Routine risks

Malpractice claims are by no means restricted to the operating room. HRMR examines a new report that highlights the risks inherent in non-surgical procedures—and how to avoid them.

While the term ‘medical malpractice’ might conjure images of botched operations, a significant portion (8 percent) of malpractice cases relate to problems with seemingly simple non-surgical procedures such as scopes, insertion of lines/ tubes/wires, imaging, injections with infusions, and biopsies.

“The first step toward risk reduction is recognizing a recurring problem and understanding its breadth and depth.”

For thousands of patients a year, screening, diagnostic, or therapeutic procedures lead to a injury or death. Many of those adverse outcomes trigger allegations of malpractice. The vast majority (88 percent) of these cases highlight skill-based errors. However, rules of practice (policy and protocol) and inadequate knowledge or judgement also play a key role

These are key findings of CRICO Strategies, a division of the Risk Management Foundation of the Harvard Medical Institutions, published in the CRICO Strategies 2013 Annual Benchmarking Report: Malpractice Risks of Routine Medical Procedures, released late in 2013.

“In the past, patient safety efforts have focused on inpatient areas, such as the operating room,” said Dr Tejal Gandhi, president of the National Patient Safety Foundation. “Now, however, medical procedures are frequently performed in settings outside of the hospital, with an increased number of adverse events being identified. We need to translate the lessons learned in hospital safety to these other settings of care to ensure that procedures are performed as safely as possible.”

Based on the analysis of 1,497 cases which alleged malpractice related to a non-surgical procedure, the study—mined from CRICO Strategies’ Comparative Benchmarking System (CBS)—highlights six primary medical procedures: scopes, injections, punctures, biopsies, insertion of tubes, and imaging.

While the very nature of procedure-related claims implies some technical or skill-based failure, the report emphasises that it is essential to understand how rule and judgement-based errors contribute to the actual point of injury.

“Clinicians are dismayed when a patient is injured, especially when the triggering event is a ‘routine’ task or common medical procedure,” it states. “The vast majority of these procedure cases involve skill errors during the technical performance of the procedure.

“Often, however, less obvious pre- and post-procedure factors exacerbate the skill errors and contribute to unexpected outcomes.”

CRICO’s study looked at medical procedure-related cases that were filed from 2007 to 2011 and found that physicians are the most commonly named defendant. These cases represent $215 million in incurred losses. While more than two thirds of the injuries were relatively minor or temporary, 14 percent of the procedure cases involved patients who died.

“Having a patient suffer a procedure-related mishap damages an organization’s morale and can register a negative fiscal and clinical punch,” the report states. “Even patients with less severe injuries may choose to alter future healthcare decisions—their own and those of friends and family members they influence— with potentially harmful repercussions.”

“Organizations that relentlessly capture and investigate nearmisses and adverse events are better able to understand and track policy failures.”

Analyzing malpractice data lets you offer healthcare providers opportunities to change specific clinical systems or clinician behaviors and reduce those dominant risks, states the report. One of the challenges to improving procedure safety is that the problem is not isolated in the ED, the OR, or the ICU.

“The risks are ubiquitous and decentralized, and the first step toward risk reduction is recognizing a recurring problem and understanding its breadth and depth,” it states. “The next hurdle is finding clinical leadership to champion the remediation of such a diffuse problem.

“Malpractice cases are proxy for systemic issues that you cannot afford to ignore or keep at the bottom of your to-do list.”

The report offers the following advice and insights on the issue of procedure-related risk.

Pathology of procedural error 

CRICO’s study analysed 1,497 cases which alleged malpractice related to a non-surgical procedure (excluding dental procedures). These cases affected patients at all stages of care: screening, diagnosis, treatment, and follow-up. Most stem from procedures that are considered routine for the clinician, if not for patients, the report notes.

“The most prevalent procedures in this study are typically within the normal limits of a diagnostic or treatment course,” it states. “Their occurrence can be particularly pernicious from the perspective of patients who expect the same level of safety vigilance that caregivers commit to more complex procedures.”

In 56 percent of procedure-related malpractice claims, physicians are named. Nurses are named in 6 percent. Collectively, these cases represent more than $215 million in total incurred costs.

