When irreplaceable specimens are inadequate

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

Q In general, I agree with not testing inadequate samples--like those that are hemolyzed--but what should we do when an irreplaceable sample is less than adequate? If, for example, we receive an unlabeled pleural biopsy or a blood sample from a patient who is extremely ill or was otherwise difficult to collect, can we run the test in those circumstances if the physician gives us a waiver?

A In the many inquiries and comments I receive about testing unacceptable, but unique, specimens, most contend that, to spare the patient another difficult or invasive collection procedure, the test should be run based on a combination of hospital policy, confirmation procedures (if the specimen were unlabeled or could be considered marginally adequate for some purposes), and physician waiver. None of these considerations changes the fact that an unreliable specimen is being tested and that the patient's care may suffer as a result.

Running a test based on a physician's waiver probably is not legally sufficient. For a waiver to effectively insulate the laboratory from liability based on questionable test results, it must come from the patient rather than the physician. If a problem arises with an irreplaceable specimen's adequacy, the hospital risk manager, and probably the hospital attorney, should be involved promptly to help resolve the problem.

Improper labeling is usually the reason for the inadequacy of an irreplaceable specimen. For instance, if the lab receives an unlabeled or mislabeled biopsy, every effort must be made to determine or confirm the originating patient's identity. This may involve simple sleuthing, alternative testing of the specimen (such as confirming that a blood sample has the same ABO type as the patient in question), or obtaining testimony from the individuals who collected the specimen. The evidence must be compiled in writing.

After identifying the patient from whom the specimen is thought to have originated, the situation, including the evidence that led to the lab's final conclusion, must be explained to the patient. Give him the opportunity to submit (at no cost to him or his insurers) to another procedure to collect a new specimen. If he decides to permit testing of the original specimen, document his decision in writing and obtain a witnessed signature before the lab processes the specimen.

If the patient is unable to make an informed choice about testing, his legally recognized surrogate must make the decision on his behalf; the physician's waiver alone will not suffice. In the absence of the consent of the patient or his surrogate, the inadequate sample should not be tested without a legal opinion to the contrary, and the reason for proceeding (or not) with the ordered test should be documented in the patient's medical record.

The same principles apply to testing difficult-to-collect specimens that are unacceptable either because of the failure to centrifuge promptly, hemolysis, or inadequate sample size. Document the reason why the sample is inadequate, then explain to the patient the risks and benefits of running and relying on the test and the degree of reliability of the results. Again, if the test is to be run on the inadequate sample, either the patient or his legal surrogate should sign the waiver.

Such a process is unattractive to most physicians and laboratories because it involves admitting a mistake, which triggers lawsuit fears. Although a patient could seize the opportunity to sue the physician, lab, and hospital, most patients will appreciate honesty and be understanding of the mistake. Any legal problems arising from the incident will be based on the actual collection error--not the admission--and will be easier to defend than an incorrect diagnosis resulting from testing an inadequate sample.

Last, but not least, any situation involving inadequate samples should prompt a review of specimen-collection and handling processes. Because most inadequate specimens are a result of "operator error" rather than inadequate policy safeguards, supervisors should take the opportunity to re-educate staff about how to avoid such mistakes.

By Barbara Harty-Golder, MD, JD

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

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MLO's "Liability and the Lab" 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.