NATIONAL HEALTH LABORATORY SERVICE (NHLS)

AFRICA N AT I O N A L H E A LT H L A B O R AT O R Y S E R V I C E ( N H L S )

Building up capacity in South Africa’s public health sector

NATIONAL

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LABORATORY

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(NHLS)

Microscope South Africa’s National Health Laboratory Service is determined to bridge the gap between public and private provision of vital lab and related health services Writer: Tom Wadlow | Project Manager: Callam Waller

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great deal of hope is hinging on the South African government’s National Health Insurance (NHI)

scheme.

Designed to address growing inequalities between public and private provision of healthcare, the premise behind NHI has been widely welcomed by industry stakeholders, be they medical organisations or consumers who stand to benefit in a potentially lifechanging way.

It is a cause for optimism for the likes of Dr Karmani Chetty, seasoned doctor and Acting CEO of South Africa’s National Health Laboratory Service (NHLS).

“The biggest challenges facing the country’s healthcare market at the moment are an under-resourced public health sector, lack of skilled and competent human resources, poor quality of services, and rising costs,” she explains.

“The South African health system is inequitable with the privileged few having disproportionate access to health services. The public sector is under-resourced relative to the size of the population that it serves and the burden of disease, and has disproportionately less human resources than the private sector, yet

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SERVING SOUTH AFRICA The NHLS commands a formidable footprint across South Africa, illustrated by the following statistics: • Operates 226 facilities in nine provinces, linked to 10 medical schools and universities of technology • Provides pathology services to approximately 80 percent of the South African population • Currently employs approximately 7,495 permanent employees (as of November 30, 2018) • Comprises a highly acclaimed superior academic team which conducts research specific to South African health matters such as tuberculosis, meningitis, malaria, pneumonia, HIV/ AIDS and cancer

has to manage significantly higher patient numbers.

“However, NHI will ensure that everyone has access to appropriate efficient and quality health services. It is intended to bring about reform that will improve service provision and will promote equity and efficiency, so as to ensure that all South Africans can use affordable, quality healthcare services regardless of their socioeconomic status.

“I am therefore very optimistic that the NHI will open up access to medical services.”

• Processed 92,468,362 tests in 2017/18 • Had a total expenditure of R7 billion in 2017/18

A nationwide mandate

Dr Chetty is a medical veteran.

Holding a specialist degree in public health, she has been involved with the industry for more than three decades, with 20-plus years of this time being spent in senior management positions.

Working in both national and provincial departments of health in

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Dr Karmani Chetty, acting CEO

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South Africa, Dr Chetty was aware of the NHLS and the challenges facing the organisation, something she is passionate about addressing in her role as Acting CEO. The group is a national public entity established by law in 2000 to provide quality, affordable and sustainable health laboratory and related public health services to all public healthcare providers, other government institutions and any private healthcare provider in need of service.

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NHLS was established in 2000

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Health System Technologies has delivered successful health information system solutions throughout South Africa in the past 20 years by adopting an implementation methodology that balances the 3 core elements of people, processes and world-class technology.

PEOPLE

PROCESS SUCCESS

TECHNOLOGY

This implementation methodology has been applied and proven in the implementation of health information solutions in 54 hospitals, 106 state pharmacies and 293 NHLS laboratories.

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Health System Technologies

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It is also mandated to support health research and provide training for health science education across the country.

The enterprise consists of two major institutes. The National Institute for Communicable Disease is responsible for surveillance and monitoring of communicable diseases, while the National Institute for Occupational Health investigates occupational diseases and provides a range of related services.

“Further, the NHLS trains pathologists, scientists, medical technologists and technicians in conjunction with university medical schools and universities of technology,” states Dr Chetty.

“It is also the largest diagnostic pathology service in South Africa, with a network of approximately 226 pathology laboratories and providing approximately 1,500 different tests in all pathology disciplines.”

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Further, the NHLS trains pathologists, scientists, medical technologists and technicians in conjunction with university medical schools and universities of technology”

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A smaller, but still important niche of the group is its South African Vaccine Producers (SAVP) subsidiary.

Situated in Sandringham, Johannesburg, it is tasked with the manufacturing of antivenom to treat snake, scorpion and spider envenomation, and is the only producer of such treatments in the whole of South Africa.

Africa is home to some of the deadliest snakes in the world, and SAVP produces antivenoms to treat bites from Black Mamba, Green Mamba, Jameson’s Mamba, Cape Cobra, Snouted Cobra, (Egyptian Cobra), Forest Cobra, Gaboon Adder, Mozambique Spitting Cobra, Puff Adder and Rinkhals.

