Disclosing Serious Pathology Errors

Pathologists are actively engaged in the quality and safety movement, and robust literature is now available detailing pathology and laboratory error reduction strategies¹. Nevertheless, despite our best efforts, harmful pathology errors are unavoidable. What should pathologists do when errors inevitably occur? This summary presents recommendations for disclosure in the unique setting of pathology error, details of which were previously published by authors Yael Heher and Suzanne Dintzis in Advances in Anatomic Pathology²

Why Should Pathology Error be Disclosed?

1. Patient Safety/Organizational Learning: Transparency is critical to the goals of the modern patient safety movement.  The rationale for full error disclosure is to understand why errors occur and how to reduce them.  If errors remain hidden, systems cannot be changed to reduce the risk of similar errors affecting other patients. 
2. Fiscal/Legal/Regulatory: Disclosure of serious error can reduce the risk of a malpractice claim and promote more favorable settlements 3–5.  The Joint Commission and some states mandate the disclosure of harmful medical error to patients.
3. Ethical/ Emotional: Open and honest communication following medical error enhances patient trust in the health care system and allows emotional relief and closure for involved patients and providers.6,7 Transparent error disclosure to affected providers and patients is morally and ethically sound. 8,9

Disclose an error that meets both of the following parameters:

1. A pathology error has occurred
2. The pathology error harmed the patient 

Many definitions of pathology error exist, and none is unanimously accepted.  To help determine whether pathology error has occurred, pathologists and quality managers could ask themselves the following question, “Did we meet our expectations for care? When the answer is no, pathology error has most likely occurred. 

Pathologists agree that serious, harmful pathology error should be disclosed to both treating clinicians and patients.10 But not all pathology errors are harmful. Most errors are non-harmful or near misses, events that had the potential to cause harm but that were caught and corrected before they reached the patient. Most pathologists agree that non-harmful errors and near misses should not be disclosed to the treating clinicians and patients.11 Although they need not be disclosed to second parties, non-harmful errors and near misses should undergo root cause analysis to reveal possible systems defects that might be improved.

• Someone who has an existing relationship with the patient
• Someone who can explain what happened
• Someone who can communicate clearly and empathically

Pathologists may find themselves in the awkward position of having to disclose a harmful pathology error without having any professional relationship with the affected patient.  Much of the time, a patient may not even know that a pathologist has been involved in their care.  Many pathologists endorse taking the initiative both in contacting treating clinicians and in participating in discussions with patients regarding pathology error; however, direct patient contact should be mediated by the physician with a preexisting therapeutic relationship with the patient.  

Because optimal disclosure requires both an existing relationship with the patient and expertise about the impact that the error will have on the patient’s care, a joint disclosure with treating clinicians might be optimal.   If the pathologist of record feels inadequately prepared for direct patient contact, a surrogate such as the director of quality assurance may be able to participate in disclosure conversations to ensure that the treating clinician’s and patient’s questions are answered fully and accurately.  If a pathologist is not present during a disclosure, it is difficult to know whether or how the pathology error was disclosed.

Risk managers are often helpful during a disclosure because they can answer patient questions about monetary compensation that may arise.  Other participants may include patient relations professionals, attorneys, and malpractice insurance representatives according to both the needs of the patient and local policy.

It is important to begin an initial conversation regarding harmful error within a week of error discovery.  Delays in reporting an error to care providers and patients can be seen as a lack of transparency or withholding of information ^12,13.Often complete information regarding the nature of the error and its causes may not be available within a week of error discovery; however, a limited disclosure, including known facts, plans to follow up with additional information as it becomes available, and a sincere apology should occur quickly.

The most common failure in error disclosure is simple lack of planning.  Formal root cause analysis must be initiated once an error is discovered.  The opinions of all affected clinical team members should be solicited, concerns addressed and consensus reached before meeting with affected patients.  If the disclosure of error to the patient will be a team disclosure, the roles of each team member during the disclosure should be planned in advance.  An error can be compounded by incorrect speculation or assignment of blame, which can further erode trust and confidence in the medical team.

Finally, a disclosure is not an event but a process.  Often additional details regarding the cause of the error and the impact of the error on patient care become available over time.  Affected providers and patients should make plans for follow up conversations.  Successful disclosure will require resources beyond the individual pathologist or pathology department.  Pathologists should make themselves familiar with resources both within their institution and external resources such as malpractice providers to help with the difficult process of disclosure.

1. Nakhleh, R. E. Error Reduction and Prevention in Surgical Pathology. (Springer, 2015).
2. Heher, Y. K. & Dintzis, S. M. Disclosure of Harmful Medical Error to Patients: A Review With Recommendations for Pathologists. Adv. Anat. Pathol. 25, 124–130 (2018).
3. Kachalia, A. et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann. Intern. Med. 153, 213–221 (2010).
4. Mello, M. M., Studdert, D. M. & Kachalia, A. The medical liability climate and prospects for reform. JAMA 312, 2146–2155 (2014).
5. Lambert, B. L. et al. The ‘Seven Pillars’ Response to Patient Safety Incidents: Effects on Medical Liability Processes and Outcomes. Health Serv. Res. 51 Suppl 3, 2491–2515 (2016).
6. Etchegaray, J. M. et al. Patients as Partners in Learning from Unexpected Events. Health Serv. Res. 51 Suppl 3, 2600–2614 (2016).
7. Truog, R. D., Browning, D. M., Johnson, J. A. & Gallagher, T. H. Talking with Patients and Families about Medical Error: A Guide for Education and Practice. (JHU Press, 2010).
8. Conway, J., Federico, F., Stewart, K. & Campbell, M. Respectful management of serious clinical adverse events. IHI Innovation Series White Paper. 2nd edn. Cambridge, MA: Institute for Healthcare Improvement (2011).
9. Snyder, L., Leffler, C. & Ethics and Human Rights Committee, American College of Physicians. Ethics manual: fifth edition. Ann. Intern. Med. 142, 560–582 (2005).
10. Dintzis, S. M. et al. Communicating pathology and laboratory errors: anatomic pathologists’ and laboratory medical directors' attitudes and experiences. Am. J. Clin. Pathol. 135, 760–765 (2011).
11. Dintzis, S. M. et al. Pathologists’ Perspectives on Disclosing Harmful Pathology Error. Arch. Pathol. Lab. Med. 141, 841–845 (2017).
12. Clinton, H. R. & Obama, B. Making patient safety the centerpiece of medical liability reform. N. Engl. J. Med. 354, 2205–2208 (2006).
13. Vincent, C., Young, M. & Phillips, A. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet 343, 1609–1613 (1994).

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