The document provides an overview of medicolegal issues and handling complaints in a hospital setting. It discusses the establishment of a new Unit Etika & Medikolegal at Hospital Kuala Lumpur including its roles and organizational structure. Key topics covered include classification of complaints, statistics on complaint types and resolutions, the complaints handling process, issues related to communication and medical documentation, and principles of obtaining valid informed consent from patients.
Basic principle of medicolegal management in emergency departmentLee Oi Wah
This document provides guidelines for managing patients' property in healthcare facilities. It states that hospitals are responsible for safely storing any valuable items patients arrive with while unconscious, and must record any movements of patient property. Signs should also inform patients not to bring valuables, and that the hospital is not liable for lost, stolen or damaged personal items. When property is unclaimed, hospitals must handle it according to established guidelines. Proper documentation in property log books is required from all relevant departments.
This document provides guidance and reminders for an educational session on informed consent. It instructs participants to turn off electronics and participate in a debriefing session. It outlines learning objectives around shared decision-making, the informed consent conversation, and obtaining consent consistent with standards. Key elements of the informed consent conversation are described, including setting the environment, discussing options and patient preferences, and documenting the discussion and patient decision. Potential challenges like incapacitated patients, treatment refusal, language barriers, and consent for minors are also addressed.
This document discusses laws related to healthcare in India. It outlines the consumer protection laws and agencies established to hear consumer complaints, including the District Forum for claims up to 20 lakh rupees, the State Commission for claims from 20 lakh to 1 crore rupees, and the National Commission for claims over 1 crore rupees. Sections 269 and 270 of the Indian Penal Code make spreading infectious diseases unlawful. The document also discusses legal standards and cases related to medical negligence, patient safety, informed consent, and confidentiality. Key defenses in medical negligence cases include arguing that standard medical practices were followed or that the patient assumed the risks.
The document discusses adverse event and serious adverse event reporting in clinical trials. It provides definitions for key terms like adverse event, serious adverse event, and unexpected adverse reaction. It outlines ICH-GCP guidelines for safety reporting, including immediate reporting of SAEs to sponsors. Finally, it presents a case study describing a subject's experience of accelerated hypertension as an SAE during a clinical trial and the appropriate reporting steps taken.
The document discusses several ethical principles in healthcare including autonomy, beneficence, non-maleficence, and justice. It also reviews issues around patient competence, capacity, consent and best interests. Guidelines are provided around withdrawing treatment, Do Not Attempt Resuscitation orders, and considering a patient's wishes based on advance directives or views of family members when a patient lacks capacity.
Adverse Events and Serious Adverse Events - Katalyst HLSKatalyst HLS
This document discusses adverse events and serious adverse events in clinical trials. It reviews FDA inspection findings related to reporting adverse events and the regulations surrounding adverse event reporting. It outlines how adverse events should be recorded, including source documentation and attribution. It also discusses reporting criteria and timelines for reporting adverse events to sponsors and regulatory bodies. Finally, it reviews considerations for auditing adverse events, such as whether events were properly graded and reported.
This document outlines safety reporting procedures for a clinical trial, including definitions of adverse events and serious adverse events, causality assessment guidelines, reporting timelines, and medical management of adverse events. Adverse events will be monitored for 28 days following vaccination and reported within required timelines. Serious adverse events must be reported within 24 hours of occurrence and followed up until resolution. The ethics committee, regulatory authorities, and sponsor will assess causality and determine compensation if needed.
Basic principle of medicolegal management in emergency departmentLee Oi Wah
This document provides guidelines for managing patients' property in healthcare facilities. It states that hospitals are responsible for safely storing any valuable items patients arrive with while unconscious, and must record any movements of patient property. Signs should also inform patients not to bring valuables, and that the hospital is not liable for lost, stolen or damaged personal items. When property is unclaimed, hospitals must handle it according to established guidelines. Proper documentation in property log books is required from all relevant departments.
This document provides guidance and reminders for an educational session on informed consent. It instructs participants to turn off electronics and participate in a debriefing session. It outlines learning objectives around shared decision-making, the informed consent conversation, and obtaining consent consistent with standards. Key elements of the informed consent conversation are described, including setting the environment, discussing options and patient preferences, and documenting the discussion and patient decision. Potential challenges like incapacitated patients, treatment refusal, language barriers, and consent for minors are also addressed.
This document discusses laws related to healthcare in India. It outlines the consumer protection laws and agencies established to hear consumer complaints, including the District Forum for claims up to 20 lakh rupees, the State Commission for claims from 20 lakh to 1 crore rupees, and the National Commission for claims over 1 crore rupees. Sections 269 and 270 of the Indian Penal Code make spreading infectious diseases unlawful. The document also discusses legal standards and cases related to medical negligence, patient safety, informed consent, and confidentiality. Key defenses in medical negligence cases include arguing that standard medical practices were followed or that the patient assumed the risks.
The document discusses adverse event and serious adverse event reporting in clinical trials. It provides definitions for key terms like adverse event, serious adverse event, and unexpected adverse reaction. It outlines ICH-GCP guidelines for safety reporting, including immediate reporting of SAEs to sponsors. Finally, it presents a case study describing a subject's experience of accelerated hypertension as an SAE during a clinical trial and the appropriate reporting steps taken.
The document discusses several ethical principles in healthcare including autonomy, beneficence, non-maleficence, and justice. It also reviews issues around patient competence, capacity, consent and best interests. Guidelines are provided around withdrawing treatment, Do Not Attempt Resuscitation orders, and considering a patient's wishes based on advance directives or views of family members when a patient lacks capacity.
