Law no. 1.567 of 12 December 2024 on the management of risks associated with healthcare

Law no. 1.567 of 12 December 2024 on the management of risks associated with healthcare Monaco (JDM no. 8726 of 20 December 2024) is the result of Bill no. 1090 (2024-02 of 4 March 2024) received by the Parliament on 26 March 2024, was passed on 4 December 2024.

The provisions of the law come into force 3 months after its publication in the Journal de Monaco.

A provision relating to the "management of risks associated with the care of individuals by healthcare professionals or establishments" had originally been included in bill no. 1040, which became Law no. 1.541 of 16 December 2022, but was ultimately dedicated solely to nosocomial infections, for the sake of "readability" (Explanatory memorandum to bill no. 1090).

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Presentation

The aim of Law no. 1.567 is for healthcare professionals and establishments to prevent "the occurrence of any undesirable event associated with healthcare affecting the person being cared for and, if such an event occurs, to identify it, analyse its causes, mitigate or eliminate its harmful effects for that person and implement measures to prevent its recurrence". (Explanatory memorandum to Bill no. 1090)

Bill no. 1090 originally distinguished between two legal frameworks for the management of risks associated with healthcare, one applicable to healthcare establishments and the other to healthcare professionals, "because the obligations incumbent on healthcare establishments cannot be identical to those of healthcare professionals due to the difference in resources, particularly human resources, that exist between them". (Explanatory memorandum to Bill no. 1090).

In addition, the Parliament extended the scope of the law, originally limited to healthcare establishments and healthcare professionals practising outside these establishments, to establishments where particularly vulnerable people stay, in particular medico-social establishments for dependent elderly people.

Provisions relating to the powers of public health inspectors are set out in Law no. 1.568 of 12 December 2024 (JDM no. 8726 of 20 December 2024), which was passed by the Parliament on the same day.

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IN DETAIL

¤ COMMON INTRODUCTORY PROVISIONS

— Definition of the concept of "adverse events associated with healthcare" ("événements indésirables associés aux soins", EIAS) (art. 1):

• "An adverse event associated with care is an event which is associated with any medical act or treatment performed on a person, which is unexpected with regard to that person's state of health and pathology and which has potentially harmful consequences for that person."

• Classification of EIAS into 3 categories: 1) nosocomial infections as defined in art. 1 of Law no. 1.541 of 16 December 2022, 2) healthcare-associated infections, 3) other EIAS not previously mentioned.

— Definition of "healthcare professional" ("professionnels de santé") (art. 2):

• "any person who pursues a professional activity in the healthcare sector subject to a particular legislative or regulatory status or whose title is protected, namely any person practising the profession of doctor, dental surgeon, midwife, psychologist or osteopath or a profession of pharmacy or medical auxiliary".

— Definition of "health care establishment" ("établissements de santé") (art. 2):

• "any public or private establishment which diagnoses, monitors and treats patients, the injured or pregnant women and which provides care with accommodation and, where appropriate, in an outpatient or home care capacity. Home care may be taken to mean the place of residence or a medical-social establishment or service with accommodation."

— Definition of a "medico-social establishment" (art. 2)

• "any public or private establishment that carries out one or more missions of general interest and social utility in the field of medico-social care for a vulnerable population."

— Obligation to manage risks associated with care (art. 3):

• "This management aims to prevent the occurrence of any undesirable event associated with care affecting the person being cared for and, in the event of such an event occurring, to identify it, analyse its causes, mitigate or eliminate its harmful effects for that person and implement measures to prevent its recurrence".

— The role of the medical inspectors of public health is to ensure the application of the Law and the regulatory texts adopted for its application (art. 4).

¤ MANAGING RISKS ASSOCIATED WITH CARE IN A HEALTH ESTABLISHMENTS (Title I)

— Obligation to draw up and implement a policy for continuous improvement in the quality and safety of care and a policy for managing the risks associated with care (art. 5).

