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Recently, two laws of major importance were published in the Journal Officiel . These ordinances (décrets n° 2002-1197 et 2002-1198) are determinant for the treatment of renal failure by renal replacement therapy. They are the fruit of an intense collaboration between professionals, representatives of the patients, Health Insurance and the government. The aim of this large concertation was to obtain an agreement about the management of quality and safety of treatments, as well as the quality of life of the patients.
The outcome was the publication of statutory texts defining four modalities of treatment for chronic renal insufficiency by renal replacement therapy :
- the centre of hemodialysis,
- the "medicalized" dialysis unit (unité de dialyse médicalisée)
- the autodialysis unit (single or assisted autodialysis - see Nurses)
- home dialysis (hemo or CAPD)
This scale of care offer takes into account the medical situation of patients and is supported by an adapted medical and paramedical infrastructure. For each modality of treatment, minimal standards for (para)medical staff are required in order to guaranty quality and security.
- Centre of Hemodialysis :
Hospitalization must be possible.
Patients for whom the presence of a nephrologist is required.
At least 8 stations, no more than 3 patients a day.
Two stations for isolated care.
At least 2 nephrologists, duty shared with other institutions if necessary.
1 nurse for 4 patients ; 1 auxiliary or 1 more nurse for 8 patients.
- Medicalized dialysis unit (unité de dialyse médicalisée - UDM) :
Patients for whom a permanent medical presence is not required
At least 6 stations.
One station for isolated care.
Visit of a nephrologist 1-3 tmes a week.
1 nurse for 4 patients.
- Autodialysis unit (simple or assisted autodialysis) :
Patients able to care themselves (except punction).
They received education.
One generator per patient.
Visit of a nephrologist every trimester
Patients who need a nurse for one or more actions of their treatment.
They received education.
One generator for 2 patients a day.
Visit of a nephrologist every month.
1 nurse for 6 patients.
- Home dialysis :
Patients who received education (in a centre, UDM or specific unit).
The help of a nurse may be requested.
- Peritoneal Dialysis :
Patients who received education.
The help of a nurse may be requested. Education and follow-up are realized by a a team with at least 1 nurse for 10 patients.
These ordinances define a new regulation system, abrogating the old-fashioned
and maladjusted "national need index" (indice national des besoins),
sharply criticized by the whole community of dialysis actors.
The new system is based upon an evaluation of health needs, taking into account epidemiologic data.
The ordinances have as main targets :
- to guarantee of free choice for the patient
- to offer the best and most adjusted care
- to preserve a care of neighbourhood
- to preserve a diversified care (especially peritoneal dialysis)
- to preserve the continuity of care and the orientation of the patients between the different modalities of treatment.
The starting of application will be progressive. During a transient period - from September 202 to new autorizations following regional plans of sanitary organization (SROS) - existing autorizations will be automatically prorogued. New authorizations will be delivered as new SROS will be developed.
(Décrets 2002 - DHOS 2002 - Chanard)