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Future Collaboration to Enhance Clinical Labs for Human and Animal Health

REMARKS BY GUEST OF HONOR

Arshad Ali, Executive Director of the Higher Education Commission (HEC), noted that the feedback he received about the workshop was extremely positive. He congratulated the organizers, especially the Pakistan Academy of Sciences (PAS) and the team from the National Academies of Sciences, Engineering, and Medicine (the National Academies) who supported this event. He noted that PAS does have a program to facilitate full membership of young scientists, and it should consider developing a program that would encourage young scientists to be involved before they become full PAS members. This could take the form of a young science leaders program, for example. HEC is also interested in programs that help promote young scientists and asked the group to follow up with suggestions and ideas. The real potential lies in the young generation and younger scientists, he said, and that is where opportunities should be created.

He said that workshops are an extremely important activity in creating the environment for knowledge sharing, as well as building relationships for further research collaboration. HEC is very interested in supporting research programs, especially programs that benefit society. HEC has developed a scheme in which it will fast track approval for research proposals with a funding commitment from the private sector of approximately 20 percent. For research programs that have direct impact on society, a similar process is planned so that the relevant HEC committee will be able to make a

decision on a faster track. HEC is also devising criteria related to faculty promotions, benefits, and rewards for basic and social sciences on separate tracks as compared to one criterion for proposals from all disciplines combined. Parameters in some disciplines, such as engineering and computer science, have been finalized. He looked forward to support from basic science experts in defining the criteria for those disciplines related to the issues discussed at the workshop. Relevant professionals are the best people to define criteria or parameters.

KEY INSIGHTS FROM BREAKOUT SESSIONS

Participants joined one of three breakout sessions on Information and Capability Needs of Labs; Information Needs at the Central Government Level; or Working toward an Electronic Morbidity and Mortality Weekly Report Model for Pakistan. The groups met concurrently, and session moderators presented reports summarizing the group discussions. In each breakout session, moderators led discussions designed to explore the information and capability needs of individual labs, the information needs of the national and other government agencies, how to work toward establishing an electronic-based reporting and communication system, and other issues related to creating better laboratory networks.¹ A key theme that emerged from the breakout sessions was the importance of effective communications and trust between leaders and practitioners. The breakout session reports offered a wide-range of proposals for sustainable laboratory enhancement that propose a solid foundation for future PAS-National Academies meetings. Summaries of the breakout session reports are presented below.

INFORMATION AND CAPABILITY NEEDS OF REMOTE LABS

Aamer Ikram moderated the breakout session on information and capability needs of remote labs. Participants examined the general information and capability needs of human and veterinary labs in Pakistan. The discussion in the session began with the geography of the country, which is diverse in climate and population density, which means that a multiplicity of issues needs to be taken into consideration when determining how to strengthen labs to, in turn, strengthen human and animal health. One size

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¹ See Appendix C for the breakout session questions.

does not fit all. At the district level, Pakistan has disparate veterinary labs as well as veterinary officers and mobile services.

At the national level, the country also has resources available through the Pakistan Agricultural Research Council and the National Veterinary Lab. Workshop participants considered how best to connect human primary, secondary, and tertiary labs; research institutes; private diagnostic labs; and different tiers of animal facilities to include those under the Livestock and Dairy Development Department, Veterinary Research Institutes, and Poultry Research Institutes in Pakistan. On the human side, even in remote areas, there is some medical care. On the animal side, labs are only available at the district level, which is a point of concern. Many laboratories that need specialized training in pathology do not have it. The lower tiers tend to be neglected, and all tiers need regular refreshers. Training needs are different for those at higher and lower tiers, but in general are less urgent than on the animal side.

Laboratory equipment and instrumentation maintenance is needed, and Pakistan has regulatory guidance available under the rules and guidelines of the Pakistan Procurement Regulatory Authority. End-user satisfaction is important for lab technicians, including on maintenance and after-sales service. Human resource needs include the need for biomedical engineers, and the prioritization and incentives for those in remote areas, which are otherwise underserved. On the veterinary side, remote areas are neglected. Post-graduate and other courses and refreshers are needed at all levels. Quality assurance needs attention. Certification/accreditation can help, along with the availability of controls, and a national repository. The National External Quality Assurance Program Pakistan is a low-cost option for external evaluations. The National Institute of Health, Pakistan plans to launch a national program on these issues.

Participants identified several cost-effective means for improving the capability of remote labs, including: leadership, training, assessment of proper requirements, and local production of kits and reagents. Special attention needs to be paid, possibly through additional PAS-National Academies workshops, to training all tiers of veterinary lab staff, providing staff with refresher courses, strengthening remote facilities, enhancing collaboration between the human and animal sectors, instituting quality control for all, and introducing more biomedical engineering expertise. Networking at all levels, including at the international level, is key.

