El concepto de Prevención

Clinical laboratory diagnostics plays a crucial role in the detection, diagnosis and treatment of disease. Clinical laboratory technologists, also referred to as clinical laboratory scientists or medical technologists, and clinical laboratory technicians, perform most of these tests. They examine and analyze body fluids and cells. They look for bacteria, parasites and other microorganisms; analyze the chemical content of fluids; match blood for transfusions; and test for drug levels in the blood that show how a patient is responding to treatment. Technologists also prepare specimens for examination, count cells, and look for abnormal cells in blood and body fluids. They use microscopes, cell counters and other sophisticated laboratory equipment. They also use automated equipment and computerized instruments capable of performing a number of tests simultaneously. One result of increasing automation and the use of computer technology: the work of technologists and technicians has become less hands-on and more analytical.

The market for clinical lab automation systems will continue to grow in part because these systems standardize work flow and eliminate many manual steps, reducing the opportunity for error due to fatigue, which in turn saves time and money for the lab. There has been hesitation on the part of some labs to invest in automation as they are uncertain of its cost benefits. Although automation is a relatively new technology in the diagnostic lab, those that harness it quickly gain a return on investment in terms of error reductions, improvements in efficiency and productivity, and other cost savings, often in a few years.

Essentially, an ever-shrinking pool of lab technologists, the growing demand for testing for aging baby boomers, new testing requirements, and the drive to reduce costs are combining to push hospital and clinical laboratory operations to incorporate more automation. In addition, an increasing demand for more intensive data gathering, including genomics and other advanced studies, is dictating reliance on automated systems.

In recent years there has been a growing concern among employers, educators, professional associations and policymakers that there is a significant shortage in the number of clinical laboratory workers. There is great concern that the shortage will worsen in the next decade as older workers retire, and vacated and new positions are not filled due to an insufficient number of new graduates coming into the field. The US Bureau of Labor Statistics (BLS) projects about 138,000 openings for medical technologists (MTs) and medical laboratory technicians (MLTs) by 2012.

http://bhpr.hrsa.gov/healthworkforce/reports/clinical/default.htm - 5Many hospitals, which had been the primary site of educational programs in the clinical laboratory sciences, closed their programs during the 1970s and 1980s due to both declining reimbursements and enrollments. The BLS projection of 138,000 job openings by 2012 for MTs and MLTs is supported by data on vacant positions. Vacancy rates range from 7% to 13% in clinical laboratories in the US.

Educational programs in clinical laboratory science programs have been declining for more than 30 years. Figure 4-1 indicates the number of National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) approved educational programs from 1975 through 2003 for medical technologist (MT), medical laboratory technician (MLT), histotechnology (HT), and phlebotomy (PBT) programs.

Figure 4-1

NAACLS-Accredited Educational Programs in Clinical Laboratory Sciences

Source: NAACLS

In 1970, there were 791 MT programs. By 2003, about 70% of these programs had closed, leaving only 240 programs in the US. The number of MLT programs (associate degree or less) increased from 210 in 1970 to a peak of 281 in 1985 and subsequently declined to 210 in 2003. Histotechnology programs also peaked in 1985 at 43 programs, and diminished to 24 programs by 2003. Data on the number of approved phlebotomy programs is available from 1987 to 2003, showing growth from 9 to 58 programs.

Programs have closed because of the decreased attractiveness of MT as a career choice, the advent of prospective payment systems (PPS), managed care and budget cuts, and an increase in the expense of running a clinical laboratory training program. Most of the closed MT programs were hospital-based. Data from NACCLS indicates that nearly 25 hospital-based programs closed each year from 1995 to 1997. The advent of PPS for hospitals, which changed their basic cost and revenue functions, is the most cited reason for the decline of hospital-based clinical laboratory training programs.

A PPS is a method of reimbursement in which Medicare payment is made based on a predetermined, fixed amount. The US Health Care Financing Administration

switched from a retrospective fee-for-service system to a PPS. Under PPS, hospitals receive a fixed amount for treating patients diagnosed with a given illness, regardless of the length of stay or type of care received. Prior to PPS, clinical laboratory tests were allowed costs under Medicare cost-based reimbursement and hospital laboratories were an important revenue center for hospitals. In such a fiscal environment, in which reimbursement for each test performed was ensured, more testing per patient was promoted.

