Labs obliged to perform properly ordered tests

Medical Laboratory Observer, Feb, 2004 by Barbara Harty-Golder

Q I am a med tech at a rural hospital. We have just started beta naturietic peptide (BNP) testing in our lab. When the manufacturer trained us, we were told that the method we use is for a diagnostic tool only. Some of our physicians, however, have been ordering daily BNPs on some of our patients, obviously using the test to monitor the patient. I have asked the chemistry technical supervisor about this and was told that if the physicians order this test, we have to run it. Does this bring in a liability issue if we allow the physicians to use a test in an inappropriate manner?

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A BNP rapidly entered the literature of laboratory medicine as a reliable tool for screening for congestive heart failure (CHF). Studies in both Europe and America demonstrated its utility in establishing the diagnosis of CHF, providing quick and accurate triage for patients with respiratory distress, and also in evaluating the severity of the process involved. BNP is attractive because it is a fast and available point-of-care test. Its appeal to physicians has become obvious to laboratories that have instituted BNP testing as part of their testing panel.

Your question concerning use of BNP poses some interesting problems. Important with any newly introduced test is that the laboratory establish sensitivity and utility of the method--and educate the medical staff accordingly. Although the initial impetus for BNP testing was to facilitate the diagnosis of CHF, subsequent use and studies have indicated that BNP levels may be used in conjunction with clinical observations to provide an assessment of the severity of illness as a means for following patients. If you have indications that your medical staff is using the test in this manner, the lab should take steps to determine whether or not the test is sufficiently discriminating to provide physicians with the information they need.

Also ensure that the medical staff is well versed in how to use the test. This probably means an inquiry to the manufacturer, a research of the literature regarding the specific methodology your lab is using, and an evaluation by the appropriate medical staff committee. Your concern provides a perfect opportunity to offer the medical staff an update on the nature of BNP testing, perhaps in the form of a newsletter, including manufacturer recommendations and test limits.

Your supervisor is correct: Except in extraordinary circumstances, the lab is obligated to perform any properly ordered test that is within its ability to perform. The ultimate issue here is not so much that the manufacturer markets the test as a diagnostic tool, but whether or not this particular test is sufficient for the way in which it is being used in practice. The best method for evaluating situations in which concern exists about utilization of a test of any kind is to document this in detail. This information can then be correlated with clinical findings and pharmacy orders during the course of treatment.

With utilization and clinical data well documented, the data from the manufacturer regarding the limitations of the test can then be accurately assessed. The medical staff can then evaluate test usage, both on an institutional and a per-provider basis. This can generally be accomplished in the framework of laboratory quality improvement, and is usually well received by the medical staff, if done in the proper spirit. Doing so should discharge the responsibility of both the lab and the institution to ensure that tests are both properly offered and used.

If the analysis reveals that the methodology offered is not appropriate for the use intended, the lab then has impetus to institute a different one--and probably an obligation to do so. If the analysis determines that method and use are compatible, so much the better. If the analysis determines that some physicians are overutilizing the test, the medical staff can also address that issue.

Interestingly, liability stemming from BNP testing is generally raised in quite a different context: failure to offer the test at all. Because BNP has gained such a reputation for utility in the diagnosis and management of congestive heart failure, some legal commentators are raising the concern that it is an essential test for primary care institutions and emergency rooms.

Barbara Harty-Golder is a pathologist-attorney consultant in Chattanooga, TN. She maintains a consulting law practice with a special interest in medical law. She writes and lectures extensively on healthcare law, risk management, and human resource management.

By Barbara Harty-Golder, MD, JD

This column is intended to provide risk management and human resource management education; it is not intended to provide specific legal advice. If you require legal advice, the services of an attorney should be sought. Dr. Harty-Golder welcomes your questions, which can be sent to her at toadehall@comcast.net.