Adverse Events and Serious Adverse Events - Katalyst HLSKatalyst HLS
This document discusses adverse events and serious adverse events in clinical trials. It reviews FDA inspection findings related to reporting adverse events and the regulations surrounding adverse event reporting. It outlines how adverse events should be recorded, including source documentation and attribution. It also discusses reporting criteria and timelines for reporting adverse events to sponsors and regulatory bodies. Finally, it reviews considerations for auditing adverse events, such as whether events were properly graded and reported.
This document outlines safety reporting procedures for a clinical trial, including definitions of adverse events and serious adverse events, causality assessment guidelines, reporting timelines, and medical management of adverse events. Adverse events will be monitored for 28 days following vaccination and reported within required timelines. Serious adverse events must be reported within 24 hours of occurrence and followed up until resolution. The ethics committee, regulatory authorities, and sponsor will assess causality and determine compensation if needed.
The document discusses principles for maintaining confidentiality in clinical trials, including:
1. Privacy, confidentiality, and anonymity of participant data should be protected according to regulatory requirements.
2. Personally identifiable participant data is kept confidential via informed consent agreements.
3. Breaches of confidentiality pose risks to participants and only essential information should be collected with consent.
Legal issues regularly arise in emergency medicine. Doctors have a duty of care to provide treatment that is in the patient's best interests and of an appropriate standard. Valid consent requires the patient be competent, receive full disclosure of risks/benefits, and freely agree to treatment. Doctors must assess a patient's capacity to consent using functional tests of their understanding. Privacy and confidentiality principles also apply but have exceptions like mandatory reporting. Proper documentation is important to demonstrate reasonable care was provided to avoid negligence claims.
This document discusses various laws related to medical negligence in India. It outlines the key principles from acts like the Contract Act 1872, Law of Torts, Consumer Protection Act 1986, and the Indian Penal Code 1860 as they relate to medical negligence cases. It also summarizes several important court cases that have helped define the duty of care expected from doctors and analyzed defenses against allegations of negligence.
The document summarizes a study that assessed patient perspectives on informed consent practices for surgery. 103 postoperative patients at PIMS/SZABMU completed a questionnaire about their consent process. The results showed significant deficiencies: only 8.73% reported complications were explained, 2.91% reported anesthesia complications explained, and 65.04% reported not understanding the information. While 86.4% were satisfied, most consent was given by others and not the patient. The authors conclude significant inadequacy exists in current informed consent practices and that practices need revising to make the process more informed.
Root Cause Analysis, Delay of Sample Sending to Referral LaboratoryZe Wehrmacht Beemer
1) There was a delay of 15 days in receiving histopathology/cytology samples from two patients at Sarawak General Hospital. The samples were requested on September 6th and 3rd but were not received by the hospital until September 19th and 18th respectively.
2) An investigation identified several contributing factors to the delay, including insufficient laboratory staff due to maternity leave, a manual paper-based request system that took time to enter requests, samples missing the scheduled weekly sending date, and a heavy workload packing samples.
3) An immediate suggestion was made to send all urgent samples immediately and station a medical officer in the laboratory to filter urgent and non-urgent requests. A plan of action was proposed
This document discusses informed consent forms and processes. It covers key elements that should be included in informed consent forms such as study description, risks, benefits, confidentiality, compensation, voluntary participation, and contact information. It also describes the informed consent process as an ongoing communication between researcher and participant that begins before the study and continues throughout. Documentation of the informed consent process is important. The document also discusses translating informed consent forms into local languages understood by participants and having them back translated to ensure accuracy.
The document provides guidelines on good medical practice and maintaining doctor-patient confidentiality. It outlines 10 golden rules of good medical practice including practicing with kindness, ethics and honesty. It discusses maintaining confidentiality of patient records and communications. Specific topics covered include doctor-patient relationships, obtaining consent, maintaining confidentiality in electronic medical records, disclosures required by law, and disclosures for purposes like medical education.
Medical errors represent a serious public health problem and occur frequently in various healthcare settings. They can involve medicines, surgery, diagnosis, equipment, or lab reports. Studies estimate medical errors may be the third leading cause of death in the US, resulting in between 200,000 to 400,000 deaths per year. Many common types of errors like misdiagnosis, unnecessary treatment, medication mistakes, and uncoordinated care have been reduced through standardized protocols and safety practices, but medical errors still frequently harm and kill patients.
DEATH on Operation Table (DOT) Dr. Sharda Jain Lifecare Centre Lifecare Centre
The document discusses death on the operation table (DOT) from the perspective of gynecologists and surgeons. It notes that DOT is always a possibility in any surgery and shares results from a survey that found 80% of DOT cases are non-preventable and often occur during emergency surgeries. The document provides strategies for handling DOT, including proper documentation, informed consent, communication with relatives and police, and the importance of support systems. It emphasizes honesty, integrity, and a sympathetic approach in these difficult situations.
Lecture 13 privacy, confidentiality and medical recordsDr Ghaiath Hussein
A lecture on privacy, confidentiality and medical records delivered to Alfarabi Medical College undergraduate medical students in the week starting 27.11.2016
The document provides an overview of Good Clinical Practice (GCP) training, including:
1. A refresher on the key events that led to the development of GCP guidelines like the Nuremberg Code and Declaration of Helsinki in response to unethical medical experiments and drug issues.
2. An overview of the regulatory framework for clinical trials in Europe and the UK, including EU directives and UK laws that implement GCP principles.
3. A discussion of what guidelines and regulations are applicable for the conduct of clinical trials today, including ICH E6 and EU Clinical Trials and GCP directives.
This document provides an overview and summary of a webinar presentation on health care consent and advance care planning. The presentation covers the legal framework for health care decision making in Ontario, including who can provide consent, the definition of capacity, substitute decision makers, informed consent, advance care planning, and resolving disagreements. It was presented by Judith Wahl from the Advocacy Centre for the Elderly.
