Uganda Health Sector Review – HIV/AIDS Response HIV/AIDS HEALTH SECTOR REVIEW 2007 - 2010 Laboratory Building Block Florence Najjuka, Marc Sam Opollo, Fred Wabwire-Mangen November 2010 i Uganda Health Sector Review – HIV/AIDS Response HIV/AIDS HEALTH SECTOR REVIEW 2010 LABORATORY BUILDING BLOCK Florence Najjuka, Marc Sam Opollo, Fred Wabwire-Mangen November 2010 Ministry of Health Kampala, Uganda Recommended citation: Najjuka Florence, Opollo Marc Sam and Fred Wabwire-Mangen, (2010); Uganda HIV Health Sector Review – Laboratory Building Block. Published by the AIDS Control Program, Ministry of Health, Government of Uganda, Kampala, Uganda, November 2010. ii Uganda Health Sector Review – HIV/AIDS Response ACKNOWLEDGEMENTS We would like to appreciate all those whose contributions lead to the generation of this report. Recognition goes to the group of consultants and other members from MoH and WHO who participated in the preparations for this review. We must also appreciate the efforts of the ACP program manager Dr. Zainab Akol for initiating the review. Thanks also go to the external consultants Taylor Ogore (WHO) and Chijioke Okoro (CDC). Gratitude goes to the DHOs, DLFPs, in charges and laboratory personnel of the selected health units of the following districts: Kampala, Kamuli, Tororo, Katakwi, Pader, Gulu, Arua, Kiboga, Kamwenge and Mbarara. Thanks go to the respondents from the following institutions: PEPFAR, PREFA, CDC, USAID, CHAI, Irish Aid, HIPS, IRCU, TASO, AIC, MJAP, Baylor Uganda, IDI, JCRC, UNAIDS, AMREF, JMS, NMS, CPHL and all other respondents. We are grateful for the contribution of all the study team members especially Dr. Christine Nalwadda (Coordinator) and Max Walusimbi (Administrator). The efforts of the following team members: John Odaa, Augustine Kaddu, Waiswa and Rudolf Buga who participated in the data collection at district level are appreciated. iii Uganda Health Sector Review – HIV/AIDS Response ACRONYMS AND ABBREVIATIONS ACP AIDS Control Program AIC AIDS Information Centre AHPC Allied Health Professionals Council AIDS Acquired Immune Deficiency Syndrome AMREF African Medical Research Foundation ART Anti-Retroviral Treatment CDC Centres for Disease Control CHAI Clinton HIV AIDS Foundation DHO District Health Officer DLFP District Laboratory Focal Person EID Early Infant Diagnosis HIPS Health Initiative for Private Sector HIV Human Immuno-deficiency Virus HSHASP Health Sector HIV AIDS Strategic Plan 2007-2010 HSSP III Health Sector Strategic Plan 2010-2015 IDI Infectious Disease Institute IRCU Inter-Religious Council of Uganda JCRC Joint Clinical Research Centre JMS Joint Medical Stores LTFs Liver Function Tests MJAP Mulago- Mbarara (teaching hospitals) Joint AIDS Project MoH Ministry of Health NMS National Medical Stores iv Uganda Health Sector Review – HIV/AIDS Response OI Opportunistic Infection PCR Polymerase Chain Reaction PEPFAR US President’s Emergency Plan for AIDS Relief PHP Private Health Practitioners PNFP Private Not for Profit PREFA Protecting Families From AIDS NDA National Drug Authority NEQAS National External Quality Assurance Scheme QA Quality Assurance STI/STD Sexually Transmitted Infection/Disease TASO The AIDS Support Organisation UBOS Uganda Bureau of Statistics UNAIDS United Nations AIDS UCMB Uganda Catholic Medical Bureau UPMB Uganda Protestant Medical Bureau USAID United States Agency for International Development WHO World Health Organisation v Uganda Health Sector Review – HIV/AIDS Response TABLE OF CONTENTS ACKNOWLEDGEMENTS ...................................................................................................................................... III ACRONYMS AND ABBREVIATIONS ...................................................................................................................... IV TABLE OF CONTENTS .............................................................................................................................................. VI LIST OF TABLES AND FIGURES ..................................................................................................................... VIII EXECUTIVE SUMMARY ............................................................................................................................................. X 1.0 INTRODUCTION AND BACKGROUND .............................................................................................................. 1 1.1 OVERVIEW OF THE BUILDING BLOCK ASSESSMENT ........................................................................................... 1 1.2 RATIONALE FOR THE BUILDING BLOCK IN THE NATIONAL HEALTH SYSTEM ........................................................... 2 1.3 TERMS OF REFERENCE .................................................................................................................................. 3 1.4 UNDERSTANDING THE TERMS OF REFERENCE .................................................................................................. 3 1.5 OBJECTIVES OF THE BUILDING BLOCK ASSESSMENT .......................................................................................... 5 2.0 METHODOLOGY .................................................................................................................................................. 6 2.1. OVERVIEW OF THE METHODOLOGY .............................................................................................................. 6 2.2 DESCRIPTION OF THE DATA COLLECTION PROCESS ........................................................................................... 6 2.3 QUALITATIVE METHOD OF DATA COLLECTION ................................................................................................. 7 2.4 QUANTITATIVE METHOD OF DATA COLLECTION............................................................................................... 7 2.6 DATA ANALYSIS, TRIANGULATION AND INTERPRETATION ................................................................................ 10 3.0 LIMITATIONS OF THE STUDY ..........................................................................................................................11 4.0 FINDINGS OF THE STUDY.................................................................................................................................12 4.1 FINDINGS OF THE DISTRICT RESPONSE .......................................................................................................... 12 4.1.1 DISTRICT LEVEL ...................................................................................................................................... 12 4.1.2. AVAILABILITY OF DOCUMENTS GUIDING ACTIVITIES AT THE FACILITIES: .......................................................... 24 4.1.3 HEALTH FACILITY LEVEL ........................................................................................................................... 30 4.2 FINDINGS OF THE NATIONAL RESPONSE......................................................................................................52 4.2.1 NATIONAL FACILITIES .............................................................................................................................. 52 4.2.2 NATIONAL STAKEHOLDERS AND PROVIDERS ............................................................................................... 58 4.2.3 OTHER PROVIDERS (PNFPS, PHPS, COE AND UNIFORMED SERVICES) .......................................................... 59 III) FORECAST AND PROCUREMENT.....................................................................................................................70 4.3 SUMMARY OF FINDINGS ...................................................................................................................... 75 4.3.1 STRENGTHS ........................................................................................................................................... 75 4.3.2 WEAKNESSES .................................................................................................................................... 76 4.3.4 OPPORTUNITIES ..................................................................................................................................... 77 4.3.5 THREATS ............................................................................................................................................... 77 vi Uganda Health Sector Review – HIV/AIDS Response 5.0 CONCLUSIONS ................................................................................................................................................78 6.0 RECOMMENDATIONS ..................................................................................................................................82 7.0 BIBLIOGRAPHY..............................................................................................................................................84 APPENDIX II ..............................................................................................................................................................91 vii Uganda Health Sector Review – HIV/AIDS Response LIST OF TABLES AND FIGURES Table 1: Analytical Frame work and Questions ............................................................................................ 8 Table 2: The distribution of facilities by levels in the sample ..................................................................... 12 Table 3: Distribution of the Health Facilities by Level and by Ownership .................................................. 13 Table 4: The frequency of supervisory visits as scheduled by districts and facility level ........................... 18 Table 5: Activities Performed by DLFPS on Supervisory visits to Facilities ................................................. 18 Table 6: Summary by District ...................................................................................................................... 20 Table 7: documents guiding activities at the facilities ................................................................................ 24 Table 8: Written guidelines and protocols found in facilities (by guideline by level) ................................. 25 Table 9: Written guidelines and protocols by ownership ........................................................................... 26 Table 10: Summary of QA Indicators; SOPS, IQA, EQA, Policies etc. .......................................................... 28 Table 11: Summary of Equipment and Reagent QA Activities per District. ................................................ 29 Table 12: The availability of personnel by cadre, by district ...................................................................... 30 Table 13: Activities Carried Out on Support Supervisory Visits .................................................................. 32 Table 14: tests reported to be currently performed by facility level.......................................................... 36 Table 15: Tests reported to be currently performed by facility ownership ............................................... 36 Table 16: Stock out of tracer reagents on the day of the visit such as ....................................................... 46 Table17: Stock out in the last 30 days ........................................................................................................ 47 Table 18: Availability of equipment related to HIV/AIDS lab work by level ............................................... 49 Table 19: Distribution of equipment numbers by ownership..................................................................... 50 Table20: Availability of Supervision Schedule and Frequency.................................................................... 53 Table 21: Availability of Separate Budget Line Items ................................................................................. 54 Table 22: Availability of Supervisory Visit Schedule and Frequency of Visit by the COEs. ......................... 64 Table 23: Availability of Separate budgets line items for laboratories ....................................................... 66 Table 24: Availability of Adequate Storage and Distribution...................................................................... 68 Table 25: Availability of Guiding Documents .............................................................................................. 69 Table 26: summary of Availability of Forecast, Procurement and guidelines ............................................ 70 Table 27: Availability of Laboratory management information systems.................................................... 73 viii Uganda Health Sector Review – HIV/AIDS Response Figures Figure1: Percentage of Districts with Separate Lab Budget ....................................................................... 27 Figure 2: Laboratory Personnel by Cadre ................................................................................................... 31 Figure 3: Personnel trained by cadre .......................................................................................................... 32 Figure 4: Last supervisory visit by ownership ............................................................................................. 34 Figure 5: Percentages of facilities visited according to period and level.................................................... 34 Figure 6: determination of what to order by ownership ............................................................................ 40 Figure 7: Determination of what to order by level ..................................................................................... 40 Figure 8: Percentage of facilities ordering monthly or quarterly (by ownership) ...................................... 41 Figure 9: Percentage of facilities ordering monthly or quarterly (by level)................................................ 41 Figure 10: Use of Stock Cards for tracking by ownership ........................................................................... 42 Figure 11: Facilities use of stock cards (by level) ........................................................................................ 42 Figure 12: Physical Inventory ...................................................................................................................... 43 Figure 13: Fuel by Government Facilities.................................................................................................... 44 Figure 14: Vehicle by government Facilities ............................................................................................... 45 Figure 15: PNFP - both vehicles and fuel .................................................................................................... 45 Figure 17: Availability of Fuel, Vehicle at HCs and hospitals ...................................................................... 46 Figure18: Laboratory conditions and available utilities %: ......................................................................... 50 ix Uganda Health Sector Review – HIV/AIDS Response EXECUTIVE SUMMARY The Ministry of Health has provided a conducive environment to implement activities under the clusters of prevention and service in the HSHARP. The CPHL was delegated to oversee laboratories in the country; it implements its activities through the DHO’s office and specifically with the district laboratory focal person. The laboratories under government and PNFP facilities are under the oversight of the CPHL and in the area of HIV/AIDS have been enabled to access HIV test kits and other essential supplies through the credit line funded by PEPFAR through CDC, some of the private laboratories do receive supplies under credit line but the majority source these supplies from the open Market. There are districts receiving assistance; there are a number of partners who supplement the supply of items required in the laboratory activities for HIV/AIDS care, these include the group in Northern Uganda, who base the assistance on district work plans and do select items to cover depending on need and interest. Such supplies are delivered to the district stores; the health facilities are then alerted on the presence of items in the store and then order and collect items. In the other districts, the partners receive reports and supply according to demand. The Forecasting is mainly carried out by CPHL together with the ministry of Health, Pharmacy division; the activity is based on monthly returns to CPHL, figures sent to NMS using the Bimonthly Report and Order Calculation Form for HIV Tests that is sent to NMS by individual facilities through the respective health sub district and district, together with figures from other partners. The other needs of laboratories are determined based on figures included in the HMIS 018B Order Form for Laboratory Reagents and other health supplies. The NGO based facilities forward forms to the diocesan bureau and DHO’s office for onward transmission. NMS is expected to deliver supplies every two months to the district hospital and district stores while PNFP facilities collect their supplies whenever money is available. When items are received, laboratory workers ensure complete stock keeping records and conduct a physical count of HIV Tests and other laboratory commodities. These activities are meant to ensure adequate supplies for the HIV testing algorithms in use, as well as other tests carried out to detect opportunistic infections, determine entry into and monitor ART as well as the early infant diagnosis. Several guiding documents should be in place to ensure a quality service conducted in a safe environment, the laboratory workers should be trained and supervised and standard equipment routinely maintained and monitored for efficiency The HIV-HSR had a component of the laboratory building block, did review existing documents, interviewed KI and did facility assessment; At the centre; it was noted that there is no direct office to which laboratories report, no document on vertical coordination, the laboratory policy did not spell out mechanism of implementation of its contents and this part will be covered in the forthcoming five year strategic plan, the same document will cover issues on accreditation too. CPHL was delegated to oversee laboratories and has been x Uganda Health Sector Review – HIV/AIDS Response involved in training of laboratory personnel on rapid testing of HIV and logistics management, it is also involved in support supervision and proficiency testing. Its activities are however hampered by inadequate funds. The supervision of private facilities is quite minimal and was carried out in only 3/10 (30%) of the districts. The role of AHP council in this area is not being effectively played. The team visited 10 districts and interviewed the DHO, DLFP and facility in charges as well as laboratory in charges, it assessed 36 government, 19 PNFP and 10 PHP facilities. Findings Availability of guiding documents varied from district to district 12-73%. The districts considered forecasting as inadequate and not timely and some did not own it There were hardly any units with separate budget items for laboratories (only 10%) and none for equipment maintenance. Measures put in place to ensure quality under the CPHL, such as, proficiency testing have not yet covered the entire country much as about 50% of labs are involved in one of the three EQA schemes (CPHL-NEQAS,EA-REQAS (AMREF based) and NTRL, while technical support supervision is hampered by inadequate funding. When it occurs, the implementers vary according to programme involved, the areas covered are varied and different activities are carried out. There is a plan to begin activities towards accreditation as well. However at the facility level a significant number of laboratorians have been trained in rapid testing of HIV 63% some with refresher courses and carry out internal QC (93%). The automated equipment were found in eight of 10 districts and were only lacking in districts without a general hospital, however the brands of the equipment were quite varied; a good number had had users trained and had contracts for the servicing and calibration. The consistent use of these machines was noted in some facilities while others mainly lacked reagents and a few were out of order. The hospitals that did not offer the service either lacked equipment or personnel. With regard to other tests offered, all laboratories offered HIV rapid testing (save for blood banks, but some did not carry out screening for STI due to lack of reagents, Tb detection due to lack of ZN stain, microscope or immersion Oil. Some lacked DBS kit. On the day of the visit about 18 labs were not in position to carry out the HIV rapid testing according to the algorithm (lacked one of the 3 kits) and 17 had none of the 3 kits. There was linkage between HIV testing and Tb detection, (all found to have TB get HIV screen, and several supervisors cover both areas). The LSMIS exists in all 10 districts, and is collected using standard forms but what is reported varies, the districts reported that facilities provide reports as per schedule at 20-100%, however the centre gives allow reporting rate yet the information captured (tests performed) is used in forecasting. xi Uganda Health Sector Review – HIV/AIDS Response NMS may deliver directly to district or to health facilities who then store the material in respective stores. The stores at the district were considered inadequate for the present and future expansion of programmes There was no standard practice as to how supplies are distributed from the district store to lower laboratories; whereas 11% had district, and 20% higher level deliver, others 26% had the laboratory picking supplies. However only 55% Hospitals, HCs had vehicles and even then only 26% hospitals and HCs had fuel for the purpose. Some laboratories have adequate storage facilities, while others the space is small and others have to share storage facilities with other clinical disciplines. In a number of facilities there are no fridges and even those with fridges, interrupted power supply is quite common. The products are stored according to the guidelines (probably introduced during training, because the documents are only available in 33% of facilities. They are stored with FEFO, those that are damaged or expired are separated from useful ones and some facilities remove such damaged or expired items from the inventory. The CPHL had trained a health worker from each government