DisclosureA. Details

In the US, the federal and most state laws mandate healthcare professionals and facilitiesto analyze adverse events that occur, disclose them to patients and their families, and report themto regulatory or accrediting agencies, including the Joint Commission (JC) and the StateDepartment of Health and Human Services (HHS). When disclosing adverse events/errors topatients and their families, […]

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In the US, the federal and most state laws mandate healthcare professionals and facilities
to analyze adverse events that occur, disclose them to patients and their families, and report them
to regulatory or accrediting agencies, including the Joint Commission (JC) and the State
Department of Health and Human Services (HHS). When disclosing adverse events/errors to
patients and their families, clinicians and healthcare facilities must provide correct details about
the errors and their potential impact. The following section describes the details needed to
disclose the clinical gaffe to the patient in the case study (Ms. Karen Viani) and her family
members.
The first important detail is the “description of the harmful error.” This includes
providing accurate and clear information about the type of error (a Lasix drug overdose) and its
potential impacts on the patient’s health and well-being, including complications and risks. This
includes the symptoms the patients felt immediately after the second Lasix drug was
administered before dinner by the evening nurse. Ms. Viani felt light-headed and fell on the
floor, sustaining a sprained right wrist and a minor laceration on her forehead. The patient then
felt disorientated before losing consciousness for a few seconds, and by the time the rapid
response team arrived, she was lucid and complained of pain in the right wrist.
Besides these immediate effects, the report to Ms. Vani and her family must also
acknowledge other likely complications she faces due to Lasix overdoses, such as nausea or
vomiting, diarrhea, constipation, stomach cramping, dizziness, blurred vision, itching or rash,
increased urination, vertigo, and excessive loss of electrolytes and water symptoms, including
drowsiness, restlessness, feeling thirsty, dry mouth, abnormal heartbeat, and muscle pain (Carter,

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2022). The patient might also suffer from hypochloremia, hypokalemia, electrolyte imbalance,
hypotension, and blood volume reduction.
The second detail is a description of the cause of the error: active and latent (Agency for
Healthcare Research and Quality, 2019). For example, the active cause of the error in Ms. Vani’s
case stems from a communication breakdown between the nurse assigned to the case and the
hospitalist. The latent or underlying cause is nurse burnout and overload due to understaffing.
The third detail required is the “corrective action(s) taken by the facility to address or minimize
the error.” For example, what actions did the hospital take to diagnose, treat, and monitor Ms.
Vani’s overdose symptoms? Did the facility provide treatment focused on replenishing the
excess electrolyte and fluid losses (FDA, n.d.)? It is also necessary to inform the patient and her
family about the payment of the extra costs due to errors; they must know that the facility will
not charge them.
Fourthly, the details of the necessary “corrective actions” the facility or medical team
(nurses and hospitalist) will take in the future to prevent the errors from reoccurring are also
required when preparing a patient disclosure report. For example, the report can include the
decision by the hospital to hire more nurses to reduce staff shortages and implement an
electronic health record (EHR) to support the accurate and timely sharing of clinical information
between staff members.
In addition, an apology for the error is required to express regret and empathy for the
inconvenience and harm caused to the patient and her family. Follow-up steps must also be
provided to describe the plan for following up with the patient’s care and therapy or for
continuous monitoring and improvement. Finally, the healthcare team’s contact information must

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be provided to allow the patient to make contact in case of any concerns, complications,
clarifications, and questions (Agency for Healthcare Research and Quality, 2019).

B. Method and Preparation

“Face-to-face communication” is arguably the most effective, empathic, and respectful
way of disclosing the details above to Ms. Vani and her family (Wolf & Hughes, 2008). In this
approach, the healthcare team (or the individual designated with compiling the error and
reporting it to the patient) meets Ms. Vani and her family in person and explains the harmful
error, why it occurred and its effects, the steps the facility has taken and plans to take to address
them, and then cap off with an apology. Face-to-face communication is better than written
communication (including letters and emails), telephone communication, and videoconferencing.
Face-to-face communication can allow the medical team or healthcare provider to
personalize information and communication, taking into account her emotional state, concerns,
and needs. It also gives room for clarity, ensuring the error(s) and its potential impacts are
explained in an easy-to-comprehend and clear manner. Moreover, face-to-face communication
can permit the healthcare provider to demonstrate compassion and empathy. It is easier to
apologize and get forgiven when the sorry comes directly from the offender’s mouth than when
the apology is written. The use of facial expressions, hand gestures, and the overall tone of voice
can influence the victim’s response. Most importantly, a face-to-face meetup can allow the
facility and its representative(s) to directly respond to the concerns and questions Ms. Vani or her
family might hold regarding the incident, providing them with an opportunity to understand the
error and its potential effects. This can also offer a more profound way of establishing trust, a
good rapport, and building a positive correlation with the patient and the family.

