The demand is growing for Medical Scribes. If you are looking for a new career and love the mix of medical language and technology, and want a challenging career with a bright future, this is for you!
This document outlines a medical scribing business run by Dr. Rima Rabindranath Das, who specializes in healthcare management. It defines key terms like EMR, EHR, and PHR. It describes the job of a medical scribe in listening to physician dictations and scribing medical reports. It outlines the skills required of a scribe and pricing models like per page or per report pricing. The document also discusses challenges in medical scribing like staff shortages and costs, and concludes by emphasizing how scribes can capture complex patient information and ensure accurate medical records.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
The document discusses various basic terminologies used in pharmacovigilance including:
1. Adverse events, adverse drug reactions, and their definitions.
2. Other terms like causality assessment, benefit risk analysis, biological products, and their brief descriptions.
3. Software and databases used for pharmacovigilance like VigiBase, Vigiflow, Vigimine, and VigiSearch.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
The document defines key terms related to clinical trial monitoring such as monitoring, monitoring visits, and monitoring reports. It describes the purpose of monitoring is to protect subjects, ensure accurate data, and ensure compliance. It discusses selecting qualified monitors and different types of monitoring visits including site evaluation, initiation, routine monitoring, and close-out visits. The key responsibilities of monitors during visits are also summarized.
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
procurement and storage of investigation productfarmanadeeb
The document discusses the responsibilities of clinical investigators and research teams regarding investigational products in clinical trials. It outlines that investigators are responsible for ensuring trials follow regulations and protecting subjects. They must also account for investigational products, maintaining records of delivery, inventory, use, and returns. The document then describes the steps research teams and pharmacies take to order, receive, verify, store, and label investigational drugs according to the protocol. Proper storage, labeling, and limited access are important to control investigational products.
This document outlines a medical scribing business run by Dr. Rima Rabindranath Das, who specializes in healthcare management. It defines key terms like EMR, EHR, and PHR. It describes the job of a medical scribe in listening to physician dictations and scribing medical reports. It outlines the skills required of a scribe and pricing models like per page or per report pricing. The document also discusses challenges in medical scribing like staff shortages and costs, and concludes by emphasizing how scribes can capture complex patient information and ensure accurate medical records.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
The document discusses various basic terminologies used in pharmacovigilance including:
1. Adverse events, adverse drug reactions, and their definitions.
2. Other terms like causality assessment, benefit risk analysis, biological products, and their brief descriptions.
3. Software and databases used for pharmacovigilance like VigiBase, Vigiflow, Vigimine, and VigiSearch.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
The document defines key terms related to clinical trial monitoring such as monitoring, monitoring visits, and monitoring reports. It describes the purpose of monitoring is to protect subjects, ensure accurate data, and ensure compliance. It discusses selecting qualified monitors and different types of monitoring visits including site evaluation, initiation, routine monitoring, and close-out visits. The key responsibilities of monitors during visits are also summarized.
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
procurement and storage of investigation productfarmanadeeb
The document discusses the responsibilities of clinical investigators and research teams regarding investigational products in clinical trials. It outlines that investigators are responsible for ensuring trials follow regulations and protecting subjects. They must also account for investigational products, maintaining records of delivery, inventory, use, and returns. The document then describes the steps research teams and pharmacies take to order, receive, verify, store, and label investigational drugs according to the protocol. Proper storage, labeling, and limited access are important to control investigational products.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN Arul Packiadhas
The document provides an overview of drug regulatory agencies in India, the US, Europe, and Japan. It discusses the common functions of drug regulation including ensuring drug safety, licensing, inspections, and adverse event monitoring. For each region, it outlines the key regulatory bodies and their responsibilities. In India, the main agencies are CDSCO, NIHFW, DTAB, ICMR, and CDTL. In the US, the FDA oversees drug approval and safety. The key European agencies are EDQM and EMA, while Japan's PMDA regulates pharmaceuticals.
This document discusses audits and inspections in clinical trials. It defines an audit as a systematic examination of trial activities and documents to determine compliance, while an inspection involves a regulatory review of documents, facilities, and resources related to a trial. The key differences between audits and inspections are that audits are conducted internally by sponsors or CROs, while inspections are done by regulatory authorities. Routine audits ensure compliance, while for-cause audits investigate non-compliance issues. Audits and inspections evaluate areas like personnel, trial conduct, documentation, drug accountability, and computer systems. Proper preparation and responding to document requests within time limits are important for audits and inspections.
The CRA oversees all stages of clinical trials from site selection to completion. They identify investigators, set up trial sites, train staff, monitor compliance, and verify informed consent and data collection. The CRA ensures protocols are followed, documents are collected, and supplies are accounted for throughout the trial. Effective communication, relationship building, attention to detail, and strong organizational skills are important for this role.