and PNFP facility up to HC III and each facility is expected to have a minimum stock of 3 months and maximum stock of 6 months for HIV test kits, however none of the respondents gave this information fully, the frequency of ordering for supplies to NMS by government facilities did not tally with the bimonthly orders meant to synchronise with the two months cycle of NMS 26%; 77% reported delayed delivery of supplies, 56% emergency orders. About 84% made physical inventory at varied intervals of Tracer reagents related to HIV testing, detection of OIs and ART management as well as infection prevention were found stocked out on the day of the visit 60% and were also reported to have been stocked out 49% in the last 1 month but some as far back as six months. The commonest reasons cited by facility in charges for delay in delivery were in relation to issues at NMS and or general market. Whereas several laboratories had adequate space for main laboratory, many lacked other essential rooms and 49% had no adequate storage, had no fridges. A number of laboratories 23% also lacked cross ventilation. There were also labs (51%) with unreliable supply or no power supply at all. Infection control supplies were in low supply 39% gloves and soap, some facilities lacked some. The concentration of chlorine reagent for management of spillage was noted to be varied and inappropriate, and so was decontamination of other clinical waste, transportation and destruction of waste. Conclusion: The assessment reveals a well established laboratory service that is constrained in the areas of funding, leadership structure, staffing, unreliable supply chain, inadequate storage, and poor infrastructure. xii Uganda Health Sector Review – HIV/AIDS Response There was a weakness in LSMIS (reporting, what is reported), varied practice in inventory management, poor facilitation in distribution of supplies, overwhelming stock outs of supplies, un-standardised equipment/equipment maintenance and thus difficult in sourcing reagents to run the automated equipment. These problems are faced by all districts but NMS irregular supplies seem to affect the Northern districts most. Recommendation: Enforce reporting Stream line what is reported frequency Increase and sustain funding for supplies Stream line activities at NMS Retrain in logistics and for the districts of Kiboga and Tororo, solve issues that hamper effective training Also involve DHO and introduce mechanism of monitoring of stock Introduce logistics training into the Blood Bank system Improve on storage facilities at district and facility Provide effective transport for distribution of supplies for the last leg Ensure dissemination of guiding documents Facilitate technical support supervision and monitor its implementation Implement the Proficiency testing part of EQA as planned (strategic plan) Establish National plans, guidelines and processes for accreditation of laboratories. Improve on infra structure Provide more funding for infection control materials Train in waste management Improve on infrastructure Improve on utilities Provide furniture and staff toilets Emphasis on standardization of automated equipment and equipment maintenance contracts xiii Uganda Health Sector Review – HIV/AIDS Response Source of reagents Investigate failure to repair equipment in Gulu and Mbarara Construct the appropriate structure for Arua and Gulu Look into Source of Hep C kit Streamline activities of donors Provide mechanism to clear damaged and expired supplies. xiv Uganda Health Sector Review – HIV/AIDS Response 1.0 INTRODUCTION AND BACKGROUND 1.1 Overview of the Building Block Assessment The HIV/AIDS response required the detection of HIV infection, monitoring progress of disease to determine need to initiate ART and monitoring response/toxicity of ART. The National Laboratory assessment report of 2004 had noted a weak laboratory service with low staffing levels which do not meeting the expected staffing norms. There was uncoordinated in-service training, need to strengthen ability of central, regional and district level laboratory supervision/coordination to perform the supervisory function and some of the laboratory workers were unqualified. In addition a number of laboratories lacked essential equipment for infection control, cold chain and diagnostic services. Also noted was need to standardize equipment. Many laboratories at all levels were unable to provide the approved range of test services on the day of the survey because of stock out of reagents. There was a weak inventory management of laboratory commodities. Whereas internal Quality Assurance (QA) procedures were used in all districts and regional hospitals and majority of HCs III and IV laboratories, there was need to standardize the procedures. There was need to establish national External QA schemes (NEQAS) especially in HIV related laboratory activities under Central Public Health Laboratories (CPHL). The laboratory infrastructure was poor save for AIM supported districts. Also identified was the need to have resources mobilized top strengthen and expand administration of health laboratories services. Since then efforts to further strengthen laboratories have been enhanced especially in areas of laboratory supplies and commodities, standardizing, maintaining and monitoring of automated equipment, training laboratory workers in HIV rapid testing together with continuing in-service training involving logistic management and support supervision .A number of documents guiding the laboratory service have been developed and disseminated and the NEQAS activities spread out all over the country. The activities of the laboratory were delegated to the Central Public health laboratories and it carries out the planning and gives direction to implementation, facilitates and monitors activities through the district health office and receives reports from the districts that are subsequently integrated into the Ministry of Health HIMS. The CPHL works closely with the Pharmacy Department of MOH and the supply chain (NMS) in the area of quantification, and Forecasting. The CPHL is developing a 5 year strategic plan and beginning to prepare for the accreditation of laboratories in Uganda. This evaluation of the HIV/AIDS health sector response will provide key evidence in laboratory service sector for HIV/AIDS to inform MOH in the process of developing the National Health Policy 2010-2020, and the Health Sector Strategic plan III 2010-2015 (HSSP III). In particular it will address the gaps regarding HIV AIDS screening, screen for OI, STI, EID and use of automated equipment. Strength and weaknesses and gaps in the laboratory for HIV/AIDS will be highlighted. 1 Uganda Health Sector Review – HIV/AIDS Response 1.2 Rationale for the Building Block in the National Health System Laboratory services are an integral part of integrated service delivery and do impact on quality of health services and health outcome. In order to make an effective national response to the HIV/AIDS epidemic, a number of critical laboratory services have been put in place and these include HIV serology to aid diagnosis and surveillance, CD4 T cell count to identify HIV infected persons who are eligible for Antiretroviral therapy (ART) and to monitor ART response, viral load determination to identify rapid disease progressors, initiate ART, identify treatment failures/non adherers which would trigger a change in drug regimen/drug resistance testing. There are also HIV related tests performed to establish baseline parameters to establish eligibility for ART, determine appropriate drug regimen and to monitor effects of antiretroviral treatment (ART) (toxicity); like Haemoglobin estimation (Hb), White cell counts, (total and differential), Liver function tests (LFTS) and Renal function tests. There is need to carry out pregnancy tests to determine appropriate drug regimen for females of reproductive age, and in order to make the early infant diagnosis, HIV DNA PCR is carried out to confirm infection in infants so as to inform cotrimoxazole prophylaxis, early entry to ART programs and decisions about breast feeding. The opportunistic and co-infections are monitored by screening for tuberculosis, Cryptococcus neoforms, Pneumocystis carinni (jeoveki) in order to ensure adequate treatment. In order to reduce the risk of HIV transmission there is need to test for sexually transmitted infections (STIs). The basic tests for identifying an HIV infection are offered in facilities having diagnostic laboratory and in the formal sector this is the Health Centre III. However there are populations residing in areas distant from HCs and these are covered in scheduled outreach activities by respective health centres. HIV screening is carried out routinely to screen blood for transfusion and at sentinel sites for surveillance; the uniformed services do carry out routine screens during the recruitment exercises. The HSSP II defines a National Health System as: ‘All institutions, structures, and actors whose actions have the primary purpose of achieving and sustaining good health, [the boundaries of which] encompass the public sector including the health services of the army, police and prisons; private health delivery systems comprising private-not-for-profit organizations (PNFP), private health practitioners (PHP), traditional and complementary medicine practitioners; and communities.’ It is assumed that the laboratory services mentioned above are available in prisons, police and the army (the uniformed services) through their respective systems. The Ministry of Health (MoH) works through the Public Private Partnership Policy to provide HIV services through PHP and PNFPs. In Uganda, PNFP facilities are mainly run by faith-based organizations. The uniformed services and private health delivery systems have all played a significant role in the health sector response to HIV/AIDS. 2 Uganda Health Sector Review – HIV/AIDS Response 1.3 Terms of Reference The major tasks are: A: Assess and document the following i. Assess and document the availability, applicability and use of guiding documents such as national policies, standards and guidelines and regulations for HIV laboratory services to ensure their rational use ii. Assess and document ACP oversight of procedures such as the criteria for choosing suppliers as well as provider payment mechanisms for laboratory supplies iii. Document the laboratory equipment according to the different levels of care and to the different providers. Is there any consistency in use of CD4,chemistry follow up iv. Linkages with T.B laboratory B: Quality assurance i. Methods available for controlling the quantity and quality of procured laboratory commodities ii. The accreditation process for laboratories and training of laboratory personnel and the extent to which the accreditation system is accomplishing its purpose iii. Systems for ensuring quality assurance systems for laboratory services and maintenance of equipment C: Management i. ii. iii. The capacity for stock tracking and management of HIV laboratory equipment and supplies at all levels (central, regional, district, health facility) Assessment of laboratory supply stock out/shortages in the last 3 years (1 year) and opportunities to prevent future stock- outs Adequacy of laboratory equipment and supplies 1.4 Understanding the Terms of Reference The Health Sector HIV/AIDS Response review for laboratory services did address the following at national, district and facility levels, and among partners (PNFP, PFP, uniformed services and other development partners): There were two main tasks 1. To assess the structures and processes in place to ensure the availability, applicability and use of guiding documents and regulations for HIV laboratory services to ensure the rational use of such documents and guidelines 2. To assess the procurement and supply of laboratory materials, and also document the appropriateness and maintenance of equipment used at different levels 3 Uganda Health Sector Review – HIV/AIDS Response These were done under four main categories namely: 1. Assessment of the organization and oversight of laboratory services 1.1. Assess the organisation in relation to levels and relationship between levels, management of supplies, vertical coordination of laboratories and availability of documents guiding activities (policy, SOPs) (a) Assess the current organization and oversight of laboratory services by the key service centre (CPHL) at the moment and the future projected function 1.2. Assess laboratory service in areas of laboratory services management information systems and laboratory supervision 2. Effectiveness of the logistics (supply chain) of laboratory commodities 2.1. Assess the supply chain of laboratory commodities including forecasting and procurement, financing, storage and distribution, and the inventory control system 3. Quality assurance in the procurement of laboratory commodities and laboratory performance 3.1. Maintenance of established quality standards: assess/verify methods available for controlling the quality and quantity of procured laboratory commodities (in line with Quality management systems) 3.2. The accreditation process: assess the accreditation process for laboratories and training of laboratory technicians and the extent to which the accreditation system is accomplishing its purpose 3.3. The laboratory testing services: assess type and technique of tests at different levels, quality assurance test procedures and availability and maintenance of equipment 4. Management of stock tracking of laboratory equipment and supplies, stock monitoring (inventory control) and preventive engineering 4.1. The laboratory supplies logistics; assess the inventory management, logistics management information system, transport frequency and mode of delivery, availability of supplies and commodities and storage of such items. 4.2. Measures put in place to ensure appropriate use, maintenance and repair of equipment 4 Uganda Health Sector Review – HIV/AIDS Response 1.5 Objectives of the Building Block Assessment a). Assess the organisation and oversight of laboratory services. b). Assess the logistic and supplies management of laboratory services. c). Assess the quality assurance of laboratory services and procurement of laboratory commodities d). Assess the laboratory management information systems. e). Determine the extent to which key HIV service providers have contributed to and aligned themselves with the HSHASP 5 Uganda Health Sector Review – HIV/AIDS Response 2.0 METHODOLOGY 2.1. Overview of the Methodology The extent of Health Sector Review is national and it encompasses every associate programmes within ACP. ACP initiated it but it covered PNFP, PHP and the forces (police, UPDF and prisons medical services). Assessment of districts, health sub-districts, and health facilities purposely chosen to mirror regional, metropolitan/rural, high/low volume, poorly/better performing sites were covered. The Health Sector strategic Plan (HSHASP) 2007-2010 is guided towards Institutional Capacity Building, Prevention, Comprehensive HIV/AIDS Care and Support which is the centre of this assessment. Each of the above thematic areas was reviewed in agreement with the WHO framework of the six Health Systems Building Blocks but modified to seven blocks as listed below: 1. 2. 3. 4. 5. 6. 7. Service Delivery Health Information Systems Health Workforce (Human Resource for HIV/AIDS) Financing Governance and Leadership (including partnerships) Medical Products and Supply Chain Management Laboratories 2.2 Description of the Data Collection Process Data was collected using both qualitative and quantitative methods. Pre-tested questionnaires were used to collect data at national, district, and facility levels. Key informant interviews and checklists and observations supplemented the questionnaires. Ten districts were selected and within each, health units were selected to include public, uniformed services (where available), PNFP (hospitals / HC), PHP (Hospitals or clinics), Blood Bank (where available) and centres of excellence (where available). The facility levels were also considered during the process of selection. At central national level, partners and headquarters of the various PNFP were selected. Selection of the District Field Study Sites Ten districts were chosen for this review centred on the eight national sero-behavioural survey regions as the major classification which is a clear indicator of heterogeneity of HIV infection in Ugandan geographical areas; Central (Kiboga and Kampala), Southwest (Mbarara), Western (Kamwenge), East Central (Kamuli), Eastern (Tororo), Northeast (Katakwi), North Central (Lira and Gulu), and Northwest (Arua). Kampala and Gulu were chosen because unique characteristics of high level of urbaneness, high HIV prevalence being the capital city and the war in Gulu which could have influenced the health system in Gulu. 6 Uganda Health Sector Review – HIV/AIDS Response Other factors considered for the choice of districts were: 1. A balance in metropolitan/rural partition in the eight districts, according to the Uganda Bureau of Statistics (UBOS); metropolitan (Arua, Mbarara, Tororo and Lira) and rural (Katakwi, Kamwenge, Kamuli and Kiboga). 2. Routine in reporting health information according to the league table 3. Presence of at least one health facility (PHP, PNFP or public), which offers HIV/AIDS care and services, and 4. How long the district has existed (at least 10 years) since the newest districts tend to report to their mother districts. 2.3 Qualitative Method of Data Collection Key Informant Interviews were conducted at the national level with Ministry of Health Commissioners of Clinical Services, Assistant Commissioner Clinical Integrated Curative services, ACP Program manager, AHPC, representatives of partners (PREFAR, USAID, CDC, HIPS, Irish Aid, UNAIDS, CHAI), some PNFPs’ (UPMB, UCMB, IRCU), Uniformed services (police, prisons, army) and PHPs. The KII guide are attached in Appendix 1 Key informant interviews were also conducted with the DHO, DLFP, and facility in charge to get an idea about. (Appendix II) Document review of available literature was carried out in order to document the context of organisation of laboratories, policy documents available to guide laboratory practice and measures to ensure quality, forecasting and procurement of consumables reagents and equipment, financing of laboratory services, storage and distribution of commodities, the inventory control system, laboratory service management information system and supervision of laboratories. Check lists were used to determine presence of reagents and supplies necessary for screening of HIV, diagnosis of TB, STIs and other opportunistic infection, monitoring of ART and safety practice together with appropriateness of infrastructure. 2.4 Quantitative Method of Data Collection Field visits were made to selected laboratories in the ten districts and an interviewer administered semi-structured questionnaire was administered to the laboratory I/C. At central national level, questionnaires were administered to selected centres of excellence, and Uganda blood transfusion headquarters, Nakasero Blood Bank and other regional blood banks if present in districts selected Mbarara, Gulu and Arua). Data was also collected from the two supply chain organisations JMS and NMS. See questionnaires in Appendix III 2.5 Analytical Frame work and Questions The table 1 below shows the details of the questions to be answered. 7 Uganda Health Sector Review – HIV/AIDS Response Table 1: Analytical Frame work and Questions Selection Quantification and forecasting Laboratory Reagents and Consumables Management and Coordination Policy Guidelines and Enabling Environment Process, Quality Assurance Management Are there adequate policies and legal What is the role of ACP and other key framework to guide the management of players (NMS, NDA, CPHL, Pharmacy Laboratory HIV/AIDS consumables, division)? reagents and equipment? Is there a working mechanism for sharing What LIAT and Coordination mechanisms of information between the different key exist and how have they been players at national level? implemented? Who takes lead role of HIV consumables, reagents and equipment? What is required for a harmonized and coordinated national supply system for HIV/AIDS laboratory reagents, consumables and equipment? Which documents guide the selection of How is the selection of HIV/AIDS HIV/AIDS laboratory reagents, laboratory supplies carried out? consumables and equipment for use in Are there considerations of long term Uganda? efficiencies in the process? How often are they updated? What quality assurance mechanisms are Are all laboratory reagents, consumables used for the selection of the supplies? and equipment used in the public sector on the EML? Who coordinates the section HIV/ AIDS laboratory reagents, consumables, and equipment in both public and private sector? How is the quantification laboratory supplies carried out? What roles do districts play in the management of HIV/AIDS laboratory consumables, reagents & equipment? Is a single selection unit for the country possible and what should be done to create one? HIV Who coordinates the national quantification of HIV/AIDS laboratory What policy and guiding documents are supplies in both public and private used in the quantification of laboratory What quality assurance mechanisms are in sector? supplies? place for quantification and forecasting? Is there a recognised functional quantification unit within the MoH? 8 of How are technical assistance initiated and structured for HIV/AIDS laboratory reagents, consumables and equipment? Uganda Health Sector Review – HIV/AIDS Response Policy guidelines and Enabling Environment Storage Distribution Commodit y use Informa tion Laboratory Reagents and Consumables Procurement Which policies guide procurement process? Process, Quality Assurance Management the national How much fund is allocated for HIV/AIDS Who is responsible for national procurement of HIV/AIDS laboratory laboratory supplies? reagents, consumables and equipment? What is the funding mechanism in place? On what basis are funds allocated for HIV/AIDS laboratory supplies? Is there national guideline for donations Which procurement methods are used for and how it is implemented? both public and key private sector? Are procurement prices compared to a reference price and how often? Which national regulations guide the Which approaches are used to manage the How are the different systems for HIV laboratory reagents and consumables storage of EMHS? storage systems? aligned and who coordinates them? Are there guidelines for national storage systems? How is the overall laboratory reagents What are the different distribution and consumables distribution system mechanisms in place? structured? Why? Is there a harmonized policy on laboratory reagents and consumables What are the order refill rates? distribution? Who provides technical oversight to the country HIV/AIDS laboratory reagents, consumables and equipment distribution mechanisms? Is there a policy on harmonization of How available are the HIV/AIDS laboratory Who provides support supervision to health facilities in relation to laboratory facility level commodity use & process? reagents and consumables? reagents, consumables and equipment? Is laboratory reagents and consumables What are the information systems in Is there a functional national system for supply data collected at the MoH place? data capturing for HIV/AIDS laboratory resource centre? reagents and consumables? 