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Effective Use of Clinical Laboratory Data

INTRODUCTION TO THE PAKISTANI MINISTRY OF NATIONAL HEALTH SERVICES, REGULATIONS, AND COORDINATION DASHBOARD

Ahsan Maqbool Ahmad from the newly formed Health Planning, Systems Strengthening and Information Analysis Unit of the Ministry of National Health Services, Regulations, and Coordination introduced the new Pakistan Health Information System dashboard (see Figure 4-1) developed by the Ministry of Health Services, Regulation, and Coordination to improve public health through improved disease surveillance.¹

The tool, created with U.S. Agency for International Development assistance, is intended as a central health information portal with links to provincial health departments and other health information systems throughout Pakistan. It is a useful repository of information, but it is not intended to be a real-time disease surveillance tool. It provides a tool to share integrated health services, logistical, and surveillance data.

The need for the dashboard arose particularly after the devolution of healthcare responsibilities to the provincial level in 2012, which significantly disturbed the vertically-integrated systems.

Ahmad led workshop attendees through a real-time demonstration of the system’s dashboard. The system houses the results of several public

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¹ Government of Pakistan. 2016. Pakistan Health Information System (PHIS)–Integrating health services, logistic and surveillance data. http://nhsrc.pk/.

health surveys based on lab diagnostic tests, which are publicly available. Following International Health Regulations (IHRs), both public and private labs are to report on all notifiable diseases by law, and experts in Pakistan are working toward full compliance. At the time of the workshop, there were 2,200 private practices linked to the system in the first phase. In addition, each district of Pakistan reports monthly on specific diseases and about 10,000 community-based centers also submit data, all of which are available via the dashboard. Pakistan has a successful Lady Health Worker program, which employs female health workers at the community level in the areas of disease prevention, diagnoses, treatment, and data submission.² Beyond geographically-collected data, the dashboard contains information on a disease-specific basis, especially for malaria, tuberculosis, and hepatitis. Along with survey results and data provided by province and district, disease trend lines have also been included. Ahmad provided an example of survey data of vaccinations across districts and subdistricts by age. These trend lines allow health officials to measure progress against goals.

The next stage of dashboard development under way at the time of the workshop was the integration of information from national healthcare accounts, which should help officials understand the returns on investments in healthcare delivery and the performance of the country against given indicators. For example, they hope to track how individuals’ healthcare expenditures have changed over time and to indicate the rates of vaccination. The dashboard displays government spending on healthcare over time (2005-2013). The logistical portion of the dashboard shows how vaccines are distributed and administered.

Another application of the next phases in dashboard development includes the ability to evaluate the performance of provincial departments of health against indicators such as management of health services, monitoring and supervision, and service delivery (each category with sub-indicators). The dashboard is a primary means by which Pakistan seeks to improve disease prevention, detection, and response across the entire country.

In response to a question during the discussion period about data quality, Ahmad replied that this concern was a motivator for the development of the dashboard because following devolution,³ there was a lack of consistency of reporting and data quality across provinces. For example, as

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² For more information see https://www.who.int/workforcealliance/knowledge/resources/casestudy_pakistan/en.

³ See https://www.hks.harvard.edu/publications/decentralization-pakistan-%ADcontext-content-and-causes.

part of the development of the dashboard, in 2015 and 2016, Baluchistan was able to convert its data and data reporting to online mechanisms. Overall, in December 2015, prior to completion of the dashboard, there was approximately 58 percent compliance with regard to data submission. In February 2016, the compliance rate increased to approximately 90 percent. The process helped facilitate reporting, which contributed to increased compliance rates. With regard to data quality, cross-province/district comparisons made possible through the dashboard allows professionals to identify anomalies more easily. Training of local professionals was also under way, which will aid the consistency and quality of data submission; 52 checklists are to be followed on how to monitor and report activity on a monthly basis. To facilitate timely reporting, a point raised by David Franz, Ahmad noted that each district now has two computer operators that receive the data reports from the facilities and between the 25th and 26th of each month, they digitize and submit the data by the 1st of each month. Going forward, they hope that data will be submitted on notifiable diseases on a weekly and daily basis, which would coincide with the IHRs.