All of this work is underpinned by a vision and set of values that make the NHLS what it is today.

Dr Chetty continues: “Our vision is to be an ‘Efficient Patient Centred

Health System Technologies

Digitally Enabled Healthcare Transformation The digitisation of the National Health Laboratory Service (NHLS) has meant better quality healthcare for millions of South Africans. The national rollout is one of the biggest IT systems of its kind in the world and recognised globally as a leading example of successful digital transformation in healthcare.

Pathology as a critical service When a doctor is treating a patient there is a very high probability that a blood test is necessary to make a diagnosis. When providing healthcare to over 50 million people, that equates to 110,000 requests and 600,000 individual tests every day from 400 government hospitals and 3,800 clinics.

And because the NHLS is the sole provider of pathology services to SA’s public health system, they play a critical role in making sure that patients get the right treatment.

In order to roll-out a centralised and real-time pathology test processing and results system for the entire public health service, the NHLS had to enlist the expertise and support of leading technology and implementation partners.

Collaborating for success The NHLS chose InterSystems as its technology provider because of its track record to successfully manage large volumes of data in various health applications throughout the world.

“In addition to having the right technology in place, we knew that rolling out the largest laboratory IT system in Africa needed the support of a strong and capable local prime contractor and implementation partner.

We chose Health Systems Technologies (HST) because it has a national footprint and track record of delivery in skills transfer and enablement,” said NHLS CEO, Dr Karmani Chetty.

HST, who has been enabling the digitisation of healthcare services in South Africa since the year 2000, provided always-on support to the NHLS by way of service desk support, training, implementation, project management and skills transfer to NHLS employees and roundthe-clock monitoring of the application.

What it means for patient care The rollout has had numerous benefits for patients but most importantly, patients are getting better care because doctors are getting the information they need to treat patients quickly and reliably. On a larger scale, the digitisation of the NHLS paves the way for a connected healthcare system that facilitates patient-centred care and a better patient experience.

The NHLS is now the single biggest and most valuable healthcare data resource in the country and because of TrakCare Lab’s and the NHLS’s data warehouse analytics capabilities, it is now possible to analyse volumes of data to understand population health better.

“Our journey to digital transformation has spanned 10 years and it’s been an incredible success. We are proud to be considered a world-class example of technology installation and implementation whereby we not only improved our service but also the skills of our employees. In all, I believe we have made massive strides towards a safer health system that provides quality services and delivers on the National Health Department’s mandate of ‘a long and healthy life for all citizens’,” concluded Dr Chetty.

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Services and Global Centre of Excellence for Innovative Laboratory Medicine’. The organisation has identified several key values as the principles that will govern behaviour for all employees within it.”

There are six such values that Dr Chetty and the NHLS swear by, the first being care, to ensure the wellbeing of patients, the environment and society.

Second is unity of purpose, all working towards a common goal, while service excellence is another key pillar of this value proposition.

Transformation and innovation are values which make sure the NHLS is a forward-thinking organisation, with all of the aforementioned principles underlined by integrity, ethics and responsibility.

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BSL-4 – a continental flagbearer

A fundamental and unique part of the NHLS laboratory network is its BSL-4 lab based at the National Institute for Communicable Diseases (NICD), a body which was set up in 2002.

The specialist communicable disease arm was established under the NHLS and came into being through the merging of the National Institute for Virology, the Virology Laboratories and Public Health Microbiology Laboratories of the South African Institute for Medical Research.

The centre deals with deadly viruses, a major killer in South Africa behind the likes of HIV and tuberculosis, diseases which form the basis of two separate NHLS priority programmes.

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SMARTSPOT

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martSpot is an innovative proficiency testing (PT) provider of external quality assessment (EQA) to molecular laboratories globally, optimising accuracy of TB and HIV diagnostics. SmartSpot has collaborated with the NHLS from inception of its Xpert MTB/RIF programme to develop a robust quality control programme for molecular diagnostics.

SmartSpot started as a research project in the Department of Molecular Medicine and Haematology (University of Witwatersrand, South Africa).

SmartSpot harnesses patented technology to manufacture shelf-stable TB quality controls that are inactive, safe and stable for 24 months at ambient temperatures reducing shipping costs by 67 percent. SmartSpot’s Result Reporting Tool (TBGxMonitor®) is user friendly and uploading results is achieved in 20 seconds with just four mouse clicks. Result reports are available in real-time for sites scoring 100 percent. SmartSpot has shipped 68,000 Spots to 40 countries and has verified 46,500 GeneXpert modules.

