Evaluation Of Informed Consent Form Completeness Using the 5M Method in General Surgery Patients

Abstract

Informed consent is a fundamental legal document in medical practice, ensuring that patients provide informed approval before undergoing medical procedures. The completeness of this document is crucial for legal compliance and patient safety, as incomplete or improperly filled out consent forms can lead to legal disputes and compromise patient well-being. This study aims to evaluate the completeness of informed consent forms for general surgery patients, employing the 5M method (Man, Money, Method, Material, and Machine) to identify the factors contributing to form deficiencies. A quantitative descriptive approach was employed, with a sample of 265 forms selected using Slovin’s formula from a total of 711 forms collected between June and August 2023 at a hospital in Indonesia. The findings indicate that incomplete forms are primarily caused by human factors, such as a lack of medical personnel’s understanding of the informed consent process, procedural issues, including unclear standard operating procedures, and system limitations, such as partial integration of electronic medical records. The analysis of these factors reveals the significant impact of human error and procedural gaps on the completeness of informed consent documentation. To enhance the quality of documentation and ensure better compliance with medical regulations, this study recommends a series of improvements, including medical staff training, revision of standard operating procedures, and optimization of electronic medical record systems. Implementing these improvements is expected to strengthen compliance with medical regulations, enhance the documentation process, and contribute to better patient safety and legal protections in the healthcare setting.