All patients deserve to receive the highest possible quality of medical care. For the most part, the responsibility of providing it falls in the hands of physicians – who depend on receiving accurate results when patients’ samples are sent in for laboratory testing.
More than 70 percent of medical decisions are influenced by lab results. They indicate the presence or absence of autoimmune conditions, cancer, viruses, parasites and bacterial infections. Even nonmedical tests can provide life-changing information, with procedures like drug screening and paternity testing.
So when laboratories don’t follow the most basic policies and procedures to ensure accuracy of the results – whether because of faulty technology, improper maintenance or simple human error – doctors can’t make informed decisions, which ultimately compromises patient care.
The Scale of the Problem
It’s all but impossible to measure the magnitude of the effects of laboratory error. According to a report from the Milwaukee Journal Sentinel, privacy laws that protect patients’ personal information also prevent it from being disclosed in inspection reports. Instead, labs themselves must uncover and report errors and their consequences.
Federal regulations for enforcing laboratory practices have been in place for 25 years, but labs are cutting corners – if not outright ignoring the rules. The Journal Sentinel investigated a number of labs across the nation and found that the problem is systemic, stemming largely from efforts to save money.
Where Technology Fits In
Highly technical laboratory machines have significantly streamlined the process of medical testing, but they need to be recalibrated, cleaned and maintained on a regular basis. When technicians don’t keep machines clean, internal tubing gets worn down, air bubbles form and pumps deteriorate. As a result, they stop working the way they should.
Electrical surges, fluctuating temperatures and constant use all cause machines to lose calibration. Additionally, in an attempt to cut costs, labs may opt for cheap calibration services for their equipment, using unapproved technology or failing to clean pipettes.
To mitigate the calibration problem, technicians must run control samples with known values to verify accuracy prior to testing patient samples. Frequently labs fail to run controls, causing unreliable results.
Theranos: A Study in Cutting Corners?
Theranos, a Silicon Valley medical processing lab, was a promising startup. Its internally developed technology aimed to eliminate human error from the testing process. At the time, CEO Elizabeth Holmes explained that the technology was highly accurate and achieved extremely low variance ranges, where tests had a margin of “allowable error” of less than 10 percent.
After a Wall Street Journal report, the company has come under massive media fire, with claims that results have been anything less than erroneous. Theranos developed a blood testing device called Edison, which has come under dispute with questions about how many tests it can perform and the accuracy of those tests. Theranos has not responded, citing trade secrets.
The problem may be that Theranos’ scientific processes were not well conceived. According to Holmes, the idea came to her as a result of her needle-phobia: Only drawing a small amount of blood from the fingertips – thus removing the need for large syringes – would make patients more willing to get blood tests, ultimately saving lives.
However, the Edison devices are dubiously reliable, and samples must be diluted due to their small size. After receiving a complaint from the New York State Department of Health, the Edison system was discovered to produce results for several tests that differed from results obtained from traditional diagnostic technology.
Manufacturers and distributors of diagnostic equipment must receive approval from the Food and Drug Administration before they can sell to labs. Theranos’ Edison machines are only used internally – so they didn’t need FDA approval to begin usage.
Moving Forward: How to Improve Accuracy of Medical Tests
Theranos is certainly not the only lab receiving criticism for technological problems, but the media explosion points to a much larger issue. Consumers and medical professionals alike often make choices based on convenience and price, instead of accuracy and research.
To solve its issue, Theranos and other labs will need to prioritize transparency. They should be able to publish data proving the accuracy of their tests – or improve, upgrade or replace technology until transparency becomes possible.
Edited by
Kyle Piscioniere