Good Clinical Practice (GCP) guidelines provide standards for conducting clinical trials involving human subjects. The history of GCP includes events like the Nuremberg Code (1949), Declaration of Helsinki (1964), and ICH guidelines (1990-1997) that were developed in response to ethical issues in clinical research. The ICH GCP guideline has 8 sections covering topics like investigator responsibilities, informed consent, and essential trial documents. GCP aims to protect subject rights and safety while ensuring reliable trial data.
The document discusses the roles and responsibilities of ethics committees (ECs) or institutional review boards (IRBs). It states that ECs are independent bodies composed of medical, scientific, and non-scientific members who ensure the protection of human subjects in clinical trials. Their key responsibilities include reviewing and approving study protocols and informed consent documents. The document outlines that ECs should have a diverse membership including specialists in different areas like science, medicine, ethics, law, and lay persons. It explains the perspectives and expertise that different member types, such as basic scientists, legal experts, and social workers, provide to the EC. Finally, it states that the primary purpose of EC/IRB review is to assure the protection of subjects' rights
A part from an incident, accident or a sentinel event, OVR would implement events, that should be of a mandatory sstep, for accreditation of health institutions.
PE101: Introduction to Patient Engagement in Health ResearchCHICommunications
The document introduces patient engagement and the PREPPP award launch. It defines patient-oriented research as research engaged conducted with patients as partners that focuses on patient priorities and aims to improve outcomes and healthcare. Patient engagement means the meaningful involvement of patients in the governance, priority-setting, conduct, and knowledge translation of research. It discusses why engagement is important to ensure research addresses issues important to patients and improves outcomes. It also outlines levels of engagement from passive to active collaborative partnerships and provides resources for learning more about patient engagement.
The document discusses mental health laws and policies in Malaysia. It provides an overview of objectives of mental health laws, China's special psychiatric hospitals called "Ankang" which classify patients into three categories, and definitions of "political maniacs" and cases of political dissidents held in psychiatric facilities. It also summarizes Malaysia's Mental Disorders Ordinance from 1952 and the new Mental Health Act from 2001, outlining admission procedures, criteria for involuntary commitment, deficiencies of the older law, and rights of patients under the new act.
Dokumen tersebut membahas tentang hubungan hukum antara pasien dan dokter, definisi kelalaian medis, penyebab terjadinya sengketa medis, dan cara menghindari kelalaian medis. Dokumen ini juga menjelaskan tanggung jawab hukum, etik, dan profesi dokter dalam memberikan pelayanan kesehatan.
The document discusses informed consent and its importance. It defines informed consent as communication between a patient and physician that results in the patient authorizing agreement to a medical intervention. Informed consent is required by law, ethics, and regulations. It helps ensure patient safety, satisfaction, and reduces litigation risks. The clinician is responsible for obtaining informed consent, but a team approach is needed. Informed consent is required for invasive or complex procedures and includes discussing diagnosis, treatment options, risks and benefits, and alternatives. Consent can be provided by a competent patient or their healthcare representative. Improving informed consent involves simplifying language, allowing questions, and ensuring understanding.
Medical Records is a foremost important in the healthcare accreditation bodies like JCI,NABH are very adherent about its documentation,retention and confidentiality.
The document discusses principles for maintaining confidentiality in clinical trials, including:
1. Privacy, confidentiality, and anonymity of participant data should be protected according to regulatory requirements.
2. Personally identifiable participant data is kept confidential via informed consent agreements.
3. Breaches of confidentiality pose risks to participants and only essential information should be collected with consent.
Legal issues regularly arise in emergency medicine. Doctors have a duty of care to provide treatment that is in the patient's best interests and of an appropriate standard. Valid consent requires the patient be competent, receive full disclosure of risks/benefits, and freely agree to treatment. Doctors must assess a patient's capacity to consent using functional tests of their understanding. Privacy and confidentiality principles also apply but have exceptions like mandatory reporting. Proper documentation is important to demonstrate reasonable care was provided to avoid negligence claims.
This document discusses various laws related to medical negligence in India. It outlines the key principles from acts like the Contract Act 1872, Law of Torts, Consumer Protection Act 1986, and the Indian Penal Code 1860 as they relate to medical negligence cases. It also summarizes several important court cases that have helped define the duty of care expected from doctors and analyzed defenses against allegations of negligence.
The document summarizes a study that assessed patient perspectives on informed consent practices for surgery. 103 postoperative patients at PIMS/SZABMU completed a questionnaire about their consent process. The results showed significant deficiencies: only 8.73% reported complications were explained, 2.91% reported anesthesia complications explained, and 65.04% reported not understanding the information. While 86.4% were satisfied, most consent was given by others and not the patient. The authors conclude significant inadequacy exists in current informed consent practices and that practices need revising to make the process more informed.
Root Cause Analysis, Delay of Sample Sending to Referral LaboratoryZe Wehrmacht Beemer
1) There was a delay of 15 days in receiving histopathology/cytology samples from two patients at Sarawak General Hospital. The samples were requested on September 6th and 3rd but were not received by the hospital until September 19th and 18th respectively.
2) An investigation identified several contributing factors to the delay, including insufficient laboratory staff due to maternity leave, a manual paper-based request system that took time to enter requests, samples missing the scheduled weekly sending date, and a heavy workload packing samples.
3) An immediate suggestion was made to send all urgent samples immediately and station a medical officer in the laboratory to filter urgent and non-urgent requests. A plan of action was proposed
This document discusses informed consent forms and processes. It covers key elements that should be included in informed consent forms such as study description, risks, benefits, confidentiality, compensation, voluntary participation, and contact information. It also describes the informed consent process as an ongoing communication between researcher and participant that begins before the study and continues throughout. Documentation of the informed consent process is important. The document also discusses translating informed consent forms into local languages understood by participants and having them back translated to ensure accuracy.
