This document summarizes a veterinary lecture on using medical records as a defense against licensing board actions. It discusses veterinary medical board requirements for recordkeeping, including documenting physical exams and anesthesia procedures. Licensing boards can obtain records through subpoenas or patient releases to investigate complaints. Poor or incomplete records can lead to citations or accusations for improper recordkeeping even if care was appropriate. Medical records are crucial, as board experts will use them to evaluate the standard of care. Defensive recordkeeping is important to protect veterinarians.
Ohio Healthcare Providers – Definition of "Medical Record" and Where It Is St...Michael Traven
Ohio Supreme Court ruled the state law definition of "medical record" is not limited to the data maintained in the provider's medical records department.
Ohio Healthcare Providers - Definition of "Medical Record" and Where It Is St...Robert Graziano
The Ohio Supreme Court ruled the state law definition of “medical record” is not limited to the data maintained in the provider’s medical records department.
The document summarizes a determination by a New York State hearing committee to revoke the medical license of Dr. Burton A. Waisbren based on prior disciplinary actions taken against him in Massachusetts and New Jersey. Specifically, the Massachusetts medical board had revoked Dr. Waisbren's license for deviations from accepted medical standards, and he had agreed to restrictions on his practice in New Jersey. The hearing committee found that this constituted professional misconduct per New York law and revoked Dr. Waisbren's New York medical license.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
HIPAA provides privacy and security provisions for safeguarding medical information. It was updated by the Affordable Care Act to include new expanded requirements. Protected health information (PHI) includes individually identifiable health information. PHI can be in any form, including written, electronic, and verbal. Key dates in HIPAA history include the signing into law in 1996 and various effective dates for rules. New HIPAA requirements for clinical studies include obtaining authorization or waiver from an IRB or Privacy Board to use or disclose PHI for research. Covered entities have faced fines for various HIPAA violations involving unencrypted devices and disclosing ePHI.
The document summarizes the hospital licensing process in the Philippines. It is a 3-phase process involving pre-inspection, inspection, and post-inspection stages. The pre-inspection phase involves coordinating with the hospital and informing them of the inspection. The inspection phase allows for interactive participation and review of documents. In the post-inspection phase, inspectors make a decision on licensing and submit a report. A license to operate is required to be accredited by PhilHealth. The document also outlines the classification system for hospitals and requirements for certificates of need, permits to construct, and one-stop shop licensing.
Ohio Healthcare Providers – Definition of "Medical Record" and Where It Is St...Michael Traven
Ohio Supreme Court ruled the state law definition of "medical record" is not limited to the data maintained in the provider's medical records department.
Ohio Healthcare Providers - Definition of "Medical Record" and Where It Is St...Robert Graziano
The Ohio Supreme Court ruled the state law definition of “medical record” is not limited to the data maintained in the provider’s medical records department.
The document summarizes a determination by a New York State hearing committee to revoke the medical license of Dr. Burton A. Waisbren based on prior disciplinary actions taken against him in Massachusetts and New Jersey. Specifically, the Massachusetts medical board had revoked Dr. Waisbren's license for deviations from accepted medical standards, and he had agreed to restrictions on his practice in New Jersey. The hearing committee found that this constituted professional misconduct per New York law and revoked Dr. Waisbren's New York medical license.
Amendments in Schedule Y in 2013,2014 inserted three new rules, new appendix XII: compensation in case of injury or death during clinical trial, amendments in ICD and appendix V inform consent form format.
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
HIPAA provides privacy and security provisions for safeguarding medical information. It was updated by the Affordable Care Act to include new expanded requirements. Protected health information (PHI) includes individually identifiable health information. PHI can be in any form, including written, electronic, and verbal. Key dates in HIPAA history include the signing into law in 1996 and various effective dates for rules. New HIPAA requirements for clinical studies include obtaining authorization or waiver from an IRB or Privacy Board to use or disclose PHI for research. Covered entities have faced fines for various HIPAA violations involving unencrypted devices and disclosing ePHI.
The document summarizes the hospital licensing process in the Philippines. It is a 3-phase process involving pre-inspection, inspection, and post-inspection stages. The pre-inspection phase involves coordinating with the hospital and informing them of the inspection. The inspection phase allows for interactive participation and review of documents. In the post-inspection phase, inspectors make a decision on licensing and submit a report. A license to operate is required to be accredited by PhilHealth. The document also outlines the classification system for hospitals and requirements for certificates of need, permits to construct, and one-stop shop licensing.
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.
The document outlines regulations regarding informed consent for biomedical research involving human subjects. It states that informed consent must be obtained from all research participants or their legal guardians. Informed consent documents must include key information such as the study's purpose and procedures, risks and discomforts, benefits, confidentiality protections, and participants' rights to withdraw. Researchers have obligations to fully inform participants and respect their autonomy by ensuring participation is voluntary and without coercion. Special procedures are required for vulnerable populations like children.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
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.
