On August 22, 2024, an Indiana medical malpractice jury awarded a now 70-year-old man and his wife $25.8 million against St. Mary Medical Center for the failure to timely report a blood test indicating early cancer to the physician who ordered the test.
The specialist had ordered the blood work in 2017 that was done at the defendant hospital to help diagnose the man’s bladder issues. The results of the testing were not reported to the specialist which resulted in a delay of 13 months in diagnosing the man’s cancer, by which time the man’s cancer had spread to his kidneys and spine (Stage IV). The man will require dialysis for the rest of his life as well as additional medical treatments.
The CDC states:
Rapid and accurate communication of critical laboratory test results is required by the Clinical Laboratory Improvement Amendments (CLIA) regulations; included in laboratory accreditation standards; noted as a National Patient Safety Goal; featured in the World Health Organization’s World Alliance for Patient Safety; and codified in the International Organization for Standardization standards for medical laboratories. Improvement in critical value notification is driven by the assumption that timely reporting will lead to more timely clinical interventions with improved treatment outcomes and prevention of co-morbidities.
Federal regulations involving CMS require that the laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner … The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values.
The AMA Code of Medical Ethics states: “Patients should be able to be confident that they will receive the results of clinical tests in a timely fashion. Physicians have a corresponding obligation to be considerate of patient concerns and anxieties and ensure that patients receive test results within a reasonable time frame.
When and how clinical test results are conveyed to patients can vary considerably in different practice environments and for different clinical tests. In some instances results are conveyed by the patient’s treating physician, in others by other practice staff, or directly by the laboratory or other entity.
To ensure that test results are communicated appropriately to patients, physicians should adopt, or advocate for, policies and procedures to ensure that:
- The patient (or surrogate decision maker if the patient lacks decision-making capacity) is informed about when he or she can reasonably expect to learn the results of clinical tests and how those results will be conveyed.
- The patient/surrogate is instructed what to do if he or she does not receive results in the expected time frame.
- Test results are conveyed sensitively, in a way that is understandable to the patient/surrogate, and the patient/surrogate receives information needed to make well-considered decisions about medical treatment and give informed consent to future treatment.
- Patient confidentiality is protected regardless of how clinical test results are conveyed.
- The ordering physician is notified before the disclosure takes place and has access to the results as they will be conveyed to the patient/surrogate, if results are to be conveyed directly to the patient/surrogate by a third party.
If you or a loved one were injured (or worse) as a result of medical malpractice in Indiana or in another U.S. state, you should promptly find an Indiana medical malpractice lawyer, or a medical malpractice lawyer in your state, who may investigate your medical malpractice claim for you and represent you or your loved one in a medical malpractice case, if appropriate.
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