Abbreviated new drug application submissionGaurav Sharma
An abbreviated new drug application (ANDA) is used to seek approval from the FDA for a generic drug equivalent to an existing branded drug. ANDAs are abbreviated because they do not require new clinical trials to establish safety and effectiveness since they reference an existing FDA-approved drug. The generic drug must demonstrate bioequivalence to the branded version in order to be approved for marketing in the US. The Hatch-Waxman Act established bioequivalence as the standard for approving generic drugs and created the ANDA pathway to facilitate approval of lower-cost generic alternatives.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
Preclinical trials involve testing new drugs and medical devices on animals before human testing to assess safety and efficacy. They include various studies such as screening tests, isolated organ tests, and toxicity tests on rodents and larger animals. The goals are to determine dosing, identify adverse effects, and collect sufficient safety data to file for approval to begin clinical trials in humans under good laboratory practices. Preclinical studies help establish that initial human trials can reasonably proceed safely.
The document discusses generic drugs, including their regulatory approval process. Generic drugs must demonstrate bioequivalence to the branded version to gain approval. They are approved through an abbreviated new drug application that shows they deliver the same amount of active ingredients as the branded drug. India has a large and growing generic drug industry that supplies over 30% of the global generic market. Recent FDA rules now require generic drug makers to pay user fees for product approvals.
The document discusses the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guideline.
ICH-GCP is an international ethical and scientific quality standard for clinical trials involving human subjects. It aims to ensure trials are scientifically sound and respect the rights, safety and well-being of participants. The guideline was developed in response to medical tragedies and the need for harmonized standards across regions to facilitate global drug development. It outlines principles for conducting clinical trials, including obtaining informed consent and ensuring confidentiality. Adherence to ICH-GCP provides assurance that clinical trial data are credible and that participants are adequately protected.
This presentation is all about generic medicines.How it works in India its benefits and how one can make people aware about by the usage of these instead of branded ones.
The document defines and explains 45 key terms related to clinical trials and research. It provides concise definitions for terms like adverse event, audit, blinding, clinical trial, compliance, documentation, good clinical practice, informed consent, investigator, monitoring, protocol, quality assurance, randomization, regulatory authority, serious adverse event, sponsor, subject, and trial site. Each term is defined in 1-2 sentences and examples are sometimes provided to further explain the term.
1. A clinical data management system (CDMS) is used to manage data from clinical trials by storing data entered in case report forms (CRFs) by investigators.
2. Data management involves planning, collection, entry, validation, manipulation, backup and documentation of data to create a high quality database. Commonly used CDMS tools include Oracle Clinical, ClinTrial, Macro and eClinical Suite.
3. Open source CDMS tools include OpenClinica, openCDMS, TrialDB and PhOSCo which are free. All CDMS tools ensure an audit trail and management of discrepancies according to roles and user access levels.
Drug information centers provide unbiased drug information to healthcare professionals and patients. The first drug information center was established in 1960 at the University of Kentucky. In Nepal, drug information centers are still in their infancy. The Drug Information Network of Nepal was established in 1996 with participation from government, academic, and non-government organizations to disseminate drug information. The network aims to optimize drug use and decision making in Nepal through sharing up-to-date, evaluated information on drugs.
The document discusses drug information centers and poison information centers. It provides details on:
- The history and development of the first drug information centers (DICs) and poison control centers (PCCs) in the 1960s in the US and other countries.
- The aims of DICs and PCCs, which include providing drug and poison information to health professionals, developing treatment guidelines, conducting research and education.
- The staffing of DICs and PCCs, which typically includes pharmacists, pharmacy technicians, toxicologists and other professionals.
- The services provided by DICs and PCCs, such as answering drug and poison inquiries via phone/email, publishing
A medication history interview is used to collect detailed information about all medications a patient is currently taking or has taken in the past. This provides insights into allergic reactions, adherence, and use of alternative medicines. The goals are to obtain complete information to compare to medical records, verify histories, and inform care. Key information includes current and past medications, reactions, effectiveness, adherence, and sources like patients, families, and records. Patient counseling then aims to improve understanding of treatment, side effects, and self-management through a structured introduction, discussion, and conclusion.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
This document discusses the field of pharmacoeconomics. It begins by defining pharmacoeconomics as the scientific discipline concerned with comparing the costs and benefits of drug therapies. It describes how pharmacoeconomics helps optimize health care resource allocation by comparing drug costs and outcomes. The document then outlines several key aspects of pharmacoeconomics including its need, challenges, evaluation methods, and applications. In conclusion, it states that pharmacoeconomics provides a means to quantify pharmaceutical value by balancing costs and outcomes to help inform better healthcare decisions.