“Injurious errors that happen during the performance of a task done countless times leave both patient and provider wondering: was it bad luck or bad practice?” states the report.

While individual cases might point to training, distraction, or miscommunication, an aggregate view of procedure cases offers a clearer picture of the broader underlying causes. While the majority (88 percent) of these cases highlight skill-based errors, CRICO’s analysis explores two correlative issues: rules of practice (policy and protocol), and inadequate knowledge or judgement demonstrated by clinicians or administrative personnel.

“More than 82 percent of all procedure-related medical treatment cases share one or the report. “Comprehensive analysis of these vulnerabilities is essential to providing organizational leaders and clinical managers with precise targets for education, training, oversight, tracking, and trending.”

Skill-related errors 

Technical skill errors by a physician, nurse or technician made up 88 percent of the procedure-related malpractice cases reviewed in CRICO’s study. These include hands-on slips, lapses, faults and failures in the physical performance of a procedure such as punctures or perforations from a misdirected NG tube or nerve injury from a blood draw.

Some of these errors reflect a lack of training; others involve seasoned clinicians, states the report. “Those exercising well-honed skills are also subject to unexpected and unprovoked slips,” it notes.

In 25 percent of cases the technical mistake was worsened by the care team’s failure to spot the error. “Most often, these cases involved a cascade of individual and team factors: failure to recognize the technical error or injury, failure to closely monitor the patient’s physiological status, failure to accurately interpret the patient’s complaints of pain or other symptoms, ineffective communication among team members regarding the patient’s condition,” states the report.

“These factors often led to the patient’s premature discharge without recognition or full resolution of developing symptoms.”

Of the six most prevalent procedures included in the study, scoping was most vulnerable to the above scenario. Nearly 70 percent of scoping cases in the study involved a puncture or perforation.

“Organizations that are constantly surveying the landscape for signals of risk stay alert to what is going wrong, where, and why.”

“This underscores the importance of paying critical attention to post-procedure identification and resolution of signs and symptoms indicative of this complication,” states the report.

The report emphasises the importance of routine skills appraisal in preventing such errors from occurring. It states that the most forward-thinking organizations are those whose annual skills reviews take into account the volume of procedures and all available data on events resulting in harm or patient complaints—and the circumstances surrounding them.

“Investigating harm at the hands of veteran clinicians allows organizations to grasp what is common to events across disparate procedures and specialties. Triangulation against malpractice data pointing to the most severe events provides leaders with a clearer path to understanding and mitigating these risks,” it states.

Rules-related factors  

Cases relating to rules-related factors are those in which care diverted from usual policy or protocol, making providers vulnerable to making technical errors.

“Driven by time constraints, limited resources, or production pressure, providers develop habitual workarounds or make in-the-moment decisions to override policies,” states the report. “But whether intentional or not, such deviation undermines policies and standard practices designed to protect both patient and provider from known vulnerabilities.”

Such situations can arise when clinicians or technicians are practicing at the boundary of their license; in training; working with unfamiliar equipment; or following a newly-modified policy or guideline.

“Whether one is fully aware of the breach, or acting on the edge of the professional boundaries of learning and orientation, the fact that ‘a rule has been broken’ is often obvious and always difficult to defend,” states the report.

It adds that factors such as lack of resources, production pressure and changes in policy or lack of awareness of a policy are all reasons why policies do not get followed.

“Organizations that relentlessly capture and investigate near-misses and adverse events are better able to understand and track policy failures,” it adds.

Knowledge and judgement-related factors  

Knowledge and judgement errors are not only heat-of-the-moment assessments or decisions, states the report: they are often distanced from the moment of the patient’s injury. For example, patient harm can relate to an executive’s decision to partner with an anesthesia group based on an incomplete understanding of its safety record.

Judgement errors in pre-procedural preparation and planning place patients and providers in situations which should not arise, such as the patient being an inappropriate candidate for the procedure; the setting being unsuitable; or the facility or setting being inadequately designed, equipped, or staffed to accommodate the volume, diversity, or complexity of patients being seen.

