The modern patient safety movement began with the release of the 1999 Institute of Medicine (IOM) report “To Err Is Human,” which estimated that up to 98,000 patients die each year from medical errors. This high number of deaths exceeded the number attributed to the eighth leading cause of death at the time, and helped refocus the health care community on the importance of patient safety. The ICU is particularly prone to medical errors as patients are very ill and require continuous monitoring. The care of ICU patients can be complex, involving multiple consultants and many medications, where life-and-death decisions often need to be made quickly. A 2006 international study of 205 ICUs found an average of 38.8 events that compromised patient safety per every 100 patient critical care days, highlighting the need for risk reduction and complication avoidance strategies in ICUs.
The Four Domains of a Patient Safety Program
A patient safety program that drives improvement for critical care patients can be categorized into 4 general domains (Figure 13–1): (1) ensuring compliance with patient safety regulations (eg, The Joint Commission National Patient Safety Goals [NPSGs]); (2) responding to adverse events by performing root cause analyses and implementing targeted corrective actions (eg, delayed response to a ventilator alarm); (3) applying evidence-based risk reduction strategies that are not required by regulations, but are considered best practices (eg, checklists); and (4) implementing strategies to meet and exceed patient safety metrics that are publicly reported or tied to pay-for-performance programs (eg, hospital-associated infections reported on public report cards). Hospitals that are leaders in patient safety excel in each of these 4 domains, and also contribute to the science of patient safety by developing new strategies for preventing errors, conducting research, and publishing their findings.
Four domains of a patient safety program.
Patient Safety Regulations
The Joint Commission NPSGs are the predominant patient safety regulations that guide hospitals' medical error reduction strategies. Established in 2002, the NPSGs require organizations to address specific areas of concern in regard to patient safety. Many of these goals target important patient safety issues in critical care units including proper patient identification, timely response to critical tests, and appropriate use of clinical alarms. Table 13–1 has a complete list of the 2016 Joint Commission NPSGs.
Table 13–12016 Joint commission patient safety goals. ||Download (.pdf) Table 13–1 2016 Joint commission patient safety goals.
|Identify patients correctly || |
Use at least 2 ways to identify patients. For example, use the patient's name and date of birth. This is done to make sure that each patient gets the correct medicine and treatment.
Make sure that the correct patient gets the correct blood when they get a blood transfusion.
|Improve staff communication || |
|Use medicines safely || |
Before a procedure, label medicines that are not labeled. For example, medicines in syringes, cups, and basins. Do this in the area where medicines and supplies are set up.
Take extra care with patients who take medicines to thin their blood.
Record and pass along correct information about a patient's medicines. Find out what medicines the patient is taking. Compare those medicines to new medicines given to the patient. Make sure the patient knows which medicines to take when they are at home. Tell the patient it is important to bring their up-to-date list of medicines every time they visit a doctor.
|Use alarms safely || |
|Prevent infection || |
Use the hand cleaning guidelines from the Centers for Disease Control and Prevention or the World Health Organization. Set goals for improving hand cleaning. Use the goals to improve hand cleaning.
Use proven guidelines to prevent infections that are difficult to treat.
Use proven guidelines to prevent infection of the blood from central lines.
Use proven guidelines to prevent infection after surgery.
Use proven guidelines to prevent infections of the urinary tract that are caused by catheters.
|Identify patient safety risks || |
|Prevent mistakes in surgery || |
Make sure that the correct surgery is done on the correct patient and at the correct place on the patient's body.
Mark the correct place on the patient's body where the surgery is to be done.
Pause before the surgery to make sure that a mistake is not being made.
Wrong patient errors occur in virtually all stages of diagnosis and treatment. On critical care units, patients are often in close proximity, elderly and encumbered with tubes and cannulas. Under these conditions patients can look alike and be confused with one another. To prevent wrong patient errors, the Joint Commission requires the use of at least 2 patient identifiers when administering medications and blood products, when collecting laboratory specimens and taking imaging tests, and when providing any type of treatment.
Critical test results that fall significantly outside the normal range and indicate potentially life-threatening conditions are common in intensive care patients. The Joint Commission requires these critical test results be reported within reasonable time frames that are established by the hospital. The intent is for patients to receive appropriate treatment as soon as possible. The Joint Commission also requires that procedures are put in place for tracking these reporting times, and that performance improvement programs are used when reporting times are not within acceptable time frames.
