MP 140 Final

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Know the most important historical facts, as well as the significant legal and ethical issues presented by the Tuskegee Syphilis Experiment

3 important facts about the Tuskegee Study is that this occurred in Tuskegee, Alabama in 1932. Another important fact is that 2/3 of the people had Syphilis, not one received proper treatment. The last, but I feel is the most important fact, is that this unethical study was done by the United States Public Health Service. 1 legal issue raised by the Tuskegee Study is that many African Americans ended up losing their lives as a result of the lack of treatment that they received. A can be seen as a legal issue since 40 years later the case was settled for $10 million. 1 ethical issue raised by the study is the United States Public Health Service lied to the participants telling them they were treated for "bad blood" and continued to lie until the study came to an end. less

Know the basics about contracts - the 2 types of contracts, a health care example of each type

A contract is a legally binding agreement between two parties. There are 2 main types of contracts: 'expressed' and 'implied'. Expressed Contracts may be written or oral. All terms are explicitly stated. An example would be a written document to buy a car or a house, your credit care agreement (all that fine print!). Implied Contracts are not written or oral. The contract is implied by the conduct of the parties. An example would be when a patient holds out his/her arm so the phlebotomist can draw blood in the lab. There are four main 'elements' of contracts: Agreement - one party makes offer, one party accepts Consideration- something of value is exchanged by the contract Legal subject matter - the contract must have a legal purpose Contractual capacity - parties to the agreement must be capable of understanding Contracts in Health Care Many contracts in the medical office are implied, but still must meet the four elements of a contract: Agreement - physician offers services, patient sees physician Consideration - patient/insurance company is charged for the service Legal subject matter - the services provided by the physician are legal Contractual capacity - both parties are competent, of legal age, and understand the offer "Breach" of Contract: When a contract violation occurs, it's called a "breach of contract" Terminating (Ending) a Contract

Understand about Codes of Ethics

AMA Code of Ethics (American Association of Medical Assistants): "Members of AAMA dedicated to the conscientious pursuit of their profession, and thus desiring to merit the high regard of the entire medical profession and the respect of the general public which they serve, do pledge themselves to strive always to: A. render service with full respect for the dignity of humanity; B. respect confidential information obtained through employment unless legally authorized or required by responsible performance of duty to divulge such information; C. uphold the honor and high principles of the profession and accept its disciplines; D. seek to continually improve the knowledge and skills of medical assistants for the benefit of patients and professional colleagues; E. participate in additional service activities aimed toward improving the health and well-being of the community." ATPO Code of Ethics (Association of Technical Personnel In Ophthalmology) Purpose The purpose of a code of ethics is to acknowledge a profession's acceptance of the responsibility and trust conferred upon it by society and to recognize the internal obligations inherent in that trust. Ethics address appropriate or inappropriate conduct and behavior as determined by the entity setting the ethical standards. An issue of ethics is resolved by the determination that the best interests of the association and its members are served. Ethical Principles Competence of the Ophthalmic Medical Profession -- Ophthalmic medical personnel must maintain competence. Competence can never be totally comprehensive, and therefore must be supplemented by other colleagues when indicated. Competence involves technical ability, cognitive knowledge, and ethical concerns for the patient. Competence includes having adequate and proper knowledge to make professionally appropriate and acceptable decisions regarding testing or measurement protocols of the ophthalmic patient. Providing Ophthalmic Services -- Ophthalmic services must be provided with compassion, respect for human dignity, honesty, and integrity. Responsibility toward Patients -- It is the responsibility of ophthalmic medical personnel to act in the best interest of the patient. Communication with the

Know about euthanasia, palliative care, hospice care and dying without a will.

Definition: The act or practice of killing hopelessly sick or injured individuals (persons or domestic animals) in a relatively painless way for reasons of mercy; also; the act or practice of allowing a hopelessly sick or injured patient to die by taking less than complete medical measures to prolong life - called also mercy killing. "An easy or painless death" (eu=good; a=without; nasia-pain) Active euthanasia: conscious act that results in death Passive euthanasia: Allowing patient to die naturally without medical interference Voluntary euthanasia: Requires patient or agent consent Involuntary euthanasia: Without patient or agent consent Curative Care is treatments and procedures to help cure the patient's disease. Palliative Care is treatments to help provide comfort and maintain the highest quality of life; often called comfort care. Care focuses on relieving pain, controlling symptoms and meeting emotional needs, and personal values of both the patient and the family members.

Know about Elizabeth Kubler Ross

Elizabeth Kubler-Ross - Stages of Grief Kubler-Ross was a Swiss American psychiatrist, and a pioneer in near-death studies. She authored the groundbreaking book On Death and Dying (1969). Through her work with terminally ill patients, she developed the theory of The Five Stages of Grief. Her work revolutionized how the medical field took care of the terminally ill. Her five stages of grief have now become widely accepted. Kubler-Ross - The Five Stages of Grief 1. Denial "I feel fine,"; "This can't be happening, not to me." Denial is a defense mechanism. 2. Anger "Why me? It's no fair!"; "How can this happen to me?"; "Who is to blame?" The individual recognizes that denial cannot continue. 3. Bargaining " I'll do anything for a few more years."; "I will give my life saving if..." Involves the hope that the individual can somehow postpone or delay death. 4. Depression "I'm so sad, why bother with anything?"; "I'm going to die soon so what's the point?" The dying person begins to understand the certainty of death. 5. Acceptance "It's going to be okay."; "I can't fight it, I may as well prepare for it." Individuals begin to come to terms with their mortality, or that of a loved one, or other tragic event. These stages could be used for anyone experiencing a loss such as separation and divorce. These stages are not meant to be complee or chronological . Some people may get stuck in one stage.

