FMHC E1 Study Guide PDF

FMHC-I E1 STUDY GUIDE GRACE BERTRAM Lecture 1 – ABC’s of FMHC intro lecture Cannot find a ppt for this lecture… anyone go to this lecture? Lecture 2 – Physician Behavior I. Address 2 pre-existing trait...

FMHC-I E1 STUDY GUIDE GRACE BERTRAM Lecture 1 – ABC’s of FMHC intro lecture Cannot find a ppt for this lecture… anyone go to this lecture? Lecture 2 – Physician Behavior I. Address 2 pre-existing traits of those who go into medical professions a. Perfectionism i. Often reinforced by the culture of medicine… desired by patients and rewarded in the field ii. NOT adaptive 1. It is a vulnerability factor for depression, anxiety, burnout, and suicide 2. Comparable to “hopelessness” as a predictor of suicidal ideation iii. Often stems from a childhood conviction of being unloved or devalued by parents 1. Corrective emotional experience via providing care/attention to our patients iv. Seek approval and increased self-worth v. Imposter syndrome – feel fraudulent when rewarded vi. Compulsive triad – self-doubt, guilt feelings, exaggerated sense of responsibility vii. Other common traits that go hand-in-hand with professionalism 1. Rigidity 2. Stubbornness 3. Inability to delegate 4. Excessive devotion to work, leading to neglect of relationships/leisure time activities viii. Narcissistic injury 1. Academic difficulty experienced for the first time 2. Inadequate academic performance is a risk factor for depression and anxiety 3. Inadequate academic performance may be a consequence of preexisting depression/anxiety b. Procrastination i. Delaying or ignoring physical health needs 1. Don’t seek regular health care for themselves and spend less time in health promoting activities ii. Delaying or ignoring relationship needs 1. Time devoted to family/friends feels selfish 2. Lack of availability to SO, family, etc and justifying excuses 3. Varying degrees of estrangement and isolation result and physician develops “workaholic” mentality... finds comfort at work instead of home 4. There are unique challenges to being in a relationship with a physician. 4 pillars of a medical marriage – intimacy, respect & appreciation, finding shared meaning, communication iii. Delaying or ignoring mental health needs 1. Anxiety and depression amongst medical students 2. More likely to engage in dishonest or unprofessional behavior when depressed or burned out iv. Significantly increased risk of suicidal thoughts and suicide v. Fear of seeking treatment for mental health issues due to stigma/ academic repercussions vi. Leads to self-medication 1. Excessive alcohol intake, illicit drug use, non-medical use of stimulant II. Address 2 areas of concerning behavior in medical professionals a. Lack of professionalism  i. American Board of Internal Medicine defines professionalism as requiring “the physician is to serve the interests of the patient above his or her own self-interest. Professionalism aspires to altruism, accountability, excellence, duty, service, honor, integrity and respect for others”. ii. American Board of Medical Specialties (ABMS) defines professionalism as a “three-part promise to acquire, maintain and advance: 1. an ethical value system grounded in the conviction that the medical profession exists to serve patients' and the public's interests, and not merely the self-interests of practitioners 2. the knowledge and technical skills necessary for good medical practice 3. the interpersonal skills necessary to work together with patients, eliciting goals and values to direct the proper use of the profession's specialized knowledge and skills, sometimes referred to as the “art” of medicine. iii. Medical professionalism pledges its members to a dynamic process of personal development, life-long-learning and professional formation, including participation in a social enterprise that continually seeks to express expertise and caring in its work.” iv. Top 10 Ethical Issues for Medical Education v. General issues at medical school level – failure to disclose errors, cheating, boundary violations, improperly disclosing PT information, posting confidential info on social media, derogatory remarks, refusal to report impaired peers b. Pleasure seeking/risk taking behaviors i. Physicians are at higher risk of prescription drug abuse due to access ii. High rate of lifetime incidence of alcoholism iii. When a physician is using substances, abuse of more than one type or class of drugs iv. Concurrent psychiatric illness contributes to use of substances among medical professionals i.e., “self-medicating” v. Many trainees at undergraduate (medical school) level or beyond will not come forward for help for fear of detrimental effect on future in medicine vi. Fear of seeking treatment for mental health issues due to stigma/ repercussions/ credential or licensure concerns III. Understand implications of concerning behaviors on future training/practice of medicine 2  a. Students who received comments regarding unprofessional behavior while in medical school were more than twice as likely to be disciplined by state medical board once a practicing physician. b. Risk taking behaviors are a viscous cycle: mental illness, substance use, eventual consequences to medical career… IV. Identify resources for DCOM students who need additional support or who are struggling with concerning behaviors a. Jason Kishpaugh, LPC, LMU Counseling Services b. http://www.lmunet.edu/student-life/counseling/mental-health for online anonymous screening for mental health issues c. Your assigned advisor d. Dean of Students or appropriate designee e. Tennessee Medical Foundation Physician’s Health Program f. https://afsp.org/our-work/education/physician-medical-student-depression-suicide-prevention/ g. Leah Snodgrass, MD, Chair of Behavioral Health Lecture 3 – Professionalism I. Define Professionalism as it relates to medicine. Professional competence is the habitual and judicious use of communication, knowledge, technical skills, clinical reasoning, emotions, values, and reflection in daily practice for the benefit of the individual and community being served. —EPSTEIN AND HUNDERT a. Who defines professionalism: 3  Every day and every location Dean(s), faculty, Societies and staff Institutions Colleagues Regulatory Patients bodies II. Articulate how professionalism affects patient safety and quality of care. a. Quality i. Provide the best care possible b. Patient safety i. Provide care in the safest manner possible c. Efficiency i. Provide care that is sustainable III. Define the three fundamental principles of Professionalism as defined by Epstein and Hundert. a. Primacy of Patient welfare i. Serving the interest of the patient. ii. This principle focuses on altruism, trust, and patient interest. The charter states: “Mar-ket forces, societal pressures, and administrative exigencies must not compromise this principle” b. Patient autonomy i. Display honesty and empower patients to make informed decisions about their treatment. ii. This principle incorporates honesty with patients and the need to educate and empower patients to make appropriate medical decisions. c. Social justice i. fair distribution of health care resources. ii. work actively to eliminate discrimination in health care iii. This principle addresses physicians' societal contract and distributive justice—that is, considering the available resources and the needs of all patients while taking care of an individual patient. IV. Recognize the core components of professionalism. a. Honesty with Patients i. Informed consent ii. Empower patients to participate in decisions pertaining to their health iii. Disclose fully and promptly all medical errors b. Improving Access to Care i. Strive to reduce barriers to equitable health care 1. High cost of care 2. Inadequate or no insurance coverage 3. Lack of availability of services 4  4. Lack of culturally competent care ii. Promote the health of the public without concern for self-interest iii. A commitment to equity entails the promotion of public health and preventive medicine, as well as public advocacy c. Improving Quality of Care i. Work collaboratively to: 1. Reduce medical error 2. Increase patient safety 3. Minimize overuse 4. Optimize outcomes of care ii. Help develop and implement better measures of quality health care d. Just Distribution of Finite Resources (Cost) i. Base individual patient care decisions on cost-effective management of limited resources ii. Work collaboratively to develop clinical guidelines iii. Avoid unnecessary tests and procedures iv. Shift in health care delivery from "pay for volume" to "pay for value." The fee-for-service system is unsustainable. e. Maintaining appropriate relations with patients i. Recognize inherent vulnerability and dependency of patients ii. We are all human and therefore all vulnerable f. Maintaining Trust by Managing Conflicts of Interest i. Recognize the existence of many opportunities to pursue private gain ii. Do not compromise professional responsibilities through personal advantage iii. Disclose all conflicts of interest involving professional activities g. Patient Confidentiality i. Adhere to all safeguards governing the disclosure of patient information 