We all plan ahead in January, but it’s also wise to take stock midyear. CLP checked in with six laboratory professionals to see where the industry stands. What are the trends? What challenges lie ahead? And where are we ever going to find enough personnel to staff the lab?

Depending on their role in the industry, the experts seated at CLP’s roundtable cite different trends impacting the clinical laboratory—yet most labs have felt the effects of all of them, and everyone shares a bleak view of the workforce shortage. In addition to staff, many labs need more resources: budget, equipment, experience. And the situation is poised to worsen as resources shrink and testing volumes continue to rise.

But it’s not all gloom and doom. Technology and a professional drive may just save the day—if we all pull together as a team.

1) Which trends had the greatest impact on the clinical lab industry in 2005?

Susan Gross: In California, the greatest impact on clinical laboratories has been the workforce shortage. This is compounded by the growth of emerging technologies, which have put increased pressure on the lab workforce, not only to manage higher testing volumes but also to acquire more advanced technical skills.

Wayne Schreier: Looking at it from the outside, doing more with less has definitely had an impact. Many of those I know in the industry are dissatisfied and feeling overworked. Many professionals have decided to retire early or move to another lab.

Lee Hilborne: The expansion of molecular diagnostics has increased the focus on public health preparedness, given the threat of bird flu. Concerns about proficiency testing and whether they assure the public quality testing were a big issue too.

Michele Best: This is the first time since CLIA [Clinical Laboratory Improvement Amendments] in 1988 that we’ve had Congressional focus on quality. It has led CAP [College of American Pathologists] to look strongly at the inspection process, with the biggest outcome being unannounced inspections of all labs—by both CAP and JCAHO. We now have to stay in a continuous state of readiness. This comes with a lot more ongoing administrative work.

2. Which trends do you expect to have the biggest impact in 2006?

Best: The greatest impact will depend on whether Lean management or automation become standard. Lab professionals are rethinking total lab automation and asking if it’s achieving goals. We purchased a front-end lab robotic system a year ago, and we are finding that it does not necessarily improve turnaround time. It doesn’t hurt it, but when you have fewer samples—not a high-volume setting—it may actually delay the stat turnaround time when compared to rapidly scanning a bar code and having the tech put it on the analyzer. Whether to follow the automation trend or the Lean management trend depends on a lab’s individual volume and setting. Hospitals in 2006 will get hit with more decreases in Medicaid and Medicare, and it’s doubtful that many facilities will be able to make multimillion-dollar investments in automation.

Hilborne: There will be increased cost pressures, and competitive bidding demonstrations may threaten the lab. There will be more issues about quality and perhaps some increased push for pay for performance.

John Tomaszewski: Molecular diagnostics, including proteomics, and computer-assisted image diagnostics are two big areas that will change the future. As science identifies the genes and their products that impact directly on carcinogenesis or even inflammatory conditions, we will want to identify these molecules in tissue and essentially create patient-tailored diagnoses. We’ll look at tissue-gene profiles, which will stratify people in terms of therapeutics; so every time there is a new therapeutic modality, people will want to know if a gene comes into play. Finances will probably play a role in deciding when to bring these tests in-house.

At the Table
Who are the experts seated at the CLP table? In alphabetical order:
1) Michele L. Best, MT(ASCP), laboratory manager, department of pathology and laboratory medicine, Howard University Hospital in Washington, DC
2) Susan Gross, senior supervisor of the clinical lab, chemistry/toxicology, San Francisco General Hospital/UCSF (San Francisco)
3) Lee Hilborne, MD, MPH, professor and associate professor of pathology and laboratory medicine, University of California, Los Angeles (UCLA); and, deputy director of global health (Asia) for the Rand Center for Domestic and International Health Security (Santa Monica, Calif)
4) Robert (Bob) Proulx, VP of marketing for Nanogen (San Diego), an advanced diagnostics company offering markers and other technologies
5) Wayne Schreier, PhD, associate professor of physiology at Nova Southeastern University, College of Medical Sciences, in Fort Lauderdale, Fla
6) John E. Tomaszewski, MD, FASCP, vice chair for anatomic pathology-hospital services, Department of Pathology and Lab Medicine, University of Pennsylvania, Philadelphia

Gross: With the workforce shortages continuing and retirements increasing at the same time as the demand for molecular testing, more sensitive assays, and increased regulations, clinical labs face major challenges.

Schreier: I’ve found that the labs most successful in improving quality and moving to automation have been the labs that have really done a complete makeover of how they do business. Drawing on some of the older techniques of the Japanese automobile industry to improve employee satisfaction and performance using employee input, many of the most successful have been using the Lean or Six Sigma methodologies. And they’ve seen remarkable improvements in their turnaround times.

