Datix

There is a conundrum in patient safety incident classification that arises because of conflicting opinions regarding just what is or is not an incident!  The primary reason for adverse event reporting is to identify learning opportunities and preventive strategies so that ultimately we can avoid, or moderate the impact of, incidents. Incidents have causes, often preventable, and these can be detected through structured processes of analysis. Causes may be related to human error, acts of commission or omission, and often result from system inefficiencies that promote opportunities for errors and mistakes. The goal of incident reporting is to identify vulnerabilities in our processes that permit, or even encourage, errors and mistakes.

Supported by the underpinnings of the logic presented above, a patient safety incident (or event) is an insufficient or failed process that results in, or has the potential to result in, an adverse outcome. It is not the outcome per se, rather the insufficient or failed process that results in the outcome. The terms patient safety “incident” and “event” are commonly used interchangeably. Trying to force utilization of one term versus the other would be like jumping into the Thames and flapping one’s arms to change the direction of the current. In this blog I will use the term “incident” exclusively.

A healthcare associated infection (HAI) is an outcome of insufficient or failed processes that might arise in the domains of environmental cleaning and disinfection, hand-hygiene, sterilization, perioperative antibiotic prophylaxis, performance of clinical procedures, adherence to protocols, bundles, guidelines; sharps disposal, isolation procedures for patients, handling of body fluids or tissues; and contamination of medications, fluids, blood products, etc. There are a myriad of causes for process insufficiencies or failures within these domains, but the singular outcome in every instance is a HAI, the outcome of the incident.

The same logic applies when considering incidents resulting in wrong site surgery injuries or harm associated with missed or erroneous diagnoses, patient falls, medication errors, etc. You may think that these examples are the actual incidents, but more precisely these are outcomes resulting from incidents. Identifying wrong-site surgery as an incident does not lead to learning and improvement, but identifying “failure to utilize the WHO Safe Surgery Checklist” is the incident because the reasons for non-compliance can be identified and rectified.

Why this connection of “incident” versus “outcome” has been so difficult to overcome pragmatically is the real question, and the answer resides in understanding just who the stakeholders are in the complex healthcare calculus and their varying data requirements. Those of us working in hospitals focus on improving processes, so we want to know what the “incidents” are. We want to know why medication errors occur. We want to know how often hand-washing protocols are not followed. We also want to know the discrete outcomes of course, but this is secondary as regards learning practices.

Hospital executive leaders, governance boards and regional healthcare authorities are primarily interested in discrete “outcomes”, though they may confuse these with patient safety “incidents”. They want to know the frequency of HAIs, patient falls, pressure ulcers, wrong-site surgical procedures and what steps are being taken to prevent these. The fact that within each of these outcome categories a myriad of different process insufficiencies or failures may come into play, with many associated causal factors, is not as important an issue for presentation at meetings or alerting medico-legal authorities. Absence of hand-washing protocols or insufficient training on hand-washing procedures may not show up on the executive or governance graphic presentations, but the incidence and prevalence of HAIs most certainly will, and appropriately so!

Clarity in definitions is certainly very important. Appreciating the basis for the tensions that exist in the definitions is the obligation of those involved in patient safety incidents and outcomes analysis.

Datix is presently working on enhancements to its current proprietary CCS classification system, and the definitions discussed above have been incorporated into the planning strategy. Our intention is to engage current users in this enhancement process.  Learning from safety incidents and exceeding the needs of all stakeholders is the quintessential goal.

Healthcare education is about mentoring and generally this means that more experienced clinicians provide top-down mentoring necessary to mould young men and women into the professionals our patients deserve. This mentoring model has been sustained for generations in healthcare, but the fact is that it may not be sufficient at least not in the realm of patient safety.

