Organizations across the continuum of care are striving to become high-reliability organizations, and part of being highly reliable means staying vigilant and identifying problems proactively.
ECRI’s annual Top 10 list helps organizations identify imminent patient safety challenges. To select the Top 10, ECRI and its affiliate, the Institute for Safe Medication Practices (ISMP), analyzed a wide scope of data, including scientific literature, patient safety events or concerns reported to or investigated by ECRI or ISMP, client research requests and queries, and other internal and external data sources.
ECRI and ISMP’s annual report helps health care organizations achieve total systems safety. A total systems approach facilitates real improvement in safety. Proactive rather than reactive, it anticipates risks and applies system-wide safety processes across the health care continuum.
Reflecting the emphasis of total systems safety on system-wide processes and cross-collaboration, the theme for this year’s list is “Reaching Farther for Safety.” Health care organizations may already have implemented measures to improve safety for these topics, yet harm continues to occur. To address these safety concerns, health care organizations and their partners may need to reach farther. The items on this year’s list may require more collaboration with community partners, more involvement across stakeholder groups, more interdepartmental planning and processes.
1. Staffing Shortages
Even before the COVID-19 pandemic, there was a persistent shortage of clinical and nonclinical staff. Staffing shortages have continued to increase throughout the pandemic.
These shortages cut across disciplines, affecting nurses, physicians, pharmacists, respiratory therapists, and more; they affect every care setting. For example, over a 10-year period (2016 to 2026), long-term care will see 678,300 job openings for nursing assistants, but 368,100 workers will move to another occupation.
By 2034, the physician shortage is projected to reach 17,800 to 48,000 in primary care and 21,000 to 77,100 in other medical specialties, raising concerns about access to care, disparities and burnout.
Organizations should implement a flexible recruitment and retention program in light of staffing shortages. Strategies include developing an inclusive, culturally competent workforce, establishing flexible staffing models, assessing their systems for psychological safety, and evaluating and addressing factors that contribute to departmental turnover rates.
2. COVID-19 Effects on Health Care Workers’ Mental Health
An often discussed but inadequately addressed collateral result of the COVID-19 pandemic is the toll it has taken on the mental health of health care workers.
Health care professionals’ mental health was already at crisis level before the COVID-19 pandemic; both physicians and nurses were at risk of burnout, emotional exhaustion or depression prior to 2020. The pandemic has now forced a reckoning with health care workers’ mental health needs.
Throughout the COVID-19 pandemic, many health care workers have sacrificed their mental health in order to deliver care. Health care organizations now need to support clinician resilience.
An organizational tone of personal connection, with leadership available to staff via transparent, two-way communication channels is crucial. Pitfalls like empty hero worship should be avoided, replaced with effective wellness programming, recognizing the connections between job-related burnout and patient outcomes, and minimizing the effort required of staff to participate in resilience activities.
3. Bias and Racism in Addressing Patient Safety
Racial and ethnic disparities have been well documented in how they affect access to care and outcomes. What is less well publicized is that disparities can even affect how adverse events are reported and responded to.
Although patients from racial and ethnic minority groups are more likely to experience an adverse event while in the hospital, providers are significantly less likely to report harmful events for patients from minority groups than from white patients.
Health care organizations should establish and implement policies designed to identify and eliminate racism and discrimination in the organization. Recognizing that racism and implicit biases may be present, they should:
- Examine the racial demographics of patient safety events and root-cause analyses performed by the organization.
- Train leaders on health equity, addressing topics that include health disparities, cultural competence and health outcomes among minorities.
- Perform health equity and cultural competence assessments. Repeat such assessments after implementing improvement initiatives.
- Take seriously all allegations of racism, bias or discrimination that originate in the organization, and thoroughly investigate and address such reports.
4. Vaccine Coverage Gaps and Errors
The success of any vaccine relies on correct, widespread administration to appropriate populations. Vaccine gaps and errors may harm patients or provide inadequate protection against serious diseases.
Vaccine administration errors pose the potential for consequences like:
- Inadequate immune protection
- Unintended patient harm
- Increased costs to providers
- Reduced confidence in the healthcare delivery system
Implementing a comprehensive vaccine promotion program requires an examination of vaccine administration protocols and strategies like:
- Storing look-alike vaccines and doses on different shelves, and maintaining proper temperatures.
- Keeping vaccines with the earliest expiration dates in the front of storage units, and removing expired products.
- Structuring treatment areas to accommodate one patient at a time.
- Utilizing trained providers with demonstrated vaccination competencies, and training staff whenever vaccines are added or recommendations updated.
- Including a pharmacist on the immunization team.
- Giving patients vaccine information in their preferred language.
