January 13, 2005


In This Issue . . .

How preventive medicine, pharmacogenomics, and genetic testing fits into the future lab.

Reimbursement 2005: What to Expect in the Coming Year
A synopsis of the changes in Medicare laboratory reimbursement.

What’s Coming in Point-of-Care Testing
Australia set to conduct nationwide POCT trial; NACB moving toward completion of POCT guidelines.

A Look at Lab Trends in 2005 and Beyond Views from Four Clinical Laboratory Professionals

As 2005 gets underway, the clinical laboratory community is buzzing with speculation about future directions in various arenas, including individualized medicine, pharmacogenomics, and genetic testing. Other hot issues bubbling up are the shift to preventive—rather than reactive—medicine, patient safety and quality measures, as well as the challenges of testing the growing population of aging adults. Strategies asked professionals representing different aspects of the clinical laboratory industry—government, reference lab, hospital lab, and IVD consulting services—to sound off on these trends and tell us how they might affect laboratory testing.


Judy Yost, MA, MT (ASCP)
Director, Division of Laboratory Services
U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS)
Baltimore, Md.

Genetic testing. “The field of genetic testing is expanding rapidly and is very complex and exciting. The related field of pharmacogenomics relates to patient or personalized medicine. This is clearly the wave of the very near future and portends great things for individuals or families with problems that are a result of a genetic mutation.”

In the coming year, laboratorians may get their first look at how the government will regulate this area. CMS is working with the Centers for Disease Control and Prevention (CDC) on proposed genetic testing standards based on recommendations from the Clinical Laboratory Improvement Advisory Committee (CLIAC) and the Secretary’s Advisory Committee on Genetic Testing (SACGT), said Yost. These standards would fall under CLIA, established in 1988 to ensure quality patient testing in the laboratory setting.

“The genetic community has mixed feelings about government oversight, so the comments to this rule, when it's published, should prove to be challenging.”

Quality measures. “Due to heightened patient safety awareness, laboratories better understand the importance of providing good quality testing. The CMS Certificate of Waiver project confirms this. Measures of quality developed by professional organizations, studies, or other sources will facilitate CMS' ability to ensure and monitor quality testing. We would look forward to working in partnership with those that initiate these projects.”
Additional information on the CLIA Certificate of Waiver/Provider Performed Microscopy (PPMP) Project can be found online by clicking here

Technology. “Some of the most exciting efforts are the concepts—and now the reality—of electronic medical records and other digital technologies, whereby the whole patient can be monitored throughout an entire physician visit or hospital stay to get a more accurate, timely, and complete program of diagnosis and treatment.” (CLN, November 2004, p. 1).

Hospital Laboratory

Stephen E. Kahn, PhD, DABCC, FABC
Vice Chair, Laboratory Medicine
Professor, Pathology, Cell Biology, Neurobiology and Anatomy
Loyola University Medical Center
Chicago, Ill.

Diagnostics and the aging population: “As a health system, we are focusing more on the aging population. There is an increased level of activity to help our patients understand the importance of taking care of themselves, listening to their physician, [and] getting certain tests done periodically.”

Individualized medicine: “We’re really not doing anything new or different in this area right now,” said Kahn. “I’m looking forward to the time when we have a better understanding of how to interpret a patient’s laboratory results in reference to what they were when this person was healthy.”

Patient safety and quality measures. Patient safety will get a lot of attention in the coming year. “We are placing major emphasis on quality issues. The focus on patient safety and medical errors throughout the institution is a top priority throughout the health system. Institutional leadership and our key quality assurance groups have devoted significant resources toward educating all employees about the 2004 Joint Commission [on Accreditation of Healthcare Organizations] safety goals. Now we’re focusing on the 2005 Joint Commission safety goals, which are similar. Key patient safety goals relating to laboratory testing that are of particular importance are improving the accuracy of patient identification, improving the effectiveness of communication, and reducing health care acquired infections.”