Once again we look to the aviation industry, this time the military arm, for examples that should serve us well. In the movie Top Gun, Tom Cruise, aka “Maverick” is reprimanded and advised to “never leave your wingman”. A simple statement but much lies below the surface. To leave your wingman, to become disengaged from other members of the team, is a crucial mistake in combat and is also a crucial mistake in medicine. Fighter pilots generally fly in two-ship formations where each aircraft serves as the protector for the other – the wingman. Healthcare teams should function like airborne formations with each member looking out for the mistakes of the others. Each person is in a sense a wingman and more importantly, extending the metaphor towards engagement with patients in partnership, each team member is the patient’s wingman!

We should encourage a collaborative culture as our patients are depending on us to work together to produce the best outcomes. They care less about who is the senior ranking person in the room and much more about who is the most current, the most “recently experienced”.

The traditional model of top-down mentoring works well in professional schools and training programs but not necessarily in the world of fully qualified physicians, surgeons, nurses and other healthcare professionals. Just who are the mentors for those who have passed all the exams and completed all the training? More importantly, who are the mentors of the very senior staff who, although esteemed and accomplished in their careers, may be too tied up with administrative duties and management challenges to spend sufficient time practicing their clinical skills and therefore may be losing some skills. For example, practicing medicine, surgery or nursing (note the term “practicing”) is not like riding a bike. Just because you have done it in the past doesn’t mean you are just as proficient when not doing it every day or every week. Top-down mentoring doesn’t fit very well when those higher-ups are less “recently experienced” than those lower down the hierarchy.

In military aviation when a senior officer, who flies less frequently, accompanies a junior officer on a mission the junior officer is often considered the flight commander because he is the more “recently experienced” pilot and he flies more frequently. After the flight there is a debriefing where the junior officer discusses the positive and less positive aspects of the mission and mentors the senior officer – top-up mentoring! The senior officer accepts this mentoring in a cordial fashion because this has been the culture of aircraft safety for many, many decades where the goal is aircraft safety and egos are put aside. “Recent experience” is what matters, and seniority outside the cockpit has nothing to do with this relationship. Safety and mission success are the issues, full-stop!

The clinical environment is like a flight deck or cockpit in many respects and opportunistic mentoring should be the rule, not the exception. Likewise, refresher mentoring for healthcare professionals, especially after involvement in adverse patient safety incidents, should be the rule and not the exception.

In healthcare we must use both models of mentoring as circumstances direct and at every opportunity. The barriers artificially created by professional titles and hierarchies have no place in this process and are subservient to the needs of patient safety. Collaboration means looking out for each other and never, ever leaving your wingman!

Healthcare safety monitoring and improvement strategies have often been compared to other industries and found to be lacking. Our profession is often compared to the airline and nuclear energy industries and even with the automotive industry. In many ways, especially in the realms of emphasis on prevention, non-attributable reporting and avoidance of the “blame culture,” the proponents of these comparisons may be right but life is not always so simple. Healthcare delivery is actually much more complicated than flying a plane, operating a nuclear energy facility or building a car.

For the sake of discussion I will lump the major elements of performance and safety in these three industries into an engineering model. To a large extent the processes and procedures requisite within these industries are confined within closed systems. By this I mean the processes are designed by engineers, quantified, measurable and quality-controlled to a high degree. Planes have redundant systems so that failure of one (even human failure to correctly operate a system) is often counterbalanced by the redundant fail-safes that have been engineered into the processes. Medicine has learned a great deal from this approach and many of our technologies are now approaching similar levels of reliability. Furthermore, we have learned much about human factors and the challenges these pose by studying models of performance inherent in these industries and the innovative human-error-reduction strategies engineered into their systems. However, there is far more variability associated with clinical assessment and diagnostic skills than with flying a plane or building a car and this is where the comparisons fall apart.

Obtaining a history, performing a physical examination, ordering and then interpreting a wide variety of laboratory and imaging investigations, prescribing therapeutics, performing interventions and providing hands-on care to humans is really, really complex and the doctors and nurses who do all this are not robots – they are humans with variable strengths and weaknesses. Of course all professionals have to meet some prescribed standards of performance, but these are not as discrete as industry standards for machines and humans are not engineered like machines. The human brain is far more complicated than any machine developed by humans, ever!

