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Examination of urine dates back to ancient times, when it was a primary diagnostic tool called uroscopy. Urinalysis remains a frequently ordered test, regularly requested as both a screening tool and a diagnostic exam utilized at wellness visits, upon being admitted to the hospital, as part of a surgical work-up and during pregnancy check-ups.
Traditional urinalysis is comprised of three distinct phases: a visual examination to evaluate color, clarity and concentration; a chemical examination to test for specific gravity, pH, protein, glucose, ketones, blood, leukocyte esterase, nitrite, bilirubin and urobilinogen; and a microscopic examination to identify and count cells, casts, crystals, bacteria and mucus that may be present.
Urinalysis has evolved, however, and particularly in recent history, both automation and point-of-care testing (POCT) have opened doors for numerous quality improvements.
"There are two key areas of evolution in urinalysis testing technology," said Maria Peluso-Lapsley, global commercial marketing manager, Urinalysis, Siemens Healthcare Diagnostics, Deerfield, IL. "First, technology delivering improvement in process management, including the movement from manual to instrument-read testing for both the POC and in the core laboratory; second, options to expand menus, including quality indicator markers."
Improving quality and efficiency remain every lab manager's ultimate goal; automation and POCT for urinalysis can be utilized to achieve that objective.
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MOVING FORWARD: Automating urinalysis can provide better patient care than traditional microscopy. (ADVANCE photo)
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A Segmented Journey
Despite some major advancements, parts of urinalysis have lagged behind other clinical laboratory modalities when it comes to automation. The visual elements of urinalysis have been incorporated into the chemical examination, and there's a great deal of automation there, explained Carl Trippiedi, senior product manager, Sysmex, Mundelein, IL, but automated urine microscopy is still catching up.
Technology for automated microscopy was lacking until the late 1990s and into the new millennium, and even then the market remained in the neighborhood of 70 percent manual microscopy until around 2003 or 2004, Trippiedi explained.
"Then, we started to see a steady growth of labs moving to automation. This was the last section of the lab where people started to budget for automation," he continued, "and it was spurred on by the lack of qualified laboratorians to do the work."
For a long time, many labs were in a position where they had to make trade-offs in terms of labor. Trippiedi said labs that don't have automated urine microscopy might decide to do reflex microscopy only if the chemical portion is positive and warrants further investigation.
"The chemical side is telling you if there are leukocytes or proteins, so if there is bleeding, they can move to the microscope and see it," Trippiedi explained.
"The trade-off that happens when you're not doing a complete urinalysis is you may be missing some pathologies not picked up by the test strip." This doesn't mean the lab was putting out inferior results, he clarified, but because the urine microscopic exam would be used in conjunction with other methods, laboratorians could rely on those other methods in cases where microscopy was skipped for a strip-negative patient.
"But when the urinalysis exam is fully automated, labs can perform a complete urinalysis for each patient, resulting in better patient care. What's more, manual microscopy is a subjective science. That means there's a level of variability that can also impact reported results. A complete automated urinalysis with standardized results means real quality improvements for the lab, Trippiedi asserted.
Widespread Benefits
The improvements garnered from automation don't end there. Trippiedi pointed out the Medicare initiatives from CMS made in October 2007, targeting urinary tract infections (UTI) and hospital-acquired infections (HAI) for cost savings. The term "present upon admission" became a big deal. Say, for example, a patient is being admitted to the hospital for a heart condition, and he has the beginnings of a UTI but the infection is not caught at the time of admission. If that UTI fully develops later in his hospital stay, CMS may consider the condition an HAI and the hospital is unable to submit a separate diagnosis related group and must treat the condition without reimbursement.
"With new pay-for-performance initiatives, the hospital could be held accountable for subjecting the patient to an HAI, when the infection was there to begin with. With an automated complete urinalysis, perhaps the evidence would have been there upon admission with a two-minute screen. It would have detected the elevated bacteria and white blood cell level," Trippiedi said.
The physician would have had the evidence to delve deeper and determine the patient has a UTI present upon admission and the hospital isn't inaccurately assumed to have caused a nosocomial infection. In the end, that's an impressive quality gain.
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