One of the
harbingers of global laboratory science is Robert Michel, editor of
The Dark Report and founder of the Executive War College (scheduled
this year in New Orleans, April 28-29). We asked Mr. Michel a few
questions about this topic since he has visited various laboratory
facilities around the world — England, Korea, Saudi Arabia, and other
countries — in his quest for information about coming changes. Here are
his latest insights:
Editor: Explain briefly the move toward
“globalization” or what is more effectively termed “standardization” of
the world’s medical laboratories.
Michel: Globalization as a trend in
laboratory medicine is propelled forward by a number of independent
trends. For example, because of consolidation within the in vitro
diagnostics (IVD) industry, a shrinking number of big IVD manufacturers
are selling the same instruments, equipment, and test kits to labs
throughout the world. That means most laboratories buy and operate the
same equipment and analyzers. Certainly, there are some differences due
to regulatory approval agencies, such as the Food and Drug
Administration in the United States and European Medicines Agency in
Europe.
Another trend that encourages standardization of
laboratory operations across international borders is the development of
evidence-based medicine and use of those guidelines by clinicians in
many countries. Independent of these factors, a general raising of
standards in healthcare is motivating many countries that traditionally
have had few or no laboratory oversight laws to adopt ISO 15189
as a mandatory laboratory accreditation requirement. [For details on ISO
15189, go online and google that term.]
Editor: You made some comparisons among India,
South Africa, Mexico, and Belgium with regard to ISO 15189. How well will
labs worldwide “mesh” with one another in light of their differences?
Michel: ISO 15189 is just one dynamic or
market force that encourages standardization of laboratory operations
across international borders. Remember that all healthcare is local.
The Dark Daily e-briefing to which you refer was making precisely
that point. In each of the four countries, there were unique population
demographics, economics, and healthcare needs. Thus, although a common
element was the use of ISO 15189 in each of these four countries for
laboratory accreditation, laboratories in each of these countries was
focused on meeting different types of healthcare needs unique to its
nation. For example, Belgium, a relatively wealthy country, is
addressing the needs of an aging population. By contrast, in India, many
areas throughout that nation lack health clinics and basic health
services. Thus, laboratories in India are motivated to provide a
different menu of lab tests than labs in Belgium.
Editor: You spoke a couple of years ago about
the proposal of sending lab tests from the United States to India via
FedEx, for example, and having the tests run overnight with e-mailed
results to the American clinicians arriving the next morning. My
understanding is that only a small percentage of laboratories there
follow any “rules and regulations” since those are voluntary in that
country.
Michel: Outside of a handful of developed
countries, there has been little effective regulation, licensure, and/or
accreditation of clinical laboratories worldwide. With medical tourism
becoming a more important factor and with many countries wanting to
demonstrate a higher level of quality within their healthcare systems,
the motive now exists to introduce some type of regulatory scheme to
license and accredit medical laboratories. The shortest, fastest, and
cheapest route for individual countries to achieve that is simply to
adopt accreditation under ISO 15189 as a requirement for laboratories.
Editor: In your conversations with laboratory
professionals, do they indicate that this “global standard” will be a
success?
Michel: It is too soon to judge whether
ISO 15189 will find success in the United States. Keep in mind that ISO
15189 medical laboratories is an accreditation standard for laboratory
organizations that want to incorporate quality-management systems and
methodologies into their daily operations. A laboratory that chooses to
pursue accreditation under ISO 15189 must still meet the requirements of
CLIA licensure and an accreditation such as offered by the College of
American Pathologists. In the short term, it is unlikely that a large
number of clinical laboratories will want to devote the time and
resources to achieving ISO 15189 accreditation in addition to the legal
mandates that govern laboratories in this country.
Editor: AACC’s award-winning website, Lab
Tests Online, has implemented translated versions of its
patient-education site: Australian English, British, German, Hungarian,
Italian, Polish, and Spanish. The U.S. site reportedly receives more
than 1 million visits per month! AACC President Gary Myers said that
this has made the site a global standard itself for patient education,
as well as a highly visible symbol of the worldwide laboratory
community.
Michel: Lab Tests Online represents a
useful example of the convergence of laboratory medicine and laboratory
operations across the globe. In every country where a Lab Tests Online
website is introduced, it becomes a popular destination and enjoys a
surprising level of traffic. This phenomenon demonstrates that consumers
and patients in most countries around the world share the trait of
wanting to be more involved in their healthcare.
Editor: In some way will the “globalization”
of the medical laboratory bring the well-deserved recognition to
laboratory professionals.
Michel: As to medical technologists, it
will take some time to achieve some form of universal certification for
technical training and skills. There is already considerable movement
across the globe of skilled laboratory labor. Given the demand for
skilled laboratory professionals in most developed countries, it is
likely that a common basis for education, professional certification,
and licensure will occur.
Plus
Advances in digital pathology drive
continued momentum and globalization
Digital pathology —
an image-based environment for the management and interpretation of
pathology information enabled by the digitization of a glass slide —
represents a new generation of technology for pathology and laboratory
professionals. Digital pathology adoption is well underway worldwide,
with almost a thousand systems in use for clinical, education, research,
and biopharma applications.