Be able to recognize the general ethical issues relating to abortion.

Ethics -- The Fetus As A Person The fetus as a person - here are two views One view is that the fetus is an innocent person, and that it is morally wrong to end the life of an innocent person. Therefore, it is morally wrong to end the life of a fetus. A second view (called 'personhood') is that no person should be denied the right to life. A 'person' applies to all human beings, including unborn offspring at every stage of biological development, including fertilization. Both views are right for any person who believes strongly in one view or the other. Ethics -- The Rights of a Pregnant Woman The second significant area posing ethical issues about abortion concerns the rights of the pregnant woman. The law does provide a legal right for a woman that would entitle her to choose an abortion. This legal right is the Right to Privacy, which most legal scholars accept as being specified in Roe v. Wade. But what ethical 'rights' does she have ? Some would say that the pregnant woman has the right to ownership of her own body ? But, is ownership a right which is clearly expressed or distinct anywhere ? Others would say that the woman has the right to equal treatment -- men can't get pregnant Still others would say that the woman has the right to self-determination -- that women have the right to decide about their own futures, and that it is morally repellent to force a woman to bear a child against her will. Other Ethical Issues There are a variety of other ethical issues which can present themselves, depending on specific situations during the pregnancy or in the life of the pregnant woman. One such area is in the case of fetal anomalies or gender. Women ask themselves: "If my fetus is (likely) deformed or otherwise not 'normal', who am I to decide if an 'abnormal' life is worse than no life at all ?". As for gender, they ask "If my fetus is a boy, and I only want a girl - am I justified in ending its life ?". A second area is if the pregnant woman is in an economic or social situation which she may consider less than adequate to raise her child. These women can ask: "If I can't afford to provide a 'good' life for my child, why should I allow him/her to live ?". A third area concerns the rights of the father.

Know the main difference(s) between euthanasia and 'death with dignity' / physician-assisted death

Euthanasia v. Physician-Assisted Death (P.A.D.) Euthanasia and P.A.D. are very different procedures for hastening death. In euthanasia, a doctor injects a patient with a lethal dosage of medication. Euthanasia is illegal in every state in the U.S., including Oregon. P.A.D. allows a terminally-ill person to end his/her life through the voluntary self-administration of lethal medications. The physician prescribes a lethal dose of medication to a patient, but the patient, not the doctor, administers the medication. Euthanasia v. P.A.D. - Laws There are no federal laws regarding either euthanasia or physician-assisted death. All 50 states and the District of Columbia prohibit euthanasia under general homicide laws. Physician-Assisted Death (P.A.D.) -- also known as "death with dignity" or "assisted suicide" -- laws are handled at the state level. Most states have specific laws prohibiting all P.A.D. , or prohibit i because they do not "recognize" the common law which allows it Ten (10) states (Oregon, Washington, Vermont, Colorado, Hawaii, Montana, New Jersey, Maine, New Mexico, and California) and the District of Columbia allow P.A.D.

Know the elements of Roe vs Wade and states' responses to abortions and Roe vs Wade

For example, in Texas, the state legislature passed a law which provided for no public funding for abortions except in cases of life endangerment, rape, and incest. The law also required that the health care provider must show an ultrasound of the fetus to the woman -- and explain what she was viewing -- within 24 hours of the procedure if the woman lived within 100 miles of the abortion facility. In 2019, 15 states introduced six-week abortion bans. They are Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, Missouri, New York, Ohio, Sought Carolina, Tennessee, Texas and West Virginia. All of these laws have been challenged in the courts, and none are currently in effect. Abortion Laws - 2021 Abortion laws restricting abortion passed in 2021 took many forms. In Montana, the Governor signed 3 bills restricting abortion in that state. The bills ban abortion after 20 weeks of gestation, require health care providers to give pregnant women the opportunity to view an ultrasound before performing an abortion, and place several restrictions on abortion pills, including requiring that they be administered in-person rather than through telehealth. Arizona's governor signed a sweeping anti-abortion bill that: bans the procedure if the woman is seeking it solely because a fetus has a genetic abnormality such as Down's syndrome; provides that doctors who perform an abortion solely because the child has a survivable genetic issue can face felony charges; confers all civil rights to unborn children ('personhood'); bans mail delivery of abortion-inducing medication; allows the father or maternal grandparents of a fetus aborted because of a genetic issue to sue; bans the spending of any state money toward organizations that provide abortion care; requires fetal remains to be buried or cremated; and forbids state universities from providing abortion care In Oklahoma, the Governor signed three anti-abortion bills into law, including ones to criminalize the procedure in certain cases and cost providers their medical licenses for performing them. Under the new law, any doctor who performs an abortion after detecting a heartbeat would be guilty of homicide. Abortion Laws and the Supreme Court --

