150602L - UNDERSTANDING AND MANAGING CLINICAL RISK

Lecture presentation to medical college students at College of Medicine, KFMC, KSAU-HS Riyadh June 2, 2015 by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical City.

Keywords: Clinical risk, reporting near misses, reporting errors, risk assessment, incident, incident monitoring.

Learning objective: Know how to apply risk management principles by identifying, assessing and reporting hazards and potential risks in the workplace.

Why clinical risk is relevant to patient safety?

·         Risk management is routine in most industries.

·         The success of a risk management programme depends on the creating and maintaining safe systems of care.

·         Many hospitals have well established systems in place for reporting adverse events. They are only beginning to focus on all aspects of clinical care to see opportunities for reducing risks to patients.

·         Unfortunately, even though a hospital may have a policy of reporting incidents such as medication errors, the actual reporting of them is often sporadic.

·         Research shows that nurses are more likely to report an incident than other health professionals, certainly more so than doctors. This may be because the blame culture in medicine is a strong deterrent to reporting.

Concern of clinical risk management

·         Clinical risk management specifically is concerned with improving the quality and safety of healthcare by identifying the circumstances and opportunities that put patients at risk of harm and then acting to prevent or control those risks.

·         The following simple four-step process is commonly used to manage clinical risks: (1) identify the risk; (2) assess the frequency and severity of the risk; (3) reduce or eliminate the risk; (4) assess the costs saved by reducing the risk or the costs if the risk eventuates.

·         Clinical risk management allows identification potential errors. Health care itself is inherently risky and although it would be impossible to eradicate all harm, there are many activities and actions that can be introduced that will minimize opportunities for errors.

·         Clinical risk is relevant to medical students because it recognizes that clinical care and treatment are risky and incidents may to occur during clinical care and treatment.

·         Health-care professionals) must actively weigh up the anticipated risks and the benefits of each clinical situation and only then take action.

Root cause analysis

·         The principle underpinning root cause analysis is that the actual (root) cause of a particular problem is rarely (immediately) recognizable at the time of the mistake or incident.

·         A superficial and biased assessment of any problem usually does not fix the problem and more incidents will occur involving others in similar situations.

·         An essential part of any root cause analysis is the implementation of the findings of the root cause analysis process.

·         Many hospitals and organizations fail to complete the process because either the recommendations involve resources that are not available or there is no commitment by the senior hospital management to carry through the recommendations.

·         Some health-care organizations that mandate reporting of incidents can become so overloaded with reported incidents with the consequence that many remain unanalyzed due to inadequate resources.

·         Even the introduction of a triage system to distinguish serious incidents from others has not resolved this dilemma in some systems.

Common activities used to manage clinical risk

·         Incident monitoring: communication, decision making.

·         Sentinel events: A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury.

·         Complaints in improving care.

Coronial Investigations

·         Most countries have some system for establishing cause of death.

·         Specifically appointed people, often called coroners, are responsible for investigating deaths in situations where the cause of death is uncertain, or thought to be due to unethical or illegal activity.

·         Coroners often have broader powers than a court of law and after reporting the facts will make recommendations for addressing any system-wide problems.

Fitness-to-practice requirements

·         Medical students and all health professionals are accountable for their actions and conduct in the clinical environment. Related to accountability is the concept of “fitness to practice”.

·         Many mistakes leading to adverse events are associated with the fitness of a doctor to practice. Are they competent? Are they practicing beyond their level of experience and skill? Are they unwell, suffering from a stress or a mental illness?

·         Most countries will have a system for registering doctors, dealing with complaints and maintaining standards.

·         Selecting the right students to study medicine is the first step in making sure that the people who are choosing medicine as a career have the professional attributes for safe and ethical practice.

·         Objective Structured Clinical Examination processes to help identify those students who in addition to their examination results also have the attitudes and behaviours best suited to medicine and patient safety.

Credentialing

·         Credentialing is the process of assessing and conferring approval on a person’s suitability to provide specific consumer/patient care and treatment services, within defined limits, based on an individual’s license, education, training, experience and competence.

·         Many hospitals have credentialing processes in place to check whether a doctor has the required skills and knowledge to undertake specific procedures or treatments.

·         Hospitals will restrict the type of procedures offered at a hospital if there are no qualified personnel or if the resources are not available or appropriate for the particular condition or treatment.

Accreditation

·         Accreditation is a formal process to ensure delivery of safe, high-quality health care based on standards and processes devised and developed by health-care professionals for health-care services.

