Tom Williams, MD, chief scientific officer, Exagen Diagnostics Inc, Albuquerque, NM.
Timothy Uphoff, PhD, clinical consultant and director of the molecular pathology laboratory, Marshfield Laboratories, Marshfield, Wis.
Gilbert Hakim, CEO of SCC Soft Computer, Clearwater, Fla.

Patricia Mullenix, BS, MT(ASCP)SH, hematology technical manager, St Joseph Medical Center, Fort Wayne, Ind.
Daniel Orr, MTA-MT, laboratory/radiology manager and medical technologist, Olathe Medical Services, Kansas City, Kan.

What’s in store for the clinical lab industry in 2008? Will molecular diagnostics continue its rapid ascent and become a fixture in labs everywhere? Will the technology be affordable for most labs? What other trends can be perceived? What about point-of-care-testing? Are there limits to what can be achieved in this area?

CLP talked to five industry cognoscenti. Here are their answers to these and other questions:

What new trends in the clinical laboratory industry do you see emerging in 2008?

Uphoff: Molecular diagnostics will continue its exponential growth. Genetic testing, such as cystic fibrosis screening. has migrated from reference labs to smaller labs. Interpretation of these test results can be challenging and requires laboratory expertise, along with genetic counseling support, to provide optimal utilization of this technology.

Hakim: In 2008, I think we can expect to see health care facilities start requiring vendors to provide integrated laboratory data and reporting across multiple departments/disciplines, including laboratory, blood bank, anatomic pathology, molecular, cytogenetics, and flow cytometry. We anticipate that the government will grow the number of states with electronic interfaces for infectious-disease reporting and expect there to be a mounting desire for hospitals to incorporate lab data into electronic medical records (EMRs).

In addition, there is no doubt that molecular testing will remain a driving force in the industry in 2008, as will the continued emphasis on positive patient identification to reduce errors. There will also be an increased trend toward robotics, as lab technicians are retiring with fewer people entering the field every year. It would not be surprising to see a single tech over multiple workstations and nontechs performing more functions, such as specimen processing and call management. Finally, I think we will continue to see the trend in core lab consolidation skyrocket in 2008 as more health care systems with multiple labs continue to cut back on the number of sites where they do testing.

Orr: Regarding new trends, it depends on whether you are talking about the regulatory or clinical-practice side of laboratory medicine. Regulatory wise, the competitive bidding project will continue to be an issue. As this could impact many labs in a negative way, I feel the lab industry will, for one of the few times in its history, come together to resist this move by the current administration. Rarely has a government initiative galvanized the lab community like this one has, and we, as laboratory professionals, are showing a united front to resist this legislation.

If we are speaking about the clinical-practice end, I feel we will see more of a move toward diversity in testing (and testing personnel) outside of the traditional laboratory setting, and as a result we’ll see an increase in the number of point-of-care tests (portable analyzers in emergency departments and glucose meters in intensive care units). Due to this diversity, the tests available will become easier to perform, and more of the functions that, historically, labs have performed will be built into the tests or testing products. This is already evident in many of the coagulation and glucose testing products currently on the market.

Mullenix: I feel sure that more emphasis will be placed on positive patient identification (ID) systems hospitalwide, including the lab. Many of these are in the form of wireless handheld devices that can scan the patient’s armband, scan a test or medication label, and give an alert if the two do not match. Lab automation systems and bar-code scanners, likewise, improve positive ID and help decrease ID errors and improve patient safety.

For molecular testing, what growth have you seen during the past year, and what do you expect in 2008?

Uphoff: Molecular diagnostics improved the turnaround times in microbiology, providing faster treatments and better outcomes for many infectious diseases. Personalized medicine will hit the forefront with warfarin genotyping as a higher-volume test. The recent US Food and Drug Administration labeling changes for this product reflect their emphasis on using this technology to improve patient safety. Genetic profiling of tumors will expand and will continue to guide the use of therapies to improve patient outcomes.

