Viral Load Specimen Referral Network Report Zambia

31 October – 4 November 2016

Kameko Nichols Independent Consultant

The Nichols Group, LLC

This project was sponsored by the Naval Health Research Center. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Naval Health Research Center.

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Table of Contents 1. Executive Summary ..................................................................................................................................... 3

2. Background .................................................................................................................................................. 3

3. Assessment overview and methodology ..................................................................................................... 4

4. Current situational analysis ......................................................................................................................... 4

4.1 Health system and laboratory network and infrastructure ................................................................ 4

Lusaka Province ........................................................................................................................................... 5

Copperbelt Province .................................................................................................................................... 6

ZDF medical service ..................................................................................................................................... 6

4.2 Specimen referral networks ................................................................................................................ 6

Health post or RHC to district ...................................................................................................................... 7

District to provincial level ............................................................................................................................ 8

4.3 Challenges ............................................................................................................................................ 9

5. Initial thoughts on overall specimen referral network improvement ....................................................... 10

5.1 Coordination of all specimen referral networks and stakeholders ................................................... 10

5.2 Clearly define a working agreement between MoH and ZDF, covering testing................................ 11

5.3 Exploration of further collaboration with ZamPost for higher-level referrals .................................. 11

5.4 Mapping of facilities and network optimisation/simulation exercises ............................................. 12

5.5 Analysis of transportation from primary facility to district laboratory ............................................. 12

6. Initial thoughts on system design for ZDF ................................................................................................. 13

6.1 Logistics ............................................................................................................................................. 13

6.2 Communication ................................................................................................................................. 14

6.3 Training/sensitisation ........................................................................................................................ 14

6.4 Documentation/Monitoring and Evaluation (M&E) .......................................................................... 15

6.5 Cost/sustainability ............................................................................................................................. 15

7. Limitations ................................................................................................................................................. 15

8. Thank you and next steps .......................................................................................................................... 16

Annex A: Terms of reference ............................................................................................................................. 17

Annex B: Proposed schedule of visit ................................................................................................................. 18

Annex C: List of informants ............................................................................................................................... 19

Annex D: List of viral load laboratories in Lusaka and Ndola ............................................................................ 20

Annex E: ZDF Health Facilities by Province ........................................................................................................ 21

Annex F: Template for assignment of health districts to reference laboratories for Early Infant Diagnosis (EID) and viral load testing ......................................................................................................................................... 24

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1. Executive Summary Well-conceived, well-designed, well-run and well-managed specimen referral networks underpin a strong laboratory system network. However, unfortunately, until recently, specimen referral networks have received minimal attention in developing countries where the challenges to creating and maintaining such a network are substantial. Specimen referral networks go hand-in-hand with laboratory equipment placement/capacity. If a robust referral network is in place to pick up and deliver specimens to the equipment for analysis, this can increase access to diagnosis in areas without a higher-level laboratory in an efficient and cost-effective manner. However, due in part to the weakness of sample referral mechanisms, it is common to further decentralise expensive and more complex laboratory analysers, which can result in challenges such as under-utilisation and further expense for staffing and maintenance at lower levels of the health system. In Zambia, there has been a decentralisation of polymerase chain reaction (PCR) laboratories to the provincial level. There are now more than adequate numbers of PCR analysers across the country to cope with demand for viral load and early infant diagnosis (EID) testing, yet there is still talk of additional equipment procurement. The Laboratory Director has been stressing to partners to refrain from purchasing additional PCR equipment but instead put funds toward specimen referral systems and equipment maintenance. It was also noted that laboratory staffing and reagent procurement are limiting factors in the full performance of the equipment. Therefore, given that the country has adequate numbers of well-equipped PCR laboratories, Zambia has the opportunity to strengthen its specimen referral networks, among other areas. Although this consultancy was focused on the Zambian Defence Force (ZDF) Medical Service, a very specific piece of the health system and laboratory network, it would be prudent to look beyond to the entire public health system. Zambia has potential to build on certain programmatic strengths (i.e. the various mechanisms through HIV partners mainly funded by the United States Government, or USG) and better coordinate and manage its specimen referral systems into one comprehensive and integrated network. Although the country currently has multiple networks in operation (similar to other countries), there are already great efforts in coordination, such as the laboratory technical working group (TWG), committed leadership at the ZDF Medical Services and the Ministry of Health (MoH), and funding already in the system (which could be utilised more efficiently). These elements are all critical to the long-term success of a specimen referral system. This initial assessment will act to inform future design and implementation phases, which should clearly be mapped out in a documented, costed and publicly-available plan, within the ZDF. This plan should be also closely monitored over time and financial/operational sustainability should be considered in the long-term even if short-term financial assistance is available.

2. Background Through the United States Department of Defense (US DoD) HIV/AIDS Prevention Program (DHAPP), implemented by John Snow Inc. (JSI), the ZDF Medical Services has received two viral load analyzers – one of which is already placed at Maina Soko Military Hospital in Lusaka and the other which will be placed at Northern Command Military Hospital in Ndola. Under the DHAPP project, JSI has been instrumental in

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installation and training of the new viral load testing equipment. As part of the handover to new implementing partners, the US DoD Zambia team has also requested JSI to provide recommendations for the future DHAPP implementers on appropriate viral load referral systems for their facilities. As such, JSI has initiated a consultancy with the objective to understand the current specimen referral networks in Zambia under the Ministry of Health’s (MoH’s) laboratory network, and to use this knowledge to provide recommendations on a proposed viral load specimen referral network for ZDF to implement. More detail can be found in the Terms of Reference (ToR) in Annex A.

3. Assessment overview and methodology The in-country assessment focused on learning as much as possible about the current MoH specimen referral networks in the context of the overall public laboratory and health systems, as well as the ZDF laboratory and health systems. Semi-structured interviews were conducted over one week with key personnel in the ZDF and the MoH, including the directorates for laboratory services, plus the viral load laboratories at Maina Soko Military Hospital, University Teaching Hospital (UTH) and the Centre for Infectious Disease Research in Zambia (CIDRZ), as well as facility and district health office (DHO) staff in Chongwe and Kafue districts. Background information was also solicited from partners JSI-DHAPP, Zambia Prevention, Care and Treatment (ZPCT) project, Project Concern International (PCI), JSI-DISCOVER, the Clinton Health Access Initiative (CHAI), the Christian Health Association of Zambia (CHAZ), EQUIP Health Zambia, in the form of partners’ in-brief and debrief discussions. The schedule of the visit can be found in Annex B and a complete list of informants in Annex C. Other data such as costs were collected, where available. This information was then compiled to give a more complete overview of the specimen referral network in Zambia and to inform ZDF’s viral load network design. The main areas discussed were the laboratory network and specimen referral within that system, in the context of viral load testing. In addition, other specimens’ logistics were also explored, in both MoH and ZDF’s networks, to see if there were any learnings to be shared and potentially any synergies. These main components are discussed in the following sections.