·         It can also refer to public recognition of achievement by a health-care organization of requirements of national health care standards.

·         CBAHI & JCI

Registration

·         Most countries require medical practitioners to be registered with a government authority or under a government instrument.

·         The principal purpose of a registration authority is to protect the health and safety of the public by providing mechanisms designed to ensure that medical practitioners are fit to practice medicine.

·         It achieves this by ensuring that only properly trained doctors are registered, and that registered doctors maintain proper standards of conduct and competence.

The role of fatigue and fitness to practice

·         There is strong scientific evidence linking fatigue and performance.

·         Studies in the Ireland and the United Kingdom also show that fatigue can impact on the well-being of residents affecting their mood (depression, anxiety, anger and confusion).

·         Recent controlled studies have confirmed the findings that sleep deprivation can negatively impact on clinical performance.

·         Fatigue has also been linked to increased risk of medical errors and motor vehicle accidents.

·         A 2004 study by Landrigan et al. was one of the first to measure the effects of sleep deprivation on medical errors. They found that interns working in the medical intensive unit and coronary care unit made substantially more serious mistakes when they worked frequent shifts of 24 hours or more than when they worked shorter shifts.

·         Other studies show that sleep deprivation can have similar symptoms to alcohol intoxication.

Stress and mental health problems

·         Strong evidence suggests physicians are prone to mental health problems, particularly depression. Students also suffer from stress and associated health problems that they carry with them when they start practicing as doctors.

·         While rates of depression and mental health problems among doctors are higher than those experienced by the general population, the literature shows that when interns and residents are supported by fellow house officers and senior clinicians, and are members of well-functioning teams, they are less likely to feel isolated and suffer stress.

·         Performance is also affected by stress.

·         There is strong evidence indicating that inadequate sleep contributes to stress and depression, rather than the number of hours worked.

·         Other stressors identified in the literature include financial status, educational debt and term allocation and emotional pressures caused by demands from patients, time pressures and interference with social life.

Work environment and organization

·         Hospitals and clinics can be very stressful places to the newcomer. Unfamiliar work practices and rosters can make it very difficult in the early phase of a new workplace. In addition, long hours cause fatigue.

·         There are well-known situations such as changeovers of shift, shift work, nights, week ends and overtime that have been noted to have an association with increased errors.

·         The factors underpinning these errors can range from lack of supervision to tiredness. Students should be extra vigilant during these times.

Supervision

·         Good supervision is essential for every student and the quality of the supervision will determine to a large extent how successfully a student integrates and adjusts to the hospital or clinical environment.

·         The failure of senior clinicians to supervise or arrange adequate supervision for medical students and interns and residents makes them more vulnerable to making mistakes either by omission (failing to do something) or commission (doing the wrong thing).

·         Students should always request supervision if it is the first time they are attempting a skill or procedure on a patient. They should also advise the patient that they are students and request their permission to proceed to treat them or perform the procedure.

·         Poor interpersonal relationships between students, other health-care professionals, interns, residents and supervisors have also been identified as factors in errors. If a student is having a problem with a supervisor, they should seek help from another faculty member who may be able to meditate or help the student with techniques to improve the relationship.

·         The literature also shows that students who have problems with inadequate skills acquisition also have poor supervision.

Communication Topics

·         Communicating accurate information in a timely way between the multiple health workers(consultants, registrars, nurses, pharmacists, radiologists, medical records and laboratory personnel) is not easy, nor are there standard ways for communicating within hospitals.

·         The role of good communication in the provision of quality health care and the role poor communication plays in substandard care are both well documented.

·         How successfully patients are treated will often depend on informal communications among staff and their understanding of the workplace.

·         Treatment errors caused by miscommunication.

·         Absent or inadequate communication is well known and occurs daily in hospitals.

·         The quality of the communication between patients and other health professionals strongly correlates with treatment outcomes.

·         Checklists, protocols and “care pathways” are effective for communicating patient care orders.

What students need to do (performance requirements)

·         Know how to report known risks or hazards in the workplace.

·         Keep accurate and complete medical records.

·         Know when and how to ask for help from a supervisor, senior clinician or other health professional.

·         Participate in meetings that discuss risk management and patient safety.

·         Respond appropriately to patients and families after an adverse event.

·         Respond appropriately to complaints.

Summary of the session

·         Doctors are responsible for the clinical outcomes of their patients.