A newly added Joint Commission regulation addresses the safety of improperly managed clinical alarm systems, which are an important part of the care and monitoring of critically ill patients. Clinical alarm systems are intended to alert caregivers of potential patient emergencies, but when improperly configured they can compromise patient safety. Critical care units have numerous clinical alarms, and the resulting noise and visual warnings can desensitize staff and cause them to miss or ignore these alarms. In some instances critical care staff will disable alarms or set alarm limits to inappropriate thresholds to decrease distractions. This new Joint Commission regulation requires that leaders establish alarm system safety as a hospital priority, establish policies addressing critical issues in alarm management (Table 13–2), and educate staff about the proper operation of alarm systems for which they are responsible.
Table 13–2Critical issues in alarm management. ||Download (.pdf) Table 13–2 Critical issues in alarm management.
Establish clinically appropriate settings for alarm signals and who has the authority to set or change alarm parameters.
Determine when alarm signals can be disabled and who has the authority to set alarm parameters to “off.”
Develop a system for monitoring and responding to alarm signals.
Create a process for checking individual alarm signals for accurate settings, proper operation, and detectability.
Failure Mode and Effects Analysis
In addition to the NPSGs, the Joint Commission requires hospitals to perform yearly proactive risk assessments of a high-risk process called a Failure Mode and Effects Analysis (FMEA). When doing an FMEA, an interdisciplinary team of experts create a detailed flow diagram of the high-risk process being evaluated. After this is completed, each step of the process is assigned 3 scores: (1) the risk of failure (1-10, with 10 representing the highest risk of failure); (2) the likelihood that the failure will be intercepted before reaching the patient (1-10, with 10 representing the least likelihood of interception); (3) the risk that the failure will cause harm (1-10, with 10 representing the highest risk for harm). The product of these three numbers is the hazard score. The steps in the workflow with the highest hazard score should be the first to be evaluated for performance improvement. In a critical care setting, some high-risk practices that may benefit from an FMEA include responding to clinical alarms, preventing hospital-acquired infections from catheters and central lines, and handoffs between clinicians.
Many states also issue patient safety regulations. Often these regulations pertain to the reporting of adverse events. For example, New York State requires serious adverse events to be reported along with a detailed analysis of what happened and proposed corrective actions. In Pennsylvania, all errors are reported, ranging from near-miss errors that do not cause harm to the most serious errors that lead to death. Other examples of state regulations concern surgical safety, sepsis, and perinatal safety. State regulations that address patient safety continue to evolve, requiring hospital leadership to pay close attention to new state-led initiatives aimed at preventing medical errors.
Responding to Adverse Events
While patient safety regulations address hazards that are believed to be universal in health care (eg, requiring confirmation of patient identification prior to administering medications), investigating adverse events and implementing corrective actions are opportunities to address issues that may be organization specific. When a serious adverse event happens to a critical care patient, a systematic investigation of the event, called a root cause analysis, should be completed by an interdisciplinary team that has expertise in the areas involved in the event. After a detailed analysis, corrective actions aimed at preventing similar events should be implemented, which can involve rethinking a poorly functioning workflow, purchasing new technology, updating a policy, and/or reeducating staff.
Unfortunately, the majority of adverse events are never reported and therefore cannot be addressed. A 2011 study by Classen et al found that among 393 adverse events detected by various mechanisms, only 4 (1%) were identified through voluntary reporting. Several strategies are being implemented to increase the reporting of adverse events. For example, many institutions are moving to electronic adverse event reporting systems that make reporting easier. These systems allow for the reporting of incidents that cause harm (eg, a patient who falls and fractures a hip), near-miss errors that do not cause harm but still provide information about hidden hazards (eg, a patient who trips over a loose wire but catches himself before falling), and unsafe conditions which can potentially lead to adverse events (eg, a loose wire). Reports of incidents, near misses, and unsafe conditions are collectively called “patient safety work product.”
In addition to implementing electronic reporting systems, some hospitals are embracing a concept called Just Culture. According to the Just Culture concept, the major focus of an adverse event investigation should be on potential system failures that led to the error as opposed to simply attributing blame to the providers involved in the error. The need to focus on system failures was highlighted in the IOM report “To Err Is Human” (Figure 13–2), and has become an important staple of modern patient safety programs. Based on this IOM report, a hospital that implements Just Culture policies can expect to see an increase in reporting of adverse events as providers come to believe that leadership is committed to improving systems instead of punishing human errors.
Excerpt from the Institute of Medicine Report “To Err Is Human”.
