The Transformation of Medical Biology in France: a Benchmark for the EU?
Within the context of the HPST (hospital, patient, health, and territories) called “the Bachelot law” and under the leadership of M. Ballereau and A.M. Gallot, governmental experts, the new law (legislative order) reforming medical biology was published in the official journal of the French Republic on January 15, 2010. Medical biology tests are medical procedures in their own right: this is the central point upon which the reform of French medical biology is focused. This reform places medical biology fully at the heart of hospital professions and patient management, becoming a determining step in healthcare delivery for the diagnosis of most pathologies and treatment follow-up.
This legislation modernizes the legal framework for medical laboratories (laboratories de biologie médicale – LBM) laid down in 1975, to take into account medical and scientific innovations, which have occurred in the discipline since that time. It provides a uniform framework for the practice of the profession, and sets out to improve the quality of service through compulsory ISO 15189 accreditation for all laboratories, no later than the end of 2016.
The Order contains 11 articles and first gives a definition of medical biology testing, the conditions under which it is to be carried out, the duties incumbent on medical laboratories, and the role of medical biologist. It is a medical procedure, which contributes towards the prevention of disease, screening, diagnosis and evaluation of the risks of onset of pathological conditions, as well as part of the decision-making, therapeutic management, and the determination or follow-up of physiological or physiopathological conditions of the human being.
In particular, the Order specifies the conditions for conducting medical biology tests outside the laboratory, and sets limits for the scope of this discipline (point-of-care testing, fast screening tests for use by clinicians and home tests for patients). The involvement of the medical biologist in the therapeutic education of patients is set out, notably for the new inspection of self-monitoring measurement devices.
The reform reasserts the professional transformation of the discipline. No longer a technician, the medical biologist has a full medical role to play and is part of patient management. Together with the clinical practitioner, the medical biologist is now responsible for the entirety of the medical procedure henceforth called a medical biology examination. Medical biologist-clinical practitioner communication is reinforced: obtaining relevant clinical information, the right to “substitute” examinations having regard to rules of good practice for proper prescription. The responsibility of the medical biologist in the preanalysis phase is specified, for example, with respect to sampling procedures in public and private sectors and in different situations (laboratory, home, care institution). The converging points with pathological anatomy and cytology are specified.
The medical biologist is a doctor or pharmacist holding a specialization diploma in Medical Biology. The rules authorizing the practicing of this discipline by other professionals, notably those trained in other countries are laid down. Should the professional qualification, as certified by training certificates issued by third party States and relevant professional experience, indicate any substantial differences compared with required qualifications in France, compensation measures are to be followed in the form of aptitude tests or adaptation courses.
The Reform therefore sets out to harmonize the operating rules for clinical pathology laboratories between the private sector and the public sector. It facilitates cooperation between public institutions and the two sectors, notably through public health cooperation groups. The Order further comprises measures intended to sustain the continuum of medical biology services within one same public health territory. The Reform also sets out to achieve the grouping of laboratories and to maintain territorial limits for medical laboratory activity. Medical laboratories may be multisite (single laboratory in a hospital or hospital district within the territory), but these sites must not be set up on more than three adjoining public health territories, unless dispensation is given by the regional public health authority .
The Reform sets up systems to guarantee a plurality of offer for medical laboratory services within a public health territory by laying down so-called precautionary rules. It is prohibited in particular for a person, whether legal or natural, to acquire shares in companies operating a medical laboratory if the result of this acquisition would be to enable such person to control a proportion, whether directly or indirectly, that is more than “33% of the total quantity of medical laboratory examinations conducted” within one same infraregional public health territory.
The Order also prohibits an interest in the share capital of laboratories to be taken by legal or natural persons engaged in a health profession authorized to prescribed pathology examinations, or engaged in the activity of supplier, distributor or manufacturer of in vitro medical diagnosis devices, or employed by an insurance company, or by provident, pension or social welfare bodies.
The Order encourages the professionalized inspection, i.e., with the imposed order and structure of examinations on the basis of reference systems, published in particular by the national authority for health (Haute Autorité de Santé – HAS) and introduces a financial penalty for any medical laboratories conducting any examinations that are not warranted under the nomenclature of medical biology procedures or under good practice recommendations in force.
The Order sets up a compulsory accreditation scheme for medical laboratories, the deadline of which is November 1, 2016, with an interim date of November 1, 2013, when evidence must be provided that they have taken steps to obtain this accreditation. This accreditation concerns all laboratories, private and public, university and non university, to reinforce the quality and safety of testing. The French accreditation committee (Comité français d’accreditation -COFRAC) is the sole body granting this accreditation based on standards NF EN ISO 15189 and 22870. Decisions given by the COFRAC are to be transmitted to the national authority for health (HAS), to the French health products safety agency (Agence française de sécurité sanitaire des produits de santé -AFSSAPS), to the Biomedicine Agency (ABM) and to the Regional Health Agency (ARS).
The Order also redefines the National Quality Control of medical biology test results, to be ensured by AFSSAPS, and additionally an obligation of external quality evaluation is introduced for all medical biology tests.
The Order also specifies the conditions for inspections to be carried out by inspection officers and their relations with COFRAC. Administrative, disciplinary, and criminal penalties are determined.
The Order describes the conditions under which medical laboratory technicians must practice their profession i.e., medical biology, or cytopathological anatomy. This particular article enables laboratory technicians to enter into the category of health professionals.
France is at the forefront in setting up compulsory accreditation. Taking part in a clinical research trial has become a challenge if a medical laboratory is not accredited. Accreditation contains the word “credit,” i.e., confidence. Etymologically, therefore, the purpose is to reinforce trust. Regulatory restrictions are the evincing of changes in context, and a response to our citizens’ expectations with regard to public health, and indeed the expectations of the international scientific community. Having regard to the critical nature of this undertaking, the IFCC, EFCC, and the ILAC (International Laboratory Accreditation Cooperation) are soon to sign a memorandum of mutual understanding not only to strengthen the credibility and trust in clinical pathology in line with internationally recognized rules, but also to support the community of clinical pathologists in the face of these cultural changes.