The document provides guidelines on good medical practice and maintaining doctor-patient confidentiality. It outlines 10 golden rules of good medical practice including practicing with kindness, ethics and honesty. It discusses maintaining confidentiality of patient records and communications. Specific topics covered include doctor-patient relationships, obtaining consent, maintaining confidentiality in electronic medical records, disclosures required by law, and disclosures for purposes like medical education.
Medical errors represent a serious public health problem and occur frequently in various healthcare settings. They can involve medicines, surgery, diagnosis, equipment, or lab reports. Studies estimate medical errors may be the third leading cause of death in the US, resulting in between 200,000 to 400,000 deaths per year. Many common types of errors like misdiagnosis, unnecessary treatment, medication mistakes, and uncoordinated care have been reduced through standardized protocols and safety practices, but medical errors still frequently harm and kill patients.
DEATH on Operation Table (DOT) Dr. Sharda Jain Lifecare Centre Lifecare Centre
The document discusses death on the operation table (DOT) from the perspective of gynecologists and surgeons. It notes that DOT is always a possibility in any surgery and shares results from a survey that found 80% of DOT cases are non-preventable and often occur during emergency surgeries. The document provides strategies for handling DOT, including proper documentation, informed consent, communication with relatives and police, and the importance of support systems. It emphasizes honesty, integrity, and a sympathetic approach in these difficult situations.
Lecture 13 privacy, confidentiality and medical recordsDr Ghaiath Hussein
A lecture on privacy, confidentiality and medical records delivered to Alfarabi Medical College undergraduate medical students in the week starting 27.11.2016
The document provides an overview of Good Clinical Practice (GCP) training, including:
1. A refresher on the key events that led to the development of GCP guidelines like the Nuremberg Code and Declaration of Helsinki in response to unethical medical experiments and drug issues.
2. An overview of the regulatory framework for clinical trials in Europe and the UK, including EU directives and UK laws that implement GCP principles.
3. A discussion of what guidelines and regulations are applicable for the conduct of clinical trials today, including ICH E6 and EU Clinical Trials and GCP directives.
This document provides an overview and summary of a webinar presentation on health care consent and advance care planning. The presentation covers the legal framework for health care decision making in Ontario, including who can provide consent, the definition of capacity, substitute decision makers, informed consent, advance care planning, and resolving disagreements. It was presented by Judith Wahl from the Advocacy Centre for the Elderly.
Good Clinical Practice (GCP) guidelines provide standards for conducting clinical trials involving human subjects. The history of GCP includes events like the Nuremberg Code (1949), Declaration of Helsinki (1964), and ICH guidelines (1990-1997) that were developed in response to ethical issues in clinical research. The ICH GCP guideline has 8 sections covering topics like investigator responsibilities, informed consent, and essential trial documents. GCP aims to protect subject rights and safety while ensuring reliable trial data.
The document discusses the roles and responsibilities of ethics committees (ECs) or institutional review boards (IRBs). It states that ECs are independent bodies composed of medical, scientific, and non-scientific members who ensure the protection of human subjects in clinical trials. Their key responsibilities include reviewing and approving study protocols and informed consent documents. The document outlines that ECs should have a diverse membership including specialists in different areas like science, medicine, ethics, law, and lay persons. It explains the perspectives and expertise that different member types, such as basic scientists, legal experts, and social workers, provide to the EC. Finally, it states that the primary purpose of EC/IRB review is to assure the protection of subjects' rights
A part from an incident, accident or a sentinel event, OVR would implement events, that should be of a mandatory sstep, for accreditation of health institutions.
PE101: Introduction to Patient Engagement in Health ResearchCHICommunications
The document introduces patient engagement and the PREPPP award launch. It defines patient-oriented research as research engaged conducted with patients as partners that focuses on patient priorities and aims to improve outcomes and healthcare. Patient engagement means the meaningful involvement of patients in the governance, priority-setting, conduct, and knowledge translation of research. It discusses why engagement is important to ensure research addresses issues important to patients and improves outcomes. It also outlines levels of engagement from passive to active collaborative partnerships and provides resources for learning more about patient engagement.
The document discusses mental health laws and policies in Malaysia. It provides an overview of objectives of mental health laws, China's special psychiatric hospitals called "Ankang" which classify patients into three categories, and definitions of "political maniacs" and cases of political dissidents held in psychiatric facilities. It also summarizes Malaysia's Mental Disorders Ordinance from 1952 and the new Mental Health Act from 2001, outlining admission procedures, criteria for involuntary commitment, deficiencies of the older law, and rights of patients under the new act.
Dokumen tersebut membahas tentang hubungan hukum antara pasien dan dokter, definisi kelalaian medis, penyebab terjadinya sengketa medis, dan cara menghindari kelalaian medis. Dokumen ini juga menjelaskan tanggung jawab hukum, etik, dan profesi dokter dalam memberikan pelayanan kesehatan.
The document discusses informed consent and its importance. It defines informed consent as communication between a patient and physician that results in the patient authorizing agreement to a medical intervention. Informed consent is required by law, ethics, and regulations. It helps ensure patient safety, satisfaction, and reduces litigation risks. The clinician is responsible for obtaining informed consent, but a team approach is needed. Informed consent is required for invasive or complex procedures and includes discussing diagnosis, treatment options, risks and benefits, and alternatives. Consent can be provided by a competent patient or their healthcare representative. Improving informed consent involves simplifying language, allowing questions, and ensuring understanding.
Medical Records is a foremost important in the healthcare accreditation bodies like JCI,NABH are very adherent about its documentation,retention and confidentiality.
This document defines a medical record, outlines its uses and purposes, and describes the different forms and documentation standards for medical records. It discusses policies around retention, destruction, and the functions of a medical records department. A medical record contains a patient's health information and is used for continued care, communication between providers, research, and administration. It must be properly documented, including being legible, signed, dated and timed. Policies on medical record retention vary but consider legal requirements and storage costs. The medical records department admits and discharges patients, codes diagnoses, files records, and compiles statistics under the responsibility of the medical records officer.
