Keeping Tainted Products out of Consumer Reach
North Carolina Food and Drug Protection Division Demonstrates Laboratory Competence with ARTEL Pipetting Proficiency Training
By Gugenberger, K., Publuished in Laboratory Equipment, June 2008.
In 2007, salmonella in peanut butter and tomatoes sickened a total of 808 North Americans. Three-hundred and fifty people became ill from E. coli-contaminated lettuce, bagged spinach, and ground beef, three of whom died. A number of patients were paralyzed after taking a tainted drug manufactured by a Chinese company that exports to the U.S. But it doesn’t end there. Reports of 25 illnesses from E. coli prompted a nationwide recall of 21.7 million pounds of ground beef products - one of the largest meat recalls in U.S. history.1 With such a staggering list of recently tainted food and drug products in the U.S., product safety is understandably a growing concern of American consumers.
The Food and Drug Protection Division of the North Carolina Department of Agriculture and Consumer Services (NCDA&CS) is playing a leading role in protecting the public from contaminated foods and drugs. “It’s our responsibility to protect North Carolina consumers,” said Steve Troxler, NC Agriculture Commissioner. “We are actively developing and implementing quality programs for inspecting our processors and manufacturers as well as sampling and testing products available in the marketplace. If we find a problem, we are committed to responding rapidly.”
The Food and Drug Protection Division’s laboratory, which tests samples for harmful substances and label claims, is the only food testing laboratory in North Carolina. To protect the state’s consumers the laboratory must be able to rapidly produce accurate and defensible analytical results. As food and drug quality issues become more rampant and the Food and Drug Administration (FDA) becomes more reliant on state laboratories to test consumable products, the NC Food and Drug Protection Division laboratory must also ensure that its results are comparable to those at federal laboratories.
To demonstrate its competency and meet federal equivalency standards, the NC Food and Drug Protection Division laboratory is seeking accreditation under ISO 17025, General Requirements for the Competence of Calibration and Testing Laboratories, developed by the International Organization for Standardization. Due to the prevalence and importance of liquid handling in its laboratory processes, the laboratory enrolled in ARTEL’s Pipetting Proficiency Training and Certification seminar. A world leader in liquid handling quality assurance, ARTEL provides objective documentation of operator pipetting proficiency, helping the NC Food and Drug Protection Division laboratory meet ISO standards related to training and competence certification. The result is documentation to verify personnel competency and increased confidence in laboratory results.
The Importance of Lab Quality in Protecting the Public 
The NCDA&CS has a core mission to protect citizens from unsafe food and drug products, ensure that consumers are purchasing quality products, and protect animal health. This responsibility is carried out through inspections and laboratory analyses. NCDA&CS also is responsible for improving the state of agriculture in North Carolina. In order for NCDA&CS to achieve its mission, it relies on a rigorous inspection program, strict enforcement of regulations, and an active educational program.
A critical arm of the NCDA&CS is the Food and Drug Protection Division, which routinely collects samples of a variety of products manufactured within the organization’s inspectional jurisdiction. At the Division’s laboratory, samples are analyzed to identify the presence of potentially harmful microorganisms, chemicals, heavy metals, foreign material, and other food safety concerns including pesticide residues. Sample results may be used to initiate product embargoes and recalls, and launch necessary public health advisories.
Competency and quality are especially critical for the NC Food and Drug Protection Division laboratory because inaccurate test results can be lethal. When a product is identified as contaminated or unfit to consume, it must be quickly removed from the market to reduce public harm. Test speed and accuracy are significantly important for early detection of contaminated or adulterated products, rapid response by the regulatory agency, and swift recovery of suspect products to protect consumers. These expedited efforts also aid in the mitigation of market quality issues and a return to providing safe, wholesome products to the consumer.
In addition, to defend its analytical work, the NC Food and Drug Protection Division laboratory must demonstrate the reliability of its methods and the competency of its employees. Without quality standards in place, laboratory data may not withstand legal scrutiny. Lastly, providing accurate results during the initial test is critical for the NC Food and Drug Protection Division laboratory due to scarcity of samples. During times of crisis, sample availability may be limited and retesting may not be an option, leaving no room for error.
Several additional current issues are leading to an even more stringent focus on laboratory quality at the NCDA&CS. First, the FDA has been inundated with increased demand for food and drug quality testing. This trend has resulted in state laboratories playing a larger role in consumer protection, conducting approximately 90 percent of food product analysis in the U.S. As federal laboratories rely more heavily on state facilities to conduct food and drug testing, it is essential that their results be comparable and that their methods and processes meet equally high standards.