Williams: We are seeing a proliferation of assays as molecular diagnostics enters the mainstream in the clinical laboratory. We are seeing volume growth in all areas of molecular diagnostics. Examples include the use of more and more multiprobe fluorescent in situ hybridization panels to study tumors, the detection of JAK2 mutations in myeloproliferative disorders, pharmacogenetic tests to adjust warfarin dosage, and human papillomavirus (HPV) testing.

Hakim: Growth in molecular and cytogenetics testing continues at a rapid rate. SCC has signed its largest contract with Genzyme, one of the largest genetics laboratories in the world, for work including the development of new probes, markers, and much more. Several SCC clients have begun molecular testing in-house, with many more planning on it. Inevitably, we will see an expansion to a wider range of genetics testing being done in-house.

Orr: This aspect of laboratory testing has really taken off in the past couple of years. The increase of assessments that are now offered through molecular testing and the reduction in specimen type and size needs will only grow by leaps and bounds in 2008. Reflex testing from one specimen source, such as HPV testing from a Thin (Cytyc Corp, Boxborough, Mass) prep specimen, now allows a health care provider to order one test and then, if results show a need to do additional assessments or testing, accomplish this without having the patient come back for collection of another specimen.

Mullenix: Our microbiology department has begun polymerase–chain-reaction testing the last half of 2007, and I see that expanding over the next year. The research department here is working on thrombophilia testing, such as factor V Leiden and prothrombin mutations, and hopes to make those available in the next year. One major concern is the unpredictable nature of the reimbursement process from year to year. These are expensive tests to set up and run, and adequate reimbursement will be critical. The field is also relatively new to the clinical area, and finding technologists with the necessary skills is still relatively difficult. Standards of performance are also relatively new and may be expected to be a moving target for a few years.

In what ways has point-of-care testing affected laboratories in 2007, and what will be its impact in 2008?

Uphoff: The Cepheid GeneXpert has demonstrated that molecular testing can be automated to a degree that point-of-care testing is technically possible. Engineering advancements will quickly move this forward, and molecular testing will add a new dimension to this testing area. As we have seen with other point-of-care tests, there is always significant personnel training that must occur to ensure quality practices.

Hakim: Hospitals are taking advantage of emergency technology to offer more point-of-care testing, faster response times, and better overall patient care. As the use of this testing continues to grow, we will continue to see more integration and interfacing of point-of-care testing into the laboratory information system (LIS). This will place a greater responsibility on the lab in regard to quality control, as well as the quality of point-of-care data. As the use of point-of-care testing grows, the desire for similar log-in security for positive patient ID tools will grow as well.

Orr: A couple of professional associates and I, through the Kansas City chapter of the Clinical Laboratory Management Association, started a four-state Point-of-Care Users Group for the Midwest a few years back. We offer biannual full-day meetings where we bring in industry experts to speak and also have vendors present the latest point-of-care tests available, so you are speaking to a subject close to my heart. It very much ties into my previous comments about the types of tests available and the large diversity of testing personnel performing these tests. It has opened up a void in the traditional lab’s role of testing oversight; hence, the need for the users’ group we started. More labs now have to designate a specific individual with a strong regulatory and technical base to oversee this.

I know from my dealing with lab product vendors that more and more of these tests will be coming out in the near future, all designed to allow non-laboratorians to perform testing.

Mullenix: Point-of-care testing is most useful in areas in which the result is needed faster than the specimen can be moved to a main laboratory site to be tested. There is a temptation to use it for other patients for convenience; however, most point-of-care testing is much more expensive than the incremental cost in the main lab. It is generally very inexpensive for me to put one more test on an instrument that is already running. In addition, most point-of-care tests are less accurate than the more sophisticated main-lab methods. I think the most useful point-of-care testing is already out there, and although methods may change, I think the economics will probably keep it from expanding much further.

What new developments in laboratory work flow will have the greatest impact on laboratories?