This document discusses the clinical trials process from protocol development through study completion. It covers developing the protocol, regulatory documents, patient recruitment, safety reporting, interim reports, and end of study activities. Key aspects include writing an approvable protocol, establishing an investigator site file, screening and enrolling suitable patients, maintaining safety oversight, and conducting closeout procedures. The goal is to provide guidance on managing all stages of a clinical trial.
The document discusses the basics of clinical research and clinical trials. It covers the key steps in drug discovery and development including target selection, validation, drug selection, optimization, pre-clinical and clinical testing. Clinical trials are systematic investigations in human subjects to evaluate safety and efficacy of new drugs, and are done in 4 phases. It takes approximately 10-12 years and $800 million to bring a new drug to market. Regulations, stakeholders, essential documents, and infrastructure requirements for clinical trials are also outlined.
The document describes a data dictionary, which includes:
1) A notation for describing the content and values of data that a software system will process and create.
2) Information about where and how data items are used.
3) A repository that also contains relationships between data items.
4) Best developed using CASE tools to represent the data dictionary notation and examples.
Physicians Angels is the first virtual real-time scribe service for medical professionals. Our innovative service offers live data entry and support to busy medical professionals. Physicians Angels helps you focus on patient care, not paper care.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
OVERVIEW OF DRUG REGULATORY AGENCIES IN INDIA, USA, EUROPE AND JAPAN Arul Packiadhas
The document provides an overview of drug regulatory agencies in India, the US, Europe, and Japan. It discusses the common functions of drug regulation including ensuring drug safety, licensing, inspections, and adverse event monitoring. For each region, it outlines the key regulatory bodies and their responsibilities. In India, the main agencies are CDSCO, NIHFW, DTAB, ICMR, and CDTL. In the US, the FDA oversees drug approval and safety. The key European agencies are EDQM and EMA, while Japan's PMDA regulates pharmaceuticals.
This document discusses audits and inspections in clinical trials. It defines an audit as a systematic examination of trial activities and documents to determine compliance, while an inspection involves a regulatory review of documents, facilities, and resources related to a trial. The key differences between audits and inspections are that audits are conducted internally by sponsors or CROs, while inspections are done by regulatory authorities. Routine audits ensure compliance, while for-cause audits investigate non-compliance issues. Audits and inspections evaluate areas like personnel, trial conduct, documentation, drug accountability, and computer systems. Proper preparation and responding to document requests within time limits are important for audits and inspections.
The CRA oversees all stages of clinical trials from site selection to completion. They identify investigators, set up trial sites, train staff, monitor compliance, and verify informed consent and data collection. The CRA ensures protocols are followed, documents are collected, and supplies are accounted for throughout the trial. Effective communication, relationship building, attention to detail, and strong organizational skills are important for this role.
Abbreviated new drug application submissionGaurav Sharma
An abbreviated new drug application (ANDA) is used to seek approval from the FDA for a generic drug equivalent to an existing branded drug. ANDAs are abbreviated because they do not require new clinical trials to establish safety and effectiveness since they reference an existing FDA-approved drug. The generic drug must demonstrate bioequivalence to the branded version in order to be approved for marketing in the US. The Hatch-Waxman Act established bioequivalence as the standard for approving generic drugs and created the ANDA pathway to facilitate approval of lower-cost generic alternatives.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
Preclinical trials involve testing new drugs and medical devices on animals before human testing to assess safety and efficacy. They include various studies such as screening tests, isolated organ tests, and toxicity tests on rodents and larger animals. The goals are to determine dosing, identify adverse effects, and collect sufficient safety data to file for approval to begin clinical trials in humans under good laboratory practices. Preclinical studies help establish that initial human trials can reasonably proceed safely.
The document discusses generic drugs, including their regulatory approval process. Generic drugs must demonstrate bioequivalence to the branded version to gain approval. They are approved through an abbreviated new drug application that shows they deliver the same amount of active ingredients as the branded drug. India has a large and growing generic drug industry that supplies over 30% of the global generic market. Recent FDA rules now require generic drug makers to pay user fees for product approvals.
The document discusses the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guideline.
ICH-GCP is an international ethical and scientific quality standard for clinical trials involving human subjects. It aims to ensure trials are scientifically sound and respect the rights, safety and well-being of participants. The guideline was developed in response to medical tragedies and the need for harmonized standards across regions to facilitate global drug development. It outlines principles for conducting clinical trials, including obtaining informed consent and ensuring confidentiality. Adherence to ICH-GCP provides assurance that clinical trial data are credible and that participants are adequately protected.