Gene therapy/engineering

Gene therapy and genetic engineering are two closely related technologies that involve altering the genetic material of organisms. The distinction between the two is based on purpose. Gene Therapy Gene therapy seeks to alter genes to correct genetic defects and thus prevent or cure genetic diseases. The goal of gene therapy is to bring people back to normalcy. The most common strategy used is to replace a deficiency or block an overactive pathway by inserting a normal copy of gene into a patient with a specific genetic disease, and turning "off" a gene to avoid a disease. Gene therapy Ethical Issues Because of its huge potential to cure diseases, the supporters of gene therapy argue loudly for its wider use -- and against government regulation to hamper its use. They say that it is the only way to cure genetic disease. They way that it cures diseases rather than just treating them. They say that if the reproductive cells of the carrier are targeted, then their offspring will be free of the defective gene(s) -- and will essentially wipe out the target disease. Those who oppose gene therapy cite reasons for their opposition. They say that gene therapy is 'against the natural order' and fear that it could be misused to create "designer babies". They say that its safety is unknown, that there have been no long term clinical trials, and that drug therapy is safer. They say that prenatal screening may lead to an increase in abortions. Experts in ethics ask "Do we have the duty to prevent suffering, or the duty to respect human life as it naturally occurs ?" Food for thought !! Gene engineering: While gene therapy aims to alter genes to prevent or cure genetic diseases, genetic engineering aims to modify the genes to enhance the capabilities of the organism beyond what is normal. Genetic engineering used extensively in agriculture. For example, most wheat, rice and soybean crops have become resistant to herbicides and pesticides through genetic engineering. Gene engineering ethical issues Ethical Issues Supporters of genetic engineering and gene editing insist that this technology will make life better by enhancing the capabilities of people and organisms beyond 'normalcy' -- for instance, by increasing peoples'

Know about GINA

Genetic Information Nondiscrimination Act (GINA) This Federal law was passed in 2008, and prevents discrimination from health insurers and employers. Because GINA is a federal law, it applies to all states. GINA sets a minimum 'standard' of protection that must be met in all states. This means that a state can't offer less or fewer protections than required by GINA. States can always choose to offer more protections than the federal standard. One large drawback of GINA is that the law does not cover life insurance, disability insurance and long-term care insurance. Oregon, California and Vermont are the only states with laws that provide protections in these three important areas. In addition, Oregon has laws which focus on genetic testing for employment and research.

Genetic testing

Genetic Testing The purpose of genetic testing is to detect gene variants associated with a specific disease or condition. When it was first used, genetic testing was most commonly found in paternity testing and forensics. Genetic tests of a person's DNA can accomplish several important public health objectives. Genetic testing can determine the genetic cause of a disease which may be sweeping through an area and killing thousands (e.g. the Ebola epidemic in Africa several years ago), or it may just confirm a suspected diagnosis for a single person. Both are important because diseases 'travel' -- because people move between countries or regions -- which causes diseases to spread more quickly than any time in our history. Genetic testing can also be used to predict future illness. For instance, it can be used to detect when an individual might pass a genetic mutation to his or her children. This mutation could be fatal if passed on, and therefore parents would have an interest in knowing if their child had the mutation -- and the children could use that knowledge later in life in making their own life decisions. Below is an example of how genetic testing can determine if cystic fibrosis, a serious and deadly disease, is passed down from parents to children: Another use for genetic testing is to predict an individual's response to therapy (e.g. chemotherapy, if the person is being treated for cancer). Today, chemotherapy drugs are customized for the patient and his/her genetic makeup. Finally, genetic testing can be used to screen newborns, fetuses, or embryos used in in vitro fertilization for genetic defects. (We will talk about infertility -- and 'assisted fertilization' techniques to overcome it -- next week.) Genetic testing ethical issues Genetic testing can raise lots of ethical issues, such as: -- Privacy and confidentiality of genetic information (who owns/controls/should have access to genetic information?) Two new laws restrict police use of DNA search method. -- When testing is appropriate or not (should testing be performed when no treatment is available ?) -- Rights of minors (should parents have the right to have their minor children tested for adult-onset diseases ?) One of the newest and

Know about the Human Genome Project - why it was undertaken, and the benefits of mapping the human genome inexpensively in the future

Genetics is the study of heredity using information from analysis of the human genome. The Human Genome Project was a government-funded project, whose aim was to identify and map ('sequence') the human genome. It was completed in 2003, and the results were made available to all physicians and scientists who could use it. Its results were (and still are) of great value to scientists hunting for disease genes. There are about 1,600 known genes that influence an individual's health and the health of their offspring. Sequencing ('mapping') means determining the exact order of the base pairs in a segment of DNA through a method known as BAC-based sequencing (BAC = "bacterial artificial chromosome"). Sequencing of 3,622 Icelanders provides insight into the role of structural variants in human diseases and other traits. Sequencing / mapping -- also known as genetic testing -- is a highly technical, expensive process, requiring the use of complex equipment, and it used to be limited to a small number of companies and research universities. However, it has been 'commercialized', and the cost has decreased dramatically. There are now small companies (such as '23 And Me') who offer to map the genes of anyone who can pay a small/reasonable fee.