9 Uganda Health Sector Review – HIV/AIDS Response 2.6 Data Analysis, Triangulation and Interpretation Quantitative data was collected through interviewer administered semi-structured questionnaires. The questionnaires were checked for completeness and errors, then entered into EpiInfo and analysed using SPSS 17.0. Qualitative data was collected using structured questionnaires and Key informant interviews. The district level data was transcribed, coded and analysed quantitatively. 10 Uganda Health Sector Review – HIV/AIDS Response 3.0 LIMITATIONS OF THE STUDY 1. Did not visit the JCRC COE in other districts 2. Missed to pick data from Mbarara UPDF 3. Only 1 police facility was visited. 11 Uganda Health Sector Review – HIV/AIDS Response 4.0 FINDINGS OF THE STUDY 4.1 Findings of the District Response 4.1.1 District Level The 2010 HIV-HSR collected laboratory based data in 65 facilities in 10 districts. Data were gathered on three key areas: The organization in relation to levels and relationship between levels, vertical coordination of laboratories, management of supplies and availability of documents guiding activities Quality assurance with regard to controlling quality and quantity of procured lab commodities, accreditation of laboratories and training of laboratory technicians and systems for ensuring quality assurance for laboratory services and maintenance of equipment Management with regard to capacity to track stock, management of HIV laboratory equipment and supplies at all levels, assess laboratory stock outs and opportunities to avoid future stock outs, and adequacy of laboratory equipment and supplies The District response: The sample included ten districts selected as urban, rural etc., of these 19 were PNFP/NGO, 36 MoH and 10 Private Expected number of functional laboratories was 117 government facilities and 60 PNFP facilities; however there were also 5 PMTC facilities offering HIV testing services. It was not easy to establish total number of PHP laboratories especially in the urban setting. Table 2: The distribution of facilities by levels in the sample Frequency Other (Clinics) Percent 6 9.2 Health Centre II 1 1.5 Health Centre III 25 38.5 Health Centre IV 12 18.5 Hospital 21 32.3 Total 65 100.0 12 Uganda Health Sector Review – HIV/AIDS Response Table 3: Distribution of the Health Facilities by Level and by Ownership Hosp HCIV HCIII Gov’t 14 25 136 PNFP 18 11 34 PHP 11 5 28 Total Functional (Perform tests) 175 148 15 78 60 10 54 18 19 17 HCII Other labs Organisation in relation to levels and relationship between levels: There is no guiding document on organisation in relation to levels; however, the ministries of health directly oversee laboratories in government and NGO sector, while the private laboratories fall under the Allied Health Professionals’ council. The Central public Health laboratories were delegated the duty to oversee activities of the laboratories. CPHL implements its duties through the DHO’s office and the District laboratory Focal Person. The DLFP coordinates lab activities in the districts including: Supervision of labs, Coordination of some EQA activities (e.g. distribution of panels, slide rechecking), Logistics (Ensures supplies get from district stores to facilities), mobilizes them to place orders, may facilitate facilities to get emergency supplies in case of stock outs, Supervises/supports facilities to implement new programs e.g. EID, Data management: mobilizes facilities to send their monthly data Identifying any issues in that need to be addressed and mobilizing the DHO to deal with them (Reports to DHO, but also brings such issues to attention of MOH) Helps identify training needs. Vertical coordination of laboratories: The DLFP is answerable to the DHO, reports from the health sub-district are sent to DLFP/DHO’s office and a district report is then sent to CPHL and subsequently MOH. 13 Uganda Health Sector Review – HIV/AIDS Response Laboratory service management information systems: The laboratory services management information systems exist in all districts and all the districts collect service statistics from the register. However only 8/10 (80%) reported collecting logistics data from stock cards. Of these, 7/10 (70%) continued reporting stock at hand, consumption, losses and adjustments and some clarified that it is only done for HIV test kits. A number of districts (all) use standard forms to collect and report laboratory service management information, however the data collected varies; all report service statistics from registers (055B), 8/10 (80%) report logistics (supplies) data (018B), 7/10 (70%) tests requested and or conducted, 5/10 (50%) data on QA and QC (this data is sent to respective organizations that conduct QA), 2/10 (20%) data on surveillance. About 4/10 (40%) send data on TB (TB Form 1) and HIV routine testing data (this is sent to different programmes) while 3/10 (30%) send data on Malaria. The data collected from Health units is sent to HSD and then to DHO for onward transmission to CPHL and ministry of health on monthly basis. This data does not include stock on hand, consumption, losses and adjustments except for HIV test kits. The number of laboratories sending reports each reporting period varies from 20%-30% (Gulu) to 100%. Twenty percent (2/10) of the districts report referrals of specimens such as DBS for DNA PCR and blood for CD4 counts. Only 1/10 (10%) report on maintenance and accidents. Monitoring of reports from facilities is conducted in 8/10 (80%) by DLFPs, 1/10 (10%) by records officers, during support supervisory visits 4/10 (40%), sending reminders 4/10, monitoring to identify defaulters 210 (20%) and 1/10 (10%) do not monitor reports due to lack of funds. The donor programmes have independent LSMIS and some partners do HIV serology but do not report, while others contribute to double reporting (Gulu district). One DLFP declined to give comments on usefulness of the system (possibly not convinced of the usefulness). About 80% of laboratories do convey reports, and this process is monitored by records officers. This has improved the laboratory services in the district. It also enables timely delivery of supplies and updating of workers on current practice, helps in logistic management and resupply of units, helps in allocation of HIV test kits and enables shifting or reagents from one health unit to another where there is stock out. Despite ensuring the reporting from all labs the delay in supplies affects laboratory services Tororo District: All (100%) of the laboratories send reports each reporting period. Monitor reporting rates and follow up to obtain missing reports is achieved through support supervision to lower units. The information is used for forecasting and quantification, monitoring of stock balances, procurement, resupply quantities and transport. The system has improved the laboratory services in the district because there is timely delivery of supplies. Katakwi District All (100%) of laboratories send reports each reporting period. 14 Uganda Health Sector Review – HIV/AIDS Response Monitoring reporting rates and follow up to obtain missing reports is achieved through the monthly supervision. The information is used for forecasting and monitoring stock balances. It has improved the laboratory services in the district because it enables the updating of workers on current practice. Pader District About 70% of laboratories send the reports each reporting period, and in order to monitor reporting rates reminders are sent when closing date for submission of reports is approaching. The information is used for fore casting and or quantification. It has improved the laboratory services in the district as it helps in logistics management-: enables resupply of health units. Gulu District About 20 to 30% of laboratories send the reports each reporting period however the entry of data into the computer enables identification of defaulters. The information received in reports is used for Forecasting and quantification. It has improved the laboratory services in the district. Because helps allocation of HIV test kits and enables shifting of reagents from one health unit to another where there are stock outs. Arua District About 80% of laboratories send reports each reporting period. Because of lack of funds, monitoring reporting rates and follow up to obtain missing reports, is not carried out. The information is used for forecasting and has improved the laboratory services in the district. Kamwenge District About 85% of laboratories send reports each reporting period. The DLFP always follow up the various Health facility laboratories. Mbarara District About 66% of the laboratories send reports each reporting period. Monitor reporting rates and follow up to obtain missing reports is achieved through the DLFP raising the respective lab in charges on phone and also during support supervision. The information collected is used for forecasting, monitoring stock balances, resupply quantities and transport. Despite all this delay in supplies affects laboratory services in the district Kiboga District About 80% of laboratories send reports each reporting period. Monitoring reporting rates and follow up to obtain missing reports is achieved through laboratory supervision. The information is used for Forecasting and or quantification, monitoring stock balances, procurement, re-supplies quantities and transport. This has improved laboratory services in the district. 15 Uganda Health Sector Review – HIV/AIDS Response Kampala District About 50% of laboratories send reports each reporting period according to schedule. It is very difficult to monitor reporting rates and follow up to obtain missing reports, but keep on sending reminders to districts. Not sure of utilization of reports, non committal on benefits of the system Supervision: There is planned monthly laboratory supervision at the laboratories of District, Health centres, PNFP and Private facilities but in practice it fluctuates due to lack of funds (may even be once year). The activity of supervision covers availability of personnel and the respective cadres, basic equipment and supplies, tests carried out and reasons for not doing them (if any), checking infra structure, quality assurance and safety being practiced. The checklists for supervision vary with the programme involved. In the course of supervision one monitors stock outs on supplies. Below are comments from the districts about support supervision: ‘…Checking on staff not only makes them to be responsible but also motivates them, they feel their work is important, over all it improves the quality of work. However there are no senior technicians, some items are missing and there is intrigue between in-charges and staff…’. ‘..the workers are aware of the close monitoring and keep up the standard, accordingly many people are turning up for testing. The challenge is that there are few operational laboratories and there is one person per laboratory (the same workers have many activities to attend to), need to recruit more staff….’ ‘…There are no incinerators, waste bags and there is low response to HIV screening. Many clients have moved back to the village and thus the need to provide Outreach activities to reach them. This will require HIV test kits, gloves, disinfectant and allowances in order to motivate staff. There are two equipped laboratories but no staff available…’. ‘…Insufficient contact…’ …’there are no mechanisms to monitor the performance of the supply chain system for the laboratories in the district. Laboratories lack vital items; no stores, transport, PPE materials, and equipment. There are no incinerators for final waste disposal and destruction. Some partners do HIV serology but do not report (under reporting), or report late, sometimes they do double reporting’ …. ….’DBS is a problem as task shifting is not possible since only laboratory personnel were trained… (DHO’) …’there are no funds for technical support supervision and the DLFP lacks transport, further more each laboratory has one staff and there is shortage of microscopes’...... 16 Uganda Health Sector Review – HIV/AIDS Response ..’There is no standard supervision check list protocol. There is need for incinerators, or deep pits for waste management and training of staff in waste management. There is inadequate laboratory supply and unreliable power supply’….. …’the use of QA/QC panels during the visits and related feedback has made workers well informed and efficient. There is a problem of inappropriate waste disposal and little knowledge on infection control practice’….. …’Despite the effort, there are times when supplies from NMS are inadequate, or near expiry items are delivered. There are very few laboratory personnel, a number of laboratories are manned by volunteers and students. There is lack of training in logistic management to the staff’ … Infrastructure etc From 4 districts of Arua, Gulu, Tororo and Kamuli, a total of 18 laboratories were covered, one of which was under renovation and structure could not be assessed. From the 17 laboratories 14 had adequate laboratory space (ref square meters….) 6 did not have stools or benches for patients, three did not have adequate storage facilities and three did not have cross ventilation. For the remaining 43 laboratories less those from the district of Pader, 15 did not have adequate storage facilities. With regard to cold chain; 11 labs did not have fridges, two needed fridges for blood transfusion and one regional blood bank had an inadequate cold storage. Frequency of support supervision: The DLFP may not supervise private laboratories. CPHL has provided some funds for DLFPs to supervise lower units but it is only enough to support a few visits a year. From the findings the frequency of visits carried per district vary from monthly, to bimonthly, quarterly 5/11(45%) District hospitals, 6/12 (50%) Health centres, 7/12 (58%) PNFP, 1/7 (14%) PHP; to every six months 0/11 (0%) hospitals, 2/12 (17%) health centres, 0% PNFP and PHP; to annually 1/11 (9%) hospitals, 1/12 (8%) health centres, 3/12 (25%) PNFP, 1/7 (14%) PHP. It may also depend on availability of funds. The activity of support supervision of lower units is carried out by several programmes, the DLFP takes routine supervisory visits and may also carry out visits under individual programmes accordingly, the areas covered may vary and so do the actual activities conducted. The facilities visited by DLFPs during supervisory visits per districts are as follows: Kiboga 7/7 (100%), Kamwenge 4/6 (67%, Kampala (govt) 4/5 (80%), Mbarara 6/6 (100%), Gulu ¾ (75%), Arua 5/5 (100%), Kamuli 3/5 (60%), Tororo 4/5 (80%) and Katakwi 2/3 (67%). Presence of standard check list was noted for 90% districts, but this check list may vary with programme involved. 17 Uganda Health Sector Review – HIV/AIDS Response Table 4: The frequency of supervisory visits as scheduled by districts and facility level Regional District HCs PNFP Private Kamuli Monthly Monthly Monthly Monthly Tororo Depends on funding Depends on funding Depends on funding Depends on funding Katakwi - Monthly Monthly Monthly Pader Quarterly Six monthly annually Nil Gulu Monthly Bimonthly Quarterly Nil Arua Once a year Quarterly Quarterly Nil Kiboga Quarterly Quarterly Quarterly Nil Mbarara Quarterly Quarterly Quarterly Quarterly Kamwenge - Quarterly Six monthly Nil Quarterly Quarterly Quarterly Nil Kampala - Despite these plans, two laboratories admitted to having no money to effect support supervision and indeed one had taken over a year without support supervision. Yet another admitted it depends on availability of funds and as such did not have a supervisory schedule. The table below shows activities conducted by DLFPs at supervisory visits. Table 5: Activities Performed by DLFPS on Supervisory visits to Facilities Activity Facilities (Percentage) Observing procedures 40 Quality Control 80 Safety Issues 60 Observes record keeping 50 Observes storage of reagents 20 18 Uganda Health Sector Review – HIV/AIDS Response Ascertains equipment availability 30 Ascertains equipment maintenance 20 On-the-job training (coaching) 40 Providing standard guidelines 10 Monitoring stock 50 Inventory 30 Infrastructure 50 Awareness of PEP 10 Availability of personnel and respective cadres 50 Tests carried out 30 Supervision from the district to lower levels should be monthly and from the centre it should be quarterly. Management of supplies: The supply chain of laboratory commodities including forecasting and procurement, financing, storage and distribution, and the inventory control system The Forecasting of supplies for Government and PNFP is carried out by CPHL (for items covered under the credit line-: CDC funding). Government facilities order through the Health sub-district and PNFP facilities order through the Diocese. PHC funds are allocated by DHO For the districts of Arua, Gulu and Pader Donors/NGO pick items to be financed from the district Work plans, alternatively they choose what to fund based on respective plans. There is no separate budget item for laboratories. 19 Uganda Health Sector Review – HIV/AIDS Response Table 6: Summary by District Arua Gulu Pader Kamuli Tororo Katakwi Mbarara Forecasting Functional Laboratories AIC Arua Kamwenge Kiboga Kampala 5 PMTCT Government 12 16 12 1 21 3 19 9 13 11 PNFP 11 4 2 1 2 2 4 1 1 32 Private 1 1 2 5 4 2 11 3 5 ? Procurement Process Credit line, donors/PHC (occasional) Credit line/ HIV Kits: NUMAT, WHO, UNICEF Credit line/ donors Credit line Credit line Credit PHC Credit line Credit line/ donors Credit line Credit line Responsible N DLFP N DLFP/ Store manager DLFP DLFP/ Dispenser DLFP Procurement Officer DLFP/ Senior Tech IDI N Monitor Process N N N N Facility Administrator DHI/ Stores person/Audit DLFP Procurement Officer DLFP, DHO, Facility I/C N Coordinate Process N N N DHO Supplies Officer District Dispenser District Supplies store manager/Drug inspector DHO DLFP N 20 line/ Arua Gulu Pader Kamuli Tororo Katakwi Mbarara Kamwenge Kiboga Kampala Program Process Individual Facility N DLFP DHO/ Procurement Officer DLFP DLFP Procurement inbuilt -- Sen. Tech IDI, DLFPcredit line & programs N/A Adequate/ timely N N N N Y/N Y N N N N Sources of Funds AIC, NTLP, PHC, Credit line, AMREF, CARE Credit line, UNICEF, NUMAT, Baylor Uganda. Credit line, UNICEF, NUMAT, Baylor Uganda, AMREF, CDC, PHC Credit line, PLAN Int., AMREF, STAR EC. Credit line, AIM. Credit line, CDC, AMREF, PHC. Credit line, MJAP. Credit line, PHC, UNICEF, Mild May, CRS, AMREF. Credit line, IDI, Baylor, AMREF, PREFAR Credit line, PHC, IDI, Partners, MJAP, PREFA, INTERACT General store/Fridge of DLFP General Store (Donor supplies) General Store General Store General Store General Store General Store General Store General Store N Adequacy N N N Y Y Y Y N Y N Expanded N N N Y N Y Y N Y N Distribution Schedule N N N Y Y Y Y Y Y N Vehicles Y N N Y N N Y N N N Financing Forecasting Uganda Health Sector Review – HIV/AIDS Response Storage/ Distribution District store level 21 Inventory Uganda Health Sector Review – HIV/AIDS Response Arua Gulu Pader Kamuli Tororo Katakwi Mbarara Kamwenge Kiboga Kampala Minimum stock Y Y - Y Y Y Y Y N N Maximum stock Y Y - Y Y Y Y Y N N Determining order Lab Lab Lab/ Facilities Higher level DLFP Lab Lab/higher level Lab Lab Lab Frequency of order from district Quarterly Depends on availability from the store Depends on donations Bimonthly Bimonthly Monthly N/A Monthly Quarterly N/A Monitor stock balance Y Y N N Y Y - Y N N Reconstitute stains N Y Y Y Y Y Y Y Y N Weakness in storage and distribution. Kampala and Kiboga are weak in monitoring stock, 5/10 (50%) do not monitor stock balance. Forecasting not considered adequate. Kampala and districts in northern Uganda do not seem to own the forecasting. 22 Uganda Health Sector Review – HIV/AIDS Response Other Concerns from the districts Gulu: ‘Credit line items delivered to Health units’. ‘Donor items collected from store’ ‘Reconstituted stains of poor quality’ ‘Funding leads to duplication, certain items being over supplied and others not catered for’ Arua: ‘No tools to monitor inventory system’ Mbarara: ‘Laboratory supplies and equipment arrive at district, predestined for different health facilities, the district store keeper confirms the type, amount and expiry dates. They are then distributed to respective units’. Kiboga: ‘Laboratory supplies and equipment are collected from district store’ Tororo: ‘NMS delivers items to district hospital stores, It also delivers items to DHO’s office (District store) for onward transmission to health centres’. Katakwi: ‘From NMS/JMS the items are delivered to the district store at the DHO’s office; 50% are distributed to HCIV and the remaining 50% go to the lower division’ Pader: Requests for an equipment credit line (have many poorly equipped labs) ‘The system uses a push system instead of pull system thus many items with short expiry dates are received leading to much wastage ‘ ‘Expired goods and damaged goods filling the store as cannot be disposed off’ Kamuli: From NMS items are delivered to the district store, these are then transported to the different units by Health sub-district Kamwenge: NMS delivers to the district; the district delivers to health sub-district and subsequently to the health facilities 23 Uganda Health Sector Review – HIV/AIDS Response The forecasting of supplies for Government and PNFP is carried out by CPHL (for items covered under the credit line:-CDC funding). Government facilities order through the health sub-district to the district and then NMS while the PNFPs facilities order through the diocese. When a deficit is noted the use of PHC funds, allocated by DHO is resorted to. Furthermore the districts of Arua, Gulu, and Pader have supplies from Donors and NGOs who pick items to be financed from the district work plans, alternatively they choose what to fund based respective (donor) plans. For other districts the partners contribute to buffer stock. 