Digital pathology systems convert individual
glass microscope slides into high-resolution digital slide images that
can be viewed and analyzed using a computer instead of a microscope. A
digital slide is a complete representation of the cells and tissues on a
glass microscope slide and can be viewed at any magnification,
transforming a computer monitor into a virtual microscope. Digital
slides and other information can be viewed 24/7 via the Internet, and
the images can be shared securely and instantly with anyone in the
world. Advanced image-management software (pathology picture archiving
and communication systems, or PACS) helps manage image workflow; user
access; security; and archival and retrieval and other related
activities.
Digital pathology is rapidly gaining momentum as
a proven and essential technology that is helping to reduce laboratory
expenses, improve operational efficiency, enhance productivity, and
improve treatment decisions and patient care. In addition to eliminating
the many inefficiencies and costs associated with use of individual
glass slides, advancements in digital slide image analysis add value by
enabling the automation of mundane tasks (i.e., counting cells) or the
automatic classification of disease patterns in histology tissue.
Advanced “smart” histology pattern-recognition tools capable of
“learning” to find specific morphologic patterns are now available.
These pattern-recognition tools analyze training slide images and
develop optimal algorithms that can locate and automatically annotate
morphologic patterns, similar to the patterns in the training sets, in
large numbers of digital slides.
The rapidly emerging digital industry has seen
remarkable progress in the emergence of standard file formats and HL-7
interfaces to laboratory information systems (LIS). Progress has also
been made in supporting organizations adopting digital pathology with
good laboratory practices (GLP) and HIPAA compliance, and with obtaining
Food and Drug Administration (FDA) clearances for the use of digital
pathology in breast cancer for select applications such as HER2 (human
epidermal growth factor receptor 2), ER (estrogen receptor), and PR
(progesterone receptor) image analysis. Some providers of
digital-pathology solutions have obtained FDA clearances for HER2 and PR
to demonstrate equivalence between reading glass slides under a
microscope and interpreting digital slides on a computer monitor. The
expected future clearance for H&E (hematoxylin and eosin stain)
breast-cancer slides represents a major milestone for the adoption of
digital pathology in the clinical market.
Recently, immunohistochemistry (IHC) image
analysis was the first digital pathology application to be cleared by
the FDA for use in the clinical market. Commercially available FDA
cleared digital IHC systems include the ability to read digital IHC
slides on a computer monitor, perform quantitative image analysis to
quantify protein expression, and create professional reports, all
integrated into an efficient clinical workflow. Such integrated
solutions help pathologists provide better patient care by providing
faster turnaround times, more informed decision making, and more
accurate and consistent test results.
Digital pathology provides tremendous flexibility
by enabling the immediate distribution of digital slide images in a
Web-based setting, independent of glass slides or microscopes. One of
the biggest benefits of digital pathology is global access to
histopathology information by pathologists who can view digital slide
images from anywhere there is Internet access, speeding the turnaround
time of secondary consultations, and expediting clinical trials and the
drug-discovery process. For example, pathologists and researchers in the
United States and Europe can view digital slides in Asia, lowering
geographic barriers and integrating global pathology labs in large
pharmaceutical companies to expedite research, clinical trials, and
facilitate international peer review using a digital pathology platform.
New digital slide-sharing networks have recently
become available to make digital pathology affordable to large numbers
of labs and pathology groups by allowing the secure transmittal of
digital slide images to a global data center, as an alternative to
investing in a costly local digital pathology infrastructure. Digital
slides at the data center can be accessed immediately via user-specific
passwords by authorized parties and shared for a variety of purposes.
Slide-sharing networks make it easy for
pathologists to share digital slides with others, regardless of
location, facilitating instant access to global pathology expertise, and
expediting the provision of pathology services to remote sites.
For example, a pathologist could share a slide for a consultation or
second opinion with a pathologist who lives just a few miles away or
anywhere in the world, eliminating slide re-cuts, shipping expenses, the
risks of slide breakage, and pathologist time traveling to a remote
site.
A digital slide-sharing network is particularly
valuable for pathologists faced with shipping glass slides
internationally. Customs laws often prohibit or slow down importation
and/or exportation of tissue. Use of digital slide networks do not
require the shipment of glass slides, therefore, participants have a
vastly simpler way to share slides internationally, faster and with
superior bandwidth.
The ability to routinely digitize glass slides
and integrate the resulting digital pathology information with LIS and
PACS is also helping drive the adoption of digital pathology in
hospitals and health-system settings, transforming how pathologists
assimilate information from disparate information sources to make more
informed interpretations.
Interfaces between digital pathology and LIS are
well underway and are critical to improving workflow. Integration
with LIS allows pathologists to retrieve and analyze patient’s digital
slides directly from the LIS as well as generate pathology reports with
relevant demographic information and clinical history through a single
access point, facilitating faster results and better communication, and
the best possible analysis and treatment for the patient.
Digital pathology continues to transform the
delivery of quality, cost-effective pathology, providing new
technological standards and reinforcing the central role of the
pathologist in patient management.
Dirk Soenksen is CEO of Aperio
Technologies in Vista, CA, which offers the ScanScope slide-scanning
system.
