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Print this pageWashington, DC - September 18, 2006 - While proficiency testing is key to the accuracy and reliability of genetic tests, many genetic testing laboratories are not performing proficiency testing on some of the genetic tests they offer, according to a recently completed survey by the Genetics and Public Policy Center. The results, which appear in the September 2006 issue of Nature Biotechnology, show that those laboratories that conduct proficiency testing (PT) for every test they offer experience the fewest errors.
PT is distinguished from other quality assurance methods in that it directly checks the ability of laboratories to report accurate test results. An outside entity tests a laboratory's proficiency by sending it a sample and verifying that it returns a correct test result and interpretation. Laboratories also may conduct informal PT by, for example, splitting a sample and performing the same test twice in order to see whether identical conclusions are reached.
"Few empirical data exist on genetic testing laboratory errors and testing quality, and no data have been made available that directly assess the relationship between the extent of participation in formal and informal PT programs and the types or frequency of genetic testing errors," the authors note. To obtain such data, the Center, which is supported at Johns Hopkins University by The Pew Charitable Trusts, asked the directors of U.S. laboratories performing health-related genetic tests to complete an online survey, and received nearly 200 eligible responses (a 55 percent response rate).
Directors were asked about the types of tests they performed, the volume, estimated number of errors and types of errors, and whether and what kinds of PT are performed in their labs. Many labs enrolled in formal, external PT programs where they were available, and conducted informal PT for tests with no formal program. However, 35 percent of the laboratories performed no PT at all for at least one test they offered, including more than one-third of the highest-volume labs. Those laboratories that did not perform PT for every test type were eight times more likely to report multiple deficiencies. Deficiencies occur when a laboratory makes an error at some stage of laboratory testing, ranging from incorrectly filling out a form, to switching a sample, to incorrectly interpreting the test result.
PT could be mandated for genetic tests if a genetic testing specialty were created under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the authors say. The survey indicates that the genetic testing industry would not find such a change onerous. "Nine out of 10 laboratory directors surveyed regard PT as useful for improving the quality of the genetic testing performed by the laboratory industry and almost no one said cost is a driver of nonparticipation in programs," the article explains. "A majority of laboratory directors supports creation of a genetic testing specialty under CLIA."
Full citation:
Hudson K, Murphy J, Kaufman D, Javitt G, Katsanis S, and J. Scott. "Oversight of US Genetic Testing Laboratories" Nature Biotechnology (2006) 24 (9): 1083-1090.
For More Information Contact:
Rick Borchelt (202.663.5978; rborche1@jhu.edu)
Shawna Williams (202.663.5979; swilliams114@jhu.edu)
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