4.1.2. Availability of documents guiding activities at the facilities: Table 7: documents guiding activities at the facilities Document Frequency Percentage (%) National guidelines and Protocols for laboratory procedures 36/63 57 Infection Prevention 45/64 70 Use of Protective Gear 42/64 66 Safe Disposal of Biohazardous Waste 43/64 67 Safe Disposal of Sharps 47/64 73 Guidelines on Post Exposure Prophylaxis (HIV) 27/65 42 Guidelines on Post Exposure Prophylaxis (Hep B) 8/65 12 Guidelines on Disposal or Destruction of Damaged and/or Expired Products 8/65 12 National Standard Operating Procedures (SOPs) for Tests Performed by Level Available in the District 47/64 73 National Guidelines and Protocols for HIV Testing in the Laboratory 45/64 70 QA Policies and Procedures 19/65 29 Written Guidelines for Storing Laboratory Supplies 21/64 33 Others 1/64 2 There was a marked variation in the availability of guiding documents. The tables below show the availability of documents by level and by ownership. 24 Uganda Health Sector Review – HIV/AIDS Response Table 8: Written guidelines and protocols found in facilities (by guideline by level) District Hospital HCIII HCIV R.R Hosp National guidelines and protocols for lab procedures 6/13 (46%) 16/22 (73%) 7/11 (64%) 2/4 (50%) National guidelines and HIV protocols 8/13 (62%) 17/23 (74%) 8/11 (73%) ¾ (75%) 10/13 (77%) 14/22 (64%) 10/12 (83%) ¼ (25%) 11/13 (85%) 16/22 (73%) 9/12 (75%) 2/4 (50%) 9/13 (69%) 16/22 73%) 8/12 (67%) ¼ (25%) 9/13 (69%) 14/22 (64%) 8/12 (67%) 2/4 (50%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 2/23 (9%) 1/12 (8%) 2/4 (50%) PPE Utilisation 12/13 (92%) 21/23 (91%) 10/12 (83%) ¾ (75%) PEP for HIV 5/13 (38%) 9/23 (39%) 4/12 (33%) 2/4 (50%) PEP for Hep B 3/13 (23%) 1/23 (4%) 1/12 (8%) 0/4 (0%) Disposal or destruction of damaged and/or expired products 2/13 (15%) 1/23 (4%) 1/12 (8%) 0/4 (0%) National SOPS 8/12 (67%) 18/23 (78%) 9/12 975%) ¾ (75%) Guidelines have improved services 8/12 (67%) 14/19 (74%) 7/10 (70%) ¾ (75%) Written guidelines on safety precautions: -Infection prevention -Safe disposal of sharps -Safe disposal of biohazards -Use of protective gears -others -none 25 Uganda Health Sector Review – HIV/AIDS Response Table 9: Written guidelines and protocols by ownership Government PHP PNFP National guidelines and protocols for lab procedures 20/34 (59%) 4/10 (40%) 12/19 (63%) National guidelines and HIV protocols 23/35 (66%) 8/10 (80%) 14/19 (74%) -Infection prevention 25/36 (69%) 7/10 (70%) 13/18 (72%) -Safe disposal of sharps 26/36 (72%) 7/10 (70%) 14/18 (78%) -Safe disposal of biohazards 23/36 (64%) 7/10 (70%) 13/18 (72%) 21/36 (58%) 7/10 (70%) 14/18 (78%) 0 (0%) 1/10 (10%) 0 (0%) 4/36 (11%) 1/10 (10%) 2/19 (11%) PPE Utilisation 30/36 (83%) 10/10 (100%) 17/19 (89%) PEP for HIV 11/36 (31%) 4/10 (40%) 12/19 (63%) PEP for Hep B 2/36 (6%) 2/10 (20%) 4/19 (21%) Disposal or destruction of damaged and/or expired products 4/36 (11%) 1/10 (10%) 3/19 (16%) National SOPS 26/36 (72%) 8/10 (80%) 13/18 (72%) Guidelines have improved services 23/33 (70%) 6/8 (75%) 12/15 (80%) Written guidelines on safety precautions: -Use of protective gears -others -none The availability of national SOPs varied from 20% (Tororo district) to 85.7% (Kiboga district) average 58.9% while that of HIV protocols varied from 20% (Tororo district ) to 83.3% (Kamwenge, Mbarara and Arua districts) to 100% (Kiboga district) average of 67%. General infection control guidelines together with safe disposal of sharps and, safe disposal of biohazardous waste and use of protective gear availability did range from 41.6% (Kamwenge district) to 62% (Kampala, Kamuli, Tororo and Katakwi) to 100% in Mbarara district. The 26 Uganda Health Sector Review – HIV/AIDS Response documents of PEP HIV did range from Nil (Kamuli and Tororo) 20% in Gulu district, 33.3% (Mbarara and Katakwi), to 85.7% in Kampala. PEP Hepatitis was least available of the infection prevention items at nil in (Arua, Tororo, Kamuli, Mbarara, Kamwenge) to 14.2% (Kiboga), 20% (Gulu, Kampala), 33.3% (Katakwi). The documents on disposal of damaged or expired commodities were so scarce that the best district at 33.3% (Katakwi) was followed by four districts at about 20% (Kampala, Arua, Tororo and Kamuli) and none at all in Kiboga, Kamwenge, Mbarara and Gulu. Whereas 60% laboratories in three districts of Arua, Gulu and Kampala had guide lines on storage of commodities, only 40% and 25% were noted in Kamuli and Tororo respectively while the districts of Kiboga, Kamwenge, Mbarara and Katakwi had none of each document per district. A number of districts did not have PEP, storage guideline, disposal of expired and damaged items. Also significantly missing were QA policies and procedures. Presence of separate budget for laboratory services is shown in the figure below. Figure1: Percentage of Districts with Separate Lab Budget The QA component The table below indicates the percentage of districts participating in QA schemes and the availability of national SOPS, how many follow national SOPs, how many have documented SOPs, and QA policies. The percentage of facilities in a district with QA policies and procedures range from 0% to 60%. At least the facilities in Kamuli, Kamwenge, Katakwi, Pader and Tororo districts (50%) do not have QA policies and procedures. Participation in EQA ranges from 0% (Katakwi) to 100 with 90% of the districts participating. Verification of results range from 0% (Kamuli, Katakwi, Tororo) to 100% with 70% of districts verifying their results. For QA indicators, there was significant variation from district to district as seen in tables 10 and 11. 27 Uganda Health Sector Review – HIV/AIDS Response Table 10: Summary of QA Indicators; SOPS, IQA, EQA, Policies etc. District Documented SOP Follow National SOP Need Reconstituted Stain Standard Printed Lab Forms Perform Internal QA Reagent Lotto-Lot Testing Verification of Results Participate in EQA QA Policies and Procedures Arua 5/5(100%) 5/5(100%) 3/5(60%) 2/5(40%) 5/5(100%) 5/5(100%) 2/5(40%) 5/5(100%) 2/5(40%) Gulu 5/5(100%) 4/5(80%) 3/5(60%) 3/5(60%) 5/5(100%) 5/5(100%) 5/5(100%) 3/5(60%) 2/5(40%) Kampala 17/19(89%) 13/20(65%) 10/20(50%) 19/20(95%) 17/17(100%) 17/17(100%) 19/20(95%) 19/20(95%) 10/21(50%) Kamuli 4/5(80%) ¾(75%) 2/5(40%) 2/5(40%) 4/4(100%) 3/5(60%) 0/5(0%) 0/5(0%) 0/5(0%) Kamwenge 4/4(100%) 4/4(100%) 6/6(100%) 3/6(50%) 5/5(100%) 5/6(83%) 3/6(50%) 5/6(83%) 0/6(0%) Katakwi 2/3(67%) 2/3(67%) 2/3(67%) 0/3(0%) 2/3(67%) 2/3(67%) 0/3(0%) 2/3(67%) 0/3)0%) Kiboga 6/7(86%) 7/7(100%) 4/7(57%) 4/7(57%) 5/7(71%) 3/7(43%) 4/7(57%) 7/7(100%) 2/7(29%) Mbarara 5/5(100%) 4/5(80%) 2/5(40%) 4/5(80%) 5/5(100%) 5/5(100%) 4/5(80%) 5/6(83%) 3/5(60%) Pader 2/4(50%) 2/4(50%) 4/4(100%) 2/4(50%) 4/4(100%) ¾(75%) 2/4(50%) 4/4(100%) 0/4(0%) Tororo 4/4(100%) 3/5(60%) 2/5(40%) 3/5(60%) 4/5(80%) 2/5(40%) 0/5(0%) 3/5(60%) 0/5(0%) Total (%) 28 Uganda Health Sector Review – HIV/AIDS Response Table 11: Summary of Equipment and Reagent QA Activities per District. District Have Standardised Equipment Equipment Maintenance Schedule Refrigerator Temperature Record Daily Equipment Include Commercial Calibration Controls in Every Test Run Arua 2/5 (40%) 2/5 (40%) 2/4 (50%) 1/5 (20%) 3/5 (60%) Gulu 0/5 (0%) 2/5 (40%) 3/5 (60%) 2/5 (40%) 5/5 (100%) Kampala 12/20 (60%) 15/20 (75%) 11/20 (55%) 16/20 (80%) 19/20 (95%) Kamuli 0/5 (0%) 1/5 (20%) 2/4 (50%) 3/5 (60%) 3/5 (60%) Kamwenge 0/6 (0%) 0/6 (0%) 1/6 (17%) 1/6 (17%) 4/6 (67%) Katakwi 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/3 (33%) Kiboga 1/7 (14%) 2/7 (29%) 3/7 (43%) 1/7 (14%) 1/6 (17%) Mbarara 2/4 (50%) 0/5 (0%) 3/5 (60%) 2/5 (40%) 5/5 (100%) Pader 0/4 (0%) ¼ (25%) ¼ (25%) ¼ (25%) ¾ (75%) Tororo 0/5 (0%) 0/5 (0%) 0/5( 0%) 1/5 (20%) 3/5 (60%) Thirty six facilities out of 65 (55%) have national guidelines and protocols for laboratory procedures and 27/65 (42%) did not have. However, 47/65 (72.3%) had SOPs for laboratory procedures and 17/65 (26.2%) did not have. But of the 47 facilities which have the SOPs, 12 (26%) did not have the national guidelines and protocols. 29 Uganda Health Sector Review – HIV/AIDS Response 4.1.3 Health Facility Level The laboratory Staffing of laboratories By 2004 the recommended staffing norms were as follows: RRH: Pathologist (1), Technologist (3), Technicians (3), Assistants (3). For district Hospitals: Technologist (1), Technicians (2), Assistant (3). HCIV: Technician (1), Assistant (1). HCIII: Assistant (1). Staffing of laboratories found to be working in the 10 districts sampled. Table 12: The availability of personnel by cadre, by district District Pathologist Scientific Officer 0 0 Arua 2 13 Kampala 0 0 Kamuli 0 0 Katakwi 0 0 Pader 0 0 Tororo 0 0 Kiboga 0 Kamwenge 0 0 0 Mbarara 1 2 Gulu 3 15 Total Technologist Technician Assistant Attendant Microscopist 7 58 0 0 1 0 2 1 2 7 78 6 32 1 2 4 5 6 2 6 12 76 6 17 8 3 7 11 9 3 10 11 85 0 4 2 0 1 0 0 0 6 2 15 3 0 4 0 5 2 4 2 0 0 18 Laboratory Assistants were the most common type of staff followed by Laboratory Technologists and Technicians (see figure 2 below). The greatest number of the Laboratory Assistants were in Kampala (20%), followed by Gulu and Tororo (13%), then Mbarara (12%). However, the Laboratory Assistants and Technicians were distributed at least in all the districts. The distribution of Laboratory Technologists was 74% in Kampala, Gulu and Arua 9% each. Forty two percent of the Technicians were in Kampala, 16% in Gulu and the rest over the other districts. Scientific Officers were 87% in Kampala and 13% in Gulu. Pathologists and Scientific Officers were found in the two urban districts of Gulu and Kampala only. 30 Uganda Health Sector Review – HIV/AIDS Response Figure 2: Laboratory Personnel by Cadre Much as the National Laboratory assessment of 2004 considered attendants and microscopists to be working illegally (not officially recognized as registered laboratory personnel), these cadres could have been trained to carry out HIV rapid testing (task shifting). When compared with the National policy guidelines for health laboratory services in Uganda, the findings are: HCIV 8/10 (80%) had at least a technician, HCIII 15/19 (79%) had at least a Lab assistant. No RRH had a pathologist, neither do any of them have a Scientific Officer, though ¾ (75%) had Lab Technologists and Technicians and 4/4 (100%) had at least a technician. District hospitals: 5/11(45%) had Scientific Officers, 5/12 (42%) at least a Lab technologist, 11/13 (85%) with staffing norms for laboratory services at each level of facility, which hospitals met staffing at least a technician but could not be established whether they meet the norms. The quality and performance level of laboratory services can be negatively impacted by not having sufficient numbers and types of laboratory staff (one PNFP hospital could not perform certain tests). The technologists in district hospitals are supposed to provide support supervision to monitor the quality of testing at all lower level laboratories in their districts. Kamuli, Katakwi and Tororo did not have a technologist (or SLO) and thus this important activity cannot be fully implemented. The potential for poor quality laboratory work to go undetected increases in those districts where many lower level laboratories are staffed by un-trained cadre. The capacity to provide essential tests for the care and management of HIV /AIDS patients can be affected by staffing levels (no task shifting for DBS) 31 Uganda Health Sector Review – HIV/AIDS Response In service training About 182/290 (63%) of lab staff in facilities assessed had received training in lab related topics in the last 12 months; proportion trained by cadre (see figure 3 below) Figure 3: Personnel trained by cadre Support supervision By the year 2000, all MOH and NGO laboratories were supposed to have received a supervisory visit from a higher level laboratory at least once every three months. Supervisory visits are also carried out by vertical health programs such as NTLP and ACP where specific elements of laboratory services are inspected The table below shows the focus of the supervisory visit (one program or all program and which program), and what was done during the visit. Table 13: Activities Carried Out on Support Supervisory Visits What Support Supervisory Visit Focused on/Covered Frequency Percentage (%) Focused on One Program 24/57 44 Focused on Multiple Programes 33/57 58 Malaria 33/61 54 32 Uganda Health Sector Review – HIV/AIDS Response STI 22/61 36 HIV/AIDS 39/61 64 TB 43/61 70 None 2/61 3 Other (CD4 tests, Biochemistry, General Lab 7/59 supervision, Plague, Syphilis) 12 Infrastructure 35/60 58 Equipment Inspected 39/60 65 Reinforcement of Universal Safety Precautions 47/60 78 Record keeping for performed tests checked 52/60 87 Inventory of Supplies Checked 39/60 65 Maintenance Records Checked 32/60 53 Stock Cards/Ledgers &/or Reports Checked 32/60 53 Quality Control 52/60 87 On-Job-Training/Coaching 30/60 50 Feedback to/from Staff 42/60 70 None of the above 0/60 00 Other 3/59 5 The Staffing and Supervision Improved the Lab 51/59 Services? 86 Any reasons: CPHL gives money only enough for few visits; some districts like Kamuli had no money 33 Uganda Health Sector Review – HIV/AIDS Response Supervision The frequency of supervision in relation to ownership of laboratories was as seen in figure below: Figure 4: Last supervisory visit by ownership The frequency of supervision in relation to levels of laboratories was noted as seen in Figure below. At least the majority (64%) of the laboratories had active supervision within the last 3 months. Figure 5: Percentages of facilities visited according to period and level. 34 Uganda Health Sector Review – HIV/AIDS Response Lab services and consistent use of automated equipment and linkage with TB:Blood transfusion services All the four regional blood banks were carrying out the essential tests, but all the three did not have Hep C ELISA kit and 1 lacked in addition the HIV ELIA kit and all lacked at least 1 of the 3 rapid test kits. Accreditation Systems for ensuring quality assurance for lab services and maintenance of equipment: Whereas some private and NGO facilities have enrolled into EQA schemes and subsequently been considered for accreditation, the government and PNFP are yet to attain full capacity; there are three schemes EA-REQAS, CPHL-NEQAS and NTLP EQA schemes which are organized from the centre and there is a collaborative scheme; UVRI (AFENET). The other EQA schemes do not report to the centre. In the CPHL/EA-REQAS, proficiency testing panels are delivered, and for NTRL there is double blind rechecking of slides. The EQA activity for automated equipment mainly involves CD4/CD8 counts. ‘…..Accreditation is being coordinated by the quality assurance subcommittee. The subcommittee is finalizing a roadmap towards accreditation. The subcommittee shall start preparing the National and regional level laboratories towards the WHO Afro regions accreditation scheme. SLMTA trainers, mentors, and auditors shall be trained; these will then prepare the laboratories through training and mentoring. Thereafter, initial and periodic assessments/audits shall be conducted.’ ……Technical Advisor MoH (CPHL). Lab testing services and quality assurance: The table below shows the range of tests that should be provided at each facility level, (if have trained staff and necessary equipment to perform particular tests on routine basis) and the proportion of health units within their category that perform it. 35 Uganda Health Sector Review – HIV/AIDS Response Table 14: tests reported to be currently performed by facility level Tests Hospital (%) HCIII HCIV RR Hosp Blood Slide for Heamoparasites 9/12(75%) 12/15(80%) 5/9 (56%) ¾ (75%) Sputum for AFB 9/12 (75%) 12/15 (80%) 5/9(56%) 2/4 (50%) Syphilis Screening 9/12 (75%) 10/15(67%) 5/9 (56%) ¾ (75%) HIV Screening 8/12 (67%) 12/15 (80%) 5/9 (56%) ¾ (75%) EID 4/9 (44%) 6/14 (43%) 1/6 (17%) ¼ (25%) DBS kit available 8/9 (89%) 9/11 (82%) 9/9 (100%) 2/4 (50%) Haematology 5/10 (50%) 2/7 (29%) 0/3 (0%) 2/4 (50%) Haematology automated 5/7 (71%) ¾ (75%) 2/3 (67%) 1/3 (33%) HB Estimation 4/9 (44%) 6/7 (86%) 1/3 (33%) ¾ (75%) WBC 5/9 (56%) 6/7 (86%) 0/2 (0%) 2/4 (50%) Differential count 5/9 (56%) 6/7 (86%) 0/2 (0%) ¾ (75%) SGOT 6/10 (60%) 5/7 (71%) ½ (50%) 0/4 (0%) SGPT 7/10 (70%) 5/7 (71%) ½ (50%) ¼ (25%) CD4 Count 5/7 (71%) 2/2 (100%) 1/1 (100%) 2/3 (67%) HIV Viral Load 0/9 (0%) 0/7 (0%) 0/2 (0%) 0/4 (0%) Table 15: Tests reported to be currently performed by facility ownership Tests Government PHP PNFP Blood Slide for Heamoparasites 18/27 (67%) 7/8 (88%) 14/18 (78%) Sputum for AFB 17/27 (63%) 7/8 (88%) 13/18 (72%) Syphilis Screening 16/27 (59%) 7/8 (88%) 14/18 (78%) HIV Screening 17/27 (63%) 7/8 (88%) 14/18 (78%) EID 8/19 (42%) 1/8 (13%) 9/17 (53%) DBS kit available 22/24 (92%) 3/3 (100%) 11/13(85%) Haematology 4/14 (29%) 2/6 (33%) 8/11 (73%) Haematology automated 6/11 (55%) 2/2 (100%) 10/11 (91%) 36 Uganda Health Sector Review – HIV/AIDS Response HB Estimation 6/13 (46%) 7/8 (88%) 10/12 (83%) WBC 5/12 (42%) 7/8 (88%) 10/12 (83%) Differential count 6/12 (50%) 6/8 (75%) 10/12 (83%) SGOT 4/13 (31%) 7/8 (88%) 11/13 (85%) SGPT 6/13 (46%) 7/8 (88%) 11/13 (85%) CD4 Count 4/12 (33%) 2/7 (29%) 7/13 (54%) HIV Viral Load O/12 (0%) 0/8 (0%) 2/12 (17%) Reasons for not performing tests included lack of equipment, staff not trained or no staff, lack of reagent, other reasons, (two facilities from Kamuli could not perform a ZN stain, (in one there was no ZN reagent and in another there was no microscope). One HC IV and 3 HC IIIs could not perform VDRL (Rukunyu, Rwamwenge, Toroma and St. Peters). Early infant Diagnosis The 5 private units in Kampala do not carry out this EID, 3 no demand and 2 not trained for the purpose. One PNFP facility and one government HC III did not have a DBS kit. Use of automated equipment: The MOH HC III at Kiruddu, has IDI as a partner but its equipment (haematology, chemistry, Immunology) is in Kiswa HC because they lack laboratory space (reported by DLFP). One PNFP hospital in Arua had no reagent for chemistry and, no automated equipment for haematology, no staff and no equipment for Haematology. The ministry of defence hospital in Gulu had no reagent for haematology and no equipment for immunology. A private hospital in Mbarara did not have (immunology/haematology) equipment. Kalongo Hospital and the General hospital and HC IV in Tororo did not have reagent for haematology equipment. The regional referral hospital in Mbarara had no reagent for haematology, and the chemistry equipment was out of order (no reagent as well). Two PNFP facilities in Kampala did not have immunology equipment. 37 Uganda Health Sector Review – HIV/AIDS Response For most tests the most frequently given reason was; 92%% reagent not available, 92% equipment not available 8% not having trained staff or no staff, other reasons 75% e.g. no Air conditioner for chemistry machine A confirmatory check was made to assess how many facilities could actually perform test on day of visit; analysis was carried out to see how many labs had both necessary equipment and reagent for selected set of tests. The ones that were able to run the tests but lacked either equipment or reagents were as follows: 2 lacked KOH, ZN 9 facilities (2 lacked immersion oil, 1 lacked a microscope), 3 lacked DBS kit, 1 lacked RPR reagents, 1 lacked CD4/chemistry/haematology reagents, 1 lacked CD4 reagents, 2 lacked chemistry reagents, 2 chemistry and haematology, 2 chemistry/immunology, 17 lacked one of the kits to complete algorithm for HIV rapid testing. Definition of what equipment and reagent was considered essential to run tests are shown below TB test: ZN stain, Microscope, immersion oil STI (Syphilis): RPR reagent, if VDRL (reagent and Microscope) HIV screening: Test Kits Appropriate HIV screen: All three test kits EID: DBS kit Automated equipment: Eight out of ten districts were found to have automated equipment for at least one of the three (haematology, immunology and chemistry) Haematology By Ownership: Government had 1 Hospitex and 4 Humacount, PNFP had 5 Humacount and Private had 1 Humacount and 3 Sysmex KX2. By level: Haematology machines were present in 1 HC II, 4 HCIIIs, 1 HC IV and 12 hospitals. Chemistry By ownership: Government had 5 Humalyser, 1 Humaster and 1 Konlab; PNFP had 2 Cobbas Intergra 400, 1 Cyan plus, 1 Dabe bearing, 1 EOS BRAVO, 1 Hospitex, 2 Humalyser, 1 Refractory plus, 2 Selectra and 1 Vitros 250; Private had 2 COBBAS Intergra 400, 2 Humalyser, 1 IMX system and 1 Visual VDDDGB 05/2010. By level: There was 1 EOS Bravo at HC II level, 1 COBBAS Intergra 400 at HC III, 1 Humaster, 1 IMX system, 1 refractory plus, 1 Selectra (6). At HC IV there was one Humalyser (3) while at 38 Uganda Health Sector Review – HIV/AIDS Response hospital level there was 1 Cyan plus, 1 Dabe bearing 1 Hospitex, 6 Humalyser, 2 Humaster, 1 Konlab, 1 Selectra, 1 Visual VdGB 05/2010 and 1 Vitros 250 (16) Immunology By owner Government: 3 BD FACSCount, 2 Cyflow, 1 Partec; PNFP had 6 BD FACS Count and 1 Point care; Private had 2 BD FACS Count and 1 Mini Vidas By level: There was none at HC II, three BD FACSCount, at HCIII(3), one Cyflow 2009 at HC IV (1)and for hospitals; four BD FACSCount, one Cyflow 2009, one Mini Vidas,, One Partec and one point care(9) The majority had the requirements for running the machines in place: Automated (haematology): test controls, correct reagents, reagents not expired (machine serviced, calibrated, trained) Automated (chemistry): as above Automated (immunology): as above Problems identified The Konlab chemistry machines from Regional referral hospitals were not maintained and lacked reagents. A PNFP facility had received a Humacount machine but there was no organized contract for maintenance Another Humacount -5 machine did not have reagent while another that had reagent lacked some standards. A Humalyser 2000 machine from a PNFP facility was semi automated A Humalyser from a ministry of internal affairs unit lacked reagent A Beckman Coulter supplied to Ministry of defence was new but had expired reagents. A FACSCount from Ministry of internal affairs and a Partec from Ministry of Health lacked reagents Blood bank seems to be doing well, but supervision and EQA in Arua were lacking. 