This document outlines the purposes and policies around records and reports maintained in hospitals. It discusses:
1) The definition of medical records as clinical, scientific, administrative, and legal documents that justify a patient's diagnosis and treatment.
2) The purposes of medical records which include studying patients, avoiding omissions, ensuring continuity of care, serving as legal evidence, and providing insurance information.
3) Hospital policies for medical records including documenting employee work, evaluating medical staff performance, and aiding future planning.
The document discusses several topics related to medical records and rights. It begins by discussing the rights of unborn children to exist without discrimination based on gender. It notes that while women have reproductive rights, those rights transfer to the unborn child once conceived.
It then provides details on medical records, including their components, uses, labeling, numbering systems, and functions of the medical records department. It outlines the process for completing records, releasing information for legal cases, and preparing records for court.
Guidelines are provided on retention periods for different types of medical records. The roles and responsibilities of the medical records committee and officer are defined. Quality indicators for evaluating the medical records department are listed. Brief definitions of related topics like
This document provides an overview of medical audits. It defines a medical audit as objectively evaluating the quality of medical care given to patients. The history of medical audits is discussed, noting some of the early pioneers in the field. Key materials for medical audits include medical records. Different types of audits are described, including internal audits done by medical records staff and external audits done by independent auditors. Methods, benefits, commonly found deficiencies, and overcoming deficiencies are outlined. The importance of complete, accurate medical records is emphasized for patient care, legal reasons, and quality assurance.
A complete medical record will have a patient information form, medical history, physical examination, consent form, nursing records, doctor’s orders and progress reports, and more.
1. The document outlines a draft clinical audit process for medical officers at health clinics to improve patient care quality.
2. The objectives are to ensure competency and safety, identify management weaknesses, and ensure comprehensive care.
3. The audit involves reviewing patient records and observing consultations using standardized forms. Medical officers will be audited at least twice yearly.
Two Factor Authentication Based Locker SystemIRJET Journal
This study evaluated the completeness of documentation in 268 medical records from four wards of a hospital from January to March 2022. The records were assessed on six types of forms, with incomplete documentation defined as less than half of entries filled out. Results showed the physician notes regarding patient status had the highest rate of incomplete documentation (87.7%), followed by the clinical pharmaceutical sheet (86.19%). The nursing sheet had the lowest rate of incomplete documentation (53.7%). The study concludes the documentation in patient records, especially physician notes and the clinical pharmaceutical sheet, was clearly inadequate. It recommends a quality improvement project and periodic assessments to boost medical record documentation completion.
Evaluation of the medical records documentation completenessIRJET Journal
This study evaluated the completeness of documentation in 268 medical records from four wards of a hospital from January to March 2022. The records were assessed on six types of forms. Overall, documentation was most incomplete for progress/physician notes (87.7% incomplete) and clinical pharmaceutical sheets (86.19% incomplete), which document patient status and treatment details. Nursing sheets had the most complete documentation (53.7% incomplete). The study concludes the medical record documentation in general is inadequately completed, especially for notes and treatment sheets. It recommends hospital quality improvement projects and periodic assessments to boost documentation.
This document outlines objectives for a customer targeting project for a company called "XXX". It involves identifying potential clients such as medical practices and laboratories that could purchase medical instruments. Key deliverables include a contact database of targets. The document describes analyzing national healthcare data to define target customer profiles and segmentations. It also describes integrating data on healthcare providers and moderate/highly complex clinical laboratories to identify matching targets for direct outreach.
Medical records document a patient's medical history and are important for continuity of care, defending malpractice claims, research, and more. A medical record chronicles a patient's examinations, treatments, test results, medications, and other details. It benefits patients by facilitating further treatment, and benefits doctors, hospitals, and other professionals by allowing them to continue care where others left off. Key characteristics of good medical records include accuracy, completeness, timeliness, and authentication. Issues can include deficiencies, legal and ethical concerns, and challenges maintaining outdated or inactive records.
Medical Records: Intro, importance, characteristics & issuesSrishti Bhardwaj
Unit 1 of MHA SEM- III's syllabus of Medical records Management
(Bharati Vidyapeeth- Center for Health Management Studies & Research, Pune)
Self made- study purpose- reference presentation
avoid hyperlinks on certain slides- inactive
sources shared on last slide as REFERENCES
Hope it helps :)
Shirlee Linke completed a practicum at Silver Lake Nursing Center to fulfill requirements for her health information technology degree from DeVry University. Over the course of 8 weeks, she gained experience in key medical records functions like auditing, closing charts, and handling record requests. The practicum helped confirm her interest in pursuing a career in health information technology, such as becoming a Registered Health Information Technician like her mentor, Theresa Oliphant.
In the growth of scientific medicine, Medical Records (now called, Health Information) have played an important role as a tool and basis for planning patient care besides Medical Education, Research and Legal protection. Manual Medical Records have undergone tremendous transformations as the healthcare policy makers and healthcare providers have realized that good healthcare could be possible only when scientific, comprehensive and integrated Medical Records are maintained from birth to death including birth information, immunizations, child growth and periodic health problems and remedies provided.
The document provides information on medical records including what they are, their components, functions of the medical record department, and processes for receiving, retrieving, completing, and releasing medical records. Some key points:
- Medical records chronicle a patient's medical history and care, including notes, test results, reports, and other documentation entered by healthcare professionals over time.
- Records are used for documenting treatment, communication between providers, collecting health statistics, and legal/insurance matters.
- The medical record department is responsible for filing, retrieving, completing, coding, and evaluating medical records as well as compiling statistics.