Understand the role of ethics committees in health care institutions (e.g. Hospitals)

Hospitals and other health care organizations have ethics committees. Members include doctors, nurses, social workers, and (often) a bioethicist. The work of ethics committees is to help to clarify the difficult ethical issues faced by hospital or medical personnel, and look at possible alternatives. Ethics committee members may help with conflict resolution, but ethics committees are not policy making committees. An excellent, local example can be found at the OHSU Center for Ethics in Health Care

Be able to define ethical relativism

However, there is one concept can impact your daily work in health care: a behavior may be considered ethical in one society and unethical in another. This is called 'Ethical Relativism'. Here's a dictionary definition: "Morality is relative to the norms of one's culture. There are no absolute truths in ethics and that what is morally right or wrong varies from person to person or from society to society. The theory believes that variances in culture and society influence whether an act is moral. This theory believes that what is right for one group may not be right for another... there is no "universal truth." In health care, you will find the term medical ethicist. A medical ethicist: Provides input on medical policies and procedures that may be affected by prevailing, new or emerging moral and ethical interpretations. Provides opinions and shares insights with doctors, clinicians, patients, or families. May be an independent consultant or may work for a clinic, research facility or hospita

Know how effective the health care legislation passed in Massachusetts has been, and whether it is similar (or very different) from the ACA

In 2006, the Massachusetts legislature passed a bill containing mechanisms for nearly all of its residents to obtain health coverage By early 2011, 98% of Mass. residents had healthcare coverage (including 99.8% of children) -- a resounding success, for sure !

Know the elements of informed consent (including who cannot give informed consent; when can a minor give informed consent)

Informed consent is when a patient agrees to allow health care personnel to examine, touch or perform a treatment that is within their scope of practice. All 50 states now have legislation that requires some form of informed consent. The physician -- not a delegated representative (support staff) -- should discuss informed consent with the patient. Failure to obtain informed consent potentially puts a physician liable for negligence or battery and constitutes medical malpractice. There are seven elements of informed consent that require understanding by the patient: 1. The proposed treatment2. Why the treatment is necessary3. Risks involved in the proposed treatment4. Available alternative modes of treatment5. Risks of these alternative modes of treatment6. Risks involved if treatment is refused7. Information must be given in the language or means of communication understood by the individual There some exceptions to informed consent. Minors cannot give informed consent, except if the minor is emancipated, married or a "mature" minor, or if the testing is for a STD which is reportable Mentally incompetent individuals cannot give informed consent Those who do not speak or understand English may not give informed consent, unless the information is given in the language or means of communication understood by the individual

Know what POLST means, what it does, who started this program, and if Oregon is one of the states where it is used.

It is a program designed to improve the quality of care people receive at the end of life. It is based on effective communication of patient wishes, documentation of medical orders on a brightly colored form and a promise by health care professionals to honor these wishes. It was started by Oregon Health Sciences University (OHSU) Center for Ethics in Health Care. Currently forty seven (47) states now have a POLST in place or are developing one. Oregon leads the way in POLST research, and keeping the POLST process up to date. As a result, in January 2019, Oregon became the first state to remove artificially administered nutrition (through a feeding tube) from their POLST form. According to an article in the Journal of the American Geriatrics Society by Susan W Tolle MD, the Director of the Center, this decision was based on research in Oregon: "In the early 1990's, Oregon law specified that artificial nutrition be provided unless refused by a patient, supporting the inclusion of this treatment option on the initial version of the POLST form. When the POLST program was developed, little was known about artificial nutrition outcomes in persons with advanced illness....Research began to demonstrate that artificial nutrition by feeding tube was of no value in patients with advanced dementia (compared to stroke with dysphagia, amyotrophic lateral sclerosis. or persistent vegetative state, where it can extend life)....(As a result of this research, we concluded that: 1. POLST is for emergency situations; artificial nutrition is not an emergency. 2. Harms outweighed the benefits (for example surrogates of those with advanced dementia might be misled to believe that tube feeding is a viable treatment option when it does not extend life and may increase suffering).

Know about Advanced Directives

Living Will is detailed instructions regarding a patient's wishes for end-of-life treatment. It may include any or all of the following: Circumstances in which treatment should be discontinued. When heroic measures should or should not be taken. Directions for organ donation, autopsy, or alternative treatment. Durable Power of Attorney is a document designating individual(s) to act on another's behalf in all legal matters. It takes effect when the grantor loses ability to make decisions such as unconsciousness or mental incompetence. Health Care Proxy is a power of attorney for health care matters. It usually relates to end-of-life situations. Do-Not-Resuscitate Order (DNR) is an order issued when a patient specifies that no CPR should be performed if his/her heart stops beating. Different procedures exist in each state.. Organ Donation Directives describe a patient's specifications regarding organ transplantation.

Know the laws relating to death and dying

Laws Relating To Death and Dying Uniform Determination of Death Act defines when death occurs. Brain death occurs when the following functions irreversibly cease: circulatory and respiratory functions. This means the entire brain, including the brain stem. Uniform Rights of Terminally Ill Act. It provides guidelines for states regarding a person's "right to die." Patient Self-Determination Act of 1990. This act requires that hospitals and other health care facilities provide written information to patients about the right to make medical decisions as well as the right to execute Advance Directives.

Know the causes of increases in Medical Malpractice costs

Medical malpractice is the improper, unskilled, or negligent treatment of a patient by a physician, dentist, nurse, pharmacist, or other health care professional. Medical malpractice insurance is what health care professionals buy to protect themselves from the cost of being sued. Medical Malpractice costs have increased dramatically over the last 20 years. This dramatic rise is in disproportion to other costs in health care. There are three (3) factors that impact medical malpractice costs: Many medical errors have disastrous and costly results for patients Judgments awarded by courts to plaintiffs who sue have increased accordingly Costs to physicians for medical malpractice insurance to protect them against these judgments have gone up This has caused some physicians to shield their assets from people who could sue them for malpractice. Is this ethical?