4. Current situational analysis

4.1 Health system and laboratory network and infrastructure The MoH, through its Directorate of Laboratory Services and support from its cooperating partners, provides a network of laboratory services throughout Zambia. The MoH hosts a laboratory TWG, which meets quarterly and is comprised of the relevant MoH staff plus donors and implementing partners. The lowest tier of the health system begins with health posts, which are not permanently staffed but receive visits from clinical outreach teams from static facilities on a regular basis. Above this tier, basic diagnosis in the form of rapid testing for malaria and HIV performed by health workers can be found at the lowest rural health centre (RHC) levels, whereas district hospitals and some larger health centres have laboratories staffed with trained technologists and technicians who can perform more complex analyses, such as clinical chemistry, haematology, CD4 count, tuberculosis (TB) microscopy, etc.

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At the level above this, found in each of the 10 provincial capitals, nearly all the hospital laboratories (except for Muchinga province, which was not yet a province when planning took place, so they currently refer to Kasama, Northern Province) also now have the capacity to run PCR analysis for EID and viral load testing. The Roche Taqman testing platform has been standardised for ease of reagent procurement/utilisation as well as service agreements for maintenance. As part of Zambia’s testing expansion effort, the MoH will soon launch and disseminate the Viral Load and Early Infant Diagnosis Testing Scale-Up Implementation Plan 2016-2020. Since the document has not been officially released, we were unable to examine it for this report. Generally, results are sent back using the same channels, in reverse, as specimens. However, for EID, there is electronic results return available. This system has not yet been extended to viral load results since the result is not a binary “yes” or “no” but requires a number to be communicated. Although there is equipment now in place to run PCR tests in nearly every province, it was mentioned that many clinicians are still not using viral load for routine monitoring, just for treatment failure confirmation. However, given the reagent stockouts, there is still a backlog in testing, which causes the laboratories to struggle with current volumes even as new equipment becomes functional. Equipment and laboratories in Lusaka and Copperbelt Provinces are outlined in the sections below and a list of all can be found in Annex D.

Lusaka Province Lusaka Province now has three PCR testing sites and a total of six analysers (one is non-functional):

1) Maina Soko Military Hospital (one new Roche Taqman 48) 2) UTH (one Roche Taqman 48 and one Taqman 96) 3) CIDRZ laboratory at Kalingalinga (two Roche Taqman 96 and one non-functional Abbott m2000)

Capacity is constrained in Lusaka Province due to previous national reagent stockouts, causing backlogs, which are still not cleared. Additional capacity at UTH and the new equipment at Maina Soko may help relieve some of the backlog from CIDRZ if staff and reagents are available and equipment is functional. There is currently a committee from Lusaka provincial health office (PHO) working on allocation of sites to laboratories based on testing capacity. Historically, most facilities across Zambia brought their specimens to CIDRZ laboratory, which has stringent quality control processes in place. They have two working Roche Taqman 96 analysers, which can run 9,000 specimens per month on a single shift or 18,000 on a double shift, which could accommodate the current demand but not the backlog. CIDRZ ensures that this equipment is covered with service agreements for maintenance, but it is costly, cited at about $17,000 per year per analyser, or more when it is running double-shifts. CIDRZ has a rejection log, which they use to track rejections even per site, which allows them to offer targeted training if a site is having increased rejections. Results are returned generally by paper but there is an electronic system underway for their 25 Lusaka district facilities. They will also place a phone call to the facility if the results contain any critical values. At UTH, they have a Roche Taqman 96 in their adult centre of excellence (COE), which has a capacity of about 5,000 tests per month and is currently running at capacity. They also have a second analyser, a Roche Taqman 48, which has a capacity of about 1,200 test per month in their virology laboratory, which has spare capacity of about 1,000 tests per month. However, the limitation is staffing as there are not enough staff at the virology

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laboratory to place full time technologists. Currently they can only run specimens twice per week but if they had two extra staff, they could run five days a week and turnaround time could reduce to possibly 48 to 72 hours, down from seven days. The primary source of specimens come from UTH itself, but also from Chirunda through the PHO. The discussions are currently for UTH to accept specimens from three clinics, which currently refer to CIDRZ, to fill the additional capacity. Results can apparently be emailed through a laboratory information system that is installed at UTH, Ndola Regional and Livingstone Regional. For facilities in town, the results are also printed and sent to PHO for distribution.

Copperbelt Province In Ndola, Copperbelt province, there will soon be three PCR testing sites and a total of three analysers:

1) Ndola Central Hospital (Taqman 48) 2) Arthur Davidson Children’s Hospital (ADH) (one Taqman 96) 3) ZDF Northern Command Military Hospital (one Taqman 48, which is not yet installed but should be in

the near future)

ZDF medical service Specifically, within the ZDF health system, each of the three branches of ZDF – Zambia National Services (ZNS), the Army and the Zambia Air Force (ZAF) – has its own medical director, who reports to the director general of medical services (DGMS) at the Ministry of Defence. Each branch also has its own health centres and hospitals (60 total), which are found within the ZDF compounds throughout the country to cater for the military staff and families. However, there are also many civilians who take advantage of the proximity and services offered by ZDF. Up to now, the uptake of viral load testing within ZDF facilities has been low – presumably in part due to the fact that ZDF facilities were still paying for testing. These payments are channelled through three separate accounts for each branch. Offering viral load testing for free within the ZDF health system should remove this barrier, although the need for a strong specimen referral network for vial load samples will then be critical. Another barrier to uptake at ZDF facilities is likely that they are not all providing anti-retroviral therapy (ART); therefore, they may refer their patients.