1. Electronic information systems for compiling patient data 2. Health Insurance Portability and Accountability Act (HIPAA) 3. Patient privacy and confidentiality ii. Disclose confidential information only when considerations of public interest override the interests of privacy 1. A provider may disclose information when law requires the disclosure, e.g., to report child or adult abuse or neglect, injuries from gunshots or criminal activity, lessen a serious and imminent threat. h. Professional Competence i. Lifelong professional development – continuing medical education ii. Maintenance of medical knowledge 1. USMLE, NBOME, licensing examination and certification boards iii. Remain competent and ensure that appropriate mechanisms are available to accomplish this goal 1. Board certification i. Professional Responsibilities i. Participate in the processes of self-regulation ii. Assist in establishing educational and standard-setting activities iii. Accept external scrutiny of professional performance j. Scientific Knowledge i. Uphold scientific standards ii. Promote research to create new knowledge iii. Ensure appropriate use of scientific information 5  V. Summarize professional responsibilities, behaviors, relationships and ethics for physicians and medical students. a. Professional Responsibilities i. Seek and accept feedback and constructive criticism ii. Commit to highest standards of competence iii. Be mindful of demeanor, language, and appearance iv. Be accountable for your actions v. Admit to and accept responsibility for mistakes in mature, honest manner vi. Be respectful of others’ time, values, rights, religious/ethnic/socioeconomic backgrounds, lifestyles, opinions, and choices, especially if different from your own b. Professional Ethics i. Have appropriate situational awareness ii. Maintain highest level of academics iii. Maintain confidentiality iv. Place others’ well-being at the center of your education v. Treat all educational resources with respect c. Unprofessional Behaviors i. Criticizing colleague’s behavior, shifting blame, rudeness, harassment, temper tantrums, inappropriate substance use, not following policies and procedures d. Professional ethics – honestly, integrity, and humility i. Be honest with yourself, colleagues, and patients ii. Acknowledge mistakes, apologize, and correct them iii. Have the courage to face the truth iv. Complying with institutional policies and procedures v. Addressing problems as they arise vi. Have the courage to say no Lecture 4 – Physician’s Health Program (TMF) A. Become familiar with physician health and wellness, illness, and impairment. a. Triad of Compulsiveness i. 80 % of physicians have OCPD traits that foster a triad of compulsiveness – doubt, guilt, exaggerated sense of responsibility ii. Illness is allowed, impairment is not permitted B. Learn about Boundary Violations, Disruptive Behavior, Addiction, and Impairment and how they can end or derail careers a. Boundary violations - The patient-physician relationship is the keystone to quality care, to the healing process and to optimal outcomes. i. Occurs anytime the professional relationship becomes anything other than about patient welfare. ii. Occurs when a physician misuses their power to exploit a patient for tangible or intangible benefit or gain. iii. Avoid dual relationships 1. Physician and patient have different roles 2. Dual relationship: Multiple roles exist between physician and patient. 6  iv. Physician Sexual Misconduct (PSM) 1. Physician-patient sex, initiated by either party, including but not limited to sexual intercourse, masturbation, genital to genital contact, oral to genital contact, etc. 2. There is a boundary violation slope … includes lots of the behaviors on the physician side that lead to a relationship beyond what is necessary to treat the patient v. Sexual contact/relations is never acceptable: 1. Harmful to the patient - may lead to coercion 2. Loss of objective care - cloud clinical judgment 3. Onus is always on the physician - exploits the dependency of the patient. 4. Can never be consensual - abuse of the inherent power differential vi. Lots of consequences of sexual misconduct – civil lawsuit, criminal prosecution felony charges, BME action on license (suspension or revocation), report to data bank vii. Lot of ways to prevent boundary violations – education of rules, training, watching out for red flags, etc. b. Disruptive behavior i. Exhibits a chronic pattern of contentious, threatening, intractable behaviors that are inappropriate in the workplace creating an atmosphere that interferes with efficient and effective work flow. ii. Lacks self-awareness and does not understand or recognize the impact of their behavior on others. iii. Uses threatening or abusive language directed at house staff, nurses, hospital personnel or peers. iv. View themselves as superior and others as incompetent, often has high IQ. v. View themselves as champions of their patients (this view is often shared by their patients). vi. Behaviors are used to intimidate, control and blame others, generally producing poor results. vii. Actions result in: 1. A decrease in workplace morale. 2. An increase in workplace stress. 3. Increased errors because of: Breakdown of communication causing mistakes. Delays making and implementing critical decisions. viii. Increased risk for litigation ix. Viewed as Unprofessional, Unethical behavior x. Increased healthcare costs. Decreased reputation of institution or practice group. Increased staff turnover c. Addiction i. Physician risk factors 1. Genetics 2. Wounded family of origin- (High ACE scores) 3. Personality traits 4. Easy access 5. Develop PTSD symptomatology in training 6. Learn to turn off emotions (Under the Mask) 7. Learn to not ask for help. ***Treat Self*** ii. Presenting Symptoms – SUD’s 1. Overachiever’s Syndrome 2. Family and marital difficulties occur early 3. Withdraws from social events 7  4.Personality changes- Jekyll and Hyde 5.Extra call or at hospital when not scheduled 6.Obtains hallway consults 7.Friction with partners or administrative staff 8.Financial issues, legal issues (DUI) 9.Work performance is typically not impaired until the more advanced stages. Illness to Impairment iii. Alcohol > Opioids > Stimulants = BZD’s d. Impairment i. Drugs, alcohol, various substance abuse, but also not being in the correct state of mind, even without the use of drugs ii. Burnout is a syndrome of: 1. Emotional depletion - Feeling emotionally depleted, frustrated, tired of going to work, hard to deal with others at work. 2. Detachment/Cynicism - Being less empathic with patients or others, detached from work, seeing patients as diagnoses, objects, sources of frustration. 3. Low personal achievement - Experiencing work as unrewarding, “going through the motions.” iii. 3 Realms of our own personal world – HOME, SOCIAL, WORK 1. On the WORK Side: a. Decreased treatment adherence, Decreased patient satisfaction b. Increased malpractice, decreased employee satisfaction, increased absenteeism, Decreased Quality of care. 2. On the Home-Social side: SUD’s, Mood D/O’s, marital issues, and suicide. iv. Treatments for burnout 1. Mindfulness training 2. Psychotherapy 3. Depression and substance use treatment 4. Support groups v. Identifying and treating burnout will decrease the risks of depression, suicide, substance use, medical errors, and personal and professional losses: 1. Burnout is recognizable, reversible, and treatable C. Become familiar with the Physician Health Programs and how to get help. a. 1978 - Tennessee Medical Association Board of Trustees established a committee for the purpose of offering professional assistance to physicians suffering from addiction. b. How can TMF help… Identification, Intervention, Assessment, Referral for Treatment, Monitoring, Earned Advocacy, Re-entry c. Confidential Tract: i. Physician is referred by self, spouse, significant other, parent, sibling, medical practice, managing partner, lawyer, MEC, CMO, CWO (wellness), patient or law enforcement. ii. Physician is evaluated, treated (if indicated), returned to work and monitored without the licensing board involvement. iii. Safe Haven clause on the renewal application for licensure. iv. Decreases stigma and resistance to getting help. d. Mandated Tract: i. Physician is referred or mandated by the BME or BOE. ii. Physician is evaluated, treated (if indicated), returned to work and monitored with mandate for compliance by Board. In Tennessee this is a public action. 