Our experience of regulatory justification of using donor material for keratoplastic operations in the Udmurt Republic

Abstract

Purpose: to share our experience of regulatory justification to supervisory authorities of performing keratoplastic operations using native donor cornea.

Methods. A comprehensive analysis of legal and regulatory framework of the Russian Federation on transplantation.

Results. The Nomenclature of Medical Services includes several types of services which contain the word “transplantation” in their names. However, not all of them require a license to perform such procedures as “surgery (organ and (or) tissue transplantation)”. The procedure for providing medical care in “surgery (transplantation of organs and (or) human tissues)” is not applicable to the “ophthalmology” profile, since the equipment and staffing requirements contained therein are not necessary to perform keratoplasty. The list of medical organizations of the subjects of the Russian Federation performing transplantation of human organs and (or) tissues contains no medical organizations of the ophthalmological profile. According to methodological recommendations on ways to pay for medical care at the expense of mandatory medical insurance, keratoplasty is classified as “st21.005. Operations on the organ of vision”.

Conclusion. A comprehensive analysis of existing regulatory documents demonstrates that keratoplasty is exclusively related to ophthalmology, it can be performed if there is a license for ophthalmology, transportation of human organs and (or) tissues for transplantation. A healthcare organization also needs to hold a license for removal and storage of human organs and (or) tissues for transplantation. However, if any healthcare organization in the region has such a license, it may donate a donor cornea to an ophthalmological hospital if the latter does not hold such a license.