Abstract

The advent of information technology in the medical field has increased tremendously. This
occurs especially in the case of medical laboratories where, with the exception of microbiology
examination, most of the examination processes are automated. Besides this, almost any
laboratory has implemented an information system which manages the flow of information
from the sampling to the result validation. Standardization plays an important role since quality
assurance is a requirement that has to be met in order to operate on the market. ISO 15189:2013
is the international standard of choice in the field. In Romania, any laboratory that aims at
contracting public funding must provide, by means of accreditation against this standard
technical competence. This standard contains special requirements that have to be met by the
information system deployed in the laboratory. However, the requirements are not detailed such
that the assessor would determine if the requirement is met or not. The present paper introduces
a practical assessment tool for the assessor such that it would help decide if the specific
requirements to the information systems of the ISO 15189:2013 are met. The tool can be used
for any type of laboratory: hospital, individual, chain and so forth. Besides the assessment tool,
the paper also discusses the main type of information systems deployed on the Romanian
market of medical laboratories.

Keywords

Quality Assurance, Medical Laboratory, Information Systems’ ISO 15189:2013