The CLP roundtable, conducted by telephone:
It’s a new year and time to consider where we are as an industry. What do laboratories want for 2007? What’s in store down the road?
CLP spoke with six experts, each of whom offered different perspectives on what they see as the trends, challenges, and financial impacts in 2007.
What trends should the clinical lab industry expect to see over the next 5 years?
Laposata: There is a trend toward the simplification of critically needed tests to make them accessible to 200-bed hospitals. We are going to learn much, much more about how a disease emerges when we understand its molecular basis, but these tests are expensive and often sent out. These facilities will be watched to see how they will pay for new molecular tests.
Hata: I see a strong movement toward molecular-based testing. There will always be a role for culture in the lab, but the fact that we now have more molecular tests available—not a great deal, but more—that are FDA approved and in kit form and easier for people to use makes them more accessible for laboratories of all sizes.
Felder: The trend toward the use of molecular diagnostic tools for infectious-disease testing will become commonplace. In addition, we will move from discrete immunoassays for single proteins to chip-based pattern testing. The increased understanding of protein patterning for cancer and occult disease testing will drive the industry toward chip-based methods. Point-of-care testing will finally live up to its promise of providing the rapid throughput necessary to help hospitals remain profitable and physician’s offices to be able to provide a more complete diagnosis in one visit. And finally, one will begin to see the incorporation of anatomic pathology automation in the core clinical diagnostics laboratory, since there will be incredible economies from this kind of consolidation—for example, Hematoxylin and Eosin slide staining.
Nichols: Certainly, POCT is another big trend. As we see staffing crunches in the lab, POCT use may rise, not just because it’s rapid and can be done on the floor, but also because it doesn’t require laboratory staff to do the testing. We may in 5 years have a molecular POCT on the market where you can stick a whole-blood sample into the device, have a handheld run the PCR, and produce an answer on an array.
Jackson: Hospitals will continue to try to treat lab tests as a direct commodity, a move enhanced by the fact that as the platforms get better and more automated, more esoteric tests become available for smaller labs. To avoid becoming a commodity, regional and national laboratories need to partner with local hospitals to promote high quality. A huge national trend is greater attention by health care systems on higher quality of care and the cost of care as a whole as opposed to individual items.
Kasoff: We are getting more requests for features that help managers with the overall workflow in the lab. Administrators are looking for decision support to help manage the lab’s day-to-day resources. For instance, a real-time, at-a-glance analysis of workflow and volumes can help with scheduling; task lists and reminders assign individual responsibilities; and communication can be enabled through e-mail or remote access. Network-management modules help to confirm IT processes, such as successful backups or error messages. In addition, remote access to results is becoming more commonplace and is another trend in the industry. The LIS field is encountering more EMRs than ever before.
Solid interoperability between the LIS and EMR is a critical part of the physician’s ability to have all the clinical information they need at their fingertips.
What will be some of the biggest challenges clinical labs will face in 2007? And how can they prepare?
Felder: The biggest challenges will be keeping costs in check while meeting the demands of more sophisticated testing paradigms, such as molecular diagnostics and proteomics.
Hata: Information management will be a challenge. We generate so many different types of data. How do we get information out quickly? How do we package data so it is simple, concise, and easy for physicians to understand? We need more mechanisms to deliver this information. Sometimes, we still have to call a doctor; a lot of programs don’t support free text. We have a multitude of different instruments and laboratory information systems, which don’t always communicate well, so we need tools to help us do that.
Laposata: The explosion of molecular testing has created concern at the national level about the complexity, expense, and clinical value of these tests. Instead of one piece of information, such as the patient is positive for hemophilia, the results of molecular-based testing require more interpretation to understand what they mean for treatment. It is quite common to get the same seven sentences of a canned interpretation in a result for two different patients; one could be an 85-year-old woman and the other one who is 22. Communication between lab-based physicians and clinicians will need to be enhanced. Unfortunately, there aren’t many lab-based doctors outside of anatomic pathology.
Jackson: Labs need to do a better job meeting the information needs of the end-user physician. Doctors are horribly information overloaded and frequently out of date with regard to all types of practice guidelines, including laboratory testing. There is a trend to spend a lot of money on proprietary panels without first making sure everyone is getting the well-established, high-benefit, cost-effective tests. Labs can become more effective educators of physicians on cost-effective use of the lab and practice guidelines that promote higher-quality, cost-effective care. Doing so will help to focus discussion on overall costs rather than individual test prices and allow labs to demonstrate lower cost of ownership.
Nichols: We need to start linking research evidence on factors leading to better outcomes in practice, such as when a test should be ordered. The industry has a lot of overutilization of lab services, tests which physicians could not defend ordering but have simply ordered as part of an entire panel. We’ve done away with panels in our facility. We still group tests within a pathway and the physician can check every box if necessary, but they can and should order discrete tests.
Laposata: As test development expands, we have tests, such as fetal fibronectin, that we don’t need often; but when we do need them, we need them right away. How does the clinical lab handle a test that is done no more than five times a month but has a such a huge bearing on the patient’s outcome that it has to be offered? How does it impact the budget? And how does this affect workflow? More stations make the lab more complicated.