8  iii. There is usually an accompanying action such as a Reprimand or Probation on license which is reported to NPDB. iv. Increases resistance to getting help. e. There is a professional screening questionnaire that designed to address increased rates of impairment, and it was created by the American Foundation for Suicide Prevention (AFSP). i. TN PSQ is intended to help connect struggling health professionals with available mental health resources in their area. ii. The TN PSQ will be used strictly as a NON-crisis service, offering an anonymous, confidential online mental health screening that will result in referrals to appropriate mental health resources and optional interaction with a program therapist. iii. Totally anonymous and voluntary D. Differentiate Medical Boards, Regulatory Medicine and PHP’s a. TMF – PHP Identifications b. If someone knows more ab this objective, pls HMU Lecture 5 – Professionalism Using Mindfulness There aren’t lecture objectives for this one... so. I. When we are not mindful of our thoughts, they skip from one unfinished idea to the next, constantly interrupting each other and overlapping in a constant stream of pictures, ideas, memories, and desires. II. What is mindfulness about? a. An awareness, without judgment, of life as it is, yourself as you are, other people as they are, in the here and now, via direct immediate experience. b. The repetitive act of directing attention to only one thing, in this one moment. III. Physiological and anatomic changes a. Reduction in cortisol levels b. Improved immune response c. Reduced blood pressure d. Increase in density of fray matter concentration e. Improved breathing rate and heart rhythm coherence f. Reduced anxiety, depression, perceived stress g. Improved mood regulation, concentration, sleep quality, sense of well-being IV. Mindfulness and YOU a. Reduced human error b. Increased coping c. Improved empathy d. Decreased emotional exhaustion e. Improvement in attitudes associated with patient-centered care V. The body keeps score a. Befriend the body? Idek I didn’t even read this whole slide. Too many words VI. Informal mindfulness exercises a. Mindfulness in your morning routine b. Mindfulness in the shower c. Mindful eating d. Rando daily mindfulness e. Thought defusion 9 Lecture 6 – State Boards-Medical Practice Act This lecture is all over the place, not sure how this will actually be tested. I. Outline the history of and process for physician licensure in the USA a. 1791: state-based system i. 10th amendment gave powers to states not specifically given to federal government by the Constitution ii. states began the function of medical regulation, licensing, and discipline of physicians b. 1859: first fully organized state medical board c. 1876: state medical boards given broad powers to set qualifications for medical practice, issue and revoke licenses d. Local control- to increase accountability and responsiveness of licensing authority e. Peers/fellow citizens familiar with context and environment of practice in the state f. Increased access and proximity to oversight body for patients and public g. Some medical licensing boards also license other health professionals II. Discuss the relationship between state licensing boards and the Federation of State Medical Boards a. American Medical Licensing Boards i. Made up of physicians who meet specified requirements and members of the Public to represent who the boards protect. b. Usually range in size from 5-20+ (depending on the state) c. Members are appointed by the state Governor for terms of 3-8 years in some cases, renewing terms is possible in some cases, term limits exist d. Members are usually volunteers. e. Licensing requirements vary by state: i. CME amount and type; amount of postgraduate training ii. special training; participation in ongoing; certification processes; types of background checks iii. any required special exams (i.e., board approved clinical competency exams; medical jurisprudence; OMT skills, etc.) f. Federation of State Medical Boards (FSMB) i. a nonprofit organization involved in assessment, policy, and credentialing related to licensure and promotes excellence in practice, licensure and regulation ii. Made up of all 71 of the licensing boards of the USA. iii. Deals with Professionalism, Health Policy, Education, Ethics, Finance, Audit, Bylaws, Advocacy, Data and Research, and other issues iv. Interstate licensure compact 1. mechanism for obtaining licensure in multiple states to meet urgent/emergent needs with specific, unique credentialing process, but under jurisdiction of each individual board. v. Primary source verification process III. List types of physician licenses in USA a. 71 licensing boards in the USA - governing all 50 states, DC, and US territories of Puerto Rico, Guam, USVI, American Samoa, and Northern Mariana Islands i. medical, osteopathic, and composite variations (Tennessee has both a medical and an osteopathic board) b. License = documentation of authority to practice medicine within a certain locality c. In legal sense, a medical school graduate must possess a medical license to practice before they can be called a physician. 10  d. In the USA, medical licensure is a function of and within the jurisdiction of the states. e. Each state has a licensing board and a Practice Act that codifies the practice of medicine in their area, creates the licensing board and sets standards and qualifications for physicians to practice medicine f. To protect the public g. All state licenses are for the i. general practice of medicine – (Requirements for initial and re-licensure vary among states) h. Types of licenses i. Full, unrestricted- some part of compact ii. Limited/ educational/institutional iii. Amended/restricted iv. Telemedicine; Special Permits; Administrative; Camp; etc. v. Physician Licensure Terms: 1-5 years usually i. Fees vary j. Application processes vary, BUT some common things: k. the application process is complex and takes up to 2-6 months if all goes well i. includes an extensive background check ii. completeness and accuracy, with truth, are expected and save time IV. Provide tips for interacting with licensing authorities a. Who is under TBOE jurisdiction? i. All DO Licensees 1. >2000 2. ~1200 in Tennessee (mailing address) 3. ~26 telemedicine licenses ii. ~ 67 Midwives iii. ~13 X-Ray Operators V. Review legal authority and structure of TBOE. a. 10th Amendment of US Constitution authorizes states to establish laws and regulations to protect health, welfare, and safety of their citizens. b. Practice of medicine is a privilege granted by the people of a state acting through elected representatives c. Created by legislative act in 1905 d. Responsible for safeguarding the health, safety and welfare of Tennesseans by requiring that all who practice osteopathic medicine within the state are qualified to do so. e. Rulemaking- promulgate rules which have force and effect of law (TCA 63-6-101,et.seq) f. Assessing Discipline VI. Outline primary duties of TBOE. a. Interprets laws, rules, and regulations to determine appropriate standards of practice to ensure the highest degree of professional conduct. b. Issues licenses to qualified candidates who have completed appropriate education and successfully completed required examinations. c. Investigates alleged violations of The Practice Act and rules. d. Disciplines licensees who are found to violate The Practice Act and other laws. e. Determines when professional conduct or the ability to practice medicine warrants modification, suspension, or revocation of licenses. f. Define/address specific issues i. Pain Medicine Specialist, Pain Clinic Medical Director ii. Addiction Specialist, Minimal Discipline for Opioid Prescribers 11  g. Attend conferences and participate in appropriate organizations h. Collaborate with other licensing authorities i. Communicate with FSMB Physicians Data Center; AOA; FSMB; Specialty Colleges; Licensing Boards; Licensure Compact j. Physician Discipline and Education k. Monitor relevant health policy/regulatory issues l. VII. Overview of TBOE routine activities a. Meet 4 times a year; other meetings if needed b. Meetings are public- can be viewed in real time or attended personally c. Review documents in interim d. Deal with disciplinary matters e. Investigate complaints f. Ratify licenses (initial, renewal, reinstatement) g. Promulgate rules – i.e., Telemedicine, collaborative practice, advise on law provisions, adopt policies and procedures h. Data collection and sharing i. Peer assistance to and rehabilitation for licensees j. Follow up on licensees who have been disciplined VIII. Discuss recent issues TBOE has dealt/is dealing with on behalf of DOs in Tennessee a. Clinical Guidelines for Management of Chronic Nonmalignant Pain b. Pain Clinic Certification and Pain Medicine Specialist c. Tennessee Pharmacist and Prescriber Collaborative Practice – rule making d. Continuing education: Drug Classification e. Registry and regulation of medical spas f. Scope of practice of mid-level, allied health and other practitioners g. Interstate Medical License Compact h. Addiction Specialist i. Minimal Discipline Standards j. Telemedicine k. Medical Marijuana l. Rules re: telemedicine, e-prescribing m. Rules re: prohibiting solicitation/marketing health services by licensees to people for health- related issues within 30 days of disaster/accident n. Collaborative, not supervisory, relationship between physicians and PAs/NPs; scope or practice “creep” o. Rules re: communicating with pt in case of ultrasound done before intentional termination of pregnancy p. Limitations on amount, frequency of opioids prescribed and/or dispensed. q. Physicians may accept goods and services as barter for care provided from patients without any health insurance r. Physicians treating family members, significant