessment and the total people screened are needed (rows 20 and 21) as inputs to calculate the cost per person screened. Drug services Value  TB  -­‐  Estimating  unit  costs  of  TB  services 15.Service  Description 27/11/19 Page  1 INTERVENTION  CLASS VACCINATION INTERVENTION  TYPE BCG  Vaccination PTB EPTB PTB EPTB PTB EPTB PTB EPTB PTB EPTB PTB EPTB REGIMEN PHASE Service  output Outpatient  vaccinations Outpatient  cough  triage Outpatient  screening  visit Outpatient  diagnostic  visit Outpatient  visit  type  1 Outpatient  visit  type  2 Outpatient  visit  type  3 Inpatient  bed-­‐day  type  1 Inpatient  bed-­‐day  type  2 Community  vaccinations Community  screening  visit Community  diagnostic  visit Community  treatment  visit Community  other  visit Community  event Lost  to  follow-­‐up  tracing  per  person  on  contact  list   (phone  calls) Patient  support  during  diagnosis Patient  support  during  treatment Other  service  type  1 Other  service  type  2 Active  Case  FindingIntensified  Case  Finding  -­‐  cough  triage Intensified  Case  Finding  -­‐  screening INTERVENTION  POPULATIONS Infant Adult Child HIV+ High-­‐risk  population HIV+ High-­‐risk  population Platform  1 Platform  2 Platform  3 Platform  4 TB  s er vi ce s Passive  Case  Finding Service  Description INSTRUCTIONS:  Service  description  data  for  TB  should  be  obtained  from  the  TB  Nurse  in  Charge  within  the  TB  clinic  or  another  staff  member  with  knowledge  of  TB  service  utilisation.  It  is  fine  to  ask  more  than  one  person  with  knowledge  of  the  quantities  provided  at  this  facility. Data  should  be  collected  only  for  service  outputs  performed  at  the  facility  or  by  staff  attached  to  the  facility  and  is  per  patient  per  intervention. QUANTITY  PER  PATIENT  (visits,  beddays  or  tests)  for  year  of  assessment TB  CASE  DETECTION  &  DIAGNOSIS Value  TB  -­‐  Estimating  unit  costs  of  TB  services 16.Drug  Services 27/11/19 Page  1 Quantities  (units)  per  (average)  patient… INTERVENTION  CLASS   (TREATMENT  ONLY) REGIMEN PHASE Total  annual   quantity   disbursed  for  TB   (in  units) In te ns iv e Co nt in ua ti on In te ns iv e Co nt in ua ti on In te ns iv e Co nt in ua ti on In te ns iv e Co nt in ua ti on Drug/pharmaceutical  product Product  code Unit  of  measure Rifampicin/Isoniazid,  Dispersible  tablet(s),  Strip(s) 2-­‐FDC/RH-­‐75/50-­‐(B)-­‐84  (28x3) Per  pack/blister Rifampicin/Isoniazid,  Film  coated  tablet(s),   Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐672 Per  pack/blister Rifampicin/Isoniazid,  Film  coated  tablet(s),   Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐336 Per  pack/blister Rifampicin/Isoniazid/Ethambutol,  Film  coated   tablet(s),  Blister(s) 3-­‐FDC/RHE-­‐150/75/275-­‐(B)-­‐ 672 Per  pack/blister Rifampicin/Isoniazid/Pyrazinamide,  Dispersible   tablet(s),  Blister(s) 3-­‐FDC/RHZ-­‐75/50/150-­‐(B)-­‐84   (28x3) Per  pack/blister Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,   Film  coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐ (B)-­‐672 Per  pack/blister Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,   Film  coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐ (B)-­‐336 Per  pack/blister Cat  I  &  III  Kit  A,  Film  coated  tablet(s),  Blister(s) PK-­‐Cat  I  &  III-­‐A Per  blister 1st  Line  TB  TREATMENT DS-­‐TB EPTB PTB D RU G S:  fi rs t-­‐ lin e   fix ed -­‐d os e   co m bi na ti on  (c om bi -­‐p ac ks ) Adult EPTB New  and  relapse Previously  treated Drug  Services INSTRUCTIONS:  In  column  E,  provide  the  total  annual  quantity  disbured  for  each  TB  drug  prescribed  at  the  facility.  In  the  remaining  cells  (columns  F-­‐BQ)  input  the  average  quanity  of  each  drug  per  average  patient  for  each  TB  regimen  and  phase  that  is  provided  at  the  facility  in  the  year  of  assessment.   Data  on  TB  drugs  can  be  sourced  from  the  TB  register  in  the  TB  Clinic  and  TB  prevention  drug  data  from  the  clinics  where  those  activities  are  performed  (e.g.  HIV  clinic),  as  well  as  the  pharmacy,  procurement  and  accounting  departments. If  a  drug  used  at  this  facility  is  not  included  in  the  list,  please  included  it  at  the  bottom  of  the  relevant  section  and  add  to  the  corresponding  section  in  the  '21.Price  list-­‐Drugs'  sheet. INTERVENTION   POPULATIONS PTB Costing guidelines for Tuberculosis interventions76 ■n As with diagnostic tests, for TB drugs one needs to first understand how medication is dispensed in terms of location (clinic, hospital, outreach or mobile clinics etc.), frequency (daily (directly observed therapy, short-course (DOTS)), monthly, twice monthly, etc.), as well as who is involved in dispensing medication (pharmacist, doctor, nurse, community health care worker etc.). ■n Following the methodology of the Data Collection Tool, the quantities to be entered should ideally be the actual average for all patients treated (for an episode of care). If this information is not available, include the protocol value for an average patient in the respective regimens. ■n If the actual values are known, a note can state the protocol value. ■n Only drug quantities for treatment that is happening at the facility should be entered. For example, if the hospital only does one week of intensive phase, then only include that one week’s worth of drugs for the hospital costing. ■n The drugs remaining to complete the treatment regimen should be included in the facility from which they are distributed, such as health centre or community facility. E. Capturing quantities related to time for staff (assessed by observations, interviews and timesheets) and usage for equipment, supplies and vehicles (observation and interviews), which are inputs for both top-down and bottom-up costing Staff time used for TB service delivery is captured using three different methods: interviews, observations and timesheets. The Data Collection Tool caters for a sheet per data collection method (Staff timesheets, Observations and Interviews). Staff timesheets ■n When one understands the flow of the facility or laboratory then one can start to assess the staff time and costs. ■n Personnel time could comprise the time of both clinical and non-clinical staff within clinics and hospitals (or different facility types), laboratory staff involved in TB technology, community health care workers involved in patient support and other TB services amongst others (see case study 3 as an example). ■n The first step is to establish who is directly involved in TB services (such as a TB focal nurse) and who provides support to TB services (for instance an administrator or clinic manager). Value  TB  -­‐  Estimating  unit  costs  of  TB  services 27/11/19 DAY  1  -­‐   day-­‐off Day  (circle  as   appropriate) Date  (dd/mm/yyyy) INSTRUCTIONS:  in  each  box  wirte  the  number  of  minutes  spent  on  each  activity. Time O ut pa ti en t   va cc in at io ns O ut pa ti en t   co ug h   tr ia ge O ut pa ti en t   sc re en ig  v is it O ut pa ti en t   di ag no st ic  v is it O ut pa ti en t   vi si t   ty pe  1 O ut pa ti en t   vi si t   ty pe  2 O ut pa ti en t   vi si t   ty pe  3 In pa ti en t   be d-­‐ da y   ty pe  1 In pa ti en t   be d-­‐ da y   ty pe  2 Co m m un it y   va cc in at io ns Co m m un it y   sc re en in g   vi si t Co m m un it y   di ag no st ic  v is it Co m m un it y   tr ea tm en t   vi si t Co m m un it y   ot he r   vi si t Co m m un it y   ev en t Lo st  t o   fo llo w -­‐u p   tr ac in g   pe r   pe rs on  o n   co nt ac t   lis t   (p ho ne ) Pa ti en t   su pp or t   du ri ng   di ag no si s   (v ou ch er ,  c as h,   ot he r) Pa ti en t   su pp or t   du ri ng   tr ea tm en t   (v ou ch er ,  c as h,   ot he r) O th er  s er vi ce  t yp e   1 O th er  s er vi ce  t yp e   2 La bo ra to ry  t es ts Ra di ol og y   te st s Ph ar m ac y A dm in  &  m an ag em en t O th er  o ve rh ea d   se rv ic es N on -­‐T B   se rv ic es Br ea k/ lu nc h Quantity  performed   for  entire  day 7:00  -­‐  7:30  am   7:30  -­‐  8:00  am 8:00  -­‐  8:30  am   8:30  -­‐  9:00  am 9:00  -­‐  9:30  am 9:30  -­‐  10:00  am Activities  (in  minutes) ??/??/???? M  /  T  /  W  /  TH  /  F  /  SA  /  SU 77 Section F. Appendices ■n For the staff that are directly involved in TB services, data can be collected about the time they spend with patients in several different ways using bottom-up methods. ■n One can observe the hands-on time they spend with TB patients, measuring with a stopwatch over the course of week to assess what proportion of their time is spent on TB tasks. ■n The type of task should be defined before one starts measuring. ■n This is useful if one is able to easily calculate all the other aspects of the costing from a bottom-up perspective. Because one can then calculate for instance the cost of treating one DS-TB case (in terms of staff time, TB drugs, TB diagnostics, capital costs (time that specific area of building space, furniture and equipment were used), portion of recurrent costs). ■n Another bottom-up approach is to use work sampling, where a staff member is contacted (usually on a mobile phone) to ask what task they are currently busy with, in order to construct a picture of what tasks are being done and for how long. ■n The proportion of time spent on TB tasks can inform this calculation. Hypothetically, 25% of a staff nurse’s time might be spent diagnosing new drug-sensitive TB cases, while 35% of his time is spent following up DS-TB cases, 10% of his time was taken up with dispensing medication, 5% was spent on record-keeping, 5% on other TB management such as meetings relating to TB., and the remaining 20% of his time was spent on tasks unrelated to TB services. Considering the salary of the staff member (in this case staff nurse), the cost of time per task can be estimated from these percentages. ■n Another way to work out the proportion of time taken for specific tasks is to ask staff to estimate how much time it takes for them to perform the task on average, and how many times they perform the task in a week. This is usually done through a mixture of giving the staff a timesheet to complete and interviewing/discussing with the staff member how long tasks actually take them. ■n A top-down way of allocation staff time is to again estimate the amount of time spent on tasks, which could be done by weighting tasks based on utilization or workload. For instance, the allocation of time to DS-TB treatment by using the allocation of number of patients treated for DS-TB treatment over all TB cases. — For more precise estimates, the time spent on DS-TB patients could be estimated using one or more of the following methods.: — Firstly, timesheets could be completed by relevant staff for a relevant period of time (a month, or several months). — If the timesheets are returned incomplete, or certain estimates do not make sense, interviews could be conducted with staff members when they are asked how much of their time is spent seeing DS-TB patients in a particular day/ week/month. — Lastly, a researcher could estimate the time spent with DS-TB patients by observing how the services are provided in a facility, and then timing those services that are relevant to these patients. ■n Often, a combination of these approaches is necessary in order to get the best estimate possible. Costing guidelines for Tuberculosis interventions78 Recommendations ■n The data collector should provide verbal instructions on how to fill the timesheets. ■n The health care worker (HCW) should fill in distributed physical timesheets where possible; if not possible, complete timesheets using interview format. ■n Timesheet should be completed per cadre; however, if nurses perform different functions (such as only DS-TB and only MDR-TB) then one timesheet should be completed per function. ■n If timesheets are absolutely not possible, estimate the proportion of staff time for the relevant service outputs. ■n To determine which outputs are applicable to a particular health care worker, be guided by the bottom-up data (observations and interviews). ■n Ensure that the total minutes per week in the timesheet add up to the working hours per week on average over the year when allocating minutes to the service outputs. ■n Note: The category ‘break/lunch’ should include any downtime when not working, even if that is because there were no TB patients or tests to perform. Observations and Interviews This data collection sheet facilitates two types of observations: A. identifying the resource – creating lists of staff, furniture, equipment and supplies used to provide TB services within a clinic or department (including laboratory); and B. measuring the resources for each TB service output – i.e. time in minutes for staff and equipment, and quantities for supplies. ■n Tables have been developed in the Observation and Interview sheets to allow data collection for five outputs in each of five facility departments. ■n Additional data collection is likely needed to obtain at least one staff time measure for every service output, so the tables can be replicated to accommodate as many measurements as needed. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 18.Observations 27/11/19 Page  1 Date  of  observation dd/mm/yyyy District  name  and  code Facility  name  and  code Observer  name Start  time  of  observation HH:MM End  time  of  observation HH:MM Informed  consent  signed  [use  dropdown] Example INSTRUCTIONS:  Indicate  the  test/service  output,  process  (list  tasks),  staff  involved,  time  taken  for  each  task,  supplies  and  equipment  used  and  quantity  used: Service/Test [use  dropdown] Process  (list  tasks) Staff   Start  time (HH:MM) End  time (HH:MM) Total  time   taken   (in  mins) Location Supplies  and  reagents  used Quantity  used  (eg:   ml  of  reagent  or  #  of   slides) Equipment  used Quantity   used   (in  mins) Smear  microscopy Stain  sputum  sample Lab  TechII 9:50:00  AM 10:12:00  AM 12:22:00  AM Staining  room Staining  reagent 5  ml  per  slide Wooden  applicator 1 N95  mask 1 Gloves  (disposable) 2 Read  slides Lab  TechII 10:20:00  AM 10:32:00  AM 12:12:00  AM Room  A  -­‐  main  lab Glass  slides 2 Microscope 12 Record  and  report  results Lab  TechII 10:35:00  AM 11:15:00  AM 12:40:00  AM Room  A  -­‐  main  lab A4  paper 2 Discard  or  sterilise  Z-­‐N   slides  for  re-­‐use Lab  TechI 1:45:00  PM 1:57:00  PM 12:12:00  AM Autoclave  room Sterilising  solution 10  ml Autoclave 12 Infectious  Bacteriology (name) (name) Observations  -­‐  resource  quantities INSTRUCTIONS:   Identify  (eg:  staff,  furniture,  equipment)  and  measure  resources  (eg:  time  spent,  supplies  used  per  task)  required  to  perform  TB  service  outputs:  itemise  the  tasks  within  each  output  and  record  the  time  taken  to  perform  each  task,  making  notes  where  relevant  (e.g.  outpatient   consultation  with  a  paediatric  TB  patient;  laboratory  analysis  for  IGRA  tests  for  9  out  of  a  maximum  of  16  samples,  etc.). It  may  be  easier  to  make  your  own  notes  during  observations  then  complete  the  tables  in  this  sheet.  Please  do  whatever  is  most  useful  to  you  for  capturing  the  information. Please  ensure  you  capture  at  least  one  type  of  staff  time  measure  (interview,  observation,  time  sheet)  for  every  service  output. NAME  OF  DEPARTMENT  1 Value  TB  -­‐  Estimating  unit  costs  of  TB  services 19.Interviews 27/11/19 Page  1 Interviews  -­‐  health  facility  and  laboratory  staff Date  of  interview dd/mm/yyyy District  name  and  code Facility  name  and  code Interviewer  name Start  time  of  interview HH:MM End  time  of  interview HH:MM Informed  consent  signed  [use  dropdown] EXAMPLE Infectious  Bacteriology INSTRUCTIONS:  Identify  the  test/service  output,  capture  the  process  (list  tasks),  staff  involved,  total  time  taken  for  each  task,  supplies  and  equipment  used  and  quantity  used: Service/  Test [use  dropdown] Process  (list  tasks) Staff   Total  time   taken   (in  mins) Location Supplies  and  reagents   used Quantity  used  (eg:   ml  of  reagent  or  #   of  slides) Equipment  used Quantity   used   (in  mins) Smear  microscopy  ZN Stain  sputum  sample Lab  TechII 20 Staining  room Staining  reagent 5  ml  per  slide Wooden  applicator 1 N95  mask 1 Gloves  (disposable) 2 Read  slides Lab  TechII 10 Room  A  -­‐  main  lab Glass  slides 2 Microscope 5 Record  and  report  results Lab  TechII 30 Room  A  -­‐  main  lab A4  paper 2 Discard  or  sterilise  Z-­‐N   slides  for  re-­‐use Lab  TechII 12 Autoclave  room Sterilising  solution 10  ml Autoclave 10 INSTRUCTIONS:  For  the  staff  time  interviews  in  the  departments  or  clinics  where  TB  services  are  provided  or  the  laboratory  or  radiology  departments,  ask  one  health  care  worker  from  each  cadre  of  staff  involved  in  the  test  or  service  output  to   describe  the  entire  process.  