5. Cognitive Biases and Diagnostic Error
Cognitive biases can result in misdiagnosis by skewing how clinicians gather and interpret evidence, take action and evaluate decisions. Four common clinician biases include:
- Anchoring bias: The clinician adheres to their initial impression in the face of conflicting evidence
- Confirmation bias: Information is “cherry picked” to support the diagnosis
- The affect heuristic: Actions are driven by emotions; this often manifests as strong feelings regarding a patient after an encounter
- Outcomes bias: Clinical results always follow prior decisions, preventing clinicians from considering feedback to improve their care delivery
Cognitive biases are difficult to perceive and even more difficult to dismantle. Nevertheless, failure to do so can result in misdiagnosis and delayed or inappropriate treatment. Simply recognizing that the bias exists may help overcome it.
6. Nonventilator Healthcare-Associated Pneumonia
Pneumonia is the most common healthcare-associated infection in the United States and is linked to substantial morbidity and mortality. Despite the attention placed on ventilator-associated pneumonia, nonventilator healthcare-associated pneumonia (NV-HAP) diagnoses in the United States make up 65% of the cases, compared with 35% associated with ventilators.
NV-HAP is a preventable event that is underreported as a health care complication. About 1 in every 100 hospitalized patients experiences NV-HAP, with mortality rates ranging from 15%-30% for hospitalized patients and 13%-41% for nursing home residents.
Proactive prevention of NV-HAP requires incorporating patient- or resident-care intervention bundles, providing staff education, conducting infection surveillance and targeting performance improvement activities around NV-HAP risks.
7. Human Factors in Operationalizing Telehealth
Overlooking human factors in the design, implementation, usability and evaluation of telehealth systems may lead to a situation mirroring what happened during the widespread adoption of electronic health records (EHRs), which caused numerous issues for providers and patients alike, including:
- fractured adoption
- interrupted workflows
- user dissatisfaction
- complete system failure
A systematic review of studies on telehealth implementation and integration challenges identified issues involving stakeholders and system users as the top hurdle (79%); issues included the lack of active involvement and collaboration to support a user-centered system design.
Provider organizations often focus on technical specifications and integration with existing EHR systems and payment models. Accounting for user experiences from all stakeholders is critical to successful implementation, optimization and sustainability.
8. International Supply Chain Disruptions
The United States heavily relies on international manufacturers to produce medical equipment, drugs, and other health care supplies.
Shortages of health care supplies can disrupt routine patient care − threatening care quality and patient safety.
There are two critical areas of concern: manufacturers are having difficulty accessing raw materials, and delivery disruptions have impacted the availability of shipping containers, unloading space, trucking capacity and delivery workers.
Planning, preparation, communication, flexibility and cooperation with outside collaborators are essential for safely navigating supply chain disruptions.
- Identify domestic and international alternatives for supplies and drugs that would leave the facility most vulnerable if a supply chain disruption were to occur.
- Demand transparency from distributors and manufacturers regarding:
- Minimum inventory levels
- Country of origin for product and raw material suppliers
- Surge capacity plans
- Re-examine sole-source, dual-source and multisource agreements.
9. Products Subject to Emergency Use Authorization
During emergencies, FDA can issue emergency use authorization (EUA) for drugs, devices or biologics for serious diseases or conditions when no FDA-approved alternatives are available. EUAs allow temporary use of unapproved products or unapproved applications of approved products; they may be revised or revoked at any time, and terminate when the emergency ends or FDA approves the product.
In some circumstances, using a product after the EUA ends may risk regulatory compliance problems or loss of federal liability protections. If necessary, a physician may continue an EUA product for a patient who started treatment with the product before revocation or termination.
Rigorous management of EUA products optimizes patient safety and minimizes risks. An appropriate committee or committees should monitor EUA status of products used in the organization, keep providers apprised of which products have EUAs and document evaluation of safety concerns before continuing a permissible use after EUA revocation or termination.
10. Telemetry Monitoring
Telemetry monitoring (TM) provides real-time measurements of monitored physiologic parameters from a distance. Technological breakdowns as well as breakdowns related to clinician response increase the risk of patient harm by the disruption in identification of critical and abnormal changes in a patient’s health status.
- Common problems include:
- alarm fatigue
- poor safety culture between departments
- infrastructure breakdowns leading to information dropouts/lost communication
- ack of effective emergency backup plans during outages
Both clinical (e.g., requiring a physician’s order to adjust settings outside default limits) and technical (e.g., updating software regularly and using segregated networks, firewalls, virtual private networks and network monitors) strategies are necessary to improve TM.
To download the full Top 10 Patient Safety Concerns report, with complete recommendations for each item, visit https://www.ecri.org/top-10-patient-safety-concerns-2022/ .
