Incident Reporting Systems

Adverse Events: Reporting and Prevention

By Tom Inglesby

The Joint Commission and the Centers for Medicare and Medicaid Services mandate that facilities have a way to track adverse events. Some states also have reporting requirement for certain types of adverse events. “I think a lot of this grew out of the advent of healthcare risk management in the mid-1970s,” notes Anna Marie Hajek, president and CEO of Clarity Group, Inc. “It was about understanding what could be a potential professional liability claim. You wanted to track incidents to enable you to better understand a potential event that could end up in a claim.”

Hajek continues, “The whole purpose of reporting really changed considerably with the Institute of Medicine report in 1999. That report was called To Err is Human. The emphasis changed—instead of looking at an incident, you were really looking at how do you identify patient harm, either potential patient harm—something that could happen to a patient—or actual harm. My company, Clarity Group, focuses on risk, quality, and safety management. If you manage the quality of your care and the safety of those in your care in the first place, you don’t have to worry about managing a claim in the second place.”

According to Hajek, “The whole concept of incident or adverse event reporting has to focus on tools that will help you to integrate patient safety across your organization. These should be integrated patient safety management tools. That becomes a really important aspect of the change that we see happening, and our product responds to that change. Even the name of our product is called the Healthcare Safety Zone Portal. That’s where we put our emphasis, on integrated patient safety management.”

She adds, “Incident reporting has been tied to what’s happened inside a hospital. Now we have to broaden that definition to all healthcare settings because as the landscape of healthcare delivery changes and becomes much more outpatient focused than it ever has been, you have to follow potential harm wherever the patient is being treated.”

This means greater emphasis on training risk management staff to look for problem areas. “Risk managers are not separate from the patient safety world,” Hajek says. “That’s why we talk about risk, quality, and safety all in one term, because you have to have risk managers that are very adept in all these areas. We do a lot of education with our clients. We do onsite work, including proactive risk modification so people can get established. There are groups, such as ASHRM [American Society for Healthcare Risk Management], that are geared toward the preparation of healthcare risk managers.”

Tallahassee Memorial Hospital (TMH) is a 772-bed facility with 3,500 employees and 500 medical staff members. Judy S. Davis, corporate risk manager, comments, “TMH uses the Clarity Healthcare Portal to document safety events throughout our entire facility, including the main hospital, behavioral health care, TMH rehabilitation, free-standing emergency center, family medicine program, as well as our outlying physician practices. The portal is web-based; readily accessible on our internal intranet by all colleagues and medical staff; easy to use with drop-down screens; integrates with our electronic health record to download demographic, coding, and diagnosis-related information; gives us real-time notifications; and provides enhancements based on needs as decided by the users.”

Davis adds, “We saw increased reporting and more consistent reporting of information with Clarity. We are able to collect and analyze events in real time for more efficient and effective decision making. It enables us to communicate quicker and oftentimes resolve patient issues while the patients are still with us.”

“Paper-based systems have too many limitations,” Hajek concludes. “Remember, collecting data is just the first part. What you have to do after that is use very robust investigation and analytical processes. If you’re going to create positive change in organizations, you need to have all three of those things working together. The whole point of reporting is to create internal transparency, so that you know what is going on and you can correct problems. You need to have a tool that’s going to allow you to get the data and also allow you to sort it, organize it, and analyze it. It all has to be done in a place where it’s easy for people to get access to that information.”

Data In, Reports Out

RiskQual Technologies in Pembroke Pines, Florida, was born out of the need to produce incident reporting tracking tools for healthcare facilities. “We used to provide services to hospitals in tracking their incident reports, claims, and litigation,” recalls Estee Wichterich, president of RiskQual. “Over the past 13 years, we’ve been enhancing our system, and it now includes incident reporting, claims management, complaints and grievances, and worker’s comp as well as quality events, peer reviews, and quality chart reviews. It’s a comprehensive, integrated system that allows any healthcare facility to track this data efficiently and effectively.”

A major problem with any computerized system is getting buy-in from those who use it. If the staff can use a system to track events quickly and easily, and that system is customizable to the facility’s patient population, it stands a better chance of being used and used properly.

“Even though all healthcare facilities have to track the same type of events,” Wichterich notes, “their patient populations are different. They may have behavioral facilities, or ambulatory care units, or physician practices. A lot of the facilities are part of groups, so it has become a much more diverse set of entities that have to be managed, where the data has to be managed at a group level to trend corporate-wide as well as at the individual facility level for specific trends.”