others, etc. Lecture 7 – Malpractice A. Negligence – the quality or state of being negligent; failure to exercise the care that a reasonability prudent person would exercise in the circumstances; an act or instance of being negligent a. Tort reform 12  B. Malpractice – a dereliction of professional duty or a failure to exercise an ordinary degree of professional skill or learning by one (such as a physician) rendering professional services which results in injury, loss, or damage; an injurous, negligent, or improper practice C. Existing evidence confirms that medical malpractice insurers benefit from tort reform, especially caps on noneconomic and total damages. D. Johns Hopkins Preventable Death Study a. The study estimates that “preventable adverse events using a weighted analysis described a range of 210,00 to 400,000 incidents per year associated with preventable medical errors among hospital patients, making this the third highest cause of death in the US Lecture 8 – HIPAA Again, no true lecture objectives. I. HIPAA overview A. What information is protected? → B. Protected health information includes any individual identifiers… i. Name ii. Any address specification (street, city, county, zip code, etc.) iii. All dates including birthdate, admission/discharge date, etc. iv. Telephone number v. Fax number vi. Email address vii. Social security number viii. Medical record number ix. Health plan beneficiary number x. Account number maintained by healthcare provider xi. Driver’s license number xii. License plate number xiii. Medical device identifier/serial number 13  xiv. Web address xv. IP address xvi. Fingerprints or other biometric identifier xvii. Full face photo xviii. Any other unique identifying number, characteristic or code C. Where is PHI? → D. How OCR enforces the HIPAA Privacy and Security rules i. Investigates complaints ii. Conduct compliance reviews to determine if covered entities are complying iii. Perform education and outreach to foster compliance with requirements E. Civil monetary penalties → F. Criminal penalties are enforced by the Department of Justice i. Being curious/ gossiping - $50k, 1 yr in jail ii. Lying to obtain info - $100k, 5 yrs in jail iii. Personal gain/ malicious harm - $250k, 10 yrs in jail II. Privacy A. Basic principal i. Define and limit the uses and disclosures of PHI B. Uses and disclosures only allowed as i. Permitted by the rule ii. Authorized by the individual in writing C. Authorization is NOT required for TPO i. Treatment ii. Payment iii. Healthcare operations iv. Examples 1. Sending records to another physician 2. Faxing clinic notes to an insurance company 3. Conducting an internal chart audit D. Authorized uses and disclosures i. Written authorization much be obtained for any use or disclosure of PHI that is not required for TPO, or, ii. Otherwise permitted or required E. Authorizations are required for i. Psychotherapy notes 1. Notes recorded by a mental health professional of a conversation during a counseling session 2. Separate from the rest of the patient’s medical record 3. Patient right of access a. Does not apply to psychotherapy notes b. At the discretion of the provider 4. Authorization required for disclosure, including treatment disclosures a. Must contain all required elements 14  b. May only be combined with another authorization for a use or disclosure of psychotherapy notes ii. Marketing iii. Sale of PHI iv. Substance abuse treatment records (separate consent required under 42 CFR part 2 – confidentiality of substance use disorder patient records) 1. Federally assisted programs 2. Provides diagnosis, treatment, or referral for treatment for SUD 3. Prohibited from disclosing information a. Must have written consent, even for treatment F. Incidental vs. Unlawful Disclosures i. Incidental disclosures of PHI as a result of permitted disclosures are not violations of HIPAA ii. Incidental disclosures 1. A conversation between a physician and a patient while in the exam room being overheard by another patient 2. A patient hears a nurse calling in a prescription for another patient while on the way to the exam room iii. Unlawful uses and disclosures 1. A conversation between a physician and a patient while in the exam room being overheard by another patient 2. A patient hears a nurse calling in a prescription for another patient while on the way to the exam room G. Communicating with others involved in the patient’s care (family, friends, or others involved in patient care or payment) i. If the patient is present and has the capacity to make health care decisions the provider may disclose relevant information if the provider does one of the following: 1. Obtains the patient's agreement 2. Gives the patient an opportunity to object and the patient does not object, or 3. Decides from the circumstances, based on professional judgment, that the patient does not object ii. If the patient is not present or is incapacitated the provider may disclose relevant information if, based on professional judgment, the disclosure is in the patient's best interest. H. Parent access to Minor Child’s PHI i. Typically, both parents have the authority to access and control their minor child’s PHI, unless a court order forbids access ii. EXCEPTION: When a minor can obtain a particular health service without parental consent under state or other applicable law, it is the minor, not the parent, who may exercise the privacy rights afforded to patients under this regulation iii. The Privacy Rule defers to state laws that require, permit or prohibit the covered entity to disclose a minor’s PHI to a parent III. Security A. Focus of the security rule i. Security Rule only focuses on electronic PHI (e-PHI) ii. Protect the confidentiality, integrity, and availability of all e-PHI that is created, received, maintained, or transmitted iii. Required Risk Analysis and the establishment of administrative, physical and technical safeguards B. General tips for securing e-PHI i. Log off when device is left unattended 15  ii. Keep login/password info confidential iii. Avoid storing e-PHI on mobile devices that are not encrypted (phones, laptops, tables, USBs) iv. Do not upload e-PHI to cloud-based storage without checking with the compliance officer v. Be on the lookout for phishing emails or other potential threats (suspicious links, attachments) C. Communicating electronically i. Email/text messaging is not specifically prohibited by HIPAA ii. However, HIPAA requires appropriate physical, administrative and technical safeguards for all PHI iii. Any device used to store, transmit or receive PHI must be included in Security Risk Analysis (laptops, smartphones, tablets, USB drives, external hard drives) D. Email & PHI i. Encrypted = secure email ii. Beware of free email 1. Typically, not "secure" 2. Never use personal email to transmit PHI iii. Email provider may be business associate E. Text messages & PHI i. Problems with texting 1. No authentication (required by security rule) a. Is the intended recipient the only one who receives the message? b. Did you text the right person/number? 2. Unauthorized access a. Is the device shared with family members? b. Does the device have a passcode? ii. Joint commission says no texting orders iii. Alternatives to texting 1. Patient portal 2. Encrypted email 3. Secure messaging applications 4. CPOE (computerized provider order entry) F. Social media HIPAA issues i. Comments about patients, even if you don’t name them ii. Pictures of patients posted on social media, without authorization iii. Conversations with patients about their care, even in a “private” inbox message iv. Business associate relationship IV. Breach Notification A. Unauthorized access, use, or disclosure of PHI considered a Breach unless “a low probability of the information being compromised” is proven B. Notification process → V. HIPAA violations A. Lecture lists a couple examples Lecture 9 – Federal Regulations and Duty to Report I. Identify the elements of the Emergency Medical Treatment and Active Labor Act (EMTALA) A. Emergency Medical Treatment and Active Labor Act (EMTALA) (1986) 16  B. Applies to providers who: i. Provide Treatment at a Hospital ii. Work or cover call in an ER C. Requires i. Emergency Screening Exam ii. Stabilizing Treatment for Emergency Conditions iii. Hospital must accept transfer of unstable patient iv. Cannot delay or condition treatment on ability to pay D. Other Requirements: On-call list, Log of patients who come to Hospital, required signage at point of care E. Does NOT apply to: i. Preventative Care (e.g. immunizations, flu shots, etc) ii. Requests for non-emergency test (e.g. BP, X-ray, MRI) iii. Gathering Evidence (e.g. BAC Text) iv. Prescheduled Appointments by Physician F. No emergency medical condition → EMTALA ends G. Medical Screening Exam: i. performed by qualified medical personnel (“QMP”). 1. Identified in documents approved by governing body 2. Competent to perform exam. 3. Privileged to perform exam. ii. Applied in non-discriminatory manner. 