“What’s wrong with your pregnancy test?” That was the question asked of me when I picked up my office phone one morning. I was early in my career as a lab director and was a bit flummoxed, both by the nature of the question (as a male, I didn’t recently undergo a pregnancy test) and by the accusatory tone of the voice on the individual on the other end of the phone. That person was the director of my organization’s emergency department. And she was not happy.
“Tell me what happened” was my response. Over the next couple of minutes I learned of a troubling scenario. A young woman had come to the emergency department the day before complaining of abdominal pain and vaginal bleeding. While these symptoms are non-specific, they are alarming in a woman of childbearing years because they could be indicative of an ectopic pregnancy. An ectopic pregnancy occurs when a fertilized egg implants in an anatomic site other than the uterus (usually the fallopian tube). This is a life-threatening event because the fallopian tube can be ruptured as the fetus grows resulting in massive internal bleeding. It’s a diagnosis that no one wants to miss.
The director told me the patient had been assessed first for a possible pregnancy by a urine pregnancy test performed in the emergency department. Because the result was interpreted as “negative,” she had been discharged without the correct diagnosis. This patient was correctly diagnosed with a ruptured ectopic pregnancy the next day, but at a different hospital (she survived). The director was angry because her department had failed to make the correct diagnosis, because, she said, of the false-negative urine pregnancy test result. That’s why she was calling me. The test was faulty and what was I going to do about it?
As a laboratory professional, I struggle with the concept of point-of-care testing. The majority of point-of-care tests are performed by non-laboratorians who may not appreciate the nuances of lab testing. Laboratory testing matters whoever is performing the test. In our quest to deliver rapid, actionable test results, have we lost the essential emphasis on quality? Just because a test is simple to perform doesn’t mean it should be done in a cavalier way. Every test, every time, for every patient no matter how simple the test may be should be done with attention to quality, competency and learning from errors.
After the call ended, I began to consider ways in which the error might have occurred. Was the correct sample tested? Was the test performed correctly? Was the result correctly interpreted? What were possible analytical reasons for the false result? Was the individual who performed the test appropriately trained on test performance? Was quality control testing performed?
Although I’ll never know for certain, all indicators pointed towards either a sample mix-up or an analytical problem as the cause of the false result. I had a medical resident tell me he had no idea that a urine pregnancy test could be wrong. In other words, he thought the test was perfect! That single comment has resonated with me for my entire career. It made me realize that a primary responsibility of laboratorians is education. We need to teach our clinical colleagues about the value of lab medicine as well as its strengths and weaknesses.
Why does lab testing matter? Because patient care decisions are frequently based on lab test results. Quality is not just important; it’s essential. Our patients deserve nothing less.