This presentation is all about generic medicines.How it works in India its benefits and how one can make people aware about by the usage of these instead of branded ones.
The document defines and explains 45 key terms related to clinical trials and research. It provides concise definitions for terms like adverse event, audit, blinding, clinical trial, compliance, documentation, good clinical practice, informed consent, investigator, monitoring, protocol, quality assurance, randomization, regulatory authority, serious adverse event, sponsor, subject, and trial site. Each term is defined in 1-2 sentences and examples are sometimes provided to further explain the term.
1. A clinical data management system (CDMS) is used to manage data from clinical trials by storing data entered in case report forms (CRFs) by investigators.
2. Data management involves planning, collection, entry, validation, manipulation, backup and documentation of data to create a high quality database. Commonly used CDMS tools include Oracle Clinical, ClinTrial, Macro and eClinical Suite.
3. Open source CDMS tools include OpenClinica, openCDMS, TrialDB and PhOSCo which are free. All CDMS tools ensure an audit trail and management of discrepancies according to roles and user access levels.
Drug information centers provide unbiased drug information to healthcare professionals and patients. The first drug information center was established in 1960 at the University of Kentucky. In Nepal, drug information centers are still in their infancy. The Drug Information Network of Nepal was established in 1996 with participation from government, academic, and non-government organizations to disseminate drug information. The network aims to optimize drug use and decision making in Nepal through sharing up-to-date, evaluated information on drugs.
The document discusses drug information centers and poison information centers. It provides details on:
- The history and development of the first drug information centers (DICs) and poison control centers (PCCs) in the 1960s in the US and other countries.
- The aims of DICs and PCCs, which include providing drug and poison information to health professionals, developing treatment guidelines, conducting research and education.
- The staffing of DICs and PCCs, which typically includes pharmacists, pharmacy technicians, toxicologists and other professionals.
- The services provided by DICs and PCCs, such as answering drug and poison inquiries via phone/email, publishing
A medication history interview is used to collect detailed information about all medications a patient is currently taking or has taken in the past. This provides insights into allergic reactions, adherence, and use of alternative medicines. The goals are to obtain complete information to compare to medical records, verify histories, and inform care. Key information includes current and past medications, reactions, effectiveness, adherence, and sources like patients, families, and records. Patient counseling then aims to improve understanding of treatment, side effects, and self-management through a structured introduction, discussion, and conclusion.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
This document discusses the field of pharmacoeconomics. It begins by defining pharmacoeconomics as the scientific discipline concerned with comparing the costs and benefits of drug therapies. It describes how pharmacoeconomics helps optimize health care resource allocation by comparing drug costs and outcomes. The document then outlines several key aspects of pharmacoeconomics including its need, challenges, evaluation methods, and applications. In conclusion, it states that pharmacoeconomics provides a means to quantify pharmaceutical value by balancing costs and outcomes to help inform better healthcare decisions.
This document discusses the clinical trials process from protocol development through study completion. It covers developing the protocol, regulatory documents, patient recruitment, safety reporting, interim reports, and end of study activities. Key aspects include writing an approvable protocol, establishing an investigator site file, screening and enrolling suitable patients, maintaining safety oversight, and conducting closeout procedures. The goal is to provide guidance on managing all stages of a clinical trial.
The document discusses the basics of clinical research and clinical trials. It covers the key steps in drug discovery and development including target selection, validation, drug selection, optimization, pre-clinical and clinical testing. Clinical trials are systematic investigations in human subjects to evaluate safety and efficacy of new drugs, and are done in 4 phases. It takes approximately 10-12 years and $800 million to bring a new drug to market. Regulations, stakeholders, essential documents, and infrastructure requirements for clinical trials are also outlined.
The document describes a data dictionary, which includes:
1) A notation for describing the content and values of data that a software system will process and create.
2) Information about where and how data items are used.
3) A repository that also contains relationships between data items.
4) Best developed using CASE tools to represent the data dictionary notation and examples.
Physicians Angels is the first virtual real-time scribe service for medical professionals. Our innovative service offers live data entry and support to busy medical professionals. Physicians Angels helps you focus on patient care, not paper care.
The document discusses concepts related to data dictionaries, including defining data flows, structures, elements, and stores. It provides examples of how each component would be defined in a data dictionary, including the level of detail needed for accurate documentation and analysis. Specific symbols and notations are presented for representing data structures algebraically and defining element attributes like name, length, type, validation rules, and more. The data dictionary is described as a key tool for analyzing a system's data and ensuring consistency across users and applications.
A data dictionary is a “virtual database” containing metadata (data about data). Data dictionary holds information about the database and the data that it stores.
