Some services can analyze and evaluate urologic specimens better than others. Here are a few pointers that could help you decide where to send your patients' specimens.
WHAT DO you know about the pathologists analyzing your patients' specimens? Are you sure the person signing off on the report is qualified to do so? How many other slides has the pathologist looked at that day? That year? Does the lab pay its pathologists using a system that encourages productivity beyond the point of proficiency and into the realm where quantity is more important than quality?
If it has been awhile since you've considered these questions, perhaps it's time to reassess how and where you execute the clinical pathology needs of your patients. Urologists who are unsure about which qualities to seek in a lab may find all the answers they need in the firm stance of M. Nasar Qureshi, MD, PhD, a uropathologist who heads QDx Pathology Services in Cranford, N.J., a full-service laboratory that also sets up in-house pathology laboratories.
“Few pathology laboratories have uropathology expertise,” he warns. “A lot of labs have gotten on the bandwagon of uropathology because that's what the marketplace holds, but most of them do not have uropathologists. I would really urge the urologist to be very clear on the credentials of the pathologist signing out the case.”
Now that so many more men undergo prostate screening at a relatively young age, often when cancer is in a very early stage—the need for a uropathologist's eye is more critical than ever, according to Dr. Qureshi. “It's one thing to find cancer in half the prostate of an 80-year-old man. The trick is not in finding wall-to-wall cancer but in looking at a 52-year-old patient and recognizing the three atypical glands, which may turn out to be cancer when pursued.”
Just do the math, Dr. Qureshi says. “The progression rate of prostate cancer from start to full-fledged disease is eight to 10 years. This man's disease is getting picked up at an extremely early stage where maybe 1% of his prostate is cancerous. He's looking at a 99% chance of cure. But if the pathologist misses it, he's coming back in five years with a full-fledged cancer, and perhaps a $5 million lawsuit against you.”
Dr. Qureshi says that this illustrates how the onus on the pathologist has increased as the changes in criteria for prostate screening have led to earlier detection. “Clinicians are looking for definitive guidance, and that is where you need a specialized uropathologist,” he explains.
Unlike many larger labs that pay their pathologists based on a high number of slides to be read each day, Dr. Qureshi takes a much different approach with his staff—one that he believes is crucial for quality assurance purposes. “I'll stop a pathologist who does more than 80 prostate slides per day, because I know there comes a saturation point where they're going to be swayed and get tired or just start saying, ‘This must be benign.' If you're going to do 150 slides a day, I'm sorry, but you're going to miss cancer.”
Tips for nephrologists
Similar advice is doled out to nephrologists by J. Charles Jennette, MD, chairman of the department of pathology and laboratory medicine and executive director of the nephropathology laboratory at the University of North Carolina in Chapel Hill. “It's very important for clinicians to check whether their specimens are going to a competent renal pathologist,” he affirms.
Specifically, nephrologists should be sure the lab is competent to prepare the tissues for light microscopy, immunofluorescence, and electron microscopy, and that a well-trained, experienced renal pathologist will not only be analyzing the specimen but also willing to help the clinician understand how those findings should guide the care of the patient.
“My own opinion is that a practicing renal pathologist needs to see at least 200 kidney specimens a year to be likely to be fully competent.”
Yet the nature of renal pathology is such that these specimens probably will only be seen by highly qualified personnel. Dr. Jennette explains: “Kidney biopsy specimens generally need to be referred to a center that has substantial volume of renal biopsy specimens, because small community hospitals and even some small academic medical centers don't have the special expertise and the histology laboratory that's required to cut the very thin sections needed for renal biopsy evaluation, nor to perform the battery of stains both for light microscopy and immunofluorescence microscopy that are routinely applied.”
The commercial labs that do offer renal pathology services generally use renal pathologists, “not general pa-thologists or even urologic pathologists,” Dr. Jennette says. Of the five million tests that his own department processes each year, only 2,000 are kidney biopsies. “And it takes us getting specimens from 250 to 300 nephrologists to get that many.”