The document discusses the role of the Medical Record Department (MRD) in hospital functioning. The MRD collects patient information from different departments to compile vital statistics about admissions, discharges, procedures, deaths, and more. This information is provided to hospital administration, government agencies, courts, and other organizations. In 2014, the MRD of a specific hospital collected data on over 62,000 patient visits, 9.3% requiring admission. Surgery and orthopedics saw the most procedures. The MRD also issues medical records to researchers and courts. In summary, the MRD plays a key role in patient care, administration, and legal/research functions through comprehensive collection and reporting of medical record data.
The document summarizes an educational activity on the NCDR-ACTION Registry, which combines data from the CRUSADE and NRMI registries on the treatment of acute coronary syndromes. It describes the features and data collection process for the NCDR-ACTION Registry, including patient presentation characteristics, medical history, in-hospital treatments, outcomes, and sample institutional reports. The faculty disclosure indicates relationships with pharmaceutical companies supporting the activity.
The IRB/IEC is an independent body that reviews clinical trial protocols and protects participant rights and well-being. It consists of at least five qualified members from diverse backgrounds. The IRB/IEC reviews trials annually, ensures informed consent, and maintains documentation for regulatory review.
This document summarizes the various federal laws and regulations governing embryonic stem cell research in the United States. It outlines protections for human subjects, recombinant DNA research, animals in research, and clinical research using cell lines or differentiated tissue. Regulations cover areas such as informed consent, institutional review boards, good laboratory practices, animal welfare, tissue practices, and xenotransplantation. Non-federal sources of oversight may also apply.
The document discusses the roles and responsibilities of investigators in clinical trials. It states that an investigator is responsible for proper conduct of a trial at their site and must be qualified by education and experience. Investigators must obtain approval from an ethics committee for the trial protocol and consent forms. They must ensure accurate reporting of trial data and documentation. Key responsibilities include proper storage and use of investigational products, training staff, protecting subjects, and record keeping.
Dr. Christine Hoang - Legislative/Regulatory Update (Congress activities, reg...John Blue
Legislative/Regulatory Update (Congress activities, regulatory activities, AVMA stance) - Dr. Christine Hoang, Assistant Director, Scientific Activities Division, American Veterinary Medical Association, from the 2013 NIAA Merging Values and Technology conference, April 15-17, 2013, Louisville, KY, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2013-niaa-merging-values-and-technology
The document discusses the legal and regulatory requirements for managing trial master files, including which documents must be retained, how they should be organized and indexed, and the proper storage conditions and duration of retention. It provides guidance on setting up essential document files for the investigator, sponsor, and third parties. The document also outlines examples of common inspection findings when trial master files are not properly maintained.
Controlled substances are drugs with high potential for abuse that are regulated by the Controlled Substances Act. This law established a closed system for proper handling of these drugs through licensing and established the DEA to enforce the law. Controlled substances are categorized into 5 schedules based on their abuse potential and legal restrictions. Strict record keeping and security measures are required for ordering, receiving, inventorying, and distributing controlled substances to ensure proper use and prevent diversion.
Laboratory Services provides a comprehensive range of diagnostic testing and clinical and consultative services .
Medicare Part B (Medical Insurance) covers medically necessary clinical diagnostic laboratory services that are ordered by your doctor or practitioner.
Laboratory tests include certain blood tests, urinalysis, tests on tissue specimens, and some screening tests. They must be provided by a laboratory that meets Medicare requirements.
The complainant alleged that Pfizer failed to properly warn about serious side effects of the smoking cessation drug Champix (varenicline), including convulsions and epilepsy. She took Champix in January 2008 and later experienced grand mal seizures and was diagnosed with epilepsy. However, the patient information provided by Pfizer at that time did not mention seizures or epilepsy as possible side effects. While information in other countries did list these risks, UK regulatory documents approved by the MHRA that Pfizer's materials had to be consistent with also did not mention them at that time. Therefore, the appeals board found no evidence that Pfizer failed to accurately reflect the available evidence in the UK patient information provided.
This document summarizes a complaint against Pfizer regarding their failure to warn about serious side effects of the smoking cessation drug Champix (varenicline), including convulsions and epilepsy. The complainant took Champix in January 2008 and experienced depression, suicidal thoughts, and later had two grand mal seizures which led to an epilepsy diagnosis. She argued that Pfizer failed to properly warn consumers in their materials. While regulatory documents like the SPC did not mention seizures at the time, the complainant provided examples from other countries that did. However, the appeals board ultimately ruled no breach of the code, as Pfizer's UK materials accurately reflected the approved regulatory documents at the time the complainant took the drug.
The FDA is seeking input on modernizing its regulations and practices for clinical trials to address increased complexity and globalization of trials. It is asking how it can encourage innovative methods to build quality into trials and eliminate challenges posed by its regulations. A public hearing was held in April where several industry speakers presented, including the CEO recommending regulatory harmonization and relief from IND safety letters. Comments can be submitted to the FDA until May 31. The newsletter then discusses two research topics - a FDA guidance on IRB continuing review criteria, emphasizing the sponsor's role in providing study-wide information, and state laws regarding consent for research with pregnant minors.