This document contains the field definitions for multiple database tables. It defines fields for a Client table including client_id, client_name, password, and other client details. It also defines fields for a User table including user details like name, password, address. Additionally, it outlines fields for a Slide table to store presentation slide details and fields for a Message table to store messages between users.
A data dictionary is a central repository that contains metadata about the data in a database. It describes the structure, elements, relationships and other attributes of the data. A well-designed database will include a data dictionary to provide information about the type of data in each table, row and column without accessing the actual database. This ensures data consistency when multiple users access the database. A data dictionary can be integrated with the database management system or be a standalone tool. It should be easily accessible and searchable by all database users.
The document discusses the purpose and importance of a data dictionary for systems analysis and design. It explains that a data dictionary defines the data about data (metadata) and includes information about entities, attributes, relationships, data flows, structures, elements and data stores. It provides examples of how these components are defined and categorized in a data dictionary. The document also outlines the process of analyzing inputs and outputs, developing data stores, and creating the overall data dictionary.
This document outlines various types of notes commonly found in patient charts, including admission notes, progress notes, discharge notes, and operative notes. It provides guidance on the components and formatting of history and physical notes, pre-operative notes, operative notes, post-operative notes, and procedure notes. Key elements discussed include the chief complaint, history of present illness, past medical history, physical exam findings, assessment, and treatment plan.
History taking a complete guide for all systems (clinical history & examinati...Updesh Yadav
This document provides guidance for medical students on taking clinical histories and performing physical examinations. It outlines the key components of a thorough history, including the presenting complaint, history of present illness, past medical history, family history, and social history. It then describes the steps of a full physical examination, with sections focused on examining each body system. The document aims to equip students with the skills needed to properly evaluate patients and identify signs and symptoms that may indicate underlying medical conditions.
Clinical Method - Patient history taking proceduresvdsriram
The document discusses principles and components of history taking in clinical practice. It provides details on how to conduct a thorough history of present illness, including general interrogation, symptom analysis using frameworks like OPQRST and OLD CARTS, and systemic review. It emphasizes the importance of properly organizing the clinical approach and establishing good patient-doctor rapport when obtaining a patient's history.
The document defines and describes the nursing process, which is a problem-solving approach used by nurses to address patient health needs. It has 6 main components: assessment, diagnosis, planning, implementation, evaluation, and outcome identification. Assessment involves collecting a health history and doing a physical exam. A nursing diagnosis identifies actual or potential patient problems that nurses can address through independent nursing action. The nursing diagnosis is developed based on assessment data and identifies the problem and its etiology.
3 history taking & physical examinationawadfadlalla1
This document provides information on nursing history taking and physical examination. It discusses the importance of obtaining an accurate patient history, which is critical for diagnosis. The key components of history taking are identified as demographic data, chief complaint, history of present illness, past medical history, family history, drug history, review of systems, and physical examination. The principles and techniques of physical examination are outlined, including inspection, palpation, percussion, and auscultation. A head-to-toe assessment approach is recommended to perform a thorough physical exam.
The document contains summaries of 20 OSCE pediatric stations including questions on Down syndrome with esophageal atresia, typhoid vaccination recommendations, hemoglobin disorders, muscular dystrophies, transverse myelitis, Ehlers Danlos syndrome, pulmonary sequestration, Reiter's syndrome, enterobiasis, cleidocranial dysplasia, Wilson's disease, spinal cord injuries, Meckel's scan, congenital hypothyroidism, hemophilia A, neurocysticercosis and their diagnoses and management. The stations cover ethics, clinical examination, choice of investigations, interpretations of tests and forming differential diagnoses.
The document discusses the key components of history for E&M coding, including the chief complaint (CC), history of present illness (HPI), review of systems (ROS), and past medical, family, and social history (PFSH). It defines each component and provides examples. The CC is a statement in the patient's words of why they are seeking care. The HPI is a chronological description of the current illness. The ROS and PFSH review the patient's symptoms and medical background. Proper documentation of these history elements is required for accurate E&M coding.
This document provides guidance on post-operative patient management for surgical residents. It discusses evaluating patients in the immediate post-operative period through discharge, including performing post-operative checks, monitoring for complications, communicating with consulting services, documenting care and managing specific post-op issues. Residents are advised to be diligent in their duties and communicate clearly with senior residents and attending surgeons.
This document outlines important terms and criteria for different types of medical documentation forms. It discusses the key elements that should be included in documentation, such as the chief complaint, history of present illness, review of systems, and past/family history. It also describes different levels of complexity in patient cases and the types of decision making and documentation required. The goal of medical documentation is to comprehensively yet efficiently record all relevant health information about a patient.
