All involved in reporting adverse events associated with care

All involved in reporting adverse events associated with care

As we approach Patient Safety Week (November 21-25, 2022), the theme of which this year is: “Reporting and Managing SAEs”, i.e. “adverse events associated with care”, let’s take the time to look at the interest of the collective culture around the learning error, not punitive but pedagogical, and its main obstacle: the difficulty of collecting reports of EIAS.

Healing can be risky. Every patient, every caregiver is aware of this. However, these risks can be assessed, particularly in their relation to the benefits provided to patients, and it appears above all that a large number could be avoided.

Indeed, the last 3 ENEIS surveys (National survey on adverse events related to care), carried out in 2004, 2009 and 2019, show that more than half of adverse events associated with care are avoidable. When we look at the fact that EIAS are the direct or indirect cause of 5% of hospitalizations, and that 10% of hospitalized patients are confronted with an adverse event during their stay in hospital, this gives a distressing idea of ​​the number of affected patients. It should be added that, in addition to the heavy human toll, medical errors and avoidable nosocomial infections represent more than 10% of hospital expenditure.

In France, there are several systems for declaring an adverse event in the field of health. Professionals but also individuals can seize it but they are clearly under-exploited. It is estimated, for example, that only one SERIOUS healthcare-associated adverse event (SAEI) in 10 is reported to the competent health authorities, even though serious adverse events are subject to mandatory reporting. This is quite regrettable because the reports make it possible to feed an EIAS database and to draw lessons from them to prevent them from happening again.

Reporting, an essential basis for working around learning error

In civil aviation, the culture of reporting adverse events is, like the checklist (a topic that 66 Million Impatients discussed last year during Patient Safety Week in this article), a pillar of security. In France, in the health sector, both struggle to become a reflex. For Professor Bertrand Millat, professor emeritus at the Montpellier University Hospital, this is the reflection of a lack of culture around learning error and according to him, the first step to changing this paradigm is to question oneself around the values ​​conveyed to the within care teams. ” If in a service, at the slightest mistake, professionals are stigmatized, punished, threatened, if the weight of the hierarchy is paralyzing, it is not a climate conducive to reporting and collective analysis of adverse events. It is not by putting the dust under the carpet that one does the housework. It is essential to succeed in initiating a form of collective discipline and not to maintain the idea of ​​a solitary exercise of care. The safety of care requires the notion of team, that is to say collective competence and solidarity in the result. The occurrence of an EIAS raises less the question of “who is responsible for it?” than that of “what is the dysfunction of the team that made its occurrence possible?” “. It is by analyzing the event together that we will be able to prevent its recurrence. An unparsed error is an error that will occur again. “, specifies Professor Millat.

Of course, in civil aviation, pilots have every interest in reporting adverse events since they too are on the plane. What are the levers to be activated so that this also becomes automatic in the health sector? Should we consider a completely anonymised, non-penalizing system? Should it work on a voluntary basis or should reporting be made a regulatory obligation and penalties for failure to report?

Obligation or volunteering around reporting?

In France, there are several systems offered to professionals to report EIAS. In particular, they can report them directly to the health authorities through this online portal. Among these adverse events, the most serious, which were redefined in the Public Health Code in 2016, are subject to a reporting obligation. According to the Public Health Code, a ” unexpected event with regard to the state of health and the pathology of the person and whose consequences are death, life-threatening, the probable occurrence of a permanent functional deficit including an anomaly or a congenital malformation . “.

Another reporting circuit exists for certain high-risk medical specialties, on a voluntary basis, regardless of the seriousness of the adverse event. This system is called “accreditation” and Professor Millat knows this program perfectly since he submitted a report on the subject to the Minister of Health last October. If Professor Millat defends the idea that an acculturation to the reporting of EIAS, rather than setting up a regulatory reporting obligation, will be more effective, he explains however that the voluntary aspect of accreditation is less born of the ambition to value the learning error only for financial reasons (at the time, doctors asked for financial assistance from the Health Insurance to cope with the increase in their insurance premiums. The latter accepted in exchange implementation of a system to reduce the number of disputes and this compensation took the form of the accreditation program). Professor Millat adds: “ The insurance system, at the origin of the accreditation system, conveys a notion contrary to that which we seek to promote around learning error since insurance works on an idea of ​​faulty error, in search of culprits. However, I think it is more effective to educate professionals by mobilizing their desire to progress rather than forcing them. I believe that it is by improving the culture around safety that we will manage to ensure that the number of reports increases. »

Can anonymization and sanctions be levers to activate the reporting dynamic?