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
1) The document discusses the responsibilities of a sponsor in conducting clinical trials, which include implementing quality control systems, securing agreements from parties involved in the trial, and ensuring compliance with regulations.
2) The sponsor is responsible for selecting qualified investigators and facilitating IRB/IEC approval of the trial.
3) Key responsibilities of the sponsor involve proper design of the trial, management of data handling and record keeping, safety monitoring of investigational products, and reporting of adverse events.
Two Ancient Chinese Secrets Can Revolutionize Your Veterinarian Practicecross-check
The American Animal Hospital Association Convention is coming up and we just discovered two ancient Chinese secrets that can revolutionize your veterinarian practice.
If you own a vetrinary clinic in Canada, there are several questions and tools you should consider to help you determine if you should sell your practice.
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.
The document outlines regulations regarding informed consent for biomedical research involving human subjects. It states that informed consent must be obtained from all research participants or their legal guardians. Informed consent documents must include key information such as the study's purpose and procedures, risks and discomforts, benefits, confidentiality protections, and participants' rights to withdraw. Researchers have obligations to fully inform participants and respect their autonomy by ensuring participation is voluntary and without coercion. Special procedures are required for vulnerable populations like children.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
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.
The document discusses the role of the Medical Record Department (MRD) in hospital functioning. The MRD collects patient information from different departments to compile vital statistics about admissions, discharges, procedures, deaths, and more. This information is provided to hospital administration, government agencies, courts, and other organizations. In 2014, the MRD of a specific hospital collected data on over 62,000 patient visits, 9.3% requiring admission. Surgery and orthopedics saw the most procedures. The MRD also issues medical records to researchers and courts. In summary, the MRD plays a key role in patient care, administration, and legal/research functions through comprehensive collection and reporting of medical record data.
The document summarizes an educational activity on the NCDR-ACTION Registry, which combines data from the CRUSADE and NRMI registries on the treatment of acute coronary syndromes. It describes the features and data collection process for the NCDR-ACTION Registry, including patient presentation characteristics, medical history, in-hospital treatments, outcomes, and sample institutional reports. The faculty disclosure indicates relationships with pharmaceutical companies supporting the activity.
The IRB/IEC is an independent body that reviews clinical trial protocols and protects participant rights and well-being. It consists of at least five qualified members from diverse backgrounds. The IRB/IEC reviews trials annually, ensures informed consent, and maintains documentation for regulatory review.
This document summarizes the various federal laws and regulations governing embryonic stem cell research in the United States. It outlines protections for human subjects, recombinant DNA research, animals in research, and clinical research using cell lines or differentiated tissue. Regulations cover areas such as informed consent, institutional review boards, good laboratory practices, animal welfare, tissue practices, and xenotransplantation. Non-federal sources of oversight may also apply.
The document discusses the roles and responsibilities of investigators in clinical trials. It states that an investigator is responsible for proper conduct of a trial at their site and must be qualified by education and experience. Investigators must obtain approval from an ethics committee for the trial protocol and consent forms. They must ensure accurate reporting of trial data and documentation. Key responsibilities include proper storage and use of investigational products, training staff, protecting subjects, and record keeping.
Dr. Christine Hoang - Legislative/Regulatory Update (Congress activities, reg...John Blue
Legislative/Regulatory Update (Congress activities, regulatory activities, AVMA stance) - Dr. Christine Hoang, Assistant Director, Scientific Activities Division, American Veterinary Medical Association, from the 2013 NIAA Merging Values and Technology conference, April 15-17, 2013, Louisville, KY, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2013-niaa-merging-values-and-technology
The document discusses the legal and regulatory requirements for managing trial master files, including which documents must be retained, how they should be organized and indexed, and the proper storage conditions and duration of retention. It provides guidance on setting up essential document files for the investigator, sponsor, and third parties. The document also outlines examples of common inspection findings when trial master files are not properly maintained.
Controlled substances are drugs with high potential for abuse that are regulated by the Controlled Substances Act. This law established a closed system for proper handling of these drugs through licensing and established the DEA to enforce the law. Controlled substances are categorized into 5 schedules based on their abuse potential and legal restrictions. Strict record keeping and security measures are required for ordering, receiving, inventorying, and distributing controlled substances to ensure proper use and prevent diversion.
Laboratory Services provides a comprehensive range of diagnostic testing and clinical and consultative services .
Medicare Part B (Medical Insurance) covers medically necessary clinical diagnostic laboratory services that are ordered by your doctor or practitioner.
Laboratory tests include certain blood tests, urinalysis, tests on tissue specimens, and some screening tests. They must be provided by a laboratory that meets Medicare requirements.