1. Does not differ based on payment status, condition, race, national origin, disability, etc. iii. Sufficient to allow reasonable determination of whether emergency condition exists 1. Dependent on clinical presentation, facility capabilities, and staffing II. Understand the policy behind the Stark Law A. Passed in two phases: Stark I (1992) & Stark II (1993) B. Named after sponsor - Congressman Pete Stark C. Governs the practice of physician self-referral for Medicare and Medicaid patients D. Except in limited cases, self-referral is prohibited E. Policy behind the law – Self-referral creates a conflict of interest, tendency to over-refer (driving up healthcare costs), and limits competition with a captive referral system. F. Prohibits financial relationship between physician or immediate family members and the entity to which referral is being made i. Ownership ii. Investment iii. Structured Compensation Arrangement G. Exceptions i. Fair Market Value Rental Office Space Bona fide employment ii. Personal Service Arrangement Physician recruitment Isolated transactions iii. Non-monetary compensation Medical staff incidental benefits In-office ancillary services iv. Temporary non-compliance Grace period for signature Value Based Arrangements v. DHS compensation up to $5K Donation of tech and services for cybersecurity vi. per year H. Penalties i. Denial of payment for services ii. Refund of monies received 17  iii. Civil penalties of up to $15,000 for each service that a person “knows or should have known” was a violation iv. Treble the amount paid by Medicare v. Exclusion from Medicare program and state healthcare programs including Medicaid vi. Up to $100,000 for each “scheme” to circumvent the law III. Assess the value of the protective effects of the Genetic Information Nondiscrimination Act (GINA) A. Passed in 2008, primarily aimed at employers and health insurance companies to prevent discrimination based upon genetic markers. B. Employers: Prohibited from using genetic information in the hiring, firing, job placement, or promotion of employees C. Health Insurance companies: Prohibited from charging higher premiums to individuals based upon genetic disposition. D. Providers need to be aware that this information is off limits. The following is deemed confidential information: genetic tests of individual or family members, manifestation of a disease or disorder in family members, inclusion of a patient in genetic services and participation in genetic research. It does not include information about the age and sex of individuals. IV. Summarize the categories and requirements for mandatory reporting as a physician. A. Child abuse i. Tenn. Code Ann. § 37-1-403(a) - State law that requires anyone who is called upon to render aid to a child who has suffered injury (mental or physical) that reasonably indicates it has been caused by brutality, abuse or neglect, to immediately report to protective services. Concurrent federal law if the diagnosis is made at a federal facility. 34 U.S.C. § 20341. ii. Tenn. Code Ann. § 37-1-403(f) - Any physician who makes a diagnosis of, or treats, or prescribes for any sexually transmitted disease in children thirteen (13) years or younger must report that to the department of health. iii. Immunity if you did it as part of examining the child or asked to render a second opinion or you have special training or experience. Tenn. Code Ann. § 37-1-410. iv. Failure to report is a crime – Class A misdemeanor. Tenn. Code Ann. § 37-1-412. B. Child sexual abuse i. Tenn. Code Ann. § 37-1-605. If you know or have reason to believe a child has been sexually abused, must report it to the Department, local law officers, or judge of the local Juvenile Court. ii. Immune from civil or criminal liability if acting in good faith. Tenn. Code Ann. § 37-1-613. iii. If you fail to report or prevent another from doing so, it is a crime. Class A misdemeanor. Tenn. Code Ann. § 37-1-615 iv. If called upon to testify or give report in a child sexual abuse case, you can’t rely upon physician/patient or any other type of privilege to avoid testifying. Tenn. Code Ann. § 37-1-614. C. Suspected victim i. f rendering aid to person injured by deadly weapon (or other means of violence) or by poison, exposure to meth lab, or appears to be victim of mutilation of female genitalia shall report immediately to chief of police or sheriff and the district attorney. ii. Exception – You do not report if the person being treated for injury (unless life threatening) is: 1. 18 years of age or older 2. Objects to the disclosure; and 3. is a victim of sexual assault or domestic abuse iii. EMT reporting to physician are not subject to this exception. iv. Immunity from civil liability for acting in good faith. D. Public health i. Mandatory Reporting of Colleagues 1. American Medical Association Code of Medical Ethics Opinion 9.031 18  ii. “Physicians have an ethical obligation to report impaired, incompetent, and/or unethical colleagues in accordance with the legal requirements in each state and assisted by [these] guidelines.” 1. Impairment 2. Incompetence 3. Unethical Conduct 4. Unethical Conduct that threatens patient care or welfare 5. Inappropriate Behavior iii. Mostly state and local laws 1. Report if abuse and neglect in surgery centers 2. Reporting on diagnosis of STDs 3. Mandatory reporting of abortions 4. Creation of birth defects registry 5. Reporting of hospital acquired infectious diseases iv. COVID 19 / Coronavirus Aid, Relief and Economic Security Act (“CARES”) (2020) 1. All labs / testing sites must report data for “all diagnostic and screening testing completed, which includes molecular, antigen and antibody testing, for each individual tested...” provides exception to HIPAA 2. Also, under OSHA, an “employer” is required to record and report cases of COVID19 that they become aware of for employees in the workplace E. Code of ethics i. Ethical obligation of physicians to take appropriate action to avert harms caused by violence and abuse. Physicians obligated to: 1. familiarize themselves with state and federal laws on reporting violence and abuse; 2. discuss sensitive issues of abuse with patient and direct them to resources; 3. inform patients about requirements to report (obtain consent if possible); 4. disclose minimal amount necessary. F. Patient privacy i. What is included in patient privacy: 1. Personal space 2. Personal data 3. Personal choices (including cultural and religious affiliations) 4. Personal relationships (family members and other intimates) G. Confidentiality i. Patients generally are entitled to decide whether and to whom their personal health information is disclosed except where disclosure is to: 1. Healthcare personnel for the purpose of providing care; 2. When required by law; 3. To others to mitigate threat when physician believes there is a reasonable probability that: a. The patient will seriously harm him/herself; b. The patient will inflict serious harm on an identifiable individual or individuals. H. Civil litigation i. Weighing need for evidence versus right of privacy. ii. Courts can order disclosure of otherwise protected health information: 1. If a party to litigation, party has put health at issue and Court need only find relevancy. 2. If a non-party, Court must find compelling justification to overcome the privacy interests. Johnson v. Nissan N. Am., 146 S.W.3d 600, 605 (Tenn. Ct. App. 2004). 19  I. Policy considerations i. State Objectives: 1. Protecting abuse survivors 2. Holding abusers accountable 3. Identifying crime/criminals 4. Maintaining order 5. Protecting public health ii. Contrary considerations 1. May increase distrust in health care providers 2. It may deter victims for seeking medical attention 3. Fearful of retaliation from abuser 4. Interferes with basic tenants of confidentiality and medical autonomy Lecture 10 – Research Ethics I. List the two government agencies in the United States that regulate human subjects research A. U.S. Department of Health and Human Services (HHS) B. U.S. Food and Drug Administration (FDA) C. Many of the regulations of the two agencies overlap, but the FDA has also developed regulations covering investigational medical devices, drugs, and biologics. II. Define “informed consent” and explain how one can confirm if a potential study participant is capable of giving informed consent A. Recruitment of participants B. Providing detailed information about the study and answering any questions that subjects may ask in a way that is understandable and giving them adequate time to make the decision of whether or not to participate. C. Obtaining voluntary participation from the participants. Even if they agree to participate, they must be allowed to withdraw from the study at any time. D. New information must be shared with the participants, even after the study ends. E. A statement explaining that this is a research study, purpose of the research, expected duration, types of procedures, and disclosure of any experimental procedures F. Description of any potential risks or discomforts for the participant G. Description of any benefits to participant H. Disclosure of any alternative procedures I. Statement describing confidentiality of records J. Explanation of any compensation that may be given or medical treatment that may be provided to participants K. Information about who to