For Claude Rambaud, vice-president of France Assos Santé, who participated in writing the report on the generalization of accreditation, if the notion of acculturation is interesting, it must be put into perspective when human lives are at stake. deplores the extreme under-reporting of adverse events. The 2019 ENEIS survey demonstrates this perfectly, since of the 123 EIAS analysed, 61 turned out to be serious events, according to the definition of the Public Health Code adopted in 2016, and yet only one was the subject of a declaration to the Regional Health Agency (ARS), the competent authority in the matter. Claude Rambaud insists: “ We do everything not to see reality in the face. It would be good in particular to change the sampling of the ENEIS survey since it is currently a random draw and the designated establishments can refuse to participate. Furthermore, in order to create an efficient EIAS database, from which the best lessons can be learned for everyone’s safety, it seems appropriate to me to make the declarations confidential, as in the civil aviation REC program, allowing the recording of the information provided in a database which guarantees the anonymity of the declarant, author of the act. On the other hand, it would be more interesting to sanction the non-declaration of a serious event revealed later. To date, the lack of an obligation to report serious events is not accompanied by any sanction, yet the low level of reports is detrimental to the prevention of avoidable accidents. It also seems important to involve victims or their families in the reporting of serious adverse events, in other words medical accidents, to improve everyone’s safety. »

If he remains attached to the principle of acculturation rather than obligation, Professor Millat corroborates this bitter observation around the under-reporting of EIAS and especially serious adverse events. He specifies that, out of approximately 130,000 events reported since the introduction of accreditation in 2006, it is estimated that approximately 20% are serious events which should have been reported to the ARS, without this having been the case. For him, the better results of reports within the framework of accreditation compared to those of the general system, which passes through the ARS, are explained by the distrust of doctors who are very reluctant to make direct statements to the health authorities, whereas in the context of accreditation, reports are collected by accrediting bodies, admittedly approved by the Haute Autorité de Santé, but made up of active peers. Would this lever of declaration between peers be effective in finally launching a dynamic around reports? What if we also left greater room for users within these reporting systems, since they are there at every stage of their care?

Users involved in reporting adverse events

It is worth remembering already that individuals can also use this portal for reporting adverse health events. A section has been specifically designed so that they can report any problem concerning products for medical use (drugs or vaccines, medical materials or devices, medicines for veterinary use), any other type of product (everyday life, cosmetics, food, etc.) as well as a medical act or examination. However, for all these situations, particularly during a medical act or examination, the users, who are not a priori specialists in the care, are therefore not in a position to know whether an adverse event has taken place, unless it has had a serious consequence. This is why it is essential to be able to provide patients with all the necessary information, on the one hand to obtain their informed consent, but also to initiate their participation in the care pathway, if they have the capacity to do so. understood. Indeed, proposing for example to a patient, to mark on his body, himself, with a marker, the side where he must be operated would make it possible to avoid the errors of side which take place each year in France and which are completely preventable. In the same way, allowing the patient to express himself at all stages of the treatment, without lowering the value of his participation, can prove to be very beneficial, for example to check that he is not being administered a drug to which he would be allergic. At each stage, and not only once the damage is done, the patient or his relatives can point out dysfunctions. None of the patient’s questions, none of his remarks, before, during and after treatment, should be taken lightly. To strengthen this collaboration between patients and caregivers, Claude Rambaud suggests, for example, offering preparation sessions for heavy medical acts or examinations, such as surgery, just as we already do to prepare couples for childbirth. And in the context of accreditation and more generally of feedback from EIAS, so that the most complete lessons can be learned from “learning errors”, it obviously campaigns for the patient’s story to be taken more into account. consideration. On this point, Professor Millat adds: “ In fact, most often, if not always, the story of an EIAS comes from the medical personnel concerned. Hearing the story of the patient or his dependents about the same event could significantly change the analysis and understanding. »

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