4.2 Specimen referral networks Specimens are readily referred in Zambia, as compared to patient referrals, although there are many fragmented mechanisms currently in place at different levels, for different specimens, run by different implementing partners. The majority of the networks appear to be funded directly or indirectly by the USG. We heard about six different networks from various partners, all around HIV-related specimens. These mechanisms are not all equal in terms of service, reliability and sustainability and are likely inefficient and not cost-effective, although it is unclear how much each system costs. As each specimen referral mechanism is slightly different, the main ones are outlined below, giving examples where relevant.

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Health post or RHC to district From health posts, outreach teams from a facility go out with a vehicle to collect specimens and drop them at a static facility for testing or further referral, depending on the analysis necessary. This model is used by JSI-DISCOVER, which use dedicated transport and trains providers. A variety of specimens are collected at the rural health centre (RHC) level and then need to be transported at least to the district hospital, where a laboratory exists. For referral tests, the RHC collects specimens and sends them to the laboratory – most of these are HIV-related or for referral to a GeneXpert analyser to detect drug-resistant TB. There is no designated staff to transport specimens to the district laboratory but the facility may have its own motorcycle. If there is no facility- or private-transport available, volunteers may be utilised to carry the specimens on public transport or other means. And, in some cases, for higher-referrals for EID and viral load testing, for example, the specimens are picked up by a partner and referred to a major laboratory, such as CIDRZ. We visited four RHCs: Chongwe RHC, Chongwe ZNS, Kafue Estates and ZAF Mount Eugenia. Certain ZDF facilities already refer their specimens to Maina Soko Military Hospital, UTH and CIDRZ using their own transport whereas other ZDF facilities benefit from CIDRZ specimen transport network in Lusaka Province. At Chongwe RHC, which is a high-volume health centre with a “district-level-type” laboratory, dry blood spot (DBS) and viral load specimens are collected on Tuesdays and Thursdays up until about 12:30pm. There is no working centrifuge to spin down the specimens, but the CIDRZ vehicle comes during the afternoon on the same day. The laboratory also has -20oC storage, where specimens could be frozen for up to two weeks, although it is where controls are stored. They receive specimens from the district outreach teams on the same days as well as from other static/satellite ART sites. For specimens that are not picked up by CIDRZ, such as sputum for TB culture or diseases under surveillance, the RHC will ask for a volunteer to carry the specimen on public transport. They have also used ZamPost to send proficiency testing (PT) results to UTH and charges are billed centrally (i.e. Chongwe RHC does not have to pay for this service but it is unclear exactly who does). Kafue Estates RHC collects DBS and few viral load specimens starting around 10:30 am and hands them off to the CIDRZ driver who comes around 11:00 am or noon. They use Ziploc bags to package the specimens and the driver packs them into a cooler box. The site also accepts sputum for GeneXpert testing from six to seven health facilities as well as CD4 specimens, and refers TB culture and drug sensitivity testing to UTH. If referrals to Lusaka are necessary, the site can use the DHO ambulance, but this does not happen frequently. Facilities that refer to Kafue Estates use their own transport, DHO transport or bicycles, although it is not known if the people carrying the specimens have been trained on biosafety. At Chongwe ZNS, which began providing ART in November 2014, they refer mainly CD4, chemistry, haematology, sputum and DBS specimens on Mondays and Wednesdays to the DHO currently as they do not have a laboratory onsite. They do, however, have a PIMA CD4 count point-of-care device (donated by JSI-DHAPP) although they do not currently have any reagents. They have not collected viral load specimens yet and would refer patients to the DHO if the patient is suspected of treatment failure. They do have a motorcycle donated by the Korean Government, which was used for specimen transport, but it is not currently working so they use personal vehicles or public transport when needed (Chongwe DHO is only six kilometres away). They rarely have transport to Lusaka and would need support to travel there.

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ZAF Mount Eugenia is a static ART site. They refer patients to CIDRZ or UTH for viral load testing but since the test has carried a cost to ZDF patients, most cannot afford to go. The laboratory here can perform CD4 count, haematology and clinical chemistry testing. DBS are sent to CDIRZ using the facility’s own Landcruiser or smaller car, which are both available for specimen transport, accompanied by a laboratory staff member. The specimens are packed in a cool box without any ice packs. Although we did not visit Eastern Province, ZDF officials recently were there and noted that the ZDF facilities seemed to be able to transport their specimens to Chipata. Also in Eastern Province, CHAZ uses motorcycles to pickup specimens from lower levels and then to deliver on to the province (using the same motorcycles).

District to provincial level From district hospitals or larger RHCs, some facilities are provided support to transport their specimens, whereas others have to work within the PHO/DHO structures or find their own transportation. For DBS specimens, this support may be provided by couriers such as express mail service (EMS) through the Zambia Postal Services Corporation (ZamPost). CHAZ and ZPCT have supported DBS transport through ZamPost’s EMS, although agreements are separate and not transparent, prohibiting bulk procurement and preferential pricing. ZPCT was also involved in transporting viral load specimens using a motorcycle from facility to district laboratory, which would act as a hub to spin down and separate the specimens before forwarding on to the province. However, they found that this system was not predictable in terms of timing so they are working with the PHO/DHOs to utilise MoH vehicles operating on scheduled routes across 86 facilities and laboratory hubs, where plasma is frozen until a vehicle comes to pick up and forward onto the provincial laboratory. Also for DBS and viral load specimens, CIDRZ offers a specimen referral system to its laboratory, as mentioned previously. CIDRZ owns and operates a fleet of six GPS-fitted Toyota Hilux 4x4s to cover six zones in Lusaka district offering pickups/drop-offs for specimens/results for EID and viral load testing twice daily in the morning and afternoon. This covers 25 public facilities and drivers are starting to use logs/chain of custody forms. According to CIDRZ, the system costs about 20,000 Zambian Kwacha per year per vehicle to travel on average 20,000 kilometres annually, plus about 12,000 Kwacha in maintenance costs per vehicle. Four of the vehicles have travelled over 250,000 kilometres; these will be replaced by Toyota Corollas since they drive primarily on Lusaka tarmac roads. They also offer transport to the rest of Lusaka Province, as well as Southern and Eastern Provinces, once per week on Wednesdays (blood is drawn same day) through drivers from their head office (separate from the laboratory at Kalingalinga) using cooler boxes and ice packs. These pickups happen from the hubs at district hospitals (one per district except one district has two hubs) as long as the hub can spin the samples and refrigerate until pickup. However, some district laboratories do not have centrifuges and facilities may ask patients to wait until close to the pickup time due to the six-hour cut-off time by which the specimen needs to reach the testing laboratory. We visited two districts: Chongwe and Kafue, where we met both DHOs and saw the district hospital. Chongwe has 33 health posts and RHCs, plus one district hospital with a total population of about 172,000. All of their facilities can be reached without much difficulty due to terrain. The district offers mobile ART to five of its sites every two weeks, when they collect specimens and bring to Chongwe District Hospital and Chongwe RHC. For viral load specimens and DBS, CIDRZ collects from the district. Kafue has 20 health facilities including one district hospital covering a population of about 155,000.