Pakistan, as a Global Health Security Agenda signatory,⁴ is working toward integrated disease surveillance mechanisms. Pakistani experts are also working to link the dashboard to the relevant systems under the One Health concept, such as those related to biosafety and biosecurity. Other linkages include climate change information, ports of entry, livestock, and universities. Finally, they are working on province-level road maps and strategies.

A.Q. Javed Iqbal from the Ministry of National Health Services, Regulations, and Coordination underscored during the discussion that the government of Pakistan is ready and committed to helping the Pakistan Academy of Sciences (PAS) in its efforts in this area, and to accomplishing the goals for the dashboard articulated by Ahmad. He also reflected on challenges to healthcare that may be elevated with more data from the dashboard, including predisposal factors such as a lack of nutrition.⁵ He

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⁴ See https://ghsagenda.org/ for more information about the Global Health Security Agenda.

⁵ For detailed statistics on malnutrition in Pakistan, Iqbal referenced: Bhutta, Z., Soofi, S., Zaidi, S., Habib, A., and Hussain, I. 2011. Pakistan National Nutrition Survey. 2011. Government of Pakistan. https://ecommons.aku.edu/pakistan_fhs_mc_women_childhealth_paediatr/262.

For an updated version, see Government of Pakistan. 2018. National Nutritional Survey 2018: Key Findings Report. https://www.unicef.org/pakistan/media/1951/file/Final%20Key%20Findings%20Report%202019.pdf.

said approximately 20-25 percent of Pakistan’s population has nutritional deficiencies. Given the importance of the dashboard, Iqbal reiterated the support of the government and expressed optimism that the initiative will be a success.

As a pharmacologist himself, Iqbal noted the disparity of the availability of pharmaceuticals for humans and animals in Pakistan. The government has tried to address this seriously. Transparency of actions in addressing this challenge has also been a priority for the government. The need to develop strong drug testing labs is important. In 2014 the government had applied for pre-qualification certification for one private laboratory in Pakistan by the World Health Organization (WHO).⁶ Pakistani government officials hope this process will be completed soon.

Finally, Iqbal noted that as the number of laboratories increases, a SWOT (strengths, weaknesses, opportunities, and threats) analysis needs to be conducted to determine the number and types of labs that are actually needed. This is a task with which PAS could ably assist the ministries. Franz followed this comment by requesting suggestions on how U.S. National Academies of Sciences, Engineering, and Medicine could help Pakistan improve reporting at the more local levels, particularly in more remote areas. Iqbal replied that assistance with regard to capacity and resources at the district or subdistrict level would be helpful.

HARNESSING MODERN COMMUNICATION FOR IMPROVED DISEASE SURVEILLANCE

Affan Shaikh began by discussing opportunities to use new technology to improve public health communication. He described these as “disruptive innovations,” the concept of transforming products and services using information technology innovations to make existing services and industries more affordable and accessible. Examples of “disruptors” and “disruptees” (the product or service being disrupted) include personal computers and mainframes, and cell phones and fixed-line phones.

Over the past century, extremely rapid human transportation and communication; frequent mass gatherings of people in one space and time; and the growing immediacy of the interaction between animals and humans

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⁶ This laboratory obtained WHO prequalification in 2014, followed by a voluntary withdrawal in 2016. See Rasheed et al. 2019. Journal of Pharmaceutical Policy and Practice 12(23):5. https://doi.org/10.1186/s40545-019-0184-z.

have all posed risks to global health security. Fast and reliable laboratory diagnosis and better management make a difference, with turnaround time (TAT) as an important indicator. There have been improvements in laboratory capacity and infrastructure, and advances in information and communication technology and transport, yet the struggle to improve TAT continues. Often human and animal health clinics are located far from diagnostic laboratories. The time required to transport samples between clinics and labs affect TAT as well as the time required for healthcare professionals and patients to receive necessary reports.⁷