INFORMATION NEEDS AT THE CENTRAL GOVERNMENT LEVEL

Ali Khan moderated this session, in which the task was to discuss and broadly rank-order the information needs of the national government. He said that participants discussed three key points: the lack of mandatory reporting of notifiable diseases; the lack of a national disease surveillance system, except for some disease-specific vertical systems (e.g., polio, tuberculosis [TB], HIV); and the lack of a laboratory response system. He said that an opportunity exists for the National Academies and PAS to convene relevant stakeholders to catalyze a strategic plan and innovative solutions to address these needs.

Participants characterized clinical labs in Pakistan. Within animal health, under the Ministry of National Food Security and Research, there are select areas of excellence. For example, they use the World Organisation for Animal Health (OIE) list of notifiable diseases. The Punjab SMS notification systems uses dengue larva detection as part of a pilot project in which photographs were used to show people why pesticides were necessary. Otherwise, paper-based surveillance is used. In the human health sector, the Ministry of National Health Services, Regulations, and Coordination oversees public clinical and specialized labs. Among the specialized labs, there are approximately 13 for TB, 8 for influenza, and 5 for hepatitis. In the private sector, there is a large number of commercial and academic labs and several smaller clinical labs. The large commercial labs provide patients with the means of seeing their lab results online. This indicates that most of these labs already have laboratory information systems in place, and the data from their systems can therefore be reported to the government. Khan learned during the workshop that negotiations are under way to allow for data integration, but this is difficult for a variety of reasons. Clearly, there are electronic data that one can acquire. The issue is never the technology; it is the people and the need for communities of trust to allow the data to be shared. Khan noted that there are no training standards for lab workers and accreditation in Pakistan is currently voluntary.

The central government has three main areas of data needs: (1) syndromic surveillance (to include acute flaccid paralysis, meningitis, bloody or watery diarrhea, unexplained severe fevers, severe respiratory illness, and hemorrhagic disease); (2) event-based surveillance (through provincial Disease Surveillance and Response Units); and (3) laboratory surveillance (for priority diseases such as measles, Crimean-Congo hemorrhagic fever,

polio, HIV, cholera, dengue, rabies, tetanus, meningitis, and whooping cough). Data can be transmitted via SMS, smartphone apps, photos, email, or fax.

Khan then reported on proposed, short-term, cost-effective suggestions from the breakout group regarding how to improve the disease surveillance system in Pakistan. The first and most important element of an effective system is commitment to the National Surveillance and Integrated Laboratory Network. All of the other pieces can come together, but until there is a national commitment, no system will be sustainable. Suggestions for improving the disease surveillance system include the creation of:

• A list of priority diseases and passage of legislation for mandatory reporting of notifiable diseases
• Training sessions for all practitioners (animal and human) on the list of notifiable diseases
• Universal access numbers for reporting health hazards/unusual illness/clusters
• A national disease surveillance system, possibly on the backbone of the District Health Information System
• A sentinel syndromic reporting system at select sites that would allow for establishment of a national baseline
• A National Laboratory Response Network with a coherent strategy; at least one public health lab in each province; enrollment of large commercial labs and those already equipped with a Laboratory Information Management System to report data; and a list of labs, including tiers with the appropriate training, information exchange, and accreditation for each tier

In general, the elements of an improved disease surveillance system collectively suggest that the government should work to strengthen rural health systems and incorporate them into the national/provincial system.

Suggestions in the breakout group also addressed what different stakeholders could do. PAS could convene relevant stakeholders for a dialogue on a national laboratory system and technical solutions with recommendations on how to proceed. Ministries could play a role in supporting research by facilitating sharing of information and samples. PAS could play an additional role by disseminating research information to the relevant ministries and the health community.

WORKING TOWARD AN ELECTRONIC MORBIDITY AND MORTALITY WEEKLY REPORT MODEL

The third breakout group was chaired by Affan Shaikh. While discussing how Pakistan can work toward an electronic Morbidity and Mortality Weekly Report (MMWR) model, participants considered the following questions: How can the Ministry of National Health Services, Regulations, and Coordination efficiently distribute epidemiologic information? What communication capabilities are available to laboratories? What are some incentives that could encourage reporting? How can two-way communication be facilitated?