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Chongwe district hospital takes its viral load, sputum for GeneXpert testing and urea/electrolyte specimens to Chongwe RHC using their hospital driver and transport maybe once or twice per week. The hospital can perform CD4 count testing and also receives samples from three satellite health facilities. In Kafue district hospital, the ART clinic asks patients to go to the hospital laboratory around 10:00 in the morning to have their blood drawn around 11:00 on Tuesday and Thursdays and then CIDRZ picks up specimens around noon, usually about 13 to 15 per pickup. Specimens are packaged by putting multiple tubes in a Ziploc bag and placing the forms on the side pocket. These bags are then placed in a cooler box brought by CIDRZ’s driver. The facility is about 78 kilometres from CIDRZ’s laboratory and drivers pass through about 12 facilities in Kafue district to collect mostly DBS but also specimens for viral load testing, if available. Other facilities also bring specimens here, mainly for clinical chemistry tests and CD4 count, possibly courtesy of the DHO driver and vehicle (this is what the laboratory thought). Sputum samples are also sent to Kafue Estates RHC for GeneXpert testing, although it was unclear how they are transported there. There results do not come back to the laboratory but instead go directly to the data associate hired by CIDRZ, who is also housed in the hospital. The data associate enters results into SmartCare, the electronic medical records system.

4.3 Challenges The challenges that we heard around specimen referrals during the visit were varied and many, including problems with quality, timeliness, documentation, communication, transportation, coordination, etc. Some of the challenges and concerns are noted below:

a) Long turnaround time to return results to facilities due to the backlog b) Concern that the time between viral load specimen collection and reaching the assigned PCR

laboratory may exceed six hours, which would likely affect specimen quality c) Weaknesses in creating, disseminating, training on and enforcing standard operating procedures

(SOPs) to ensure quality and biosafety d) Insufficient guidance and materials for proper triple packaging, i.e. viral load tubes are wrapped in the

requisition forms and then put into a cooler box provided by CIDRZ’s drivers e) Lack of formalised and standardised training for drivers who are transporting specimens f) Laboratories are not recording specimens that are referred to a higher level before they leave, only

when the results are returned g) Similarly, for specimens that are received and then further referred by the mid-tier laboratory, there

is no quality check performed – the specimens are sometimes received in a box and the laboratory does not check/reject before passing along to the driver.

h) Drivers are not using chain of custody forms for any samples that are referred – there is no form signed by the facility and driver and laboratory to show chain of custody (although CIDRZ is adding this)

i) Communication is weak between testing laboratories and referral sites – facilities noted that if there are delays in testing and results return due to any reason (reagent stock outs, backlogs, equipment breakdowns, staff shortages), they are not notified by the testing laboratory and they are often not called if the testing laboratory finds a critical result, i.e. a positive EID

j) Reports of specimen rejection rates at the testing laboratories were varied but where rejections were noted, it was commonly cited as an insufficient amount of specimen quantity or incorrectly/incompletely filled paperwork

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k) Concern for what happens to specimen referrals as CIDRZ transitions its support of certain facilities to the MoH, including for specimen transport

There are also the broader issues with the laboratory, such as the reagent stock-outs, backlogs, insufficient HR, equipment breakdowns and lack of maintenance, which threaten patient care and management despite the continued purchase of new equipment. CDIRZ laboratory has enough capacity to store the specimens at -80oC, but the backlog plus current receipt of specimens is greater than the capacity of the equipment. As such, results are very delayed coming back from CIDRZ – the data associate said that results from specimens drawn in March are just being received, which begs the question of the relevancy of these results with relation to patient care, monitoring and treatment now that it is seven months later. UTH unfortunately can only store specimens for six weeks as they do not have the deep freeze capacity. They also experience frequent equipment breakdowns and problems with power cuts (their UPS is not working properly at the moment).

5. Initial thoughts on overall specimen referral network improvement In Zambia, it was found that there are various vertical systems that have been created for different disease programmes by different partners and for different laboratories at central level without significant effort toward integration or coordination. In the following sub-sections, various initial thoughts on improvement across the entire specimen referral network are listed, and these will be further explored in the next section. These options are not mutually exclusive so multiple suggestions can be considered and applied together.

5.1 Coordination of all specimen referral networks and stakeholders Even if the sample transport systems throughout the health system remain fragmented, there should be communication between the systems at all levels. To start, stakeholders from each sample transport system, referenced within this report but also beyond (possibly in other sectors that were not explored here within, such as for diseases under surveillance or outbreak response), should be convened, and overall systems supported, including operations and routing/schedules, should be presented. Any procedures, guidelines and policies should also be collected such that laboratories such CIDRZ, UTH and Maina Soko can take these into consideration by setting the overarching standard operating procedures (SOPs), guidelines and policies for any medical/health samples collected, packaged, transported, tested and results returned; these should all be part of the national laboratory strategy and policy. It would also be a good idea to create a laboratory handbook – this would be developed by the laboratory, but would primarily serve as a guide for clinicians and anyone who collects, packages and transports specimens and results. Although specimen referral will take a group of technical and implementing partners, clear leadership must be established, and broad stakeholder inclusion will be important. The broader stakeholder group should embark on strategic and operational planning for strengthening the specimen referral networks, meeting regularly to discuss sample transport, as a sub-group of the laboratory TWG. This sub-group should be governed by clear terms of reference.

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Regardless of who is deemed the coordination leader, there will likely also need to be a technical partner in-country to help with the organisation of partners as well as the implementation of any plans to move sample transport forward. This technical partner should be identified immediately (this may have already happened) and recognised by the group to support and work closely with the leader. It should also be discussed how to gain efficiencies and harmonise and/or integrate the various systems over time. This may not occur immediately, during which time it is important to at least set up the communication and coordination functions, but there should be plans for how to ensure that resources are not being used inefficiently under multiple sample referral networks. The components of a harmonised/integrated network are included in the following recommendations as well.