In an effort to prove the reliability of its results, the NC Food and Drug Protection Division laboratory is applying for accreditation to ISO 17025, an international standard for calibration and testing laboratories. To be recognized by ISO, laboratories must demonstrate that they operate successfully under a rigorous quality management system. They must also prove their ability to generate technically valid results and demonstrate competent performance of their equipment, procedures, and personnel.
“The state of North Carolina has made it a priority to develop one of the best food and drug inspection and analytical testing programs in the nation,” said Joe Reardon, Director of the NCDA&CS Food and Drug Protection Division.
Achieving Excellence Through Training
To demonstrate its ability to produce accurate results on par with federal standards and achieve accreditation to ISO 17025, the NC Food and Drug Protection laboratory sought to increase its personnel training program.
“A critical component to quality programs is having competent laboratory employees,” said Ron Willett, Laboratory Technical Director, NCDA&CS. “Our staff must be competent not only in educational background and training, but also technique and skill.”
Because liquid handling is an important component of its sample testing processes, the laboratory focused on standardizing operator pipetting skills. The organization turned to ARTEL because of the company’s expertise in liquid handling and knowledge of best practices, and FDA-2400 compliance.
ARTEL’s Pipetting Proficiency Training and Certification program is designed to minimize risk of operator error and improve data quality. The program employs the ARTEL Method™ of training, which is a standardized, consistent teaching approach. The method includes education about the mechanical function of pipettes and various causes of failure including choice of pipetting mode, tip insertion depth, and aspiration rates.
For standardized and comparable skills assessment, ARTEL tests attendee pipetting technique pre- and post-training using the ARTEL PCS® (Pipette Calibration System). The PCS provides NIST-traceable measurements of volume accuracy and precision and verifies volume in seconds, supplying instant feedback on proper technique. It also provides automatic documentation, an important factor in ISO accreditation. ARTEL’s PCS technology meets the FDA-2400 checksheet criteria, which is used to standardize milk laboratories and is an important standard for the department’s customers.
“ARTEL’s on-site training gave us a stronger understanding of the mechanics of pipettes and the importance of proper technique,” said Willett. “After the training, laboratory personnel demonstrated pipetting proficiency, and this has strengthened overall confidence in our results.”
Now the NCDA&CS also uses the PCS to calibrate its pipettes. Based on ratiometric photometry, the PCS measures the absorbance of light by two standardized dyes to simultaneously determine the accuracy and precision of liquid volume dispenses. Prior to the PCS, the NC Food and Drug Protection laboratory calibrated its pipettes using mass analysis of de-ionized water. This method does not produce traceable results, is affected by environmental conditions, and can be time consuming.
The Importance of Liquid Handling in Keeping America Safe
With ARTEL training and technology in place, the NC Food and Drug Protection Division laboratory has established a stringent liquid handling quality assurance program. Given that pipettes are commonly used in food and drug quality analysis, and these tests are often highly quantitative, any error in liquid handling can compromise data integrity. For example, pipetting error may result in false negative results, allowing tainted products to remain on the market. Conversely, pipetting error could produce false positive results, leading to the unnecessary pulling of uncontaminated products from store shelves.
“In our laboratory, liquid handling quality assurance is crucial in our responsibility to ensure the public that food and drugs are safe for consumption,” said Audrey Pilkington, Quality Systems Manager, North Carolina Department of Agriculture and Consumer Services.
For example, accurate liquid handling is critical in the feed laboratory, which analyzes commercial animal feed products. This department often tests forage and grains for nitrate and aflatoxin levels and these tests are purely quantitative. Pipetting error can affect test results and the laboratory’s ability to identify harmful concentrations of these contaminants.
The forage laboratory, which analyzes animal feed for farmers at a low cost, is also highly dependent on accurate pipetting. Farmers commonly purchase byproducts from manufacturers for integration into animal feed, including protein-rich gluten. The Forage Protection program tests the gluten for protein content to ensure that farmers blend in the correct amount of byproduct to provide feed with adequate nutritional value. Accurate analytical results are contingent upon the starting concentration and volume of standards. Liquid handling error can compromise the integrity of the testing.
Also consider the fertilizer laboratory, which tests regulatory samples to verify that label claims are accurate. By providing these analyses, the consumer can be confident that what they purchase is what has been promised by product manufacturers and marketers. The division verifies, for example, that a label claim on a bag of fertilizer stating that the product contains 10 percent nitrogen content is accurate in that the fertilizer actually does contain 10 percent nitrogen. These analyses rely on an accurate starting volume and laboratory quality is a fundamental requirement.
Pipetting Training for a Better Tomorrow
In light of recent food and drug contamination issues, the responsibility of state testing laboratories in the mission to keep consumers safe is likely to grow. And laboratory quality and accurate test results are crucial in this mission. By equipping its personnel with critical pipetting skills, the NC Food and Drug Protection laboratory is strengthening the line of defense against the consumption of contaminated products.