The complainant alleged that Pfizer failed to properly warn about serious side effects of the smoking cessation drug Champix (varenicline), including convulsions and epilepsy. She took Champix in January 2008 and later experienced grand mal seizures and was diagnosed with epilepsy. However, the patient information provided by Pfizer at that time did not mention seizures or epilepsy as possible side effects. While information in other countries did list these risks, UK regulatory documents approved by the MHRA that Pfizer's materials had to be consistent with also did not mention them at that time. Therefore, the appeals board found no evidence that Pfizer failed to accurately reflect the available evidence in the UK patient information provided.
This document summarizes a complaint against Pfizer regarding their failure to warn about serious side effects of the smoking cessation drug Champix (varenicline), including convulsions and epilepsy. The complainant took Champix in January 2008 and experienced depression, suicidal thoughts, and later had two grand mal seizures which led to an epilepsy diagnosis. She argued that Pfizer failed to properly warn consumers in their materials. While regulatory documents like the SPC did not mention seizures at the time, the complainant provided examples from other countries that did. However, the appeals board ultimately ruled no breach of the code, as Pfizer's UK materials accurately reflected the approved regulatory documents at the time the complainant took the drug.
The FDA is seeking input on modernizing its regulations and practices for clinical trials to address increased complexity and globalization of trials. It is asking how it can encourage innovative methods to build quality into trials and eliminate challenges posed by its regulations. A public hearing was held in April where several industry speakers presented, including the CEO recommending regulatory harmonization and relief from IND safety letters. Comments can be submitted to the FDA until May 31. The newsletter then discusses two research topics - a FDA guidance on IRB continuing review criteria, emphasizing the sponsor's role in providing study-wide information, and state laws regarding consent for research with pregnant minors.
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
1) The document discusses the responsibilities of a sponsor in conducting clinical trials, which include implementing quality control systems, securing agreements from parties involved in the trial, and ensuring compliance with regulations.
2) The sponsor is responsible for selecting qualified investigators and facilitating IRB/IEC approval of the trial.
3) Key responsibilities of the sponsor involve proper design of the trial, management of data handling and record keeping, safety monitoring of investigational products, and reporting of adverse events.
Two Ancient Chinese Secrets Can Revolutionize Your Veterinarian Practicecross-check
The American Animal Hospital Association Convention is coming up and we just discovered two ancient Chinese secrets that can revolutionize your veterinarian practice.
If you own a vetrinary clinic in Canada, there are several questions and tools you should consider to help you determine if you should sell your practice.
Organs are composed of tissues which are made of cells. There are four main types of tissues - epithelial tissue which covers and protects the body, nervous tissue which controls body functions, muscular tissue which enables movement, and connective tissue such as bone, cartilage and fibrous tissue which provide structure and support to the body.
This document provides an overview of the main tissues in the human body, including epithelial, connective, muscular, nervous, and vascular tissues. It describes the key characteristics and functions of each tissue type, with examples of their locations. Simple epithelial tissues include squamous, cuboidal, and columnar cells. Connective tissues include loose connective tissue, dense irregular and dense regular connective tissue, adipose tissue, and supporting tissues like cartilage and bone. The three main muscle tissues are skeletal, cardiac, and smooth muscle. Nervous tissue contains neurons, nerves, and axons. Vascular tissues comprise the blood and lymph systems.
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.for more details please visit
www.indiandentalacademy.com
This document summarizes the histology of bone. It discusses the four main cell types found in bone - osteoprogenitor cells, osteoblasts, osteocytes, and osteoclasts - and their functions in bone formation and resorption. The organic and inorganic components of bone matrix are described. Finally, the microscopic arrangement of bone cells and matrix in lamellae, Haversian canals, and Volkmann's canals is outlined.
The document describes the layers and structures of blood vessels and the heart. It discusses the three layers of arteries and veins: the tunica intima, tunica media, and tunica adventitia. It notes the differences between artery and vein layers, including the presence of the internal and external elastic lamina in arteries. The document also examines capillary subtypes and the morphological features of cardiac muscle cells.
This document contains light microscope images of decalcified compact bone and spongy bone from the Histology Department of Cairo University's Faculty of Medicine. The images show Haversian systems, Haversian canals, osteocytes, interstitial lamellae, and trabecular bone.
"Abdominal Exploration-When to cut, anatomic review and surgical techniques"
Presented by Dr. Earl (Trey) F. Calfee, III
Form more information about nashville Veterinary Specialists and Animal Emergency services, please visit our website at http://www.nashvillevetspecialists.com
Managing a veterinary clinic chain in FinlandProvet Cloud
Description of managing a veterinary clinic chain in Finland by Veikko Tuovinen. This presentation was sponsored by Provet Cloud in Brno 2nd of October 2015.
The document discusses the structure and function of the nervous system. It describes how the nervous system is composed of nervous tissue, including neurons and neuroglial cells. Neurons are the conducting cells that send and receive signals, while neuroglial cells provide support and insulation. The document outlines the key cell types, their roles, and organizational structure of the central and peripheral nervous systems.