5.2 Clearly define a working agreement between MoH and ZDF, covering testing From interviews, a working arrangement and more formal memorandum of understanding (MoU) has been forged between the MoH and ZDF for HIV services and supplies. The MoU was mentioned to cover supply of consumables from the MoH to ZDF, but there seem to also be other collaborations underway. At least informally, the two work together in district or provincial hubs to serve as backup for each other’s laboratory services (if there are staffing shortages, equipment maintenance issues or reagent stock-outs). Further, the ZDF facilities currently refer all of their viral load testing/DBS specimens for EID to MoH laboratories, although, as mentioned previously, there is a charge for viral load testing. It is crucial to re-work the MoU to include a sharing of laboratory and other health services between MoH and ZDF, especially in light of the additional PCR capacity that ZDF will have at two of its hospitals, which will help to relieve the MoH system.

5.3 Exploration of further collaboration with ZamPost for higher-level referrals ZamPost is a state-owned enterprise (SOE) offering postal, courier, logistical and financial services. It sits under the Ministry of Transport, Works, Supply and Communication and covers all districts in the country through its 144 post offices. EMS Zambia utilises the post office infrastructure, including a fleet of delivery vehicles, and is currently used to transport DBS specimens across the country to their nearest PCR laboratory. However, partners utilising EMS have separate, non-transparent agreements with ZamPost instead of negotiating one, low bulk price that any partner could receive. It would be good to see if these contracts could be consolidated – and also if there is any interest/ability from ZamPost in carrying other specimens. In other countries across Africa, the national post system’s infrastructure is used for specimen referrals. In Ethiopia, for example, all specimens are shifting toward transport through the national post. Also, given that the post systems are a quasi-government agency, it makes it easier for the MoH to sustain this relationship in the future, when necessary. It would be advisable to have initial meetings with ZamPost once a sample transport lead is identified as one of the initial activities under the goal of strengthening specimen referral networks. If any agreement is reached, this must be captured in a written and signed contract – there are many examples that can be shared and guidance can be given. Beyond the contractual agreement, it is extremely important that the partnership as a whole is managed by the contracting agent, which should be the sample transport MoH government lead (even if the funding is coming from a third party) and reviewed on a regular basis with feedback given by both parties.

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Another government enterprise is Medical Stores Limited (MSL), which is an autonomous government agency established by an act of Parliament, located in Lusaka with provincial depots across the country. Although it may not be a system that can be used for specimen transport, its expertise in logistics and distribution, coupled with its strategic warehouse locations and distribution points, could provide insight into the logistics network for specimens. Further, given that MSL has recently started outsourcing to third-party transporters, it may be beneficial to discuss with them on how they implemented this system and how they currently monitor its performance.

5.4 Mapping of facilities and network optimisation/simulation exercises When information is collected on pickup and drop off sites, routes and schedules from each network, this data can be used to create a geographic information system (GIS) that can help visualise this information onto a map and input into further software programmes that can then help to rationalise and/or optimise the networks. One example of such open-source software called LabEQIP was created by a private company called Llamasoft under USAID funding for the Supply Chain Management System (SCMS) project. The programme can also simulate events such as adding new facilities or laboratory capacity to determine how that impacts the route network and the costs before such activities are actually carried out. In other words, ‘what if’ scenarios can be easily examined before any funds are spent irrationally. There are already efforts to use this software in Zambia for the immunisation supply chain, efforts of which could be built off to create specimen transport networks and schedules.

5.5 Analysis of transportation from primary facility to district laboratory Officially, there is no transport system to take the specimens from the health centre level to the district laboratory/DHO for testing or further referral. It is understood that there are facility motorcycles available at some sites. The MoH Laboratory Director also mentioned that Lusaka district used to collect and drop off proficiency testing samples in the entire province using four functional motorcycles owned by the district. However, funds to fuel and maintain them may or may not be available through the facility or district. The costs are likely low, as visits to the districts may be combined with other activities such as supplies’ pickup and meetings. The current practice is far less expensive for the central government (compared to buying new motorcycles for every health facility or creating a dedicated courier system) and may be more sustainable and/or preferable for now. Nevertheless, it would be worthwhile to do a cost analysis of ensuring that every health centre has a motorcycle that it can access for all activities at the facility, including sample transport (which would involve a gap analysis of which ones have and do not have facility motorcycles). This cost analysis should then be fed into the funding needs of the facility so it can account for this need in its overall budget. Further to the idea of access to transport at the primary health facility level, if samples are collected on certain days, this time should be built into the schedule of the vehicle so that other activities that require transport, such as outreach sessions, are not planned at the same time.

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Transport is necessary not only for specimen referral, but transport is an integral building block of the entire health system. Transport provides support for such areas as (a) supply chain management and distribution of medicines, vaccines, consumables, laboratory reagents and other commodities, (b) mobilisation of outreach health visits by individual health care workers or teams focused on priority areas such as immunisations to increase coverage and reach in catchment areas, (c) referral of patient specimens for diagnostic and monitoring purposes, (d) mobilisation of supportive supervision visits, (e) patient referrals, both emergency and non-emergency, etc. As such, it would be advisable for all activities to be examined to determine which ones require transportation – this can also be done at other levels of the health system (although it is somewhat outside of the scope of specimen transport).