- Strict processes are followed for receiving records at discharge or death, retrieving records for care or authorized
Medical Documentation Improvement InitiativeOmer Khan
The document proposes an initiative to improve medical resident documentation at SBAHC. It outlines a 4-step plan: 1) demonstrate the purpose of good documentation; 2) conduct a needs assessment; 3) engage physicians in a clinical documentation improvement program; 4) develop documentation tools. The initiative aims to address deficiencies in documentation, which impacts patient care and outcomes. Good documentation is important for quality care, legal protection, and demonstrating the care provided. The proposal also includes policies and procedures for house physician patient care responsibilities, including conducting assessments and documenting findings.
Medical Records Department of a 50 bedded Private Hospital Dr. Shruti Aggarwal
The document provides information about medical records at a 50-bed private hospital in Dehradun, India. It discusses the purpose and importance of medical records, describing them as an essential means of communication among healthcare professionals and for ensuring quality of care. It also outlines the infrastructure, staffing, components, constraints, and quality assurance processes involved in managing medical records at the hospital.
Infection Prevention Practices on the Healthcare Frontier: Emerging Models of...bden129
This document summarizes an educational session on infection prevention in emerging ambulatory care delivery models. It discusses trends driving the shift to outpatient care like declining inpatient volumes and growing outpatient encounters. Emerging models described include micro-hospitals, ambulatory surgery centers, and "hospital at home" programs. These models require new staffing approaches for infection prevention. The document outlines challenges for infection preventionists in these settings and resources available to assist them.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Co-Chairs, Val J. Lowe, MD, and Cyrus A. Raji, MD, PhD, prepared useful Practice Aids pertaining to Alzheimer’s disease for this CME/AAPA activity titled “Alzheimer’s Disease Case Conference: Gearing Up for the Expanding Role of Neuroradiology in Diagnosis and Treatment.” For the full presentation, downloadable Practice Aids, and complete CME/AAPA information, and to apply for credit, please visit us at https://bit.ly/3PvVY25. CME/AAPA credit will be available until June 28, 2025.
Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Know the difference between Endodontics and Orthodontics.Gokuldas Hospital
Your smile is beautiful.
Let’s be honest. Maintaining that beautiful smile is not an easy task. It is more than brushing and flossing. Sometimes, you might encounter dental issues that need special dental care. These issues can range anywhere from misalignment of the jaw to pain in the root of teeth.
Test bank for karp s cell and molecular biology 9th edition by gerald karp.pdfrightmanforbloodline
Test bank for karp s cell and molecular biology 9th edition by gerald karp.pdf
Test bank for karp s cell and molecular biology 9th edition by gerald karp.pdf
Test bank for karp s cell and molecular biology 9th edition by gerald karp.pdf
Are you looking for a long-lasting solution to your missing tooth?
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2. Outline
• Introduction
• Management of Complaints and Medicolegal Cases
• Communication
• Medical Documentation
• Consent
• Medical Negligence
• References
4. • Established on 4th January 2019
• Headed by Timbalan Pengarah (Perubatan) III
• Consist of :
• Ketua Penolong Pengarah Kanan(1)
• Pegawai Perubatan Pentadbir (2)
• Pembantu Tadbir (PT)
• Unit Komunikasi Korporat(UKK)
• Unit Rekod Perubatan
5. Organizational Chart
CARTA ORGANISASI
UNIT ETIKA & MEDICOLEGAL
HOSPITAL KUALA LUMPUR
KETUA
UNIT MEDICOLEGAL HKL
PENYELIA JURURAWAT
(MATRON)
PEMBANTU TADBIR (PT)
TIMBALAN PENGARAH III
(PERUBATAN)
PENGARAH
HOSPITAL KUALA LUMPUR
JUSA B
MEDICAL OFFICER (MO)
KETUA JURURAWAT
KETUA
UNIT KOMUNIKASI KORPORAT (UKK)
HKL
MEDICAL OFFICER (MO) MEDICAL OFFICER (MO)
6. Main Roles of the Unit
1. To facilitate complaints and medicolegal processes
2. Reference centre for medicolegal issues and cases
3. To provide medical education regarding legal issue pertaining
medical practice
9. APA KATA PELANGGAN ????
Lambat
Tidak kompeten
Perkhidmatan out-dated
Swasta lebih baik!