SmartSpot recently presented a study of 8,916 TB quality control specimens tested across 430 instruments in 26 countries. 97.2 percent of the results correlated highlighting the robust performance of its controls. Of the 2.8 percent incorrect results identified, the key pre-analytical errors were sample switching (13.8 percent), cross-contamination (36.6 percent) and insufficient elution (49.6 percent).

Xxxxxxxx xxxxxxxx xxxxxxxxxxx xxxxxxxxx If identification and intervention is not implemented, this error rate could contribute globally to 600,000 misdiagnosed patients per annum.

NHLS’s BSL-4 lab is based at the National Institute for Communicable Diseases

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In response to the global health strategy of 95-95-95, expansion of HIV viral load testing requires highly centralised and remote viral load monitoring. SmartSpot has anticipated this demand by developing thermostable HIV VL quality controls.

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Our PT reduces misdiagnosis Purposely designed EQA that enables fast and effective corrective action Compatible with leading molecular TB 1 and HIV 2 diagnostic assays

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1TB controls are compatible with Xpert MTB/RIF & MTB/RIF Ultra; Abbott MTB and Genotype MTBDRplus & MTBDRsl 2HIV controls are compatible with Xpert HIV-1 Viral Load; COBAS AmpliPrep/COBAS Taqman HIV-1; Abbott RealTime HIV; Biocentric Generic HIV Charge Virale and Aptima HIV-1 SmartSpot Quality (Pty) Ltd, Registration No: 2015/195788/07, Corner De Korte & Hospital str, Braamfontein, Johannesburg, 2001, South Africa, +27 10 001 3920 Pat. US8,709,712, AP3303, OAPI 16243, ZA2012/08058 | Pat Pending. IN 10108/CHENP/2012

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ITEC TIYENDE

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ith over 15 years in existence, Itec Tiyende, one of the ICT industry’s BEE leaders (Level 1 B-BBEE certified), has delivered simple, smart solutions that help businesses run more efficiently.

Itec Tiyende’s long-standing partnership with NHLS in providing managed print services on a national basis and deploying a permanent on-site technician is testament to Itec Tiyende creating smart and efficient business solutions for its customers.

Our ability to simplify operations and reduce costs has made us a preferred technology partner to businesses and organisations across all sectors of the economy, including education, labour, government and big business.

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“This is the only BSL-4 suite laboratory in South Africa and in the African continent, which is a strategic biocontainment infrastructure for diagnosis and investigations of outbreaks caused by the deadliest viruses known to humans and animals”

Last year Statistics South Africa released data from 2016 on the leading causes of death in the country, stating that human immunodeficiency virus, influenza and pneumonia, and other viral diseases accounted for more than 12.5 percent of all fatalities.

Another deadly virus, Ebola, ravaged West Africa in 2014-2016 in what was the largest and most complex outbreak since it was first discovered in 1976.

It was this initial discovery in the 1970s, along with the sudden emergence of Lassa and Marburg and

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CEPHEID

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hrough its Xpert® MTB/Rif product, endorsed by the World Health Organization in 2010¹, Cepheid has helped to reduce time to diagnose and treat tuberculosis.

occurrence of laboratory infections in Europe and America that prompted the development of maximum-security laboratories (biosafety level four – BSL-4).

“The South African Department of Health decided to construct a BSL-4 laboratory at what is now known as the NICD in 1976,” recalls Dr Chetty.

“Construction was completed in 1979, and in 1980 the facility started to operate for the purpose of providing a diagnostic and investigatory service for viral haemorrhagic fevers in southern Africa.

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Indeed, the WHO now recommends that Xpert® MTB/Rif be used instead of sputum smear microscopy as the screening test for TB².

There is also evidence of a significant reduction in the time to MDR-TB treatment and improved diagnostic certainty².

Cepheid’s GeneXpert® Systems bring molecular testing to settings where it would otherwise not be available with an extensive menu of assays that can address the many challenges in low- and middle-income countries.

1. https://www.who.int/mediacentre/news/ releases/2010/tb_test_20101208/en/ 2. Dowdy D. Xpert at 8 years: where are we now, and what should we do next?

