Tuesday, August 27, 2019
I am NOT the first person who has thought about this. I am NOT the first person who has experienced this. This is NOT my first time to struggle with the dilemma of tests performed inside the medical system but outside the laboratory. But it has reached a level that needs attention.
So about 7 months ago, my family doc thought that that it would be a good idea for me at my age to have a screening occult blood test done to rule out a silent bowel cancer. Unfortunately the test did not rule out bowel cancer, but understand the test is VERY specific, which means it is detects blood, but VERY non-specific in that there are a bazillion reasons that one can have a positive blood test, and NOT have bowel cancer. In fact the highest probability was that I do not and did not have any good reason to suspect I have cancer. But in the modern era, if there is even the tiniest suspicion one has to do a follow-up test, a bowel scoping (colonoscopy).
So a scoping is arranged and 6 months (!!) later, I get an appointment and after going through all the preparations I have my test, which I am told indicates no cancer. No surprise, but YAY, none the less.
But for a guy who spends his time thinking about Quality and performance, this was a really unsatisfying experience because, what if the test result was wrong. As we all know, it can happen.
One thing is always certain… errors occur. Maybe the doc doing the test is incompetent, or maybe he was distracted or maybe is under a lot of stress, too much work and not enough time. Maybe the scope was defective. Maybe the biopsy that was taken was taken incorrectly from the wrong place. The reality is that our system makes the assumption that the scope doc is competent, but we have NOTHING but faith to back that up.
In the laboratory we perform Quality Control regularly to ensure that our equipment works, our reagents work. We can, to the extent possible, ensure that samples were collected properly and transported properly. We can maintain quality indicators to monitor for incorrect reports, and we can most certainly monitor for complaints. Further we have External Quality Assessment (Proficiency Testing) to monitor that our staff are proficient/competent. And we have regular Quality Indicators that can measure and record all sorts of parameters to give us early detection of problems arising. It is part of our norm, part of our routine. It is called verification and validation of the process.
In clinical care we don’t have that or do that. We have Trust me… Trust ME! I didn’t see any evidence of cancer… Trust me. I didn’t see anything that looked like a polyp… Trust me. Or, I saw a polyp and took a biopsy correctly… Trust me. Of course I know what I am looking at with my scope. I am a good doctor… I was trained at the best place by the best people. I always am careful… I never make mistakes… TRUST ME.
Let me argue, the days of trust are getting pretty thin, and I can see a time in the not-do-distant future that “Trust, but verify” does not only apply to nuclear physics and bomb site laboratories. There are many many organizations where Quality processes are the norm (maybe not in physician or lawyer offices or teachers and certainly not politicians) where regular audit, and re-certification is the routine. Think about restaurants, and food chain, and medical equipment suppliers, and medical laboratories where audits to ISO international standards are routine in most countries around the world. (Even politicians have a form of validation and verification every 4 years!). In the United States, if a medical laboratory does poorly on its proficiency testing, the facility can lose its ability to bill for federal funds. In Canada, a laboratory can be closed until the quality requirements are addressed.
In the olden days, one could make the argument “Yes we agree, but there is no way one can make an assessment, and measurement, a determination. That is no longer the case. In the medical laboratory we can make samples that closely simulate typical laboratory sample proficiency testing is can be a real-to-life experience. In the medical training arena there are dolls that look like and act like real patients. Some of these can be and are used in examination and training settings. We no longer rely solely on actors playing patients.
What we need to do as individuals, as interested parties, as professionals start the movement. Verification by demand.
It won’t stop all errors, but it will provide documentation of meeting requirements and help professionals become aware of potential weaknesses, and provide our customers, our patients and their families with the confidence that we take Quality Monitoring and Quality Improvement seriously.