Internist searches for answers when test results go missing
By Paul S. Mueller, FACP
A 61-year-old asymptomatic man sees his internist for a preventive medicine evaluation. The internist has cared for the patient for 10 years. The examination and laboratory studies are normal, except for the prostate specific antigen (PSA), which is 11.8 ng/mL. Surprised by this finding, the internist reviews the patient’s previous blood work. A year ago, the PSA was 8.2 ng/mL and three years ago it was normal. There is no evidence in the medical record that the patient was informed of, or that the internist acted upon, the prior abnormal PSA result. However, the internist is certain she never saw it. She wonders what to do next.
A high-power microscopic view of the glandular portion of the prostate gland
According to the American Medical Association (AMA) Code of Ethics, “an error is an unintended act or omission, or a flawed system or plan that harms or has the potential to harm a patient.” Mishandling of an abnormal test result is a common health care-related error that results in diagnosis and treatment delays. Evidence suggests that many clinically relevant abnormal test results, including abnormal blood and imaging test results, lack evidence of clinician awareness in patients’ medical records.
In fact, 83% of internists who responded to a survey administered by Poon et al recalled at least one recent test result that they wished they had known about sooner. In another study, Wahls and Cram found that 30% of primary care providers reported encountering one or more patients with delays in diagnosis or treatment because of mishandled test results within the 2 previous weeks. The commonest delayed diagnoses were cancers and endocrine and cardiac disorders.
Mishandling of abnormal PSA results is also common. In a Veterans Affairs study, Nepple et al identified 327 men who had an abnormal PSA result before they were diagnosed with prostate cancer. The time between the first abnormal PSA result and a documented clinician response ranged from 0 to 1,342 days. Overall, 253 men (77%) had a timely clinician response to the abnormal PSA (≤30 days). However, 23 men (7%) had a response in 31 to 180 days, 24 (7%) had a response in 181 to 360 days, and 27 (8%) had a response after 360 days. For men who experienced a timely clinician response, the median number of days between the abnormal PSA result and a request for urological consultation was 1 day; the median time to prostate biopsy was 69 days. However, for men who experienced a delayed clinician response, the median number of days between the abnormal PSA result and the request for urological consultation or prostate biopsy was 342 days and 526 days, respectively.
Not surprisingly, clinicians experience negative emotions when they realize they have committed an error. Nevertheless, they are ethically obligated to disclose errors to patients. According to the College’s Ethics Manual, clinicians “should disclose to patients information about procedural or judgment errors made in the course of care if such information is material to the patient’s well-being. Errors do not necessarily constitute improper, negligent or unethical behavior, but failure to disclose them may.” Indeed, the ethical rationale for disclosing errors to patients is strong.
First, clinicians should act in the best interests of patients. In this case, withholding the prior abnormal PSA result from the patient does not serve the patient. Instead, the internist should explain the nature of the error and its implications and continue to provide professional and compassionate care. Notably, nondisclosure of errors damages trust as many patients eventually learn of errors. If the internist in the case refers the patient for prostate biopsy without disclosing the error, it is possible the patient will learn of the error from the consulting urologist.
Secondly, respect for patient autonomy requires that clinicians disclose errors to patients to allow for informed decision making. The patient in the case has the right to know about the previous abnormal PSA result so that he can act upon it according to his health care-related goals and values.
Finally, justice requires that patients be given what is due to them, such as information about their medical condition and, if injured, appropriate compensation. Clinicians’ duties regarding health care-related errors, however, go beyond disclosure. Clinicians should encourage and participate in efforts to prevent errors. Indeed, many errors, including mishandling of test results, are caused by systems problems. Clinicians should play a central role in identifying, reducing and preventing errors.
What do patients want? Virtually all want to know about errors, even minor ones. Patients desire disclosure about what happened, why it happened, the implications for their health and future care, and strategies for preventing future errors. Notably, patients are more likely to consider litigation if errors are not disclosed.
There are benefits to disclosing errors to patients. For patients, disclosing errors informs them, allows for proper diagnosis and treatment, resolves uncertainty and promotes trust. For clinicians, disclosing errors may relieve stress, foster patient forgiveness, promote trust, improve practice (such as by adopting systems that prevent errors) and reduce litigation. In fact, health care organizations that have implemented programs to fully disclose errors and provide appropriate compensation to patients have experienced neutral or beneficial effects related to litigation.
The internist resolved to disclose the error to the patient. She met with the patient and his wife at her office. She learned that the patient did not recall hearing about the prior PSA result. She then disclosed the prior and current PSA results and acknowledged that the prior result was mishandled. The patient appeared upset by the news and expressed feeling angry and helpless. The internist acknowledged these emotions. However, the patient later stated that he appreciated the internist’s honesty. Together, the internist and patient formulated a plan for further assessment, treatment and follow-up. The internist also notified the sentinel event group at her institution to engage in an analysis of the error.
Paul S. Mueller, FACP, is a former member of ACP’s Ethics, Professionalism and Human Rights Committee and an associate professor of medicine at the Mayo Clinic in Rochester, Minn. He directs the ethics curriculum at Mayo Medical School. Send in your comments on this case or others from your practice. The opinions expressed in this column represent the views of the contributor and do not reflect the opinion of ACP or the ACP Ethics, Professionalism and Human Rights Committee. For ACP case studies, go online.
American Medical Association Council on Ethical and Judicial Affairs. Code of Medical Ethics of the American Medical Association: Current Opinions and Annotations, 2008-2009 edition (Chicago, IL: AMA Press, 2008).
Nepple KG, Joudi FN, Hillis SL, Wahls TL. “Prevalence of delayed clinician response to elevated prostate-specific antigen values.” Mayo Clin Proc 2008;83:439-445.
Wahls TL, Cram PM. “The frequency of missed test results and associated treatment delays in a highly computerized health system.” BMC Family Practice 2007;8:32.
Poon EG, Gandhi TK, Sequist TD, Murff HJ, Karson AS, Bates DW. “ ‘I wish I had seen this test result earlier!’ Dissatisfaction with test result management systems in primary care.” Arch Intern Med 2004;164:2223-2228.
Snyder L, Leffler C, for the Ethics and Human Rights Committee, American College of Physicians. Ethics manual, 5th ed. Ann Intern Med 2005;142:560-582.
Levinson W, Gallagher TH. “Disclosing medical errors to patients: a status report in 2007.” CMAJ 2007;177:265-267.
Murphy JG, McEvoy MT. “Revealing medical errors to your patients.” Chest 2008;133:1064-1065.
Suggested steps when disclosing medical errors
While the rationale for disclosing errors to patients is strong, clinicians may feel uncomfortable doing so. Here are some suggested steps:
- Speak in private with the patient, his or her loved ones, and essential members of the health care team present. Avoid interruptions (such as pagers) and allow time for questions.
- Discern the patient’s perception of the problem before disclosing the error. For example, you might ask, “Do you recall the results of your PSA from a year ago?” Such questions allow for correction of misinformation.
- Speak clearly and check for comprehension (such as, “Is there anything I can clarify?”). The patient should understand what happened and the consequences of the error.
- Avoid attributing blame (such as, “The laboratory must have forgotten to call me about the result”). Patients desire a sincere apology and want to know how the clinician and organization will act to prevent future errors.
- Acknowledge the patient’s emotional response to the disclosure by using empathic statements, such as, “I can see that you are upset by this news.”
- Formulate a plan for further assessment, treatment, and follow-up and how you will work to prevent future errors.
- Document all discussions related to the error and its disclosure.
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