This document provides information on taking a case history. It discusses the importance of gathering a patient's chief complaint, medical history, dental history, and personal history. It outlines the key components of a case history, including statistics, examination findings, diagnosis, and treatment plan. It also describes different methods for obtaining a patient's history, such as interviews, questionnaires, and a combination approach. The goal of a case history is to understand the nature of a patient's illness and provide relevant information to aid in diagnosis and treatment decisions.
What is Medical Lab Technology, Difference between Treatment, Prognosis and Diagnosis, Role of Doctor or Physician and Medical Lab Technologist, Vital Signs, Significance of Vital Signs Assessment, Difference Between Signs and Symptoms in Patient Assessment, Example Case Study on Signs and Symptoms, Definition of Disease, Definition of Illness, Definition of Infection, Factors Contributing to Disease, Introduction to Factors Contributing to Disease, Types of Samples that Can be Collected from Patients for Clinical Diagnosis, Additional Types of Samples for Clinical Diagnosis.
Here are the key differences between the 1995 and 1997 E/M examination guidelines:
1995 Guidelines:
- Based on extent of exam (problem focused, expanded problem focused, detailed, comprehensive)
- Defines extent by number of body areas/organ systems examined
1997 Guidelines:
- Based on organ systems/body areas examined and elements documented
- Defines extent by minimum number of elements documented across organ systems/body areas
- More flexibility in choice of organ systems/areas examined
So in summary, 1995 based on scope of exam, 1997 based on documentation of exam elements.
This document provides an overview of how to take a thorough medical history and conduct respiratory and cardiovascular examinations. It outlines the traditional framework for taking a medical history, including the presenting complaint, past medical history, allergies, medications, and review of systems. It emphasizes important details to obtain for patients with respiratory symptoms, including a frailty assessment. The document also provides guidance on examining the chest, heart, and lungs, with notes on auscultation findings and common respiratory and cardiac conditions.
This document provides guidance on taking a thorough medical history. It outlines the key components of a medical history, including identifying data, chief complaint, present illness, past medical history, family history, social history, and review of systems. The present illness section should provide a chronological account of the patient's symptoms and issues that prompted them to seek care. Gathering detailed information about symptoms, such as location, quality, timing and exacerbating/relieving factors is important for diagnosis. A comprehensive history helps health workers understand the patient's perspective and identify pertinent medical factors.
This document discusses the basics of pathophysiology. It begins by defining anatomy, physiology, and pathophysiology, noting that pathophysiology builds on knowledge of normal structure and function by exploring how disease develops and changes anatomy and physiology. It then discusses several key pathophysiology topics: the causes and mechanisms of disease; how pathologists study tissues and cells to determine disease cause; how normal and abnormal structure and function relate to disease signs and symptoms; and how specific diseases affect individual organ systems based on normal structure and function. The document emphasizes that understanding pathophysiology helps physicians develop effective prevention, diagnostic, treatment, and management strategies for disease.
This document provides guidance on coding an established patient encounter based on the documentation provided. It examines the history, physical exam, and medical decision making components needed to assign an E/M code. The history taken includes chief complaint, past medical history, social history and medications. The physical exam documents the general appearance, respiratory, cardiovascular and gastrointestinal systems. The medical decision making is determined to be straightforward based on the information given.
This document outlines the course content for a 9th semester differential diagnosis and clinical decision making course. It discusses topics like intro to medical screening, differential diagnosis of various body systems, the process of differential diagnosis, screening and its purpose, reasons for medical disease screening, red and yellow flags, and the physical therapist's role in disease diagnosis, prevention, and clinical reasoning. Key terms like quicker, sicker, and signed prescription in relation to medical screening are also defined. A case example demonstrates recognition of red flags that warrant physician consultation.
Rethinking DNACPR orders: ethical issues and a proposal for change - Fritzintensivecaresociety
This document summarizes the key issues regarding DNACPR (Do Not Attempt Cardiopulmonary Resuscitation) orders and proposes an alternative approach called the Universal Form of Treatment Options (UFTO). The summary includes:
1. There are several ethical issues with the current use of DNACPR orders, including that they are not routinely completed for patients, sometimes result in inappropriate resuscitation attempts, and often lack discussions with patients and families.
2. The document proposes the UFTO as an alternative, which aims to remove the ad hoc nature of consideration, improve discussions, and shift the focus to goals of care rather than a "resus/no resus" decision.
3. A study
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2. The medical record is an important part of
the patient’s care in the clinic or
emergency room.
The information a scribe records on the
chart could affect how the patient is
managed currently or in the future.
3. To communicate relevant information to
other medical personnel.
It is a legal document that can be
presented in a court of law.
4. A physician may be asked to testify in
cases of:
◦ Rape
◦ Homicide
◦ Assault
◦ Child abuse
◦ Civil procedures involving personal injury
5. The method used in charting the patient’s
stay through the clinic/ED must follow a
logical progression.