Int J Tuberc Lung Dis. 1 January 2019; 23(1):3-4. Accessed March 2019. https://doi. org/10.5588/ijtld.18.0717

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XpertÂŽ MTB/RIF Ultra* Raising the Standard for Tuberculosis Diagnosis Rapid Active Case Finding for TB Elimination

Rapid diagnostic tests should be key to the diagnostic work-up for all TB presumptive cases1

* CE-IVD. In Vitro Diagnostic Medical Device. Not available in all countries. Not available in the United States.

Product catalog numbers: GXMTB/RIF-ULTRA-10 & GXMTB/RIF-ULTRA-50 1 The World Health Organization (WHO). European Tuberculosis Laboratory Initiative. Algorithm for laboratory diagnosis and treatment-monitoring of pulmonary tuberculosis and drugresistant tuberculosis using state-of-the-art rapid molecular diagnostic technologies. Accessed Mar 2017. http://www.euro. who.int/__data/assets/pdf_file/0006/333960/ ELI-Algorithm.pdf CEPHEID SOUTH AFRICA PHONE +27 11 234 9636 EMAIL info-rsa@cepheid.com

WEB

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“This is the only BSL-4 suite laboratory in South Africa and in the African continent, which is a strategic biocontainment infrastructure for diagnosis and investigations of outbreaks caused by the deadliest viruses known to humans and animals.

“In addition, it characterises newly emerging pathogens like, for example, the newly emerged Lujo haemorrhagic fever virus in 2008, which caused a highly fatal nosocomial outbreak in South Africa. The facility is also used for experimental infection studies as well as for production of strategic diagnostic reagents, development and validation of diagnostic assays.”

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The facility is at the cutting edge of research and vital to Africa’s capacity to investigate and deal with deadly viruses.

“The BSL-4 at the NICD/NHLS campus is specifically designed to receive, handle, store, and propagate biohazard class 4 pathogens and conduct diagnosis and investigations on those pathogens,” Dr Chetty adds.

Many of these pathogens are foreign to South Africa and extremely easy to transmit for both humans and animals. They are also capable of direct transmission from person to person, and often produce diseases for which no specific prevention or treatment are yet available.

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Detailing more about the BSL-4 facility’s setup, Dr Chetty says: “The lab is supported by three major systems.

“One – safety and security; two – containment; and three – operational systems. These systems are interacting with one another to provide the required level of maximum biocontainment, security and operational functionality, with necessary backup systems and redundancy in case of emergencies.”

Safeguarding the future

The BSL-4, and indeed all NHLS labs around South Africa, are staffed

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Supplier of laboratory chemicals and consumables Thembane Chemicals is a women-owned company and a proud level 2 BBBEE contributor. We are a specialist product and services provider to a myriad of sectors that include but not limited to the Laboratory, Chemical, Medical, Food, Steel, Water, Mining, and Education sectors. We provide quality products, competitive prices and personalised service - forging long-term relationships with our clients We supply chemicals in various grades, and in a wide range of volumes and weights, to suit customer expectations.

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of laboratories and making enhancements to IT infrastructure are The NHLS is currently looking at a also in the Acting CEO’s line of sight.

Add in plans to expand its expertise number of ways in which it can diversify and services and the future for the its service offerings as well as its client organisation, and thus South Africa’s public health sector, looks increasingly base and markets” promising.

“The NHLS is currently looking at a the pathology and public health by qualified health professionals, the number of ways in which it can diversify departments based at the medical and lifeblood of any health service. its service offerings as well as its client dental schools in question, with teaching base and markets. This includes private Dr Chetty admits that the provided in a range of subcategories organisation is affected by a shortage healthcare providers, but also other of pathology skills, and addressing this such as anatomical pathology, chemical government and public sector clients, is a central priority for the next decade pathology, haematology, human both in South Africa and the rest of genetics, immunology, microbiology of development.

Africa,” Dr Chetty concludes. and virology.

“The NHLS is actively developing Looking ahead to the rest of this its employees through the work year and beyond, recruitment and skills plan,” she elaborates. “It also training is listed among Dr Chetty’s appoints academic staff jointly with major objectives. medical universities and universities of Top of the list is to strengthen National Health Laboratory Service technology, and has signed an umbrella Tel: +27 11 386 6000 agreement on the working relationships the NHLS’s financial standing and enquiries@nhls.ac.za and teaching and training outputs.” improve operational efficiencies, while continuing accreditation www.nhls.ac.za Such training is conducted through

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1 Modderfontein Road Sandringham Johannesburg 2192 South Africa Tel: +27 11 386 6000 enquiries@nhls.ac.za www.nhls.ac.za

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