Based on the discussion and his previous work, Shaikh created a data-flowchart mapping the disease surveillance process from the the subdistrict (tehsil) level to the district, divisional, provincial, and national levels for both human and animal health. At the subdistrict level, Rural Health Clinics (about 1,800 in total), Mother and Child Health Centers (about 1,500), and Basic Health Units (more than 5,000) make passive surveillance contributions to the Health Management Information System dashboard operated by the Ministry of National Health Services, Regulations, and Coordination (see earlier workshop presentation about the Dashboard, see Figure 4-1). Patients send a sample to the district level for laboratory diagnoses because there are no labs at the subdistrict level. At the district level, District Headquarters and Technical Headquarters provide passive surveillance data to the dashboard. Public health benefits of disease surveillance include a disease survey, vaccinations, and 24-hour response.

At the subdistrict level (tehsil) on the veterinary side, there are veterinary offices and veterinary assistants who report to the principal veterinarian. Breakout group members estimated that approximately 95 percent of centers at the subdistrict level have basic SMS coverage in Urdu, Roman Urdu, and/or English, and about 50 percent have greater data coverage (that would allow them to send pictures of a rash, etc.). They can report emergences, suspect cases, signs/symptoms, and tests needed at the subdistrict level via text message. In Punjab, for example, 6.5 million farmers are registered in a mobile veterinary service.² This access provides vital services to them.

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² 2016. Working toward an Electronic “MMWR Model:” How can the Ministry most efficiently distribute such information. Breakout Session C. A Joint Pakistan-U.S. Workshop on Strengthening and Sustaining a Network of Public and Animal Health Clinical Laboratories in Pakistan. Islamabad, September 27-29.

On the animal side, there are Division Livestock Officers. At the top of the data flow chart are the provincial and national levels. It is reasonable to presume that all labs have access to computers and internet at the district level, many participants concluded. At the divisional level, there are Regional Referral Hospitals with their own labs, and often when a subdistrict or district lab in certain provinces does not have facilities to conduct a specific pathogenic test, samples are sent directly to the Regional Referral Hospitals. The Provincial Director General reports to the Chief Veterinary Officer. These data are sent to the dashboard. It was unclear from the breakout session discussion how the specialized units conduct sample collection and how the data are integrated into the IHR frameworks.

Next Shaikh described the laboratory needs as described by session participants. These include diagnostic equipment, greater professionalism in reporting, feedback from officials at higher levels and increased coordination with labs, including at universities.

Participants also discussed incentives to encourage greater reporting. Health insurance mechanisms were discussed as possible aggregating channels; however participants largely felt that they would complicate rather than simplify efforts. Proposed incentives for greater private-sector reporting included regional reporting linked to accreditation and certification whereby failure to report would result in penalties. Centralized applications or software solutions were also proposed wherein data would be collected (e.g., a laboratory management system). Participants suggested that a decrease in the gap in training and equipment may facilitate greater reporting between private and public labs. These improvements would increase public confidence and encourage greater use of public labs resulting in faster treatment.

As was noted in the breakout session, many people never receive treatment based on lab tests. Rather, if one treatment fails, another is tried, and this process is repeated over and over. It became clear that officials need to study this situation and determine why so many people do not receive diagnostic tests. Labor costs and lag time were suggested as possible reasons. These could be contributing factors to the lack of livestock testing as well. Given distances to labs, at times up to two hours away, it may be impossible for people to travel or take livestock to diagnostic labs. Cultural change was also discussed as critical: how can people be encouraged to have the necessary tests and to receive the proper treatment?

Another point discussed in the session was two-way communication, which is how the government engages the reporting entities, avoiding

scenarios of one-way communication from labs to the ministries. In this regard, participants proposed the development of standard operating procedures and guidelines, including how to share and receive samples, and how to report data. Specific feedback on reporting was also suggested so that officials can improve the quality of reporting. Routine as well as situational data are both critical, which is one reason why MMWR is so helpful. Participants expressed interest in targeting data collection, reporting and feedback to particular regions, and making summary reports in full available to other regions on a confidential basis. The OIE World Animal Health Information System may be a model.

Shaikh concluded by drawing upon his recent experience in Swaziland and the African Field Epidemiology Network where he and his colleagues undertook a similar mapping exercise in six countries of how disease surveillance is conducted using information technology. The key to success is building the lower-level building blocks of public and animal health surveillance before proceeding. This means that there is a need for a more comprehensive understanding of what is occurring at the lower levels with government organization frameworks, national legislation and policies, procedures and practices, and workforce capability. Public health surveillance could be strengthened by mapping Pakistan’s data flow related to reporting, analysis, response, and feedback activities. A baseline SWOT (strengths, weaknesses, opportunities, threats) assessment of capacity could help, based on key informant interviews, focus group discussions, and a desk review. This includes structural issues, such as clearly defined roles and responsibilities, coordination, and data sharing mechanisms. He also suggested an information and communications technology assessment and implementation of appropriate e-Surveillance tools.

Shaikh concluded with a quote by Nelson Mandela: “It always seems impossible until it’s done.”