Developing quality programs must be an interdisciplinary effort, Dr. Kahn said. “When you want to improve turnaround time for cardiac markers in the ED [emergency department], you must bring together the right groups of interested individuals, because the testing process doesn’t start in the lab…there are plenty of opportunities for improving the quality of the testing process that take you beyond the laboratory—either at the front end or the back end.”

Genetic testing. “We are currently rewriting and expanding our genetic testing policy, which focuses on the key clinical issues, medicolegal issues, and financial issues including reimbursement. Of course, the medical privacy and security procedures in place for how that information will be handled in an electronic medical record are critical.”

This genetic testing policy will also need to be revisited once CMS releases the proposed genetic testing rule developed in collaboration with the Centers for Disease Control and Prevention, and with the input of the U.S. Department of Health and Human Service’s Secretary’s Advisory Committee on Genetics, Health, and Safety (SACGHS), noted Kahn.

Reference Lab

Gary Milburn, PhD
National Director, Genomics and Esoteric Testing, Hospital Sales and Marketing
Quest Diagnostics, Inc.
Chantilly, Va.

Preventive medicine. “I think there’s a general trend in the population that preventive health care makes more sense than reactive health care.” The challenge is convincing those in charge of reimbursement—Medicare, Medicaid, or private insurers—of the value of predictive risk analysis, said Milburn. “That is sort of the big issue that’s holding this whole area back. It is coming…cholesterol testing is now acceptable; lipid analysis, triglycerides, HDL, LDL, and even sub-particle analysis for lipids is mainstream in terms of predicting whether you are at risk for a heart attack or a stroke. The difference is that these are cheap tests to be done. [But] when you start looking at genetic tests that are expensive to do, the beneficial outcomes right now have not been well documented and the payers have yet to agree to pay for them.”

Individualized medicine. While this new approach to medicine gives physicians a genetic snapshot of each patient’s potential response to drug therapy, labs will need to keep an eye on more than just the technology that will make this type of testing routine. “I think what’s going to drive [individualized medicine] is the risk management of these patients that have adverse drug effects, and unfortunately, that’s more of a defensive measure than an offensive measure…It’s going to be the liability issues—law suits—that’s going to be driving initial personalized medicine…The paradigm of doing a test before a pill is prescribed will come, but…it’s hard to predict when.”

IVD Consulting Firm

Mark Hughes
Senior Consultant
Enterprise Analysis Corp.
Stamford, Conn.

Workforce Issues. The shortage of technicians is having a rippling effect on the clinical laboratory world, said Hughes. “A lot of lab techs are going to be retiring, so you have a crucial issue about how you get the work done. Laboratories are becoming more like factories,” he added. In response, there is a greater move towards laboratory automation and platform consolidation, such as the new generation of clinical chemistry systems that integrate immunoassay with clinical chemistry. “We are seeing the impact trickle into other areas as well, because now we are starting to see the emergence of automated microscopy procedures, like the new systems for doing cervical cancer screening for Pap smears.”

Individualized medicine. “We already have several examples of so-called personalized medicine out there on the market—the HER2neu testing for breast cancer is the most obvious example. There are also examples of new drugs coming onto the market where you are going to have an associated test, [and this] will continue to gradually occur over the next few years. My guess is it’s going to be a relatively slow progress in that area.”

Genetic Testing. “We did a big study on the whole area of molecular testing last year and we’ve seen a lot of evidence of growth in genetic testing. Most of the molecular testing that is done today is done for infectious diseases, but our survey work indicates that genetic testing is also growing. It’s obviously from a much smaller base, but it is growing and for some tests at considerably high rates.” Genetic testing for cystic fibrosis is one example of a test that has experienced significant volume increases, with some labs reporting a doubling of volume in the recent years, explained Hughes. “We’ve also seen double digit growth in volume in many laboratories for coagulation genetic defect [testing].”

While currently smaller in volume compared to other lab tests, Hughes predicted that genetic predisposition testing will escalate. “I think it’s going to continue to grow, particularly when there are areas where a genetic predisposition test is available [and] there is some kind of intervention that can be taken, whether it’s surgery, drugs, or a lifestyle change,” he added.

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