6. Initial thoughts on system design for ZDF Design of a referral network for VL specimens to ZDF laboratories cannot happen without taking into consideration the public/MOH network and should happen holistically. The design should therefore take place only after discussions are had between the parties and ideally, a new MoU forged. It will also be good to keep in mind that ZPCT is currently validating DBS for viral load testing, which could make the transport much easier, as many sites (even non-ART sites) are already sending DBS for EID. Further, where it makes sense to transport other specimens at the same time (i.e. VL and DBS for EID, chemistry and hematology that is already referred to Maina Soko), this should be considered

6.1 Logistics Recommendations:

• Start with ZDF’s ART sites as the viral load specimen referral sites • Link those ZDF ART sites to the nearest MoH or ZDF provincial PCR laboratory • Build off of already-existing logistics networks where possible for specimen referral • For sites without any access to transport, work with the DHO/PHO to determine if support can be

provided by them for all (MoH and ZDF) facilities that require it Specimen referrals for viral load testing can only be effective in ART sites as viral load monitoring is done for patients on ART. Therefore, the ZDF facilities that are also ART sites needs to be fully confirmed to determine the pickup sites. It appears that 51 out of the 60 total ZDF facilities are ART sites (see Annex E). From those ZDF facilities providing ART outside of Lusaka and Copperbelt Provinces, it should be clarified that they will all refer viral load and DBS specimens to their provincial capital laboratory. As such, each of those ZDF ART sites should be assigned to its provincial PCR laboratory. There should be clear delineations/zoning of which facilities refer to which VL laboratories (see Annex F for an example of a template that could be used to document and share this zoning with all health facilities and laboratories) – and this zoning should not only stick to administrative boundaries, if possible, such as MSL did with its regional warehouses and distribution points. The zoning can start according to administrative boundaries but then it would be good to plot all ZDF facilities on a map to see which ones are too far to reach their respective provincial hospital laboratories within 6 hours. If there is a closer testing facility in a nearby province, the zoning should be reassigned.

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It would also be helpful to survey the current ZDF ART sites by phone or email to see which ones are already referring any types of specimens using their own transport means to a higher level (i.e. provincial testing laboratory) – these facilities should be the first in line for consideration to refer VL specimens. Similarly, they should be asked if any other partner is providing specimen transport support to them. For example, if there are specific ZDF facilities in Lusaka Province that receive specimen transport support from CIDRZ, ZDF should approach CIDRZ with the MoH to discuss if there is any possibility to drop certain specimens at Maina Soko Military Hospital. Although this may add a marginal additional cost to CIDRZ’s specimen transport system, it would also help with its capacity overload. For specimen referral logistics in Ndola, it should first be confirmed if one of the three PCR analysers will be transferred to Kitwe, which seems to make sense. Also, ADH is very close to Northern Command Military Hospital in Ndola and ZPCT mentioned that the specimen transport system implemented by the PHO/DHO carries about 700 specimens per week, which could potentially benefit Northern Command as well.

6.2 Communication Recommendations:

• Communication channels and contact details should be well documented and widely shared Communication systems need to be properly set up and implemented according to well-documented procedures as we have seen this area to be a challenge in the current referral networks. All contacts need to be documented and shared between referring facilities and receiving laboratories such that any delays in return of results, as well as any priority results, can be communicated via phone by the testing laboratory to the facility that referred the specimen. Similarly, there needs to be a dialogue between patients, clinicians and the laboratories so that all parties understand if there is a stock out/backlog or if equipment is down.

6.3 Training/sensitisation Recommendations:

• Broad sensitisation and stakeholder consultations should be conducted early on to ensure support from clinicians, laboratory staff, support staff, DHOs, PHOs, etc.

If all stakeholders are sensitised early on, it will make implementation smoother. Stakeholders extend beyond ZDF, MoH, implementing partners and donors in Lusaka to include clinicians, lower-level RHCs and laboratories, drivers, etc. Clinicians needs to be well-trained and sensitised on the use of viral load to regularly monitor patients on ART and where CD4 testing then fits in. ZDF staff needs to be sensitised that all DBS and viral load specimens will not go to the PCR analysers in Maina Soko and Northern Command and on the other side, provincial staff needs to be sensitised that ZDF’s specimens in their province will come to them for testing. Proper biosafety, packaging and quality training needs to be implemented to both laboratory, clinical staff and drivers and proper packaging materials must be supplied to the sites.

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6.4 Documentation/Monitoring and Evaluation (M&E) Recommendations:

• Consider M&E upfront during design phase and choose realistic indicators to track regularly • Ensure proper documentation and chain of custody of specimens and results throughout the entire

turnaround process It is crucial that the monitoring and evaluation system for the specimen referral network is considered upfront during the design phase. This would include quality control during specimen collection, packaging, transport, etc. It is very difficult to monitor and evaluate a specimen referral system due to data challenges, such as in tracking individual specimens, lack of detailed rejection logs at the laboratories and an incomplete cost pictures. To robustly measure performance of a specimen referral system, the following need to be documented:

1. Testing volumes at the laboratory to indicate increase in access to diagnostics 2. Individual specimen turnaround time from specimen collection to return of results 3. Rejection rates at the laboratory to measure quality of specimens received over time 4. Unit costs such as cost per specimen transported or result issued to measure system efficiency

At very least, recognising the gaps in the current system, specimens need to be quality checked and logged at the referring laboratory before they are sent on to the testing laboratory. Also, chain of custody/transport logs need to accompany the shipments to show at least how many specimens/results are transported per facility and should be signed by both sending and receiving parties, including drivers, along every change of hands.

6.5 Cost/sustainability Recommendations:

• In the longer-term, overall specimen referral networks should be optimised for sustainability and cost-effectiveness

Finally, but very importantly, although there are many ways to design a specimen referral network, options which are cost-effective and sustainable must be prioritised. This means that instead of creating an entirely new system for ZDF’s viral load network, it will likely be more cost-effective to merge it with other existing specimen referral systems where possible.

7. Limitations The initial assessment visit was five days, which is enough time to get a sense of the broad network for specimen referrals, but not enough time to gather much detail or cross-check information. There were meetings that we were not able to schedule in this short amount of time and time with individual implementing partners was not possible. We were able to do field visits, but this only included a small number of facilities, all of which were relatively easy to access from their referral locations. Cost details were also

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sparse but this information will be critical to better understand during the upcoming design and implementation phase.

8. Thank you and next steps The consultant is incredibly grateful to JSI for organising this consultancy, setting up, attending and providing background and logistics support and for the MoH and ZDF for facilitating this work and for ZDF accompanying the entire mission, as well as all of the individuals and entities that gave their time, opinions and critical information. This information has been compiled and consolidated in this report, but will hopefully also feed directly into the design and plan for ZDF’s viral load referral networks. The next steps may include follow-up on any additional information needed for the planning phase and then creating and implementing the designed network, with support from implementing partners, including PCI.