Tidak mesra pelanggan
Fail selalu hilang
Menunggu lama
Sistem yang mengelirukan
Komunikasi kurang berkesan
11. 15 HARI BEKERJA
16 -365 HARI
5 HARI BEKERJA
Classification of Complaints
12. PENGHARMONIAN KLASIFIKASI KOMPLEKSITI ADUAN
JENIS
ADUAN
KRITERIA ADUAN CONTOH ADUAN
MUDAH
(Penyelesaian 5
hari bekerja)
Aduan tidak memerlukan lawatan ke lokasi mahupun
melibatkan penubuhan Jawatankuasa Siasatan
Aduan panggilan telefon Klinik Oftalmologi tidak
berjawab
Masalah parking
Aduan kebersihan tandas, kafetaria & wad
Aduan pegawai bercakap kasar/tidak senyum
Mempunyai maklumbalas ‘standard’ seperti isu parking, shuttle,
doktor tidak senyum
Memerlukan tindakan pembetulan segera
Aduan dikemukakan untuk perhatian dan penambahbaikan
segera pihak jabatan terlibat (penyelesaian terus peringkat
jabatan)
SEDERHANA
(Penyelesaian 15
hari bekerja)
Aduan memerlukan siasatan lanjut/lawatan ke lokasi Kualiti perkhidmatan dan layanan yang tidak
memuaskan
Aduan keracunan makanan, tarikh luput, makanan
rosak
Kegagalan komunikasi (verbal/non-verbal)
Aduan memerlukan tindakan pembetulan segera, kelewatan
boleh mendatangkan mudarat kepada orang awam
KOMPLEKS
(Penyelesaian 365
hari bekerja)
Aduan memerlukan siasatan yang terperinci melibatkan lawatan
ke lokasi dan penubuhan Jawatankuasa Siasatan dan yang
berkaitan
Aduan salahlaku anggota perubatan/anggota lain
(disiplin, integriti, kesilapan perawatan/diagnosis)
Kelewatan laporan perubatan, kelewatan
pembedahan
Aduan kelewatan tindakan
Semua aduan klinikal medico legal atau berpotensi medico legal
14. BULAN/
PERKARA
JAN FEB MAC APR MEI JUN JULAI OGOS SEPT OCT JUMLAH
ADUAN
MUDAH
14 11 30 16 18 13 9 15 18 8 152
ADUAN
SEDERHANA
25 13 11 7 16 11 36 19 (5) 17 (9) 15 (13) 170
ADUAN
KOMPLEKS
14 19 (5) 19 (6) 9 (6) 8 (6) 15 (12) 25 (17) 18 (16) 9 8 144
Petunjuk: ( ) aduan masih dalam siasatan
15. BULAN/
PERKARA
JAN FEB MAC APR MEI JUN JULAI OGOS SEPT OCT JUMLAH
PENGHARGAAN 35 16 17 27 19 8 61 31 29 6 249
CADANGAN 6 5 10 7 5 3 3 2 6 6 53
PERTANYAAN 32 30 85 64 52 30 94 33 20 30 470
16. STATISTIK ADUAN
KES MEDICO LEGAL 2012-2017
TAHUN 2012 2013 2014 2015 2016 2017 JUMLA
H
SIASATAN DALAMAN 5 13 9 6 13 6 52
JAWATANKUASA PENYIASATAN BEBAS 6 11 9 - 9 6 41
JUMLAH 11 24 18 6 22 12 93
18. Medicolegal Statistics (Department 2018)
DEPARTMENT TOTAL NO OF CASES
GENERAL MEDICINE 2
GENERAL SURGERY 2
OBSTETRIC & GYNAECOLOGY 2
EMERGENCY & TRAUMA 1
ORTHOPAEDIC 1
OPTHALMOLOGY 1
DERMATOLOGY 1
ONCOLOGY & RADIOTHERAPY 1
NATIONAL TRANSPLANS UNIT 1
19. Ex Gratia Payout 2016-2018
YEAR AMOUNT
2016 RM 613,488.93
2017 RM 359,332.00
2018 RM 16,947.00
20. Ex Gratia Payout (Department 2016-2018)
DEPARTMENT AMOUNT
GENERAL SURGERY RM 10,837.80 (1 CASE)
OBSTETRIC & GYNAECOLOGY RM 761,528.93 (3 CASES)
ORTHOPAEDIC RM 17,200.00 ( 2 CASES)
EMERGENCY & TRAUMA RM 61,402.93 ( 3 CASES)
ENT RM 40,000.00 (1 CASE)
NEUROSURGERY RM 24,800.00 (1 CASE)
UROLOGY RM 30,000.00 ( 1 CASE)
21. Complaints : Flow Chart
CARTA ALIRAN ADUAN KOMPLEKS (MEDICOLEGAL) HKL
ADUAN
MUDAH SEDERHANA KOMPLEKS
POTENTI NON-MEDICOLEGAL
SIASATAN
SURAT
MAKLUM
NO
YES
TAMAT
GRIEVAN INTERNA EXTERNA
KKM
YES
KKM
NO
NO EX GRATIA
TAMAT YES
TAWARAN EX GRATIA
TAK TERIMA TERIMA PENANG
KKM
TAMAT
INQUIRY
EXTERNAL
INQUIRY
24. Issues Related to Communication
Tidak mesra pelanggan
Kasar
Sombong
Salah maklumat
Pilih bulu
Masalah dalaman Jabatan
Lambat
Masalah saluran komunikasi
Sikap kakitangan
Kurang prihatin
25. ‘Hand over/pass over’ kes/syif
Tidak dokumenkan dalam BHT/ buku log
Kurang fasiliti
Kekurangan maklumat
Boss vs leader
Cara penerangan/penjelasan
Berbincang di hadapan pesakit
Kurang ‘common sense’
Tiada komunikasi dalaman / ‘silo’
28. Medical Records
• A medical records is documented information about the health of an
identifiable individual recorded by a practitioner or other healthcare
professional either personally or at his or her instructions.
• It should contains sufficient information to identify the patient,
support the diagnosis based on history, physical examination and
investigations, justify the professional management given, record the
course and results thereof and ensure the continuity of care provided
by practitioners and other healthcare workers to that particular
patient.
MMC Guideline 002/2006 : Medical Records and Medical Reports
29. • Medical records
-Doctor/Nursing notes
-Charts
-Investigations results – laboratory, imaging
-Prescription
-Forms – Consent,SSSL form
30. • The records should be reliable to provide a comprehensive
and satisfactory explanation to what happened at that
material time.
• Proper and appropriate medical documentation is the
hallmark of good medical practice
31.
32. Issue Related to Documentation
• Missing page or missing crucial part of documentation
-Make police report
-Paginate every page
• If it isn’t written down, you didn't do it
eg: Explanation on treatment or procedure
Explanation on risk
33.
34. • Chartology
-Documentation in chart/patient’s note doesn’t reflect
patient’s condition
• Illegible handwriting
• Incomplete entry (eg: date,time,name of doctors/nurses)
• Unorganized entry
• Computerized system : copy and paste
35.
36. Good Medical Records
• Entry should be legible
• Time and date included
• Signature with stamp
• Use standard and accepted abbreviations
• Each page should have patient’s name and ID
• Never tamper or alter the information that has been recorded
• Additional information for previous record should be marked
as ‘addendum’ and signed with current date
37.