39 Uganda Health Sector Review – HIV/AIDS Response Stock management A: Determination of what to order: By ownership: Government: 32/36, PNFP: 13/19, Private: 8/10 this decision was by lab in-charge. Figure 6: determination of what to order by ownership By level: HC III: 21/25, HC IV: 10/12, Hospital: 17/21 Figure 7: Determination of what to order by level 40 Uganda Health Sector Review – HIV/AIDS Response B: Frequency of ordering: The frequency of ordering varies in number either ordered monthly or quarterly as shown: Figure 8: Percentage of facilities ordering monthly or quarterly (by ownership) Govt: monthly 9/35, quarterly 8/35 PNFP: monthly 4/19, quarterly 7/19 Figure 9: Percentage of facilities ordering monthly or quarterly (by level) HC II : monthly, HC III : monthly 3/25, quarterly 5/25, HC IV: monthly 4/12, quarterly 3/12 and Hospital: monthly 8/21, quarterly 7/21 41 Uganda Health Sector Review – HIV/AIDS Response C. Stock cards The use of Stock cards in tracking amount of stock, damage and expiry was noted as follows Figure 10: Use of Stock Cards for tracking by ownership Government: 34/36, PNFP 16/19, private 5/10 Figure 11: Facilities use of stock cards (by level) HC II 1/1, HCIII 22/25, HC IV 11/12, Hospital 17/21 42 Uganda Health Sector Review – HIV/AIDS Response D: Delays Fifty labs (77%) reported delays in delivery of ordered supplies as follows: 3 (6%) within 7 days, 10/50 (20%) within 1 month, 4/50 (8%) within 2 months, 9/50 (18%) within 3 months, 6/50 (12%) within 4 months, 2/50 (4%) within 5 months, 5/50 (10%) within 6 months, and 9/50 (18%) more than 6 months. E: Emergency orders At least 45/65 (69%) of the labs used the pharmacy/store based ordering system, 25 (56%) of these made emergency orders : 7/25 (28%) made 1 emergency order, 7/25 (28%) 2 emergency orders, 5/25 (20%) 3 emergency orders, 3/25 (12%) 4 emergency orders, 2/25 (8%) 5 emergency orders, 1/25 (4%) 6 emergency orders, and 1/25 (4%) 20 emergency orders. Fifth Division Pader depends entirely on emergency orders. F: Physical Inventory Was done in 57/68 (84%) of labs, 10/68 (15%) did not, 1/68 (2%) did it in varied manner. The figure below shows percentages of facilities with physical inventory. Figure 12: Physical Inventory G: Distribution (Commodity management): 97% (31/32) of MOH respondents, 93% (14/15) of PHP and 89% (8/9) of PNFP thought that ordering and receiving supplies through the NMS credit line has improved. The higher the level of facility the shorter the time it takes to receive supplies: the majority of hospitals 9/12 (75%) and HC IVs 2/3 (67%) level reported receiving supplies within one months whereas the majority HC III 6/10 (60%) equally received in one months. The remainder received the commodities in two to three months. However there was such a variation up to 180 days. Six out of seven (86%) of the Private and COEs received supplies in one month. 43 Uganda Health Sector Review – HIV/AIDS Response H: Transport NMS delivers directly to 8/21 (38%)of hospitals, 3/12 (25%) of HC IVs, 8/24 (33%) of HC IIIs and not at all to HC IIs while the District Medical store delivers to 1/21 (5%) hospitals, 3/12 (25%) HC IVs, 2/24 (8%) HC IIIs and no HC II. Seventeen laboratories pick supplies, for 6 laboratories the supplier delivers and in 13 laboratories, the delivery is by a higher level and 9 are served by NMS. Arua region made quarterly orders; lead time did range from 5 days to 180 days, the unit where NMS delivered had the lead time of 180 days. All had stock outs. However in Gulu, order frequency varies, from 2/5 being quarterly to 3/5 being monthly; none of the units had deliveries from NMS, lead time was 4 days to 40 days, all had stock outs except the PNFP facility that sources from open market but also makes many emergency orders. The district with streamlined delivery, Mbarara; NMS delivers to 1 facility, higher level delivers to 3 facilities, laboratory picks for 2 facilities. The lead time varied from 2 days to several months. On the day of the visit only blood bank and RRH had stock out but the facility served by NMS had had no HIV Kits for about 4 to 5 months! Again the long lead time was for the NMS delivery. This district has varied orders ranging from 2/6 (33%) quarterly, 2/6 (33%) monthly and 1/6 (17%) bimonthly. The impression is whether lab picks, higher level or NMS there may be stock outs unless you source from open market, but the delivery from NMS takes unusually long. Refer to delivery schedule of NMS This observation is collaborated in comments from Facility in charges, for Gulu there was no stock of supplies, Arua no stock at NMS, Pader lack of stock at NMS, Kamuli reported no kit from Ministry of Health and Katakwi reported delay of delivery from NMS. The figure below show availability of vehicles and fuel at Health facilities Figure 13: Fuel by Government Facilities 44 Uganda Health Sector Review – HIV/AIDS Response Figure 14: Vehicle by government Facilities Figure 15: PNFP - both vehicles and fuel Figure 16: Private - both vehicles and fuel 45 Uganda Health Sector Review – HIV/AIDS Response By level : Figure 17: Availability of Fuel, Vehicle at HCs and hospitals Stock out of Tracer Reagents Table 16: Stock out of tracer reagents on the day of the visit such as (a) HIV test kits, ZN reagents and DBS kit by ownership Government 4/36 3/36 9/36 1/36 5/36 Determine Statpack Unigold ZN reagent DBS Kit PNFP 2/19 2/19 4/19 2/19 2/12 PHP 1/10 0/10 1/10 Nil 2/10 b) HIV test kits, ZN reagents and DBS Kit by level of facility HCII HCIII HCIV Hospital Determine Nil 3/25 1/12 3/21 Statpack Nil 2/15 1/12 4/21 Unigold Nil 9/25 2/12 3/21 ZN Reagents Nil 2/25 Nil 1/21 DBS Kit Nil 4/25 2/12 3/21 46 Uganda Health Sector Review – HIV/AIDS Response Table17: Stock out in the last 30 days c) HIV test kits, ZN Reagents and DBS by ownership Government PNFP Private Determine 4/36 2/19 Nil Statpack 5/36 3/19 0/10 Unigold 7/36 3/19 2/10 ZN reagents 0/36 1/19 Nil DBS kit 3/36 2/19 Nil d) HIV test kits, ZN Reagents and DBS Kits by level HCII HCIII HCIV Hospital Determine Nil 1/25 1/12 4/21 Statpack Nil 3/25 1/12 4/21 Unigold Nil 8/25 Nil 4/21 ZN Reagents Nil 1/25 Nil 1/21 DBS Kit Nil 2/25 1/12 2/21 Laboratories without ZN reagent were: Mbarara RRH, Bondo HC (government), and St. Balikuddembe HC (PNFP). Arua RRH and 5th Division Hospital Pader did not have immersion oil and ZN reagents respectively, therefore could not perform ZN test. The facilities that did not have all the three HIV test kits (Determine, Statpack and Unigold) were: 4th Division Hosp Gulu (MOD) Tororo District (General) Hospital Kamuli Mission Hospital Pajule HCIV (Pader) 47 Uganda Health Sector Review – HIV/AIDS Response What is reported? Thirty five facilities report Stock status but also report lab tests (from the centre Lab tests performed are reported monthly to CPHL through DHO Office, while the stock status is reported bimonthly (ideally to NMS), the majority of laboratories reported monthly and hardly any mentioned NMS as a destination of their reports. (Possibly sent by District office): does this have a problem with determining bimonthly deliveries by NMS? Another 22 laboratories send lab reports but no stock status. At least 18 laboratories do report surveillance data in addition to the above. The introduction of the credit line funded by PEPFAR through CDC has enabled the training of laboratory personnel in calculating average monthly consumption, determining minimum and maximum stock levels, monitoring stock and making orders at intervals. However 60% (24/40) health units had stock out, 66% (23/35) made emergency orders, and 71 % (46/65) had experienced delays in delivery. The findings from this survey continue to portray an inadequate supply chain system, weak supervision and inconsistency in level of knowledge by the HCWs. In 49/58 (84%%) of laboratories, the facility staff are responsible for determining ordering lab supplies rather than higher authority. -Management of HIV lab equipment and supplies at all levels With regard to automated equipment, equipment supplied is by MoH and partners. Each had the users trained on use of machine (by nature of supplier), the duration of training could only be recalled by 3/31 (10%) of users, the training was carried out by MoH 2/15 (13%), partners 2/15 (13%), manufacturer 11/15 (73%). Looking at type of equipment 28/65 (43%) had a calibration record. The activity of servicing and calibration has been ongoing. The servicing and or supplies for equipment in regional hospitals of Gulu and Mbarara seemed problematic; the maintenance unit of MOH could not repair equipment in Gulu. No clear explanation was given for Mbarara. The blood transfusion service uses a central arrangement of maintenance of equipment, and the service is outsourced from Abbot Nairobi; however this tends to cause delays. The uniformed services with automated equipment were noted to have problems; machines not in use for lack of reagents (Prisons), expired (UPDF), the condition of automated equipment (Humalyser 2000) in a UPDF laboratory in Mbarara could not be established. The reagents are essential for TB, STI, and OI tests together with reagents used for tests by automated equipment and a kit used for early infant diagnosis. All these reagents are vital in the management of HIV/AIDS patients. Even when equipment and trained personnel are present, the lack of reagents renders performing tests impossible. 48 Uganda Health Sector Review – HIV/AIDS Response Availability of infection control commodities A significant number had inadequate supplies of soap 25/64 (39%, gloves 25/64 (39%), sharps boxes 16/64(25%), Waste bags 26/64 (41%), but there are also units that had none of respective items. A few facilities had all commodities. Adequacy of laboratory equipment and supplies From equipment a number of labs had refrigerators to preserve reagents and autoclaves to sterile and or decontaminate clinical waste; centrifuges etc, (see table 18 and 19). If any labs have no microscope, (as one in Kamuli) it means they cannot do the basic range of tests including STI diagnosis of gonorrhoea and OI detection; Cryptococcus in CSF and Cryptosporidium in stool, as well as reading ZN smears for TB. Table 18: Availability of equipment related to HIV/AIDS lab work by level RRH DH HCIII HCIV Autoclave 0(0%) 0(0%) 4/17 (24%) 6/10(60%) Flow Cytometer 2/4(50%) 4/11(36%) 2/13(15%) 1/9(11%) Balance 0 (0%) 0 (0%) 10/17(59%) 8/11(73%) Haematology Machine 1/3(33%) 6/11(55%) 4/13(31%) 1/9(11%) Refrigerator ½(50%) 10/11(91%) 9/16(56%) 9/12(75%) Bench Top centrifuge ¼(25%) 1/11(9%) 0(0%) 0(0%) With regard to automated equipment, the district hospitals of Katakwi and Kamwenge did not have this type of equipment. The equipment at the regional hospitals of Gulu and Mbarara was not functioning. However these two centres have JCRC centres A number of facilities had automated equipment by ownership 49 Uganda Health Sector Review – HIV/AIDS Response Table 19: Distribution of equipment numbers by ownership Government PNFP PHP Lab Refrigerator 14/23 6/9 7/7 Blood bank refrigerator 5/21 2/8 2/4 Haematology machine 6/28 10/17 6/7 Flow Cytometer 7/28 7/17 2/6 However none of such centres had viral load equipment. By ownership and level who were best equipped? From the responses of DLFP (Intermediate administration) Lab infrastructure: Assessment of infrastructure to facilitate GCLP. The laboratory infra structure in the 10 districts is as shown in the table below. Figure18: Laboratory conditions and available utilities %: 50 Uganda Health Sector Review – HIV/AIDS Response Waste management In the year 2006 the survey of laboratories for materials that were infectious or potentially infectious with respect to wild poliovirus included a component on safety, and the findings revealed a poor waste management system The most widely available Jik (hypochlorite is 3.5 %-3.8% of available chlorine), which should be prepared daily in range of 0.25 to 1 or 2% depending on level of soiling. From the HIV-HSR assessment there is a variation in practice with regard to decontamination of waste. Jik and Lysol are used but only 2/18 (11%) use the right concentration, very few laboratories autoclave clinical waste before disposal 4/18 (22%). The two labs that use Hibitane and Savlon fail the concept of using a virucidal and tuberculocidal agent. Whereas the rest have hypochlorite or phenolic, of those using hypochlorite only 9 out of 54 (15%) use concentration of 0.5 to 2% available chlorine (assumption being Jik on market is 3.5 to 3.85% available chlorine). It is transported by 6/60 (10%) in wheeled “carts” the majority do it manually and it is dumped in pits, burnt from open ground and incinerated 11/60 (18%). With regard to treatment of waste before it leaves the lab 24/52 (46%) decontaminate sputum and 11/55 (20%) decontaminate stool. 51 Uganda Health Sector Review – HIV/AIDS Response 4.2 Findings of the National Response 4.2.1 National Facilities a) Organisation and Oversight of Laboratory Services Assistant commissioner NDC is the chairperson of the National Laboratory Advisory committee. The cochair is the Assistant Commissioner Clinical Integrated curative and both are Medical Doctors. The chairperson chairs meetings that govern the laboratory activities like: policies, standards, service delivery, and interest in terms of strategic plans to roll out laboratory activities. However there is thinking that these are not the right people to oversee the laboratory. This was assigned so that at least there is something in place. ……..‘ACP talks about HIV components of laboratories and I would not accept to chair the laboratory committee because it is wrong. How would the other program managers pay allegiance to me?’…. MoH KI. There is need for a more strategic action. The laboratory network is diverse and there is need for Assistant commissioner in charge of laboratories and other diagnostics under the Commissioner Clinical Services. Under whom there should be principal medical officer for laboratories and for radiology. There is a lot of coordination between NDC and CS concerning this. CPHL: Was delegated to mange laboratories. Administratively both CPHL and ACP are under the NDC department. CPHL was given responsibility to handle the laboratory component of HIV response. Most of the staff of ACP is in CPHL. Dr. Opio, the chair person of lab advisory committee wrote the national lab policy and World Bank project to implement it. Under HIV/AIDS, there is plan to build a new home for CPHL and funding is already available. For implementation, there is a policy in place, national strategic plan (logistics, infrastructure, human resource). Technical monitoring is a component under CPHL. Q/A policy describe monitoring but actual monitoring is not happening. There is international technical assistance on evaluation, health curriculum. There is a government structure for personnel in CPHL. ACP wanted EID and CPHL recruited a person attached to CPHL. People from CPHL try to structure or adopt from others the job descriptions for the personnel. For project staff the job descriptions are reviewed yearly. The qualifications are determined by the technocrats and partners. 52 Uganda Health Sector Review – HIV/AIDS Response Table20: Availability of Supervision Schedule and Frequency CPHL ACP Schedule Frequency Schedule Frequency National Laboratories Yes Quarterly Yes Quarterly Regional Laboratories Yes Quarterly Yes Quarterly District Laboratories Yes Monthly Yes Quarterly Health Centre Laboratories Yes Monthly Don’t Know Don’t Know PNFP Laboratories Yes Monthly No N/A PHP Laboratories No N/A No N/A CPHL: The schedules are however not followed due to inadequate funding or late funding. The activities normally covered during supervisory visits are: checking and reviewing data, proficiency testing, discussing issues identified and possible remedies, meeting clinicians to discuss their attitudes towards lab services offered, debriefing management about the activities. There is a standard supervision checklist. The supply chain performance is monitored at national, district and facility level using M&E tool. Includes information management. ACP: Activities covered during supervisory visits include: checking data n lab, staff data and training needs, lab requirements (equipment and reagents), physical inspection, onsite mentoring, corrective action. There is a standard checklist. To monitor supply chain performance, when they order reagents, a copy of the order is given to ACP, then coordinate with NMS if they have not supplied or check if the HC as received the supplies. b) Logistics and Supplies Management i) Sources of Funding: HIV/AIDS is heavily funded. A bigger percentage comes from a few other partners (AMREF, CHAI and CDC). Salaries, structures, some fuel (10 million=/quarter are from the MoH. Equipment is funded by DANIDA, UNFPA, PEPFAR, and CDC. Laboratory supplies are direct from CDC under the credit line while Global Fund, WHO and UNICEF are the other sources of funding. CPHL: government funds about 10%, CDC 60%, CHAI 3%, WHO 10%, UNICEF 10%. Funds are not sufficient to cover needed supplies and equipment. The gap is about 40%. There is no committee or person coordinating the different sources of funds. 53 Uganda Health Sector Review – HIV/AIDS Response ACP Laboratory Services: CDC is funding 100%. The funds are not enough to cover all the needed supplies and equipment. The gap is about 60%. There is no committee or person coordinating different sources of funds. ii) Allocation of Funds: It depends on the services being offered and the level of facility. The funds from CDC-MoH corporate agreement comes blocked for CPHL. CPHL belonging to NDC is an agreement. A straight line allocation for the CDC laboratory fund is made to the qualifying HCIII, HCIV and hospitals. Subsequent changes are catered for according to usage and needs. CPHL: 33% to HCIII, 50% to HCIV, 17% to hospitals. These are for credit line. ACP: There is no system, seems to be random. Financial decisions follow government system. Table 21: Availability of Separate Budget Line Items Budget Services for laboratory Budget Supplies for Laboratory Budget for Equipment CPHL No Yes (donor funded) No ACP No No Yes Lab iii) Supplies Management: NMS supplies public institutions; JMS supplies PNFP and PHP choose where to buy from. NMS supplies HCIII and above. Each health unit gets lab supplies and test kits directly from NMS. The orders for the HCIII, HCIV and hospitals are put to NMS bimonthly according to the published delivery schedule. Orders submitted on time are processed according to the delivery schedule and delivered to the district headquarters. Adequate amount supplies are not received in an appropriate time. NMS noted the following: Poor quantification, poor ordering pattern, poor staffing and training at facility level, resulting in supplies arriving late or inadequate supplies being delivered. ACP: Ordering is to NMS direct. Forecasting and monitoring is done by APC. One system is used- order together but other stake holders may also supply specific items. Duplicate supplies are sometimes done. Partners interested in HCT supply HIV test kits. Donors (NUMAT, STAR E, STAR EC, PREFA, EGPAF), NTRL supply specific items. Small projects like IDI, Baylor Uganda, also supply specific items. 54 Uganda Health Sector Review – HIV/AIDS Response iv. Quality Assurance of Laboratory Services & Procurement of Laboratory Commodities i) Training and private practice: currently the AHPC is mandated to registration of Allied Health Professionals and inspection of health facilities; inspection and accreditation of training schools; approve courses of different categories of laboratory professionals. The basic requirements for laboratory private practitioners are: Must have a diploma in medical laboratory technology Must be registered with AHPC Must have worked for a minimum of 4 years in a large institution or health facility where you are supervised Must have annual practising license. However, there is no mechanism in place to assess the level and appropriateness of training of laboratory personnel. But the MoH leases with MoE to ensure the curriculum is relevant. In health infrastructure department, there is specifications/guidelines used for space and safety. The DHO, registrar AHPC uses the checklist and guidelines to permit such registration. For basic equipment, test to be done, records of investigations; the guidelines, scope of tests to be carries out, and referral sheets are used. Also during support supervision, MoH together with CPHL finds out which tests are done at each facility level. ii) Quality Assurance: AHPC should carry out support supervision under on-spot inspection to ensure compliance with the required standard. Clinical services department EQA is not yet very strong. AHPC does not have a mechanism for assessing the presence of SOPs for lab tests but CS department (curative integrated) check for use and steps during support supervision. Records and documents kept are assessed by visual inspection (AHPC); CS department does this during support supervision (LHMIS). Assessing waste disposal of clinical and chemical waste is done by CS during support supervision. AHPC does visual inspection; use professional board (board of MLT). It is desirable to do it quarterly but resources do not allow. Therefore inspection depends on availability of resources. AHPC should be inspecting all the stand alone labs, those in clinics and government facilities but does not have the total number. Neither do they have the records of those carrying out HIV tests. The total number of labs in public facilities from HCIII upwards should be 2100 but the number functioning and those doing HIV tests are not known according to the commissioner CS. 55 Uganda Health Sector Review – HIV/AIDS Response ‘….the records may not be clear because there are so many facilities testing within the hospital’…… Assistant commissioner CS integrated curative. CPHL: Uganda- NEQAS (CPHL based), EA-REQAS (AMREF based), CD4- UK-NEQAS, UVRI AFNET (HIV serology) and NTRL (TB-PT) are the operators of EQA in most labs. Some labs are participating in more than one scheme but those schemes have separate databases. Some labs have collaborations with international EQA /accreditation bodies and NEQAS neither have the inventory nor report to CPHL. At least 50% of labs in each district have access to one of the two local EQA schemes (Uganda-NEQAS & EA- REQAS). Currently there are no integrated national QA performance indicators. However for UgandaNEQAS HIV/AIDS; sensitivity is 92.3%, specificity 88.5%, PPN 88.9%, NPV 92.0%. Plans are underway to put in place an integrated comprehensive National Quality Assurance Database and uniform performance indicators for QA operators and participating laboratories. ‘….Not all labs do external controls (known positives/negatives as routine). Reason: We have not provided them with these controls. They may not have the capacity of producing these controls on their own….’