As the shift from fee-for-service to prospective payment took place, the revenues generated for hospitals by their clinical laboratories decreased. In the current environment of reimbursement on a per case basis rather than on a per test basis, more laboratory testing per patient can result in a financial loss for hospitals. The resulting fiscal strain has made it difficult to maintain hospital-based clinical laboratory science programs because revenue that previously was used to support training is no longer available. With overall decreases in hospital revenues, paying for the staff needed to support training programs is a burden.

Clinical laboratory practitioners work in a variety of settings, most often hospitals, but also in physicians’ offices, colleges, and the biotechnology industry.

Table 4-1

National Employment of Laboratory Workers by Industry Setting, 2002

Hospital and Clinics 60% Physician Offices 15% Medical Laboratories 14% Education 3% Research and Manufacturig 4% Government and Other 4%

Source: Bureau of Labor Statistics, 2002

High standards of quality and customer service are required from clinical laboratories. Meeting these requirements, however, is becoming increasingly problematic

because of decreases in staffing and efforts to control cost. Laboratory directors are faced with the challenge to balance cost with the goals of quality, patient safety and clinical service demands. Laboratory automation offers a potential solution and has become routinely implemented in clinical laboratories. According to recent reports, 32% of laboratories in the US have installed form of automation, 17% of which is total laboratory automation (TLA).

The benefits of automation are well documented and emanate from the replacement of manual, potentially dangerous, error-prone steps with automated processes requiring little human operator intervention. This can increase productivity, decrease turnaround time, improve staff safety, minimize errors, improve the handling of specimens, and allow the reallocation of personnel for growth and expansion of services. Furthermore, by providing rapid turn-around time for critical tests, intralaboratory tracking of specimens, and preventing errors in specimen aliquoting, the benefits of automation can have a positive impact on worker safety, an issue that has been given increased attention by government regulations and accrediting organizations. Ultimately, the benefits of automation can be realized as improvements in service to both caregivers and patients.

Regarding worker safety in the lab, in several states, the government has enacted bloodborne pathogen and sharps-injury legislation that is pushing hospitals to implement strict guidelines to better protect health care workers. The language in these bills includes protecting lab workers from biological and biohazard exposures.

These laws will affect the design and sales of automated equipment as labs look for key features, such as automated decapping and recapping, which can protect lab technicians from being splashed by samples. As worker safety is increasingly legislated throughout the US, closed-tube systems will become more important. These systems access the sample by automatically piercing through the caps rather than using a decapping method. As more labs move toward automation, there will also be more demand for standardized interfaces that will allow different manufacturer's instruments to connect and work together. This will particularly be an issue with the growth of modular automation. When a lab's needs grow, requiring further automation, it will be important that individual pieces of equipment can be upgraded or connected to customize laboratory growth.

Over the past few decades laboratory automation has significantly decreased the hands-on nature of the work. Today, many experienced laboratory scientists spend more

time analyzing results, developing and modifying procedures, and establishing and monitoring quality control programs than they do performing tests. In the last two decades, clinical laboratories have seen substantial growth in testing volumes. However, nearly all labs in the US and Europe are experiencing difficulties in hiring qualified technologists.

Labs are looking for more automation and increased productivity from their products. They can no longer afford to run the bulk of their workload manually or on instruments that merely mechanize the reading steps of the analysis. And, the next wave of automation software is evolving away from fragmented, complex systems. New software is integrating all aspects of lab management, from sample logistics to results management, archiving and retrieval. Labs will achieve productivity gains by consolidating data and instrument management, and not requiring lab personnel to monitor and manage various data feeds on multiple screens.

Back in the 1990s, there were two distinct competing schools of thought for lab automation: total lab automation (TLA) and modular, or task-targeted, automation. In some instances, the capital cost, maintenance and complexity of TLA did not make that choice appealing. When equipment vendors found that many laboratories could not afford TLA, modular automation appeared on the scene. In many instances, automation has become a customized process that may range from automating only a few steps of the analytical process, depending on the needs and resources of each laboratory. Technology is also available to automate core laboratories, which combine chemistry and hematology testing for further efficiency. Each laboratory must decide for itself whether or not automation should be implemented and, if so, when, and to what extent.

Now, even newer improvements to lab automation are becoming a necessity as the market becomes more established. Even more open solutions are becoming available. Mid-volume labs desire flexible, small powerful analyzers that can function as stand- alone instruments or be linked through automation to other analyzers. The idea is to reduce as much as possible any human touching or manipulating samples. Systems now must achieve quite predictable turnaround times and decrease errors. Many smaller- volume labs are beginning to accept automation. Regardless of their size, labs are realizing that in order to overcome the obstacles in today’s market, they must consider automated solutions.

