Background: There is growing trend for some surgical procedures previously performed in hospitals to be done in alternative settings, including office-based facilities. There has been some safety concerns reported in the media, which document serious adverse events following procedures performed in an office-based setting. To understand the current regulatory oversight of surgery in this setting ASERNIP-S conducted a review of the legislative and accreditation process governing these facilities in Australia.
Methods: Using rapid review methodology, internet searches targeted government Web sites for relevant publicly-available documents. Use of consolidated versions of legislative instruments ensured currency of information. Standards were sourced directly from the issuing authorities or those that oversee the accreditation process.
Results: Within Australia, healthcare facilities for surgery and their licensing are defined by each state and territory, which results in significant jurisdictional variation. These variations relate to the need for anesthesia beyond conscious sedation and listing of procedures in legislative instruments. In 2013, Australia adopted National Safety and Quality Health Service standards (NSQHS standards) for the accreditation of hospitals and day surgery centers; however, there is no NSQHS standard for office-based facilities. The main legislative driver for compliance is access to reimbursement schemes for service delivery.
Conclusions: The legislative and accreditation framework creates a situation whereby healthcare facilities that provide services outside the various legal definitions of surgery and those not covered by a reimbursement scheme, can operate without licensing and accreditation oversight. This situation exposes patients to potential increased risk of harm when receiving treatment in such unregulated facilities.
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http://dx.doi.org/10.1017/S0266462317001052 | DOI Listing |
J Med Syst
January 2025
Advancing a Healthier Wisconsin Endowment, Medical College of Wisconsin, Milwaukee, WI, USA.
Medical devices significantly enhance healthcare by integrating advanced technology to improve patient outcomes. Ensuring their safety and reliability requires a delicate balance between innovation and rigorous oversight, managed through the collaborative efforts of standards development organizations, standards accrediting organizations, and regulatory agencies such as the U.S.
View Article and Find Full Text PDFAnal Bioanal Chem
January 2025
European Commission, Joint Research Centre, Directorate F - Health and Food, Geel, Belgium.
Certified reference materials (CRMs) play a crucial role in ensuring the quality of analytical measurements. Particularly, the EU labelling legislation on genetically modified organisms (GMOs) in food and feed products explicitly requires CRMs for its implementation. The CRMs are used to calibrate and control the quantitative real-time polymerase chain reaction (qPCR) method and support official control laboratories, such as National Reference Laboratories (NRLs), in maintaining their ISO/IEC 17025 accreditation.
View Article and Find Full Text PDFBMC Med Educ
December 2024
Department of Medical Education, Geisinger Commonwealth School of Medicine, Geisinger College of Health Sciences, 525 Pine Street, Scranton, PA, 18509, USA.
Background: The American Society of Clinical Nutrition recommends 37 to 44 h of undergraduate medical nutrition education. The Total Health Curriculum at Geisinger Commonwealth School of Medicine (GCSOM) contains 14 h of objective-based nutritional instruction. This study aimed to examine the perceptions of key stakeholders regarding the role of nutrition in medicine and to identify barriers, opportunities for improvement, and roles/responsibilities for innovative implementation of nutrition education.
View Article and Find Full Text PDFGMS J Med Educ
December 2024
Kassenärztliche Bundesvereinigung, Dezernat Sicherstellung und Versorgungsstruktur, Abteilung Sicherstellung, Berlin, Germany.
Aims: Comprehensive provision of general healthcare (i.e. primary care) within the populace is contingent on there being enough general practitioners (GPs) in proximity to patients.
View Article and Find Full Text PDFInt J Legal Med
December 2024
Department of Medical Biology, Section Clinical Anatomy and Embryology, AmsterdamUMC, Location Academic Medical Centre, Meibergdreef 9, Amsterdam, AZ, 1105, The Netherlands.
Forensic taphonomy is the study of postmortem changes of human remains for the purpose of answering legal investigative questions. Many variables can affect the pattern and rate of decomposition of remains, posing challenges for taphonomic studies and estimation of the postmortem interval. Given the gap in knowledge regarding the suitability of using frozen remains to extrapolate conclusions to fresh material, investigating the effects of freeze-thaw cycles followed by burial on human remains is vital for forensic practice and taphonomic research.
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