38. The Past Speaks
• It is well to remember that issues related to medical documentation
will not come into play in the near future but will be called into
questions years later when the practitioner or members of the
healthcare team that provided the care will no longer be at the scene,
or even if they are there they will not be able to recollect exactly what
happened to that particular patient, having attended to hundreds, if
not thousands of patients subsequently.
• Only the actual medical records will be there to tell the story
39. Litigation Aspect - DEFENCE
•Do proper medical records - will have better
evidence before the court if documented
thus better chance of success
•Full disclosure – do not hide
40. • Write and keep proper medical records
• Maintain accurate and proper documentation of care
No record = No defence
Bad records = Bad defence
Good records = Good defence
• If something wasn’t recorded, it wasn’t done
41. Good Medical Practice
10 Golden Rules of Good Medical Practice :
1. Practice with kindness, ethics and honesty
2. Upgrade professional knowledge and clinical skills
3. Maintain good patient records
4. Maintain good communication with patients and relatives
5. Maintain doctor-patient confidentiality
6. Allow second opinion and referral to colleagues
7. Maintain good working relationship with colleagues
8. Be conscious of cost of healthcare
9. Avoid publicity, self-promotion and abuse of position
10. Be a partner in promoting global health
43. CONSENT
• CONSENT is the voluntary acquiescence by a person to the proposal
of another; the act of result of reaching an accord; a concurrence of
minds; actual willingness that an act or an infringement of an interest
shall occur
MMC Guideline : Consent for Treatment of Patients by Registered Medical Practitioner
44. The General Legal and Ethical Principle
• For adult patients of sound mind is that, legally valid consent must be
obtained before a doctor or other health professional can start
treatment for a patient.
• Without legally valid consent, the doctor will be committing trespass
to person, namely battery (non-consensual touching).
46. • Expressed consent: usually occurs when the patient signs the consent
form.
• Implied consent: could be by offering one’s arm for injection in a
surgery
• A signed consent form is merely evidence that the patient signed the
form but does not mean that he necessarily understood the
significance or implications of the treatment, which is being proposed
in the form
47. Informed Consent
• Medico legal requirement to ensure that a patient knows all of
the risks and costs involved in a treatment
MMC Guideline : Consent for Treatment of Patients by Registered Medical Practitioner
48. Legally Valid Consent
• Mental competence – reach the age of majority, given by a person
with legal capacity – able to have sufficient understanding
• Own free will – no duress, undue influence
• Sufficient information of the proposed treatment – consent must be
real, must be informed in nature not just “in a form” only
• In the language that the patient understands
• Witness (another doctor, nurse etc.)
49. Who can take consent?
• REGISTERED MEDICAL PRACTITIONER
• Practitioner & patient must have met or know each other: doctor
patient relationship
• The practitioner who is planning to do the procedure/surgery must
establish personal contact before the intended procedure
• Nature, objectives & alternatives must be explained
• Risk & complications
50. Who can give consent?
Malaysian Law
• Age of Majority Act 1971
• S2: Subject to section 4, the minority of all males and females shall cease
and determine within Malaysia at the age of eighteen years and every such
male and female attaining that age shall be of the age of majority.
• When a child presents with an adult, establish the relations of the adult
• Parents
• Legal guardian
51. Mental Health Act 2001
• Persons who are incapable or impaired decision making ability
• If emergency situation – previous condition applied
• For elective or non-emergency procedure, consent from relative/next of
kin/legal guardian if available
• If no relative/next of kin/legal guardian and patient incapable of giving
consent, consensus from two psychiatrists (one must be the primary
doctor) must be obtained
• S 77: consent – by patient; guardian; 2 psychiatrists
• S77(5): capability of patient giving consent (factors to be considered)
53. Medical Negligence
• Defined by Winfield as “the breach of a legal duty to take care
which results in damage, undesired by the defendant, to the
plaintiff.”
• In Loghelly Iron & Coal v M’Mullan [1934] - Lord Wright stated
“Negligence means more than heedless or careless conduct…it
properly connotes the complex concept of duty, breach and
damage thereby suffered by the person to whom the duty was
owing.”
54. • Prof. Fleming: Negligence is the conduct falling below the standard
demanded for the protection of others against unreasonable risk of
harm.
• Blyth v Birmingham Waterworks Co (1856) 11 Ex 781: Negligence is
the omission to do something which a reasonable man, guided upon
those consideration which ordinarily regulate the conduct of human
affairs would do or doing something which a prudent and reasonable
man would not do.
55. Medical Negligence…
• Failure to meet the standard of practice of an average qualified
doctor practicing in the specialty in question
• Occurs not merely when there is an error, but when the degree of
error exceeds the accepted norm
56. Principal Elements of Negligence
• a) duty of care or an existing legal duty on the part of the defendant
to the plaintiff to exercise care in such conduct of the defendant as
falls within the scope of the duty;
• (b) breach of duty or failure to conform to the standard of care which
the defendant owes the plaintiff;
• (c) causation or consequential damage to the plaintiff , that is, the
plaintiff suffers damage as a result of the defendant’s breach of duty.
57.
58.
59. REFERENCES
1. Guidelines on the Management of Complaints and Medicolegal Cases ,
Medical Practive Division MOH March 2007
2. Guidelines on Ex Gratia for Medicolegal Complaints
1st Edition October 2018 Medicolegal Section,Medical Practice Division
3. Medical Negligence Law in Malaysia
Dr Puteri Nemie Jahn Kassim
4. Garis Panduan Pengendalian dan Pengurusan Reod Perubatan Pesakit bagi Hospital Hospital
dan Institut Perubatan .Pekeliling KPK Bil 17/2010
5. Guideline of The Malaysian Medical Council 002/2006 : Medical Records and Reports