Capture  all  staff  involved,  the  length  of  time  it  takes  and  the  supplies  and  equipment  used,  where  applicable. Please  ensure  you  capture  at  least  one  type  of  staff  time  measure  (interview,  observation,  time  sheet)  for  every  service  output. NAME  OF  DEPARTMENT  1 (name) (name) 79 Section F. Appendices ■n The sheets have also been formatted so that, when printed, there is one table per sheet. This means that data can be collected either electronically (inputted directly into the Data Collection Sheets) or on hard copies (information recorded on the printed sheets of paper). Use whichever data collection method is best suited. ■n When interviewing the doctor and/or nurse involved in TB inpatient services, ask if he or she can list other people (e.g. other clinicians) who are involved in this TB service and obtain interviews with these people where possible, or ask the ward nurse about their time spent on TB services (e.g. cleaners, porters, etc.). ■n Because the staff cost component of the unit costs derived by each method will be compared during analysis (Data Entry Tool), please try to use all three methods to measure the staff time for each service output. ■n Recognizing that this is not always possible, it is important that at least one methodology is applied to each service output. A supply wastage proportion assumption needs to be documented. Based on the experience of Value TB study, an examples of waste proportions used for Xpert® MTB/RIF was 3–5%. ■n Informed consent forms need to be given to every person from whom data is collected by interviews, observations and timesheets and kept separately in a secure location. As a reminder within the tool, there is a drop down to indicate whether consent has been obtained. ■n All staff time measures (interviews, observation and timesheets) should be given to at least one health care worker in each cadre of staff involved in every service output. ■n It may sometimes not be possible to administer all three methods (interviews, observation and timesheets) to each health care worker, however, please ensure that each health care worker’s time is measure by at least one method. ■n Information on utilization within the health facility, such as the annual number of outpatient and community visits for TB-related services and for the entire facility, can be collected and entered in this sheet. ■n A breakdown is also provided for top-down and bottom-up relevant quantities. For example, for drugs, the top-down quantities refer to the total amount of each TB medication disbursed within the facility, while for the bottom-up quantities sampled usage by patients is collected. ■n The template for staff-time interviews is used as one method to capture the quantity and allocation of staff time. ■n The second method is that of weekly timesheet templates, also printable. ■n During the detailed costing, these would be printed out or provided on electronic tablets to staff members at the beginning of the data collection week and collected at the end of the week. ■n An example of total staff time for a chest x-ray would be the staff time including taking the chest x-ray; reading, interpreting and noting results. Costing guidelines for Tuberculosis interventions80 Supplies ■n This datasheet includes on an exhaustive list of supplies (mostly laboratory supplies and infection control) used for TB services at a facility (with prices collected as mentioned above). ■n For each supply category, the annual expenditure and percentage use for TB will be collected. ■n ‘Wastage of supplies’ refers to the percent of supplies discarded (expired or thrown out). ■n The value should be for the facility in question; if this value cannot be obtained, an estimated value for the country can be used. Price list-equipmentValue  TB  -­‐  Estimating  unit  costs  of  TB  services 23.Price  list-­‐Equipment 27/11/19 Page  1 Equipment  or  furniture  name  or  description Manufacturer Model Unit  price (local  currency) Unit  price (USD) Useful  life Analytical  balance Analytical  balance  (electronic)  for  DST Autoclave  -­‐  horizontal Autoclave  -­‐  vertical Autoclave  (basic  unit  for  media  kitchen)  -­‐  1 Autoclave  (basic  unit  for  media  kitchen)  -­‐  2 Autoclave  (basic  unit  for  media  kitchen)  -­‐  3 Autoclave  (basic  unit  for  media  kitchen)  -­‐  4 Automatic  filling  station AVR  (for  autoclave) BACTEC  -­‐  starter  kit BACTEC  MGIT  320  System BACTEC  MGIT  960  system BACTEC  printer Balance  (analytical) Balance  (precision) Balance  (precision)  -­‐  electronic Biosafety  cabinet  -­‐  2  filters Biosafety  cabinet  -­‐  3  filters Biosafety  cabinet  -­‐  BSC  Type  II  A Biosafety  cabinet,  with  horizontal  laminar  airflow   hood  and  UV  light Biosafety  cabinet,  with  vertical  laminar  flow  hood  and   UV  light Blender  with  glass  jar Bottle  washer Price  List  for  Equipment  and  furniture This  sheet  can  be  used  to  get  prices  of  equipment  from  the  facility  or  from  a  central  source  such  as  the  Ministry  of  Health  or  Regional  Health  Authority.   INSTRUCTIONS:  Please  provide  data  for  the  yellow  cells.  The  list  of  equipment  is  not  exhaustive  so  please  provide  any  additional  equipment  or  furniture  that  has  been  purchased   for  health  facilities  to  provide  TB  services. The  unit  price  (local  currency)  should  be  used  for  any  equipment  purchased  or  available  locally;  for  any  purchased  or  only  available  outside  the  country,  input  the  unit  price  in   USD. Po w er ed  e qu ip m en t Value  TB  -­‐  Estimating  unit  costs  of  TB  services 17.Supplies 27/11/19 Page  1 Name  or  description  of  supply Annual   expenditure (local  currency) %  use  for  TB TB  service  output   type  1 [use  dropdown] %  use  for  TB  service   output  type  1 TB  service  output   type  2 [use  dropdown] %  use  for  TB  service   output  type  2 TB  service  output   type  3 [use  dropdown] %  use  for  TB  service   output  type  3 Notes 0.5-­‐10  μl  tips   100-­‐1000  μl  pipette  tips   100-­‐1000  μl  pipette  tips   100-­‐1000  μl  pipette  tips  (Long  tip)   10-­‐100  μl  tips   1-­‐20  μl  tips   1-­‐200  μl  pipette  tips   1-­‐200  μl  tips   20-­‐200  μl  pipette  tips   20-­‐200  μl  pipette  tips   2ml  standard  reaction  tube   Applicator  stick  (disposable) BACTEC  MGIT  960  AST  transport   rack  –  445942.   BACTEC  MGIT  960  Supplement  Kit   (100  tests,  PANTA  and  OADC   combined)  Catalogue  No:  245124   BACTEC  MGIT  960  Supplement  Kit   (PANTA  and  OADC  combined) BACTEC  MGIT  OADC  Kit  for  Manual   MGIT  Catalogue  No:  245116   BACTEC  MGIT  PANTATM  Kit  for   Manual  MGIT  Catalogue  No:   245114   BACTEC  MGIT  PZA  kit BACTEC  MGIT  PZA  tubes BACTEC  MGIT  S.I.R.E.  Kit  for   Manual  MGIT  Catalogue  No:   245119   BACTEC™  MGIT™  960  SIRE  kit,  One   kit  is  sufficient  for  40  test   Catalogue  No:  245123   Bags  for  waste  bin  –  30  Litres   Bags  for  waste  bin-­‐  2  Litres   Balloon  HDPE  -­‐  10l Balloon  HDPE  -­‐  30l Price  List  for  Supplies This  sheet  can  be  used  to  get  prices  on  supplies  from  the  facility  or  from  a  central  source  such  as  the  Ministry  of  Health  or  Regional  Health  Authority.   INSTRUCTIONS:  The  list  of  supplies  is  not  exhaustive  so  please  insert  any  additional  supplies  that  have  been  provided  to  health  facilities  to  provide  TB  services  at  the  bottom  of  the  appropriate  supplies  section. Also  ensure  that  this  list  matches  the  list  in  sheet  '22.Price  list-­‐Supplies'. M ed ic al  s up pl ie s (%  of  use  of  TB  use) 81 Section F. Appendices ■n The equipment price list should be collected centrally and used for each facility. ■n The Data Collection Tool’s default equipment labels should be preserved. ■n If the prices paid for the equipment are known, inflate using CPI and convert to USD using the exchange rate of that year. ■n The standard and most appropriate value for the unit price is the replacement cost. Lists ■n The Lists sheet provides the selections for the dropdowns used throughout the tool. Only enter relevant data in the yellow cells of this sheet, namely columns Q “Possible additional units” and R “Possible additional tests (lab and radiology)”. ■n Do not make any other edits to this sheet. ■n This sheet asks for the time taken (in minutes) to collect all the data needed to complete the respective sheets in the Data Entry Tool, as well as time it takes to transfer data from the Data Collection Tool to the Data Entry Tool. ■n To facilitate this documentation, several of the data collection sheets include space at the top to input the start and end dates and times for the data collection. ■n Appreciating that in many instances the data collection for a sheet may not happen in one discrete time period, the dates and times included in some sheets are meant to be an aid in capturing this information. ■n Complete times will likely also require piecing together time spent based on input from each data collector. ■n A template for data collector timesheets has been included in the Data Collection Tool as a way to collect more detailed time information from each data collector. ■n Using it is optional, but it may also be useful for the study to use it during the piloting stage as a way of estimating the time needed to for data collection in each facility. ■n A pilot would take approximately a week and would test the tool adaption and data availability. Country Facility  level Geography Ethiopia Community  health  unit Urban India Health  post/dispensary Rural Kenya Health  centre Philippines Primary  (sub-­‐county/district)  hospital Georgia Secondary  (county/general)  hospital Tertiary  (national/  teaching/  referral/  specialised)  hospital Basic  laboratory  (stand  alone) Basic  laboratory  (linked  to  facility) Laboratory  (full) Reference  laboratory INSTRUCTIONS:  Please  DO  NOT  make  changes  to  this  sheet.  This  sheet  should  remain  locked. Drop-­‐down  lists Costing guidelines for Tuberculosis interventions82 Data Entry Tool The next section is an overview of the (generic/unadapted) Data Entry Tool (see Figure 10b), which is used for data analysis at the facility level to generate bottom-up and top-down unit costs. When clean and finalised, Data Entry Tools for each of the facilities should be safely stored and shared with study investigators for pooled analysis. ■n The Data Entry Tool, used by data analysts, aims to distill the information from the Data Collection Tool and to generate unit cost per patient per output, top- down and bottom-up (Appendix 9). It also allows users to drill down into the cost components of a unit cost. It gives the data analyst the opportunity to clean and review the data collected and review the ingredients and method to calculate unit costs. ■n Practically, the Data Entry Tool (provided in Excel) has calculations and links which summarize the cost data by service outputs in capital and recurrent categories (‘Dataset output’) and intervention type by TB services, laboratory and radiology tests (‘Dataset patient’). These datasets can be explored in Excel or exported into software such as STATA or RStudio for pooled analysis. Box B. Transferring data from Data Collection Tool to Data Entry Tool: the process Data should be transferred from the data collection to the data entry sheets by pasting the Values or Values & Number Formatting only. This will ensure that the cell format is not changed and that there are no links to other files. Do not enter data in any non-yellow cells or make any edits to this sheet as it provides the selections for the dropdowns used throughout the tool. Identical sheets in Data Collection and Data Entry Tools are listed here and mere copying (as described above) is sufficient. Ensure that any edits or additions made to the lists are replicated (with the same spelling and order). Fig. 10a. The Value TB Costing Tool Suite (Data Collection Tool highlighted in orange) Value TB generic facility provider cost Data Collection Tool Facility provider cost Data Collection Tool (Country-specific assumptions & parameters, facility-selection of relevant TB service delivery outputs) Costing Guidelines for Tuberculosis Interventions (for facility provider costing) Facility provider cost Data Entry Tool for one facility used for initial analysis tool (generic/no adaptation required) Number of facilities in sample Extraction of P’s and Q’s for analysis in a statistical package Value TB cost model – analysis Unit costs for all TB interventions/services for one country • Per visit/test BU and TD • Per patient BU and TD X 83 Section F. Appendices General information ■n The sheets for collecting information about the facility, including capital assets (buildings, equipment, furniture, vehicles and training) and recurrent costs (staff and other expenditure) are in blue, while price lists for drugs, equipment and supplies are colour-coded in green. ■n Service utilization data are in light grey and calculation sheets are in orange. Data should not be inputted into these orange sheets as they calculate unit costs and generate results. ■n There is an additional yellow sheet that should be used for capturing the time taken by data collectors to perform the data collection. ■n Title page, Glossary and Instructions sheets are similar to those in the Data Collection Tool, but the instructions have been adapted to give guidance on how to use the Data Entry Tool. Title page ■n This provides an overview of the Value TB study, outlining the aims of the study and the tool, as well as how the data can be used. Country Facility  level Geography Ethiopia Community  health  unit Urban India Health  post/dispensary Rural Kenya Health  centre Philippines Primary  (sub-­‐county/district)  hospital Georgia Secondary  (county/general)  hospital Tertiary  (national/  teaching/  referral/  specialised)  hospital Basic  laboratory  (stand  alone) Basic  laboratory  (linked  to  facility) Laboratory  (full) Reference  laboratory INSTRUCTIONS:  Please  DO  NOT  make  changes  to  this  sheet.  This  sheet  should  remain  locked. Drop-­‐down  lists COUNTRY  A VALUE-­‐TB  is  a  three-­‐year  project,  funded  by  the  Bill  and  Melinda  Gates  Foundation,  established  to  work  with  National   VALUE-­‐TB Data  entry  and  calculation  tool  for  estimating  unit  costs  of  TB  services  in   Project  overview: Tuberculosis  Programmes  (NTPs)  from  high  TB  burden  countries  to  collect  unit  cost  data,  using  new  standardised  methods.   The  included  TB  interventions  are  those  that  are  most  relevant  for  future  local  planning  and  resource  requirement  projections  and  have  been  jointly  defined  by  the  NTP  and  the  VALUE-­‐ TB  team. There  are  two  tools  required  to  estimate  the  unit  costs  of  TB  services  at  the  facility  level:  this  is  the  Data  Entry  Tool,  which  accompanies  the  data  collection  tool.  The  data  collection   tool  was  used  first  by  data  collectors  at  the  facility  to  gather  the  required  data.  Then  this  Data  Entry  Tool  should  be  compiled  by  the  study  principal  investigator  or  study  coordinator  to   produce  the  calculated  unit  costs. This  cost  Data  Entry  Tool  has  been  developed  to  estimate  the  unit  costs  of  a  comprehensive  set  of  TB  services  from  the  providers'  perspective.  Once  the  data  from  the  data  collection   tool  have  been  entered  into  the  relevant  sheet  in  this  tool,  unit  costs  are  produced  for  bottom-­‐up  and  top-­‐down  as  well  as  economic  and  financial  costs  of  the  TB  services  offered  at   this  facility. The  estimated  time  for  transferring  data  from  the  data  collection  tool  into  this  Data  Entry  Tool,  including  data  management  of  the  sheets  and  validation  of  the  calculations,  is  1  day  for   smaller  facilities  and  up  to  3  days  for  larger  facilities.   The  cost  data  collected  in  this  tool  can  further  be  used: for  programme  management,  funding  and  planning to  inform  the  estimates  of  the  costs  of  TB  services  globally March  13,  2019 Version  2.0 Costing guidelines for Tuberculosis interventions84 Glossary ■n The glossary defines the acronyms and abbreviations used within the tool. Instructions ■n Instructions describe the colour-coding of the sheets and the cells in the tool, and how they should be used. Parameters ■n This sheet contains key data on the year of assessment, country name, factors for valuing assets and prices (e.g. useful life, discount rates, exchange rates, monthly minimum wage, etc). There are also factors for converting measures of time to common units (e.g. minutes in an hour, average days in a month, etc.). ■n The source of all the data needs to be provided, whether it is from a specific agency, website, established methodology or an assumption. ■n The ‘useful life’ values (Data Collection Tool, column G for both Price List- Equipment and Equipment Inventory) can be obtained from WHO CHOICE or Parameters of the Data Entry Tool for different sizes of equipment. ■n The country in which this tool is being used (Title Page, cell M3) will be updated when the country name has been included in the Parameters sheet (cell C16). Value  TB  -­‐  Estimating  unit  costs  of  TB  services 2.Glossary 27/11/19 Page  1 AE adverse  events ACF active  case  finding AFB acid-­‐fast  bacilli ALT alanine  aminotransferase  (also  known  as  SGPT) AST asparate  aminotransferase  (also  known  as  SGOT) BCG bacille  Calmette-­‐Guérin BSC biosafety  cabinet BU bottom-­‐up  cost  estimation/allocation BUN blood  urea  nitrogen CBC complete  blood  count CCC comprehensive  care  clinic Glossary Value  TB  -­‐  Estimating  unit  costs  of  TB  services 3.Instructions 27/11/19 Page  1 1. 2. Instructions The  black,  blue,  grey  and  green  sheets  are  for  inputting  data  collected  in  the  data  collection  tool.   Generic  data  for  the  country  should  be  entered  in  the  4.Parameters  sheet  and  then  locked. The  orange  sheets  are  where  the  results  are  generated;  data  should  not  be  entered  in  these  sheets.   The  yellow  sheet  is  for  capturing  the  time  it  takes  to  collect  all  the  cost  data,  including  transfering  the  data  from  the  data  collection  to  the  data   entry  sheets. One  data  entry  workbook  should  be  used  for  each  facility  being  costed. There  is  a  'List'  sheet  at  the  end  of  this  workbook  is  linked  to  data  throughout  the  tool.  Please  do  not  enter  data  or  edit  this  sheet. The  'Notes'  sheet  is  a  free  space  in  the  tool  for  you  to  keep  track  of  any  unresolved  issues  and  is  not  linked  to  data  in  the  rest  of  the  tool.  Please   feel  free  to  use  so  that  it  best  suits  your  needs. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 4.Parameters 27/11/19 Page  1 Parameter  name Value Source Year  of  assessment Latest  financial  or  calendar  year  of  complete  data No.  of  months  evaluated 12 Assumption No.  of  days  in  a  month 30 Assumption No.  of  weeks  in  a  month 4.348214286 Julian  calender No.  of  weeks  in  a  year 52 Assumption No.  of  days  in  a  year 365 Assumption No.  workdays  in  a  year 250 Based  on  holiday  calendar  for  the  country No.  workdays  in  a  month 22 No.  working  hours  in  a  day 8 B s d  on  fa ility  or  country  regulations  or  contracts No.  minutes  in  an  hour 60 Assumption No.  of  working  minutes  in  a  year 120000 Calculation Country COUNTRY  A INSTRUCTIONS:  Validate  the  values;  then  lock  the  entire  sheet Parameter  Assumptions 85 Section F. Appendices ■n Values in this sheet should only be entered once for a particular country. Once this has been done, no edits should be made to this data and the tool can then be replicated for all facilities with the same parameter data. To ensure the sheet is not edited, it should be locked: [Review tab>Protect Sheet (in the Changes menu)>’Select locked cells’ should be ticked>select ‘OK’]. Facility characteristics ■n The values from the data collection Facility Characteristics should be copied and pasted into this Data Entry Tool. ■n Do not transfer data from the source, year of data or notes cells in the Data Collection Tool. ■n Ensure that the dropdown selections for the additional service output types have been selected properly. A. Reviewing completed sheets The following review and calculations for unit cost generation will be performed using the Data Entry Tool. This section of the guidelines will cover (A) reviewing completed sheets and (B) generation of unit costs using the associated Data Entry Tool. Building space Amortizing capital costs: ■n Check the calculations for the annualized economic and financial costs, as well as the allocations of the building costs to the direct, support and indirect facility departments (see Box A). ■n The useful life years of the building (from Parameters) feeds into the calculation for ‘Annualized economic costs (local currency)’ taking the standard discount rate (from Parameters),‘Value if sold today (local currency)’, and useful life years of the building, and running a PMT function which calculates the annualized/amortized amount. