Published 8/1/2013
Brad Waddell, MD

Data Collection: Critical for Surgical Safety

Adverse event reporting can drive improvements in patient safety

Collection is one of the six “Critical Cs of Surgical Safety” identified by the AAOS Patient Safety Committee to minimize surgical harm (Table 1). Reporting of medical errors is critical to improving patient safety for several reasons.

In 1999, the Institute of Medicine (IOM) released its report To Err is Human: Building a Safer Health System. The IOM estimated that up to one million preventable adverse events occurred each year in the United States; it attributed up to 98,000 deaths to preventable adverse events. Although these numbers have been challenged, the IOM report clearly identified a problem that needed to be addressed.

In its report, the IOM recommended creating and expanding reporting systems and encouraged mandatory reporting systems for certain events. Since then, policies within medical institutions and laws passed by Congress have fostered both mandatory and voluntary reporting.

The goal of reporting
Reporting events and analyzing safety data can drive continuous quality improvement and innovation. The primary goal of reporting is to enable institutions and individuals to learn from experience.

Based on information in event reports, institutions can make policy changes designed to decrease the chance that these events will recur. Reports can point out dangers associated with new procedures or drugs, as well as experiences that lead to safer methods. In the long run, they can be used to identify hazardous trends that require attention.

When the IOM initially released its report, physicians and other healthcare personnel expressed significant concerns about potential liability in reporting events. Reluctance to report can stem from fear of punishment, fear of damage to reputation, fear of liability, or a lack of perceived benefit. Regardless of the source, reluctance to report can undermine the usefulness of a reporting system.

Congress eased some of the concerns and encouraged reporting with the passage of the Patient Safety and Quality Improvement Act of 2005. This act provided for the creation of patient safety organizations to protect information gathered in the pursuit of improved patient safety from being used in medical liability cases.

The AAOS encourages the establishment of a nonpunitive environment with regard to medical error and adverse event reporting. Such an environment enables employees to see reporting as a method for improving both patient safety and internal systems. Most medical errors occur as a result of system failures, not individual failures, and research shows that bad systems lead to preventable events.

Reporting systems
Event reporting should not be, and is not, limited to serious events, such as wrong-site surgery or accidental death. Data collection should be focused on improving patient outcomes as well. For example, data collection should include pulmonary complications, cardiac complications, surgical-site infections, venous thromboembolism, and readmissions.

National systems are already in place to facilitate the collection of these data. The National Healthcare Safety Network within the Centers for Disease Control and Prevention collects data on hospital-acquired infections. The Centers for Medicare and Medicaid Services (CMS) is actively involved in monitoring and attempting to reduce hospital readmissions.

Multiple reporting systems have been established to gather patient safety data at the following four levels:

  • individual institution
  • voluntary national
  • mandatory state
  • mandatory national

Individual institution reporting
Each institution should have a system in place to routinely and systematically collect safety data with the goal of improving patient safety and minimizing surgical harm. Each institution should foster an environment that is not punitive and encourages safety reporting. Anonymous safety reporting lines, online reporting systems, and praise for reporting events can improve safety data reporting in an institution.

Furthermore, each institution should follow data including, but not limited to, surgical-site infections, cardiac and pulmonary complications, and deaths.

Voluntary national reporting
Several national voluntary medical safety reporting systems are in operation. These include the Medication Errors Reporting Program within the Institute for Safe Medication Practices, the Quantros MedMARX adverse drug reporting program, and the Joint Commission’s Sentinel Events Reporting Program.

These entities collect safety data and publish safety recommendations. Like other large-scale reporting systems, they are able to take data from multiple sources and make recommendations that may save other institutions from making the same mistakes.

Mandatory state reporting
Currently, at least 27 states have mandatory reporting systems. Medical institutions are required to report a list of events specified by the state. When used correctly, mandatory reporting has the potential to result in real and lasting changes that can increase patient safety and prevent harm to patients. It enables the state, which has far more resources than any individual institution, to analyze and produce recommendations based on the reported events.

Mandatory national reporting
On several occasions, Congress has funded different national agencies to establish national reporting initiatives. CMS actively collects patient safety data and recently established the Partnership for Patients initiative. This initiative, which involves 26 states and 3,700 participating hospitals, intends to reduce the incidence of hospital-acquired conditions by 40 percent from 2010 levels and improve transitions of care.

By analyzing reports and identifying solutions, CMS and Partnership for Patients can encourage system changes to decrease preventable events. As funding for patient safety initiatives increases, these initiatives can become vital allies in the effort to make safer health systems.

The impact of reporting
Improvements from reporting range from system-wide changes that have an immediate impact to subtle changes that may take years to make a difference. For example, removing concentrated potassium chloride from nursing units and implementing the “Sign Your Site” campaign are system-wide changes that have contributed to patient safety.

Orthopaedic surgery can greatly benefit from these reporting systems. Orthopaedic surgeons should, as the AAOS recommends, promote reporting systems that benefit patients while protecting the information and healthcare personnel surrounding the event. Congress must ensure that patient confidentiality is upheld and legal protection is maintained for all information and persons involved.

Finally, when events occur, orthopaedic surgeons should go a step farther. Honesty with patients and clear communication is paramount. Open dialogue with patients, support after such an event, and assurances that lessons will be learned and changes made as a result of the event are key.

Brad Waddell, MD, is a member of the AAOS Patient Safety Committee. He can be reached at bwaddell@ochsner.org

Additional Resources


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