Chapter 2 of 9
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Adverse Events
A culture of safety is inherently important to the success of a risk management program. Establishing a positive work environment and promoting transparency empowers staff to report adverse events and to be a part of the solution in preventing recurrences. Success also requires a collaborative team approach that includes all providers, staff and managers through encouraging reporting and open dialogue to implement actions to prevent recurrence.
Responding to Adverse Events
The Institute for Healthcare Improvement (IHI) defines an “adverse event” as an “unintended physical injury resulting from or contributed to by medical care (including absence of indicated medical treatment), that requires additional monitoring, treatment, or hospitalization, or that results in death.” The Agency for Healthcare Research and Quality has additional information on defining adverse events, near misses and errors. These events may either be preventable medical errors or non-preventable occurrences. Most, but not all, adverse events and/or medical errors that occur in an outpatient setting are related to clinical diagnosis errors, clinical procedure injuries, laboratory test reporting, or medication errors.
Care must be taken to minimize the likelihood of negative outcomes and to prepare providers and staff to respond appropriately if an adverse event occurs.
Proactive risk reduction strategies, such as clinical and operational policy management, use of effective communication techniques and diagnostic test result tracking, among other strategies, may reduce the likelihood of unanticipated clinical events. However, once an adverse event has occurred, prompt identification and management is imperative to limit the impact.
The first priority should be patient stabilization and ensuring prompt emergency treatment, if indicated. Transparent communication with the patient and family regarding the event and subsequent treatment plans enhances trust, minimizing misunderstandings that often lead to litigious actions.
Many states have issued mandatory adverse event reporting requirements with specific definitions of reportable events, and timeframes for reporting, follow-up and investigation. The specific reporting requirements vary by state. In addition, mandatory reporting to state licensure boards vary by state and also should be considered when an adverse event arises. Failure to comply with these mandatory reporting requirements can result in adverse regulatory action against the healthcare entity and involved providers.
Post-event interventions, including trending and analyzing incidents, as well as implementing necessary process, system, and policy changes, should be performed by practice administrators/managers and clinical leaders.
Ongoing training and preparation are critical to loss reduction. Staff members should be aware of:
- How to reduce the risk of events.
- To whom events should be reported.
- How events should be reported, and how quickly.
- Who should communicate with the patient regarding the facts of the event.
- After immediate medical care is provided to the patient, the following risk management steps should be taken:
- Notify administrative and clinical leadership.
- Secure any equipment, medications or supplies involved in the event and remove them from service.
- Have a provider review the medical facts with the patient as soon as possible after the event.
- Postpone sending the patient’s bill for services until the event has been investigated.
Adverse event reports are the most common method for reporting and recording untoward events and near-misses. Near misses are events that, if not interrupted, have the potential to cause harm. The standardized format of the adverse event report enables staff members to clearly, concisely and consistently document anything they witness that deviates from routine care.
Reports
The adverse event report is designed to:
- Capture relevant, objective information regarding the event and surrounding circumstances.
- Notify management of a potentially serious or actionable situation.
- Provide information to management to determine if the situation requires mandatory external reporting requirements to state or licensure boards, the FDA and others.
- Facilitate analysis of data to track and trend adverse events and near-misses. By tracking incidents according to the type of event, time of day and department, organizations can identify where and when problems tend to originate, as well as underlying issues, such as staffing levels, training gaps or communication lapses. Incidents should be categorized by both frequency (i.e. the number of times an event occurs) and severity (i.e. the event’s seriousness and potential impact).
Adverse event reports should include:
- Identity of the party who witnessed or was first to become aware of the event.
- Factual and objective information regarding the event.
- Time and location of the event.
- Names and contact information of any witnesses.
- Description of the patient’s condition after the event.
Although a computerized adverse event reporting system permits ease in trending, paper reporting systems also may be utilized. Irrespective of the reporting method, adverse event reports should include factual, objective information regarding the event, including the patient’s statement in quotes, if the patient is cognitively able to report what happened. The report should NOT include statements regarding blame or admissions of liability.
When the adverse event report is completed, the report should be reviewed by the individual responsible for receiving and managing the adverse event reporting process, as well as administrative and clinical leadership.
Investigation
An investigation should be initiated as soon as possible after the event, ideally prior to the end of the work day. Conducting the investigation immediately following the event preserves accuracy, as memories fade and perceptions of details vary over time. The scope of the investigation may depend upon the incident type and event severity. The individual responsible for receiving and managing adverse event reports should conduct the initial investigation and determine next steps.