contact if the participant has questions or if the participant experiences a research-related injury L. Consent forms should also be easy to understand, using simple language, short sentences and paragraphs, and avoid abbreviations and jargon (no higher than 8 th grade reading level) M. Several tests have been developed in order to determine if a potential participant is capable of giving informed consent N. However, these tests are time-consuming and require trained personnel to administer O. It has been determined that the best method for identifying the capacity to provide informed consent is the teach-back method i. The researcher asks the participant to paraphrase the study and/or reiterate the important elements, and then the researcher provides corrective feedback. ii. If the participant does not clearly understand the study after several iterations of the teach- back method, then they should not be enrolled in the study 20  P. Under some circumstances, the requirement for informed consent may be waived (must be approved by Institutional Review Board, or IRB): i. Government projects, if they are conducted by the state or local government and are meant to evaluate: 1. A program that benefits the public 2. Procedures for such programs 3. Alternatives to those programs 4. Changes in payment methods or levels of service 5. Research that could not practicably be carried out without the waiver ii. General waivers and alterations 1. Research involves no more than minimal risk 2. Waiver will not adversely affect the rights and welfare of participants 3. Research could not practicably be carried out without the waiver 4. Participants will be provided with pertinent information after participation III. Give specific examples of vulnerable populations A. Individuals who are members of a vulnerable population require special considerations if they are to be participants in a study. B. If the individual has difficulty providing voluntary, informed consent due to limitations in decision- making capacity, situational circumstances, or they are especially at risk for exploitation C. Categories of vulnerability: i. Cognitive or Communicative vulnerability ii. Institutional vulnerability iii. Deferential vulnerability iv. Medical vulnerability v. Economic vulnerability vi. Social vulnerability D. Specific examples of vulnerable populations: i. Pregnant women ii. Human fetuses iii. Neonates iv. Prisoners v. Children vi. Individuals with physical disabilities vii. Individuals with mental disabilities or cognitive impairments viii. Economically disadvantaged ix. Socially disadvantaged x. Terminally ill or very sick xi. Racial or ethnic minorities xii. Institutionalized persons (correctional facilities, nursing homes, mental health facilities) IV. Explain the IRB’s role in the review of human subjects research A. For studies in which children are subjects, permission may be needed from two different parties: i. Consent from the parents (for any child that has not reached the age of majority) ii. Assent (affirmative agreement) from the child 1. There is no official guideline for the age at which assent is required, but seven years of age has been suggested as the cut-off 2. However, this is dependent on the maturity of the individual child and this requirement is therefore typically determined by the IRB B. HIPAA compliance for research activities can be assessed by either the IRB or, if applicable, a separate Privacy Board. 21  i. HIPAA generally requires written consent from the data subject for research use of the individual’s protected health information (PHI). ii. However, fully de-identified data may be used without any authorization from individual data subjects. C. The institutional review board (IRB) is a review committee established to help protect the rights and welfare of human research subjects D. Any and all research studies involving human subjects must be reviewed and approved by the IRB prior to their initiation E. Research is defined as “a systematic investigation designed to develop or contribute to generalizable knowledge.” F. Federal regulations give the IRB the authority to: i. Approve research ii. Disapprove research iii. Modify research iv. Conduct continuing reviews v. Observe/verify changes vi. Suspend or terminate approval vii. Observe the consent process and research procedures G. Three categories for IRB review: i. If the research does not involve more than “minimal risk,” the IRB will consider the study as either exempt or expedited 1. The Chair of the IRB committee alone is authorized to approve studies falling under these categories H. If the IRB determines that there is more than “minimal risk” involved, a full committee review is required I. There are various consequences for not following IRB regulations... suspension, loss of licenses, termination of employment. Etc. V. Define “minimal risk” as it relates to human subjects research A. “Minimal risk” is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” Lecture 11-14 – Medical Ethics/Bioethics I-IV I. Provide overview of classical philosophical influences on the foundations of modern medical bioethics and of the rationale for learning the fundamentals of bioethics practice. A. Subjective paths to reach conclusions i. Each person has a unique set of experiences and influences that guide personal values ii. Influences of socioeconomic conditions, family, friends, geography, culture, heritage, religion, etc. iii. Bioethics: deals with ethical implications of biological research and applications in medicine B. Process varies among people C. Ethics vs conscience i. Ethics is morally based, guided by society ii. Conscience is one person’s thoughts about beliefs and actions iii. Bioethics/medical ethics is also influenced by practice standards, state and federal law, and “best practice” guidelines. D. Fundamental concepts 22  i. Ethics is not morality- it is based on values and reasoning, uses persuasion to get message across; morality involves adhering to a specific belief system or coder of conduct. ii. Morality relies on an authority to justify its message- could be religious, political, personal; ethics has a flexible set of solutions based on logic and facts. iii. Ethical decisions should respect values and attitudes of patients, but this can cause conflict if patient is overridden. E. Confucius (500’s BC) i. Memorializing the dead ii. Courage is doing the right thing iii. Rise up after failure F. Socrates (400’s BC) i. Inductive reasoning → critical thinking that moves from specific details to generalities ii. Teach and learn by asking questions and reflect in a deeper, more meaningful way iii. Encourage open discussion II. Describe the elements of and errors involved in ethical reasoning A. Every position taken should be based on good reasons, justifying the position B. Reasons given must be: i. Relevant to the position ii. Provide evidence for a position iii. Support a conclusion as an argument, a justified conclusion iv. Logical: distinguishing truth from falsehood and valid – connecting premises and conclusions v. Principle based – based in recognized ethical principle/concept vi. Consistent – not contradictory, not making personal exceptions C. Components of ethical reasoning i. Universalization – what anyone should do in like circumstances ii. Impartiality – treating everyone the same iii. No double standards iv. Onus of proof is on those who vary from this v. Reasonableness – being open to other viewpoints, fair minded (trying to see the best in the reasoning of others) and being willing to admit problems with one’s own position, to be willing to change one’s mind. vi. Civility – rational and fair argument without attacking D. Errors in ethical reasoning i. Slippery Slope 1. A small change in status quo will lead to terrible results, no place to “draw the line” ii. Ad Hominem – (“To the man”) 1. Personal attack on an individual position usually without considering all the facts or reasons for a position iii. Tu quoque (“You, too”) 1. Two wrongs make a right iv. Straw Man/Red Herring 1. Focusing on a different, irrelevant issue than the original one because the different one is easier to oppose 2. Distracting from the real argument by raising irrelevant, but associated, issues v. Post hoc, Ergo Propter Hoc (“After this, therefore, because of this”) 1. Just because one thing happened before another doesn’t mean the first one caused the second one 2. Supposed causal links are specified 23  vi. Appeal to Authority 1. Reasons and arguments justify a position, not just any authority 2. Authority cited must be relevant to the topic in question vii. Appeals to Feelings and Upbringing 1. How someone feels about something or what they were brought up to believe doesn’t count as a reason for it 2. Reasons justify ethical positions, not feelings or upbringing viii. Ad Populum (“Everybody does it”) 1. Just because something is popular doesn’t make it ethical ix. False Dichotomy (“Either – Or”) 1. Issues considered to be one of two extremes, opposed alternatives with nothing in between x. Equivocation 1. Clarify Key terms and avoid many meanings for a term xi. “Begging” the Question (Assuring without proof) 1. When