Africa gears up for five-star laboratories

18 Aug 2009

Tatum Anderson

Source: Center for Global Development (see original article)

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Several African nations are drawing up plans to revamp their country’s laboratories to qualify for World Health Organization laboratory accreditation under a new scheme designed specifically for developing countries.

The accreditation process has been put together by the World Health Organization’s African Regional Office (WHO/AFRO), together with a group of US partners including the Centres for Disease Control and Prevention (CDC), the Clinical Laboratory Standards Institute (CLSI), the America Society of Microbiology (ASM), the Association of Public Health Laboratories (APHL) and the American Society for Clinical Pathology (ASCP).

The accreditation system, launched in Kigali last month, is essentially a points system. Laboratories will have to improve specific everyday work practices to qualify for points. For instance, they might have to show documented proof that laboratory technicians have the right qualifications and vaccinations, or demonstrate accurate forecasts of the reagents that they need to ensure they do not run out of stock. When they’ve collected enough points, laboratories will be eligible for a single star; once they've gained five stars they be awarded WHO/AFRO laboratory accreditation. All levels of facility, from national reference laboratories to rural clinic outposts, will be able to participate in the scheme, say organizers.

At least eight pilot countries, including Tanzania, Ethiopia and Cote D’Ivoire, are now deciding which laboratories will be the first to join the scheme and what sort of help they can provide to assist participating laboratories to work their way up the points scale.

An accreditation scheme is deemed necessary because of the parlous state of many African laboratories. Functioning laboratories are essential to identify a disease; they also help ensure patients get the correct treatments and allow resistance to be tracked. Yet years of neglect and underfunding in Africa has left laboratories without water, electricity, equipment and laboratory health workers. According to the non-governmental organization Treatment Action Group this has led, as an example, to simple smear microscopy – a method used to diagnose tuberculosis (TB) – only being available in 18% of public health facilities in Kenya. A similar situation exists elsewhere, such that only a fraction of the 8.8 million new cases of TB are detected every year. This poor disease detection allows diseases to spread.

Laboratories throughout the world are already subject to accreditation procedures, usually carried out by international accreditation agencies such as the International Organization for Standardization (ISO). However many laboratories are so far below stringent international levels that they require training and guidance to get anywhere close to ISO standards, says Anna Murphy, a consultant at ACPS (which helped devise the accreditation system and training courses for laboratory managers). "The point system effectively acts as a detailed step-by-step guide to improving laboratories, one process at a time," says Murphy.

Processes by which to improve laboratories are often absent because of the dearth of skilled technicians. In 2004 Rwanda had only 39 laboratory health workers nationwide while Senegal only had 66. This means that even the most talented laboratory health workers may not have benefited from the invaluable mentorship and on-the-job advice Murphy says she received from experienced colleagues when beginning her career in the US. “When I first started on the job, I had a lot of role models with twenty or thirty years of experience. In a lot of countries the role models are not there,” she said. “We are teaching everything that we have learned along the way, putting 30 years of accelerated experience and role models into a [training scheme].”

Murphy points out that the new accreditation system is not designed to penalize laboratories for not having the latest high-tech testing equipment. “We are not saying these are the tests you have to have to do, but that what you do, you must do well,” she says. "With a final WHO/AFRO accreditation, laboratories will be almost be at a high enough standard that international agencies can accredit them," she adds.

Although the accreditation appears to have an HIV/AIDS and TB slant – it is supported by CDC Global AIDS Program and US President’s Emergency Plan for AIDS Relief (PEPFAR) – Murphy says it is also applicable to laboratories carrying out tests for other diseases that affect participating countries.

The new scheme has been welcomed by the Center for Global Development, a US think-tank. Members of its Drug Resistance Working group said: “Thankfully, the poor state of medical laboratory services, particularly in Sub-Saharan Africa, is becoming more widely recognized – as is the need to find innovative ways to end the neglect.”

Nationwide improvements

Individual laboratories will not be able to win five stars without government help, however. A laboratory’s ability to forecast the reagents that it will require, for instance, is useless if a government-run supply chain is unable to provide supplies as needed. As such, the accreditation scheme has been specifically designed to force governments to help out too. Countries are expected to implement nationwide strategies to improve infrastructure way beyond individual facilities.

This is why the launch in Kigali last month was so crucial. With so many different national participants – from health and finance ministries to laboratory directors – it was important to get the 'thumbs up' for the scheme from individual countries, say organizers.

Thirteen countries including Rwanda, Botswana, Nigeria, Cameroon, Cote d’Ivoire, Ethiopia, Kenya and Zambia attended the launch. Many of these countries have previously expressed concern about the state of their laboratories by participating in The Maputo Declaration on the need to strengthen laboratory systems last year.

It is now up to countries to develop plans to improve their entire laboratory systems, although it remains unclear how improvements will be funded and how other problems – such as how to improve staff retention – will be solved. WHO/AFRO was unavailable for comment.

A glut of global efforts

This new accreditation process has been developed at the same time as several other strategies have been developed. The World Bank is also understood to be planning its own laboratory-strengthening programme, for instance. Disease-specific schemes such as the Global Laboratory Initiative (GLI) for TB already exist; the WHO has already accredited specific laboratories for the detection of diseases including polio, measles, influenza, and drug-resistant TB; and CDC and PEPFAR are already running laboratory strengthening initiatives with commercial companies such as Eli Lilly and diagnostic company Becton, Dickinson. It’s unclear how or whether any of these strategies will be linked with the accreditation process and, importantly, whether there will be duplication between strategies.

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19 Aug 2009 by OYEWALE TOMORI:

This is a step in te roght direction. The African WHO Regional Polio and Measles Laboratory Networks als have an annual accreditation process. It may be good for the two groups to get together for exchange and to see areas of agreement for improvement Oyewale Tomori