The challenge is to have a system that allows them to capture that information for incident complaints, grievances, or other issues and to drill down for more details. “Our system was designed with that in mind,” says Wichterich, “to be easy to use for the staff and the risk managers, to quickly gather their data, trend their data very easily, and also be flexible to meet their specific needs at each of their facilities.”

Acadia Healthcare Company in Franklin, Tennessee, is a behavioral health organization with 54 facilities in the United States and 28 facilities in England and Scotland. Dulce Mooney, vice president of Risk Management at Acadia Healthcare, says, “To maintain a robust risk management approach in an organization, it is imperative to have an open line of communication available without threat of punishment to the incident reporter. The RiskQual incident reporting system allows us to improve processes and techniques to avoid complacency and placing blame.”

Benefits at Acadia have been many. Mooney explains, “It provides reporting to the C-suite and board of directors, tracking and trending of facility data, analyzing data for process improvement, satisfying mandatory government reporting obligations by supplying incident data. And the program has the ability to have different modules (incident, quality, claims) link data across the interface so that all information is organized and easily accessible.”

Healthcare is highly regulated, and facilities have to do more and more data trending and analysis. “The change has been not just to have a tracking system but something that can ultimately reduce patient harm and cater to ongoing patient safety,” Wichterich says. “We’ve implemented a PSO (patient safety organization) reporting module so that facilities can know their information is secure. The system needs to be able to track and trend the common formats and be able to modify them as needed. Keeping up with all of these regulations and new trends is important to making the system adapt as changes occur.”

All facilities will have to have some type of electronic event reporting system in 2015 and show that they are managing their events, as well as patient safety. Broward Health, Fort Lauderdale, Florida, implemented RiskQual’s system. Alumine Bellone, director of risk and insurance services, says, “Broward Health was looking to purchase a system capable of tracking and managing reporting capabilities to monitor and control risk and address patient safety issues. With RiskQual, we have automation of processes, data consolidation, and reporting improvements and auditability capabilities. The system’s flexibility has allowed us to customize it to meet our specific needs. The reporting module is easy to use and reports generated are extremely helpful as we address patient safety issues. Customer service has been great in being available to assist us as needed.”

Wichterich adds, “The key to reporting more events is having a system that allows the staff to report events easily and quickly and not feel that the information is being used punitively. The staff needs to understand what follow-up is being done and what improvements are being made, so that some of these events can be prevented in the future. How can the staff be assisted by management in analyzing the events to help them to prevent these events from happening? The trend now in the industry is to develop a collaborative ‘just culture’ type of environment where the facilities maintain communication with staff in a non-punitive fashion to encourage reporting and ensure that patient safety is at the heart of why event reporting is necessary.”

Training Trends

In most cases, incident reporting is part of the hospital’s overall IT structure. Some facilities are still using paper forms to collect the initial data but, as we’ve seen, that will soon change due to added requirements for computerization. As more hospitals move to fully computerized forms and point-of-service data entry, training and education will help smooth the transition. Medical Interactive Community LLC, a two-year-old company in Metairie, Louisiana, is a provider of online risk management resources that can help.

Medical Interactive’s MiCapture software is an integrated risk management system designed to assist risk managers in applying loss reduction strategies in a more efficient and effective manner. Using a laptop or notebook computer enabled with MiCapture, risk managers can complete the entire assessment process on-site.

MiCapture was designed to make their jobs easier by tracking and trending data far more effectively than traditional paper assessments. MiCapture also helps reduce expenses by decreasing workload and increasing productivity. Managers can track the quantity and quality of assessments by region or by specialty. MiCapture has the ability to benchmark data and compare similarities between specialties, organizations, or regions. It features pre-generated assessment questions and templates, and on-site reports and recommendations that can be customized to fit the needs of each organization.

While the MiCapture software does not include an incident-reporting feature, adding that function is one of the goals of Medical Interactive Community for 2015. They currently do have educational programs that address issues related to incident reporting.

In addition, Medical Interactive offers a detailed “Incident Reporting Policy” template, available online, that covers the basic goals: accurately document an incident and staff response, provide a non-punitive environment conducive to reporting, use data to analyze safety issues, and identify trends so improvement can be implemented.

