Brief Review of Accreditation Policy For X-Ray Compliance Testing Laboratory The Compli¬ance Test Program has been Implemented Since 2011 and The Updated Regulation was in 2018

Abstract

Brief Review of Accreditation Policy For X-Ray Compliance Testing Laboratory The Compli¬ance Test Program has been Implemented Since 2011 and The Updated Regulation was in 2018. According to the implementation progress, adjustments are needed to the dynamics of the problems that arise. In 2021, it is planned to prepare a draft amendment to BAPETEN Regulation Number 2 of 2018; therefore, an analysis of the implementation profile of the regulation is carried out to identify existing obstacles. One of the problems identified is the polemic of the urgency of accreditation obligations for the Compliance Testing Laboratory, which is the institution appointed by the Head of BAPETEN to carry out compliance tests and issue compliance certificates. Currently, 78% of laboratories are not accredited, most of which are importing companies. Therefore, it will have implications for reducing laboratory availability and constraining the compliance test process in health facilities. This paper aims to identify aspects that can hinder the application for laboratory accreditation, especially for importing companies, and the proposed solution that can recommend. This paper uses a regulatory impact analysis approach. The study results show that laboratory accreditation is essential to maintain the quality of services, competencies, and outputs of the laboratory so that four options that LUK can take are proposed in dealing with obstacles in applying for accreditation. This paper can provide contributions in preparing the draft amendments to BAPETEN Regulation Number 2 of 2018.