The most common method is to consider
the chart to have four generalized
sections:
◦ Subjective
◦ Objective
◦ Assessment
◦ Plan
6. The Subjective portion includes:
◦ Chief Complaint (CC)
◦ History of Present Illness (HPI)
◦ Review of Systems (ROS)
◦ Past Medical History (PMHx)
◦ Family History (FHx)
◦ Social History (SHx)
7. The Subjective section pertains to any
information that the patient and/or family
states.
This information is dependent upon the
patient’s condition, beliefs, personality, etc.
This section will contain the patient’s story
in his/her own words.
8. Chief Complaint
◦ The main reason the patient has come to
the clinic/ED.
◦ Every chart must have a Chief
Complaint.
◦ A short statement in the first sentence of
the HPI identifying why the patient has
come to the clinic/ED.
◦ Should be in the patient’s own words (if
possible).
9. History of Present Illness (HPI)
◦ Explains the Chief Complaint.
◦ Describes why the patient is in the
clinic/ED and lists any pertinent positives
and negatives.
◦ This should be in a narrative paragraph
consisting of 4-5 sentences depending
on the severity of the patient’s condition.
◦ The HPI is a chronological description of
the development of the patient’s present
illness from the first sign/symptom or
from the previous encounter to the
10. 8 dimensions of HPI - directly related to
Chief Complaint
◦ Location
◦ Quality
◦ Severity
◦ Duration
◦ Timing
◦ Context
◦ Modifying factors
◦ Associated signs and symptoms
11. Location
◦ A place on the body
Examples: R flank, midsternal chest, etc.
Quality
◦ Description of the complaint
Constant, dull, crampy, intermittent, etc.
Severity
◦ How bad is it?
◦ Usually on a scale of 1 to 10
Examples: Acute, mild/moderate/severe, 7/10, 3
pads in the last hour, etc.
12. Duration
◦ How long do the episodes last?
Examples: 30 seconds each, 5 years, etc.
Timing
◦ When did it start?
Examples: 3:00 AM, this afternoon, etc.
Context
◦ What were you doing when it happened?
Examples: Running laps, just ate 7
doughnuts, awoken from sleep, etc.
13. Modifying factors
◦ What makes it better or worse?
Examples: Worse with activity, improve
with nitroglycerin, increased pain with
movement.
Associated signs and symptoms
◦ Any other symptoms
Examples: If CC is chest
pain, associated with diaphoresis and
N/V.
14. A review of the patient’s past medical,
social history, and family medical history.
Depending on the circumstances or
encounter, the patient’s Chief Complaint
could be an indication of a complication of,
or a result of, a preexisting condition or the
patient’s past medical history.
15. Past Medical History (PMHx)
◦ Includes injuries, chronic illnesses, and
surgeries.
Social History (SHx)
◦ Identifies behavioral risks such as
tobacco alcohol, or drug use.
Family History (FHx)
◦ Includes relevant past family medical
information.
16. Past Medical History (PMHx)
◦ Hypertension (HTN), coronary artery disease
(CAD), chronic obstructive pulmonary disease
(COPD), diabetes (DM), coronary artery bypass graft
(CABG), cancer (Ca).
Past Surgical History
◦ A subcategory under PMHx.
Social History (SHx)
◦ Tobacco use (Tob), alcohol use (EtOH), intravenous
drug use (IVDA), living situation (lives alone, lives with
others, nursing home, or lives at home with parents).
Family History (FHx)
◦ Includes genetic traits, DM, Ca, cardiac disease, etc.
17. Common ROS:
◦ General
◦ Eyes
◦ ENT
◦ CVS
◦ Resp
◦ GI
◦ GU
Review of Systems
(ROS)
Identifies any recent
symptoms the
patient may have
other than the
current illness.
18. A Review of Systems is an inventory of
body systems obtained through a series of
questions seeking to identify signs and/or
symptoms which the patient may be
experiencing or has experienced.
19. General Symptoms
◦ e.g. diaphoresis, cold symptoms, fever, chills.
Eyes
◦ e.g. Visual changes, blindness, ophthalmoplegia, blurry, eye
pain, discharge.
Ear, Nose, Throat, Mouth
◦ e.g. dysphagia, tinnitus, epistaxis, rhinorrhea.
Cardiovascular
◦ e.g. palpitations, edema, cyanosis, dyspnea on exertion, CP.
Respiratory
◦ e.g. SOB/dyspnea, wheezing, cough.
Gastrointestinal
◦ e.g. dysmenorrhea, dyspareunia, dysuria, vaginal bleeding.