In addition, the patients we are privileged to care for are also not as uniform as the raw materials or machines so effectively utilized for building a car or making a plane fly. They are inherently highly variable in terms of their physical characteristics, nutritional status, genetics, psychological constitution, abusive/addictive behaviors, socio-economic background, fears, belief systems and responses to medications.  The healthcare “industry” is only just beginning to come to grips with some of these challenging aspects. I am not saying that we do not have a lot to learn from the engineering industries because we certainly do, especially in the realm of development and sustainment of a patient safety culture that embodies professional collaboration as the hallmark of patient- centered care; but we are not the same as them.

In other industries humans operate machines that are fail-safe designed. Doctors and nurses and other healthcare professionals do not simply operate machines – they are themselves highly designed, yet imperfect machines that embody the soul and spirit of compassion and with all these imperfections hope to improve the plight of other vulnerable humans, also machines of a sort, who are suffering and frightened. We shouldn’t beat ourselves up for not being planes or even pilots because we are much more than that; we are healthcare professionals.

Caring for patients is fraught with danger.  Every time we stand at the bedside we bring benefits but also risks. Problems with our systems of care and personal lapses from a range of human factors often result in harm, preventable harm. Healthcare is all about partnership, patients and healthcare professionals partnering to achieve desired outcomes. It is all about trust and obligation.

When patients are harmed we need to focus on those aspects of trust and obligation and discuss adverse events, the damaging outcomes, the remedies to treat these outcomes and the steps to prevent further adverse events.  This is part of our fiduciary relationship with those we serve. We need to be open and honest and to build and sustain bridges of communication, yet we are often not adequately prepared to do so! Of course, individual circumstances should dictate seeking guidance from hospital administration resources and hospital attorneys beforehand, but that should not trump the ethics of honesty and trustful behaviour.

Unfortunately, most physicians and nurses are not specifically train to deliver bad news as a result of mistakes or system errors. Nonetheless, it is the right thing to do and there is some evidence emerging that open disclosure actually decreases medical malpractice suits. Physicians and nurses need mentoring in how to talk with patients about adverse events, and institutions should have formal plans in place that address disclosure. The Institute for Healthcare Improvement in the USA has published guidance on preparing for disclosure and the management of serious adverse events. I was trained as a paediatric oncologist and therefore have had a lot of experience in sharing very bad news. To start with I was not very good at this and frankly was highly intimidated by such discussions. Fortunately, I had good mentors who coached me through the process so a few months into my training I was much better. I have always been a compassionate guy who just needed some help sharing facts and compassion when the facts were very frightening.

Years ago I was involved in an incident where a patient under my care was administered 10 times the appropriate dose of a chemotherapeutic agent for cancer.  A situation had called me away from the bedside and someone else administered the medication on my behalf.  An incorrect dose had been prepared by the pharmacy and had I not been reluctant to call for oncology staff back up, I would have been present to give the medication and would have recognized the mistake. When I realized what had happened I was certain that the overdose would kill the patient, a young child with Wilms tumor.

Knees rattling (and other organs shimmering) I called my consultant immediately and he advised that we meet with the family to discuss what had happened. He also mentioned to me that although the child had received a very high dose of medication we actually did not know that he would die, but only that he would likely become severely myelosuppressed.

The meeting was hugely challenging for all parties but with honesty and compassion I explained what had happened, how it had happened and what steps we would take to care for the child going forward. The family was upset and very frightened but interestingly remained grateful and confident in our care.  To cut a long story short the child, despite 10 days of severe myelosuppression recovered nicely. The child was ultimately cured of his illness and my relationship with the family was strengthened and sustained.

OK, I know not all stories will end like this, but the approach of honesty and compassion has served me well over the years. Institutions need to be prepared and formal disclosure planning and team training in disclosure should be part of the safety culture.

I have always washed my hands in front of patients, always; and I’ll tell you why.  Part of the reason is to prevent infection, but mostly it has to do with humility and the deeply human connection I want to convey to patients. I want to be safe, and I want them to know this. I always wash my hands in front of patients!

