Risk Management - Concepts of Implementation for the Clinical Practice

The quality of medical care in diagnostics, therapy and care has been continuously improved in the course of recent years by implementation of manifold external and especially internal measures. This is essential in times of economisation, rationalisation and globalisation. The number of reported liability losses claimed by patients against hospitals parallels the quality-improvement campaign and establishment of certification procedures, and reaches record level. Today's hospital patients are increasingly informed and capable of criticism, and are not willing to accept the outcomes of modern medicine science as being fate. They articulate their expectations for medicine and care, and object alleged malfeasance. In future, these patients will read up more on preventive standards, assumedly more than they will catch up on quality management and certification.

The number of reported liability losses claimed by patients against hospitals parallels the quality-improvement campaign and establishment of certification procedures, and reaches record level.

The players in healthcare - physicians in the first instance - ought to respond the claims development, which constitutes another trend causing concern, with the implementation of prevention measures in terms of risk management. Statistics show that allegations of error in treatment are without legal cause in many cases. One third of claims is settled, two thirds a re filed away without assuming any liability. This constant level extends over several years.

Nonetheless, each reported allegation involves time-consuming investigations, hearings and entails analysis efforts for the accused. The situation becomes particularly tragic for clinics, if potential allegations of error in treatment are passed to the blaze of publicity and the media becomes interested. This could nullify the longstanding efforts to create a positive image in a short time. There are numerous examples of it - and a reversal of this trend is not expected.

Risk management is nothing new! daily team meetings, ward rounds, mortality conferences etc. are measures of prevention that belong in variable degrees to the repertoire of therapeutic teams in every specialist department. Methodical risk management surveys structures, processes andresults of medical and care procedures from the perspective of former claims. It concerns prophylactic strategies for error prevention and thus, reduction of forensic risks by gathering existing weak points and potential losses.

If not before, it is then, when losses occur, that risks of clinics or specialist departments become known - it is easy to be wise after the event - but then it is too late. Professional risk management capitalises on an ample wealth of experience gathered from incidents that occurred in other comparable facilities. These experiences and their derivable prevention measures are passed on to the clinic staff during the implementation of risk management processes.

RISK MANAGEMENT PROCESS

The development and implementation process of a risk management system consists of four steps. The phase of risk identification is followed by risk assessment. This is followed by risk handling and implementation of appropriate actions for the optimisation of the safety level. After implementation of these steps, known and reorganised risks are controlled through the determination of suitable supervision parameters for risk monitoring and controlling. This risk management process basically matches the pdca - cycle [plan, do, check & act], which is known from the quality doctrine.

Essential, real and looming risks are defined for the respective clinic or specialist department and its medical focus during the phase of Risk Identification. In anaesthetics, these are for example risks of misintubation, or problems with false diagnosis regarding emergencies in accident surgery, or misapplication of chemotherapeutica in oncology. These are examples deriving from loss experience for specific risks. The thread potential equals themenace to thecaremission. Riskidentification requires attentiveness, consciousness and sensitisation of all involved members of a therapeutic team; it is not only the responsibility of physicians, but also a task for the nursing care and medical assistance professions. Staff members usually know the thread potentials of their direct working area through their vocational education, further trainings, and last but not least through their work experience. However, risks seem to be controllable duetocertain routine processesthat emerge, especially, if risks have not resulted in losses in the past. Therefore, it is important to take the opportunity for unreserved and self-critical reflection, which is offered during the phase of risk identification. It must not be affected by hierarchic structures and other disruptive factors.

Potential consequences of identified risks are quantified in the Risk Assessment phase. The degree of risk is assessed by quantifyingthe probability of occurrence and the size of potential loss involved. The outcome is shown in a simple two-dimensional risk-portfolio-scheme, for example:

The area between the opposing poles of loss potential and occurrence probability shows the therapeutic team the need for action. The assessment of identified risks ignites a fruitful interaction process, and mostly a practicable solution is being elaborated at its final stage.

Risk Handling constitutes phase 3 of the risk management process. The task is to draw consequences from the risks that were previously identified and assessed.