Poorly documented incidents can pose significant costs to a facility during a malpractice claim. To mitigate these costs, training RNs, LPNs, and APRNs to formulate easily understandable, concise incident reports is the goal of one of Medical Interactive’s inexpensive monographs. With proper documentation, risk managers will be able to collect the data needed to address patient safety issues and provide protection in the event of a malpractice claim. Their monograph explores some of the myths and fears surrounding incident reporting, how the report should be written, and steps for developing a “just culture” in the facility.

Medical Interactive sells to hospitals and other healthcare facilities and, since their educational materials are available on their website, many doctors and medical professionals obtain them directly.

With more parts of the ACA being implemented, increased awareness of event reporting in the profession has led Medical Interactive to create a template within their software to address incident reporting. Because of its litigation and insurance experience, Medical Interactive understands that poorly documented incidents can create significant risk for individual providers, hospitals, or other healthcare facilities. That is why their programs focus on how to properly document incidents to address patient safety issues and provide protection in the event of a claim.

Take Action

“I believe the major issue today is not with incident reporting itself, but with taking action on the reported data in order to truly affect change.” These are the words of Catherine Lathem, vice president of product management at RL Solutions, Toronto, Canada. “For example, if a hospital were to report 20 patient falls in one month, the responsibility of adverse event management should not stop once the incident is captured; rather data-driven action that is focused on prevention is a very critical step in the incident report arena.”  

Many of RL’s client organizations are starting to look further into the data gathered from incident reporting and are measuring the impact of change based on reported incidents. As Lathem says, “Organizations are now looking at those 20 patient falls that have occurred and are asking ‘what changes has the organization made to prevent these 20 falls from happening again?’ Success is now based on how many reported adverse events have actually led to change. This is a very important shift in the way leadership is looking at incident reporting and the impact that adverse event reporting can have on patient outcomes in a proactive environment.”

The Affordable Care Act has had a positive impact on incident reporting across the country as it has focused legislative attention on healthcare quality, improving patient outcomes and reducing risk. “It is my opinion that there is still a degree of ambiguity around the requirements for incident reporting and the role of patient safety organizations,” Lathem notes, “so I would not encourage the implementation of more rules. Instead, I would lean towards clarity of legislation. Again, I think that reporting for the sake of reporting benefits no one. Reporting potential risks and adverse events should lead to change, which would improve patient outcomes and at the same time, lower the cost of care. Focusing on quality of care improves patient outcomes and can drive costs down, which is something positive that we can all stand behind.”

The Joint Commission is working with organizations around root cause analysis, which is one way for healthcare agencies to support taking incident reporting to the next level, by diving into the details and coming out of the investigation with a plan for improvement. “RL Solutions has been leveraging innovative technology over the past several years to enable healthcare organizations to remain current and compliant with requirements,” says Lathem. “Our product evolution has also been supporting the notion of adverse event capturing as one role of the risk manager and creating a software system to support real-time information that can be analyzed and acted upon.”

RL has been investing in developing post-event capture modules which include root cause analysis, peer review, real-time surveillance of healthcare-associated infections and conditions, and most recently, RL Dashboards. According to Lathem, “RL Dashboards empower executives, healthcare leadership, and even frontline managers to have a view of the organization and assess the impact of incident reporting in overall patient care in real time. Proactive surveillance products that trigger potential risks and enable teams to take action before an adverse event happens would improve this. RL has proactive surveillance in our RL6:Infection module, and we’re integrating this technology into our adverse risk management system, RL6:Risk.”

She adds, “Measurement tools that enable organizations to see the impact of proactive risk management are now available in our standard RL6:Risk product suite. RL has also been evolving our customizable, schedulable reports, as reporting is a critical component of adverse event management. RL has also been focusing our R&D efforts on our adverse events life cycle suite of products that takes an incident report, an infection case, or a patient feedback submission and manages it, analyzes the event, conducts a root cause analysis on the case, then routes the case for a peer review, which results in an action plan for improvement. The interventions, improvements and trends can then all be reported graphically in dashboards.  By partnering with our clients and legislative bodies, RL is able to provide software solutions to all of the different vectors of an adverse event. This will help our healthcare teams make data-driven decisions and subsequently improve patient safety.”

