June Gibbs Brown
Inspector General
Department of Health and Human Services
Wilbur J. Cohen Building
330 Independence Avenue, SW
Washington, DC 20201

Dear Inspector General Brown:

The American Association for Clinical Chemistry (AACC) welcomes the opportunity to comment on the Office of the Inspector General’s (OIG’s) revised Compliance Program Guidance for Clinical Laboratories. We are pleased that the OIG has modified the initial plan to address the issues raised by laboratorians. However, we still have concerns regarding the OIG’s new provision on reflex testing.

The OIG revised compliance guidance states that "reflex testing occurs when initial test results are positive or outside normal parameters and indicate that a second related test is medically appropriate." AACC agrees with this definition. We believe that reflex testing, if done appropriately, results in faster, more cost-effective diagnoses. It permits the laboratory to follow-up an abnormal result immediately, without waiting for the initial test report to be generated, sent to the physician, and the subsequent test ordered. Further, reflex testing saves the government money by eliminating the need for a second specimen collection, since the initial sample is typically available.

From the laboratory’s perspective, the purpose of reflex testing is not to increase the number of tests performed, but to reduce the time between the initial patient consultation and the subsequent diagnosis and, necessary treatment. For example, laboratories often follow-up an abnormal TSH test (for a thyroid condition) with a free T4 and/or T3 test(s) to more narrowly define the condition. If the laboratory reflexes to one of these tests, depending on the initial test result, the physician will get the test result earlier and be able to more quickly identify and treat the condition—at no additional cost—since the physician would have ordered the follow-up test anyway.

Although AACC is pleased that the OIG revised plan recognizes the value of reflex testing and we agree that laboratories should only perform medically appropriate tests, we are concerned that some aspects of this provision are impractical and counterproductive. The compliance plan states that:

"in order to avoid performing unnecessary reflex tests, labs may want to design their requisition form in such a way which would only allow for the reflex test when necessary. Therefore, the condition under which the reflex test will be performed should be clearly indicated on the requisition form. Laboratories may wish to adopt a similar policy for confirmation testing which may be mandatory."

We do not believe it is feasible for laboratories to list all the conditions resulting in reflex testing or the related algorithms on the requisition form. Nor is it appropriate to use the requisition form as the mechanism for educating the physician about reflex testing. Instead, laboratories and physicians should

work together to develop agreed upon protocols that specify the reflex tests, the conditions resulting in the reflex and the next test(s) in the sequence. In addition, both the physician and laboratory should periodically review the outcomes of these algorithms and revise them accordingly. We believe the use of agreed upon protocols between the physician and laboratory (kept on file by the laboratory) is a better approach to ensuring active physician participating in the test ordering process, rather than making the requisition form longer and complex for practitioners.

By way of background, AACC is the principal association of clinical chemists--professional laboratory scientists--including MDs, PhDs and medical technologists. AACC’s members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and help maintain high professional standards.

If we may be of any assistance, please call me at (708) 216-4725 or Vince Stine, Director, Government Affairs at (202) 835-8721.




Stephen Kahn, PhD, DABCC


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