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 5.Facility  Characteristics 27/11/19 Page  1 Facility  name Facility  location/address  1 Facility  location/address  2 Geography  1  -­‐  urbanicity  (see  dropdown) Geography  2 Geography  3 Facility  level  (see  dropdown) Ownership  (see  dropdown) Size  (approximate)  of  facility  buildings  (m2) Size  (approximate)  of  land  (m2) Operating  hours  of  facility (total  opening  hours  per  week) Operating  hours  for  TB  services (total  opening  hours  per  week) Total  hospital  beds  (inpatient) (all) (DS-­‐TB) (MDR-­‐TB) (TB-­‐HIV) Total  day  beds  (outpatient) (all) (DS-­‐TB) (MDR-­‐TB) (TB-­‐HIV) Total  outpatient  visits (all) (DS-­‐TB) (MDR-­‐TB) (TB-­‐HIV) Size  of  catchment  population Total  clinical,  alli d,  and  auxiliary  staff  FTE Total  support  and  administrative  staff  FTE Total  staff  FTE Facility  Characteristics INSTRUCTIONS:  Data  from  the  '6.Facility  characteristics'  sheet  from  the  data  collection  workbook  should  be  pasted  here. Value Ch ar ac te ri st ic s (days  of  the  week) (days  of  the  week) Owned,  rented  or  donated   [dropdown] Value  if  sold  today (local  currency) Builiding  -­‐  general  information Name  of  department  or  clinic  or  room  or  area  or  building Name  of  department/  clinic/   room/  area/  building  in   language  of  site Size  of  department/  clinic/   room/  area/  building (m2) Outpatient  Department  (OPD) -­‐                                                                                         OPD:  General OPD:  Registration  office/reception  area OPD:  TB  clinic TB:  Common/waiting  area TB:  Sputum  collection  room  or  space TB:  Consultation  area  (with  doctor) TB:  Convalesing  area  (with  nurse) TB:  Dispensary  for  medication TB:  Laboratory TB:  Management  of  TB  services  (eg:  office(s)  of   nurse  in  charge  for  TB  clinics) Ph ys ic al  fa ci lit ie s Building    space   INSTRUCTIONS:  Data  collected  in  the  '7.Building  Space'  sheet  should  be  pasted  in  the  yellow  cells  of  this  sheet. Departments  are  in  bolded  font  in  column  B.   Costing guidelines for Tuberculosis interventions86 ■n The same calculation is done for the local discount rate (from the Parameters sheet). ■n There are check cells in column AO, which ensure that the proportion of building space allocated to each department adds up to 100%. If this is not the case, ‘ERROR’ will be returned in the check cell and the department allocations need to be amended. Equipment top-down Equipment time (top-down) calculation: ■n The proportion of time for each relevant TB service output should be calculated using service statistics for that particular output divided by the service statistics for all tests (outputs) performed using that piece of equipment. If the tests (outputs) performed by that piece of equipment are not known, all tests in the lab can be used. ■n Using a top-down approach, the expenditure of all the equipment and furniture are allocated to TB services using an allocation factor (for instance, number of TB tests processed divided by the total number of tests processed in a laboratory). ■n If the equipment was used for more than three service outputs, information can be entered for the same piece of equipment on two separate rows, ensuring that the percent usage for TB has been split between the two rows. ■n The values in columns I, K and M should total 100%. Equipment BU Equipment  name Department Clinic  or  room Manufacturer [if  applicable] Model [if  applicable] Analytical  balance Analytical  balance  (electronic)  for  DST Autoclave  -­‐  horizontal Autoclave  -­‐  vertical Autoclave  (basic  unit  for  media  kitchen)  -­‐  1 Autoclave  (basic  unit  for  media  kitchen)  -­‐  2 Autoclave  (basic  unit  for  media  kitchen)  -­‐  3 Autoclave  (basic  unit  for  media  kitchen)  -­‐  4 Automatic  filling  station AVR  (for  autoclave) BACTEC  -­‐  starter  kit BACTEC  MGIT  320  System BACTEC  MGIT  960  system BACTEC  printer Balance  (analytical) Balance  (precision) Balance  (precision)  -­‐  electronic Po w er ed  e qu ip m en t Equipment  and  furniture INSTRUCTIONS:  This  should  be  a  complete  list  of  all  equipment  and  furniture  used  in  any  of  the  TB  inteventions,  taken  from  sheet  '8.Equipment  Inventory'  from  the  data  collection  tool. The  list  of  equipment  in  this  sheet  should  match  (same  names  and  same  order)  the  'Price  list-­‐Equipment'  sheet  in  this  tool. TOTAL  CLINIC  OPENING  MINUTES  PER  WEEK Enter  method  for  time  measurement Equipment   category Name  or  description  of  equipment  or  furniture Financial  price   per  minute Economic  price   per  minute Outpatient   vaccinations Outpatie nt  cough   triage Outpatie nt   screenin g  visit Outpatie nt   diagnosti c  visit Outpatie nt  visit   type  1 Outpatie nt  visit   type  2 Analytical  balance 0.00 0.00 Analytical  balance  (electronic)  for  DST 0.00 0.00 Autoclave  -­‐  horizontal 0.00 0.00 Autoclave  -­‐  vertical 0.00 0.00 Autoclave  (basic  unit  for  media  kitchen)  -­‐  1 0.00 0.00 Autoclave  (basic  unit  for  media  kitchen)  -­‐  2 0.00 0.00 Autoclave  (basic  unit  for  media  kitchen)  -­‐  3 0.00 0.00 Autoclave  (basic  unit  for  media  kitchen)  -­‐  4 0.00 0.00 Automatic  filling  station 0.00 0.00 AVR  (for  autoclave) 0.00 0.00 BACTEC  -­‐  starter  kit 0.00 0.00 INSTRUCTIONS:  All  equipment  and  furniture  allocation  estimates  should  be  summarised  from  the  data  collection  "19.Observations"  sheet,  and  entered  into  this  input  sheet  after  observations  have  been  completed. DO  NOT  insert  rows  in  this  sheet  as  the  list  of  equipment/furniture  in  column  B  is  linked  to  the  'Price  list-­‐Equipment'  sheet  in  this  tool,  which  is  where  all  edits  to  the  list  should  be  made. Equipment  and  furniture  observations  entry Minutes  per  service  output Po w er ed  e qu ip m en t 87 Section F. Appendices Equipment time (bottom-up) calculation: ■n From the observations and/or interviews performed during data collection, enter the quantity of time (in minutes) that the relevant pieces of equipment were used to perform each service output. ■n The method used to measure the time each piece of equipment was utilized for each service output needs to be selected. ■n It is possible to select a combination of observation and interview in cases where observation of the entire service was not possible because of ethical issues or if the entire service did not naturally occur during the data collection period. Training Allocate training across departments: ■n After copying data from Data collection, check that the correct proportions and service outputs appear in the relevant department and service output allocation boxes to the right of the sheet. Staff top-down Name  of  training Facility,  or  if  offsite   provide  location Training   provider   (institution  or   programme   name) Date  of   training Duration (days) Number  of   partipants  from  this   facility 1 2 3 4 5 6 7 8 9 10 11 12 Training   INSTRUCTIONS:  Training  data  should  be  TB  related,  for  the  entire  facility.  A  value  of  3  years  has  been  used  from  the  '4.Parameters'  sheet  as  the  useful  life  for  training  as  this  is  a  commonly  used  value  but  if  a  different  value  is  applicable  to  your  context,  please  enter  it  in  cell  C25   of  '4.Parameters'. Health  care  worker  category Gross  annual  salary   (local  currency) Gross  annual   benefits (local  currency) Total  working   hours  per  week  or   full-­‐time   equivalent  (FTE) Quantity Clinical,  allied  and  auxiliary  staff Support  and  administrative  staff Total  Staff PERCENT  TIMESHEETS,  % Staff   category Staff  title Gross  annual  salary   received (local  currency) Gross  annual   benefits  received (local  currency) Working  hours  per   week  on  average   over  the  year Staff  time   measurement   method  -­‐  TD Outpatient   vaccinations Head  of  facility Registrar Doctor  1 Doctor  2 Doctor  3 Clinical  Officer  1  (TB/CCC) Clinical  Officer  2  (OPD) TB  Nurse  in  Charge MCH  Nurse Nurse  2 Nurse  3 Nurse  4 Nurse  5 Cl in ic al ,  a lli ed  a nd  a ux ili ar y   st af f Staff  timesheet  entry  -­‐  TOP-­‐DOWN INSTRUCTIONS:  The  salary,  benefits  and  working  hours  per  average  week  for  each  health  care  worker  in  the  facility  should  be  pasted  from  the  '9.Staff  Salaries'  sheet  in  the  data  collection  tool. Using  the  total  staff  time  values  (in  minutes)  from  the  data  collection  sheet  '20.Staff  time  sheets',  calculate  the  the  equivalent  time  (in  minutes)  per  week  spent  on  each  output.  Then  insert  those  values  into  the  corresponding  yellow  cells  of  this  sheet.  The  proportion  of  time  spent  on  each  output  will  then  be  calculated  in  this  sheet. Total  minutes  per  week  (from  timesheets) Fa ci lit y   St af f Costing guidelines for Tuberculosis interventions88 Review automatically calculated proportions of health care worker time spent on each service output – top-down method: ■n For staff performing TB services within a cadre who were not given timesheets, one can assume their time distribution is the same as the staff member within that cadre (in the same department or clinic) who did complete a timesheet. Therefore, the minutes per week for each service output should be duplicated from the timesheet collected for the staff member within that cadre at the facility. In this situation, the top-down staff time measurement method will also be ‘timesheet’. ■n The top-down method will be ‘interview’ if the timesheet was completed by sitting with the staff member and asking them how they spend their time over a specific period of time. ■n For support and administrative staff, top-down measurement is likely to be based on ‘assumption’, where their total working hours per week can be allocated to TB versus non-TB services by using service statistics. ■n For example, for a driver attached to the facility, time allocated to ‘Other overhead services’ can be allocated by ((TB outpatient visits + TB inpatient bed-days)/(total facility outpatient visits + total facility inpatient bed-days)) * total minutes worked per week. The remaining minutes in their work week should be allocated to ‘Non- TB services’. ■n At the end of the staff categories “clinical, allied and auxiliary staff” and “support and administrative staff”, there is space to include the title of 15 and 10 additional staff members, respectively. This has been indicated in blue font. ■n Only change text in the cells with blue font in column B. ■n This sheet contains the original list of health care workers used throughout the tool. ■n The list in Staff BU has been linked to the list in this sheet. Staff BU Review automatically calculated the proportion of health care worker time spent on each service output – bottom-up method: ■n The minutes per service output should be entered based on observations or interviews performed for each service output at the facility. TOTAL  CLINIC  OPENING  MINUTES PERCENT  OBSERVATIONS,  % Enter  method  for  time  measurement Staff   category Health  care  worker  type Financial  salary  per  minute Outpatient   vaccinations Outpatie nt  cough   triage Outpatie nt   screenin g  visit Outpatient   diagnostic   visit Outpatie nt  visit   type  1 Outpatie nt  visit   type  2 Outpatie nt  visit   type  3 Head  of  facility Registrar Doctor  1 Doctor  2 Doctor  3 Clinical  Officer  1  (TB/CCC) Clinical  Officer  2  (OPD) TB  Nurse  in  Charge MCH  Nurse Nurse  2 Nurse  3 Nurse  4 Minutes  per  service  output INSTRUCTIONS:  All  staff  time  estimates  for  each  service  output  should  be  summarised  from  the  "18.Interviews"  and  "19.Observations"  data  collection  sheets  and  entered  into  this  input  sheet  after  all  interviews  and  observations  have  been  completed. To  ensure  there  is  no  double  counting  of  staff  time  values,  if  more  than  one  of  a  particular  health  care  worker  category  has  been  interviewed  or  observed  for  a  service  output,  distinguish  the  type  of  output  (e.g.  outpatient  treatment  visit  in  OPD  versus  outpatient  treatment  visit  in  DOTS  clinic)  and  assign  the  staff  time  to  the  appropriate  output.  If  more  than  one  health  care  worker  was  interviewed  or  observed  for  a  service  output  in  the  same  department/clinic,  calculate  the  average  of  their  time. Staff  time  observations  and  interviews  entry  -­‐  BOTTOM-­‐UP Cl in ic al ,  a lli ed ,  a nd  a ux ili ar y   st af f 89 Section F. Appendices ■n Only enter values for the person(s) who actually perform the job. ■n Be sure to select the method used for staff time measurement for each output in row 6. ■n The list of healthcare workers is linked to the list of staff in the Staff top-down sheet. ■n Check that the correct value for ‘financial salary per minute’ appears for the corresponding health care worker from the Staff sheet. Review drug quantities: The analyst will review: — Total annual quantity disbursed for TB (in units) (Data Entry Tool – Drugs top-down) — Average number of drugs per patient (Data Entry Tool – Drugs bottom-up) Supplies top-down Review supplies quantities (top-down) and allocation of office and general supplies: ■n In the method embedded in the Data Entry Tool, 100% of ‘Office supplies’ and ‘General supplies’ have been allocated to ‘Admin & Management’ and ‘Other Overhead’, respectively. ■n Ensure that the proportions for each category of supplies is accurate and that the economic costs have been properly allocated. ■n All other supplies (‘Medical supplies’ and ‘Chemicals and reagents’) have been allocated to the service outputs identified during observations or interviews. ■n Do a spot check to ensure that the service outputs and proportions for each supply item with data is being pulled into the correct department and service output cost calculation. Wastage  of  supplies,  % Name  or  description  of  supply Annual  expenditure (local  currency) %  use  for  TB [eg.  based  on  TB   tests/all  tests   performed  by  total   numbers  of  machines] TB  service  output  type   1 [see  dropdown] %  use  for  TB   service  output   type  1 TB  service  output   type  2 [see  dropdown] 0.5-­‐10  μl  tips   100-­‐1000  μl  pipette  tips   100-­‐1000  μl  pipette  tips   100-­‐1000  μl  pipette  tips  (Long  tip)   10-­‐100  μl  tips   1-­‐20  μl  tips   1-­‐200  μl  pipette  tips   1-­‐200  μl  tips   20-­‐200  μl  pipette  tips   20-­‐200  μl  pipette  tips   2ml  standard  reaction  tube   Applicator  stick  (disposable) BACTEC  MGIT  960  AST  transport  rack  –   445942.   BACTEC  MGIT  960  Supplement  Kit  (100  tests,   PANTA  and  OADC  combined)  Catalogue  No:   245124   M ed ic al  s up pl ie s Supplies  expenditures INSTRUCTIONS:  Columns  C-­‐J  in  the  data  collection  '17.Supplies'  sheet  should  be  copied  and  pasted  into  the  corresponding  columns  in  this  data  entry  sheet. The  list  of  supplies  in  this  sheet  should  match  (same  names  and  same  order)  the  'Price  list-­‐Supplies'  sheet  in  this  tool. Costing guidelines for Tuberculosis interventions90 Supplies BU Complete supplies bottom-up calculations: ■n From the observations and/or interviews performed during data collection, enter the quantity of each supply (in units) that was utilized for each service output. ■n The analyst selects whether these quantitates have been obtained by observation, interview or a mixture of the two. ■n This value is applicable to all the supply quantity values obtained for the entire facility. ■n Selection of the method should be based on whether the majority of values were obtained by observation (select ‘Observation’), interview (select ‘Interview’) or about equal (select ‘Mix’). ■n For the ‘Mix’ method, the default in the tool is 50% observation to 50% interview but this can be changed by varying the ‘Time measurement allocation for ‘Mix’ method’ in cell C24 of the Parameters sheet. ■n Do a spot check that the price per unit for each supply is being pulled in correctly from Price list-supplies and that the calculation for the cost of supplies for each output is being applied to the correct quantity. Review drug, supplies and equipment prices In this tool, drugs used to treat adverse events have not been included in the unit costs. Data collection time (Optional) Review data collection time if one wishes to analyse the time invested in the costing study itself and use the evidence to inform the data collection. ■n This sheet asks for the time taken (in minutes) to collect all the data needed to complete the respective sheets in the Data Entry Tool as well as time it takes to transfer data from the Data Collection Tool to the Data Entry Tool. ■n To facilitate documentation, several of the data collection sheets include space at the top to input the start and end dates and times for the data collection. Method  of  quantity  measurement Type  of   supply Name  or  description  of  supply Price  per  unit Outpatie nt   vaccinati ons Outpatie nt  cough   triage Outpatie nt   screenin g  visit Outpatie nt   diagnosti c  visit Outpatie nt  visit   type  1 Outpatie nt  visit   type  2 Outpatie nt  visit   type  3 Inpatient   bed-­‐day   type  1 Inpatient   bed-­‐day   type  2 0.5-­‐10  μl  tips   0.00 100-­‐1000  μl  pipette  tips   0.00 100-­‐1000  μl  pipette  tips   0.00 100-­‐1000  μl  pipette  tips  (Long  tip)   0.00 10-­‐100  μl  tips   0.00 1-­‐20  μl  tips   0.00 1-­‐200  μl  pipette  tips   0.00 1-­‐200  μl  tips   0.00 20-­‐200  μl  pipette  tips   0.00 20-­‐200  μl  pipette  tips   0.00 2ml  standard  reaction  tube   0.00 Applicator  stick  (disposable) 0.00 BACTEC  MGIT  960  AST  transport  rack  –   0.00 Quantity  (units)  per  service  output Supplies  observation  entry INSTRUCTIONS:  All  supply  allocation  estimates  should  be  summarised  from  the  data  collection  "18.Interviews"  and  "19.Observations"  sheets,  and  entered  into  this  input  sheet  after  interviews  and  observations  have  been  completed. The  list  of  supplies  in  this  sheet  should  match  (same  names  and  same  order)  the  'Price  list-­‐Supplies'  sheet  in  this  tool. M ed ic al  s up pl ie s Aluminium  foil 0.00 Bags  (transparent  polypropylene) 0.00 Bottle  brush 0.00 Bowl 0.00 Broom 0.00 Bubble  wrap  (packing) 0.00 Bucket  -­‐  heavy  duty  plastic 0.00 Bucket  (stainless  steel) 0.00 Bucket  with  lid  (stainless  steel) 0.00 Cotton  balls 0.00 Cotton  wool 0.00 Cryobox 0.00 Desiccator 0.00 Detergent/washing  powder 0.00 Disinfectant  -­‐  liquid 0.00 Disinfectant  for  BSC  surface 0.00 Disinfectant  for  cleaning  instruments 0.00 Disinfectant  for  floors 0.00 Disinfectant  for  hands 0.00 Dustpan 0.00 Hand  cleanser 0.00 Hand  sanitiser 0.00 Liquid  soap 0.00 Mop 0.00 Mop  head 0.00 Paper  towels 0.00 Rinse  aid  for  dish  washer 0.00 Salt  for  dish  washer 0.00 Silica  gel  (for  desiccator) 0.00 Spatula 0.00 Styro  box 0.00 Surface  cleaner 0.00 G en er al  s up pl ie s 91 Section F. Appendices ■n Appreciating that in many instances the data collection for a sheet may not happen in one discrete time period, the dates and times included in some sheets are meant to be an aid in capturing this information. ■n Complete times will likely also require piecing together time spent based on input from each data collector. ■n A template for data collector timesheets has been included in the Data Collection Tool as a way to collect more detailed time information from each data collector. Using it is optional, but it may also be useful for the study to use it during the piloting stage as a way of estimating the time needed to for data collection in each facility. ■n A pilot study would take approximately a week and would test the tool adaption and data availability. Service statistics Review service statistics and allocations of main cost components in the unit costs. ■n The Data Entry Tool will generate automatic calculations, but the analyst will be making choices in the two options available for allocation keys depending on data available at the facility. Start  date: End  date: Sheet  name Collected  for  this   facility   (see  dropdown) Time  taken  to  complete  data   collection (in  minutes) 4.Parameters 5.Facility  Characteristics 6.Building  Space 7a.Building 7b.Building  BU 8.Transport 9.Training 10a.Staff  TD 10b.Staff  BU 11.Recurrent  Other 12a.Drugs  TD 12b.Drugs    BU 13a.Supplies 13b.Supplies  OBSERVATION 14.Service  Statistics 15.Service  Description 17.Price  list-­‐Drugs 18.Price  list-­‐Equipment 19.Price  list-­‐Supplies INSTRUCTIONS:  Report  the  time  taken,  in  minutes,  to  collect  all  the  data  in  each  sheet  listed  below.   