Before proceeding to the details, Shaikh stated that it is critical to remember that the goal of improved communications is the set of solutions that the technologies can bring, not the technologies themselves. Modern mobile communications, including increased use of Short Message Service (SMS, texting) applications and wireless internet on phones, are becoming ubiquitous and can improve TAT. Of the 5 billion global wireless subscribers, greater than 70 percent reside in low-resource countries. Often mobile networks have greater coverage than roads, telephone lines, electricity, or wired Internet. Mobile phone networks allow for electronic surveillance to empower and enable efficient and effective public health workflow processes designed to prevent, predict, detect, and respond to infectious diseases. Public health informatics is a growing field leveraging public health surveillance (PHS) with the power of technology and its capacity to analyze digital data. What used to take hours with paper and pen can be accomplished now with a few keystrokes and clicks of a mouse.

The vision that emerges is a public health workforce that can implement the latest techniques and use the latest technology to share the best practices and networks locally, nationally, regionally, and globally. The future state of PHS will have public health data, information, and messages available whenever they are needed, wherever they are needed. An analogy may be the availability of weather data via a cell phone app, Shaikh explained.

Another important concept is that of “One”: one sign-on entry, one set of informatic standards, one-stop shopping for information, one set of tools for viewing and managing information, one set of guidelines for establishing and managing databases, One Health, one system that allows individual

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⁷ The report Transforming Public Health Surveillance provides some ideas for solutions. See Mcnabb, S. N., et al. 2016. Transforming Public Health Surveillance: Proactive Measures for Prevention, Detection, and Response. https://www.elsevier.com/books/transforming-public-health-surveillance/jn-mcnabb/978-0-7020-6337-4.

access from any device, one source for customized views and databases, and one set of tools for public health management.

As PHS expands with digital and wireless communications, uniform standards will further advance adoption, integration, and benefit. Standardization of the following processes and tools are particularly beneficial:

• System sign-on and data entry
• Data collection for interoperability
• Access to all information via a grid network
• Tools for viewing and managing information
• Establishment and maintenance of databases

Still, Shaikh warned that “one size does not fit all.” As a case study, he analyzed the 2014 Ebola outbreak. The largest Ebola epidemic to date occurred in West Africa, starting in Guinea and spreading quickly to Liberia, Sierra Leone, and Nigeria. Complacency, inaction, limited infrastructure, poor healthcare systems and health surveillance, and limited health education contributed to the spread. WHO declared Ebola a public health emergency of international concern in August 2014.⁸ There were 28,657 clinically compatible cases and 11,325 confirmed deaths.⁹ It served as a grim reminder that novel, zoonotic viruses cause human disease and remain a persistent threat to global health security.¹⁰

During the outbreak, mHero, a two-way mobile phone–based communication system using basic text messages to connect ministries of health and health workers was used as an information transmission mechanism. It was a simple talk-and-text system, so no smartphone or tablet was required. It allowed a ministry to rapidly send critical information to health workers’ mobile phones during the outbreak. It allowed for broadcast messaging, the reporting of emerging cases, sharing of reference and training materials, testing and improving the knowledge of health

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⁸ World Health Organization. 2019. Ebola outbreak in the Democratic Republic of the Congo declared a Public Health Emergency of International Concern. https://www.who.int/news/item/17-07-2019-ebola-outbreak-in-the-democratic-republic-of-the-congo-declared-a-public-health-emergency-of-international-concern.

⁹ CDC. 2019. 2014-2016 Ebola Outbreak in West Africa. https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html.

¹⁰ Zumla, A., et al. 2015. Middle East respiratory syndrome in the shadow of Ebola. Respiratory Medicine, 3(2): doi: 10.1016/S2213-2600(14)70316-9.

workers, and better coordinating among ministries of health and other facilities.

mHero was successful because it was well designed,¹¹ had large numbers of mobile phone subscriptions, was flexible and scaled, and could trigger a notification both centrally and locally. Health workers were receptive to mHero messages, wanting to share information and actively participate in the system.¹² Experience through the pilot phase provided important lessons for enhancing mHero approach and high-level buy-in (i.e., engagement strategy, tools, and technologies).

