French Public Health Code
In forceThe essential safety and quality requirements, referred to in Article L. 4011-2, with which the protocols provided for in Article L. 4011-1 must comply are as follows 4011-1 are as follows:
1° Comply with the good practice recommendations drawn up or validated by the Haute Autorité de santé;
2° Define the quality and safety conditions relating to the purpose of the protocol, with regard to :
a) The new intervention method, detailing the derogatory and non-derogatory acts and activities that make it up;
b) The eligibility and withdrawal criteria for the patients concerned;
c) The professional qualifications and, where applicable, the specialities of the delegating professional(s) and those of the professional(s) receiving delegation, known as delegates;
3° State the conditions of professional experience and additional theoretical and practical training required of the delegating professional(s) in relation to the delegated acts and activities;
4° Define the conditions of quality and safety of the patient care process relating to :
a) the procedures for their inclusion in the protocol and the different stages of intervention by the healthcare professionals, by means of decision trees associating an action with each situation identified, without the delegated professionals being able to make a diagnosis or therapeutic choice not provided for in the protocol ;
b) The inclusion of this new form of care in the patient's care pathway and the procedures for transmitting information to all the healthcare professionals concerned, in order to ensure continuity of care;
c) The situations justifying the patient's redirection to the delegating professional and the timeframes for implementation;
5° Defining the procedures for informing the patient and sharing health data within a secure framework in compliance with the provisions of Article L. 1110-4;
6° Determining the organisational conditions of the team with regard to:
a) The availability of the delegating professional(s) to the delegated professional(s) and the availability of a sufficient number of delegators and delegates in relation to the number of patients being cared for;
b) The risk management approach providing for the identification and analysis of risks relating to the application of the various stages of the protocol and the analysis and treatment of undesirable events as a team;
c) The declaration by healthcare professionals of their commitment to the cooperative approach governed by the protocol to their respective professional liability insurance companies or to the healthcare establishments to which they are attached, or, in the case of professionals from the armed forces health service, to the latter.