Taking care of patients is a unique honour and privilege and an enormous responsibility. Patients hold us accountable for our care and caring, and they have the right to expect that we will assure their safety as they move through the continuum of healthcare. Quality health care is all about safety and outcomes, and the human connection is the facilitator. When healthcare professionals really connect with patients, really empathize and really listen, then the foundation is firmly built for safe, high-quality outcomes.

I was recently at a conference where I heard Dr. Stephen Bergman, a Harvard psychiatrist and medical fiction author, talk about the human connection.  I got to thinking about my experiences, the mentors I’ve had over the years, and how they affected my career. Since communication is such an important part of safe care, understanding patient perspectives and working with their belief systems becomes part of our shared strategy for success, and this has a lot to do with hand-washing, by the way!

One of my mentors was Professor Charles A. Janeway at the Children’s Hospital Boston, Massachusetts. Charlie was an internationally distinguished scientist and physician, revered and almost worshiped by many around the world. He was in his 70s when I knew him and still made teaching rounds with the registrars and medical students. What I learned most from him had less to do with immunology, his forte, and much more to do with humility and humanity, because he could really connect with patients.

I recall an afternoon when the distinguished Harvard professor was being introduced to a teenaged mother and her sick toddler, who was suffering from juvenile rheumatoid arthritis.  A junior house officer had first presented the “case” out of earshot. Charlie introduced himself, took off his starched white coat, rolled up his sleeves, washed his hands for over a minute and sat down on a chair so that he could be at eye level with the mother, who was clutching her fearful and sick child. He extended his hand onto hers, asked her to explain her worries and to tell her story. Any tension in the room immediately evaporated as she cried and poured out her concerns and beliefs, and he really, really listened. He then calmly asked if he might examine her child, stood up, washed his hands again, sat down and began to examine the little girl, by first touching her toes before moving up to more threatening parts of the exam.

When he had finished, he briefly talked with the mother to explain the course of treatment and then asked her if she understood what he had said and if she had any questions. As he left the room, he again washed his hands, thanked the young mother for her help when examining her child and promised to return to see her and her child again. It was drama… pure, effective theatre… human connection… high-quality, safe care!

In the conference room down the hall our group stopped to discuss the child (not the “case”), and one of the medical students asked the professor why he had washed his hands three times. He replied, “Once to prevent infection and twice to emphasize to this young mother how much I cared about her child and respected her concerns and beliefs. I wanted her to know that I really cared, and… there is something about water, and washing, which sends that message.  Hence, the link between the human connection and hand-washing.

Communication inefficiencies have been identified as common causes of patient safety incidents and harm. Simple solutions exist to address communication failure but are not consistently utilized in healthcare settings. Why this is may have more to do with culture than anything else.

The breadth of communication challenges covers the sharing or transfer of information between healthcare professionals and support staff and more broadly the exchange of information between healthcare professionals and patients, family members or other care givers for example social services and other community resources. Communicating relevant information around the care of patients during transitions in healthcare is an area of particular vulnerability.

Communication hazard zones include:

• Handoffs in patient care related to personnel shift changes
• Healthcare team dynamics within particular settings
• Patient transitions between clinical settings within institutions or more broadly across internal and external institutions

Each of these situations have their own communication challenges that are further complicated by individual personalities, the robustness of the patient safety culture, proximity of healthcare settings, processes of communication, urgency, patient preferences, etc.

The airline industry has developed, and sustained, a culture of safety over the past fifty years that includes assured communication techniques that prevent flight incidents, and healthcare professionals should learn from this experience. Aircrew coordination relies on standardized checklists that are utilized within a cultural environment where everyone is respected and encouraged to speak up if there are concerns regarding safety at any time. The strong and admired leader of the crew is that individual who encourages and welcomes relevant timely discourse. Furthermore, the flight deck environment is viewed as a “special space” where distractions are not to be tolerated.

Communication in healthcare settings can easily be enhanced by the adoption of standardized checklists where discrete relevant information is shared effectively before the “baton” has been passed, and the “baton” is not passed until all participants in the transition agree that the checklist has been completed.  Verbal or written acknowledgement that communication has been completed is a key component of this process as it closes the loop.