Kasoff: Developing a comprehensive solution that can interface with physician’s office billing systems, EMRs, and reference labs is a challenge. Labs should continue to explore and implement these systems into their workflow. In California, the ELINCS project [EHR-lab interoperability and connectivity standards] is an initiative to standardize the electronic delivery of test results from several laboratories to a central database.
What do laboratories have on their wish lists for the New Year?
Hata: I would say staff, staff, staff, and staff, and not staphylococcus. The issue is on the forefront of everyone’s mind. It’s become extremely difficult to get well-qualified laboratorians. There are problems with laboratory schools being able to turn out enough grads and get them into the labs that need them; a situation that has been going on for number of years and is expected to continue in the future. It will require flexibility and creativity on the lab side to address that, and automation can help. But labs need to look at it from a practical standpoint. Will the automation help your specific situation?
Felder: Clinical laboratories are still facing staff shortages, ongoing training issues, and the need to compete with local and national commercial laboratories. Thus, affordable automation tools and process-control software really top the list.
Jackson: Our wish list is heavy with automation and software, but we have already done a lot for the big areas, like specimen handling. What we would love are some good platforms for molecular testing and other areas where the vendors haven’t had as much automation available—specimen prep for molecular is still heavily manual, and we would love to automate that more.
Nichols: Lab automation will continue to grow over the next 5 years simply as a means to reduce redundant processes and save labor for the higher-level functions that require medical technologists and thought processes. We also need software tools to handle some of the labor. And we need interfaces to allow analyzers to communicate with the LIS. I expect to see more middleware that actually processes results and sends them to the LIS. Of course, another big item on the wish list is the EMR. [President George W. Bush] has mandated that, over the next 5 years, everyone should move to a total EMR system. And while hospitals are still lagging behind in implementation because of cost and resources, we are going to be pushing physician order entry as well as the interpretation of results through the EMR.
Kasoff: A lot of lab managers are looking to simplify their lives with automation. Integration between systems, such as the LIS, EMR, reference labs, hospital information systems, and practice-management software, can save transcription errors and offer a total connectivity solution.
Laposata: I think people are wishing for some relief on how to deal with the exploding send-out budgets. Just a few years ago, ours was under $2 million. Now, it’s more than $6 million.
What will labs spend the big money on in 2007?
Nichols: The biggest expense is still going to be labor. Certainly lab automation is expensive, but when you amortize cost over volume and the number of years an instrument operates, labor is our most expensive resource—and most valuable in the lab.
Hata: We need to pay people better in order to retain them. We also need to take a look at the amount of money being sent on send-outs. Where can money be saved by bringing tests in-house?
Felder: The most expensive single cost will be the planning, purchase, and training necessary for moving toward an automated laboratory.
Laposata: Certainly we try to get more automation. As you automate more processes, you need fewer techs for the simple things. Robots can pull tubes off the line and load centrifuge and aliquot samples with little human intervention. The tech it displaces can then be redeployed to conduct more complex testing.
Jackson: We are spending a lot on software and IT overall at the moment—automation, business intelligence software, decision-making programs, workflow management. We want to more easily mine our database to understand trends both on the business side and within internal workflow. Information can be used to optimize turnaround times and to more effectively manage contracts. The LIS vendors have dropped the ball in some areas, but we are seeing some of the IT vendors, such as database companies, pick it up. So we are looking to some nonlab IT vendors to solve our problems.
What will be the moneymakers and cost savers?
Nichols: Pharmacogenomics seems to be the area producing high-margin, high-profile products and services, but it will become increasingly difficult for labs to pursue these labor-intensive tests as the health care system becomes more cost and resource sensitive. Continued assessment of what is being sent out can lead to cost savings, as can assessment of proper test utilization. Simply restricting the use of stat testing for tests that are truly stat, such as for those patients in intraoperative surgeries or needing emergent care on the floor, could save money by reducing the pressure on our technologists.
Felder: Infectious-disease testing by molecular diagnostics will be faster, less expensive, and more definitive. Thus, many medical centers will eliminate much repeat testing and the costs associated with late or misdiagnosis.
Kasoff: Many hospitals and large clinics are starting to take a hard look at their aging LIS systems and looking at more intuitive systems with an improved TOC. LIS’s should be intuitive, easy to learn, and easy to use. That will ultimately translate into workflow enhancements and, given the high rate of employee turnover in the industry, that can be a big help.
Laposata: Large labs will potentially benefit from some level of automation, but it may be hard to justify for the 200-bed hospital because the time to ROI would be too long. Big academic medical centers are generating revenue with spin-offs. The University of New Mexico spun off a lab which performs breast cancer molecular testing. Another group just launched a pharmacogenomics lab.
Hata: We need to examine utilization. Just because you see a lot of publicity about a test doesn’t mean it’s the best one. Keeping operations as efficient as possible can save labs money. This does not mean a reduction in head count but greater efficiency in workflow, including doing the right test the right way the first time.
Renee DiIulio is a contributing writer for CLP. For more information, contact .
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