Patient Safety Organizations
To optimize lessons learned from adverse events, the federal government enacted the Patient Safety and Quality Improvement Act of 2005 which authorized the creation of patient safety organizations (PSOs) to collect and analyze patient safety work product from health care facilities, and provide feedback and assistance to effectively minimize patient risk. The Patient Safety and Quality Improvement Act also provides federal protections that prohibit the use of patient safety work product in criminal, civil, or disciplinary proceedings in order to encourage providers to report medical errors without fear of repercussions and lawsuits. In addition, the federal Agency for Healthcare Quality and Research (AHRQ) produced a set of common definitions and reporting formats, known as “common formats,” which allow health care facilities to exchange data with PSOs in a standardized manner. PSOs, in turn, transmit deidentified patient safety work product to the national network of patient safety databases (NPSD), which is maintained by AHRQ. The NPSD has been aggregating patient safety data from across the United States, analyzing the data, and eventually will make recommendations for improving patient safety (Figure 13–3).
The network of patient safety databases.
Patient Safety Best Practices
There are many approaches to improving patient safety that are not required by regulation, and not implemented as a direct response to an adverse event. They are good ideas, with strong evidence to support their effectiveness in preventing errors and avoiding complications. Many of these best practices are appropriate in a critical care setting.
Team training is a well-established approach for preventing errors in high-risk industries such as the military and the airline industry, and is now being applied to the medical industry. The underlying theory behind medical team training is that highly trained individuals (eg, physicians, nurses, and technicians) acting together as a cohesive team are more effective and in the best interest of their patients. This includes strong leadership, where the team leader articulates clear goals and makes decisions using input from team members. Effective team work also requires clear communication with briefs and debriefs before and after procedures and complex patient encounters, and ad hoc huddles when unexpected urgent situations arise. It is important that team members “cross-check” each other, offering assistance when needed, and that team members are respectful of each other, so that all team members feel comfortable speaking up.
AHRQ collaborated with the United States Department of Defense to develop a team training program called Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS), which is specifically designed for the medical industry. Many hospitals are now using the AHRQ TeamSTEPPS program to teach the principles of medical team work, with a focus on 4 core competencies: team leadership, situation monitoring, mutual support, and communication.
In one study, an academic medical center reported on the implementation of the TeamSTEPPS program in their pediatric and surgical ICUs, where all pediatric ICU (PICU), surgical ICU (SICU), and respiratory therapy staff received TeamSTEPPS training. The staff felt the implementation was effective and improved teamwork on the unit and objective patient safety measures significantly improved after the TeamSTEPPS program was implemented. Another study examined the relationship between the level of self-identified teamwork and their mortality rates in 17 ICUs. This study found that the units with lower mortality rates had teams with a deeper understanding of how well their teams functioned, were more trusting of other team members, and perceived themselves as more organized when compared to the units with the higher mortality rates.
Simulation is a promising new strategy for improving patient safety. Similar to flight simulators used by the airline industry, health care simulators allow providers to learn a procedure or protocol using high-tech mannequins instead of live patients. The old adage, “see one, do one, teach one” is being replaced by continuous practice in a simulation laboratory. Simulation allows providers to learn new technical skills, practice their responsiveness to high-stress clinical emergencies, and practice working as a team. It is being incorporated into medical school curricula, as well as the continuing education classes of nurses, residents, and attending physicians.
Health care simulation is usually conducted in replicate clinical settings with the same equipment used to treat real patients. It is common for simulation centers to have mock inpatient rooms, emergency bays, and operating suites, each equipped with sophisticated video equipment that captures multiple angles. Outside the simulation room, often behind a one-way mirror, is a trained technician controlling the faux clinical scenario by manipulating the simulated patient's vital signs, clinical alarms, and even their verbal responses through a microphone.
The most important part of health care simulation is the debriefing which occurs once the simulated clinical scenario is completed. A video of the simulation is played back, and all participants review their actions with a trained specialist who facilitates the conversation, making sure to highlight what went right and where there are potential areas for improvement. In the ICU, simulation is an ideal tool for teaching residents, fellows, and nurses many aspects of critical care medicine, ranging from the technical skills of placing a central catheter with ultrasound guidance to the essential cultural skill of working effectively together as a team.
Critical Care Staffing and Telemedicine
Patients in critical care units often have life-threatening illnesses which require complicated care plans, rapid decision making, close monitoring, and constant support from highly trained doctors and nurses who specialize in caring for the sickest of patients. Several studies have demonstrated improved outcomes when these patients are cared for in closed units, and when their care is supervised by critical care attending physicians. The Leapfrog Group, which is a consortium of Fortune 500 companies and other large health care purchasers that work together to drive improvements in patient safety, have made appropriate ICU staffing a major pillar in their patient safety program. To meet the Leapfrog Group's standard on ICU staffing, a hospital must (1) have an intensivist present during daytime hours and provide clinical care exclusively in the ICU, (2) ensure that the intensivists return pages at least 95% of the time when they are not present on site, and (3) arrange for a Fundamental Critical Care Support (FCCS) certified physician or physician extender to reach ICU patients within 5 minutes of being called or paged. When an intensivist is not available on site, it is acceptable if they are available via telemedicine.