Communication should be accomplished in quiet zones that are free from distractions. The kinds of information to be communicated should be standardized, yet customized by professional staff to address unique requirements. Before beginning invasive procedures or when confronting evolving clinical challenges, especially emergent situations, healthcare teams should employ the techniques of “time out” and “huddling” to have frank shared discussions and to complete necessary checklists.

A great example of standardization is the WHO Surgical Safety Checklist, the adoption of which has been shown to reduce surgical operative morbidity considerably and surgical mortality by nearly 50%. Yet despite the clear evidence of effectiveness there is still reluctance and resistance to universal adoption. Reasons for this are complex but essentially point to the failure of institutions, and some healthcare professionals, to embrace and sustain a culture of openness towards sharing of information, respect for the opinions of all team members and encouragement to speak up when safety concerns are detected.  Healthcare professionals need to accept the fact that they can and may make mistakes, and that the adoption of standardized checklists and procedures is the most effective way to reduce variability and prevent incidents; particularly during handoffs, transitions or when performing invasive procedures.

Sustainment of a culture of respect and enhanced information sharing will require all of us to work together. Our patients are depending on us to finally get this right; and the public is getting restless!

When adverse events occur our attention focuses on the injured patient; the person we have the responsibility to serve. There are other “collateral” victims of course as hospitals may be subject to public relations scrutiny and malpractice suits. Sometimes forgotten is the fact that healthcare professionals are also victims, and this is especially the case when patients are harmed as a result of professional errors.

Doctors and nurses do not go to work intending to harm patients, but processes are imperfect and often judgement can be clouded. Sometimes we make mistakes because we make assumptions, we perceive situations or circumstances in a fashion that blinds us to relevant data or we fail to communicate respectfully with colleagues or subordinates that might lead us to reach different conclusions.

When patients are harmed many professionals become distressed and emotionally troubled, yet often have nowhere, or no one, to turn to. This may be the case in particular for physicians and surgeons who have been trained or indoctrinated to be in charge, to be seen as the leaders of the team; and where admissions of errors may be perceived as weaknesses.

I recall the case of highly respected hand surgeon who performed a tendon release procedure on the wrong finger of the wrong hand (wrong site surgery) having refused to use the World Health Organization (WHO) surgical safety checklist because she “had never had this happen before.” Admittedly, her hospital had not adopted the checklist as standard operating procedure, but she had recently attended a teaching conference where the effectiveness of the checklist had been discussed. She was rushed on the morning of the procedure, was complacent, she made assumptions and did not respectfully listen to a nurse who raised a question about the procedure. Such was the power of her presence and her reputation that she was not further challenged in the operating theatre.  Sound familiar?

When the reality of the situation hit her she felt tremendous guilt and remorse yet her colleagues were less than truly understanding, reaching out to her with comments such as “these things just happen from time to time” or “even the best of us make these mistakes”; almost as if there were some justification for what had happened or that she was less than “one of the best”.

The fact is that wrong site surgery should never happen and is completely preventable. The hand surgeon had acted irresponsibly. This highly successful surgeon recognized that she was not infallible. She did not need patronizing comments from surgical colleagues.

In fact there are three very important steps to assisting this surgeon that may result in her becoming a better doctor in every sense, and these processes should have been embedded in hospital culture and policies. First, the surgeon needed to be the leader of the disclosure team that met with the patient, and she should have had mentoring in the processes of disclosure; of sharing honestly and openly with patients our regrets and remorse when thing go wrong and expressing the sentiment to work better to never let this happen again. Secondly, her institution had an obligation to require her to meet with professionals, often trained physicians and surgeons, to share her feelings and to receive revalidation of her value. Thirdly, she should have been given the opportunity to assume a mentorship role in teaching the tools of respectful communication.

Unfortunately only hospitals with robust patient safety cultures achieve these three objectives, and many hospitals have not yet moved this far along in their safety journeys.