.Technical Advisor to MoH (CPHL). The TAT of EQA and feedback has been one of the obstacles in the delivery of EQA services. Normally results should be reported within 15 days but the far rural districts have not been doing very well in the TAT. Uganda- NEQAS has last year piloted EQA scheme where the facilities run under the EQA materials under observation and feedback is given to the facilities instantly. The national SOPs are reviewed every 3-5 years. Review at facility levels happen in situation of extremely poor performance. CPHL and some partners have implemented corrective action for those facilities which are performing below required standards including: CD4 QMS targeting a) improvement of health facilities and b) regional capacity both by BD, IDI, CDC and MoH. Service and maintenance of FACS count/ FACSCalibur by BD, IDI, CDC and MoH. District facility training in HIV rapid testing and TB smear microscopy The MoH conducts Area Team supervision the outcome of which is reported to the respective technical persons within the MoH. MoH headquarters is also scheduled to visit regions and districts 4 times a year, and districts scheduled for monthly supervision to the lower levels but some how the visits are not routine. So there are at least one or two supervisory visits a year to the districts and lower levels as integrated or vertical. iii) Procurement and commodities: There is a procedure through UVRI enabling the public facilities to obtain approved HIV testing kits but none for the private facilities. However there is need to pass it to NDA for regulation. Financial support towards HIV diagnosis is from PEPFAR, Global fund. 56 Uganda Health Sector Review – HIV/AIDS Response At the MoH the user determines which equipment should be bought depending on whether they can afford. MoH also considers which equipment fits the facility level. In CPHL, technical assistance of the laboratory technical logistics person from USAID, together with CPHL chief technologist. The chief technologist is responsible for the infrastructure and equipment. The QA subcommittee is tasked with that job. The present equipment maintenance system is decided by equipment and maintenance sub committee. Criteria used to determine which HIV/AIDS lab equipment to buy, Type of service offered Level of facility Follow health centre delivery system 1 year guarantee Deliver, install and train users Opportunity for contract and follow-up A lot of the equipment is donated CT17 intervention subcommittee on logistics is responsible for determining which test kits should be bought. ‘….The kits are taken to UVRI for evaluation. v. UVRI gives a technical report which is looked at by the technical committee which interprets for the CT17 subcommittee which recommends. The national committee of CT17 then writes proposal, CT17 then will clear it depending on cost effectiveness, easy to use, store, portable etc, and make a decision. There is no document for evaluation of process in Uganda. It is not clear where the process took place. UVRI had no team, no scientific committee; the vendors would go and pay the person, on a personal relationship with the person. Kits were being evaluated individually, not as a set from which to choose the ones to form a testing algorithm. UVRI would draft a short note to National drug authority (NDA), (not ACP), before even the CT17 clears it. No copy is sent to ACP. And yet NDA always wants a letter from ACP before any procurement. They would then come asking for a letter from ACP, when ACP did not know about the process. UVRI had conflict of interest. The same person would recommend that a kit is good, the next time it is the same person to evaluate the performance of the kit!!!’…… LMIS: Findings from both ACP and CPHL show that there is laboratory management information system. There are national standard forms used to collect and report lab services management information. The forms include service statistics, logistics data, lab tests requested/conducted, and others like surveillance. The other systems used to collect such information are: supervision, logistics forms, HMIS order forms, and HIV bimonthly registers. 57 Uganda Health Sector Review – HIV/AIDS Response The facilities send a copy to the district and original to ACP. The district then sends copies to CPHL and NMS. For general supplies it is monthly, HIV is bimonthly. Stock at hand, consumption, losses and adjustments of lab reagents and consumables are included in the reports. About 60% of the districts send the reports to CPHL according to schedule meanwhile 45% and 30% of laboratories send reports CPHL and ACP respectively according to schedule every reporting period. Reporting rates and follow-up is done through data analysis on demand (due to lack of manpower) and support supervision. Decisions made basing on these reports include: forecasting, monitoring stock balances, procurement, re-supply quantities, transport/delivery and Training needs assessment. 4.2.2 National Stakeholders and Providers The national stakeholders here encompass the MoH, donors and partners. The roles of the national stakeholders vary a lot and include the following: 1. Train/support training for personnel to carry out rapid tests, QA and QC. Some of the partners support laboratory capacity building. 2. Renovations, construction expansion of facilities to create space for testing services. CDC has provided funds to construct a new building CPHL in Butabika. 3. Purchase/supply of equipment like microscopes, centrifuges (50% co-purchase for accredited PHP member clinics) and buffer stock of laboratory supplies like HIV test kits, chemistry, Craig, DNA PCR, CD4 reagents for MoH and partners (CHAI). 4. Forecasting of HIV/AIDS laboratory supplies 5. Support supervision and QA/QC services. 6. Provision of grants to pay for laboratory services in another laboratory if such a service is not available on site, e.g. CD4 count. 7. Strengthening coordination of Uganda AIDS Commission (UAC) & UN joint mission on AIDS, Ministry of local government. 8. Indirectly support service delivery through civil society funds in the prevention of PMTCT, CT. 9. Advocacy for workplace HIV/AIDS policy. 10. Accreditation of partner (PHP) clinics by HIPS and 58 Uganda Health Sector Review – HIV/AIDS Response 11. Training on ART logistics, forecasting, requisitioning and reporting. 12. USAID offers support to JCRC COE towards Viral load, DNA PCR, Resistance testing, TB culture and sensitivity, Biosafety and syphilis screening. Other support go to TASO, NUMAT (CD4 machines), STAR E and STAR CE, TB CAP (TB microscopy in 12 districts, SUSTAIN (building laboratory capacity in 13 districts). 13. Support towards research (UNAIDS): vaccine production, sero-survey (block amount was given and some could have ended up in buying test kits or training). 14. UNAIDS further contributed 102 million dollars towards global fund. 15. Besides the common roles, CDC offers training on Biosafety and Biosecurity, certification of engineers for Biosafety cabinets, WHO accreditation process, national health policy, development of strategic plans, sustainable laboratory management and training in laboratory management, QA( HIV serology, CD4 Count, Clinical chemistry, Haematology), infrastructure support for existing NTRL. 4.2.3 Other Providers (PNFPs, PHPs, COE and Uniformed Services) a) The organisation and oversight of laboratory services JCRC: Has 6 regional centres of excellence and JCRC Mengo. There is no committee which coordinate vertical laboratory activities in the country. All lab supplies are managed through one system and there are no duplicate supplies of reagents and equipment. Baylor Uganda: Indirect Satellites: By association through the MoH. In Kampala, this is done with Kampala City Council. Direct Satellites: Operated by the Baylor Staff and include- Kampala, Kawempe, Kitgum, Kaberamaido, Post Natal clinic in Mulago. Kilembe and Palisa are to start. Mulago and Kampala Satellites report to the Baylor Centre of Excellence (COE) – Senior Lab Technologist. Districts and associates report to laboratory coordinator. Responsibilities: To improve Paediatric HIV diagnosis i.e. Hb estimation, HIV screening, Dry Blood Spot (DBS), and CD4 count. Direct Satellites: The COE plus 7 satellites, and 4 national expansion Program (NEP) sites (RCOE). The satellites include: Kiswa HC, Naguru, Kirudu, Kawempe, Kawaala, Kisenyi, and Post natal Clinic Mulago. 59 Uganda Health Sector Review – HIV/AIDS Response All lab supplies are managed through multiple systems. Duplicate supplies and equipment are made. Local purchase, Government pipeline through NMS and JMS, Donations. Reporting: -Through local internet report; MoH MHIS; Donor- Back to donor specifics according to their requirements. The Laboratory coordinator in charge of national expansion program coordinates vertical laboratory activities. TASO: Has 11 centres each with its laboratory. There are 2 technicians to oversee laboratories. Each at a region which is more advanced than the centre laboratories. Procurement committee of TASO coordinate vertical laboratory activities in the country. All supplies are managed through one system. There are no duplicate supplies. IDI: Support districts labs and government health centres III and IVs plus some HC IIs. Have been working together with MJAP to support 6 labs in Kampala. IDI is mainly developing capacities in infectious diseases. Do baseline and support some labs e.g. Kiboga district. IDI is managing 32 labs in 6 districts including Kampala, Kiboga, Masindi, Bulisa, Hoima, and Kibaale. All supplies are managed through one system. The program gives buffer stock for TB, HIV testing, treatment and care. There are no duplicate supplies of reagents, consumables and equipment and it’s supplied through the district whenever there is need, although procurement and supply management is weak. MJAP: Program manger Laboratory Services Coordinator Team Leader Laboratory Technicians Lab Runners (Assistants) 60 Uganda Health Sector Review – HIV/AIDS Response Each unit has a team leader and supervisor. The team leader handles QA issues and the supervisor analyses weekly Q/A reports, verify consumables at consumer level. MJAP supports 7 Referral Hospitals Labs (Jinja, Mbale, Soroti, Masaka, F/Portal, Kabale, and Hoima. In Kampala there are 2 additional sites- Naguru and Kawempe. Others are: Mbarara municipality HCIV and Bwizibwera HCIV. All supplies are managed under one program. There are no duplicate supplies of reagents, consumables or equipment. Purchase when there is none from NMS. Vertical laboratory activities in the country are coordinated by the Lab services coordinator. AIC: AIC has 8 branches each with a laboratory. Supports Health Centres, gives HIV test kits and they report to AIC. Conducts outreaches/ mobile field screening. 3% of the samples are sent to UVRI for external QA. Have 8 laboratories. All Lab supply is managed through one system. But TB supplies are got from the districts. AIC only procures when the district do not have, as a buffer stock. All vertical lab activities in the country are coordinated by Medical services manager and Lab officer. Prisons Medical Services: Has the Murchison Bay Hospital Lab which is independent, and 3 Regional centre labs at the HCIV levels. There is no person or committee coordinating vertical lab activities in the country. Police Medical Services: Manage 6 Regional Labs: Arua, Masindi Police Training School, Jinja, Mbale, Nsambya, And Naguru. Intend to open more in Masaka, Soroti, Gulu, Mbarara, and F/Portal. The labs are at HCII levels. Personnel: 2 are awaiting deployment, and 2 are for training. There is no unit, person or committee coordinating vertical laboratory activities in the country. UPDF: Organisation of Laboratories UPDF Chieftaincy of Medical Services Bombo General Military Hospital District HC IV HC III Referral Hospital Labs (Nakasongola, Rubongi) Division Lab Brigade Lab (independent unit) Battalion 61 Uganda Health Sector Review – HIV/AIDS Response Manages 20 Brigade (HCIII) Labs: Mubende, Masaka, Makindye, Oliva Tambo Leadership Training School-Kaweweta, Masindi, Singo, Kabamba, Jinja (Staff College, Military College Gadaffi Barracks), Nakasero, Kitante, PGB (5 total), Kasese, Katabi Airforce, Buhanga, Kanyamirima. Division (HCIV) Labs: Mbarara, Gulu, Lira (Achol Pii), Moroto, Kakiri =5 Referral (District) Labs: Rubongi, Nakasognola and Bombo = 3 Sample collection points: MoD clinic at Mbuya Barracks= 1 Mobile in the field: Nzara field hospital, Oboo in Somalia=2. Total number of labs= 31. The Director of HIV/AIDS in conjunction with head of laboratories coordinates the vertical laboratory activities in the country. Support Supervision JCRC: The activities covered include checking instrument performance, QA/QC, safety, staffing issues, supplies, lab performance and any other related issues. There is a standard checklist. Supply chain performance is monitored manually. Based on the consumption, when the stock reaches minimum level, new orders are placed. Some fast moving items have standing orders in place. Frequency of stock outs, partial orders, number of rejected items is also monitored. Baylor Uganda: Activities covered include initiation of labs to provide paediatric HIV services; mentorship on paediatric HIV diagnosis, current protocol, procedures and reporting methods; check for equipment service/working status; quantify stock needs based on what is available; work with them to improve skills. There is a standard checklist. No mechanism exists for monitoring supply chain performance. TASO: Activities routinely covered include display of SOPs, cleanliness, use of PPE, waste disposal, QA standards checked. There is a standard checklist. Supply chain performance is monitored through software which is in every lab and coordinated to the H/Qs. AIC: Activities routinely covered include looking at what they do, identify issues that need to be addressed, raise their challenges. There is a standard checklist but no mechanism in place to monitor supply chain performance. IDI: Activities routinely covered include organisation and management, personnel, sample collection and transportation, process control activities including QA, lab information system, document control records, number of tests, safety, infrastructure, process improvement, monitoring of incidents, supply chain management, equipment and general assessment. There is a standard checklist which is able to pick out stock outs. MJAP: Activities routinely covered include QA, stocks, disposal systems, availability of SOPS, and check action on previous recommendations. There is a standard checklist. Supply chain performance is monitored through checking lead time. 62 Uganda Health Sector Review – HIV/AIDS Response Prisons Medical Services: Check TB records, select slides for EQA, give feedback on previous EQA TB slides. There neither standard checklist nor mechanism to monitor supply chain performance. Police Medical Services: activities covered include presence of personnel at station, consider most urgent needs, and check records. There is no standard checklist. Supply chain performance is monitored records for supplies receipt. Table 22 below shows the availability of support supervisory schedule in different centres of excellence and how often the visits are. 63 Uganda Health Sector Review – HIV/AIDS Response Table 22: Availability of Supervisory Visit Schedule and Frequency of Visit by the COEs. Nat Lab Reg Lab Dist Lab HC Lab PNFP Lab PHP Lab Sched No Yes No No No No Freq n/A Quarterly N/a N/A N/a N/A Sched Yes Yes Yes Yes No No Freq Biannual Quarterly Quarterly Quarterly N/A N/A Sched No Yes Yes N/A No No Freq N/A Biannual Biannual N/A N/A N/A Sched Yes Yes No Yes No No Freq Quarterly Quarterly N/A Quarterly N/A N/A Sched No No Yes Yes No No Freq N/A N/A 2 weekly Quarterly N/A N/A Prisons Med Service Sched Yes No No No No No Freq Quarterly N/A N/A N/A N/A N/A Police Med Sched No No No No No No Freq N/A N/A N/A N/A N/A N/A Sched Yes Yes No No No No Freq Quarterly Quarterly N/A Monthly N/A N/A JCRC Baylor TASO AIC IDI MJAP 64 Uganda Health Sector Review – HIV/AIDS Response b) Logistics and Supplies Management i) Source of Funding: JCRC: About 40% of all the funds come from user (research) fees, 55% from PEPFAR and 5% from other donors. The funds are not sufficient to cover needed supplies and equipment. The gap is 15-20%. Baylor Uganda: About 10% of the funds is from government, CHAI contributes 95% towards CD4 count reagents, Abbot fund 95% of HIV test kits, Baylor international 5%. However funds are not sufficient to cover needed supplies and equipment, the gap is about 30%. No committee or person coordinates the different sources of funds. TASO: CDC for automated equipment, all other donors pool funds in a basket for procurement of the rest of the supplies. TB reagents are from NTLP, at the district from TB focal persons. The details of the % contribution could not be obtained. Funds are sufficient to cover needed supplies and equipment. There is a committee which coordinates the different sources of funds. IDI: About 90% of funds are from CDC; IDI, ACORD and BD contribute 10%. Funds are not sufficient to cover the needed supplies and equipment. The gap is 95%. There is a committee which coordinates the different sources of funds. MJAP: From government about 20%, CDC 80%. Funds are sufficient to cover needed supplies and equipment. There is a committee which coordinates the different sources of funds. AIC: The funds are from CDC, CSF and NUMAT. The funds are not sufficient to cover the needed supplies and equipment. The gap is about 40%. There is a committee which coordinates the different sources of funds. Prisons Medical Services: About 10% of funds come government, 40% from International Committee of the Red Cross, 40% CEC (EU), 5% from Global Fund and 5% from AMREF/CDC. The funds are not enough to cover needed supplies and equipment. The gap is 70%. There is a committee which coordinates the different sources of funds. Police Medical Services: About 95% of the funds come from government and 5% from AMREF. The funds are not sufficient and the gap is about 80%. There is a committee which coordinate the different sources of funds. ii) Allocation of Funds: JCRC: Financial resources are allocated to the laboratories according to needs. In donor funded programes, depends on demand, ≈ 40%. Baylor Uganda: The laboratory coordinator raises the budget, send to CDC which makes adjustments, and then fund. TASO: Each lab makes its budget. Finance committee uses previous consumption and projection to allocate money for labs. 65 Uganda Health Sector Review – HIV/AIDS Response IDI: Allocation depends on the grant that has been approved. If the grant is for the lab, then 100% is used in labs. This year it was 15% but the rationale is not clear. Financial decisions are made at IDI. MJAP: The laboratory budgets for their requirements. AIC: Allocations depend on the budget. If it is granted, it’s that vote which is used. AIC Branches make budgets and send to headquarters. Allocation is determined by the H/Qs depending on the volume of work per branch. Prisons Medical Services: There is no formula. Depends on what is available. Police Medical Services: Allocations depends on how much funds have been allocated to police medical services by the police finance committee. Since lab receives supplies from NMS, fund allocation is for ‘top up’ only. No financial decisions are made at different levels. Table 23: Availability of Separate budgets line items for laboratories Budget for Lab Services Budget for Lab supplies Budget for Lab Equipment JCRC Yes Yes Yes Baylor Uganda Yes No No TASO Yes No Yes IDI Yes Yes Yes MJAP Yes Yes Yes AIC Yes Yes Yes Prisons No No No Police No No No iii) Supplies Management JCRC: Laboratory supplies are managed in one system. No duplicate supplies are made, its only PEPFAR. The supplies are ordered through logistics and purchasing using a bottom up approach. Baylor Uganda: There are multiple systems of supplies management; local purchase, government pipeline through NMS and JMS, donations. Reporting is through local internet report, MoH HMIS, donor specific according to their requirements. Request are made on HMIS, reviewed at Baylor and general requisition is raised, approved by HoD and Finance, Issues voucher is generated at stores and signed by finance and HoD. Supplies are issued and delivered at district stores. If vehicles are proceeding to facilities the district raises issue voucher and Baylor proceeds to the facility. 