Manifold measures, which have been defined in line with risk identification and assessment, become effective as risk handling strategies:

Examples for department-specific risks in

...surgical care

• Development and implementation of requirements-oriented, pre-operative preparation standards.
• Continuousmedicaldevice-relatedtrainingand instruction.

...in-patient care

• Establishment of scoringsystemsforthe riskof patient
• fall and decubitus ulcer.
• Development of interdisciplinary treatment paths.

...emergency care

• Resuscitation trainings for all therapeutic team members and interactive CRM measures (Crew Resource Management).
• Continuous critical retrospective analyses of emergency missions.

... anaesthetics

• Provisionof centrally availablematerialsets for complicated intubations, and training of employees.
• Developmento finter disciplinary association/ enlistment rules.

From medical everyday life it is known that sources of incidents, complications and losses are multifactorial. Misinterpretations, lacks of attention and misunderstandings add up to a constellation, that overrides the established safety barriers. The meanwhile well-known 'Swiss - Cheese  - Scheme' adapted from Reason, illustrates, that single holes in a multifaceted safety net are non-effective, but that holes fatefully correspondent to one another will cause the unintentional result. This visualization may be employed in a useful way in orderto create risk awareness and to control risks and hazards in the risk management process.

Considering, for example the problem of wrong-side surgery in surgical care, safety barriers are established in all clinics; however, in a differently developed manner and pervasion. In risk management it is to question for example, whether:

• the surgeon knows the patient to be operated on;
• the surgical area is adequately marked where appropriate;
• thepatient is adequately interviewed before anaesthesia;
• a suitable identification system is provided.

Clinic-wide Risks

Not only discipline-specific risks, but also perils that are irrespective of specialist departments and which require a preventive concept for the entire clinic, are revealed by each analysis performed on risk management grounds. Over the past years, media have shown a continuously growing interest in the topic 'medical malpractice in hospitals'. This has brought vexatious experiences to some clinics that have been through the mills of journalism without chance of an unbiased, objective statement.

Risk management also provides preventive training measures for this purpose, such as:

• writing press releases;
• simulation of press conferences;
• creation of a code of practice for the 'case of media
• emergency';
• pre-test interviews for live performances;
• clinic-internal information activities.

A sustainable consciousness for risks and perils has to be achieved in clinical care.

A CIRS (Critical Incident Reporting System) should be installed and trained, as it is an effective instrument, that allows for identification of known and unknown risks. This procedure gathers near losses, i.e. incidents, which had the potential to lead to an undesirable outcome if left to progress (e.g. malfunction of an alerting system and as a consequence thereof, physician was not reached). The awareness that critical incidents, slight and severe complications, as well as serious losses are associated with each other, forms the basis of such a system. The systematic examination of critical incidents without consequences of loss and identification of its causation may help prevent potential real losses by introduction of adequate prevention measures. A comprehensive risk survey and reorganisation, i.e. implementation of the entire risk management process is inevitable, as otherwise the introduction of a CIRS may be ineffective. Initially, a process of growing consciousness has to be started. Members of the therapeutic team screen their respective fields of activities underthe aspect of risks, and introduce preventive measures during this process. The process of growing consciousness may be followed by CIRS for stabilisation and completion purposes.

Conclusion

Staff members of clinics have to keep pace with the rapid development of medical science, but their possibilitiesare restricted by legal practice and claims settlement. Moving within this field of tension requires medical and legal expertise.

Risk management is based on four pillars:

• efficient documentation on services rendered in diagnostics, therapy and care;
• extensive patient education and information;
• organisation of workflow;
• properand professional treatment.

A sustainable consciousness for risks and perils has to be achieved in clinical care. A comprehensive approach, which embraces all occupational groups beyond hierarchy levels, and the understandingfor risk reduction, which was elaborated in these groups lead to the fact, that sensitive work processes are not only eyed from the medical and economic perspective, but also from the liability- relevant point of view.

Normally, clinics dispose of a tight network of safety barriers, and of a critical incident instrument by implementing a house risk managment system (e.g. the software riskop). Liability insurers of hospitals increasingly askfor evidence of prevention measures for the elevation of patient safety, as precondition for risk coverage. A clinic-wide risk management concept that is integrated into the quality management structures, offers a distinguished chance to visualise measures of risk prevention and, last but not least, its demonstration to patients.

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