A second case study presented by Shaikh centered on improving HIV testing in Swaziland using SMS-based systems. In 2007, 26 percent of the population was infected.¹³ There were 3,000 requests for CD4 tests per month coming from about 40 different clinics.¹⁴ The tests require nurses to draw blood, which is then transported to the central lab via bicycle for analysis. However, the lab tests take two days, and the full TAT for the results to reach the health workers and patients is fairly long and unpredictable. How could an SMS system help in this situation?

Swaziland’s Ministry of Health expressed interest in implementing a Medical Informatics System in cooperation with the Taiwan Medical System. First, they examined factors contributing to longer TAT in Swaziland. These included the practice by clinics of storing samples until 25-30 had been collected and then sending them to the diagnostic lab rather than sending them immediately after collection, and the practice of sending results to regional clinics and then requiring representatives from the local clinics to collect them. Both practices contributed to the loss of results. For peripheral clinics, TAT was up to 2 to 3 weeks. Most health clinics lack computers or Internet access; however, they have electricity and are within mobile network coverage. The system provided results by text with the patient name, a bar code, test name, and results, improving TAT

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¹¹ The following nine principles for good digital development were followed when designing mHero: (1) design with the user, (2) understand the existing ecosystem, (3) design for scale, (4) build to be sustainable, (5) be data driven, (6) use open standards, open data, open source, and open innovation, (7) reuse and improve, (8) address privacy and security, and (9) be collaborative.

¹² USAID. (2015). mHealth Compendium. https://slidelegend.com/mhealth-compendium-african-strategies-for-health_59c0d9ef1723dd5142fc6bfd.html.

¹³ Jian, W. S., et al. 2012. LabPush: a pilot study of providing remote clinics with laboratory results via short message service (SMS) in Swaziland, Africa. PloS One, 7(9). https://doi.org/10.1371/journal.pone.0044462.

¹⁴ Ibid.

by as much as 21 days, and reducing the number of lost results. The SMS system supplemented the paper-based system. Three years later, a follow-up study showed some barriers, which arose from a misunderstanding of the application’s purpose leading to incongruent expectations between software developers and health workers.

Solutions, not technology, are the key to success. First, PHS must be developed, and electronic surveillance can be a way to accomplish it. PHS strengthening involves strategies to thoughtfully adopt policies that allow for:

• Reportable disease lists and frequencies, case definitions based on global best practices, for example
• A harmonized, synergized, and integrated local, district, provincial and national PHS workflow process
• Standardized reporting instruments
• Workforce training

The goal is to leverage advancements and opportunities to empower, enable, and enhance core functions that allow public health workers to do their jobs better, faster, and cheaper. Emerging trends that can be incorporated include One Health approaches, public health genomics, big data, geographic information systems, participatory surveillance, crowdsourcing, predictive surveillance, drone deliveries, and equal access to the Internet for all. The work begins with PHS, with the end goal of electronic surveillance.

Shaikh concluded with a list of principles for digital development:

• Design with the users
• Understand the existing ecosystem
• Design for scale
• Build for sustainability
• Be data driven
• Use open standards, open data, open source, and open innovation
• Reuse and improve
• Address privacy

USING DATA FROM LABORATORY NETWORKS EFFECTIVELY

Current Use of Clinical Lab Data Across Pakistan

The “One Health Triad,” which considers the interrelationship among healthy people, healthy animals, and a healthy environment served as the organizing principle for Qurban Ali’s presentation. He provided data on the population of Pakistan (more than 200 million, with about 130 million rural and about 74 million urban residents),¹⁵ and the main livestock species include 42.8 million head of cattle, 36.64 million buffalo, 29.79 million sheep, 70.3 million goats, and 1 million camels. Data on wildlife populations are harder to obtain. Each year, Pakistan’s livestock produces 54.3 million tons of milk, 2 million tons of beef, 0.69 million tons of mutton, and 1.2 million tons of poultry meat, as well as 16.2 billion eggs. This is the landscape upon which Pakistan’s Laboratory Network (PLN) is overlaid.¹⁶

The Role of Laboratory Networks

The PLN responds to the need for networking between people and institutions. It fosters cooperation and collaboration, which in turn fosters the ability and freedom to work independently. The objectives are to (1) build sustainable, integrated laboratory capacity; (2) provide quality, accurate, timely, affordable diagnostic tests; (3) collect, compile, analyze, and abstract statistical information for intersectoral sharing and use; (4) provide institutional use of information; and (5) implement prevention, surveillance, and treatment programs.

