A generation ago, newspaper headlines told the public that medical labs were "far from infallible," that pap tests often missed cervical cancer because of errors and inaccurate cholesterol tests hurt the war on heart disease.
These reports sounded a wake-up call to the laboratory community and led to the passage of federal minimum standards for quality assurance in the nation's clinical laboratories.
Today, there are similar alarms. A salmonella outbreak causes product recalls and officials link salmonella to deaths; the FDA reportedly didn't increase testing after an '07 outbreak.
Are food testing laboratories detecting critical pathogens before food products reach the consumer? Not always.
The problems in the late 1980s aren't exactly the same as today's food crisis, but it's a similar warning sign.
Recent nationwide recalls of peanut products, tomatoes and jalapeño peppers garnered wide public attention. Smaller, more common recalls, ranging from brand-specific black licorice to salad dressing, receive barely a mention.
The Centers for Disease Control and Prevention estimates a whopping 76 million cases of food-borne illnesses occur each year in the United States. Of this number, 5,000 people die. Already, nine people died from salmonella poisoning likely originating from tainted peanut butter.
Unfortunately, the snooze button on this wake-up call has been pushed more than once. Over the past couple of years, Congress has conducted more than a dozen hearings on food safety. Key legislators have introduced legislation aimed at increasing oversight of food facilities. Public policymakers and the media repeatedly point fingers at the Food and Drug Administration and its lack of adequate resources.
Beyond identifying the problem, the true solutions are much more difficult to pinpoint. Criminal allegations, lack of standard reporting mechanisms, a paucity of facility inspectors and a dearth of quality assurance methods all play a role -- just as in the crises of the past.
Admirably, the clinical laboratory community recognized the need to increase quality assurance oversight in all sites of practice. A number of methods are now employed to ensure accurate testing results, including examining processes, equipment, procedures, and the skills and training of the testing personnel.
Among these various tools, proficiency testing is the only objective measure used to compare test results of one laboratory against a peer group of laboratories performing the same analysis on the same samples.
Unreliable testing of patient samples was a common perception for clinical and physician office laboratories more than 20 years ago. Today, with the oversight and educational approach of the Clinical Laboratory Improvement Amendments of 1988, accuracy of clinical laboratory testing has improved. A 2007 retrospective study by the American Proficiency Institute demonstrated that improvement quantitatively.
There are many conscientious food laboratories that adhere to strict quality practices, but the food industry might do well to embrace the clinical lab's approach to improving its own testing practices.
Quality measures mandated for the clinical laboratory are still voluntary for the food laboratory. Unfortunately, the potential adverse impact of an inaccurate result is remarkably similar for the consumer. It's bad news that demands action.
About the authors: Daniel C. Edson is president of the American Proficiency Institute, based in Traverse City. Robin Stombler is president of Auburn Health Strategies, LLC, based in Arlington, VA.
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