JUNE 14, 2001


My name is Rob Christenson, PhD, and I am a Professor of Pathology at the University of Maryland Medical School and Director of the Clinical Chemistry, Toxicology and Rapid Response Laboratories at the University of Maryland Medical Center in Baltimore. Today, I am here representing the American Association for Clinical Chemistry. AACC is the principal association of professional laboratorians, representing more than 10,000 professional laboratory directors and scientists working in hospitals, independent laboratories and the diagnostics industry worldwide.

In recent years, technological advances have allowed manufacturers to develop new and simpler laboratory testing devices, which make it easier for individuals with less training to accurately perform tests that previously could only be conducted in more sophisticated laboratories. This technology-driven trend is likely to accelerate in the near future. Clearly, there are great benefits to simple, waived tests, such as the potential for diagnosing and treating the patient earlier and reducing overall health care costs. However, as we move forward in this dynamic and fast growing area, it is important to remember that no device is "foolproof" and that errors can and do occur.
Although AACC generally supports placing simple and highly accurate devices in the waiver category, we believe it is important that the FDA recognize that some tests, if inaccurate, present a greater "risk of harm" to the patient and the public than others. AACC believes that these tests should receive a higher level of scrutiny than the waiver category currently provides. It is our view that the HIV test is such a test, because an incorrect result, either a false-positive or false-negative, could have devastating results for the patient, his or her family and, potentially, society.

If a laboratory obtains a false-positive result, it means that the test inaccurately identified the person as HIV positive when he or she is not. Such a result could have devastating consequences for all concerned. This mistake could occur for a variety of reasons, such as biologic changes taking place in the patient, the known inherent technical limitation of the method, or due to a process error. AACC believes that all positive HIV tests must be subject to a confirmatory test.

AACC is also concerned about the potential harm associated with a false-negative result. In this instance, the laboratory reports that an individual is not HIV positive, when, in fact, he or she is infected. This means that such patients will not be started on treatment critical to delaying the onset of AIDS and prolonging their lives. From a public health perspective, the laboratory's failure to detect the disease means that these people may not take necessary measures to prevent the spread of the infectious viral agent, thereby possibly infecting other individuals with the deadly disease.
Although AACC believes that manufacturers can develop highly accurate HIV tests, we have serious reservations about permitting tests with significant patient and public health implications, such as HIV testing, in laboratories that are not subject to periodic inspection-either private or public, are not required to have trained health care personnel perform the tests and are not required to participate in proficiency testing to evaluate the accuracy of their testing.

Ironically, the only substantive requirement placed on waiver facilities-that they follow the manufacturers' instructions-is not being followed. According to a recent HCFA study, which was described earlier, nearly one-half of all waiver facilities that were reviewed failed to perform or appropriately follow the manufacturer's instructions. We are concerned that these findings, which indicate possible QC problems in these facilities, might result in mistakes that could harm the patient and the public.

AACC recognizes the difficult decision before the panel-whether to waive HIV kits, so that more people may have access to such testing or continue to restrict such testing to moderate and high complexity testing to ensure the quality of the results. At this time, we believe the most prudent course of action for the panel is to keep such tests as moderate and high complexity. If federal oversight of waiver facilities could be strengthened, then reopening this issue may be appropriate.

Finally, AACC recommends that the FDA, in conjunction with its partner agencies, manufacturers and laboratories, develop a list of the tests and/or diseases, such as HIV, that should not be waived at this time, because of the significant "risk of harm" to the patient and the general public. As part of this process, the agencies may want to consult with the appropriate congressional leaders, such as the authors of the statute, regarding which criteria-risk of harm or ease of use should take precedence in making waiver determinations. This should help eliminate some of the confusion regarding what, if any, limitations should be placed on the waived category.
On behalf of AACC, I would like to thank you for the opportunity to comment on this critically important public health issue.

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