For serious events, a root cause analysis (RCA) team may be assembled. Such a team will include providers, nursing, ancillary staff and practice/clinical managers. This team should continually ask “why” when analyzing the human, process and systems failures that led to the adverse event until all contributing factors are known. For less serious matters, discussion with those who first became aware of the event may suffice. In either situation, the information obtained should identify factors that led to the event so that actions may be implemented to prevent a recurrence.
The investigation should be performed under the auspices of the performance/quality improvement plan, which may help protect the adverse event report and subsequent investigation materials from legal discovery. However, discoverability of adverse events and investigation information varies among states. Investigative findings should be documented on a separate form specifically used for performance improvement activities.
Follow-Up
Educational programs for staff should be ongoing and include information regarding patient safety, adverse event reporting criteria, report completion, the investigative process, and patient safety enhancements as an outcome of the process. Education for those responsible for the investigative process should include the importance of investigative objectivity, witness interviewing skills, use of open-ended questions, and keen listening skills.
Documentation
Care must be exercised when documenting an adverse event in the patient healthcare information record. Factual and objective clinical information, patient treatment, patient response to treatment and follow-up plans, if applicable, should be documented. Reference to an adverse event report, or copies of the adverse event report, should not be included in the healthcare information record.
Adverse Event Policy and Procedure
Detailed written policies outlining the adverse event reporting process should be in place to address the following:
- Definition of an adverse event and near-miss.
- Individual responsible for completing adverse event reports.
- Internal management and administrative notification requirements.
- Details to be included in the adverse event report.
- Documentation in the patient healthcare information record.
- Timeframes for internal and external reporting.
- Individual responsible for external reporting, i.e. state, licensing board, FDA and others.
- Sequestering of equipment and/or supplies if they are suspected of contributing to the adverse event.
- Adverse event report review and signatures.
- Investigation process and timeframes.
- Monitoring compliance with the adverse event reporting process.
- Development of an action plan, responsibility, process, and timeframes.
- Monitoring the effectiveness of the action plan.
- Security, storage and retention of adverse event report form.
Communicating with Patients and Families Following an Adverse Event
As trust is the cornerstone of a therapeutic relationship, it is imperative that providers are skilled in how to communicate transparently with patients in all aspects of care, especially during times of crisis following an adverse event. Offering provider workshops on effective communication and difficult patient conversations may enhance their communication skills. Administrative and clinical leadership should be consulted before any discussions with the patient or family occur in order to ensure a balanced, objective approach is taken.
When an adverse event has occurred, the patient’s primary provider should communicate directly with the patient, or the patient’s designated healthcare proxy. If possible, communicate in person, preferably in a quiet, comfortable setting. Every effort should be made to accommodate the patient and family regarding place and time. When additional information becomes available, schedule a follow-up meeting with the patient and/or family.
Emphasize facts during the discussion, focusing on what happened and how it may affect the patient’s prognosis, if this is known. Be honest with the patient, and do not speculate about the causes of the event. Express empathy without assigning blame or criticizing
the care or response of other providers. Be prepared to answer questions about what steps will be taken to prevent such events in the future.
Consult with legal counsel regarding the provisions of the state’s disclosure law, as well as any laws addressing apologies to patients and admission of liability.
Quality Improvement Fundamentals
Most inefficiencies and errors in healthcare settings are the result of failures in processes related to communication, the appropriate use of clinical protocols, healthcare information record documentation, scheduling and patient education. These failures can be more easily identified and corrected in settings that work to empower staff. Staff should understand that they are accountable for the processes they implement. Managers should provide staff with the resources necessary to fulfill their duties and grant them the authority to address issues that arise.
Culture of Safety
The safety culture of an organization represents a combination of attitudes and behaviors designed to promote patient safety. Creating a culture of safety is an essential component in the reduction and prevention of patient harm and improving the quality of care and services.
Key elements demonstrating an organization’s commitment to a culture of safety include:
- Recognition of the high risk nature of patient care and a commitment to consistently providing safe care.
- Maintaining an environment where staff feel comfortable in reporting and discussing errors and near-misses without fear of reprisal.
- Establishing zero tolerance and requiring individual accountability for reckless behavior versus human error regardless of the existence of harm or severity of harm.
- Collaboration/teamwork across ranks and disciplines to find solutions to patient safety concerns.
- Commitment of resources responsive to patient safety initiatives.
- Analysis of system, process and human factors that contribute to errors, near misses, unexpected outcomes, and patient complaints.