Prevent the Preventable

CRG Medical, a technology company in Houston, Texas, developed the award-winning “Purple Button,” an AHRQ Common Formats mobile application that enables healthcare providers to visualize data in the KBCore hazard detection and early-warning database through predefined reports. Clinicians are able to capture and share patient safety knowledge in seconds. KBCore recently won first place in the Office of the National Coordinator’s Patient Safety Reporting System Challenge 2.0 for its platform-agnostic “Purple Button” medical event reporting system.

The system provides a tool for PSOs, hospitals, and other organizations seeking to comply with federal recommendations about patient safety reports. With the help of Purple Button technology, hospitals and healthcare organizations have a secure method of generating and analyzing patient safety event reports. The Purple Button enables clinicians to record and submit patient safety events or unsafe conditions via Direct Project secure messaging.

President and CEO of KBCore, Douglas Dotan says, “Our goal is to provide patient safety organizations and quality managers with knowledge that something needs fixing before it causes harm. We designed a way that physicians and clinicians can be engaged in real time at the bedside; it represents a change in the way events are managed and a culture change so people will say, ‘Keeping patients safe is our goal.’”

When medical professionals see  problems or unsafe conditions, but can’t leave the bedside and go to a computer to report them, they can do so by using their smartphones. “The Purple Button,” Dotan explains, “can be used on any Android or iOS device, any iPad or iPhone. In 60 to 90 seconds, you can take preventive action and alert people as to something that needs to be fixed, using common formats. This is not about events that cause harm, that need to be reported, but rather things that didn’t cause harm but could have.”

Errors can be prevented by using data when that data are analyzed and acted upon. Dr. Mark Cohen started the National Recall Alert Center (NRAC) 42 years ago, while still in medical school. “We are a central clearing house on product recall information,” he explains. “We deal with multiple resources to find out what is being recalled, then we get that information out to our member hospitals.”

NRAC operates what they call ECLASS—an enhanced closed-loop alerting service and system. It’s a management system as well as a tracking, tracing, and reporting system. Cohen says, “It instantly tells hospitals and people in various departments within the hospital what’s being recalled and then manages the whole system for them. It produces reports for whatever organizations are involved. We do all the management, alerting, tracking, and tracing, and we know if the alert has been opened. And that is important, based on the class of recall; some alerts are ‘class one,’ which means that it can cause death of the patient. If the client hasn’t opened the alert within a certain period of time, we escalate it up to somebody else in the facility. This is a critical step because it means that no recalls can ever be lost.”

The NRAC system is in the cloud and does not require any IT intervention at the hospital level. Cohen claims, “The entire learning curve is eight minutes, and it’s done over the phone and by video. One of the many unique things is that every hospital gets a representative, a liaison at our office, in case they have any questions or problems.”

Cohen adds, “We’re going to be introducing the KBCore programs and concepts to each of our 3,000-plus members because we feel it goes hand-in-hand with our work.”

According to Dotan, “Advanced warning and hazard detection will prevent harm to patients by having people engage in the process. This is a tool that will help people engage in prevention and reduce medical errors and costs. We’re teaming with NRAC because we’re providing the same answers from slightly different angles. We don’t deal with recall alerts, but we see alerts as a critical part of patient safety and quality improvement. That’s why we’ve aligned ourselves with NRAC.”

Changing Culture

Many of the developed countries of the world have government-run or -supported healthcare. This is certainly true in Britain and Canada. In 1986, a law firm in London that specialized in defending National Health Service (NHS) hospitals against medical malpractice claims founded patient safety software company Datix from the concept that the best way to protect hospitals from lawsuits being brought by patients is to stop harming patients in the first place.

In 2003, Britain’s National Patient Safety Agency (NPSA) set up a central database, the National Reporting and Learning System (NRLS), for the reporting of all patient safety incidents.  “Hospitals with a Datix system could electronically upload data to the NRLS,” recalls Jonathan Hazan, chief executive of Datix. “This led to a rapid expansion of Datix, and today we have almost an 80 percent share of the market in the UK. The company is also expanding in the USA, Canada, and other parts of the world.”

Adverse event reporting and analysis can be very data intensive. Hazan comments, “We help our customers to make it as easy as possible and advise them not to collect data that they don’t need. Different events require different pieces of data; don’t collect anything that is irrelevant.”