66 Uganda Health Sector Review – HIV/AIDS Response TASO: The laboratory supplies are managed though one system. There are no duplicate supplies. The centres make requisition and they come to pick the supplies using their transport/vehicle. IDI: The supplies are managed though one system. IDI give buffer stock for TB, HIV testing, treatment and care. There are no duplicate supplies; everything is supplied through the district whenever there is need. Procurement and supplies management is still weak though. Supplies and reagents are distributed through the government system. MJAP: All lab supplies are managed through one system. There is no duplicate supplies and reagent distributed. Only purchase when there is none from the NMS. After quarterly evaluations, procurement is done; items are brought to stores, then higher trucks accompanied by program staff to deliver the items to their destination. AIC: All the lab supplies and reagents are managed through one system. But TB supplies are got from the districts. AIC only procures when the district do not have, as a buffer stock. No duplicate supplies are distributed, all are given to the headquarters, and then the H/Qs distributes. Requisitions originate from the branches to H/Q stores. The branches may collect items or could be sent by buses. Prisons Medical Services: Laboratory supplies are managed using one system. The regional labs rely on MoH and sometimes they encroach on what Murchison Bay Hospital get. All are got through the lab credit line. There are no duplicate supplies. No program is committed to supplying HIV tests kits, equipment and reagents. MoH was not even allowing Prisons medical services to access lab credit line from NMS and JMS until recently. No distribution system for lab supplies, reagents and equipment. Police Medical Services: some supplies are got from NMS and some are bought from open market. There are no duplicate supplies. There is no distribution system for lab reagents, supplies and equipment. UPDF: Utilises NMS credit line (general) but this does not cover all requirements. Every facility has its own account. It’s budgeted centrally then allocated to facilities. These are either delivered or facilities pick it up. US Department of defence procures the lab supplies centrally then it’s allocated. There are duplicate supplies through multiple programs. Storage and distribution: Table 20 below shows the availability of adequate storage capacity, cold storage and presence of distribution system. Only AIC and Prisons have vehicles which can deliver supplies to the health centre level. Police, Prisons and IDI do not have established distribution system. JCRC, MJAP, IDI and Police do not have vehicles do delivering supplies to any level. IDI do not have a central store. Only AIC, TASO and Police have adequate cold storage. 67 Uganda Health Sector Review – HIV/AIDS Response Table 24: Availability of Adequate Storage and Distribution JCRC Baylor Uganda TASO AIC MJAP IDI Prisons Med Police Med Services Services Central Store for lab supplies and Yes equipment Yes Yes Yes Yes No Yes Yes Adequate storage capacity currently Yes No Yes Yes Yes N/A N/A No Adequate cold storage No No Yes Yes No N/A N/A Yes Adequate storage & cold chain for Not expanded programmes next 3 years? sure No Yes Yes No. (No cold Present storage handle 65%. chain). N/A N/A would No Established distribution system Yes Yes Yes Yes Yes No Central N/A Yes Yes Yes No N/A Yes N/A Regional N/A Yes Yes Yes No N/A Yes N/A District N/A Yes Yes N/A N/A N/A N/A N/A Health Centres N/A No No Yes N/A Yes N/A N/A No Sufficient number of functional vehicles to meet distribution schedules at: 68 N/A Uganda Health Sector Review – HIV/AIDS Response c) Quality Assurance of Laboratory Services and Procurement of Lab Commodities i) Quality Assurance Table 25: Availability of Guiding Documents Baylor Uganda TASO MJAP AIC IDI Prisons Med Police Med Services Services Evaluating and approving N/A reagents for disease screening No No No No No Not sure N/A Body /person monitoring No quality of reagents Lab team Proc. Commit. Lab Supervisor s Not sure No Yes (For TB) No Body/person deciding quality of Lab equipment to purchase Director Lab Coordinator Lab I/C Lab Mulago Coord. Med Serv Yes Mgr Lab Focal Lab Tech. Person (PMS) Synchronis ed Yes directors No No No JCRC Monitoring maintenance equipment Yes (Job Lab cards) Coordinator Lab service package by level Not sure Yes No No Not sure No Yes N/A Lab test techniques No Yes No No Not sure No Yes N/A Standard Documented SOPs Yes Yes Yes Yes No No Yes Yes List of essential supplies (SOP) Yes No Yes No N/A N/A No No List of essential equipment Yes (SOP) No Yes No Not sure N/A No Yes 69 Uganda Health Sector Review – HIV/AIDS Response JCRC Baylor Uganda TASO MJAP AIC IDI Prisons Med Police Med services Service National procedures for QA Yes Yes Yes Yes No No No No Procedures for Internal QA Yes Yes Yes Yes No N/A No N/A Procedures for External QA Yes Yes Yes Yes No N/A No N/A Yes All Heamat. & Heamat, Chemistry Chemistry Immunol Immunol Heamatol, Chemistrty, Immunol Only 1 N/A Immunol at Much. Bay Automated Standardised equipment No iii) Forecast and Procurement Table 26: summary of Availability of Forecast, Procurement and guidelines JCRC Baylor Uganda TASO MJAP AIC IDI Prison Med Services Police Med Services Forecast Made for Lab supplies Yes Yes Yes Yes Yes No No No Programs without forecast STI, Malaria STI, TB, malaria N/A No No HIV, STI, TB, Malaria HIV, STI, TB, malaria HIV,STI,TB, malaria National procurement guidelines for: 70 Uganda Health Sector Review – HIV/AIDS Response a) Lab supplies Yes Yes Yes Yes Yes No Yes No b) Lab Equipment Yes Yes Yes Yes Yes No Not sure No 3 Months 6-8 weeks 2 weeks Supplies 2-4 weeks; 1 month 1 Month 1 month 2 weeks Average Lead time Equipment 4-6 weeks Person/committee responsible for : a) Procuring lab supplies Yes Yes Yes Yes Yes Yes Yes Yes b) Monitoring procurement process Yes Yes Yes Yes Yes Yes Yes Yes c) Coordinating procurement N/A Yes Yes Yes Yes Yes No Yes Procuring lab supplies (Who) Purchasing Procurement Procurement Lab & Med Procurement services officer team committee department Mgr. Procurement N/A unit Procurement officer PMS. Adequate supplies at right time Yes Yes No No Yes Yes 71 No No Uganda Health Sector Review – HIV/AIDS Response Procurement Processes: JCRC: Researchers come with new tests request which is forwarded to logistics department which also request for purchase from procurement. This department orders through finance department. Baylor Uganda: Identify and list specification of needed items, raise a general request which is approved by lab and finance departments. Procurement calls for quotations from pre-qualified suppliers. Quotations are reviewed in procurement evaluation committee with the technical persons/requesters. LPO is issued to the selected supplier. The requester then checks the items at delivery before storage. TASO: When minimum stock level is reached, raise the purchase order to H/Qs which then requests for quotations from suppliers. A minimum of 3 quotations are required, then procurement committee does the costing. Procurement is done as a whole; there are no differences by program. MJAP: Use procurement guideline which is in line with donors. AIC: Request for quotations from prequalified companies every quarter or when need arises. Choose the best offer then recommend. Procurement committee sits in the presence of a technical person and approves purchase. IDI: Fill the request form for buffer supplies; call the project coordinator at the district level, which forwards it or sometimes they bring it themselves through the project pharmacist then to the procurement unit. Sometimes they lack transport and IDI provides. Police Medical Services: The procurement officer informs the technician how much has been allocated for lab services. The technician then lists what are most needed, collect profoma invoices, procurement committee chooses the best, issues LPO, it’s supplied and payment voucher is issued. Prisons Medical services: It’s only at Murchison Bay hospital through the credit line. d) Laboratory Management Information Systems This varies a lot among the COEs and Uniformed Services. The table below summarises the information from the different organisations. JCRC: The data is picked from the individual instruments and then tabulated for various uses. This is done bimonthly. The number of tests done is reported. Reporting rates are monitored through receipt of monthly lab reports by lab regional COE coordinator and logistics officer. The information is disseminated to M&E, and top management. Decisions made basing on this report are: forecasting/quantification, procurement, transport, monitoring stock balances, re-supply quantity. Others are for inventory. IDI: Other information collected is referral samples/patients. Facility collects, send to Medical superintendent/In charge CPHL. Not certain about the percentage of districts /labs that send reports according to schedule. Not certain about decisions made basing on this report. 72 Uganda Health Sector Review – HIV/AIDS Response Table 27: Availability of Laboratory management information systems JCRC Baylor Uganda TASO AIC MJAP IDI Prisons Med Services Police Med Services LMIS No Yes Yes Yes Yes Yes Yes No Standard National Forms No Yes Yes No Yes No Yes Yes a) Service Statistics No Y (tests) Yes No Yes Yes Yes Yes b) Logistics data No Yes (Kits) Yes No No No Yes No c) Requested tests No Yes Yes No No Yes Yes Yes d) Other Information No Yes (Results) Yes No No Y(Referral) Y (PMTCT) No Any other system No Yes (Stock card) Y( Donor Tools) Yes Yes No No Yes (AMREF Tool) Reporting system Yes Yes Yes Yes Yes No No Yes Integrated with MoH No Yes Yes Yes Yes Yes Yes No a) Stock at Hand No No Yes No No DK Yes No b) Consumption No No Yes No No DK Yes No c) Losses and adjustments No No Yes No No DK Yes No Do the forms include: Following data included: AIC: Other systems used to collect data are M&E tools. Health centres report to regional branch. Regional branch aggregate what they have collected and send to H/Qs. All the labs send their reports each reporting period according to schedule. Reports are sent through Emails. Emails are used to track reports. Decisions made basing on these reports are: forecasting/quantification, procurement, monitoring stock balances, re-supply quantities. 73 Uganda Health Sector Review – HIV/AIDS Response MJAP: Other systems used to collect data include logistics management system, test returns and test performed. Reporting system is quarterly, test returns, activities (training etc). Satellites report to RRHs which then report to H/Qs. About 80% of the labs send these reports each reporting period on schedule Managers use phone calls to track missing reports. Decisions basing on these reports are: forecasting/quantification, monitoring stock balances, procurement. TASO: Other systems used to collect these data include: manual and electronic; other tolls prepared by TASO to capture other indicators required by donors. Each centre makes a report monthly, quarterly, biannually and annually. Lab technicians send monthly reports to medical coordinator who sends centre monthly report to H/Qs copied to the regional offices. Information sent include number of people tested and persons who performed them. All the labs sent the reports each reporting period on schedule. Monitoring of reporting rates are through set deadlines. Reminders are sent before and after the deadline. In case of delays centres are contacted to send reports. Decisions made basing on the reports include: forecasting, monitoring stock balances, procurement, resupply, staffing levels/unit. Baylor Uganda: Other systems used to collect data are stock cards and despatch forms. Data collected by assistant data managers at regional COEs, cleaned and reported to DHMIS focal person, DHO’s office, and Data manager at Baylor. About 70% of districts and 40% of labs send reports each reporting period on schedule. There is no provision for tracking reporting rates. Decisions made basing on these reports include: forecasting/quantification, transport/delivery, re-supply quantities. Prisons Medical Services: The other data collected is on PMTCT. The units report to the districts. Only Gulu reports to CPHL. Murchison Bay Hospital compiles data and give to HMIS focal person who takes a copy to Prisons H/Qs, another to MoH, and CPHL. No lab sends the reports each reporting period on schedule. Ther is no control over reporting rates. No decision is made basing on these reports. Police Medical Services: Other system used to collect data is AMREF designed tool for support supervision. Unit data is sent to chief nursing officer, then the technician get the lab data from her. The data is filled at Nsambya Police Medical Service H/Qs. About 80% of the labs send reports each reporting period on schedule. There is no provision in place to track reporting rates. No decisions are made basing on the reports. 74 Uganda Health Sector Review – HIV/AIDS Response 4.3 Summary of Findings 4.3.1 Strengths National Able to mention we have HIV/AIDS laboratory component. There is National Lab Policy and National Advisory Committee on Laboratory in place and working on strategic plan. Infrastructure: new construction and renovations by some partners. Good distribution of laboratories in most ART facilities, physically or through referrals. Therefore CD4 counts services are available for all patients before they start treatment. The regional network of labs under JCRC. EID concepts which has seen about 50,000 children tested by referring samples. Uplifted the positions of laboratory coordinators and recruited laboratory personnel especially for districts. CPHL: designed the structure of the new building in Butabika and restructuring in terms of management and functions. PNFP and PHP labs have done a lot District The QC activity is carried by 80% of DLFP during supervision, they also cover safety practice and 50% cover record keeping, monitor stock levels and assess infrastructure. The credit line facility is available for all 10 districts, 9/10 (90%) of the districts have partners to supplement credit line (1/10 partner has wound up) 8/10 of districts use reconstituted stain from higher centre Facility Infection prevention related guide lines (66-70%), SOPs for test performed by level at 73% and National guidelines and protocols for HIV testing in 70%. Training in logistics and HIV rapid testing. Access to EQA 75 Uganda Health Sector Review – HIV/AIDS Response 4.3.2 Weaknesses National Poor coordination of laboratories at the national level. Leadership of labs lack proper structure and there is none at the MoH to coordinate. There is a perception that ‘we don’t have many lab specialists for leadership.’ There is also poor coordination between ACP and research centres/service providers. The technologists at the RR labs and DLFPs are not utilised for supervision, they lack funding and approved structure. There is not enough qualified lab staff within the MoH structure to supervise. DLFP is not a full time job, they are appointed by DHO. The supervision and coordination are poor but can be better if reorganised. Integrated supervision is making lab services not being attended to in detail. How the Regional JCRC labs relate with the RRH labs. The JCRC regional lab networks are poorly managed by MoH. There are not enough qualified personnel and the most qualified are concentrated around Kampala and Gulu yet some people don’t want to work with graduates from Makerere University. Funding: is donor dependent. There is no structure of allocation of funds. It is therefore difficult to mobilise funds for lab services. The MoH does not have separate budget for lab services, lab equipment or supplies. Policy implementation: dissemination of policies requires human resource, finance and infrastructure. While the DLFPs know the policies, hardly any DHO can talk about it. Poor coordination amongst donors and service providers which lead to some information not being got or double reporting. Equipment: there is absolute need for equipment, maintenance contract, and standardisation of equipment. There is no well defined human resource to operate and maintain the automated equipment in the country. Supply management: system is not clear. At national level, it’s only HIV; there is no proper supply management system. Some kits get finished because transportation is a problem. CPHL: it took time to adjust the policy, the structure is not clear. There is no strategic plan. For funding it works as a unit, staffing is inadequate, personnel requires proper management, lack of new technologies. There are a lot of interests in labs from different people both locally and internationally. District Supervision activities carried out varies from district to district. Districts in North and Kampala seem not to own the forecasting process (donor /partner effect). Forecasting not considered timely by 9/10 (90%) of districts. 76 Uganda Health Sector Review – HIV/AIDS Response The storage capacities at the districts are not adequate for current and future expansion of programs. There is no distribution schedule for the Northern and Kampala districts. There are no vehicles to facilitate distribution of commodities in 7/10 (70%) of the districts. The districts of Kampala and Kiboga do not seem to be paying attention to observing max and min stock levels. Users perceive the reconstituted stain from higher level to be of poor quality. Facility Several of the guiding documents were not available in several districts such as QA policies in only 29%, PEP Hep B and guidelines for disposal of damaged and expired products at 12%, guidelines for storage of lab supplies 33%, PEP HIV at 42%. The greatest weakness probably being lack of separate budget for laboratories in 80% of facilities. 4.3.4 Opportunities Strategic plan: HSSP III should be utilised as a chance to achieve the following:Strengthen the general laboratory service coordination Take advantage of the HIV/AIDS funds for proper infrastructure development Human resource development and motivation (upgrade level of training) Streamline logistics, reagents and equipment e.g. through regional workshops for small equipment and outsource maintenance of big/automated equipment (service contracts) Standardisation and accreditation of all labs from HCIII upwards Consider UPDF, Police and Prisons medical lab services in the HSSP III Construct CPHL building, improve on equipment, supplies and reagents, put in place human resource and motivate, then finally make it autonomous. 4.3.5 Threats Donor fatigue Unexpected events 77 Uganda Health Sector Review – HIV/AIDS Response 5.0 CONCLUSIONS 5.1 By Assessment Objectives The Ministry of Health (MOH) has made progress in expanding the package of HIV/AIDs related services (ART,PMTCS,VCT,EID , treatment of STIs, OIs and TB, and safe blood provision) and with regard to laboratories, the HSHASP ( 2007-2010 ) ensured availability of laboratory commodities. For this expansion in service to translate into effective quality services, where by it improves the logistic system to improve customer service and ensures commodity availability by securing adequate funding for laboratory commodities; It is critical that the MOH and donor partners do the following: 1. Organisation and oversight of Laboratory services No clear structure is in place to oversee laboratory services right from MoH. At the districts the DLFP is appointed by the DHO (may be compromising) with no minimum qualification considered, and has no budget for supervision. Support supervision takes place but technical supervision is hindered by lack of funds and yet the higher level utilizes this opportunity to assess performance and carry out some EQA activities. There is need to avail these funds. Several Private facilities are not supervised by the centre. In the area of staffing and training there has been an effort at task-shifting for HIV rapid testing but not for EID and some districts see this as a weakness. However several health facilities cannot handle automated equipment despite serving as general hospitals because they lack the right cadre of staff The centre may have trained at least one laboratory worker from HCIII upwards in the entire country but none of the respondents was very conversant with the current max-minimum stock for HIV test kits, ordering frequency varied (Is it the high attrition or mode of training?) there is need to reassess the training modalities and retrain All the laboratories in the Blood Bank services are not conversant with the expected inventory management; therefore do train in Logistic management procedures The management of clinical waste continues to be problematic while an availability of infection control commodity is inconsistent. There is a need to continuously train on Standard precautions and transmission based precautions and to identify a reliable source of funding for commodities and construction of incinerators (or new technology that is environment friendly) The Policy and regulatory environment for laboratory services, has been a matter of discussion for long there is need for an office at national level that will ensure effective dissemination and utilization of guidelines and protocols, availability of funds for technical support supervision for both government and private facilities, enhancing LMIS, monitoring supply chain, appropriate recruitment of laboratory workers, in service training etc 78 Uganda Health Sector Review – HIV/AIDS Response There is need to disseminate the guidelines that were not evenly available, avail guidelines that were scarce e.g. PEP and disposal of damaged and expired items. 2. Logistic and supplies management of laboratory services Involvement of District (DLFPS) in activities of forecasting and monitoring stock and retrain laboratory workers in inventory management. There is a manual for logistics training generated from the centre (CPHL)that is quite elaborate on Inventory management however the findings at the district (Northern and Kampala) showed that the district did no t the forecasting. Furthermore the knowledge in relation to max -min inventory control system at the facility level was not in line with the recommendations in the manual (6 months max and 3 months minimum). It was also noted that reordering periods vary, resupply is unpredictable and they do not tally with reporting. There is a possibility that the District that should be supervising lower levels is not yet fully conversant with the expectations of the centre and subsequent training should involve the district officials and facility workers. In the area of storage and distribution, there is an urgent need to disseminate guidelines on storage (the information is available in training manual of logistics but no official guidelines in 88%) several units urgently require cold chain and the storage of flammables and corrosives leaves a lot to be desired. It is quite difficult to store commodities because a big number of laboratories lack store facilities while other have inadequate space and there may be no shelves or cupboards. There is need to formulate a policy on handling damaged and expired commodities and to enable its implementation as soon as possible. Some laboratories did not have HIV test kits (all the three (5 labs) one of the three (17 labs) on the day of the visit, but even those that had kits had experienced stock out, several times, in the last one year. Some laboratories did not have RPR/VDRL reagents, strips; Some laboratories did not have DBS kits. 3. Quality assurance of laboratory services and procurement of laboratory commodities With regard to Quality assurance and quality control; there is no Policy on quality control (where one would expect a definition and enforcement procedures and policies for internal and external retesting for quality control. The internal QC procedures are carried out by a significant number of laboratories. There are only three EQA programmes and these are accessed by about 50% of laboratories in the country. However the training manual on logistics addressed procedures for management of commodities, visual inspection and handling of suspect, damaged or expired commodities. 