a conclusion that requires good reasons is assumed without argument III. Review the fundamental principles and concepts and contextual history of bioethics 4 fundamental principles: A. Autonomy – the right to make decisions about one’s own body and life without coercion by others. People should be able to make their own medical decisions as long as their decisions don’t harm others. Respect patient’s decisions about their own health as long as they are competent to do so. B. Beneficence – “helping others”; basis for compassion; includes self-sacrifice. Promote the patient’s best interests, doing good for the patient. i. May conflict with autonomy ii. Calculated risks are ok if potential benefits outweigh potential risks C. Non-maleficence/nonmalfeasance – not harming others; “First, do no harm.” Prohibits corruption, incompetence, nontherapeutic or dangerous experiments. Do only what you’re technically competent to do; get consent for treatment D. Justice – treating people in a similar manner, impartially and without regard to gender, race, sexuality, culture, wealth; medical benefits are distributed fairly without discrimination. Restriction of resources never on an individual basis. This is an administrative health policy issue Classical ethical theories: E. Moral Relativism i. No universal truths exist across cultures ii. What is right and wrong must be defined in each society 1. Flaws: doesn’t consider outside viewpoints F. Utilitarianism (Jeremy Bentham and John Stuart Mill) i. Right acts produce the greatest amount of good for the greatest number of people “utility” ii. 4 basic tenets: 1. Consequentialism – consequences count, not intention or motives 2. Maximization – the more people affected, the more important the result 3. Theory of Value (“good”) – harmful vs. good consequences 4. Scope-of-morality premise – each person’s happiness counts iii. Flaws: trolley problem, triage – allocation of scarce resources 1. Abandon those who will die anyway and those who will live anyway 2. Help only those “on the edge” 3. Save maximal lives 4. Violation of sanctity of life of one to save many G. Kantian Ethics (18th Century) 24  i. Ethics is not a matter of consequences, but of duty 1. Only one correct motive – to be a good person, do what is right, have a “pure will” 2. Duty is celebrated (deontological) because it emphasizes acting from obligation, not having the right desires/feelings 3. Only good will is valuable ii. A right act has a maxim that is universalizable – something is right only if one can will its maxim/rule to be acted on by all others iii. A right act always treats other humans as “ends-in-themselves” 1. All must be treated as having absolute, infinite worth, not relative worth 2. Someone’s welfare can’t be sacrificed for the good of others iv. People are free only when they act rationally 1. We act morally when we understand why certain rules are right and freely choose to correct our actions to those rules, not because we’re used to doing something or because it feels right v. Flaws: 1. Doesn’t tell how to resolve conflicts with competing maxims/ rules 2. Treating each person as if they have infinite value is not always practical or how to deal with “trade-offs” 3. But – Kant’s ethics grounds the outrage over “ends-in-themselves” human experimentation and informed consent requirements for participants in research IV. Outline a scheme for analyzing cases in bioethics A. Medical Indications i. Grounded in beneficence and nonmaleficence ii. What is the medical problem? History? Diagnosis? Prognosis? iii. Is the problem acute, chronic, critical, emergent, reversible? iv. What are the appropriate diagnostic and therapeutic interactions? v. What are the treatment goals? vi. What is the probability of success? vii. What is the plan if treatment fails? viii. How can the patient be benefitted by medical and/or nursing care and how can harm be avoided? (Risks, benefits, probable outcomes) B. Patient Preferences i. Grounded in respect for autonomy ii. Is the patient mentally capable and legally competent? Is there evidence of incapacity? iii. If competent with capacity, what does the patient state about treatment preferences? What does the patient want and what are their goals? iv. Has the patient been informed about benefits and risks, understand the information and given consent? v. Has the patient been given sufficient information? Do they comprehend? Do they understand inherent uncertainties in the situation and the options available? Are they being coerced? vi. If incapacitated/without capacity, who is the appropriate surrogate? Is the surrogate using appropriate standards for making decisions? vii. Has the patient expressed prior preferences? (Advanced Directive, etc.) viii. Is the patient unable or unwilling to cooperate with treatment? If so, why? ix. Is the patient’s right to choose being respected to the extent reasonable/possible in ethics and law? C. Quality of Life i. Grounded in beneficence, nonmaleficence, and respect for autonomy 25  ii. What are the prospects, with and without treatment, for a return to “normal”, premorbid life? iii. What physical, mental, or social deficits is the patient likely to experience if treatment succeeds? iv. Are there any biases that might prejudice the provider’s evaluation of the patient’s quality of life? v. Is the patient’s present or future condition such that their continued life might be judged undesirable? vi. Is there any plan and rationale to forego treatment? vii. Are there plans for comfort and palliative care? D. Contextual Features – social, economic, legal, administrative i. Grounded in principles of loyalty and fairness ii. Are there family or other issues that might influence treatment decisions? iii. Are there provider issues that might influence treatment decisions? iv. Are there financial or economic factors? v. Are there religious or cultural factors? vi. Are there limits on confidentiality? vii. Are there problems of allocation of resources? viii. How does the law affect treatments? ix. Is clinical research involved? x. Is there conflict of interest on the part of providers, institution, or others involved with the case? E. Interpret and assess the case in light of ethical principles and these elements V. Describe and define many of the fundamental bioethical concepts of capacity, competence, advanced planning, informed consent, confidentiality, euthanasia and physician assisted suicide, futile care, terminal sedation, reproductive issues, organ/tissue donation, HIV/AIDS related issues, forbidden activities, experimentation, doctor-patient relationship, and mandatory reporting. A. Capacity – usually determined by physician i. Capacity is the mental ability to make informed decisions about one’s own health; patient is assumed to have this until substantial proof otherwise. ii. Capacitated people must be able to understand and retain information given to them and use the information to make an informed decision and communicate that decision to their providers iii. Decision must be in line with previously held beliefs and not the result of psychiatric symptoms (such as delusions or hallucinations) iv. Incapacity can be caused by some psychiatric or neurologic disorders, lack of consciousness, developmental disorders, severe pain, drugs or alcohol, and age v. Family member concern is not enough to deem incapacity B. An incapacitated patient… i. Cannot give informed consent ii. Informed consent must still occur, with transfer to someone else iii. Family member, friend, social worker or POA iv. Physicians and other providers cannot make informed consent decisions v. Informed consent must be given: vi. Via advance directive or will, when patient decides in advance what they want or don’t want-this is first priority vii. Via surrogate/proxy – identified in advance by patient before incapacity via medical power of attorney viii. If no medical POA, then via family member (spouse, adult children, parents) 26  ix. All patient representatives should choose what they think the patient would want if they could speak for themselves, not what they want for the patient C. Advanced directives i. Patient communicates wishes for health care in advance of being unable to make decisions for themselves. ii. Living will: should be as specific as possible. iii. Health care proxy/Power of Attorney: limited to health care; over-rules all other decision makers; proxy must carry out wishes of the patient (oral or written). iv. If no advance directive: spouse, parents, adult children, siblings, friends, in that order usually D. Decisional capacity i. Ability to comprehend, evaluate, and choose among realistic options ii. A clinical judgement, not legal iii. Engage patient in conversation, observe their behavior and talk with 3rd parties who know them; ensure they’re not severely depressed as underlying issue. iv. If too quick in agreeing with recommendations, understanding may be compromised v. Not determined by global psychiatric diagnosis. Many people with mental illness can make reasonable decisions about medical choices. vi. Stringency of criteria for capacity maybe should vary with seriousness of situation and urgency for