“Twenty-four percent of cases with skill errors also reflect judgement errors,” states the report. “Analysis of adverse event trends and peer review outcomes is vital to tracking the course of judgement-related errors. A broader view of what contributed to a pattern of errant decisions is more likely to prevent future events than attention strictly focused on a single patient or physician.” 

Disclosure & apology 

“A patient injured during a medical procedure can be set adrift on a sea of pain and fear,” states the report. “A provider’s behavior immediately after the injury will set the stage for the days that follow.

“The best outcomes result in complete healing: resolution of injuries and restoration of trust. The worst scenarios involve patients whose needs are not met through compassionate and informative communication by those responsible.” 

These patients often turn to the legal system, either in the hope that financial recompense will soothe their wounds, or that a lawsuit will uncover the truth about what went wrong.

“The legal system can work to compensate patients for injuries caused by true negligence, but it can also mean prolonged and unnecessary suffering,” states the report. “Organizations that train providers to compassionately and effectively disclose and apologize in the aftermath of an adverse event save their patients from an unnecessary sense of abandonment, and steer both patients and providers to calmer waters.”

What works 

The report highlights the value of constant vigilance in preventing procedure-related malpractice cases.

“Organizations that are constantly surveying the landscape for signals of risk stay alert to what is going wrong, where, and why,” it states.

This vigilance should include assessing providers’ technical skills; knowledge of safety policies; clinical judgement; and providing the means to maintain and enhance those capabilities.

Acknowledgement and discussion of near-misses and errors is becoming a more widely accepted practice. Maine Medical Center (MMC) is seeking to make those discussions more informed and meaningful by introducing human factors and cognitive systems engineering methods as a foundation for root cause analysis (RCA) information gathering.

“In collaboration with Applied Research Associates, MMC started piloting a concept called Team Sensemaking Critical Incident Method, whereby MMC physicians and nurses are now able to develop a traditional RCA event timeline that reflects their role in each step of the event, as well as their thought processes,” states the report.

“This serves to confirm the facts surrounding an event and encourages providers to recall any distractions (eg, a beeper sounding during a time out) or confusion that led to a misstep, and their influence on decision-making.”

This approach has led providers to become more comfortable acknowledging their fallibility and provides patient safety leaders with rich information on less visible vulnerabilities that can lead to patient harm.

The report also emphasises the importance of competency reviews to confirm that providers are knowledgeable about the techniques and safety policies for routine procedures. As an example of good practice it cites the University of Florida Health Jacksonville, which has turned to simulation in order to enable its providers to test and polish their skills on a regular basis.

This organization also examined its patient safety data for more heavily veiled causes of potential patient harm.

“Upon review of adverse event data, the medical center identified a series of events coincidental to the implementation of new clips and handles in its colonoscopy equipment,” it states. “It quickly responded by adding simulation training for gastroenterology technicians on the new equipment. Plans are in place to extend new equipment training to nurses, and to physicians as a complement to their standard simulation training requirements.”

The report also cites an example from the University of California, San Francisco (UCSF), whose risk manager saw a worrisome trend of high-dollar cases involving IV infiltrations. She carried out an in-depth analysis of malpractice cases and (more recent) adverse events and discovered provider knowledge gaps spanning the full spectrum of this high-frequency procedure.

“Based on this more pinpoint comprehension of the risk factors for infiltration, the director of risk management, chief nurse, and adverse event manager developed a multifaceted educational campaign to mitigate the clinical and legal risks associated with safe IV medication administration,” states the report.

This case emphasizes the importance of finding clinical leadership to champion whatever measures are needed to mitigate the risks related to routine procedures. Often the key is to gather data that clearly demonstrate the need for improvement.

“Moving the needle on patient safety improvement is hard work,” says Mark Reynolds, CRICO’s president. “In order to get healthcare leaders’ attention, to convince clinicians to carve time out of an already overburdened schedule, to motivate insurance providers to fund solutions, you have to show up with credible evidence that you are tackling the right problems.”

This is where CRICO Strategies can come in. The CRICO Strategies CBS database currently holds 275,000 medical malpractice cases from 500 hospitals and provides a unique insight into what goes wrong, and why.

“Our CBS database and the surrounding expertise enable CRICO and CRICO Strategies members to be proactive and effective in addressing patient safety over the long term across an entire organization,” says Reynolds.