While data analysis can point out problems, that’s not the only use for Datix. “For me, it is about helping to promote a culture of safety,” says Hazan. “It is true Datix software can be used as a data analysis tool, but healthcare organizations are increasingly using Datix to build awareness of patient safety and change the culture. This is something I believe in absolutely and passionately. People need to feel encouraged to report incidents rather than live in fear of raising genuine concerns.  It’s also important that people know things are going to improve as a result of reporting an incident.”

To promote ease of use, the Datix incident report forms need to be as short and as simple as possible. “At some of the best organizations, you’ll find there is an emphasis on narrative rather than check boxes and drop downs,” Hazan explains. “The investigating team can find out further information based on detailed contained in the narrative. Some of the best lessons can be learned from the reporter simply telling the story.”

Culture change can start either at the top or the bottom of the hierarchy. As Hazan concludes, “You need to engage people on the front line of incident reporting, but there also has to be real commitment to a culture of safety at the highest levels of the organization. The CEO needs to believe in the message and to make sure it is being effectively heard and acted on by managers throughout the organization. Everyone has to understand and believe in a just, risk-aware culture where learning is the key. The message has to come from the top and be transmitted throughout the organization.”

A Classic Challenge

A physician who saw the opportunity to help healthcare facilities and providers do a better job of managing their safety and risks founded Quantros in Milpitas, California, in 1997.

Mike Weber, director of product management and safety solutions at Quantros, hasn’t seen a great impact from the Affordable Care Act (ACA) yet. “We think it is coming, especially with Medicare and Medicaid. Facilities will need to be part of a PSO, a patient safety organization. Some of the regulations within the PSO are going to drive standardization in terms of how incident data is captured. That’s a big focus for us, to ensure that we’re adjusting to some of those regulations and standardization.”

One aspect of the ACA—increased use of computerization, such as the electronic medical record (EMR)—will certainly have an impact. “This represents a classic challenge,” Weber insists. “If you ask many physicians, they’ll not have kind words for EMRs. The challenge is getting these folks comfortable with the technology. That means the technology has to be accessible, to be fast, to be able to capture data that’s important, and not be that different from pulling out a piece of paper. There is a big opportunity for safety incident reporting, especially with companies like Quantros and some of our competitors, to make the systems very fast and easy to access. With all the different formats in which you can capture data, whether a smartphone, a tablet, or a more traditional workstation, it’s no longer such a burden to capture important incident data.”

Quantros has made a large investment in upgrading the safety event manager product specifically to make it easier to use. “There is about a year of combined research around usability testing for the software, from a clinical standpoint and with a focus on best practices,” Weber explains. “We have a system called smart classification that basically uses analytics to read the description somebody is entering into their alerts and be able to determine what that event type is and help them choose the right classification. The idea is to reduce the ‘friction of data capture,’ so risk managers and administrators within the hospitals and other environments can manage that data. If you don’t understand the flow of things, it’s hard to create a picture of how you can improve.”

Could the analytics be used to evaluate and design a prevention program? Weber hedges slightly and says, “I would say that to some extent, yes. We focus more on the tools that help hospitals and other facilities come up with the right programs, because there isn’t a lot of standardization on what is the best method of doing those interventions. It’s somewhat unproven as to exactly what’s the right protocol. There are many different methodologies out there for analysis. We try to create the framework more than prescribe specific protocols hospitals should follow.”

At Quantros, the future is starting to take shape. “Probably the biggest thing will be more use of analytics,” says Weber. “Being able to take data and identify variants, the pertinent positives and negatives of what’s going on. If you’re capturing a lot of standardized data, it also allows for much greater comparative reporting and benchmarking. If a hospital wants to understand how they’re doing, they need to know where they are with respect to getting incidents captured. They also need to understand where they are with respect to other facilities. That’s a big piece of where I see it going.”

On the technology side, as hospitals develop more sophisticated mobile strategies, arming physicians, nurses, and other staff members with tablets or smartphones, it will be much easier to capture data and manage it more effectively. Weber predicts, “There is an opportunity to increase the voice of the patient, as well. Through safety incident capture and reporting, we can get inside the patient experience and figure out ways to connect with a patient who experiences something that they feel is a mistake or causes harm. Being able to give that back to the hospitals is a big opportunity for safety incident reporting and management.”

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Tom Inglesby is an author based in southern California who writes frequently about medical technologies and improvement strategies.