WHO categorizes health information systems under five interrelated subsystems, one of which relates to routine service reporting.¹⁷ Laboratory forms and service delivery records are important data collection instruments for patient/client management. The ultimate objectives of any health information system are not only to gain information, but also to ensure that the information collected is used to increase efficiency of health services. Lab

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¹⁵ 2016 data retrieved from https://data.worldbank.org.

¹⁶ Usmani, R. H. 2016. Strengthening Network of Animal Health Clinical and Diagnostic Laboratories in Pakistan. 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.

¹⁷ Hassan, S., et al. 2015. An Audit of Clinical Laboratory Data of 25[OH]D at Aga Khan University as Reflecting Vitamin D Deficiency in Pakistan. https://jpma.org.pk/PdfDownload/7540.pdf.

information can also be utilized by policy makers and healthcare providers to create a body of knowledge on a particular subject.

Ali presented background information about veterinary labs worldwide. More than 180 countries and territories are members of the World Animal Health Organization (OIE).¹⁸ OIE maintains a web-based World Animal Health Information System portal, called the Animal Health Situation.¹⁹ This portal allows OIE members to report animal health data to OIE, which compiles this information in a comprehensive dataset on animal health. This data can be used for decision-making on imports and exports, as well as to manage Highly Infectious and Economically Important Diseases (known as Transboundary Animal Disease). Given the health and economic effects of these diseases, many of which are highly infectious, these data are critical to decision-makers. Of the diseases on the OIE list, seven to eight of them are endemic to Pakistan. On the veterinary medical side, laboratory services play an important role in the curative and preventive aspects of animal health and understanding of epidemiology and determinants of disease. Lab reporting data help to improve management, establish priorities of prevention, plan preventive programs, identify high-risk groups, and understand local epidemiological trends and patterns for the purposes of control of animal disease, control of zoonosis, and food security.

Pakistan’s medical lab network is multi-faceted, including a large private sector, explained Ali. This network includes the Aga Khan University Hospital and Shaukat Khanum Clinical Laboratory Service, which have networks consisting of multiple collection facilities and main clinical laboratories in Karachi and Lahore, respectively. This network of laboratory services provides same-day and real-time reporting of many test results. Clinical test results needed urgently can be sent directly to the consulting doctor or patient. Faculty and technical staff working with the clinical laboratories are also proactively involved in laboratory-based medical research and teaching. Laboratory data generated are used for Continuing Medical Education programs at all levels and are shared with the physician community at large.

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¹⁸ OIE. 2020. About us. https://www.oie.int/about-us.

¹⁹ OIE. 2020. WAHIS Interface: Animal health situation. https://www.oie.int/en/animal-health-in-the-world/wahis-portal-animal-health-data.

Advances and Challenges

There have been enormous advances in health laboratory systems and operations over the years. These advances have greatly expanded disease and health risk knowledge, revolutionized diagnostics and surveillance (in terms of relevancy and capacity), and facilitated appropriate control strategies. Clinical laboratories are increasingly tasked with emergency preparedness and response, environment health, food safety, global health, infectious diseases, informatics, laboratory systems and standards, genetic and newborn screening, and research. From a narrow local, state, or national perspective, today’s clinical health laboratories are recognized as essential components of vital national and global surveillance, control, and eradication programs.²⁰

In Pakistan, said Ali, there are several levels of medical and veterinary laboratories. They include model private-sector laboratories and public-sector medical/hospital and basic health labs (which are labs that people access on a daily basis). There are also public-sector veterinary labs at the provincial and basic district levels. Universities (private and public) also maintain high-end labs such as at the University Diagnostic Lab at University of Veterinary and Animal Sciences, Lahore.