3) But automation has been a trend expected to bring direct and indirect savings. Are the hospitals and facilities with automated systems beginning to see benefits?

Hilborne: With any automation, there are good and unexpected consequences. Automated specimen processing is increasing—will increase. There are high up-front costs but also hopes that efficiency will improve and staff costs will decrease downstream. Increased automation to confirm patient identification is important for safety and will continue.

Schreier: The labs I have seen show the greatest turnaround after automation implemented Six Sigma and/or Lean methodology at the same time. The biggest improvement is probably the reduction in lab errors. A lot of the bar coding and sample-sorting automation has definitely eliminated some of the human error that was observed in proficiency surveys.

Best: I think hospitals with higher volumes would tend to agree that labs processing a significant outreach volume—5,000 to 7,000 specimens per day—have had significant turnaround improvement, which does affect the flow through the emergency department (ED). So for large EDs and outreach volumes, total lab automation makes a lot of sense.

Tomaszewski: Anatomic pathologists are at the earlier part of the curve for automation, but simple things like robotic cassette and slide printers are becoming more common and really boost productivity. Tissue-processing technology is changing quickly: 1-hour tissue processing is a reality. I also think how we deal with slides will change. Right now, we take a piece of glass and push it in front of a microscope, but 10 years from now, we won’t be pushing glass. We’ll be looking at slides on a screen, much like in radiology. This will allow us to mathematically manipulate the digital data field, allowing more quantitative and computer-assisted diagnoses.

Gross: Advances in automation have always had a positive impact on costs and, most importantly, on staffing. With the current and projected workforce shortages in the laboratory, automation and autovalidation of results of the common tests will be essential for survival of laboratories.

4) What impact has EMR [electronic medical records] had on the lab? How will this change over the next few years?

Hilborne: The impact of EMR will be to better involve the lab in decision support. So if someone is on a drug, for example, that has adverse renal impact, the computer will use the lab results and [provide] feedback to the ordering physician. There will be, hopefully, expedited delivery of information as well as more timely care.

Gross: The EMR has a positive effect on the lab, as the providers can readily see current and long-term laboratory results in addition to other clinical data, even though there is no direct correlation in our system of lab data with pharmacy or other clinical information. In the future, there should be improvements in algorithms available to correlate lab data with other clinical data and in availability of the information via remote access.

Best: The EMR has great potential, because physicians will directly order and have access to their results instantaneously from anywhere. Very often, lab testing is overused because of the ordering process. If a physician is controlling the order, we expect less overutilization on the in-patient side, which can help to reduce expenses since in-patient testing is purely cost. It could also have a significant impact on paper and administrative costs as well as safety. All of the information from pharmacies and the patient will be electronically available to the physician when making decisions.

5) What new solutions to the workforce shortage exist?

Hilborne: Automation. And there needs to be increased recruitment. But the hiring of a less skilled workforce is a big problem. Without skilled workers, mistakes will increase.

Best: The shortage is of great concern to me, because I have not heard any new solutions. In the next 4 or 5 years, we’ll have massive retirement of lab staff, which could amount to 60,000 people leaving the profession. I have seen activity among the professional organizations [Best is on the board of directors of the American Society for Clinical Pathology], but we are still in a reactive mode, hiring temps or stealing personnel. What we need to do is decide what we are going to do to achieve the numbers of professionals we need with the correct skill mix. We either need to make them or buy them—for instance, we could get a class of med techs from a university to work with us.

Schreier: Here in south Florida, one of the biggest providers of med techs, Florida International University, cancelled its med tech program a couple of years ago with dramatic impact. There needs to be more schools and better pay to attract people. It’s an issue we’ve discussed a lot and thought about a lot, but haven’t come up with any good solutions.

Tomaszewski: It’s getting to a real crisis point. The population has really aged demographically and has not been filled from the bottom. Unless addressed, it will begin to shut things down. But we can’t address it by hiring just anyone, or we will increase risk. The American health system needs to see if training systems are adequate for the future. I don’t think they are.

6) As molecular diagnostic tests increase, how does this impact other lab segments, such as hematology and chemistry?

Schreier: Molecular diagnostics is going to increase significantly and probably much more rapidly than people have anticipated. The FDA focus on pharmacogenomic testing will increase the amount of genetic testing performed. Its impact will depend on how expensive that testing is and whether it will be outsourced or done only by large lab chains.

Hilborne: Molecular diagnostics will probably reduce some traditional tests, but it will also impact surgical and other diagnostic pathology services. In the beginning, it will be add-ons and substitutions, similar to MRI, which has not replaced the traditional x-ray.

Gross: When we installed an automated track system for chemistry and immunochemistry, one of the benefits was that we were able to put more clinical laboratory scientist time into the expansion of toxicology and newer tests, such as molecular testing.