Also  include  the  time  taken  to  transfer  from  data  collection  to  date  entry  tool. Data  Collection  time Year  of  data  (latest  financial  or  calendar  year) Unit Annual  quantity  -­‐  entire  facility Annual  quantity  -­‐  TB  services  only Outpatient  visits TB  Clinic MCH  Clinic Paediatric  Clinic HIV  Clinic Chronic  Disease  (diabetes)  Clinic Comprehensive  Care  Clinic Inpatient  beddays Inpatient  admissions Laboratory  tests  (all  labs) Microbiology  Lab  -­‐  tests Bacteriology  Lab  -­‐  tests Laboratory:  main  (clinical  path,  incl  haematology)  -­‐  tests Area  for  blood,  serum,  plasma  collection  -­‐  samples Area  for  sputum  sample  collection  -­‐  samples Area  for  AFB  and  GeneXpert  -­‐  tests Area  for  biopsy  -­‐  tests Area  for  LPA  -­‐  tests Laboratory:  culture  -­‐  tests Radiology  tests Service  Statistics  and  Allocation  Keys INSTRUCTIONS:  Copy  and  paste  data  from  the  '14.Service  Statistics'  sheet  in  the  data  collection  tool. Se ct io n   I:   H ea lt h   fa ci lit y   st at is ti cs Costing guidelines for Tuberculosis interventions92 ■n Here is a description of the allocation of all the main cost categories (i.e. space, equipment, staff time, drugs, transport). ■n It will be followed by a description of its implementation in the Data Entry Tool through sheets on Service statistics, Summary top-down and Summary bottom-up. Description of cost components allocations Space ■n For comprehensive care clinics in OPD where services are integrated, such as TB screening for all patients with HIV, questions could address the proportion of time spent screening for TB (or work out the proportion based on number of minutes for screening/total time for HIV consultation) and use this time to allocate a portion of the space (i.e. incorporate time where spaces are shared, with the assumption that visits take the same amount of time). ■n The top-down allocation is calculated using TB visits over total clinic headcount multiplied by the total building space (for example TB visits/total clinic headcount*total building space (500/5000)*100m2=10m2). Box C. Allocation for space Ideal: measure bottom-up space directly – i.e. the proportion of space used for a service If direct measurement is not possible, use visits for the allocation or ask staff who use the space to estimate the proportion for TB versus non-TB services For general OPD, recommended allocation = total TB outpatient visits/total outpatient visits For MCH in OPD where BCG vaccination and screening occurs, the recommended allocation = (total BCG vaccine visits + total TB screening visits)/total MCH OP visits For inpatient department (IPD), recommended allocation = total TB inpatient bed-days/total department inpatient bed-days For laboratory or radiology departments, recommended allocation = total TB tests/total department tests Box D. Allocation for equipment To allocate equipment cost to TB service: Ideal: use the number of tests to calculate the allocation. If one knows which tests the equipment is used for, denominator=sum of those test numbers; if one does NOT know which tests it is used for, denominator=all tests in that laboratory (i.e. microscope: used for ZN/Malaria/Stool testing only) EXCEPT: for equipment for culture and DST tests, including MGIT, incubator, Xpert® MTB/RIF if also used for HIV, influenza, etc. testing. Here time can be included in the calculation. Observation should be the default; if not available then use interview data. For instance, if MDR-TB testing is not done frequently then interview data may be the only option. It is also possible to ask for a demonstration which can be observed. 93 Section F. Appendices Drugs top-down and Drugs bottom-up ■n Top-down drug cost is estimated as the total annual quantity of drugs disbursed at the facility by the unit price of the drugs. ■n Top-down costing would involve looking at the expenditure of TB medication divided by the number of patients taking the medication. ■n This would usually involve step down accounting methods or allocation to move from an aggregate value to disaggregated costs for different regimens or individual drugs. Box E. Allocation for staff time using a top-down measurement method Ideal: Staff timesheets for at least one cadre of health care worker performing each TB service output. Based on the total time spent on each output, the proportion of time for each TB output will be calculated in the Data Entry Tool. Alternatives: For direct service personnel without timesheets, the assumption is that the proportion of time spent on TB should be the same as other personnel in that cadre of health professional. For example, if timesheets were collected for one doctor, nurse and nursing assistant, but there are additional doctors, nurses and nursing assistants providing TB services in the facility, it can be assumed that the timesheet values for “doctor 1” can be used for “doctor 2” and “doctor 3” as well. The same assumptions will also apply for the other cadres. For support staff, the head of facility or registrar, the proportion of time for TB is estimated (assumption) based on the total TB outpatient visits divided by the total facility outpatient visits: — % time for TB (support staff, facility head, registrar) = total TB outpatient visits/total outpatient visits for facility For head of laboratory, radiology and the inpatient department, use laboratory tests, radiology tests and bed-days, respectively. — % time for TB (laboratory head) = total TB laboratory tests/total laboratory tests in facility — % time for TB (radiology head) = total TB radiology tests/total radiology tests in facility — % time for TB (inpatient department head) = total TB bed-days/total bed-days for facility Specialized personnel providing direct services (e.g. phlebotomists, pharmacists, social workers, etc.) should be interviewed to provide an estimate of the proportion of time spent on TB, and of that time, how it is split between various departments (e.g. outpatient and inpatient departments for social workers). Other options: If one cannot measure directly, then use service statistics for the allocation. If the health care worker provides outpatient services, estimate using number of TB outpatient visits/Total outpatient visits. If the health care worker provides both outpatient and inpatient services, estimate using number of TB outpatient visits+TB inpatient bed-days/Total outpatient visits+Total inpatient bed-days Box F. Allocation for staff time using a bottom-up measurement method Ideal: Number of hours measured directly, and proportion of time spent on each task will be calculated in the Data Entry Tool Alternatives: a rough estimate given by the staff interviewed, or the percentage time for TB (%)= Department 1+ 2. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 12a.Drugs  TD 27/11/19 Page  1 Drug/pharmaceutical  product  description (medicine,  strength,  formulation,  packaging) Product  code Unit  of  measure Total  annual  quantities   disbursed  for  TB  (in  units) Estimated  expenditure (local  currency) Rifampicin/Isoniazid,  Dispersible  tablet(s),  Strip(s) 2-­‐FDC/RH-­‐75/50-­‐(B)-­‐84  (28x3) Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐672 Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐336 Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid/Ethambutol,  Film  coated  tablet(s),  Blister(s) 3-­‐FDC/RHE-­‐150/75/275-­‐(B)-­‐672 Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid/Pyrazinamide,  Dispersible  tablet(s),  Blister(s) 3-­‐FDC/RHZ-­‐75/50/150-­‐(B)-­‐84  (28x3) Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film  coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐(B)-­‐672 Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film  coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐(B)-­‐336 Per  pack/blister -­‐                                                                                       Cat  I  &  III  Kit  A,  Film  coated  tablet(s),  Blister(s) PK-­‐Cat  I  &  III-­‐A Per  blister -­‐                                                                                       0 0 0 -­‐                                                                                       0 0 0 -­‐                                                                                       0 0 0 -­‐                                                                                       0 0 0 -­‐                                                                                       D RU G S:  fi rs t-­‐ lin e   fix ed -­‐d os e   co m bi na ti on  (c om bi -­‐p ac ks ) INSTRUCTIONS:  Total  quatity  of  drugs  disbursed  for  TB  should  be  taken  from  column  E  of  the  data  collection  sheet  '16.Drug  Services'  and  copied  in  the  yellow  cells  of  this  data  entry  sheet. NOTE:  If  any  drug  was  added  to  the  data  collection  sheets  '16.Drug  Services'  and  '21.Price  list-­‐Drugs',  please  ensure  that  they  are  also  included  (extra  yellow  rows)  in  the  appropriate  section  of  this  data  entry  sheet. Drugs  -­‐  quantities Value  TB  -­‐  Estimating  unit  costs  of  TB  services 12b.Drugs  BU 27/11/19 Page  1 VACCINATION BCG   PHASE Price  per  dose   (local  price) In te ns iv e Co nt in ua ti on In te ns iv e Co nt in ua ti on In te ns iv e Co nt in ua ti on In te ns iv e Co nt in ua ti on Drug/pharmaceutical  product  description (medicine,  strength,  formulation,  packaging) Product  code Unit  of  measure Rifampicin/Isoniazid,  Dispersible  tablet(s),  Strip(s) 2-­‐FDC/RH-­‐75/50-­‐(B)-­‐84  (28x3) Per  pack/blister 0.00 Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐672 Per  pack/blister 0.00 Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐336 Per  pack/blister 0.00 Rifampicin/Isoniazid/Ethambutol,  Film  coated   tablet(s),  Blister(s) 3-­‐FDC/RHE-­‐150/75/275-­‐(B)-­‐672 Per  pack/blister 0.00 Rifampicin/Isoniazid/Pyrazinamide,  Dispersible   tablet(s),  Blister(s) 3-­‐FDC/RHZ-­‐75/50/150-­‐(B)-­‐84   (28x3) Per  pack/blister 0.00 Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film   coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐(B)-­‐ 672 Per  pack/blister 0.00 Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film   coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐(B)-­‐ 336 Per  pack/blister 0.00 Cat  I  &  III  Kit  A,  Film  coated  tablet(s),  Blister(s) PK-­‐Cat  I  &  III-­‐A Per  blister 0.00 0 0 0 0.00 0 0 0 0.00 0 0 0 0.00 0 0 0 0.00 Infant Quantities  (doses)  per  (average)  patient… Adult PTB EPTB PTB EPTB Drugs  -­‐  Interview  entry  form INSTRUCTIONS:  For  each  TB  regimen  and  phase  the  quantity  of  each  drug  (item)  prescribed  or  given  to  an  average  patient  should  be  obtained  from  the  data  collection  sheet  '16.Drug  Services'. If  a  drug  used   t  this  facility  is   ot  included  in   he  list,  please   ncluded  i  at  the  bottom  of  the  relevant  section  and  add  to  the  corresponding  section  in  the  'Price  list-­‐Drugs'  sheet  in  this  tool. 1st  Line  TB  TREATMENTINTERVENTION  CLASS  (TREATMENT  ONLY) INTERVENTION  POPULATIONS DS-­‐TB D RU G S:  fi rs t-­‐ lin e   fix ed -­‐d os e   co m bi na ti on  (c om bi -­‐p ac ks ) REGIMEN New  and  relapse Previously  treated Costing guidelines for Tuberculosis interventions94 ■n Similarly, to cost diagnostic tests one may need to allocate the cost of TB drugs from the expenditure of all drugs in a facility, and then further allocate costs to specific TB regimens i.e. first-line, retreatment, second-line and third-line treatment. ■n Bottom-up drug cost is calculated as the product of the drug prices and the average quantity per average patient for each TB treatment and prevention regimen by phase. ■n For a bottom-up costing, one would look at the patient TB drug usage. ■n For smaller facilities, this may include abstraction of all the patients’ medication records; for larger facilities a sample of patient records might be used. ■n Together with a price list for TB medication, one could calculate the average cost of TB medication (e.g. first-time treatment) for a relevant amount of time, for instance per month or per annum. Transport ■n Care should be taken that transport is captured either in overhead costs; or above service level costs or in vehicle costs (capital costs), and that it is not double counted. ■n The ‘Life expectancy (years)’ needs to be provided for each vehicle being costed in this sheet. ■n If there is no locally specific value, be sure to include the value provided in Parameters. Recurrent other ■n The proportion of recurrent costs allocated to TB services has been calculated using service statistics for outpatient visits (TB outpatient visits/total facility outpatient visits). ■n In a cost analysis, overhead inputs are allocated accordingly to various departments or activities. Inputs could be allocated to ‘cost centres’ (depending on how cost data are organized, and cost centres are defined). ■n An allocation basis needs to be defined for allocating each input to various cost centres. For instance, some costs can be assigned directly to certain cost centres. Vehicle  name Number  of   vehicles Life  expectancy   (years) Own,  rent  or   donated If  own  or  donated,   Current  market   value  of  all   vehicles (local  currency) If  rent,  total   annual  rental   value (local  currency) Total  annual   maintenance   costs   (insurance,   repairs  etc.) (local  currency) Ambulance Bicycle Motorcycle   Small  car Large  car SUV Mini-­‐van Van Mobile  clinic Bus Other Total  Veh cl  Costs Transport INSTRUCTIONS:  All  transportation  costs  and  proportions  should  be  transferred  from  the  data  collection  sheet  "11.Transportation"  into  this  input  sheet. 95 Section F. Appendices ■n If ‘inpatient care’ is a cost centre, then the line item ‘laundry’ could be allocated to that centre, using ‘a patient day equivalent’ as an allocation method. ■n If ‘maintenance’ is a cost centre, then ‘floor space utilized by department’ could be a useful allocation method. ■n Allocation of overhead inputs usually requires step down costing. Service description ■n The values in cells C13 to CE84 of Service Description should be copied and pasted into C14 to CE85 of this Data Entry Tool. Price list-drugs ■n The transportation mark-up values for first-line and second-line drugs are linked to the formulae in column N. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 11.Recurrent  Other 27/11/19 Page  1 Recurrent  overhead  costs  (ENTIRE  FACILITY)   -­‐  disaggregated Annual  expenditure (Local  currency) Percent  allocated  to  TB   services,  % Water Sewerage  and  sanitation Electricity  (light  and  heat) Gas Bio-­‐safety  disposal Other TOTAL  UTILITIES Internet Telephone Post TV  and  radio Other TOTAL  COMMUNICATIONS Stationery  and  general  office  supplies Printing Subscriptions Packaging Photocopying Other  admin  costs TOTAL  ADMINISTRATIVE INSTRUCTIONS:  Annual  expenditure  from  the  '10.Recurrent  Expenditure'  data  collection  sheet  should  be  pasted  into  column  C  in  this  data  entry  sheet. Other  recurrent  expenditures A dm in is tr at iv e U ti lit ie s Co m m un ic at io ns INTERVENTION  CLASS VACCINATION INTERVENTION  TYPE BCG  Vaccination PTB EPTB PTB EPTB PTB EPTB PTB EPTB PTB REGIMEN PHASE Service  output Outpatient  vaccinations Outpatient  cough  triage Outpatient  screening  visit Outpatient  diagnostic  visit Outpatient  visit  type  1 Outpatient  visit  type  2 Outpatient  visit  type  3 Inpatient  bed-­‐day  type  1 Inpatient  bed-­‐day  type  2 Community  vaccinations Community  screening  visit Community  diagnostic  visit Community  treatment  visit Service  Description TB  s er vi ce s INTERVENTION  POPULATIONS Adult Child HIV+ High-­‐risk  population INSTRUCTIONS:  The  data  from  the  '15.Service  Description'  sheet  in  the  data  collection  tool  should  entered  into  the  corresponding  cell  in  this  input  sheet. Quantity  per  patient  (visits,  beddays  or  tests)  for  year  of  assessment TB  CASE  DETECTION  &  DIAGNOSIS Passive  Case  Finding Intensified  Case  Finding  -­‐  cough  triage Intensified  Case  Finding  -­‐  screening Infant HIV+ First-­‐line  drugs Second-­‐line  drugs Transportation  mark-­‐up  (within  country),  % Drug/pharmaceutical  product  description (medicine,  strength,  formulation,  packaging) Product  code  (eg   GDF) Unit  of  measure Strength Unit  of   measure Rifampicin/Isoniazid,  Dispersible  tablet(s),  Strip(s) 2-­‐FDC/RH-­‐75/50-­‐(B)-­‐ 84  (28x3) Per  pack/blister Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐ (B)-­‐672 Per  pack/blister Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐ (B)-­‐336 Per  pack/blister Rifampicin/Isoniazid/Ethambutol,  Film  coated  tablet(s),   Blister(s) 3-­‐FDC/RHE-­‐ 150/75/275-­‐(B)-­‐672 Per  pack/blister Rifampicin/Isoniazid/Pyrazinamide,  Dispersible  tablet(s),   Blister(s) 3-­‐FDC/RHZ-­‐ 75/50/150-­‐(B)-­‐84   (28x3) Per  pack/blister Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film   coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐ 150/75/400/275-­‐(B)-­‐ 672 Per  pack/blister Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film   coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐ 150/75/400/275-­‐(B)-­‐ 336 Per  pack/blister Cat  I  &  III  Kit  A,  Film  coated  tablet(s),  Blister(s) PK-­‐Cat  I  &  III-­‐A Per  blister Price  List  for  Drugs INSTRUCTIONS:  Copy  and  paste  data  from  the  '21.Price  list-­‐Drugs'  sheet  in  the  data  collection  tool  into  the  yellow  cells.   