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Annex A: Terms of reference TERMS OF REFERENCE (TORs) John Snow Inc., DHAPP July 2016 Assessment of and Recommendation for Viral Load Sample Referral System Background The Zambia Defence Force Medical Services is initiating viral load testing in 2 sites. The DHAPP project, implemented by JSI, has been instrumental in installation and training of the new viral load testing equipment. The US DOD Zambia team has request JSI to provide recommendations for the future DHAPP implementers on appropriate viral load referral systems for their facilities. Scope of Work The Consultant will review and report on existing referral networks for viral load testing in the Ministry of Health (MOH) and provide recommendations on a proposed system for the Zambia Defence Forces (ZDF) to implement. The objective of this activity includes:

• Work with local partners, MOH, ZDF, DOD, CDC, etc. to conduct a situational analysis of the status of sample referral systems for viral load testing. This includes:

a. Information and data collection, analysis and review, and a report on existing referral networks in Zambia

b. Evaluate status, coverage, strengths, readiness to respond to viral load scale up and running costs (where available) for existing networks

c. Examine existing infrastructure such as road networks, courier companies, seasonal weather conditions and ability to maintain cold chain, among others

d. Provide a summary reports on status of referral networks with recommendations for a sample referral network for ZDF, including a proposed rollout/implementation of the recommended plan.

Timeline The consultancy will run from 29th August through 31st October with a maximum of 20 billable days. These days would include administration and desk-based reviews (if possible) followed by travel and an in-country visit for a week. During the visit, from 26th to 30th September, interviews with key stakeholders would be held in Lusaka and then a visit to one referring health centre and one laboratory would be arranged for the consultant. After this, the information would be analysed and the final report would be due to JSI, DHAPP by 31st October.

Deliverables • Summary report on current referral systems for viral load samples in Zambia and recommendations

for a proposed ZDF referral system to be implemented by the DHAPP project.

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Annex B: Proposed schedule of visit

Day Time Facility Focus Areas MOH/ZDF Persons Responsible

JSI

Monday

31-10-2016

09:30 – 12:30

14:00 – 17:00

AIDSFree

Mika Hotel

Getting orientation with the situation in the ZDF – the laboratory network, the laboratories and capacity, meeting any relevant stakeholders.

Meeting partners involved in VL sample/results transportation to and from testing laboratories.

Dr. Malyangu

MoH, ZDF, PCI, JSI-DISCOVER, CHAZ, CHAI, ZPCT, FHI360, CIDRZ

Wendy/ Kameko – Consultant/ Lucas

Tuesday

01-11-2016

08:30 – 16:00

14:30 – 15:30

MOH HQ, CIDRZ-Lab, UTH Viral Load Laboratory and Mina Soko Military Hosp.

Visit MoH/ZDF viral load laboratories in Lusaka.

Visiting MoH laboratory directorate to get an idea of what is happening in the non-military systems

-Kingsley Lapukeni MoH,

-Dr. Malyangu - ZDF

Kameko – Consultant/ Lucas

Wednesday

02-11-2016

08:30 – 16:00 Chongwe District Hosp,

ZNS Chongwe

Visit some sites that refer samples to the testing laboratories, preferably rural facilities within Lusaka province.

MoH/ZDF Kameko – Consultant/ Lucas

Thursday

03-11-2016

08:30 – 16:00 Kafue District Hosp, Kafue Estate Clinic, and Apollo-

ZAF Mount Eugene

Visit some sites that refer samples to the testing laboratories, preferably rural facilities within Lusaka province.

MoH/ZDF Kameko – Consultant/ Lucas

Friday

04-11-2016

08:30 -12:00 AIDSFree Conference room

Debrief to stake holders MOH, ZDF and Partners

Kameko – Consultant/Wendy/Lucas

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Annex C: List of informants (in order of meeting)

Organisation/Department Name Position

John Snow, Inc.

Wendy Nicodemus Country Director Lucas Msimuko Systems Implementation Specialist

AIDSFree/DHAPP Kalasa Mwanda Deputy Project Director – Clinical Care,

USAID DISCOVER Health Maureen Simuyandi Deputy Country Director, AIDSFree

Maina Soko Military Hospital

General Evans Malyangu Pathologist / Commandant, Maina Soko Military Hosp. (DFMS)

Lt. Colonel B.B. Chungu Biomedical Scientist Lt. Colonel O. Muleba Biomedical Scientist

Clinton Health Access Initiative Jacob Chatora Laboratory Technical Advisor – Peds HIV

University Teaching Hospital (UTH) Dr. Hamakwa M. Mantina Head – Dept. of Pathology &

Microbiology Katoba Kanjere Musukwa Principal Biomedical Scientist

ZPCT Hilary Lumano Senior Laboratory Advisor CHAZ Powell Choonga Senior Laboratory Specialist

Mike Masona Laboratory Logistics Officer

PCI

Winfred Khondowe Deputy Program Manager Victor Mulubwa Supply Chain Advisor Darius Simbeye Laboratory Advisor Webster Sikazwe Supply Chain Management Officer

EQUIP Health Thikazi Jere Clinical Manager Angela Taylor Strategic Advisor Damaseke Sheltone Clinical Coordinator

CIDRZ Ranjit Warrier Laboratory Director Mabvuto Phiri Laboratory Operations Manager Felicitas Mwale Laboratory Services Coordinator

Chongwe DHO Kenneth Lwando District Pharmacist Chongwe RHC Edward Kabwe Laboratory Technologist Ministry of Health Davy Nsama Deputy Director – Laboratory Services Chongwe District Hospital George Manda Lab. Attendant ZNS Chongwe Clinic Susiku Mwitumwa Dennis Data Associate

Kafue District Hospital Josephine Banda Laboratory Technologist Mulasikwanda Wakumelo CIDRZ Data Associate

Kafue DHO Emmanuel Chitukwi Data Associate Kafue Estates Health Centre Constance Chitusha Lab Technologist ZAF Mount Eugenia Maj A. Moonga Nurse Midwife

Mwaba Fred Laboratory Technician

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Annex D: List of viral load laboratories in Lusaka and Ndola

Province Name of Laboratory Viral Load Equipment

Lusaka CIDRZ Roche Taqman 96 x 2 Abbott m2000 (non-functional)

University Teaching Hospital (UTH) – Adult Centre of Excellence UTH – Virology Laboratory

Roche Taqman 96 Roche Taqman 48

Maina Soko Military Hospital Roche Taqman 48 Copperbelt Ndola Regional Hospital Roche Taqman 48

Arthur Davidson Children’s Hospital (ADH) Roche Taqman 96 Northern Command Military Hospital Roche Taqman 48

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Annex E: ZDF Health Facilities by Province (next page)

Facility Name Level District Province Catchment population

ART Site?