Management systems at laboratories can be used to communicate effectively by utilizing all channels to assure that information is communicated to those who need it for various purposes. In Pakistan, as in other resource-constrained countries, a large amount of clinical data and information are produced by human and animal health labs. The data generated originate from (1) lower-level public-sector labs (sent to the higher-level labs monthly or quarterly as mandated), and (2) public-sector labs at higher levels, which share data up through the applicable reporting chain. Data from universities/colleges or research labs are used in coordinated or individual research efforts and for publication purposes to a fair extent. However, these data, in comparison, are rarely used more broadly.

Innovations to data management systems have been variably introduced and used in clinical labs. Such data have multiple uses depending on the nature of the constituent information, and could be used to depict epidemiological trends, population behavior, trends and risks, as well as for policy and planning purposes for healthcare and disease control. Currently, however, there is a scarcity of automation and data management, although

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²⁰ CDC. 2011. Laboratory Contributions to Public Health. https://www.cdc.gov/mmwr/preview/mmwrhtml/su6004a6.htm?s_cid=su6004a6_w.

these data are very useful. Global concerns over newly emerging diseases, zoonotic diseases, and risk reduction at its source have been receiving greater attention with the introduction of the IHRs. Implementation can allow national governments to enhance global and national security from disease and hunger. IHRs highlight the role of laboratories and their societal obligation for efficient and meaningful use of clinical data generation.

Ali noted that a number of operational constraints limit capabilities in Pakistan. In the public sector there are few sizable well-organized International Organization for Standardization–accredited laboratories. Small laboratories, which constitute more than 90 percent of Pakistan’s total, have challenges, including inadequate staff training, weak and deficient physical infrastructure, and a lack of standard data collection and management. There is a global trend of physicians ordering numerous tests, often which do not necessarily provide diagnostic or therapeutic value—this reduces lab efficiency and focus. Another issue is increased workloads among lab personnel. Clinicians sometimes provide incomplete lab forms, which leads to reduced credibility of data. Negligence in lab report collection and delivery to the requesting physician results in waste of public health funds. Finally, there is a dire paucity of studies on these laboratory operational constraints, data collection, and management and use of data.

Ali closed with a number of suggestions. To improve the capacity of laboratories, staff should be trained on the importance and techniques of data collection and its management and communication, particularly in smaller labs. Minimal requirements of staff training, infrastructure, and data management and automation should be met prior to granting of lab certification. Opportunities should be created in the public and private sectors for repeated meetings and follow-up for adequate intercommunication. Networks should be designed in a way that facilitates new opportunities for laboratory leaders to learn about inter-sectoral communication and efficient use of laboratory data. There should also be opportunities for medical and veterinary staff and students who work (or will work) in laboratory systems to be educated about the effective use of lab data. Laboratory information management software should be used for efficient management of data.

During the discussion period, greater efforts to connect the clinical labs, particularly provincial-level labs, with universities for statistical analysis and data management were proposed as having significant potential.

VALUE OF DATA FROM CLINICAL LABORATORIES FOR PUBLIC HEALTH, ANIMAL HEALTH, AND OUTBREAK RESPONSE

Julie Pavlin began her presentation by reminding workshop participants why public health laboratories are so critical. In particular, they are essential to disease prevention, control, and surveillance and to public health preparedness and response; serve as reference labs for difficult-to-diagnose diseases; help keep food safe; and serve as locations for training among local, national, and international experts. In the United States, labs participate in several disease surveillance programs, including the National Outbreak Reporting System, which collects data on reportable diseases; the CaliciNet, which uses that information to link outbreaks to common sources; and NoroSTAT, in which seven state labs and the U.S. Centers for Disease Control and Prevention work together to establish and maintain standard practices for norovirus outbreaks to allow for rapid reporting to quickly link epidemiology with lab data.