Please  enter  a  transportation  and  logistics  mark-­‐up  for  the  facility. This  sheet  can  be  used  to  get  prices  on  drugs  from  the  facility  or  from  a  central  source  such  as  the  Ministry  of  Health  or  Regional  Health  Authority.   D RU G S:  fi rs t-­‐ lin e   fix ed -­‐d os e   co m bi na ti on  (c om bi -­‐p ac ks ) Costing guidelines for Tuberculosis interventions96 ■n Check that the list of drugs is being linked to the correct mark-up value based on which regimen they are used for. ■n Also do a spot check of the calculations of the unit prices and costs per tablet/dose (local currency and USD) to ensure values from different rows are not being pulled in. ■n In this tool, drugs used to treat adverse events have not been included in the unit costs. ■n If this data is easily available and one does not wish to lose it, one can enter them in the ‘DRUGS: vaccines’ section (rows 160–165). Drugs top-down and Drugs bottom-up ■n Ensure that any edits or additions made to this sheet are replicated (with the same spelling and order) in Drugs top-down and Drugs bottom-up sheets. Price list-equipment ■n Vehicles, equipment and furniture costs can be found in the facility records and inflated to the costed year, or by contacting local medical and furniture supplies for prices. Value  TB  -­‐  Estimating  unit  costs  of  TB  services 12a.Drugs  TD 27/11/19 Page  1 Drug/pharmaceutical  product  description (medicine,  strength,  formulation,  packaging) Product  code Unit  of  measure Total  annual  quantities   disbursed  for  TB  (in  units) Estimated  expenditure (local  currency) Rifampicin/Isoniazid,  Dispersible  tablet(s),  Strip(s) 2-­‐FDC/RH-­‐75/50-­‐(B)-­‐84  (28x3) Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐672 Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐336 Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid/Ethambutol,  Film  coated  tablet(s),  Blister(s) 3-­‐FDC/RHE-­‐150/75/275-­‐(B)-­‐672 Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid/Pyrazinamide,  Dispersible  tablet(s),  Blister(s) 3-­‐FDC/RHZ-­‐75/50/150-­‐(B)-­‐84  (28x3) Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film  coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐(B)-­‐672 Per  pack/blister -­‐                                                                                       Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film  coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐(B)-­‐336 Per  pack/blister -­‐                                                                                       Cat  I  &  III  Kit  A,  Film  coated  tablet(s),  Blister(s) PK-­‐Cat  I  &  III-­‐A Per  blister -­‐                                                                                       0 0 0 -­‐                                                                                       0 0 0 -­‐                                                                                       0 0 0 -­‐                                                                                       0 0 0 -­‐                                                                                       D RU G S:  fi rs t-­‐ lin e   fix ed -­‐d os e   co m bi na ti on  (c om bi -­‐p ac ks ) INSTRUCTIONS:  Total  quatity  of  drugs  disbursed  for  TB  should  be  taken  from  column  E  of  the  data  collection  sheet  '16.Drug  Services'  and  copied  in  the  yellow  cells  of  this  data  entry  sheet. NOTE:  If  any  drug  was  added  to  the  data  collection  sheets  '16.Drug  Services'  and  '21.Price  list-­‐Drugs',  please  ensure  that  they  are  also  included  (extra  yellow  rows)  in  the  appropriate  section  of  this  data  entry  sheet. Drugs  -­‐  quantities Value  TB  -­‐  Estimating  unit  costs  of  TB  services 12b.Drugs  BU 27/11/19 Page  1 VACCINATION BCG   PHASE Price  per  dose   (local  price) In te ns iv e Co nt in ua ti on In te ns iv e Co nt in ua ti on In te ns iv e Co nt in ua ti on In te ns iv e Co nt in ua ti on Drug/pharmaceutical  product  description (medicine,  strength,  formulation,  packaging) Product  code Unit  of  measure Rifampicin/Isoniazid,  Dispersible  tablet(s),  Strip(s) 2-­‐FDC/RH-­‐75/50-­‐(B)-­‐84  (28x3) Per  pack/blister 0.00 Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐672 Per  pack/blister 0.00 Rifampicin/Isoniazid,  Film  coated  tablet(s),  Blister(s) 2-­‐FDC/RH-­‐150/75-­‐(B)-­‐336 Per  pack/blister 0.00 Rifampicin/Isoniazid/Ethambutol,  Film  coated   tablet(s),  Blister(s) 3-­‐FDC/RHE-­‐150/75/275-­‐(B)-­‐672 Per  pack/blister 0.00 Rifampicin/Isoniazid/Pyrazinamide,  Dispersible   tablet(s),  Blister(s) 3-­‐FDC/RHZ-­‐75/50/150-­‐(B)-­‐84   (28x3) Per  pack/blister 0.00 Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film   coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐(B)-­‐ 672 Per  pack/blister 0.00 Rifampicin/Isoniazid/Pyrazinamide/Ethambutol,  Film   coated  tablet(s),  Blister(s) 4-­‐FDC/RHZE-­‐150/75/400/275-­‐(B)-­‐ 336 Per  pack/blister 0.00 Cat  I  &  III  Kit  A,  Film  coated  tablet(s),  Blister(s) PK-­‐Cat  I  &  III-­‐A Per  blister 0.00 0 0 0 0.00 0 0 0 0.00 0 0 0 0.00 0 0 0 0.00 Infant Quantities  (doses)  per  (average)  patient… Adult PTB EPTB PTB EPTB Drugs  -­‐  Interview  entry  form INSTRUCTIONS:  For  each  TB  regimen  and  phase  the  quantity  of  each  drug  (item)  prescribed  or  given  to  an  average  patient  should  be  obtained  from  the  data  collection  sheet  '16.Drug  Services'. If  a  drug  used   t  this  facility  is   ot  included  in   he  list,  please   ncluded  i  at  the  bottom  of  the  relevant  section  and  add  to  the  corresponding  section  in  the  'Price  list-­‐Drugs'  sheet  in  this  tool. 1st  Line  TB  TREATMENTINTERVENTION  CLASS  (TREATMENT  ONLY) INTERVENTION  POPULATIONS DS-­‐TB D RU G S:  fi rs t-­‐ lin e   fix ed -­‐d os e   co m bi na ti on  (c om bi -­‐p ac ks ) REGIMEN New  and  relapse Previously  treated Equipment  or  furniture  name  or  description Manufacturer Model Unit  price (local  currency) Unit  price (USD) Useful  life (in  years) Analytical  balance Analytical  balance  (electronic)  for  DST Autoclave  -­‐  horizontal Autoclave  -­‐  vertical Autoclave  (basic  unit  for  media  kitchen)  -­‐  1 Autoclave  (basic  unit  for  media  kitchen)  -­‐  2 Autoclave  (basic  unit  for  media  kitchen)  -­‐  3 Autoclave  (basic  unit  for  media  kitchen)  -­‐  4 Automatic  filling  station AVR  (for  autoclave) BACTEC  -­‐  starter  kit BACTEC  MGIT  320  System BACTEC  MGIT  960  system BACTEC  printer Balance  (analytical) Balance  (precision) Balance  (precision)  -­‐  electronic Biosafety  cabinet  -­‐  2  filters Biosafety  cabinet  -­‐  3  filters Biosafety  cabinet  -­‐  BSC  Type  II  A Biosafety  cabinet,  with  horizontal  laminar  airflow   hood  and  UV  light Biosafety  cabinet,  with  vertical  laminar  flow  hood  and   UV  light Blender  with  glass  jar Bottle  washer Camera  1  -­‐  digital Price  List  for  Equipment  and  furniture This  sheet  can  be  used  to  get  prices  of  equipment  from  the  facility  or  from  a  central  source  such  as  the  Ministry  of  Health  or  Regional  Health  Authority.   INSTRUCTIONS:  Please  provide  data  for  the  yellow  cells.  The  list  of  equipment  is  not  exhaustive  so  please  provide  any  additional  equipment   or  furniture  that  has  been  purchased  for  health  facilities  to  provide  TB  services. Po w er ed  e qu ip m en t 97 Section F. Appendices Price list-supplies ■n Check that the calculations for the unit prices (local currency and USD) are not pulling values from different rows. Notes ■n Any questions, unresolved issues or queries about unit cost values can be listed in this sheet. ■n This provides one central place to store this information for each facility and incorporates the contact and resolution. Name  or  description  of  supply Unit  of   measure Package   amount  or   volume Annual   Quantity Price  per  package (local  currency) Price  per   package (USD) 0.5-­‐10  μl  tips   100-­‐1000  μl  pipette  tips   100-­‐1000  μl  pipette  tips   100-­‐1000  μl  pipette  tips  (Long  tip)   10-­‐100  μl  tips   1-­‐20  μl  tips   1-­‐200  μl  pipette  tips   1-­‐200  μl  tips   20-­‐200  μl  pipette  tips   20-­‐200  μl  pipette  tips   2ml  standard  reaction  tube   Applicator  stick  (disposable) BACTEC  MGIT  960  AST  transport  rack  –  445942.   BACTEC  MGIT  960  Supplement  Kit  (100  tests,  PANTA  and   BACTEC  MGIT  960  Supplement  Kit  (PANTA  and  OADC   BACTEC  MGIT  OADC  Kit  for  Manual  MGIT  Catalogue  No:   BACTEC  MGIT  PANTATM  Kit  for  Manual  MGIT  Catalogue   BACTEC  MGIT  PZA  kit BACTEC  MGIT  PZA  tubes BACTEC  MGIT  S.I.R.E.  Kit  for  Manual  MGIT  Catalogue  No:   BACTEC™  MGIT™  960  SIRE  kit,  One  kit  is  sufficient  for  40   Bags  for  waste  bin  –  30  Litres   Bags  for  waste  bin-­‐  2  Litres   Balloon  HDPE  -­‐  10l Balloon  HDPE  -­‐  30l BBL  MGIT  Tubes  for  use  in  Bactec  MGIT  960  (7ml)  -­‐  100   BCG  vaccines Price  list  for  Supplies INSTRUCTIONS:  Any  additional  supplies  that  are  not  already  included  in  this  sheet  should  be  added  to  the  bottom  of  the  appropriate  section. M ed ic al  s up pl ie s Sheet  name Outstanding  data  or  question Who  to  ask Notes  or  outstanding  issues Figure 11. Shared above service level costs Weighting based on staff numbers: 2 staff at this facility working on TB = 100 000*2/12 =$16 667 above service level cost for facility 1 3 staff at this facility working on TB = 100 000*3/12 =$25 000 above service level cost for facility 2 1 staff at this facility working on TB = 100 000*1/12 =$8 333 above service level cost for facility 3 2 staff at this facility working on TB = 100 000*2/12 =$16 667 above service level cost for facility 4 4 staff at this facility working on TB = 100 000*4/12 =$33 333 above service level cost for facility 5 Above service level cost for district = $100 000 Only 5 laboratories in the district with a total of 12 staff Costing guidelines for Tuberculosis interventions98 B. Generation of unit costs Service statistics caters for some these allocation calculations ■n The percent allocation of healthcare worker time spent on TB directly is calculated from the timesheets, adding together the values by facility department (Outpatient, Inpatient, Community, Other TB, Admin & Management, Other Overhead and Pharmacy). ■n It then allocates a proportion of the total for each department to the service outputs provided in that department, then allocates to each department based on the proportion of time spent on TB in the entire facility. ■n It estimates the number of minutes for all TB services, i.e. minutes per service (derived from either observation or interview) * number of each TB service output. ■n The tool then allocates a proportion of the services within the relevant department to each service output type in that department. ■n It provides the size of the facility departments allocated to TB services and column M then calculates the proportion of all facility space used for TB by department. ■n It calculates the proportion of services utilized for each service output within each facility departments. ■n The ‘Drug wastage factor’ is documented ■n The human resources bottom-up to top-down (HR bottom-up/top-down) capacity adjustment factor documents what proportion of the top-down estimate of staff time use is equivalent to the bottom-up estimate of staff time use. Capacity adjustment factor ■n The HR BU/TD capacity adjustment factor, automatically generated in the Data Entry Tool, tells us what proportion of the top-down estimate of staff time use is equivalent to the bottom-up estimate of staff time use. ■n The numerator is the total hours per week estimated using the bottom-up approach for all TB services in the facility = [(Total minutes in the year for all TB services) + (an administration factor for admin & management, other overhead and pharmacy costs), converted to hours per week]. Year  of  data  (latest  financial  or  calendar  year) Unit Annual  quantity  -­‐  entire  facility Annual  quantity  -­‐  TB  services  only Outpatient  visits TB  Clinic MCH  Clinic Paediatric  Clinic HIV  Clinic Chronic  Disease  (diabetes)  Clinic Comprehensive  Care  Clinic Inpatient  beddays Inpatient  admissions Laboratory  tests  (all  labs) Microbiology  Lab  -­‐  tests Bacteriology  Lab  -­‐  tests Laboratory:  main  (clinical  path,  incl  haematology)  -­‐  tests Area  for  blood,  serum,  plasma  collection  -­‐  samples Area  for  sputum  sample  collection  -­‐  samples Area  for  AFB  and  GeneXpert  -­‐  tests Area  for  biopsy  -­‐  tests Area  for  LPA  -­‐  tests Laboratory:  culture  -­‐  tests Radiology  tests Service  Statistics  and  Allocation  Keys INSTRUCTIONS:  Copy  and  paste  data  from  the  '14.Service  Statistics'  sheet  in  the  data  collection  tool. Se ct io n   I:   H ea lt h   fa ci lit y   st at is ti cs 99 Section F. Appendices ■n The denominator is the total hours per week estimated using the top-down approach for all TB services in the facility = (total working hours per week over the year for staff included in the study * proportion of their working hours per week over the year allocated to TB) * 80%. ■n If HR bottom-up/top-down capacity adjustment factor <1, the bottom-up estimates are lower than the top-down estimates. ■n If HR bottom-up/top-down capacity adjustment factor >1, the top-down estimates are lower than the bottom-up estimates. Summary bottom-up, Summary top-down, Patient top-down, Patient bottom-up Results (automatized in Data Entry Tool): unit cost generation: ■n Summary top-down, Summary bottom-up, and Patient bottom-up sheets show intermediate results. They are auto-populated and do not need the analyst to do anything, as the formulae generate unit costs for the facility. ■n The bottom-up approach to costing these items is by auditing/counting how many there are within the facility. ■n The allocation of these costs to TB services is standardized within the sheets. First estimation is done through output (i.e. visits) and then cost per patient is estimated in the Patient top-down and Patient bottom-up sheets. ■n This sheet calculates the bottom-up unit costs for an average patient by pulling in the service output bottom-up unit costs (from Summary bottom-up) and the quantities of each output per patient Service description. ■n To check the sheet, do a spot check to ensure the formulae are pulling in the correct values and that there are no missing or error values due to missing unit cost or quantity data. ■n The top-down approach would list all the equipment and furniture (or expenditure of all the equipment and furniture) and allocate these to TB services using a standardized allocation factor specific to the different inputs. ■n This sheet multiplies the top-down unit costs of the service outputs (from Summary top-down) by the quantity of each service output (from Service description) for an average patient for each of the populations and regimen within each intervention type. ■n The patient costs are also provided by phase of treatment and includes the costs of drugs specific to the regimen and phase. ■n To check the results in this sheet, the analyst will do a spot check to ensure the cells contain the correct values and that there are no missing or error values due to missing unit cost or quantity data. Costing guidelines for Tuberculosis interventions100 Summary top-down Total costs for TB services are allocated for different input categories: The allocation criteria for the input categories comprising the unit costs is indicated. A stepped approach has been used to obtain the unit costs for each cost centre and service output: 1. (columns C–S): costs are initially pulled in from the departments for the equip- ment/furniture, training, staff, and supplies input categories. For the remaining inputs, the costs are allocated based on the criteria indicated in row 5. For example, for ‘Building space’ (column C), the total economic costs allocated to each department are pulled in from Buildings space, then within each department these costs are allocated to each service output using the services statistics allocation keys in Service statistics (column I). The same process is repeated for vehicles; other (non-medical) supplies; capital maintenance; utilities; fuel and other recurrent transport (including maintenance and courier services); food (including food services), supplements; including food services; and other recurrent. The costs of drugs have not been included in the summary sheets but pulled in to the Patient top-down sheet. 2. (columns T–AJ): administration and management, other overhead and pharmacy costs (columns C–S) are allocated to each department based on the TB versus total facility service utilization. Then these department costs are allocated based on the quantity of service outputs provided in that department for the year. 3. (columns AK-BA): direct costs (columns C–S) and administration and management, other overhead and pharmacy costs (columns T–AJ) are summed. 4. (column BB): ‘unit’ or service output quantities are pulled in from Service statistics. 5. (columns BC–BS): the unit costs are calculated by dividing the total unit costs (columns AK–BA) for each service output by the total units for each service output. 