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Before the face-to-face disclosure, the staff must be informed about all the details
involved in the disclosure (the error, the causes, and the corrective actions). Staff must also
receive training on the best error disclosure practices, including communicating clearly and
soundly in an empathic, accurate, and apologetic to the patient and her family. Role-playing is a
technique that can allow staff to get acquainted with the error-disclosing process through a
simulated environment, helping them build confidence. Preparation also means granting staff
support services and resources, such as a counselor or patient safety officer, and the hospital’s
standard protocol for error disclosure to patients. Staff members should also be trained for the
emotional weight linked with disclosing errors of such a magnitude and given the necessary
support to process their emotions.
Equally, preparing the patient and her family for the disclosure entails equipping them
with the resources, help, and information they need to understand the errors (causes, effects, and
corrective actions taken), respond emotionally and physically to the errors, the compensation
they are entitled to, and their constitutional rights to file a lawsuit, including the protocols and
options available and their potential outcomes. Part of this process involves assigning the patient
and her family a counselor to gauge their preferences, concerns, and needs, including their
emotional status. The patients then need to be notified of the impending disclosure meeting, and
information on why, where, how, with who, and what the meeting involves must be provided.

C. Reporting

In the US, federal and state laws require that healthcare organizations file and report
errors to regulatory and accrediting agencies, including the State Department of Health and
Human Services and the Joint Commission. This is purely due to accountability reasons and for
these agencies to establish organizational compliance with clinical standards and guarantee the

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safety and well-being of care provided to patients. Although requirements vary, healthcare
providers are generally required to disclose the harmful errors, provide a detailed explanation of
the causes (active and latent factors), how the errors affected the patient and will affect them in
the future, the corrective steps taken to minimize the error and the corrective actions the
organization and clinical plans to prevent recurrences. Different accrediting and licensing
agencies have unique reporting requirements. For example, the National Quality Forum in 2005
enacted guidelines for clinicians that recommend disclosing accurate data about the errors,
expressing regret, offering an apology, and encouraging organizations to create and implement a
disclosure support system.
In 2001, the Joint Commission on Accreditation of Healthcare Organizations also
mandated hospitals to report all unanticipated outcomes to patients (Hannawa, 2012). The Joint
Commission has a framework that clearly stipulates three reporting requirements for healthcare
providers: (1) description of the event, (2) root-cause analysis, and (3) corrective actions. In the
first part, event description, providers must explain when the event occurred (date, day of the
week, and time), provide a detailed summary of the event (including timeline), and state their
diagnosis, medications provided, autopsy outcomes, and past psychiatric/medical history. The
root-cause analysis part has a table that lists questions, prompts, analysis findings, root-cause
types, and causal factors/root-cause details for providers to fill in. Questions about root causes
fall under eight main areas: communication, environmental, equipment/device/supply/health IT,
task/process, staff performance, team, management/supervisory/workforce, and organizational
culture factors. Finally, in the corrective actions section, providers must identify the root cause
type, causal factors, corrective actions taken, action strengths, measure of success, and sample
size (Joint Commission, n.d.).

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Finally, although jurisdictional differences might exist between states, requirements for
reporting medical errors to State Departments of Health and Human Services remain the same.
This is because quality control is performed by a single federal body: the Agency for Healthcare
Research and Quality (AHRQ). Based on AHRQ guidelines, root-cause analysis (RCA) and
corrective action plan (CAP) reports sent to the State Department of Health and Human Services
must provide a detailed account of the events, contributing/latent factors, their root causes,
specific corrective actions taken or will be implemented to deter recurrence, a plan for evaluating
and monitoring the effectiveness and efficacy of the corrective interventions, regulatory
violations that might have occurred and how to address them, and staff education and training
related to the incident (AHRQ, 2019). The RCA must identify active and latent errors. 

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References

Agency for Healthcare Research and Quality. (2019). Disclosure of errors.
https://psnet.ahrq.gov/primer/disclosure-errors
Carter, A. (2022, June 13). Furosemide, oral tablet. Medical News Today.
https://www.medicalnewstoday.com/articles/furosemide-oral-tablet#important-warnings
FDA. (n.d.). Lasix.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016273s066lbl.pdf
Hannawa, A. F. (2012). Medical error disclosure: A pressing agenda for public health
researchers. Journal of Public Health Research, 1(3), 214-215. doi:
10.4081/jphr.2012.e33
Joint Commission. (n.d.). Framework for root-cause analysis and corrective actions.
https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-
topics/sentinel-
event/rca_framework_101017.pdf?db=web&hash=B2B439317A20C3D1982F9FBB94E1
724B&hash=B2B439317A20C3D1982F9FBB94E1724B
Wolf, Z. N., & Hughes, R. G. (2008). Chapter 35 – error reporting and disclosure. In R. G.
Hughes (Ed.), Patient safety and quality: An evidence-based handbook for nurses.
Rockville: Agency for Healthcare Research and Quality.
https://www.ncbi.nlm.nih.gov/books/NBK2652/

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