Clinical labs also provide vital information for disease surveillance. Pakistan, like the United States, has many such labs dispersed widely across geographic areas. Some labs are very small, some are remote, and some are public while others are private. Clinical labs employ a variety of fee structures and some specialize, for example, in zoonotic diseases, which means that they actually conduct a wide range of tests from culture tests to molecular tests. The quality of the performance of these labs can also vary. Taken together, these labs represent the entire population and generate a great deal of data that can be used to detect disease earlier than if one only uses public health lab data. However, there are often challenges associated with this: Are the labs obligated to report? Do they receive anything in return for reporting? Do they feel that reporting is burdensome? There is also a lack of standardization in terms of tests being ordered and the generated results, and there are challenges with rapidly transmitting lab data to central repositories. Nonetheless, data from labs can be used for public health purposes to confirm information coming from other sources. This can, in turn, help determine the best types of data (e.g., syndromic or lab data) and test codes that most accurately indicate disease prevalence. Just to illustrate, on Hep A, the report states: “Sensitivity and positive predictive value were 100% and 71% (95% confidence interval, 62%–79%) for IgM, 94% (92%–100%)

and 48% (40%–56%) for ICD-9 codes and 97% (92%–100%) and 100% (96%–100%) for combination electronic health record data.”²¹

Disease surveillance is a critical concern among professionals in all countries. Early detection of possible outbreaks is essential to maintaining public health. Pavlin shared the results of a study conducted in New York City that examined clusters of gastrointestinal cases reported around the city to determine whether there were similar causes, which found that 41 percent of cases were confirmed clusters.²² A similar study was conducted in Texas on West Nile disease in an attempt to determine when people started to get sick.²³ The study found that if a certain test was used over others, the illness was identified seven days earlier than if another test was used. This type of data analysis can also help with chronic diseases. Data from lab tests can help hone prevention measures as well. Similarly, animal health can be improved through the use of lab data. She referenced a study conducted in Sweden, which focused on analyzing the number and type of tests ordered, not the results of the test. From these data, warning indicators could be identified.²⁴ Finally, genome testing is the wave of the future, although at this stage standardization is a concern. Pavlin concluded by focusing on the simple elements of lab data that can enhance disease surveillance. One can learn a great deal by studying lab test orders based on syndromic indicators. The severity of the illnesses associated with various tests can also be important indicators of disease trends.

In sum, clinical laboratories generate a wealth of data useful for public health surveillance. They can be especially useful indicators of more severe diseases and can provide data to review simple test orders or more in-depth analyses of results. However, clinical labs vary in resources, types and quality of tests available and utilized, nomenclature, and ability to transmit data.

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²¹ Allen-Dicker, J., and Klompas, M. 2012. Comparison of electronic laboratory reports, administrative claims, and electronic health record data for acute viral hepatitis surveillance. Journal of Public Health Management and Practice. 18(3): 209–214. https://doi.org/10.1097/PHH.0b013e31821f2d73.

²² See Chang, H. G., et al. 2014. Early detection of possible outbreaks from electronic laboratory reports. Online Journal of Public Health Informatics, 6(1), e131. doi:10.5210/ojphi.v6i1.5077.

²³ Yendell, S., et al. 2015. Use of laboratory reports as predictors of West Nile virus disease cases, Texas, 2008–2012. Epidemiology and Infection, 143(2), 419-426. doi:10.1017/S0950268814000909.

²⁴ Dórea, F. C., et al. 2015. Veterinary syndromic surveillance in practice: costs and benefits for governmental organizations. Infection Ecology & Epidemiology, 5: 1-6. doi: 10.3402/iee.v5.29973.

The varying capacities of labs in these areas provide challenges in the areas of human and animal health, disease surveillance, and the quality and usability of data the labs generate.

Following her presentation, there were several questions from workshop participants. In particular, one participant asked about how to ensure the implementation of standards in a lab after accreditation. Are inspections made? If so, how frequent are the inspections, and are they routine or surprise inspections? Pavlin replied that standards are ensured through a rigorous process of annual assessments and surprise assessments if a complaint about a lab is received. She stated that those who conduct assessments receive specific training to conduct the associated audits. Finally, while registration of labs is an important first step, accreditation should follow. She noted her experience in the Middle East where registration of labs was only extended every two years if the lab had been accredited.