treatment. Low standards may apply to something with highly likely benefits and low risk and higher standards may be needed for higher risk, less benefit situations E. Competence – a legal term i. Determined by a judge/court of law ii. People are assumed competent until there is substantial proof demonstrating otherwise iii. Incompetence must be determined only after a thorough examination iv. Does patient have the legal authority to make personal choices? Is usually a legal issue v. In medicine, decisional incapacity is when legally competent people have mental capacity compromised by illness, pain, anxiety, hospitalization, being comatose, delusional, unconscious, disoriented may interfere with decisional capacity. F. Minors and capacity i. Minors are usually those under age 18 ii. Minors do not have the capacity to make medical decisions iii. Parents or their properly specified designee give consent for medical treatment and most rules of confidentiality do not apply to minors iv. Exception: emancipated minors v. Emancipation is process where a minor obtains the right to make their own medical decisions 1. File legally to become officially emancipated 2. Minors who can document they are on their own and are self-supporting 3. Married 4. Have children of their own 5. Pregnant 6. In these cases, the minor will be treated as an adult in medical situations vi. Minors right to confidentiality 1. No need for parental consent for: a. S – Contraception, pregnancy treatment, treatment of STD/STI, the fact that the patient is sexually active b. D – Alcohol or other substance use issues, or medical situations resulting from this 27  c. R&R – Emergencies in which parent can’t be contacted in time to provide needed care. 2. Abortion a. Parental advance notification may be required, even if consent is not (varies by state) b. Parental permission may be required in some states; this requires informed consent from the parent/guardian G. Informed consent i. Practical application of respect for the patient’s autonomy ii. The process of describing different treatment options to the patient and then asking their permission to move ahead with the chosen plan. The person most knowledgeable about a procedure or course of action should obtain informed consent. iii. For informed consent to be valid, the patient must: 1. Be given all relevant information about proposed treatment based on best clinical judgement before making a decision 2. Be advised of potential benefits, risk, negative outcomes possible, cost, alternative treatment options including that of no treatment, and prognosis 3. Understand the information provided and express their preferences 4. Not be coerced or pressured by anyone – best discussed in private 5. Must be documented iv. Telephone consent 1. Valid if obtained by family member, health care proxy, or other valid surrogate decision maker. 2. Equal to oral advanced directive 3. Harder to prove if contested. 4. Verify: a. Is the person you’re speaking to really the acceptable surrogate? b. Does the person know the patient’s wishes? c. Did you have someone witness the consent? v. Consent issues 1. Patients who are unconscious or otherwise incapacitated in an emergency are assumed to provide consent 2. Physicians provide needed care until the patient becomes competent/regains consciousness or family/proxy can be contacted 3. To avoid preventable complications: a. Avoid technical language b. Be aware of and address patient anxiety, inattention, fear, limited understanding c. Note selective hearing caused by fear, denial, or preoccupation with illness d. Allow enough time for this communication to occur 4. Pregnant women can refuse care. 5. Decisions are based on maternal wishes. Mother’s autonomy over her body supersedes the rights of the fetus or the father. The fetus has no “intrinsic” rights. 6. A mom who has delivered a child can refuse care for herself but the child can receive treatment without parental consent. 7. Never Competent Patient: best to get parental or guardian consent, or 3rd party court designee; best option is an advanced directive, health care proxy, or DPOA. H. Treatment decisions 28  i. Patients or their proxies have the right to reject any offered or ongoing treatment plan at any time and for any reason ii. Competent patients can refuse one treatment option without refusing all options iii. Patient’s refusal of treatment does not constitute physician abandonment of the patient. Physicians still must do all they can for patients except what they’ve chosen to not accept. iv. Refusal of medical care is not “suicide” and is not automatically considered grounds for deeming a patient incapacitated. I. Physician assisted suicide i. Only legal in a few states and even then is rare ii. Physicians cannot administer medications; patient must self-administer iii. Includes giving excessive doses of medication, such as pain meds iv. Does not include medically appropriate dosage of pain medication provided patient or designee is given information about possible side effects v. Patient can always refuse food and water and die of dehydration vi. Patients sustained on a machine can still refuse care and request treatment be stopped vii. Considered wrong always on COMLEX-USA and USMLE. J. Euthanasia: providing or administering the method of death. Illegal in the USA, even if the patient is pre-terminal. Not ethically acceptable in any circumstances. K. Terminal sedation/Law of Double Effect: Issue is intent; main ethical duty is to relieve suffering. L. Futile Care: no obligation to do tests or treatment that will not benefit the patient even if the family demands it. M. Confidentiality i. Rules and procedures that limit sharing information with anyone outside the medical team ii. Increases trust between patient and physician while increasing the amount and quality of information received iii. Prevents harm to patients by having personal information released to people they don’t want to have it. iv. Applies to family members unless permission is given in private that information can be given. Do not ask patients in front of family if you can talk to family – that is coercive and may result in incorrect answer v. Avoid speaking about patients in public places vi. Make sure medical records are secure vii. HIPAA – confidentiality mandated by state and federal law viii. Require reasonable efforts to limit use and disclosure of individually identifiable information ix. Allows information sharing among caregivers, for consultations and care coordination. x. Records can be released if subpoena or court ordered search warrant. xi. Must be broken in cases of: xii. Reportable diseases – many infectious diseases(HIV, TB,measles,mumps,rubella,pertussis) , cancer, sexually transmitted diseases (HIV/AIDS, syphilis, gonorrhea, etc.); contact tracing informs re: exposure risk xiii. Adverse medical events – medical errors xiv. Severe cases of violence xv. All gunshot and knife wounds (also to police) xvi. Child or vulnerable adult/elder abuse or neglect, even if suspected – know signs of abuse and of neglect xvii. Stated/demonstrated intent to harm someone xviii. NOT: intimate partner violence, provided not life-threatening and not caused by firearm. N. HIV and TB related issues 29  i. Separate consent required for HIV testing and for sharing its results. ii. Cannot compel testing of pregnant women; should offer to all pregnant women; cannot mandate use of retrovirals iii. Partners: get patient to discuss first, optimally; if they refuse, Dept. of Health can begin contact tracing. The physician is legally protected if they contact the partner. iv. TB: contact tracing can be done to do PPD testing by health department. v. TB patients can be incarcerated in a hospital setting if positive acid-fast bacilli in sputum or if they refuse treatment O. Doctor-patient relationship/ experimentation i. NO obligation to see or treat a patient except in the ED. ii. Small gifts are ok if no expectation of different or higher degree of care as a result of the gift. iii. Gifts from pharmaceutical industry are always considered unethical and often are illegal. iv. Sexual contact between physician and patient is always inappropriate. v. Complex process exists to end DPR- cannot be sudden, must give “reasonable” notice in writing, must care for patient until patient finds alternative care or deadline occurs. vi. Experimentation: subject must be fully informed of risks and benefits, participation must be voluntary; prisoners have same rights as other patients; IRB must be involved; studies must seek to answer valid questions. Disclose sources of financial support- possible bias? P. Mandatory reporting and forbidden activities i. Child abuse ii. Torture iii. Elder abuse iv. Executions v. Gunshot wounds vi. Physician behavior that affects patient care vii. Impaired drivers: varies among states viii. Visual impairment ix. Error of colleague: Discuss, confer, try to reach consensus with evidence- based medicine, local higher authority; not licensing board, payer, etc. Q. Reproductive issues i. Abortion: no compulsion/ethical mandates to perform if ethically unacceptable to physician. Adult patient has the right to have one,