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Spokane, Washington  Est. May 19, 1883

Regulatory inaction persists despite ‘Wild West’ of medical testing

Ellen Gabler Tribune News Service

ATLANTA – A federal advisory committee at the U.S. Centers for Disease Control and Prevention has again taken no action after discussing concerns about a growing category of medical tests described by one member as the “Wild West” of lab testing.

Federal regulators said during a meeting last month they don’t have the authority or resources to address the tests that have long-standing quality issues, yet are increasingly used in doctor’s offices, emergency rooms and retail clinics across the country.

Health care decisions are frequently based on medical tests that are essentially waived from oversight and regulation. Thousands of the “waived tests” have been developed to quickly and cheaply detect conditions including influenza, Hepatitis C, HIV and Lyme disease, among others.

The tests are supposed to be foolproof – no training or qualifications are required for those who do them – but the tests are often done incorrectly, which can lead to wrong results and serious harm to patients, a Milwaukee Journal Sentinel investigation found.

Waived testing “does fall through the cracks. I think we all agree,” Karen Dyer, director of the division of laboratory services for the U.S. Centers for Medicare and Medicaid Services, which oversees clinical laboratory testing, said at the meeting.

A director with the U.S. Food and Drug Administration, Alberto Gutierrez, acknowledged a “weakness in the system” that prevents regulators from being able to track how many patients are harmed.

Some members of the advisory committee – which is made up of 20 doctors, lab professionals, scientists and public health regulators from around the country – also expressed frustration at their collective inability to make well-thought-out recommendations on any issue, including the ever-expanding sector of waived tests.

The percentage of facilities dedicated to waived tests has gone from 20 percent in 1992 to more than 70 percent of the country’s 250,000 labs. A two-year license costs $150.

By law, facilities that do the tests cannot be routinely inspected by government regulators. Up to 2 percent can be scheduled for “educational visits” each year.

“That’s basically all we can do,” Dyer told the advisory group. “We would really like to look at doing more. We are limited by law.”

The advisory group – which meets twice a year and is supposed to provide guidance on clinical laboratory issues to the U.S. Department of Health and Human Services – has discussed waived testing during at least 30 of its past 50 meetings.

“When the topic keeps coming up, you feel like you aren’t doing the job,” said Qian-Yun Zhang, a member of the advisory group, and laboratory medical director at the University of New Mexico’s University Hospital. “I don’t think we have a solution.”

Zhang was concerned at the dismal performance of labs doing waived tests. Dyer’s presentation to the committee showed 52 percent of labs in a government spot check last year were not in compliance with policies meant to ensure safe, quality care.

Dyer said the Centers for Medicare and Medicaid will now send education and training material to all labs that apply for the $150 license to do waived tests.

The Journal Sentinel investigation found that only a few thousand of those 180,000 labs had received materials. Even when more do, it’s unclear if that will address the problem.

“Education just gives you the potential for doing the right thing. It doesn’t monitor actual practice,” said Barbara Zehnbauer, director of the CDC’s division of laboratory systems, which is also involved with the advisory group.

The only requirement for doing waived tests is to follow the manufacturer’s instructions. But studies have shown that often doesn’t happen.

The Journal Sentinel found that health regulators, trade organizations and manufacturers have talked for years about needing more comprehensive studies to quantify problems with waived tests. The groups say they can’t take significant action to address problems until more data is gathered. Yet there are no plans to gather the data.

Gutierrez, the director of the FDA’s center for devices and radiological health, said during the meeting that the only data that is gathered is “passively” collected by the FDA, which accepts complaints and problems from manufacturers and health care professionals, many of whom would not think to report problems.

“We don’t get a lot of information,” he said.

The advisory group discussed having the FDA improve its post-market surveillance of waived tests, or requiring manufacturers to develop measurable performance standards for people using their tests.

But no specific action was taken and committee members seemed unclear as to what regulators could do about the problem.

“It would appear that there is no authority vested in any federal authority to do what you are asking to be done,” said Burton Wilcke, the chairman of the committee and an assistant professor in the department of medical and radiation sciences at the University of Vermont.

“I think that may be the problem: Nobody actually owns the problem,” said Hardeep Singh, another committee member, who runs the quality and informatics program at the Veterans Affairs Medical Center in Houston.

On a broader scale, members of the committee who have grown frustrated with its lack of action asked regulators to rethink the two-day meeting, where members often seem confused about what they are asked to vote on after quick discussions, and uninformed about various topics.

“It just seems like it’s not working in 15-minute aliquots, twice a year,” said Richard D. Press, a professor and director of molecular pathology at Oregon Health & Sciences University.

Regulators from the CDC who help coordinate the meeting said they would try to address the problems.