79 Uganda Health Sector Review – HIV/AIDS Response The process of accreditation is just beginning under SLAMT and will apply to selected laboratories; however there exist several EQA activities under different programmes and these do not report to the centre. There is no national plan, guidelines and processes for accreditation of laboratories. The QA/QC activities should be strengthened There has been significant coverage in HIV rapid testing but refresher training is not uniformly distributed. Product selection: A significant number of the automated equipment come from donors, a number of facilities did not have reagents and in one district none of the users had been trained while in the same district two facilities did not have maintenance contracts for the equipment. There is need to have equipment that can utilize open systems; the Ministry should attempt to draw to the attention of donors of automated equipment, to the recommendations of the National Equipment Policy. The Uniformed services should utilize the credit line and also follow the established guidelines from the MOH To ensure availability of commodities, an attempt should be made to align the delivery schedule of NMS and the determined inventory control duration to avoid stock outs. There is a need to ensure procurement for all items needed to complete a testing protocol (e.g. national algorithm for HIV test protocol). A number of facilities attributed stock out of commodities to NMS (delay to deliver, lack of transport, being stocked out or loss of requisition). There is a problem of transport of commodities from Districts to lower centers, need to provide transport (vehicles plus fuel). The maintenance of laboratory equipment is quite low at around 30%, and the practice is not uniform. There is some good record from the users of automated equipment the majority of whom secured service contracts and thus have routine servicing and calibration. However the equipment supplied by Government in two Regional Hospitals could not be repaired by the national equipment maintenance unit, (it is not in use). 4. Laboratory management information systems By strengthening the LMIS whereby if quantification is to rely on comparing multiple types of forecasting methodologies using logistic, demographic, and service statistics data, then the information from the district should be conveyed to the centre in time and also processed promptly. MOH should ensure the computerization of the LMIS. Furthermore there should be coordination between the activities of partners and the ministry to ensure reporting and avoid double reporting. Ensure Private facilities and CoEs send reports to the centre. 80 Uganda Health Sector Review – HIV/AIDS Response 5. Extent to which key HIV service providers have contributed to and aligned themselves with HSHASP Very many centres of excellence belonging to different PNFP organisations are providing various HIV/AIDS services from HCT, ART, Resistance testing to CD4 monitoring e.g. AIC, MJAP; others are providing buffer stock of HIV/AIDS supplies e.g. Baylor Uganda, PREFAR; and others provide reagents for automated equipment e.g. CHAI. The uniformed services have not done much, the community they should serve are underserved because there are few facilities e.g. Police runs only 3 labs in the country and prisons 6. UPDF has some facilities which are mobile in the field. Basically the funding of HIV laboratory supplies and equipment are heavily donor dependent with CDC taking a Lion’s share. 5.2 Key Emerging Messages • No leadership and coordination structure. • Unreliable distribution system due to various reasons (transport, schedule, ordering, logistics knowledge) • Stock out of HIV test kits, DBS Kits, Hep C ELISA kits, RPR, reagents for machines • Prisons were not accessing credit line till recently. • Distribution of guiding documents varied • Levels of reporting vary from district to district, PHP and CEOs do not report • Supervision is irregular and the activities vary • EQA not well established • Maintenance and calibration of general equipment is weak • Inadequate infrastructure • Inadequate supplies of infection control materials, weak waste management • Lack of separate budget for Laboratory services. 81 Uganda Health Sector Review – HIV/AIDS Response 6.0 RECOMMENDATIONS 6.1 Policy Level Recommendation There is need for a very clear structure in the MoH and Public Service for leadership of laboratories in Uganda. There should be a commitment from the MoH on laboratories. MoH should lobby for funding (separate budget) for laboratory services o Reagent and equipment procurement o Equipment maintenance o Motivation of personnel There need for reprogramming laboratory services. The right diagnosis for the laboratory services problem should be found. MoH human resource department should have each desk for laboratory, nursing and clinical. Should define human resource required for laboratory services in Uganda both specific and general: o Operating automated equipment (CD4 count machines, Chemistry machines, and haematology). o Maintaining automated equipment. DLFP should be a full time job with qualification attached (Graduate). The terms of reference of AHPC should be reviewed. The right training should be implemented. Standardise of laboratory services right from HCIII upwards. Endeavour to fill at least 80% of the laboratory vacancies. Harmonise the activities of implementing partners, COEs & PHP (stock cards, reporting, targeting facilities). Streamline the activities of NMS (not to stock out, lead time Improve on infrastructure in one rural district, and ARUA, GULU regional labs Provide storage appropriate for cold chain Facilitate EQA activities in the entire country 82 Uganda Health Sector Review – HIV/AIDS Response Uniformed services should be included in the credit line. Enable Regional and district technical support supervision There is need for a laboratory commodities committee that will coordinate donor and government inputs and develop commodity security strategy for lab services 6.2 Programmatic Recommendations Ensure adequate storage & transport at the district level for the distribution of supplies Review the supply of reagents for automated equipment Identify a definite source of funds for infection control supplies Investigate transmission of reports from the districts to center Put in place equipment maintenance contract. Ensure training in use of automated equipment Ensure the equipment preventive engineering. Disseminate the PEP (HIV/HepB), storage, disposal and QA policies The Logistics office at CPHL should be facilitated to monitor the performance of the supply chain; the current state of affairs needs urgent redress for example; 6.3 Interventions for Key Stakeholders Encourage laboratory professionals to do management training. Sensitise people about the roles and importance of laboratory services. Need new technology in CPHL. Retrain laboratory workers in all districts and Blood banks–stock levels, reporting, ordering There is a need to streamline the activities of partners to ensure that items supplied are not duplicates of the main credit line while other essential items are left out. (Some partners tend to use a Push system while government is using a pull-system) 83 Uganda Health Sector Review – HIV/AIDS Response 7.0 BIBLIOGRAPHY Assessment tool for laboratory services (ATLAS 2006) Early Infant Diagnosis (information Pack) Guidelines for Private Practice for Allied Health professional and registered Nurses Health Sector Strategic Plan II (2005/06-2009/2010) Health Sector HIV/AIDS Strategic Plan, 2007-2010 HIV prevention response and Modes of transmission Analysis HIV/AIDS Drug Procurement and Supply chain management (Elizabeth Glaser Paediatric AIDS Foundation) Laboratory support supervision (draft document-CPHL) Logistics for HIV tests and laboratory reagents and supplies; the National logistics training for the Ministry of Health in Uganda (Facilitators’ guide) January 2009 MoH 2005. Health Sector Strategic Plan II 2005/6-2009/10, p13. National lab assessment National Medical Equipment Policy (2009)(MOH National laboratory Assessment Survey 2004 National report for the Phase 1 activities for laboratory containment of Wild polioviruses in Uganda; NTF (November 2007) Proceedings of Dissemination of the automated Equipment report (July 2006)-Kampala Resources for managing the laboratory supply chain (USAID/DELIVER) Stakeholder’s Workshop on Laboratory Management System (14th-16th March 2005) Uganda National Policy Guidelines for HIV Counselling and Testing (July 2005);Bench guidelines (Algorithm for HIV testing for babies and adults Uganda Health Facilities Survey 2006: Performance of HIV/AIDS and Family planning commodity logistics system (USAID) Uganda national Health Laboratory Service Policy (August 2009) 84 Uganda Health Sector Review – HIV/AIDS Response 8.0 APPENDICES 8.1 National Data Collection Tools 8.2 District Data Collection Tools A Review of the Uganda Health Sector Response to HIV/AIDS KII Guide for ACP Interviewer Name: Date: Organisation: Interviewee Name: Interviewee Title: Telephone Contact: CPHL was delegated to manage laboratories. 1. What is the administrative and communication structure between ACP and CPHL? 2. What coordination mechanism is in place and function between ACP and CPHL? 3. What mechanism is in place to support CPHL? a) Planning, b) Implementation, c) Evaluation 4. a) Who decides which cadre of personnel should be recruited in CPHL? b) Who defines the job description of such officers? C) Are there written job descriptions for each of the laboratory staff members in CPHL? d) Who determines the qualifications required? 5. a) Is there any person or committee in ACP/MoH which is responsible for CPHL and/or HIV laboratory services? If yes, Skip to 6 85 Uganda Health Sector Review – HIV/AIDS Response 6. 7. 8. 9. b) If there is none, is there need for one? c) What kind/cadre of person would you recommend to be responsible for HIV lab services? (Title, responsibility, qualification) Who is that person or chairperson or that committee? (Title, responsibilities, qualification). . Does the person have the right qualification? (specify) What are the sources of funding for laboratory services? How are funds allocated to laboratory services? 10. a) Is there a person who determines which equipment should be bought? b) What criteria are used to determine which HIV/AIDS lab equipment to buy? 11. Is there a person or committee who determines which HIV test kits to buy? What criteria are used to select the HIV test kits? 12. Is there a mechanism for monitoring HIV/AIDS laboratory services? 13. What are some of your achievements in the laboratory services in the last three years? 14. What are the future plans for the laboratory services in the next 5 years? 15. What are some of the major challenges concerning HIV/AIDS laboratory services in this country?. a) Leadership b) Personnel(qualification/number) c) Funding/allocation d) Supplies e) Equipment/maintenance f) Supervision g) QA/QC h) Policies 16. What are the suggestions for the possible solution to these challenges? 17. If you are to prioritize solutions, which area would you start with and which one last? 86 Uganda Health Sector Review – HIV/AIDS Response A Review of Uganda Health Sector HIV/AIDS Response KII Guide for Commissioner NDC/ Clinical services (MoH) Name of Interviewer: …………………………………………….. Date: ……../……….../ ………. Name of Interviewee: ……………………………………………. Title of Interviewee: ……………………………………………… Telephone contact: ……………………………………………….. 1. What are the current activities and responsibilities of the commission in terms of: a) Licensing and registering individuals b) Accreditation of laboratory training schools c) Training of laboratory personnel 2. With regard to registration of private practitioners, what are the basic requirements? 3. Is there a mechanism in place to assess: a) The level and appropriateness of training of laboratory personnel? b) Appropriateness of premises – i) structure -ii) furniture c) Availability of basic equipment, supplies? d) Tests to be carried out? e) Records (investigations being carried out, Reagents, Tests reports) 4. Considering the protection of patients, staff and the public, a) Are there mechanisms for assessing quality assurance? b) Are there mechanisms for assessing presence of SOPs for laboratory tests? c) Assess documents and records kept? d) Safe disposal of waste i) chemical ii) clinical 5. a) What is the number of laboratories covered under your service? b) How many of the labs are carrying out i) HIV/AIDS tests? 87 Uganda Health Sector Review – HIV/AIDS Response ii) STI tests iii) Hepatitis tests? c) Any procedure/facilitation enabling them obtain approved HIV testing kits? d) Any financial support towards HIV/AIDS diagnosis? e) Any support towards lab construction? 6. a) Is there any person or committee in MoH who is responsible for coordinating and administering HIV laboratory services? If yes, Skip to 7 b) If there is none, is there need for one? c) What kind/cadre of person would you recommend to be responsible for HIV lab services? (Title, responsibility, qualification). 7. 8. Who is that person or chairperson or that committee? (Title, responsibilities, qualification) Do you think that is the right person/committee/office? 9. What are the sources of funding for laboratory services? 10. How are funds allocated to laboratory services? 11. a) Is there a person who determines which equipment should be bought? b) What criteria are used to determine which HIV/AIDS lab equipment to buy? 12. What is the link between NMS and JMS and private practice? 13. Is there a person or committee who determines which HIV test kits to buy? What criteria are used to select the HIV test kits? 14. Who determines which posts should be created for HIV laboratory services? 15. Who determines the qualification of such a person? 16. Is there a mechanism for monitoring HIV laboratory services? (Describe). 17. What are some of your achievements? a) In the laboratory services in the last three years? b) In CPHL in the last 3 years? 18. Which are the reasons for CPHL not meeting targets? 88 Uganda Health Sector Review – HIV/AIDS Response 19. What are the future plans for a) laboratory services in the next 5 years? b) CPHL in the next 5 years? 20. What are some of the major challenges concerning HIV/AIDS laboratory services in this country? i) Leadership j) Personnel(qualification/number) k) Funding/allocation l) Supplies m) Equipment/maintenance n) Supervision o) QA/QC p) Policies 21. What are the suggestions for the possible solution to these challenges? 22. If you are to prioritize solutions, which area would you start with and which one last? A Review of the Uganda Health Sector HIV/AIDS Response KII Guide (USGs) Interviewer ……………………………………………………. Date ……/……/……… Organisation …………………………………………………….. Title of interviewee ………………………………………… Physical Address …………………………………………… Telephone contact ………………………………………… 1. a) Is there any specific support towards HIV/AIDS you have been giving to laboratory services? b) Which ones: c) How is the support to the HIV/AIDs laboratory services delivered? d) Which are the measurable outputs for the support offered? 89 Uganda Health Sector Review – HIV/AIDS Response 2. a) Is there a separate budget for supporting laboratory services as regards HIV/AIDS? b) Is there a mechanism for monitoring the implementation of this? c) Specify… 3. a) Is there a separate line item for HIV laboratory supplies? b) What mechanism is there to oversee the implementation? 4. a) Is there a separate line item for HIV laboratory equipment? b) What mechanism is there to monitor the implementation? 5. What are some of the challenges you face as regards support to HIV/AIDS laboratory services? 6. What could be the solution to such challenges? 90 Uganda Health Sector Review – HIV/AIDS Response APPENDIX II A Review of the Uganda Health Sector HIV Response KII Guide for CAO, District ………………………………………………. Name of Interviewer …………………………………. Date ………………………….. 1. How are laboratories organized in this district? 2. Does your office do anything to ensure laboratory supplies and consumables are available always? 3. How effective is it? 4. a) Does your office contribute in any way to procurement of Lab supplies? b) Does your office contribute anything towards forecasting of HIV /Health laboratory supplies? 5. What are the sources of funds for HIV Laboratory equipment /supplies? 6. What role do you play in the a) Inventory of HIV laboratory supplies b) Storage of HIV lab supplies c) Distribution of HIV Lab supplies 7. Does your office participate in supervision of laboratories? 8. What role does your office play in recruitment of laboratory personnel? 9. What are the major areas of concern for laboratory services in this district? 10. How can these concerns be addressed? 11. How are the funds allocated to laboratories in this district? 12. Is there a separate line item for laboratories? 91 A Review of the Uganda Health Sector HIV Response KII for Facility I/C Facility Name……………………………………District ………………………………… Name of Interviewer: ………………………………………………………………………. Hospital/ HC In-charge 1. What are the sources of funding for laboratory supplies? ……………………………………………………………………………………… 2. What are the sources laboratory supplies? …………………………………………………………………………………….. 3. Who orders the laboratory supplies? ................................................................................................................................. 4. Who approves the order? ………………………………………………………… 5. Is there any minimum stock at which re-ordering is done? ……………………………………………………………………………………… 6. Is there any maximum stock level above which the supplies request is not approved? ………………………………………………………………………………………… …... 7. Who determines these levels? Ask questions from the facility level tool in the following sections? National guidelines and Protocols 1. (a)Are national guide lines and protocols for laboratory procedures available in this laboratory? □ Yes □ no □ Don’t know/not sure (b) Are national guidelines and protocols for HIV testing available in this lab? □ Yes □ No □ Don’t know/not sure 2. (a) Are written guidelines on safety precautions available in this laboratory?(Check all that apply) □ Infection prevention □ Safe disposal of sharps (i.e., Uganda Health Sector Review – HIV/AIDS Response needles, etc) □ Safe disposal of bio-hazardous medical waste □ Use of protective gear □ Other (specify)__________________ (b) Are the PPE being utilized? (Interviewer Observe) □ None available □ Yes 3. Are written guidelines for post-exposure prophylaxis (PEP) for HIV available in this laboratory? □ No □ Yes □ no □ Don’t know/not sure 4. Are written guidelines for post-exposure prophylaxis (PEP) for hepatitis B available in this laboratory? □ Yes □ no □ Don’t know/not sure 5. Are there written guidelines for disposal or destruction of damaged and/or expired products? □ Yes □ no □ Don’t know/not sure 6. Are the national standard operating procedures (SOPs) available in this laboratory? □ Yes □ no □ Don’t know/not sure 92 Uganda Health Sector Review – HIV/AIDS Response Laboratory Personnel 1. Current working staff by category: Title Number Number who have attended refresher laboratoryrelated training course or workshop in the past 12 months Pathologist Laboratory scientific officer Laboratory technologist Laboratory technician Laboratory assistants Laboratory attendants Microscopists 1. Inventory management (a) Inventory management 1. (a) Does the laboratory have a set minimum stock level for HIV test reagents and consumables at which orders need to be placed? □ Yes □ No □ Don’t know/not sure 93 Uganda Health Sector Review – HIV/AIDS Response (b) In what period? __________ months 2. (a)Does the laboratory have a set maximum stock level for reagents and consumables above which the inventory level should not go? □ Yes □ No □ Don’t know/not sure (b) What period? ___________months 3. Who determines how much to order? □ Laboratory In-charge □ Higher level authorities □ Other (specify)__________________ If the general store (or pharmacy/dispensary) of a facility orders reagents, ask the facility store questions 4-8, if not skip to question 9 4. Which data elements do you use to calculate how much to order? DO NOT READ LIST. PROMPT”ANYTHING ELSE” (check all that apply.) □ Average monthly consumption □ Number of tests performed □ Stock remaining in the laboratory □ Set maximum stock level for reagents □ Other (specify) _______________ □ Don’t know/not sure 5. Where does this facility send its order for re-supply? (check all that apply) □ National medical stores □ Regional medical stores 94 Uganda Health Sector Review – HIV/AIDS Response □ District medical stores □ Private supplier/open market □ Other (specify) 6. How often do you place orders? □ Monthly □ Quarterly □ Every 6 months □ Other (specify) 7. How many emergency orders have you placed in the last year? Number_________________________ 8. Under normal circumstances, how long does it take from the time you place an order to the time the supplies are available for use _______________days 9. In the last year, did you have an order that took longer than usual to fill? □ Yes □ Don’t know/not sure? □ No (go to Q. 12) □ Don’t know/not sure (go to Q. 12) 10. For this order, how long did it take you to receive your supplies to the time of order? 11. What were the reasons for the delay in receiving the supplies? 12. How often is a physical inventory of reagents and consumable supplies Every___________months 95 Uganda Health Sector Review – HIV/AIDS Response conducted in the laboratory? 13. In your current system, do some stains need to be reconstituted at the regional or district level as ready to use for health centers? □ Yes (specify below) □ No □ Don’t know/not sure If yes to question 13, specify why: □ Lack of technical experience □ lack of weighing balances □ Other: (specify)____________________________________________________ 14. Has this inventory system improved the laboratory services in this facility? 96