Dr. Jennette has some important instructions for nephrologists regarding how to obtain an adequate sample for the nephropathologist: Clinicians should be sure that the person performing the kidney biopsy —often a radiologist—uses a 14- or 16-gauge needle rather than the smaller 18-gauge needles that are typically used for tumor biopsies at sites other than the kidney. “With the kidney, you need the bigger needle because you must have enough of the architecture to be able to make the diagnosis,” Dr. Jennette notes.
In addition, the sample must come from the surface cortex of the organ, not from deep within as is often the case with tumors.
Nephrologists should be aware that with new therapies come new potential renal risks. “For example, the adverse effects of VEGF on kidneys weren't recognized a year ago, but now they are,” Dr. Jennette says.
Molecular testing
Molecular testing is very much on the minds of pathology experts and the clinicians they serve. “I think in the next five to 10 years there's going to be a significant change in pathology services through molecular testing,” predicts James R. Miller, MD, a hospital pathologist and owner of Pathology Services, Inc., in St. Louis. “We'll certainly be better able to tell a clinician that this particular prostate biopsy, for example, is a pre-malignant condition that probably needs to be managed aggressively, or that this is a malignant condition that's going to be best treated by this particular type of tumor therapy.”
Such events are already in the works at Aureon Laboratories in Yonkers, N.Y. CEO Vijay Aggarwal, PhD, tells Renal & Urology News that the independent lab has just launched Prostate Px+, a test designed to predict outcomes in patients with prostate cancer.
“From a needle biopsy sample that's taken at the time of diagnosis of prostate cancer,” Dr. Aggarwal reports, “we can now determine whether this is an aggressive tumor that needs aggressive therapy, or a slow-growing, indolent tumor that needs no treatment, less aggressive treatment, or no treatment until a later date.”
Dr. Aggarwal believes many pathologists would like to be able not only to diagnose disease, but also give the clinician some guidance in terms of how aggressive the disease is and what sort of treatment might be indicated.
Prostate Px+ testing is the only service that Aureon offers “because we really think there's a specific need for this type of testing,” says Dr. Aggarwal. “Prostate cancer is a widely diagnosed disease today, and more important, it's a field in which the decision about what to do is very unclear; some of the tools used to stage tumors today are fairly inaccurate, and because of human intervention, also subjective.”
Dr. Aggarwal points out that elevated PSA levels may be caused by other conditions, which can be misleading. In addition, Gleason grading has become less helpful to the urologist because on the Gleason scale of 2 to 10, 85% of the grades come in at 6 or 7. “So it really doesn't provide much guidance to the phy-sician about how aggressive the disease might be when diagnosed. The molecular variables incorporated in Prostate Px+ fill this gap.”
Do-it-yourself pathology
For a growing number of urology practices, establishing in-office laboratories holds more appeal than sending the work outside. (This model is not cost-effective for nephrologists.) The popularity surge may be related to the crackdown on “pod” labs by the Centers for Medicare & Medicaid Services. These facilities essentially served as physician office labs for various practices, but were located far from the practice itself—sometimes in a different state. Now, all physician office labs must operate in the same location in which the practice sees the bulk of its patients.
Having set up about two dozen in-office urology labs around the country—and counting—Bernie Ness, co-founder of the Chicago-based pathology consulting firm TWINCREST, has received a lot of positive feedback from his clients.
“The physicians have noticed an increase in the quality of the pathology readings, since the same pathologist does the reading day in and day out,” he says.
As a survivor of prostate cancer who remembers the frustration he felt when his specimens would be sent not to the best pathologists but simply to the labs dictated by his insurance coverage, Ness is particularly attuned to the improvements in patient care. “One physician told us that having the pathologist as part of the practice made a big difference, because when necessary he could just walk the patient down the hall and have the pathologist explain a complex finding.”
And administratively, of course, “it's easier [for urologists] to mainly be dealing with their own lab rather than, say, four outside labs that they had been using.”
