Direct access testing demands specific lab responsibilities

Our state allows patients to order laboratory tests directly. What is the labs responsibility when this sort of test is ordered?

Historically, medical professionals including laboratorians have opposed direct access testing (DAT), through which patients order their own laboratory studies without having a physician evaluate which tests might be needed. The increasingly consumer-oriented atmosphere of modern medicine, coupled with the well-publicized reluctance of managed care plans and Medicare to pay for some tests, has made DAT an appealing alternative to both patients and legislators. As a result, some states have revised their clinical laboratory laws, permitting patients to order their own medical tests.

If your state permits DAT, the first obligation of the laboratory is to review the relevant legislation to determine what, if any, discretionary limits the laboratory has with respect to offering DAT services. The College of American Pathologists takes the position that laboratories should be free to determine whether or not to offer DAT services. state law will determine to what degree laboratories retain the option of what tests to offer.

Once a direct access request for testing is accepted by the laboratory, it must be treated in the same way that any other specimen is managed. Test reports should include the result, as well as normal ranges. The information is subject to the same privacy and release restrictions that HIPAA places on all medical records. Patients may not be aware that test results will not automatically be forwarded to their physician or become a part of office medical records unless they make a specific request. it is important that DAT requests include an option for the laboratory to release information to the patients physician, if the patient desires.

The laboratory has the same responsibility to perform the test properly, produce reliable test results and communicate them properly to the individual ordering the test. In the case of a physicians office, systems already exist to make this possible. With DAT, the laboratory has to set up a system to permit timely communication of results. The patient should be alerted that, in some instances (i.e., determination of a critical value), it may be important to his health that the laboratory contact him immediately. telephone numbers, as well as a release to leave information on an answering machine, if necessary, also should be a part of the ordering process.

If the laboratory staff members undertake to explain the meaning of test results to a patient (either in writing or in conversation), they have established a duty of care and a patient-care relationship that will be enforceable in a court of law. great pains must be taken to ensure that the patient understands the import of the test results received, apropos his health and medical care.

The better option may be to include on all DAT reports a disclaimer indicating that the interpretation of test results is a medical matter, best undertaken by the patient and his physician. Affirmatively state that the laboratory only provides information and does not and will not interpret the results. Then, encourage the patient to make his physician immediately aware of any test results, so that the two of them can discuss the implications for the patients ongoing care.

Finally, physicians who order tests know what test results mean; patients might not. The extent to which a laboratory owes a duty to the patient to explain test results is not yet determined. such a duty may well be defined by zealous plaintiffs lawyers and overreaching courts one reason prudence may dictate that laboratories are given the option to refrain from DAT.

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.

November 2003: Vol. 35, No. 11

© 2003 Nelson Publishing, Inc. All rights reserved.