Know the principal difference(s) between Medicare and Medicaid.

Medicare is the government sponsored health care program for people 65 years of age or older (+ certain others, such as those on kidney dialysis). In 2015, Medicare covered ~ 55 million Americans. Medicare is run by the federal government, so the program and coverage is the same in all states. Medicaid is the U.S government sponsored health care program for low-income individuals and families. Medicaid is run by individual states, so types of coverage and policies varies between states. Medicaid payments cover ~60% of all nursing home residents and ~37% of all childbirths. Currently, Medicaid federal and state funding in Oregon amounts to approximately $6.5 billion a year, and covers nearly a million people in Oregon. Oregon's Medicaid program is called The Oregon Health Plan (OHP)

Know history and ethical issues of Oregon's Death with Dignity Act (DWDA)

Oregon's DWDA in November 1994, Oregon voters passed Measure 16, which legalized physician-assisted dying with certain restrictions. Oregon was the first U.S. state to permit some terminally ill patients to determine the time of their own death. This law was first known as the "assisted suicide law," but eventually became known as the Death With Dignity Act (DWDA) or "Physician-Assisted Death (PAD). After the legal case of Washington v. Gluckberg was decided in June 1997, the Oregon Legislature referred Measure 51 to Oregon voters the following November. Measure 51 sought to repeal the Death With Dignity Act, but was rejected by 60% of voters. Oregon began to allow assisted suicide under the DWDA starting in 1998. In 2005 the act was challenged by the George W. Bush administration, but was upheld by the Supreme Court of the United States in Gonzales v. Oregon (2006). PAD - Ethical Issues Pro and Con Pro All persons have a moral right to choose freely what they will do with their lives as long as they inflict no harm to others. This right of free choice includes the right to end one's life when they choose We have an obligation to relieve the suffering of our fellow human beings and to respect their dignity. There are many who want to die, but whose disease, handicap, or condition renders them unable to end their lives in a dignified manner. When such people ask for assistance in exercising heir right to die, their wishes should be respected. Con Society has a moral duty to protect and to preserve all life. to allow people to assist others in destroying their lives violates a fundamental duty we have to respect human life. A society committed to preserving and protecting life should not commission people to destroy it. Sanctioning assisted suicide would violate the rights of others. Doctors and nurses might find themselves "pressured" to cooperate in a patient's suicide. In order to satisfy the desires of a patient wanting to die, it's unjust to demand that others go against their own deeply held convictions.

Be able to recognize countries around the world which allow P.A.D.

P.A.D. / Voluntary Euthanasia In Other Countries Physician-assisted suicide is legal in some countries, under certain circumstances, including Austria, Belgium, Canada, Germany, Luxembourg, the Netherlands, New Zealand, Spain, Switzerland, parts of the United States and parts of Australia.

Know what other states have passed, are trying to pass, or recently defeated laws similar to Oregon's.

P.A.D. In Other States In the U.S. As you learned last week, there are no federal laws regarding physician-assisted death. Physician-Assisted Death (P.A.D.) -- also known as "death with dignity" or "assisted suicide" -- laws are handled at the state level. Most states have specific laws prohibiting all P.A.D. , or prohibit it because they do not "recognize" the common law which allows it Ten (10) states (Oregon, Washington, Vermont, Colorado, Hawaii, Montana, New Jersey, Maine, New Mexico, and California) and the District of Columbia allow P.A.D.

Know about Physician-Assisted Death (in general, separate from the DWDA).

P.A.D. allows a terminally-ill person to end his/her life through the voluntary self-administration of lethal medications. The physician prescribes a lethal dose of medication to a patient, but the patient, not the doctor, administers the medication.

Know about risk management and compliance reporting

Risk management/compliance reporting can reduce the incidents that could possibly lead to a charge of malpractice. Many large clinics and health care systems have departments that focus solely on risk management/compliance reporting and involve all levels of staff in being accountable for reducing risk and providing a safe environment for patients. Risk management/compliance reporting involves designating a compliance officer or contact person, developing and implementing compliance program policies and procedures, conducting training and education of staff in these procedures. When conducting internal monitoring and auditing, it is important to respond appropriately to detected offenses, develop corrective actions, and enforce disciplinary standards following guidelines set forth in the program policies and procedures.

Know why the major laws relating to abortion (including the Hyde Amendment) are important.

Roe v Wade -- 1973 In 1973, the U.S. Supreme Court, in Roe v. Wade, legalized abortion in four significant ways. The Court legalized abortions in all trimesters when a woman's doctor believed the abortion was necessary for her physical or mental health. Secondly, the Court also declared all the individual state bans on abortion during the first trimester to be unconstitutional. Thirdly, the Court allowed states to regulate but not proscribe (forbid) abortion during the second trimester. Finally, the Court allowed states to proscribe (forbid) abortion during the third trimester (except where the abortion was in the best interest of the woman's physical or mental health - see above). Roe v Wade was an important precedent, and it is rare (although it does happen) that the Court overrules cases considered precedents. Abortion - Since Roe v Wade After Roe v Wade, there were both important court decisions made, and laws passed by Congress, relating to abortion. About 20 years after Roe v Wade, the Supreme Court considered an important case relating to when abortions could be performed or not. In 1992, in the case of Planned Parenthood v. Casey, the Court overturned the trimester framework in Roe v. Wade. The Court decision made it legal for states to proscribe (forbid) abortion after the point of fetal viability, excepting in instances that would risk the woman's health. 'Fetal viability' means that the fetus could survive on its own outside the uterus. The length of time is based on the medical / scientific evidence. This period of time is commonly accepted as 24 to 28 weeks of gestation. So the effect of the Court's decision was to outlaw abortions after 24 - 28 weeks. In 2003, the U.S. Congress enacted the Partial-Birth Abortion Ban Act, and President George W. Bush signed it into law. This statute outlawed a form of late-term abortion, referred to in medical literature as 'intact dilation and extraction'. The law was challenged in three appeals courts, but the Supreme Court held that it was constitutional. Congress has also passed legislation which affected abortion rights. The most important of these laws was the Hyde Amendment, passed in 1976, which barred the use of certain federal funds to pay for abo

