Current Review of Clinical Testing Compliance to Global Standards in Latin America

Understanding the factors that shape the market of ISO 15189 accredited clinical laboratories and how opportunities emerge.

The medical testing market is a small but critical part of a country’s healthcare services. By offering testing and diagnostic services, medical testing laboratories support a variety of other medical practitioners by making them able to better treat or prevent illnesses in their patients. In this highly specialised field, accreditation to ISO 15189 testifies to the technical competence of clinical laboratories and conformity to international standards.

What is Medical Testing?

Medical testing is the assessment of specimens in a laboratory in order to better diagnose or treat patients. Accreditation includes conforming to quality management, technical, as well as safety and ethical standards.

The ISO 15189 standard, however, does not have especially high uptake in Latin America. Not only is the standard not mandatory, but other competing international standards are available to medical testing laboratories. The result is that, within Latin America, ISO 15189 accredited laboratories typically represent less than 1% of the total population of medical laboratories.

Despite this, the number of laboratories maintaining ISO 15189 accreditation is rapidly growing among certain types of facilities. We find that the need for international recognition is a critical driver when it comes to unmandated uptake of ISO 15189 accreditation. Ultimately, however, widespread use of ISO 15189 will depend on future regulation or incentives, as evidenced by countries like France.

ISO 15189: Limited uptake in Latin America

Government intervention plays a key role in the uptake of ISO 15189. At this time, only a few countries including Australia, Latvia, France, and the Netherlands, mandate accreditation to ISO 15189. For such countries, mandatory accreditation allows medical testing laboratories to become a key pillar of the healthcare system since the standards are highly technical and laboratories undergo regular audit.

Lacking such government intervention, however, laboratories often seek other, less burdensome forms of accreditation or no accreditation at all. Among the tens of thousands of medical testing laboratories in Latin America, only 111 are accredited to ISO 15189. In any given country, ISO 15189 accredited laboratories account for less than 1% of the total laboratories. Part of the reason for this low uptake is the fact that accreditation is not mandated and that medical testing laboratories often opt for other ISO standards which, though less sector specific, also attest to the quality of the laboratory.

ISO 15189 is a particularly stringent standard in that it uses quality management systems similar to ISO 9001, and testing standards similar to ISO 17025, but also contains additional technical standards specific to medical testing laboratories. Without regulation mandating use of ISO 15189, medical testing laboratories have some leeway in terms of how they attest to the quality of their work while still using internationally recognized standards.

Aspiring to be recognised internationally appears to be the main reasons for getting accredited

Given that accreditation to ISO 15189 is not mandatory, and less stringent alternatives are available, medical testing laboratories within Latin America are a unique group. Though they might typically offer the same types of services as unaccredited laboratories, ISO 15189 accreditation affirms a higher degree of competence. In examining the sum of the accredited medical testing laboratories in Latin America, Sector & Segment has been able to identify the key characteristics of accredited bodies in the region.

ISO 15189 accredited medical testing laboratories are predominantly national firms. That is to say they only operate within a single country. Out of all of the accredited laboratories examined, only one was a global firm: Quest Diagnostics operating in Mexico. It is likely that for firms such as Quest Diagnostics seeking to expand globally, ISO 15189 accreditation helps to build a strong reputation and meet both local and global standards.

Accredited medical testing laboratories also tend to offer services to the market rather than simply for internal use. This makes sense, as non-mandatory accreditation largely serves as a tool for demonstrating competency and technical expertise to clients or external parties. In a small minority of cases, however, internally-oriented laboratories also stand to benefit from accreditation since it helps testifies to the overall credibility within an institution or company.

Much more variety exists within the types of services offered by these accredited laboratories. While the majority of accredited laboratories focus on offering services in the field of medical testing (which belongs to the broader field of TIC, “testing, inspection, and certification”), 44% engage in a wider variety of business. In the case of laboratories, this could mean offering hospital or non-test related research services.

Within medical testing services available, most ISO 15189 accredited laboratories ultimately specialize in a few key medical areas. On average, accredited laboratories in Latin America offer services in four medical areas. Most commonly, those are the core commercial areas in medical testing: Clinical Chemistry, Haematology and Coagulation, Immunology, Immunochemistry and Endocrinology, and Urinalysis.