The telemedicine model was initially envisioned as a tool for providing specialty medical expertise to rural communities that do not have ready access to tertiary care; today it is used by critical care medicine as a means of expanding the geographic range of critical care physicians. The critical care physician is often physically located in a room offsite, with access to patient monitors and electronic health records. He or she remotely keeps a watchful eye on the vital signs, laboratory results, and overall well-being of dozens of critically ill patients, sometimes from several different units across a health system. The critical care physician has direct communication with the local ICU team, and is available to them 24 hours a day, 7 days a week.
Pay-for-Performance and Public Reporting
Pay-for-performance is a new approach for driving improvement in medical care by using financial incentives to reward hospitals that perform well on preestablished safety and quality measures. The broad categories of measures used by these programs include surveys of patients' experiences and timeliness and effectiveness of care, as well as readmissions, complications, and deaths. For example, the Center for Medicare and Medicaid Services (CMS) has implemented the 2014 Hospital Value-Based Purchasing (Hospital VBP) Program which adjusts hospitals' payments based on their performance on several safety and quality metrics, some of which are directly affected by the care patients receive in ICUs (eg, pneumonia 30-day mortality rate).
In addition to financial incentives, safety and quality measures are used in publicly displayed hospital report cards that inform patients of each hospitals strengths and weaknesses (eg, Medicare's Hospital Compare website hospitalcompare.gov), thus motivating hospitals to implement programs for improving their performance on these measures and ultimately improving patient safety. Many of the quality and safety measures used in these programs are collected in the ICUs (eg, infection control surveillance data reported for both central line-associated bloodstream infections [CLABSIs] and catheter-associated urinary tract infections historically have been collected exclusively from ICUs).
Pneumonia 30-Day Mortality Rate
In the United States, pneumonia results in more than a million admissions each year, and is the second leading cause of hospitalization among patients over 65 years. As a result, pneumonia has been a focus of quality improvement programs for a decade. The CMS has attempted to accelerate the improvement in the care of patients with pneumonia by publically reporting the 30-day mortality rate for pneumonia patients on Hospital Compare, and have included this same metric in their pay-for-performance value-based purchasing program.
Central Line-Associated Bloodstream Infections
An estimated 80,000 CLABSIs occur in United States' hospitals each year, causing up to 28,000 deaths in ICUs. The majority of patients in an ICU have a central venous catheter to ensure reliable intravenous access. However, the presence of these devices places the patients at risk for developing a CLABSI. These hospital-acquired infections are an important measure on Medicare's Hospital Compare report card portal which compares the quality of care at over 4000 Medicare-certified hospitals across the country. Hospital Compare uses the CLABSI data that the Centers for Disease Control and Prevention (CDC) collect from hospitals' ICUs via the National Healthcare Safety Network (NHSN) tool.
As CLABSIs have become an important and often-used publicly reported metric, they have received much attention from quality improvement and patient safety researchers. One noteworthy study, led by Dr. Peter Pronovost and widely known as the “Keystone Project,” measured the effectiveness of decreasing the rate of CLABSIs by implementing various interventions across 103 ICUs. The study interventions included 5 procedures recommended by the CDC, including hand washing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters. At the start of the study clinicians were educated about practices to control infection and harm resulting from CLABSIs: a central-line cart with necessary supplies was created; a checklist was used to ensure adherence to infection-control practices; providers were stopped (in nonemergency situations) if these practices were not being followed; the removal of catheters was discussed at daily rounds; and the teams received feedback regarding the number and rates of CLABSIs. The study lasted 18 months, and demonstrated a large and sustained reduction (up to 66%) in rates of CLABSIs that was maintained throughout the study period. The success of this initiative has led to the adoption of many of the best practices used in the study by ICUs across the country, particularly the use of the checklist.
When “To Err Is Human” was first released by the IOM in 1999, many of the recommendations for improving patient safety were based on anecdotal accountings of errors and expert opinion. Now, 15 years later, there is increasingly more evidence defining best practices. Critical care leaders who are committed to providing safe care for their patients should exert effort to implement these evidence-based practices. Those who want to lead in patient safety should innovate new approaches for preventing errors, and study these approaches using rigorous research methodology.