Successful reporting and learning systems which enhance patient safety have the characteristics outlined in Table 40.2 [22]. A “reporting culture ” is one which creates the psychological safety for individuals to timely report any incident without fear of reprisal and maintains the confidentiality of patients and staff to the greatest extent possible. Individuals who report must be aware that their reporting makes a difference. As events are reported and validated, a response should be initiated even if reporting is anonymous. It is possible to learn from even seemingly insignificant incidents and all events should be reported. The awareness that reports are taken seriously by the organization promotes an environment in which frontline workers are more likely to increase the level of surveillance and reporting [23].

The analysis of reported events provides insight into how all factors causing the event converge so that steps can be taken to make the system safer. Granular clinical information regarding events, particularly using a combination of narrative and structured data, provides fertile ground for identifying major categories of defects in the system. Additionally, the reporting system must be capable of disseminating its findings in a comprehensive and understandable way and make recommendations for change by addressing the systems issues rather than targeting on individual or group performance [24].

To get the maximum benefit , events must be evaluated, categorized, and analyzed by individuals with expertise who understand both clinical context and are additionally trained to recognize underlying systemic issues. Clinical personnel with additional training in human factors, systems engineering, patient safety, and other related fields are excellent candidates for these activities. Legal protection for reporting should also be an essential component of a patient safety program [25, 26]. The absence of such protection may stifle the desire to report, even if reporting is anonymous.

In addition to the attributes noted in Table 40.1, good hospital-based reporting systems allow reporting by anyone in the organization, including patients. Multiple sources of reporting provide richer, more granular contextual information as opposed to a single source. Good systems particularly value the important role patients and their family members play in improving safety. These systems also gain invaluable information regarding a patient’s experience and the needs of the community directly from the “voice of the customer” perspective [25–27].

As noted, there is pervasive underreporting of adverse events and near misses thereby perpetuating the risk to patients and missing opportunities to learn. In a completely open and just culture, incidents and failures are honestly discussed by all staff, patients, and families enabling the causes of serious events to be established and lessons to be learned. Organizations with the best reporting culture go to great lengths to ensure that reports and investigations carry no blame or liability. Top management in these healthcare systems vigorously promotes the message of a “blame-free and nonpunitive” reporting environment [28]. Additionally, feedback is given to individuals who report on the outcome of an investigation and what measures have been taken.

High reporting rates in organizations with a strong reporting culture do not necessarily indicate inferior quality but, rather, an environment that encourages the reporting of errors and adverse events. This “reporting paradox” gives the appearance that the incidence of safety events is higher in these organizations. On the contrary, higher levels of reporting allow an institution to integrate the learnings derived into quality and safety improvement efforts, focusing on system-level changes leading to a safer healthcare environment [29].

It is essential to introduce norms in professional schools and graduate training programs that inculcate learning and nonpunitive safety reporting to have a sustainable impact on the future workforce so that a reporting culture becomes second nature. In addition, heightened expectations from consumers, patient advocacy groups, regulators, and accreditors that errors and near misses are to be reported as a professional obligation will contribute to the necessary culture change.

No single approach to address patient safety will detect all adverse events . Incident reporting systems are one of many ways to monitor and collect information . Each approach by itself may not be sufficient to create significant change. As such, the ability to integrate the entire set of patient safety activities in an organization allows for a more robust, safety-focused approach. For example, the abstraction of clinical data for purposes of generating insurance claims may be also used to identify adverse events and possibly near misses which can then be investigated. Analysis of these data may allow an organization to monitor and view events across different dimensions using AHRQ Patient Safety Indicators (PSI ) and with the addition of ICD-10 hospital discharge codes specific to medical errors [30].

An organization’s patient safety portfolio may include such activities as direct observation through routine “patient safety walk-rounds ,” medical record audits and focused reviews, workforce safety attitude surveys, failure modes and effects analysis (FMEA) , and the use of the Global Medication Trigger Tool [30]. Additionally, a periodic review of an institution’s malpractice claims, although subject to selection bias, may be useful in focusing attention on specific areas of concern.

How can we transform the current culture of blame and resistance to one of learning and increasing safety? Understanding the balance of barriers and incentives to reporting is the first step (Fig. 40.1) [31]. Each healthcare organization has its own unique set of characteristics, values, practices, and culture, all of which contribute to the degree by which its workforce is willing to report safety-related events [32]. As noted earlier, fear of punishment or retribution is a particularly strong factor, especially in rigidly hierarchical organizations. Reluctance to report may be bred at the clinical microsystem, mesosystem, and even macrosystem level depending on the group dynamics and culture of an organization as well as its leadership structure [33].

The high-paced, high-tempo, and intense nature of delivering high-quality healthcare creates limitations in time as well as physical and emotional energy. Time constraints, pervasive in healthcare, are compounded by an absence of communication with staff when safety issues are reported and by a general lack of acknowledgement, encouragement, and positive feedback ultimately demotivating frontline providers from reporting. In one study, most respondents believed that lack of feedback was the greatest deterrent to reporting [31]. At a minimum, feedback based on the findings from investigations and analysis should occur. Ideally, it also should include recommendations for changes which are developed in collaboration with great input from the staff. This approach emphasizes the importance of open, honest, and timely communication and feedback [34].

The main reasons for not reporting events are related to fear of collegial reputation and blame, a high workload, and a lack of clarity as to whether an event should be reported [35]. Measures to increase the reliability of reporting include providing clear definitions of incidents (Table 40.1), simplifying the ease of reporting, and providing ongoing education and feedback. In general, different types of IRS have inherent conflicts and trade-offs (Table 40.3) which should be understood in order to make the best use of the information obtained.

Reporting is only of value if it leads to meaningful change . Failure to do anything about events instills a sense of futility and discourages workers at all levels from reporting. Safety awareness becomes integral to providers’ work when an organization is visibly willing to make fundamental changes in response to reported events [36]. On the other hand, delays or a lack of response from supervisors and hospital leaders will discourage an already beleaguered workforce from reporting events, particularly near misses [37].

Meaningful analysis, learning, and dissemination of lessons learned require expertise in safety systems, accident investigation, and human factors. Faulty, incomplete, or lax analysis and interpretation and the application of ineffective, misguided, or potentially unsafe processes may result in reluctance by frontline workers to report in the future particularly when ineffective fixes add burdensome administrative tasks which detract from clinical responsibilities and do not make patients safer. Additionally, inabilities to access the reporting system either by physical access, cumbersome computer program rules and incompatibilities, or simply poor usability of the software interface also serve as impediments to reporting [38].