Table 3.
Requirements for registration of a genetic clinic
Place | Equipment | Employees |
---|---|---|
A room with an area of 20 m2 with appropriate aseptic arrangements | Equipment and accessories necessary for carrying out clinical examination by an obstetrician/gynecologist | A gynecologist with adequate experience in prenatal diagnostic procedures (should have performed at least 20 procedures under the supervision of a gynecologist experienced in the procedure, which is going to be carried out, for example, chorionic villi biopsy, amniocentesis, cordocentesis, and others indicated at B above) |
Equipment, accessories necessary for other facilities required for operations envisaged in the act | ||
An ultrasonography machine* | ||
Appropriate catheters and equipment for carrying out chorionic villi aspirations per vagina or per abdomen* | ||
Appropriate sterile needle for amniocentesis or cordocentesis* | ||
A suitable fetoscope with appropriate accessories for fetoscopy, fetal skin or organ biopsy, or fetal blood sampling shall be optional | ||
Equipment for dry and wet sterilization | A radiologist or registered medical practitioner for carrying out ultrasonography. The required experience shall be 100 cases under supervision of a similarly qualified person experienced in these techniques | |
Equipment for carrying out emergency procedures such as evacuation of uterus or resuscitation in case of need | ||
Platforms for FISH, NGS, and CGH arrays |
*These constitute the minimum requirement of equipment for conducting the relevant procedure. FISH=Fluorescence in situ hybridization, NGS=Next-generation sequencing, CGH=Comparative genomic hybridization