There is Steady Convergence In Lab Operations Worldwide

Common analyzers, common reagents support growing “international” standard for most labs

IS THERE AN ACCELERATING CONVERGENCE OF LABORATORY OPERATIONS by major clinical laboratories throughout the world? In recent weeks, THE DARK REPORT has seen tantalizing evidence that the answer to this question should be “yes.”

This trend has strategic implications for independent commercial laboratories and hospital-based laboratories in the United States. It also has implications for in vitro diagnostics (IVD)manufacturers.

If laboratory operations are now following a path of global convergence, it could mean development of a universal standard for laboratory performance. However, this will not be a standard mandated by individual governments. It will be a de facto “best practices” standard—one that laboratories follow because it helps them deliver the highest quality laboratory services while at the same time maintaining or improving competitive position.

My thinking on this point crystallized during a week-long trip to Colombia earlier this month. THE DARK REPORT was hosted by two regional teams for Roche Diagnostics and Sysmex Corporation. In Cartagena, Colombia, the Roche region encompassing Central America and the Caribbean was conducting its second annual DIAmante program for laboratory leaders within the Caribbean Basin. The Colombia Roche region was supporting that effort and arranged site visits of two large clinical laboratories in Bogota, Colombia for THE DARK REPORT.

The laboratory site visits came first during the trip and I shared some of the useful management insights that resulted from these visits in a DARK Daily e-briefing (which can be found at The DIAmante Conference took place on December 1. In attendance were approximately 40 senior-level lab directors and public health system administrators responsible for lab testing services in their countries.

Thirteen Nations Attended

Thirteen nations were represented, ranging from Guatemala and Panama in Central America to Cuba, Jamaica, and Barbados in the Caribbean. There is a significant point to make about this audience. The health systems in these countries have limited resources and national spending on health typically ranges from under 1% to 3% of gross domestic product (GDP). The scale of these labs is accordingly smaller, with 700 patients per day representing a large volume.

The one-day DIAmante conference was organized around the goal of helping attendees learn ways to more effectively sell the value that lab services can add to the health system. Four speakers were featured during the day. They were: Prof. Dr. José Louis Segú, Global Lab Trends There is Steady Convergence In Lab Operations Worldwide Common analyzers, common reagents support growing “international” standard for most labs Prof. Dr. Jordi Ordónez-Llanos (both from Spain), Robert Michel, and Dr. Alba Garzón of Colombia.

Thus, the faculty represented two speakers from Europe and one speaker each from North America and South America. The remarkable outcome was that all four speakers hit complementary points about how laboratory testing adds value to the entire health system. In other words, regardless of the regional differences in their respective health systems, all four speakers identified opportunities and institutional challenges in nearly identical ways.

Furthermore, throughout the day, questions and comments from attendees made it clear that these same opportunities and challenges were applicable in their own nations.

Four Universal Themes

I recognized four “universal themes” that translate into forces that would tend to cause laboratory operations in most countries to converge toward a common operational template. First, the most important laboratories in every nation, including the island nations of the Caribbean, are seeking accreditation that helps them relate their regional performance to that of other laboratories in other countries.

One path taken by these laboratories is to pursue compliance with ISO 15189–Medical Laboratory standards. Another path is to seek accreditation by an internationally-recognized provider. It is this market that the laboratory accreditation programs of the College of American Pathologists (CAP), Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and others would like to pursue.

Second, there is growing interest by laboratories to learn and implement Deming-based quality management systems. Dr. Garzón is an early Six Sigma practitioner at Laboratorio Echevarra in Bogota, where her laboratory is achieving as high as 5.47 sigma in certain microbiology laboratory processes. Her presentation energized the attendees, many of whom expressed strong interest to immediately launch similar quality improvement initiatives in their own country’s laboratories, if they could access the expertise needed to do such programs successfully.

Third, another powerful factor feeding convergence of laboratory operations worldwide is the universal pursuit of improving patient safety and raising healthcare outcomes. In fact, the ability of a Lean or Six Sigma program to help a laboratory support these goals was widely recognized by attendees.

Fourth, for more than 15 years, the instrument systems and diagnostic assays sold by the leading in vitro diagnostics (IVD) manufacturers have been sold throughout the world, with relatively few significant modifications. During my site visits to laboratories in Colombia and to labs in Argentina last October, it was obvious to me that the IVD manufacturers have provided a common technology base. This technology base becomes a common bond among laboratories in almost any country and makes it possible for them to share operational successes and develop “world class” applications.

Collectively, I argue that these four factors are visible evidence that the operations and fundamental strategies of major laboratories in most countries worldwide are converging. This process will be ongoing and is unlikely to be stopped or derailed.

Thus, lab executives and pathologists in the United States would be well-served to pay closer attention to developments in international laboratory accreditation and the emergence of Web-based QA/QC programs. It will be these vehicles which form the foundation for an international set of laboratory management best practices.


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