The document discusses bone tissue and the process of ossification. It describes the main functions of bone as support, protection, movement, and mineral storage. There are two types of bone tissue - compact bone, which is dense bone providing strength and protection, and spongy bone, which is light and porous. Bone is formed through two processes - intramembranous ossification which forms flat bones from membranes, and endochondral ossification where cartilage is replaced by bone to form most long bones. The document outlines the key cell types and structural components involved in bone formation and remodeling.
The document summarizes the activities and placements of a student during their veterinary clinical internship program. It describes 9 placements, including at veterinary hospitals and farms in Bangladesh and India. The student engaged in various activities like attending classes, treating animals, conducting post-mortems, and learning about vaccine production and farm management. They gained skills but had some limitations due to placement durations and accommodations. The student recommends extending internship durations and including placements at local veterinary facilities.
Nervous system and mechanism of pain sensationDeepa jinan
summary of nervous system, including peripheral nervous system and central nervous system, a brief on nerve anatomy and functioning,gate control theory, mechanism of dental pain
The presentation include general definition of bone and it's functions. Also, describe the chemical composition of bone and then specifically describe alveolar process.
This document contains a series of questions asking to identify various anatomical structures, tissues, cells and other features in histological sections under microscopy across multiple organ systems. The questions require labeling layers, epithelial tissues, connective tissues, muscle tissues, glands, secretions and other cellular structures seen in histological slides of tissues from organs like the skin, stomach, kidney and others.
This document contains a 500 question practice exam on histology for medical school. The questions cover topics like cartilage, organs, tissues, cells, microscopy, and other topics commonly addressed in histology courses. Each question is multiple choice format with 5 possible answers. The document provides questions, answers, and is authored by Mysticalraine from the Department of Histology for use by the School of Medicine.
Bone is a mineralized connective tissue that forms the endoskeleton of vertebrates. It has both compact and spongy structures and develops through either membranous or endochondral ossification. Bone is made up of osteoprogenitor cells, osteoblasts, osteocytes, and osteoclasts. Osteoblasts form new bone tissue while osteoclasts resorb old or damaged bone. The intricate blood supply through nutrient arteries is essential for bone growth and healing. Fractures heal through the formation of a hematoma, fibrocartilaginous callus, bony callus, and remodeling into secondary bone.
Bone tissue is a specialized form of connective tissue composed of cells and a mineralized extracellular matrix. The matrix is made up of collagen fibers and hydroxyapatite crystals that give bone its rigidity. There are two types of bone tissue: compact bone which forms the dense outer layer, and spongy or cancellous bone which is found at the ends of long bones and has a spongy, mesh-like structure. Bones develop through two processes - intramembranous ossification which forms flat bones, and endochondral ossification where cartilage is replaced by bone to form most other bones including long bones.
This document provides a summary of the National Agriculture Law Update presented at Tennessee College of Law's Agriculture Law & Policy Symposium on October 9, 2015. It discusses several key topics including the Veterinary Feed Directive which establishes new requirements for veterinary oversight of medically important antibiotics in animal feed. It also summarizes litigation over the definition of "waters of the United States" and lawsuits against Syngenta related to its genetically modified corn trait approval in China.
Regulatory requirement for approval of BiologicsArpitha Aarushi
The document is a presentation on regulatory requirements for approval of biologics submitted by Arpitha B. M. to Dr. D. Manjula. It contains an introduction, history of biologics regulation citing key events, sources and types of biologics, differences between biologics and chemical drugs, the regulatory approval process including biological license application, and references. The presentation provides an overview of biologics, their regulation and approval process in India.
The document summarizes the history and development of drug regulation laws in the United States from the early 1900s to present day. Key acts and amendments established safety testing requirements for drugs, created the FDA, and defined the modern drug approval process including preclinical research and multi-phase clinical trials. The modern system aims to balance drug accessibility while ensuring safety and efficacy through a rigorous review and oversight process from development through post-marketing.
This document summarizes the history and development of drug regulation laws in the United States from the early 1900s to present day. It describes key laws and acts that established pre-market safety testing and approval requirements for new drugs, including the Federal Food, Drug, and Cosmetic Act of 1938, Kefauver-Harris Amendments of 1962, and Prescription Drug User Fee Act of 1992. The document also provides an overview of the drug development process, including pre-clinical animal studies and three phases of clinical trials required by the FDA before a new drug can be approved.
This document summarizes the history and development of drug regulation laws in the United States from the early 1900s to present day. It describes key laws and acts that established pre-market safety testing and approval requirements for new drugs, including the Federal Food, Drug, and Cosmetic Act of 1938, Kefauver-Harris Amendments of 1962, and Prescription Drug User Fee Act of 1992. The stages of clinical drug trials and requirements for Investigational New Drug Applications to the FDA are also outlined.
