Laboratories Must Disclose Errors to Patients

After a laboratory test is performed, the lab may realize that it made an error that may impact patient care.  Is the lab obligated to report the error? The answer is a resounding Yes. When an error is not reported and the patient is injured as a result of the lab test error, a laboratory test error attorney will be able to assist you in making a claim. The error should be reported to the treating physician who can then inform the patient. By federal law, the Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) through the Clinical Laboratory Improvement Amendments (CLIA) as implemented by federal regulations. These regulations require that mistakes be disclosed to the patient’s physician:

When errors in the reported patient test results are detected, the laboratory must do the following:

(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors.

(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results.

(3) Maintain duplicates of the original report, as well as the corrected report.


Lab Mistakes Must Be Corrected Before A Patient Is Treated

Patients must not be treated based on a misdiagnosis founded on an erroneous lab report. If the error is discovered soon after the report, the harm to the patient may be minimized. If the error is found months or years later, some laboratories may refrain from disclosure out of concern for legal liability exposure. This, however, not only is morally wrong, it is contrary to legal requirements.

According to the American Medical Association Code of Medical Ethics, Ethics Opinion 8.12, a physician must inform patients of mistakes.  “It is a fundamental ethical requirement that a physician should at all times deal honestly and openly with patients. Patients have a right to know their past and present medical status and to be free of any mistaken beliefs concerning their conditions. Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care. Ethical responsibility includes informing patients of changes in their diagnoses resulting from retrospective review of test results or any other information. This obligation holds even though the patient’s medical treatment or therapeutic options may not be altered by the new information.”

Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient.  However, some physicians are unwilling to face the responsibility for actions that result from their errors.  These situations often come to light when a patient is injured, and a review of their medical records and laboratory tests is performed by  another doctor or a knowledgable laboratory malpractice error attorney.

A laboratory or doctor that commits errors as a result of negligence should be held accountable. Other errors may not constitute a breach of the standard of care, but the failure to disclose them may constitute negligence or worse. If an error is not disclosed and the deceptive nondisclosure causes a preventable adverse outcome, a court could award both compensatory and punitive damages. Clinical laboratories must disclose their errors that may impact patient care, and their failure to do so creates a cause of action of any person injured by their negligence.

If you or a loved one has questions regarding laboratory mistakes or laboratory testing errors, or wants to discuss a potential claim, contact us at 410 583 8000 or use our Quick Contact form.  All consultations are free and confidential, and consultations are made with the attorney who would handle your case.


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