6. (column BT): total unit cost for each service output is obtained by adding the unit cost for each input. ■n There are check cells in row 92 of this sheet. Allocation  criteria Service  statistics Direct Direct Direct Service  statistics Cost  Centres/  Services Buildings Laboratory  and   Medical   equipment Other  equipment Furniture Vehicles OVERHEAD  AND  SUPPORT  DEPARTMENTS 0.00 0.00 0.00 0.00 0.00 Admin  and  management   0.00 0.00 0.00 0.00 0.00 Other  overheads 0.00 0.00 0.00 0.00 0.00 PHARMACY 0.00 0.00 0.00 0.00 0.00 OUTPATIENT  SERVICES 0.00 0.00 0.00 0.00 0.00 Outpatient  vaccinations 0.00 0.00 0.00 0.00 0.00 Outpatient  cough  triage 0.00 0.00 0.00 0.00 0.00 Outpatient  screening  visit 0.00 0.00 0.00 0.00 0.00 Outpatient  diagnostic  visit 0.00 0.00 0.00 0.00 0.00 Outpatient  visit  type  1 0.00 0.00 0.00 0.00 0.00 Outpatient  visit  type  2 0.00 0.00 0.00 0.00 0.00 Outpatient  visit  type  3 0.00 0.00 0.00 0.00 0.00 INPATIENT  SERVICES 0.00 0.00 0.00 0.00 0.00 INSTRUCTIONS:  DO  NOT  ENTER  DATA  IN  THIS  SHEET. This  sheet  presents  the  top-­‐down  unit  costs  of  service  outputs. Summary  Costs  -­‐  TOP-­‐DOWN  (Economic) CAPITAL   ALL  Departments 101 Section F. Appendices ■n If the values in this row do not match that of the summary values in rows 90 and 91, check the calculations and values in the preceding cells and related sheets for errors such as missing data or broken links. ■n The unit costs of the service outputs and the summary costs for each input should be reviewed to assess reasonableness of the calculated values with respect to the local context and cost composition. Summary bottom-up Total Unit Cost for each service output – bottom-up approach: Step 1 for this sheet is an additional step. The subsequent steps follow a similar approach to that of steps 1–6 of the Summary top-down sheet. 1. (columns C–J): For each service output, the direct unit costs obtained from the bottom-up methods of data collection (observation or interview) are pulled in directly for the equipment, staff and supplies input categories (sheets 7b on Equipment BU, 10b on Staff bottom-up and 13b on Supplies bottom-up, respectively). 2. (columns K–AA): a. For the input categories that were not measured using a bottom-up approach, the top-down values (Summary top-down, columns C–S) are multiplied by the HR bottom-up/top-down capacity adjustment factor b. For inputs the equipment, staff and supplies inputs, the direct unit costs are multiplied by the total unit quantity for each service output. The unit cost for the department is the sum of the unit costs for the service outputs provided in that department. 3. (columns AB–AR): the admin & management, other overhead and pharmacy costs (columns K–AA) are allocated to each department based on the TB versus total facility service utilization. Then these department costs for each service output are allocated based on the quantity of the service outputs provided in that department for the year. Allocation  criteria Direct Direct Direct Observation  or   Interview Cost  Centres/  Services Laboratory  and   Medical   equipment Other  equipment Furniture Clinical  staff OVERHEAD  AND  SUPPORT    DEPARTMENTS Admin  and  management   Other  overheads PHARMACY OUTPATIENT  SERVICES 0.00 0.00 0.00 0.00 Outpatient  vaccinations 0.00 0.00 0.00 0.00 Outpatient  cough  triage 0.00 0.00 0.00 0.00 Outpatient  screening  visit 0.00 0.00 0.00 0.00 Outpatient  diagnostic  visit 0.00 0.00 0.00 0.00 Outpatient  visit  type  1 0.00 0.00 0.00 0.00 Outpatient  visit  type  2 0.00 0.00 0.00 0.00 Outpatient  visit  type  3 0.00 0.00 0.00 0.00 INPATIENT  SERVICES 0.00 0.00 0.00 0.00 INSTRUCTIONS:  DO  NOT  ENTER  DATA  IN  THIS  SHEET.   This  sheet  presents  the  bottom-­‐up  unit  costs  of  service  outputs. Summary  Costs  -­‐  BOTTOM-­‐UP  (Economic) DIRECT  UNIT  COSTS  PULLED  IN  FROM  OBSERVATIONS  /  INTERVIEWS Costing guidelines for Tuberculosis interventions102 4. (columns AS–BI): direct costs (columns K–AA) and admin & management, other overhead and pharmacy costs (columns AB–AR) are summed. 5. (column BJ): ‘unit’ or service output quantities are pulled in from Service statistics. 6. (columns BK–CA) – the Unit Costs for each service output is calculated by dividing the total unit costs (columns AK–BA) for that output by the total units (quantity). 7. (column CB): Total Unit Cost for each service output is obtained by adding the unit cost for each input. ■n There are check cells in row 92 of this sheet. ■n If the values in this row do not match that of the Summary values in rows 90 and 91, check the calculations and values in the preceding cells and related sheets for errors such as missing data or broken links. ■n The unit costs of the service outputs and the summary costs for each input should be reviewed to assess reasonableness of the calculated values with respect to the local context and cost composition. Patient top-down Calculate unit cost for an average patient – top-down: ■n This sheet multiplies the top-down unit costs of the service outputs (from Summary top-down) by the quantity of each service output (from Service description) for an average patient for each of the populations and regimen within each intervention type. ■n The patient costs are provided by phase of treatment and include the costs of drugs specific to the regimen and phase. ■n To check the sheet, do a spot check to ensure the formulae are pulling in the correct values and that there are no missing or error values due to missing unit cost or quantity data. INTERVENTION  CLASS VACCINATION INTERVENTION  TYPE BCG  Vaccination PTB EPTB PTB EPTB PTB REGIMEN PHASE Outpatient  vaccinations     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Outpatient  cough  triage     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Outpatient  screening  visit     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Outpatient  diagnostic  visit     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Outpatient  visit  type  1     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Outpatient  visit  type  2     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Outpatient  visit  type  3     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Inpatient  bed-­‐day  type  1     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Inpatient  bed-­‐day  type  2     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Community  vaccinations     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Com unity  screening  visit     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Community  diagnostic  visit     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Community  treatment  visit     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Community  other  visit     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Community  event     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               Lost  to  follow-­‐up  tracing  per  person  on  contact  list   (phone  calls)     -­‐                                                         -­‐                             -­‐                               -­‐                       -­‐                       -­‐                               INTERVENTION  POPULATIONS Infant Adult Child HIV+  UNIT  COST  PER   OUTPUT     Passive  Case  Finding Intensified  Case  Finding  -­‐  cough  triage Cost  per  patient  -­‐  TOP-­‐DOWN INSTRUCTIONS:  DO  NOT  ENTER  DATA  IN  THIS  SHEET. QUANTITY  PER  PATIENT  (visits,  beddays  or  tests)  for  year  of  assessment TB  CASE  DETECTION  &  DIAGNOSIS TB  s er vi ce s 103 Section F. Appendices Patient bottom-up Calculate unit cost for an average patient – bottom-up: ■n This sheet calculates the bottom-up unit costs for an average patient by pulling in the service output bottom-up unit costs (from Summary bottom-up) and the quantities of each output per patient (Service description). ■n To check the sheet, do a spot check to ensure the formulae are pulling in the correct values and that there are no missing or error values due to missing unit cost or quantity data. Datasets are produced per facility ■n Each data set from a facility will be analysed with traditional statistical packages to meet the study objectives. Dataset output ■n This sheet contains the unit costs of all the service outputs presented by inputs. ■n The quantities and prices of building space and staff time have also been presented for each service output. ■n They are presented in a dataset format to allow for easy uploading into statistical software and for publication in the GHCC database. INTERVENTION  CLASS  VACCINATI ON   INTERVENTION  TYPE  BCG    PTB    EPTB    PTB    EPTB   REGIMEN PHASE Outpatient  vaccinations     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Outpatient  cough  triage     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Outpatient  screening  visit     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Outpatient  diagnostic  visit     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Outpatie t  visit  type  1     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Outpatient  visit  type  2     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Outpatient  visit  type  3     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Inpatient  bed-­‐day  type  1     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Inpatient  bed-­‐day  type  2     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Community  vaccinations     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Community  screening  visit     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Community  diagnostic  visit     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Community  treatment  visit     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           Community  other  visit     -­‐                           -­‐                           -­‐                           -­‐                           -­‐                           TB  s er vi ce s Cost  per  patient  -­‐  BOTTOM-­‐UP INSTRUCTIONS:  DO  NOT  ENTER  DATA  IN  THIS  SHEET. QUANTITY  PER  PATIENT  (visits,  beddays  or  tests)  for  year  of  assessment  UNIT  COST   PER   OUTPUT     TB  CASE  DETECTION  &  DIAGNOSIS  Passive  Case  Finding   INTERVENTION  POPULATIONS  Infant    Adult    Child   Dataset  output  costs Country Facility  name Geography  1  -­‐   urbanicity   (see   dropdown) Geography  2 Geography  3 Facility  level  (see   dropdown) COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 COUNTRY  A 0 0 0 0 0 Costing guidelines for Tuberculosis interventions104 Dataset patient ■n This sheet contains the unit costs for each patient receiving vaccination, TB case detection and diagnosis, TB treatment and TB prevention by the service outputs. ■n Both the top-down and bottom-up costing approaches are presented, along with financial and economic costs. ■n Intervention class, type, populations, regimen and phase for both top-down and bottom-up costing approaches, as well as the financial and economic costs, are calculated. Dataset  patient  costs Country Facility  name Geography   (see   dropdown) Facility  level   (see   dropdown) Ownership   (see   dropdown) Size   (approximat e)  of  facility   buildings   (m2) Total   hospital  beds   (inpatient) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) COUNTRY  A 0 0 0 0 0 (all) 105 Section F. Appendices Appendix 9. Non-exhaustive list of unit cost per patient per output, top-down and bottom-up generated by the data entry tool ALT also known as SGPT Aspirates (EPTB) AST also known as SGOT Body fluid analysis PCR-DNA (children) Bronchial lavage (children) CD4 count Creatinine Creatinine clearance Culture (liquid media) [e.g.: MB/Bact Alert, Bactec MGIT 960] Culture (solid medium) [e.g.: Lowenstein-Jensen, Ogawa or Stonebrink] Digital x-ray DST – FLD (liquid media) (isoniazid, rifampicin, ethambutol, streptomycin) DST – FLD (solid media) (isoniazid, rifampicin, ethambutol, streptomycin) DST – SLD (liquid media) (fluoroquinolone injectables) DST – SLD (solid media) (fluoroquinolone injectables) ECG Erythrocyte sedimentation rate Fine needle biopsy (children) Full haemogram (red blood cell, white blood cell and platelet tests) Gastric lavage (children) Glucose (RBS) HIV confirmatory test HIV rapid test IGRA Lactic acid LAMP LF- LAM (rapid antibody or antigen detection tests for TB) Lipase LPA – FLD LPA – SLD Microscopy (ZN) Sputum induction Thyroid stimulating hormone Total white blood cell count TST or PPD or Mantoux test X-ray (film) Xpert® MTB/RIF Community diagnostic visit Community event Community other visit Community screening visit Community treatment visit Community vaccinations (BCG vaccination) Inpatient bed-day Lost to follow-up tracing (using phone calls) Outpatient cough triage Outpatient diagnostic visit Outpatient screening visit Outpatient vaccinations (BCG vaccination) Outpatient visit Patient support during diagnosis Patient support during treatment Costing guidelines for Tuberculosis interventions106 Appendix 10. Terms of reference for the study team The below terms of reference are an example taken from the Value TB Study. DATA COLLECTION TEAM DUTIES AND QUALIFICATIONS  It is anticipated that cost data will be collected from between 15–25 providers of TB services and interventions nationally  (both health facilities and laboratories). The data collection process involves visits to each site lasting between 1–3 days depending on the size and type of provider. The data collection instrument will examine financial and TB service records. In addition, all rooms and equipment used for TB will be listed. Finally, staff will be interviewed about their time spent on different activities. In some cases, activities will be observed. In addition, data collectors will need to collect data on local prices of salaries, supplies and equipment costs. The data collection process will be piloted in a small number of sites in the first instance  (in approximately 2 sites). This will be followed by a detailed costing in approximately 5 sites. All data will be entered electronically into mobile phones or tablets. The study team will comprise of the VALUE-TB principal investigator (PI) and local PI  (hereafter referred to as ‘VALUE-TB PI’ and ‘PI’ respectively)  who will joint- ly lead the study. Due to the large scale of the study, it is envisaged that  at least 2 research assistants will be required over a period of one year, with a local consult- ant or member of the National TB Programme (NTP) in a supervisory role (PI). It is expected that these 2 research assistants would each collect data from approximate- ly 15–25 facilities over a period of one year (working full time for 40 hours a week, with approximately 1 week per facility).  Roles/responsibilities of the NTP  a. Work with the VALUE-TB team to identify local consultants. Specifically, the NTP should identify an appropriate local PI and a data collection/analysis team.  ba. Work with the VALUE-TB team to design the study protocol so that it meets local needs.  c. Host workshops to train data collectors, provide logistical  support, and facil- itate  access to providers to enable data collection activities  including retrieving salary and expenditure data. d. Support the process of local ethics submission and provide local oversight for the study.  e. Attend and contribute to a data analysis workshop in Geneva.  f. Facilitate dissemination of key findings and aid translation of research into policy.  g. Contribute and where relevant lead the write up of results.  Country Principal Investigator (PI) (approximately half time position,  0.5 FTE over 1 year)  Each national VALUE TB provider cost collection should have a designated principal investigator (PI). More than one PI can also be nominated. The PI(s) should be a senior 107 Section F. Appendices person from the Ministry of Health and/or the contracted external organization who has both TB experience and experience in overseeing and managing research or health facility-based data collection. The PI assumes overall responsible for all data collection  activities and is a nominated person on the protocol and in any ethics committee applications.  If no data collection manager is assigned then the day-to-day management of the cost collection is the responsibility of the PI. This entails managing the implementation of the cost collection. If possible, this person should be actively involved in the design of the study. The PI supervises the work of research assistants who collect the data. For this to happen, there needs to be close collaboration between the PI and the research assistants in the field via either direct supervision or regular reports from the staff or online cost collection tool that allow for quality control. If no data manager is assigned  then the PI  is responsible for  flagging quality data issues periodically and  managing the data collected by  research assistants. This person should have some expertise in data management for cost collection or public health research and prior experience in managing data would be highly beneficial. The majority of countries will collect data in an online tool. If this is the case, the PI should be familiar with the online data collection system and should be able to troubleshoot and rectify any data collection problems. Roles and responsibilities  ■n Oversees the development of the research protocol and ethical clearance  ■n Acts as a liaison person for communication with partners and stakeholders outside the data collection team, with staff from the NTP, the public health service, local research institutions and other government departments.  Manages  funding for the  data collection and funding reports, ensuring that funds are managed according to national procedures ■n Assembles the data collection team that has all the expertise needed to design, implement, and analyse the TB provider cost data ■n Liaises with the research assistants on a frequent basis and oversees their work ■n Maintains and ensures the quality of the study’s conduct and writes the final study report and ensures that it is disseminated to the key stakeholders identified during the stakeholder analysis  ■n Convenes jointly with NTP the dissemination of results with stakeholders (health and non-health)  ■n Establishes contact with facilities sampled for the study and facilitates the welcoming of the research assistant and the key information providers within each facility.  ■n Oversees the day-to-day management of the data collection  ■n Assists in the design of the data collection together with the VALUE TB PI  ■n Adapts training manual and cost collection materials  ■n Prepares standard operating procedures  ■n Trains research assistants before data collection and provides retraining if mid- term review identifies such a need  Costing guidelines for Tuberculosis interventions108 ■n Supervises the work of data collection research assistants through on-site visits or through periodic reports  ■n Monitors the operational implementation of the data collection ■n Flags data quality issues periodically (i.e. every two weeks) to  VALUE  TB PI and completes regular data management reports  ■n Adapts the electronic data collection instrument (with validation by VALUE TB PI) in an effective and feasible manner to support the cost collection  ■n Coordinates data management activities for the  cost collection: receiving, batching, cleaning, and merging data from different sources (e.g. NTP regarding prices vs data collection for diagnostic tools)  ■n Is responsible for the validation of double-entered data files  ■n Ensures that data are properly stored and backed up  ■n Checks validated data files regularly  (weekly if electronic)  for systematic errors (cleaning)  ■n Prepares database to be ready for analysis and data entry screens  ■n Contributes to the analysis of results Key tasks  ■n Adapts and develops the protocol  as per methodology developed by VALUE  TB team and with input from the VALUE TB PI, NTP and National Technical Advisory Group (as needed)  ■n Drafts letter with the NTP manager (and WHO) addressed to facilities involved in the study to communicate the purpose of the study and request facility managers to share the information requested by the research assistant (which may be listed in the letter)  ■n Ensures that  cost data collection  and analysis are conducted according to the protocol and the plan  ■n Discusses any problems encountered during the data collection, and then proposes and decides on feasible solutions, in collaboration with the data collection team and the technical advisory group (if needed)  ■n Endorses the TB provider cost results ■n Translates study results into policy recommendations  ■n Engages with NTP for results dissemination  ■n Coordinates overall implementation of cost collection in the field ■n Plans the field implementation and required training, including preparation of training materials as appropriate ■n Contacts and coordinates with local authorities  ■n Ensures quality assurance processes are implemented according to the protocol  ■n Supervises implementation in the health facilities and laboratories  ■n Plans and co-ordinates data collection monitoring visits comprising all partners involved in data collection implementation  109 Section F. Appendices ■n Oversees the provision of supplies and required materials  ■n Involved in the analysis of the results  ■n Organizes the writing of activity reports and the final report  ■n Plans the detailed budget of the cost collection and periodically reports to funders on funds utilization (as per contract)  ■n Provide any logistic support for the cost collection team  ■n Arrange pilot-testing and its evaluation  ■n Liaise with local officials in the health care facilities and laboratories (during pre- cost collection visits and actual field work)  ■n Report without delay any major problems in preparation, execution or data management of the cost collection  Qualifications  ■n Preferably at least 5 years of managerial experience in the field of public health preferably with costing or health economics experience  ■n Strong managerial skills, including being able to delegate tasks  ■n Extensive knowledge of TB management including the context in which the data is being collected  ■n Knowledge of laboratory and facility-based costing ■n Working within or having access to an organization that has an infrastructure that can support  ■n Facility-based costing in the field Research assistants (2 FTE over 1 year may cover 15–25 facilities each)  The  research assistants  will be based at the health facilities and  laboratories  for a period of one week per facility and  will conduct  the  data  collection  mostly regarding  quantities  of resources used in TB prevention,  diagnosis and care. They will need to be employed for the cost collection and cleaning periods and may or may not need to be full time depending. The research assistants should have good social and communication skills and should be thoroughly trained in costing techniques and the  Data Collection Tools. The  research assistants  should also have the ability to manage technology if the online Data Collection Tool is used. Roles and responsibilities ■n Carries out interviews with TB  providers  with due respect for privacy and confidentiality ■n Analyses client registers, financial records, pharmacy/laboratory  records, and other TB-related documentation and extracts required information from them  ■n Enters, manages, and keeps economic data collected from the field  ■n Participates in data cleaning and analysis with support from the PI  ■n Communicates promptly with study coordinator on any bottlenecks arising (technical or managerial)  Costing guidelines for Tuberculosis interventions110 Qualifications ■n Prior experiences in cost collection desirable ■n Demonstrated good computer skills in Microsoft Excel and Word packages  ■n Good knowledge of the Kenyan health system  ■n Fluent in the local language spoken in the cluster or health facility  ■n Good administration and organizational skills  ■n Well-developed social and communication skills, particularly with regards to staff  ■n Prior experience in undertaking field work for public health research or facility based costing  Technical advisory group  The technical advisory group advises the PI  on all technical aspects of the  cost collection  and also  on issues such as the  cost collection  approval and acceptance process. It provides technical input (statistical, epidemiological and health economics) into all activities for which the PI is responsible and consists of experts in these fields. Collaboration with the technical advisory group is substantial during the design and adaptation of the protocol, but ad-hoc during actual data collection. Members of the technical advisory group perform these activities on a part-time basis. Their workload will be different in different phases of the survey, ranging from ad hoc meetings during the implementation to more intensive involvement during the design or the analysis phase. The technical advisory group may include international experts. The suggested composition of the national technical advisory group and terms of reference are provided below.  In the initial stages, for the purpose of the generic TB provider cost collection instru- ment  and guidelines  and to ensure consistency across  cost collection  conducted in different countries with a common methodology, there will also be an international technical advisory group which will be coordinated by  the VALUE  TB Team. Involve ment of the international advisory group will also be  more  substantial when  supporting  the translation of results into policy recommendation and the dissemination of results.  Data will become part of the GHCC data repository after dissemination. This is an open access database which can be freely accessed. The purpose of this sharing is to enable cost to be generalized to other settings where unit costs are not yet available. Composition of national technical advisory group  ■n Social scientist/epidemiologist/survey expert  ■n Health economist/analyst  ■n Statistician or data analyst  ■n International development agencies ■n Private sector ■n Civil society ■n Health insurance ■n WHO Country Office 111 Section F. Appendices Terms of reference for the national tuberculosis advisory group  ■n Advise on the cost collection  ■n Advise on the design, pre-testing and production of  costing materials (e-survey instrument design, SOP revision, etc.)  ■n Provide technical assistance during training and pilot-testing  ■n Provide ad-hoc advice to data collection co-ordinator during cost collection imple- mentation based on preliminary data analysis, monitoring missions ■n Support local data manager and PI in analysis of results  ■n Provide feedback on interpretation of results, results dissemination strategy, and policy implications and follow-up  OTHER POTENTIAL TEAM MEMBERS  Data collection co-ordinator The day-to-day management of the  cost collection  is the responsibility of the  data collection co-ordinator who may be a Ministry of Health staff member or someone from an external organization. The data collection co-ordinator should report to the PI. The main work of the data collection co-ordinator is managing the implementation of the cost collection. If possible, this person should be actively involved in the design of the study.  The data collection co-ordinator supervises the work of research assistants who collect the data. For this to happen, there needs to be close collaboration between the data collection  co-ordinator and the  research assistants  in the field via either direct supervision or regular reports from the staff or online cost collection tool that allow for quality control. The work of the data collection co-ordinator can be substantial, and the position may need to be half time or more. Roles and responsibilities  ■n Establishes contact with facilities sampled for the study and facilitates the welcoming of the research assistant and the key information providers within each facility.  ■n Oversees the day-to-day management of the data collection  ■n Assists in the design of the data collection  ■n Adapts training manual and cost collection materials  ■n Prepares standard operating procedures  ■n Trains research assistants before data collection and provides retraining if mid- term review identifies such a need  ■n Supervises the work of data collection research assistants through on-site visits or through periodic reports  ■n Monitors the operational implementation of the survey Costing guidelines for Tuberculosis interventions112 Key tasks  ■n Coordinates overall implementation of cost collection in the field ■n Plans the field implementation and required training, including preparation of training materials as appropriate ■n Together with the PI, contacts and coordinates with local authorities  ■n Ensures quality assurance processes are implemented according to the protocol  ■n Supervises implementation in the health facilities and laboratories  ■n Plans and co-ordinates data collection monitoring visits comprising all partners involved in data collection implementation  ■n Oversees the provision of supplies and required materials  ■n Involved in the analysis of the results  ■n Organizes the writing of activity reports and the final report  ■n Plans the detailed budget of the cost collection and periodically reports to funders on funds utilization (as per contract)  ■n Provide any logistic support for the cost collection team  ■n Arrange pilot-testing and its evaluation  ■n Liaise with the PI on a regular basis, and provide the PI with updates ■n Liaise with local officials in the health care facilities and laboratories (during pre- cost collection visits and actual field work)  ■n Report without delay any major problems in preparation, execution or data management of the cost collection  Qualifications  ■n Preferably at least 3 years of research experience in the field of public health  ■n Strong managerial and coordination skills  ■n Knowledge of public health research and health economics  ■n Knowledge of TB  ■n Expertise in field work  ■n Experience in planning and conducting cost data collection or health facility data collection  Data manager The data manager is responsible for flagging quality data issues periodically to data collection co-ordinator and managing the data collected by research assistants. This person should have some expertise in data management for cost collection or public health research and prior experience in managing data would be highly beneficial. The majority of countries will collect data in an online tool. If this is the case, the data manager should be familiar with the online data collection system and should be able to troubleshoot and rectify any data collection problems. Depending on the composition of the data collection team, the data manager will usually report to the PI or the data collection co-ordinator.  113 Section F. Appendices Roles and responsibilities  ■n Flags data quality issues periodically (i.e. daily/bi-weekly) to  PI  and  completes regular data management reports  ■n Adapts the electronic data collection instrument (with supervision  from PI and validation by VALUE TB PI) in an effective and feasible manner to support the cost collection  ■n Coordinates data management activities for the  cost collection: receiving, batching, cleaning, and merging data from different sources (e.g. NTP regarding prices vs data collection for diagnostic tools)  ■n Is responsible for the validation of double-entered data files  ■n Ensures that data are properly stored and backed up  ■n Checks validated data files regularly for systematic errors (cleaning)  ■n Prepares database to be ready for analysis and data entry screens  ■n Contributes to the analysis of results (led by PI)  ■n Liaises with the data collection co-ordinator on a regular basis  ■n Reports without delay any problems encountered in data management  Qualifications  ■n Proven experience in leading and motivating teams  ■n Proven extensive experience with health facility based  costing  or public health research  ■n Experience in analysing data to provide summary statistics ■n Experience in troubleshooting data collection problems including the identification of systematic entry and ad hoc errors  ■n Good administrative skills including maintenance of adequate documentation for costing or public health research Costing guidelines for Tuberculosis interventions114 Appendix 11. Three Case Studies Case study 1: Description of work flow within a Kenyan clinic Here is an example of a peri-urban clinic that was visited for a morning to understand the workflow and flow of patients. This clinic is situated in the outskirts of Nairobi on a dirt road (with potholes and stones) with market stalls on either side of the road. There are gates to the clinic that stand open and are opened further by unarmed security for cars. The area is described by the clinic staff as a township and ‘shanty’ (area of informal housing). The main clinic is a brick and concrete structure with grass outside and a covered outdoor waiting area. The small laboratory is housed in a shipping container with wide windows and no running water. Lights are on in the corridor. Posters are stuck on the walls with health messages, a staff list, diagnostic algorithms etc. Patients wait in a separate area outside under a shelter (roof that protects them from the sun and rain). The TB clinic is situated in the main clinic building in room that is accessed from a separate door. The HIV services are provided in a room diagonally across from the TB room and one can see inside when the doors are open. The patients hand the staff their yellow TB patient cards through the open windows (through bur- glar bars). Staff speak to the patient (in Kiswahili) through the open window. The TB nurse (deputy in charge (the in-charge sister was absent from the clinic this particular morning)) checks the TB register and patient card. The patient enters the facility and is weighed in the passageway by a staff member. The patient sits on a chair a metre away from the TB nurse. Two counsellors are also involved in TB services (however were not present on the initial visit to this facility). A separate patient costing study (led by WHO) is underway at the facility and a data collector was present in the TB clinic room. Patients are given their anti-tuberculosis medication weekly from pre-packed boxes which have a unique identifier (patient initiation date) written on the side of the box. Boxes are stored on a shelf in the consultation room. The pre-packaging is done a central public dispensary. Treatment is observed (daily) at home by a treatment support partner or by a community health care worker. Nutrition packages (maize flour and peanut butter) are given if a patient’s body mass index (BMI) is below a threshold of 18. Masks are used when initiating a patient (although this was not observed as no new patients were seen). A small laboratory is situated outside with two laboratory technicians (only one was present). Microscopy specimens are decontaminated, the slides are prepared and are then read under an electron microscope (two are available). There is a decontamination hood (biosafety cabinet) in the corner with an extraction fan. This was not working but was due to be repaired shortly. If the TB nurse requests an Xpert® MTB/RIF or culture (DST, LPA etc.) then specimens are sent to a nearby facility or reference laboratory respectively. MDR-TB services are offered at the clinic however there are very few cases (the TB nurse had attended one patient in the recent past). This patient was asked to come to the clinic in the afternoon when fewer patients were present and the sister made home visits if the patient was too sick to attend the clinic (going on foot) to limit exposure. Children are treated for TB in the facility. In the surrounding area, 20 community health care workers are assigned to make home visits to patients (with external funding). 