Musculoskeletal
◦ e.g. arthralgia, myalgia.
20. Skin/Breast
◦ e.g. rashes, hives, discoloration, pallor,
mastectomy.
Neurological
◦ e.g. H/A, dizziness, LOC, numbness,
paresthesia.
Psychiatric
◦ e.g. suicidal, depressed.
Endocrine
◦ e.g. cold intolerance, heat intolerance,
polydipsia, polyuria.
21. EXCEPTIONS:
◦ If a patient is unable to provide any information
due to severity of illness, inebriation, intubation,
unconscious, etc., you may check the “Unable to
obtain HPI/ROS/PMFHSH secondary to pt’s
condition.
◦ Be careful when using this caveat, and only use it
if it really applies (HPI, Past Medical/Social/Family
History, and ROS only).
◦ Ask the physician for clarification when needed.
◦ Speaking another language is not an exception.
◦ Physical exam must be documented.
22. The Objective portion includes:
◦Physical Exam
◦Medical Decision-Making
Elements
23. The Objective section contains
information that is obtained through
observation and testing and is
independent of an individual’s
interpretation.
24. Physical Examination (PEx)
◦ Information is more medically-oriented
◦ Information elicited through observation,
palpitation, percussion, and auscultation.
Medical Decision Making (MDM)
◦ Documented under “Progress Notes” and
contains Differential Diagnosis, Progress
notes, attending note.
25. Differential Diagnosis (DDx)
◦ Lists the different conditions that testing
will rule out.
Progress Notes
◦ Any new subjective information provided
by the patient and any new or changed
findings upon reexamination of the
patient.
26. Example:
Re-eval at 1532 – Pt states she is improved. Nausea resolved. PEx: Abd
soft, NT/ND, nl active BS. Pt will be discharged and f/u with PMD advised
within 24 hours.
27. Attending Note
◦ Recorded when a physician oversees a
resident case.
◦ This will follow the SOAP format.
◦ Example:
A) Attending Note: Reviewed and agree c Hx.
B) PEx – GI: abd soft, NT, CVS: RRR s MGR. RESP: Lungs CTA.
C) A: UTI vs. Kidney stone
D) P: Labs, CT abd/pelvis r/o stone
28. The Assessment
portion includes:
◦ Diagnosis:
The physician’s
impression of
the patient after
combining the
information in
both the
Subjective &
29. The Plan consists of:
◦ How the physician manages the patient’s
care after the final diagnosis has been
identified and can include:
Admission
◦ Ensure that the chart has been coded to
the appropriate level and enter
admission information.
Discharge Instructions
◦ Lists the various treatments, medications
30. Level 1: Visits requiring very minor care.
This level is seldom used in the ED but
would be used in a clinic setting.
◦ Removal of sutures from a well-healed, uncomplicated laceration.
◦ Tetanus toxoid immunization; Depo-Provera injection; hormone
injections.
◦ Several uncomplicated insect bites.
Level 2: Diagnosis reached without the aid
of any labs or x-rays.
◦ Painful sunburn with blister formation on the back in an otherwise
healthy patient.
◦ Child presenting with impetigo localized to the face.
◦ Minor traumatic injury of an extremity with localized pain, swelling,
and bruising.
◦ Red, swollen cystic lesion on patient’s back in an otherwise
healthy patient.
31. Level 3: Visits requiring minor lab work such as
CBC, U/A, or a few x-rays.
◦ Well-appearing child who has a fever, diarrhea, and
abdominal cramps and is tolerating oral fluid.
◦ Inversion ankle injury, patient is unable to bear weight on
the injured foot and ankle.
◦ Acute pain associated with a suspected foreign body in the
painful eye.
◦ Blunt head injury with local swelling and bruising without
subsequent confusion, loss of consciousness, or memory
deficit in an otherwise young and healthy adult.
Level 4: Visits requiring extensive lab workup or CT
scan.
◦ Child sustaining a head injury (falling off bicycle) with brief
loss of consciousness.
32. Level 5: Visits requiring admission into the
hospital, critical care patients.
◦ Complicated overdose requiring aggressive management to
prevent side effects from the ingested materials.
◦ New onset of palpitations/tachycardia requiring IV drugs.
◦ Active upper gastrointestinal bleeding.
◦ Motor vehicle accident with intraabdominal injuries or
multiple extremity injuries.
◦ Acute onset of chest pain compatible with symptoms of
cardiac ischemia and/or pulmonary embolus.
◦ Sudden onset of “the worst headache of my life” with
associated meningismus, nausea, and vomiting.
◦ New onset of a cerebral vascular accident.
◦ Acute febrile illness in an adult, associated with shortness of
breath and an altered level of alertness.