— Organisation in charge of the fight against EIAS (Chapter I)

• Obligation to set up an organisation responsible for the implementation of the policy for managing risks associated with healthcare, whose members must be chosen from among the professionals working in the health care organisation (professionals employed by the health care organisation and professionals working exclusively on a self-employed basis in the health care organisation - including at least two doctors assigned to different departments, a nurse and, where appropriate, a pharmacist and a biohygienist) (art. 6).

• Tasks of the organisation, which may be divided between its members in accordance with the establishment's internal rules (art. 7).

— Reporting of certain EIAS (Chapter II)

The law is based on the provisions of the French Public Health Code (art. R.1413-67 to R.1413-73 created by Decree no. 2016-1606 of 25 November 2016 on the reporting of serious adverse events associated with healthcare and regional support structures for healthcare quality and patient safety).

• Obligation to report either a nosocomial infection or a serious adverse event associated with healthcare ("événement indésirable grave associé aux soins", EIGAS), without delay, to the director of health action (art. 8 to 12).

• The declaration of a nosocomial infection concerns any nosocomial infection which is either:
1) is unexpected or unusual due to the nature or characteristics, in particular the resistance profile to anti-infectives, of the pathogen in question ;
2) is unexpected or unusual due to the location or circumstances of the infection in the person affected;
3) occurs in the form of clustered cases;
4) has resulted in death;
5) is a notifiable disease.

• An EIGAS report concerns any adverse event associated with healthcare, the consequence of which is either death, a life-threatening situation or the probable occurrence of a permanent functional impairment, including a congenital anomaly or malformation.

• Content of the report (art. 13 and 14)

— Corrective measures to prevent recurrence (Chapter III, art. 15)

• Analysis and corrective action plan to be communicated in writing to the Director of the Direction sanitaire.

— Informing the victim of an EIAS (Chapter IV, art. 16)

• In the case of a nosocomial infection, Law no. 1.541 of 16 December 2022 already lays down the rules governing this information.

• These same rules apply to other EIAS.

¤ MANAGEMENT OF RISKS ASSOCIATED WITH CARE OUTSIDE A HEALTH ESTABLISHMENT AND A MEDICO-SOCIAL ESTABLISHMENT (Title II)

— Reporting certain EIAS (Chapter I)

• Obligation for any healthcare professional practising outside a healthcare establishment and a medico-social establishment to report either a healthcare-associated infection or an EIGAS detected, without delay, to the director of health action (art. 17 and 18)

• The declaration of a healthcare-associated infection concerns any healthcare-associated infection which is either:
1) is unexpected or unusual due to the nature or characteristics, in particular the anti-infectious drug resistance profile, of the pathogen in question ;
2) is unexpected or unusual due to the location or circumstances of the
of the infection in [the person affected ;
3) occurs in the form of clustered cases;
4) has resulted in death;
5) is a notifiable disease.

• The declaration of an EIGAS concerns any adverse event associated with care, the consequence of which is either death, or the endangering of vital prognosis, or the probable occurrence of a permanent functional deficit, including a congenital anomaly or malformation.

— Informing the victim of an EIAS (Chapter II, art. 18)

•The provisions of Law no. 1.541 of 16 December 2022 relating to nosocomial infections also apply to any healthcare professional practising outside a healthcare establishment and a medico-social establishment for any healthcare-associated infection and any EIAS.

¤ MANAGEMENT OF RISKS ASSOCIATED IN A MEDICO-SOCIAL ESTABLISHMENT (Title II)

— Declaration of certain EIAS (Chapter I, art. 20)

• Obligation to report the occurrence of any healthcare-associated infection, or any serious healthcare-associated adverse event, observed in their departments, to the health action directorate, under the same conditions as representatives of healthcare establishments and healthcare professionals.

— Corrective measures to prevent recurrence (Chapter II, art. 21)

• Obligation for the legal representative of medico-social establishments to notify the director of the direction sanitaire, action, in writing, of corrective measures to prevent a repeat offence.

— Information for victims of an EIAS (Chapter III, art. 22)

• Obligation to inform victims, by reference to the provisions of Chapter IV of Law no. 1.541 of 16 December 2022 on nosocomial infections, in the event of the occurrence of any healthcare-associated infection or adverse event associated with healthcare.

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