Know about Scope of Practice

Scope of Practice Scope of Practice describes the procedures, actions, and processes that a health care practitioner is permitted to undertake in keeping with the term of their professional license.

Know what the 'individual mandate' is.

The ACA dramatically expanded healthcare coverage to more people by 2014. It did this several ways. It expanded the federal-state Medicaid program to include people with low incomes up to ~$30,000 per year for family of four. The previous income level was much lower. It required states to establish health insurance 'exchanges' -- or to use the federal government's exchange -- for individuals and small businesses to purchase affordable health insurance. It provided for mandatory health care coverage starting in 2014 by requiring individuals to purchase insurance (the 'individual mandate') - or pay a fine.

Stem cells

Stem cells are simple cells in the body that are able to develop into any one of various kinds of cells (such as blood cells, skin cells, etc.). This means that under certain physiologic or experimental conditions, they can be induced to become tissue or organ specific cells with specific functions. There are several types of stem cells: Human embryonic stem cells from blastocysts and responsible for fetal development Somatic (adult stem cells) located in bone marrow and tissue and responsible to maintain and repair the tissue in which they are found Induced pluripotent stem cells (iPSCs) are adult stem cells genetically reprogrammed to an embryonic stem cell-like state Focus of Stem Cell Research Stem cell research is currently focused on 2 areas. The first area is in the testing of new drugs. For example, cancer cells 'lines' of stem cells are now used to screen potential anti-tumor drugs. The second area is in the generation of cells and tissues for cell-based therapies. For example, stem cells are used to repair damaged organs, and as a source of replacement cells. Ethical Issues The use of adult stem cells is now generally accepted. There are now Stem Cell Centers in major cities, which advertise that they use the stem cells from one's own body to address your problems with diseases such as arthritis, Parkinson's, COPD, multiple sclerosis, and more. Rick Perry, the former Governor of Texas, has announced that he received stem cell treatment for his chronic back pain. Most ethical issues relating to stem cell research relates to the use of embryonic stem cells. The use of embryonic stem cells in reproductive research is considered by most as unethical. The core ethical question: is an embryo a fetus - and thus a person? Those who argue that an embryo is life argue that the embryo is entitled to legal protection, thus the controversy. The development and exclusive use of adult stem cells in research will eliminate this ethical issue

Know the different types of surrogacy

Surrogacy is a strategy used when a woman who wants to be a mother is unable to carry an embryo to term. ('Surrogate' means 'taking the place of another' and, in this lecture, always refers to a woman. ) A woman's inability to carry to term can be for many reasons, most of which are outside her control. But, the result is the same: she needs help from others to have the baby she so much desires. There are 2 main types of surrogacy -- traditional and gestational. The main difference between them is which female the embryo is from -- that is, who is the genetic mother of the child. Traditional surrogacy occurs when the embryo is from the surrogate. She is the child's genetic mother. In the illustration below, she is labeled 'Mother'. In most cases, the sperm is taken from the male ('Father' below) and used to fertilize the ovum in the 'Mother'. The 'Father's wife' is the person unable to carry the embryo to term, and thus needs the help of 'Mother's' reproductive system to grow and birth the baby. In the typical case of traditional surrogacy, the 'Mother, 'Father', and 'Father's wife' have a written contract providing that the baby will be turned over by 'Mother' to the couple immediately upon birth, and that 'Mother' has no rights or obligations to the child upon birth / this transfer. The second type of surrogacy is Gestational surrogacy. This occurs when the surrogate has an embryo transferred to her uterus, and she carries it to term and delivery. In this case, the surrogate is not the genetic mother of the child. Surrogacy - Legal Issues There is no federal law governing surrogacy. It falls under state jurisdiction and the legal situation for surrogacy varies greatly from state to state. In these laws, what matters most is: (1) where the contract is completed; (2) where the surrogate mother resides; and (3) where the birth takes place.