This document outlines standards for Institutional Review Boards (IRBs) that review clinical investigations regulated by the FDA. IRBs are formally designated groups that review and provide oversight of biomedical research involving human subjects to ensure their protection. Any clinical investigation submitted to the FDA for review must first be approved by an IRB. The standards specify requirements for IRB composition, functions, operations, and record keeping to ensure the rights and welfare of human subjects. IRBs must be properly registered and maintain adequate documentation of their reviews and activities.
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.
FDA Enforcement: What Every Clinical Director Should KnowMichael Swit
Half day tutorial presentation on key compliance concerns for those involved in clinical studies, with an emphasis on the key issues FDA examines and also a review of FDA's enforcement powers, ranging from warning letters to criminal prosecutions.
Medical Records as a Defense to Your LicenseJustin Hein
This document provides biographical information about Steven L. Simas, an attorney specializing in health care law, professional licensing, and civil litigation. It lists his experience, including as Deputy Attorney General and legal counsel for health care organizations. The document also summarizes standards and requirements for medical and physical therapy recordkeeping from licensing boards, how boards investigate cases using records, and examples of accusations and citations related to improper recordkeeping.
The document provides guidelines on International Conference on Harmonization-Good Clinical Practice (ICH-GCP). It discusses the aims and objectives of ICH-GCP which are to ensure clinical trials are scientifically and ethically sound. It describes the origin and development of GCP from the Nuremberg Code and Declaration of Helsinki. The key sections of ICH-GCP are summarized, including the responsibilities of ethics committees, investigators, sponsors, and the components of clinical trial protocols. In summary, the document outlines the international standards for conducting clinical research involving human subjects in a safe, ethical and rigorous manner.
Schedule Y is the law in India that regulates clinical trials. It was established in 1988 under the Drugs and Cosmetics Act and amended in 2005 to better protect citizens and ensure data is acceptable internationally. Schedule Y outlines requirements for permission to import or manufacture new drugs and conduct clinical trials. It describes the responsibilities of sponsors, investigators, and ethics committees. It provides guidelines for informed consent, different trial phases, and special populations. Overall, Schedule Y aims to enable stringent yet favorable regulations for clinical trials in India.
The United States has always been and remains to be the leading place
for the conduct of clinical trials. According to Clinicaltrials.gov, the largest
clinical trials registry, 32% of registered clinical trials were conducted in
the U.S. as of May 2022 (1). Factors such as the availability of qualified
healthcare professionals, high-quality infrastructure and facilities,
cutting-edge research, an efficient regulatory system, and a high
standard of ethics and participant protection make the U.S. the leading
country for clinical trials.
Clinical trials follow extensive preclinical research to test the safety and
efficacy of a new drug, medical device, or biological in humans. They are
usually divided into three phases: phases I, II, and III which are designed
to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse
events. Figure 1 shows the typical route from discovery and preclinical
studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing
drugs to the market and have the highest attrition rate, only 10% of drugs
that enter phase I trials are granted marketing approval. Therefore,
clinical trials should be conducted by experts that are
well-versed with all the regulations and guidelines in a particular region to
boost the chances of drug approval.
The United States Food and Drug Administration (US FDA) is the
regulatory body that approves and oversees the conduct of clinical trials
for drugs, medical devices, and biologicals that are intended to be
marketed in the U.S and is touted to have the most stringent standards
for drug approval. The primary role of the FDA is to protect public health
by ensuring that medicinal products and devices are safe and efficacious.
Therefore, it is necessary for sponsors/investigators or contract research
organizations (CRO) that are conducting clinical trials to be familiar with
regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the
regulations and guidelines set by the FDA. It is important to know what is needed for a
successful clinical trial, from selecting an appropriate study site to obtaining informed
consent from participants. Additionally, it is essential to understand the requirements for data
collection and analysis, as well as how to develop an effective protocol. Clinical trial services
in USA can provide guidance on all of these aspects and more, helping you ensure that your
clinical trial meets all necessary standards
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
The document discusses the Abbreviated New Drug Application (ANDA) process overseen by the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). It describes the requirements for an ANDA, including establishing bioequivalence to the reference listed drug through bioequivalence studies, and certifying patent status. Upon receiving an ANDA, the CDER determines if the application is complete and acceptable for review. If approved, generic drugs must demonstrate equivalence to the reference drug in dosage form, strength, quality and performance.
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Veterinary Medical Records as a Defense to Your License
1. LOOMIS BASIN VETERINARY CLINIC
WINTER LECTURE SERIES
Medical Records as a Defense to
your Veterinary License
2. Experience
• Simas & Associates, Ltd. –2002 to present
• Deputy Attorney General, Office of the Attorney General
• American Veterinary Medical Legal Association
• California Academy of Attorneys for Health Care
Professionals
• Legal Counsel, California Physical Therapy Association
Practice Areas
• Veterinary Medical Board and Malpractice Defense
• Health Care Law
• Professional Licensing and Regulation
• Civil Litigation and Appeals
• Employment Law and Workplace Regulation
3. Veterinary Medical Board’s Standards for
Recordkeeping
• Test Your Knowledge
• What the Board Requires in your Records
Veterinary Medical Records Compared
to Medical Records
How Licensing Boards Build Cases Using
Medical Records
Accusations and Citations for Improper
Recordkeeping
6. QUESTION:
When conducting a physical
examination of a patient, it is
proper to record just “normal” if
the readings/data are normal?