Smart-care

Previously Referring

to:

Provincial testing facility

Distance to

Provincial Hospital

1 Northern Command Military Hospital Hospital Ndola Copperbelt 50,000 Yes No

Ndola Central Hospital

Northern Command

Military Hospital

0 2 1 Commando Camp Clinic HC Ndola Copperbelt 5,007 Yes Yes 15km 3 Kalewa Camp Hospital HC Ndola Copperbelt 9,263 Yes Yes 3km 4 Taung-up Army Urban Health Centre HC Mufulira Copperbelt 5,808 Yes Yes 68km 5 Tug-Argan Camp Clinic HC Ndola Copperbelt 8,926 Yes Yes 72km 6 ZNS Kitwe HC Kitwe Copperbelt 6,633 Yes Yes 60 km 7 ZCCF Kitwe HC Kitwe Copperbelt 2,000 Yes Yes 8 Maina Soko Military Hospital Hospital Lusaka Lusaka 30,000 Yes Yes

UTH/CIDRZ

Maina Soko

Military Hospital

0 9 Army School of Ordinance HC Lusaka Lusaka 13,000 Yes No 10 L 85 HC Lusaka Lusaka 18,000 Yes No 11 Arakan Barracks (2ZR) Urban Health Centre HC Lusaka Lusaka 20,000 Yes Yes 1km 12 Mikango Camp RHC HC Chongwe Lusaka 6,079 Yes Yes 35km 13 ZAF Logistics Command HC Lusaka Lusaka 3,000 Yes No 13km 14 ZAF Lusaka Base Sick Quarters HC Lusaka Lusaka 1,773 Yes Yes 26km 15 ZAF Medical HQ Lusaka Hospital Lusaka Lusaka 3,086 Yes No 2km 16 ZAF Mt. Eugenia Rural Health Centre HC Chilanga Lusaka 20,000 Yes Yes 20km 17 ZAF Twin Palm HC Chongwe Lusaka 12,094 Yes Yes 7km 18 ZNS LDB Headquarters Clinic HC Chilanga Lusaka 7,000 Yes No 2km 19 ZNS Chamba Valley HC Lusaka Lusaka 4,000 Yes No 20 ZNS Chikumbi (Lusaka) HC Lusaka Lusaka 6,000 No No 21 ZNS BB (Lusaka West) HC Lusaka Lusaka 4,000 Yes No 22 ZNS Makeni HC Lusaka Lusaka 8,000 Yes Yes 13km 23 ZNS Safaris HC Chilanga Lusaka 3,500 No No 37km 24 ZNS Kafue HC Kafue Lusaka 1,880 Yes Yes 54 km 25 ZNS Sopelo (Lusaka West Camp Clinic) HC Kafue Lusaka 10,339 No No 52km 26 ZNS Chongwe Health Post HC Chongwe Lusaka 4,746 Yes Yes 51km 27 ZNS Airport Farms HC Chongwe Lusaka 3,667 Yes No 30km 28 ZNS Nyimba HC Nyimba Eastern 9,247 Yes Yes 229km

29 ZNS Lumezi HC Lundazi Eastern 6,371 Yes Yes Chipata General Hospital

173km 30 ZNS Mutetezi HC Katete Eastern 5,774 Yes Yes 71km 31 ZNS Chiwoko HC Chipata Eastern 9,247 Yes Yes 51km 32 Eastern Region HC Chipata Eastern Unknown No No 1km 33 Gondar Barracks HC Chipata Eastern 14,174 Yes Yes 15km 34 ZNS Mangango HC Kaoma Western 3,560 Yes No Lewanika

General Hospital

35 Western Region HC Mongu Western Unknown No No 5km 36 Luena HC Kaoma Western 5,317 Yes Yes 190km 37 ZAF Mbala HC Mbala Northern 5,003 Yes Yes

Kasama General Hospital

167km 38 ZNS Mbala HC Mbala Northern 8,352 Yes No 169km 39 Northern Region Camp clinic HC Kasama Northern Unknown No No 40 ZNS Chishimba HC Kasama Northern 8,419 Yes No 41 ZNS Mpika HC Mpika Muchinga 2,825 Yes No 42 ZNS Luamfumu HC Mansa Luapula 7,452 Yes Yes Mansa

General

43 Luapula Regional Clinic HC Mansa Luapula Unknown No No 44 ZNS Mumbezhi HC Solwezi Northwestern 2,334 Yes No

Solwezi General Hospital

45 ZNS Kamitonte HC Solwezi Northwestern 4,354 Yes Yes 46 ZNS Katandano HC Solwezi Northwestern 4,200 Yes Yes 47 North-Western Region HC Solwezi Northwestern Unknown No No 48 ZNS Choma HC Livingstone Southern 2,656 Yes Yes Livingstone

Central Hospital

49 ZAF Livingstone HC Livingstone Southern 4,025 Yes Yes 7km 50 Southern Region Clinic HC Livingstone Southern Unknown No No 51 Mecco (Kanona) HC Serenje Central 9,396 Yes Yes

Kabwe General Hospital

52 ZNS Luanshimba HC Mukushi Central 1,397 Yes No 53 ZNS Munsakamba HC Mukushi Central 3,126 Yes No 54 Chindwin Camp Hospital HC Kabwe Central 6,471 Yes Yes 15km 55 Kohima Camp Hospital HC Kabwe Central 3,124 Yes Yes 15km 56 ZAF Kabwe Sick Quarters HC Kabwe Central 3,124 Yes Yes 14km 57 ZAF Mumbwa HC Mumbwa Central 5,282 Yes Yes 148km 58 ZNS Kabwe HC Kabwe Central 5,356 Yes Yes 17km 59 ZNS Chisamba HC Chisamba Central 9,988 Yes Yes 148km 60 ZNS Kalenda HC Mumbwa Central 2,665 Yes No 156km

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Annex F: Template for assignment of health districts to reference laboratories for Early Infant Diagnosis (EID) and viral load testing

Reference Laboratory Health Districts University Teaching Hospital (Lusaka)

CIDRZ (Lusaka)

Maina Soko (Lusaka)