A newly formed stakeholder group wants the Food and Drug Administration (FDA) to ease restrictions on where diagnostic tests can be performed. James Boiani, head of the Coalition for CLIA Waiver Reform and an attorney with Epstein Becker & Green PC in Washington, D.C., told Bloomberg BNA May 28 the group wants the FDA to ease its regulations and ensure patients have easy access to important diagnostic tests. All facilities in the country that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). According to the coalition, all laboratory tests must be reviewed by the FDA and assigned a complexity level (low/waived, moderate, or high). The complexity level dictates where the test can be performed. Moderate- and high-complexity tests may be performed only in sophisticated laboratories that satisfy the strict requirements of CLIA (including personnel training, quality standards, proficiency testing, and recordkeeping requirements, among others). Boiani said tests performed in CLIA-waived labs are simple and are often performed at the point of care, such as a physician’s office. Such testing can save time, lives, and health care dollars, he said, because […]
A newly formed stakeholder group wants the Food and Drug Administration (FDA) to ease restrictions on where diagnostic tests can be performed.
James Boiani, head of the Coalition for CLIA Waiver Reform and an attorney with Epstein Becker & Green PC in Washington, D.C., told Bloomberg BNA May 28 the group wants the FDA to ease its regulations and ensure patients have easy access to important diagnostic tests.
All facilities in the country that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
According to the coalition, all laboratory tests must be reviewed by the FDA and assigned a complexity level (low/waived, moderate, or high). The complexity level dictates where the test can be performed. Moderate- and high-complexity tests may be performed only in sophisticated laboratories that satisfy the strict requirements of CLIA (including personnel training, quality standards, proficiency testing, and recordkeeping requirements, among others).
Boiani said tests performed in CLIA-waived labs are simple and are often performed at the point of care, such as a physician’s office. Such testing can save time, lives, and health care dollars, he said, because the results get to patients much faster than if the tests were sent away.
If a user needs special laboratory expertise and training to run a test, its use needs to be restricted to nonwaived labs. But if the tests can be performed in the hands of untrained users the same as trained users, then it should be allowed in a CLIA-waived lab. According to the coalition, the majority of point-of-care testing in the United States is done at CLIA-waived laboratories, which represent nearly 70 percent of all laboratories in the country.
Interpretation Issue
Boiani said the coalition wants the FDA to change the way it interprets the CLIA law. The agency’s current requirements for CLIA-waived labs put the emphasis on how accurate the tests are, rather than how effective they are.
“The only issue is whether the tests perform the same way” in a CLIA-waived lab, Boiani said. If they do, “there’s no reason to restrict access to only complex labs. The results are being used the same way.”
In 2001, the agency first issued a draft guidance document explaining the CLIA application process for manufacturers, which focused mainly on performance in a waived lab versus a nonwaived lab.
The agency issued two other guidance documents on CLIA waivers since, most recently in 2008, but each has deviated from the 2001 guidance, Boiani said. He said the coalition is pushing for the FDA to issue a new guidance document that is more in line with the 2001 version than the 2008 version.
“FDA got it right the first time,” Boiani said. “The current regulations don’t seem like they’re adding much.” He added the FDA isn’t focusing on the right question, which is, “Will the tests perform equally well?”
Takeaway: A new stakeholder group wants the FDA to reform the CLIA waiver process to focus on the user of the test, rather than the test itself.