·         One way for doctors to manage this is to identify areas prone to errors and adverse events.

·         The proactive intervention of a systems approach to minimizing the opportunities for errors can prevent adverse events.

·         Individuals can also maintain a safe clinical working environment by looking after their own health and responding appropriately to concerns from patients and colleagues.

Case #1: Inadequacy in orthopaedic surgeon’s practice management systems

Accurate and legible records are essential for maintaining continuity of care.

Brian was being treated by a new specialist and needed his records from the orthopaedic surgeon who operated on his knee two years earlier. When the records finally arrived, Brian’s new doctor informed him that they were not “up to scratch”. The records were poorly documented with no meaningful notes concerning the consent discussion for Brian’s operation. There were also gaps in the information recorded in the operation report and there was no documentation of the orthopaedic surgeon’s verbal advice about the risks and complications of the operation. Brian was dismayed to discover that the surgeon had not followed up on a missed postoperative review.

Case #2: Acknowledgment of medical error

This case shows the value of open disclosure.

Frank is a resident of an aged care facility. One night, a nurse mistakenly gave Frank insulin, even though he does not have diabetes. The nurse immediately recognized his error and brought it the attention of the other staff, who in turn informed Frank and his family. The facility took immediate action to help Frank and arranged his transfer to a hospital where he was admitted and observed before being returned to the aged care facility. The nurse was commended for fully and immediately disclosing the incorrect administration of the insulin. Following this incident, the nurse undertook further training in medications to minimize the possibility of a similar error occurring.

Case #3: General practice rooms not up to standard

This case shows the importance of complaints to improving health care.

When Denise visited her local medical practice, she was shocked to see that the practice was not as hygienic as she expected. It was so bad that she complained to the New South Wales Department of Health. A health inspector noted that Dettol was stored in a drink container, drugs were stored beyond their use-by date, there was no adrenaline in the surgery to treat a heart attack, patients at times had unsupervised access to the doctor’s medical bag containing injectable narcotics and a prescription pad, paper sheets on the examination table were not changed between patients and the doctor did not wash his hands following examinations. There were also no sinks in the consulting rooms. The Health Care Complaints Commission recommended counseling by the New South Wales Medical Board and an on-site visit to advise the staff on Department of Health guidelines on infection control and make sure the appropriate steps had been taken to protect public health. Denise was glad to learn that the centre made improvements as a result of her complaint.

Case #4: Inadequate complaints management

This case shows the importance of timely attention to complaints.

Alexandra had been seeing a psychologist who was practicing in a private hospital. On both her first and second consultations, the psychologist breached patient confidentiality by discussing personal details about his other patients. Alexandra decided she should raise her concerns with someone at the hospital. She attended one meeting with hospital representatives about a number of concerns she had with the hospital, including those with the psychologist. Many months passed with no written response from the hospital detailing the actions they had promised to take. With the help of the Patient Support Office, Alexandra attended a meeting with an official of the office and the chief executive officer and deputy chief executive officer of the hospital. The hospital made an apology to Alexandra and a commitment to ongoing staff training in complaints management. They also encouraged Alexandra to lodge a formal complaint with the Psychologists Registration Board regarding the psychologist’s behaviour.

Case #5: An impaired nurse

This case shows how health professionals need to maintain their fitness to practice.

During Alan’s operation, a nurse knowingly replaced the painkiller fentanyl, which was ordered to treat Alan, with water. This nurse placed Alan in physical jeopardy because of the nurse's desperate need to obtain an opiate drug to satisfy his drug addiction. This was not the first time that the nurse had stolen Schedule 8 drugs for the purposes of self administering them. A number of complaints had been made about the nurse while working at a

Case #6: A junior doctor with bipolar disorder

The case shows how important it is to refer colleagues who are unwell and to protect patients from clinicians who behave unethically.

Irene was upset because her new doctor verbally abused her during the consultation at the hospital clinic. She asked for another doctor and made a complaint to the hospital administration. Irene’s complaint was just one of a number of complaints against the doctor including others concerning a refusal to treat a patient, making sexual advances to staff and patients and neglecting his own diabetes condition. He also refused to comply with psychiatric treatment suggestions. One year earlier, the doctor had been investigated for prescribing errors and sexual advances to patients. At that time, the doctor was reviewed and diagnosed with a long-standing bipolar (manic depressive) disorder. He had made undertakings in relation to treatment of his mental illness, which he was obviously not observing now.