7. False-probably not.
• Veterinary Medical Board
Regulations (to be discussed)
provide that you must record “data,
including that obtained by
instrumentation, from the physical
examination.”
Is just writing “normal” recording
“data”?
8. HYPOTHETICAL:
Jojo, a 5 year old beagle, presents on referral
from the regular veterinarian to a multi-
speciality emergency clinic for a post
surgical pyometra consult with an internal
medicine specialist Dr. McGillicuddy at 4:48
p.m. Dr. McGillicuddy conducts a physical
exam upon presentation and refers the
matter at 5:24 p.m.
to the surgeon Dr. Barnabus whose surgical
practice and office are at the same clinic.
9. Dr. Barnabus reviews the record with
Dr. McGillicuddy, including the
results of her physical exam. Dr.
Barnabus performs surgery at 5:48
p.m. and saves the dog’s life.
Does Dr. Barnabus have to perform a
separate physical exam?
10. Veterinary Board said YES and sent Dr.
Barnabus an “Education Letter” which
stated:
• The Veterinary Medical Board has completed its
internal investigation of the above referenced
complaint, and is closing this case with this letter
of education. Although the Board did not take any
action against your license at this time you are
advised that any violation of the practice act,
including regulations of the Board, can result in
the Board pursuing enforcement action including,
but not limited to, the issuance of a citation and
fine.
11. In an effort to educate licensees and to
maintain the minimum standards of practice
in California, the Board is taking this
opportunity to remind you that as a licensee
you are obligated to be in compliance with
the laws and regulations governing
veterinary medicine in CA at all times. The
Board is advising you to take time to
familiarize yourself with the information
required in all medical records and to take
steps to insure that in the future your
records contain all required information.
12. The Board cited its
recordkeeping regulation 2032.3,
subdivision (7) which provides
that the record must contain:
(7) Data, including that obtained by instrumentation,
from the physical examination (No physical exam
findings recorded for March 3, 2011); and
That there has to be a physical examination 12 hours
prior to anesthesia (Regulation 2032.4).
13. QUESTION:
A veterinarian must keep records
for which following period
according to the Board?
a) 4 years from the last visit
b) 3 years from the first visit
c) 3 years from the last visit
d) 4 years from the last visit
14. ANSWER:
c) 3 years from the last visit
according to Title 16, California
Code of Regulations, section 2032.3
Can be a defense in a Veterinary
Medical Board Investigation
15. QUESTION:
Mrs. Jones brings her cat Fluffy in for boarding. The
cat suffers from diabetes. Mrs. Jones is going on a
cruise for 10 days and will be unreachable.
STOP: see where this is headed yet?
Coast Hills Veterinary Clinic takes the cat in for
boarding. On day two of the Fluffy’s stay, she gets
really sick, vomiting, etc. and needs IV fluids.
What should the attending veterinarian do?
Can the doctor just treat Fluffy in the kennel?
16. ISSUES:
Was there a physical exam?
Was there a
veterinarian/patient/client
relationship?
Boarding v. Hospitalization—big
issue for the Board regarding
recordkeeping.
18. Veterinary Practice Act Provides (Bus. &
Prof. Code § 4855):
A veterinarian subject to the provisions of this chapter shall,
as required by regulation of the board, keep a written record
of all animals receiving veterinary services, and provide a
summary of that record to the owner of animals receiving
veterinary services, when requested. The minimum amount
of information which shall be included in written records
and summaries shall be established by the board. The
minimum duration of time for which a licensed premise shall
retain the written record or a complete copy of the written
record shall be determined by the board.
19. Veterinary Medical Board Regulations Title
16, California Code of Regulations, §2032.3
provides:
(a) Every veterinarian performing any act requiring a license pursuant to
the provisions of Chapter 11, Division 2, of the code, upon any animal or
group of animals shall prepare a legible, written or computer generated
record concerning the animal or animals which shall contain the following
information:
• (1) Name or initials of the veterinarian responsible for
entries.
• (2) Name, address and phone number of the client.
• (3) Name or identity of the animal, herd or flock.
20. (4) Except for herds or flocks, age, sex, breed, species, and
color of the animal.
(5) Dates (beginning and ending) of custody of the animal, if
applicable.
(6) A history or pertinent information as it pertains to each
animal, herd, or flock's medical status.
(7) Data, including that obtained by instrumentation, from the
physical examination.
(8) Treatment and intended treatment plan, including
medications, dosages and frequency of use.
21. (9) Records for surgical procedures shall include a
description of the procedure, the name of the surgeon, the
type of sedative/anesthetic agents used, their route of
administration, and their strength if available in more than
one strength.
