The recent rise in real-time PCR has enabled the practice of molecular biology in our service. New infections tests may be developed, as well as some genetic tests after regulatory approval. If we considered the possibility of using this powerful tool for several years, then the science supplies of a reliable biologist became a determining factor for the development of this new sector of activity. Based on practical experience, we present the characteristics, limitations and assets associated with the implementation of this activity in a multivalent biology laboratory environment. The organizational consequences associated with the practice of genetic research have necessitated a review of the entire biological process from prescribing a biological act to presenting the results to the patient. The same applies to archiving procedures for all supporting documents. In general, the role of the Department of Biology is reinforced by the adoption of therapeutic decisions that are optimized over time and the establishment of a new dialogue with clinicians. The need to develop this activity has been confirmed by all the authorities of the center.
A new analysis may be developed by legal permissions. If the use of lab supplies has been considered in our service for several years, the hiring of an experienced chemist-clinician was the initial factor in this new area of activity. The purpose of this article is to show the reality of this new activity in the service of general biology. Organizational implications for the practice of genetic testing – a review of test results. The same goes for procedures for all related documents. The role of the clinical chemist and laboratory equipment is growing, some therapeutic decisions are being made, and a new doctor has been created with the clinicians. The need for its development was confirmed by the entire authority of the hospital.
Molecular Biology Services has long been reserved for highly specialized structures because of the complexity of its implementation. In fact, the available methods were delicate, not automated, and required restrictions on the organization of extremely limited premises. Nevertheless, the development of methods in recent years has contributed to the decompletion of this activity and placed it at the disposal of specialized medical biological laboratories. As mentioned in GBEA (Guidelines for the Good Work of Medical Biological Assays), “the introduction of molecular biology methods based on nucleic acid amplification imposes structural constraints aimed at limiting the possibility of cross-contamination with amplification products”, with three separate and independent zones: a zone designated for the preparation of reagents, a zone for sample preparation and a zone for carrying out stages of amplification and analysis of amplified products. The lawmaker, however, foresaw the advent of new science supplies, stating that “the automation of molecular biology analysis could change the requirements for facilities.” Thus, the recent development of real-time or real-time PCR methods for polymerase chain reaction (PCR) significantly reduces limitations, and moreover, automated solutions are currently available on the market. In general, the practice of molecular biology requires compliance with the “classical” elementary rules inherent in the implementation of any ordinary act of medical biology and the availability of science lab equipment.
In addition, the purpose of this article is to describe the methods by which the Department of Biology could introduce molecular biology for diagnostic purposes, in the field of infections and genetics. This activity has been carried out regularly since the beginning of 2006. We will also discuss the organizational implications of regulations. The deployment of this new tool in biology was facilitated by the involvement in November 2004 of a biologist with experience in this field. All efforts were supported by the general management, the Commission of the medical institution and the management of the “Cross-cutting activity” unit, the unit uniting the department of biology, emergency care, resuscitation, the department of nephrology and hemodialysis, as well as medical imaging and pharmaceuticals.