Uphoff: Automation, multiplexing, and random-access instrumentation for molecular diagnostics will reduce costs, improve throughput, and improve turnaround times. These advancements will also speed further migration of this technology from large reference labs to smaller labs.

Hakim: The ability to cluster instruments for greater increases in productivity and reducing turnaround time is the unique thing that SCC LIS provides that will have the greatest impact on lab work flow. Automation in both front- and back-end processing will also surely impact lab work flow, as will increased reliance on robotics and, as mentioned, the desire to embrace technology such as autoverification. Also impacting lab work flow is the increased use of Lean and Six Sigma, leading to greater efficiency and decreased labor requirements.

Orr: Not an easy question! Many labs in the past year have changed their overall work flow through the utilization of manufacturing processes (Lean and Six Sigma). This has required health care organizations to sink large resources into personnel, equipment, and processes. Of course, the EMR is changing the landscape of many health care organizations and how they process and perform laboratory testing. The ability directly to order and put results into a patient’s medical record through electronic interfaces will increase the efficiency of many organizations, but bring with it the need for improved security processes, from an information-technology standpoint. Ensuring confidentially will be challenged with electronic data transfer, and the potential of abuse increases with the greater use.

Mullenix: I think that lab automation is becoming more common and beginning to have more of an impact the past few years. It can accession specimens into the lab, separate specimens by department and test or instrument, centrifuge specimens if needed, rack the tubes according to instrument needs, and even place the tests on the correct instrument. This obviously frees up staff to perform other tasks. In addition, middleware is becoming more available to fill the gap between the instruments and the LIS. It allows the connection of multiple instruments to one workstation, allowing one technologist to report from several instruments. It even transmits the graphics from the hematology instruments and allows the user to develop rules telling the technologists what they should do when specific flags are present. This greatly improves consistency in handling atypical results.

What is the biggest challenge that clinical laboratories will face in 2008?

Uphoff: For our laboratory, the biggest challenge will be choosing the best technologies and platforms for growth that will provide clinically useful results at a manageable cost. The ability to attract well-trained laboratory personnel is critical and will continue to be a challenge for all labs.

Williams: I think the technology to perform complex testing gets easier to use each year. The real challenge for us is providing high-quality laboratory data, integrated with other relevant information, to physicians electronically (so they can provide the best patient care). Otherwise, the sheer quantity, diversity, and complexity of the results that the lab can produce can seem overwhelming to clinicians.

Hakim: Personnel shortages will continue to be a challenge in 2008, requiring labs to look for LISs that improve productivity. With an expected 5% growth in testing and a reduced labor pool, labs will need LISs with artificial intelligence to assist the technician in improved productivity and quality of reporting. Also, 2008 will bring increased competition for small and medium independent labs, and pressure to reduce costs and produce integrated reports and call-management systems across multiple lab departments.

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Orr: Biggest challenges: to me, these will be the ability to meet our health care providers’ expectations for more advanced testing while ensuring that sufficient reimbursement is attainable from the diverse group of organizations that provide it. Insurance companies, Medicare intermediaries, and private payors view reimbursement differently, and this will again cause many labs to struggle to survive, depending upon the mix of these payors.

We all want to offer the latest and greatest, but often, these are not well reimbursed, at least not until global utilization is achieved. If the parent health care organization is not willing potentially to bear an initial loss, these services will not be offered and the organization may lose market share in its local or national market. To put it simply, do we get paid fairly for the work we do?

Mullenix: Reimbursement, reimbursement, reimbursement: competitive bidding may very well be on the horizon, and Medicare/Medicaid reimbursement is always a moving target. Add in the huge increase in losses due to uncompensated care that hospitals face, and the potential closing of many hospitals is a real possibility. In addition to that, we are seeing more and more buyouts of major instrument and reagent manufacturers and suppliers. This leaves us with fewer choices and may well impact costs with less competition.

Alan Ruskin is staff writer for CLP.