115 Section F. Appendices Case study 2: Data collection in a hospital laboratory in Romania To obtain the quantities, specifications and some costs for consumables, chemical, reagents and equipment used to analyse sputum smear (Ziehl Neelsen (ZN)) and culture Lowenstein-Jensen (LJ) samples for TB, a detailed interview was conducted with the senior microbiologist who performed the tests. The quantities were provided by the microbiologist during the interview and confirmed by observation of the analysis processes. The ZN and LJ samples were prepared for analysis in batches of 10, so observation of the analysis process occurred by returning to the laboratory two days later when there were sufficient samples. Test-specific capital costs, primarily the equipment used in analysing the ZN and LJ tests, were determined by annualising the value of the equipment. This included the purchase price when obtained or the current market value, which was divided by the life expectancy of the equipment (at a 3% discount rate). The annual cost of maintenance was added to this value. The mean capital cost per test utilizing each piece of equipment was calculated by dividing the total annualized cost of each piece of equipment by the annual number of tests performed. To obtain recurrent (utilities, insurance, linens and soft inventory, sterilization, cleaning, security and general office supplies) and capital (value of buildings and land, furniture, computers, general non-medical equipment and vehicles) overhead costs an interview was conducted with the financial director of the hospital during the following week. For salary and benefits information, the HR manager was called into the interview by the financial director and provided this personnel information, which was already available from an annual HR report. Additional overhead costs that were not readily available in pre-existing reports or in electronic files were later obtained by sending spreadsheets with the information required, for completion by the financial director. The mean overhead costs per ZN and LJ tests were calculated by multiplying these annual overhead costs by the proportion of the square footage of the respective laboratories spaces which were on two different floors of the hospital wing. This was then divided by the total annual number of sputum samples analysed by ZN and LJ tests for each respective laboratory space. While the square footage of the hospital wing with the laboratories was provided by surveyor reports from the financial director, the space where the respective tests were performed was measured using a tape measure. The annual number of tests performed in each laboratory was obtained from the senior microbiologist. Case study 3: Personnel time in Indonesia The staff costs associated with IGRA tests in Indonesia were calculated by conducting interviews with the resident doctors who drew blood from patients in the clinic and time-motion studies to observe the laboratory technicians performing the analysis in an immunology laboratory. The resident doctors were interviewed about the patient flow in the clinic. They were asked to estimate the time taken for the full patient consultation as well as the IGRA specific activities (talking to patient about the test and taking the blood) for a single patient. Data on the total time worked per month, the volume of patients seen at the Costing guidelines for Tuberculosis interventions116 clinic and the number of patients receiving an IGRA test was obtained from the doctor in charge of the clinic. For the immunology laboratory, the laboratory doctor was contacted and briefed on the objectives and methodology of the study which sought to determine the unit costs of screening and diagnostic tests for TB at a teaching hospital in West Java, Indonesia. Through the laboratory doctor, an appointment was made to meet with the two laboratory technicians who performed analysis of the blood samples. During this meeting, the technicians were also briefed on the objectives and costing methodology of the study. They explained the work flow of the analysis and the equipment used as well as some of the challenges of IGRA tests, particularly with maintaining the quality of the blood sample when collecting the blood from patients, during transportation and in the laboratory. They were then asked to participate in a time-motion study to capture the time taken for each task as well as details of the consumables, chemicals and reagents used. Since the IGRA test was new to the facility (implemented within the last year) the volume of samples was inconsistent and insufficient for daily analysis. Therefore, the analysis was done in batches, usually at the end of the week, and the time-motion study was scheduled for the following Friday. On the day of the time-motion study the technicians were asked to review a diagram of the sample workflow and a list of the IGRA relevant equipment, consumables, chemicals and reagents that had been created after the initial meeting. Edits were made to the workflow and lists as needed. Each task was numbered sequentially. For the time-motion study data collection, the observer sat in a corner of the laboratory that provided a clear view of the processes involved in the analysis of the samples. As the technicians performed each task, the digital stopwatch on the observer’s phone was used to capture the time of each task by taking the lap time and notes were made about the activities in each task as well as the equipment and consumables used. The entire process for analysis was timed and annotated without interacting with the technicians. Waiting time and recording of results were also included in the time- motion study. After the study, the technician was again asked to review the workflow as well as fill in any gaps with respect to the process or equipment, consumables, chemicals or reagents. The time-motion study was repeated the following Friday, but with a more junior technician. An average of the time taken to perform analysis on an IGRA test was used for the unit costs calculation. Note 1: Before approaching any of the clinicians or laboratory staff the approval letters from the ethics review committee and permission letters were forwarded to the persons in charge of the clinic and laboratory. Note 2: The time taken for administration of the samples (when samples were delivered to the laboratory, and storage and disposal after analysis) was obtained by interviewing the laboratory doctor and technicians. It was not possible to include this in the time-motion study as these processes did not happen at the same time as the analysis. 117 Section F. Appendices Appendix 12. Informed Consent Templates Information Sheet NAME OF INSTITUTION Study Title: Costing the delivery of tuberculosis services in country name from a health systems’ perspective Lay Title: Examining how much it costs to deliver tuberculosis services in country name Lead institutions Investigator Other Institutions Who is carrying out this study and what is this study about? This study is being carried out by name of lead institution with the Ministry of Health’s National Tuberculosis Programme, in collaboration with collaborator name (Principal Investigator). (Briefly describe lead institution). Our researchers are visiting health facilities providing services for Tuberculosis (TB), to estimate the costs of providing these services. The aim of this research is to provide a comprehensive set of unit costs for TB services in country name. This cross- sectional survey involves (insert number of facilities) healthcare facilities in country name sampled from private (for-profit and non-profit) and public facilities of different service levels. Your facility is one of those selected through a two-stage stratified cluster sampling process. The study will involve interviews with key staff members (between three and five individuals) in your facility, document reviews, observations and timesheets filled in by some of these staff members. Why do you want to talk to the staff and what does it involve? This study would involve key members of clinical staff. We would like to ask a number of questions about the running costs of providing TB services, the activities that the staff are involved in with regards to TB care, and how much time is taken up by each activity. If you agree to participate in this research, trained research assistants will perform the following: ■n We will ask some questions about the clinical staff’s knowledge and experiences with managing patients with TB, the training and supervision that they have received, and the challenges that they encountered while managing TB. ■n In order to value the type and quantities of inputs used in the staff’s daily clinical duties, we will review your facility’s project reports, financial and expenditure records, with the consent of the facility in-charge. Costing guidelines for Tuberculosis interventions118 ■n We would also like to observe the staff as they carry out their daily clinical duties, in order to understand how much time in general it takes to conduct these activities. The observations will involve being present at the facility and observing and making notes about the conduct of various TB services provided. We will not be present during patient consultations but will record the length of time of the consultation by observing from a common area adjacent to the consultation area. ■n We would also like the staff to complete a timesheet that covers their activities during their working hours over the period of one week in order to have information on time spent on various activities. Are there any risks or disadvantages to participation? There is no major risk in participating in this study. The interview will take about 60 minutes, while the observations will be conducted over a working day. We will not record the interview or the observations, but we will take detailed notes. All responses and observations will be treated confidentially. The study participants may be uncertain whether they have the correct answers to some of the questions and this may make them feel uncomfortable. The participants are free to refuse to answer any questions. Are there any advantages to participation? There are no individual benefits to taking part. In talking to us however, the study participants will directly help the National Tuberculosis Programme improve its services, and will help to plan its spending over the medium term. The overall data collected may also help National TB Programmes in other countries estimate the costs of their TB services, and plan better for their resources. Who will have access to the information obtained? All of our documents are stored securely in locked cabinets and on password protected computers. The interview will not bear any names; this way the responses will be anonymous. Information on the workload and typical resources used in the process of providing TB services will be aggregated into a total estimate of the unit cost per TB episode. The knowledge gained from this research will be shared in summary form, without revealing individuals’ identities, with all participating facilities, the NTP and collaborating institutions, and the wider scientific community, for instance through policy briefs and scientific publications. In order to carry out this study, we will also share anonymized individual information we collect or generate with the Global Health Cost Consortium (GHCC) in ways that do not reveal individual participants’ identities. The cost data from this project will be incorporated in the web-based GHCC platform to improve extrapolations of cost across settings undertaken by the GHCC. Who has allowed this research to take place? All research has to be approved before it begins by several institutional, national and international committees who look carefully at planned work. They must agree that the research is important, relevant to country name and follows nationally and 119 Section F. Appendices internationally agreed research guidelines. This includes ensuring that all participants’ safety and rights are respected. What will happen if I refuse to participate? All participation in research is voluntary. The staff are free to decide if they want to take part or not. If they do agree to participate, they can change their mind at any time without any consequences and without the need to give a reason. What if I have any questions? You are free to ask me any question about this research. If you have any further questions about the study, you are free to contact the research team using the contacts below: Name, address, and contact information of lead at the research institute xxx, Telephone: +xxx, Email: xxx@yyy.com If you want to ask someone independent anything about this research, please contact: Name, address, and contact information of the ethics lead at the research institute xxx, Telephone: +xxx, Email: xxx@yyy.com Costing guidelines for Tuberculosis interventions120 Informed Consent Forms NAME OF INSTITUTION Study Title: Costing the delivery of tuberculosis services in country name from a health systems’ perspective Lay Title: Examining how much it costs to deliver tuberculosis services in country name Lead institutions Investigator Other Institutions Who is carrying out this study and what is this study about? This study is being carried out by name of lead institution with the Ministry of Health’s National Tuberculosis Programme, in collaboration with collaborator name (Principal Investigator). (Briefly describe lead institution). Our researchers are visiting health facilities providing services for Tuberculosis (TB), to estimate the costs of providing these services. The aim of this research is to provide a comprehensive set of unit costs for TB services in country name. This cross- sectional survey involves (insert number of facilities) healthcare facilities in country name sampled from private (for-profit and non-profit) and public facilities of different service levels. Your facility is one of those selected through a two-stage stratified cluster sampling process. The study will involve interviews with key staff members (between 3 and 5 individuals) in your facility, document reviews, observations and timesheets filled in by some of these staff members. Why do you want to talk to me and what does it involve? As a key member of staff, we would like to ask you a number of questions about the running costs of providing TB services, the activities that are you are involved in, and how much of your time is taken up by each activity. If you agree to participate in this research, trained research assistants will perform the following: ■n We will ask some questions about your knowledge and experiences with managing patients with TB, the training and supervision that you have received, and the challenges that you encountered while managing TB. ■n In order to value the type and quantities of inputs used in your daily clinical duties, we will review your facility’s project reports, financial and expenditure records, with your consent. ■n We would also like to observe you as you carry out your daily clinical duties, in order to understand how much time in general it takes you to conduct these activities. The observations will involve being present at the facility and observing and making notes about the conduct of various TB services provided. We will not be present during 121 Section F. Appendices patient consultations but record the length of time of the consultation by observing from a common area adjacent to the consultation area. ■n We would also like to ask you to complete a timesheet that covers your activities during your working hours over the period of one week. Are there any risks or disadvantages to me of taking part? There are no major risks in participating in the study. The interview will take about 60 minutes, while the observations will be conducted over a working day. We will not record the interview or the observations, but we will take detailed notes. All responses and observations will be treated confidentially. You may be uncertain whether you have the correct answers to some of the questions to be asked and this may make you feel uncomfortable. You are free to refuse to answer any questions. However, in order to have good results from the study, it is important that you try to answer all questions correctly. Are there any advantages to me of taking part? There are no individual benefits to taking part. In talking to us however, you will directly help the National Tuberculosis Programme improve its services, and will help to plan its spending over the medium term. The overall data collected may also help National TB Programmes in other countries estimate the costs of their TB services, and plan better for their resources. Who will have access to the information I give? All of our documents are stored securely in locked cabinets and on password protected computers. Your questionnaire will not bear your names; this way your responses will be anonymous. Information on your workload and typical resources used in the process of providing TB services will be aggregated into a total estimate of the unit cost per TB episode. The knowledge gained from this research will be shared in summary form, without revealing individuals’ identities, with all participating facilities, the NTP and collaborating institutions, and the wider scientific community, for instance through policy briefs and scientific publications. In order to carry out this study, we will also share anonymized individual information we collect or generate with the Global Health Cost Consortium (GHCC) in ways that do not reveal individual participants’ identities. The cost data from this project will be incorporated in the web-based GHCC platform to improve extrapolations of cost across settings undertaken by the GHCC. Who has allowed this research to take place? All research has to be approved before it begins by several institutional, national and international committees who look carefully at planned work. They must agree that the research is important, relevant to country name and follows nationally and internationally agreed research guidelines. This includes ensuring that all participants’ safety and rights are respected. Costing guidelines for Tuberculosis interventions122 What will happen if I refuse to participate? All participation in research is voluntary. You are free to decide if you want to take part or not. If you do agree to participate, you can change your mind at any time without any consequences and without the need to give a reason. What if I have any questions? You are free to ask me any question about this research. If you have any further questions about the study, you are free to contact the research team using the contacts below: Name, address, and contact information of lead at the research institute xxx, Telephone: +xxx, Email: xxx@yyy.com If you want to ask someone independent anything about this research, please contact: Name, address, and contact information of the ethics lead at the research institute xxx, Telephone: +xxx, Email: xxx@yyy.com CONSENT FORM I have had the study explained to me. I have understood all that has been read/ explained and had my questions answered satisfactorily. Please write your initials next to each of the following three statements to provide consent. ____________ Yes, I agree for the interview/discussion to be conducted ____________ Yes, I agree to take part in the observational research ____________ Yes, I agree to fill in a working timesheet over one week I understand that I can change my mind at any stage and it will not affect me in any way. Signature: Date: Participant/guardian name: Time: (please print name) [Following section is recommended where verbal consent is obtained, and must be signed by person undertaking informed consent.] I have followed the study’s standard operating procedure to obtain consent from the participant. S/he appeared to understand the nature and purpose of the study and consents to participation in the study. S/he has been given opportunity to ask questions which have been answered satisfactorily. Designee/investigator’s signature: Date: Designee/investigator’s name: Time: (please print name 123 Section F. Appendices References 1. Zumla, AI, Oliver M, Sharma V, Masham S, Herbert N. World TB Day 2016— advancing global tuberculosis control efforts. Lancet Infectious Diseases. 2016;16(4):396–8. 2. Kendall EA, Fojo AT, Dowdy DW. Expected effects of adopting a 9 month regimen for multidrug-resistant tuberculosis: a population modelling analysis. Lancet Respir Med. 2017;5(3):191–199. 3. 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