Know purpose of OHP and purpose of changes in OHP in 2011 and 2012

The Oregon Health Plan (OHP) started in 1989 as a series of public and private health insurance reforms intended to provide access to affordable health insurance for all Oregonians. The original Plan had three main components: extending Medicaid eligibility* to all state residents with incomes below the federal poverty level; establishing a High Risk Insurance Pool for people refused health coverage because of pre-existing medical conditions*; providing small businesses with a broader range of insurance options*, and their employees with a better ability to retain their health insurance when changing jobs In 2011 and 2012, the State Legislature approved a comprehensive overhaul of the Oregon Health Plan.. These new laws: Emphasize prevention and better management of chronic illnesses Restructure health care delivery to oversee all the physical, mental and dental care of state-funded patients through Coordinated Care Organizations (CCOs) Are similar to the approach being used at the national level in the Affordable Care Act Goals of the new laws: To drive down health care utilization and costs by at least 2% per member per year Reduce the number of low-income patients with chronic illnesses (such as asthma and congestive heart failure) who have to go to the hospital for treatment

Know what the Oregon Medical Practice Act is, what professions it regulates (and those it does not), and why it exists (its powers/authority)

The Oregon Medical Practice Act regulates the following medical professions: Physicians and Surgeons; Podiatric Physicians and Surgeons; Physician Assistants; and Acupuncturists. It does not regulate: Nurses, Certified Nurse Midwives (regulated by the Oregon State Board of Nursing) Chiropractors (regulated by the Oregon Board of Chiropractic Examiners) Massage Therapists (regulated by the Oregon Board of Massage Therapists) Medical Assistants - M.A.'s are certified, not licensed. Dentists The Oregon Medical Practice Act establishes rules and regulations guiding the practice of medicine. It also investigates and disciplines violators.

Describe the Standard of Care for Physicians/health care workers

The first is that individuals with more training are held to a higher standard of care. An example would be the standard of care expected of a registered nurse would be higher than that of a nurses aid because a registered nurse has more training. In general health care workers are held to the standard of care of their training and expertise. Health care workers who perform duties usually performed by those with a high level of training may be held to the higher standard of care. The second is what is called the "Reasonable Person Standard." A person may be held negligent if they fail to perform an act that a reasonable person would perform under similar circumstances. An example would be a registered nurse giving a patient ten times the usual dose of medication. A reasonable "competent" nurse should know the proper dosage of medications that they give to patients and not give the patient the incorrect dose. Therefore, in this case the nurse who gave ten times the usual dose of medication could be determined to be negligent. Physicians are held to the standard of care of other practitioners with similar training in the same or comparable community. That means that a specialist is held to a higher standard of care in his or her specialty.

Know the general responsibilities of physicians to the public

There are several laws which require physicians to provide specific information to certain agencies both federal and state. These include but are not limited to collection of vital statistics that are collected by state and federal governments (examples are births and deaths); reporting of public health matters such as certain communicable diseases (examples include Tuberculosis/TB, HIV/AIDS, and more) as well as certain injuries; reporting Child or Elder Abuse; and complying with the Controlled Substance Act (see 'Federal Drug Regulations' below).

Know the ways health care workers can prevent medical malpractice

This can mean lots of things. But, at a minimum, it means that the office should carefully select and supervise employees to make sure they are sympathetic to patients' concerns. As for treatment, they should explore all reasonable diagnostic methods prior to treatment, and use conservative and less dangerous treatment when possible. Even though patients may ask or expect, they should limit or avoid diagnosing and prescribing by phone or over the Internet. Whenever possible, they should have male physicians examine female patients with a female assistant in the room -- and the same rule should apply to female physicians examining male patients (the common term is "chaperone"). In terms of ensuring that their office operates with safety as a top priority, they should monitor equipment and facilities for safety on a regular basis and know the risk of toxic or hazardous agents and make MSDS information available. There are many things that health care workers can also do to minimize the possibility of medical malpractice claims. When providing daily care, it is always important to follow protocol for making appointments and maintain complete and accurate records. This can include relating phone and other messages accurately, checking each drug at least 3 times before administering, and otherwise following practice standards for similar practices, level of education, and location. And, of course, document, document, document -- as patient records are often used as evidence in a lawsuit.

Know issues about genetic discrimination in general and Oregon in particular

This is called 'Genetic Discrimination' -- the different treatment of individuals based on their actual or presumed genetic differences. Here are some examples of where potential genetic discrimination may exist -- employment, life insurance, or health insurance benefits. It can affect many, many people -- employees, students, parents, children -- practically everyone. Oregon, California and Vermont are the only states with laws that provide protections in these three important areas. In addition, Oregon has laws which focus on genetic testing for employment and research. GINA

Understand the basic differences between law & ethics

Types of Law There are many types of laws. Case Law, which originally comes from English Common Law, were oral traditions and not written down. Now, previous court decisions which become the basis for future cases are called "precedents." Current court decisions often follow precedent but adapt the decision to updated circumstances. A good example of this is "email" -- which was not considered "writing" 30 years ago, but now is. Statutory Law are laws enacted by the Congress or state Legislatures. Administrative Law are statutes passed by the legislative branch to define the powers of procedures of governmental agencies like the Oregon Health Authority (OHA). Regulations are developed by federal or state government agencies to enforce the laws passed by the legislative branch

Know how laws are formed and the types of laws (caselaw, common law, etc.): know about criminal & civil laws, how they are different and some examples of each

Types of Law There are many types of laws. Case Law, which originally comes from English Common Law, were oral traditions and not written down. Now, previous court decisions which become the basis for future cases are called "precedents." Current court decisions often follow precedent but adapt the decision to updated circumstances. A good example of this is "email" -- which was not considered "writing" 30 years ago, but now is. Statutory Law are laws enacted by the Congress or state Legislatures. Administrative Law are statutes passed by the legislative branch to define the powers of procedures of governmental agencies like the Oregon Health Authority (OHA). Regulations are developed by federal or state government agencies to enforce the laws passed by the legislative branch Criminal laws are crimes against the state. Criminal 'charges' are brought forward by the government; examples are murder, burglary, robbery, rape -- and practicing medicine without a license. Less serious crimes are called misdemeanors; punishment is by fines or jail time of less than one year. More serious crimes are called felonies , with punishment by fines or imprisonment of more than one year. Civil Laws Charges for violation of civil laws are brought by one citizen against another. Violation of civil laws does not include imprisonment. But, being found in violation of certain civil laws can cost you all your money or your career. Examples of civil laws that we will discuss in this course are Wrongful Death, Negligence, Medical Malpractice, and Breach of Contract (among others).