Variations in the perception of safety may exist among staff, which is often due to variations in how patient safety events have been managed across the organization. Leaders and managers should be cognizant of the issues that staff encounter and understand what guides their behavior.
The first step in achieving a culture of safety is to survey providers and staff through the use of a standardized tool.
AHRQ’s Survey on Patient Safety Culture™ (SOPS®) and the
Safety Attitudes Questionnaire.
Perception by staff of an inferior safety culture has been linked to increased error rates. Results from the AHRQ perception survey on safety culture measure responses around teamwork training, executive walk rounds, establishing safety teams, and use of structured communication.
Structured communication is a systematic approach to communication that focuses on organizing and controlling the flow of information so that information communicated is more accessible, prompt, appropriate and meaningful. Standardized communication strategies also assist the recipient of the information in taking or directing action to be taken. Examples of structured communication techniques are:
Basics of Quality Improvement
Quality improvement is the framework to systematically monitor and evaluate processes and systems that impact patient care in order to standardize practice and reduce variation, thereby increasing the probability of achieving the desired outcome. Quality improvement:
- Is internally driven, empowering all employees to participate in achieving improvements
- Focuses on improving systems and processes
- Proactively prevents problems and errors by monitoring and improving processes
- Continuously aspires to improve quality
Risk management and quality improvement are aligned in their focus on safety and positive outcomes. Continuous reporting and monitoring of adverse events facilitates the identification of process and system failures that cause or contribute to negative outcomes, thereby enabling preventative action to be taken before serious adverse events occur.
A suggested framework for quality improvement is the
Plan Do Study Act (PDSA) model developed by W. Edwards Deming This cyclical process is designed to determine whether the planned change leads to improvement. The model can be used on large and small scale projects and will facilitate the creation of successful improvement plans.
PDSA Cycle
Plan
Plan the pilot test by defining the problem and designing a solution. Predict what will happen and why. Develop a plan to test the change (solution). Who? What? When? Where? What data must be collected?
Do
Test the plan on a small scale. Collect data. Document problems and unexpected outcomes, including successes. Begin analysis of the data.
Study
Analyze the data and determine where adjustments to the plan are needed. Re-test. Collect data and analyze again until the desired outcome is achieved. Finally, continue to test the plan on a larger scale to confirm that the plan performs as designed.
Act
Once the plan has been tested and proven to be effective in resolving the process or system issue, take action to implement the plan on a facility-wide basis. Ongoing monitoring will reveal if and where additional revisions are needed.
Data Collection and Monitoring
Data on key clinical and operational processes should be systematically collected and analyzed to identify potential failures that may lead to patient injury or adverse outcomes. Data collection may include manual review of healthcare information record documentation or computer data collection measured against established benchmarks or expected standards. Direct observation of processes may provide insight on behavioral variations and workarounds, thus revealing weaknesses and failures that should be addressed to achieve an effective and efficient approach.
Establishing key performance metrics provides opportunity for data collection, monitoring and improvement of processes, systems, and decrease in variation among staff in implementing tasks, such as the following:
Process measures
- Medication reconciliation discrepancies
- Ordered tests that are not performed
- Unreported and/or undocumented test results
- Misplaced or mislabeled specimens
- Lack of follow-up on significant missed appointments
- Excessive patient wait times
- Monitoring compliance with infection control measures and handwashing procedures
- Failure to perform time-out procedures
- Errors in surgical instrument/sponge counts
Outcome measures
- Patient satisfaction surveys
- Adverse drug reactions
- Patient or visitor accidents
- Facility acquired infection rates
- Surgical complication rates
- Retained foreign body post procedures
- Mortality rates
Accreditation
Voluntary accreditation of an outpatient facility and/or office-based surgical practice (OBS) by an independent third party is typically viewed by state medical boards and patients as a sign of commitment to quality and patient safety. In order to achieve accreditation, outpatient facilities and/or provider practices must participate in ongoing self-evaluation, peer review and education. The outpatient facility and/or practice also typically commits to an onsite survey by the accrediting body at a cadence determined by the accrediting body.
Several states either require or encourage accreditation for settings where conscious or deep sedation/analgesia and general anesthesia are provided. In some states, accreditation may serve as a substitute for a state-mandated and administered inspection.
Each state determines acceptable accrediting bodies and whether accreditation may be used in lieu of a mandatory state inspection. The Joint Commission provides
examples of state reliance on accreditation and certification. Several states permit only accredited office settings to provide higher levels of anesthesia.
Some of the most commonly recognized accrediting bodies for outpatient settings and provider practices include:
Continue reading Chapter 2: Operational Risks
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