(10) Diagnosis or tentative diagnosis at the beginning of
custody of animal.
(11) If relevant, a prognosis of the animal's condition.
(12) All medications and treatments prescribed and
dispensed, including strength, dosage, quantity, and
frequency.
(13) Daily progress, if relevant, and disposition of the case.
22. Recordkeeping for patients under
anesthesia (Title 16, Cal. Code Regs. Section
2032.4)
• For all surgeries under anesthesia, you must chart:
Veterinarian Physical examination within 12 hours of the
administration of general anesthesia
Method of respiratory monitoring which “may” include
Observation of animal’s chest movements;
Observing rebreathing bag; or
Respirometer
Method of cardiac monitoring “shall be provided” and
“may” include use of stethoscope or electrocardiographic
monitor
Recommend charting observation time for safe recovery
23.
24. Medical Practice Act –Business &
Professions Code §2266 provides:
• The failure of a physician and surgeon to
maintain adequate and accurate records relating
to the provision of services to their patients
constitutes unprofessional conduct.
• What is “adequate and accurate”?
Depends upon clinical circumstances
Matter of expert opinion
25. A Comprehensive Patient Record
Contains:
Patient’scondition and treatment
Any consultation informing the patient of his or
her condition
Discussion of intended procedures, risks,
hazards, and alternative therapy
Any instructions given to a patient by telephone
26. Any cautions regarding prescription drugs that
may interfere with a patient’s occupation or
driving safely
Special note should be made of any allergies or
sensitivities
Surgical records which are comprehensive and
promptly dictated or written. The anesthetist
should record both pre- and post-operative
information.
27. Instructions to patients on follow-up care.
Pathology and X-ray reports.
The justification for treatment.
• Source: Guide to the Laws of Practicing Medicine
by Physicians and Surgeons, Sixth Edition, 2010,
Medical Board of California
(http://www.mbc.ca.gov/publications/laws_guide.pdf)
28. Contrast with Medical Board record
requirements:
• Veterinary Board does not rely exclusively upon
standard of care and judgment of practitioners
• Veterinary Board has very specific requirements
• Does not rely upon “expert testimony” to
determine violation
• More objective?
• More nitpicky?
• Which is better?
29.
30. After a licensing board receives a formal
complaint or has other reason to
investigate, it has the following tools to
do so:
• Subpoenas
• Release from complaining party
• Interviews
• Medical records
31. Subpoenas:
Under the Administrative Procedure Act (Govt. Code §
11180), the head of each department may issue a
subpoena to investigate:
All matters relating to the business activities and
subjects of the department's jurisdiction;
The violation of any law or any rule or order of the
department; and
Any other matter that some rule of law authorizes the
department to investigate.
32. Other methods of licensing Boards obtaining
records (how your charts get to the Board):
• Release from complaining party or patient
(often without licensee’s knowledge)
• Premises Inspections
• 30 Day Demand Letter for Records
Failure to respond as “unprofessional conduct”
“Consulting veterinarian” v. “respondent”
• Reports of Settlement
• Other clinic’s records
33.
34. Licensing Board actions against health care
professionals
• Accusations
• Citations
Recordkeeping violations (grounds for license
discipline)
• Failure to keep “adequate” records
• Failure to keep records
• Failure to document treatment in the records
• Failure to document things required by Board (e.g.
anesthesia requires physical exam within 12 hours,
discharge summary for PT Board, etc.)
35. How recordkeeping problems manifest in
a licensing hearing:
• The Golden Rule : “If it is not in the record, it
did not happen”
Difficult patient case
Difficult client
Owner-declined service
Referrals
History & Physical
Prescribing issues
Pain management
36. • If the licensee met the standard of care, it
must be in the record
“Defensive recordkeeping”
Can be the difference between a finding of
negligence or not
Can cause the Board to bring a case or not
Alterations to record or amendments
Can be viewed as “altering records”
Scary examples:
Relief veterinarian took set of records “home to complete”
Veterinarian had separate “intake sheet” as part of record
Amendments to computerized records
37. Medical records and use of experts in
licensing defense cases
• Medical records are the tool of the expert
witnesses
• Board experts look first at medical records
• Medical records can cause license discipline
or other issues even if care was proper
38. Examples
Veterinary Board overnight hospitalization case
Overnight monitoring not in record
Veterinarian provided uncontroverted testimony
ALJ found “no overnight monitoring”
Vision insurance audit
All information regarding charges was in record
Auditors could not find it
Finding “optometrist sent in incorrect and unjustified charges”
Medical Board LASIK case
Informed consent records
“Eval” versus “Reeval” in cataract case
39. Steven L. Simas
SIMAS & ASSOCIATES, LTD.
Government & Administrative Law
Sacramento -916.789.9800
San Luis Obispo -805.547.9300
w w w .simasgovlaw .com
ssimas@simasgovlaw.com