Labs are demanding flexibility in the automation systems. They are seeking open solutions that will connect to instrument platforms, many of them from competitors, and

offer more testing options and choices. Simply put, one vendor alone cannot provide all of the complete automated testing systems that labs require. The vendors that can offer economic open automation will gain a greater share of the lab automation market in the years to come. With the marketing of smaller, cost-effective integrated products, viable automation has become available for smaller and mid-volume labs. Such solutions give these operations the ability to consolidate their routine clinical chemistry and immunoassay testing into one smaller integrated platform. With a new generation of analyzers, automation is not only targeted to the larger lab operations.

And new middleware will continue to optimize the performance of automation systems. Middleware -- software that connects various components or applications -- can help a lab’s main information system communicate and assign special processing tasks to equipment. Middleware enhances performance. This software is applied to technology platforms. The software allows individual labs to significantly customize various aspects of their installed automation systems. Labs considering middleware must be certain that any new system can communicate with its LIMS.

Middleware consists of a set of enabling services that allow multiple processes running on one or more machines to interact across a network. This technology has evolved to provide for interoperability in support of the move to client-server architecture. It is used most often to support complex, distributed applications. It includes web servers, application servers, content management systems, and similar tools that support application development and delivery.

This software sits "in the middle" between application software working on different operating systems. It is similar to the middle layer of a three-tier single system architecture, except that it is stretched across multiple systems or applications. Examples include database systems, telecommunications software, transaction monitors, and messaging-and-queueing software. The distinction between operating system and middleware functionality is, to some extent, arbitrary. While core kernel functionality can only be provided by the operating system itself, some functionality previously provided by separately sold middleware is now integrated in operating systems. Middleware generally consists of a library of functions, and enables a number of applications – simulations or federates in HLA terminology – to page these functions from the common library rather than re-create them for each application

Middleware is needed if labs want to automate reflex, repeat and add-on testing. Doing so produces time and labor savings for labs. Rather than hunting down samples in

storage and putting them back onto the analyzers for testing, a technologist in an automated lab with middleware only needs to review the results from the desired samples at the middleware work station. Robotics and middleware take over and do the rest, from finding the samples in storage to putting them back on the automation line, as well as testing and reporting the results, including any requisite checks.

With its potential for strong growth, the world market for clinical laboratory automation systems will fare better than the drug development lab automation market. Expect to see annual growth in the 6% to 9% range, given the clinical lab’s labor and productivity issues. While there are many clinical-diagnostic laboratories that have harnessed automation in some shape or form, many more, especially the smaller-volume labs, have yet to install any automation. With the availability of modular automation, these smaller-volume labs now have a greater choice of automation product options. Tables 4-2 through 4-6 indicate the expected growth in this market in the near term worldwide by geographical segment. Table 4-7 estimates the installed base of major clinical laboratory automation systems in the US. The market is expected to experience a 25% to 35% annual growth rate, given in part to the lack of automation in clinical labs.

Table 4-2

World Market for Clinical Laboratory Automation Systems 2008-2012

Revenues (in billions)

2008 2009 2010 2011 2012

$5.00 $5.30 $5.78 $6.30 $6.87

Source: Kalorama Information

Table 4-3

North American Market for Clinical Laboratory Automation Systems 2008-2012

Revenues (in billions)

2008 2009 2010 2011 2012

$2.75 $2.92 $3.17 $3.46 $3.77

Table 4-4

European Market for Clinical Laboratory Automation Systems 2008-2012

Revenues (in billions)

2008 2009 2010 2011 2012

$1.25 $1.32 $1.45 $1.58 $1.72

Source: Kalorama Information

Table 4-5

Asian Market for Clinical Laboratory Automation Systems 2008-2012

Revenues (in billions)

2008 2009 2010 2011 2012

$0.50 $0.53 $0.58 $0.63 $0.69

Table 4-6

Rest of World Market for Clinical Laboratory Automation Systems 2008-2012

Revenues (in billions)

2008 2009 2010 2011 2012

$0.50 $0.53 $0.58 $0.63 $0.69

Source: Kalorama Information

Table 4-7

Clinical Laboratory Automation Systems US Installed Base – Major Systems

2006-2012

2006 2007 2008 2009 2010 2011 2012

660 823 1,029 1,338 1,739 2,348 3,170

Source: Kalorama Information