Best: But routine labs will also continue to grow. The aging population will be diagnosed with chronic and acute conditions, so the lab workload will increase strikingly, while the workforce shortage gets worse.

Robert Proulx: Although molecular methods continue to improve and provide laboratories with the ability to readily undertake complex multiparameter or multiplexed diagnostic assays, the method and extent of reimbursement for such tests is uncertain.

7) What reimbursement hurdles do labs need to address? How are these expected to change over the next few years?

Proulx: Reimbursement codes exist for molecular methods, such as nucleic acid extraction, amplification, and detection, but it is unclear if reimbursement for complex testing will be based on a multiple of the codes. To date, the FDA [Food and Drug Administration in Rockville, MD] and CMS [Centers for Medicare and Medicaid Services in Baltimore] have not provided complete guidance in this area. Once they do, labs and vendors will be better able to assess the value in impact for diagnostic testing.

Hilborne: The big issue may be competitive bidding. The clinical lab fee schedule is also an issue. If competitive bidding goes in, it will have an impact, making labs look like a commodity rather than a professional service. This is dangerous for the lab and the patients.

Best: Many hospitals are already operating on a razor-thin margin, and there are many concerns about [President George W.] Bush’s proposals to cut Medicaid and Medicare, which at a certain point will affect care. At the same time, requirements for patient safety, such as automation and bar coding, cause expenses to go up. They’ll be looking at testing, such as pathology’s IHC slides, that we can bill for and the number of types of IHC codes we can bill for. There will be continuing efforts to continue to decrease reimbursement and, with that, comes pressure to decrease utilization.

8) How will pay-for-performance programs affect clinical labs?

Best: Right now, a hospital has to test data on quality indicators for CMS and JCAHO [Joint Commission on Accreditation of Healthcare Organizations], and if we don’t perform at a certain level, we can expect to not be reimbursed. The Medicaid and Medicare programs will not reimburse hospitals that do not meet the quality standards posted on the CMS Web site. But it’s the hospitals that report, so I’m not sure how it will affect the lab.

Schreier: In principal it’s a good idea, but I have read only one study, from a group at Harvard published last year in JAMA [Rosenthal, Frank et al in the October 2005 issue of the Journal of the American Medical Association]. They compared a physician group in California using pay for performance with a North Pacific Physician Group with no pay for performance. There was an improvement [due to pay for performance], but it was very slight, and it appeared the labs that benefited the most were the ones already doing a good job. It didn’t seem to make a difference to labs that were poor performers to begin with, so I don’t know how it will work.

9) What is the biggest challenge facing the industry in the coming year?

Gross: The biggest challenge will be to improve the technical staff, not only in numbers but, more importantly, in technical skills and understanding of new technologies, regulatory guidelines, and the flexibility to meet new challenges.

Schreier: Having to do more with less and providing the proper work environment to attract people into the field are issues. I sometimes have a hard time recommending people go into the lab field, because some labs have come under such pressure that it’s not a satisfying environment. It depends on the lab and how it’s run.

Hilborne: I think there is broadly a PR issue. People don’t know what the lab does, so it’s an easy target. We need to change that.

Tomaszewski: There are challenges to becoming mainstream: Many institutions may need to set up labs they don’t already have—core molecular labs, core FIH labs, core proteomics labs. These are sizable investments, but the federal government has been very reluctant to reimburse many, if not most, of these tests.

Best: We need to continue to focus very strongly on patient safety. JCAHO has published very aggressive patient-safety goals for 2005 and 2006, and labs have to ensure patient safety in all of their operations. There is a lot of talk about continuing to improve efficiencies through better process-improvement activities. Of course, we’ve already talked about declining reimbursements, which are bound to occur. And the preparation for major disasters and emergencies continues to affect us. Bird flu, for instance, would be a huge challenge for hospitals.

10) How can labs address these challenges?

Hilborne: The laboratory societies need to get on the same page and really make the case for the professional service that labs offer. I think we’ve got plenty of messages, but they need to be louder, and people need to step up and be vocal. Nursing surely has!

Gross: Every laboratorian—whether a pathologist, director, clinical laboratory scientist, or phlebotomist—needs to assist in promoting the profession to the public and to the younger generation. To retain and recruit staff, management and lab professionals need to keep salaries competitive and the profession in the spotlight.

Best: We need to develop very creative solutions to the workforce shortage, and we need to start now. Labs need to focus on retention. At this rate, we need to keep staff until they are 75, so we will need more ergonomically friendly labs. Automation has had a good impact, allowing med techs to do less routine work and to be deployed into other more interesting job areas. Also, the lab plays an important role in patient safety, but an interdisciplinary team is needed to work on this. We can’t do it by ourselves.

Renee DiIulio is a contributing writer for Clinical Lab Products.