Billions of dollars are spent annually on urine specimen collection and analysis as they are critical clinical components vital to human health. The mid-stream clean catch (MSCC) process is the gold standard of ambulatory urine specimen collection for clinical diagnosis of urinary tract infections (UTI). The MSCC process is over 60 years old and is plagued by ridiculously high specimen contamination rates. The MSCC has resisted numerous attempts aimed at improving it.
The purpose of this study was to determine if utilizing the concepts of Human Systems Engineering (HSE) could improve the urine specimen collection process. HSE concepts were not only targeted toward the problems, they were also used in the quest to develop effective solutions. Results obtained demonstrate that HSE concepts, when applied to urine specimen collection, can and do make a difference in terms of specimen quality and patient satisfaction. One low cost easily implemented targeted HSE-informed intervention effort resulted in a specimen contamination rate reduction of 16.6%.
A second targeted HSE-informed intervention involving the redesign of the specimen cup, its instruction set, and additional sign placement made it three times less likely for participants to provide a contaminated MSCC sample. The redesigned specimen cup automatically captures and isolates an initial void sample from an MSCC sample, both derived from one continuously provided patient specimen. Clinical utility comes in the form of improved MSCC specimen quality and a separated initial void available for analysis using Nucleic Acid Amplification Testing (NAAT) or other test protocols. Capturing and isolating both an initial void and an MSCC at the same time allows for a more complete diagnostic workup utilizing a higher quality MSCC without requiring the patient to follow two different protocols to urinate into two different specimen cups.
The redesigned specimen cup also provides for automatic overflow prevention, incorporates a new ergonomic grip, and a saddle adapter that provides affordances for both women and men in terms of urine capture and the reduced likelihood of urinating on one’s self.