Once a practice does decide to move forward, Ness advises the group on matters ranging from the design and size of the lab, to the equipment and staff needed, to recruitment of and pay structures for lab staff. He also provides pathology reporting software and billing expertise.
Ness has found that the in-office laboratory option is not economically viable for urology practices referring fewer than 4,000 biopsy vials a year. Urologists who do choose to establish their own lab generally should plan on making an investment of about $150,000. And they can't split the costs with other practices. “No lab-sharing is allowed; all practices using the lab must have the same federal I.D. number,” Ness cautions.
The client-bill model
As it happens, there is a legal but sometimes controversial middle ground between office labs
and outside labs for urologists: the client-bill, or purchase-service, model. A physician choosing this option bills the patient directly for lab services delivered by an outside vendor, and then the physician pays the lab a discounted fee for the lab work rendered.
Jeffrey Small, MD, is a strong proponent. “I'd heard about this and as a solo practitioner, I was intrigued,” recounts the Bridgeport, Conn. urologist. “It's good for the patients and it's a way to keep your head above water financially with reimbursements being cut in other areas.”
Although Medicare won't pay physicians through the client-bill model, many other insurers will. Some practitioners worry about the conflicts of interest potentially spawned by this close relationship between physician and lab, but Dr. Small believes the strategy makes smart business sense for urologists, and he has been impressed by Lakewood Pathology Associates, his partner in this arrangement. “I have easy access to the pathologist, and because Lakewood is a smaller, growing lab, they go beyond the call of duty in customer service.”
Edwin Hendrick, the senior vice president of sales and marketing for Lakewood, is happy to hear that. “We think there's now a market and a niche for a higher-service-oriented laboratory, and that has allowed us to take business away from some of the larger providers.”
Based in Lakewood, N.J., the lab's new leadership team can be found on the West Coast, the target of their expansion plans. (Dr. Qureshi of QDx was a partner and medical director of the company prior to its being acquired by the current owner.)
Hendrick says his company sees urologists being forced to use larger labs because of insurance, accept longer turnaround times, and endure a lack of support on the pathology side. “The urologists want to trust the people they're dealing with [in the laboratory] and know that those people will be there on a day-today basis.” But he believes that one of the greatest benefits a urologist can get from the lab is knowledge about the latest available tests. “It's hard for busy urologists to read up on all the new molecular and genetic markers that are out there,” explains Hendrick. “They're going to have to rely on some of the vendors even more so now to show them what's [available] in the marketplace that can help their practice.”
Beyond Renal Pathology:Lab Issues for Nephrologists
TO SOME EXTENT the lab is probably a nephrologist's most important tool, suggests Csaba Kovesdy, MD. “We are dealing by and large with an asymptomatic disease, and the way we track the disease and its consequences is by using the lab,” explains the division chief of nephrology at the VA Medical Center in Salem, Virginia. “Having a good laboratory support service is essential to our work.”
Still, renal pathology is not an everyday activity for most nephrologists. “It's really the clinical chemistry laboratory and the hematology laboratory that we rely on multiple times every day.”
To that end, Dr. Kovesdy outlines two key lab issues for nephrologists:
• Nephrologists used to assess each inpatient's urine themselves, but now the only official assessment can come from a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). “I think it was thought that the lab could do an equally good or better job than we nephrologists could, and I would venture to say that 99% of my colleagues would vehemently disagree with that. It is a major issue that is unresolved and probably will remain unresolved from our standpoint.”
• The measurement of serum creatinine is not standardized, and the varying measurements between labs can amount to significant differences in glomerular filtration rate. This can lead to the misdiagnosis of certain conditions, especially if the patient's kidney function is relatively close to normal. Parathyroid hormone is not standardized, either, making it difficult to follow recommendations for treatment based on parathyroid hormone measurements done with different assays. “Again,” Dr. Kovesdy says, “it's one of those issues that probably won't be resolved in the near future because it affects a relatively narrow segment of physicians since parathyroid hormones are measured predominantly by nephrologists.”