The number of medical areas that laboratories operate across varies significantly by country, along with the number of test methods used and tests executed. Mexico’s medical testing laboratories, for example, on average cover 4 medical areas, 28 test methods and 58 tests. Whereas Ecuador’s laboratories cover 2 medical areas, 20 test methods, and 27 tests.

Because uptake of ISO 15189 is limited in most countries, it is hard to draw any conclusions. Uruguay has only one accredited laboratory, but it covers 6 medical areas and conducts more than 70 tests. In examining accredited medical testing markets in Latin America, each country has to be examined individually in order to fully understand its needs and opportunities.

What makes accredited laboratories stand out from non-accredited laboratories?

Because Mexico is host to the most developed market of accredited ISO 15189 laboratories, it gives us a broader indication of how accredited laboratories are distinct from other laboratories, and what the motivating factors might be for attaining accreditation. We find that accredited laboratories in Mexico tend to be far larger than those that are not accredited, and also more likely to be publicly run.

The vast majority of medical testing laboratories in Mexico are small operations. 94% of laboratories in Mexico have fewer than 10 employees. In comparison, accredited laboratories tend to be much larger – only 27% of accredited laboratories have fewer than 10 employees. Furthermore, 13% of accredited laboratories have more than 250 employees. These larger organizations stand to benefit more from accreditation since they can spread the cost of accreditation over business, improve their reputation, and standardize management practices and technical competencies across a large number of laboratories.

Accredited laboratories in Mexico are also much more likely to be publicly run. 13% of accredited laboratories are public compared to only 1% of all laboratories in Mexico. This is likely because accreditation is often closely tied to government regulation and is driven by the government’s aim of improving domestic quality. In the case of Mexico, the Mexican norm NMX-EC-15189-IMNC, which establishes the ISO 15189 standard locally, was put into place in 2005 and has been promoted as a way of improving quality ever since. As such, public entities are likely expected to cooperate in the drive towards standardization and higher standards.

In countries with less developed markets, accredited laboratories tend to be elite institutions and points of reference for other laboratories and organizations in the country. In Uruguay, for example, the only ISO 15189 accredited laboratory claims to serve over 80 institutions across Uruguay. As the only ISO 15189 accredited laboratory in Uruguay, it is able to distinguish itself from all other medical testing laboratories in the country.

In some cases, these laboratories also provide services internationally or aim to have international recognition in a particular field. In such cases, laboratories are able to leverage their ISO 15189 accreditation to support that image. In Brazil, for example, one of the country’s 3 accredited laboratories is the Mendelics Analise Genomica SA, which aims to be recognised as a global reference for genetic diagnostics and interpretation.

ISO 15189 is growing in popularity in Latin America

Although ISO 15189 remains a voluntary standard across Latin America, the number of laboratories has shown significant growth in the last five years. Between 2013 and 2018, the number of laboratories in Latin America grew by a CAGR of 21%.

In cases such as Ecuador and El Salvador, an accredited medical testing market only emerged recently. In 2013 neither country had any ISO 15189 accredited bodies but by 2018 they had 8 and 2 accredited bodies respectively. Argentina, which evidenced the strongest growth in the examined years, went from having 1 accredited body to 11.

Most of the laboratories being accredited are not seeking to generate a reputation in highly specialised fields. Instead they are focusing on core medical areas such as Clinical Chemistry, Haematology, and Immunology, Immunochemistry, and Endocrinology. We find that medical areas which are most common also tend to be some of the fastest growing within Latin America. This shows that within the relatively young Latin American market, demand is primarily for highly competent laboratories that can perform staple medical tests.

This growth is a testament to the increasing popularity of the standard across Latin America. Although accredited laboratories remain a small proportion of the total number of laboratories, larger laboratories, especially those seeking some form of international recognition, are turning to ISO 15189 accreditation. Wider uptake, however, will likely require some form of government regulation or incentive.

Sector & Segment are committed to continue tracking the evolution of the regulation and ISO 15189 accreditation uptake over time.