Know about organ donation

Uniform Anatomical Gift Act of 1968 - Revised in 1987 & 2006 "Model" act which created a legal procedure for persons who wish to donate their organs (after their death) and for hospitals and medical institutions wanting to accept them. Been adopted in some form by all 50 states Forbids the sale of body parts (the recipient cannot pay for the donated organ but must pay for the cost of transportation and transplant. National Organ Transplant Federal Law of 1984 Established Organ Procurement Organizations (OPO's) and the Organ Procurement and Transplantation Network (OPTN). These organizations work together to provide organs throughout that U.S. This law created "the list." Recently an Op-Ed article was published in the New York Times arguing that it is time for the national government to provide oversight and require transparency in the organ recovery system. Specifically to eliminate self-reporting of data and change the standards used to evaluate OPO's performance. The Trump Administration's Unified Agenda of Regulatory and Deregulatory Actions (Agenda) has published and assigned this topic to the Department of Health and Human Services (HHS). (Spring 2019) Banned the interstate sale of organs Created a Task Force to study organ transplant policy issues Patient Self Determination Act (PSDA) Uniform law adopted by every state that governs organ and body donations Covers how anatomical gifts can be made and offers suggested form for making donations Provides a list of relatives who an authorized organ donation in absence of arrangements made before death States are free to adopt the act as written or modify it through the state's legislative process Organ Donation in Oregon To register as a organ, eye, and tissue donor: Must be 15 years of age or older Sign up on the Donor Registry by one of the following: Asking DMV to put a "D" code on your license, permit or identification card or Signing up online at Donate Life Northwest It is very important that you also inform your family of your wishes to be a donor. These actions ensure your decision is known and honored by your family and the organ, eye, and tissue recovery agencies. Donations and Transplants Are Linked Required Request Law of 1986 Came from one

Know about negligence - is it intentional or unintentional? What is it? Some examples in a medical environment: know the "4 D's"

Unintentional torts occur when someone injures another unintentionally. The most common tort in the health care system is negligence. Negligence happens when a health care provider fails to exercise ordinary care and the patient is injured. Negligence has 4 parts or "elements" which start with the letter "D." All of these elements must be present before negligence can be established. Duty - the person charged with negligence owed a duty to the accuser ("duty to care," "standard of care") Derelict - the provider of care breached the duty of care (was 'derelict') to the patient . Direct Cause - the breach of care was the (or a) direct cause of the patient's injuries Damages - there is a legally recognizable injury/damage to the patient Duty - physician had a duty to care/provide emergency care for this patient who was seeking care in the Emergency Department Derelict - physician breached the duty of care to the patient as standard of care would be lab work and a referral to a surgeon Direct Cause - the breach of care was a direct cause of the patient suffering a ruptured appendix and peritonitis with the need for care in a hospital Damages - injury/damage to the patient was the ruptured appendix and peritonitis and the risks associated with these complications

Know about infertility - the definition, the 4 different options to overcome it, ethical issues and laws associated with each

We will look at the various ways that infertility can be overcome. (Medical literature refers to these approaches as 'assisted reproductive technologies'.) There are 4 major approaches: (1) Artificial insemination (AI) -- the injection of viable semen into the woman's reproductive system; (2) 'Assisted' Fertilization -- either In vitro fertilization (IVF) or In vivo fertilization; (3) Surrogacy -- where a woman carries and delivers a child for another couple or person; (4) Adoption There is no federal law to govern the practice of assisted conception in the United States, but there are many state laws relating to fetal research, abortion, human subject protection, etc. We will look at some of the Oregon laws in detail later in this lecture. AI ethical issues Ethical Issues: The development of AI has brought up several important ethical issues. The most common relate to medical information about the donor -- and thus also the offspring of the AI procedure -- and the selection of the sex / gender of the offspring. Does an individual have the right to be informed about his or her heritage by learning the medical history of the donor? This does not happen in all cases, for sure. Many doctors compound the problem by failing to keep records on the identities and medical histories of donors. The second major area of ethical concern relates to the selection of the sex of the offspring. Unlike just a few years ago, medical technology now allows recipients to know the sex of their offspring well before birth -- and, in theory, allows recipients to choose whether the embryo(s) of just one sex or another should live. Some religions condemn this practice as unnatural, while others disagree. Other ethical questions relate to whether it is 'right' (or 'wrong' -- unethical and exploitative) to offer expensive, difficult, painful, and frustrating fertility procedures to desperate people when there may be little chance that a successful pregnancy will result.

Know the difference between in vitro and in vivo.

he first, and by far more common, method is In vitro fertilization (IVF). In vitro means "outside the body". IVF accounts for >99% of all assisted reproductive technology procedures. The second method is in vivo fertilization (in vivo means "within the living"), but we will not discuss it in detail in the course because it is so rarely used.


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